SUPPORT for Patients and Communities Act

Bill: 115-hr-6
Sponsor: full_name: Rep. Walden, Greg [R-OR-2]
Introduced: 2018-06-13
Policy area: Health
Subjects: Administrative law and regulatory procedures

Administrative remedies

Adoption and foster care

Alaska Natives and Hawaiians

Child health

Congressional oversight

Correctional facilities and imprisonment

Criminal investigation, prosecution, interrogation

Department of Health and Human Services

Digestive and metabolic diseases

Drug safety, medical device, and laboratory regulation

Drug therapy

Drug trafficking and controlled substances

Drug, alcohol, tobacco use

Food and Drug Administration (FDA)

Fraud offenses and financial crimes

Government information and archives

Government studies and investigations

Hazardous wastes and toxic substances

Health care costs and insurance

Health care coverage and access

Health care quality

Health facilities and institutions

Health information and medical records

Health personnel

Health programs administration and funding

Health promotion and preventive care

Health technology, devices, supplies

Home and outpatient care

Indian social and development programs

Juvenile crime and gang violence

Licensing and registrations

Medicaid

Medical research

Medical tests and diagnostic methods

Medicare

Mental health

Minority health

Prescription drugs

Public participation and lobbying

Retail and wholesale trades

Right of privacy

Rural conditions and development

State and local government operations

Surgery and anesthesia

Women's health
Latest action: action_date: 2018-10-24
text: Became Public Law No: 115-271.

Summaries:
action_date: 2018-06-13
action_desc: Introduced in House
text: <p><b>Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act</b></p> <p>This bill makes several changes to state Medicaid programs to address opioid and substance use disorders. Specifically, the bill:</p> <ul> <li>modifies provisions related to coverage for juvenile inmates and former foster care youth,</li> <li>establishes a demonstration project to increase provider treatment capacity for substance use disorders,</li> <li>requires the establishment of drug management programs for at-risk beneficiaries,</li> <li>establishes drug review and utilization requirements, </li> <li>extends the enhanced federal matching rate for expenditures regarding substance use disorder health home services, and</li> <li>temporarily requires coverage of medication-assisted treatment.</li> </ul> <p>The bill also alters Medicare requirements to address opioid use. Specifically, the bill:</p> <ul> <li> exempts substance use disorder telehealth services from specified requirements,</li> <li>requires the initial examination for new enrollees to include an opioid use disorder screening,</li> <li>modifies provisions regarding electronic prescriptions and post-surgical pain management,</li> <li>requires prescription drug plan sponsors to establish drug management programs for at-risk beneficiaries, and</li> <li>requires coverage for services provided by certified opioid treatment programs.</li> </ul> <p> The bill also addresses other opioid-related issues. Specifically, the bill:</p> <ul> <li>establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids, and </li> <li>increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).</li> </ul> <p> Additionally, the bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.</p>

action_date: 2018-06-22
action_desc: Passed House amended
text: <p><b>Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act </b></p> <p>TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS</p> <p>(Sec. 1001) The bill prohibits termination of Medicaid eligibility for juveniles who are inmates of public institutions. </p> <p>(Sec. 1003) The Centers for Medicare &amp; Medicaid Services (CMS) must establish a demonstration project to increase provider treatment capacity for substance-use disorders. </p> <p>(Sec. 1004) State Medicaid programs must establish drug management programs and drug-review and utilization requirements for at-risk beneficiaries.</p> <p>(Sec. 1007) The bill extends the enhanced federal matching rate for expenditures regarding substance-use disorder health-home services under Medicaid.</p> <p>The bill also temporarily requires coverage of medication-assisted treatment under Medicaid.</p> <p>TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS</p> <p>(Sec. 2001) The bill exempts substance-use disorder telehealth services from specified requirements, such as geographic restrictions, under Medicare.</p> <p>(Sec. 2003) The initial examination for new Medicare enrollees must include an opioid-use disorder screening and prescription history review.</p> <p>(Sec. 2004) The bill temporarily freezes Medicare payment at 2016 levels for specified spinal surgery outpatient procedures that are conducted in ambulatory surgical centers. </p> <p>(Sec. 2005) In general, prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs. </p> <p>(Sec. 2006) Medicare prescription drug plan sponsors must establish drug-management programs for at-risk beneficiaries.</p> <p>(Sec. 2007) The bill also requires coverage for services provided by certified opioid-treatment programs under Medicare.</p> <p>TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS</p> <p>(Sec. 3002) The bill establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids, including a new grant program for public health laboratories and a pilot program for point-of-use drug testing. </p> <p>(Sec. 3003) The bill increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).</p> <p>(Sec. 3007)&nbsp;The Department of Health and Human Services&nbsp;(HHS) must survey entities that receive federal funds for substance-use disorder treatment services; the scope of the survey must include the types of services provided, the populations served, and the adequacy of services. </p> <p>TITLE IV--OFFSETS </p> <p>(Sec. 4001) The bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.</p> <p>TITLE V--OTHER MEDICAID PROVISIONS</p> <p>Subtitle A--Mandatory Reporting with Respect to Adult Behavioral Health Measures </p> <p>(Sec. 5001) The bill requires certain Medicaid quality health measures to include behavioral health measures.</p> <p>Subtitle B--Medicaid IMD Additional Info</p> <p><i>Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act</i></p> <p>(Sec. 5012) The Medicaid and Children's Health Insurance Program (CHIP) Payment and Access Commission must report on information relating to services for Medicaid enrollees who are patients in institutions for mental diseases (IMDs), including the number and type of IMDs in each sampled state, services offered, and funding sources.</p> <p>Subtitle C--CHIP Mental Health Parity</p> <p><i>CHIP Mental Health Parity Act</i></p> <p>(Sec. 5022) CHIP plans must cover mental health and substance-use disorder services. Financial requirements and treatment limitations applicable to such services shall not differ from those applicable to other medical services under CHIP.</p> <p>Subtitle D--Medicaid Reentry</p> <p><i>Medicaid Reentry Act</i></p> <p>(Sec. 5032) The CMS must convene a stakeholder workgroup in order to develop best practices for states to help inmates released from public institutions transition to the community with health care&nbsp;(such as by ensuring continuity of health insurance or Medicaid coverage). The CMS must also issue a letter to states outlining opportunities for Medicaid demonstration waivers based on identified best practices.</p> <p>Subtitle E--Medicaid Partnership</p> <p><i>Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act</i></p> <p>(Sec. 5042) Each state must establish a qualifying prescription drug monitoring program (PDMP) and require health care providers to check the PDMP for a Medicaid enrollee's prescription drug history before prescribing controlled substances to the enrollee. </p> <p>TITLE VI--OTHER MEDICARE PROVISIONS </p> <p>Subtitle A--Testing of&nbsp;Incentive Payments for Behavioral Health Providers for Adoption and Use of Certified Electronic Health Record Technology</p> <p>(Sec. 6001) The Center for Medicare and Medicaid Innovation may test models to provide incentive payments to behavioral health providers for adopting electronic health records technology and for using that technology to improve the quality and coordination of care.</p> <p>Subtitle B--Abuse Deterrent Access</p> <p><i>Abuse Deterrent Access Act of 2018</i></p> <p>(Sec. 6012) The CMS must report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in a prescription drug plan under Medicare or Medicare Advantage (MA). </p> <p>Subtitle C--Medicare Opioid Safety Education</p> <p><i>Medicare Opioid Safety Education Act of 2018</i></p> <p>(Sec. 6022) The CMS must provide Medicare beneficiaries with educational resources regarding opioid use and pain management, as well as descriptions of covered alternative (non-opioid) pain-management treatments.</p> <p>Subtitle D--Opioid Addiction Action Plan</p> <p><i>Opioid Addiction Action Plan Act</i></p> <p>(Sec. 6032) The CMS must develop an action plan to provide recommendations on changes to the Medicare and Medicaid programs to enhance the treatment and prevention of opioid addiction, as well as coverage and payment of medication-assisted treatment. </p> <p>The CMS must also publish a report that includes an evaluation of price trends for opioid overdose-reversal drugs (e.g., naloxone) and recommendations on ways to lower consumer prices for such drugs. </p> <p>Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders in Medicare</p> <p><i>Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act</i></p> <p>(Sec. 6042) The CMS must carry out a demonstration program to increase access to opioid-use disorder treatment services for Medicare beneficiaries, improve physical and mental health outcomes for such beneficiaries, and reduce Medicare expenditures. </p> <p>Subtitle F--Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment </p> <p><i>Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act of 2018 or the REACH OUT Act of 2018</i> </p> <p>(Sec. 6052) The CMS must also award grants, contracts, or cooperative agreements to qualifying organizations in order to support efforts to curb outlier prescribers of opioids under the Medicare prescription drug benefit and MA prescription drug plans. </p> <p>Subtitle G--Preventing Addiction for Susceptible Seniors </p> <p><i>Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018</i> </p> <p>(Sec. 6062) The bill requires electronic prescription programs to be able to securely transmit prior authorization requests for covered drugs under Medicare. </p> <p>(Sec. 6063) The CMS must also establish a secure online portal to allow data sharing among the CMS, Medicare prescription drug benefit plans, and MA plans. The portal must also support referrals by such plans of substantiated fraud, waste, or abuse. </p> <p>(Sec. 6064) The bill also establishes individuals who are identified as at-risk beneficiaries for prescription drug abuse as qualifying participants in medication therapy management programs under the Medicare prescription drug benefit. </p> <p>(Sec. 6065) The CMS must also identify outlier prescribers of opioids under Medicare prescription drug benefit plans and MA plans, based on specialty and geographic area, and annually notify such prescribers of their status. </p> <p>Subtitle H--Expanding Oversight of Opioid Prescribing and Payment </p> <p><i>Expanding Oversight of Opioid Prescribing and Payment Act of 2018</i> </p> <p>(Sec. 6072) The Medicare Payment Advisory Commission must report on Medicare payment for opioid and non-opioid pain management treatments, current incentives for prescribing opioid and non-opioid treatments, and how opioid use is currently tracked and monitored. </p> <p>Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery </p> <p><i>Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018</i> </p> <p>(Sec. 6082) The CMS must review payments under Medicare for opioid and non-opioid pain-management procedures, specifically with respect to ambulatory outpatient surgical procedures and hospital outpatient department services. The CMS must ensure that there are no payment incentives for using opioids instead of non-opioid alternatives and must make revisions accordingly. </p> <p>(Sec. 6083) The bill also requires payment under Medicare to federally qualified health centers and rural health clinics that have health care practitioners who are newly certified to provide medication-assisted treatment (e.g., buprenorphine). </p> <p>(Sec. 6085) The Center for Medicare and Medicaid Innovation may test models to help individuals learn about the availability of psychologist services under Medicare, as well as to explore the use of a behavioral health help-line that is available 24-7 to prevent unnecessary hospitalizations and emergency department visits. </p> <p>Subtitle J--Combating Opioid Abuse for Care in Hospitals </p> <p><i>Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018</i> </p> <p>(Sec. 6092) The CMS must publish guidance for hospitals on pain management and opioid-use disorder prevention strategies for Medicare beneficiaries. </p> <p>Technical expert panels must also recommend opioid-use disorder quality measures for hospital reports, methods to reduce opioid use in surgical settings, and pain-management strategies.</p> <p>Subtitle K--Stop Excessive Narcotics in Our&nbsp;Retirement Communities Protection </p> <p><i>Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 or the SENIOR Communities Protection Act of 2018</i> </p> <p>(Sec. 6102) The bill authorizes the suspension of payments to a pharmacy under the Medicare prescription drug benefit and MA prescription drug plans pending the investigation of a credible allegation of fraud by the pharmacy. </p> <p>Subtitle L--Providing Reliable Options for Patients and Educational Resources </p> <p><i>Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018</i> </p> <p>(Sec. 6112) Medicare and MA prescription drug plan sponsors must annually disclose information to enrollees about the risks of prolonged opioid use, as well as coverage of nonpharmacological therapies, devices, and non-opioid medications. </p> <p>(Sec. 6113) The bill also requires Medicare medication therapy management programs and MA in-home health-risk assessments to include information about the safe disposal of prescription drugs. </p> <p>(Sec. 6114) The bill prohibits inclusion of pain-management questions in certain health care system surveys, unless the questions address the risks of opioid use and the availability of non-opioid alternatives. </p> <p>TITLE VII--OTHER HEALTH PROVISIONS </p> <p>Subtitle A--Synthetic Drug Awareness </p> <p><i>Synthetic Drug Awareness Act of 2018</i> </p> <p>(Sec. 7002) The bill requires the Surgeon General to report on the health effects of new psychoactive substances (also known as synthetic drugs). The report specifically relates to substances used by individuals aged 12 to 18 since January 2010. Examples of synthetic drugs include synthetic marijuana (also known as "spice") and synthetic amphetamines (also known as "bath salts"). </p> <p>Subtitle B--Empowering Pharmacists in the Fight against Opioid Abuse </p> <p><i>Empowering Pharmacists in the Fight Against Opioid Abuse Act</i> </p> <p>(Sec. 7012) HHS must develop training programs and materials on the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or indicative of abuse or diversion. </p> <p>Subtitle C-- Indexing Narcotics, Fentanyl, and Opioids </p> <p><i>Indexing Narcotics, Fentanyl, and Opioids Act of 2018 or the INFO Act </i></p> <p>(Sec. 7022) HHS must establish a public information dashboard that coordinates programs related to opioid-abuse reduction, allows data sharing between different programs and regions of the country, and recommends alternatives to controlled substances for pain management. </p> <p>Subtitle D--Ensuring Access to Quality Sober Living </p> <p><i>Ensuring Access to Quality Sober Living Act of 2018</i> </p> <p>(Sec. 7032) The bill amends the Public Health Service Act to require HHS to develop best practices for operating recovery housing (shared living environments free from alcohol and illegal drug use and centered on peer support and connection to services that&nbsp;promote recovery from substance-use disorders). </p> <p>Subtitle E--Advancing Cutting Edge Research </p> <p><i>Advancing Cutting Edge Research Act or the ACE Research Act</i> </p> <p>(Sec. 7042) The bill expands the National Institutes of Health's unique research initiatives to include cutting-edge research that is urgently required to respond to a public health threat. (Unique research initiatives may be supported through transactions other than contracts, grants, or cooperative agreements.)</p> <p>Subtitle F--Jessie's Law</p> <p><i>Jessie's Law</i></p> <p>(Sec. 7052) HHS must develop best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records.</p> <p>(Sec. 7053) The bill also requires the CMS and the Health Resources and Services Administration to notify annually health care providers about health information that may be disclosed under federal privacy laws to families, caregivers, and health care providers during emergencies, including overdoses. </p> <p>Subtitle G--Safe Disposal of Unused Medication</p> <p><i>Safe Disposal of Unused Medication Act</i></p> <p>(Sec. 7062) The bill amends the Controlled Substances Act to allow a hospice employee to handle lawfully dispensed controlled substances of a deceased hospice patient to assist with disposal of the controlled substances, so long as such disposal occurs onsite in accordance with applicable law.</p> <p>Subtitle H--Substance Use Disorder Workforce Loan Repayment</p> <p><i>Substance Use Disorder Workforce Loan Repayment Act of 2018</i></p> <p>(Sec. 7072) The bill creates a loan repayment program for individuals who complete a period of service in a substance-use disorder treatment job in a mental health professional shortage area or a county where the drug overdose death rate is higher than the national average.</p> <p>Subtitle I--Preventing Overdoses While in Emergency Rooms</p> <p><i>Preventing Overdoses While in Emergency Rooms Act of 2018</i></p> <p>(Sec. 7082) HHS must establish a grant program to develop protocols for discharging patients who are treated for a drug overdose and to enhance the integration and coordination of postdischarge care for individuals with a substance-use disorder.</p> <p>Subtitle J--Alternatives to Opioids in the Emergency Department</p> <p><i>Alternatives to Opioids in the Emergency Department Act or the ALTO Act</i></p> <p>(Sec. 7092) HHS must also establish a demonstration program through which hospitals and emergency departments receive grants to support alternative pain-management protocols and treatments that limit the use and prescription of opioids in emergency departments. </p> <p>Subtitle K--Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now</p> <p><i>Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act</i></p> <p>(Sec. 7102) The bill amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Food and Drug Administration (FDA) to destroy&nbsp;illegally imported or hazardous drugs. </p> <p>(Sec. 7103) The bill requires the FDA to halt the distribution of a drug that is found to be a public hazard and, if appropriate, order the drug to be recalled. </p> <p>(Sec. 7104) The FDA may consider all drugs from a single manufacturer, distributor, or importer as adulterated or misbranded if a pattern emerges, unless otherwise shown. </p> <p>(Sec. 7105) The bill establishes a fund to support efforts by the FDA to address the opioid epidemic, including educational campaigns and inspections of imported drugs. </p> <p>(Sec. 7106) The FDA must deny an application for a new drug that contains&nbsp;a controlled substance and that is found to be unsafe due to a potential for misuse or abuse. </p> <p>Subtitle L--Treatment, Education, and Community Help to Combat Addiction</p> <p><i>Treatment, Education, and Community Help to Combat Addiction Act of 2018 or the TEACH to Combat Addiction Act of 2018</i></p> <p>(Sec. 7112) The bill requires the Substance Abuse and Mental Health Services Administration (SAMHSA) to designate Regional Centers of Excellence in Substance Use Disorder Education. Such centers must improve pain-management and substance-use disorder education through the distribution of evidence-based curricula for health care professional schools. </p> <p>Subtitle M--Guidance from National Mental Health and Substance Use Policy Laboratory </p> <p>(Sec. 7121) The National Mental Health and Substance Use Policy Laboratory within SAMHSA must issue guidance for SAMHSA grant applicants in order to encourage funding of evidence-based practices and to help applicants properly articulate funding rationales.</p> <p>Subtitle N--Comprehensive Opioid Recovery Centers</p> <p><i>Comprehensive Opioid Recovery Centers Act of 2018</i></p> <p>(Sec. 7132) The bill also requires SAMHSA to award grants to establish or operate at least 10 comprehensive opioid recovery centers across the country. Such centers must conduct outreach and provide specified treatment and recovery services, including approved drug treatments (e.g., methadone), counseling, residential rehabilitation, and job-placement assistance. </p> <p>Subtitle O--Poison Center Network Enhancement </p> <p><i>Poison Center Network Enhancement Act of 2018</i> </p> <p>(Sec. 7142) The bill reauthorizes through FY2023&nbsp;and revises the national toll-free phone number, public-awareness campaign, and grant program relating to poison-control centers, including provisions that specifically address the role of poison-control centers in combating opioid misuse.</p> <p>Subtitle P--Eliminating Opioid Related Infectious Diseases</p> <p><i>Eliminating Opioid Related Infectious Diseases Act of 2018</i></p> <p>(Sec. 7152) HHS must expand its grant program for combating hepatitis C infections to include other infections associated with illicit drug use (e.g., HIV). The bill also includes Indian tribes in the program.</p> <p>Subtitle Q--Better Pain Management through Better Data</p> <p><i>Better Pain Management Through Better Data Act of 2018</i></p> <p>(Sec. 7162) The FDA must develop guidance regarding alternative methods for collecting data on opioid sparing (i.e., the use of drugs that reduce pain while also allowing reduced use or avoidance of oral opioids) and using such information in product labels.</p> <p>Subtitle R--Special Registration for Telemedicine Clarification</p> <p><i>Special Registration for Telemedicine Clarification Act of 2018</i></p> <p>(Sec. 7172) The bill establishes a deadline for the Drug Enforcement Administration (DEA) to promulgate regulations for the special registration of practitioners to practice telemedicine.</p> <p>Subtitle S--Peer Support Communities of Recovery</p> <p><i>Peer Support Communities of Recovery Act</i></p> <p>(Sec. 7182) SAMHSA may award grants to nonprofits that focus on substance-use disorder in order to establish regional technical-assistance centers. Such centers must implement peer-delivered addiction-recovery support services and establish recovery community organizations and centers.</p> <p>Subtitle T--Stop Illicit Drug Importation</p> <p><i>Stop Illicit Drug Importation Act of 2018</i></p> <p>(Sec. 7192) The bill prohibits the importation of drugs containing substances that have been requested, or are under review, to be scheduled as controlled substances.</p> <p>(Sec. 7194) The FDA may prohibit a person from importing drugs or controlled substances under specified circumstances, including if the person has shown&nbsp;a pattern of importing adulterated or misbranded drugs that pose a serious health threat. </p> <p>Subtitle U--Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigation Strategies</p> <p><i>Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 or the CONNECTIONS Act</i></p> <p>(Sec. 7202) The Centers for Disease Control and Prevention may provide technical assistance and award grants in order to improve PDMPs, promote new approaches for responding to emerging public health crises, and improve overdose data reporting. </p> <p>(Sec. 7203) The bill also alters requirements relating to PDMPs. Among other changes, the bill authorizes federal support for specific PDMP improvements regarding use, data reporting, and intrastate and interstate interoperability. </p> <p>Subtitle V--Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging</p> <p><i>Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act</i></p> <p>(Sec. 7212) The FDA may require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs. </p> <p>Subtitle W--Postapproval study requirements</p> <p>(Sec. 7221) The FDA may also require a post-approval study for certain drugs that contain&nbsp;controlled substances in order to assess potential reduced effectiveness. </p> <p>TITLE VIII--MISCELLANEOUS</p> <p>Subtitle A--Synthetics Trafficking and Overdose Prevention</p> <p><i>Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018</i></p> <p>(Sec. 8002) The bill increases shipment-tracking responsibilities&nbsp;and coordination between the U.S. Postal Service and the U.S. Customs and Border Protection regarding international shipments of controlled substances, such as through communication requirements and the development of technology to detect illicit fentanyl. </p> <p>Subtitle B--Recognizing Early Childhood Trauma Related to Substance Abuse</p> <p><i>Recognizing Early Childhood Trauma Related to Substance Abuse Act of 2018</i> </p> <p>(Sec. 8012) HHS must provide resources to early childhood care and education providers and other professionals working with young children on ways to recognize and respond to children who may be affected by a family member's or other adult's substance abuse. </p> <p>Subtitle C--Assisting States' Implementation of Plans of Safe Care </p> <p><i>Assisting States' Implementation of Plans of Safe Care Act</i> </p> <p>(Sec. 8022) HHS must also provide states with guidance and technical assistance regarding their plans under the Child Abuse Prevention and Treatment Act for assuring the safe care of infants affected by prenatal substance use. </p> <p>Subtitle D--Improving the Federal Response to Families Impacted by Substance Use Disorder</p> <p><i>Improving the Federal Response to Families Impacted by Substance Use Disorder Act</i></p> <p>(Sec. 8032) The bill establishes the Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders to recommend ways to better coordinate the responses of federal agencies to substance-use disorders and the opioid crisis. </p> <p>Subtitle E--Establishment of an Advisory Committee on Opioids and the Workplace</p> <p>(Sec. 8041) The Department of Labor must establish an Advisory Committee on Opioids and the Workplace to recommend ways to address the impact of opioid abuse on the workplace and to support workers who abuse opioids.</p> <p>Subtitle F--Veterans Treatment Court Improvement</p> <p><i>Veterans Treatment Court Improvement Act of 2018</i></p> <p>(Sec. 8052) The Department of Veterans Affairs (VA) must hire at least 50 Veterans Justice Outreach Specialists under the Veterans Justice Outreach Program. Each of these specialists must serve as part of a justice team in a veterans treatment court or other veteran-focused court. </p> <p>Subtitle G--Peer Support Counseling Program for Women Veterans</p> <p>(Sec. 8061) The VA must also emphasize appointing peer-support counselors for women veterans. The VA shall recruit women peer-support counselors with expertise in gender-specific issues and services, VA services and benefits, and employment mentoring. </p> <p>Subtitle H--Treating Barriers to Prosperity</p> <p><i>Treating Barriers to Prosperity Act of 2018</i></p> <p>(Sec. 8072) The bill allows the Appalachian Regional Commission to support projects and activities addressing drug abuse, such as infrastructure development for telemedicine. </p> <p>Subtitle I--Supporting Grandparents Raising Grandchildren</p> <p><i>Supporting Grandparents Raising Grandchildren Act</i></p> <p>(Sec. 8083) The bill establishes an Advisory Council to Support Grandparents Raising Grandchildren. The council must develop resources to help older relatives meet the needs of the children in their care and maintain their own health and emotional well-being. </p> <p>Subtitle J--Reauthorizing and Extending Grants for Recovery from Opioid Use Programs</p> <p><i>Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018</i></p> <p>(Sec. 8092) The bill reauthorizes through FY2023 the comprehensive opioid abuse grant program&nbsp;administered by&nbsp;the Department of Justice.</p> <p>TITLE IX--SITSA ACT</p> <p><i>Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 or the SITSA Act</i></p> <p>(Sec. 9002) The bill establishes a new, sixth schedule of controlled substances--schedule A. A drug or substance in schedule A has a chemical structure that is similar to a controlled substance in schedule I, II, III, IV, or V, and has a similar or greater&nbsp;depressive, stimulant, or hallucinogenic effect than a controlled substance&nbsp;in one of those schedules. </p> <p>The bill also authorizes, and establishes procedures for, the DEA to place a drug or substance in schedule A. </p> <p>The bill also establishes registration and labeling requirements, as well as criminal penalties, relating to schedule A substances.</p> <p>(Sec. 9012) The bill also sets forth factors that may be considered to determine whether a controlled substance analogue is intended for human consumption. Under current law, a controlled substance analogue that is intended for human consumption is treated as a schedule I controlled substance and is subject to certain regulatory controls.</p> <p>TITLE X--THRIVE ACT</p> <p><em>Transitional Housing for Recovery in Viable Environments Demonstration Program Act or the THRIVE Act </em></p> <p>(Sec. 10002) The bill amends the United States Housing Act of 1937 to require the Department of Housing and Urban Development to establish a five-year demonstration program for nonprofit organizations and tribally designated housing entities to provide low-income rental-assistance vouchers to individuals recovering from an opioid- or other substance-use disorder. </p> <p>TITLE XI--IMD CARE ACT</p> <p><i>Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act</i></p> <p>(Sec. 11002) The bill temporarily allows states to apply to receive federal Medicaid payment for services provided in IMDs and for other medically necessary services for enrollees (aged 21 to 64) with opioid-use or cocaine-use disorders. Services may be covered for a total of up to 30 days in a 12-month period for an eligible enrollee. States must include specified information in their applications, including plans to improve access to outpatient care. </p> <p>Current law generally prohibits federal payment under Medicaid for services provided in IMDs for individuals under the age of 65 (although states may receive payment through certain mechanisms, such as through a Medicaid demonstration waiver). </p>

action_date: 2018-10-24
action_desc: Public Law
text: <p><b>Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act </b></p> <p>TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS </p> <p>(Sec. 1001) The bill prohibits termination of Medicaid eligibility for juveniles who are inmates of public institutions. </p> <p>(Sec. 1003) The Centers for Medicare &amp; Medicaid Services (CMS) must establish a demonstration project to increase provider treatment capacity for substance-use disorders. </p> <p>(Sec. 1004) State Medicaid programs must establish drug-review and utilization requirements, including safety measures for subsequent prescriptions of opioids. </p> <p>(Sec. 1006) The bill extends the enhanced federal matching rate for expenditures regarding substance-use disorder health-home services under Medicaid.</p> <p>The bill also temporarily requires coverage of medication-assisted treatment under Medicaid.</p> <p>(Sec. 1007) The bill allows state Medicaid programs to cover residential pediatric recovery center services for infants with neonatal abstinence syndrome.</p> <p>(Sec. 1012) States may also receive federal payment under Medicaid for outside services that are provided to pregnant and postpartum women who are substance-use disorder patients at institutions for mental diseases (IMDs).</p> <p>(Sec. 1016) State Medicaid agencies, to the extent permitted under state law, may also access prescription drug monitoring programs (PDMPs), facilitate access to PDMPs for Medicaid providers and managed care entities, and share accessed information with such providers and entities. </p> <p>TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS</p> <p>(Sec. 2001) The bill exempts substance-use disorder telehealth services from specified requirements, such as geographic restrictions, under Medicare.</p> <p>(Sec. 2002) The initial examination for new enrollees and annual wellness visits under Medicare must include a substance-use disorder screening and a review of any current opioid prescriptions.</p> <p>(Sec. 2003) In general, prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs. </p> <p>(Sec. 2004) Medicare prescription drug plan sponsors must establish drug-management programs for at-risk beneficiaries.</p> <p>(Sec. 2005) The bill also requires coverage for services provided by certified opioid-treatment programs under Medicare.</p> <p>(Sec. 2006) The CMS must notify Medicare prescription drug plan sponsors about individuals who have a history of opioid-related overdoses, so that such individuals are included in drug-management programs for at-risk beneficiaries. </p> <p>(Sec. 2008) The bill authorizes the suspension of payments to a pharmacy under the Medicare prescription drug benefit and Medicare Advantage (MA) prescription drug plans pending the investigation of a credible allegation of fraud by the pharmacy.</p> <p>TITLE III--FDA AND CONTROLLED SUBSTANCE PROVISIONS</p> <p>Subtitle A--FDA Provisions </p> <p>Chapter 1--In General </p> <p>(Sec. 3001) The Food and Drug Administration (FDA) must issue guidance that addresses the challenges of developing nonaddictive products to treat pain and addiction. </p> <p>(Sec. 3002) The FDA must also issue guidance regarding the prescription of opioid analgesics for pain management. </p> <p>Chapter 2--Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now</p> <p><i>Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act</i></p> <p>(Sec. 3012) The bill requires the FDA to halt the distribution of a controlled substance that is found to be a public hazard and, if appropriate, order the controlled substance to be recalled. </p> <p>(Sec. 3013) The FDA may consider all drugs from a single manufacturer, distributor, or importer as adulterated or misbranded if a pattern emerges, unless otherwise shown.</p> <p>(Sec. 3014) The FDA must coordinate with the Department of Homeland Security and the U.S. Postal Service to improve screening and identification of unlawful controlled substances at international drug import facilities.</p> <p>Chapter 3--Stop Illicit Drug Importation</p> <p><i>Stop Illicit Drug Importation Act of 2018</i></p> <p>(Sec. 3022) The FDA may prohibit a person from importing drugs or controlled substances under specified circumstances, including if the person has shown a pattern of importing adulterated or misbranded drugs that pose a serious health threat. </p> <p>The bill also prohibits the importation, in accordance with specified criteria, of counterfeit drugs and drugs that pose a significant public health concern. </p> <p>Chapter 4--Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging</p> <p><i>Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act</i></p> <p>(Sec. 3032) The FDA may require certain packaging and disposal measures to mitigate the risk of abuse or misuse of a drug. </p> <p>Chapter 5--Postapproval Study Requirements</p> <p>(Sec. 3041) The FDA may also require a post-approval study for certain drugs in order to assess potential reduced effectiveness. </p> <p>Subtitle B--Controlled Substance Provisions</p> <p>Chapter 1--More Flexibility with Respect to Medication-Assisted Treatment for Opioid Use Disorders</p> <p>(Sec. 3201) The bill increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).</p> <p>(Sec. 3204) The bill amends the Controlled Substances Act to allow a pharmacy to deliver a controlled substance to a practitioner, in accordance with a prescription, to be administered to a specific patient for maintenance or detoxification treatment. </p> <p>Chapter 2--Empowering Pharmacists in the Fight Against Opioid Abuse</p> <p><i>Empowering Pharmacists in the Fight Against Opioid Abuse Act</i></p> <p>(Sec. 3212) The Department of Health and Human Services (HHS) must develop training programs and materials on the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or of suspicious origin. </p> <p>Chapter 3--Safe Disposal of Unused Medication</p> <p><i>Safe Disposal of Unused Medication Act</i></p> <p>(Sec. 3222) The bill allows a hospice employee, under specified circumstances, to handle lawfully dispensed controlled substances of a hospice patient in order to assist with disposal of the controlled substances, so long as such disposal occurs onsite in accordance with applicable law.</p> <p>Chapter 4--Special Registration for Telemedicine Clarification</p> <p><i>Special Registration for Telemedicine Clarification Act of 2018</i></p> <p>(Sec. 3232) The bill establishes a deadline for the Drug Enforcement Administration (DEA) to promulgate regulations for the special registration of practitioners to practice telemedicine.</p> <p>Chapter 5--Synthetic Abuse and Labeling of Toxic Substances</p> <p>(Sec. 3241) The bill also sets forth factors that may be considered to determine whether a controlled substance analogue is intended for human consumption. Under current law, a controlled substance analogue that is intended for human consumption is treated as a schedule I controlled substance and is subject to certain regulatory controls.</p> <p>Chapter 6--Access to Increased Drug Disposal</p> <p><i>Access to Increased Drug Disposal Act of 2018</i></p> <p>(Sec. 3252) The bill directs the Office of Justice Programs in the Department of Justice (DOJ) to award grants to states to increase the number of pharmacies and other eligible entities (e.g., narcotic treatment programs) that collect unused prescription drugs for disposal. Grants must be used for costs associated with the collection and disposal of such drugs.</p> <p>Chapter 7--Using Data to Prevent Opioid Diversion</p> <p><i>Using Data to Prevent Opioid Diversion Act of 2018</i></p> <p>(Sec. 3272) In order to identify and prevent drug diversion, the DEA must use an automated data system to inform drug manufacturers and distributors about the quantity and type of opioids that are distributed to pharmacies and practitioners. </p> <p>Chapter 8--Opioid Quota Reform</p> <p><i>Opioid Quota Reform Act</i></p> <p>(Sec. 3282) The DEA must also estimate the extent of any diversion of specified controlled substances (e.g., fentanyl) when determining manufacturing quotas for such substances. In estimating diversion rates, the DEA must consider information relating to overdose deaths and abuse of such substances. </p> <p>Chapter 9--Preventing Drug Diversion</p> <p><i>Preventing Drug Diversion Act of 2018</i></p> <p>(Sec. 3292) The bill also establishes reporting requirements regarding suspicious orders of controlled substances; information must be collected in a centralized DEA database and shared with states.</p> <p>TITLE IV--OFFSETS </p> <p>(Sec. 4001) The bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.</p> <p>(Sec. 4003) The bill amends the Internal Revenue Code to expand the religious conscience exemption under the Patient Protection and Affordable Care Act to exempt individuals who rely solely on a religious method of healing and for whom the acceptance of medical health services would be inconsistent with their religious beliefs from the requirement to purchase and maintain minimum essential health care coverage.</p> <p>TITLE V--OTHER MEDICAID PROVISIONS</p> <p>Subtitle A--Mandatory Reporting with Respect to Adult Behavioral Health Measures </p> <p>(Sec. 5001) The bill requires certain Medicaid quality health measures to include behavioral health measures.</p> <p>Subtitle B--Medicaid IMD Additional Info</p> <p><i>Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act</i></p> <p>(Sec. 5012) The Medicaid and Children's Health Insurance Program (CHIP) Payment and Access Commission must report on information relating to services for Medicaid enrollees who are patients in IMDs, including the number and type of IMDs in each sampled state, services offered, and funding sources.</p> <p>Subtitle C--CHIP Mental Health and Substance Use Disorder Parity</p> <p><i>CHIP Mental Health and Substance Use Disorder Parity Act</i></p> <p>(Sec. 5022) CHIP plans must cover mental health and substance-use disorder services. Financial requirements and treatment limitations applicable to such services shall not differ from those applicable to other medical services under CHIP.</p> <p>Subtitle D--Medicaid Reentry</p> <p><i>Medicaid Reentry Act</i></p> <p>(Sec. 5032) The CMS must convene a stakeholder workgroup in order to develop best practices for states to help inmates released from public institutions transition to the community with health care&nbsp;(such as by ensuring continuity of health insurance or Medicaid coverage). The CMS must also issue a letter to states outlining opportunities for Medicaid demonstration waivers based on identified best practices.</p> <p>Subtitle E--Medicaid Partnership</p> <p><i>Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act</i></p> <p>(Sec. 5042) Each state must establish a qualifying PDMP and require health care providers to check the PDMP for a Medicaid enrollee's prescription drug history before prescribing controlled substances to the enrollee. </p> <p>Subtitle F--IMD CARE Act</p> <p><i>Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act</i></p> <p>(Sec. 5052) The bill temporarily allows states to apply to receive federal Medicaid payment for specified services provided in IMDs for enrollees (aged 21 to 64) with substance-use disorders. Services may be covered for a total of up to 30 days in a 12-month period for an eligible enrollee. </p> <p>Current law generally prohibits federal payment under Medicaid for services provided in IMDs for individuals under the age of 65 (although states may receive payment through certain mechanisms, such as through a Medicaid demonstration waiver). </p> <p>Subtitle G--Medicaid Improvement Fund</p> <p>(Sec. 5061) The bill reauthorizes annual funding for the Medicaid Improvement Fund beginning in FY2021. (The fund is used to improve management of the Medicaid program by the CMS, such as through demonstration project evaluations.)</p> <p>TITLE VI--OTHER MEDICARE PROVISIONS </p> <p>Subtitle A--Testing of&nbsp;Incentive Payments for Behavioral Health Providers for Adoption and Use of Certified Electronic Health Record Technology</p> <p>(Sec. 6001) The Center for Medicare and Medicaid Innovation may test models to provide incentive payments to behavioral health providers for adopting electronic health records technology and for using that technology to improve the quality and coordination of care.</p> <p>Subtitle B--Abuse Deterrent Access</p> <p><i>Abuse Deterrent Access Act of 2018</i></p> <p>(Sec. 6012) The CMS must report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in a prescription drug plan under Medicare or MA, as well as the effectiveness and impact of such formulations. </p> <p>Subtitle C--Medicare Opioid Safety Education</p> <p>(Sec. 6021) The CMS must provide Medicare beneficiaries with educational resources regarding opioid use and pain management, as well as descriptions of covered alternative (non-opioid) pain-management treatments.</p> <p>Subtitle D--Opioid Addiction Action Plan</p> <p><i>Opioid Addiction Action Plan Act</i></p> <p>(Sec. 6032) The CMS must develop an action plan to provide recommendations on changes to the Medicare and Medicaid programs to enhance the treatment and prevention of opioid addiction, as well as coverage and payment of medication-assisted treatment. </p> <p>The CMS must also publish a report that includes an evaluation of price trends for opioid overdose-reversal drugs (e.g., naloxone) and recommendations on ways to lower consumer prices for such drugs. </p> <p>Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders in Medicare</p> <p><i>Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act</i></p> <p>(Sec. 6042) The CMS must carry out a demonstration program to increase access to opioid-use disorder treatment services for Medicare beneficiaries, improve physical and mental health outcomes for such beneficiaries, and reduce Medicare expenditures. </p> <p>Subtitle F--Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment </p> <p><i>Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act of 2018 or the REACH OUT Act of 2018</i> </p> <p>(Sec. 6052) The CMS must also award grants, contracts, or cooperative agreements to qualifying organizations in order to support efforts to curb outlier prescribers of opioids under the Medicare prescription drug benefit and MA prescription drug plans. </p> <p>Subtitle G--Preventing Addiction for Susceptible Seniors </p> <p><i>Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018</i> </p> <p>(Sec. 6062) The bill requires electronic prescription programs to be able to securely transmit prior authorization requests for covered drugs under Medicare. </p> <p>(Sec. 6063) The CMS must also establish a secure online portal to allow data sharing among the CMS, Medicare prescription drug benefit plans, and MA plans. The portal must also support referrals by such plans of substantiated fraud, waste, or abuse. </p> <p>(Sec. 6064) The bill also establishes individuals who are identified as at-risk beneficiaries for prescription drug abuse as qualifying participants in medication therapy management programs under the Medicare prescription drug benefit. </p> <p>(Sec. 6065) The CMS must also identify outlier prescribers of opioids under Medicare prescription drug benefit plans and MA plans, based on specialty and geographic area, and annually notify such prescribers of their status. </p> <p>Subtitle H--Expanding Oversight of Opioid Prescribing and Payment </p> <p><i>Expanding Oversight of Opioid Prescribing and Payment Act of 2018</i> </p> <p>(Sec. 6072) The Medicare Payment Advisory Commission must report on Medicare payment for opioid and non-opioid pain management treatments, current incentives for prescribing opioid and non-opioid treatments, and how opioid use is currently tracked and monitored. </p> <p>Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery </p> <p><i>Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018</i> </p> <p>(Sec. 6082) The CMS must review payments under Medicare for opioid and non-opioid pain-management procedures, specifically with respect to ambulatory outpatient surgical procedures and hospital outpatient department services. The CMS must ensure that there are no payment incentives for using opioids instead of non-opioid alternatives and must make revisions accordingly. </p> <p>(Sec. 6083) The bill also requires payment under Medicare to federally qualified health centers and rural health clinics that have health care practitioners who are newly certified to provide medication-assisted treatment (e.g., buprenorphine). </p> <p>(Sec. 6085) The Center for Medicare and Medicaid Innovation may test models to help individuals learn about the availability of psychologist services under Medicare, as well as to explore the use of a behavioral health help-line that is available 24-7 to prevent unnecessary hospitalizations and emergency department visits. </p> <p>Subtitle J--Combating Opioid Abuse for Care in Hospitals </p> <p><i>Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018</i> </p> <p>(Sec. 6092) The CMS must publish guidance for hospitals on pain management and opioid-use disorder prevention strategies for Medicare beneficiaries. </p> <p>Technical expert panels must also recommend opioid-use disorder quality measures for hospital reports, methods to reduce opioid use in surgical settings, and pain-management strategies.</p> <p><i></i></p> <p>Subtitle K--Providing Reliable Options for Patients and Educational Resources </p> <p><i>Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018</i> </p> <p>(Sec. 6102) Medicare and MA prescription drug plan sponsors must annually disclose information to enrollees about the risks of prolonged opioid use, as well as coverage of nonpharmacological therapies, devices, and non-opioid medications. </p> <p>(Sec. 6103) The bill also requires Medicare medication therapy management programs and MA in-home health-risk assessments to include information about the safe disposal of prescription drugs. </p> <p>(Sec. 6104) The bill prohibits inclusion of pain-management questions in certain health care system surveys, unless the questions address the risks of opioid use and the availability of non-opioid alternatives. </p> <p>Subtitle L--Fighting the Opioid Epidemic With Sunshine</p> <p>(Sec. 6111) The bill expands Medicaid and Medicare reporting requirements related to the transparency of physician ownership or investment interests by including additional health care practitioners (e.g., physician assistants and nurses) in such requirements.</p> <p>TITLE VII--PUBLIC HEALTH PROVISIONS </p> <p>Subtitle A--Awareness and Training</p> <p><i></i></p> <p>(Sec. 7001) The bill requires HHS and the Surgeon General to report on the health effects of new psychoactive substances (also known as "synthetic drugs") that are used by adolescents and young adults. Examples of synthetic drugs include synthetic marijuana (also known as "spice") and synthetic amphetamines (also known as "bath salts"). </p> <p>(Sec. 7002) The bill also reauthorizes through FY2023 and revises the grant program for first responders regarding opioid overdose treatment, which is administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). The bill includes safety training for handling specified drugs (e.g., fentanyl) as a component of the grant program.</p> <p><i></i></p> <p>Subtitle B--Pilot Program for Public Health Laboratories to Detect Fentanyl and Other Synthetic Opioids</p> <p>(Sec. 7011) HHS must establish a grant program to improve coordination between public health laboratories and law enforcement regarding synthetic opioid detection.</p> <p>Subtitle C-- Indexing Narcotics, Fentanyl, and Opioids </p> <p>(Sec. 7021) HHS must establish a public information dashboard that coordinates programs related to opioid-abuse reduction, allows data sharing between different programs and regions of the country, and provides information on alternatives to controlled substances for pain management. </p> <p>(Sec. 7023) HHS must also develop national milestones to measure progress in reducing the opioid crisis over a five-year period based on certain metrics. </p> <p>Subtitle D--Ensuring Access to Quality Sober Living </p> <p><i></i></p> <p>(Sec. 7031) The bill amends the Public Health Service Act to require SAMHSA to develop best practices for operating recovery housing (shared living environments free from alcohol and illegal drug use and centered on peer support and connection to services that&nbsp;promote recovery from substance-use disorders). </p> <p>Subtitle E--Advancing Cutting Edge Research </p> <p><i></i></p> <p>(Sec. 7041) The bill expands the National Institutes of Health's unique research initiatives to include cutting-edge research that is urgently required to respond to a public health threat. (Unique research initiatives may be supported through transactions other than contracts, grants, or cooperative agreements.)</p> <p>Subtitle F--Jessie's Law</p> <p>(Sec. 7051) HHS must develop best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records.</p> <p>(Sec. 7052) The bill also requires the CMS and the Health Resources and Services Administration to notify annually health care providers about health information that may be disclosed under federal privacy laws to families, caregivers, and health care providers during emergencies, including overdoses. </p> <p>Subtitle G--Protecting Pregnant Women and Infants</p> <p>(Sec. 7061) The bill requires HHS to issue several reports relating to pregnant and postpartum women with substance-use disorders, including non-opioid pain management practices.</p> <p>(Sec. 7065) The bill also authorizes a grant program that supports the care of infants who are affected by substance-use disorders (e.g., infants with neonatal abstinence syndrome).</p> <p>Subtitle H--Substance Use Disorder Treatment Workforce </p> <p>(Sec. 7071) The bill creates a loan repayment program for individuals who complete a period of service in a substance-use disorder treatment job in a mental health professional shortage area or a county where the drug overdose death rate is higher than the national average.</p> <p>(Sec. 7073) The bill also reauthorizes through FY2023 and revises&nbsp;a grant program regarding pain care training for health care professionals. The bill specifically requires information about opioid misuse and nonaddictive treatments to be incorporated into the grant program.</p> <p>Subtitle I--Preventing Overdoses While in Emergency Rooms</p> <p>(Sec. 7081) HHS must establish a grant program to implement best practices (as developed by HHS) regarding treatment for individuals who experience a drug overdose, including emergency treatment and the use of recovery coaches. </p> <p>Subtitle J--Alternatives to Opioids in the Emergency Department</p> <p>(Sec. 7091) HHS must also establish a demonstration program through which hospitals and emergency departments receive grants to support alternatives to opioids for pain management. </p> <p><i></i></p> <p>Subtitle K--Treatment, Education, and Community Help to Combat Addiction</p> <p>(Sec. 7101) The bill requires SAMHSA to designate Regional Centers of Excellence in Substance Use Disorder Education. Such centers must improve substance-use disorder training through the distribution of evidence-based resources for health care professional schools. </p> <p>(Sec. 7102) HHS must also award grants to support substance-use disorder prevention and treatment programs for children, adolescents, and young adults.</p> <p>Subtitle L--Information from National Mental Health and Substance Use Policy Laboratory </p> <p>(Sec. 7111) The National Mental Health and Substance Use Policy Laboratory within SAMHSA must issue guidance for SAMHSA grant applicants in order to encourage funding of evidence-based practices and to help applicants properly articulate funding rationales.</p> <p>Subtitle M--Comprehensive Opioid Recovery Centers</p> <p>(Sec. 7121) The bill also requires SAMHSA to award grants to establish or operate at least 10 comprehensive opioid recovery centers across the country. Such centers must conduct outreach and provide specified treatment and recovery services, including approved drug treatments (e.g., methadone), counseling, residential rehabilitation, and job-placement assistance. </p> <p>Subtitle N--Trauma-Informed Care </p> <p>(Sec. 7131) The Centers for Disease Control and Prevention (CDC) may collect and report data using specified surveys regarding adverse childhood experiences, particularly with respect to rural and tribal areas. </p> <p>(Sec. 7135) HHS must provide resources to early childhood care and education providers and other professionals working with young children on ways to recognize and respond to children who may be affected by a family member's or other adult's substance abuse. </p> <p>Subtitle O--Eliminating Opioid Related Infectious Diseases</p> <p>(Sec. 7141) The bill expands the CDC grant program for combating hepatitis C infections to include other infections associated with illicit drug use (e.g., HIV). The bill also includes Indian tribes in the program.</p> <p>Subtitle P--Peer Support Communities of Recovery</p> <p>(Sec. 7151) SAMHSA must award grants to support recovery community organizations (nonprofit organizations that are wholly or principally governed by individuals in recovery for substance-use disorders). </p> <p>Subtitle Q--Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigation Strategies</p> <p>(Sec. 7161) The CDC may provide technical assistance and award grants in order to improve PDMPs, promote new approaches for responding to emerging public health crises, and improve overdose data reporting. </p> <p>(Sec. 7162) The bill also alters requirements relating to PDMPs. Among other changes, the bill authorizes federal support for specific PDMP improvements regarding use, data reporting, and intrastate and interstate interoperability. </p> <p>Subtitle R--Review of Substance Use Disorder Treatment Providers Receiving Federal Funding</p> <p>(Sec. 7171) HHS must review entities that receive federal funds for substance-use disorder treatment services; the scope of the review must include the types of services provided, the populations served, and the adequacy of services.</p> <p>Subtitle S--Other Health Provisions</p> <p>(Sec. 7183) HHS must establish a grant program to help individuals who are in substance-use disorder treatment or recovery to live independently and to participate in the workforce. </p> <p><i></i></p> <p>TITLE VIII--MISCELLANEOUS</p> <p>Subtitle A--Synthetics Trafficking and Overdose Prevention</p> <p><i>Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018</i></p> <p>(Sec. 8002) The bill increases shipment-tracking responsibilities&nbsp;and coordination between the U.S. Postal Service and the U.S. Customs and Border Protection regarding international shipments of controlled substances, such as through communication requirements and the development of technology to detect illicit fentanyl. </p> <p><i></i></p> <p>Subtitle B--Opioid Addiction Recovery Fraud Prevention</p> <p><i>Opioid Addiction Recovery Fraud Prevention Act of 2018</i></p> <p>(Sec. 8022) The bill prohibits unfair or deceptive trade practices regarding substance-use disorder treatment services or products.</p> <p>Subtitle C--Addressing Economic and Workforce Impacts of the Opioid Crisis</p> <p>(Sec. 8041) The Department of Labor must establish a pilot program that awards grants in order to address the economic and workforce impacts of substance-use disorders, such as through treatment services for employees.</p> <p>Subtitle D--Peer Support Counseling Program for Women Veterans</p> <p>(Sec. 8051) The Department of Veterans Affairs (VA) must also emphasize appointing peer-support counselors for women veterans. The VA shall recruit women peer-support counselors with expertise in gender-specific issues and services, VA services and benefits, and employment mentoring. </p> <p>Subtitle E--Treating Barriers to Prosperity</p> <p><i>Treating Barriers to Prosperity Act of 2018</i></p> <p>(Sec. 8062) The bill allows the Appalachian Regional Commission to support projects and activities addressing drug abuse, such as infrastructure development for telemedicine. </p> <p>Subtitle F--Pilot Program to Help Individuals in Recovery from a Substance Use Disorder Become Stably Housed</p> <p>(Sec. 8071) The bill authorizes a grant program, based on funding formulas determined by the Department of Housing and Urban Development, to help states provide temporary housing for individuals who are in recovery from a substance-use disorder.</p> <p>Subtitle G--Human Services</p> <p>(Sec. 8081) HHS must develop guidance for states on ways to support family-focused residential treatment programs (substance-use disorder treatment programs for pregnant and postpartum women, as well as parents and guardians, which allow their children to remain with them during treatment). The guidance must include descriptions of funding opportunities under Medicaid and federal foster care and adoption assistance programs.</p> <p>Subtitle H--Reauthorizing and Extending Grants for Recovery from Opioid Use Programs</p> <p><i>Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018</i></p> <p>(Sec. 8092) The bill reauthorizes through FY2023 the comprehensive opioid abuse grant program administered by DOJ.</p> <p>Subtitle I--Fighting Opioid Abuse in Transportation</p> <p><i>Fighting Opioid Abuse in Transportation Act</i></p> <p>(Sec. 8102) The bill institutes a series of requirements relating to transportation workplace drug- and alcohol-testing. Among other things, the bill requires the Department of Transportation (DOT) to establish a public database with testing results for each mode of transportation; DOT must also include fentanyl in drug-testing policies, if HHS determines that inclusion is justified based on the reliability and cost-effectiveness of available testing.</p> <p>Subtitle J--Eliminating Kickbacks in Recovery</p> <p><i>Eliminating Kickbacks in Recovery Act of 2018</i></p> <p>(Sec.8122) The bill amends the federal criminal code make it a crime to knowingly and willfully solicit, receive, pay, or offer payment for referrals to a recovery home, clinical treatment facility, or laboratory, subject to limitations.</p> <p>Subtitle K--Substance Abuse Prevention</p> <p><i>Substance Abuse Prevention Act of 2018</i></p> <p>(Sec. 8202) The bill reauthorizes several programs relating to drug control through FY2023, including the Office of National Drug Control Policy, the Drug-Free Communities Program, and the High-Intensity Drug Trafficking Area Program.</p> <p>The bill also reauthorizes and establishes several other judicial, treatment, and administrative programs relating to controlled substances. Among other things, the bill reauthorizes funding for drug courts, authorizes grants to support the safe handling of fentanyl by first responders, and authorizes grants for family substance-use disorder treatment services. </p> <p><i></i></p>

tv_txt: I 115th CONGRESS 2d Session H. R. 6 IN THE HOUSE OF REPRESENTATIVES AN ACT To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Title I—Medicaid Provisions to Address the Opioid Crisis Sec. 1001. At-risk youth Medicaid protection. Sec. 1002. Health Insurance for Former Foster Youth. Sec. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program. Sec. 1004. Drug management program for at-risk beneficiaries. Sec. 1005. Medicaid drug review and utilization. Sec. 1006. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder. Sec. 1007. Medicaid health homes for opioid-use-disorder Medicaid enrollees. Title II—Medicare Provisions to Address the Opioid Crisis Sec. 2001. Authority not to apply certain Medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder. Sec. 2002. Encouraging the use of non-opioid analgesics for the management of post-surgical pain. Sec. 2003. Requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. Sec. 2004. Modification of payment for certain outpatient surgical services. Sec. 2005. Requiring e-prescribing for coverage of covered part D controlled substances. Sec. 2006. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries. Sec. 2007. Medicare coverage of certain services furnished by opioid treatment programs. Title III—Other Health Provisions to Address the Opioid Crisis Sec. 3001. Clarifying FDA regulation of non-addictive pain and addiction therapies. Sec. 3002. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths. Sec. 3003. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Sec. 3004. High-quality, evidence-based opioid analgesic prescribing guidelines and report. Sec. 3005. Report on opioids prescribing practices for pregnant women. Sec. 3006. Guidelines for prescribing naloxone. Sec. 3007. Requiring a survey of substance use disorder treatment providers receiving Federal funding. Title IV—Offsets Sec. 4001. Promoting value in Medicaid managed care. Sec. 4002. Extending period of application of Medicare secondary payer rules for individuals with end stage renal disease. Sec. 4003. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program. Title V—Other Medicaid Provisions Subtitle A—Mandatory reporting with respect to adult behavioral health measures Sec. 5001. Mandatory reporting with respect to adult behavioral health measures. Subtitle B—Medicaid IMD Additional Info Sec. 5011. Short title. Sec. 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid. Subtitle C—CHIP Mental Health Parity Sec. 5021. Short title. Sec. 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program. Subtitle D—Medicaid Reentry Sec. 5031. Short title. Sec. 5032. Promoting State innovations to ease transitions integration to the community for certain individuals. Subtitle E—Medicaid Partnership Sec. 5041. Short title. Sec. 5042. Medicaid providers are required to note experiences in record systems to help in-need patients. Title VI—Other Medicare Provisions Subtitle A—Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Sec. 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. Subtitle B—Abuse Deterrent Access Sec. 6011. Short title. Sec. 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare. Subtitle C—Medicare Opioid Safety Education Sec. 6021. Short title. Sec. 6022. Provision of information regarding opioid use and pain management as part of Medicare & You handbook. Subtitle D—Opioid Addiction Action Plan Sec. 6031. Short title. Sec. 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment. Subtitle E—Advancing High Quality Treatment for Opioid Use Disorders in Medicare Sec. 6041. Short title. Sec. 6042. Opioid use disorder treatment demonstration program. Subtitle F—Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Sec. 6051. Short title. Sec. 6052. Grants to provide technical assistance to outlier prescribers of opioids. Subtitle G—Preventing Addiction for Susceptible Seniors Sec. 6061. Short title. Sec. 6062. Electronic prior authorization for covered part D drugs. Sec. 6063. Program integrity transparency measures under Medicare parts C and D. Sec. 6064. Expanding eligibility for medication therapy management programs under part D. Sec. 6065. Medicare notifications to outlier prescribers of opioids. Sec. 6066. No additional funds authorized. Subtitle H—Expanding Oversight of Opioid Prescribing and Payment Sec. 6071. Short title. Sec. 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program. Sec. 6073. No additional funds authorized. Subtitle I—Dr. Todd Graham Pain Management, Treatment, and Recovery Sec. 6081. Short title. Sec. 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments. Sec. 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics. Sec. 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans. Sec. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report. Sec. 6086. Pain management study. Subtitle J—Combating Opioid Abuse for Care in Hospitals Sec. 6091. Short title. Sec. 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program. Sec. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs. Sec. 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use. Sec. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries. Subtitle K—Stop Excessive Narcotics in our Retirement Communities Protection Sec. 6101. Short title. Sec. 6102. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies. Subtitle L—Providing Reliable Options for Patients and Educational Resources Sec. 6111. Short title. Sec. 6112. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. Sec. 6113. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs. Sec. 6114. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management. Title VII—Other Health Provisions Subtitle A—Synthetic Drug Awareness Sec. 7001. Short title. Sec. 7002. Report on effects on public health of synthetic drug use. Subtitle B—Empowering Pharmacists in the Fight Against Opioid Abuse Sec. 7011. Short title. Sec. 7012. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription. Subtitle C—Indexing Narcotics, Fentanyl, and Opioids Sec. 7021. Short title. Sec. 7022. Establishment of substance use disorder information dashboard. Sec. 7023. Interagency Substance Use Disorder Coordinating Committee. Subtitle D—Ensuring Access to Quality Sober Living Sec. 7031. Short title. Sec. 7032. National recovery housing best practices. Subtitle E—Advancing Cutting Edge Research Sec. 7041. Short title. Sec. 7042. Unique research initiatives. Subtitle F—Jessie’s Law Sec. 7051. Short title. Sec. 7052. Inclusion of opioid addiction history in patient records. Sec. 7053. Communication with families during emergencies. Subtitle G—Safe Disposal of Unused Medication Sec. 7061. Short title. Sec. 7062. Disposal of controlled substances of a deceased hospice patient by employees of a qualified hospice program. Subtitle H—Substance Use Disorder Workforce Loan Repayment Sec. 7071. Short title. Sec. 7072. Loan repayment program for substance use disorder treatment employees. Subtitle I—Preventing Overdoses While in Emergency Rooms Sec. 7081. Short title. Sec. 7082. Program to support emergency room discharge and care coordination for drug overdose patients. Subtitle J—Alternatives to Opioids in the Emergency Department Sec. 7091. Short title. Sec. 7092. Emergency department alternatives to opioids demonstration program. Subtitle K—Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Sec. 7101. Short title. Sec. 7102. Detention, refusal, and destruction of drugs offered for importation. Sec. 7103. Notification, nondistribution, and recall of adulterated or misbranded drug products. Sec. 7104. Single source pattern of shipments of adulterated or misbranded drugs. Sec. 7105. Fund to strengthen efforts of FDA to combat the opioid and substance use epidemic. Sec. 7106. Consideration of potential for misuse and abuse required for drug approval. Subtitle L—Treatment, Education, and Community Help to Combat Addiction Sec. 7111. Short title. Sec. 7112. Establishment of Regional Centers of Excellence in Substance Use Disorder Education. Subtitle M—Guidance from National Mental Health and Substance Use Policy Laboratory Sec. 7121. Guidance from National Mental Health and Substance Use Policy Laboratory. Subtitle N—Comprehensive Opioid Recovery Centers Sec. 7131. Short title. Sec. 7132. Comprehensive opioid recovery centers. Subtitle O—Poison Center Network Enhancement Sec. 7141. Short title. Sec. 7142. Reauthorization of poison control centers national toll-free number. Sec. 7143. Reauthorization of nationwide public awareness campaign to promote poison control center utilization. Sec. 7144. Reauthorization of the poison control center grant program. Subtitle P—Eliminating Opioid Related Infectious Diseases Sec. 7151. Short title. Sec. 7152. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors. Subtitle Q—Better Pain Management Through Better Data Sec. 7161. Short title. Sec. 7162. Guidance addressing alternative approaches to data collection and labeling claims for opioid sparing. Subtitle R—Special Registration for Telemedicine Clarification Sec. 7171. Short title. Sec. 7172. Deadline for interim final regulations for a special registration To engage in the practice of telemedicine. Subtitle S—Peer Support Communities of Recovery Sec. 7181. Short title. Sec. 7182. Building communities of recovery. Subtitle T—Stop Illicit Drug Importation Sec. 7191. Short title. Sec. 7192. Detention, refusal, and destruction of drugs offered for importation. Sec. 7193. Seizure. Sec. 7194. Debarring violative individuals or companies. Subtitle U—Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Sec. 7201. Short title. Sec. 7202. Preventing overdoses of controlled substances. Sec. 7203. Prescription drug monitoring program. Subtitle V—Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Sec. 7211. Short title. Sec. 7212. Improved technologies, controls, or measures with respect to the packaging or disposal of certain drugs. Subtitle W—Postapproval study requirements Sec. 7221. Postapproval study requirements. Title VIII—Miscellaneous Subtitle A—Synthetics Trafficking and Overdose Prevention Sec. 8001. Short title; table of contents. Sec. 8002. Customs fees. Sec. 8003. Mandatory advance electronic information for postal shipments. Sec. 8004. International postal agreements. Sec. 8005. Cost recoupment. Sec. 8006. Development of technology to detect illicit narcotics. Sec. 8007. Civil penalties for postal shipments. Sec. 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest. Sec. 8009. Effective date; regulations. Subtitle B—Recognizing Early Childhood Trauma Related to Substance Abuse Sec. 8011. Short title. Sec. 8012. Recognizing Early Childhood Trauma Related to Substance Abuse. Subtitle C—Assisting States’ Implementation of Plans of Safe Care Sec. 8021. Short title. Sec. 8022. Assisting States with implementation of plans of safe care. Subtitle D—Improving the Federal Response to Families Impacted by Substance Use Disorder Sec. 8031. Short title. Sec. 8032. Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders. Subtitle E—Establishment of an Advisory Committee on Opioids and the Workplace Sec. 8041. Establishment of an Advisory Committee on Opioids and the Workplace. Subtitle F—Veterans Treatment Court Improvement Sec. 8051. Short title. Sec. 8052. Hiring by Department of Veterans Affairs of additional Veterans Justice Outreach Specialists. Subtitle G—Peer support counseling program for women veterans Sec. 8061. Peer support counseling program for women veterans. Subtitle H—Treating Barriers to Prosperity Sec. 8071. Short title. Sec. 8072. Drug abuse mitigation initiative. Subtitle I—Supporting Grandparents Raising Grandchildren Sec. 8081. Short title. Sec. 8082. Findings. Sec. 8083. Advisory Council To Support Grandparents Raising Grandchildren. Sec. 8084. Definitions. Subtitle J—Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Sec. 8091. Short title. Sec. 8092. Reauthorization of the comprehensive opioid abuse grant program. Title IX—SITSA Act Sec. 9001. Short title. Sec. 9002. Establishment of schedule A. Sec. 9003. Temporary and permanent scheduling of schedule A substances. Sec. 9004. Penalties. Sec. 9005. False labeling of schedule A controlled substances. Sec. 9006. Registration requirements for handlers of schedule A substances. Sec. 9007. Additional conforming amendments. Sec. 9008. Controlled substance analogues. Sec. 9009. Rules of construction. Sec. 9010. Study by Comptroller General. Sec. 9011. Report on controlled substance analogues sold by means of the Internet. Sec. 9012. Controlled substance analogues. Title X—THRIVE Act Sec. 10001. Short title. Sec. 10002. Demonstration program to study the impact of using rental vouchers for supportive housing for individuals recovering from opioid use disorders or other substance use disorders. Sec. 10003. Repeal of Rental Voucher Demonstration Program. Sec. 10004. Demonstration Close-Out. Sec. 10005. No additional funds authorized. Title XI—IMD CARE Act Sec. 11001. Short title. Sec. 11002. Medicaid State plan option to provide services for certain individuals with targeted SUDs in institutions for mental diseases. Sec. 11003. Promoting value in Medicaid managed care. I Medicaid Provisions to Address the Opioid Crisis 1001. At-risk youth Medicaid protection (a) In general Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ) is amended— (1) in subsection (a)— (A) by striking and at the end of paragraph (82); (B) by striking the period at the end of paragraph (83) and inserting ; and ; and (C) by inserting after paragraph (83) the following new paragraph: (84) provide that— (A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate; (B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and (C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, such individual such that the State makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution. ; and (2) by adding at the end the following new subsection: (nn) Juvenile; eligible juvenile; public institution For purposes of subsection (a)(84) and this subsection: (1) Juvenile The term juvenile means an individual who is— (A) under 21 years of age; or (B) described in subsection (a)(10)(A)(i)(IX). (2) Eligible juvenile The term eligible juvenile means a juvenile who is an inmate of a public institution and who— (A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or (B) is determined eligible for such medical assistance while an inmate of a public institution. (3) Inmate of a public institution The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (29) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution. . (b) No change in exclusion from medical assistance for inmates of public institutions Nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision (A) following paragraph (29) of section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance. (c) No change in continuity of eligibility before adjudication or sentencing Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced. (d) Effective date (1) In general Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 1002. Health Insurance for Former Foster Youth (a) Coverage continuity for former foster care children up to age 26 (1) In general Section 1902(a)(10)(A)(i)(IX) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A)(i)(IX) ) is amended— (A) in item (bb), by striking are not described in or enrolled under and inserting are not described in and are not enrolled under ; (B) in item (cc), by striking responsibility of the State and inserting responsibility of a State ; and (C) in item (dd), by striking the State plan under this title or under a waiver of the and inserting a State plan under this title or under a waiver of such a . (2) Effective date The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023. (b) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States— (1) on best practices for— (A) removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and (B) conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and (2) which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program Section 1903 of the Social Security Act ( 42 U.S.C. 1396b ) is amended by adding at the end the following new subsection: (aa) Demonstration project to increase substance use provider capacity (1) In general Not later than the date that is 180 days after the date of the enactment of this section, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall— (A) for the first 18-month period of such project, award planning grants described in paragraph (3); and (B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5). (2) Purpose The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities: (A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph. (B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services. (C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that— (i) are authorized to dispense drugs approved by the Food and Drug Administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder; (ii) have in effect a registration or waiver under section 303(g) of the Controlled Substances Act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the Assistant Secretary for Mental Health and Substance Use for purposes of carrying out the requirements of such section 303(g); and (iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services. (D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of— (i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, in accordance with guidelines issued by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome; (ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan); (iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or (iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan). (3) Planning grants (A) In general The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that have a State plan (or waiver of the State plan) approved under this title; (ii) select States in a manner that ensures geographic diversity; and (iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Activities described Activities described in this subparagraph are, with respect to a State, each of the following: (i) Activities that support the development of an initial assessment of the behavioral health treatment needs of the State to determine the extent to which providers are needed (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following: (I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder. (II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver). (III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II). (IV) Projections regarding the extent to which the State participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the State plan (or waiver) during the period of the demonstration project. (ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers. (D) Funding For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended. (4) Post-planning States (A) In general The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that received a planning grant under paragraph (3); (ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application; (iii) select States in a manner that ensures geographic diversity; and (iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Applications (i) In general A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following: (I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i). (II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services. (III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following: (aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services. (bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State. (cc) Milestones and timeliness for implementing activities set forth in the plan. (dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan). (IV) A proposed process for reporting the information required under paragraph (6)(A), including information to assess the effectiveness of the efforts of the State to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection. (V) The expected financial impact of the demonstration project under this subsection on the State. (VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State. (VII) A preliminary plan for how the State will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project. (VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable. (ii) Consultation In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation. (5) Payment (A) In general For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter. (B) Qualified sums defined For purposes of subparagraph (A), the term qualified sums means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use treatment or recovery services. (C) Non-duplication of payment In the case that payment is made under subparagraph (A) with respect to expenditures for substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished. (6) Reports (A) State reports A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use treatment or recovery services for which payment is made to the State under this subsection, on the following: (i) The specific activities with respect to which payment under this subsection was provided. (ii) The number of providers that delivered substance use disorder treatment or recovery services in the State under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project. (iii) The number of individuals enrolled under the State plan (or a waiver of such plan) who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project. (iv) Other matters as determined by the Secretary. (B) CMS reports (i) Initial report Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on— (I) the States awarded planning grants under paragraph (3); (II) the criteria used in such selection; and (III) the activities carried out by such States under such planning grants. (ii) Interim report Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report— (I) on activities carried out under the demonstration project under this subsection; (II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph; (III) with a description of the strengths and limitations of such demonstration project; and (IV) with a plan for the sustainability of such project. (iii) Final report Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report— (I) providing updates on the matters reported in the interim report under clause (ii); (II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and (III) evaluating such demonstration project. (C) AHRQ report Not later than 3 years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, on consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4). (7) Data sharing and best practices During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected. (8) CMS funding There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended. . 1004. Drug management program for at-risk beneficiaries (a) In general Title XIX of the Social Security Act is amended by inserting after section 1927 ( 42 U.S.C. 1396r–8 ) the following new section: 1927A. Drug management program for at-risk beneficiaries (a) In general Beginning January 1, 2020, a State shall operate a qualified drug management program under which a State may enroll certain at-risk beneficiaries identified by the State under the program. (b) Qualified drug management program For purposes of this section, the term qualified drug management program means, with respect to a State, a program carried out by the State (including through a contract with a pharmacy benefit manager) that provides at least for the following: (1) Identification of at-risk individuals Under the program, the State identifies, in accordance with subsection (c), individuals enrolled under the State plan (or waiver of the State plan) who are at-risk beneficiaries. (2) Elements of program (A) In general Under the program, the State, with respect to each individual identified under paragraph (1) and enrolled under the program under paragraph (5)— (i) subject to subparagraphs (B) and (C), selects at least one, but not more than three, health care providers and at least one, but not more than three, pharmacies for each such individual for purposes of clause (ii), in accordance with a selection process that takes into account reasonable factors such as the individual’s previous utilization of items and services from health care providers and pharmacies, geographic proximity of the individual to such health care providers and pharmacies, access of the individual to health care, reasonable travel time, information regarding housing status, and any known preference of the individual for a certain health care provider or pharmacy; and (ii) requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause (i) for such individual and dispensed by a pharmacy selected under clause (i) for such individual in order for such controlled substance to be covered under the State plan (or waiver). (B) Beneficiary preference In the case of an individual receiving a notice under paragraph (3)(A) of being identified as potentially being an at-risk beneficiary described in such paragraph, such individual may submit, during the 30-day period following receipt of such notice, preferences for which health care providers and pharmacies the individual would prefer the State to select under subparagraph (A). The State shall select or change the selection of health care providers and pharmacies under subparagraph (A) for the individuals based on such preferences, except that in the case that State determines that such selection (or change of selection) of a health care provider or pharmacy under subparagraph (A) is contributing or would contribute to prescription drug abuse or drug diversion by the individual, the State may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph. If the State selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual, the State shall provide the individual with at least 30 days written notice of the selection or change of selection and a rationale for the selection or change. (C) Treatment of pharmacy with multiple locations For purposes of subparagraph (A)(i), in the case of a pharmacy that has multiple locations that share real-time electronic prescription data, all such locations of the pharmacy shall collectively be treated as one pharmacy. (D) Treatment of existing FFS drug management programs In the case of a patient review and restriction program (as identified in the annual report submitted to the Secretary under section 1927(g)(3)(D)) operated by a State pursuant to section 1915(a)(2) before the date of the enactment of this section, such program shall be treated as a qualified drug management program. (E) Reasonable access The program shall ensure, including through waiver of elements of the program (including under subparagraph (A)(ii)), reasonable access to health care (including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph (A)) in the case of individuals with multiple residences, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (3) Notification to identified individuals Under the program, the State provides each individual who is identified under paragraph (1), prior to enrolling such individual under the program, at least one notification of each of the following: (A) Notice that the State has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance. (B) The name, address, and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph (2)(A). (C) Information describing all State and Federal public health resources that are designed to address such abuse or misuse to which the individual has access, including mental health services, substance use disorder and recovery services, and other counseling services. (D) Notice of, and information about, the right of the individual to— (i) submit preferences of the individual for health care providers and pharmacies to be selected under paragraph (2)(A), including as described in paragraph (2)(B); (ii) appeal under paragraph (4)— (I) such identification described in subparagraph (A); and (II) the selection of health care providers and pharmacies under paragraph (2)(A). (E) An explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance, including an explanation of the program. (F) Information, including a contact list and clear instructions, that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph (2)(B) and any other communications relating to the program. (4) Appeals process Under the program, the State provides for an appeals process under which, with respect to an individual identified under paragraph (1)— (A) such individual may appeal— (i) such identification; and (ii) the selection of a health care provider or pharmacy under paragraph (2)(A); (B) in the case of an appeal described in subparagraph (A)(ii), the State shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph (2)(A), unless the State determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual; (C) such individual is provided a period of not less than 30 days following the date of receipt of the notice described in paragraph (3) to submit such appeal; and (D) the State must make a determination with respect to an appeal described in subparagraph (A), and notify the individual of such determination, prior to enrollment of such individual in the program. (5) Enrollment Under the program, the State initially enrolls individuals who are identified under paragraph (1) in the program for a 12-month period— (A) in the case of such an individual who does not submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph, beginning on the day after the last day of such period; and (B) in the case of such an individual who does submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph but such appeal is denied, beginning not later than 30 days after the date of such denial. (6) Notification of health care providers and pharmacies Under the program, the State provides to each health care provider and pharmacy selected for an individual under paragraph (2)— (A) notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph (2); (B) information on such program and the role of being so selected; and (C) a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected. (7) Continuation of enrollment Under the program, the State, with respect to an individual enrolled under the program, provides for a process to— (A) not later than 30 days before the end of the 12-month period for which the individual is so enrolled pursuant to paragraph (5)— (i) assess, in accordance with publicly available evidence-based guidelines, whether or not such individual should continue to be enrolled under the program; and (ii) notify such individual of the results of the assessment under clause (i); (B) continue, subject to subparagraph (C), enrollment of such individual if such assessment recommends such continuation; and (C) appeal the continuation of enrollment in accordance with the appeals process described in paragraph (4). (c) At-Risk beneficiary (1) Identification For purposes of this section, a State shall identify an individual enrolled under the State plan (or waiver of the State plan) as an at-risk beneficiary if the individual is not an exempted individual described in paragraph (2) and— (A) is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance; or (B) the State received notification from a PDP sponsor or Medicare Advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section 1860D–4(c)(5) and such identification has not been terminated under subparagraph (F) of such section. (2) Exempted individual described For purposes of paragraph (1), an exempted individual described in this paragraph is an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as an exempted individual for purposes of paragraph (1). (d) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b)(6) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (e) Reports (1) Annual reports A State operating a qualified drug management program shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2021, the following information: (A) The number of individuals enrolled under the State plan (or waiver of the State plan) who are enrolled under the program and the percentage of individuals enrolled under the State plan (or waiver) who are enrolled under such program. (B) The number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program, including the daily morphine milligram equivalents and the quantity prescribed for each such prescription. (C) The number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program. (D) The number of health care providers writing prescriptions for controlled substances (other than prescriptions for a refill) for individuals enrolled under such program. (E) Any other data that the Secretary may require. (F) Any report submitted by a managed care entity under subsection (f)(1)(B) with respect to the year involved. For each such report for a year after 2021, the information described in this paragraph shall be provided in a manner that compares such information with respect to the prior calendar year to such information with respect to the second prior calendar year. (2) MACPAC reports and review Not later than 2 years after the date of the enactment of this section, the Medicaid and CHIP Payment and Access Commission (in this section referred to as MACPAC ), in consultation with the National Association of Medicaid Directors, pharmacy benefit managers, managed care organizations, health care providers (including pharmacists), beneficiary advocates, and other stakeholders, shall publish a report that includes— (A) best practices for operating drug management programs, based on a review of a representative sample of States administering such a program; (B) a summary of the experience of the appeals process under drug management programs operated by several States, such as the frequency at which individuals appealed the identification of being an at-risk individual, the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program, the timeframes for such appeals, a summary of the reasons for such appeals, and the design of such appeals processes; (C) a summary of trends and the effectiveness of qualified drug management programs operated under this section; and (D) recommendations to States on how improvements can be made with respect to the operation of such programs. In reporting on State practices, the MACPAC shall consider how such programs have been implemented in rural areas, under fee-for-service as well as managed care arrangements, and the extent to which such programs have resulted in increased efficiencies to such States or to the Federal Government under this title. (3) Report on plan for coordinated care Not later than January 1, 2021, each State operating a qualified drug management program shall submit to the Administrator of the Centers for Medicare & Medicaid Services a report on how such State plans to provide coordinated care for individuals enrolled under the State plan (or waiver of the State plan) and— (A) who are enrolled under the program; or (B) who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity. (f) Applicability to managed care entities (1) In general With respect to any contract that a State enters into on or after January 1, 2020, with a managed care entity (as defined in section 1932(a)(1)(B)) pursuant to section 1903(m), the State shall, as a condition of the contract, require the managed care entity— (A) to operate a qualified drug management program (as defined in subsection (b)) for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph (2); (B) to submit to the State an annual report on the matters described in subparagraphs (A) through (E) of subsection (e)(1); and (C) to submit to the State a list (and as necessary update such list) of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph (A) for purposes of allowing State plans for which medical assistance is paid on a fee-for-service basis to have access to such information. (2) Application For purposes of applying, with respect to a managed care entity— (A) under paragraph (1)(A)— (i) the definition of the term qualified drug management program under subsection (b), other than paragraph (2)(D) of such subsection; and (ii) the provisions of paragraphs (1) and (2) of subsection (c); and (B) under paragraph (1)(B), the report requirements described in subparagraphs (A) through (E) of subsection (e)(1); each reference in such subsection (b) and paragraphs of subsection (c) to a State or the State (other than to a State plan or the State plan ) shall be deemed a reference to the managed care entity, each reference under such subsection, paragraphs, or subparagraphs to individuals enrolled under the State plan (or waiver of the State plan) shall be deemed a reference to individuals enrolled with such entity, and each reference under such subsection, paragraphs, or subparagraphs to individuals enrolled under the qualified drug management program operated by the State shall be deemed a reference to individuals enrolled under the qualified drug management program operated by the managed care entity. (g) Controlled substance defined For purposes of this section, the term controlled substance means a drug that is included in schedule II, III, or IV of section 202(c) of the Controlled Substances Act, or any combination thereof, as specified by the State. . (b) Guidance on at-Risk population transitioning between Medicaid FFS and managed care Not later than October 1, 2019, the Secretary of Health and Human Services shall issue guidance for State Medicaid programs, with respect to individuals who are enrolled under a State plan (or waiver of such plan) under title XIX of the Social Security Act and under a drug management program, for purposes of providing best practices— (1) for transitioning, as applicable, such individuals from fee-for-service Medicaid (and such a program operated by the State) to receiving medical assistance under such title through a managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) with a contract that with the State pursuant to section 1903(m) of such Act (and such a program operated by such entity); and (2) for transitioning, as applicable, such individuals from receiving medical assistance under such title through a managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) with a contract that with the State pursuant to section 1903(m) of such Act (and such a program operated by such entity) to fee-for-service Medicaid (and such a program operated by the State). (c) Guidance on at-Risk population transitioning to Medicare (1) In general Not later than January 1, 2020, the Secretary of Health and Human Services, after consultation with the Federal Coordinated Health Care Office established under section 2602 of the Patient Protection and Affordable Care Act ( 42 U.S.C. 1315b ), shall issue guidance for State Medicaid programs, with respect to transitioning individuals, providing for— (A) notification to be submitted by the State to the Centers for Medicare & Medicaid Services and such individuals of the status of such individuals as transitioning individuals; (B) notification to such individuals about enrollment under a prescription drug plan under part D of such title or under a MA–PD plan under part C of such title; (C) best practices for transitioning such individuals to such a plan; and (D) best practices for coordination between the qualified drug management program (as described in section 1927A(b) of the Social Security Act, as added by subsection (a)) carried out by the State and a drug management program carried out under such a plan pursuant to section 1860D–4(c)(5) of the Social Security Act ( 42 U.S.C. 1395w–10(c)(5) ). (2) Transitioning individuals For purposes of paragraph (1), a transitioning individual is an individual who, with respect to a month— (A) is enrolled under the State plan (or waiver of the State plan) and under the qualified drug management program (as described in section 1927A(b) of the Social Security Act, as added by subsection (a)) carried out by the State; and (B) is expected to become eligible for the Medicare program under title XVIII of such Act during the subsequent 12-month period. 1005. Medicaid drug review and utilization (a) Medicaid drug utilization review (1) State plan requirement Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by section 101, is further amended— (A) in paragraph (83), at the end, by striking and ; (B) in paragraph (84), at the end, by striking the period and inserting ; and ; and (C) by inserting after paragraph (84) the following new paragraph: (85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1). . (2) Drug review and utilization requirements Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ), as amended by section 101, is further amended by adding at the end the following new subsection: (oo) Drug review and utilization requirements (1) In general For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following: (A) Claims review limitations (i) In general The State has in place— (I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State; (II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and (III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and— (aa) benzodiazepines; or (bb) antipsychotics. (ii) Managed care entities The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause. (iii) Rules of construction Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver). (B) Program to monitor antipsychotic medications by children The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically. (C) Fraud and abuse identification The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled. (D) Reports The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary. (E) Clarification Nothing shall prevent a State from satisfying the requirement— (i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019; (ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or (iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date. (2) Annual report by Secretary For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D). (3) Exceptions (A) Certain individuals exempted The drug review and utilization requirements under this subsection shall not apply with respect to an individual who— (i) is receiving— (I) hospice or palliative care; or (II) treatment for cancer; (ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (iii) the State elects to treat as exempted from such requirements. (B) Exception relating to ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). . (3) Managed care entities Section 1932 of the Social Security Act ( 42 U.S.C. 1396u–2 ) is amended by adding at the end the following new subsection: (i) Drug utilization review activities and requirements Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42 of the Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018. . (b) Identifying and addressing inappropriate prescribing and billing practices under Medicaid (1) In general Section 1927(g) of the Social Security Act ( 42 U.S.C. 1396r–8(g) ) is amended— (A) in paragraph (1)(A)— (i) by striking of section 1903(i)(10)(B) and inserting of section 1902(a)(54) ; (ii) by striking , by not later than January 1, 1993, ; (iii) by inserting after gross overuse, the following: excessive utilization, ; and (iv) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization ; and (B) in paragraph (2)(B)— (i) by inserting after gross overuse, the following: excessive utilization, ; and (ii) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization . (2) Effective date The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020. 1006. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder (a) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include— (1) the types of services, including post-discharge services and parenting supports, for families of babies with neonatal abstinence syndrome that States may cover under the Medicaid program under title XIX of the Social Security Act; (2) best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and post-discharge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes; (3) recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home visiting services; and (4) guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and post-discharge services, including parenting supports. (b) GAO study Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title. 1007. Medicaid health homes for opioid-use-disorder Medicaid enrollees (a) Extension of enhanced FMAP for certain health homes for individuals with substance use disorders Section 1945 of the Social Security Act ( 42 U.S.C. 1396w–4 ) is amended— (1) in subsection (c)— (A) in paragraph (1), by inserting subject to paragraph (4), after except that, ; and (B) by adding at the end the following new paragraph: (4) Special rule relating to substance use disorder health homes (A) In general In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. Nothing in this section shall be construed as prohibiting a State with a State plan amendment that is approved under this section and that is not an SUD-focused State plan amendment from additionally having approved on or after such date an SUD-focused State plan amendment under this section, including for purposes of application of this paragraph. (B) Report requirements In the case of a State with an SUD-focused State plan amendment for which the application of the Federal medical assistance percentage has been extended under subparagraph (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment: (i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual. (ii) The access of such individuals to health care. (iii) The total expenditures of such individuals for health care. For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures. (C) Best practices Not later than October 1, 2020, the Secretary shall make publicly available on the Internet website of the Centers for Medicare & Medicaid Services best practices for designing and implementing an SUD-focused State plan amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals. (D) Definitions For purposes of this paragraph: (i) SUD-eligible individuals The term SUD-eligible individual means, with respect to a State, an individual who satisfies all of the following: (I) The individual is an eligible individual with chronic conditions. (II) The individual is an individual with a substance use disorder. (III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary. (ii) SUD-focused State plan amendment The term SUD-focused State plan amendment means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals. . (b) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment (1) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29) . (2) Inclusion of medication-assisted treatment as medical assistance Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (28), by striking and at the end; (B) by redesignating paragraph (29) as paragraph (30); and (C) by inserting after paragraph (28) the following new paragraph: (29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and . (3) Medication-assisted treatment defined; Waivers Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended by adding at the end the following new subsection: (ee) Medication-assisted treatment (1) Definition For purposes of subsection (a)(29), the term medication-assisted treatment — (A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), including methadone, and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat opioid use disorders; and (B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy. (2) Exception The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, if before the beginning of such period the State certifies to the satisfaction of the Secretary that implementing such provisions statewide for all individuals eligible to enroll in the State plan (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3). . (4) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025. (B) Exception for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. II Medicare Provisions to Address the Opioid Crisis 2001. Authority not to apply certain Medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder Section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) is amended— (1) in paragraph (2)(B)(i), by inserting and paragraph (7)(E) after Subject to clause (ii) ; and (2) by adding at the end the following new paragraphs: (7) Authority not to apply certain requirements in the case of certain treatment of substance use disorder or co-occurring mental health disorder (A) In general For purposes of payment under this subsection, in the case of telehealth services described in subparagraph (C) furnished on or after January 1, 2020, to an eligible beneficiary (as defined in subparagraph (F)) for the treatment of a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder, the Secretary is authorized to, through rulemaking, not apply any of the requirements described in subparagraph (B). (B) Requirements described For purposes of this paragraph, the requirements described in this subparagraph are any of the following: (i) Qualifications for an originating site under paragraph (4)(C)(ii). (ii) Geographic limitations under paragraph (4)(C)(i). (C) Telehealth services described For purposes of this paragraph, the telehealth services described in this subparagraph are services that are both telehealth services (as described in paragraph (4)(F)) and identified by the Secretary, through rulemaking, as services that are the most commonly furnished (as defined by the Secretary) under this part to individuals diagnosed with a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder. (D) Clarification Nothing in this paragraph shall be construed as limiting or otherwise affecting the authority of the Secretary to limit or eliminate the non-application pursuant to this paragraph of any of the requirements under subparagraph (B). (E) Treatment of originating site facility fee No facility fee shall be paid under paragraph (2)(B) to an originating site with respect to a telehealth service described in subparagraph (B) for which payment is made under this subsection by reason of the non-application of a requirement described in subparagraph (B) pursuant to this paragraph if payment for such service would not otherwise be permitted under this subsection if such requirement were applied. (F) Eligible beneficiary defined For purposes of this paragraph, the term eligible beneficiary means an individual who— (i) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under this part; (ii) has a diagnosis for a substance use disorder; and (iii) meets such other criteria as the Secretary determines appropriate. (G) Report Not later than 5 years after the date of the enactment of this paragraph, the Secretary shall submit to Congress a report on the impact of any non-application under this paragraph of any of the requirements described in subparagraph (B) on (i) the utilization of health care services related to substance use disorder, such as behavioral health services and emergency department visits; and (ii) health outcomes related to substance use disorder, such as substance use overdose deaths. (H) Funding For purposes of carrying out this paragraph, in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended. (8) Rule of construction Nothing in this subsection may be construed as waiving requirements under this title to comply with applicable State law, including State licensure requirements. . 2002. Encouraging the use of non-opioid analgesics for the management of post-surgical pain Section 1833(t)(6) of the Social Security Act ( 42 U.S.C. 1395l(t)(6) ) is amended— (1) in subparagraph (C)(i), by inserting or, in the case of an eligible non-opioid analgesic (as defined in subparagraph (J)), during a period of 5 years, after 3 years, ; and (2) by adding at the end the following new subparagraph: (J) Eligible non-opioid analgesic defined In this paragraph, the term eligible non-opioid analgesic means a drug or biological— (i) that is an analgesic that is not an opioid; (ii) that demonstrated substantial clinical improvement, as determined by the Secretary; and (iii) for which payment— (I) as an outpatient hospital service under this part was not being made as of the date of the enactment of this subparagraph; or (II) was being made under this paragraph as of such date. . 2003. Requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination (a) In general Section 1861(ww) of the Social Security Act ( 42 U.S.C. 1395x(ww) ) is amended— (1) in paragraph (1), by inserting and a review of current opioid prescriptions and screening for opioid use disorder (as defined in paragraph (4)), before but does not include ; and (2) by adding at the end the following new paragraph: (4) (A) For purposes of paragraph (1), the term a review of current opioid prescriptions and screening for opioid use disorder means, with respect to an individual— (i) a review by a physician or qualified non-physician practitioner of all current prescriptions of the individual; and (ii) in the case of an individual determined by the review of a physician or qualified non-physician practitioner under subparagraph (A) to have a current prescription for opioids for chronic pain that has been prescribed for a minimum period of time (as specified by the Secretary)— (I) a review by the physician or practitioner of the potential risk factors to the individual for opioid use disorder; (II) an evaluation by the physician or practitioner of pain of the individual; (III) the provision of information regarding non-opioid treatment options for the treatment and management of any chronic pain of the individual; and (IV) if determined necessary by the physician or practitioner based on the results of the review and evaluation conducted as described in this paragraph, an appropriate referral by the physician or practitioner for additional treatment. (B) For purposes of this paragraph, the term qualified non-physician practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist. . (b) Clarification Nothing in the amendments made by subsection (a) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination. (c) Effective date The amendments made by subsection (a) shall apply with respect to initial preventive physical examinations furnished on or after January 1, 2020. 2004. Modification of payment for certain outpatient surgical services (a) Freeze of payment for certain services furnished in ambulatory surgical centers Section 1833(i)(2) of the Social Security Act ( 42 U.S.C. 1395l(i)(2) ) is amended by adding at the end the following new subparagraph: (F) (i) With respect to a targeted procedure (as defined in clause (ii)) furnished during 2020 or a subsequent year (before 2024) to an individual in an ambulatory surgical center, the payment amount for such procedure that would otherwise be determined under the revised payment system under subparagraph (D), without application of this subparagraph, shall be equal to the payment amount for such procedure furnished in 2016. (ii) For purposes of clause (i), the term targeted procedure means a procedure to which Healthcare Common Procedure Coding System code 62310 (or, for years beginning after 2016, 62321), 62311 (or, for years beginning after 2016, 62323), 62264, 64490, 64493, or G0260, or any successor code, apply. (iii) This subparagraph shall not be applied in a budget-neutral manner. . (b) Data collection (1) In general The Comptroller General shall collect data relating to the cost differential between targeted procedures (as defined in section 1833(i)(2)(F)(ii) of the Social Security Act, as added by subsection (a)) that are performed in a hospital operating room and such procedures that are performed in an office setting within a hospital in order to determine whether such procedures are being properly coded for claims, based on setting, for payment under section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ) and to determine if further changes are needed in the classification system for covered outpatient department services (as described in section 1833(t)(2)(A) of the Social Security Act ( 42 U.S.C. 1395l(t)(2)(A) ). (2) Report Not later than 4 years after the date of the enactment of this Act, the Comptroller General shall submit a report to the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate containing— (A) a determination of whether procedures described in paragraph (1) are being properly coded for claims, based on setting, for payment under section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ); and (B) recommendations on any changes the Comptroller General determines are needed in the classification system for covered outpatient department services (as described in section 1833(t)(2)(A) of the Social Security Act ( 42 U.S.C. 1395l(t)(2)(A) ). (c) Study Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on the extent to which procedures described in section 1833(i)(2)(F)(ii) of the Social Security Act, as added by subsection (a), are effective at preventing the need for opioids for individuals furnished such procedures. 2005. Requiring e-prescribing for coverage of covered part D controlled substances (a) In general Section 1860D–4(e) of the Social Security Act ( 42 U.S.C. 1395w–104(e) ) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, pursuant to rulemaking, specify circumstances with respect to which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispenser are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who has received a waiver or a renewal thereof for a specified period determined by the Secretary, not to exceed 1 year, from the requirement to use electronic prescribing, pursuant to a process established by regulation by the Secretary, due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner allowing for the dispensing of a non-patient specific prescription pursuant to a standing order, approved protocol for drug therapy, collaborative drug management, or comprehensive medication management, in response to a public health emergency, or other circumstances where the practitioner may issue a non-patient specific prescription; (vi) a prescription issued by a practitioner prescribing a drug under a research protocol; (vii) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use; and (viii) a prescription issued by a practitioner for an individual who— (I) receives hospice care under this title; or (II) is a resident of a skilled nursing facility (as defined in section 1819(a)), or a medical institution or nursing facility for which payment is made for an institutionalized individual under section 1902(q)(1)(B), for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy, as determined by the Secretary in accordance with this paragraph. (C) Dispensing Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral or fax prescriptions that are consistent with laws and regulations. Nothing in this paragraph shall be construed as affecting the ability of the beneficiary involved to designate a particular pharmacy to dispense a prescribed drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, pursuant to rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. 2006. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended— (1) in paragraph (1), by inserting after subparagraph (E) the following new subparagraph: (F) With respect to plan years beginning on or after January 1, 2021, a drug management program for at-risk beneficiaries described in paragraph (5). ; and (2) in paragraph (5)(A), by inserting (and for plan years beginning on or after January 1, 2021, a PDP sponsor shall) after A PDP sponsor may . 2007. Medicare coverage of certain services furnished by opioid treatment programs (a) Coverage Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (FF), by striking at the end and ; (2) in subparagraph (GG), by inserting at the end ; and ; and (3) by adding at the end the following new subparagraph: (HH) opioid use disorder treatment services (as defined in subsection (jjj)). . (b) Opioid use disorder treatment services and opioid treatment program defined Section 1861 of the Social Security Act is amended by adding at the end the following new subsection: (jjj) Opioid use disorder treatment services; opioid treatment program (1) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act for use in the treatment of opioid use disorder; (B) dispensing and administration of such medications, if applicable; (C) substance use counseling by a professional to the extent authorized under State law to furnish such services; (D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (E) toxicology testing, and (F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation). (2) Opioid treatment program The term opioid treatment program means an entity that is opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (A) is enrolled under section 1866(j); (B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and (D) meets such additional conditions as the Secretary may find necessary to ensure— (i) the health and safety of individuals being furnished services under such program; and (ii) the effective and efficient furnishing of such services. . (c) Payment (1) In general Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (A) by striking and (BB) and inserting (BB) ; and (B) by inserting before the semicolon at the end the following , and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary . (2) Payment determination Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (w) Opioid use disorder treatment services (1) In general The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program. (2) Considerations The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (3) Annual updates The Secretary shall provide an update each year to the bundled payment amounts under this subsection. . (d) Including opioid treatment programs as Medicare providers Section 1866(e) of the Social Security Act ( 42 U.S.C. 1395cc(e) ) is amended— (1) in paragraph (1), by striking at the end and ; (2) in paragraph (2), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new paragraph: (3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section). . III Other Health Provisions to Address the Opioid Crisis 3001. Clarifying FDA regulation of non-addictive pain and addiction therapies (a) Public meetings Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction, which may include— (1) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c )) for the development of non-addictive medical products intended to treat pain or addiction; and (2) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not later than 1 year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-opioid or non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; and (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence. (c) Medical product defined In this section, the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )). 3002. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths (a) Public health laboratories to detect fentanyl Part F of title III of the Public Health Service Act ( 42 U.S.C. 262 et seq.) is amended— (1) in the heading of part F, by striking and clinical laboratories and inserting , clinical laboratories, and public health laboratories ; and (2) by adding at the end the following new subpart: 4 Public Health Laboratories 355. Public health laboratories to detect fentanyl (a) In general The Secretary shall establish a program to award grants to Federal, State, and local agencies to support the establishment or operation of public health laboratories to detect fentanyl, its analogues, and other synthetic opioids, as described in subsection (b). (b) Standards The Secretary, in consultation with the Director of the National Institute of Standards and Technology, shall— (1) develop standards for safely and effectively handling and testing fentanyl, its analogues, and other synthetic opioids; (2) develop fentanyl and fentanyl analog reference materials and quality control standards and protocols to calibrate instrumentation for clinical diagnostics and postmortem surveillance; and (3) include in the standards developed pursuant to paragraph (1) procedures for encountering new and emerging synthetic opioid formulations and reporting those findings to other Federal, State, and local public health laboratories. (c) Laboratories The Secretary shall require grantees under subsection (a) to— (1) follow the standards established under subsection (b) and be capable of providing systematic and routine laboratory testing of drugs for the purposes of obtaining and disseminating public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate; (2) work with law enforcement agencies and public health authorities, as feasible, to develop real-time information on the purity and movement of fentanyl, its analogues, and other synthetic opioids; (3) assist State and local law enforcement agencies in testing seized drugs when State and local forensic laboratories request additional assistance; (4) provide early warning information and advice to Federal, State, and local law enforcement agencies and public health authorities regarding potential significant changes in the supply of fentanyl, its analogues, and other synthetic opioids; (5) provide biosurveillance for non-fatal exposures; and (6) provide diagnostic testing for non-fatal exposures of emergency personnel. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023. . (b) Enhanced fentanyl surveillance Title III of the Public Health Service Act is amended by inserting after section 317T of such Act ( 42 U.S.C. 247b–22 ) the following new section: 317U. Enhanced fentanyl surveillance (a) In general The Director of the Centers for Disease Control and Prevention shall enhance its drug surveillance program by— (1) expanding its surveillance program to include all 50 States and the territories of the United States; (2) increasing and accelerating the collection of data on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including related overdose data from medical examiners and drug treatment admissions; and (3) utilizing available and emerging information on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including information from— (A) the National Drug Early Warning System; (B) State and local public health authorities; and (C) Federal, State, and local public health laboratories. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023. . (c) Pilot program for point-of-Use testing of illicit drugs for dangerous contaminants Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: 399V–7. Pilot program for point-of-Use testing of illicit drugs for dangerous contaminants (a) In general The Secretary shall— (1) establish a pilot program through which 5 State or local agencies conduct, in 5 States, point-of-use testing of illicit drugs for dangerous contaminants; (2) establish metrics to evaluate the success of the pilot program in reducing drug overdose rates; and (3) based on such metrics, conduct an annual evaluation of the pilot program and submit an annual report to the Congress containing the results of such evaluation. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023. . 3003. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders (a) Conforming applicable number Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(B)(iii) ) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; (bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); or (cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)). . (b) Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended— (1) in subclause (I), by striking or at the end; and (2) by amending subclause (II) to read as follows: (II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or . (c) Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ), as amended by subsection (b), is further amended by adding at the end the following: (III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife. . (d) Definition of qualifying other practitioner Section 303(g)(2)(G)(iv) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iv) ) is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant . (e) Report by Secretary Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iii) )) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment— (1) the average frequency with which qualifying practitioners see their patients; (2) the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral; (3) the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered; (4) the average monthly patient caseload for each type of qualifying practitioner; (5) the treatment retention rates for patients; (6) overdose and mortality rates; and (7) any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner. 3004. High-quality, evidence-based opioid analgesic prescribing guidelines and report (a) Guidelines The Commissioner of Food and Drugs shall develop high-quality, evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain in the relevant therapeutic areas where such guidelines do not exist. (b) Public input In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall— (1) conduct a public workshop, open to representatives of State medical societies and medical boards, various medical specialties including pain medicine specialty societies, patient groups, pharmacists, universities, and others; and (2) provide a period for the submission of comments by the public. (c) Report Not later than the date that is 2 years after the date of enactment of this Act, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the guidelines under subsection (a) will be utilized to protect the public health. (d) Updates The Commissioner of Food and Drugs shall periodically— (1) update the guidelines under subsection (a), informed by public input described in subsection (b); and (2) submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under subsection (c). (e) Statement To accompany guidelines and recommendations The Commissioner of Food and Drugs shall ensure that any opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable— (1) are intended to help inform clinical decisionmaking by prescribers and patients; and (2) should not be used by other parties, including pharmacy benefit management companies, retail or community pharmacies, or public and private payors, for the purposes of restricting, limiting, delaying, or denying coverage for or access to a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. (f) Definition In this section, the term evidence-based means informed by a robust and systemic review of treatment efficacy and clinical evidence. 3005. Report on opioids prescribing practices for pregnant women (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Centers for Disease Control and Prevention, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration shall develop and submit to the Congress a report— (1) on opioids prescribing practices for pregnant women and recommendations for such practices; (2) that provides recommendations for identifying and reducing opioids misuse during pregnancy; (3) on prescription opioid misuse during pregnancy in urban and rural areas; (4) on prescription opioid use during pregnancy for the purpose of medication-assisted treatment in urban and rural areas; (5) evaluating current utilization of non-opiate pain management practices in place of prescription opioids during pregnancy; (6) providing guidelines encouraging the use of non-opioid pain management practices during pregnancy when safe and effective; and (7) that provides recommendations for increasing public awareness and education of opioid use disorder in pregnancy, including available treatment resources in urban and rural areas. (b) No additional funds No additional funds are authorized to be appropriated for purposes of carrying out subsection (a). 3006. Guidelines for prescribing naloxone (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidelines for prescribing an opioid overdose reversal drug. (b) Contents In issuing guidelines under subsection (a), the Secretary shall address the following: (1) Co-prescribing an opioid overdose reversal drug in conjunction with any prescribed opioid. (2) Dosage safety. (3) Prescribing an opioid overdose reversal drug to an individual other than a patient. (4) Standing orders. (5) Other distribution, education, and safety measures as determined necessary. 3007. Requiring a survey of substance use disorder treatment providers receiving Federal funding (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall conduct a survey of all entities that receive Federal funding for the purpose of providing substance use disorder treatment services. The survey shall direct such entities to provide the following information: (1) The length of time the entity has provided substance use disorder treatment services. (2) A detailed description of the patient population served by the entity, including but not limited to the number of patients, type of addictions, geographic area served, as well as gender, racial, ethnic and socioeconomic demographics of such patients. (3) A detailed description of the types of addiction for which the entity has the experience, capability, and capacity to provide such services. (4) An explanation of how the entity handles patients requiring treatment for a substance use disorder that the organization is not able to treat. (5) A description of what is needed, in the opinion of the entity, in order to improve the entity’s ability to meet the addiction treatment needs of the communities served by that entity. (6) Based on the identified needs of the communities served, a description of unmet needs and inadequate services and how such needs and services could be better addressed through additional Federal, State, or local government resources or funding to treat addiction to methamphetamine, crack cocaine, other types of cocaine, heroin, opioids, and other commonly abused drugs. (b) Report Not later than 1 year after the date of the enactment of this Act, the Secretary shall develop and submit to Congress a plan to direct appropriate resources to entities that provide substance use disorder treatment services in order to address inadequacies in services or funding identified through the survey described in subsection (a). IV Offsets 4001. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). . 4002. Extending period of application of Medicare secondary payer rules for individuals with end stage renal disease Section 1862(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395y(b)(1)(C) ) is amended— (1) in the last sentence, by inserting and before January 1, 2020 after date of enactment of the Balanced Budget Act of 1997 ; and (2) by adding at the end the following new sentence: Effective for items and services furnished on or after January 1, 2020 (with respect to periods beginning on or after July 1, 2018), clauses (i) and (ii) shall be applied by substituting 33-month for 12-month each place it appears. . 4003. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program Clause (i) of section 1862(b)(7)(A) of the Social Security Act ( 42 U.S.C. 1395y(b)(7)(A) ) is amended to read as follows: (i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been— (I) a primary plan to the program under this title; or (II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and . V Other Medicaid Provisions A Mandatory reporting with respect to adult behavioral health measures 5001. Mandatory reporting with respect to adult behavioral health measures Section 1139B of the Social Security Act ( 42 U.S.C. 1320b–9b ) is amended— (1) in subsection (b)— (A) in paragraph (3)— (i) by striking Not later than January 1, 2013 and inserting the following: (A) Voluntary reporting Not later than January 1, 2013 ; and (ii) by adding at the end the following: (B) Mandatory reporting with respect to behavioral health measures Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults. ; and (B) in paragraph (5), by adding at the end the following new subparagraph: (C) Behavioral health measures Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures. ; and (2) in subsection (d)(1)(A)— (A) by striking the such plan and inserting such plan ; and (B) by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)) . B Medicaid IMD Additional Info 5011. Short title This subtitle may be cited as the Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act . 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid (a) In general Not later than January 1, 2020, the Medicaid and CHIP Payment and Access Commission established under section 1900 of the Social Security Act ( 42 U.S.C. 1396 ) shall conduct an exploratory study, using data from a representative sample of States, and submit to Congress a report on at least the following information, with respect to services furnished to individuals enrolled under State plans under the Medicaid program under title XIX of such Act ( 42 U.S.C. 1396 et seq.) (or waivers of such plans) who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such State plans (or waivers): (1) A description of such institutions for mental diseases in each such State, including at a minimum— (A) the number of such institutions in the State; (B) the facility type of such institutions in the State; and (C) any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services. (2) With respect to each such institution for mental diseases in each such State, a description of— (A) such services provided at such institution; (B) the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and (C) the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process. (3) A description of— (A) any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and (B) any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments. (4) A summary of State requirements (such as certification, licensure, and accreditation) applied by each such State to such institutions in order for such institutions to receive payment under the State plan (or waiver) and how each such State determines if such requirements have been met. (5) A summary of State standards (such as quality standards, clinical standards, and facility standards) that such institutions must meet to receive payment under such State plans (or waivers) and how each such State determines if such standards have been met. (6) Recommendations for actions by Congress and the Centers for Medicare & Medicaid Services. such as how State Medicaid programs may improve care and improve standards and including a recommendation for how the Centers for Medicare & Medicaid Services can improve data collection from such programs to address any gaps in information. (b) Stakeholder input In carrying out subsection (a), the Medicaid and CHIP Payment and Access Commission shall seek input from State Medicaid directors and stakeholders, including at a minimum the Substance Abuse and Mental Health Services Administration, Centers for Medicare & Medicaid Services, State Medicaid officials, State mental health authorities, Medicaid beneficiary advocates, health care providers, and Medicaid managed care organizations. (c) Definitions In this section: (1) Representative sample of States The term representative sample of States means a non-probability sample in which at least two States are selected based on the knowledge and professional judgment of the selector. (2) State The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (3) Institution for mental diseases The term institution for mental diseases has the meaning given such term in section 435.1009 of title 42, Code of Federal Regulations, or any successor regulation. C CHIP Mental Health Parity 5021. Short title This subtitle may be cited as the CHIP Mental Health Parity Act . 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program (a) In general Section 2103(c)(1) of the Social Security Act ( 42 U.S.C. 1397cc(c)(1) ) is amended by adding at the end the following new subparagraph: (E) Mental health and substance use disorder services (as defined in paragraph (5)). . (b) Mental health and substance use disorder services (1) In general Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended— (A) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and (B) by inserting after paragraph (4) the following new paragraph: (5) Mental health and substance use disorder services Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income women (as defined in section 2112(d)) shall— (A) include coverage of mental health services (including behavioral health treatment) necessary to prevent, diagnose, and treat a broad range of mental health symptoms and disorders, including substance use disorders; and (B) be delivered in a culturally and linguistically appropriate manner. . (2) Conforming amendments (A) Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ) is amended, in the matter before paragraph (1), by striking paragraphs (5), (6), and (7) and inserting paragraphs (5), (6), (7), and (8) . (B) Section 2110(a) of the Social Security Act ( 42 U.S.C. 1397jj(a) ) is amended— (i) in paragraph (18), by striking substance abuse each place it appears and inserting substance use ; and (ii) in paragraph (19), by striking substance abuse and inserting substance use . (C) Section 2110(b)(5)(A)(i) of the Social Security Act ( 42 U.S.C. 1397jj(b)(5)(A)(i) ) is amended by striking subsection (c)(5) and inserting subsection (c)(6) . (c) Assuring access to care Section 2102(a)(7)(B) of the Social Security Act ( 42 U.S.C. 1397bb(c)(2) ) is amended by striking section 2103(c)(5) and inserting paragraphs (5) and (6) of section 2103(c) . (d) Mental health services parity Subparagraph (A) of paragraph (7) of section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) (as redesignated by subsection (b)(1)) is amended to read as follows: (A) In general A State child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services (as described in paragraph (5)) provided under such plan comply with the requirements of section 2726(a) of the Public Health Service Act in the same manner as such requirements or limitations apply to a group health plan under such section. . (e) Effective date (1) In general Subject to paragraph (2), the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is 1 year after the date of the enactment of this Act. (2) Exception for State legislation In the case of a State child health plan under title XXI of the Social Security Act (or a waiver of such plan), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan (or waiver) to meet any requirement imposed by the amendments made by this section, the respective plan (or waiver) shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this section. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. D Medicaid Reentry 5031. Short title This subtitle may be cited as the Medicaid Reentry Act . 5032. Promoting State innovations to ease transitions integration to the community for certain individuals (a) Stakeholder group development of best practices; State Medicaid program innovation (1) Stakeholder group best practices Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a stakeholder group of representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, and other relevant representatives from local, State, and Federal jail and prison systems to develop best practices (and submit to the Secretary and Congress a report on such best practices) for States— (A) to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and (B) to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution. (2) State Medicaid program innovation The Secretary of Health and Human Services shall work with States on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the Medicaid program under title XIX of the Social Security Act transition, with respect to enrollment for medical assistance under such program, seamlessly to the community. (b) Guidance on innovative service delivery systems demonstration project opportunities Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a State Medicaid Director letter, based on best practices developed under subsection (a)(1), regarding opportunities to design demonstration projects under section 1115 of the Social Security Act ( 42 U.S.C. 1315 ) to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title XIX of such Act, including systems for, with respect to a period (not to exceed 30 days) immediately prior to the day on which such individuals are expected to be released from such institution— (1) providing assistance and education for enrollment under a State plan under the Medicaid program under title XIX of such Act for such individuals during such period; and (2) providing health care services for such individuals during such period. (c) Rule of construction Nothing under title XIX of the Social Security Act or any other provision of law precludes a State from reclassifying or suspending (rather than terminating) eligibility of an individual for medical assistance under title XIX of the Social Security Act while such individual is an inmate of a public institution. E Medicaid Partnership 5041. Short title This subtitle may be cited as the Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act . 5042. Medicaid providers are required to note experiences in record systems to help in-need patients (a) Requirements under the Medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) is amended by inserting after section 1943 the following new section: 1944. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances (a) In general Beginning October 1, 2021, a State shall, subject to subsection (d), require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance. (b) Qualified prescription drug monitoring program described A qualified prescription drug monitoring program described in this subsection is, with respect to a State, a prescription drug monitoring program administered by the State that, at a minimum, satisfies each of the following criteria: (1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible: (A) Information regarding the prescription drug history of a covered individual with respect to controlled substances. (B) The number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period. (C) The name, location, and contact information (or other identifying number selected by the State, such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent 12-month period. (2) The program facilitates the integration of information described in paragraph (1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe controlled substances. A qualified prescription drug monitoring program described in this subsection, with respect to a State, may have in place, in accordance with applicable State and Federal law, a data sharing agreement with the State Medicaid program that allows the medical director and pharmacy director of such program (and any designee of such a director who reports directly to such director) to access the information described in paragraph (1) in an electronic format. The State Medicaid program under this title may facilitate reasonable and limited access, as determined by the State and ensuring documented beneficiary protections regarding the use of such data, to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under section 1903(m) or under section 1905(t)(3), or the medical director or pharmacy director of any entity has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the State plan (or waiver of the State plan). All applicable State and Federal security and privacy laws shall apply to the directors or designees of such directors of any State Medicaid program or entity accessing a qualified prescription drug monitoring program under this section. (c) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (d) Ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the application of the requirement under subsection (a), with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (e) Reports (1) State reports Each State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2023, information including, at a minimum, the following information for the most recent 12-month period: (A) The percentage of covered providers (as determined pursuant to a process established by the State) who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance. (B) Aggregate trends with respect to prescribing controlled substances such as— (i) the quantity of daily morphine milligram equivalents prescribed for controlled substances; (ii) the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and (iii) the types of controlled substances prescribed, including the dates of such prescriptions, the supplies authorized (including the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this title and title XVIII). (C) Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified drug management program before dispensing a controlled substance to such individual. (2) Report by CMS Not later than October 1, 2023, the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information: (A) Guidance for States on how States can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection (b). (B) Best practices for how States and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances. (f) Increase to Federal matching rate for certain expenditures relating to qualified prescription drug management programs The Secretary shall increase the Federal medical assistance percentage or Federal matching rate that would otherwise apply to a State under section 1903(a) for a calendar quarter occurring during the period beginning October 1, 2018, and ending September 30, 2021, for expenditures by the State for activities under the State plan (or waiver of the State plan) to implement a prescription drug management program that satisfies the criteria described in paragraphs (1) and (2) of subsection (b) if the State (in this subsection referred to as the administering State ) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug management program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program. In no case shall an increase under this subsection result in a Federal medical assistance percentage or Federal matching rate that exceeds 100 percent. (g) Rule of construction Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified drug management program before dispensing controlled substances to such individuals. (h) Definitions In this section: (1) Controlled substance The term controlled substance means a drug that is included in schedule II of section 202(c) of the Controlled Substances Act and, at the option of the State involved, a drug included in schedule III or IV of such section. (2) Covered individual The term covered individual means, with respect to a State, an individual who is enrolled in the State plan (or under a waiver of such plan). Such term does not include an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as exempted from such term. (3) Covered provider (A) In general The term covered provider means, subject to subparagraph (B), with respect to a State, a health care provider who is participating under the State plan (or waiver of the State plan) and licensed, registered, or otherwise permitted by the State to prescribe a controlled substance (or the designee of such provider). (B) Exceptions (i) In general Beginning October 1, 2021, for purposes of this section, such term does not include a health care provider included in any type of health care provider determined by the Secretary to be exempt from application of this section under clause (ii). (ii) Exceptions process Not later than October 1, 2020, the Secretary, after consultation with the National Association of Medicaid Directors, national health care provider associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of health care providers (if any) that should be exempted from the definition of the term covered provider for purposes of this section. . (b) Guidance Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs. (c) Development of model State practices (1) In general Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act, as added by subsection (a), for the following purposes: (A) Monitoring and preventing fraud, waste, and abuse. (B) Improving health care for individuals enrolled in a State plan under title XIX of such Act (or waiver of such plan) who— (i) transition in and out of coverage under such title; (ii) may have sources of health care coverage in addition to coverage under such title; or (iii) pay for prescription drugs with cash. (C) Any other purposes specified by the Secretary. (2) Elements of model practices The model practices described in paragraph (1)— (A) shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and (B) shall include any appropriate beneficiary protections and privacy guidelines. (3) Consultation In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act) with contracts with States pursuant to section 1903(m) of such Act, pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records. (d) Report by Comptroller General Not later than October 1, 2020, the Comptroller General of the United States shall issue a report examining the operation of prescription drug monitoring programs administered by States, including data security and access standards used by such programs. VI Other Medicare Provisions A Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ) is amended by adding at the end the following new clause: (xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))). . B Abuse Deterrent Access 6011. Short title This subtitle may be cited at the Abuse Deterrent Access Act of 2018 . 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare (a) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an MA–PD plan under part C of title XVIII of the Social Security Act or a prescription drug plan under part D of such title of such Act, taking into account any barriers preventing such individuals from accessing such formulations under such MA–PD or part D plans, such as cost-sharing tiers, fail-first requirements, the price of such formulations, and prior authorization requirements. (b) Definition of abuse-deterrent opioid formulation In this section, the term abuse-deterrent opioid formulation means an opioid that is a prodrug or that has certain abuse-deterrent properties, such as physical or chemical barriers, agonist or antagonist combinations, aversion properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid. C Medicare Opioid Safety Education 6021. Short title This subtitle may be cited as the Medicare Opioid Safety Education Act of 2018 . 6022. Provision of information regarding opioid use and pain management as part of Medicare & You handbook (a) In general Section 1804 of the Social Security Act ( 42 U.S.C. 1395b–2 ) is amended by adding at the end the following new subsection: (d) The notice provided under subsection (a) shall include— (1) educational resources, compiled by the Secretary, regarding opioid use and pain management; and (2) a description of alternative, non-opioid pain management treatments covered under this title. . (b) Effective date The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019. D Opioid Addiction Action Plan 6031. Short title This subtitle may be cited as the Opioid Addiction Action Plan Act . 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment (a) In general Not later than January 1, 2019, the Secretary of Health and Human Services (in this section referred to as the Secretary ), in collaboration with the Pain Management Best Practices Inter-Agency Task Force convened under section 101(b) of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), shall develop an action plan that provides recommendations described in subsection (b). (b) Action plan components Recommendations described in this subsection are, based on an examination by the Secretary of potential obstacles to an effective response to the opioid crisis, recommendations, as determined appropriate by the Secretary, on the following: (1) Recommendations on changes to the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act that would enhance coverage and payment under such programs of all medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treat and minimize risk of opioid addiction, including recommendations on changes to the Medicare prospective payment system for hospital inpatient department services under section 1886(d) of such Act ( 42 U.S.C. 1395ww(d) ) and the Medicare prospective payment system for hospital outpatient department services under section 1833(t) of such Act ( 42 U.S.C. 1395l(t) ) that would allow for separate payment for such therapies, if medically appropriate and if necessary to encourage development and adoption of such therapies. (2) Recommendations for payment and service delivery models to be tested by the Center for Medicare and Medicaid Innovation and other federally authorized demonstration projects, including value-based models, that may encourage the use of appropriate medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treat and minimize risk of opioid addiction. (3) Recommendations for data collection that could facilitate research and policy making regarding prevention of opioid addiction and coverage and payment under the Medicare and Medicaid programs of appropriate opioid addiction treatments. (4) Recommendations for policies under the Medicare program and under the Medicaid program that can expand access for rural, or medically underserved communities to the full range of medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treatment and minimize risk of opioid addiction. (5) Recommendations on changes to the Medicare program and the Medicaid program to address coverage or payment barriers to patient access to medical devices that are non-opioid based treatments approved by the Food and Drug Administration for the management of acute pain and chronic pain, for monitoring substance use withdrawal and preventing overdoses of controlled substances, and for treating substance use disorder. (c) Stakeholder meetings (1) In general Beginning not later than 3 months after the date of the enactment of this Act, the Secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan recommendations described in subsection (b). (2) Participants Participants of meetings described in paragraph (1) shall include representatives from the Food and Drug Administration and National Institutes of Health, biopharmaceutical industry members, medical researchers, health care providers, the medical device industry, the Medicare program, the Medicaid program, and patient advocates. (d) Request for information Not later than 3 months after the date of the enactment of this section, the Secretary shall issue a request for information seeking public feedback regarding ways in which the Centers for Medicare & Medicaid Services can help address the opioid crisis through the development of and application of the action plan. (e) Report to Congress Not later than June 1, 2019, the Secretary shall submit to Congress, and make public, a report that includes— (1) a summary of recommendations that have emerged under the action plan; (2) the Secretary’s planned next steps with respect to the action plan; and (3) an evaluation of price trends for drugs used to reverse opioid overdoses (such as naloxone), including recommendations on ways to lower such prices for consumers. (f) Definition of Medication-Assisted treatment In this section, the term medication-assisted treatment includes opioid treatment programs, behavioral therapy, and medications to treat substance abuse disorder. E Advancing High Quality Treatment for Opioid Use Disorders in Medicare 6041. Short title This subtitle may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 6042. Opioid use disorder treatment demonstration program Title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E ( 42 U.S.C. 1395cc–5 ) the following new section: 1866F. Opioid use disorder treatment demonstration program (a) Implementation of 4-year demonstration program (1) In general Not later than January 1, 2021, the Secretary shall implement a 4-year demonstration program under this title (in this section referred to as the Program ) to increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce expenditures under this title. Under the Program, the Secretary shall make payments under subsection (e) to participants (as defined in subsection (c)(1)(A)) for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams, or arranging for such services to be furnished, to applicable beneficiaries participating in the Program. (2) Opioid use disorder treatment services For purposes of this section, the term opioid use disorder treatment services — (A) means, with respect to an applicable beneficiary, services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act for the treatment of opioid use disorders in an outpatient setting; and (B) includes— (i) medication assisted treatment; (ii) treatment planning; (iii) psychiatric, psychological, or counseling services (or any combination of such services), as appropriate; (iv) social support services, as appropriate; and (v) care management and care coordination services, including coordination with other providers of services and suppliers not on an opioid use disorder care team. (b) Program design (1) In general The Secretary shall design the Program in such a manner to allow for the evaluation of the extent to which the Program accomplishes the following purposes: (A) Reduces hospitalizations and emergency department visits. (B) Increases use of medication-assisted treatment for opioid use disorders. (C) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV). (D) Does not increase the total spending on items and services under this title. (E) Reduces deaths from opioid overdose. (F) Reduces the utilization of inpatient residential treatment. (2) Consultation In designing the Program, including the criteria under subsection (e)(2)(A), the Secretary shall, not later than 3 months after the date of the enactment of this section, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups. (c) Participants; opioid use disorder care teams (1) Participants (A) Definition In this section, the term participant means an entity or individual— (i) that is otherwise enrolled under this title and that is— (I) a physician (as defined in section 1861(r)(1)); (II) a group practice comprised of at least one physician described in subclause (I); (III) a hospital outpatient department; (IV) a federally qualified health center (as defined in section 1861(aa)(4)); (V) a rural health clinic (as defined in section 1861(aa)(2)); (VI) a community mental health center (as defined in section 1861(ff)(3)(B)); (VII) a clinic certified as a certified community behavioral health clinic pursuant to section 223 of the Protecting Access to Medicare Act of 2014; or (VIII) any other individual or entity specified by the Secretary; (ii) that applied for and was selected to participate in the Program pursuant to an application and selection process established by the Secretary; and (iii) that establishes an opioid use disorder care team (as defined in paragraph (2)) through employing or contracting with health care practitioners described in paragraph (2)(A), and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the Program. (B) Preference In selecting participants for the Program, the Secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence. (2) Opioid use disorder care teams (A) In general For purposes of this section, the term opioid use disorder care team means a team of health care practitioners established by a participant described in paragraph (1)(A) that— (i) shall include— (I) at least one physician (as defined in section 1861(r)(1)) furnishing primary care services or addiction treatment services to an applicable beneficiary; and (II) at least one eligible practitioner (as defined in paragraph (3)(A)), who may be a physician who meets the criterion in subclause (I); and (ii) may include other practitioners licensed under State law to furnish psychiatric, psychological, counseling, and social services to applicable beneficiaries. (B) Requirements for receipt of payment under Program In order to receive payments under subsection (e), each participant in the Program shall— (i) furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services; (ii) meet minimum criteria, as established by the Secretary; and (iii) submit to the Secretary, in such form, manner, and frequency as specified by the Secretary, with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team, data and such other information as the Secretary determines appropriate to— (I) monitor and evaluate the Program; (II) determine if minimum criteria are met under clause (ii); and (III) determine the incentive payment under subsection (e). (3) Eligible practitioners; Other provider-related definitions and application provisions (A) Eligible practitioners For purposes of this section, the term eligible practitioner means a physician or other health care practitioner, such as a nurse practitioner, that— (i) is enrolled under section 1866(j)(1); (ii) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and (iii) has in effect a waiver in accordance with section 303(g) of the Controlled Substances Act for such purpose and is otherwise in compliance with regulations promulgated by the Substance Abuse and Mental Health Services Administration to carry out such section. (B) Addiction specialists For purposes of subsection (e)(1)(B)(iv), the term addiction specialist means a physician that possesses expert knowledge and skills in addiction medicine, as evidenced by appropriate certification from a specialty body, a certificate of advanced qualification in addiction medicine, or completion of an accredited residency or fellowship in addiction medicine or addiction psychiatry, as determined by the Secretary. (d) Participation of applicable beneficiaries (1) Applicable beneficiary defined In this section, the term applicable beneficiary means an individual who— (A) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B; (B) is not enrolled in a Medicare Advantage plan under part C; (C) has a current diagnosis for an opioid use disorder; and (D) meets such other criteria as the Secretary determines appropriate. Such term shall include an individual who is dually eligible for benefits under this title and title XIX if such individual satisfies the criteria described in subparagraphs (A) through (D). (2) Voluntary beneficiary participation; limitation on number of beneficiaries An applicable beneficiary may participate in the Program on a voluntary basis and may terminate participation in the Program at any time. Not more than 20,000 applicable beneficiaries may participate in the Program at any time. (3) Services In order to participate in the Program, an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant. Participation under the Program shall not affect coverage of or payment for any other item or service under this title for the applicable beneficiary. (4) Beneficiary access to services Nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this title and applicable beneficiaries shall not be required to relinquish access to any benefit under this title as a condition of receiving services from a participant in the Program. (e) Payments (1) Per applicable beneficiary per month care management fee (A) In general The Secretary shall establish a schedule of per applicable beneficiary per month care management fees. Such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this title to the health care practitioners in the participant’s opioid use disorder care team or, if applicable, to the participant. A participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries, including services not otherwise eligible for payment under this title. (B) Payment amounts In carrying out subparagraph (A), the Secretary shall— (i) consider payments otherwise payable under this title for opioid use disorder treatment services and the needs of applicable beneficiaries; (ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care; (iii) pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months, to reflect the greater time and costs required for the planning and initiation of treatment, as compared to maintenance of treatment; (iv) pay higher per applicable beneficiary per month care management fees for participants that have established opioid use disorder care teams that include an addiction specialist (as defined in subsection (c)(3)(B)); and (v) take into account whether a participant’s opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services. (C) No duplicate payment The Secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month. (2) Incentive payments (A) In general Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid (using a methodology established and at a time determined appropriate by the Secretary) to participants based on the performance of participants with respect to criteria, as determined appropriate by the Secretary, in accordance with subparagraph (B). (B) Criteria (i) In general Criteria described in subparagraph (A) may include consideration of the following: (I) Patient engagement and retention in treatment. (II) Evidence-based medication-assisted treatment. (III) Other criteria established by the Secretary. (ii) Required consultation and consideration In determining criteria described in subparagraph (A), the Secretary shall— (I) consult with stakeholders, including clinicians in the primary care community and in the field of addiction medicine; and (II) consider existing clinical guidelines for the treatment of opioid use disorders. (C) No duplicate payment The Secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary. (f) Multipayer strategy In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the Program under subsection (e)(2)(C). The Secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the Program. (g) Evaluation (1) In general The Secretary shall conduct an intermediate and final evaluation of the program. Each such evaluation shall determine the extent to which each of the purposes described in subsection (b) have been accomplished under the Program. (2) Reports The Secretary shall submit to the Secretary and Congress— (A) a report with respect to the intermediate evaluation under paragraph (1) not later than 3 years after the date of the implementation of the Program; and (B) a report with respect to the final evaluation under paragraph (1) not later than 6 years after such date. (h) Funding (1) Administrative funding For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841. (2) Care management fees and incentives For the purposes of making payments under subsection (e), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 for each of fiscal years 2021 through 2024. (3) Availability Amounts transferred under this subsection for a fiscal year shall be available until expended. (i) Waivers The Secretary may waive any provision of this title as may be necessary to carry out the Program under this section. . F Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment 6051. Short title This subtitle may be cited as the Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Act of 2018 or the REACH OUT Act of 2018 . 6052. Grants to provide technical assistance to outlier prescribers of opioids (a) Grants authorized The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, through the Centers for Medicare & Medicaid Services, award grants, contracts, or cooperative agreements to eligible entities for the purposes described in subsection (b). (b) Use of funds Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance— (1) to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids; (2) to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and (3) to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids. (c) Application Each eligible entity seeking to receive a grant, contract, or cooperative agreement under subsection (a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. (d) Geographic distribution In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State. (e) Definitions In this section: (1) Eligible entity The term eligible entity means— (A) an organization— (i) that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and (ii) that has at least— (I) one individual who is a representative of consumers on its governing body; and (II) one individual who is a representative of health care providers on its governing body; or (B) an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act ( 42 U.S.C. 1320c et seq.). (2) Outlier prescriber of opioids The term outlier prescriber of opioids means a prescriber, identified by the Secretary of Health and Human Services (through use of prescriber information provided by prescriber National Provider Identifiers included pursuant to section 1860D–4(c)(4)(A) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4)(A) ) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under part D of title XVIII of such Act ( 42 U.S.C. 1395w–101 et seq.) and MA–PD plans under part C of such title ( 42 U.S.C. 1395w–21 et seq.)) as prescribing, as compared to other prescribers in the specialty of the prescriber and geographic area, amounts of opioids in excess of a threshold (and other criteria) specified by the Secretary, after consultation with stakeholders. (3) Prescribers The term prescriber means any health care professional, including a nurse practitioner or physician assistant, who is licensed to prescribe opioids by the State or territory in which such professional practices. (f) Funding For purposes of implementing this section, $75,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act ( 42 U.S.C. 1395t ), to remain available until expended. G Preventing Addiction for Susceptible Seniors 6061. Short title This subtitle may be cited as the Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018 . 6062. Electronic prior authorization for covered part D drugs (a) Inclusion in electronic prescription program Section 1860D–4(e)(2) of the Social Security Act ( 42 U.S.C. 1395w–104(e)(2) ) is amended by adding at the end the following new subparagraph: (E) Electronic prior authorization (i) In general Not later than January 1, 2021, the program shall provide for the secure electronic transmission of— (I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and (II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional. (ii) Electronic transmission (I) Exclusions For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i). (II) Standards In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors. (III) Application Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual. . (b) Sense of Congress regarding electronic prior authorization It is the sense of the Congress that— (1) there should be increased use of electronic prior authorizations for coverage of covered part D drugs for part D eligible individuals enrolled in prescription drug plans under part D of title XVIII of the Social Security Act and MA–PD plans under part C of such title to reduce access delays by resolving coverage issues before prescriptions for such drugs are transmitted; and (2) greater priority should be placed on increasing the adoption of use of such electronic prior authorizations among prescribers of such drugs, pharmacies, PDP sponsors, and Medicare Advantage organizations. 6063. Program integrity transparency measures under Medicare parts C and D (a) In general Section 1859 of the Social Security Act ( 42 U.S.C. 1395w–28 ) is amended by adding at the end the following new subsection: (i) Program integrity transparency measures (1) Program integrity portal (A) In general Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure Internet website portal (or other successor technology) that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or an entity responsible for carrying out program integrity activities under this part and part D) for the purpose of enabling through such portal (or other successor technology)— (i) the referral by such plans of substantiated fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and (ii) data sharing among such MA plans, prescription drug plans, and the Secretary. (B) Required uses of portal The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure Internet website portal (or other successor technology) established under subparagraph (A): (i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period. (ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise. (iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation. (iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal (or other successor technology) with respect to activities of substantiated fraud, waste, or abuse of a provider of services or supplier, if such provider or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken. (C) Rulemaking For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes substantiated fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.7.1. In carrying out this subsection, a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for substantiated fraud, waste, or abuse. (D) HIPAA compliant information only For purposes of this subsection, communications may only occur if the communications are permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (2) Quarterly reports Beginning 2 years after the date of enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal (or other successor technology) described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall— (A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and (B) be anonymized information submitted by plans without identifying the source of such information. (3) Clarification Nothing in this subsection shall be construed as precluding or otherwise affecting referrals described in subparagraph (A) that may otherwise be made to law enforcement entities or to the Secretary. . (b) Contract requirement to communicate plan corrective actions against opioid over-prescribers Section 1857(e) of the Social Security Act ( 42 U.S.C. 1395w–27(e) ) is amended by adding at the end the following new paragraph: (5) Communicating plan corrective actions against opioids over-prescribers (A) In general Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on the investigations and other actions taken by such plans related to providers of services who prescribe a high volume of opioids. (B) Process Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A). (C) Regulations For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking— (i) specify a definition for the term high volume of opioids and a method for determining if a provider of services prescribes such a high volume; and (ii) establish the process described in subparagraph (B) and the types of information that shall be submitted through such process. . (c) Reference under part D to program integrity transparency measures Section 1860D–4 of the Social Security Act ( 42 U.S.C. 1395w–104 ) is amended by adding at the end the following new subsection: (m) Program integrity transparency measures For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i). . 6064. Expanding eligibility for medication therapy management programs under part D Section 1860D–4(c)(2)(A)(ii) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(A)(ii) ) is amended— (1) by redesignating subclauses (I) through (III) as items (aa) through (cc), respectively, and adjusting the margins accordingly; (2) by striking are part D eligible individuals who— and inserting are the following: (I) Part D eligible individuals who— ; and (3) by adding at the end the following new subclause: (II) Beginning January 1, 2021, at-risk beneficiaries for prescription drug abuse (as defined in paragraph (5)(C)). . 6065. Medicare notifications to outlier prescribers of opioids Section 1860D–4(c)(4) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4) ) is amended by adding at the end the following new subparagraph: (D) Outlier prescriber notification (i) Notification Beginning not later than 2 years after the date of the enactment of this subparagraph, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be an outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified and that includes resources on proper prescribing methods and other information specified in accordance with clause (iii). (ii) Identification of outlier prescribers of opioids (I) In general The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the threshold established under subclause (II), conduct an analysis to identify prescribers that are outlier opioid prescribers for a period specified by the Secretary. (II) Establishment of threshold For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish a threshold, based on prescriber specialty and geographic area, for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area. (III) Exclusions The Secretary may exclude the following individuals and prescribers from the analysis under this clause: (aa) Individuals receiving hospice services. (bb) Individuals with a cancer diagnosis. (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Office of Inspector General of the Department of Health and Human Services. (iii) Contents of notification The Secretary shall, based on input from stakeholders, specify the resources and other information to be included in notifications provided under clause (i). (iv) Modifications and expansions (I) Frequency Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input. (II) Expansion to other prescriptions The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary. (v) Opioids defined For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary through program instruction or otherwise. . 6066. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle and the amendments made by this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. H Expanding Oversight of Opioid Prescribing and Payment 6071. Short title This subtitle may be cited as the Expanding Oversight of Opioid Prescribing and Payment Act of 2018 . 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program Not later than March 15, 2019, the Medicare Payment Advisory Commission shall submit to Congress a report on, with respect to the Medicare program under title XVIII of the Social Security Act, the following: (1) A description of how the Medicare program pays for pain management treatments (both opioid and non-opioid pain management alternatives) in both inpatient and outpatient hospital settings. (2) The identification of incentives under the hospital inpatient prospective payment system under section 1886 of the Social Security Act ( 42 U.S.C. 1395ww ) and incentives under the hospital outpatient prospective payment system under section 1833(t) of such Act ( 42 U.S.C. 1395l(t) ) for prescribing opioids and incentives under each such system for prescribing non-opioid treatments, and recommendations as the Commission deems appropriate for addressing any of such incentives that are adverse incentives. (3) A description of how opioid use is tracked and monitored through Medicare claims data and other mechanisms and the identification of any areas in which further data and methods are needed for improving data and understanding of opioid use. 6073. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. I Dr. Todd Graham Pain Management, Treatment, and Recovery 6081. Short title This subtitle may be cited as the Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 . 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments (a) Outpatient prospective payment system Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended by adding at the end the following new paragraph: (22) Review and revisions of payments for non-opioid alternative treatments (A) In general With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary— (i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives; (ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and (iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management. (B) Priority In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management. (C) Revisions If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B). (D) Rules of construction Nothing in this paragraph shall be construed to preclude the Secretary— (i) from conducting a demonstration before making the revisions described in subparagraph (C); or (ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management. . (b) Ambulatory surgical centers Section 1833(i) of the Social Security Act ( 42 U.S.C. 1395l(i) ) is amended by adding at the end the following new paragraph: (8) The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1833(t)), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary). . 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics (a) Federally qualified health centers Section 1834(o) of the Social Security Act ( 42 U.S.C. 1395m(o) ) is amended by adding at the end the following new paragraph: (3) Additional payments for certain FQHCs with physicians or other practitioners receiving DATA 2000 waivers (A) In general In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally-qualified health center services (as defined in section 1861(aa)(3)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph (C) the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Federally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practitioner. (B) Application In order to receive a payment described in subparagraph (A), a Federally-qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally-qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center. (C) Requirements For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following: (i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B). (ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Acton or after January 1, 2019. (D) Funding For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended. . (b) Rural health clinic Section 1833 of the Social Security Act ( 42 U.S.C. 1395l ) is amended— (1) by redesignating the subsection (z) relating to medical review of spinal subluxation services as subsection (aa); and (2) by adding at the end the following new subsection: (bb) Additional payments for certain rural health clinics with physicians or practitioners receiving DATA 2000 waivers (1) In general In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in section 1861(aa)(1)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner. (2) Application In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic. (3) Requirements For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following: (A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2). (B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Acton or after January 1, 2019. (4) Funding For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended. . 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans (a) In general Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall submit to Congress a report on the availability of supplemental health care benefits (as described in section 1852(a)(3)(A) of the Social Security Act ( 42 U.S.C. 1395w–22(a)(3)(A) )) designed to treat or prevent substance use disorders under Medicare Advantage plans offered under part C of title XVIII of such Act. Such report shall include the analysis described in subsection (c) and any differences in the availability of such benefits under specialized MA plans for special needs individuals (as defined in section 1859(b)(6) of such Act ( 42 U.S.C. 1395w–28(b)(6) )) offered to individuals entitled to medical assistance under title XIX of such Act and other such Medicare Advantage plans. (b) Consultation The Secretary shall develop the report described in subsection (a) in consultation with relevant stakeholders, including— (1) individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act; (2) entities who advocate on behalf of such individuals; (3) Medicare Advantage organizations; (4) pharmacy benefit managers; and (5) providers of services and suppliers (as such terms are defined in section 1861 of such Act ( 42 U.S.C. 1395x )). (c) Contents The report described in subsection (a) shall include an analysis on the following: (1) The extent to which plans described in such subsection offer supplemental health care benefits relating to coverage of— (A) medication-assisted treatments for opioid use, substance use disorder counseling, peer recovery support services, or other forms of substance use disorder treatments (whether furnished in an inpatient or outpatient setting); and (B) non-opioid alternatives for the treatment of pain. (2) Challenges associated with such plans offering supplemental health care benefits relating to coverage of items and services described in subparagraph (A) or (B) of paragraph (1). (3) The impact, if any, of increasing the applicable rebate percentage determined under section 1854(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395w–24(b)(1)(C) ) for plans offering such benefits relating to such coverage would have on the availability of such benefits relating to such coverage offered under Medicare Advantage plans. (4) Potential ways to improve upon such coverage or to incentivize such plans to offer additional supplemental health care benefits relating to such coverage. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report (a) CMI models Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) is amended by adding at the end the following new clauses: (xxv) Supporting ways to familiarize individuals with the availability of coverage under part B of title XVIII for qualified psychologist services (as defined in section 1861(ii)). (xxvi) Exploring ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services (such as for treating depression) through use of a 24-hour, 7-day a week help line that may inform individuals about the availability of treatment options, including the availability of qualified psychologist services (as defined in section 1861(ii)). . (b) GAO study and report Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, on mental and behavioral health services under the Medicare program under title XVIII of the Social Security Act, including an examination of the following: (1) Information about services furnished by psychiatrists, clinical psychologists, and other professionals. (2) Information about ways that Medicare beneficiaries familiarize themselves about the availability of Medicare payment for qualified psychologist services (as defined in section 1861(ii) of the Social Security Act ( 42 U.S.C. 1395x(ii) ) and ways that the provision of such information could be improved. 6086. Pain management study (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a study analyzing best practices as well as payment and coverage for pain management services under title XVIII of the Social Security Act and submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report containing options for revising payment to providers and suppliers of services and coverage related to the use of multi-disciplinary, evidence-based, non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act. The Secretary shall make such report available on the public website of the Centers for Medicare & Medicaid Services. (b) Consultation In developing the report described in subsection (a), the Secretary shall consult with— (1) relevant agencies within the Department of Health and Human Services; (2) licensed and practicing osteopathic and allopathic physicians, behavioral health practitioners, physician assistants, nurse practitioners, dentists, pharmacists, and other providers of health services; (3) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (4) substance abuse and mental health professional organizations; (5) pain management professional organizations and advocacy entities, including individuals who personally suffer chronic pain; (6) medical professional organizations and medical specialty organizations; (7) licensed health care providers who furnish alternative pain management services; (8) organizations with expertise in the development of innovative medical technologies for pain management; (9) beneficiary advocacy organizations; and (10) other organizations with expertise in the assessment, diagnosis, treatment, and management of pain, as determined appropriate by the Secretary. (c) Contents The report described in subsection (a) shall include the following: (1) An analysis of payment and coverage under title XVIII of the Social Security Act with respect to the following: (A) Evidence-based treatments and technologies for chronic or acute pain, including such treatments that are covered, not covered, or have limited coverage under such title. (B) Evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids. (C) Evidence-based treatments and technologies that treat substance use disorders. (D) Items and services furnished by practitioners through a multi-disciplinary treatment model for pain management, including the patient-centered medical home. (E) Medical devices, non-opioid based drugs, and other therapies (including interventional and integrative pain therapies) approved or cleared by the Food and Drug Administration for the treatment of pain. (F) Items and services furnished to beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, or have comorbidities and require consultation or management of pain with one or more specialists in pain management, mental health, or addiction treatment. (2) An evaluation of the following: (A) Barriers inhibiting individuals entitled to benefits under part A or enrolled under part B of such title from accessing treatments and technologies described in subparagraphs (A) through (F) of paragraph (1). (B) Costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain, such as acupuncture, therapeutic massage, and items and services furnished by integrated pain management programs. (C) Pain management guidance published by the Federal Government that may be relevant to coverage determinations or other coverage requirements under title XVIII of the Social Security Act. (3) An assessment of all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids. Such assessment shall consider incorporating into such guidance relevant elements of the Va/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain published in February 2017 by the Department of Veterans Affairs and Department of Defense, including adoption of elements of the Department of Defense and Department of Veterans Affairs pain rating scale. (4) The options described in subsection (d). (5) The impact analysis described in subsection (e). (d) Options The options described in this subsection are, with respect to individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act, legislative and administrative options for accomplishing the following: (1) Improving coverage of and payment for pain management therapies without the use of opioids, including interventional pain therapies, and options to augment opioid therapy with other clinical and complementary, integrative health services to minimize the risk of substance use disorder, including in a hospital setting. (2) Improving coverage of and payment for medical devices and non-opioid based pharmacological and non-pharmacological therapies approved or cleared by the Food and Drug Administration for the treatment of pain as an alternative or augment to opioid therapy. (3) Improving and disseminating treatment strategies for beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, and treatment strategies to address health disparities related to opioid use and opioid abuse treatment. (4) Improving and disseminating treatment strategies for beneficiaries with comorbidities who require a consultation or comanagement of pain with one or more specialists in pain management, mental health, or addiction treatment, including in a hospital setting. (5) Educating providers on risks of coadministration of opioids and other drugs, particularly benzodiazepines. (6) Ensuring appropriate case management for beneficiaries who transition between inpatient and outpatient hospital settings, or between opioid therapy to non-opioid therapy, which may include the use of care transition plans. (7) Expanding outreach activities designed to educate providers of services and suppliers under the Medicare program and individuals entitled to benefits under part A or under part B of such title on alternative, non-opioid therapies to manage and treat acute and chronic pain. (8) Creating a beneficiary education tool on alternatives to opioids for chronic pain management. (e) Impact analysis The impact analysis described in this subsection consists of an analysis of any potential effects implementing the options described in subsection (d) would have— (1) on expenditures under the Medicare program; and (2) on preventing or reducing opioid addiction for individuals receiving benefits under the Medicare program. J Combating Opioid Abuse for Care in Hospitals 6091. Short title This subtitle may be cited as the Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018 . 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program (a) In general Not later than January 1, 2019, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall develop and publish on the public website of the Centers for Medicare & Medicaid Services guidance for hospitals receiving payment under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) on pain management strategies and opioid use disorder prevention strategies with respect to individuals entitled to benefits under such part. (b) Consultation In developing the guidance described in subsection (a), the Secretary shall consult with relevant stakeholders, including— (1) medical professional organizations; (2) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (3) health care consumers or groups representing such consumers; and (4) other entities determined appropriate by the Secretary. (c) Contents The guidance described in subsection (a) shall include, with respect to hospitals and individuals described in such subsection, the following: (1) Best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder, including— (A) methods to identify such individuals at-risk of opioid use disorder, including risk stratification; (B) ways to prevent, recognize, and treat opioid overdoses; and (C) resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs. (2) Best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders, including education on— (A) the adverse effects of prolonged opioid use; (B) non-opioid, evidence-based, non-pharmacological pain management treatments; (C) monitoring programs for individuals who have been prescribed opioids; and (D) the prescribing of naloxone along with an initial opioid prescription. (3) Best practices for such hospitals to make such individuals aware of the risks associated with opioid use (which may include use of the notification template described in paragraph (4)). (4) A notification template developed by the Secretary, for use as appropriate, for such individuals who are prescribed an opioid that— (A) explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely; (B) highlights multimodal and evidence-based non-opioid alternatives for pain management; (C) encourages such individuals to talk to their health care providers about such alternatives; (D) provides for a method (through signature or otherwise) for such an individual, or person acting on such individual’s behalf, to acknowledge receipt of such notification template; (E) is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and (F) includes any other information determined appropriate by the Secretary. (5) Best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital, including— (A) ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners; (B) guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs; (C) strategies to reduce long-term opioid prescriptions; and (D) methods to identify such practitioners who may be over-prescribing opioids. (6) Other information the Secretary determines appropriate, including any such information from the Opioid Safety Initiative established by the Department of Veterans Affairs or the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs (a) In general Section 1890A of the Social Security Act ( 42 U.S.C. 1395aaa–1 ) is amended by adding at the end the following new subsection: (g) Technical expert panel review of opioid and opioid use disorder quality measures (1) In general Not later than 180 days after the date of the enactment of this subsection, the Secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders, including care, prevention, diagnosis, health outcomes, and treatment furnished to individuals with opioid use disorders. The Secretary may use the entity with a contract under section 1890(a) and amend such contract as necessary to provide for the establishment of such technical expert panel. (2) Review and assessment Not later than 1 year after the date the technical expert panel described in paragraph (1) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall— (A) review quality measures that relate to opioids and opioid use disorders, including existing measures and those under development; (B) identify gaps in areas of quality measurement that relate to opioids and opioid use disorders, and identify measure development priorities for such measure gaps; and (C) make recommendations to the Secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System under section 1848(q), the alternative payment models under section 1833(z)(3)(C), the shared savings program under section 1899, the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and the hospital value-based purchasing program under section 1886(o). (3) Consideration of measures by secretary The Secretary shall consider— (A) using opioid and opioid use disorder measures (including measures used under the Merit-Based Incentive Payment System under section 1848(q), measures recommended under paragraph (2)(C), and other such measures identified by the Secretary) in alternative payment models under section 1833(z)(3)(C) and in the shared savings program under section 1899; and (B) using opioid measures described in subparagraph (A), as applicable, in the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii),and in the hospital value-based purchasing program under section 1886(o). (4) Prioritization of measure development The Secretary shall prioritize for measure development the gaps in quality measures identified under paragraph (2)(B). . (b) Expedited endorsement process for opioid measures Section 1890(b)(2) of the Social Security Act ( 42 U.S.C. 1395aaa(b)(2) ) is amended by adding at the end the following new flush sentence: Such endorsement process shall, as determined practicable by the entity, provide for an expedited process with respect to the endorsement of such measures relating to opioids and opioid use disorders. . 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use (a) Technical expert panel on reducing surgical setting opioid use (1) In general Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a technical expert panel, including medical and surgical specialty societies and hospital organizations, to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings and on best practices for pain management, including with respect to the following: (A) Approaches that limit patient exposure to opioids during the perioperative period, including pre-surgical and post-surgical injections, and that identify such patients at risk of opioid use disorder pre-operation. (B) Shared decision making with patients and families on pain management, including recommendations for the development of an evaluation and management code for purposes of payment under the Medicare program under title XVIII of the Social Security Act that would account for time spent on shared decision making. (C) Education on the safe use, storage, and disposal of opioids. (D) Prevention of opioid misuse and abuse after discharge. (E) Development of a clinical algorithm to identify and treat at-risk, opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period. (2) Report Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress and make public a report containing the recommendations developed under paragraph (1) and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge from such setting. (b) Data collection on perioperative opioid use Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains the following: (1) The diagnosis-related group codes identified by the Secretary as having the highest volume of surgeries. (2) With respect to each of such diagnosis-related group codes so identified, a determination by the Secretary of the data that is both available and reported on opioid use following such surgeries, such as with respect to— (A) surgical volumes, practices, and opioid prescribing patterns; (B) opioid consumption, including— (i) perioperative days of therapy; (ii) average daily dose at the hospital, including dosage greater than 90 milligram morphine equivalent; (iii) post-discharge prescriptions and other combination drugs that are used before intervention and after intervention; (iv) quantity and duration of opioid prescription at discharge; and (v) quantity consumed and number of refills; (C) regional anesthesia and analgesia practices, including pre-surgical and post-surgical injections; (D) naloxone reversal; (E) post-operative respiratory failure; (F) information about storage and disposal; and (G) such other information as the Secretary may specify. (3) Recommendations for improving data collection on perioperative opioid use, including an analysis to identify and reduce barriers to collecting, reporting, and analyzing the data described in paragraph (2), including barriers related to technological availability. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall post on the public website of the Centers for Medicare & Medicaid Services all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids and applicable to opioid prescriptions for individuals entitled to benefits under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) or enrolled under part B of such title of such Act ( 42 U.S.C. 1395j et seq.). (b) Update of guidance (1) Periodic update The Secretary shall, in consultation with the entities specified in paragraph (2), periodically (as determined appropriate by the Secretary) update guidance described in subsection (a) and revise the posting of such guidance on the website described in such subsection. (2) Consultation The entities specified in this paragraph are the following: (A) Medical professional organizations. (B) Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )). (C) Health care consumers or groups representing such consumers. (D) Other entities determined appropriate by the Secretary. K Stop Excessive Narcotics in our Retirement Communities Protection 6101. Short title This subtitle may be cited as the Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 or the SENIOR Communities Protection Act of 2018 . 6102. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies (a) In general Section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended by adding at the end the following new paragraph: (7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies (A) In general The provisions of section 1862(o) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such provisions apply with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. (B) Rule of construction Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review. . (b) Application to MA–PD plans Section 1857(f)(3) of the Social Security Act ( 42 U.S.C. 1395w–27(f)(3) ) is amended by adding at the end the following new subparagraph: (D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies Section 1860D–12(b)(7). . (c) Conforming amendment Section 1862(o)(3) of the Social Security Act ( 42 U.S.C. 1395y(o)(3) ) is amended by inserting , section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), after this subsection . (d) Clarification relating to credible allegation of fraud Section 1862(o) of the Social Security Act ( 42 U.S.C. 1395y(o) ) is amended by adding at the end the following new paragraph: (4) Credible allegation of fraud In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud. . (e) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020. L Providing Reliable Options for Patients and Educational Resources 6111. Short title This subtitle may be cited as the Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018 . 6112. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain Section 1860D–4(a)(1) of the Social Security Act ( 42 U.S.C. 1395w–104(a)(1) ) is amended— (1) in subparagraph (A), by inserting , subject to subparagraph (C), before including ; (2) in subparagraph (B), by adding at the end the following new clause: (vi) For plan year 2021 and each subsequent plan year, subject to subparagraph (C), with respect to the treatment of pain— (I) the risks associated with prolonged opioid use; and (II) coverage of nonpharmacological therapies, devices, and nonopioid medications— (aa) in the case of an MA-PD plan under part C, under such plan; and (bb) in the case of a prescription drug plan, under such plan and under parts A and B. ; and (3) by adding at the end the following new subparagraph: (C) Targeted provision of information A PDP sponsor of a prescription drug plan may, in lieu of disclosing the information described in subparagraph (B)(vi) to each enrollee under the plan, disclose such information through mail or electronic communications to a subset of enrollees under the plan, such as enrollees who have been prescribed an opioid in the previous 2-year period. . 6113. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs (a) Medicare Advantage Section 1852 of the Social Security Act ( 42 U.S.C. 1395w–22 ) is amended by adding at the end the following new subsection: (n) Provision of information relating to the safe disposal of certain prescription drugs (1) In general In the case of an individual enrolled under an MA or MA-PD plan who is furnished an in-home health risk assessment on or after January 1, 2021, such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal. (2) Criteria The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances. . (b) Prescription drug plans Section 1860D–4(c)(2)(B) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(B) ) is amended— (1) by striking may include elements that promote ; (2) by redesignating clauses (i) through (iii) as subclauses (I) through (III) and adjusting the margins accordingly; (3) by inserting before subclause (I), as so redesignated, the following new clause: (i) may include elements that promote— ; (4) in subclause (III), as so redesignated, by striking the period at the end and inserting ; and ; and (5) by adding at the end the following new clause: (ii) with respect to plan years beginning on or after January 1, 2021, shall provide for— (I) the provision of information to the enrollee on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under section 1852(n)(2), including information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal; and (II) cost-effective means by which an enrollee may so safely dispose of such drugs. . 6114. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management (a) Restriction on the use of pain questions in HCAHPS Section 1886(b)(3)(B)(viii) of the Social Security Act ( 42 U.S.C. 1395ww(b)(3)(B)(viii) ) is amended by adding at the end the following new subclause: (XII) (aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2019, such survey may not include questions about communication by hospital staff with an individual about such individual’s pain unless such questions take into account, as applicable, whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain. (bb) The Secretary shall not include on the Hospital Compare Internet website any measures based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 about communication by hospital staff with an individual about such individual’s pain. . (b) Restriction on use of 2018 pain questions in the hospital value-based purchasing program Section 1886(o)(2)(B) of the Social Security Act ( 42 U.S.C. 1395ww(o)(2)(B) ) is amended by adding at the end the following new clause: (iii) HCAHPS pain questions The Secretary may not include under subparagraph (A) a measure that is based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 about communication by hospital staff with an individual about the individual’s pain. . VII Other Health Provisions A Synthetic Drug Awareness 7001. Short title This subtitle may be cited as the Synthetic Drug Awareness Act of 2018 . 7002. Report on effects on public health of synthetic drug use (a) In general Not later than 3 years after the date of the enactment of this Act, the Surgeon General of the Public Health Service shall submit to Congress a report on the health effects of new psychoactive substances (including synthetic drugs) used since January 2010 by persons who are at least 12 years of age but no more than 18 years of age. (b) New psychoactive substance defined For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act ( 21 U.S.C. 802(32) ). B Empowering Pharmacists in the Fight Against Opioid Abuse 7011. Short title This subtitle may be cited as the Empowering Pharmacists in the Fight Against Opioid Abuse Act . 7012. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Director of the Centers for Disease Control and Prevention, and the Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate programs and materials for training pharmacists, health care providers, and patients on— (1) circumstances under which a pharmacist may, consistent with section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or otherwise indicative of abuse or diversion; and (2) any Federal requirements pertaining to declining to fill a prescription under such cir­cum­stances. (b) Materials included In developing materials under subsection (a), the Secretary of Health and Human Services shall include information educating— (1) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and (2) other health care practitioners and the public on a pharmacist’s responsibility to decline to fill prescriptions in certain circumstances. (c) Stakeholder input In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients. C Indexing Narcotics, Fentanyl, and Opioids 7021. Short title This subtitle may be cited as the Indexing Narcotics, Fentanyl, and Opioids Act of 2018 or the INFO Act . 7022. Establishment of substance use disorder information dashboard Title XVII of the Public Health Service Act ( 42 U.S.C. 300u et seq.) is amended by adding at the end the following new section: 1711. Establishment of substance use disorder information dashboard (a) In general Not later than 6 months after the date of the enactment of this section, the Secretary of Health and Human Services shall, in consultation with the Director of National Drug Control Policy, establish and periodically update a public information dashboard that— (1) coordinates information on programs within the Department of Health and Human Services related to the reduction of opioid abuse and other substance use disorders; (2) provides access to publicly available data from other Federal agencies; State, local, and Tribal governments; nonprofit organizations; law enforcement; medical experts; public health educators; and research institutions regarding prevention, treatment, recovery, and other services for opioid use disorder and other substance use disorders; (3) provides comparable data on substance use disorder prevention and treatment strategies in different regions and population of the United States; (4) provides recommendations for health care providers on alternatives to controlled substances for pain management, including approaches studied by the National Institutes of Health Pain Consortium and the National Center for Complimentary and Integrative Health; and (5) provides guidelines and best practices for health care providers regarding treatment of substance use disorders. (b) Controlled substance defined In this section, the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ). . 7023. Interagency Substance Use Disorder Coordinating Committee (a) Establishment Not later than 3 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, in consultation with the Director of National Drug Control Policy, establish a committee, to be known as the Interagency Substance Use Disorder Coordinating Committee (in this section referred to as the Committee ), to coordinate all efforts within the Department of Health and Human Services concerning substance use disorder. (b) Membership (1) Federal members The following individuals shall be the Federal members of the Committee: (A) The Secretary, who shall service as the Chair of the Committee. (B) The Attorney General of the United States. (C) The Secretary of Labor. (D) The Secretary of Housing and Urban Development. (E) The Secretary of Education. (F) The Secretary of Veterans Affairs. (G) The Commissioner of Social Security. (H) The Assistant Secretary for Mental Health and Substance Use. (I) The Director of the Centers for Disease Control and Prevention. (J) The Director of the National Institutes of Health and the Directors of such national research institutes of the National Institutes of Health as the Secretary determines appropriate. (K) The Administrator of the Centers for Medicare & Medicaid Services. (L) The Director of National Drug Control Policy. (M) Representatives of other Federal agencies that serve individuals with substance use disorder. (2) Non-Federal members The Committee shall include a minimum of 17 non-Federal members appointed by the Secretary, of which— (A) at least two such members shall be an individual who has received treatment for a diagnosis of an opioid use disorder; (B) at least two such members shall be an individual who has received treatment for a diagnosis of a substance use disorder other than an opioid use disorder; (C) at least two such members shall be a State Alcohol and Substance Abuse Director; (D) at least two such members shall be a representative of a leading research, advocacy, or service organization for adults with substance use disorder; (E) at least two such members shall— (i) be a physician, licensed mental health professional, advance practice registered nurse, or physician assistant; and (ii) have experience in treating individuals with opioid use disorder or other substance use disorders; (F) at least one such member shall be a substance use disorder treatment professional who is employed with an opioid treatment program; (G) at least one such member shall be a substance use disorder treatment professional who has research or clinical experience in working with racial and ethnic minority populations; (H) at least one such member shall be a substance use disorder treatment professional who has research or clinical mental health experience in working with medically underserved populations; (I) at least one such member shall be a State-certified substance use disorder peer support specialist; (J) at least one such member shall be a drug court judge or a judge with experience in adjudicating cases related to substance use disorder; (K) at least one such member shall be a law enforcement officer or correctional officer with extensive experience in interacting with adults with a substance use disorder; and (L) at least one such member shall be an individual with experience providing services for homeless individuals and working with adults with a substance use disorder. (c) Terms (1) In general A member of the Committee appointed under subsection (b)(2) shall be appointed for a term of 3 years and may be reappointed for one or more 3-year terms. (2) Vacancies A vacancy on the Committee shall be filled in the same manner in which the original appointment was made. Any individual appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and may serve after the expiration of such term until a successor has been appointed. (d) Meetings The Committee shall meet not fewer than two times each year. (e) Duties The Committee shall— (1) monitor opioid use disorder and other substance use disorder research, services, and support and prevention activities across all relevant Federal agencies, including coordination of Federal activities with respect to opioid use disorder and other substance use disorders; (2) identify and provide to the Secretary recommendations for improving Federal grants and programs for the prevention and treatment of, and recovery from, opioid use disorder and other substance use disorders; (3) review substance use disorder prevention and treatment strategies in different regions and populations in the United States and evaluate the extent to which Federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies; (4) make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in paragraphs (1) through (3); (5) make recommendations to the Secretary regarding public participation in decisions relating to opioid use disorder and other substance use disorders and the process by which public feedback can be better integrated into such decisions; and (6) make recommendations to ensure that opioid use disorder and other substance use disorder research, services, and support and prevention activities of the Department of Health and Human Services and other Federal agencies are not unnecessarily duplicative. (f) Annual report (1) In general Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the life of the Committee, the Committee shall publish on the public information dashboard established under section 7022(a) a report summarizing the activities carried out by the Committee pursuant to subsection (e), including any findings resulting from such activities. (2) Recommendation for Committee extension After the publication of the second report of the Committee under paragraph (1), the Secretary shall submit to Congress a recommendation on whether or not the operations of the Committee should continue after the termination date described in subsection (i). (g) Working groups The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to enable the working group to carry out the duties delegated to the working group. (h) Federal Advisory Committee Act The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee only to the extent that the provisions of such Act do not conflict with the requirements of this section. (i) Sunset The Committee shall terminate on the date that is 6 years after the date on which the Committee is established under subsection (a). D Ensuring Access to Quality Sober Living 7031. Short title This subtitle may be cited as the Ensuring Access to Quality Sober Living Act of 2018 . 7032. National recovery housing best practices Part P of title III of the Public Health Service Act is amended by adding at the end the following new section: 399V–7. National recovery housing best practices (a) Best practices The Secretary of Health and Human Services, in consultation with the Secretary for Housing and Urban Development, patients with a history of opioid use disorder, and other stakeholders, which may include State accrediting entities and reputable providers, analysts, and stakeholders of recovery housing services, such as the National Alliance for Recovery Residences, shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing. (b) Dissemination The Secretary shall disseminate the best practices identified or developed under subsection (a) to— (1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices; (2) recovery housing entities; and (3) the public, as appropriate. (c) Definitions In this section: (1) The term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services, including medication-assisted treatment services, that promote sustained recovery from substance use disorders. (2) The term State includes any of the several States, the District of Columbia, each Indian tribe or tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), and any territory or possession of the United States. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $3,000,000 for the period of fiscal years 2019 through 2021. . E Advancing Cutting Edge Research 7041. Short title This subtitle may be cited as the Advancing Cutting Edge Research Act or the ACE Research Act . 7042. Unique research initiatives Section 402(n)(1) of the Public Health Service Act ( 42 U.S.C. 282(n)(1) ) is amended— (1) in subparagraph (A), by striking or ; (2) in subparagraph (B), by striking the period and inserting ; or ; and (3) by adding at the end the following: (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat. . F Jessie’s Law 7051. Short title This subtitle may be cited as Jessie’s Law . 7052. Inclusion of opioid addiction history in patient records (a) Best practices (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding— (A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient; (B) what constitutes the patient’s request for the purpose described in subparagraph (A); and (C) the process and methods by which the information should be so displayed. (2) Dissemination The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies. (b) Requirements In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following: (1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder. (2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications. (3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers. (4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, to have access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations. (5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations. (6) All applicable Federal and State laws and regulations. 7053. Communication with families during emergencies (a) Promoting awareness of authorized disclosures during emergencies The Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services and the Administrator of the Health Resources and Services Administration, shall annually develop and disseminate written materials (electronically or by other means) to health care providers regarding permitted disclosures under Federal health care privacy law during emergencies, including overdoses, of certain health information to families, caregivers, and health care providers. (b) Use of material For the purposes of carrying out subsection (a), the Secretary of Health and Human Services may use material produced under section 11004 of the 21st Century Cures Act ( 42 U.S.C. 1320d–2 note). G Safe Disposal of Unused Medication 7061. Short title This subtitle may be cited as the Safe Disposal of Unused Medication Act . 7062. Disposal of controlled substances of a deceased hospice patient by employees of a qualified hospice program Subsection (g) of section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ) is amended by adding at the end the following: (5) (A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance after the death of such person, so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law. (B) For the purposes of this paragraph: (i) The terms hospice care and hospice program have the meanings given to those terms in section 1861(dd) of the Social Security Act. (ii) The term employee of a qualified hospice program means a physician, nurse, or other person who— (I) is employed by, or pursuant to arrangements made by, a qualified hospice program; (II) (aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and (bb) is acting within the scope of such employment in accordance with applicable State law; and (III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion. (iii) The term qualified hospice program means a hospice program that— (I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death; (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the patient or patient representative and family; (bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and (cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and (III) at the time following the disposal of the controlled substances— (aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and (bb) the time, date, and manner in which that disposal occurred. . H Substance Use Disorder Workforce Loan Repayment 7071. Short title This subtitle may be cited as the Substance Use Disorder Workforce Loan Repayment Act of 2018 . 7072. Loan repayment program for substance use disorder treatment employees Title VII of the Public Health Service Act is amended— (1) by redesignating part F as part G; and (2) by inserting after part E ( 42 U.S.C. 294n et seq.) the following: F Substance use disorder treatment employees 781. Loan repayment program for substance use disorder treatment employees (a) In general The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a program under which— (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection (b) on the principal of and interest on any eligible loan; and (2) the individuals each agree to complete a period of service in a substance use disorder treatment job, as described in subsection (d). (b) Payments For each year of obligated service by an individual pursuant to an agreement under subsection (a), the Secretary shall make a payment to such individual as follows: (1) Service in a shortage area The Secretary shall pay— (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1/6 of the principal of and interest on each eligible loan of the individual which is outstanding on the date the individual began service pursuant to the agreement; and (B) for completion of the sixth and final year of such service, the remainder of such principal and interest. (2) Maximum amount The total amount of payments under this section to any individual shall not exceed $250,000. (c) Eligible loans The loans eligible for repayment under this section are each of the following: (1) Any loan for education or training for a substance use disorder treatment job. (2) Any loan under part E of title VIII (relating to nursing student loans). (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, or Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965). (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965. (5) Any other Federal loan as determined appropriate by the Secretary. (d) Period of service The period of service required by an agreement under subsection (a) shall consist of up to 6 years of full-time employment, with no more than 1 year passing between any 2 years of covered employment, in a substance use disorder treatment job in the United States in— (1) a Mental Health Professional Shortage Area, as designated under section 332; or (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per 100,000 people over the past 3 years for which official data is available from the State, is higher than the most recent available national average overdose death rate per 100,000 people, as reported by the Centers for Disease Control and Prevention. (e) Ineligibility for double benefits No borrower may, for the same service, receive a reduction of loan obligations or a loan repayment under both— (1) this subsection; and (2) any Federally supported loan forgiveness program, including under section 338B, 338I, or 846 of this Act, or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965. (f) Breach (1) Liquidated damages formula The Secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under subsection (a). (2) Limitation The failure by an individual to complete the full period of service obligated pursuant to such an agreement, taken alone, shall not constitute a breach of the agreement, so long as the individual completed in good faith the years of service for which payments were made to the individual under this section. (g) Additional criteria The Secretary— (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed and in addition to the criteria and rules specified in this section; and (2) shall give notice to the committees specified in subsection (h) of any criteria and rules so established. (h) Report to Congress Not later than 5 years after the date of enactment of the Substance Use Disorder Workforce Loan Repayment Act of 2018 , and every other year thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on— (1) the number and location of borrowers who have qualified for loan repayments under this section; and (2) the impact of this section on the availability of substance use disorder treatment employees nationally and in shortage areas and counties described in subsection (d). (i) Definition In this section: (1) The term municipality means a city, town, or other public body created by or pursuant to State law, or an Indian Tribe. (2) The term substance use disorder treatment job means a full-time job (including a fellowship)— (A) where the primary intent and function of the job is the direct treatment or recovery support of patients with or in recovery from a substance use disorder, such as a physician, physician assistant, registered nurse, nurse practitioner, advanced practice registered nurse, social worker, recovery coach, mental health counselor, addictions counselor, psychologist or other behavioral health professional, or any other relevant professional as determine by the Secretary; and (B) which is located at a substance use disorder treatment program, private physician practice, hospital or health system-affiliated inpatient treatment center or outpatient clinic (including an academic medical center-affiliated treatment program), correctional facility or program, youth detention center or program, inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or other specialty community behavioral health center, recovery center, school, community-based organization, telehealth platform, migrant health center, health program or facility operated by a tribe or tribal organization, Federal medical facility, or any other facility as determined appropriate for purposes of this section by the Secretary. (j) Authorization of appropriations There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2028. . I Preventing Overdoses While in Emergency Rooms 7081. Short title This subtitle may be cited as the Preventing Overdoses While in Emergency Rooms Act of 2018 . 7082. Program to support emergency room discharge and care coordination for drug overdose patients (a) In general The Secretary of Health and Human Services shall establish a program (in this subtitle referred to as the Program ) to develop protocols for discharging patients who have presented with a drug overdose and enhance the integration and coordination of care and treatment options for individuals with substance use disorder after discharge. (b) Grant establishment and participation (1) In general In carrying out the Program, the Secretary shall award grants on a competitive basis to not more than 20 eligible entities described in paragraph (2). (2) Eligibility (A) In general To be eligible for a grant under this subsection, an entity shall be— (i) a health care site described in subparagraph (B); or (ii) a health care site coordinator described in subparagraph (C). (B) Health care sites To be eligible for a grant under this section, a health care site shall— (i) submit an application to the Secretary at such time, in such manner, and containing such information as specified by the Secretary; (ii) have an emergency department; (iii) (I) have a licensed health care professional onsite who has a waiver under section 303(g) of the Controlled Substances Act ( 21 U.S.C. 823(g) ) to dispense or prescribe covered drugs; or (II) have a demonstrable plan to hire a sufficient number of full-time licensed health care professionals who have waivers described in subclause (I) to administer such treatment onsite; (iv) have in place an agreement with a sufficient number and range of entities certified under applicable State and Federal law, such as pursuant to registration or a waiver under section 303(g) of the Controlled Substances Act ( 21 U.S.C. 823(g) ) or certification as described in section 8.2 of title 42 of the Code of Federal Regulations, to provide treatment for substance use disorder such that the entity or the resulting network of entities with an agreement with the hospital cumulatively are capable of providing all evidence-based services for the treatment of substance use disorder, as medically appropriate for the individual involved, including— (I) medication-assisted treatment; (II) withdrawal and detoxification services that include patient evaluation, stabilization, and readiness for and entry into treatment; and (III) counseling; (v) deploy onsite peer recovery specialists to help connect patients with treatment and recovery support services; and (vi) include the provision of overdose reversal medication in discharge protocols for opioid overdose patients. (C) Health care site coordinators To be eligible for a grant under this section, a health care site coordinator shall— (i) be an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 (and exempt from tax under section 501(a) of such Code) or a State, local, or Tribal government; (ii) submit an application to the Secretary at such time, in such manner, and containing such information as specified by the Secretary; and (iii) have an agreement with multiple eligible health care sites described in subparagraph (B). (3) Preference In awarding grants under this section, the Secretary may give preference to eligible entities described in paragraph (2) that meet either or both of the following criteria: (A) The eligible health care site is, or the eligible health care site coordinator has an agreement described in paragraph (2)(C)(iii) with a site that is, a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act ( 42 U.S.C. 1395x(mm)(1) )), a low-volume hospital (as defined in section 1886(d)(12)(C)(i) of such Act ( 42 U.S.C. 1395ww(d)(12)(C)(i) )), or a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act ( 42 U.S.C. 1395ww(d)(5)(D)(iii) )). (B) The eligible health care site or the eligible health care site coordinator is located in a geographic area with a drug overdose rate that is higher than the national rate, or in a geographic area with a rate of emergency department visits for overdoses that is higher than the national rate, as determined by the Secretary based on the most recent data from the Centers for Disease Control and Prevention. (4) Medication-assisted treatment defined For purposes of this section, the term medication-assisted treatment means the use of a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a biological product licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), in combination with behavioral health services, to provide an individualized approach to the treatment of substance use disorders, including opioid use disorders. (c) Period of grant A grant awarded to an eligible entity under this section shall be for a period of at least 2 years. (d) Grant uses (1) Required uses A grant awarded under this section to an eligible entity shall be used for both of the following purposes: (A) To establish policies and procedures that address the provision of overdose reversal medication, prescription and dispensing of medication-assisted treatment to an emergency department patient who has had a non-fatal overdose or who is at risk of a drug overdose, and the subsequent referral to evidence-based treatment upon discharge for patients who have experienced a non-fatal drug overdose or who are at risk of a drug overdose. (B) To develop best practices for treating non-fatal drug overdoses, including with respect to care coordination and integrated care models for long term treatment and recovery options for individuals who have experienced a non-fatal drug overdose. (2) Additional permissible uses A grant awarded under this section to an eligible entity may be used for any of the following purposes: (A) To hire emergency department peer recovery specialists; counselors; therapists; social workers; or other licensed medical professionals specializing in the treatment of substance use disorder. (B) To establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment, follow up, and transportation to treatment facilities. (C) To provide for options for increasing the availability and access of medication-assisted treatment and other evidence-based treatment for individuals with substance use disorders. (D) To offer consultation with and referral to other supportive services that help in treatment and recovery. (e) Reporting requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the entity has received such grant that includes information on— (A) the number of individuals treated at the site (or, in the case of an eligible health care site coordinator, at sites covered by the agreement referred to in subsection (b)(2)(C)(iii)) for non-fatal overdoses in the emergency department; (B) the number of individuals administered each medication-assisted treatment at such site or sites in the emergency department; (C) the number of individuals referred by such site or sites to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals; (D) the frequency and number of patient readmissions for non-fatal overdoses and substance use disorder; (E) for what the grant funding was used; and (F) the effectiveness of, and any other relevant additional data regarding, having an onsite health care professional to administer and begin medication-assisted treatment for substance use disorders. (2) Report by Secretary Not less than 1 year after the conclusion of the Program, the Secretary shall submit to Congress a report that includes— (A) findings of the Program; (B) overall patient outcomes under the Program, such as with respect to hospital readmission; (C) what percentage of patients treated by a site funded through a grant under this section were readmitted to a hospital for non-fatal or fatal overdose; (D) an evaluation determining the effectiveness of having a practitioner onsite to administer and begin medication-assisted treatment for substance use disorder; and (E) a compilation of voluntary guidelines and best practices from the reports submitted under paragraph (1). (f) Authorization of appropriations There is authorized to be appropriated to carry out this subtitle $50,000,000 for the period of fiscal years 2019 through 2023. J Alternatives to Opioids in the Emergency Department 7091. Short title This subtitle may be cited as the Alternatives to Opioids in the Emergency Department Act or the ALTO Act . 7092. Emergency department alternatives to opioids demonstration program (a) Demonstration program grants The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall carry out a demonstration program under which the Secretary shall award grants to hospitals and emergency departments, including freestanding emergency departments, to develop, implement, enhance, or study alternative pain management protocols and treatments that limit the use and prescription of opioids in emergency departments. (b) Eligibility To be eligible to receive a grant under subsection (a), a hospital or emergency department shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (c) Geographic diversity In awarding grants under this section, the Secretary shall seek to ensure geographical diversity among grant recipients. (d) Use of funds Grants under subsection (a) shall be used to— (1) target common painful conditions, such as renal colic, sciatica, headaches, musculoskeletal pain, and extremity fractures; (2) train providers and other hospital personnel on protocols and the use of treatments that limit the use and prescription of opioids in the emergency department; and (3) provide alternatives to opioids to patients with painful conditions, not including patients who present with pain related to cancer, end-of-life symptom palliation, or complex multisystem trauma. (e) Consultation The Secretary shall implement a process for recipients of grants under subsection (a) to consult (in a manner that allows for sharing of evidence-based best practices) with each other and with persons having robust knowledge, including emergency departments and physicians that have successfully deployed alternative pain management protocols, such as non-drug approaches studied through the National Center for Complimentary and Integrative Health including acupuncture that limit the use of opioids. The Secretary shall offer to each recipient of a grant under subsection (a) technical support as necessary. (f) Report to the Secretary Each recipient of a grant under this section shall submit to the Secretary (during the period of such grant) annual reports on the progress of the program funded through the grant. These reports shall include, in accordance with State and Federal statutes and regulations regarding disclosure of patient information— (1) a description of and specific information about the alternative pain management protocols employed; (2) data on the alternative pain management protocols and treatments employed, including— (A) during a baseline period before the program began, as defined by the Secretary; (B) at various stages of the program, as determined by the Secretary; and (C) the conditions for which the alternative pain management protocols and treatments were employed; (3) the success of each specific alternative pain management protocol; (4) data on the opioid prescriptions written, including— (A) during a baseline period before the program began, as defined by the Secretary; (B) at various stages of the program, as determined by the Secretary; and (C) the conditions for which the opioids were prescribed; (5) the demographic characteristics of patients who were treated with an alternative pain management protocol, including age, sex, race, ethnicity, and insurance status and type; (6) data on patients who were eventually prescribed opioids after alternative pain management protocols and treatments were employed; and (7) any other information the Secretary deems necessary. (g) Report to Congress Not later than 1 year after completion of the demonstration program under this section, the Secretary shall submit a report to the Congress on the results of the demonstration program and include in the report— (1) the number of applications received and the number funded; (2) a summary of the reports described in subsection (f), including standardized data; and (3) recommendations for broader implementation of pain management protocols that limit the use and prescription of opioids in emergency departments or other areas of the health care delivery system. (h) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2021. K Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now 7101. Short title This subtitle may be cited as the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act . 7102. Detention, refusal, and destruction of drugs offered for importation (a) Increasing the maximum dollar amount of drugs subject to destruction The sixth sentence in section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking except that the Secretary and all that follows through the two periods at the end and inserting except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is declared to be valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 or such higher amount as the Commissioner of Food and Drugs may set based on a finding by the Commissioner that the higher amount is in the interest of public health), or if such drug is entering the United States by mail, and was not brought into compliance as described under subsection (b). . (b) Destruction of articles of concern The sixth sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ), as amended by subsection (a), is further amended by inserting before the period at the end the following: ; and the Secretary of Health and Human Services may destroy, without the opportunity for export, any article refused admission under clause (6) of the third sentence of this subsection . (c) Technical amendments The seventh, eighth, and ninth sentences of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) are amended— (1) by striking a drug each place it appears and inserting an article ; and (2) by striking the drug each place it appears and inserting the article . (d) Rule of construction The last sentence in section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended to read as follows: Clauses (2), (5), and (6) of the third sentence of this subsection shall not be construed to prohibit the admission of narcotic or nonnarcotic drugs or other substances, the importation of which is permitted under the Controlled Substances Import and Export Act. . 7103. Notification, nondistribution, and recall of adulterated or misbranded drug products (a) Prohibited Acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (eee) The failure to comply with any order issued under section 569D. . (b) Notification, nondistribution, and recall of adulterated or misbranded drugs Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: 569D. Notification, Nondistribution, And Recall Of Adulterated Or Misbranded Drugs (a) Order To cease distribution and recall (1) In general Upon a determination that the use or consumption of, or exposure to, a drug may present an imminent or substantial hazard to the public health, the Secretary shall issue an order requiring any person who distributes the drug to immediately cease distribution of the drug. (2) Hearing An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on— (A) the actions required by the order; and (B) whether the order should be amended to require a recall of the drug. (3) Inadequate grounds If, after providing an opportunity for a hearing under paragraph (2), the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. (4) Amendment to order to require recall If, after providing an opportunity for an informal hearing under paragraph (2), the Secretary determines that the order should be amended to include a recall of the drug with respect to which the order was issued, the Secretary shall— (A) amend the order to require a recall; and (B) after consultation with the drug sponsor, specify a timetable in which the recall will occur. (5) Notice to persons affected An order under this subsection shall require any person who distributes the drug to provide for notice, including to individuals as appropriate, to persons who may be affected by the order to cease distribution of or recall the drug, as applicable. (6) Action following order Any person who is subject to an order under paragraph (1) or (4) shall immediately cease distribution of or recall, as applicable, the drug and provide notification as required by such order. (b) Notice to consumers and health officials The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to— (1) consumers to whom the drug was, or may have been, distributed; and (2) appropriate State and local health officials. (c) Order To recall (1) Contents An order to recall a drug under subsection (a) shall— (A) require periodic reports to the Secretary describing the progress of the recall; and (B) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall. (2) Assistance allowed In providing for notice under paragraph (1)(B), the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary. (3) Nondelegation An order under this section shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research, is an official senior to such Director, or is so designated by such Director. (d) Savings clause Nothing contained in this section shall be construed as limiting— (1) the authority of the Secretary to issue an order to cease distribution of, or to recall, an drug under any other provision of this Act or the Public Health Service Act; or (2) the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act. . (c) Drugs subject to refusal The third sentence of subsection (a) of section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by inserting or (5) in the case of a drug, such drug is subject to an order under section 568 to cease distribution of or recall the drug, before then such article shall be refused admission . (d) Application Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall apply with respect to a drug as of such date, not later than 1 year after the date of the enactment of this Act, as the Secretary of Health and Human Services shall specify. 7104. Single source pattern of shipments of adulterated or misbranded drugs Section 801 of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: (t) Single source pattern of shipments of adulterated or misbranded drugs If the Secretary identifies a pattern of adulterated or misbranded drugs being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order choose to treat all drugs being offered for import from such manufacturer, distributor, or importer as adulterated or misbranded unless otherwise demonstrated. . 7105. Fund to strengthen efforts of FDA to combat the opioid and substance use epidemic Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq.) is amended by adding at the end the following: 1015. Fund to strengthen efforts of FDA to combat the opioid and substance use epidemic (a) In general The Commissioner of Food and Drugs shall use any funds appropriated pursuant to the authorization of appropriations under subsection (c) to carry out the programs and activities described in subsection (d) to strengthen and facilitate the Food and Drug Administration’s efforts to address the opioid and substance use epidemic. Such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities. (b) FDA Opioid and Substance Use Epidemic Response Fund (1) Establishment of fund There is established in the Treasury a fund, to be known as the FDA Opioid and Substance Use Epidemic Response Fund (referred to in this subsection as the Fund ), for purposes of funding the programs and activities described in subsection (d). (2) Transfer For the period of fiscal years 2019 through 2023, $110,000,000 shall be transferred to the Fund from the general fund of the Treasury. (3) Amounts deposited Any amounts transferred under paragraph (2) shall remain unavailable in the Fund until such amounts are appropriated pursuant to subsection (c). (c) Appropriations (1) Authorization of appropriations For the period of fiscal years 2019 through 2023, there is authorized to be appropriated from the Fund to the Food and Drug Administration, for the purpose of carrying out the programs and activities described in subsection (d), an amount not to exceed the total amount transferred to the Fund under subsection (b)(2). Notwithstanding subsection (g), such funds shall remain available until expended. (2) Offsetting future appropriations For any of fiscal years 2019 through 2023, for any discretionary appropriation out of the Fund to the Food and Drug Administration pursuant to the authorization of appropriations under paragraph (1) for the purpose of carrying out the programs and activities described in subsection (d), the total amount of such appropriations for the applicable fiscal year (not to exceed the total amount remaining in the Fund) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985, and the amount transferred to the Fund shall be reduced by the same amount. (d) Food and Drug Administration The entirety of the funds made available pursuant to subsection (c)(1) shall be for the Commissioner of Food and Drugs, pursuant to applicable authorities in the Public Health Service Act ( 42 U.S.C. 201 et seq.) or this Act and other applicable Federal law, to support widespread innovation in non-opioid and non-addictive medical products for pain treatment, access to opioid addiction treatments, appropriate use of approved opioids, and efforts to reduce illicit importation of opioids. Such support may include the following programs and activities: (1) Obligating contract funds beginning in fiscal year 2019 for an educational campaign that will— (A) educate patients and their families to differentiate opioid medications; (B) raise awareness about preferred storage and disposal methods; and (C) inform patients, families, and communities about medication-assisted treatment options. (2) Building the Food and Drug Administration’s presence in international mail facilities, including through— (A) improvements in equipment and information technology enhancements to identify unapproved, counterfeit, or other unlawful pharmaceuticals for destruction; (B) increased and improved surveillance; (C) renovations at international mail facility locations; and (D) the purchase of laboratory equipment. (3) Enhancing the identification and targeting of entities offering products and products being offered by such entities for import into the United States through review and analysis of Internet websites, import data, and other sources of intelligence for purposes of making the best use of the Food and Drug Administration’s inspection and analytical resources. (4) Increasing the number of staff of the Food and Drug Administration to increase the number of packages being examined, ensuring the safety of the staff undertaking such examinations, and ensuring that packages identified as illegal, counterfeit, misbranded, or adulterated are removed from commerce through available authorities, including administrative destruction. (5) Enhancing the Food and Drug Administration’s criminal investigations resources (including full-time equivalent employees and equipment), imports surveillance, and international work. (6) Obtaining for the Food and Drug Administration equipment and full-time equivalent employees needed to efficiently screen and analyze products offered for import, including by building data libraries of new substances and analogues to facilitate identification and evaluation of pharmaceutical-based agents and by purchasing screening technologies for use at international mail facilities. (7) Operating the Food and Drug Administration’s forensic laboratory facility to ensure adequate laboratory space and functionality for additional work and full-time equivalent employees. (e) Accountability and oversight (1) Work plan (A) In general Not later than 180 days after the date of enactment of this Act, the Commissioner of Food and Drugs shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection (c) for each of fiscal years 2019 through 2023 and the contents described in subparagraph (B). (B) Contents The work plan submitted under subparagraph (A) shall include— (i) the amount of money to be obligated or expended out of the Fund in each fiscal year for each program and activity described in subsection (d); and (ii) a description and justification of each such program and activity. (2) Reports (A) Annual reports Not later than October 1 of each of fiscal years 2020 through 2024, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— (i) the amount of money obligated or expended out of the Fund in the prior fiscal year for each program and activity described in subsection (d); (ii) a description of all programs and activities using funds provided pursuant to the authorization of appropriations under subsection (c); and (iii) how the programs and activities are advancing public health. (B) Additional reports At the request of the Committee on Health, Education, Labor and Pensions of the Senate or the Committee on Energy and Commerce of the House of Representatives, the Commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the programs and activities undertaken with such funding. (f) Limitations Notwithstanding any transfer authority authorized by this section or any appropriations Act, any funds made available pursuant to the authorization of appropriations under subsection (c) may not be used for any purpose other than the programs and activities described in subsection (d) to strengthen and facilitate the Food and Drug Administration’s efforts to address the opioid and substance use epidemic. (g) Sunset This section shall expire on September 30, 2022, except that— (1) this subsection does not apply to reporting under subsection (e)(2); and (2) this section shall remain in effect until such time, and to such extent, as may be necessary for the funds transferred by subsection (b)(2) to be fully expended. . 7106. Consideration of potential for misuse and abuse required for drug approval (a) In general Section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ) is amended— (1) in the first sentence— (A) by striking or (7) and inserting (7) ; and (B) by inserting or (8) if the drug is or contains a controlled substance for which a listing in any schedule is in effect under the Controlled Substances Act or that is permanently scheduled pursuant to section 201 of such Act, on the basis of information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, the drug is unsafe for use due to the risks of abuse or misuse or there is insufficient information to show that the drug is safe for use considering such risks; before he shall issue an order refusing to approve the application ; and (2) in the second sentence, by striking (6) and inserting (8) . (b) Withdrawal authority Section 505(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(e) ) is amended in the first sentence— (1) by striking or (5) and inserting (5) ; and (2) by inserting the following: ; or (6) that, in the case of a drug that is or contains a controlled substance for which a listing in any schedule is in effect under the Controlled Substances Act or that is permanently scheduled pursuant to section 201 of such Act, on the basis of new information before him with respect to such drug, evaluated together with the information available to him when the application was approved, that the drug is unsafe for use due to the risks of abuse or misuse after of a material fact . (c) Rule of construction Nothing in the amendments made by this section shall be construed to limit or narrow, in any manner, the meaning or application of the provisions of paragraphs (1), (2), (3), (4), (5), and (7) of section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ) or paragraphs (1) and (2) of section 505(e) of such Act ( 21 U.S.C. 355(e) ). L Treatment, Education, and Community Help to Combat Addiction 7111. Short title This subtitle may be cited as the Treatment, Education, and Community Help to Combat Addiction Act of 2018 or the TEACH to Combat Addiction Act of 2018 . 7112. Establishment of Regional Centers of Excellence in Substance Use Disorder Education Part D of title V of the Public Health Service Act is amended by inserting after section 549 ( 42 U.S.C. 290ee–4 ) the following new section: 550. Regional Centers of Excellence in Substance Use Disorder Education (a) In general The Secretary, in consultation with such other agencies as are appropriate, shall, subject to the availability of appropriations, establish a solicitation process and award cooperative agreements to eligible entities for the designation of such entities as Regional Centers of Excellence in Substance Use Disorder Education and support of such regional centers of excellence to enhance and improve how health professionals are educated in substance use disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. An eligible entity designated by the Secretary as a Regional Center of Excellence in Substance Use Disorder Education shall carry out the activities described in subsection (b). (b) Selection of centers of excellence (1) Eligible entities To be eligible to receive a cooperative agreement under subsection (a), an entity shall— (A) be an entity specified by the Secretary that offers education to students in various health professions, which may include— (i) a health system; (ii) a teaching hospital; (iii) a medical school; (iv) a certified behavioral health clinic; or (v) any other health profession school, school of public health, or Cooperative Extension Program at institutions of higher education engaged in an aspect of the prevention, treatment, or recovery of substance use disorders; (B) be accredited by the appropriate educational accreditation body; (C) demonstrate an existing strategy, and have in place a plan for continuing such strategy, or a proposed strategy to implement a curriculum based on best practices for substance use disorder prevention, treatment, and recovery; (D) demonstrate community engagement and participation through community partners, including other health profession schools, mental health counselors, social workers, peer recovery specialists, substance use treatment programs, community health centers, physicians’ offices, certified behavioral health clinics, law enforcement, and the business community; and (E) provide to the Secretary such information, at such time, and in such manner, as the Secretary may require. (2) Diversity In awarding cooperative agreements under subsection (a), the Secretary shall take into account regional differences among eligible entities and shall make an effort to ensure geographic diversity. (c) Dissemination of information (1) Public posting The Secretary shall make information provided to the Secretary under subsection (b)(1)(E) publically available on the Internet website of the Department of Health and Human Services. (2) Evaluation The Secretary shall evaluate each project carried out by a Regional Center of Excellence in Substance Use Disorder Education under this section and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities. (d) Funding There is authorized to be appropriated to carry out this section, $4,000,000 for each of fiscal years 2019 through 2023. . M Guidance from National Mental Health and Substance Use Policy Laboratory 7121. Guidance from National Mental Health and Substance Use Policy Laboratory Section 501A(b) of the Public Health Service Act ( 42 U.S.C. 290aa–0(b) ) is amended— (1) in paragraph (5), by striking and at the end; (2) in paragraph (6), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (7) issue and periodically update guidance for entities applying for grants from the Substance Abuse and Mental Health Services Administration in order to— (A) encourage the funding of evidence-based practices; (B) encourage the replication of promising or effective practices; and (C) inform applicants on how to best articulate the rationale for the funding of a program or activity. . N Comprehensive Opioid Recovery Centers 7131. Short title This subtitle may be cited as the Comprehensive Opioid Recovery Centers Act of 2018 . 7132. Comprehensive opioid recovery centers (a) In general Part D of title V of the Public Health Service Act is amended by adding at the end the following new section: 550. Comprehensive opioid recovery centers (a) In general The Secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center (referred to in this section as a Center ). (b) Grant period (1) In general A grant awarded under subsection (a) shall be for a period not less than 3 years and not more than 5 years. (2) Renewal A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph, the Secretary shall consider the data submitted under subsection (h). (c) Minimum number of Centers The Secretary shall allocate the amounts made available under subsection (i) in such amounts that not fewer than 10 Centers will be established across the United States. (d) Application In order to be eligible for a grant under subsection (a), an entity shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (1) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activities described in subsection (g); and (2) such other information as the Secretary may require. (e) Priority In awarding grants under subsection (a), the Secretary shall give priority to eligible entities located in a State or Indian country (as defined in section 1151 of title 18, United States Code)— (1) with a high per capita drug overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or (2) based on any other criteria or need, as determined by the Secretary. (f) Use of grant funds An eligible entity awarded a grant under subsection (a) shall use the grant funds to establish or operate a Center to carry out the activities described in subsection (g). (g) Center activities and services Each Center shall, at a minimum, carry out the activities described in this subsection. In the case of a Center that determines that a service described in paragraph (2) cannot reasonably be carried out by the Center, such Center shall contract with such other entities as may be necessary to ensure that patients have access to the full range of services described in such paragraph. (1) Community outreach Each Center shall carry out the following outreach activities: (A) Train and supervise outreach staff to work with schools, workplaces, faith-based organizations, State and local health departments, law enforcement, and first responders to ensure that such institutions are aware of the services of the Center. (B) Disseminate and make available online evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders. (2) Treatment and recovery services Each Center shall provide the following treatment and recovery services: (A) Ensure that intake evaluations meet the clinical needs of patients. (B) Periodically conduct patient assessments to ensure continued and meaningful recovery, as defined by the Assistant Secretary for Mental Health and Substance Use. (C) Provide the full continuum of treatment services, including— (i) all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act and all biological products licensed under section 351 of this Act, including methadone, to treat substance use disorders, including opioid use disorder and alcohol use disorder; (ii) withdrawal management, which shall include medically supervised detoxification that includes patient evaluation, stabilization, and readiness for and entry into treatment; (iii) counseling and case management, including counseling and recovery services for any possible co-occurring mental illness; (iv) residential rehabilitation; (v) recovery housing; (vi) community-based and peer recovery support services; (vii) job training and placement assistance to support reintegration into the workforce; and (viii) other best practices, as determined by the Secretary. (D) Administer an onsite pharmacy and provide toxicology services. (E) Establish and operate a secure and confidential electronic health information system. (F) Offer family support services such as child care, family counseling, and parenting interventions to help stabilize families impacted by substance use disorder. (h) Data reporting and program oversight With respect to a grant awarded under subsection (a) to an eligible entity for a Center, not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period (including the duration of any renewal period for such grant), the entity shall submit data, as appropriate, to the Secretary regarding— (1) the programs and activities funded by the grant; (2) health outcomes of individuals with a substance use disorder who received services from the Center; (3) the effectiveness of interventions designed, tested, and evaluated by the Center; and (4) any other information that the Secretary may require for the purpose of— (A) evaluating the effectiveness of the Center; and (B) ensuring that the Center is complying with all the requirements of the grant, including providing the full continuum of services described in subsection (g)(2)(C) and providing drugs and devices for overdose reversal under such subsection. (i) Authorization of appropriations There is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. . (b) Reports to Congress (1) Preliminary report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a preliminary report that analyzes data submitted under section 550(h) of the Public Health Service Act, as added by subsection (a). (2) Final report Not later than 1 year after submitting the preliminary report required under paragraph (1), the Secretary of Health and Human Services shall submit to Congress a final report that includes— (A) an evaluation of the effectiveness of comprehensive opioid recovery centers established or operated pursuant to section 550 of the Public Health Service Act, as added by subsection (a); (B) recommendations on whether the grant program established under such section 550 should be reauthorized and expanded; and (C) standards and best practices for the treatment of substance use disorders, as identified through such grant program. O Poison Center Network Enhancement 7141. Short title This subtitle may be cited as the Poison Center Network Enhancement Act of 2018 . 7142. Reauthorization of poison control centers national toll-free number Section 1271 of the Public Health Service Act ( 42 U.S.C. 300d–71 ) is amended to read as follows: 1271. Establishment and maintenance of the national toll-free number and enhanced communications capabilities (a) In general The Secretary shall provide coordination and assistance to poison control centers for— (1) the development, establishment, implementation, and maintenance of a nationwide toll-free phone number; and (2) the enhancement of communications capabilities, which may include text capabilities. (b) Consultation The Secretary may consult with nationally recognized professional organizations in the field of poison control to determine the best and most effective means of achieving the goals described in paragraphs (1) and (2) of subsection (a). (c) Rule of construction In assisting with public health emergencies, responses, or preparedness, nothing in this section shall be construed to restrict the work of poison control centers or the use of their resources by the Secretary or other governmental agencies. (d) Authorization of appropriations There is authorized to be appropriated to carry out this section $700,000 for each of fiscal years 2019 through 2023. . 7143. Reauthorization of nationwide public awareness campaign to promote poison control center utilization Section 1272 of the Public Health Service Act ( 42 U.S.C. 300d–72 ) is amended to read as follows: 1272. Nationwide public awareness campaign to promote poison control center utilization and their public health emergency response capabilities (a) In general The Secretary shall— (1) carry out, and expand upon, a national public awareness campaign to educate the public and health care providers about— (A) poisoning, toxic exposure, and drug misuse prevention; and (B) the availability of poison control center resources in local communities; and (2) as part of such campaign, highlight the nationwide toll-free number and enhanced communications capabilities supported under section 1271. (b) Consultation In carrying out and expanding upon the national campaign under subsection (a), the Secretary may consult with nationally recognized professional organizations in the field of poison control response for the purpose of determining the best and most effective methods for achieving public awareness. (c) Contract with entity The Secretary may carry out subsection (a) by entering into contracts with one or more public or private entities, including nationally recognized professional organizations in the field of poison control and national media firms, for the development and implementation of the awareness campaign under subsection (a), which may include— (1) the development and distribution of poisoning and toxic exposure prevention, poison control center, and public health emergency awareness and response materials; (2) television, radio, internet, and newspaper public service announcements; and (3) other means and activities to provide for public and professional awareness and education. (d) Evaluation The Secretary shall— (1) establish baseline measures and benchmarks to quantitatively evaluate the impact of the nationwide public awareness campaign carried out under this section; and (2) on a biennial basis, prepare and submit to the appropriate committees of Congress an evaluation of the nationwide public awareness campaign. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section, $800,000 for each of fiscal years 2019 through 2023. . 7144. Reauthorization of the poison control center grant program Section 1273 of the Public Health Service Act ( 42 U.S.C. 300d–73 ) is amended to read as follows: 1273. Maintenance of the poison control center grant program (a) Authorization of program The Secretary shall award grants to poison control centers accredited under subsection (c) (or granted a waiver under subsection (d)) and nationally recognized professional organizations in the field of poison control for the purposes of— (1) preventing, and providing treatment recommendations for, poisonings and toxic exposures including opioid and drug misuse; (2) assisting with public health emergencies, responses, and preparedness; and (3) complying with the operational requirements needed to sustain the accreditation of the center under subsection (c). (b) Additional uses of funds In addition to the purposes described in subsection (a), a poison center or professional organization awarded a grant under such subsection may also use amounts received under such grant— (1) to research, establish, implement, and evaluate best practices in the United States for poisoning prevention, poison control center outreach, opioid and drug misuse information and response, and public health emergency, response, and preparedness programs; (2) to research, develop, implement, revise, and communicate standard patient management guidelines for commonly encountered toxic exposures; (3) to improve national toxic exposure and opioid misuse surveillance by enhancing cooperative activities between poison control centers in the United States and the Centers for Disease Control and Prevention and other governmental agencies; (4) to research, improve, and enhance the communications and response capability and capacity of the Nation’s network of poison control centers to facilitate increased access to the centers through the integration and modernization of the current poison control centers communications and data system, including enhancing the network’s telephony, internet, data, and social networking technologies; (5) to develop, support, and enhance technology and capabilities of nationally recognized professional organizations in the field of poison control to collect national poisoning, toxic occurrence, and related public health data; (6) to develop initiatives to foster the enhanced public health utilization of national poison data collected by such organizations; (7) to support and expand the toxicologic expertise within poison control centers; and (8) to improve the capacity of poison control centers to answer high volumes of contacts and internet communications, and to sustain and enhance the poison control center’s network capability to respond during times of national crisis or other public health emergencies. (c) Accreditation Except as provided in subsection (d), the Secretary may award a grant to a poison control center under subsection (a) only if— (1) the center has been accredited by a nationally recognized professional organization in the field of poison control, and the Secretary has approved the organization as having in effect standards for accreditation that reasonably provide for the protection of the public health with respect to poisoning; or (2) the center has been accredited by a State government, and the Secretary has approved the State government as having in effect standards for accreditation that reasonably provide for the protection of the public health with respect to poisoning. (d) Waiver of accreditation requirements (1) In general The Secretary may grant a waiver of the accreditation requirements of subsection (c) with respect to a nonaccredited poison control center that applies for a grant under this section if such center can reasonably demonstrate that the center will obtain such an accreditation within a reasonable period of time as determined appropriate by the Secretary. (2) Renewal The Secretary may renew a waiver under paragraph (1). (3) Limitation The Secretary may not, after the date of enactment of the Poison Control Network Enhancement Act of 2018, grant to a poison control center waivers or renewals that total more than 5 years. (e) Supplement not supplant Amounts made available to a poison control center under this section shall be used to supplement and not supplant other Federal, State, or local funds provided for such center. (f) Maintenance of effort A poison control center, in utilizing the proceeds of a grant under this section, shall maintain the annual recurring expenditures of the center for its activities at a level that is not less than 80 percent of the average level of such recurring expenditures maintained by the center for the preceding 3 fiscal years for which a grant is received. (g) Authorization of appropriations There is authorized to be appropriated to carry out this section, $28,600,000 for each of fiscal years 2019 through 2023. The Secretary may utilize an amount not to exceed 6 percent of the amount appropriated pursuant to the preceding sentence for each fiscal year for coordination, dissemination, technical assistance, program evaluation, data activities, and other program administration functions, which are determined by the Secretary to be appropriate for carrying out the program under this section. . P Eliminating Opioid Related Infectious Diseases 7151. Short title This subtitle may be cited as the Eliminating Opioid Related Infectious Diseases Act of 2018 . 7152. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors Section 317N of the Public Health Service Act ( 42 U.S.C. 247b–15 ) is amended to read as follows: 317N. Surveillance and education regarding infections associated with illicit drug use and other risk factors (a) In general The Secretary may (directly and through grants to public and nonprofit private entities) provide for programs for the following: (1) To cooperate with the States and Indian tribes in implementing or maintaining a surveillance system to determine the incidence of infections commonly associated with illicit drug use, including infections commonly associated with injection drug use such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections. (2) To identify, counsel, and offer testing to individuals who are at risk of infections as a result of injection drug use, receiving blood transfusions prior to July 1992, or other risk factors. (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services. (4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary. (5) To improve the education, training, and skills of health professionals in the detection and control of infections and the coordination of treatment of addiction and infectious diseases described in paragraph (1), with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, infectious diseases clinicians, and HIV clinicians. (b) Laboratory procedures The Secretary may (directly or through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection (a)(1). (c) Definitions In this section: (1) The term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (2) The term injection drug use means— (A) intravenous administration of a substance in schedule I under section 202 of the Controlled Substances Act; (B) intravenous administration of a substance in schedule II, III, IV, or V under section 202 of the Controlled Substances Act that has not been approved for intravenous use under— (i) section 505 of the Federal Food, Drug and Cosmetic Act; or (ii) section 351 of the Public Health Service Act; or (C) intravenous administration of a substance in schedule II, III, IV, or V under section 202 of the Controlled Substances Act that has not been prescribed to the person using the substance. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023. . Q Better Pain Management Through Better Data 7161. Short title This subtitle may be cited as the Better Pain Management Through Better Data Act of 2018 . 7162. Guidance addressing alternative approaches to data collection and labeling claims for opioid sparing (a) In general For purposes of assisting sponsors in collecting and incorporating opioid-sparing data in product labeling, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall conduct a public meeting and update or issue one or more guidances in accordance with subsection (b). (b) Guidance (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall update or issue one or more guidances addressing— (A) alternative methods for data collection on opioid sparing; (B) alternative methods for inclusion of such data in product labeling; and (C) investigations other than clinical trials, including partially controlled studies and objective trials without matched controls such as historically controlled analyses, open-label studies, and meta-analyses, on opioid sparing for inclusion in product labeling. (2) Contents The guidances under paragraph (1) shall address— (A) innovative clinical trial designs for ethically and efficiently collecting data on opioid sparing for inclusion in product labeling; (B) primary and secondary endpoints for the reduction of opioid use while maintaining adequate pain control; (C) use of real world evidence, including patient registries, and patient reported outcomes to support inclusion of opioid-sparing data in product labeling; and (D) how sponsors may obtain feedback from the Secretary relating to such issues prior to— (i) commencement of such data collection; or (ii) the submission of resulting data to the Secretary. (3) Public meeting Prior to updating or issuing the guidances required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patients, and provider organizations, through a public meeting to be held not later than 12 months after the date of enactment of this Act. (4) Timing The Secretary shall— (A) not later than 12 months after the date of the public meeting required by paragraph (3), update or issue the one or more draft guidances required by paragraph (1); and (B) not later than 12 months after the date on which the public comment period for such draft guidances closes, finalize such guidances. (c) Definition In this section: (1) The terms opioid sparing and opioid-sparing refer to the use of drugs or devices (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) that reduce pain while enabling the reduction, replacement, or avoidance of oral opioids. (2) The term Secretary means the Secretary of Health and Human Services. R Special Registration for Telemedicine Clarification 7171. Short title This subtitle may be cited as the Special Registration for Telemedicine Clarification Act of 2018 . 7172. Deadline for interim final regulations for a special registration To engage in the practice of telemedicine Section 311(h)(2) of the Controlled Substances Act ( 21 U.S.C. 831(h)(2) ) is amended by striking The Attorney General shall, with the concurrence of the Secretary, promulgate regulations and inserting Not later than 1 year after the date of enactment of the Special Registration for Telemedicine Clarification Act of 2018 , the Attorney General shall, with the concurrence of the Secretary, promulgate interim final regulations . S Peer Support Communities of Recovery 7181. Short title This subtitle may be cited as the Peer Support Communities of Recovery Act . 7182. Building communities of recovery Section 547 of the Public Health Service Act ( 42 U.S.C. 290ee–2 ) is amended— (1) in subsection (a)— (A) in the heading, by striking Definition and inserting Definitions ; (B) in the matter preceding paragraph (1), by striking In this section, the term recovery community organization means an independent nonprofit organization that— and inserting In this section: ; (C) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving such subparagraphs (as so redesignated) 2 ems to the right; (D) by inserting before subparagraph (A) (as so redesignated) the following: (1) Recovery community organization The term recovery community organization means an independent nonprofit organization that— ; and (E) by adding at the end the following: (2) Eligible entity The term eligible entity means— (A) a national nonprofit entity focused on substance use disorder with a network of local affiliates and partners that are geographically and organizationally diverse; or (B) a nonprofit organization— (i) focused on substance use disorder; (ii) established by individuals in personal or family recovery; and (iii) serving prevention, treatment, recovery, payor, faith-based, and criminal justice stakeholders in the implementation of local addiction and recovery initiatives. ; (2) in subsection (b)— (A) by striking The Secretary shall award grants to recovery community organizations and inserting The Secretary— (1) shall award grants to recovery community organizations ; (B) by striking services. and inserting services and allow such organizations to use such grant funds to carry out the activities described in subparagraphs (A) through (C) of subsection (c)(2); and ; and (C) by adding at the end the following: (2) may award grants to eligible entities for purposes of establishing regional technical assistance centers, in accordance with subsection (c)(2)(D). ; (3) by striking subsection (c); (4) by redesignating subsections (d) and (e) as subsections (c) and (d), respectively; (5) in subsection (c) (as so redesignated)— (A) in paragraph (1), by striking shall be used and inserting to a recovery community organization shall be used ; (B) in paragraph (2)— (i) in subparagraph (A), in the matter preceding clause (i), by inserting before build the following: in the case of a grant awarded to a recovery community organization, ; (ii) in subparagraph (B)— (I) by inserting before reduce the following: in the case of a grant awarded to a recovery community organization, ; and (II) by striking and at the end; (iii) in subparagraph (C)— (I) by inserting before conduct the following: in the case of a grant awarded to a recovery community organization, ; and (II) by striking the period at the end and inserting ; and ; and (iv) by adding at the end the following: (D) in the case of a grant awarded to an eligible entity, provide for the establishment of regional technical assistance centers to provide regional technical assistance for the following: (i) Implementation of regionally driven, peer-delivered addiction recovery support services before, during, after, or in conjunction with addiction treatment. (ii) Establishment of recovery community organizations. (iii) Establishment of recovery community centers. ; and (6) in subsection (d) (as so redesignated), by inserting before the period the following: , and $15,000,000 for each of fiscal years 2019 through 2023 . T Stop Illicit Drug Importation 7191. Short title This short title may be cited as the Stop Illicit Drug Importation Act of 2018 . 7192. Detention, refusal, and destruction of drugs offered for importation (a) Articles treated as drugs for purposes of importation Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by adding at the end the following: (t) Articles treated as drugs for purposes of this section (1) Labeled articles An article shall not be treated as a drug pursuant to this subsection if— (A) an electronic import entry for such article is submitted using an authorized electronic data interchange system; and (B) such article is designated in such system as a drug, device, dietary supplement, or other product that is regulated under this Act. (2) Articles covered Subject to paragraph (1), for purposes of this section, an article described in this paragraph may be treated by the Secretary as a drug if it— (A) is or contains an ingredient that is an active ingredient that is contained within— (i) a drug that has been approved under section 505 of this Act; or (ii) a biological product that has been approved under section 351 of the Public Health Service Act; (B) is or contains an ingredient that is an active ingredient in a drug or biological product if— (i) an investigational use exemption has been authorized for such drug or biological product under section 505(i) of this Act or section 351(a) of the Public Health Service Act; (ii) substantial clinical investigation has been instituted for such drug or biological product; and (iii) the existence of such clinical investigation has been made public; or (C) is or contains a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subparagraph (A) or (B). (3) Effect Except to the extent that an article may be treated as a drug pursuant to paragraph (2), this subsection shall not be construed as bearing on or being relevant to the question of whether any article is a drug as defined in section 201(g). . (b) Articles of concern (1) Delivery by Treasury to HHS The first sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking and cosmetics and inserting cosmetics, and potential articles of concern (as defined in subsection (u)) . (2) Refused admission The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking then such article shall be refused admission and inserting or (5) such article is an article of concern (as defined in subsection (u)), or (6) such article is a drug that is being imported or offered for import in violation of section 301(cc), then such article shall be refused admission . (3) Definition of article of concern Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended, is further amended by adding at the end the following: (u) Article of concern defined For purposes of subsection (a), the term article of concern means an article that is or contains a drug or other substance— (1) for which, during the 24-month period prior to the article being imported or offered for import, the Secretary of Health and Human Services— (A) has requested that, based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section 201 of the Controlled Substances Act, the Attorney General initiate the process to control the drug or other substance in accordance with such Act; or (B) has, following the publication by the Attorney General of a notice in the Federal Register of the intention to issue an order temporarily scheduling such drug or substance in schedule I of section 202 of the Controlled Substances Act pursuant to section 201(h) of such Act, made a determination that such article presents an imminent hazard to public safety; and (2) with respect to which the Attorney General has not— (A) scheduled the drug or other substance under such Act; or (B) notified the Secretary of Health and Human Services that the Attorney General has made a determination not to schedule the drug or other substance under such Act. . 7193. Seizure Section 304(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334(b) ) is amended by striking the first sentence and inserting the following: The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty rather than the procedure used for civil asset forfeiture proceedings set forth in section 983 of title 18, United States Code. On demand of either party any issue of fact joined in any such a case brought under this section shall be tried by jury. A seizure brought under this section is not governed by Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions. Exigent circumstances shall be deemed to exist for all seizures brought under this section, and in such cases, the summons and arrest warrant shall be issued by the clerk of the court without court review. . 7194. Debarring violative individuals or companies (a) Prohibited act Section 301(cc) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(cc) ) is amended— (1) by inserting after an article of food the following: or a drug ; and (2) by inserting after a person debarred the following: from such activity . (b) Debarment Section 306(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a(b) ) is amended— (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking paragraph (2) and inserting paragraph (2) or (3) ; (B) in subparagraph (B), by striking or at the end; (C) in subparagraph (C), by striking the period at the end and inserting , or ; and (D) by adding at the end the following: (D) a person from importing or offering to import into the United States— (i) a controlled substance as defined in section 102(6) of the Controlled Substances Act; or (ii) any drug, if such drug is declared to be valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930), or if such drug is entering the United States by mail. ; and (2) in paragraph (3)— (A) in the paragraph heading after food by inserting or drug ; (B) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and moving the indentation of each such clause 2 ems to the right; (C) after making the amendments required by subparagraph (B), by striking A person is subject and inserting the following: (A) Food A person is subject ; and (D) by adding at the end the following: (B) Importation of drugs A person is subject to debarment under paragraph (1)(D) if— (i) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); or (ii) the person has engaged in a pattern of importing or offering for import articles of drug that are— (I) (aa) adulterated, misbranded, or in violation of section 505; and (bb) present a threat of serious adverse health consequences or death to humans or animals; or (II) controlled substances whose importation is prohibited pursuant to section 401(m) of the Tariff Act of 1930. (C) Definition For purposes of subparagraph (B), the term pattern of importing or offering for import articles of drug means importing or offering for import articles of drug described in subclause (I) or (II) of subparagraph (B)(ii) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer. . U Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies 7201. Short title This subtitle may be cited as the Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 or the CONNECTIONS Act . 7202. Preventing overdoses of controlled substances Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: 399V–7. Preventing overdoses of controlled substances (a) Evidence-Based prevention grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out any evidence-based prevention activity described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying out any such activity; and (C) award grants to States, localities, and Indian tribes for purposes of carrying out any such activity. (2) Evidence-based prevention activities An evidence-based prevention activity described in this paragraph is any of the following activities: (A) With respect to a State, improving the efficiency and use of the State prescription drug monitoring program by— (i) encouraging all authorized users (as specified by the State) to register with and use the program and making the program easier to use; (ii) enabling such users to access any updates to information collected by the program in as close to real-time as possible; (iii) providing for a mechanism for the program to automatically flag any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing practices relating to such substances; (iv) enhancing interoperability between the program and any electronic health records system, including by integrating the use of electronic health records into the program for purposes of improving clinical decisionmaking; (v) continually updating program capabilities to respond to technological innovation for purposes of appropriately addressing a controlled substance overdose epidemic as such epidemic may occur and evolve; (vi) facilitating data sharing between the program and the prescription drug monitoring programs of neighboring States; and (vii) meeting the purpose of the program established under section 399O, as described in section 399O(a). (B) Achieving community or health system interventions through activities such as— (i) establishing or improving controlled substances prescribing interventions for insurers and health systems; (ii) enhancing the use of evidence-based controlled substances prescribing guidelines across sectors and health care settings; and (iii) implementing strategies to align the prescription of controlled substances with the guidelines described in clause (ii). (C) Evaluating interventions to better understand what works to prevent overdoses, including those involving prescription and illicit controlled substances. (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging public health crises and opportunities to address such crises, such as enhancing public education and awareness on the risks associated with opioids. (b) Enhanced surveillance of controlled substance overdose grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out any controlled substance overdose surveillance activity described in paragraph (2); (B) provide training and technical assistance to States for purposes of carrying out any such activity; (C) award grants to States for purposes of carrying out any such activity; and (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to section 505(d)(1)(A) (relating to the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of alcohol or other drugs). (2) Controlled substance overdose surveillance activities A controlled substance overdose surveillance activity described in this paragraph is any of the following activities: (A) Enhancing the timeliness of reporting data to the public, including data on fatal and nonfatal overdoses of controlled substances. (B) Enhancing comprehensiveness of data on controlled substances overdoses by collecting information on such overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and other risk factors. (C) Using data to help identify risk factors associated with controlled substances overdoses. (D) With respect to a State, supporting entities involved in providing information to inform efforts within the State, such as by coroners and medical examiners, to improve accurate testing and reporting of causes and contributing factors to controlled substances overdoses. (E) Working to enable information sharing regarding controlled substances overdoses among data sources. (c) Definitions In this section: (1) Controlled substance The term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act. (2) Indian tribe The term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations For purposes of carrying out this section and section 399O, there is authorized to be appropriated $486,000,000 for each of fiscal years 2019 through 2023. . 7203. Prescription drug monitoring program Section 399O of the Public Health Service Act ( 42 U.S.C. 280g–3 ) is amended to read as follows: 399O. Prescription drug monitoring program (a) Program (1) In general Each fiscal year, the Secretary, in consultation with the Director of National Drug Control Policy, acting through the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Mental Health and Substance Use, and the National Coordinator for Health Information Technology, shall support States for the purpose of improving the efficiency and use of PDMPs, including— (A) establishment and implementation of a PDMP; (B) maintenance of a PDMP; (C) improvements to a PDMP by— (i) enhancing functional components to work toward— (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow, within a State; (II) more timely inclusion of data within a PDMP; (III) active management of the PDMP, in part by sending proactive or unsolicited reports to providers to inform prescribing; and (IV) ensuring the highest level of ease in use and access of PDMPs by providers and their delegates, to the extent that State laws allow; (ii) improving the intrastate interoperability of PDMPs by— (I) making PDMPs more actionable by integrating PDMPs within electronic health records and health information technology infrastructure; and (II) linking PDMP data to other data systems within the State, including— (aa) the data of pharmacy benefit managers, medical examiners and coroners, and the State’s Medicaid program; (bb) worker’s compensation data; and (cc) prescribing data of providers of the Department of Veterans Affairs and the Indian Health Service within the State; (iii) improving the interstate interoperability of PDMPs through— (I) sharing of dispensing data in near-real time across State lines; and (II) integration of automated queries for multistate PDMP data and analytics into clinical workflow to improve the use of such data and analytics by practitioners and dispensers; or (iv) improving the ability to include treatment availability resources and referral capabilities within the PDMP. (2) State legislation As a condition on the receipt of support under this section, the Secretary shall require a State to demonstrate that the State has enacted legislation or regulations— (A) to provide for the implementation of the PDMP; and (B) to permit the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained by the PDMP. (b) PDMP strategies The Secretary shall encourage a State, in establishing, improving, or maintaining a PDMP, to implement strategies that improve— (1) the reporting of dispensing in the State of a controlled substance to an ultimate user so the reporting occurs not later than 24 hours after the dispensing event; (2) the consultation of the PDMP by each prescribing practitioner, or their designee, in the State before initiating treatment with a controlled substance, or any substance as required by the State to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event; (3) the consultation of the PDMP before dispensing a controlled substance, or any substance as required by the State to be reported to the PDMP; (4) the proactive notification to a practitioner when patterns indicative of controlled substance misuse by a patient, including opioid misuse, are detected; (5) the availability of data in the PDMP to other States, as allowable under State law; and (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for surveillance, epidemiology, statistical research, or educational purposes. (c) Drug misuse and abuse In consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State receiving support under this section— (1) shall establish a program to notify practitioners and dispensers of information that will help to identify and prevent the unlawful diversion or misuse of controlled substances; and (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for carrying out drug diversion investigations if the State determines that information in the PDMP maintained by the State indicates an unlawful diversion or abuse of a controlled substance. (d) Evaluation and reporting As a condition on receipt of support under this section, the State shall report on interoperability with PDMPs of other States and Federal agencies, where appropriate, intrastate interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient. (e) Evaluation and reporting A State receiving support under this section shall provide the Secretary with aggregate nonidentifiable information, as permitted by State law, to enable the Secretary— (1) to evaluate the success of the State’s program in achieving the purpose described in subsection (a); or (2) to prepare and submit to the Congress the report required by subsection (i)(2). (f) Education and access to the monitoring system A State receiving support under this section shall take steps to— (1) facilitate prescribers and dispensers, and their delegates, as permitted by State law, to use the PDMP, to the extent practicable; and (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs. (g) Electronic format The Secretary may issue guidelines specifying a uniform electronic format for the reporting, sharing, and disclosure of information pursuant to PDMPs. (h) Rules of construction (1) Functions otherwise authorized by law Nothing in this section shall be construed to restrict the ability of any authority, including any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, to perform functions otherwise authorized by law. (2) Additional privacy protections Nothing in this section shall be construed as preempting any State from imposing any additional privacy protections. (3) Federal privacy requirements Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( Public Law 104–191 ; 110 Stat. 2033) and section 543 of this Act. (4) No Federal private cause of action Nothing in this section shall be construed to create a Federal private cause of action. (i) Progress report Not later than 3 years after the date of enactment of the CONNECTIONS Act, the Secretary shall— (1) complete a study that— (A) determines the progress of States in establishing and implementing PDMPs consistent with this section; (B) provides an analysis of the extent to which the operation of PDMPs has— (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances; (ii) established or strengthened initiatives to ensure linkages to substance use disorder treatment services; or (iii) affected patient access to appropriate care in States operating PDMPs; (C) determine the progress of States in achieving interstate interoperability and intrastate interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress and recommendations for addressing these barriers; (D) determines the progress of States in implementing near real-time electronic PDMPs; (E) provides an analysis of the privacy protections in place for the information reported to the PDMP in each State receiving support under this section and any recommendations of the Secretary for additional Federal or State requirements for protection of this information; (F) determines the progress of States in implementing technological alternatives to centralized data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such alternatives to enhance the privacy and security of individually identifiable data; and (G) evaluates the penalties that States have enacted for the unauthorized use and disclosure of information maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify as appropriate for purposes of subsection (a)(2); and (2) submit a report to the Congress on the results of the study. (j) Advisory council (1) Establishment A State may establish an advisory council to assist in the establishment, improvement, or maintenance of a PDMP consistent with this section. (2) Limitation A State may not use Federal funds for the operations of an advisory council to assist in the establishment, improvement, or maintenance of a PDMP. (3) Sense of Congress It is the sense of the Congress that, in establishing an advisory council to assist in the establishment, improvement, or maintenance of a PDMP, a State should consult with appropriate professional boards and other interested parties. (k) Definitions For purposes of this section: (1) The term controlled substance means a controlled substance (as defined in section 102 of the Controlled Substances Act) in schedule II, III, or IV of section 202 of such Act. (2) The term dispense means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, irrespective of whether the dispenser uses the internet or other means to effect such delivery. (3) The term dispenser means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user. (4) The term interstate interoperability with respect to a PDMP means the ability of the PDMP to electronically share reported information with another State if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing of a controlled substance prescribed by a practitioner whose principal place of business is located in such other State. (5) The term intrastate interoperability with respect to a PDMP means the integration of PDMP data within electronic health records and health information technology infrastructure or linking of a PDMP to other data systems within the State, including the State’s Medicaid program, workers’ compensation programs, and medical examiners or coroners. (6) The term nonidentifiable information means information that does not identify a practitioner, dispenser, or an ultimate user and with respect to which there is no reasonable basis to believe that the information can be used to identify a practitioner, dispenser, or an ultimate user. (7) The term PDMP means a prescription drug monitoring program that is State-controlled. (8) The term practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the individual practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. (9) The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (10) The term ultimate user means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the person’s household, or for the use of an animal owned by the person or by a member of the person’s household. (11) The term clinical workflow means the integration of automated queries for prescription drug monitoring programs data and analytics into health information technologies such as electronic health record systems, health information exchanges, and/or pharmacy dispensing software systems, thus streamlining provider access through automated queries. . V Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging 7211. Short title This subtitle may be cited as the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act . 7212. Improved technologies, controls, or measures with respect to the packaging or disposal of certain drugs (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505–1 ( 21 U.S.C. 355–1 ) the following new section: 505–2. Safety-enhancing packaging and disposal features (a) Orders (1) In general The Secretary may issue an order requiring the holder of a covered application to implement or modify one or more technologies, controls, or measures with respect to the packaging or disposal of one or more drugs identified in the covered application, if the Secretary determines such technologies, controls, or measures to be appropriate to help mitigate the risk of abuse or misuse of such drug or drugs, which may include by reducing the availability of unused drugs. (2) Prior consultation The Secretary may not issue an order under paragraph (1) unless the Secretary has consulted with relevant stakeholders, through a public meeting, workshop, or otherwise, about matters that are relevant to the subject of the order. (3) Assuring access and minimizing burden Technologies, controls, or measures required under paragraph (1) shall— (A) be commensurate with the specific risk of abuse or misuse of the drug listed in the covered application; (B) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular any available evidence regarding the expected or demonstrated public health impact of such technologies, controls, or measures; and (C) reduce the risk of abuse or misuse of such drug. (4) Order contents An order issued under paragraph (1) may— (A) provide for a range of options for implementing or modifying the technologies, controls, or measures required to be implemented by such order; and (B) incorporate by reference standards regarding packaging or disposal set forth in an official compendium, established by a nationally or internationally recognized standard development organization, or described on the public website of the Food and Drug Administration, so long as the order includes the rationale for incorporation of such standard. (5) Orders applicable to drug class When a concern about the risk of abuse or misuse of a drug relates to a pharmacological class, the Secretary may, after consultation with relevant stakeholders, issue an order under paragraph (1) which applies to the pharmacological class. (b) Compliance The holder of a covered application shall— (1) submit a supplement containing proposed changes to the covered application to comply with an order issued under subsection (a) not later than— (A) 180 calendar days after the date on which the order is issued; or (B) (i) such longer time period as specified by the Secretary in such order; or (ii) if a request for an alternative date is submitted by the holder of such application not later than 60 calendar days after the date on which such order is issued— (I) such requested alternative date if agreed to by the Secretary; or (II) another date as specified by the Secretary; and (2) implement the changes approved pursuant to such supplement not later than the later of— (A) 90 calendar days after the date on which the supplement is approved; or (B) the end of such longer period as is— (i) determined to be appropriate by the Secretary; or (ii) approved by the Secretary pursuant to a request by the holder of the covered application that explains why such longer period is needed, including to satisfy any other applicable Federal statutory or regulatory requirements. (c) Alternative measures The holder of the covered application may propose, and the Secretary shall approve, technologies, controls, or measures regarding packaging, storage, or disposal other than those specified in the applicable order issued under subsection (a), if such technologies, controls, or measures are supported by data and information demonstrating that such alternative technologies, controls, or measures can be expected to mitigate the risk of abuse or misuse of the drug or drugs involved, including by reducing the availability of unused drugs, to at least the same extent as the technologies, controls, or measures specified in such order. (d) Dispute resolution If a dispute arises in connection with a supplement submitted under subsection (b), the holder of the covered application may appeal a determination made with respect to such supplement using applicable dispute resolution procedures specified by the Secretary in regulations or guidance. (e) Definitions In this section— (1) the term covered application means an application submitted under subsection (b) or (j) of section 505 for approval under such section or an application submitted under section 351 of Public Health Service Act for approval under such section, with respect to a drug that is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act; and (2) the term relevant stakeholders may include scientific experts within the drug manufacturing industry; brand and generic drug manufacturers; standard development organizations; wholesalers and distributors; payers; health care providers; pharmacists; pharmacies; manufacturers; poison centers; and representatives of the National Institute on Drug Abuse, the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Drug Enforcement Agency, the Consumer Product Safety Commission, individuals who specialize in treating addiction, and patient and caregiver groups. . (b) Prohibited acts Section 501 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 ) is amended by inserting after paragraph (j) the following: (k) If it is a drug approved under a covered application (as defined in section 505–2(e)), the holder of which does not meet the requirements of paragraphs (1) and (2) of subsection (b) of such section. . (c) Required content of an abbreviated new drug application Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(2)(A) ) is amended— (1) in clause (vii)(IV), by striking and at the end; (2) in clause (viii), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (ix) if the drug is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act, information to show that the applicant has proposed technologies, controls, or measures related to the packaging or disposal of the drug that provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505–2, if applicable. . (d) Grounds for refusing To approve an abbreviated new drug application Section 505(j)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(4) ), is amended— (1) in subparagraph (J), by striking or at the end; (2) in subparagraph (K), by striking the period at the end and inserting ; or ; and (3) by adding at the end the following: (L) if the drug is a drug described in paragraph (2)(A)(ix) and the applicant has not proposed technologies, controls, or measures related to the packaging or disposal of such drug that the Secretary determines provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505–2. . (e) Rules of construction (1) Any labeling describing technologies, controls, or measures related to packaging or disposal intended to mitigate the risk of abuse or misuse of a drug product that is subject to an abbreviated new drug application, including labeling describing differences from the reference listed drug resulting from the application of section 505–2 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall not be construed— (A) as changes to labeling not permissible under clause (v) of section 505(j)(2)(A) of such Act ( 21 U.S.C. 355(j)(2)(A) ), or a change in the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug under clause (i) of such section; or (B) to preclude approval of an abbreviated new drug application under subparagraph (B) or (G) of section 505(j)(4) of such Act ( 21 U.S.C. 355(j)(4) ). (2) For a covered application that is an application submitted under subsection (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), subsection (j)(2)(A) of such section 505 shall not be construed to limit the type of data or information the Secretary of Health and Human Services may request or consider in connection with making any determination under section 505–2. (f) GAO report Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to the Congress a report containing— (1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies; (2) identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act, are made available to the public and barriers to the use of such disposal products; (3) identification of ways in which packaging technologies are made available to the public and barriers to the use of such technologies; (4) a description of Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including— (A) identification of the Federal agencies that oversee such products; (B) identification of the methods of disposal of controlled substances recommended by these agencies for site-of-use, in-home disposal; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; (5) a description of Federal oversight, if any, of controlled substance packaging technologies, including— (A) identification of the Federal agencies that oversee such technologies; (B) identification of the technologies recommended by these agencies, including unit dose packaging, packaging that provides a set duration, or other packaging systems that may mitigate abuse or misuse; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and (6) recommendations on— (A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agencies should be responsible for such oversight and, as applicable, approval of such products or technologies; and (B) the potential role of the Federal Government in evaluating such products to ensure product efficacy. W Postapproval study requirements 7221. Postapproval study requirements (a) Purposes of study Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(B) ) is amended by adding at the end the following: (iv) To assess a potential reduction in effectiveness of the drug for the conditions of use prescribed, recommended, or suggested in the labeling thereof if— (I) the drug involved— (aa) is or contains a substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act; or (bb) is a drug that has not been approved under this section or licensed under section 351 of the Public Health Service Act, for which an application for such approval or licensure is pending or anticipated, and for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act; and (II) the potential reduction in effectiveness could result in the benefits of the drug no longer outweighing the risks. . (b) Establishment of requirement Section 505(o)(3)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(C) ) is amended by striking such requirement and all that follows through safety information. and inserting the following: such requirement— (i) in the case of a purpose described in clause (i), (ii), or (iii) of subparagraph (B), only if the Secretary becomes aware of new safety information; and (ii) in the case of a purpose described in clause (iv) of such subparagraph, if the Secretary determines that new effectiveness information exists. . (c) Applicability Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ) is amended by adding at the end the following new subparagraph: (G) Applicability The conduct of a study or clinical trial required pursuant to this paragraph for the purpose specified in subparagraph (B)(iv) shall not be considered a new clinical investigation for the purpose of a period of exclusivity under clause (iii) or (iv) of subsection (c)(3)(E) or clause (iii) or (iv) of subsection (j)(5)(F). . (d) New effectiveness information defined Section 505(o)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(2) ) is amended by adding at the end the following new subparagraph: (D) New effectiveness information The term new effectiveness information , with respect to a drug that is or contains a controlled substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act, means new information about the effectiveness of the drug, including a new analysis of existing information, derived from— (i) a clinical trial; an adverse event report; a postapproval study or clinical trial (including a study or clinical trial under paragraph (3)); (ii) peer-reviewed biomedical literature; (iii) data derived from the postmarket risk identification and analysis system under subsection (k); or (iv) other scientific data determined to be appropriate by the Secretary. . (e) Conforming amendments with respect to labeling changes Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(4) ) is amended— (1) in subparagraph (A)— (A) in the heading, by inserting or new effectiveness after safety ; (B) by striking safety information and inserting new safety information or new effectiveness information such ; and (C) by striking believes should be and inserting believes changes should be made to ; (2) in subparagraph (B)(i)— (A) by striking new safety information and by inserting new safety information or new effectiveness information ; and (B) by inserting indications, after boxed warnings, ; (3) in subparagraph (C), by inserting or new effectiveness information after safety information ; and (4) in subparagraph (E), by inserting or new effectiveness information after safety information . (f) Rule of construction Nothing in the amendments made by this section shall be construed to alter, in any manner, the meaning or application of the provisions of paragraph (3) of section 505(o) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o) ) with respect to the authority of the Secretary of Health and Human Services to require a postapproval study or clinical trial for a purpose specified in clauses (i) through (iii) of subparagraph (B) of such paragraph (3) or paragraph (4) of such section 505(o) with respect to the Secretary’s authority to require safety labeling changes. VIII Miscellaneous A Synthetics Trafficking and Overdose Prevention 8001. Short title; table of contents This subtitle may be cited as the Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 . 8002. Customs fees (a) In general Section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(b)(9) ) is amended by adding at the end the following: (D) (i) With respect to the processing of items that are sent to the United States through the international postal network by Inbound Express Mail service or Inbound EMS (as that service is described in the mail classification schedule referred to in section 3631 of title 39, United States Code), the following payments are required: (I) $1 per Inbound EMS item. (II) If an Inbound EMS item is formally entered, the fee provided for under subsection (a)(9), if applicable. (ii) Notwithstanding section 451 of the Tariff Act of 1930 ( 19 U.S.C. 1451 ), the payments required by clause (i), as allocated pursuant to clause (iii)(I), shall be the only payments required for reimbursement of U.S. Customs and Border Protection for customs services provided in connection with the processing of an Inbound EMS item. (iii) (I) The payments required by clause (i)(I) shall be allocated as follows: (aa) 50 percent of the amount of the payments shall be paid on a quarterly basis by the United States Postal Service to the Commissioner of U.S. Customs and Border Protection in accordance with regulations prescribed by the Secretary of the Treasury to reimburse U.S. Customs and Border Protection for customs services provided in connection with the processing of Inbound EMS items. (bb) 50 percent of the amount of the payments shall be retained by the Postal Service to reimburse the Postal Service for services provided in connection with the customs processing of Inbound EMS items. (II) Payments received by U.S. Customs and Border Protection under subclause (I)(aa) shall, in accordance with section 524 of the Tariff Act of 1930 ( 19 U.S.C. 1524 ), be deposited in the Customs User Fee Account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities. Amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services. (III) Payments retained by the Postal Service under subclause (I)(bb) shall be used to directly reimburse the Postal Service for the costs incurred in providing services in connection with the customs processing of Inbound EMS items. (iv) Beginning in fiscal year 2021, the Secretary, in consultation with the Postmaster General, may adjust, not more frequently than once each fiscal year, the amount described in clause (i)(I) to an amount commensurate with the costs of services provided in connection with the customs processing of Inbound EMS items, consistent with the obligations of the United States under international agreements. . (b) Conforming amendments Section 13031(a) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(a) ) is amended— (1) in paragraph (6), by inserting (other than an item subject to a fee under subsection (b)(9)(D)) after customs officer ; and (2) in paragraph (10)— (A) in subparagraph (C), in the matter preceding clause (i), by inserting (other than Inbound EMS items described in subsection (b)(9)(D)) after release ; and (B) in the flush at the end, by inserting or of Inbound EMS items described in subsection (b)(9)(D), after (C), . (c) Effective date The amendments made by this section shall take effect on January 1, 2020. 8003. Mandatory advance electronic information for postal shipments (a) Mandatory advance electronic information (1) In general Section 343(a)(3)(K) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended to read as follows: (K) (i) The Secretary shall prescribe regulations requiring the United States Postal Service to transmit the information described in paragraphs (1) and (2) to the Commissioner of U.S. Customs and Border Protection for international mail shipments by the Postal Service (including shipments to the Postal Service from foreign postal operators that are transported by private carrier) consistent with the requirements of this subparagraph. (ii) In prescribing regulations under clause (i), the Secretary shall impose requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo, taking into account the parameters set forth in subparagraphs (A) through (J). (iii) The regulations prescribed under clause (i) shall require the transmission of the information described in paragraphs (1) and (2) with respect to a shipment as soon as practicable in relation to the transportation of the shipment, consistent with subparagraph (H). (iv) Regulations prescribed under clause (i) shall allow for the requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) to be implemented in phases, as appropriate, by— (I) setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the Commissioner; and (II) taking into consideration— (aa) the risk posed by such shipments; (bb) the volume of mail shipped to the United States by or through a particular country; and (cc) the capacities of foreign postal operators to provide that information to the Postal Service. (v) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2018, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for not less than 70 percent of the aggregate number of mail shipments, including 100 percent of mail shipments from the People’s Republic of China, described in clause (i). (II) If the requirements of subclause (I) are not met, the Comptroller General of the United States shall submit to the appropriate congressional committees, not later than June 30, 2019, a report— (aa) assessing the reasons for the failure to meet those requirements; and (bb) identifying recommendations to improve the collection by the Postal Service of the information described in paragraphs (1) and (2). (vi)(I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2020, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for 100 percent of the aggregate number of mail shipments described in clause (i). (II) The Commissioner, in consultation with the Postmaster General, may determine to exclude a country from the requirement described in subclause (I) to transmit information for mail shipments described in clause (i) from the country if the Commissioner determines that the country— (aa) does not have the capacity to collect and transmit such information; (bb) represents a low risk for mail shipments that violate relevant United States laws and regulations; and (cc) accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant United States laws and regulations through an alternate means. (III) The Commissioner shall, at a minimum on an annual basis, re-evaluate any determination made under subclause (II) to exclude a country from the requirement described in subclause (I). If, at any time, the Commissioner determines that a country no longer meets the requirements under subclause (II), the Commissioner may not further exclude the country from the requirement described in subclause (I). (IV) The Commissioner shall, on an annual basis, submit to the appropriate congressional committees— (aa) a list of countries with respect to which the Commissioner has made a determination under subclause (II) to exclude the countries from the requirement described in subclause (I); and (bb) information used to support such determination with respect to such countries. (vii) (I) The Postmaster General shall, in consultation with the Commissioner, refuse any shipments received after December 31, 2020, for which the information described in paragraphs (1) and (2) is not transmitted as required under this subparagraph, except as provided in subclause (II). (II) If remedial action is warranted in lieu of refusal of shipments pursuant to subclause (I), the Postmaster General and the Commissioner shall take remedial action with respect to the shipments, including destruction, seizure, controlled delivery or other law enforcement initiatives, or correction of the failure to provide the information described in paragraphs (1) and (2) with respect to the shipments. (viii) Nothing in this subparagraph shall be construed to limit the authority of the Secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties. (ix) In this subparagraph, the term appropriate congressional committees means— (I) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (II) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. . (2) Joint strategic plan on mandatory advance information Not later than 60 days after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving— (A) the transmission of information as required by section 343(a)(3)(K) of the Trade Act of 2002, as amended by paragraph (1); and (B) the presentation by the Postal Service to U.S. Customs and Border Protection of all mail targeted by U.S. Customs and Border Protection for inspection. (b) Capacity building (1) In general Section 343(a) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended by adding at the end the following: (5) Capacity building (A) In general The Secretary, with the concurrence of the Secretary of State, and in coordination with the Postmaster General and the heads of other Federal agencies, as appropriate, may provide technical assistance, equipment, technology, and training to enhance the capacity of foreign postal operators— (i) to gather and provide the information required by paragraph (3)(K); and (ii) to otherwise gather and provide postal shipment information related to— (I) terrorism; (II) items the importation or introduction of which into the United States is prohibited or restricted, including controlled substances; and (III) such other concerns as the Secretary determines appropriate. (B) Provision of equipment and technology With respect to the provision of equipment and technology under subparagraph (A), the Secretary may lease, loan, provide, or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the Secretary may prescribe, including nonreimbursable loans or the transfer of ownership of equipment and technology. . (2) Joint strategic plan on capacity building Not later than 1 year after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly develop and submit to the appropriate congressional committees a joint strategic plan— (A) detailing the extent to which U.S. Customs and Border Protection and the United States Postal Service are engaged in capacity building efforts under section 343(a)(5) of the Trade Act of 2002, as added by paragraph (1); (B) describing plans for future capacity building efforts; and (C) assessing how capacity building has increased the ability of U.S. Customs and Border Protection and the Postal Service to advance the goals of this subtitle and the amendments made by this subtitle. (c) Report and consultations by Secretary of Homeland Security and Postmaster General (1) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 3 years after the Postmaster General has met the requirement under clause (vi) of subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following: (A) An assessment of the status of the regulations required to be promulgated under that subparagraph. (B) An update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph. (C) A summary of deliberations between the United States Postal Service and foreign postal operators with respect to issues relating to the transmission of that information. (D) A summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph. (E) An assessment of the quality of that information being received by foreign postal operators, as determined by the Secretary of Homeland Security, and actions taken to improve the quality of that information. (F) A summary of policies established by the Universal Postal Union that may affect the ability of the Postmaster General to obtain the transmission of that information. (G) A summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology. (H) Such other information as the Secretary of Homeland Security and the Postmaster General consider appropriate with respect to obtaining the transmission of information required by that subparagraph. (2) Consultations Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the Postmaster General has met the requirement under clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as amended by subsection (a)(1), to arrange for the transmission of information with respect to 100 percent of the aggregate number of mail shipments described in clause (i) of that section, the Secretary of Homeland Security and the Postmaster General shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments. (d) Government Accountability Office report Not later than June 30, 2019, the Comptroller General of the United States shall submit to the appropriate congressional committees a report— (1) assessing the progress of the United States Postal Service in achieving the transmission of the information required by subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), for the percentage of shipments required by that subparagraph; (2) assessing the quality of the information received from foreign postal operators for targeting purposes; (3) assessing the specific percentage of targeted mail presented by the Postal Service to U.S. Customs and Border Protection for inspection; (4) describing the costs of collecting the information required by such subparagraph (K) from foreign postal operators and the costs of implementing the use of that information; (5) assessing the benefits of receiving that information with respect to international mail shipments; (6) assessing the feasibility of assessing a customs fee under section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 8002, on international mail shipments other than Inbound Express Mail service in a manner consistent with the obligations of the United States under international agreements; and (7) identifying recommendations, including recommendations for legislation, to improve the compliance of the Postal Service with such subparagraph (K), including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by— (A) requiring the Postal Service to serve as the consignee for international mail shipments containing goods; or (B) designating a customs broker to act as an importer of record for international mail shipments containing goods. (e) Technical correction Section 343 of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended in the section heading by striking advanced and inserting advance . (f) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8004. International postal agreements (a) Existing agreements (1) In general In the event that any provision of this subtitle, or any amendment made by this Act, is determined to be in violation of obligations of the United States under any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, the Secretary of State should negotiate to amend the relevant provisions of the agreement so that the United States is no longer in violation of the agreement. (2) Rule of construction Nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle. (b) Future agreements (1) Consultations Before entering into, on or after the date of the enactment of this Act, any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, that is related to the ability of the United States to secure the provision of advance electronic information by foreign postal operators, the Secretary of State should consult with the appropriate congressional committees (as defined in section 8003(f)). (2) Expedited negotiation of new agreement To the extent that any new postal treaty, convention, or other international agreement related to international postal services would improve the ability of the United States to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section 343(a)(3)(K) of the Trade Act of 2002, as amended by section 8003(a)(1), the Secretary of State should expeditiously conclude such an agreement. 8005. Cost recoupment (a) In general The United States Postal Service shall, to the extent practicable and otherwise recoverable by law, ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators. (b) Costs not considered revenue The recovery of costs under subsection (a) shall not be deemed revenue for purposes of subchapter I and II of chapter 36 of title 39, United States Code, or regulations prescribed under that chapter. 8006. Development of technology to detect illicit narcotics (a) In general The Postmaster General and the Commissioner of U.S. Customs and Border Protection, in coordination with the heads of other agencies as appropriate, shall collaborate to identify and develop technology for the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States by mail. (b) Outreach to private sector The Postmaster General and the Commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States. 8007. Civil penalties for postal shipments Section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ) is amended by adding at the end the following new subsection: (e) Civil penalties for postal shipments (1) Civil penalty A civil penalty shall be imposed against the United States Postal Service if the Postal Service accepts a shipment in violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (2) Modification of civil penalty (A) In general U.S. Customs and Border Protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph (1) if U.S. Customs and Border Protection determines that the United States Postal Service— (i) has a low error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002; (ii) is cooperating with U.S. Customs and Border Protection with respect to the violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or (iii) has taken remedial action to prevent future violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (B) Written notification U.S. Customs and Border Protection shall issue a written notification to the Postal Service with respect to each exercise of the authority of subparagraph (A) to reduce or dismiss a civil penalty imposed pursuant to paragraph (1). (3) Ongoing lack of compliance If U.S. Customs and Border Protection determines that the United States Postal Service— (A) has repeatedly committed violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, (B) has failed to cooperate with U.S. Customs and Border Protection with respect to violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and (C) has an increasing error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002, civil penalties may be imposed against the United States Postal Service until corrective action, satisfactory to U.S. Customs and Border Protection, is taken. . 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest (a) In general The Commissioner of U.S. Customs and Border Protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection (b) with respect to each violation of section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ), as amended by section 8007, and section 584 of such Act ( 19 U.S.C. 1584 ) that occurred during the previous year. (b) Information described The information described in this subsection is the following: (1) The name and address of the violator. (2) The specific violation that was committed. (3) The location or port of entry through which the items were transported. (4) An inventory of the items seized, including a description of the items and the quantity seized. (5) The location from which the items originated. (6) The entity responsible for the apprehension or seizure, organized by location or port of entry. (7) The amount of penalties assessed by U.S. Customs and Border Protection, organized by name of the violator and location or port of entry. (8) The amount of penalties that U.S. Customs and Border Protection could have levied, organized by name of the violator and location or port of entry. (9) The rationale for negotiating lower penalties, organized by name of the violator and location or port of entry. (c) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8009. Effective date; regulations (a) Effective date This subtitle and the amendments made by this subtitle (other than the amendments made by section 8002) shall take effect on the date of the enactment of this Act. (b) Regulations Not later than 1 year after the date of the enactment of this Act, such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed. B Recognizing Early Childhood Trauma Related to Substance Abuse 8011. Short title This subtitle may be cited as the Recognizing Early Childhood Trauma Related to Substance Abuse Act of 2018 . 8012. Recognizing Early Childhood Trauma Related to Substance Abuse (a) Dissemination of information The Secretary of Health and Human Services shall disseminate information, resources, and, if requested, technical assistance to early childhood care and education providers and professionals working with young children on— (1) ways to properly recognize children who may be impacted by trauma related to substance abuse by a family member or other adult; and (2) how to respond appropriately in order to provide for the safety and well-being of young children and their families. (b) Goals The information, resources, and technical assistance provided under subsection (a) shall— (1) educate early childhood care and education providers and professionals working with young children on understanding and identifying the early signs and risk factors of children who might be impacted by trauma due to exposure to substance abuse; (2) suggest age-appropriate communication tools, procedures, and practices for trauma-informed care, including ways to prevent or mitigate the effects of trauma; (3) provide options for responding to children impacted by trauma due to exposure to substance abuse that consider the needs of the child and family, including recommending resources and referrals for evidence-based services to support such family; and (4) promote whole-family and multi-generational approaches to prevent separation and support re-unification of families whenever possible and in the best interest of the child. (c) Rule of construction Such information, resources, and if applicable, technical assistance, shall not be construed to amend the requirements under— (1) the Child Care and Development Block Grant Act of 1990 ( 42 U.S.C. 9858 et seq.); (2) the Head Start Act ( 42 U.S.C. 9831 et seq.); or (3) the Individuals with Disabilities Education Act ( 20 U.S.C. 1400 et seq.). C Assisting States’ Implementation of Plans of Safe Care 8021. Short title This subtitle may be cited as the Assisting States’ Implementation of Plans of Safe Care Act . 8022. Assisting States with implementation of plans of safe care (a) In general The Secretary of Health and Human Services shall provide written guidance and, if appropriate, technical assistance to support States in complying with, and implementing, subsections (b)(2)(B)(iii) and (d)(18) of section 106 of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5106a ) in order to promote better protections for young children and family-centered responses. (b) Requirements The guidance and technical assistance shall— (1) enhance States’ understanding of requirements and flexibilities under the law, including clarifying key terms; (2) address State-identified challenges with developing, implementing, and monitoring plans of safe care; (3) disseminate best practices related to developing and implementing plans of safe care, including differential response, collaboration and coordination, and identification and delivery of services, while recognizing needs of different populations and varying community approaches across States; (4) support collaboration between health care providers, social service agencies, public health agencies, and the child welfare system, to promote a family-centered treatment approach; (5) prevent separation and support reunification of families if in the best interests of the child; (6) recommend treatment approaches for serving infants, pregnant women, and postpartum women whose infants may be affected by substance use that are designed to keep infants with their mothers and families whenever appropriate, including recommendations to encourage pregnant women to receive health and other support services during pregnancy; (7) support State efforts to develop technology systems to manage and monitor implementation of plans of safe care; and (8) help States improve the long-term safety and well-being of young children and their families. (c) Construction The guidance and technical assistance shall not be construed to amend the requirements of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5101 et seq.). (d) Definition For purposes of this section, the term State has the meaning given such term in section 3 of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5101 note). D Improving the Federal Response to Families Impacted by Substance Use Disorder 8031. Short title This subtitle may be cited as the Improving the Federal Response to Families Impacted by Substance Use Disorder Act . 8032. Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders (a) Establishment There is established a task force, to be known as the Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders (in this section referred to as “Task Force”). (b) Responsibilities The Task Force— (1) shall identify, evaluate, and recommend ways in which Federal agencies can better coordinate responses to substance use disorders and the opioid crisis; and (2) shall carry out the additional duties described in subsection (d). (c) Membership (1) Number and appointment The Task Force shall be composed of 12 Federal officials having responsibility for, or administering programs related to, the duties of the Task Force. The Secretary of Health and Human Services, the Secretary of Education, the Secretary of Agriculture, and the Secretary of Labor shall each appoint two members to the Task Force from among the Federal officials employed by the Department of which they are the head. Additional Federal agency officials appointed by the Secretary of Health and Human Services shall fill the remaining positions of the Task Force. (2) Chairperson The Secretary of Health and Human Services shall designate a Federal official employed by the Department of Health and Human Services to serve as the chairperson of the Task Force. (3) Deadline for appointment Each member shall be appointed to the Task Force not later than 60 days after the date of the enactment of this Act. (4) Additional agency input The Task Force may seek input from other Federal agencies and offices with experience, expertise, or information relevant in responding to the opioid crisis. (5) Vacancies A vacancy in the Task Force shall be filled in the manner in which the original appointment was made. (6) Prohibition of compensation Members of the Task Force may not receive pay, allowances, or benefits by reason of their service on the Task Force. (d) Duties The Task Force shall carry out the following duties: (1) Solicit input from stakeholders, including frontline service providers, medical professionals, educators, mental health professionals, researchers, experts in infant, child, and youth trauma, child welfare professionals, and the public, in order to inform the activities of the Task Force. (2) Develop a strategy on how the Task Force and participating Federal agencies will collaborate, prioritize, and implement a coordinated Federal approach with regard to responding to substance use disorders, including opioid misuse, that shall include— (A) identifying options for the coordination of existing grants that support infants, children, and youth, and their families as appropriate, who have experienced, or are at risk of experiencing, exposure to substance abuse disorders, including opioid misuse; and (B) other ways to improve coordination, planning, and communication within and across Federal agencies, offices, and programs, to better serve children and families impacted by substance use disorders, including opioid misuse. (3) Based off the strategy developed under paragraph (2), evaluate and recommend opportunities for local- and State-level partnerships, professional development, or best practices that— (A) are designed to quickly identify and refer children and families, as appropriate, who have experienced or are at risk of experiencing exposure to substance abuse; (B) utilize and develop partnerships with early childhood education programs, local social services organizations, and health care services aimed at preventing or mitigating the effects of exposure to substance use disorders, including opioid misuse; (C) offer community-based prevention activities, including educating families and children on the effects of exposure to substance use disorders, including opioid misuse, and how to build resilience and coping skills to mitigate those effects; (D) in accordance with Federal privacy protections, utilize non-personally identifiable data from screenings, referrals, or the provision of services and supports to evaluate and improve processes addressing exposure to substance use disorders, including opioid misuse; and (E) are designed to prevent separation and support reunification of families if in the best interest of the child. (4) In fulfilling the requirements of paragraphs (2) and (3), consider evidence-based, evidence-informed, and promising best practices related to identifying, referring, and supporting children and families at risk of experiencing exposure to substance abuse or experiencing substance use disorder, including opioid misuse, including— (A) prevention strategies for those at risk of experiencing or being exposed to substance abuse, including misuse of opioids; (B) whole-family and multi-generational approaches; (C) community-based initiatives; (D) referral to, and implementation of, trauma-informed practices and supports; and (E) multi-generational practices that assist parents, foster parents, and kinship and other caregivers (e) FACA The Federal Advisory Committee Act ( 5 U.S.C. App. 2 ) shall not apply to the Task Force. (f) Action plan; reports The Task Force— (1) shall prepare a detailed action plan to be implemented by participating Federal agencies to create a collaborative, coordinated response to the opioid crisis, which shall include— (A) relevant information identified and collected under subsection (d); (B) a proposed timeline for implementing recommendations and efforts identified under subsection (d); and (C) a description of how other Federal agencies and offices with experience, expertise, or information relevant in responding to the opioid crisis that have provided input under subsection (c)(4) will be participating in the coordinated approach; (2) shall submit to the Congress a report describing the action plan prepared under paragraph (1), including, where applicable, identification of any recommendations included in such plan that require additional legislative authority to implement; and (3) shall submit a report to the Governors describing the opportunities for local- and State-level partnerships, professional development, or best practices recommended under subsection (d)(3). (g) Dissemination (1) In general The action plan and reports required under subsection (f) shall be— (A) disseminated widely, including among the participating Federal agencies and the Governors; and (B) be made publicly available online in an accessible format. (2) Deadline The action plan and reports required under subsection (f) may be released on separate dates but shall be released not later than 9 months after the date of the enactment of this Act. (h) Termination The Task Force shall terminate 30 days after the dissemination of the action plan and reports under subsection (g). (i) Funding The administrative expenses of the Task Force shall be paid out of existing Department of Health and Human Services funds or appropriations. (j) Definitions For purposes of this section: (1) The term Governor means the chief executive officer of a State. (2) The term participating Federal agencies means all the Executive agencies (as defined in section 105 of title 5, United States Code) whose officials have been appointed to the Task Force. (3) The term State means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. E Establishment of an Advisory Committee on Opioids and the Workplace 8041. Establishment of an Advisory Committee on Opioids and the Workplace (a) Establishment Not later than 90 days after enactment of this Act, the Secretary of Labor shall establish an Advisory Committee on Opioids and the Workplace (referred to in this subtitle as the Advisory Committee ) to advise the Secretary on actions the Department of Labor can take to provide informational resources and best practices on how to appropriately address the impact of opioid abuse on the workplace and support workers abusing opioids. (b) Membership (1) Composition The Secretary of Labor shall appoint as members of the Advisory Committee 19 individuals with expertise in employment, workplace health programs, human resources, substance use disorder, and other relevant fields. The Advisory Committee shall be composed as follows: (A) Four of the members shall be individuals representative of employers or other organizations representing employers. (B) Four of the members shall be individuals representative of workers or other organizations representing workers, of which at least two must be representatives designated by labor organizations. (C) Three of the members shall be individuals representative of health benefit plans, employee assistance plan providers, workers’ compensation program administrators, and workplace safety and health professionals. (D) Eight of the members shall be individuals representative of substance abuse treatment and recovery experts, including medical doctors, licensed addiction therapists, and scientific and academic researchers, of which one individual may be a representative of a local or State government agency that oversees or coordinates programs that address substance use disorder. (2) Chair From the members appointed under paragraph (1), the Secretary of Labor shall appoint a chairperson. (3) Terms Each member of the Advisory Committee shall serve for a term of 3 years. A member appointed to fill a vacancy shall be appointed only for the remainder of such term. (4) Quorum A majority of members of the Advisory Committee shall constitute a quorum and action shall be taken only by a majority vote of the members. (5) Voting The Advisory Committee shall establish voting procedures. (6) No compensation Members of the Advisory Committee shall serve without compensation. (7) Disclosure Every member of the Advisory Committee must disclose the entity, if applicable, that he or she is representing. (c) Duties (1) Advisement (A) In general The Advisory Committee established under subsection (a) shall advise the Secretary of Labor on actions the Department of Labor can take to provide informational resources and best practices on how to appropriately address the impact of opioid abuse on the workplace and support workers abusing opioids. (B) Considerations In providing such advice, the Advisory Committee shall take into account— (i) evidence-based and other employer substance abuse policies and best practices regarding opioid use or abuse, including benefits provided by employee assistance programs or other employer-provided benefits, programs, or resources; (ii) the effect of opioid use or abuse on the safety of the workplace as well as policies and procedures addressing workplace safety and health; (iii) the impact of opioid abuse on productivity and absenteeism, and assessments of model human resources policies that support workers abusing opioids, such as policies that facilitate seeking and receiving treatment and returning to work; (iv) the extent to which alternative pain management treatments other than opioids are or should be covered by employer-sponsored health plans; (v) the legal requirements protecting employee privacy and health information in the workplace, as well as the legal requirements related to nondiscrimination; (vi) potential interactions of opioid abuse with other substance use disorders; (vii) any additional benefits or resources available to an employee abusing opioids that promote retaining employment or reentering the workforce; (viii) evidence-based initiatives that engage employers, employees, and community leaders to promote early identification of opioid abuse, intervention, treatment, and recovery; (ix) workplace policies regarding opioid abuse that reduce stigmatization among fellow employees and management; and (x) the legal requirements of the Mental Health Parity and Addiction Equity Act and other laws related to health coverage of substance abuse and mental health services and medications. (2) Report Prior to its termination as provided in subsection (j), the Advisory Committee shall issue a report to the Secretary of Labor and to the Committee on Education and the Workforce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, detailing successful programs and policies involving workplace resources and benefits, including recommendations or examples of best practices for how employers can support and respond to employees impacted by opioid abuse. (d) Meetings The Advisory Committee shall meet at least twice a year at the call of the chairperson. (e) Staff support The Secretary of Labor shall make available staff necessary for the Advisory Committee to carry out its responsibilities. (f) Federal Advisory Committee Act The Federal Advisory Committee Act shall apply to the Advisory Committee established under this subtitle. (g) No appropriated funds No additional funds are authorized to be appropriated to carry out this subtitle. Expenses of the Advisory Committee shall be paid with funds otherwise appropriated to Departmental Management within the Department of Labor. (h) Ex officio Three nonvoting representatives from agencies within the Department of Health and Human Services whose responsibilities include opioid prescribing guidelines, workplace safety, and monitoring of substance abuse and prevention programs shall be appointed by the Secretary of Labor and designated as ex officio members. (i) Agenda The Secretary of Labor or a representative of the Secretary shall consult with the Chair in establishing the agenda for Committee meetings. (j) Termination The Advisory Committee established under this subtitle shall terminate 3 years after the date of enactment of this Act. F Veterans Treatment Court Improvement 8051. Short title This subtitle may be cited as the Veterans Treatment Court Improvement Act of 2018 . 8052. Hiring by Department of Veterans Affairs of additional Veterans Justice Outreach Specialists (a) Hiring of additional Veterans Justice Outreach Specialists (1) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall hire not fewer than 50 Veterans Justice Outreach Specialists and place each such Veterans Justice Outreach Specialist at an eligible Department of Veterans Affairs medical center in accordance with this section. (2) Requirements The Secretary shall ensure that each Veterans Justice Outreach Specialist employed under paragraph (1)— (A) serves, either exclusively or in addition to other duties, as part of a justice team in a veterans treatment court or other veteran-focused court; and (B) otherwise meets Department hiring guidelines for Veterans Justice Outreach Specialists. (b) Eligible Department of Veterans Affairs medical centers For purposes of this section, an eligible Department of Veterans Affairs medical center is any Department of Veterans Affairs medical center that— (1) complies with all Department guidelines and regulations for placement of a Veterans Justice Outreach Specialist; (2) works within a local criminal justice system with justice-involved veterans; (3) maintains an affiliation with one or more veterans treatment courts or other veteran-focused courts; and (4) either— (A) routinely provides Veterans Justice Outreach Specialists to serve as part of a justice team in a veterans treatment court or other veteran-focused court; or (B) establishes a plan that is approved by the Secretary to provide Veterans Justice Outreach Specialists employed under subsection (a)(1) to serve as part of a justice team in a veterans treatment court or other veteran-focused court. (c) Placement priority The Secretary shall prioritize the placement of Veterans Justice Outreach Specialists employed under subsection (a)(1) at eligible Department of Veterans Affairs medical centers that have or intend to establish an affiliation, for the purpose of carrying out the Veterans Justice Outreach Program, with a veterans treatment court, or other veteran-focused court, that— (1) was established on or after the date of the enactment of this Act; or (2) (A) was established before the date of the enactment of this Act; and (B) is not fully staffed with Veterans Justice Outreach Specialists. (d) Reports (1) Report by Secretary of Veterans Affairs (A) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to Congress a report on the implementation of this section and its effect on the Veterans Justice Outreach Program. (B) Contents The report submitted under paragraph (1) shall include the following: (i) The status of the efforts of the Secretary to hire Veterans Justice Outreach Specialists pursuant to subsection (a)(1), including the total number of Veterans Justice Outreach Specialists hired by the Secretary pursuant to such subsection and the number that the Secretary expects to hire pursuant to such subsection. (ii) The total number of Veterans Justice Outreach Specialists assigned to each Department of Veterans Affairs medical center that participates in the Veterans Justice Outreach Program, including the number of Veterans Justice Outreach Specialists hired under subsection (a)(1) disaggregated by Department of Veterans Affairs medical center. (iii) The total number of eligible Department of Veterans Affairs medical centers that sought placement of a Veterans Justice Outreach Specialist under subsection (a)(1), how many Veterans Justice Outreach Specialists each such center sought, and how many of such medical centers received no placement of a Veterans Justice Outreach Specialist under subsection (a)(1). (iv) For each eligible Department of Veterans Affairs medical center— (I) the number of justice-involved veterans who were served or are expected to be served by a Veterans Justice Outreach Specialist hired under subsection (a)(1); and (II) the number of justice-involved veterans who do not have access to a Veterans Justice Outreach Specialist. (2) Report by Comptroller General of the United States (A) In general Not later than 3 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the implementation of this section and the effectiveness of the Veterans Justice Outreach Program. (B) Contents The report required by subparagraph (A) shall include the following: (i) An assessment of whether the Secretary has fulfilled the Secretary's obligations under this section. (ii) The number of veterans who are served by Veterans Justice Outreach Specialists hired under subsection (a)(1), disaggregated by demographics (including discharge status). (iii) An identification of any subgroups of veterans who underutilize services provided under laws administered by the Secretary, including an assessment of whether these veterans have access to Veterans Justice Outreach Specialists under the Veterans Justice Outreach Program. (iv) Such recommendations as the Comptroller General may have for the Secretary to improve the effectiveness of the Veterans Justice Outreach Program. (e) Definitions In this section: (1) Justice team The term justice team means the group of individuals, which may include a judge, court coordinator, prosecutor, public defender, treatment provider, probation or other law enforcement officer, program mentor, and Veterans Justice Outreach Specialist, who assist justice-involved veterans in a veterans treatment court or other veteran-focused court. (2) Justice-involved veteran The term justice-involved veteran means a veteran with active, ongoing, or recent contact with some component of a local criminal justice system. (3) Local criminal justice system The term local criminal justice system means law enforcement, jails, prisons, and Federal, State, and local courts. (4) Veterans Justice Outreach Program The term Veterans Justice Outreach Program means the program through which the Department of Veterans Affairs identifies justice-involved veterans and provides such veterans with access to Department services. (5) Veterans Justice Outreach Specialist The term Veterans Justice Outreach Specialist means an employee of the Department of Veterans Affairs who serves as a liaison between the Department and the local criminal justice system on behalf of a justice-involved veteran. (6) Veterans treatment court The term veterans treatment court means a State or local court that is participating in the veterans treatment court program (as defined in section 2991(i)(1) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797aa(i)(1) )). G Peer support counseling program for women veterans 8061. Peer support counseling program for women veterans (a) In general Section 1720F(j) of title 38, United States Code, is amended by adding at the end the following new paragraph: (4) (A) As part of the counseling program under this subsection, the Secretary shall emphasize appointing peer support counselors for women veterans. To the degree practicable, the Secretary shall seek to recruit women peer support counselors with expertise in— (i) female gender-specific issues and services; (ii) the provision of information about services and benefits provided under laws administered by the Secretary; or (iii) employment mentoring. (B) To the degree practicable, the Secretary shall emphasize facilitating peer support counseling for women veterans who are eligible for counseling and services under section 1720D of this title, have post-traumatic stress disorder or suffer from another mental health condition, are homeless or at risk of becoming homeless, or are otherwise at increased risk of suicide, as determined by the Secretary. (C) The Secretary shall conduct outreach to inform women veterans about the program and the assistance available under this paragraph. (D) In carrying out this paragraph, the Secretary shall coordinate with such community organizations, State and local governments, institutions of higher education, chambers of commerce, local business organizations, organizations that provide legal assistance, and other organizations as the Secretary considers appropriate. (E) In carrying out this paragraph, the Secretary shall provide adequate training for peer support counselors, including training carried out under the national program of training required by section 304(c) of the Caregivers and Veterans Omnibus Health Services Act of 2010 ( 38 U.S.C. 1712A note). . (b) Funding The Secretary of Veterans Affairs shall carry out paragraph (4) of section 1720F(j) of title 38, United States Code, as added by subsection (a), using funds otherwise made available to the Secretary. No additional funds are authorized to be appropriated by reason of such paragraph. (c) Report to Congress Not later than 2 years after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on the peer support counseling program under section 1720F(j) of title 38, United States Code, as amended by this section. Such report shall include— (1) the number of peer support counselors in the program; (2) an assessment of the effectiveness of the program; and (3) a description of the oversight of the program. H Treating Barriers to Prosperity 8071. Short title This subtitle may be cited as the Treating Barriers to Prosperity Act of 2018 . 8072. Drug abuse mitigation initiative (a) In general Chapter 145 of title 40, United States Code, is amended by inserting after section 14509 the following: 14510. Drug abuse mitigation initiative (a) In general The Appalachian Regional Commission may provide technical assistance to, make grants to, enter into contracts with, or otherwise provide amounts to individuals or entities in the Appalachian region for projects and activities to address drug abuse, including opioid abuse, in the region, including projects and activities— (1) to facilitate the sharing of best practices among States, counties, and other experts in the region with respect to reducing such abuse; (2) to initiate or expand programs designed to eliminate or reduce the harm to the workforce and economic growth of the region that results from such abuse; (3) to attract and retain relevant health care services, businesses, and workers; and (4) to develop relevant infrastructure, including broadband infrastructure that supports the use of telemedicine. (b) Limitation on available amounts Of the cost of any activity eligible for a grant under this section— (1) not more than 50 percent may be provided from amounts appropriated to carry out this section; and (2) notwithstanding paragraph (1)— (A) in the case of a project to be carried out in a county for which a distressed county designation is in effect under section 14526, not more than 80 percent may be provided from amounts appropriated to carry out this section; and (B) in the case of a project to be carried out in a county for which an at-risk designation is in effect under section 14526, not more than 70 percent may be provided from amounts appropriated to carry out this section. (c) Sources of assistance Subject to subsection (b), a grant provided under this section may be provided from amounts made available to carry out this section in combination with amounts made available— (1) under any other Federal program (subject to the availability of subsequent appropriations); or (2) from any other source. (d) Federal share Notwithstanding any provision of law limiting the Federal share under any other Federal program, amounts made available to carry out this section may be used to increase that Federal share, as the Appalachian Regional Commission determines to be appropriate. . (b) Clerical amendment The analysis for chapter 145 of title 40, United States Code, is amended by inserting after the item relating to section 14509 the following: 14510. Drug abuse mitigation initiative. . I Supporting Grandparents Raising Grandchildren 8081. Short title This subtitle may be cited as the Supporting Grandparents Raising Grandchildren Act . 8082. Findings Congress finds the following: (1) More than 2,500,000 grandparents in the United States are the primary caretaker of their grandchildren, and experts report that such numbers are increasing as the opioid epidemic expands. (2) Between 2009 and 2016, the incidence of parental alcohol or other drug use as a contributing factor for children’s out-of-home placement rose from 25.4 to 37.4 percent. (3) When children cannot remain safely with their parents, placement with relatives is preferred over placement in foster care with nonrelatives because placement with relatives provides stability for children and helps them maintain family connections. (4) The number of foster children placed with a grandparent or other relative increased from 24 percent in 2006 to 32 percent in 2016, according to data from the Department of Health and Human Services. (5) Grandparents' lives are enhanced by caring for their grandchildren; the overwhelming majority of grandparents report experiencing significant benefits in serving as their grandchildren’s primary caregivers. (6) Providing full-time care to their grandchildren may decrease grandparents’ ability to address their own physical and mental health needs and personal well-being. (7) Grandparents would benefit from better coordination and dissemination of information and resources available to support them in their caregiving responsibilities. 8083. Advisory Council To Support Grandparents Raising Grandchildren (a) Establishment There is established an Advisory Council to Support Grandparents Raising Grandchildren. (b) Membership (1) In general The Advisory Council shall be composed of the following members, or their designee: (A) The Secretary of Health and Human Services. (B) The Secretary of Education. (C) The Administrator of the Administration for Community Living. (D) The Director of the Centers for Disease Control and Prevention. (E) The Assistant Secretary for Mental Health and Substance Use. (F) The Assistant Secretary for the Administration for Children and Families. (G) A grandparent raising a grandchild. (H) An older relative caregiver of children. (I) As appropriate, the head of other Federal departments, or agencies, identified by the Secretary of Health and Human Services as having responsibilities, or administering programs, relating to current issues affecting grandparents or other older relatives raising children. (2) Lead agency The Department of Health and Human Services shall be the lead agency for the Advisory Council. (c) Duties (1) In general (A) Information The Advisory Council shall identify, promote, coordinate, and disseminate to the public information, resources, and the best practices available to help grandparents and other older relatives— (i) meet the health, educational, nutritional, and other needs of the children in their care; and (ii) maintain their own physical and mental health and emotional well-being. (B) Opioids In carrying out the duties described in subparagraph (A), the Advisory Council shall consider the needs of those affected by the opioid crisis. (C) Native Americans In carrying out the duties described in subparagraph (A), the Advisory Council shall consider the needs of members of Native American tribes. (2) Report (A) In general Not later than 180 days after the date of enactment of this Act, the Advisory Council shall submit a report to— (i) the appropriate committees; (ii) the State agencies that are responsible for carrying out family caregiver programs; and (iii) the public online in an accessible format. (B) Report format The report shall include— (i) best practices, resources, and other useful information for grandparents and other older relatives raising children identified under paragraph (1)(A) including, if applicable, any information related to the needs of children who have been impacted by the opioid epidemic; (ii) an identification of any gaps in items under clause (i); and (iii) where applicable, identification of any additional Federal legislative authority necessary to implement the activities described in clause (i) and (ii). (3) Follow-up report Not later than 2 years after the date on which the report required under paragraph (2)(A) is submitted, the Advisory Council shall submit a follow-up report that includes the information identified in paragraph (2)(B) to— (A) the appropriate committees; (B) the State agencies that are responsible for carrying out family caregiver programs; and (C) the public online in an accessible format. (4) Public input (A) In general The Advisory Council shall establish a process for public input to inform the development of, and provide updates to, the best practices, resources, and other information described in paragraph (1) that shall include— (i) outreach to States, local entities, and organizations that provide information to, or support for, grandparents or other older relatives raising children; and (ii) outreach to grandparents and other older relatives with experience raising children. (B) Nature of outreach Such outreach shall ask individuals to provide input on— (i) information, resources, and best practices available, including identification of any gaps and unmet needs; and (ii) recommendations that would help grandparents and other older relatives better meet the health, educational, nutritional, and other needs of the children in their care, as well as maintain their own physical and mental health and emotional well-being. (d) FACA The Advisory Council shall be exempt from the requirements of the Federal Advisory Committee Act (5 U.S.C. App.). (e) Funding No additional funds are authorized to be appropriated to carry out this subtitle. (f) Sunset The Advisory Council shall terminate on the date that is 3 years after the date of enactment of this Act. 8084. Definitions In this subtitle: (1) Advisory Council In this subtitle, the term Advisory Council means the Advisory Council to Support Grandparents Raising Grandchildren that is established under section 8083. (2) Appropriate committees In this subtitle, the term appropriate committees means the following: (A) The Special Committee on Aging of the Senate. (B) The Committee on Health, Education, Labor, and Pensions of the Senate. (C) The Committee on Education and the Workforce of the House of Representatives. (D) The Committee on Energy and Commerce of the House of Representatives. J Reauthorizing and Extending Grants for Recovery from Opioid Use Programs 8091. Short title This subtitle may be cited as the Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018 . 8092. Reauthorization of the comprehensive opioid abuse grant program Section 1001(a)(27) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10261(a)(27) ) is amended by striking through 2021 and inserting and 2018, and $330,000,000 for each of fiscal years 2019 through 2023 . IX SITSA Act 9001. Short title This title may be cited as the Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 or the SITSA Act . 9002. Establishment of schedule A Section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ) is amended— (1) in subsection (a), by striking five schedules of controlled substances, to be known as schedules I, II, III, IV, and V and inserting six schedules of controlled substances, to be known as schedules I, II, III, IV, V, and A ; (2) in subsection (b), by adding at the end the following: (6) Schedule A (A) In general The drug or substance— (i) has— (I) a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule I, II, III, IV, or V; and (II) an actual or predicted stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I, II, III, IV, or V; and (ii) is not— (I) listed or otherwise included in any other schedule in this section or by regulation of the Attorney General; and (II) with respect to a particular person, subject to an exemption that is in effect for investigational use, for that person, under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) to the extent conduct with respect to such substance is pursuant to such exemption. (B) Predicted stimulant, depressant, or hallucinogenic effect For purpose of this paragraph, a predicted stimulant, depressant, or hallucinogenic effect on the central nervous system may be based on— (i) the chemical structure and— (I) the structure activity relationships; or (II) binding receptor assays and other relevant scientific information about the substance; (ii) (I) the current or relative potential for abuse of the substance; and (II) the clandestine importation, manufacture, or distribution, or diversion from legitimate channels, of the substance; or (iii) the capacity of the substance to cause a state of dependence, including physical or psychological dependence that is similar to or greater than that of a controlled substance in schedule I, II, III, IV, or V. ; and (3) in subsection (c), in the matter preceding schedule I, by striking IV, and V and inserting IV, V, and A . 9003. Temporary and permanent scheduling of schedule A substances Section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) is amended by adding at the end the following: (k) Temporary and permanent scheduling of schedule A substances (1) The Attorney General may issue a temporary order adding a drug or substance to schedule A if the Attorney General finds that— (A) the drug or other substance satisfies the criteria for being considered a schedule A substance; and (B) adding such drug or substance to schedule A will assist in preventing abuse of the drug or other substance. (2) A temporary scheduling order issued under paragraph (1) shall not take effect until 30 days after the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued. The temporary scheduling order shall expire not later than 5 years after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (5), extend the temporary scheduling order for up to 180 days. (3) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent order issued under paragraph (5) with regard to the same substance, or upon the subsequent issuance of any scheduling order under this section. (4) A temporary scheduling order issued under paragraph (1) shall not be subject to judicial review. (5) (A) Beginning no earlier than 3 years after issuing an order temporarily scheduling a drug or other substance under this subsection, the Attorney General may, by rule, issue a permanent order adding a drug or other substance to schedule A if such drug or substance satisfies the criteria for being considered a controlled substance in schedule A under this subsection, except as provided in subparagraph (B). (B) If the Secretary has determined, based on relevant scientific studies and necessary data requested by the Secretary and gathered by the Attorney General, that a drug or other substance that has been temporarily placed in schedule A does not have sufficient potential for abuse to warrant control in any schedule, and so advises the Attorney General in writing, the Attorney General may not issue a permanent scheduling order under subparagraph (A) and shall, within 30 days of receiving the Secretary’s advice issue an order immediately terminating the temporary scheduling order. (6) Before initiating proceedings under paragraph (1), the Attorney General shall transmit notice of a temporary order proposed to be issued to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary of Health and Human Services in response to a notice transmitted pursuant to this paragraph. (7) On the date of the publication of a notice in the Federal Register pursuant to paragraph (2), the Attorney General shall transmit the same notice to Congress. The temporary scheduling order shall take effect according to paragraph (2), except that the temporary scheduling order may be disapproved by an Act of Congress within 180 days from the date of publication of the notice in the Federal Register. . 9004. Penalties (a) Controlled Substances Act The Controlled Substances Act ( 21 U.S.C. 801 et seq.) is amended— (1) in section 401(b)(1) ( 21 U.S.C. 841(b)(1) ), by adding at the end the following: (F) (i) In the case of any controlled substance in schedule A, such person shall be sentenced to a term of imprisonment of not more than 10 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 15 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $500,000 if the defendant is an individual or $2.5 million if the defendant is other than an individual, or both. (ii) If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 30 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18, United States Code, or $1 million if the defendant is an individual or $5 million if the defendant is other than an individual, or both. (iii) Any sentence imposing a term of imprisonment under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of not less than 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of not less than 4 years in addition to such term of imprisonment. ; (2) in section 403(a) ( 21 U.S.C. 843(a) )— (A) in paragraph (8), by striking or at the end; (B) in paragraph (9), by striking the period at the end and inserting ; or ; and (C) by inserting after paragraph (9) the following: (10) to export a substance in violation of the controlled substance laws of the country to which the substance is exported. ; and (3) in section 404 ( 21 U.S.C. 844 ), by inserting after subsection (a) the following: (b) A person shall not be subject to a criminal or civil penalty under this title or under any other Federal law solely for possession of a schedule A controlled substance. . (b) Controlled Substances Import and Export Act Section 1010(b) of the Controlled Substances Import and Export Act ( 21 U.S.C. 960(b) ) is amended by adding at the end the following: (8) In the case of a violation under subsection (a) involving a controlled substance in schedule A, the person committing such violation shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $1 million if the defendant is an individual or $5 million if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to not more than life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18, United States Code, or $2 million if the defendant is an individual or $10 million if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, United States Code, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of not less than 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of not less than 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results. . 9005. False labeling of schedule A controlled substances (a) In general Section 305 of the Controlled Substances Act ( 21 U.S.C. 825 ) is amended by adding at the end the following: (f) False labeling of schedule A controlled substances (1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, a schedule A substance or product containing a schedule A substance, unless the substance or product bears a label clearly identifying a schedule A substance or product containing a schedule A substance by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC). (2) (A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act. (B) A product is described in this subparagraph if the product— (i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act; or (ii) is exempt from the provisions of section 505 of such Act relating to new drugs because— (I) it is intended solely for investigational use as described in section 505(i) of such Act; and (II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application. . (b) Penalties Section 402 of the Controlled Substances Act ( 21 U.S.C. 842 ) is amended— (1) in subsection (a)(16), by inserting or subsection (f) after subsection (e) ; and (2) in subsection (c)(1)(D), by inserting or a schedule A substance after anabolic steroid . 9006. Registration requirements for handlers of schedule A substances (a) Controlled Substances Act Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (k) (1) The Attorney General shall register an applicant to manufacture schedule A substances if— (A) the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and (B) the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection. (2) In determining the public interest under paragraph (1)(B), the Attorney General shall consider— (A) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule A compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes; (B) compliance with applicable State and local law; (C) promotion of technical advances in the art of manufacturing substances described in subparagraph (A) and the development of new substances; (D) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of substances described in paragraph (A); (E) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and (F) such other factors as may be relevant to and consistent with the public health and safety. (3) If an applicant is registered to manufacture controlled substances in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection. (l) (1) The Attorney General shall register an applicant to distribute schedule A substances— (A) if the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and (B) unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. (2) In determining the public interest under paragraph (1)(B), the Attorney General shall consider— (A) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (B) compliance with applicable State and local law; (C) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of substances described in subparagraph (A); (D) past experience in the distribution of controlled substances; and (E) such other factors as may be relevant to and consistent with the public health and safety. (3) If an applicant is registered to distribute a controlled substance in schedule I or II under subsection (b), the applicant shall not be required to apply for a separate registration under this subsection. (m) (1) (A) Not later than 90 days after the date on which a substance is placed in schedule A, any practitioner who was engaged in research on the substance before the placement of the substance in schedule A and any manufacturer or distributor who was handling the substance before the placement of the substance in schedule A shall register with the Attorney General. (B) (i) If an applicant described in subparagraph (A) is registered pursuant to subsection (f) to conduct research with a controlled substance in schedule I or II on the date on which another substance is placed in schedule A, the applicant may, subject to clause (iii), conduct research with that other controlled substance in schedule A while the application for registration pursuant to subparagraph (A) is pending. (ii) If an applicant described in subparagraph (A) is registered pursuant to subsection (f) as described in clause (i) to conduct research with a controlled substance in schedule III, IV, or V on the date on which another substance is placed in schedule A, the applicant may, subject to clause (iii), conduct research with that other controlled substance in schedule A while the application for registration pursuant to subparagraph (A) is pending, provided the substance for which the applicant is registered to conduct research is in the same schedule as, or a less-restricted schedule than, the controlled substance whose similarity in chemical structure and actual or predicted effect to the controlled substance in schedule A formed the basis for placement of the substance in schedule A, as set forth in the order published in the Federal Register placing the substance in schedule A. (iii) The permission to conduct research pursuant to clause (i) or clause (ii) is conditional on the applicant's complying with the registration and other requirements for controlled substances in schedule A. (iv) This subparagraph does not apply to applicants registered pursuant to subsection (f) whose authorization to conduct research with any controlled substances is limited to doing so as a coincident activity pursuant to applicable regulations of the Attorney General. (2) (A) Not later than 60 days after the date on which the Attorney General receives an application for registration to conduct research on a schedule A substance, the Attorney General shall— (i) grant, or initiate proceedings under section 304(c) to deny, the application; or (ii) request supplemental information from the applicant. (B) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) in connection with an application described in subparagraph (A), the Attorney General shall grant or deny the application. (n) (1) The Attorney General shall register a scientific investigator or a qualified research institution to conduct research with controlled substances in schedule A in accordance with this subsection. In evaluating applications for such registration, the Attorney General shall apply the criteria set forth in subsection (f) of this section that apply to practitioners seeking a registration to conduct research with a schedule I controlled substance, except that the applicant shall not be required to submit a research protocol. (2) If the applicant is not currently registered under subsection (f) to conduct research with a schedule I controlled substance, the Attorney General shall refer the application to the Secretary, who shall determine whether the applicant will be engaged in bona fide research and is qualified to conduct such research. The 60-day period under subsection (m)(2)(A) shall be tolled during the period beginning on the date on which the Attorney General refers an application to the Secretary under this paragraph, and ending on the date on which the Secretary submits a determination related to such referral to the Attorney General. (3) An applicant who meets the criteria under subsection (m)(1)(B) with respect to a particular schedule A controlled substance shall be considered qualified to conduct research with that substance. The Attorney General shall modify such applicant’s registration to include such schedule A controlled substance in accordance with this paragraph. The applicant shall notify the Attorney General of his intent to conduct research with a controlled substance in schedule A. Upon receiving such notification, the Attorney General shall modify the practitioner’s existing registration to authorize research with schedule A controlled substances, unless the Attorney General determines that the registration modification would be inconsistent with the public interest based on the criteria of subsection (f). (4) Registrations issued under this subsection to a qualified research institution will apply to all agents and employees of that institution acting within the scope of their professional practice. (5) At least 30 days prior to conducting any research with a controlled substance in schedule A, the registrant shall provide the Attorney General with written notification of the following: (A) The name of and drug code for each substance. (B) The name of each individual with access to each substance. (C) The amount of each substance. (D) Other similar information the Attorney General may require. (6) The quantity of a schedule A controlled substance possessed by a person registered under this subsection shall be appropriate for the research being conducted, subject to the additional limitations set forth in this paragraph. To reduce the risk of diversion, the Attorney General may establish limitations on the quantity of schedule A controlled substances that may be manufactured or possessed for purposes of research under this subsection and shall publish such limitations on the website of the Drug Enforcement Administration. A person registered under this subsection may, based on legitimate research needs, apply to the Attorney General to manufacture or possess an amount greater than that so specified by the Attorney General. The Attorney General shall specify the manner in which such applications shall be submitted. The Attorney General shall act on an application filed under this subparagraph within 30 days of receipt of such application. If the Attorney General fails to act within 30 days, the registrant shall be allowed to manufacture and possess up to the amount requested. The Attorney General shall have the authority to reverse the increase for cause. (7) The Attorney General shall by regulation specify the manner in which applications for registration under this subsection shall be submitted. (8) Registrants authorized under this subsection may manufacture and possess schedule A controlled substances up to the approved amounts only for use in their own research setting or institution. Manufacturing for use in any other setting or institution shall require a manufacturer’s registration under section 303(a). . (b) Controlled Substances Import and Export Act Section 1008 of the Controlled Substances Import and Export Act ( 21 U.S.C. 958 ) is amended by adding at the end the following: (j) (1) The Attorney General shall register an applicant to import or export a schedule A substance if— (A) the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and (B) the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection. (2) In determining the public interest under paragraph (1)(B), the Attorney General shall consider the factors described in subparagraphs (A) through (F) of section 303(k)(2). (3) If an applicant is registered to import or export a controlled substance in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection. . 9007. Additional conforming amendments (a) Controlled Substances Act The Controlled Substances Act ( 21 U.S.C. 801 et seq.) is amended— (1) in section 303(c) ( 21 U.S.C. 823(c) )— (A) by striking subsections (a) and (b) and inserting subsection (a), (b), (k), or (l) ; and (B) by striking schedule I or II and inserting schedule I, II, or A ; (2) in section 306 ( 21 U.S.C. 826 )— (A) in subsection (a), in the first sentence, by striking schedules I and II and inserting schedules I, II, and A ; (B) in subsection (b), in the second sentence, by striking schedule I or II and inserting schedule I, II, or A ; (C) in subsection (c), in the first sentence, by striking schedules I and II and inserting schedules I, II, and A ; (D) in subsection (d), in the first sentence, by striking schedule I or II and inserting schedule I, II, or A ; (E) in subsection (e), in the first sentence, by striking schedule I or II and inserting schedule I, II, or A ; and (F) in subsection (f), in the first sentence, by striking schedules I and II and inserting schedules I, II, and A ; (3) in section 308(a) ( 21 U.S.C. 828(a) ), by striking schedule I or II and inserting schedule I, II, or A ; (4) in section 402(b) ( 21 U.S.C. 842(b) ), in the matter preceding paragraph (1), by striking schedule I or II and inserting schedule I, II, or A ; (5) in section 403(a)(1) ( 21 U.S.C. 843(a)(1) ), by striking schedule I or II and inserting schedule I, II, or A ; and (6) in section 511(f) ( 21 U.S.C. 881(f) ), by striking schedule I or II each place it appears and inserting schedule I, II, or A . (b) Controlled Substances Import Export Act The Controlled Substances Import and Export Act ( 21 U.S.C. 951 et seq.) is amended— (1) in section 1002(a) ( 21 U.S.C. 952(a) )— (A) in the matter preceding paragraph (1), by striking schedule I or II and inserting schedule I, II, or A ; and (B) in paragraph (2), by striking schedule I or II and inserting schedule I, II, or A ; (2) in section 1003 ( 21 U.S.C. 953 )— (A) in subsection (c), in the matter preceding paragraph (1), by striking schedule I or II and inserting schedule I, II, or A ; and (B) in subsection (d), by striking schedule I or II and inserting schedule I, II, or A ; (3) in section 1004(1) ( 21 U.S.C. 954(1) ), by striking schedule I and inserting schedule I or A ; (4) in section 1005 ( 21 U.S.C. 955 ), by striking schedule I or II and inserting schedule I, II, or A ; and (5) in section 1009(a) ( 21 U.S.C. 959(a) ), by striking schedule I or II and inserting schedule I, II, or A . 9008. Controlled substance analogues Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended— (1) in paragraph (6), by striking or V and inserting V, or A ; (2) in paragraph (14)— (A) by striking schedule I(c) and and inserting schedule I(c), schedule A, and ; and (B) by striking schedule I(c), and inserting schedule I(c) and schedule A, ; and (3) in paragraph (32)(A), by striking (32)(A) and all that follows through clause (iii) and inserting the following: (32) (A) Except as provided in subparagraph (C), the term controlled substance analogue means a substance whose chemical structure is substantially similar to the chemical structure of a controlled substance in schedule I or II— (i) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or (ii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II. . 9009. Rules of construction Nothing in this title, or the amendments made by this title, may be construed to limit— (1) the prosecution of offenses involving controlled substance analogues under the Controlled Substances Act ( 21 U.S.C. 801 et seq.); or (2) the authority of the Attorney General to temporarily or permanently schedule, reschedule, or decontrol controlled substances under provisions of section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) that are in effect on the day before the date of enactment of this title. 9010. Study by Comptroller General Not later than 2 years after the date of enactment of this title, the Comptroller General of the United States shall complete a study and submit a report to the Committees on the Judiciary of the House of Representatives and of the Senate regarding the costs associated with the amendments made by section 4, including— (1) the annual amounts expended by Federal agencies in carrying out the amendments; (2) the costs associated with arrests, trials, convictions, imprisonment, or imposition of other sanctions in accordance with the amendments; and (3) the impact (including the fiscal impact) of the amendments on existing correctional facilities and the likelihood that those amendments will create a need for additional capacity for housing prisoners. 9011. Report on controlled substance analogues sold by means of the Internet Not later than 1 year after the date of the enactment of this title, and annually thereafter, the Administrator of the Drug Enforcement Administration shall make publicly available on the website of the Drug Enforcement Administration a report on, for the previous year, the lawful and unlawful sale of controlled substance analogues (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )) by means of the Internet, including the following information: (1) The types of controlled substance analogues that were sold, and the number of sales for each such substance. (2) The name of each person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance analogue by means of the Internet, whether lawfully or unlawfully. (3) An estimate of the total revenue for all of the vendors described in paragraph (2) for all of the sales described in paragraph (1). 9012. Controlled substance analogues Section 203 of the Controlled Substances Act ( 21 U.S.C. 813 ) is amended— (1) by striking A controlled and inserting (a) In general .—A controlled ; and (2) by adding at the end the following: (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws. (c) Limitation For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption. . X THRIVE Act 10001. Short title This title may be cited as the Transitional Housing for Recovery in Viable Environments Demonstration Program Act or the THRIVE Act . 10002. Demonstration program to study the impact of using rental vouchers for supportive housing for individuals recovering from opioid use disorders or other substance use disorders Section 8(o) of the United States Housing Act of 1937 ( 42 U.S.C. 1437f(o) ) is amended by adding at the end the following new paragraph: (21) Rental Voucher Demonstration Program for supportive housing for individuals recovering from opioid use disorders or other substance use disorders (A) Establishment The Secretary shall establish a demonstration program under which the Secretary shall set aside, allocate, and distribute directly to eligible entities, from amounts made available for rental assistance under this subsection, the amounts specified in subparagraph (B) for an eligible entity to provide a voucher for such assistance to a covered individual through a supportive housing program that provides treatment for opioid use disorders or other substance use disorders (as applicable), coordination with workforce development providers, and such assistance, as determined by the entity. (B) Amount The amount specified in this subparagraph is, for fiscal year 2019, the amount necessary to provide the lesser of— (i) 0.5 percent of the total number of vouchers renewed under this subsection during the fiscal year ending immediately before the date of the enactment of this paragraph; or (ii) 10,000 vouchers. (C) Criteria for eligible entities An eligible entity shall— (i) provide an evidence-based treatment program and demonstrate the ability to coordinate with workforce development providers for individuals recovering from an opioid use disorder or other substance use disorder, as applicable, that meet standards established by the Secretary; and (ii) demonstrate prior experience administering rental assistance vouchers, demonstrate prior experience administering supportive housing programs under the McKinney-Vento Homeless Act, or demonstrate a partnership with a public housing agency or a housing program of a State, unit of local government, or Indian tribe (as such term is defined in section 4 of the Native American Housing and Self-Determination Act of 1996 ( 25 U.S.C. 4103 )) that ensures effective administration of rental assistance vouchers. (D) Application To receive a rental assistance voucher under this paragraph, an eligible entity shall submit an application to the Secretary that shall include— (i) a description of the terms of treatment program, coordination with workforce development providers, and rental assistance to be provided to a covered individual, and assurances that such description shall be communicated to covered individuals that receive vouchers pursuant to the demonstration program established under this paragraph; (ii) a transitional plan that begins on the date on which a covered individual completes the treatment program of the eligible entity that includes information on additional treatment, coordination with workforce development opportunities, and housing resources and services available to such covered individual; and (iii) evidence sufficient to demonstrate that the local government having jurisdiction over the location of any supportive housing facility to be used by the eligible entity in connection with the demonstration program under this paragraph permits such facilities in such location. (E) Selection In selecting eligible entities to receive rental assistance vouchers under this paragraph, the Secretary shall— (i) ensure that such eligible entities— (I) are diverse; (II) represent an appropriate balance of eligible entities located in urban and rural areas, including tribal communities; (III) have adequate resources for treatment, recovery, and supportive services; (IV) fully comply with the Fair Housing Act ( 42 U.S.C. 3601 et seq.) and the Civil Rights Act of 1964 ( 42 U.S.C. 2000a et seq.); (V) appropriately reflect the impact that opioids are having in tribal communities; and (VI) provide supportive and transitional housing programs in diverse geographic regions with high rates of mortality due to opioid use disorders or other substance use disorders, as applicable, based on data of the Centers for Disease Control and Prevention; and (ii) consider, in consultation with the Secretary of Health and Human Services and the Secretary of Labor— (I) the success of each recipient eligible entity at helping individuals complete the treatment program of the eligible entity and refrain from illicit opioid or other substance usage, as applicable; (II) the coordination with workforce development providers by the eligible entity; (III) the percentage of participants in unsubsidized employment during the second and fourth calendar quarter after exit from the program; and (IV) the percentage of participants in the treatment program of the eligible entity that do not relapse into opioid or other substance usage, as applicable. (F) Reissuance of voucher Upon termination of the provision of rental assistance through a voucher to a covered individual, the eligible entity that initially offered such voucher may use such voucher to provide rental assistance to another covered individual. (G) Duration The Secretary shall not make rental assistance available under this paragraph after the expiration of the 5-year period beginning on the date of the enactment of this paragraph. (H) Waivers The Secretary may, through publication of a notice in the Federal Register, waive or specify alternative requirements for any provision of statue or regulation governing the use of vouchers under this subsection (except for requirements relating to fair housing, nondiscrimination, labor standards, or the environment) upon a finding by the Secretary that such waiver or alternative requirement is necessary for the purposes of this paragraph. (I) Reports (i) By the eligible entity An eligible entity that receives a rental assistance voucher under this paragraph shall submit to the Secretary— (I) annually, the transitional plan described in subparagraph (D)(ii) and information on each covered individual’s housing upon termination of the provision of rental assistance through a voucher to such covered individual in a manner that protects the privacy of such covered individual; and (II) not later than 4 years after the date of the enactment of this paragraph, a plan describing the treatment and housing options for any covered individual assisted by such voucher who will not have completed the program before the day that is 5 years after such date of enactment. (ii) By the Secretary The Secretary shall submit to Congress a report that analyzes the impact of rental assistance provided under this paragraph— (I) not later than 2 years after the date of the enactment of this paragraph; and (II) not later than 4 years after the date of the enactment of this paragraph. (J) Definitions In this paragraph: (i) Eligible entity The term eligible entity means a tribally designated housing entity (as such term is defined in section 4 of the Native American Housing and Self-Determination Act of 1996 ( 24 U.S.C. 4103 )), or a nonprofit organization, that meets the criteria described under subparagraph (C). (ii) Covered individual The term covered individual means an individual recovering from an opioid use disorder or other substance use disorder. . 10003. Repeal of Rental Voucher Demonstration Program Effective the day that is 5 years after the date of the enactment of this title, paragraph (21) of section 8(o) of the United States Housing Act of 1937 ( 42 U.S.C. 1437f(o) ), as added by this title, is repealed. 10004. Demonstration Close-Out An eligible entity that provided vouchers for rental assistance under paragraph (21) of section 8(o) of the United States Housing Act of 1937 ( 42 U.S.C. 1437f(o) ), as added by this title, shall return any such vouchers to the Secretary of Housing and Urban Development not later than the day that is 5 years after the date of the enactment of this title for use only for renewals of expiring contracts for such assistance. 10005. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this title and the amendments made by this title. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. XI IMD CARE Act 11001. Short title This title may be cited as the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act . 11002. Medicaid State plan option to provide services for certain individuals with targeted SUDs in institutions for mental diseases Section 1915 of the Social Security Act ( 42 U.S.C. 1396n ) is amended by adding at the end the following new subsection: (l) State plan option To provide services for certain individuals in institutions for mental diseases (1) In general With respect to calendar quarters beginning during the period beginning January 1, 2019, and ending December 31, 2023, a State may elect, through a State plan amendment, to, notwithstanding section 1905(a), provide medical assistance for services furnished in institutions for mental diseases and for other medically necessary services furnished to eligible individuals with targeted SUDs, in accordance with the requirements of this subsection. (2) Payments (A) In general Amounts expended under a State plan amendment under paragraph (1) for services described in such paragraph furnished, with respect to a 12-month period, to an eligible individual with a targeted SUD who is a patient in an institution for mental diseases shall be treated as medical assistance for which payment is made under section 1903(a) but only to the extent that such services are furnished for not more than a period of 30 days (whether or not consecutive) during such 12-month period. (B) Clarification Payment made under this paragraph for expenditures under a State plan amendment under this subsection with respect to services described in paragraph (1) furnished to an eligible individual with a targeted SUD shall not affect payment that would otherwise be made under section 1903(a) for expenditures under the State plan (or waiver of such plan) for medical assistance for such individual. (3) Information required in State plan amendment (A) In general A State electing to provide medical assistance pursuant to this subsection shall include with the submission of the State plan amendment under paragraph (1) to the Secretary— (i) a plan on how the State will improve access to outpatient care during the period of the State plan amendment, including a description of— (I) the process by which eligible individuals with targeted SUDs will make the transition from receiving inpatient services in an institution for mental diseases to appropriate outpatient care; and (II) the process the State will undertake to ensure eligible individuals with targeted SUDs are provided care in the most integrated setting appropriate to the needs of the individuals; and (ii) a description of how the State plan amendment ensures an appropriate clinical screening of eligible individuals with targeted SUDs, including assessments to determine level of care and length of stay recommendations based upon the multidimensional assessment criteria of the American Society of Addiction Medicine and to determine the appropriate setting for such care. (B) Report Not later than the sooner of December 31, 2024, or 1 year after the date of the termination of a State plan amendment under this subsection, the State shall submit to the Secretary a report that includes at least— (i) the number of eligible individuals with targeted SUDs who received services pursuant to such State plan amendment; (ii) the length of the stay of each such individual in an institution for mental diseases; (iii) the type of outpatient treatment, including medication-assisted treatment, each such individual received after being discharged from such institution; (iv) the number of eligible individuals with any co-occuring disorders who received services pursuant to such State plan amendment and the co-occuring disorders from which they suffer; and (v) information regarding the effects of a State plan amendment on access to community care for individuals suffering from a mental disease other than substance use disorder. (4) Definitions In this subsection: (A) Eligible individual with a targeted SUD The term eligible individual with a targeted SUD means an individual who— (i) with respect to a State, is enrolled for medical assistance under the State plan (or a waiver of such plan); (ii) is at least 21 years of age; (iii) has not attained 65 years of age; and (iv) has been diagnosed with at least one targeted SUD. (B) Institution for mental diseases The term institution for mental diseases has the meaning given such term in section 1905(i). (C) Opioid prescription pain reliever The term opioid prescription pain reliever includes hydrocodone products, oxycodone products, tramadol products, codeine products, morphine products, fentanyl products, buprenorphine products, oxymorphone products, meperidine products, hydromorphone products, methadone, and any other prescription pain reliever identified by the Assistant Secretary for Mental Health and Substance Use. (D) Other medically necessary services The term other medically necessary services means, with respect to an eligible individual with a targeted SUD who is a patient in an institution for mental diseases, items and services that are provided to such individual outside of such institution to the extent that such items and services would be treated as medical assistance for such individual if such individual were not a patient in such institution. (E) Targeted SUD (i) In general The term targeted SUD means an opioid use disorder or a cocaine use disorder. (ii) Cocaine use disorder The term cocaine use disorder means a disorder that meets the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (or a successor edition), for either dependence or abuse for cocaine, including cocaine base (commonly referred to as crack cocaine ). (iii) Opioid use disorder The term opioid use disorder means a disorder that meets the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (or a successor edition), for heroin use disorder or pain reliever use disorder (including with respect to opioid prescription pain relievers). . 11003. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). .

Passed the House of Representatives June 22, 2018. Karen L. Haas, Clerk.

tv_txt: I 115th CONGRESS 2d Session H. R. 6 IN THE HOUSE OF REPRESENTATIVES June 13, 2018 Mr. Walden (for himself, Mr. Pallone , Mr. Brady of Texas , Mr. Neal , Mr. Roe of Tennessee , Mr. Shuster , Ms. Foxx , Mr. Goodlatte , Mr. Walz , Mr. DeFazio , and Mr. Burgess ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Ways and Means , and the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act . (b) Table of contents The table of contents for the Act is as follows: Sec. 1. Short title; table of contents. Title I—Medicaid Provisions to Address the Opioid Crisis Sec. 101. At-risk youth Medicaid protection. Sec. 102. Health Insurance for Former Foster Youth. Sec. 103. Demonstration project to increase substance use provider capacity under the Medicaid program. Sec. 104. Drug management program for at-risk beneficiaries. Sec. 105. Medicaid drug review and utilization. Sec. 106. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder. Sec. 107. Medicaid health homes for opioid-use-disorder Medicaid enrollees. Title II—Medicare Provisions to Address the Opioid Crisis Sec. 201. Authority not to apply certain Medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder. Sec. 202. Encouraging the use of non-opioid analgesics for the management of post-surgical pain. Sec. 203. Requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. Sec. 204. Modification of payment for certain outpatient surgical services. Sec. 205. Requiring e-prescribing for coverage of covered part D controlled substances. Sec. 206. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries. Sec. 207. Medicare coverage of certain services furnished by opioid treatment programs. Title III—Other Health Provisions to Address the Opioid Crisis Sec. 301. Clarifying FDA regulation of non-addictive pain and addiction therapies. Sec. 302. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths. Sec. 303. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Title IV—Offsets Sec. 401. Promoting value in Medicaid managed care. Sec. 402. Extending period of application of Medicare secondary payer rules for individuals with end stage renal disease. Sec. 403. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program. I Medicaid Provisions to Address the Opioid Crisis 101. At-risk youth Medicaid protection (a) In general Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ) is amended— (1) in subsection (a)— (A) by striking and at the end of paragraph (82); (B) by striking the period at the end of paragraph (83) and inserting ; and ; and (C) by inserting after paragraph (83) the following new paragraph: (84) provide that— (A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate; (B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and (C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, such individual such that the State makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution. ; and (2) by adding at the end the following new subsection: (nn) Juvenile; eligible juvenile; public institution For purposes of subsection (a)(84) and this subsection: (1) Juvenile The term juvenile means an individual who is— (A) under 21 years of age; or (B) described in subsection (a)(10)(A)(i)(IX). (2) Eligible juvenile The term eligible juvenile means a juvenile who is an inmate of a public institution and who— (A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or (B) is determined eligible for such medical assistance while an inmate of a public institution. (3) Inmate of a public institution The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (29) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution. . (b) No change in exclusion from medical assistance for inmates of public institutions Nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision (A) following paragraph (29) of section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance. (c) No change in continuity of eligibility before adjudication or sentencing Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced. (d) Effective date (1) In general Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 102. Health Insurance for Former Foster Youth (a) Coverage continuity for former foster care children up to age 26 (1) In general Section 1902(a)(10)(A)(i)(IX) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A)(i)(IX) ) is amended— (A) in item (bb), by striking are not described in or enrolled under and inserting are not described in and are not enrolled under ; (B) in item (cc), by striking responsibility of the State and inserting responsibility of a State ; and (C) in item (dd), by striking the State plan under this title or under a waiver of the and inserting a State plan under this title or under a waiver of such a . (2) Effective date The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023. (b) Guidance Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States— (1) on best practices for— (A) removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and (B) conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and (2) which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26. 103. Demonstration project to increase substance use provider capacity under the Medicaid program Section 1903 of the Social Security Act ( 42 U.S.C. 1396b ) is amended by adding at the end the following new subsection: (aa) Demonstration project To increase substance use provider capacity (1) In general Not later than the date that is 180 days after the date of the enactment of this section, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall— (A) for the first 18-month period of such project, award planning grants described in paragraph (3); and (B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5). (2) Purpose The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities: (A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph. (B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services. (C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that— (i) are authorized to dispense drugs approved by the Food and Drug Administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder; (ii) have in effect a registration or waiver under section 303(g) of the Controlled Substances Act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the Assistant Secretary for Mental Health and Substance Use for purposes of carrying out the requirements of such section 303(g); and (iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services. (D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of— (i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, in accordance with guidelines issued by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome; (ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan); (iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or (iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan). (3) Planning grants (A) In general The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that have a State plan (or waiver of the State plan) approved under this title; (ii) select States in a manner that ensures geographic diversity; and (iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Activities described Activities described in this subparagraph are, with respect to a State, each of the following: (i) Activities that support the development of an initial assessment of the behavioral health treatment needs of the State to determine the extent to which providers are needed (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following: (I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder. (II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver). (III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II). (IV) Projections regarding the extent to which the State participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the State plan (or waiver) during the period of the demonstration project. (ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers. (D) Funding For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended. (4) Post-planning States (A) In general The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that received a planning grant under paragraph (3); (ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application; (iii) select States in a manner that ensures geographic diversity; and (iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Applications (i) In general A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following: (I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i). (II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services. (III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following: (aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services. (bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State. (cc) Milestones and timeliness for implementing activities set forth in the plan. (dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan). (IV) A proposed process for reporting the information required under paragraph (6)(A), including information to assess the effectiveness of the efforts of the State to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection. (V) The expected financial impact of the demonstration project under this subsection on the State. (VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State. (VII) A preliminary plan for how the State will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project. (VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable. (ii) Consultation In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation. (5) Payment (A) In general For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter. (B) Qualified sums defined For purposes of subparagraph (A), the term qualified sums means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use treatment or recovery services. (C) Non-duplication of payment In the case that payment is made under subparagraph (A) with respect to expenditures for substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished. (6) Reports (A) State reports A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use treatment or recovery services for which payment is made to the State under this subsection, on the following: (i) The specific activities with respect to which payment under this subsection was provided. (ii) The number of providers that delivered substance use disorder treatment or recovery services in the State under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project. (iii) The number of individuals enrolled under the State plan (or a waiver of such plan) who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project. (iv) Other matters as determined by the Secretary. (B) CMS reports (i) Initial report Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on— (I) the States awarded planning grants under paragraph (3); (II) the criteria used in such selection; and (III) the activities carried out by such States under such planning grants. (ii) Interim report Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report— (I) on activities carried out under the demonstration project under this subsection; (II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph; (III) with a description of the strengths and limitations of such demonstration project; and (IV) with a plan for the sustainability of such project. (iii) Final report Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report— (I) providing updates on the matters reported in the interim report under clause (ii); (II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and (III) evaluating such demonstration project. (C) AHRQ report Not later than three years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, on consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4). (7) Data sharing and best practices During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected. (8) CMS funding There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended. . 104. Drug management program for at-risk beneficiaries (a) In general Title XIX of the Social Security Act is amended by inserting after section 1927 ( 42 U.S.C. 1396r–8 ) the following new section: 1927A. Drug management program for at-risk beneficiaries (a) In general Beginning January 1, 2020, a State shall operate a qualified drug management program under which a State may enroll certain at-risk beneficiaries identified by the State under the program. (b) Qualified drug management program For purposes of this section, the term qualified drug management program means, with respect to a State, a program carried out by the State (including through a contract with a pharmacy benefit manager) that provides at least for the following: (1) Identification of at-risk individuals Under the program, the State identifies, in accordance with subsection (c), individuals enrolled under the State plan (or waiver of the State plan) who are at-risk beneficiaries. (2) Elements of program (A) In general Under the program, the State, with respect to each individual identified under paragraph (1) and enrolled under the program under paragraph (5)— (i) subject to subparagraphs (B) and (C), selects at least one, but not more than three, health care providers and at least one, but not more than three, pharmacies for each such individual for purposes of clause (ii), in accordance with a selection process that takes into account reasonable factors such as the individual’s previous utilization of items and services from health care providers and pharmacies, geographic proximity of the individual to such health care providers and pharmacies, access of the individual to health care, reasonable travel time, information regarding housing status, and any known preference of the individual for a certain health care provider or pharmacy; and (ii) requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause (i) for such individual and dispensed by a pharmacy selected under clause (i) for such individual in order for such controlled substance to be covered under the State plan (or waiver). (B) Beneficiary preference In the case of an individual receiving a notice under paragraph (3)(A) of being identified as potentially being an at-risk beneficiary described in such paragraph, such individual may submit, during the 30-day period following receipt of such notice, preferences for which health care providers and pharmacies the individual would prefer the State to select under subparagraph (A). The State shall select or change the selection of health care providers and pharmacies under subparagraph (A) for the individuals based on such preferences, except that in the case that State determines that such selection (or change of selection) of a health care provider or pharmacy under subparagraph (A) is contributing or would contribute to prescription drug abuse or drug diversion by the individual, the State may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph. If the State selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual, the State shall provide the individual with at least 30 days written notice of the selection or change of selection and a rationale for the selection or change. (C) Treatment of pharmacy with multiple locations For purposes of subparagraph (A)(i), in the case of a pharmacy that has multiple locations that share real-time electronic prescription data, all such locations of the pharmacy shall collectively be treated as one pharmacy. (D) Treatment of existing FFS drug management programs In the case of a patient review and restriction program (as identified in the annual report submitted to the Secretary under section 1927(g)(3)(D)) operated by a State pursuant to section 1915(a)(2) before the date of the enactment of this section, such program shall be treated as a qualified drug management program. (E) Reasonable access The program shall ensure, including through waiver of elements of the program (including under subparagraph (A)(ii)), reasonable access to health care (including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph (A)) in the case of individuals with multiple residences, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (3) Notification to identified individuals Under the program, the State provides each individual who is identified under paragraph (1), prior to enrolling such individual under the program, at least one notification of each of the following: (A) Notice that the State has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance. (B) The name, address, and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph (2)(A). (C) Information describing all State and Federal public health resources that are designed to address such abuse or misuse to which the individual has access, including mental health services, substance use disorder and recovery services, and other counseling services. (D) Notice of, and information about, the right of the individual to— (i) submit preferences of the individual for health care providers and pharmacies to be selected under paragraph (2)(A), including as described in paragraph (2)(B); (ii) appeal under paragraph (4)— (I) such identification described in subparagraph (A); and (II) the selection of health care providers and pharmacies under paragraph (2)(A). (E) An explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance, including an explanation of the program. (F) Information, including a contact list and clear instructions, that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph (2)(B) and any other communications relating to the program. (4) Appeals process Under the program, the State provides for an appeals process under which, with respect to an individual identified under paragraph (1)— (A) such individual may appeal— (i) such identification; and (ii) the selection of a health care provider or pharmacy under paragraph (2)(A); (B) in the case of an appeal described in subparagraph (A)(ii), the State shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph (2)(A), unless the State determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual; (C) such individual is provided a period of not less than 30 days following the date of receipt of the notice described in paragraph (3) to submit such appeal; and (D) the State must make a determination with respect to an appeal described in subparagraph (A), and notify the individual of such determination, prior to enrollment of such individual in the program. (5) Enrollment Under the program, the State initially enrolls individuals who are identified under paragraph (1) in the program for a 12-month period— (A) in the case of such an individual who does not submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph, beginning on the day after the last day of such period; and (B) in the case of such an individual who does submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph but such appeal is denied, beginning not later than 30 days after the date of such denial. (6) Notification of health care providers and pharmacies Under the program, the State provides to each health care provider and pharmacy selected for an individual under paragraph (2)— (A) notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph (2); (B) information on such program and the role of being so selected; and (C) a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected. (7) Continuation of enrollment Under the program, the State, with respect to an individual enrolled under the program, provides for a process to— (A) not later than 30 days before the end of the 12-month period for which the individual is so enrolled pursuant to paragraph (5)— (i) assess, in accordance with publicly available evidence-based guidelines, whether or not such individual should continue to be enrolled under the program; and (ii) notify such individual of the results of the assessment under clause (i); (B) continue, subject to subparagraph (C), enrollment of such individual if such assessment recommends such continuation; and (C) appeal the continuation of enrollment in accordance with the appeals process described in paragraph (4). (c) At-Risk beneficiary (1) Identification For purposes of this section, a State shall identify an individual enrolled under the State plan (or waiver of the State plan) as an at-risk beneficiary if the individual is not an exempted individual described in paragraph (2) and— (A) is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance; or (B) the State received notification from a PDP sponsor or Medicare Advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section 1860D–4(c)(5) and such identification has not been terminated under subparagraph (F) of such section. (2) Exempted individual described For purposes of paragraph (1), an exempted individual described in this paragraph is an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as an exempted individual for purposes of paragraph (1). (d) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b)(6) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (e) Reports (1) Annual reports A State operating a qualified drug management program shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2021, the following information: (A) The number of individuals enrolled under the State plan (or waiver of the State plan) who are enrolled under the program and the percentage of individuals enrolled under the State plan (or waiver) who are enrolled under such program. (B) The number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program, including the daily morphine milligram equivalents and the quantity prescribed for each such prescription. (C) The number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program. (D) The number of health care providers writing prescriptions for controlled substances (other than prescriptions for a refill) for individuals enrolled under such program. (E) Any other data that the Secretary may require. (F) Any report submitted by a managed care entity under subsection (f)(1)(B) with respect to the year involved. For each such report for a year after 2021, the information described in this paragraph shall be provided in a manner that compares such information with respect to the prior calendar year to such information with respect to the second prior calendar year. (2) MACPAC reports and review Not later than two years after the date of the enactment of this section, the Medicaid and CHIP Payment and Access Commission (in this section referred to as MACPAC ), in consultation with the National Association of Medicaid Directors, pharmacy benefit managers, managed care organizations, health care providers (including pharmacists), beneficiary advocates, and other stakeholders, shall publish a report that includes— (A) best practices for operating drug management programs, based on a review of a representative sample of States administering such a program; (B) a summary of the experience of the appeals process under drug management programs operated by several States, such as the frequency at which individuals appealed the identification of being an at-risk individual, the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program, the timeframes for such appeals, a summary of the reasons for such appeals, and the design of such appeals processes; (C) a summary of trends and the effectiveness of qualified drug management programs operated under this section; and (D) recommendations to States on how improvements can be made with respect to the operation of such programs. In reporting on State practices, the MACPAC shall consider how such programs have been implemented in rural areas, under fee-for-service as well as managed care arrangements, and the extent to which such programs have resulted in increased efficiencies to such States or to the Federal Government under this title. (3) Report on plan for coordinated care Not later than January 1, 2021, each State operating a qualified drug management program shall submit to the Administrator of the Centers for Medicare & Medicaid Services a report on how such State plans to provide coordinated care for individuals enrolled under the State plan (or waiver of the State plan) and— (A) who are enrolled under the program; or (B) who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity. (f) Applicability to managed care entities (1) In general With respect to any contract that a State enters into on or after January 1, 2020, with a managed care entity (as defined in section 1932(a)(1)(B)) pursuant to section 1903(m), the State shall, as a condition of the contract, require the managed care entity— (A) to operate a qualified drug management program (as defined in subsection (b)) for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph (2); (B) to submit to the State an annual report on the matters described in subparagraphs (A) through (E) of subsection (e)(1); and (C) to submit to the State a list (and as necessary update such list) of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph (A) for purposes of allowing State plans for which medical assistance is paid on a fee-for-service basis to have access to such information. (2) Application For purposes of applying, with respect to a managed care entity— (A) under paragraph (1)(A)— (i) the definition of the term qualified drug management program under subsection (b), other than paragraph (2)(D) of such subsection; and (ii) the provisions of paragraphs (1) and (2) of subsection (c); and (B) under paragraph (1)(B), the report requirements described in subparagraphs (A) through (E) of subsection (e)(1); each reference in such subsection (b) and paragraphs of subsection (c) to a State or the State (other than to a State plan or the State plan ) shall be deemed a reference to the managed care entity, each reference under such subsection, paragraphs, or subparagraphs to individuals enrolled under the State plan (or waiver of the State plan) shall be deemed a reference to individuals enrolled with such entity, and each reference under such subsection, paragraphs, or subparagraphs to individuals enrolled under the qualified drug management program operated by the State shall be deemed a reference to individuals enrolled under the qualified drug management program operated by the managed care entity. (g) Controlled substance defined For purposes of this section, the term controlled substance means a drug that is included in schedule II, III, or IV of section 202(c) of the Controlled Substances Act, or any combination thereof, as specified by the State. . (b) Guidance on at-Risk population transitioning between Medicaid FFS and managed care Not later than October 1, 2019, the Secretary of Health and Human Services shall issue guidance for State Medicaid programs, with respect to individuals who are enrolled under a State plan (or waiver of such plan) under title XIX of the Social Security Act and under a drug management program, for purposes of providing best practices— (1) for transitioning, as applicable, such individuals from fee-for-service Medicaid (and such a program operated by the State) to receiving medical assistance under such title through a managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) with a contract that with the State pursuant to section 1903(m) of such Act (and such a program operated by such entity); and (2) for transitioning, as applicable, such individuals from receiving medical assistance under such title through a managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) with a contract that with the State pursuant to section 1903(m) of such Act (and such a program operated by such entity) to fee-for-service Medicaid (and such a program operated by the State). (c) Guidance on at-Risk population transitioning to Medicare (1) In general Not later than January 1, 2020, the Secretary of Health and Human Services, after consultation with the Federal Coordinated Health Care Office established under section 2602 of the Patient Protection and Affordable Care Act ( 42 U.S.C. 1315b ), shall issue guidance for State Medicaid programs, with respect to transitioning individuals, providing for— (A) notification to be submitted by the State to the Centers for Medicare & Medicaid Services and such individuals of the status of such individuals as transitioning individuals; (B) notification to such individuals about enrollment under a prescription drug plan under part D of such title or under a MA–PD plan under part C of such title; (C) best practices for transitioning such individuals to such a plan; and (D) best practices for coordination between the qualified drug management program (as described in section 1927A(b) of the Social Security Act, as added by subsection (a)) carried out by the State and a drug management program carried out under such a plan pursuant to section 1860D–4(c)(5) of the Social Security Act ( 42 U.S.C. 1395w–10(c)(5) ). (2) Transitioning individuals For purposes of paragraph (1), a transitioning individual is an individual who, with respect to a month— (A) is enrolled under the State plan (or waiver of the State plan) and under the qualified drug management program (as described in section 1927A(b) of the Social Security Act, as added by subsection (a)) carried out by the State; and (B) is expected to become eligible for the Medicare program under title XVIII of such Act during the subsequent 12-month period. 105. Medicaid drug review and utilization (a) Medicaid drug utilization review (1) State plan requirement Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by section 101, is further amended— (A) in paragraph (83), at the end, by striking and ; (B) in paragraph (84), at the end, by striking the period and inserting ; and ; and (C) by inserting after paragraph (84) the following new paragraph: (85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1). . (2) Drug review and utilization requirements Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ), as amended by section 101, is further amended by adding at the end the following new subsection: (oo) Drug review and utilization requirements (1) In general For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following: (A) Claims review limitations (i) In general The State has in place— (I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State; (II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and (III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and— (aa) benzodiazepines; or (bb) antipsychotics. (ii) Managed care entities The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause. (iii) Rules of construction Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver). (B) Program to monitor antipsychotic medications by children The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically. (C) Fraud and abuse identification The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled. (D) Reports The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary. (E) Clarification Nothing shall prevent a State from satisfying the requirement— (i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019; (ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or (iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date. (2) Annual report by Secretary For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D). (3) Exceptions (A) Certain individuals exempted The drug review and utilization requirements under this subsection shall not apply with respect to an individual who— (i) is receiving— (I) hospice or palliative care; or (II) treatment for cancer; (ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (iii) the State elects to treat as exempted from such requirements. (B) Exception relating to ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). . (3) Managed care entities Section 1932 of the Social Security Act ( 42 U.S.C. 1396u–2 ) is amended by adding at the end the following new subsection: (i) Drug utilization review activities and requirements Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42 of the Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018. . (b) Identifying and addressing inappropriate prescribing and billing practices under Medicaid (1) In general Section 1927(g) of the Social Security Act ( 42 U.S.C. 1396r–8(g) ) is amended— (A) in paragraph (1)(A)— (i) by striking of section 1903(i)(10)(B) and inserting of section 1902(a)(54) ; (ii) by striking , by not later than January 1, 1993, ; (iii) by inserting after gross overuse, the following: excessive utilization, ; and (iv) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization ; and (B) in paragraph (2)(B)— (i) by inserting after gross overuse, the following: excessive utilization, ; and (ii) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization . (2) Effective date The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020. 106. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder (a) Guidance Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include— (1) the types of services, including post-discharge services and parenting supports, for families of babies with neonatal abstinence syndrome that States may cover under the Medicaid program under title XIX of the Social Security Act; (2) best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and post-discharge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes; (3) recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home visiting services; and (4) guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and post-discharge services, including parenting supports. (b) GAO study Not later than one year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title. 107. Medicaid health homes for opioid-use-disorder Medicaid enrollees (a) Extension of enhanced FMAP for certain health homes for individuals with substance use disorders Section 1945 of the Social Security Act ( 42 U.S.C. 1396w–4 ) is amended— (1) in subsection (c)— (A) in paragraph (1), by inserting subject to paragraph (4), after except that, ; and (B) by adding at the end the following new paragraph: (4) Special rule relating to substance use disorder health homes (A) In general In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. Nothing in this section shall be construed as prohibiting a State with a State plan amendment that is approved under this section and that is not an SUD-focused State plan amendment from additionally having approved on or after such date an SUD-focused State plan amendment under this section, including for purposes of application of this paragraph. (B) Report requirements In the case of a State with an SUD-focused State plan amendment for which the application of the Federal medical assistance percentage has been extended under subparagraph (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment: (i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual. (ii) The access of such individuals to health care. (iii) The total expenditures of such individuals for health care. For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures. (C) Best practices Not later than October 1, 2020, the Secretary shall make publicly available on the Internet website of the Centers for Medicare & Medicaid Services best practices for designing and implementing an SUD-focused State plan amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals. (D) Definitions For purposes of this paragraph: (i) SUD-eligible individuals The term SUD-eligible individual means, with respect to a State, an individual who satisfies all of the following: (I) The individual is an eligible individual with chronic conditions. (II) The individual is an individual with a substance use disorder. (III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary. (ii) SUD-focused State plan amendment The term SUD-focused State plan amendment means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals. . (b) Requirement for State Medicaid plans To provide coverage for medication-Assisted treatment (1) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29) . (2) Inclusion of medication-assisted treatment as medical assistance Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (28), by striking and at the end; (B) by redesignating paragraph (29) as paragraph (30); and (C) by inserting after paragraph (28) the following new paragraph: (29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and . (3) Medication-assisted treatment defined; Waivers Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended by adding at the end the following new subsection: (ee) Medication-Assisted treatment (1) Definition For purposes of subsection (a)(29), the term medication-assisted treatment — (A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), including methadone, and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat opioid use disorders; and (B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy. (2) Exception The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, if before the beginning of such period the State certifies to the satisfaction of the Secretary that implementing such provisions statewide for all individuals eligible to enroll in the State plan (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3). . (4) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025. (B) Exception for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. II Medicare Provisions to Address the Opioid Crisis 201. Authority not to apply certain Medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder Section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) is amended— (1) in paragraph (2)(B)(i), by inserting and paragraph (7)(E) after Subject to clause (ii) ; and (2) by adding at the end the following new paragraphs: (7) Authority not to apply certain requirements in the case of certain treatment of substance use disorder or co-occurring mental health disorder (A) In general For purposes of payment under this subsection, in the case of telehealth services described in subparagraph (C) furnished on or after January 1, 2020, to an eligible beneficiary (as defined in subparagraph (F)) for the treatment of a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder, the Secretary is authorized to, through rulemaking, not apply any of the requirements described in subparagraph (B). (B) Requirements described For purposes of this paragraph, the requirements described in this subparagraph are any of the following: (i) Qualifications for an originating site under paragraph (4)(C)(ii). (ii) Geographic limitations under paragraph (4)(C)(i). (C) Telehealth services described For purposes of this paragraph, the telehealth services described in this subparagraph are services that are both telehealth services and identified by the Secretary, through rulemaking, as services that are the most commonly furnished (as defined by the Secretary) under this part to individuals diagnosed with a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder. (D) Clarification Nothing in this paragraph shall be construed as limiting or otherwise affecting the authority of the Secretary to limit or eliminate the non-application pursuant to this paragraph of any of the requirements under subparagraph (B). (E) Treatment of originating site facility fee No facility fee shall be paid under paragraph (2)(B) to an originating site with respect to a telehealth service described in subparagraph (B) for which payment is made under this subsection by reason of the non-application of a requirement described in subparagraph (B) pursuant to this paragraph if payment for such service would not otherwise be permitted under this subsection if such requirement were applied. (F) Eligible beneficiary defined For purposes of this paragraph, the term eligible beneficiary means an individual who— (i) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under this part; (ii) has a diagnosis for a substance use disorder; and (iii) meets such other criteria as the Secretary determines appropriate. (G) Report Not later than 5 years after the date of the enactment of this paragraph, the Secretary shall submit to Congress a report on the impact of any non-application under this paragraph of any of the requirements described in subparagraph (B) on (i) the utilization of health care services related to substance use disorder, such as behavioral health services and emergency department visits; and (ii) health outcomes related to substance use disorder, such as substance use overdose deaths. (H) Funding For purposes of carrying out this paragraph, in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended. (8) Rule of construction Nothing in this subsection may be construed as waiving requirements under this title to comply with applicable State law, including State licensure requirements. . 202. Encouraging the use of non-opioid analgesics for the management of post-surgical pain Section 1833(t)(6) of the Social Security Act ( 42 U.S.C. 1395l(t)(6) ) is amended— (1) in subparagraph (C)(i), by inserting or, in the case of an eligible non-opioid analgesic (as defined in subparagraph (J)), during a period of 5 years, after 3 years, ; and (2) by adding at the end the following new subparagraph: (J) Eligible non-opioid analgesic defined In this paragraph, the term eligible non-opioid analgesic means a drug or biological— (i) that is an analgesic that is not an opioid; (ii) that demonstrated substantial clinical improvement; and (iii) for which payment— (I) as an outpatient hospital service under this part was not being made as of the date of the enactment of this subparagraph; or (II) was being made under this paragraph as of such date. . 203. Requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination (a) In general Section 1861(ww) of the Social Security Act ( 42 U.S.C. 1395x(ww) ) is amended— (1) in paragraph (1), by inserting and a review of current opioid prescriptions and screening for opioid use disorder (as defined in paragraph (4)), before but does not include ; and (2) by adding at the end the following new paragraph: (4) (A) For purposes of paragraph (1), the term a review of current opioid prescriptions and screening for opioid use disorder means, with respect to an individual— (i) a review by a physician or qualified non-physician practitioner of all current prescriptions of the individual; and (ii) in the case of an individual determined by the review of a physician or qualified non-physician practitioner under subparagraph (A) to have a current prescription for opioids for chronic pain that has been prescribed for a minimum period of time (as specified by the Secretary)— (I) a review by the physician or practitioner of the potential risk factors to the individual for opioid use disorder; (II) an evaluation by the physician or practitioner of pain of the individual; (III) the provision of information regarding non-opioid treatment options for the treatment and management of any chronic pain of the individual; and (IV) if determined necessary by the physician or practitioner based on the results of the review and evaluation conducted as described in this paragraph, an appropriate referral by the physician or practitioner for additional treatment. (B) For purposes of this paragraph, the term qualified non-physician practitioner means a physician assistant, nurse practitioner, or certified clinical nurse specialist. . (b) Effective date The amendments made by subsection (a) shall apply with respect to initial preventive physical examinations furnished on or after January 1, 2020. 204. Modification of payment for certain outpatient surgical services (a) Freeze of payment for certain services furnished in ambulatory surgical centers Section 1833(i)(2) of the Social Security Act ( 42 U.S.C. 1395l(i)(2) ) is amended by adding at the end the following new subparagraph: (F) (i) With respect to a targeted procedure (as defined in clause (ii)) furnished during 2020 or a subsequent year (before 2024) to an individual in an ambulatory surgical center, the payment amount for such procedure that would otherwise be determined under the revised payment system under subparagraph (D), without application of this subparagraph, shall be equal to the payment amount for such procedure furnished in 2016. (ii) For purposes of clause (i), the term targeted procedure means a procedure to which Healthcare Common Procedure Coding System 62310 (or, for years beginning after 2016, 62321), 62311 (or, for years beginning after 2016, 62323), 62264, 64490, 64493, or G0260 (or any successor code) applies. (iii) This subparagraph shall not be applied in a budget-neutral manner. . (b) Data collection (1) In general The Comptroller General shall collect data relating to the cost differential between targeted procedures (as defined in section 1833(i)(2)(F)(ii) of the Social Security Act, as added by subsection (a)) that are performed in a hospital operating room and such procedures that are performed in an office setting within a hospital in order to determine whether such procedures are being properly coded for claims, based on setting, for payment under section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ) and to determine if further changes are needed in the classification system for covered outpatient department services (as described in section 1833(t)(2)(A) of the Social Security Act ( 42 U.S.C. 1395l(t)(2)(A) ). (2) Report Not later than 4 years after the date of the enactment of this Act, the Comptroller General shall submit a report to the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate containing— (A) a determination of whether procedures described in paragraph (1) are being properly coded for claims, based on setting, for payment under section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ); and (B) recommendations on any changes the Comptroller General determines are needed in the classification system for covered outpatient department services (as described in section 1833(t)(2)(A) of the Social Security Act ( 42 U.S.C. 1395l(t)(2)(A) ). (c) Study Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on the extent to which procedures described in section 1833(i)(2)(F)(ii) of the Social Security Act, as added by subsection (a), are effective at preventing the need for opioids for individuals furnished such procedures. 205. Requiring e-prescribing for coverage of covered part D controlled substances (a) In general Section 1860D–4(e) of the Social Security Act ( 42 U.S.C. 1395w–104(e) ) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, pursuant to rulemaking, specify circumstances with respect to which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispenser are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who has received a waiver or a renewal thereof for a specified period determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing, pursuant to a process established by regulation by the Secretary, due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner allowing for the dispensing of a non-patient specific prescription pursuant to a standing order, approved protocol for drug therapy, collaborative drug management, or comprehensive medication management, in response to a public health emergency, or other circumstances where the practitioner may issue a non-patient specific prescription; (vi) a prescription issued by a practitioner prescribing a drug under a research protocol; (vii) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use; and (viii) a prescription issued by a practitioner for an individual who— (I) receives hospice care under this title; or (II) is a resident of a skilled nursing facility (as defined in section 1819(a)), or a medical institution or nursing facility for which payment is made for an institutionalized individual under section 1902(q)(1)(B), for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy, as determined by the Secretary in accordance with this paragraph. (C) Dispensing Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral or fax prescriptions that are consistent with laws and regulations. Nothing in this paragraph shall be construed as affecting the ability of the beneficiary involved to designate a particular pharmacy to dispense a prescribed drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, pursuant to rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. 206. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended— (1) in paragraph (1), by inserting after subparagraph (E) the following new subparagraph: (F) With respect to plan years beginning on or after January 1, 2021, a drug management program for at-risk beneficiaries described in paragraph (5). ; and (2) in paragraph (5)(A), by inserting (and for plan years beginning on or after January 1, 2021, a PDP sponsor shall) after A PDP sponsor may . 207. Medicare coverage of certain services furnished by opioid treatment programs (a) Coverage Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (FF), by striking at the end and ; (2) in subparagraph (GG), by inserting at the end ; and ; and (3) by adding at the end the following new subparagraph: (HH) opioid use disorder treatment services (as defined in subsection (jjj)). . (b) Opioid use disorder treatment services and opioid treatment program defined Section 1861 of the Social Security Act is amended by adding at the end the following new subsection: (jjj) Opioid use disorder treatment services; opioid treatment program (1) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act for use in the treatment of opioid use disorder; (B) dispensing and administration of such medications, if applicable; (C) substance use counseling by a professional to the extent authorized under State law to furnish such services; (D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (E) toxicology testing, and (F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation). (2) Opioid treatment program The term opioid treatment program means an entity that is opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (A) is enrolled under section 1866(j); (B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and (D) meets such additional conditions as the Secretary may find necessary to ensure— (i) the health and safety of individuals being furnished services under such program; and (ii) the effective and efficient furnishing of such services. . (c) Payment (1) In general Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (A) by striking and (BB) and inserting (BB) ; and (B) by inserting before the semicolon at the end the following , and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary . (2) Payment determination Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (w) Opioid use disorder treatment services (1) In general The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program. (2) Considerations The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (3) Annual updates The Secretary shall provide an update each year to the bundled payment amounts under this subsection. . (d) Including opioid treatment programs as Medicare providers Section 1866(e) of the Social Security Act ( 42 U.S.C. 1395cc(e) ) is amended— (1) in paragraph (1), by striking at the end and ; (2) in paragraph (2), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new paragraph: (3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section). . III Other Health Provisions to Address the Opioid Crisis 301. Clarifying FDA regulation of non-addictive pain and addiction therapies (a) Public meetings Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction, which may include— (1) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c )) for the development of non-addictive medical products intended to treat pain or addiction; and (2) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not later than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-opioid or non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; and (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence. (c) Medical product defined In this section, the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )). 302. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths (a) Public health laboratories To detect fentanyl Part F of title III of the Public Health Service Act ( 42 U.S.C. 262 et seq.) is amended— (1) in the heading of part F, by striking and clinical laboratories and inserting , clinical laboratories, and public health laboratories ; and (2) by adding at the end the following new subpart: 4 Public Health Laboratories 355. Public health laboratories to detect fentanyl (a) In general The Secretary shall establish a program to award grants to Federal, State, and local agencies to support the establishment or operation of public health laboratories to detect fentanyl, its analogues, and other synthetic opioids, as described in subsection (b). (b) Standards The Secretary, in consultation with the Director of the National Institute of Standards and Technology, shall— (1) develop standards for safely and effectively handling and testing fentanyl, its analogues, and other synthetic opioids; (2) develop fentanyl and fentanyl analog reference materials and quality control standards and protocols to calibrate instrumentation for clinical diagnostics and postmortem surveillance; and (3) include in the standards developed pursuant to paragraph (1) procedures for encountering new and emerging synthetic opioid formulations and reporting those findings to other Federal, State, and local public health laboratories. (c) Laboratories The Secretary shall require grantees under subsection (a) to— (1) follow the standards established under subsection (b) and be capable of providing systematic and routine laboratory testing of drugs for the purposes of obtaining and disseminating public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate; (2) work with law enforcement agencies and public health authorities, as feasible, to develop real-time information on the purity and movement of fentanyl, its analogues, and other synthetic opioids; (3) assist State and local law enforcement agencies in testing seized drugs when State and local forensic laboratories request additional assistance; (4) provide early warning information and advice to Federal, State, and local law enforcement agencies and public health authorities regarding potential significant changes in the supply of fentanyl, its analogues, and other synthetic opioids; (5) provide biosurveillance for non-fatal exposures; and (6) provide diagnostic testing for non-fatal exposures of emergency personnel. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023. . (b) Enhanced fentanyl surveillance Title III of the Public Health Service Act is amended by inserting after section 317T of such Act ( 42 U.S.C. 247b–22 ) the following new section: 317U. Enhanced fentanyl surveillance (a) In general The Director of the Centers for Disease Control and Prevention shall enhance its drug surveillance program by— (1) expanding its surveillance program to include all 50 States and the territories of the United States; (2) increasing and accelerating the collection of data on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including related overdose data from medical examiners and drug treatment admissions; and (3) utilizing available and emerging information on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including information from— (A) the National Drug Early Warning System; (B) State and local public health authorities; and (C) Federal, State, and local public health laboratories. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023. . (c) Pilot program for point-of-Use testing of illicit drugs for dangerous contaminants Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: 399V–7. Pilot program for point-of-use testing of illicit drugs for dangerous contaminants (a) In general The Secretary shall— (1) establish a pilot program through which 5 State or local agencies conduct, in 5 States, point-of-use testing of illicit drugs for dangerous contaminants; (2) establish metrics to evaluate the success of the pilot program in reducing drug overdose rates; and (3) based on such metrics, conduct an annual evaluation of the pilot program and submit an annual report to the Congress containing the results of such evaluation. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023. . 303. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders (a) Conforming applicable number Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(B)(iii) ) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; (bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); or (cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)). . (b) Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended— (1) in subclause (I), by striking or at the end; and (2) by amending subclause (II) to read as follows: (II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or . (c) Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ), as amended by subsection (b), is further amended by adding at the end the following: (III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife. . (d) Definition of qualifying other practitioner Section 303(g)(2)(G)(iv) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iv) ) is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant . (e) Report by Secretary Not later than two years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iii) )) who are treating, in the case of physicians, 100 or more patients, and in the case of qualifying practitioners who are not physicians, 30 or more patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment— (1) the average frequency with which qualifying practitioners see their patients; (2) the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral; (3) the average frequency with which random toxicology testing is administered; (4) the average monthly patient caseload for each type of qualifying practitioner; (5) the treatment retention rates for patients; (6) overdose and mortality rates; and (7) any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner. IV Offsets 401. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2025), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is equal to or greater than 85 percent; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). . 402. Extending period of application of Medicare secondary payer rules for individuals with end stage renal disease Section 1862(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395y(b)(1)(C) ) is amended— (1) in the last sentence, by inserting and before January 1, 2020 after date of enactment of the Balanced Budget Act of 1997 ; and (2) by adding at the end the following new sentence: Effective for items and services furnished on or after January 1, 2020 (with respect to periods beginning on or after July 1, 2018), clauses (i) and (ii) shall be applied by substituting 33-month for 12-month each place it appears. . 403. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program Clause (i) of section 1862(b)(7)(A) of the Social Security Act ( 42 U.S.C. 1395y(b)(7)(A) ) is amended to read as follows: (i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been— (I) a primary plan to the program under this title; or (II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and .

tv_txt: II Calendar No. 485 115th CONGRESS 2d Session H. R. 6 IN THE SENATE OF THE UNITED STATES June 25, 2018 Received; read the first time June 26, 2018 Read the second time and placed on the calendar AN ACT To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Title I—Medicaid Provisions to Address the Opioid Crisis Sec. 1001. At-risk youth Medicaid protection. Sec. 1002. Health Insurance for Former Foster Youth. Sec. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program. Sec. 1004. Drug management program for at-risk beneficiaries. Sec. 1005. Medicaid drug review and utilization. Sec. 1006. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder. Sec. 1007. Medicaid health homes for opioid-use-disorder Medicaid enrollees. Title II—Medicare Provisions to Address the Opioid Crisis Sec. 2001. Authority not to apply certain Medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder. Sec. 2002. Encouraging the use of non-opioid analgesics for the management of post-surgical pain. Sec. 2003. Requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. Sec. 2004. Modification of payment for certain outpatient surgical services. Sec. 2005. Requiring e-prescribing for coverage of covered part D controlled substances. Sec. 2006. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries. Sec. 2007. Medicare coverage of certain services furnished by opioid treatment programs. Title III—Other Health Provisions to Address the Opioid Crisis Sec. 3001. Clarifying FDA regulation of non-addictive pain and addiction therapies. Sec. 3002. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths. Sec. 3003. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Sec. 3004. High-quality, evidence-based opioid analgesic prescribing guidelines and report. Sec. 3005. Report on opioids prescribing practices for pregnant women. Sec. 3006. Guidelines for prescribing naloxone. Sec. 3007. Requiring a survey of substance use disorder treatment providers receiving Federal funding. Title IV—Offsets Sec. 4001. Promoting value in Medicaid managed care. Sec. 4002. Extending period of application of Medicare secondary payer rules for individuals with end stage renal disease. Sec. 4003. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program. Title V—Other Medicaid Provisions Subtitle A—Mandatory reporting with respect to adult behavioral health measures Sec. 5001. Mandatory reporting with respect to adult behavioral health measures. Subtitle B—Medicaid IMD Additional Info Sec. 5011. Short title. Sec. 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid. Subtitle C—CHIP Mental Health Parity Sec. 5021. Short title. Sec. 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program. Subtitle D—Medicaid Reentry Sec. 5031. Short title. Sec. 5032. Promoting State innovations to ease transitions integration to the community for certain individuals. Subtitle E—Medicaid Partnership Sec. 5041. Short title. Sec. 5042. Medicaid providers are required to note experiences in record systems to help in-need patients. Title VI—Other Medicare Provisions Subtitle A—Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Sec. 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. Subtitle B—Abuse Deterrent Access Sec. 6011. Short title. Sec. 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare. Subtitle C—Medicare Opioid Safety Education Sec. 6021. Short title. Sec. 6022. Provision of information regarding opioid use and pain management as part of Medicare & You handbook. Subtitle D—Opioid Addiction Action Plan Sec. 6031. Short title. Sec. 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment. Subtitle E—Advancing High Quality Treatment for Opioid Use Disorders in Medicare Sec. 6041. Short title. Sec. 6042. Opioid use disorder treatment demonstration program. Subtitle F—Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Sec. 6051. Short title. Sec. 6052. Grants to provide technical assistance to outlier prescribers of opioids. Subtitle G—Preventing Addiction for Susceptible Seniors Sec. 6061. Short title. Sec. 6062. Electronic prior authorization for covered part D drugs. Sec. 6063. Program integrity transparency measures under Medicare parts C and D. Sec. 6064. Expanding eligibility for medication therapy management programs under part D. Sec. 6065. Medicare notifications to outlier prescribers of opioids. Sec. 6066. No additional funds authorized. Subtitle H—Expanding Oversight of Opioid Prescribing and Payment Sec. 6071. Short title. Sec. 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program. Sec. 6073. No additional funds authorized. Subtitle I—Dr. Todd Graham Pain Management, Treatment, and Recovery Sec. 6081. Short title. Sec. 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments. Sec. 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics. Sec. 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans. Sec. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report. Sec. 6086. Pain management study. Subtitle J—Combating Opioid Abuse for Care in Hospitals Sec. 6091. Short title. Sec. 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program. Sec. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs. Sec. 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use. Sec. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries. Subtitle K—Stop Excessive Narcotics in our Retirement Communities Protection Sec. 6101. Short title. Sec. 6102. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies. Subtitle L—Providing Reliable Options for Patients and Educational Resources Sec. 6111. Short title. Sec. 6112. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. Sec. 6113. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs. Sec. 6114. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management. Title VII—Other Health Provisions Subtitle A—Synthetic Drug Awareness Sec. 7001. Short title. Sec. 7002. Report on effects on public health of synthetic drug use. Subtitle B—Empowering Pharmacists in the Fight Against Opioid Abuse Sec. 7011. Short title. Sec. 7012. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription. Subtitle C—Indexing Narcotics, Fentanyl, and Opioids Sec. 7021. Short title. Sec. 7022. Establishment of substance use disorder information dashboard. Sec. 7023. Interagency Substance Use Disorder Coordinating Committee. Subtitle D—Ensuring Access to Quality Sober Living Sec. 7031. Short title. Sec. 7032. National recovery housing best practices. Subtitle E—Advancing Cutting Edge Research Sec. 7041. Short title. Sec. 7042. Unique research initiatives. Subtitle F—Jessie’s Law Sec. 7051. Short title. Sec. 7052. Inclusion of opioid addiction history in patient records. Sec. 7053. Communication with families during emergencies. Subtitle G—Safe Disposal of Unused Medication Sec. 7061. Short title. Sec. 7062. Disposal of controlled substances of a deceased hospice patient by employees of a qualified hospice program. Subtitle H—Substance Use Disorder Workforce Loan Repayment Sec. 7071. Short title. Sec. 7072. Loan repayment program for substance use disorder treatment employees. Subtitle I—Preventing Overdoses While in Emergency Rooms Sec. 7081. Short title. Sec. 7082. Program to support emergency room discharge and care coordination for drug overdose patients. Subtitle J—Alternatives to Opioids in the Emergency Department Sec. 7091. Short title. Sec. 7092. Emergency department alternatives to opioids demonstration program. Subtitle K—Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Sec. 7101. Short title. Sec. 7102. Detention, refusal, and destruction of drugs offered for importation. Sec. 7103. Notification, nondistribution, and recall of adulterated or misbranded drug products. Sec. 7104. Single source pattern of shipments of adulterated or misbranded drugs. Sec. 7105. Fund to strengthen efforts of FDA to combat the opioid and substance use epidemic. Sec. 7106. Consideration of potential for misuse and abuse required for drug approval. Subtitle L—Treatment, Education, and Community Help to Combat Addiction Sec. 7111. Short title. Sec. 7112. Establishment of Regional Centers of Excellence in Substance Use Disorder Education. Subtitle M—Guidance from National Mental Health and Substance Use Policy Laboratory Sec. 7121. Guidance from National Mental Health and Substance Use Policy Laboratory. Subtitle N—Comprehensive Opioid Recovery Centers Sec. 7131. Short title. Sec. 7132. Comprehensive opioid recovery centers. Subtitle O—Poison Center Network Enhancement Sec. 7141. Short title. Sec. 7142. Reauthorization of poison control centers national toll-free number. Sec. 7143. Reauthorization of nationwide public awareness campaign to promote poison control center utilization. Sec. 7144. Reauthorization of the poison control center grant program. Subtitle P—Eliminating Opioid Related Infectious Diseases Sec. 7151. Short title. Sec. 7152. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors. Subtitle Q—Better Pain Management Through Better Data Sec. 7161. Short title. Sec. 7162. Guidance addressing alternative approaches to data collection and labeling claims for opioid sparing. Subtitle R—Special Registration for Telemedicine Clarification Sec. 7171. Short title. Sec. 7172. Deadline for interim final regulations for a special registration To engage in the practice of telemedicine. Subtitle S—Peer Support Communities of Recovery Sec. 7181. Short title. Sec. 7182. Building communities of recovery. Subtitle T—Stop Illicit Drug Importation Sec. 7191. Short title. Sec. 7192. Detention, refusal, and destruction of drugs offered for importation. Sec. 7193. Seizure. Sec. 7194. Debarring violative individuals or companies. Subtitle U—Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Sec. 7201. Short title. Sec. 7202. Preventing overdoses of controlled substances. Sec. 7203. Prescription drug monitoring program. Subtitle V—Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Sec. 7211. Short title. Sec. 7212. Improved technologies, controls, or measures with respect to the packaging or disposal of certain drugs. Subtitle W—Postapproval study requirements Sec. 7221. Postapproval study requirements. Title VIII—Miscellaneous Subtitle A—Synthetics Trafficking and Overdose Prevention Sec. 8001. Short title; table of contents. Sec. 8002. Customs fees. Sec. 8003. Mandatory advance electronic information for postal shipments. Sec. 8004. International postal agreements. Sec. 8005. Cost recoupment. Sec. 8006. Development of technology to detect illicit narcotics. Sec. 8007. Civil penalties for postal shipments. Sec. 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest. Sec. 8009. Effective date; regulations. Subtitle B—Recognizing Early Childhood Trauma Related to Substance Abuse Sec. 8011. Short title. Sec. 8012. Recognizing Early Childhood Trauma Related to Substance Abuse. Subtitle C—Assisting States’ Implementation of Plans of Safe Care Sec. 8021. Short title. Sec. 8022. Assisting States with implementation of plans of safe care. Subtitle D—Improving the Federal Response to Families Impacted by Substance Use Disorder Sec. 8031. Short title. Sec. 8032. Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders. Subtitle E—Establishment of an Advisory Committee on Opioids and the Workplace Sec. 8041. Establishment of an Advisory Committee on Opioids and the Workplace. Subtitle F—Veterans Treatment Court Improvement Sec. 8051. Short title. Sec. 8052. Hiring by Department of Veterans Affairs of additional Veterans Justice Outreach Specialists. Subtitle G—Peer support counseling program for women veterans Sec. 8061. Peer support counseling program for women veterans. Subtitle H—Treating Barriers to Prosperity Sec. 8071. Short title. Sec. 8072. Drug abuse mitigation initiative. Subtitle I—Supporting Grandparents Raising Grandchildren Sec. 8081. Short title. Sec. 8082. Findings. Sec. 8083. Advisory Council To Support Grandparents Raising Grandchildren. Sec. 8084. Definitions. Subtitle J—Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Sec. 8091. Short title. Sec. 8092. Reauthorization of the comprehensive opioid abuse grant program. Title IX—SITSA Act Sec. 9001. Short title. Sec. 9002. Establishment of schedule A. Sec. 9003. Temporary and permanent scheduling of schedule A substances. Sec. 9004. Penalties. Sec. 9005. False labeling of schedule A controlled substances. Sec. 9006. Registration requirements for handlers of schedule A substances. Sec. 9007. Additional conforming amendments. Sec. 9008. Controlled substance analogues. Sec. 9009. Rules of construction. Sec. 9010. Study by Comptroller General. Sec. 9011. Report on controlled substance analogues sold by means of the Internet. Sec. 9012. Controlled substance analogues. Title X—THRIVE Act Sec. 10001. Short title. Sec. 10002. Demonstration program to study the impact of using rental vouchers for supportive housing for individuals recovering from opioid use disorders or other substance use disorders. Sec. 10003. Repeal of Rental Voucher Demonstration Program. Sec. 10004. Demonstration Close-Out. Sec. 10005. No additional funds authorized. Title XI—IMD CARE Act Sec. 11001. Short title. Sec. 11002. Medicaid State plan option to provide services for certain individuals with targeted SUDs in institutions for mental diseases. Sec. 11003. Promoting value in Medicaid managed care. I Medicaid Provisions to Address the Opioid Crisis 1001. At-risk youth Medicaid protection (a) In general Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ) is amended— (1) in subsection (a)— (A) by striking and at the end of paragraph (82); (B) by striking the period at the end of paragraph (83) and inserting ; and ; and (C) by inserting after paragraph (83) the following new paragraph: (84) provide that— (A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate; (B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and (C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, such individual such that the State makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution. ; and (2) by adding at the end the following new subsection: (nn) Juvenile; eligible juvenile; public institution For purposes of subsection (a)(84) and this subsection: (1) Juvenile The term juvenile means an individual who is— (A) under 21 years of age; or (B) described in subsection (a)(10)(A)(i)(IX). (2) Eligible juvenile The term eligible juvenile means a juvenile who is an inmate of a public institution and who— (A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or (B) is determined eligible for such medical assistance while an inmate of a public institution. (3) Inmate of a public institution The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (29) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution. . (b) No change in exclusion from medical assistance for inmates of public institutions Nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision (A) following paragraph (29) of section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance. (c) No change in continuity of eligibility before adjudication or sentencing Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced. (d) Effective date (1) In general Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 1002. Health Insurance for Former Foster Youth (a) Coverage continuity for former foster care children up to age 26 (1) In general Section 1902(a)(10)(A)(i)(IX) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A)(i)(IX) ) is amended— (A) in item (bb), by striking are not described in or enrolled under and inserting are not described in and are not enrolled under ; (B) in item (cc), by striking responsibility of the State and inserting responsibility of a State ; and (C) in item (dd), by striking the State plan under this title or under a waiver of the and inserting a State plan under this title or under a waiver of such a . (2) Effective date The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023. (b) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States— (1) on best practices for— (A) removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and (B) conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and (2) which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program Section 1903 of the Social Security Act ( 42 U.S.C. 1396b ) is amended by adding at the end the following new subsection: (aa) Demonstration project to increase substance use provider capacity (1) In general Not later than the date that is 180 days after the date of the enactment of this section, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall— (A) for the first 18-month period of such project, award planning grants described in paragraph (3); and (B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5). (2) Purpose The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities: (A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph. (B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services. (C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that— (i) are authorized to dispense drugs approved by the Food and Drug Administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder; (ii) have in effect a registration or waiver under section 303(g) of the Controlled Substances Act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the Assistant Secretary for Mental Health and Substance Use for purposes of carrying out the requirements of such section 303(g); and (iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services. (D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of— (i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, in accordance with guidelines issued by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome; (ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan); (iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or (iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan). (3) Planning grants (A) In general The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that have a State plan (or waiver of the State plan) approved under this title; (ii) select States in a manner that ensures geographic diversity; and (iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Activities described Activities described in this subparagraph are, with respect to a State, each of the following: (i) Activities that support the development of an initial assessment of the behavioral health treatment needs of the State to determine the extent to which providers are needed (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following: (I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder. (II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver). (III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II). (IV) Projections regarding the extent to which the State participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the State plan (or waiver) during the period of the demonstration project. (ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers. (D) Funding For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended. (4) Post-planning States (A) In general The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that received a planning grant under paragraph (3); (ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application; (iii) select States in a manner that ensures geographic diversity; and (iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Applications (i) In general A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following: (I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i). (II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services. (III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following: (aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services. (bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State. (cc) Milestones and timeliness for implementing activities set forth in the plan. (dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan). (IV) A proposed process for reporting the information required under paragraph (6)(A), including information to assess the effectiveness of the efforts of the State to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection. (V) The expected financial impact of the demonstration project under this subsection on the State. (VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State. (VII) A preliminary plan for how the State will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project. (VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable. (ii) Consultation In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation. (5) Payment (A) In general For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter. (B) Qualified sums defined For purposes of subparagraph (A), the term qualified sums means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use treatment or recovery services. (C) Non-duplication of payment In the case that payment is made under subparagraph (A) with respect to expenditures for substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished. (6) Reports (A) State reports A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use treatment or recovery services for which payment is made to the State under this subsection, on the following: (i) The specific activities with respect to which payment under this subsection was provided. (ii) The number of providers that delivered substance use disorder treatment or recovery services in the State under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project. (iii) The number of individuals enrolled under the State plan (or a waiver of such plan) who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project. (iv) Other matters as determined by the Secretary. (B) CMS reports (i) Initial report Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on— (I) the States awarded planning grants under paragraph (3); (II) the criteria used in such selection; and (III) the activities carried out by such States under such planning grants. (ii) Interim report Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report— (I) on activities carried out under the demonstration project under this subsection; (II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph; (III) with a description of the strengths and limitations of such demonstration project; and (IV) with a plan for the sustainability of such project. (iii) Final report Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report— (I) providing updates on the matters reported in the interim report under clause (ii); (II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and (III) evaluating such demonstration project. (C) AHRQ report Not later than 3 years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, on consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4). (7) Data sharing and best practices During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected. (8) CMS funding There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended. . 1004. Drug management program for at-risk beneficiaries (a) In general Title XIX of the Social Security Act is amended by inserting after section 1927 ( 42 U.S.C. 1396r–8 ) the following new section: 1927A. Drug management program for at-risk beneficiaries (a) In general Beginning January 1, 2020, a State shall operate a qualified drug management program under which a State may enroll certain at-risk beneficiaries identified by the State under the program. (b) Qualified drug management program For purposes of this section, the term qualified drug management program means, with respect to a State, a program carried out by the State (including through a contract with a pharmacy benefit manager) that provides at least for the following: (1) Identification of at-risk individuals Under the program, the State identifies, in accordance with subsection (c), individuals enrolled under the State plan (or waiver of the State plan) who are at-risk beneficiaries. (2) Elements of program (A) In general Under the program, the State, with respect to each individual identified under paragraph (1) and enrolled under the program under paragraph (5)— (i) subject to subparagraphs (B) and (C), selects at least one, but not more than three, health care providers and at least one, but not more than three, pharmacies for each such individual for purposes of clause (ii), in accordance with a selection process that takes into account reasonable factors such as the individual’s previous utilization of items and services from health care providers and pharmacies, geographic proximity of the individual to such health care providers and pharmacies, access of the individual to health care, reasonable travel time, information regarding housing status, and any known preference of the individual for a certain health care provider or pharmacy; and (ii) requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause (i) for such individual and dispensed by a pharmacy selected under clause (i) for such individual in order for such controlled substance to be covered under the State plan (or waiver). (B) Beneficiary preference In the case of an individual receiving a notice under paragraph (3)(A) of being identified as potentially being an at-risk beneficiary described in such paragraph, such individual may submit, during the 30-day period following receipt of such notice, preferences for which health care providers and pharmacies the individual would prefer the State to select under subparagraph (A). The State shall select or change the selection of health care providers and pharmacies under subparagraph (A) for the individuals based on such preferences, except that in the case that State determines that such selection (or change of selection) of a health care provider or pharmacy under subparagraph (A) is contributing or would contribute to prescription drug abuse or drug diversion by the individual, the State may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph. If the State selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual, the State shall provide the individual with at least 30 days written notice of the selection or change of selection and a rationale for the selection or change. (C) Treatment of pharmacy with multiple locations For purposes of subparagraph (A)(i), in the case of a pharmacy that has multiple locations that share real-time electronic prescription data, all such locations of the pharmacy shall collectively be treated as one pharmacy. (D) Treatment of existing FFS drug management programs In the case of a patient review and restriction program (as identified in the annual report submitted to the Secretary under section 1927(g)(3)(D)) operated by a State pursuant to section 1915(a)(2) before the date of the enactment of this section, such program shall be treated as a qualified drug management program. (E) Reasonable access The program shall ensure, including through waiver of elements of the program (including under subparagraph (A)(ii)), reasonable access to health care (including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph (A)) in the case of individuals with multiple residences, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (3) Notification to identified individuals Under the program, the State provides each individual who is identified under paragraph (1), prior to enrolling such individual under the program, at least one notification of each of the following: (A) Notice that the State has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance. (B) The name, address, and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph (2)(A). (C) Information describing all State and Federal public health resources that are designed to address such abuse or misuse to which the individual has access, including mental health services, substance use disorder and recovery services, and other counseling services. (D) Notice of, and information about, the right of the individual to— (i) submit preferences of the individual for health care providers and pharmacies to be selected under paragraph (2)(A), including as described in paragraph (2)(B); (ii) appeal under paragraph (4)— (I) such identification described in subparagraph (A); and (II) the selection of health care providers and pharmacies under paragraph (2)(A). (E) An explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance, including an explanation of the program. (F) Information, including a contact list and clear instructions, that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph (2)(B) and any other communications relating to the program. (4) Appeals process Under the program, the State provides for an appeals process under which, with respect to an individual identified under paragraph (1)— (A) such individual may appeal— (i) such identification; and (ii) the selection of a health care provider or pharmacy under paragraph (2)(A); (B) in the case of an appeal described in subparagraph (A)(ii), the State shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph (2)(A), unless the State determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual; (C) such individual is provided a period of not less than 30 days following the date of receipt of the notice described in paragraph (3) to submit such appeal; and (D) the State must make a determination with respect to an appeal described in subparagraph (A), and notify the individual of such determination, prior to enrollment of such individual in the program. (5) Enrollment Under the program, the State initially enrolls individuals who are identified under paragraph (1) in the program for a 12-month period— (A) in the case of such an individual who does not submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph, beginning on the day after the last day of such period; and (B) in the case of such an individual who does submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph but such appeal is denied, beginning not later than 30 days after the date of such denial. (6) Notification of health care providers and pharmacies Under the program, the State provides to each health care provider and pharmacy selected for an individual under paragraph (2)— (A) notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph (2); (B) information on such program and the role of being so selected; and (C) a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected. (7) Continuation of enrollment Under the program, the State, with respect to an individual enrolled under the program, provides for a process to— (A) not later than 30 days before the end of the 12-month period for which the individual is so enrolled pursuant to paragraph (5)— (i) assess, in accordance with publicly available evidence-based guidelines, whether or not such individual should continue to be enrolled under the program; and (ii) notify such individual of the results of the assessment under clause (i); (B) continue, subject to subparagraph (C), enrollment of such individual if such assessment recommends such continuation; and (C) appeal the continuation of enrollment in accordance with the appeals process described in paragraph (4). (c) At-Risk beneficiary (1) Identification For purposes of this section, a State shall identify an individual enrolled under the State plan (or waiver of the State plan) as an at-risk beneficiary if the individual is not an exempted individual described in paragraph (2) and— (A) is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance; or (B) the State received notification from a PDP sponsor or Medicare Advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section 1860D–4(c)(5) and such identification has not been terminated under subparagraph (F) of such section. (2) Exempted individual described For purposes of paragraph (1), an exempted individual described in this paragraph is an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as an exempted individual for purposes of paragraph (1). (d) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b)(6) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (e) Reports (1) Annual reports A State operating a qualified drug management program shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2021, the following information: (A) The number of individuals enrolled under the State plan (or waiver of the State plan) who are enrolled under the program and the percentage of individuals enrolled under the State plan (or waiver) who are enrolled under such program. (B) The number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program, including the daily morphine milligram equivalents and the quantity prescribed for each such prescription. (C) The number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program. (D) The number of health care providers writing prescriptions for controlled substances (other than prescriptions for a refill) for individuals enrolled under such program. (E) Any other data that the Secretary may require. (F) Any report submitted by a managed care entity under subsection (f)(1)(B) with respect to the year involved. For each such report for a year after 2021, the information described in this paragraph shall be provided in a manner that compares such information with respect to the prior calendar year to such information with respect to the second prior calendar year. (2) MACPAC reports and review Not later than 2 years after the date of the enactment of this section, the Medicaid and CHIP Payment and Access Commission (in this section referred to as MACPAC ), in consultation with the National Association of Medicaid Directors, pharmacy benefit managers, managed care organizations, health care providers (including pharmacists), beneficiary advocates, and other stakeholders, shall publish a report that includes— (A) best practices for operating drug management programs, based on a review of a representative sample of States administering such a program; (B) a summary of the experience of the appeals process under drug management programs operated by several States, such as the frequency at which individuals appealed the identification of being an at-risk individual, the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program, the timeframes for such appeals, a summary of the reasons for such appeals, and the design of such appeals processes; (C) a summary of trends and the effectiveness of qualified drug management programs operated under this section; and (D) recommendations to States on how improvements can be made with respect to the operation of such programs. In reporting on State practices, the MACPAC shall consider how such programs have been implemented in rural areas, under fee-for-service as well as managed care arrangements, and the extent to which such programs have resulted in increased efficiencies to such States or to the Federal Government under this title. (3) Report on plan for coordinated care Not later than January 1, 2021, each State operating a qualified drug management program shall submit to the Administrator of the Centers for Medicare & Medicaid Services a report on how such State plans to provide coordinated care for individuals enrolled under the State plan (or waiver of the State plan) and— (A) who are enrolled under the program; or (B) who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity. (f) Applicability to managed care entities (1) In general With respect to any contract that a State enters into on or after January 1, 2020, with a managed care entity (as defined in section 1932(a)(1)(B)) pursuant to section 1903(m), the State shall, as a condition of the contract, require the managed care entity— (A) to operate a qualified drug management program (as defined in subsection (b)) for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph (2); (B) to submit to the State an annual report on the matters described in subparagraphs (A) through (E) of subsection (e)(1); and (C) to submit to the State a list (and as necessary update such list) of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph (A) for purposes of allowing State plans for which medical assistance is paid on a fee-for-service basis to have access to such information. (2) Application For purposes of applying, with respect to a managed care entity— (A) under paragraph (1)(A)— (i) the definition of the term qualified drug management program under subsection (b), other than paragraph (2)(D) of such subsection; and (ii) the provisions of paragraphs (1) and (2) of subsection (c); and (B) under paragraph (1)(B), the report requirements described in subparagraphs (A) through (E) of subsection (e)(1); each reference in such subsection (b) and paragraphs of subsection (c) to a State or the State (other than to a State plan or the State plan ) shall be deemed a reference to the managed care entity, each reference under such subsection, paragraphs, or subparagraphs to individuals enrolled under the State plan (or waiver of the State plan) shall be deemed a reference to individuals enrolled with such entity, and each reference under such subsection, paragraphs, or subparagraphs to individuals enrolled under the qualified drug management program operated by the State shall be deemed a reference to individuals enrolled under the qualified drug management program operated by the managed care entity. (g) Controlled substance defined For purposes of this section, the term controlled substance means a drug that is included in schedule II, III, or IV of section 202(c) of the Controlled Substances Act, or any combination thereof, as specified by the State. . (b) Guidance on at-Risk population transitioning between Medicaid FFS and managed care Not later than October 1, 2019, the Secretary of Health and Human Services shall issue guidance for State Medicaid programs, with respect to individuals who are enrolled under a State plan (or waiver of such plan) under title XIX of the Social Security Act and under a drug management program, for purposes of providing best practices— (1) for transitioning, as applicable, such individuals from fee-for-service Medicaid (and such a program operated by the State) to receiving medical assistance under such title through a managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) with a contract that with the State pursuant to section 1903(m) of such Act (and such a program operated by such entity); and (2) for transitioning, as applicable, such individuals from receiving medical assistance under such title through a managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) with a contract that with the State pursuant to section 1903(m) of such Act (and such a program operated by such entity) to fee-for-service Medicaid (and such a program operated by the State). (c) Guidance on at-Risk population transitioning to Medicare (1) In general Not later than January 1, 2020, the Secretary of Health and Human Services, after consultation with the Federal Coordinated Health Care Office established under section 2602 of the Patient Protection and Affordable Care Act ( 42 U.S.C. 1315b ), shall issue guidance for State Medicaid programs, with respect to transitioning individuals, providing for— (A) notification to be submitted by the State to the Centers for Medicare & Medicaid Services and such individuals of the status of such individuals as transitioning individuals; (B) notification to such individuals about enrollment under a prescription drug plan under part D of such title or under a MA–PD plan under part C of such title; (C) best practices for transitioning such individuals to such a plan; and (D) best practices for coordination between the qualified drug management program (as described in section 1927A(b) of the Social Security Act, as added by subsection (a)) carried out by the State and a drug management program carried out under such a plan pursuant to section 1860D–4(c)(5) of the Social Security Act ( 42 U.S.C. 1395w–10(c)(5) ). (2) Transitioning individuals For purposes of paragraph (1), a transitioning individual is an individual who, with respect to a month— (A) is enrolled under the State plan (or waiver of the State plan) and under the qualified drug management program (as described in section 1927A(b) of the Social Security Act, as added by subsection (a)) carried out by the State; and (B) is expected to become eligible for the Medicare program under title XVIII of such Act during the subsequent 12-month period. 1005. Medicaid drug review and utilization (a) Medicaid drug utilization review (1) State plan requirement Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by section 101, is further amended— (A) in paragraph (83), at the end, by striking and ; (B) in paragraph (84), at the end, by striking the period and inserting ; and ; and (C) by inserting after paragraph (84) the following new paragraph: (85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1). . (2) Drug review and utilization requirements Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ), as amended by section 101, is further amended by adding at the end the following new subsection: (oo) Drug review and utilization requirements (1) In general For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following: (A) Claims review limitations (i) In general The State has in place— (I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State; (II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and (III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and— (aa) benzodiazepines; or (bb) antipsychotics. (ii) Managed care entities The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause. (iii) Rules of construction Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver). (B) Program to monitor antipsychotic medications by children The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically. (C) Fraud and abuse identification The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled. (D) Reports The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary. (E) Clarification Nothing shall prevent a State from satisfying the requirement— (i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019; (ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or (iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date. (2) Annual report by Secretary For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D). (3) Exceptions (A) Certain individuals exempted The drug review and utilization requirements under this subsection shall not apply with respect to an individual who— (i) is receiving— (I) hospice or palliative care; or (II) treatment for cancer; (ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (iii) the State elects to treat as exempted from such requirements. (B) Exception relating to ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). . (3) Managed care entities Section 1932 of the Social Security Act ( 42 U.S.C. 1396u–2 ) is amended by adding at the end the following new subsection: (i) Drug utilization review activities and requirements Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42 of the Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018. . (b) Identifying and addressing inappropriate prescribing and billing practices under Medicaid (1) In general Section 1927(g) of the Social Security Act ( 42 U.S.C. 1396r–8(g) ) is amended— (A) in paragraph (1)(A)— (i) by striking of section 1903(i)(10)(B) and inserting of section 1902(a)(54) ; (ii) by striking , by not later than January 1, 1993, ; (iii) by inserting after gross overuse, the following: excessive utilization, ; and (iv) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization ; and (B) in paragraph (2)(B)— (i) by inserting after gross overuse, the following: excessive utilization, ; and (ii) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization . (2) Effective date The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020. 1006. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder (a) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include— (1) the types of services, including post-discharge services and parenting supports, for families of babies with neonatal abstinence syndrome that States may cover under the Medicaid program under title XIX of the Social Security Act; (2) best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and post-discharge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes; (3) recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home visiting services; and (4) guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and post-discharge services, including parenting supports. (b) GAO study Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title. 1007. Medicaid health homes for opioid-use-disorder Medicaid enrollees (a) Extension of enhanced FMAP for certain health homes for individuals with substance use disorders Section 1945 of the Social Security Act ( 42 U.S.C. 1396w–4 ) is amended— (1) in subsection (c)— (A) in paragraph (1), by inserting subject to paragraph (4), after except that, ; and (B) by adding at the end the following new paragraph: (4) Special rule relating to substance use disorder health homes (A) In general In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. Nothing in this section shall be construed as prohibiting a State with a State plan amendment that is approved under this section and that is not an SUD-focused State plan amendment from additionally having approved on or after such date an SUD-focused State plan amendment under this section, including for purposes of application of this paragraph. (B) Report requirements In the case of a State with an SUD-focused State plan amendment for which the application of the Federal medical assistance percentage has been extended under subparagraph (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment: (i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual. (ii) The access of such individuals to health care. (iii) The total expenditures of such individuals for health care. For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures. (C) Best practices Not later than October 1, 2020, the Secretary shall make publicly available on the Internet website of the Centers for Medicare & Medicaid Services best practices for designing and implementing an SUD-focused State plan amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals. (D) Definitions For purposes of this paragraph: (i) SUD-eligible individuals The term SUD-eligible individual means, with respect to a State, an individual who satisfies all of the following: (I) The individual is an eligible individual with chronic conditions. (II) The individual is an individual with a substance use disorder. (III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary. (ii) SUD-focused State plan amendment The term SUD-focused State plan amendment means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals. . (b) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment (1) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29) . (2) Inclusion of medication-assisted treatment as medical assistance Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (28), by striking and at the end; (B) by redesignating paragraph (29) as paragraph (30); and (C) by inserting after paragraph (28) the following new paragraph: (29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and . (3) Medication-assisted treatment defined; Waivers Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended by adding at the end the following new subsection: (ee) Medication-assisted treatment (1) Definition For purposes of subsection (a)(29), the term medication-assisted treatment — (A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), including methadone, and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat opioid use disorders; and (B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy. (2) Exception The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, if before the beginning of such period the State certifies to the satisfaction of the Secretary that implementing such provisions statewide for all individuals eligible to enroll in the State plan (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3). . (4) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025. (B) Exception for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. II Medicare Provisions to Address the Opioid Crisis 2001. Authority not to apply certain Medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder Section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) is amended— (1) in paragraph (2)(B)(i), by inserting and paragraph (7)(E) after Subject to clause (ii) ; and (2) by adding at the end the following new paragraphs: (7) Authority not to apply certain requirements in the case of certain treatment of substance use disorder or co-occurring mental health disorder (A) In general For purposes of payment under this subsection, in the case of telehealth services described in subparagraph (C) furnished on or after January 1, 2020, to an eligible beneficiary (as defined in subparagraph (F)) for the treatment of a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder, the Secretary is authorized to, through rulemaking, not apply any of the requirements described in subparagraph (B). (B) Requirements described For purposes of this paragraph, the requirements described in this subparagraph are any of the following: (i) Qualifications for an originating site under paragraph (4)(C)(ii). (ii) Geographic limitations under paragraph (4)(C)(i). (C) Telehealth services described For purposes of this paragraph, the telehealth services described in this subparagraph are services that are both telehealth services (as described in paragraph (4)(F)) and identified by the Secretary, through rulemaking, as services that are the most commonly furnished (as defined by the Secretary) under this part to individuals diagnosed with a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder. (D) Clarification Nothing in this paragraph shall be construed as limiting or otherwise affecting the authority of the Secretary to limit or eliminate the non-application pursuant to this paragraph of any of the requirements under subparagraph (B). (E) Treatment of originating site facility fee No facility fee shall be paid under paragraph (2)(B) to an originating site with respect to a telehealth service described in subparagraph (B) for which payment is made under this subsection by reason of the non-application of a requirement described in subparagraph (B) pursuant to this paragraph if payment for such service would not otherwise be permitted under this subsection if such requirement were applied. (F) Eligible beneficiary defined For purposes of this paragraph, the term eligible beneficiary means an individual who— (i) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under this part; (ii) has a diagnosis for a substance use disorder; and (iii) meets such other criteria as the Secretary determines appropriate. (G) Report Not later than 5 years after the date of the enactment of this paragraph, the Secretary shall submit to Congress a report on the impact of any non-application under this paragraph of any of the requirements described in subparagraph (B) on (i) the utilization of health care services related to substance use disorder, such as behavioral health services and emergency department visits; and (ii) health outcomes related to substance use disorder, such as substance use overdose deaths. (H) Funding For purposes of carrying out this paragraph, in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended. (8) Rule of construction Nothing in this subsection may be construed as waiving requirements under this title to comply with applicable State law, including State licensure requirements. . 2002. Encouraging the use of non-opioid analgesics for the management of post-surgical pain Section 1833(t)(6) of the Social Security Act ( 42 U.S.C. 1395l(t)(6) ) is amended— (1) in subparagraph (C)(i), by inserting or, in the case of an eligible non-opioid analgesic (as defined in subparagraph (J)), during a period of 5 years, after 3 years, ; and (2) by adding at the end the following new subparagraph: (J) Eligible non-opioid analgesic defined In this paragraph, the term eligible non-opioid analgesic means a drug or biological— (i) that is an analgesic that is not an opioid; (ii) that demonstrated substantial clinical improvement, as determined by the Secretary; and (iii) for which payment— (I) as an outpatient hospital service under this part was not being made as of the date of the enactment of this subparagraph; or (II) was being made under this paragraph as of such date. . 2003. Requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination (a) In general Section 1861(ww) of the Social Security Act ( 42 U.S.C. 1395x(ww) ) is amended— (1) in paragraph (1), by inserting and a review of current opioid prescriptions and screening for opioid use disorder (as defined in paragraph (4)), before but does not include ; and (2) by adding at the end the following new paragraph: (4) (A) For purposes of paragraph (1), the term a review of current opioid prescriptions and screening for opioid use disorder means, with respect to an individual— (i) a review by a physician or qualified non-physician practitioner of all current prescriptions of the individual; and (ii) in the case of an individual determined by the review of a physician or qualified non-physician practitioner under subparagraph (A) to have a current prescription for opioids for chronic pain that has been prescribed for a minimum period of time (as specified by the Secretary)— (I) a review by the physician or practitioner of the potential risk factors to the individual for opioid use disorder; (II) an evaluation by the physician or practitioner of pain of the individual; (III) the provision of information regarding non-opioid treatment options for the treatment and management of any chronic pain of the individual; and (IV) if determined necessary by the physician or practitioner based on the results of the review and evaluation conducted as described in this paragraph, an appropriate referral by the physician or practitioner for additional treatment. (B) For purposes of this paragraph, the term qualified non-physician practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist. . (b) Clarification Nothing in the amendments made by subsection (a) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination. (c) Effective date The amendments made by subsection (a) shall apply with respect to initial preventive physical examinations furnished on or after January 1, 2020. 2004. Modification of payment for certain outpatient surgical services (a) Freeze of payment for certain services furnished in ambulatory surgical centers Section 1833(i)(2) of the Social Security Act ( 42 U.S.C. 1395l(i)(2) ) is amended by adding at the end the following new subparagraph: (F) (i) With respect to a targeted procedure (as defined in clause (ii)) furnished during 2020 or a subsequent year (before 2024) to an individual in an ambulatory surgical center, the payment amount for such procedure that would otherwise be determined under the revised payment system under subparagraph (D), without application of this subparagraph, shall be equal to the payment amount for such procedure furnished in 2016. (ii) For purposes of clause (i), the term targeted procedure means a procedure to which Healthcare Common Procedure Coding System code 62310 (or, for years beginning after 2016, 62321), 62311 (or, for years beginning after 2016, 62323), 62264, 64490, 64493, or G0260, or any successor code, apply. (iii) This subparagraph shall not be applied in a budget-neutral manner. . (b) Data collection (1) In general The Comptroller General shall collect data relating to the cost differential between targeted procedures (as defined in section 1833(i)(2)(F)(ii) of the Social Security Act, as added by subsection (a)) that are performed in a hospital operating room and such procedures that are performed in an office setting within a hospital in order to determine whether such procedures are being properly coded for claims, based on setting, for payment under section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ) and to determine if further changes are needed in the classification system for covered outpatient department services (as described in section 1833(t)(2)(A) of the Social Security Act ( 42 U.S.C. 1395l(t)(2)(A) ). (2) Report Not later than 4 years after the date of the enactment of this Act, the Comptroller General shall submit a report to the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate containing— (A) a determination of whether procedures described in paragraph (1) are being properly coded for claims, based on setting, for payment under section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ); and (B) recommendations on any changes the Comptroller General determines are needed in the classification system for covered outpatient department services (as described in section 1833(t)(2)(A) of the Social Security Act ( 42 U.S.C. 1395l(t)(2)(A) ). (c) Study Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on the extent to which procedures described in section 1833(i)(2)(F)(ii) of the Social Security Act, as added by subsection (a), are effective at preventing the need for opioids for individuals furnished such procedures. 2005. Requiring e-prescribing for coverage of covered part D controlled substances (a) In general Section 1860D–4(e) of the Social Security Act ( 42 U.S.C. 1395w–104(e) ) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, pursuant to rulemaking, specify circumstances with respect to which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispenser are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who has received a waiver or a renewal thereof for a specified period determined by the Secretary, not to exceed 1 year, from the requirement to use electronic prescribing, pursuant to a process established by regulation by the Secretary, due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner allowing for the dispensing of a non-patient specific prescription pursuant to a standing order, approved protocol for drug therapy, collaborative drug management, or comprehensive medication management, in response to a public health emergency, or other circumstances where the practitioner may issue a non-patient specific prescription; (vi) a prescription issued by a practitioner prescribing a drug under a research protocol; (vii) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use; and (viii) a prescription issued by a practitioner for an individual who— (I) receives hospice care under this title; or (II) is a resident of a skilled nursing facility (as defined in section 1819(a)), or a medical institution or nursing facility for which payment is made for an institutionalized individual under section 1902(q)(1)(B), for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy, as determined by the Secretary in accordance with this paragraph. (C) Dispensing Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral or fax prescriptions that are consistent with laws and regulations. Nothing in this paragraph shall be construed as affecting the ability of the beneficiary involved to designate a particular pharmacy to dispense a prescribed drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, pursuant to rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. 2006. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended— (1) in paragraph (1), by inserting after subparagraph (E) the following new subparagraph: (F) With respect to plan years beginning on or after January 1, 2021, a drug management program for at-risk beneficiaries described in paragraph (5). ; and (2) in paragraph (5)(A), by inserting (and for plan years beginning on or after January 1, 2021, a PDP sponsor shall) after A PDP sponsor may . 2007. Medicare coverage of certain services furnished by opioid treatment programs (a) Coverage Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (FF), by striking at the end and ; (2) in subparagraph (GG), by inserting at the end ; and ; and (3) by adding at the end the following new subparagraph: (HH) opioid use disorder treatment services (as defined in subsection (jjj)). . (b) Opioid use disorder treatment services and opioid treatment program defined Section 1861 of the Social Security Act is amended by adding at the end the following new subsection: (jjj) Opioid use disorder treatment services; opioid treatment program (1) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act for use in the treatment of opioid use disorder; (B) dispensing and administration of such medications, if applicable; (C) substance use counseling by a professional to the extent authorized under State law to furnish such services; (D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (E) toxicology testing, and (F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation). (2) Opioid treatment program The term opioid treatment program means an entity that is opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (A) is enrolled under section 1866(j); (B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and (D) meets such additional conditions as the Secretary may find necessary to ensure— (i) the health and safety of individuals being furnished services under such program; and (ii) the effective and efficient furnishing of such services. . (c) Payment (1) In general Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (A) by striking and (BB) and inserting (BB) ; and (B) by inserting before the semicolon at the end the following , and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary . (2) Payment determination Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (w) Opioid use disorder treatment services (1) In general The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program. (2) Considerations The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (3) Annual updates The Secretary shall provide an update each year to the bundled payment amounts under this subsection. . (d) Including opioid treatment programs as Medicare providers Section 1866(e) of the Social Security Act ( 42 U.S.C. 1395cc(e) ) is amended— (1) in paragraph (1), by striking at the end and ; (2) in paragraph (2), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new paragraph: (3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section). . III Other Health Provisions to Address the Opioid Crisis 3001. Clarifying FDA regulation of non-addictive pain and addiction therapies (a) Public meetings Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction, which may include— (1) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c )) for the development of non-addictive medical products intended to treat pain or addiction; and (2) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not later than 1 year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-opioid or non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; and (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence. (c) Medical product defined In this section, the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )). 3002. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths (a) Public health laboratories to detect fentanyl Part F of title III of the Public Health Service Act ( 42 U.S.C. 262 et seq.) is amended— (1) in the heading of part F, by striking and clinical laboratories and inserting , clinical laboratories, and public health laboratories ; and (2) by adding at the end the following new subpart: 4 Public Health Laboratories 355. Public health laboratories to detect fentanyl (a) In general The Secretary shall establish a program to award grants to Federal, State, and local agencies to support the establishment or operation of public health laboratories to detect fentanyl, its analogues, and other synthetic opioids, as described in subsection (b). (b) Standards The Secretary, in consultation with the Director of the National Institute of Standards and Technology, shall— (1) develop standards for safely and effectively handling and testing fentanyl, its analogues, and other synthetic opioids; (2) develop fentanyl and fentanyl analog reference materials and quality control standards and protocols to calibrate instrumentation for clinical diagnostics and postmortem surveillance; and (3) include in the standards developed pursuant to paragraph (1) procedures for encountering new and emerging synthetic opioid formulations and reporting those findings to other Federal, State, and local public health laboratories. (c) Laboratories The Secretary shall require grantees under subsection (a) to— (1) follow the standards established under subsection (b) and be capable of providing systematic and routine laboratory testing of drugs for the purposes of obtaining and disseminating public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate; (2) work with law enforcement agencies and public health authorities, as feasible, to develop real-time information on the purity and movement of fentanyl, its analogues, and other synthetic opioids; (3) assist State and local law enforcement agencies in testing seized drugs when State and local forensic laboratories request additional assistance; (4) provide early warning information and advice to Federal, State, and local law enforcement agencies and public health authorities regarding potential significant changes in the supply of fentanyl, its analogues, and other synthetic opioids; (5) provide biosurveillance for non-fatal exposures; and (6) provide diagnostic testing for non-fatal exposures of emergency personnel. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023. . (b) Enhanced fentanyl surveillance Title III of the Public Health Service Act is amended by inserting after section 317T of such Act ( 42 U.S.C. 247b–22 ) the following new section: 317U. Enhanced fentanyl surveillance (a) In general The Director of the Centers for Disease Control and Prevention shall enhance its drug surveillance program by— (1) expanding its surveillance program to include all 50 States and the territories of the United States; (2) increasing and accelerating the collection of data on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including related overdose data from medical examiners and drug treatment admissions; and (3) utilizing available and emerging information on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including information from— (A) the National Drug Early Warning System; (B) State and local public health authorities; and (C) Federal, State, and local public health laboratories. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023. . (c) Pilot program for point-of-Use testing of illicit drugs for dangerous contaminants Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: 399V–7. Pilot program for point-of-Use testing of illicit drugs for dangerous contaminants (a) In general The Secretary shall— (1) establish a pilot program through which 5 State or local agencies conduct, in 5 States, point-of-use testing of illicit drugs for dangerous contaminants; (2) establish metrics to evaluate the success of the pilot program in reducing drug overdose rates; and (3) based on such metrics, conduct an annual evaluation of the pilot program and submit an annual report to the Congress containing the results of such evaluation. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023. . 3003. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders (a) Conforming applicable number Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(B)(iii) ) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; (bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); or (cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)). . (b) Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended— (1) in subclause (I), by striking or at the end; and (2) by amending subclause (II) to read as follows: (II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or . (c) Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ), as amended by subsection (b), is further amended by adding at the end the following: (III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife. . (d) Definition of qualifying other practitioner Section 303(g)(2)(G)(iv) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iv) ) is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant . (e) Report by Secretary Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iii) )) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment— (1) the average frequency with which qualifying practitioners see their patients; (2) the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral; (3) the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered; (4) the average monthly patient caseload for each type of qualifying practitioner; (5) the treatment retention rates for patients; (6) overdose and mortality rates; and (7) any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner. 3004. High-quality, evidence-based opioid analgesic prescribing guidelines and report (a) Guidelines The Commissioner of Food and Drugs shall develop high-quality, evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain in the relevant therapeutic areas where such guidelines do not exist. (b) Public input In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall— (1) conduct a public workshop, open to representatives of State medical societies and medical boards, various medical specialties including pain medicine specialty societies, patient groups, pharmacists, universities, and others; and (2) provide a period for the submission of comments by the public. (c) Report Not later than the date that is 2 years after the date of enactment of this Act, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the guidelines under subsection (a) will be utilized to protect the public health. (d) Updates The Commissioner of Food and Drugs shall periodically— (1) update the guidelines under subsection (a), informed by public input described in subsection (b); and (2) submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under subsection (c). (e) Statement To accompany guidelines and recommendations The Commissioner of Food and Drugs shall ensure that any opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable— (1) are intended to help inform clinical decisionmaking by prescribers and patients; and (2) should not be used by other parties, including pharmacy benefit management companies, retail or community pharmacies, or public and private payors, for the purposes of restricting, limiting, delaying, or denying coverage for or access to a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. (f) Definition In this section, the term evidence-based means informed by a robust and systemic review of treatment efficacy and clinical evidence. 3005. Report on opioids prescribing practices for pregnant women (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Centers for Disease Control and Prevention, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration shall develop and submit to the Congress a report— (1) on opioids prescribing practices for pregnant women and recommendations for such practices; (2) that provides recommendations for identifying and reducing opioids misuse during pregnancy; (3) on prescription opioid misuse during pregnancy in urban and rural areas; (4) on prescription opioid use during pregnancy for the purpose of medication-assisted treatment in urban and rural areas; (5) evaluating current utilization of non-opiate pain management practices in place of prescription opioids during pregnancy; (6) providing guidelines encouraging the use of non-opioid pain management practices during pregnancy when safe and effective; and (7) that provides recommendations for increasing public awareness and education of opioid use disorder in pregnancy, including available treatment resources in urban and rural areas. (b) No additional funds No additional funds are authorized to be appropriated for purposes of carrying out subsection (a). 3006. Guidelines for prescribing naloxone (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidelines for prescribing an opioid overdose reversal drug. (b) Contents In issuing guidelines under subsection (a), the Secretary shall address the following: (1) Co-prescribing an opioid overdose reversal drug in conjunction with any prescribed opioid. (2) Dosage safety. (3) Prescribing an opioid overdose reversal drug to an individual other than a patient. (4) Standing orders. (5) Other distribution, education, and safety measures as determined necessary. 3007. Requiring a survey of substance use disorder treatment providers receiving Federal funding (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall conduct a survey of all entities that receive Federal funding for the purpose of providing substance use disorder treatment services. The survey shall direct such entities to provide the following information: (1) The length of time the entity has provided substance use disorder treatment services. (2) A detailed description of the patient population served by the entity, including but not limited to the number of patients, type of addictions, geographic area served, as well as gender, racial, ethnic and socioeconomic demographics of such patients. (3) A detailed description of the types of addiction for which the entity has the experience, capability, and capacity to provide such services. (4) An explanation of how the entity handles patients requiring treatment for a substance use disorder that the organization is not able to treat. (5) A description of what is needed, in the opinion of the entity, in order to improve the entity’s ability to meet the addiction treatment needs of the communities served by that entity. (6) Based on the identified needs of the communities served, a description of unmet needs and inadequate services and how such needs and services could be better addressed through additional Federal, State, or local government resources or funding to treat addiction to methamphetamine, crack cocaine, other types of cocaine, heroin, opioids, and other commonly abused drugs. (b) Report Not later than 1 year after the date of the enactment of this Act, the Secretary shall develop and submit to Congress a plan to direct appropriate resources to entities that provide substance use disorder treatment services in order to address inadequacies in services or funding identified through the survey described in subsection (a). IV Offsets 4001. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). . 4002. Extending period of application of Medicare secondary payer rules for individuals with end stage renal disease Section 1862(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395y(b)(1)(C) ) is amended— (1) in the last sentence, by inserting and before January 1, 2020 after date of enactment of the Balanced Budget Act of 1997 ; and (2) by adding at the end the following new sentence: Effective for items and services furnished on or after January 1, 2020 (with respect to periods beginning on or after July 1, 2018), clauses (i) and (ii) shall be applied by substituting 33-month for 12-month each place it appears. . 4003. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program Clause (i) of section 1862(b)(7)(A) of the Social Security Act ( 42 U.S.C. 1395y(b)(7)(A) ) is amended to read as follows: (i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been— (I) a primary plan to the program under this title; or (II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and . V Other Medicaid Provisions A Mandatory reporting with respect to adult behavioral health measures 5001. Mandatory reporting with respect to adult behavioral health measures Section 1139B of the Social Security Act ( 42 U.S.C. 1320b–9b ) is amended— (1) in subsection (b)— (A) in paragraph (3)— (i) by striking Not later than January 1, 2013 and inserting the following: (A) Voluntary reporting Not later than January 1, 2013 ; and (ii) by adding at the end the following: (B) Mandatory reporting with respect to behavioral health measures Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults. ; and (B) in paragraph (5), by adding at the end the following new subparagraph: (C) Behavioral health measures Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures. ; and (2) in subsection (d)(1)(A)— (A) by striking the such plan and inserting such plan ; and (B) by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)) . B Medicaid IMD Additional Info 5011. Short title This subtitle may be cited as the Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act . 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid (a) In general Not later than January 1, 2020, the Medicaid and CHIP Payment and Access Commission established under section 1900 of the Social Security Act ( 42 U.S.C. 1396 ) shall conduct an exploratory study, using data from a representative sample of States, and submit to Congress a report on at least the following information, with respect to services furnished to individuals enrolled under State plans under the Medicaid program under title XIX of such Act ( 42 U.S.C. 1396 et seq.) (or waivers of such plans) who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such State plans (or waivers): (1) A description of such institutions for mental diseases in each such State, including at a minimum— (A) the number of such institutions in the State; (B) the facility type of such institutions in the State; and (C) any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services. (2) With respect to each such institution for mental diseases in each such State, a description of— (A) such services provided at such institution; (B) the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and (C) the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process. (3) A description of— (A) any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and (B) any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments. (4) A summary of State requirements (such as certification, licensure, and accreditation) applied by each such State to such institutions in order for such institutions to receive payment under the State plan (or waiver) and how each such State determines if such requirements have been met. (5) A summary of State standards (such as quality standards, clinical standards, and facility standards) that such institutions must meet to receive payment under such State plans (or waivers) and how each such State determines if such standards have been met. (6) Recommendations for actions by Congress and the Centers for Medicare & Medicaid Services. such as how State Medicaid programs may improve care and improve standards and including a recommendation for how the Centers for Medicare & Medicaid Services can improve data collection from such programs to address any gaps in information. (b) Stakeholder input In carrying out subsection (a), the Medicaid and CHIP Payment and Access Commission shall seek input from State Medicaid directors and stakeholders, including at a minimum the Substance Abuse and Mental Health Services Administration, Centers for Medicare & Medicaid Services, State Medicaid officials, State mental health authorities, Medicaid beneficiary advocates, health care providers, and Medicaid managed care organizations. (c) Definitions In this section: (1) Representative sample of States The term representative sample of States means a non-probability sample in which at least two States are selected based on the knowledge and professional judgment of the selector. (2) State The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (3) Institution for mental diseases The term institution for mental diseases has the meaning given such term in section 435.1009 of title 42, Code of Federal Regulations, or any successor regulation. C CHIP Mental Health Parity 5021. Short title This subtitle may be cited as the CHIP Mental Health Parity Act . 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program (a) In general Section 2103(c)(1) of the Social Security Act ( 42 U.S.C. 1397cc(c)(1) ) is amended by adding at the end the following new subparagraph: (E) Mental health and substance use disorder services (as defined in paragraph (5)). . (b) Mental health and substance use disorder services (1) In general Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended— (A) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and (B) by inserting after paragraph (4) the following new paragraph: (5) Mental health and substance use disorder services Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income women (as defined in section 2112(d)) shall— (A) include coverage of mental health services (including behavioral health treatment) necessary to prevent, diagnose, and treat a broad range of mental health symptoms and disorders, including substance use disorders; and (B) be delivered in a culturally and linguistically appropriate manner. . (2) Conforming amendments (A) Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ) is amended, in the matter before paragraph (1), by striking paragraphs (5), (6), and (7) and inserting paragraphs (5), (6), (7), and (8) . (B) Section 2110(a) of the Social Security Act ( 42 U.S.C. 1397jj(a) ) is amended— (i) in paragraph (18), by striking substance abuse each place it appears and inserting substance use ; and (ii) in paragraph (19), by striking substance abuse and inserting substance use . (C) Section 2110(b)(5)(A)(i) of the Social Security Act ( 42 U.S.C. 1397jj(b)(5)(A)(i) ) is amended by striking subsection (c)(5) and inserting subsection (c)(6) . (c) Assuring access to care Section 2102(a)(7)(B) of the Social Security Act ( 42 U.S.C. 1397bb(c)(2) ) is amended by striking section 2103(c)(5) and inserting paragraphs (5) and (6) of section 2103(c) . (d) Mental health services parity Subparagraph (A) of paragraph (7) of section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) (as redesignated by subsection (b)(1)) is amended to read as follows: (A) In general A State child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services (as described in paragraph (5)) provided under such plan comply with the requirements of section 2726(a) of the Public Health Service Act in the same manner as such requirements or limitations apply to a group health plan under such section. . (e) Effective date (1) In general Subject to paragraph (2), the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is 1 year after the date of the enactment of this Act. (2) Exception for State legislation In the case of a State child health plan under title XXI of the Social Security Act (or a waiver of such plan), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan (or waiver) to meet any requirement imposed by the amendments made by this section, the respective plan (or waiver) shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this section. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. D Medicaid Reentry 5031. Short title This subtitle may be cited as the Medicaid Reentry Act . 5032. Promoting State innovations to ease transitions integration to the community for certain individuals (a) Stakeholder group development of best practices; State Medicaid program innovation (1) Stakeholder group best practices Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a stakeholder group of representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, and other relevant representatives from local, State, and Federal jail and prison systems to develop best practices (and submit to the Secretary and Congress a report on such best practices) for States— (A) to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and (B) to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution. (2) State Medicaid program innovation The Secretary of Health and Human Services shall work with States on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the Medicaid program under title XIX of the Social Security Act transition, with respect to enrollment for medical assistance under such program, seamlessly to the community. (b) Guidance on innovative service delivery systems demonstration project opportunities Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a State Medicaid Director letter, based on best practices developed under subsection (a)(1), regarding opportunities to design demonstration projects under section 1115 of the Social Security Act ( 42 U.S.C. 1315 ) to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title XIX of such Act, including systems for, with respect to a period (not to exceed 30 days) immediately prior to the day on which such individuals are expected to be released from such institution— (1) providing assistance and education for enrollment under a State plan under the Medicaid program under title XIX of such Act for such individuals during such period; and (2) providing health care services for such individuals during such period. (c) Rule of construction Nothing under title XIX of the Social Security Act or any other provision of law precludes a State from reclassifying or suspending (rather than terminating) eligibility of an individual for medical assistance under title XIX of the Social Security Act while such individual is an inmate of a public institution. E Medicaid Partnership 5041. Short title This subtitle may be cited as the Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act . 5042. Medicaid providers are required to note experiences in record systems to help in-need patients (a) Requirements under the Medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) is amended by inserting after section 1943 the following new section: 1944. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances (a) In general Beginning October 1, 2021, a State shall, subject to subsection (d), require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance. (b) Qualified prescription drug monitoring program described A qualified prescription drug monitoring program described in this subsection is, with respect to a State, a prescription drug monitoring program administered by the State that, at a minimum, satisfies each of the following criteria: (1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible: (A) Information regarding the prescription drug history of a covered individual with respect to controlled substances. (B) The number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period. (C) The name, location, and contact information (or other identifying number selected by the State, such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent 12-month period. (2) The program facilitates the integration of information described in paragraph (1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe controlled substances. A qualified prescription drug monitoring program described in this subsection, with respect to a State, may have in place, in accordance with applicable State and Federal law, a data sharing agreement with the State Medicaid program that allows the medical director and pharmacy director of such program (and any designee of such a director who reports directly to such director) to access the information described in paragraph (1) in an electronic format. The State Medicaid program under this title may facilitate reasonable and limited access, as determined by the State and ensuring documented beneficiary protections regarding the use of such data, to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under section 1903(m) or under section 1905(t)(3), or the medical director or pharmacy director of any entity has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the State plan (or waiver of the State plan). All applicable State and Federal security and privacy laws shall apply to the directors or designees of such directors of any State Medicaid program or entity accessing a qualified prescription drug monitoring program under this section. (c) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (d) Ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the application of the requirement under subsection (a), with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (e) Reports (1) State reports Each State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2023, information including, at a minimum, the following information for the most recent 12-month period: (A) The percentage of covered providers (as determined pursuant to a process established by the State) who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance. (B) Aggregate trends with respect to prescribing controlled substances such as— (i) the quantity of daily morphine milligram equivalents prescribed for controlled substances; (ii) the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and (iii) the types of controlled substances prescribed, including the dates of such prescriptions, the supplies authorized (including the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this title and title XVIII). (C) Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified drug management program before dispensing a controlled substance to such individual. (2) Report by CMS Not later than October 1, 2023, the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information: (A) Guidance for States on how States can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection (b). (B) Best practices for how States and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances. (f) Increase to Federal matching rate for certain expenditures relating to qualified prescription drug management programs The Secretary shall increase the Federal medical assistance percentage or Federal matching rate that would otherwise apply to a State under section 1903(a) for a calendar quarter occurring during the period beginning October 1, 2018, and ending September 30, 2021, for expenditures by the State for activities under the State plan (or waiver of the State plan) to implement a prescription drug management program that satisfies the criteria described in paragraphs (1) and (2) of subsection (b) if the State (in this subsection referred to as the administering State ) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug management program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program. In no case shall an increase under this subsection result in a Federal medical assistance percentage or Federal matching rate that exceeds 100 percent. (g) Rule of construction Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified drug management program before dispensing controlled substances to such individuals. (h) Definitions In this section: (1) Controlled substance The term controlled substance means a drug that is included in schedule II of section 202(c) of the Controlled Substances Act and, at the option of the State involved, a drug included in schedule III or IV of such section. (2) Covered individual The term covered individual means, with respect to a State, an individual who is enrolled in the State plan (or under a waiver of such plan). Such term does not include an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as exempted from such term. (3) Covered provider (A) In general The term covered provider means, subject to subparagraph (B), with respect to a State, a health care provider who is participating under the State plan (or waiver of the State plan) and licensed, registered, or otherwise permitted by the State to prescribe a controlled substance (or the designee of such provider). (B) Exceptions (i) In general Beginning October 1, 2021, for purposes of this section, such term does not include a health care provider included in any type of health care provider determined by the Secretary to be exempt from application of this section under clause (ii). (ii) Exceptions process Not later than October 1, 2020, the Secretary, after consultation with the National Association of Medicaid Directors, national health care provider associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of health care providers (if any) that should be exempted from the definition of the term covered provider for purposes of this section. . (b) Guidance Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs. (c) Development of model State practices (1) In general Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act, as added by subsection (a), for the following purposes: (A) Monitoring and preventing fraud, waste, and abuse. (B) Improving health care for individuals enrolled in a State plan under title XIX of such Act (or waiver of such plan) who— (i) transition in and out of coverage under such title; (ii) may have sources of health care coverage in addition to coverage under such title; or (iii) pay for prescription drugs with cash. (C) Any other purposes specified by the Secretary. (2) Elements of model practices The model practices described in paragraph (1)— (A) shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and (B) shall include any appropriate beneficiary protections and privacy guidelines. (3) Consultation In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act) with contracts with States pursuant to section 1903(m) of such Act, pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records. (d) Report by Comptroller General Not later than October 1, 2020, the Comptroller General of the United States shall issue a report examining the operation of prescription drug monitoring programs administered by States, including data security and access standards used by such programs. VI Other Medicare Provisions A Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ) is amended by adding at the end the following new clause: (xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))). . B Abuse Deterrent Access 6011. Short title This subtitle may be cited at the Abuse Deterrent Access Act of 2018 . 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare (a) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an MA–PD plan under part C of title XVIII of the Social Security Act or a prescription drug plan under part D of such title of such Act, taking into account any barriers preventing such individuals from accessing such formulations under such MA–PD or part D plans, such as cost-sharing tiers, fail-first requirements, the price of such formulations, and prior authorization requirements. (b) Definition of abuse-deterrent opioid formulation In this section, the term abuse-deterrent opioid formulation means an opioid that is a prodrug or that has certain abuse-deterrent properties, such as physical or chemical barriers, agonist or antagonist combinations, aversion properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid. C Medicare Opioid Safety Education 6021. Short title This subtitle may be cited as the Medicare Opioid Safety Education Act of 2018 . 6022. Provision of information regarding opioid use and pain management as part of Medicare & You handbook (a) In general Section 1804 of the Social Security Act ( 42 U.S.C. 1395b–2 ) is amended by adding at the end the following new subsection: (d) The notice provided under subsection (a) shall include— (1) educational resources, compiled by the Secretary, regarding opioid use and pain management; and (2) a description of alternative, non-opioid pain management treatments covered under this title. . (b) Effective date The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019. D Opioid Addiction Action Plan 6031. Short title This subtitle may be cited as the Opioid Addiction Action Plan Act . 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment (a) In general Not later than January 1, 2019, the Secretary of Health and Human Services (in this section referred to as the Secretary ), in collaboration with the Pain Management Best Practices Inter-Agency Task Force convened under section 101(b) of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), shall develop an action plan that provides recommendations described in subsection (b). (b) Action plan components Recommendations described in this subsection are, based on an examination by the Secretary of potential obstacles to an effective response to the opioid crisis, recommendations, as determined appropriate by the Secretary, on the following: (1) Recommendations on changes to the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act that would enhance coverage and payment under such programs of all medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treat and minimize risk of opioid addiction, including recommendations on changes to the Medicare prospective payment system for hospital inpatient department services under section 1886(d) of such Act ( 42 U.S.C. 1395ww(d) ) and the Medicare prospective payment system for hospital outpatient department services under section 1833(t) of such Act ( 42 U.S.C. 1395l(t) ) that would allow for separate payment for such therapies, if medically appropriate and if necessary to encourage development and adoption of such therapies. (2) Recommendations for payment and service delivery models to be tested by the Center for Medicare and Medicaid Innovation and other federally authorized demonstration projects, including value-based models, that may encourage the use of appropriate medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treat and minimize risk of opioid addiction. (3) Recommendations for data collection that could facilitate research and policy making regarding prevention of opioid addiction and coverage and payment under the Medicare and Medicaid programs of appropriate opioid addiction treatments. (4) Recommendations for policies under the Medicare program and under the Medicaid program that can expand access for rural, or medically underserved communities to the full range of medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treatment and minimize risk of opioid addiction. (5) Recommendations on changes to the Medicare program and the Medicaid program to address coverage or payment barriers to patient access to medical devices that are non-opioid based treatments approved by the Food and Drug Administration for the management of acute pain and chronic pain, for monitoring substance use withdrawal and preventing overdoses of controlled substances, and for treating substance use disorder. (c) Stakeholder meetings (1) In general Beginning not later than 3 months after the date of the enactment of this Act, the Secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan recommendations described in subsection (b). (2) Participants Participants of meetings described in paragraph (1) shall include representatives from the Food and Drug Administration and National Institutes of Health, biopharmaceutical industry members, medical researchers, health care providers, the medical device industry, the Medicare program, the Medicaid program, and patient advocates. (d) Request for information Not later than 3 months after the date of the enactment of this section, the Secretary shall issue a request for information seeking public feedback regarding ways in which the Centers for Medicare & Medicaid Services can help address the opioid crisis through the development of and application of the action plan. (e) Report to Congress Not later than June 1, 2019, the Secretary shall submit to Congress, and make public, a report that includes— (1) a summary of recommendations that have emerged under the action plan; (2) the Secretary’s planned next steps with respect to the action plan; and (3) an evaluation of price trends for drugs used to reverse opioid overdoses (such as naloxone), including recommendations on ways to lower such prices for consumers. (f) Definition of Medication-Assisted treatment In this section, the term medication-assisted treatment includes opioid treatment programs, behavioral therapy, and medications to treat substance abuse disorder. E Advancing High Quality Treatment for Opioid Use Disorders in Medicare 6041. Short title This subtitle may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 6042. Opioid use disorder treatment demonstration program Title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E ( 42 U.S.C. 1395cc–5 ) the following new section: 1866F. Opioid use disorder treatment demonstration program (a) Implementation of 4-year demonstration program (1) In general Not later than January 1, 2021, the Secretary shall implement a 4-year demonstration program under this title (in this section referred to as the Program ) to increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce expenditures under this title. Under the Program, the Secretary shall make payments under subsection (e) to participants (as defined in subsection (c)(1)(A)) for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams, or arranging for such services to be furnished, to applicable beneficiaries participating in the Program. (2) Opioid use disorder treatment services For purposes of this section, the term opioid use disorder treatment services — (A) means, with respect to an applicable beneficiary, services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act for the treatment of opioid use disorders in an outpatient setting; and (B) includes— (i) medication assisted treatment; (ii) treatment planning; (iii) psychiatric, psychological, or counseling services (or any combination of such services), as appropriate; (iv) social support services, as appropriate; and (v) care management and care coordination services, including coordination with other providers of services and suppliers not on an opioid use disorder care team. (b) Program design (1) In general The Secretary shall design the Program in such a manner to allow for the evaluation of the extent to which the Program accomplishes the following purposes: (A) Reduces hospitalizations and emergency department visits. (B) Increases use of medication-assisted treatment for opioid use disorders. (C) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV). (D) Does not increase the total spending on items and services under this title. (E) Reduces deaths from opioid overdose. (F) Reduces the utilization of inpatient residential treatment. (2) Consultation In designing the Program, including the criteria under subsection (e)(2)(A), the Secretary shall, not later than 3 months after the date of the enactment of this section, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups. (c) Participants; opioid use disorder care teams (1) Participants (A) Definition In this section, the term participant means an entity or individual— (i) that is otherwise enrolled under this title and that is— (I) a physician (as defined in section 1861(r)(1)); (II) a group practice comprised of at least one physician described in subclause (I); (III) a hospital outpatient department; (IV) a federally qualified health center (as defined in section 1861(aa)(4)); (V) a rural health clinic (as defined in section 1861(aa)(2)); (VI) a community mental health center (as defined in section 1861(ff)(3)(B)); (VII) a clinic certified as a certified community behavioral health clinic pursuant to section 223 of the Protecting Access to Medicare Act of 2014; or (VIII) any other individual or entity specified by the Secretary; (ii) that applied for and was selected to participate in the Program pursuant to an application and selection process established by the Secretary; and (iii) that establishes an opioid use disorder care team (as defined in paragraph (2)) through employing or contracting with health care practitioners described in paragraph (2)(A), and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the Program. (B) Preference In selecting participants for the Program, the Secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence. (2) Opioid use disorder care teams (A) In general For purposes of this section, the term opioid use disorder care team means a team of health care practitioners established by a participant described in paragraph (1)(A) that— (i) shall include— (I) at least one physician (as defined in section 1861(r)(1)) furnishing primary care services or addiction treatment services to an applicable beneficiary; and (II) at least one eligible practitioner (as defined in paragraph (3)(A)), who may be a physician who meets the criterion in subclause (I); and (ii) may include other practitioners licensed under State law to furnish psychiatric, psychological, counseling, and social services to applicable beneficiaries. (B) Requirements for receipt of payment under Program In order to receive payments under subsection (e), each participant in the Program shall— (i) furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services; (ii) meet minimum criteria, as established by the Secretary; and (iii) submit to the Secretary, in such form, manner, and frequency as specified by the Secretary, with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team, data and such other information as the Secretary determines appropriate to— (I) monitor and evaluate the Program; (II) determine if minimum criteria are met under clause (ii); and (III) determine the incentive payment under subsection (e). (3) Eligible practitioners; Other provider-related definitions and application provisions (A) Eligible practitioners For purposes of this section, the term eligible practitioner means a physician or other health care practitioner, such as a nurse practitioner, that— (i) is enrolled under section 1866(j)(1); (ii) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and (iii) has in effect a waiver in accordance with section 303(g) of the Controlled Substances Act for such purpose and is otherwise in compliance with regulations promulgated by the Substance Abuse and Mental Health Services Administration to carry out such section. (B) Addiction specialists For purposes of subsection (e)(1)(B)(iv), the term addiction specialist means a physician that possesses expert knowledge and skills in addiction medicine, as evidenced by appropriate certification from a specialty body, a certificate of advanced qualification in addiction medicine, or completion of an accredited residency or fellowship in addiction medicine or addiction psychiatry, as determined by the Secretary. (d) Participation of applicable beneficiaries (1) Applicable beneficiary defined In this section, the term applicable beneficiary means an individual who— (A) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B; (B) is not enrolled in a Medicare Advantage plan under part C; (C) has a current diagnosis for an opioid use disorder; and (D) meets such other criteria as the Secretary determines appropriate. Such term shall include an individual who is dually eligible for benefits under this title and title XIX if such individual satisfies the criteria described in subparagraphs (A) through (D). (2) Voluntary beneficiary participation; limitation on number of beneficiaries An applicable beneficiary may participate in the Program on a voluntary basis and may terminate participation in the Program at any time. Not more than 20,000 applicable beneficiaries may participate in the Program at any time. (3) Services In order to participate in the Program, an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant. Participation under the Program shall not affect coverage of or payment for any other item or service under this title for the applicable beneficiary. (4) Beneficiary access to services Nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this title and applicable beneficiaries shall not be required to relinquish access to any benefit under this title as a condition of receiving services from a participant in the Program. (e) Payments (1) Per applicable beneficiary per month care management fee (A) In general The Secretary shall establish a schedule of per applicable beneficiary per month care management fees. Such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this title to the health care practitioners in the participant’s opioid use disorder care team or, if applicable, to the participant. A participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries, including services not otherwise eligible for payment under this title. (B) Payment amounts In carrying out subparagraph (A), the Secretary shall— (i) consider payments otherwise payable under this title for opioid use disorder treatment services and the needs of applicable beneficiaries; (ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care; (iii) pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months, to reflect the greater time and costs required for the planning and initiation of treatment, as compared to maintenance of treatment; (iv) pay higher per applicable beneficiary per month care management fees for participants that have established opioid use disorder care teams that include an addiction specialist (as defined in subsection (c)(3)(B)); and (v) take into account whether a participant’s opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services. (C) No duplicate payment The Secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month. (2) Incentive payments (A) In general Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid (using a methodology established and at a time determined appropriate by the Secretary) to participants based on the performance of participants with respect to criteria, as determined appropriate by the Secretary, in accordance with subparagraph (B). (B) Criteria (i) In general Criteria described in subparagraph (A) may include consideration of the following: (I) Patient engagement and retention in treatment. (II) Evidence-based medication-assisted treatment. (III) Other criteria established by the Secretary. (ii) Required consultation and consideration In determining criteria described in subparagraph (A), the Secretary shall— (I) consult with stakeholders, including clinicians in the primary care community and in the field of addiction medicine; and (II) consider existing clinical guidelines for the treatment of opioid use disorders. (C) No duplicate payment The Secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary. (f) Multipayer strategy In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the Program under subsection (e)(2)(C). The Secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the Program. (g) Evaluation (1) In general The Secretary shall conduct an intermediate and final evaluation of the program. Each such evaluation shall determine the extent to which each of the purposes described in subsection (b) have been accomplished under the Program. (2) Reports The Secretary shall submit to the Secretary and Congress— (A) a report with respect to the intermediate evaluation under paragraph (1) not later than 3 years after the date of the implementation of the Program; and (B) a report with respect to the final evaluation under paragraph (1) not later than 6 years after such date. (h) Funding (1) Administrative funding For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841. (2) Care management fees and incentives For the purposes of making payments under subsection (e), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 for each of fiscal years 2021 through 2024. (3) Availability Amounts transferred under this subsection for a fiscal year shall be available until expended. (i) Waivers The Secretary may waive any provision of this title as may be necessary to carry out the Program under this section. . F Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment 6051. Short title This subtitle may be cited as the Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Act of 2018 or the REACH OUT Act of 2018 . 6052. Grants to provide technical assistance to outlier prescribers of opioids (a) Grants authorized The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, through the Centers for Medicare & Medicaid Services, award grants, contracts, or cooperative agreements to eligible entities for the purposes described in subsection (b). (b) Use of funds Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance— (1) to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids; (2) to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and (3) to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids. (c) Application Each eligible entity seeking to receive a grant, contract, or cooperative agreement under subsection (a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. (d) Geographic distribution In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State. (e) Definitions In this section: (1) Eligible entity The term eligible entity means— (A) an organization— (i) that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and (ii) that has at least— (I) one individual who is a representative of consumers on its governing body; and (II) one individual who is a representative of health care providers on its governing body; or (B) an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act ( 42 U.S.C. 1320c et seq.). (2) Outlier prescriber of opioids The term outlier prescriber of opioids means a prescriber, identified by the Secretary of Health and Human Services (through use of prescriber information provided by prescriber National Provider Identifiers included pursuant to section 1860D–4(c)(4)(A) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4)(A) ) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under part D of title XVIII of such Act ( 42 U.S.C. 1395w–101 et seq.) and MA–PD plans under part C of such title ( 42 U.S.C. 1395w–21 et seq.)) as prescribing, as compared to other prescribers in the specialty of the prescriber and geographic area, amounts of opioids in excess of a threshold (and other criteria) specified by the Secretary, after consultation with stakeholders. (3) Prescribers The term prescriber means any health care professional, including a nurse practitioner or physician assistant, who is licensed to prescribe opioids by the State or territory in which such professional practices. (f) Funding For purposes of implementing this section, $75,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act ( 42 U.S.C. 1395t ), to remain available until expended. G Preventing Addiction for Susceptible Seniors 6061. Short title This subtitle may be cited as the Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018 . 6062. Electronic prior authorization for covered part D drugs (a) Inclusion in electronic prescription program Section 1860D–4(e)(2) of the Social Security Act ( 42 U.S.C. 1395w–104(e)(2) ) is amended by adding at the end the following new subparagraph: (E) Electronic prior authorization (i) In general Not later than January 1, 2021, the program shall provide for the secure electronic transmission of— (I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and (II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional. (ii) Electronic transmission (I) Exclusions For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i). (II) Standards In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors. (III) Application Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual. . (b) Sense of Congress regarding electronic prior authorization It is the sense of the Congress that— (1) there should be increased use of electronic prior authorizations for coverage of covered part D drugs for part D eligible individuals enrolled in prescription drug plans under part D of title XVIII of the Social Security Act and MA–PD plans under part C of such title to reduce access delays by resolving coverage issues before prescriptions for such drugs are transmitted; and (2) greater priority should be placed on increasing the adoption of use of such electronic prior authorizations among prescribers of such drugs, pharmacies, PDP sponsors, and Medicare Advantage organizations. 6063. Program integrity transparency measures under Medicare parts C and D (a) In general Section 1859 of the Social Security Act ( 42 U.S.C. 1395w–28 ) is amended by adding at the end the following new subsection: (i) Program integrity transparency measures (1) Program integrity portal (A) In general Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure Internet website portal (or other successor technology) that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or an entity responsible for carrying out program integrity activities under this part and part D) for the purpose of enabling through such portal (or other successor technology)— (i) the referral by such plans of substantiated fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and (ii) data sharing among such MA plans, prescription drug plans, and the Secretary. (B) Required uses of portal The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure Internet website portal (or other successor technology) established under subparagraph (A): (i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period. (ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise. (iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation. (iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal (or other successor technology) with respect to activities of substantiated fraud, waste, or abuse of a provider of services or supplier, if such provider or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken. (C) Rulemaking For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes substantiated fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.7.1. In carrying out this subsection, a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for substantiated fraud, waste, or abuse. (D) HIPAA compliant information only For purposes of this subsection, communications may only occur if the communications are permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (2) Quarterly reports Beginning 2 years after the date of enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal (or other successor technology) described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall— (A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and (B) be anonymized information submitted by plans without identifying the source of such information. (3) Clarification Nothing in this subsection shall be construed as precluding or otherwise affecting referrals described in subparagraph (A) that may otherwise be made to law enforcement entities or to the Secretary. . (b) Contract requirement to communicate plan corrective actions against opioid over-prescribers Section 1857(e) of the Social Security Act ( 42 U.S.C. 1395w–27(e) ) is amended by adding at the end the following new paragraph: (5) Communicating plan corrective actions against opioids over-prescribers (A) In general Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on the investigations and other actions taken by such plans related to providers of services who prescribe a high volume of opioids. (B) Process Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A). (C) Regulations For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking— (i) specify a definition for the term high volume of opioids and a method for determining if a provider of services prescribes such a high volume; and (ii) establish the process described in subparagraph (B) and the types of information that shall be submitted through such process. . (c) Reference under part D to program integrity transparency measures Section 1860D–4 of the Social Security Act ( 42 U.S.C. 1395w–104 ) is amended by adding at the end the following new subsection: (m) Program integrity transparency measures For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i). . 6064. Expanding eligibility for medication therapy management programs under part D Section 1860D–4(c)(2)(A)(ii) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(A)(ii) ) is amended— (1) by redesignating subclauses (I) through (III) as items (aa) through (cc), respectively, and adjusting the margins accordingly; (2) by striking are part D eligible individuals who— and inserting are the following: (I) Part D eligible individuals who— ; and (3) by adding at the end the following new subclause: (II) Beginning January 1, 2021, at-risk beneficiaries for prescription drug abuse (as defined in paragraph (5)(C)). . 6065. Medicare notifications to outlier prescribers of opioids Section 1860D–4(c)(4) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4) ) is amended by adding at the end the following new subparagraph: (D) Outlier prescriber notification (i) Notification Beginning not later than 2 years after the date of the enactment of this subparagraph, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be an outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified and that includes resources on proper prescribing methods and other information specified in accordance with clause (iii). (ii) Identification of outlier prescribers of opioids (I) In general The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the threshold established under subclause (II), conduct an analysis to identify prescribers that are outlier opioid prescribers for a period specified by the Secretary. (II) Establishment of threshold For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish a threshold, based on prescriber specialty and geographic area, for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area. (III) Exclusions The Secretary may exclude the following individuals and prescribers from the analysis under this clause: (aa) Individuals receiving hospice services. (bb) Individuals with a cancer diagnosis. (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Office of Inspector General of the Department of Health and Human Services. (iii) Contents of notification The Secretary shall, based on input from stakeholders, specify the resources and other information to be included in notifications provided under clause (i). (iv) Modifications and expansions (I) Frequency Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input. (II) Expansion to other prescriptions The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary. (v) Opioids defined For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary through program instruction or otherwise. . 6066. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle and the amendments made by this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. H Expanding Oversight of Opioid Prescribing and Payment 6071. Short title This subtitle may be cited as the Expanding Oversight of Opioid Prescribing and Payment Act of 2018 . 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program Not later than March 15, 2019, the Medicare Payment Advisory Commission shall submit to Congress a report on, with respect to the Medicare program under title XVIII of the Social Security Act, the following: (1) A description of how the Medicare program pays for pain management treatments (both opioid and non-opioid pain management alternatives) in both inpatient and outpatient hospital settings. (2) The identification of incentives under the hospital inpatient prospective payment system under section 1886 of the Social Security Act ( 42 U.S.C. 1395ww ) and incentives under the hospital outpatient prospective payment system under section 1833(t) of such Act ( 42 U.S.C. 1395l(t) ) for prescribing opioids and incentives under each such system for prescribing non-opioid treatments, and recommendations as the Commission deems appropriate for addressing any of such incentives that are adverse incentives. (3) A description of how opioid use is tracked and monitored through Medicare claims data and other mechanisms and the identification of any areas in which further data and methods are needed for improving data and understanding of opioid use. 6073. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. I Dr. Todd Graham Pain Management, Treatment, and Recovery 6081. Short title This subtitle may be cited as the Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 . 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments (a) Outpatient prospective payment system Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended by adding at the end the following new paragraph: (22) Review and revisions of payments for non-opioid alternative treatments (A) In general With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary— (i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives; (ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and (iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management. (B) Priority In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management. (C) Revisions If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B). (D) Rules of construction Nothing in this paragraph shall be construed to preclude the Secretary— (i) from conducting a demonstration before making the revisions described in subparagraph (C); or (ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management. . (b) Ambulatory surgical centers Section 1833(i) of the Social Security Act ( 42 U.S.C. 1395l(i) ) is amended by adding at the end the following new paragraph: (8) The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1833(t)), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary). . 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics (a) Federally qualified health centers Section 1834(o) of the Social Security Act ( 42 U.S.C. 1395m(o) ) is amended by adding at the end the following new paragraph: (3) Additional payments for certain FQHCs with physicians or other practitioners receiving DATA 2000 waivers (A) In general In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally-qualified health center services (as defined in section 1861(aa)(3)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph (C) the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Federally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practitioner. (B) Application In order to receive a payment described in subparagraph (A), a Federally-qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally-qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center. (C) Requirements For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following: (i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B). (ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Acton or after January 1, 2019. (D) Funding For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended. . (b) Rural health clinic Section 1833 of the Social Security Act ( 42 U.S.C. 1395l ) is amended— (1) by redesignating the subsection (z) relating to medical review of spinal subluxation services as subsection (aa); and (2) by adding at the end the following new subsection: (bb) Additional payments for certain rural health clinics with physicians or practitioners receiving DATA 2000 waivers (1) In general In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in section 1861(aa)(1)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner. (2) Application In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic. (3) Requirements For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following: (A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2). (B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Acton or after January 1, 2019. (4) Funding For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended. . 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans (a) In general Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall submit to Congress a report on the availability of supplemental health care benefits (as described in section 1852(a)(3)(A) of the Social Security Act ( 42 U.S.C. 1395w–22(a)(3)(A) )) designed to treat or prevent substance use disorders under Medicare Advantage plans offered under part C of title XVIII of such Act. Such report shall include the analysis described in subsection (c) and any differences in the availability of such benefits under specialized MA plans for special needs individuals (as defined in section 1859(b)(6) of such Act ( 42 U.S.C. 1395w–28(b)(6) )) offered to individuals entitled to medical assistance under title XIX of such Act and other such Medicare Advantage plans. (b) Consultation The Secretary shall develop the report described in subsection (a) in consultation with relevant stakeholders, including— (1) individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act; (2) entities who advocate on behalf of such individuals; (3) Medicare Advantage organizations; (4) pharmacy benefit managers; and (5) providers of services and suppliers (as such terms are defined in section 1861 of such Act ( 42 U.S.C. 1395x )). (c) Contents The report described in subsection (a) shall include an analysis on the following: (1) The extent to which plans described in such subsection offer supplemental health care benefits relating to coverage of— (A) medication-assisted treatments for opioid use, substance use disorder counseling, peer recovery support services, or other forms of substance use disorder treatments (whether furnished in an inpatient or outpatient setting); and (B) non-opioid alternatives for the treatment of pain. (2) Challenges associated with such plans offering supplemental health care benefits relating to coverage of items and services described in subparagraph (A) or (B) of paragraph (1). (3) The impact, if any, of increasing the applicable rebate percentage determined under section 1854(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395w–24(b)(1)(C) ) for plans offering such benefits relating to such coverage would have on the availability of such benefits relating to such coverage offered under Medicare Advantage plans. (4) Potential ways to improve upon such coverage or to incentivize such plans to offer additional supplemental health care benefits relating to such coverage. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report (a) CMI models Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) is amended by adding at the end the following new clauses: (xxv) Supporting ways to familiarize individuals with the availability of coverage under part B of title XVIII for qualified psychologist services (as defined in section 1861(ii)). (xxvi) Exploring ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services (such as for treating depression) through use of a 24-hour, 7-day a week help line that may inform individuals about the availability of treatment options, including the availability of qualified psychologist services (as defined in section 1861(ii)). . (b) GAO study and report Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, on mental and behavioral health services under the Medicare program under title XVIII of the Social Security Act, including an examination of the following: (1) Information about services furnished by psychiatrists, clinical psychologists, and other professionals. (2) Information about ways that Medicare beneficiaries familiarize themselves about the availability of Medicare payment for qualified psychologist services (as defined in section 1861(ii) of the Social Security Act ( 42 U.S.C. 1395x(ii) ) and ways that the provision of such information could be improved. 6086. Pain management study (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a study analyzing best practices as well as payment and coverage for pain management services under title XVIII of the Social Security Act and submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report containing options for revising payment to providers and suppliers of services and coverage related to the use of multi-disciplinary, evidence-based, non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act. The Secretary shall make such report available on the public website of the Centers for Medicare & Medicaid Services. (b) Consultation In developing the report described in subsection (a), the Secretary shall consult with— (1) relevant agencies within the Department of Health and Human Services; (2) licensed and practicing osteopathic and allopathic physicians, behavioral health practitioners, physician assistants, nurse practitioners, dentists, pharmacists, and other providers of health services; (3) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (4) substance abuse and mental health professional organizations; (5) pain management professional organizations and advocacy entities, including individuals who personally suffer chronic pain; (6) medical professional organizations and medical specialty organizations; (7) licensed health care providers who furnish alternative pain management services; (8) organizations with expertise in the development of innovative medical technologies for pain management; (9) beneficiary advocacy organizations; and (10) other organizations with expertise in the assessment, diagnosis, treatment, and management of pain, as determined appropriate by the Secretary. (c) Contents The report described in subsection (a) shall include the following: (1) An analysis of payment and coverage under title XVIII of the Social Security Act with respect to the following: (A) Evidence-based treatments and technologies for chronic or acute pain, including such treatments that are covered, not covered, or have limited coverage under such title. (B) Evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids. (C) Evidence-based treatments and technologies that treat substance use disorders. (D) Items and services furnished by practitioners through a multi-disciplinary treatment model for pain management, including the patient-centered medical home. (E) Medical devices, non-opioid based drugs, and other therapies (including interventional and integrative pain therapies) approved or cleared by the Food and Drug Administration for the treatment of pain. (F) Items and services furnished to beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, or have comorbidities and require consultation or management of pain with one or more specialists in pain management, mental health, or addiction treatment. (2) An evaluation of the following: (A) Barriers inhibiting individuals entitled to benefits under part A or enrolled under part B of such title from accessing treatments and technologies described in subparagraphs (A) through (F) of paragraph (1). (B) Costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain, such as acupuncture, therapeutic massage, and items and services furnished by integrated pain management programs. (C) Pain management guidance published by the Federal Government that may be relevant to coverage determinations or other coverage requirements under title XVIII of the Social Security Act. (3) An assessment of all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids. Such assessment shall consider incorporating into such guidance relevant elements of the Va/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain published in February 2017 by the Department of Veterans Affairs and Department of Defense, including adoption of elements of the Department of Defense and Department of Veterans Affairs pain rating scale. (4) The options described in subsection (d). (5) The impact analysis described in subsection (e). (d) Options The options described in this subsection are, with respect to individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act, legislative and administrative options for accomplishing the following: (1) Improving coverage of and payment for pain management therapies without the use of opioids, including interventional pain therapies, and options to augment opioid therapy with other clinical and complementary, integrative health services to minimize the risk of substance use disorder, including in a hospital setting. (2) Improving coverage of and payment for medical devices and non-opioid based pharmacological and non-pharmacological therapies approved or cleared by the Food and Drug Administration for the treatment of pain as an alternative or augment to opioid therapy. (3) Improving and disseminating treatment strategies for beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, and treatment strategies to address health disparities related to opioid use and opioid abuse treatment. (4) Improving and disseminating treatment strategies for beneficiaries with comorbidities who require a consultation or comanagement of pain with one or more specialists in pain management, mental health, or addiction treatment, including in a hospital setting. (5) Educating providers on risks of coadministration of opioids and other drugs, particularly benzodiazepines. (6) Ensuring appropriate case management for beneficiaries who transition between inpatient and outpatient hospital settings, or between opioid therapy to non-opioid therapy, which may include the use of care transition plans. (7) Expanding outreach activities designed to educate providers of services and suppliers under the Medicare program and individuals entitled to benefits under part A or under part B of such title on alternative, non-opioid therapies to manage and treat acute and chronic pain. (8) Creating a beneficiary education tool on alternatives to opioids for chronic pain management. (e) Impact analysis The impact analysis described in this subsection consists of an analysis of any potential effects implementing the options described in subsection (d) would have— (1) on expenditures under the Medicare program; and (2) on preventing or reducing opioid addiction for individuals receiving benefits under the Medicare program. J Combating Opioid Abuse for Care in Hospitals 6091. Short title This subtitle may be cited as the Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018 . 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program (a) In general Not later than January 1, 2019, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall develop and publish on the public website of the Centers for Medicare & Medicaid Services guidance for hospitals receiving payment under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) on pain management strategies and opioid use disorder prevention strategies with respect to individuals entitled to benefits under such part. (b) Consultation In developing the guidance described in subsection (a), the Secretary shall consult with relevant stakeholders, including— (1) medical professional organizations; (2) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (3) health care consumers or groups representing such consumers; and (4) other entities determined appropriate by the Secretary. (c) Contents The guidance described in subsection (a) shall include, with respect to hospitals and individuals described in such subsection, the following: (1) Best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder, including— (A) methods to identify such individuals at-risk of opioid use disorder, including risk stratification; (B) ways to prevent, recognize, and treat opioid overdoses; and (C) resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs. (2) Best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders, including education on— (A) the adverse effects of prolonged opioid use; (B) non-opioid, evidence-based, non-pharmacological pain management treatments; (C) monitoring programs for individuals who have been prescribed opioids; and (D) the prescribing of naloxone along with an initial opioid prescription. (3) Best practices for such hospitals to make such individuals aware of the risks associated with opioid use (which may include use of the notification template described in paragraph (4)). (4) A notification template developed by the Secretary, for use as appropriate, for such individuals who are prescribed an opioid that— (A) explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely; (B) highlights multimodal and evidence-based non-opioid alternatives for pain management; (C) encourages such individuals to talk to their health care providers about such alternatives; (D) provides for a method (through signature or otherwise) for such an individual, or person acting on such individual’s behalf, to acknowledge receipt of such notification template; (E) is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and (F) includes any other information determined appropriate by the Secretary. (5) Best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital, including— (A) ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners; (B) guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs; (C) strategies to reduce long-term opioid prescriptions; and (D) methods to identify such practitioners who may be over-prescribing opioids. (6) Other information the Secretary determines appropriate, including any such information from the Opioid Safety Initiative established by the Department of Veterans Affairs or the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs (a) In general Section 1890A of the Social Security Act ( 42 U.S.C. 1395aaa–1 ) is amended by adding at the end the following new subsection: (g) Technical expert panel review of opioid and opioid use disorder quality measures (1) In general Not later than 180 days after the date of the enactment of this subsection, the Secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders, including care, prevention, diagnosis, health outcomes, and treatment furnished to individuals with opioid use disorders. The Secretary may use the entity with a contract under section 1890(a) and amend such contract as necessary to provide for the establishment of such technical expert panel. (2) Review and assessment Not later than 1 year after the date the technical expert panel described in paragraph (1) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall— (A) review quality measures that relate to opioids and opioid use disorders, including existing measures and those under development; (B) identify gaps in areas of quality measurement that relate to opioids and opioid use disorders, and identify measure development priorities for such measure gaps; and (C) make recommendations to the Secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System under section 1848(q), the alternative payment models under section 1833(z)(3)(C), the shared savings program under section 1899, the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and the hospital value-based purchasing program under section 1886(o). (3) Consideration of measures by secretary The Secretary shall consider— (A) using opioid and opioid use disorder measures (including measures used under the Merit-Based Incentive Payment System under section 1848(q), measures recommended under paragraph (2)(C), and other such measures identified by the Secretary) in alternative payment models under section 1833(z)(3)(C) and in the shared savings program under section 1899; and (B) using opioid measures described in subparagraph (A), as applicable, in the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii),and in the hospital value-based purchasing program under section 1886(o). (4) Prioritization of measure development The Secretary shall prioritize for measure development the gaps in quality measures identified under paragraph (2)(B). . (b) Expedited endorsement process for opioid measures Section 1890(b)(2) of the Social Security Act ( 42 U.S.C. 1395aaa(b)(2) ) is amended by adding at the end the following new flush sentence: Such endorsement process shall, as determined practicable by the entity, provide for an expedited process with respect to the endorsement of such measures relating to opioids and opioid use disorders. . 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use (a) Technical expert panel on reducing surgical setting opioid use (1) In general Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a technical expert panel, including medical and surgical specialty societies and hospital organizations, to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings and on best practices for pain management, including with respect to the following: (A) Approaches that limit patient exposure to opioids during the perioperative period, including pre-surgical and post-surgical injections, and that identify such patients at risk of opioid use disorder pre-operation. (B) Shared decision making with patients and families on pain management, including recommendations for the development of an evaluation and management code for purposes of payment under the Medicare program under title XVIII of the Social Security Act that would account for time spent on shared decision making. (C) Education on the safe use, storage, and disposal of opioids. (D) Prevention of opioid misuse and abuse after discharge. (E) Development of a clinical algorithm to identify and treat at-risk, opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period. (2) Report Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress and make public a report containing the recommendations developed under paragraph (1) and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge from such setting. (b) Data collection on perioperative opioid use Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains the following: (1) The diagnosis-related group codes identified by the Secretary as having the highest volume of surgeries. (2) With respect to each of such diagnosis-related group codes so identified, a determination by the Secretary of the data that is both available and reported on opioid use following such surgeries, such as with respect to— (A) surgical volumes, practices, and opioid prescribing patterns; (B) opioid consumption, including— (i) perioperative days of therapy; (ii) average daily dose at the hospital, including dosage greater than 90 milligram morphine equivalent; (iii) post-discharge prescriptions and other combination drugs that are used before intervention and after intervention; (iv) quantity and duration of opioid prescription at discharge; and (v) quantity consumed and number of refills; (C) regional anesthesia and analgesia practices, including pre-surgical and post-surgical injections; (D) naloxone reversal; (E) post-operative respiratory failure; (F) information about storage and disposal; and (G) such other information as the Secretary may specify. (3) Recommendations for improving data collection on perioperative opioid use, including an analysis to identify and reduce barriers to collecting, reporting, and analyzing the data described in paragraph (2), including barriers related to technological availability. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall post on the public website of the Centers for Medicare & Medicaid Services all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids and applicable to opioid prescriptions for individuals entitled to benefits under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) or enrolled under part B of such title of such Act ( 42 U.S.C. 1395j et seq.). (b) Update of guidance (1) Periodic update The Secretary shall, in consultation with the entities specified in paragraph (2), periodically (as determined appropriate by the Secretary) update guidance described in subsection (a) and revise the posting of such guidance on the website described in such subsection. (2) Consultation The entities specified in this paragraph are the following: (A) Medical professional organizations. (B) Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )). (C) Health care consumers or groups representing such consumers. (D) Other entities determined appropriate by the Secretary. K Stop Excessive Narcotics in our Retirement Communities Protection 6101. Short title This subtitle may be cited as the Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 or the SENIOR Communities Protection Act of 2018 . 6102. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies (a) In general Section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended by adding at the end the following new paragraph: (7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies (A) In general The provisions of section 1862(o) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such provisions apply with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. (B) Rule of construction Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review. . (b) Application to MA–PD plans Section 1857(f)(3) of the Social Security Act ( 42 U.S.C. 1395w–27(f)(3) ) is amended by adding at the end the following new subparagraph: (D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies Section 1860D–12(b)(7). . (c) Conforming amendment Section 1862(o)(3) of the Social Security Act ( 42 U.S.C. 1395y(o)(3) ) is amended by inserting , section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), after this subsection . (d) Clarification relating to credible allegation of fraud Section 1862(o) of the Social Security Act ( 42 U.S.C. 1395y(o) ) is amended by adding at the end the following new paragraph: (4) Credible allegation of fraud In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud. . (e) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020. L Providing Reliable Options for Patients and Educational Resources 6111. Short title This subtitle may be cited as the Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018 . 6112. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain Section 1860D–4(a)(1) of the Social Security Act ( 42 U.S.C. 1395w–104(a)(1) ) is amended— (1) in subparagraph (A), by inserting , subject to subparagraph (C), before including ; (2) in subparagraph (B), by adding at the end the following new clause: (vi) For plan year 2021 and each subsequent plan year, subject to subparagraph (C), with respect to the treatment of pain— (I) the risks associated with prolonged opioid use; and (II) coverage of nonpharmacological therapies, devices, and nonopioid medications— (aa) in the case of an MA-PD plan under part C, under such plan; and (bb) in the case of a prescription drug plan, under such plan and under parts A and B. ; and (3) by adding at the end the following new subparagraph: (C) Targeted provision of information A PDP sponsor of a prescription drug plan may, in lieu of disclosing the information described in subparagraph (B)(vi) to each enrollee under the plan, disclose such information through mail or electronic communications to a subset of enrollees under the plan, such as enrollees who have been prescribed an opioid in the previous 2-year period. . 6113. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs (a) Medicare Advantage Section 1852 of the Social Security Act ( 42 U.S.C. 1395w–22 ) is amended by adding at the end the following new subsection: (n) Provision of information relating to the safe disposal of certain prescription drugs (1) In general In the case of an individual enrolled under an MA or MA-PD plan who is furnished an in-home health risk assessment on or after January 1, 2021, such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal. (2) Criteria The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances. . (b) Prescription drug plans Section 1860D–4(c)(2)(B) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(B) ) is amended— (1) by striking may include elements that promote ; (2) by redesignating clauses (i) through (iii) as subclauses (I) through (III) and adjusting the margins accordingly; (3) by inserting before subclause (I), as so redesignated, the following new clause: (i) may include elements that promote— ; (4) in subclause (III), as so redesignated, by striking the period at the end and inserting ; and ; and (5) by adding at the end the following new clause: (ii) with respect to plan years beginning on or after January 1, 2021, shall provide for— (I) the provision of information to the enrollee on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under section 1852(n)(2), including information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal; and (II) cost-effective means by which an enrollee may so safely dispose of such drugs. . 6114. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management (a) Restriction on the use of pain questions in HCAHPS Section 1886(b)(3)(B)(viii) of the Social Security Act ( 42 U.S.C. 1395ww(b)(3)(B)(viii) ) is amended by adding at the end the following new subclause: (XII) (aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2019, such survey may not include questions about communication by hospital staff with an individual about such individual’s pain unless such questions take into account, as applicable, whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain. (bb) The Secretary shall not include on the Hospital Compare Internet website any measures based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 about communication by hospital staff with an individual about such individual’s pain. . (b) Restriction on use of 2018 pain questions in the hospital value-based purchasing program Section 1886(o)(2)(B) of the Social Security Act ( 42 U.S.C. 1395ww(o)(2)(B) ) is amended by adding at the end the following new clause: (iii) HCAHPS pain questions The Secretary may not include under subparagraph (A) a measure that is based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 about communication by hospital staff with an individual about the individual’s pain. . VII Other Health Provisions A Synthetic Drug Awareness 7001. Short title This subtitle may be cited as the Synthetic Drug Awareness Act of 2018 . 7002. Report on effects on public health of synthetic drug use (a) In general Not later than 3 years after the date of the enactment of this Act, the Surgeon General of the Public Health Service shall submit to Congress a report on the health effects of new psychoactive substances (including synthetic drugs) used since January 2010 by persons who are at least 12 years of age but no more than 18 years of age. (b) New psychoactive substance defined For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act ( 21 U.S.C. 802(32) ). B Empowering Pharmacists in the Fight Against Opioid Abuse 7011. Short title This subtitle may be cited as the Empowering Pharmacists in the Fight Against Opioid Abuse Act . 7012. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Director of the Centers for Disease Control and Prevention, and the Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate programs and materials for training pharmacists, health care providers, and patients on— (1) circumstances under which a pharmacist may, consistent with section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or otherwise indicative of abuse or diversion; and (2) any Federal requirements pertaining to declining to fill a prescription under such cir­cum­stances. (b) Materials included In developing materials under subsection (a), the Secretary of Health and Human Services shall include information educating— (1) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and (2) other health care practitioners and the public on a pharmacist’s responsibility to decline to fill prescriptions in certain circumstances. (c) Stakeholder input In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients. C Indexing Narcotics, Fentanyl, and Opioids 7021. Short title This subtitle may be cited as the Indexing Narcotics, Fentanyl, and Opioids Act of 2018 or the INFO Act . 7022. Establishment of substance use disorder information dashboard Title XVII of the Public Health Service Act ( 42 U.S.C. 300u et seq.) is amended by adding at the end the following new section: 1711. Establishment of substance use disorder information dashboard (a) In general Not later than 6 months after the date of the enactment of this section, the Secretary of Health and Human Services shall, in consultation with the Director of National Drug Control Policy, establish and periodically update a public information dashboard that— (1) coordinates information on programs within the Department of Health and Human Services related to the reduction of opioid abuse and other substance use disorders; (2) provides access to publicly available data from other Federal agencies; State, local, and Tribal governments; nonprofit organizations; law enforcement; medical experts; public health educators; and research institutions regarding prevention, treatment, recovery, and other services for opioid use disorder and other substance use disorders; (3) provides comparable data on substance use disorder prevention and treatment strategies in different regions and population of the United States; (4) provides recommendations for health care providers on alternatives to controlled substances for pain management, including approaches studied by the National Institutes of Health Pain Consortium and the National Center for Complimentary and Integrative Health; and (5) provides guidelines and best practices for health care providers regarding treatment of substance use disorders. (b) Controlled substance defined In this section, the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ). . 7023. Interagency Substance Use Disorder Coordinating Committee (a) Establishment Not later than 3 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, in consultation with the Director of National Drug Control Policy, establish a committee, to be known as the Interagency Substance Use Disorder Coordinating Committee (in this section referred to as the Committee ), to coordinate all efforts within the Department of Health and Human Services concerning substance use disorder. (b) Membership (1) Federal members The following individuals shall be the Federal members of the Committee: (A) The Secretary, who shall service as the Chair of the Committee. (B) The Attorney General of the United States. (C) The Secretary of Labor. (D) The Secretary of Housing and Urban Development. (E) The Secretary of Education. (F) The Secretary of Veterans Affairs. (G) The Commissioner of Social Security. (H) The Assistant Secretary for Mental Health and Substance Use. (I) The Director of the Centers for Disease Control and Prevention. (J) The Director of the National Institutes of Health and the Directors of such national research institutes of the National Institutes of Health as the Secretary determines appropriate. (K) The Administrator of the Centers for Medicare & Medicaid Services. (L) The Director of National Drug Control Policy. (M) Representatives of other Federal agencies that serve individuals with substance use disorder. (2) Non-Federal members The Committee shall include a minimum of 17 non-Federal members appointed by the Secretary, of which— (A) at least two such members shall be an individual who has received treatment for a diagnosis of an opioid use disorder; (B) at least two such members shall be an individual who has received treatment for a diagnosis of a substance use disorder other than an opioid use disorder; (C) at least two such members shall be a State Alcohol and Substance Abuse Director; (D) at least two such members shall be a representative of a leading research, advocacy, or service organization for adults with substance use disorder; (E) at least two such members shall— (i) be a physician, licensed mental health professional, advance practice registered nurse, or physician assistant; and (ii) have experience in treating individuals with opioid use disorder or other substance use disorders; (F) at least one such member shall be a substance use disorder treatment professional who is employed with an opioid treatment program; (G) at least one such member shall be a substance use disorder treatment professional who has research or clinical experience in working with racial and ethnic minority populations; (H) at least one such member shall be a substance use disorder treatment professional who has research or clinical mental health experience in working with medically underserved populations; (I) at least one such member shall be a State-certified substance use disorder peer support specialist; (J) at least one such member shall be a drug court judge or a judge with experience in adjudicating cases related to substance use disorder; (K) at least one such member shall be a law enforcement officer or correctional officer with extensive experience in interacting with adults with a substance use disorder; and (L) at least one such member shall be an individual with experience providing services for homeless individuals and working with adults with a substance use disorder. (c) Terms (1) In general A member of the Committee appointed under subsection (b)(2) shall be appointed for a term of 3 years and may be reappointed for one or more 3-year terms. (2) Vacancies A vacancy on the Committee shall be filled in the same manner in which the original appointment was made. Any individual appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and may serve after the expiration of such term until a successor has been appointed. (d) Meetings The Committee shall meet not fewer than two times each year. (e) Duties The Committee shall— (1) monitor opioid use disorder and other substance use disorder research, services, and support and prevention activities across all relevant Federal agencies, including coordination of Federal activities with respect to opioid use disorder and other substance use disorders; (2) identify and provide to the Secretary recommendations for improving Federal grants and programs for the prevention and treatment of, and recovery from, opioid use disorder and other substance use disorders; (3) review substance use disorder prevention and treatment strategies in different regions and populations in the United States and evaluate the extent to which Federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies; (4) make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in paragraphs (1) through (3); (5) make recommendations to the Secretary regarding public participation in decisions relating to opioid use disorder and other substance use disorders and the process by which public feedback can be better integrated into such decisions; and (6) make recommendations to ensure that opioid use disorder and other substance use disorder research, services, and support and prevention activities of the Department of Health and Human Services and other Federal agencies are not unnecessarily duplicative. (f) Annual report (1) In general Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the life of the Committee, the Committee shall publish on the public information dashboard established under section 7022(a) a report summarizing the activities carried out by the Committee pursuant to subsection (e), including any findings resulting from such activities. (2) Recommendation for Committee extension After the publication of the second report of the Committee under paragraph (1), the Secretary shall submit to Congress a recommendation on whether or not the operations of the Committee should continue after the termination date described in subsection (i). (g) Working groups The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to enable the working group to carry out the duties delegated to the working group. (h) Federal Advisory Committee Act The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee only to the extent that the provisions of such Act do not conflict with the requirements of this section. (i) Sunset The Committee shall terminate on the date that is 6 years after the date on which the Committee is established under subsection (a). D Ensuring Access to Quality Sober Living 7031. Short title This subtitle may be cited as the Ensuring Access to Quality Sober Living Act of 2018 . 7032. National recovery housing best practices Part P of title III of the Public Health Service Act is amended by adding at the end the following new section: 399V–7. National recovery housing best practices (a) Best practices The Secretary of Health and Human Services, in consultation with the Secretary for Housing and Urban Development, patients with a history of opioid use disorder, and other stakeholders, which may include State accrediting entities and reputable providers, analysts, and stakeholders of recovery housing services, such as the National Alliance for Recovery Residences, shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing. (b) Dissemination The Secretary shall disseminate the best practices identified or developed under subsection (a) to— (1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices; (2) recovery housing entities; and (3) the public, as appropriate. (c) Definitions In this section: (1) The term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services, including medication-assisted treatment services, that promote sustained recovery from substance use disorders. (2) The term State includes any of the several States, the District of Columbia, each Indian tribe or tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), and any territory or possession of the United States. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $3,000,000 for the period of fiscal years 2019 through 2021. . E Advancing Cutting Edge Research 7041. Short title This subtitle may be cited as the Advancing Cutting Edge Research Act or the ACE Research Act . 7042. Unique research initiatives Section 402(n)(1) of the Public Health Service Act ( 42 U.S.C. 282(n)(1) ) is amended— (1) in subparagraph (A), by striking or ; (2) in subparagraph (B), by striking the period and inserting ; or ; and (3) by adding at the end the following: (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat. . F Jessie’s Law 7051. Short title This subtitle may be cited as Jessie’s Law . 7052. Inclusion of opioid addiction history in patient records (a) Best practices (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding— (A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient; (B) what constitutes the patient’s request for the purpose described in subparagraph (A); and (C) the process and methods by which the information should be so displayed. (2) Dissemination The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies. (b) Requirements In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following: (1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder. (2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications. (3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers. (4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, to have access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations. (5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations. (6) All applicable Federal and State laws and regulations. 7053. Communication with families during emergencies (a) Promoting awareness of authorized disclosures during emergencies The Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services and the Administrator of the Health Resources and Services Administration, shall annually develop and disseminate written materials (electronically or by other means) to health care providers regarding permitted disclosures under Federal health care privacy law during emergencies, including overdoses, of certain health information to families, caregivers, and health care providers. (b) Use of material For the purposes of carrying out subsection (a), the Secretary of Health and Human Services may use material produced under section 11004 of the 21st Century Cures Act ( 42 U.S.C. 1320d–2 note). G Safe Disposal of Unused Medication 7061. Short title This subtitle may be cited as the Safe Disposal of Unused Medication Act . 7062. Disposal of controlled substances of a deceased hospice patient by employees of a qualified hospice program Subsection (g) of section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ) is amended by adding at the end the following: (5) (A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance after the death of such person, so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law. (B) For the purposes of this paragraph: (i) The terms hospice care and hospice program have the meanings given to those terms in section 1861(dd) of the Social Security Act. (ii) The term employee of a qualified hospice program means a physician, nurse, or other person who— (I) is employed by, or pursuant to arrangements made by, a qualified hospice program; (II) (aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and (bb) is acting within the scope of such employment in accordance with applicable State law; and (III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion. (iii) The term qualified hospice program means a hospice program that— (I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death; (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the patient or patient representative and family; (bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and (cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and (III) at the time following the disposal of the controlled substances— (aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and (bb) the time, date, and manner in which that disposal occurred. . H Substance Use Disorder Workforce Loan Repayment 7071. Short title This subtitle may be cited as the Substance Use Disorder Workforce Loan Repayment Act of 2018 . 7072. Loan repayment program for substance use disorder treatment employees Title VII of the Public Health Service Act is amended— (1) by redesignating part F as part G; and (2) by inserting after part E ( 42 U.S.C. 294n et seq.) the following: F Substance use disorder treatment employees 781. Loan repayment program for substance use disorder treatment employees (a) In general The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a program under which— (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection (b) on the principal of and interest on any eligible loan; and (2) the individuals each agree to complete a period of service in a substance use disorder treatment job, as described in subsection (d). (b) Payments For each year of obligated service by an individual pursuant to an agreement under subsection (a), the Secretary shall make a payment to such individual as follows: (1) Service in a shortage area The Secretary shall pay— (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1/6 of the principal of and interest on each eligible loan of the individual which is outstanding on the date the individual began service pursuant to the agreement; and (B) for completion of the sixth and final year of such service, the remainder of such principal and interest. (2) Maximum amount The total amount of payments under this section to any individual shall not exceed $250,000. (c) Eligible loans The loans eligible for repayment under this section are each of the following: (1) Any loan for education or training for a substance use disorder treatment job. (2) Any loan under part E of title VIII (relating to nursing student loans). (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, or Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965). (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965. (5) Any other Federal loan as determined appropriate by the Secretary. (d) Period of service The period of service required by an agreement under subsection (a) shall consist of up to 6 years of full-time employment, with no more than 1 year passing between any 2 years of covered employment, in a substance use disorder treatment job in the United States in— (1) a Mental Health Professional Shortage Area, as designated under section 332; or (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per 100,000 people over the past 3 years for which official data is available from the State, is higher than the most recent available national average overdose death rate per 100,000 people, as reported by the Centers for Disease Control and Prevention. (e) Ineligibility for double benefits No borrower may, for the same service, receive a reduction of loan obligations or a loan repayment under both— (1) this subsection; and (2) any Federally supported loan forgiveness program, including under section 338B, 338I, or 846 of this Act, or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965. (f) Breach (1) Liquidated damages formula The Secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under subsection (a). (2) Limitation The failure by an individual to complete the full period of service obligated pursuant to such an agreement, taken alone, shall not constitute a breach of the agreement, so long as the individual completed in good faith the years of service for which payments were made to the individual under this section. (g) Additional criteria The Secretary— (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed and in addition to the criteria and rules specified in this section; and (2) shall give notice to the committees specified in subsection (h) of any criteria and rules so established. (h) Report to Congress Not later than 5 years after the date of enactment of the Substance Use Disorder Workforce Loan Repayment Act of 2018 , and every other year thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on— (1) the number and location of borrowers who have qualified for loan repayments under this section; and (2) the impact of this section on the availability of substance use disorder treatment employees nationally and in shortage areas and counties described in subsection (d). (i) Definition In this section: (1) The term municipality means a city, town, or other public body created by or pursuant to State law, or an Indian Tribe. (2) The term substance use disorder treatment job means a full-time job (including a fellowship)— (A) where the primary intent and function of the job is the direct treatment or recovery support of patients with or in recovery from a substance use disorder, such as a physician, physician assistant, registered nurse, nurse practitioner, advanced practice registered nurse, social worker, recovery coach, mental health counselor, addictions counselor, psychologist or other behavioral health professional, or any other relevant professional as determine by the Secretary; and (B) which is located at a substance use disorder treatment program, private physician practice, hospital or health system-affiliated inpatient treatment center or outpatient clinic (including an academic medical center-affiliated treatment program), correctional facility or program, youth detention center or program, inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or other specialty community behavioral health center, recovery center, school, community-based organization, telehealth platform, migrant health center, health program or facility operated by a tribe or tribal organization, Federal medical facility, or any other facility as determined appropriate for purposes of this section by the Secretary. (j) Authorization of appropriations There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2028. . I Preventing Overdoses While in Emergency Rooms 7081. Short title This subtitle may be cited as the Preventing Overdoses While in Emergency Rooms Act of 2018 . 7082. Program to support emergency room discharge and care coordination for drug overdose patients (a) In general The Secretary of Health and Human Services shall establish a program (in this subtitle referred to as the Program ) to develop protocols for discharging patients who have presented with a drug overdose and enhance the integration and coordination of care and treatment options for individuals with substance use disorder after discharge. (b) Grant establishment and participation (1) In general In carrying out the Program, the Secretary shall award grants on a competitive basis to not more than 20 eligible entities described in paragraph (2). (2) Eligibility (A) In general To be eligible for a grant under this subsection, an entity shall be— (i) a health care site described in subparagraph (B); or (ii) a health care site coordinator described in subparagraph (C). (B) Health care sites To be eligible for a grant under this section, a health care site shall— (i) submit an application to the Secretary at such time, in such manner, and containing such information as specified by the Secretary; (ii) have an emergency department; (iii) (I) have a licensed health care professional onsite who has a waiver under section 303(g) of the Controlled Substances Act ( 21 U.S.C. 823(g) ) to dispense or prescribe covered drugs; or (II) have a demonstrable plan to hire a sufficient number of full-time licensed health care professionals who have waivers described in subclause (I) to administer such treatment onsite; (iv) have in place an agreement with a sufficient number and range of entities certified under applicable State and Federal law, such as pursuant to registration or a waiver under section 303(g) of the Controlled Substances Act ( 21 U.S.C. 823(g) ) or certification as described in section 8.2 of title 42 of the Code of Federal Regulations, to provide treatment for substance use disorder such that the entity or the resulting network of entities with an agreement with the hospital cumulatively are capable of providing all evidence-based services for the treatment of substance use disorder, as medically appropriate for the individual involved, including— (I) medication-assisted treatment; (II) withdrawal and detoxification services that include patient evaluation, stabilization, and readiness for and entry into treatment; and (III) counseling; (v) deploy onsite peer recovery specialists to help connect patients with treatment and recovery support services; and (vi) include the provision of overdose reversal medication in discharge protocols for opioid overdose patients. (C) Health care site coordinators To be eligible for a grant under this section, a health care site coordinator shall— (i) be an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 (and exempt from tax under section 501(a) of such Code) or a State, local, or Tribal government; (ii) submit an application to the Secretary at such time, in such manner, and containing such information as specified by the Secretary; and (iii) have an agreement with multiple eligible health care sites described in subparagraph (B). (3) Preference In awarding grants under this section, the Secretary may give preference to eligible entities described in paragraph (2) that meet either or both of the following criteria: (A) The eligible health care site is, or the eligible health care site coordinator has an agreement described in paragraph (2)(C)(iii) with a site that is, a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act ( 42 U.S.C. 1395x(mm)(1) )), a low-volume hospital (as defined in section 1886(d)(12)(C)(i) of such Act ( 42 U.S.C. 1395ww(d)(12)(C)(i) )), or a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act ( 42 U.S.C. 1395ww(d)(5)(D)(iii) )). (B) The eligible health care site or the eligible health care site coordinator is located in a geographic area with a drug overdose rate that is higher than the national rate, or in a geographic area with a rate of emergency department visits for overdoses that is higher than the national rate, as determined by the Secretary based on the most recent data from the Centers for Disease Control and Prevention. (4) Medication-assisted treatment defined For purposes of this section, the term medication-assisted treatment means the use of a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a biological product licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), in combination with behavioral health services, to provide an individualized approach to the treatment of substance use disorders, including opioid use disorders. (c) Period of grant A grant awarded to an eligible entity under this section shall be for a period of at least 2 years. (d) Grant uses (1) Required uses A grant awarded under this section to an eligible entity shall be used for both of the following purposes: (A) To establish policies and procedures that address the provision of overdose reversal medication, prescription and dispensing of medication-assisted treatment to an emergency department patient who has had a non-fatal overdose or who is at risk of a drug overdose, and the subsequent referral to evidence-based treatment upon discharge for patients who have experienced a non-fatal drug overdose or who are at risk of a drug overdose. (B) To develop best practices for treating non-fatal drug overdoses, including with respect to care coordination and integrated care models for long term treatment and recovery options for individuals who have experienced a non-fatal drug overdose. (2) Additional permissible uses A grant awarded under this section to an eligible entity may be used for any of the following purposes: (A) To hire emergency department peer recovery specialists; counselors; therapists; social workers; or other licensed medical professionals specializing in the treatment of substance use disorder. (B) To establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment, follow up, and transportation to treatment facilities. (C) To provide for options for increasing the availability and access of medication-assisted treatment and other evidence-based treatment for individuals with substance use disorders. (D) To offer consultation with and referral to other supportive services that help in treatment and recovery. (e) Reporting requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the entity has received such grant that includes information on— (A) the number of individuals treated at the site (or, in the case of an eligible health care site coordinator, at sites covered by the agreement referred to in subsection (b)(2)(C)(iii)) for non-fatal overdoses in the emergency department; (B) the number of individuals administered each medication-assisted treatment at such site or sites in the emergency department; (C) the number of individuals referred by such site or sites to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals; (D) the frequency and number of patient readmissions for non-fatal overdoses and substance use disorder; (E) for what the grant funding was used; and (F) the effectiveness of, and any other relevant additional data regarding, having an onsite health care professional to administer and begin medication-assisted treatment for substance use disorders. (2) Report by Secretary Not less than 1 year after the conclusion of the Program, the Secretary shall submit to Congress a report that includes— (A) findings of the Program; (B) overall patient outcomes under the Program, such as with respect to hospital readmission; (C) what percentage of patients treated by a site funded through a grant under this section were readmitted to a hospital for non-fatal or fatal overdose; (D) an evaluation determining the effectiveness of having a practitioner onsite to administer and begin medication-assisted treatment for substance use disorder; and (E) a compilation of voluntary guidelines and best practices from the reports submitted under paragraph (1). (f) Authorization of appropriations There is authorized to be appropriated to carry out this subtitle $50,000,000 for the period of fiscal years 2019 through 2023. J Alternatives to Opioids in the Emergency Department 7091. Short title This subtitle may be cited as the Alternatives to Opioids in the Emergency Department Act or the ALTO Act . 7092. Emergency department alternatives to opioids demonstration program (a) Demonstration program grants The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall carry out a demonstration program under which the Secretary shall award grants to hospitals and emergency departments, including freestanding emergency departments, to develop, implement, enhance, or study alternative pain management protocols and treatments that limit the use and prescription of opioids in emergency departments. (b) Eligibility To be eligible to receive a grant under subsection (a), a hospital or emergency department shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (c) Geographic diversity In awarding grants under this section, the Secretary shall seek to ensure geographical diversity among grant recipients. (d) Use of funds Grants under subsection (a) shall be used to— (1) target common painful conditions, such as renal colic, sciatica, headaches, musculoskeletal pain, and extremity fractures; (2) train providers and other hospital personnel on protocols and the use of treatments that limit the use and prescription of opioids in the emergency department; and (3) provide alternatives to opioids to patients with painful conditions, not including patients who present with pain related to cancer, end-of-life symptom palliation, or complex multisystem trauma. (e) Consultation The Secretary shall implement a process for recipients of grants under subsection (a) to consult (in a manner that allows for sharing of evidence-based best practices) with each other and with persons having robust knowledge, including emergency departments and physicians that have successfully deployed alternative pain management protocols, such as non-drug approaches studied through the National Center for Complimentary and Integrative Health including acupuncture that limit the use of opioids. The Secretary shall offer to each recipient of a grant under subsection (a) technical support as necessary. (f) Report to the Secretary Each recipient of a grant under this section shall submit to the Secretary (during the period of such grant) annual reports on the progress of the program funded through the grant. These reports shall include, in accordance with State and Federal statutes and regulations regarding disclosure of patient information— (1) a description of and specific information about the alternative pain management protocols employed; (2) data on the alternative pain management protocols and treatments employed, including— (A) during a baseline period before the program began, as defined by the Secretary; (B) at various stages of the program, as determined by the Secretary; and (C) the conditions for which the alternative pain management protocols and treatments were employed; (3) the success of each specific alternative pain management protocol; (4) data on the opioid prescriptions written, including— (A) during a baseline period before the program began, as defined by the Secretary; (B) at various stages of the program, as determined by the Secretary; and (C) the conditions for which the opioids were prescribed; (5) the demographic characteristics of patients who were treated with an alternative pain management protocol, including age, sex, race, ethnicity, and insurance status and type; (6) data on patients who were eventually prescribed opioids after alternative pain management protocols and treatments were employed; and (7) any other information the Secretary deems necessary. (g) Report to Congress Not later than 1 year after completion of the demonstration program under this section, the Secretary shall submit a report to the Congress on the results of the demonstration program and include in the report— (1) the number of applications received and the number funded; (2) a summary of the reports described in subsection (f), including standardized data; and (3) recommendations for broader implementation of pain management protocols that limit the use and prescription of opioids in emergency departments or other areas of the health care delivery system. (h) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2021. K Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now 7101. Short title This subtitle may be cited as the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act . 7102. Detention, refusal, and destruction of drugs offered for importation (a) Increasing the maximum dollar amount of drugs subject to destruction The sixth sentence in section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking except that the Secretary and all that follows through the two periods at the end and inserting except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is declared to be valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 or such higher amount as the Commissioner of Food and Drugs may set based on a finding by the Commissioner that the higher amount is in the interest of public health), or if such drug is entering the United States by mail, and was not brought into compliance as described under subsection (b). . (b) Destruction of articles of concern The sixth sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ), as amended by subsection (a), is further amended by inserting before the period at the end the following: ; and the Secretary of Health and Human Services may destroy, without the opportunity for export, any article refused admission under clause (6) of the third sentence of this subsection . (c) Technical amendments The seventh, eighth, and ninth sentences of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) are amended— (1) by striking a drug each place it appears and inserting an article ; and (2) by striking the drug each place it appears and inserting the article . (d) Rule of construction The last sentence in section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended to read as follows: Clauses (2), (5), and (6) of the third sentence of this subsection shall not be construed to prohibit the admission of narcotic or nonnarcotic drugs or other substances, the importation of which is permitted under the Controlled Substances Import and Export Act. . 7103. Notification, nondistribution, and recall of adulterated or misbranded drug products (a) Prohibited Acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (eee) The failure to comply with any order issued under section 569D. . (b) Notification, nondistribution, and recall of adulterated or misbranded drugs Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: 569D. Notification, Nondistribution, And Recall Of Adulterated Or Misbranded Drugs (a) Order To cease distribution and recall (1) In general Upon a determination that the use or consumption of, or exposure to, a drug may present an imminent or substantial hazard to the public health, the Secretary shall issue an order requiring any person who distributes the drug to immediately cease distribution of the drug. (2) Hearing An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on— (A) the actions required by the order; and (B) whether the order should be amended to require a recall of the drug. (3) Inadequate grounds If, after providing an opportunity for a hearing under paragraph (2), the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. (4) Amendment to order to require recall If, after providing an opportunity for an informal hearing under paragraph (2), the Secretary determines that the order should be amended to include a recall of the drug with respect to which the order was issued, the Secretary shall— (A) amend the order to require a recall; and (B) after consultation with the drug sponsor, specify a timetable in which the recall will occur. (5) Notice to persons affected An order under this subsection shall require any person who distributes the drug to provide for notice, including to individuals as appropriate, to persons who may be affected by the order to cease distribution of or recall the drug, as applicable. (6) Action following order Any person who is subject to an order under paragraph (1) or (4) shall immediately cease distribution of or recall, as applicable, the drug and provide notification as required by such order. (b) Notice to consumers and health officials The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to— (1) consumers to whom the drug was, or may have been, distributed; and (2) appropriate State and local health officials. (c) Order To recall (1) Contents An order to recall a drug under subsection (a) shall— (A) require periodic reports to the Secretary describing the progress of the recall; and (B) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall. (2) Assistance allowed In providing for notice under paragraph (1)(B), the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary. (3) Nondelegation An order under this section shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research, is an official senior to such Director, or is so designated by such Director. (d) Savings clause Nothing contained in this section shall be construed as limiting— (1) the authority of the Secretary to issue an order to cease distribution of, or to recall, an drug under any other provision of this Act or the Public Health Service Act; or (2) the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act. . (c) Drugs subject to refusal The third sentence of subsection (a) of section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by inserting or (5) in the case of a drug, such drug is subject to an order under section 568 to cease distribution of or recall the drug, before then such article shall be refused admission . (d) Application Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall apply with respect to a drug as of such date, not later than 1 year after the date of the enactment of this Act, as the Secretary of Health and Human Services shall specify. 7104. Single source pattern of shipments of adulterated or misbranded drugs Section 801 of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: (t) Single source pattern of shipments of adulterated or misbranded drugs If the Secretary identifies a pattern of adulterated or misbranded drugs being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order choose to treat all drugs being offered for import from such manufacturer, distributor, or importer as adulterated or misbranded unless otherwise demonstrated. . 7105. Fund to strengthen efforts of FDA to combat the opioid and substance use epidemic Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq.) is amended by adding at the end the following: 1015. Fund to strengthen efforts of FDA to combat the opioid and substance use epidemic (a) In general The Commissioner of Food and Drugs shall use any funds appropriated pursuant to the authorization of appropriations under subsection (c) to carry out the programs and activities described in subsection (d) to strengthen and facilitate the Food and Drug Administration’s efforts to address the opioid and substance use epidemic. Such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities. (b) FDA Opioid and Substance Use Epidemic Response Fund (1) Establishment of fund There is established in the Treasury a fund, to be known as the FDA Opioid and Substance Use Epidemic Response Fund (referred to in this subsection as the Fund ), for purposes of funding the programs and activities described in subsection (d). (2) Transfer For the period of fiscal years 2019 through 2023, $110,000,000 shall be transferred to the Fund from the general fund of the Treasury. (3) Amounts deposited Any amounts transferred under paragraph (2) shall remain unavailable in the Fund until such amounts are appropriated pursuant to subsection (c). (c) Appropriations (1) Authorization of appropriations For the period of fiscal years 2019 through 2023, there is authorized to be appropriated from the Fund to the Food and Drug Administration, for the purpose of carrying out the programs and activities described in subsection (d), an amount not to exceed the total amount transferred to the Fund under subsection (b)(2). Notwithstanding subsection (g), such funds shall remain available until expended. (2) Offsetting future appropriations For any of fiscal years 2019 through 2023, for any discretionary appropriation out of the Fund to the Food and Drug Administration pursuant to the authorization of appropriations under paragraph (1) for the purpose of carrying out the programs and activities described in subsection (d), the total amount of such appropriations for the applicable fiscal year (not to exceed the total amount remaining in the Fund) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985, and the amount transferred to the Fund shall be reduced by the same amount. (d) Food and Drug Administration The entirety of the funds made available pursuant to subsection (c)(1) shall be for the Commissioner of Food and Drugs, pursuant to applicable authorities in the Public Health Service Act ( 42 U.S.C. 201 et seq.) or this Act and other applicable Federal law, to support widespread innovation in non-opioid and non-addictive medical products for pain treatment, access to opioid addiction treatments, appropriate use of approved opioids, and efforts to reduce illicit importation of opioids. Such support may include the following programs and activities: (1) Obligating contract funds beginning in fiscal year 2019 for an educational campaign that will— (A) educate patients and their families to differentiate opioid medications; (B) raise awareness about preferred storage and disposal methods; and (C) inform patients, families, and communities about medication-assisted treatment options. (2) Building the Food and Drug Administration’s presence in international mail facilities, including through— (A) improvements in equipment and information technology enhancements to identify unapproved, counterfeit, or other unlawful pharmaceuticals for destruction; (B) increased and improved surveillance; (C) renovations at international mail facility locations; and (D) the purchase of laboratory equipment. (3) Enhancing the identification and targeting of entities offering products and products being offered by such entities for import into the United States through review and analysis of Internet websites, import data, and other sources of intelligence for purposes of making the best use of the Food and Drug Administration’s inspection and analytical resources. (4) Increasing the number of staff of the Food and Drug Administration to increase the number of packages being examined, ensuring the safety of the staff undertaking such examinations, and ensuring that packages identified as illegal, counterfeit, misbranded, or adulterated are removed from commerce through available authorities, including administrative destruction. (5) Enhancing the Food and Drug Administration’s criminal investigations resources (including full-time equivalent employees and equipment), imports surveillance, and international work. (6) Obtaining for the Food and Drug Administration equipment and full-time equivalent employees needed to efficiently screen and analyze products offered for import, including by building data libraries of new substances and analogues to facilitate identification and evaluation of pharmaceutical-based agents and by purchasing screening technologies for use at international mail facilities. (7) Operating the Food and Drug Administration’s forensic laboratory facility to ensure adequate laboratory space and functionality for additional work and full-time equivalent employees. (e) Accountability and oversight (1) Work plan (A) In general Not later than 180 days after the date of enactment of this Act, the Commissioner of Food and Drugs shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection (c) for each of fiscal years 2019 through 2023 and the contents described in subparagraph (B). (B) Contents The work plan submitted under subparagraph (A) shall include— (i) the amount of money to be obligated or expended out of the Fund in each fiscal year for each program and activity described in subsection (d); and (ii) a description and justification of each such program and activity. (2) Reports (A) Annual reports Not later than October 1 of each of fiscal years 2020 through 2024, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— (i) the amount of money obligated or expended out of the Fund in the prior fiscal year for each program and activity described in subsection (d); (ii) a description of all programs and activities using funds provided pursuant to the authorization of appropriations under subsection (c); and (iii) how the programs and activities are advancing public health. (B) Additional reports At the request of the Committee on Health, Education, Labor and Pensions of the Senate or the Committee on Energy and Commerce of the House of Representatives, the Commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the programs and activities undertaken with such funding. (f) Limitations Notwithstanding any transfer authority authorized by this section or any appropriations Act, any funds made available pursuant to the authorization of appropriations under subsection (c) may not be used for any purpose other than the programs and activities described in subsection (d) to strengthen and facilitate the Food and Drug Administration’s efforts to address the opioid and substance use epidemic. (g) Sunset This section shall expire on September 30, 2022, except that— (1) this subsection does not apply to reporting under subsection (e)(2); and (2) this section shall remain in effect until such time, and to such extent, as may be necessary for the funds transferred by subsection (b)(2) to be fully expended. . 7106. Consideration of potential for misuse and abuse required for drug approval (a) In general Section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ) is amended— (1) in the first sentence— (A) by striking or (7) and inserting (7) ; and (B) by inserting or (8) if the drug is or contains a controlled substance for which a listing in any schedule is in effect under the Controlled Substances Act or that is permanently scheduled pursuant to section 201 of such Act, on the basis of information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, the drug is unsafe for use due to the risks of abuse or misuse or there is insufficient information to show that the drug is safe for use considering such risks; before he shall issue an order refusing to approve the application ; and (2) in the second sentence, by striking (6) and inserting (8) . (b) Withdrawal authority Section 505(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(e) ) is amended in the first sentence— (1) by striking or (5) and inserting (5) ; and (2) by inserting the following: ; or (6) that, in the case of a drug that is or contains a controlled substance for which a listing in any schedule is in effect under the Controlled Substances Act or that is permanently scheduled pursuant to section 201 of such Act, on the basis of new information before him with respect to such drug, evaluated together with the information available to him when the application was approved, that the drug is unsafe for use due to the risks of abuse or misuse after of a material fact . (c) Rule of construction Nothing in the amendments made by this section shall be construed to limit or narrow, in any manner, the meaning or application of the provisions of paragraphs (1), (2), (3), (4), (5), and (7) of section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ) or paragraphs (1) and (2) of section 505(e) of such Act ( 21 U.S.C. 355(e) ). L Treatment, Education, and Community Help to Combat Addiction 7111. Short title This subtitle may be cited as the Treatment, Education, and Community Help to Combat Addiction Act of 2018 or the TEACH to Combat Addiction Act of 2018 . 7112. Establishment of Regional Centers of Excellence in Substance Use Disorder Education Part D of title V of the Public Health Service Act is amended by inserting after section 549 ( 42 U.S.C. 290ee–4 ) the following new section: 550. Regional Centers of Excellence in Substance Use Disorder Education (a) In general The Secretary, in consultation with such other agencies as are appropriate, shall, subject to the availability of appropriations, establish a solicitation process and award cooperative agreements to eligible entities for the designation of such entities as Regional Centers of Excellence in Substance Use Disorder Education and support of such regional centers of excellence to enhance and improve how health professionals are educated in substance use disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. An eligible entity designated by the Secretary as a Regional Center of Excellence in Substance Use Disorder Education shall carry out the activities described in subsection (b). (b) Selection of centers of excellence (1) Eligible entities To be eligible to receive a cooperative agreement under subsection (a), an entity shall— (A) be an entity specified by the Secretary that offers education to students in various health professions, which may include— (i) a health system; (ii) a teaching hospital; (iii) a medical school; (iv) a certified behavioral health clinic; or (v) any other health profession school, school of public health, or Cooperative Extension Program at institutions of higher education engaged in an aspect of the prevention, treatment, or recovery of substance use disorders; (B) be accredited by the appropriate educational accreditation body; (C) demonstrate an existing strategy, and have in place a plan for continuing such strategy, or a proposed strategy to implement a curriculum based on best practices for substance use disorder prevention, treatment, and recovery; (D) demonstrate community engagement and participation through community partners, including other health profession schools, mental health counselors, social workers, peer recovery specialists, substance use treatment programs, community health centers, physicians’ offices, certified behavioral health clinics, law enforcement, and the business community; and (E) provide to the Secretary such information, at such time, and in such manner, as the Secretary may require. (2) Diversity In awarding cooperative agreements under subsection (a), the Secretary shall take into account regional differences among eligible entities and shall make an effort to ensure geographic diversity. (c) Dissemination of information (1) Public posting The Secretary shall make information provided to the Secretary under subsection (b)(1)(E) publically available on the Internet website of the Department of Health and Human Services. (2) Evaluation The Secretary shall evaluate each project carried out by a Regional Center of Excellence in Substance Use Disorder Education under this section and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities. (d) Funding There is authorized to be appropriated to carry out this section, $4,000,000 for each of fiscal years 2019 through 2023. . M Guidance from National Mental Health and Substance Use Policy Laboratory 7121. Guidance from National Mental Health and Substance Use Policy Laboratory Section 501A(b) of the Public Health Service Act ( 42 U.S.C. 290aa–0(b) ) is amended— (1) in paragraph (5), by striking and at the end; (2) in paragraph (6), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (7) issue and periodically update guidance for entities applying for grants from the Substance Abuse and Mental Health Services Administration in order to— (A) encourage the funding of evidence-based practices; (B) encourage the replication of promising or effective practices; and (C) inform applicants on how to best articulate the rationale for the funding of a program or activity. . N Comprehensive Opioid Recovery Centers 7131. Short title This subtitle may be cited as the Comprehensive Opioid Recovery Centers Act of 2018 . 7132. Comprehensive opioid recovery centers (a) In general Part D of title V of the Public Health Service Act is amended by adding at the end the following new section: 550. Comprehensive opioid recovery centers (a) In general The Secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center (referred to in this section as a Center ). (b) Grant period (1) In general A grant awarded under subsection (a) shall be for a period not less than 3 years and not more than 5 years. (2) Renewal A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph, the Secretary shall consider the data submitted under subsection (h). (c) Minimum number of Centers The Secretary shall allocate the amounts made available under subsection (i) in such amounts that not fewer than 10 Centers will be established across the United States. (d) Application In order to be eligible for a grant under subsection (a), an entity shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (1) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activities described in subsection (g); and (2) such other information as the Secretary may require. (e) Priority In awarding grants under subsection (a), the Secretary shall give priority to eligible entities located in a State or Indian country (as defined in section 1151 of title 18, United States Code)— (1) with a high per capita drug overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or (2) based on any other criteria or need, as determined by the Secretary. (f) Use of grant funds An eligible entity awarded a grant under subsection (a) shall use the grant funds to establish or operate a Center to carry out the activities described in subsection (g). (g) Center activities and services Each Center shall, at a minimum, carry out the activities described in this subsection. In the case of a Center that determines that a service described in paragraph (2) cannot reasonably be carried out by the Center, such Center shall contract with such other entities as may be necessary to ensure that patients have access to the full range of services described in such paragraph. (1) Community outreach Each Center shall carry out the following outreach activities: (A) Train and supervise outreach staff to work with schools, workplaces, faith-based organizations, State and local health departments, law enforcement, and first responders to ensure that such institutions are aware of the services of the Center. (B) Disseminate and make available online evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders. (2) Treatment and recovery services Each Center shall provide the following treatment and recovery services: (A) Ensure that intake evaluations meet the clinical needs of patients. (B) Periodically conduct patient assessments to ensure continued and meaningful recovery, as defined by the Assistant Secretary for Mental Health and Substance Use. (C) Provide the full continuum of treatment services, including— (i) all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act and all biological products licensed under section 351 of this Act, including methadone, to treat substance use disorders, including opioid use disorder and alcohol use disorder; (ii) withdrawal management, which shall include medically supervised detoxification that includes patient evaluation, stabilization, and readiness for and entry into treatment; (iii) counseling and case management, including counseling and recovery services for any possible co-occurring mental illness; (iv) residential rehabilitation; (v) recovery housing; (vi) community-based and peer recovery support services; (vii) job training and placement assistance to support reintegration into the workforce; and (viii) other best practices, as determined by the Secretary. (D) Administer an onsite pharmacy and provide toxicology services. (E) Establish and operate a secure and confidential electronic health information system. (F) Offer family support services such as child care, family counseling, and parenting interventions to help stabilize families impacted by substance use disorder. (h) Data reporting and program oversight With respect to a grant awarded under subsection (a) to an eligible entity for a Center, not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period (including the duration of any renewal period for such grant), the entity shall submit data, as appropriate, to the Secretary regarding— (1) the programs and activities funded by the grant; (2) health outcomes of individuals with a substance use disorder who received services from the Center; (3) the effectiveness of interventions designed, tested, and evaluated by the Center; and (4) any other information that the Secretary may require for the purpose of— (A) evaluating the effectiveness of the Center; and (B) ensuring that the Center is complying with all the requirements of the grant, including providing the full continuum of services described in subsection (g)(2)(C) and providing drugs and devices for overdose reversal under such subsection. (i) Authorization of appropriations There is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. . (b) Reports to Congress (1) Preliminary report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a preliminary report that analyzes data submitted under section 550(h) of the Public Health Service Act, as added by subsection (a). (2) Final report Not later than 1 year after submitting the preliminary report required under paragraph (1), the Secretary of Health and Human Services shall submit to Congress a final report that includes— (A) an evaluation of the effectiveness of comprehensive opioid recovery centers established or operated pursuant to section 550 of the Public Health Service Act, as added by subsection (a); (B) recommendations on whether the grant program established under such section 550 should be reauthorized and expanded; and (C) standards and best practices for the treatment of substance use disorders, as identified through such grant program. O Poison Center Network Enhancement 7141. Short title This subtitle may be cited as the Poison Center Network Enhancement Act of 2018 . 7142. Reauthorization of poison control centers national toll-free number Section 1271 of the Public Health Service Act ( 42 U.S.C. 300d–71 ) is amended to read as follows: 1271. Establishment and maintenance of the national toll-free number and enhanced communications capabilities (a) In general The Secretary shall provide coordination and assistance to poison control centers for— (1) the development, establishment, implementation, and maintenance of a nationwide toll-free phone number; and (2) the enhancement of communications capabilities, which may include text capabilities. (b) Consultation The Secretary may consult with nationally recognized professional organizations in the field of poison control to determine the best and most effective means of achieving the goals described in paragraphs (1) and (2) of subsection (a). (c) Rule of construction In assisting with public health emergencies, responses, or preparedness, nothing in this section shall be construed to restrict the work of poison control centers or the use of their resources by the Secretary or other governmental agencies. (d) Authorization of appropriations There is authorized to be appropriated to carry out this section $700,000 for each of fiscal years 2019 through 2023. . 7143. Reauthorization of nationwide public awareness campaign to promote poison control center utilization Section 1272 of the Public Health Service Act ( 42 U.S.C. 300d–72 ) is amended to read as follows: 1272. Nationwide public awareness campaign to promote poison control center utilization and their public health emergency response capabilities (a) In general The Secretary shall— (1) carry out, and expand upon, a national public awareness campaign to educate the public and health care providers about— (A) poisoning, toxic exposure, and drug misuse prevention; and (B) the availability of poison control center resources in local communities; and (2) as part of such campaign, highlight the nationwide toll-free number and enhanced communications capabilities supported under section 1271. (b) Consultation In carrying out and expanding upon the national campaign under subsection (a), the Secretary may consult with nationally recognized professional organizations in the field of poison control response for the purpose of determining the best and most effective methods for achieving public awareness. (c) Contract with entity The Secretary may carry out subsection (a) by entering into contracts with one or more public or private entities, including nationally recognized professional organizations in the field of poison control and national media firms, for the development and implementation of the awareness campaign under subsection (a), which may include— (1) the development and distribution of poisoning and toxic exposure prevention, poison control center, and public health emergency awareness and response materials; (2) television, radio, internet, and newspaper public service announcements; and (3) other means and activities to provide for public and professional awareness and education. (d) Evaluation The Secretary shall— (1) establish baseline measures and benchmarks to quantitatively evaluate the impact of the nationwide public awareness campaign carried out under this section; and (2) on a biennial basis, prepare and submit to the appropriate committees of Congress an evaluation of the nationwide public awareness campaign. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section, $800,000 for each of fiscal years 2019 through 2023. . 7144. Reauthorization of the poison control center grant program Section 1273 of the Public Health Service Act ( 42 U.S.C. 300d–73 ) is amended to read as follows: 1273. Maintenance of the poison control center grant program (a) Authorization of program The Secretary shall award grants to poison control centers accredited under subsection (c) (or granted a waiver under subsection (d)) and nationally recognized professional organizations in the field of poison control for the purposes of— (1) preventing, and providing treatment recommendations for, poisonings and toxic exposures including opioid and drug misuse; (2) assisting with public health emergencies, responses, and preparedness; and (3) complying with the operational requirements needed to sustain the accreditation of the center under subsection (c). (b) Additional uses of funds In addition to the purposes described in subsection (a), a poison center or professional organization awarded a grant under such subsection may also use amounts received under such grant— (1) to research, establish, implement, and evaluate best practices in the United States for poisoning prevention, poison control center outreach, opioid and drug misuse information and response, and public health emergency, response, and preparedness programs; (2) to research, develop, implement, revise, and communicate standard patient management guidelines for commonly encountered toxic exposures; (3) to improve national toxic exposure and opioid misuse surveillance by enhancing cooperative activities between poison control centers in the United States and the Centers for Disease Control and Prevention and other governmental agencies; (4) to research, improve, and enhance the communications and response capability and capacity of the Nation’s network of poison control centers to facilitate increased access to the centers through the integration and modernization of the current poison control centers communications and data system, including enhancing the network’s telephony, internet, data, and social networking technologies; (5) to develop, support, and enhance technology and capabilities of nationally recognized professional organizations in the field of poison control to collect national poisoning, toxic occurrence, and related public health data; (6) to develop initiatives to foster the enhanced public health utilization of national poison data collected by such organizations; (7) to support and expand the toxicologic expertise within poison control centers; and (8) to improve the capacity of poison control centers to answer high volumes of contacts and internet communications, and to sustain and enhance the poison control center’s network capability to respond during times of national crisis or other public health emergencies. (c) Accreditation Except as provided in subsection (d), the Secretary may award a grant to a poison control center under subsection (a) only if— (1) the center has been accredited by a nationally recognized professional organization in the field of poison control, and the Secretary has approved the organization as having in effect standards for accreditation that reasonably provide for the protection of the public health with respect to poisoning; or (2) the center has been accredited by a State government, and the Secretary has approved the State government as having in effect standards for accreditation that reasonably provide for the protection of the public health with respect to poisoning. (d) Waiver of accreditation requirements (1) In general The Secretary may grant a waiver of the accreditation requirements of subsection (c) with respect to a nonaccredited poison control center that applies for a grant under this section if such center can reasonably demonstrate that the center will obtain such an accreditation within a reasonable period of time as determined appropriate by the Secretary. (2) Renewal The Secretary may renew a waiver under paragraph (1). (3) Limitation The Secretary may not, after the date of enactment of the Poison Control Network Enhancement Act of 2018, grant to a poison control center waivers or renewals that total more than 5 years. (e) Supplement not supplant Amounts made available to a poison control center under this section shall be used to supplement and not supplant other Federal, State, or local funds provided for such center. (f) Maintenance of effort A poison control center, in utilizing the proceeds of a grant under this section, shall maintain the annual recurring expenditures of the center for its activities at a level that is not less than 80 percent of the average level of such recurring expenditures maintained by the center for the preceding 3 fiscal years for which a grant is received. (g) Authorization of appropriations There is authorized to be appropriated to carry out this section, $28,600,000 for each of fiscal years 2019 through 2023. The Secretary may utilize an amount not to exceed 6 percent of the amount appropriated pursuant to the preceding sentence for each fiscal year for coordination, dissemination, technical assistance, program evaluation, data activities, and other program administration functions, which are determined by the Secretary to be appropriate for carrying out the program under this section. . P Eliminating Opioid Related Infectious Diseases 7151. Short title This subtitle may be cited as the Eliminating Opioid Related Infectious Diseases Act of 2018 . 7152. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors Section 317N of the Public Health Service Act ( 42 U.S.C. 247b–15 ) is amended to read as follows: 317N. Surveillance and education regarding infections associated with illicit drug use and other risk factors (a) In general The Secretary may (directly and through grants to public and nonprofit private entities) provide for programs for the following: (1) To cooperate with the States and Indian tribes in implementing or maintaining a surveillance system to determine the incidence of infections commonly associated with illicit drug use, including infections commonly associated with injection drug use such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections. (2) To identify, counsel, and offer testing to individuals who are at risk of infections as a result of injection drug use, receiving blood transfusions prior to July 1992, or other risk factors. (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services. (4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary. (5) To improve the education, training, and skills of health professionals in the detection and control of infections and the coordination of treatment of addiction and infectious diseases described in paragraph (1), with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, infectious diseases clinicians, and HIV clinicians. (b) Laboratory procedures The Secretary may (directly or through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection (a)(1). (c) Definitions In this section: (1) The term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (2) The term injection drug use means— (A) intravenous administration of a substance in schedule I under section 202 of the Controlled Substances Act; (B) intravenous administration of a substance in schedule II, III, IV, or V under section 202 of the Controlled Substances Act that has not been approved for intravenous use under— (i) section 505 of the Federal Food, Drug and Cosmetic Act; or (ii) section 351 of the Public Health Service Act; or (C) intravenous administration of a substance in schedule II, III, IV, or V under section 202 of the Controlled Substances Act that has not been prescribed to the person using the substance. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023. . Q Better Pain Management Through Better Data 7161. Short title This subtitle may be cited as the Better Pain Management Through Better Data Act of 2018 . 7162. Guidance addressing alternative approaches to data collection and labeling claims for opioid sparing (a) In general For purposes of assisting sponsors in collecting and incorporating opioid-sparing data in product labeling, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall conduct a public meeting and update or issue one or more guidances in accordance with subsection (b). (b) Guidance (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall update or issue one or more guidances addressing— (A) alternative methods for data collection on opioid sparing; (B) alternative methods for inclusion of such data in product labeling; and (C) investigations other than clinical trials, including partially controlled studies and objective trials without matched controls such as historically controlled analyses, open-label studies, and meta-analyses, on opioid sparing for inclusion in product labeling. (2) Contents The guidances under paragraph (1) shall address— (A) innovative clinical trial designs for ethically and efficiently collecting data on opioid sparing for inclusion in product labeling; (B) primary and secondary endpoints for the reduction of opioid use while maintaining adequate pain control; (C) use of real world evidence, including patient registries, and patient reported outcomes to support inclusion of opioid-sparing data in product labeling; and (D) how sponsors may obtain feedback from the Secretary relating to such issues prior to— (i) commencement of such data collection; or (ii) the submission of resulting data to the Secretary. (3) Public meeting Prior to updating or issuing the guidances required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patients, and provider organizations, through a public meeting to be held not later than 12 months after the date of enactment of this Act. (4) Timing The Secretary shall— (A) not later than 12 months after the date of the public meeting required by paragraph (3), update or issue the one or more draft guidances required by paragraph (1); and (B) not later than 12 months after the date on which the public comment period for such draft guidances closes, finalize such guidances. (c) Definition In this section: (1) The terms opioid sparing and opioid-sparing refer to the use of drugs or devices (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) that reduce pain while enabling the reduction, replacement, or avoidance of oral opioids. (2) The term Secretary means the Secretary of Health and Human Services. R Special Registration for Telemedicine Clarification 7171. Short title This subtitle may be cited as the Special Registration for Telemedicine Clarification Act of 2018 . 7172. Deadline for interim final regulations for a special registration To engage in the practice of telemedicine Section 311(h)(2) of the Controlled Substances Act ( 21 U.S.C. 831(h)(2) ) is amended by striking The Attorney General shall, with the concurrence of the Secretary, promulgate regulations and inserting Not later than 1 year after the date of enactment of the Special Registration for Telemedicine Clarification Act of 2018 , the Attorney General shall, with the concurrence of the Secretary, promulgate interim final regulations . S Peer Support Communities of Recovery 7181. Short title This subtitle may be cited as the Peer Support Communities of Recovery Act . 7182. Building communities of recovery Section 547 of the Public Health Service Act ( 42 U.S.C. 290ee–2 ) is amended— (1) in subsection (a)— (A) in the heading, by striking Definition and inserting Definitions ; (B) in the matter preceding paragraph (1), by striking In this section, the term recovery community organization means an independent nonprofit organization that— and inserting In this section: ; (C) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving such subparagraphs (as so redesignated) 2 ems to the right; (D) by inserting before subparagraph (A) (as so redesignated) the following: (1) Recovery community organization The term recovery community organization means an independent nonprofit organization that— ; and (E) by adding at the end the following: (2) Eligible entity The term eligible entity means— (A) a national nonprofit entity focused on substance use disorder with a network of local affiliates and partners that are geographically and organizationally diverse; or (B) a nonprofit organization— (i) focused on substance use disorder; (ii) established by individuals in personal or family recovery; and (iii) serving prevention, treatment, recovery, payor, faith-based, and criminal justice stakeholders in the implementation of local addiction and recovery initiatives. ; (2) in subsection (b)— (A) by striking The Secretary shall award grants to recovery community organizations and inserting The Secretary— (1) shall award grants to recovery community organizations ; (B) by striking services. and inserting services and allow such organizations to use such grant funds to carry out the activities described in subparagraphs (A) through (C) of subsection (c)(2); and ; and (C) by adding at the end the following: (2) may award grants to eligible entities for purposes of establishing regional technical assistance centers, in accordance with subsection (c)(2)(D). ; (3) by striking subsection (c); (4) by redesignating subsections (d) and (e) as subsections (c) and (d), respectively; (5) in subsection (c) (as so redesignated)— (A) in paragraph (1), by striking shall be used and inserting to a recovery community organization shall be used ; (B) in paragraph (2)— (i) in subparagraph (A), in the matter preceding clause (i), by inserting before build the following: in the case of a grant awarded to a recovery community organization, ; (ii) in subparagraph (B)— (I) by inserting before reduce the following: in the case of a grant awarded to a recovery community organization, ; and (II) by striking and at the end; (iii) in subparagraph (C)— (I) by inserting before conduct the following: in the case of a grant awarded to a recovery community organization, ; and (II) by striking the period at the end and inserting ; and ; and (iv) by adding at the end the following: (D) in the case of a grant awarded to an eligible entity, provide for the establishment of regional technical assistance centers to provide regional technical assistance for the following: (i) Implementation of regionally driven, peer-delivered addiction recovery support services before, during, after, or in conjunction with addiction treatment. (ii) Establishment of recovery community organizations. (iii) Establishment of recovery community centers. ; and (6) in subsection (d) (as so redesignated), by inserting before the period the following: , and $15,000,000 for each of fiscal years 2019 through 2023 . T Stop Illicit Drug Importation 7191. Short title This short title may be cited as the Stop Illicit Drug Importation Act of 2018 . 7192. Detention, refusal, and destruction of drugs offered for importation (a) Articles treated as drugs for purposes of importation Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by adding at the end the following: (t) Articles treated as drugs for purposes of this section (1) Labeled articles An article shall not be treated as a drug pursuant to this subsection if— (A) an electronic import entry for such article is submitted using an authorized electronic data interchange system; and (B) such article is designated in such system as a drug, device, dietary supplement, or other product that is regulated under this Act. (2) Articles covered Subject to paragraph (1), for purposes of this section, an article described in this paragraph may be treated by the Secretary as a drug if it— (A) is or contains an ingredient that is an active ingredient that is contained within— (i) a drug that has been approved under section 505 of this Act; or (ii) a biological product that has been approved under section 351 of the Public Health Service Act; (B) is or contains an ingredient that is an active ingredient in a drug or biological product if— (i) an investigational use exemption has been authorized for such drug or biological product under section 505(i) of this Act or section 351(a) of the Public Health Service Act; (ii) substantial clinical investigation has been instituted for such drug or biological product; and (iii) the existence of such clinical investigation has been made public; or (C) is or contains a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subparagraph (A) or (B). (3) Effect Except to the extent that an article may be treated as a drug pursuant to paragraph (2), this subsection shall not be construed as bearing on or being relevant to the question of whether any article is a drug as defined in section 201(g). . (b) Articles of concern (1) Delivery by Treasury to HHS The first sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking and cosmetics and inserting cosmetics, and potential articles of concern (as defined in subsection (u)) . (2) Refused admission The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking then such article shall be refused admission and inserting or (5) such article is an article of concern (as defined in subsection (u)), or (6) such article is a drug that is being imported or offered for import in violation of section 301(cc), then such article shall be refused admission . (3) Definition of article of concern Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended, is further amended by adding at the end the following: (u) Article of concern defined For purposes of subsection (a), the term article of concern means an article that is or contains a drug or other substance— (1) for which, during the 24-month period prior to the article being imported or offered for import, the Secretary of Health and Human Services— (A) has requested that, based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section 201 of the Controlled Substances Act, the Attorney General initiate the process to control the drug or other substance in accordance with such Act; or (B) has, following the publication by the Attorney General of a notice in the Federal Register of the intention to issue an order temporarily scheduling such drug or substance in schedule I of section 202 of the Controlled Substances Act pursuant to section 201(h) of such Act, made a determination that such article presents an imminent hazard to public safety; and (2) with respect to which the Attorney General has not— (A) scheduled the drug or other substance under such Act; or (B) notified the Secretary of Health and Human Services that the Attorney General has made a determination not to schedule the drug or other substance under such Act. . 7193. Seizure Section 304(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334(b) ) is amended by striking the first sentence and inserting the following: The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty rather than the procedure used for civil asset forfeiture proceedings set forth in section 983 of title 18, United States Code. On demand of either party any issue of fact joined in any such a case brought under this section shall be tried by jury. A seizure brought under this section is not governed by Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions. Exigent circumstances shall be deemed to exist for all seizures brought under this section, and in such cases, the summons and arrest warrant shall be issued by the clerk of the court without court review. . 7194. Debarring violative individuals or companies (a) Prohibited act Section 301(cc) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(cc) ) is amended— (1) by inserting after an article of food the following: or a drug ; and (2) by inserting after a person debarred the following: from such activity . (b) Debarment Section 306(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a(b) ) is amended— (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking paragraph (2) and inserting paragraph (2) or (3) ; (B) in subparagraph (B), by striking or at the end; (C) in subparagraph (C), by striking the period at the end and inserting , or ; and (D) by adding at the end the following: (D) a person from importing or offering to import into the United States— (i) a controlled substance as defined in section 102(6) of the Controlled Substances Act; or (ii) any drug, if such drug is declared to be valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930), or if such drug is entering the United States by mail. ; and (2) in paragraph (3)— (A) in the paragraph heading after food by inserting or drug ; (B) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and moving the indentation of each such clause 2 ems to the right; (C) after making the amendments required by subparagraph (B), by striking A person is subject and inserting the following: (A) Food A person is subject ; and (D) by adding at the end the following: (B) Importation of drugs A person is subject to debarment under paragraph (1)(D) if— (i) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); or (ii) the person has engaged in a pattern of importing or offering for import articles of drug that are— (I) (aa) adulterated, misbranded, or in violation of section 505; and (bb) present a threat of serious adverse health consequences or death to humans or animals; or (II) controlled substances whose importation is prohibited pursuant to section 401(m) of the Tariff Act of 1930. (C) Definition For purposes of subparagraph (B), the term pattern of importing or offering for import articles of drug means importing or offering for import articles of drug described in subclause (I) or (II) of subparagraph (B)(ii) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer. . U Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies 7201. Short title This subtitle may be cited as the Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 or the CONNECTIONS Act . 7202. Preventing overdoses of controlled substances Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: 399V–7. Preventing overdoses of controlled substances (a) Evidence-Based prevention grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out any evidence-based prevention activity described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying out any such activity; and (C) award grants to States, localities, and Indian tribes for purposes of carrying out any such activity. (2) Evidence-based prevention activities An evidence-based prevention activity described in this paragraph is any of the following activities: (A) With respect to a State, improving the efficiency and use of the State prescription drug monitoring program by— (i) encouraging all authorized users (as specified by the State) to register with and use the program and making the program easier to use; (ii) enabling such users to access any updates to information collected by the program in as close to real-time as possible; (iii) providing for a mechanism for the program to automatically flag any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing practices relating to such substances; (iv) enhancing interoperability between the program and any electronic health records system, including by integrating the use of electronic health records into the program for purposes of improving clinical decisionmaking; (v) continually updating program capabilities to respond to technological innovation for purposes of appropriately addressing a controlled substance overdose epidemic as such epidemic may occur and evolve; (vi) facilitating data sharing between the program and the prescription drug monitoring programs of neighboring States; and (vii) meeting the purpose of the program established under section 399O, as described in section 399O(a). (B) Achieving community or health system interventions through activities such as— (i) establishing or improving controlled substances prescribing interventions for insurers and health systems; (ii) enhancing the use of evidence-based controlled substances prescribing guidelines across sectors and health care settings; and (iii) implementing strategies to align the prescription of controlled substances with the guidelines described in clause (ii). (C) Evaluating interventions to better understand what works to prevent overdoses, including those involving prescription and illicit controlled substances. (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging public health crises and opportunities to address such crises, such as enhancing public education and awareness on the risks associated with opioids. (b) Enhanced surveillance of controlled substance overdose grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out any controlled substance overdose surveillance activity described in paragraph (2); (B) provide training and technical assistance to States for purposes of carrying out any such activity; (C) award grants to States for purposes of carrying out any such activity; and (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to section 505(d)(1)(A) (relating to the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of alcohol or other drugs). (2) Controlled substance overdose surveillance activities A controlled substance overdose surveillance activity described in this paragraph is any of the following activities: (A) Enhancing the timeliness of reporting data to the public, including data on fatal and nonfatal overdoses of controlled substances. (B) Enhancing comprehensiveness of data on controlled substances overdoses by collecting information on such overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and other risk factors. (C) Using data to help identify risk factors associated with controlled substances overdoses. (D) With respect to a State, supporting entities involved in providing information to inform efforts within the State, such as by coroners and medical examiners, to improve accurate testing and reporting of causes and contributing factors to controlled substances overdoses. (E) Working to enable information sharing regarding controlled substances overdoses among data sources. (c) Definitions In this section: (1) Controlled substance The term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act. (2) Indian tribe The term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations For purposes of carrying out this section and section 399O, there is authorized to be appropriated $486,000,000 for each of fiscal years 2019 through 2023. . 7203. Prescription drug monitoring program Section 399O of the Public Health Service Act ( 42 U.S.C. 280g–3 ) is amended to read as follows: 399O. Prescription drug monitoring program (a) Program (1) In general Each fiscal year, the Secretary, in consultation with the Director of National Drug Control Policy, acting through the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Mental Health and Substance Use, and the National Coordinator for Health Information Technology, shall support States for the purpose of improving the efficiency and use of PDMPs, including— (A) establishment and implementation of a PDMP; (B) maintenance of a PDMP; (C) improvements to a PDMP by— (i) enhancing functional components to work toward— (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow, within a State; (II) more timely inclusion of data within a PDMP; (III) active management of the PDMP, in part by sending proactive or unsolicited reports to providers to inform prescribing; and (IV) ensuring the highest level of ease in use and access of PDMPs by providers and their delegates, to the extent that State laws allow; (ii) improving the intrastate interoperability of PDMPs by— (I) making PDMPs more actionable by integrating PDMPs within electronic health records and health information technology infrastructure; and (II) linking PDMP data to other data systems within the State, including— (aa) the data of pharmacy benefit managers, medical examiners and coroners, and the State’s Medicaid program; (bb) worker’s compensation data; and (cc) prescribing data of providers of the Department of Veterans Affairs and the Indian Health Service within the State; (iii) improving the interstate interoperability of PDMPs through— (I) sharing of dispensing data in near-real time across State lines; and (II) integration of automated queries for multistate PDMP data and analytics into clinical workflow to improve the use of such data and analytics by practitioners and dispensers; or (iv) improving the ability to include treatment availability resources and referral capabilities within the PDMP. (2) State legislation As a condition on the receipt of support under this section, the Secretary shall require a State to demonstrate that the State has enacted legislation or regulations— (A) to provide for the implementation of the PDMP; and (B) to permit the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained by the PDMP. (b) PDMP strategies The Secretary shall encourage a State, in establishing, improving, or maintaining a PDMP, to implement strategies that improve— (1) the reporting of dispensing in the State of a controlled substance to an ultimate user so the reporting occurs not later than 24 hours after the dispensing event; (2) the consultation of the PDMP by each prescribing practitioner, or their designee, in the State before initiating treatment with a controlled substance, or any substance as required by the State to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event; (3) the consultation of the PDMP before dispensing a controlled substance, or any substance as required by the State to be reported to the PDMP; (4) the proactive notification to a practitioner when patterns indicative of controlled substance misuse by a patient, including opioid misuse, are detected; (5) the availability of data in the PDMP to other States, as allowable under State law; and (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for surveillance, epidemiology, statistical research, or educational purposes. (c) Drug misuse and abuse In consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State receiving support under this section— (1) shall establish a program to notify practitioners and dispensers of information that will help to identify and prevent the unlawful diversion or misuse of controlled substances; and (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for carrying out drug diversion investigations if the State determines that information in the PDMP maintained by the State indicates an unlawful diversion or abuse of a controlled substance. (d) Evaluation and reporting As a condition on receipt of support under this section, the State shall report on interoperability with PDMPs of other States and Federal agencies, where appropriate, intrastate interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient. (e) Evaluation and reporting A State receiving support under this section shall provide the Secretary with aggregate nonidentifiable information, as permitted by State law, to enable the Secretary— (1) to evaluate the success of the State’s program in achieving the purpose described in subsection (a); or (2) to prepare and submit to the Congress the report required by subsection (i)(2). (f) Education and access to the monitoring system A State receiving support under this section shall take steps to— (1) facilitate prescribers and dispensers, and their delegates, as permitted by State law, to use the PDMP, to the extent practicable; and (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs. (g) Electronic format The Secretary may issue guidelines specifying a uniform electronic format for the reporting, sharing, and disclosure of information pursuant to PDMPs. (h) Rules of construction (1) Functions otherwise authorized by law Nothing in this section shall be construed to restrict the ability of any authority, including any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, to perform functions otherwise authorized by law. (2) Additional privacy protections Nothing in this section shall be construed as preempting any State from imposing any additional privacy protections. (3) Federal privacy requirements Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( Public Law 104–191 ; 110 Stat. 2033) and section 543 of this Act. (4) No Federal private cause of action Nothing in this section shall be construed to create a Federal private cause of action. (i) Progress report Not later than 3 years after the date of enactment of the CONNECTIONS Act, the Secretary shall— (1) complete a study that— (A) determines the progress of States in establishing and implementing PDMPs consistent with this section; (B) provides an analysis of the extent to which the operation of PDMPs has— (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances; (ii) established or strengthened initiatives to ensure linkages to substance use disorder treatment services; or (iii) affected patient access to appropriate care in States operating PDMPs; (C) determine the progress of States in achieving interstate interoperability and intrastate interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress and recommendations for addressing these barriers; (D) determines the progress of States in implementing near real-time electronic PDMPs; (E) provides an analysis of the privacy protections in place for the information reported to the PDMP in each State receiving support under this section and any recommendations of the Secretary for additional Federal or State requirements for protection of this information; (F) determines the progress of States in implementing technological alternatives to centralized data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such alternatives to enhance the privacy and security of individually identifiable data; and (G) evaluates the penalties that States have enacted for the unauthorized use and disclosure of information maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify as appropriate for purposes of subsection (a)(2); and (2) submit a report to the Congress on the results of the study. (j) Advisory council (1) Establishment A State may establish an advisory council to assist in the establishment, improvement, or maintenance of a PDMP consistent with this section. (2) Limitation A State may not use Federal funds for the operations of an advisory council to assist in the establishment, improvement, or maintenance of a PDMP. (3) Sense of Congress It is the sense of the Congress that, in establishing an advisory council to assist in the establishment, improvement, or maintenance of a PDMP, a State should consult with appropriate professional boards and other interested parties. (k) Definitions For purposes of this section: (1) The term controlled substance means a controlled substance (as defined in section 102 of the Controlled Substances Act) in schedule II, III, or IV of section 202 of such Act. (2) The term dispense means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, irrespective of whether the dispenser uses the internet or other means to effect such delivery. (3) The term dispenser means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user. (4) The term interstate interoperability with respect to a PDMP means the ability of the PDMP to electronically share reported information with another State if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing of a controlled substance prescribed by a practitioner whose principal place of business is located in such other State. (5) The term intrastate interoperability with respect to a PDMP means the integration of PDMP data within electronic health records and health information technology infrastructure or linking of a PDMP to other data systems within the State, including the State’s Medicaid program, workers’ compensation programs, and medical examiners or coroners. (6) The term nonidentifiable information means information that does not identify a practitioner, dispenser, or an ultimate user and with respect to which there is no reasonable basis to believe that the information can be used to identify a practitioner, dispenser, or an ultimate user. (7) The term PDMP means a prescription drug monitoring program that is State-controlled. (8) The term practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the individual practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. (9) The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (10) The term ultimate user means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the person’s household, or for the use of an animal owned by the person or by a member of the person’s household. (11) The term clinical workflow means the integration of automated queries for prescription drug monitoring programs data and analytics into health information technologies such as electronic health record systems, health information exchanges, and/or pharmacy dispensing software systems, thus streamlining provider access through automated queries. . V Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging 7211. Short title This subtitle may be cited as the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act . 7212. Improved technologies, controls, or measures with respect to the packaging or disposal of certain drugs (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505–1 ( 21 U.S.C. 355–1 ) the following new section: 505–2. Safety-enhancing packaging and disposal features (a) Orders (1) In general The Secretary may issue an order requiring the holder of a covered application to implement or modify one or more technologies, controls, or measures with respect to the packaging or disposal of one or more drugs identified in the covered application, if the Secretary determines such technologies, controls, or measures to be appropriate to help mitigate the risk of abuse or misuse of such drug or drugs, which may include by reducing the availability of unused drugs. (2) Prior consultation The Secretary may not issue an order under paragraph (1) unless the Secretary has consulted with relevant stakeholders, through a public meeting, workshop, or otherwise, about matters that are relevant to the subject of the order. (3) Assuring access and minimizing burden Technologies, controls, or measures required under paragraph (1) shall— (A) be commensurate with the specific risk of abuse or misuse of the drug listed in the covered application; (B) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular any available evidence regarding the expected or demonstrated public health impact of such technologies, controls, or measures; and (C) reduce the risk of abuse or misuse of such drug. (4) Order contents An order issued under paragraph (1) may— (A) provide for a range of options for implementing or modifying the technologies, controls, or measures required to be implemented by such order; and (B) incorporate by reference standards regarding packaging or disposal set forth in an official compendium, established by a nationally or internationally recognized standard development organization, or described on the public website of the Food and Drug Administration, so long as the order includes the rationale for incorporation of such standard. (5) Orders applicable to drug class When a concern about the risk of abuse or misuse of a drug relates to a pharmacological class, the Secretary may, after consultation with relevant stakeholders, issue an order under paragraph (1) which applies to the pharmacological class. (b) Compliance The holder of a covered application shall— (1) submit a supplement containing proposed changes to the covered application to comply with an order issued under subsection (a) not later than— (A) 180 calendar days after the date on which the order is issued; or (B) (i) such longer time period as specified by the Secretary in such order; or (ii) if a request for an alternative date is submitted by the holder of such application not later than 60 calendar days after the date on which such order is issued— (I) such requested alternative date if agreed to by the Secretary; or (II) another date as specified by the Secretary; and (2) implement the changes approved pursuant to such supplement not later than the later of— (A) 90 calendar days after the date on which the supplement is approved; or (B) the end of such longer period as is— (i) determined to be appropriate by the Secretary; or (ii) approved by the Secretary pursuant to a request by the holder of the covered application that explains why such longer period is needed, including to satisfy any other applicable Federal statutory or regulatory requirements. (c) Alternative measures The holder of the covered application may propose, and the Secretary shall approve, technologies, controls, or measures regarding packaging, storage, or disposal other than those specified in the applicable order issued under subsection (a), if such technologies, controls, or measures are supported by data and information demonstrating that such alternative technologies, controls, or measures can be expected to mitigate the risk of abuse or misuse of the drug or drugs involved, including by reducing the availability of unused drugs, to at least the same extent as the technologies, controls, or measures specified in such order. (d) Dispute resolution If a dispute arises in connection with a supplement submitted under subsection (b), the holder of the covered application may appeal a determination made with respect to such supplement using applicable dispute resolution procedures specified by the Secretary in regulations or guidance. (e) Definitions In this section— (1) the term covered application means an application submitted under subsection (b) or (j) of section 505 for approval under such section or an application submitted under section 351 of Public Health Service Act for approval under such section, with respect to a drug that is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act; and (2) the term relevant stakeholders may include scientific experts within the drug manufacturing industry; brand and generic drug manufacturers; standard development organizations; wholesalers and distributors; payers; health care providers; pharmacists; pharmacies; manufacturers; poison centers; and representatives of the National Institute on Drug Abuse, the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Drug Enforcement Agency, the Consumer Product Safety Commission, individuals who specialize in treating addiction, and patient and caregiver groups. . (b) Prohibited acts Section 501 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 ) is amended by inserting after paragraph (j) the following: (k) If it is a drug approved under a covered application (as defined in section 505–2(e)), the holder of which does not meet the requirements of paragraphs (1) and (2) of subsection (b) of such section. . (c) Required content of an abbreviated new drug application Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(2)(A) ) is amended— (1) in clause (vii)(IV), by striking and at the end; (2) in clause (viii), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (ix) if the drug is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act, information to show that the applicant has proposed technologies, controls, or measures related to the packaging or disposal of the drug that provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505–2, if applicable. . (d) Grounds for refusing To approve an abbreviated new drug application Section 505(j)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(4) ), is amended— (1) in subparagraph (J), by striking or at the end; (2) in subparagraph (K), by striking the period at the end and inserting ; or ; and (3) by adding at the end the following: (L) if the drug is a drug described in paragraph (2)(A)(ix) and the applicant has not proposed technologies, controls, or measures related to the packaging or disposal of such drug that the Secretary determines provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505–2. . (e) Rules of construction (1) Any labeling describing technologies, controls, or measures related to packaging or disposal intended to mitigate the risk of abuse or misuse of a drug product that is subject to an abbreviated new drug application, including labeling describing differences from the reference listed drug resulting from the application of section 505–2 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall not be construed— (A) as changes to labeling not permissible under clause (v) of section 505(j)(2)(A) of such Act ( 21 U.S.C. 355(j)(2)(A) ), or a change in the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug under clause (i) of such section; or (B) to preclude approval of an abbreviated new drug application under subparagraph (B) or (G) of section 505(j)(4) of such Act ( 21 U.S.C. 355(j)(4) ). (2) For a covered application that is an application submitted under subsection (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), subsection (j)(2)(A) of such section 505 shall not be construed to limit the type of data or information the Secretary of Health and Human Services may request or consider in connection with making any determination under section 505–2. (f) GAO report Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to the Congress a report containing— (1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies; (2) identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act, are made available to the public and barriers to the use of such disposal products; (3) identification of ways in which packaging technologies are made available to the public and barriers to the use of such technologies; (4) a description of Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including— (A) identification of the Federal agencies that oversee such products; (B) identification of the methods of disposal of controlled substances recommended by these agencies for site-of-use, in-home disposal; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; (5) a description of Federal oversight, if any, of controlled substance packaging technologies, including— (A) identification of the Federal agencies that oversee such technologies; (B) identification of the technologies recommended by these agencies, including unit dose packaging, packaging that provides a set duration, or other packaging systems that may mitigate abuse or misuse; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and (6) recommendations on— (A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agencies should be responsible for such oversight and, as applicable, approval of such products or technologies; and (B) the potential role of the Federal Government in evaluating such products to ensure product efficacy. W Postapproval study requirements 7221. Postapproval study requirements (a) Purposes of study Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(B) ) is amended by adding at the end the following: (iv) To assess a potential reduction in effectiveness of the drug for the conditions of use prescribed, recommended, or suggested in the labeling thereof if— (I) the drug involved— (aa) is or contains a substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act; or (bb) is a drug that has not been approved under this section or licensed under section 351 of the Public Health Service Act, for which an application for such approval or licensure is pending or anticipated, and for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act; and (II) the potential reduction in effectiveness could result in the benefits of the drug no longer outweighing the risks. . (b) Establishment of requirement Section 505(o)(3)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(C) ) is amended by striking such requirement and all that follows through safety information. and inserting the following: such requirement— (i) in the case of a purpose described in clause (i), (ii), or (iii) of subparagraph (B), only if the Secretary becomes aware of new safety information; and (ii) in the case of a purpose described in clause (iv) of such subparagraph, if the Secretary determines that new effectiveness information exists. . (c) Applicability Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ) is amended by adding at the end the following new subparagraph: (G) Applicability The conduct of a study or clinical trial required pursuant to this paragraph for the purpose specified in subparagraph (B)(iv) shall not be considered a new clinical investigation for the purpose of a period of exclusivity under clause (iii) or (iv) of subsection (c)(3)(E) or clause (iii) or (iv) of subsection (j)(5)(F). . (d) New effectiveness information defined Section 505(o)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(2) ) is amended by adding at the end the following new subparagraph: (D) New effectiveness information The term new effectiveness information , with respect to a drug that is or contains a controlled substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act, means new information about the effectiveness of the drug, including a new analysis of existing information, derived from— (i) a clinical trial; an adverse event report; a postapproval study or clinical trial (including a study or clinical trial under paragraph (3)); (ii) peer-reviewed biomedical literature; (iii) data derived from the postmarket risk identification and analysis system under subsection (k); or (iv) other scientific data determined to be appropriate by the Secretary. . (e) Conforming amendments with respect to labeling changes Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(4) ) is amended— (1) in subparagraph (A)— (A) in the heading, by inserting or new effectiveness after safety ; (B) by striking safety information and inserting new safety information or new effectiveness information such ; and (C) by striking believes should be and inserting believes changes should be made to ; (2) in subparagraph (B)(i)— (A) by striking new safety information and by inserting new safety information or new effectiveness information ; and (B) by inserting indications, after boxed warnings, ; (3) in subparagraph (C), by inserting or new effectiveness information after safety information ; and (4) in subparagraph (E), by inserting or new effectiveness information after safety information . (f) Rule of construction Nothing in the amendments made by this section shall be construed to alter, in any manner, the meaning or application of the provisions of paragraph (3) of section 505(o) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o) ) with respect to the authority of the Secretary of Health and Human Services to require a postapproval study or clinical trial for a purpose specified in clauses (i) through (iii) of subparagraph (B) of such paragraph (3) or paragraph (4) of such section 505(o) with respect to the Secretary’s authority to require safety labeling changes. VIII Miscellaneous A Synthetics Trafficking and Overdose Prevention 8001. Short title; table of contents This subtitle may be cited as the Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 . 8002. Customs fees (a) In general Section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(b)(9) ) is amended by adding at the end the following: (D) (i) With respect to the processing of items that are sent to the United States through the international postal network by Inbound Express Mail service or Inbound EMS (as that service is described in the mail classification schedule referred to in section 3631 of title 39, United States Code), the following payments are required: (I) $1 per Inbound EMS item. (II) If an Inbound EMS item is formally entered, the fee provided for under subsection (a)(9), if applicable. (ii) Notwithstanding section 451 of the Tariff Act of 1930 ( 19 U.S.C. 1451 ), the payments required by clause (i), as allocated pursuant to clause (iii)(I), shall be the only payments required for reimbursement of U.S. Customs and Border Protection for customs services provided in connection with the processing of an Inbound EMS item. (iii) (I) The payments required by clause (i)(I) shall be allocated as follows: (aa) 50 percent of the amount of the payments shall be paid on a quarterly basis by the United States Postal Service to the Commissioner of U.S. Customs and Border Protection in accordance with regulations prescribed by the Secretary of the Treasury to reimburse U.S. Customs and Border Protection for customs services provided in connection with the processing of Inbound EMS items. (bb) 50 percent of the amount of the payments shall be retained by the Postal Service to reimburse the Postal Service for services provided in connection with the customs processing of Inbound EMS items. (II) Payments received by U.S. Customs and Border Protection under subclause (I)(aa) shall, in accordance with section 524 of the Tariff Act of 1930 ( 19 U.S.C. 1524 ), be deposited in the Customs User Fee Account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities. Amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services. (III) Payments retained by the Postal Service under subclause (I)(bb) shall be used to directly reimburse the Postal Service for the costs incurred in providing services in connection with the customs processing of Inbound EMS items. (iv) Beginning in fiscal year 2021, the Secretary, in consultation with the Postmaster General, may adjust, not more frequently than once each fiscal year, the amount described in clause (i)(I) to an amount commensurate with the costs of services provided in connection with the customs processing of Inbound EMS items, consistent with the obligations of the United States under international agreements. . (b) Conforming amendments Section 13031(a) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(a) ) is amended— (1) in paragraph (6), by inserting (other than an item subject to a fee under subsection (b)(9)(D)) after customs officer ; and (2) in paragraph (10)— (A) in subparagraph (C), in the matter preceding clause (i), by inserting (other than Inbound EMS items described in subsection (b)(9)(D)) after release ; and (B) in the flush at the end, by inserting or of Inbound EMS items described in subsection (b)(9)(D), after (C), . (c) Effective date The amendments made by this section shall take effect on January 1, 2020. 8003. Mandatory advance electronic information for postal shipments (a) Mandatory advance electronic information (1) In general Section 343(a)(3)(K) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended to read as follows: (K) (i) The Secretary shall prescribe regulations requiring the United States Postal Service to transmit the information described in paragraphs (1) and (2) to the Commissioner of U.S. Customs and Border Protection for international mail shipments by the Postal Service (including shipments to the Postal Service from foreign postal operators that are transported by private carrier) consistent with the requirements of this subparagraph. (ii) In prescribing regulations under clause (i), the Secretary shall impose requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo, taking into account the parameters set forth in subparagraphs (A) through (J). (iii) The regulations prescribed under clause (i) shall require the transmission of the information described in paragraphs (1) and (2) with respect to a shipment as soon as practicable in relation to the transportation of the shipment, consistent with subparagraph (H). (iv) Regulations prescribed under clause (i) shall allow for the requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) to be implemented in phases, as appropriate, by— (I) setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the Commissioner; and (II) taking into consideration— (aa) the risk posed by such shipments; (bb) the volume of mail shipped to the United States by or through a particular country; and (cc) the capacities of foreign postal operators to provide that information to the Postal Service. (v) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2018, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for not less than 70 percent of the aggregate number of mail shipments, including 100 percent of mail shipments from the People’s Republic of China, described in clause (i). (II) If the requirements of subclause (I) are not met, the Comptroller General of the United States shall submit to the appropriate congressional committees, not later than June 30, 2019, a report— (aa) assessing the reasons for the failure to meet those requirements; and (bb) identifying recommendations to improve the collection by the Postal Service of the information described in paragraphs (1) and (2). (vi)(I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2020, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for 100 percent of the aggregate number of mail shipments described in clause (i). (II) The Commissioner, in consultation with the Postmaster General, may determine to exclude a country from the requirement described in subclause (I) to transmit information for mail shipments described in clause (i) from the country if the Commissioner determines that the country— (aa) does not have the capacity to collect and transmit such information; (bb) represents a low risk for mail shipments that violate relevant United States laws and regulations; and (cc) accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant United States laws and regulations through an alternate means. (III) The Commissioner shall, at a minimum on an annual basis, re-evaluate any determination made under subclause (II) to exclude a country from the requirement described in subclause (I). If, at any time, the Commissioner determines that a country no longer meets the requirements under subclause (II), the Commissioner may not further exclude the country from the requirement described in subclause (I). (IV) The Commissioner shall, on an annual basis, submit to the appropriate congressional committees— (aa) a list of countries with respect to which the Commissioner has made a determination under subclause (II) to exclude the countries from the requirement described in subclause (I); and (bb) information used to support such determination with respect to such countries. (vii) (I) The Postmaster General shall, in consultation with the Commissioner, refuse any shipments received after December 31, 2020, for which the information described in paragraphs (1) and (2) is not transmitted as required under this subparagraph, except as provided in subclause (II). (II) If remedial action is warranted in lieu of refusal of shipments pursuant to subclause (I), the Postmaster General and the Commissioner shall take remedial action with respect to the shipments, including destruction, seizure, controlled delivery or other law enforcement initiatives, or correction of the failure to provide the information described in paragraphs (1) and (2) with respect to the shipments. (viii) Nothing in this subparagraph shall be construed to limit the authority of the Secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties. (ix) In this subparagraph, the term appropriate congressional committees means— (I) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (II) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. . (2) Joint strategic plan on mandatory advance information Not later than 60 days after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving— (A) the transmission of information as required by section 343(a)(3)(K) of the Trade Act of 2002, as amended by paragraph (1); and (B) the presentation by the Postal Service to U.S. Customs and Border Protection of all mail targeted by U.S. Customs and Border Protection for inspection. (b) Capacity building (1) In general Section 343(a) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended by adding at the end the following: (5) Capacity building (A) In general The Secretary, with the concurrence of the Secretary of State, and in coordination with the Postmaster General and the heads of other Federal agencies, as appropriate, may provide technical assistance, equipment, technology, and training to enhance the capacity of foreign postal operators— (i) to gather and provide the information required by paragraph (3)(K); and (ii) to otherwise gather and provide postal shipment information related to— (I) terrorism; (II) items the importation or introduction of which into the United States is prohibited or restricted, including controlled substances; and (III) such other concerns as the Secretary determines appropriate. (B) Provision of equipment and technology With respect to the provision of equipment and technology under subparagraph (A), the Secretary may lease, loan, provide, or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the Secretary may prescribe, including nonreimbursable loans or the transfer of ownership of equipment and technology. . (2) Joint strategic plan on capacity building Not later than 1 year after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly develop and submit to the appropriate congressional committees a joint strategic plan— (A) detailing the extent to which U.S. Customs and Border Protection and the United States Postal Service are engaged in capacity building efforts under section 343(a)(5) of the Trade Act of 2002, as added by paragraph (1); (B) describing plans for future capacity building efforts; and (C) assessing how capacity building has increased the ability of U.S. Customs and Border Protection and the Postal Service to advance the goals of this subtitle and the amendments made by this subtitle. (c) Report and consultations by Secretary of Homeland Security and Postmaster General (1) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 3 years after the Postmaster General has met the requirement under clause (vi) of subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following: (A) An assessment of the status of the regulations required to be promulgated under that subparagraph. (B) An update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph. (C) A summary of deliberations between the United States Postal Service and foreign postal operators with respect to issues relating to the transmission of that information. (D) A summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph. (E) An assessment of the quality of that information being received by foreign postal operators, as determined by the Secretary of Homeland Security, and actions taken to improve the quality of that information. (F) A summary of policies established by the Universal Postal Union that may affect the ability of the Postmaster General to obtain the transmission of that information. (G) A summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology. (H) Such other information as the Secretary of Homeland Security and the Postmaster General consider appropriate with respect to obtaining the transmission of information required by that subparagraph. (2) Consultations Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the Postmaster General has met the requirement under clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as amended by subsection (a)(1), to arrange for the transmission of information with respect to 100 percent of the aggregate number of mail shipments described in clause (i) of that section, the Secretary of Homeland Security and the Postmaster General shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments. (d) Government Accountability Office report Not later than June 30, 2019, the Comptroller General of the United States shall submit to the appropriate congressional committees a report— (1) assessing the progress of the United States Postal Service in achieving the transmission of the information required by subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), for the percentage of shipments required by that subparagraph; (2) assessing the quality of the information received from foreign postal operators for targeting purposes; (3) assessing the specific percentage of targeted mail presented by the Postal Service to U.S. Customs and Border Protection for inspection; (4) describing the costs of collecting the information required by such subparagraph (K) from foreign postal operators and the costs of implementing the use of that information; (5) assessing the benefits of receiving that information with respect to international mail shipments; (6) assessing the feasibility of assessing a customs fee under section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 8002, on international mail shipments other than Inbound Express Mail service in a manner consistent with the obligations of the United States under international agreements; and (7) identifying recommendations, including recommendations for legislation, to improve the compliance of the Postal Service with such subparagraph (K), including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by— (A) requiring the Postal Service to serve as the consignee for international mail shipments containing goods; or (B) designating a customs broker to act as an importer of record for international mail shipments containing goods. (e) Technical correction Section 343 of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended in the section heading by striking advanced and inserting advance . (f) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8004. International postal agreements (a) Existing agreements (1) In general In the event that any provision of this subtitle, or any amendment made by this Act, is determined to be in violation of obligations of the United States under any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, the Secretary of State should negotiate to amend the relevant provisions of the agreement so that the United States is no longer in violation of the agreement. (2) Rule of construction Nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle. (b) Future agreements (1) Consultations Before entering into, on or after the date of the enactment of this Act, any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, that is related to the ability of the United States to secure the provision of advance electronic information by foreign postal operators, the Secretary of State should consult with the appropriate congressional committees (as defined in section 8003(f)). (2) Expedited negotiation of new agreement To the extent that any new postal treaty, convention, or other international agreement related to international postal services would improve the ability of the United States to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section 343(a)(3)(K) of the Trade Act of 2002, as amended by section 8003(a)(1), the Secretary of State should expeditiously conclude such an agreement. 8005. Cost recoupment (a) In general The United States Postal Service shall, to the extent practicable and otherwise recoverable by law, ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators. (b) Costs not considered revenue The recovery of costs under subsection (a) shall not be deemed revenue for purposes of subchapter I and II of chapter 36 of title 39, United States Code, or regulations prescribed under that chapter. 8006. Development of technology to detect illicit narcotics (a) In general The Postmaster General and the Commissioner of U.S. Customs and Border Protection, in coordination with the heads of other agencies as appropriate, shall collaborate to identify and develop technology for the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States by mail. (b) Outreach to private sector The Postmaster General and the Commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States. 8007. Civil penalties for postal shipments Section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ) is amended by adding at the end the following new subsection: (e) Civil penalties for postal shipments (1) Civil penalty A civil penalty shall be imposed against the United States Postal Service if the Postal Service accepts a shipment in violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (2) Modification of civil penalty (A) In general U.S. Customs and Border Protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph (1) if U.S. Customs and Border Protection determines that the United States Postal Service— (i) has a low error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002; (ii) is cooperating with U.S. Customs and Border Protection with respect to the violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or (iii) has taken remedial action to prevent future violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (B) Written notification U.S. Customs and Border Protection shall issue a written notification to the Postal Service with respect to each exercise of the authority of subparagraph (A) to reduce or dismiss a civil penalty imposed pursuant to paragraph (1). (3) Ongoing lack of compliance If U.S. Customs and Border Protection determines that the United States Postal Service— (A) has repeatedly committed violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, (B) has failed to cooperate with U.S. Customs and Border Protection with respect to violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and (C) has an increasing error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002, civil penalties may be imposed against the United States Postal Service until corrective action, satisfactory to U.S. Customs and Border Protection, is taken. . 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest (a) In general The Commissioner of U.S. Customs and Border Protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection (b) with respect to each violation of section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ), as amended by section 8007, and section 584 of such Act ( 19 U.S.C. 1584 ) that occurred during the previous year. (b) Information described The information described in this subsection is the following: (1) The name and address of the violator. (2) The specific violation that was committed. (3) The location or port of entry through which the items were transported. (4) An inventory of the items seized, including a description of the items and the quantity seized. (5) The location from which the items originated. (6) The entity responsible for the apprehension or seizure, organized by location or port of entry. (7) The amount of penalties assessed by U.S. Customs and Border Protection, organized by name of the violator and location or port of entry. (8) The amount of penalties that U.S. Customs and Border Protection could have levied, organized by name of the violator and location or port of entry. (9) The rationale for negotiating lower penalties, organized by name of the violator and location or port of entry. (c) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8009. Effective date; regulations (a) Effective date This subtitle and the amendments made by this subtitle (other than the amendments made by section 8002) shall take effect on the date of the enactment of this Act. (b) Regulations Not later than 1 year after the date of the enactment of this Act, such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed. B Recognizing Early Childhood Trauma Related to Substance Abuse 8011. Short title This subtitle may be cited as the Recognizing Early Childhood Trauma Related to Substance Abuse Act of 2018 . 8012. Recognizing Early Childhood Trauma Related to Substance Abuse (a) Dissemination of information The Secretary of Health and Human Services shall disseminate information, resources, and, if requested, technical assistance to early childhood care and education providers and professionals working with young children on— (1) ways to properly recognize children who may be impacted by trauma related to substance abuse by a family member or other adult; and (2) how to respond appropriately in order to provide for the safety and well-being of young children and their families. (b) Goals The information, resources, and technical assistance provided under subsection (a) shall— (1) educate early childhood care and education providers and professionals working with young children on understanding and identifying the early signs and risk factors of children who might be impacted by trauma due to exposure to substance abuse; (2) suggest age-appropriate communication tools, procedures, and practices for trauma-informed care, including ways to prevent or mitigate the effects of trauma; (3) provide options for responding to children impacted by trauma due to exposure to substance abuse that consider the needs of the child and family, including recommending resources and referrals for evidence-based services to support such family; and (4) promote whole-family and multi-generational approaches to prevent separation and support re-unification of families whenever possible and in the best interest of the child. (c) Rule of construction Such information, resources, and if applicable, technical assistance, shall not be construed to amend the requirements under— (1) the Child Care and Development Block Grant Act of 1990 ( 42 U.S.C. 9858 et seq.); (2) the Head Start Act ( 42 U.S.C. 9831 et seq.); or (3) the Individuals with Disabilities Education Act ( 20 U.S.C. 1400 et seq.). C Assisting States’ Implementation of Plans of Safe Care 8021. Short title This subtitle may be cited as the Assisting States’ Implementation of Plans of Safe Care Act . 8022. Assisting States with implementation of plans of safe care (a) In general The Secretary of Health and Human Services shall provide written guidance and, if appropriate, technical assistance to support States in complying with, and implementing, subsections (b)(2)(B)(iii) and (d)(18) of section 106 of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5106a ) in order to promote better protections for young children and family-centered responses. (b) Requirements The guidance and technical assistance shall— (1) enhance States’ understanding of requirements and flexibilities under the law, including clarifying key terms; (2) address State-identified challenges with developing, implementing, and monitoring plans of safe care; (3) disseminate best practices related to developing and implementing plans of safe care, including differential response, collaboration and coordination, and identification and delivery of services, while recognizing needs of different populations and varying community approaches across States; (4) support collaboration between health care providers, social service agencies, public health agencies, and the child welfare system, to promote a family-centered treatment approach; (5) prevent separation and support reunification of families if in the best interests of the child; (6) recommend treatment approaches for serving infants, pregnant women, and postpartum women whose infants may be affected by substance use that are designed to keep infants with their mothers and families whenever appropriate, including recommendations to encourage pregnant women to receive health and other support services during pregnancy; (7) support State efforts to develop technology systems to manage and monitor implementation of plans of safe care; and (8) help States improve the long-term safety and well-being of young children and their families. (c) Construction The guidance and technical assistance shall not be construed to amend the requirements of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5101 et seq.). (d) Definition For purposes of this section, the term State has the meaning given such term in section 3 of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5101 note). D Improving the Federal Response to Families Impacted by Substance Use Disorder 8031. Short title This subtitle may be cited as the Improving the Federal Response to Families Impacted by Substance Use Disorder Act . 8032. Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders (a) Establishment There is established a task force, to be known as the Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders (in this section referred to as “Task Force”). (b) Responsibilities The Task Force— (1) shall identify, evaluate, and recommend ways in which Federal agencies can better coordinate responses to substance use disorders and the opioid crisis; and (2) shall carry out the additional duties described in subsection (d). (c) Membership (1) Number and appointment The Task Force shall be composed of 12 Federal officials having responsibility for, or administering programs related to, the duties of the Task Force. The Secretary of Health and Human Services, the Secretary of Education, the Secretary of Agriculture, and the Secretary of Labor shall each appoint two members to the Task Force from among the Federal officials employed by the Department of which they are the head. Additional Federal agency officials appointed by the Secretary of Health and Human Services shall fill the remaining positions of the Task Force. (2) Chairperson The Secretary of Health and Human Services shall designate a Federal official employed by the Department of Health and Human Services to serve as the chairperson of the Task Force. (3) Deadline for appointment Each member shall be appointed to the Task Force not later than 60 days after the date of the enactment of this Act. (4) Additional agency input The Task Force may seek input from other Federal agencies and offices with experience, expertise, or information relevant in responding to the opioid crisis. (5) Vacancies A vacancy in the Task Force shall be filled in the manner in which the original appointment was made. (6) Prohibition of compensation Members of the Task Force may not receive pay, allowances, or benefits by reason of their service on the Task Force. (d) Duties The Task Force shall carry out the following duties: (1) Solicit input from stakeholders, including frontline service providers, medical professionals, educators, mental health professionals, researchers, experts in infant, child, and youth trauma, child welfare professionals, and the public, in order to inform the activities of the Task Force. (2) Develop a strategy on how the Task Force and participating Federal agencies will collaborate, prioritize, and implement a coordinated Federal approach with regard to responding to substance use disorders, including opioid misuse, that shall include— (A) identifying options for the coordination of existing grants that support infants, children, and youth, and their families as appropriate, who have experienced, or are at risk of experiencing, exposure to substance abuse disorders, including opioid misuse; and (B) other ways to improve coordination, planning, and communication within and across Federal agencies, offices, and programs, to better serve children and families impacted by substance use disorders, including opioid misuse. (3) Based off the strategy developed under paragraph (2), evaluate and recommend opportunities for local- and State-level partnerships, professional development, or best practices that— (A) are designed to quickly identify and refer children and families, as appropriate, who have experienced or are at risk of experiencing exposure to substance abuse; (B) utilize and develop partnerships with early childhood education programs, local social services organizations, and health care services aimed at preventing or mitigating the effects of exposure to substance use disorders, including opioid misuse; (C) offer community-based prevention activities, including educating families and children on the effects of exposure to substance use disorders, including opioid misuse, and how to build resilience and coping skills to mitigate those effects; (D) in accordance with Federal privacy protections, utilize non-personally identifiable data from screenings, referrals, or the provision of services and supports to evaluate and improve processes addressing exposure to substance use disorders, including opioid misuse; and (E) are designed to prevent separation and support reunification of families if in the best interest of the child. (4) In fulfilling the requirements of paragraphs (2) and (3), consider evidence-based, evidence-informed, and promising best practices related to identifying, referring, and supporting children and families at risk of experiencing exposure to substance abuse or experiencing substance use disorder, including opioid misuse, including— (A) prevention strategies for those at risk of experiencing or being exposed to substance abuse, including misuse of opioids; (B) whole-family and multi-generational approaches; (C) community-based initiatives; (D) referral to, and implementation of, trauma-informed practices and supports; and (E) multi-generational practices that assist parents, foster parents, and kinship and other caregivers (e) FACA The Federal Advisory Committee Act ( 5 U.S.C. App. 2 ) shall not apply to the Task Force. (f) Action plan; reports The Task Force— (1) shall prepare a detailed action plan to be implemented by participating Federal agencies to create a collaborative, coordinated response to the opioid crisis, which shall include— (A) relevant information identified and collected under subsection (d); (B) a proposed timeline for implementing recommendations and efforts identified under subsection (d); and (C) a description of how other Federal agencies and offices with experience, expertise, or information relevant in responding to the opioid crisis that have provided input under subsection (c)(4) will be participating in the coordinated approach; (2) shall submit to the Congress a report describing the action plan prepared under paragraph (1), including, where applicable, identification of any recommendations included in such plan that require additional legislative authority to implement; and (3) shall submit a report to the Governors describing the opportunities for local- and State-level partnerships, professional development, or best practices recommended under subsection (d)(3). (g) Dissemination (1) In general The action plan and reports required under subsection (f) shall be— (A) disseminated widely, including among the participating Federal agencies and the Governors; and (B) be made publicly available online in an accessible format. (2) Deadline The action plan and reports required under subsection (f) may be released on separate dates but shall be released not later than 9 months after the date of the enactment of this Act. (h) Termination The Task Force shall terminate 30 days after the dissemination of the action plan and reports under subsection (g). (i) Funding The administrative expenses of the Task Force shall be paid out of existing Department of Health and Human Services funds or appropriations. (j) Definitions For purposes of this section: (1) The term Governor means the chief executive officer of a State. (2) The term participating Federal agencies means all the Executive agencies (as defined in section 105 of title 5, United States Code) whose officials have been appointed to the Task Force. (3) The term State means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. E Establishment of an Advisory Committee on Opioids and the Workplace 8041. Establishment of an Advisory Committee on Opioids and the Workplace (a) Establishment Not later than 90 days after enactment of this Act, the Secretary of Labor shall establish an Advisory Committee on Opioids and the Workplace (referred to in this subtitle as the Advisory Committee ) to advise the Secretary on actions the Department of Labor can take to provide informational resources and best practices on how to appropriately address the impact of opioid abuse on the workplace and support workers abusing opioids. (b) Membership (1) Composition The Secretary of Labor shall appoint as members of the Advisory Committee 19 individuals with expertise in employment, workplace health programs, human resources, substance use disorder, and other relevant fields. The Advisory Committee shall be composed as follows: (A) Four of the members shall be individuals representative of employers or other organizations representing employers. (B) Four of the members shall be individuals representative of workers or other organizations representing workers, of which at least two must be representatives designated by labor organizations. (C) Three of the members shall be individuals representative of health benefit plans, employee assistance plan providers, workers’ compensation program administrators, and workplace safety and health professionals. (D) Eight of the members shall be individuals representative of substance abuse treatment and recovery experts, including medical doctors, licensed addiction therapists, and scientific and academic researchers, of which one individual may be a representative of a local or State government agency that oversees or coordinates programs that address substance use disorder. (2) Chair From the members appointed under paragraph (1), the Secretary of Labor shall appoint a chairperson. (3) Terms Each member of the Advisory Committee shall serve for a term of 3 years. A member appointed to fill a vacancy shall be appointed only for the remainder of such term. (4) Quorum A majority of members of the Advisory Committee shall constitute a quorum and action shall be taken only by a majority vote of the members. (5) Voting The Advisory Committee shall establish voting procedures. (6) No compensation Members of the Advisory Committee shall serve without compensation. (7) Disclosure Every member of the Advisory Committee must disclose the entity, if applicable, that he or she is representing. (c) Duties (1) Advisement (A) In general The Advisory Committee established under subsection (a) shall advise the Secretary of Labor on actions the Department of Labor can take to provide informational resources and best practices on how to appropriately address the impact of opioid abuse on the workplace and support workers abusing opioids. (B) Considerations In providing such advice, the Advisory Committee shall take into account— (i) evidence-based and other employer substance abuse policies and best practices regarding opioid use or abuse, including benefits provided by employee assistance programs or other employer-provided benefits, programs, or resources; (ii) the effect of opioid use or abuse on the safety of the workplace as well as policies and procedures addressing workplace safety and health; (iii) the impact of opioid abuse on productivity and absenteeism, and assessments of model human resources policies that support workers abusing opioids, such as policies that facilitate seeking and receiving treatment and returning to work; (iv) the extent to which alternative pain management treatments other than opioids are or should be covered by employer-sponsored health plans; (v) the legal requirements protecting employee privacy and health information in the workplace, as well as the legal requirements related to nondiscrimination; (vi) potential interactions of opioid abuse with other substance use disorders; (vii) any additional benefits or resources available to an employee abusing opioids that promote retaining employment or reentering the workforce; (viii) evidence-based initiatives that engage employers, employees, and community leaders to promote early identification of opioid abuse, intervention, treatment, and recovery; (ix) workplace policies regarding opioid abuse that reduce stigmatization among fellow employees and management; and (x) the legal requirements of the Mental Health Parity and Addiction Equity Act and other laws related to health coverage of substance abuse and mental health services and medications. (2) Report Prior to its termination as provided in subsection (j), the Advisory Committee shall issue a report to the Secretary of Labor and to the Committee on Education and the Workforce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, detailing successful programs and policies involving workplace resources and benefits, including recommendations or examples of best practices for how employers can support and respond to employees impacted by opioid abuse. (d) Meetings The Advisory Committee shall meet at least twice a year at the call of the chairperson. (e) Staff support The Secretary of Labor shall make available staff necessary for the Advisory Committee to carry out its responsibilities. (f) Federal Advisory Committee Act The Federal Advisory Committee Act shall apply to the Advisory Committee established under this subtitle. (g) No appropriated funds No additional funds are authorized to be appropriated to carry out this subtitle. Expenses of the Advisory Committee shall be paid with funds otherwise appropriated to Departmental Management within the Department of Labor. (h) Ex officio Three nonvoting representatives from agencies within the Department of Health and Human Services whose responsibilities include opioid prescribing guidelines, workplace safety, and monitoring of substance abuse and prevention programs shall be appointed by the Secretary of Labor and designated as ex officio members. (i) Agenda The Secretary of Labor or a representative of the Secretary shall consult with the Chair in establishing the agenda for Committee meetings. (j) Termination The Advisory Committee established under this subtitle shall terminate 3 years after the date of enactment of this Act. F Veterans Treatment Court Improvement 8051. Short title This subtitle may be cited as the Veterans Treatment Court Improvement Act of 2018 . 8052. Hiring by Department of Veterans Affairs of additional Veterans Justice Outreach Specialists (a) Hiring of additional Veterans Justice Outreach Specialists (1) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall hire not fewer than 50 Veterans Justice Outreach Specialists and place each such Veterans Justice Outreach Specialist at an eligible Department of Veterans Affairs medical center in accordance with this section. (2) Requirements The Secretary shall ensure that each Veterans Justice Outreach Specialist employed under paragraph (1)— (A) serves, either exclusively or in addition to other duties, as part of a justice team in a veterans treatment court or other veteran-focused court; and (B) otherwise meets Department hiring guidelines for Veterans Justice Outreach Specialists. (b) Eligible Department of Veterans Affairs medical centers For purposes of this section, an eligible Department of Veterans Affairs medical center is any Department of Veterans Affairs medical center that— (1) complies with all Department guidelines and regulations for placement of a Veterans Justice Outreach Specialist; (2) works within a local criminal justice system with justice-involved veterans; (3) maintains an affiliation with one or more veterans treatment courts or other veteran-focused courts; and (4) either— (A) routinely provides Veterans Justice Outreach Specialists to serve as part of a justice team in a veterans treatment court or other veteran-focused court; or (B) establishes a plan that is approved by the Secretary to provide Veterans Justice Outreach Specialists employed under subsection (a)(1) to serve as part of a justice team in a veterans treatment court or other veteran-focused court. (c) Placement priority The Secretary shall prioritize the placement of Veterans Justice Outreach Specialists employed under subsection (a)(1) at eligible Department of Veterans Affairs medical centers that have or intend to establish an affiliation, for the purpose of carrying out the Veterans Justice Outreach Program, with a veterans treatment court, or other veteran-focused court, that— (1) was established on or after the date of the enactment of this Act; or (2) (A) was established before the date of the enactment of this Act; and (B) is not fully staffed with Veterans Justice Outreach Specialists. (d) Reports (1) Report by Secretary of Veterans Affairs (A) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to Congress a report on the implementation of this section and its effect on the Veterans Justice Outreach Program. (B) Contents The report submitted under paragraph (1) shall include the following: (i) The status of the efforts of the Secretary to hire Veterans Justice Outreach Specialists pursuant to subsection (a)(1), including the total number of Veterans Justice Outreach Specialists hired by the Secretary pursuant to such subsection and the number that the Secretary expects to hire pursuant to such subsection. (ii) The total number of Veterans Justice Outreach Specialists assigned to each Department of Veterans Affairs medical center that participates in the Veterans Justice Outreach Program, including the number of Veterans Justice Outreach Specialists hired under subsection (a)(1) disaggregated by Department of Veterans Affairs medical center. (iii) The total number of eligible Department of Veterans Affairs medical centers that sought placement of a Veterans Justice Outreach Specialist under subsection (a)(1), how many Veterans Justice Outreach Specialists each such center sought, and how many of such medical centers received no placement of a Veterans Justice Outreach Specialist under subsection (a)(1). (iv) For each eligible Department of Veterans Affairs medical center— (I) the number of justice-involved veterans who were served or are expected to be served by a Veterans Justice Outreach Specialist hired under subsection (a)(1); and (II) the number of justice-involved veterans who do not have access to a Veterans Justice Outreach Specialist. (2) Report by Comptroller General of the United States (A) In general Not later than 3 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the implementation of this section and the effectiveness of the Veterans Justice Outreach Program. (B) Contents The report required by subparagraph (A) shall include the following: (i) An assessment of whether the Secretary has fulfilled the Secretary's obligations under this section. (ii) The number of veterans who are served by Veterans Justice Outreach Specialists hired under subsection (a)(1), disaggregated by demographics (including discharge status). (iii) An identification of any subgroups of veterans who underutilize services provided under laws administered by the Secretary, including an assessment of whether these veterans have access to Veterans Justice Outreach Specialists under the Veterans Justice Outreach Program. (iv) Such recommendations as the Comptroller General may have for the Secretary to improve the effectiveness of the Veterans Justice Outreach Program. (e) Definitions In this section: (1) Justice team The term justice team means the group of individuals, which may include a judge, court coordinator, prosecutor, public defender, treatment provider, probation or other law enforcement officer, program mentor, and Veterans Justice Outreach Specialist, who assist justice-involved veterans in a veterans treatment court or other veteran-focused court. (2) Justice-involved veteran The term justice-involved veteran means a veteran with active, ongoing, or recent contact with some component of a local criminal justice system. (3) Local criminal justice system The term local criminal justice system means law enforcement, jails, prisons, and Federal, State, and local courts. (4) Veterans Justice Outreach Program The term Veterans Justice Outreach Program means the program through which the Department of Veterans Affairs identifies justice-involved veterans and provides such veterans with access to Department services. (5) Veterans Justice Outreach Specialist The term Veterans Justice Outreach Specialist means an employee of the Department of Veterans Affairs who serves as a liaison between the Department and the local criminal justice system on behalf of a justice-involved veteran. (6) Veterans treatment court The term veterans treatment court means a State or local court that is participating in the veterans treatment court program (as defined in section 2991(i)(1) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797aa(i)(1) )). G Peer support counseling program for women veterans 8061. Peer support counseling program for women veterans (a) In general Section 1720F(j) of title 38, United States Code, is amended by adding at the end the following new paragraph: (4) (A) As part of the counseling program under this subsection, the Secretary shall emphasize appointing peer support counselors for women veterans. To the degree practicable, the Secretary shall seek to recruit women peer support counselors with expertise in— (i) female gender-specific issues and services; (ii) the provision of information about services and benefits provided under laws administered by the Secretary; or (iii) employment mentoring. (B) To the degree practicable, the Secretary shall emphasize facilitating peer support counseling for women veterans who are eligible for counseling and services under section 1720D of this title, have post-traumatic stress disorder or suffer from another mental health condition, are homeless or at risk of becoming homeless, or are otherwise at increased risk of suicide, as determined by the Secretary. (C) The Secretary shall conduct outreach to inform women veterans about the program and the assistance available under this paragraph. (D) In carrying out this paragraph, the Secretary shall coordinate with such community organizations, State and local governments, institutions of higher education, chambers of commerce, local business organizations, organizations that provide legal assistance, and other organizations as the Secretary considers appropriate. (E) In carrying out this paragraph, the Secretary shall provide adequate training for peer support counselors, including training carried out under the national program of training required by section 304(c) of the Caregivers and Veterans Omnibus Health Services Act of 2010 ( 38 U.S.C. 1712A note). . (b) Funding The Secretary of Veterans Affairs shall carry out paragraph (4) of section 1720F(j) of title 38, United States Code, as added by subsection (a), using funds otherwise made available to the Secretary. No additional funds are authorized to be appropriated by reason of such paragraph. (c) Report to Congress Not later than 2 years after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on the peer support counseling program under section 1720F(j) of title 38, United States Code, as amended by this section. Such report shall include— (1) the number of peer support counselors in the program; (2) an assessment of the effectiveness of the program; and (3) a description of the oversight of the program. H Treating Barriers to Prosperity 8071. Short title This subtitle may be cited as the Treating Barriers to Prosperity Act of 2018 . 8072. Drug abuse mitigation initiative (a) In general Chapter 145 of title 40, United States Code, is amended by inserting after section 14509 the following: 14510. Drug abuse mitigation initiative (a) In general The Appalachian Regional Commission may provide technical assistance to, make grants to, enter into contracts with, or otherwise provide amounts to individuals or entities in the Appalachian region for projects and activities to address drug abuse, including opioid abuse, in the region, including projects and activities— (1) to facilitate the sharing of best practices among States, counties, and other experts in the region with respect to reducing such abuse; (2) to initiate or expand programs designed to eliminate or reduce the harm to the workforce and economic growth of the region that results from such abuse; (3) to attract and retain relevant health care services, businesses, and workers; and (4) to develop relevant infrastructure, including broadband infrastructure that supports the use of telemedicine. (b) Limitation on available amounts Of the cost of any activity eligible for a grant under this section— (1) not more than 50 percent may be provided from amounts appropriated to carry out this section; and (2) notwithstanding paragraph (1)— (A) in the case of a project to be carried out in a county for which a distressed county designation is in effect under section 14526, not more than 80 percent may be provided from amounts appropriated to carry out this section; and (B) in the case of a project to be carried out in a county for which an at-risk designation is in effect under section 14526, not more than 70 percent may be provided from amounts appropriated to carry out this section. (c) Sources of assistance Subject to subsection (b), a grant provided under this section may be provided from amounts made available to carry out this section in combination with amounts made available— (1) under any other Federal program (subject to the availability of subsequent appropriations); or (2) from any other source. (d) Federal share Notwithstanding any provision of law limiting the Federal share under any other Federal program, amounts made available to carry out this section may be used to increase that Federal share, as the Appalachian Regional Commission determines to be appropriate. . (b) Clerical amendment The analysis for chapter 145 of title 40, United States Code, is amended by inserting after the item relating to section 14509 the following: 14510. Drug abuse mitigation initiative. . I Supporting Grandparents Raising Grandchildren 8081. Short title This subtitle may be cited as the Supporting Grandparents Raising Grandchildren Act . 8082. Findings Congress finds the following: (1) More than 2,500,000 grandparents in the United States are the primary caretaker of their grandchildren, and experts report that such numbers are increasing as the opioid epidemic expands. (2) Between 2009 and 2016, the incidence of parental alcohol or other drug use as a contributing factor for children’s out-of-home placement rose from 25.4 to 37.4 percent. (3) When children cannot remain safely with their parents, placement with relatives is preferred over placement in foster care with nonrelatives because placement with relatives provides stability for children and helps them maintain family connections. (4) The number of foster children placed with a grandparent or other relative increased from 24 percent in 2006 to 32 percent in 2016, according to data from the Department of Health and Human Services. (5) Grandparents' lives are enhanced by caring for their grandchildren; the overwhelming majority of grandparents report experiencing significant benefits in serving as their grandchildren’s primary caregivers. (6) Providing full-time care to their grandchildren may decrease grandparents’ ability to address their own physical and mental health needs and personal well-being. (7) Grandparents would benefit from better coordination and dissemination of information and resources available to support them in their caregiving responsibilities. 8083. Advisory Council To Support Grandparents Raising Grandchildren (a) Establishment There is established an Advisory Council to Support Grandparents Raising Grandchildren. (b) Membership (1) In general The Advisory Council shall be composed of the following members, or their designee: (A) The Secretary of Health and Human Services. (B) The Secretary of Education. (C) The Administrator of the Administration for Community Living. (D) The Director of the Centers for Disease Control and Prevention. (E) The Assistant Secretary for Mental Health and Substance Use. (F) The Assistant Secretary for the Administration for Children and Families. (G) A grandparent raising a grandchild. (H) An older relative caregiver of children. (I) As appropriate, the head of other Federal departments, or agencies, identified by the Secretary of Health and Human Services as having responsibilities, or administering programs, relating to current issues affecting grandparents or other older relatives raising children. (2) Lead agency The Department of Health and Human Services shall be the lead agency for the Advisory Council. (c) Duties (1) In general (A) Information The Advisory Council shall identify, promote, coordinate, and disseminate to the public information, resources, and the best practices available to help grandparents and other older relatives— (i) meet the health, educational, nutritional, and other needs of the children in their care; and (ii) maintain their own physical and mental health and emotional well-being. (B) Opioids In carrying out the duties described in subparagraph (A), the Advisory Council shall consider the needs of those affected by the opioid crisis. (C) Native Americans In carrying out the duties described in subparagraph (A), the Advisory Council shall consider the needs of members of Native American tribes. (2) Report (A) In general Not later than 180 days after the date of enactment of this Act, the Advisory Council shall submit a report to— (i) the appropriate committees; (ii) the State agencies that are responsible for carrying out family caregiver programs; and (iii) the public online in an accessible format. (B) Report format The report shall include— (i) best practices, resources, and other useful information for grandparents and other older relatives raising children identified under paragraph (1)(A) including, if applicable, any information related to the needs of children who have been impacted by the opioid epidemic; (ii) an identification of any gaps in items under clause (i); and (iii) where applicable, identification of any additional Federal legislative authority necessary to implement the activities described in clause (i) and (ii). (3) Follow-up report Not later than 2 years after the date on which the report required under paragraph (2)(A) is submitted, the Advisory Council shall submit a follow-up report that includes the information identified in paragraph (2)(B) to— (A) the appropriate committees; (B) the State agencies that are responsible for carrying out family caregiver programs; and (C) the public online in an accessible format. (4) Public input (A) In general The Advisory Council shall establish a process for public input to inform the development of, and provide updates to, the best practices, resources, and other information described in paragraph (1) that shall include— (i) outreach to States, local entities, and organizations that provide information to, or support for, grandparents or other older relatives raising children; and (ii) outreach to grandparents and other older relatives with experience raising children. (B) Nature of outreach Such outreach shall ask individuals to provide input on— (i) information, resources, and best practices available, including identification of any gaps and unmet needs; and (ii) recommendations that would help grandparents and other older relatives better meet the health, educational, nutritional, and other needs of the children in their care, as well as maintain their own physical and mental health and emotional well-being. (d) FACA The Advisory Council shall be exempt from the requirements of the Federal Advisory Committee Act (5 U.S.C. App.). (e) Funding No additional funds are authorized to be appropriated to carry out this subtitle. (f) Sunset The Advisory Council shall terminate on the date that is 3 years after the date of enactment of this Act. 8084. Definitions In this subtitle: (1) Advisory Council In this subtitle, the term Advisory Council means the Advisory Council to Support Grandparents Raising Grandchildren that is established under section 8083. (2) Appropriate committees In this subtitle, the term appropriate committees means the following: (A) The Special Committee on Aging of the Senate. (B) The Committee on Health, Education, Labor, and Pensions of the Senate. (C) The Committee on Education and the Workforce of the House of Representatives. (D) The Committee on Energy and Commerce of the House of Representatives. J Reauthorizing and Extending Grants for Recovery from Opioid Use Programs 8091. Short title This subtitle may be cited as the Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018 . 8092. Reauthorization of the comprehensive opioid abuse grant program Section 1001(a)(27) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10261(a)(27) ) is amended by striking through 2021 and inserting and 2018, and $330,000,000 for each of fiscal years 2019 through 2023 . IX SITSA Act 9001. Short title This title may be cited as the Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 or the SITSA Act . 9002. Establishment of schedule A Section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ) is amended— (1) in subsection (a), by striking five schedules of controlled substances, to be known as schedules I, II, III, IV, and V and inserting six schedules of controlled substances, to be known as schedules I, II, III, IV, V, and A ; (2) in subsection (b), by adding at the end the following: (6) Schedule A (A) In general The drug or substance— (i) has— (I) a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule I, II, III, IV, or V; and (II) an actual or predicted stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I, II, III, IV, or V; and (ii) is not— (I) listed or otherwise included in any other schedule in this section or by regulation of the Attorney General; and (II) with respect to a particular person, subject to an exemption that is in effect for investigational use, for that person, under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) to the extent conduct with respect to such substance is pursuant to such exemption. (B) Predicted stimulant, depressant, or hallucinogenic effect For purpose of this paragraph, a predicted stimulant, depressant, or hallucinogenic effect on the central nervous system may be based on— (i) the chemical structure and— (I) the structure activity relationships; or (II) binding receptor assays and other relevant scientific information about the substance; (ii) (I) the current or relative potential for abuse of the substance; and (II) the clandestine importation, manufacture, or distribution, or diversion from legitimate channels, of the substance; or (iii) the capacity of the substance to cause a state of dependence, including physical or psychological dependence that is similar to or greater than that of a controlled substance in schedule I, II, III, IV, or V. ; and (3) in subsection (c), in the matter preceding schedule I, by striking IV, and V and inserting IV, V, and A . 9003. Temporary and permanent scheduling of schedule A substances Section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) is amended by adding at the end the following: (k) Temporary and permanent scheduling of schedule A substances (1) The Attorney General may issue a temporary order adding a drug or substance to schedule A if the Attorney General finds that— (A) the drug or other substance satisfies the criteria for being considered a schedule A substance; and (B) adding such drug or substance to schedule A will assist in preventing abuse of the drug or other substance. (2) A temporary scheduling order issued under paragraph (1) shall not take effect until 30 days after the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued. The temporary scheduling order shall expire not later than 5 years after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (5), extend the temporary scheduling order for up to 180 days. (3) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent order issued under paragraph (5) with regard to the same substance, or upon the subsequent issuance of any scheduling order under this section. (4) A temporary scheduling order issued under paragraph (1) shall not be subject to judicial review. (5) (A) Beginning no earlier than 3 years after issuing an order temporarily scheduling a drug or other substance under this subsection, the Attorney General may, by rule, issue a permanent order adding a drug or other substance to schedule A if such drug or substance satisfies the criteria for being considered a controlled substance in schedule A under this subsection, except as provided in subparagraph (B). (B) If the Secretary has determined, based on relevant scientific studies and necessary data requested by the Secretary and gathered by the Attorney General, that a drug or other substance that has been temporarily placed in schedule A does not have sufficient potential for abuse to warrant control in any schedule, and so advises the Attorney General in writing, the Attorney General may not issue a permanent scheduling order under subparagraph (A) and shall, within 30 days of receiving the Secretary’s advice issue an order immediately terminating the temporary scheduling order. (6) Before initiating proceedings under paragraph (1), the Attorney General shall transmit notice of a temporary order proposed to be issued to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary of Health and Human Services in response to a notice transmitted pursuant to this paragraph. (7) On the date of the publication of a notice in the Federal Register pursuant to paragraph (2), the Attorney General shall transmit the same notice to Congress. The temporary scheduling order shall take effect according to paragraph (2), except that the temporary scheduling order may be disapproved by an Act of Congress within 180 days from the date of publication of the notice in the Federal Register. . 9004. Penalties (a) Controlled Substances Act The Controlled Substances Act ( 21 U.S.C. 801 et seq.) is amended— (1) in section 401(b)(1) ( 21 U.S.C. 841(b)(1) ), by adding at the end the following: (F) (i) In the case of any controlled substance in schedule A, such person shall be sentenced to a term of imprisonment of not more than 10 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 15 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $500,000 if the defendant is an individual or $2.5 million if the defendant is other than an individual, or both. (ii) If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than 30 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18, United States Code, or $1 million if the defendant is an individual or $5 million if the defendant is other than an individual, or both. (iii) Any sentence imposing a term of imprisonment under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of not less than 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of not less than 4 years in addition to such term of imprisonment. ; (2) in section 403(a) ( 21 U.S.C. 843(a) )— (A) in paragraph (8), by striking or at the end; (B) in paragraph (9), by striking the period at the end and inserting ; or ; and (C) by inserting after paragraph (9) the following: (10) to export a substance in violation of the controlled substance laws of the country to which the substance is exported. ; and (3) in section 404 ( 21 U.S.C. 844 ), by inserting after subsection (a) the following: (b) A person shall not be subject to a criminal or civil penalty under this title or under any other Federal law solely for possession of a schedule A controlled substance. . (b) Controlled Substances Import and Export Act Section 1010(b) of the Controlled Substances Import and Export Act ( 21 U.S.C. 960(b) ) is amended by adding at the end the following: (8) In the case of a violation under subsection (a) involving a controlled substance in schedule A, the person committing such violation shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $1 million if the defendant is an individual or $5 million if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to not more than life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18, United States Code, or $2 million if the defendant is an individual or $10 million if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, United States Code, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of not less than 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of not less than 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results. . 9005. False labeling of schedule A controlled substances (a) In general Section 305 of the Controlled Substances Act ( 21 U.S.C. 825 ) is amended by adding at the end the following: (f) False labeling of schedule A controlled substances (1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, a schedule A substance or product containing a schedule A substance, unless the substance or product bears a label clearly identifying a schedule A substance or product containing a schedule A substance by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC). (2) (A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act. (B) A product is described in this subparagraph if the product— (i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act; or (ii) is exempt from the provisions of section 505 of such Act relating to new drugs because— (I) it is intended solely for investigational use as described in section 505(i) of such Act; and (II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application. . (b) Penalties Section 402 of the Controlled Substances Act ( 21 U.S.C. 842 ) is amended— (1) in subsection (a)(16), by inserting or subsection (f) after subsection (e) ; and (2) in subsection (c)(1)(D), by inserting or a schedule A substance after anabolic steroid . 9006. Registration requirements for handlers of schedule A substances (a) Controlled Substances Act Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (k) (1) The Attorney General shall register an applicant to manufacture schedule A substances if— (A) the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and (B) the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection. (2) In determining the public interest under paragraph (1)(B), the Attorney General shall consider— (A) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule A compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes; (B) compliance with applicable State and local law; (C) promotion of technical advances in the art of manufacturing substances described in subparagraph (A) and the development of new substances; (D) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of substances described in paragraph (A); (E) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and (F) such other factors as may be relevant to and consistent with the public health and safety. (3) If an applicant is registered to manufacture controlled substances in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection. (l) (1) The Attorney General shall register an applicant to distribute schedule A substances— (A) if the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and (B) unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. (2) In determining the public interest under paragraph (1)(B), the Attorney General shall consider— (A) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (B) compliance with applicable State and local law; (C) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of substances described in subparagraph (A); (D) past experience in the distribution of controlled substances; and (E) such other factors as may be relevant to and consistent with the public health and safety. (3) If an applicant is registered to distribute a controlled substance in schedule I or II under subsection (b), the applicant shall not be required to apply for a separate registration under this subsection. (m) (1) (A) Not later than 90 days after the date on which a substance is placed in schedule A, any practitioner who was engaged in research on the substance before the placement of the substance in schedule A and any manufacturer or distributor who was handling the substance before the placement of the substance in schedule A shall register with the Attorney General. (B) (i) If an applicant described in subparagraph (A) is registered pursuant to subsection (f) to conduct research with a controlled substance in schedule I or II on the date on which another substance is placed in schedule A, the applicant may, subject to clause (iii), conduct research with that other controlled substance in schedule A while the application for registration pursuant to subparagraph (A) is pending. (ii) If an applicant described in subparagraph (A) is registered pursuant to subsection (f) as described in clause (i) to conduct research with a controlled substance in schedule III, IV, or V on the date on which another substance is placed in schedule A, the applicant may, subject to clause (iii), conduct research with that other controlled substance in schedule A while the application for registration pursuant to subparagraph (A) is pending, provided the substance for which the applicant is registered to conduct research is in the same schedule as, or a less-restricted schedule than, the controlled substance whose similarity in chemical structure and actual or predicted effect to the controlled substance in schedule A formed the basis for placement of the substance in schedule A, as set forth in the order published in the Federal Register placing the substance in schedule A. (iii) The permission to conduct research pursuant to clause (i) or clause (ii) is conditional on the applicant's complying with the registration and other requirements for controlled substances in schedule A. (iv) This subparagraph does not apply to applicants registered pursuant to subsection (f) whose authorization to conduct research with any controlled substances is limited to doing so as a coincident activity pursuant to applicable regulations of the Attorney General. (2) (A) Not later than 60 days after the date on which the Attorney General receives an application for registration to conduct research on a schedule A substance, the Attorney General shall— (i) grant, or initiate proceedings under section 304(c) to deny, the application; or (ii) request supplemental information from the applicant. (B) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) in connection with an application described in subparagraph (A), the Attorney General shall grant or deny the application. (n) (1) The Attorney General shall register a scientific investigator or a qualified research institution to conduct research with controlled substances in schedule A in accordance with this subsection. In evaluating applications for such registration, the Attorney General shall apply the criteria set forth in subsection (f) of this section that apply to practitioners seeking a registration to conduct research with a schedule I controlled substance, except that the applicant shall not be required to submit a research protocol. (2) If the applicant is not currently registered under subsection (f) to conduct research with a schedule I controlled substance, the Attorney General shall refer the application to the Secretary, who shall determine whether the applicant will be engaged in bona fide research and is qualified to conduct such research. The 60-day period under subsection (m)(2)(A) shall be tolled during the period beginning on the date on which the Attorney General refers an application to the Secretary under this paragraph, and ending on the date on which the Secretary submits a determination related to such referral to the Attorney General. (3) An applicant who meets the criteria under subsection (m)(1)(B) with respect to a particular schedule A controlled substance shall be considered qualified to conduct research with that substance. The Attorney General shall modify such applicant’s registration to include such schedule A controlled substance in accordance with this paragraph. The applicant shall notify the Attorney General of his intent to conduct research with a controlled substance in schedule A. Upon receiving such notification, the Attorney General shall modify the practitioner’s existing registration to authorize research with schedule A controlled substances, unless the Attorney General determines that the registration modification would be inconsistent with the public interest based on the criteria of subsection (f). (4) Registrations issued under this subsection to a qualified research institution will apply to all agents and employees of that institution acting within the scope of their professional practice. (5) At least 30 days prior to conducting any research with a controlled substance in schedule A, the registrant shall provide the Attorney General with written notification of the following: (A) The name of and drug code for each substance. (B) The name of each individual with access to each substance. (C) The amount of each substance. (D) Other similar information the Attorney General may require. (6) The quantity of a schedule A controlled substance possessed by a person registered under this subsection shall be appropriate for the research being conducted, subject to the additional limitations set forth in this paragraph. To reduce the risk of diversion, the Attorney General may establish limitations on the quantity of schedule A controlled substances that may be manufactured or possessed for purposes of research under this subsection and shall publish such limitations on the website of the Drug Enforcement Administration. A person registered under this subsection may, based on legitimate research needs, apply to the Attorney General to manufacture or possess an amount greater than that so specified by the Attorney General. The Attorney General shall specify the manner in which such applications shall be submitted. The Attorney General shall act on an application filed under this subparagraph within 30 days of receipt of such application. If the Attorney General fails to act within 30 days, the registrant shall be allowed to manufacture and possess up to the amount requested. The Attorney General shall have the authority to reverse the increase for cause. (7) The Attorney General shall by regulation specify the manner in which applications for registration under this subsection shall be submitted. (8) Registrants authorized under this subsection may manufacture and possess schedule A controlled substances up to the approved amounts only for use in their own research setting or institution. Manufacturing for use in any other setting or institution shall require a manufacturer’s registration under section 303(a). . (b) Controlled Substances Import and Export Act Section 1008 of the Controlled Substances Import and Export Act ( 21 U.S.C. 958 ) is amended by adding at the end the following: (j) (1) The Attorney General shall register an applicant to import or export a schedule A substance if— (A) the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and (B) the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection. (2) In determining the public interest under paragraph (1)(B), the Attorney General shall consider the factors described in subparagraphs (A) through (F) of section 303(k)(2). (3) If an applicant is registered to import or export a controlled substance in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection. . 9007. Additional conforming amendments (a) Controlled Substances Act The Controlled Substances Act ( 21 U.S.C. 801 et seq.) is amended— (1) in section 303(c) ( 21 U.S.C. 823(c) )— (A) by striking subsections (a) and (b) and inserting subsection (a), (b), (k), or (l) ; and (B) by striking schedule I or II and inserting schedule I, II, or A ; (2) in section 306 ( 21 U.S.C. 826 )— (A) in subsection (a), in the first sentence, by striking schedules I and II and inserting schedules I, II, and A ; (B) in subsection (b), in the second sentence, by striking schedule I or II and inserting schedule I, II, or A ; (C) in subsection (c), in the first sentence, by striking schedules I and II and inserting schedules I, II, and A ; (D) in subsection (d), in the first sentence, by striking schedule I or II and inserting schedule I, II, or A ; (E) in subsection (e), in the first sentence, by striking schedule I or II and inserting schedule I, II, or A ; and (F) in subsection (f), in the first sentence, by striking schedules I and II and inserting schedules I, II, and A ; (3) in section 308(a) ( 21 U.S.C. 828(a) ), by striking schedule I or II and inserting schedule I, II, or A ; (4) in section 402(b) ( 21 U.S.C. 842(b) ), in the matter preceding paragraph (1), by striking schedule I or II and inserting schedule I, II, or A ; (5) in section 403(a)(1) ( 21 U.S.C. 843(a)(1) ), by striking schedule I or II and inserting schedule I, II, or A ; and (6) in section 511(f) ( 21 U.S.C. 881(f) ), by striking schedule I or II each place it appears and inserting schedule I, II, or A . (b) Controlled Substances Import Export Act The Controlled Substances Import and Export Act ( 21 U.S.C. 951 et seq.) is amended— (1) in section 1002(a) ( 21 U.S.C. 952(a) )— (A) in the matter preceding paragraph (1), by striking schedule I or II and inserting schedule I, II, or A ; and (B) in paragraph (2), by striking schedule I or II and inserting schedule I, II, or A ; (2) in section 1003 ( 21 U.S.C. 953 )— (A) in subsection (c), in the matter preceding paragraph (1), by striking schedule I or II and inserting schedule I, II, or A ; and (B) in subsection (d), by striking schedule I or II and inserting schedule I, II, or A ; (3) in section 1004(1) ( 21 U.S.C. 954(1) ), by striking schedule I and inserting schedule I or A ; (4) in section 1005 ( 21 U.S.C. 955 ), by striking schedule I or II and inserting schedule I, II, or A ; and (5) in section 1009(a) ( 21 U.S.C. 959(a) ), by striking schedule I or II and inserting schedule I, II, or A . 9008. Controlled substance analogues Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended— (1) in paragraph (6), by striking or V and inserting V, or A ; (2) in paragraph (14)— (A) by striking schedule I(c) and and inserting schedule I(c), schedule A, and ; and (B) by striking schedule I(c), and inserting schedule I(c) and schedule A, ; and (3) in paragraph (32)(A), by striking (32)(A) and all that follows through clause (iii) and inserting the following: (32) (A) Except as provided in subparagraph (C), the term controlled substance analogue means a substance whose chemical structure is substantially similar to the chemical structure of a controlled substance in schedule I or II— (i) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or (ii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II. . 9009. Rules of construction Nothing in this title, or the amendments made by this title, may be construed to limit— (1) the prosecution of offenses involving controlled substance analogues under the Controlled Substances Act ( 21 U.S.C. 801 et seq.); or (2) the authority of the Attorney General to temporarily or permanently schedule, reschedule, or decontrol controlled substances under provisions of section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) that are in effect on the day before the date of enactment of this title. 9010. Study by Comptroller General Not later than 2 years after the date of enactment of this title, the Comptroller General of the United States shall complete a study and submit a report to the Committees on the Judiciary of the House of Representatives and of the Senate regarding the costs associated with the amendments made by section 4, including— (1) the annual amounts expended by Federal agencies in carrying out the amendments; (2) the costs associated with arrests, trials, convictions, imprisonment, or imposition of other sanctions in accordance with the amendments; and (3) the impact (including the fiscal impact) of the amendments on existing correctional facilities and the likelihood that those amendments will create a need for additional capacity for housing prisoners. 9011. Report on controlled substance analogues sold by means of the Internet Not later than 1 year after the date of the enactment of this title, and annually thereafter, the Administrator of the Drug Enforcement Administration shall make publicly available on the website of the Drug Enforcement Administration a report on, for the previous year, the lawful and unlawful sale of controlled substance analogues (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )) by means of the Internet, including the following information: (1) The types of controlled substance analogues that were sold, and the number of sales for each such substance. (2) The name of each person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance analogue by means of the Internet, whether lawfully or unlawfully. (3) An estimate of the total revenue for all of the vendors described in paragraph (2) for all of the sales described in paragraph (1). 9012. Controlled substance analogues Section 203 of the Controlled Substances Act ( 21 U.S.C. 813 ) is amended— (1) by striking A controlled and inserting (a) In general .—A controlled ; and (2) by adding at the end the following: (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws. (c) Limitation For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption. . X THRIVE Act 10001. Short title This title may be cited as the Transitional Housing for Recovery in Viable Environments Demonstration Program Act or the THRIVE Act . 10002. Demonstration program to study the impact of using rental vouchers for supportive housing for individuals recovering from opioid use disorders or other substance use disorders Section 8(o) of the United States Housing Act of 1937 ( 42 U.S.C. 1437f(o) ) is amended by adding at the end the following new paragraph: (21) Rental Voucher Demonstration Program for supportive housing for individuals recovering from opioid use disorders or other substance use disorders (A) Establishment The Secretary shall establish a demonstration program under which the Secretary shall set aside, allocate, and distribute directly to eligible entities, from amounts made available for rental assistance under this subsection, the amounts specified in subparagraph (B) for an eligible entity to provide a voucher for such assistance to a covered individual through a supportive housing program that provides treatment for opioid use disorders or other substance use disorders (as applicable), coordination with workforce development providers, and such assistance, as determined by the entity. (B) Amount The amount specified in this subparagraph is, for fiscal year 2019, the amount necessary to provide the lesser of— (i) 0.5 percent of the total number of vouchers renewed under this subsection during the fiscal year ending immediately before the date of the enactment of this paragraph; or (ii) 10,000 vouchers. (C) Criteria for eligible entities An eligible entity shall— (i) provide an evidence-based treatment program and demonstrate the ability to coordinate with workforce development providers for individuals recovering from an opioid use disorder or other substance use disorder, as applicable, that meet standards established by the Secretary; and (ii) demonstrate prior experience administering rental assistance vouchers, demonstrate prior experience administering supportive housing programs under the McKinney-Vento Homeless Act, or demonstrate a partnership with a public housing agency or a housing program of a State, unit of local government, or Indian tribe (as such term is defined in section 4 of the Native American Housing and Self-Determination Act of 1996 ( 25 U.S.C. 4103 )) that ensures effective administration of rental assistance vouchers. (D) Application To receive a rental assistance voucher under this paragraph, an eligible entity shall submit an application to the Secretary that shall include— (i) a description of the terms of treatment program, coordination with workforce development providers, and rental assistance to be provided to a covered individual, and assurances that such description shall be communicated to covered individuals that receive vouchers pursuant to the demonstration program established under this paragraph; (ii) a transitional plan that begins on the date on which a covered individual completes the treatment program of the eligible entity that includes information on additional treatment, coordination with workforce development opportunities, and housing resources and services available to such covered individual; and (iii) evidence sufficient to demonstrate that the local government having jurisdiction over the location of any supportive housing facility to be used by the eligible entity in connection with the demonstration program under this paragraph permits such facilities in such location. (E) Selection In selecting eligible entities to receive rental assistance vouchers under this paragraph, the Secretary shall— (i) ensure that such eligible entities— (I) are diverse; (II) represent an appropriate balance of eligible entities located in urban and rural areas, including tribal communities; (III) have adequate resources for treatment, recovery, and supportive services; (IV) fully comply with the Fair Housing Act ( 42 U.S.C. 3601 et seq.) and the Civil Rights Act of 1964 ( 42 U.S.C. 2000a et seq.); (V) appropriately reflect the impact that opioids are having in tribal communities; and (VI) provide supportive and transitional housing programs in diverse geographic regions with high rates of mortality due to opioid use disorders or other substance use disorders, as applicable, based on data of the Centers for Disease Control and Prevention; and (ii) consider, in consultation with the Secretary of Health and Human Services and the Secretary of Labor— (I) the success of each recipient eligible entity at helping individuals complete the treatment program of the eligible entity and refrain from illicit opioid or other substance usage, as applicable; (II) the coordination with workforce development providers by the eligible entity; (III) the percentage of participants in unsubsidized employment during the second and fourth calendar quarter after exit from the program; and (IV) the percentage of participants in the treatment program of the eligible entity that do not relapse into opioid or other substance usage, as applicable. (F) Reissuance of voucher Upon termination of the provision of rental assistance through a voucher to a covered individual, the eligible entity that initially offered such voucher may use such voucher to provide rental assistance to another covered individual. (G) Duration The Secretary shall not make rental assistance available under this paragraph after the expiration of the 5-year period beginning on the date of the enactment of this paragraph. (H) Waivers The Secretary may, through publication of a notice in the Federal Register, waive or specify alternative requirements for any provision of statue or regulation governing the use of vouchers under this subsection (except for requirements relating to fair housing, nondiscrimination, labor standards, or the environment) upon a finding by the Secretary that such waiver or alternative requirement is necessary for the purposes of this paragraph. (I) Reports (i) By the eligible entity An eligible entity that receives a rental assistance voucher under this paragraph shall submit to the Secretary— (I) annually, the transitional plan described in subparagraph (D)(ii) and information on each covered individual’s housing upon termination of the provision of rental assistance through a voucher to such covered individual in a manner that protects the privacy of such covered individual; and (II) not later than 4 years after the date of the enactment of this paragraph, a plan describing the treatment and housing options for any covered individual assisted by such voucher who will not have completed the program before the day that is 5 years after such date of enactment. (ii) By the Secretary The Secretary shall submit to Congress a report that analyzes the impact of rental assistance provided under this paragraph— (I) not later than 2 years after the date of the enactment of this paragraph; and (II) not later than 4 years after the date of the enactment of this paragraph. (J) Definitions In this paragraph: (i) Eligible entity The term eligible entity means a tribally designated housing entity (as such term is defined in section 4 of the Native American Housing and Self-Determination Act of 1996 ( 24 U.S.C. 4103 )), or a nonprofit organization, that meets the criteria described under subparagraph (C). (ii) Covered individual The term covered individual means an individual recovering from an opioid use disorder or other substance use disorder. . 10003. Repeal of Rental Voucher Demonstration Program Effective the day that is 5 years after the date of the enactment of this title, paragraph (21) of section 8(o) of the United States Housing Act of 1937 ( 42 U.S.C. 1437f(o) ), as added by this title, is repealed. 10004. Demonstration Close-Out An eligible entity that provided vouchers for rental assistance under paragraph (21) of section 8(o) of the United States Housing Act of 1937 ( 42 U.S.C. 1437f(o) ), as added by this title, shall return any such vouchers to the Secretary of Housing and Urban Development not later than the day that is 5 years after the date of the enactment of this title for use only for renewals of expiring contracts for such assistance. 10005. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this title and the amendments made by this title. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. XI IMD CARE Act 11001. Short title This title may be cited as the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act . 11002. Medicaid State plan option to provide services for certain individuals with targeted SUDs in institutions for mental diseases Section 1915 of the Social Security Act ( 42 U.S.C. 1396n ) is amended by adding at the end the following new subsection: (l) State plan option To provide services for certain individuals in institutions for mental diseases (1) In general With respect to calendar quarters beginning during the period beginning January 1, 2019, and ending December 31, 2023, a State may elect, through a State plan amendment, to, notwithstanding section 1905(a), provide medical assistance for services furnished in institutions for mental diseases and for other medically necessary services furnished to eligible individuals with targeted SUDs, in accordance with the requirements of this subsection. (2) Payments (A) In general Amounts expended under a State plan amendment under paragraph (1) for services described in such paragraph furnished, with respect to a 12-month period, to an eligible individual with a targeted SUD who is a patient in an institution for mental diseases shall be treated as medical assistance for which payment is made under section 1903(a) but only to the extent that such services are furnished for not more than a period of 30 days (whether or not consecutive) during such 12-month period. (B) Clarification Payment made under this paragraph for expenditures under a State plan amendment under this subsection with respect to services described in paragraph (1) furnished to an eligible individual with a targeted SUD shall not affect payment that would otherwise be made under section 1903(a) for expenditures under the State plan (or waiver of such plan) for medical assistance for such individual. (3) Information required in State plan amendment (A) In general A State electing to provide medical assistance pursuant to this subsection shall include with the submission of the State plan amendment under paragraph (1) to the Secretary— (i) a plan on how the State will improve access to outpatient care during the period of the State plan amendment, including a description of— (I) the process by which eligible individuals with targeted SUDs will make the transition from receiving inpatient services in an institution for mental diseases to appropriate outpatient care; and (II) the process the State will undertake to ensure eligible individuals with targeted SUDs are provided care in the most integrated setting appropriate to the needs of the individuals; and (ii) a description of how the State plan amendment ensures an appropriate clinical screening of eligible individuals with targeted SUDs, including assessments to determine level of care and length of stay recommendations based upon the multidimensional assessment criteria of the American Society of Addiction Medicine and to determine the appropriate setting for such care. (B) Report Not later than the sooner of December 31, 2024, or 1 year after the date of the termination of a State plan amendment under this subsection, the State shall submit to the Secretary a report that includes at least— (i) the number of eligible individuals with targeted SUDs who received services pursuant to such State plan amendment; (ii) the length of the stay of each such individual in an institution for mental diseases; (iii) the type of outpatient treatment, including medication-assisted treatment, each such individual received after being discharged from such institution; (iv) the number of eligible individuals with any co-occuring disorders who received services pursuant to such State plan amendment and the co-occuring disorders from which they suffer; and (v) information regarding the effects of a State plan amendment on access to community care for individuals suffering from a mental disease other than substance use disorder. (4) Definitions In this subsection: (A) Eligible individual with a targeted SUD The term eligible individual with a targeted SUD means an individual who— (i) with respect to a State, is enrolled for medical assistance under the State plan (or a waiver of such plan); (ii) is at least 21 years of age; (iii) has not attained 65 years of age; and (iv) has been diagnosed with at least one targeted SUD. (B) Institution for mental diseases The term institution for mental diseases has the meaning given such term in section 1905(i). (C) Opioid prescription pain reliever The term opioid prescription pain reliever includes hydrocodone products, oxycodone products, tramadol products, codeine products, morphine products, fentanyl products, buprenorphine products, oxymorphone products, meperidine products, hydromorphone products, methadone, and any other prescription pain reliever identified by the Assistant Secretary for Mental Health and Substance Use. (D) Other medically necessary services The term other medically necessary services means, with respect to an eligible individual with a targeted SUD who is a patient in an institution for mental diseases, items and services that are provided to such individual outside of such institution to the extent that such items and services would be treated as medical assistance for such individual if such individual were not a patient in such institution. (E) Targeted SUD (i) In general The term targeted SUD means an opioid use disorder or a cocaine use disorder. (ii) Cocaine use disorder The term cocaine use disorder means a disorder that meets the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (or a successor edition), for either dependence or abuse for cocaine, including cocaine base (commonly referred to as crack cocaine ). (iii) Opioid use disorder The term opioid use disorder means a disorder that meets the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (or a successor edition), for heroin use disorder or pain reliever use disorder (including with respect to opioid prescription pain relievers). . 11003. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). .

Passed the House of Representatives June 22, 2018. Karen L. Haas, Clerk

June 26, 2018 Read the second time and placed on the calendar

tv_txt: 115th CONGRESS 2d Session In the House of Representatives, U. S., September 28, 2018 HOUSE AMENDMENT TO SENATE AMENDMENT:

That the House agree to the amendment of the Senate to the bill (H.R. 6) entitled An Act to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. , with the following In lieu of the matter proposed to be inserted by the Senate amendment, insert the following 1. Short title; table of contents (a) Short title This Act may be cited as the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Title I—Medicaid Provisions to Address the Opioid Crisis Sec. 1001. At-risk youth Medicaid protection. Sec. 1002. Health insurance for former foster youth. Sec. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program. Sec. 1004. Medicaid drug review and utilization. Sec. 1005. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder. Sec. 1006. Medicaid health homes for substance-use-disorder Medicaid enrollees. Sec. 1007. Caring recovery for infants and babies. Sec. 1008. Peer support enhancement and evaluation review. Sec. 1009. Medicaid substance use disorder treatment via telehealth. Sec. 1010. Enhancing patient access to non-opioid treatment options. Sec. 1011. Assessing barriers to opioid use disorder treatment. Sec. 1012. Help for moms and babies. Sec. 1013. Securing flexibility to treat substance use disorders. Sec. 1014. MACPAC study and report on MAT utilization controls under State Medicaid programs. Sec. 1015. Opioid addiction treatment programs enhancement. Sec. 1016. Better data sharing to combat the opioid crisis. Sec. 1017. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid. Sec. 1018. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid. Title II—Medicare Provisions to Address the Opioid Crisis Sec. 2001. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders. Sec. 2002. Comprehensive screenings for seniors. Sec. 2003. Every prescription conveyed securely. Sec. 2004. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries. Sec. 2005. Medicare coverage of certain services furnished by opioid treatment programs. Sec. 2006. Encouraging appropriate prescribing under Medicare for victims of opioid overdose. Sec. 2007. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries. Sec. 2008. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies. Title III—FDA and Controlled Substance Provisions Subtitle A—FDA provisions Chapter 1—In general Sec. 3001. Clarifying FDA regulation of non-addictive pain products. Sec. 3002. Evidence-based opioid analgesic prescribing guidelines and report. Chapter 2—Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Sec. 3011. Short title. Sec. 3012. Notification, nondistribution, and recall of controlled substances. Sec. 3013. Single source pattern of imported illegal drugs. Sec. 3014. Strengthening FDA and CBP coordination and capacity. Chapter 3—Stop Illicit Drug Importation Sec. 3021. Short title. Sec. 3022. Restricting entrance of illicit drugs. Chapter 4—Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Sec. 3031. Short title. Sec. 3032. Safety-enhancing packaging and disposal features. Chapter 5—Postapproval study requirements Sec. 3041. Clarifying FDA postmarket authorities. Subtitle B—Controlled substance provisions Chapter 1—More flexibility with respect to medication-Assisted treatment for opioid use disorders Sec. 3201. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Sec. 3202. Medication-assisted treatment for recovery from substance use disorder. Sec. 3203. Grants to enhance access to substance use disorder treatment. Sec. 3204. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation. Chapter 2—Empowering Pharmacists in the Fight Against Opioid Abuse Sec. 3211. Short title. Sec. 3212. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription. Chapter 3—Safe Disposal of Unused Medication Sec. 3221. Short title. Sec. 3222. Disposal of controlled substances of a hospice patient by employees of a qualified hospice program. Sec. 3223. GAO study and report on hospice safe drug management. Chapter 4—Special Registration for Telemedicine Clarification Sec. 3231. Short title. Sec. 3232. Regulations relating to a special registration for telemedicine. Chapter 5—Synthetic Abuse and Labeling of Toxic Substances Sec. 3241. Controlled substance analogues. Chapter 6—Access to Increased Drug Disposal Sec. 3251. Short title. Sec. 3252. Definitions. Sec. 3253. Authority to make grants. Sec. 3254. Application. Sec. 3255. Use of grant funds. Sec. 3256. Eligibility for grant. Sec. 3257. Duration of grants. Sec. 3258. Accountability and oversight. Sec. 3259. Duration of program. Sec. 3260. Authorization of appropriations. Chapter 7—Using Data To Prevent Opioid Diversion Sec. 3271. Short title. Sec. 3272. Purpose. Sec. 3273. Amendments. Sec. 3274. Report. Chapter 8—Opioid Quota Reform Sec. 3281. Short title. Sec. 3282. Strengthening considerations for DEA opioid quotas. Chapter 9—Preventing Drug Diversion Sec. 3291. Short title. Sec. 3292. Improvements to prevent drug diversion. Title IV—Offsets Sec. 4001. Promoting value in Medicaid managed care. Sec. 4002. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program. Sec. 4003. Additional religious exemption from health coverage responsibility requirement. Sec. 4004. Modernizing the reporting of biological and biosimilar products. Title V—Other Medicaid Provisions Subtitle A—Mandatory reporting with respect to adult behavioral health measures Sec. 5001. Mandatory reporting with respect to adult behavioral health measures. Subtitle B—Medicaid IMD Additional Info Sec. 5011. Short title. Sec. 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid. Subtitle C—CHIP Mental Health and Substance Use Disorder Parity Sec. 5021. Short title. Sec. 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program. Subtitle D—Medicaid Reentry Sec. 5031. Short title. Sec. 5032. Promoting State innovations to ease transitions integration to the community for certain individuals. Subtitle E—Medicaid Partnership Sec. 5041. Short title. Sec. 5042. Medicaid providers are required to note experiences in record systems to help in-need patients. Subtitle F—IMD CARE Act Sec. 5051. Short title. Sec. 5052. State option to provide Medicaid coverage for certain individuals with substance use disorders who are patients in certain institutions for mental diseases. Subtitle G—Medicaid Improvement Fund Sec. 5061. Medicaid Improvement Fund. Title VI—Other Medicare Provisions Subtitle A—Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Sec. 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. Subtitle B—Abuse Deterrent Access Sec. 6011. Short title. Sec. 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare. Subtitle C—Medicare Opioid Safety Education Sec. 6021. Medicare opioid safety education. Subtitle D—Opioid Addiction Action Plan Sec. 6031. Short title. Sec. 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment. Subtitle E—Advancing High Quality Treatment for Opioid Use Disorders in Medicare Sec. 6041. Short title. Sec. 6042. Opioid use disorder treatment demonstration program. Subtitle F—Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Sec. 6051. Short title. Sec. 6052. Grants to provide technical assistance to outlier prescribers of opioids. Subtitle G—Preventing Addiction for Susceptible Seniors Sec. 6061. Short title. Sec. 6062. Electronic prior authorization for covered part D drugs. Sec. 6063. Program integrity transparency measures under Medicare parts C and D. Sec. 6064. Expanding eligibility for medication therapy management programs under part D. Sec. 6065. Commit to opioid medical prescriber accountability and safety for seniors. Sec. 6066. No additional funds authorized. Subtitle H—Expanding Oversight of Opioid Prescribing and Payment Sec. 6071. Short title. Sec. 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program. Sec. 6073. No additional funds authorized. Subtitle I—Dr. Todd Graham Pain Management, Treatment, and Recovery Sec. 6081. Short title. Sec. 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments. Sec. 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics. Sec. 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans. Sec. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report. Sec. 6086. Dr. Todd Graham pain management study. Subtitle J—Combating Opioid Abuse for Care in Hospitals Sec. 6091. Short title. Sec. 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program. Sec. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs. Sec. 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use. Sec. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries. Subtitle K—Providing Reliable Options for Patients and Educational Resources Sec. 6101. Short title. Sec. 6102. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. Sec. 6103. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs. Sec. 6104. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management. Subtitle L—Fighting the Opioid Epidemic With Sunshine Sec. 6111. Fighting the opioid epidemic with sunshine. Title VII—Public Health Provisions Subtitle A—Awareness and training Sec. 7001. Report on effects on public health of synthetic drug use. Sec. 7002. First responder training. Subtitle B—Pilot program for public health laboratories To detect fentanyl and other synthetic opioids Sec. 7011. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids. Subtitle C—Indexing Narcotics, Fentanyl, and Opioids Sec. 7021. Establishment of substance use disorder information dashboard. Sec. 7022. Interdepartmental Substance Use Disorders Coordinating Committee. Sec. 7023. National milestones to measure success in curtailing the opioid crisis. Sec. 7024. Study on prescribing limits. Subtitle D—Ensuring Access to Quality Sober Living Sec. 7031. National recovery housing best practices. Subtitle E—Advancing Cutting Edge Research Sec. 7041. Unique research initiatives. Sec. 7042. Pain research. Subtitle F—Jessie’s Law Sec. 7051. Inclusion of opioid addiction history in patient records. Sec. 7052. Communication with families during emergencies. Sec. 7053. Development and dissemination of model training programs for substance use disorder patient records. Subtitle G—Protecting Pregnant Women and Infants Sec. 7061. Report on addressing maternal and infant health in the opioid crisis. Sec. 7062. Protecting moms and infants. Sec. 7063. Early interventions for pregnant women and infants. Sec. 7064. Prenatal and postnatal health. Sec. 7065. Plans of safe care. Subtitle H—Substance Use Disorder Treatment Workforce Sec. 7071. Loan repayment program for substance use disorder treatment workforce. Sec. 7072. Clarification regarding service in schools and other community-based settings. Sec. 7073. Programs for health care workforce. Subtitle I—Preventing Overdoses While in Emergency Rooms Sec. 7081. Program to support coordination and continuation of care for drug overdose patients. Subtitle J—Alternatives to Opioids in the Emergency Department Sec. 7091. Emergency department alternatives to opioids demonstration program. Subtitle K—Treatment, Education, and Community Help To Combat Addiction Sec. 7101. Establishment of regional centers of excellence in substance use disorder education. Sec. 7102. Youth prevention and recovery. Subtitle L—Information from National Mental Health and Substance Use Policy Laboratory Sec. 7111. Information from National Mental Health and Substance Use Policy Laboratory. Subtitle M—Comprehensive Opioid Recovery Centers Sec. 7121. Comprehensive opioid recovery centers. Subtitle N—Trauma-Informed Care Sec. 7131. CDC surveillance and data collection for child, youth, and adult trauma. Sec. 7132. Task force to develop best practices for trauma-informed identification, referral, and support. Sec. 7133. National Child Traumatic Stress Initiative. Sec. 7134. Grants to improve trauma support services and mental health care for children and youth in educational settings. Sec. 7135. Recognizing early childhood trauma related to substance abuse. Subtitle O—Eliminating Opioid Related Infectious Diseases Sec. 7141. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors. Subtitle P—Peer Support Communities of Recovery Sec. 7151. Building communities of recovery. Sec. 7152. Peer support technical assistance center. Subtitle Q—Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Sec. 7161. Preventing overdoses of controlled substances. Sec. 7162. Prescription drug monitoring program. Subtitle R—Review of substance use disorder treatment providers receiving Federal funding Sec. 7171. Review of substance use disorder treatment providers receiving Federal funding. Subtitle S—Other health provisions Sec. 7181. State response to the opioid abuse crisis. Sec. 7182. Report on investigations regarding parity in mental health and substance use disorder benefits. Sec. 7183. CAREER Act. Title VIII—Miscellaneous Subtitle A—Synthetics Trafficking and Overdose Prevention Sec. 8001. Short title. Sec. 8002. Customs fees. Sec. 8003. Mandatory advance electronic information for postal shipments. Sec. 8004. International postal agreements. Sec. 8005. Cost recoupment. Sec. 8006. Development of technology to detect illicit narcotics. Sec. 8007. Civil penalties for postal shipments. Sec. 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest. Sec. 8009. Effective date; regulations. Subtitle B—Opioid Addiction Recovery Fraud Prevention Sec. 8021. Short title. Sec. 8022. Definitions. Sec. 8023. Unfair or deceptive acts or practices with respect to substance use disorder treatment service and products. Subtitle C—Addressing economic and workforce impacts of the opioid crisis Sec. 8041. Addressing economic and workforce impacts of the opioid crisis. Subtitle D—Peer support counseling program for women veterans Sec. 8051. Peer support counseling program for women veterans. Subtitle E—Treating Barriers to Prosperity Sec. 8061. Short title. Sec. 8062. Drug abuse mitigation initiative. Subtitle F—Pilot program to help individuals in recovery from a substance use disorder become stably housed Sec. 8071. Pilot program to help individuals in recovery from a substance use disorder become stably housed. Subtitle G—Human Services Sec. 8081. Supporting family-focused residential treatment. Sec. 8082. Improving recovery and reunifying families. Sec. 8083. Building capacity for family-focused residential treatment. Subtitle H—Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Sec. 8091. Short title. Sec. 8092. Reauthorization of the comprehensive opioid abuse grant program. Subtitle I—Fighting Opioid Abuse in Transportation Sec. 8101. Short title. Sec. 8102. Alcohol and controlled substance testing of mechanical employees. Sec. 8103. Department of Transportation public drug and alcohol testing database. Sec. 8104. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data. Sec. 8105. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl and other substances. Sec. 8106. Status reports on hair testing guidelines. Sec. 8107. Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid. Sec. 8108. Electronic recordkeeping. Sec. 8109. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse. Subtitle J—Eliminating Kickbacks in Recovery Sec. 8121. Short title. Sec. 8122. Criminal penalties. Subtitle K—Substance Abuse Prevention Sec. 8201. Short title. Sec. 8202. Reauthorization of the Office of National Drug Control Policy. Sec. 8203. Reauthorization of the Drug-Free Communities Program. Sec. 8204. Reauthorization of the National Community Anti-Drug Coalition Institute. Sec. 8205. Reauthorization of the High-Intensity Drug Trafficking Area Program. Sec. 8206. Reauthorization of drug court program. Sec. 8207. Drug court training and technical assistance. Sec. 8208. Drug overdose response strategy. Sec. 8209. Protecting law enforcement officers from accidental exposure. Sec. 8210. COPS Anti-Meth Program. Sec. 8211. COPS anti-heroin task force program. Sec. 8212. Comprehensive Addiction and Recovery Act education and awareness. Sec. 8213. Reimbursement of substance use disorder treatment professionals. Sec. 8214. Sobriety Treatment and Recovery Teams (START). Sec. 8215. Provider education. Sec. 8216. Definitions. Sec. 8217. Amendments to administration of the Office. Sec. 8218. Emerging threats committee, plan, and media campaign. Sec. 8219. Drug interdiction. Sec. 8220. GAO Audit. Sec. 8221. National Drug Control Strategy. Sec. 8222. Technical and conforming amendments to the Office of National Drug Control Policy Reauthorization Act of 1998. Subtitle L—Budgetary effects Sec. 8231. Budgetary effect. I Medicaid Provisions to Address the Opioid Crisis 1001. At-risk youth Medicaid protection (a) In general Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ) is amended— (1) in subsection (a)— (A) by striking and at the end of paragraph (82); (B) by striking the period at the end of paragraph (83) and inserting ; and ; and (C) by inserting after paragraph (83) the following new paragraph: (84) provide that— (A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate; (B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and (C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, such individual such that the State makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution. ; and (2) by adding at the end the following new subsection: (nn) Juvenile; eligible juvenile; public institution For purposes of subsection (a)(84) and this subsection: (1) Juvenile The term juvenile means an individual who is— (A) under 21 years of age; or (B) described in subsection (a)(10)(A)(i)(IX). (2) Eligible juvenile The term eligible juvenile means a juvenile who is an inmate of a public institution and who— (A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or (B) is determined eligible for such medical assistance while an inmate of a public institution. (3) Inmate of a public institution The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (30) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution. . (b) No change in exclusion from medical assistance for inmates of public institutions Nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision (A) following paragraph (30) of section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), as redesignated by section 1006(b)(2)(B) of this Act, including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance. (c) No change in continuity of eligibility before adjudication or sentencing Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced. (d) Effective date (1) In general Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 1002. Health insurance for former foster youth (a) Coverage continuity for former foster care children up to age 26 (1) In general Section 1902(a)(10)(A)(i)(IX) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A)(i)(IX) ) is amended— (A) in item (bb), by striking are not described in or enrolled under and inserting are not described in and are not enrolled under ; (B) in item (cc), by striking responsibility of the State and inserting responsibility of a State ; and (C) in item (dd), by striking the State plan under this title or under a waiver of the and inserting a State plan under this title or under a waiver of such a . (2) Effective date The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023. (b) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States— (1) on best practices for— (A) removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and (B) conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and (2) which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program Section 1903 of the Social Security Act ( 42 U.S.C. 1396b ) is amended by adding at the end the following new subsection: (aa) Demonstration project To increase substance use provider capacity (1) In general Not later than the date that is 180 days after the date of the enactment of this subsection, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall— (A) for the first 18-month period of such project, award planning grants described in paragraph (3); and (B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5). (2) Purpose The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities: (A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph. (B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services. (C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that— (i) are authorized to dispense drugs approved by the Food and Drug Administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder; (ii) have in effect a registration or waiver under section 303(g) of the Controlled Substances Act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the Assistant Secretary for Mental Health and Substance Use for purposes of carrying out the requirements of such section 303(g); and (iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services. (D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of— (i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, in accordance with guidelines issued by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome; (ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan); (iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or (iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan). (3) Planning grants (A) In general The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that have a State plan (or waiver of the State plan) approved under this title; (ii) select States in a manner that ensures geographic diversity; and (iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Activities described Activities described in this subparagraph are, with respect to a State, each of the following: (i) Activities that support the development of an initial assessment of the behavioral health treatment needs of the State to determine the extent to which providers are needed (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following: (I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder. (II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver). (III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II). (IV) Projections regarding the extent to which the State participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the State plan (or waiver) during the period of the demonstration project. (ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers. (D) Funding For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended. (4) Post-planning States (A) In general The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that received a planning grant under paragraph (3); (ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application; (iii) select States in a manner that ensures geographic diversity; and (iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Applications (i) In general A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following: (I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i). (II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services. (III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following: (aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services. (bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State. (cc) Milestones and timeliness for implementing activities set forth in the plan. (dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan). (IV) A proposed process for reporting the information required under paragraph (6)(A), including information to assess the effectiveness of the efforts of the State to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection. (V) The expected financial impact of the demonstration project under this subsection on the State. (VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State. (VII) A preliminary plan for how the State will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project. (VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable. (ii) Consultation In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation. (5) Payment (A) In general For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter. (B) Qualified sums defined For purposes of subparagraph (A), the term qualified sums means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use disorder treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use disorder treatment or recovery services. (C) Non-duplication of payment In the case that payment is made under subparagraph (A) with respect to expenditures for substance use disorder treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished. (6) Reports (A) State reports A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use disorder treatment or recovery services for which payment is made to the State under this subsection, on the following: (i) The specific activities with respect to which payment under this subsection was provided. (ii) The number of providers that delivered substance use disorder treatment or recovery services in the State under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project. (iii) The number of individuals enrolled under the State plan (or a waiver of such plan) who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project. (iv) Other matters as determined by the Secretary. (B) CMS reports (i) Initial report Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on— (I) the States awarded planning grants under paragraph (3); (II) the criteria used in such selection; and (III) the activities carried out by such States under such planning grants. (ii) Interim report Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report— (I) on activities carried out under the demonstration project under this subsection; (II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph; (III) with a description of the strengths and limitations of such demonstration project; and (IV) with a plan for the sustainability of such project. (iii) Final report Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report— (I) providing updates on the matters reported in the interim report under clause (ii); (II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and (III) evaluating such demonstration project. (C) AHRQ report Not later than 3 years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4). (7) Data sharing and best practices During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected. (8) CMS funding There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended. . 1004. Medicaid drug review and utilization (a) Medicaid drug utilization review (1) State plan requirement Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by section 1001, is further amended— (A) in paragraph (83), at the end, by striking and ; (B) in paragraph (84), at the end, by striking the period and inserting ; and ; and (C) by inserting after paragraph (84) the following new paragraph: (85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1). . (2) Drug review and utilization requirements Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ), as amended by section 1001, is further amended by adding at the end the following new subsection: (oo) Drug review and utilization requirements (1) In general For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following: (A) Claims review limitations (i) In general The State has in place— (I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State; (II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and (III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and— (aa) benzodiazepines; or (bb) antipsychotics. (ii) Managed care entities The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause. (iii) Rules of construction Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver). (B) Program to monitor antipsychotic medications by children The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically. (C) Fraud and abuse identification The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled. (D) Reports The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary. (E) Clarification Nothing shall prevent a State from satisfying the requirement— (i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019; (ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or (iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date. (2) Annual report by Secretary For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D). (3) Exceptions (A) Certain individuals exempted The drug review and utilization requirements under this subsection shall not apply with respect to an individual who— (i) is receiving— (I) hospice or palliative care; or (II) treatment for cancer; (ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (iii) the State elects to treat as exempted from such requirements. (B) Exception relating to ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). . (3) Managed care entities Section 1932 of the Social Security Act ( 42 U.S.C. 1396u–2 ) is amended by adding at the end the following new subsection: (i) Drug utilization review activities and requirements Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42, Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018. . (b) Identifying and addressing inappropriate prescribing and billing practices under Medicaid (1) In general Section 1927(g) of the Social Security Act ( 42 U.S.C. 1396r–8(g) ) is amended— (A) in paragraph (1)(A)— (i) by striking of section 1903(i)(10)(B) and inserting of section 1902(a)(54) ; (ii) by striking , by not later than January 1, 1993, ; (iii) by inserting after gross overuse, the following: excessive utilization, ; and (iv) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization ; and (B) in paragraph (2)(B)— (i) by inserting after gross overuse, the following: excessive utilization, ; and (ii) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization . (2) Effective date The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020. 1005. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder (a) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include— (1) best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and postdischarge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes; (2) recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home-visiting services; (3) guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and postdischarge services, including parenting supports, and infant-caregiver bonding, including breastfeeding when it is appropriate; and (4) guidance regarding suggested terminology and ICD codes to identify infants with neonatal abstinence syndrome and neonatal opioid withdrawal syndrome, which could include opioid-exposure, opioid withdrawal not requiring pharmacotherapy, and opioid withdrawal requiring pharmacotherapy. (b) GAO study Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title. 1006. Medicaid health homes for substance-use-disorder Medicaid enrollees (a) Extension of enhanced FMAP for certain health homes for individuals with substance use disorders Section 1945(c) of the Social Security Act ( 42 U.S.C. 1396w–4(c) ) is amended— (1) in paragraph (1), by inserting subject to paragraph (4), after except that, ; and (2) by adding at the end the following new paragraph: (4) Special rule relating to substance use disorder health homes (A) In general In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. Nothing in this section shall be construed as prohibiting a State with a State plan amendment that is approved under this section and that is not an SUD-focused State plan amendment from additionally having approved on or after such date an SUD-focused State plan amendment under this section, including for purposes of application of this paragraph. (B) Report requirements In the case of a State with an SUD-focused State plan amendment for which the application of the Federal medical assistance percentage has been extended under subparagraph (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment: (i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual. (ii) The access of such individuals to health care. (iii) The total expenditures of such individuals for health care. For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures. (C) Best practices Not later than October 1, 2020, the Secretary shall make publicly available on the internet website of the Centers for Medicare & Medicaid Services best practices for designing and implementing an SUD-focused State plan amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals. (D) Definitions For purposes of this paragraph: (i) SUD-eligible individuals The term SUD-eligible individual means, with respect to a State, an individual who satisfies all of the following: (I) The individual is an eligible individual with chronic conditions. (II) The individual is an individual with a substance use disorder. (III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary. (ii) SUD-focused State plan amendment The term SUD-focused State plan amendment means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals. . (b) Requirement for State Medicaid plans To provide coverage for medication-Assisted treatment (1) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29) . (2) Inclusion of medication-assisted treatment as medical assistance Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (28), by striking and at the end; (B) by redesignating paragraph (29) as paragraph (30); and (C) by inserting after paragraph (28) the following new paragraph: (29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and . (3) Medication-assisted treatment defined; Waivers Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended by adding at the end the following new subsection: (ee) Medication-Assisted treatment (1) Definition For purposes of subsection (a)(29), the term medication-assisted treatment — (A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), including methadone, and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat opioid use disorders; and (B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy. (2) Exception The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, if before the beginning of such period the State certifies to the satisfaction of the Secretary that implementing such provisions statewide for all individuals eligible to enroll in the State plan (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3). . (4) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025. (B) Exception for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. 1007. Caring recovery for infants and babies (a) State plan amendment Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by sections 1001 and 1004, is further amended— (1) in paragraph (84)(C), by striking and after the semicolon; (2) in paragraph (85), by striking the period at the end and inserting ; and ; and (3) by inserting after paragraph (85), the following new paragraph: (86) provide, at the option of the State, for making medical assistance available on an inpatient or outpatient basis at a residential pediatric recovery center (as defined in subsection (pp)) to infants with neonatal abstinence syndrome. . (b) Residential pediatric recovery center defined Section 1902 of such Act ( 42 U.S.C. 1396a ), as amended by sections 1001 and 1004, is further amended by adding at the end the following new subsection: (pp) Residential pediatric recovery center defined (1) In general For purposes of section 1902(a)(86), the term residential pediatric recovery center means a center or facility that furnishes items and services for which medical assistance is available under the State plan to infants with the diagnosis of neonatal abstinence syndrome without any other significant medical risk factors. (2) Counseling and services A residential pediatric recovery center may offer counseling and other services to mothers (and other appropriate family members and caretakers) of infants receiving treatment at such centers if such services are otherwise covered under the State plan under this title or under a waiver of such plan. Such other services may include the following: (A) Counseling or referrals for services. (B) Activities to encourage caregiver-infant bonding. (C) Training on caring for such infants. . (c) Effective date The amendments made by this section take effect on the date of enactment of this Act and shall apply to medical assistance furnished on or after that date, without regard to final regulations to carry out such amendments being promulgated as of such date. 1008. Peer support enhancement and evaluation review (a) In general Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Committee on Health, Education, Labor and Pensions of the Senate a report on the provision of peer support services under the Medicaid program. (b) Content of report (1) In general The report required under subsection (a) shall include the following information: (A) Information on State coverage of peer support services under Medicaid, including— (i) the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers; (ii) the populations to which States have provided such coverage; (iii) the payment models, including any alternative payment models, used by States to pay providers of such services; and (iv) where available, information on Federal and State spending under Medicaid for peer support services. (B) Information on selected State experiences in providing medical assistance for peer support services under State Medicaid plans and whether States measure the effects of providing such assistance with respect to— (i) improving access to behavioral health services; (ii) improving early detection, and preventing worsening, of behavioral health disorders; (iii) reducing chronic and comorbid conditions; and (iv) reducing overall health costs. (2) Recommendations The report required under subsection (a) shall include recommendations, including recommendations for such legislative and administrative actions related to improving services, including peer support services, and access to peer support services under Medicaid as the Comptroller General of the United States determines appropriate. 1009. Medicaid substance use disorder treatment via telehealth (a) Definitions In this section: (1) Comptroller General The term Comptroller General means the Comptroller General of the United States. (2) School-based health center The term school-based health center has the meaning given that term in section 2110(c)(9) of the Social Security Act ( 42 U.S.C. 1397jj(c)(9) ). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Underserved area The term underserved area means a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act ( 42 U.S.C. 254e(a)(1)(A) )) and a medically underserved area (according to a designation under section 330(b)(3)(A) of the Public Health Service Act ( 42 U.S.C. 254b(b)(3)(A) )). (b) Guidance to States regarding Federal reimbursement for furnishing services and treatment for substance use disorders under Medicaid using services delivered via telehealth, including in school-Based health centers Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue guidance to States on the following: (1) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders, including assessment, medication-assisted treatment, counseling, medication management, and medication adherence with prescribed medication regimes, using services delivered via telehealth. Such guidance shall also include guidance on furnishing services and treatments that address the needs of high-risk individuals, including at least the following groups: (A) American Indians and Alaska Natives. (B) Adults under the age of 40. (C) Individuals with a history of non-fatal overdose. (D) Individuals with a co-occurring serious mental illness and substance use disorder. (2) State options for Federal reimbursement of expenditures under Medicaid for education directed to providers serving Medicaid beneficiaries with substance use disorders using the hub and spoke model, through contracts with managed care entities, through administrative claiming for disease management activities, and under Delivery System Reform Incentive Payment ( DSRIP ) programs. (3) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders for individuals enrolled in Medicaid in a school-based health center using services delivered via telehealth. (c) GAO evaluation of children's access to services and treatment for substance use disorders under Medicaid (1) Study The Comptroller General shall evaluate children’s access to services and treatment for substance use disorders under Medicaid. The evaluation shall include an analysis of State options for improving children's access to such services and treatment and for improving outcomes, including by increasing the number of Medicaid providers who offer services or treatment for substance use disorders in a school-based health center using services delivered via telehealth, particularly in rural and underserved areas. The evaluation shall include an analysis of Medicaid provider reimbursement rates for services and treatment for substance use disorders. (2) Report Not later than 1 year after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. (d) Report on reducing barriers to using services delivered via telehealth and remote patient monitoring for pediatric populations under Medicaid (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a report to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives identifying best practices and potential solutions for reducing barriers to using services delivered via telehealth to furnish services and treatment for substance use disorders among pediatric populations under Medicaid. The report shall include— (A) analyses of the best practices, barriers, and potential solutions for using services delivered via telehealth to diagnose and provide services and treatment for children with substance use disorders, including opioid use disorder; and (B) identification and analysis of the differences, if any, in furnishing services and treatment for children with substance use disorders using services delivered via telehealth and using services delivered in person, such as, and to the extent feasible, with respect to— (i) utilization rates; (ii) costs; (iii) avoidable inpatient admissions and readmissions; (iv) quality of care; and (v) patient, family, and provider satisfaction. (2) Publication The Secretary shall publish the report required under paragraph (1) on a public internet website of the Department of Health and Human Services. 1010. Enhancing patient access to non-opioid treatment options Not later than January 1, 2019, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue 1 or more final guidance documents, or update existing guidance documents, to States regarding mandatory and optional items and services that may be provided under a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.), or under a waiver of such a plan, for non-opioid treatment and management of pain, including, but not limited to, evidence-based, non-opioid pharmacological therapies and non-pharmacological therapies. 1011. Assessing barriers to opioid use disorder treatment (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study regarding the barriers to providing medication used in the treatment of substance use disorders under Medicaid distribution models such as the buy-and-bill model, and options for State Medicaid programs to remove or reduce such barriers. The study shall include analyses of each of the following models of distribution of substance use disorder treatment medications, particularly buprenorphine, naltrexone, and buprenorphine-naloxone combinations: (A) The purchasing, storage, and administration of substance use disorder treatment medications by providers. (B) The dispensing of substance use disorder treatment medications by pharmacists. (C) The ordering, prescribing, and obtaining substance use disorder treatment medications on demand from specialty pharmacies by providers. (2) Requirements For each model of distribution specified in paragraph (1), the Comptroller General shall evaluate how each model presents barriers or could be used by selected State Medicaid programs to reduce the barriers related to the provision of substance use disorder treatment by examining what is known about the effects of the model of distribution on— (A) Medicaid beneficiaries’ access to substance use disorder treatment medications; (B) the differential cost to the program between each distribution model for medication-assisted treatment; and (C) provider willingness to provide or prescribe substance use disorder treatment medications. (b) Report Not later than 15 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. 1012. Help for moms and babies (a) Medicaid State plan Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), as amended by section 1006, is further amended by adding at the end the following new sentence: In the case of a woman who is eligible for medical assistance on the basis of being pregnant (including through the end of the month in which the 60-day period beginning on the last day of her pregnancy ends), who is a patient in an institution for mental diseases for purposes of receiving treatment for a substance use disorder, and who was enrolled for medical assistance under the State plan immediately before becoming a patient in an institution for mental diseases or who becomes eligible to enroll for such medical assistance while such a patient, the exclusion from the definition of medical assistance set forth in the subdivision (B) following paragraph (30) of the first sentence of this subsection shall not be construed as prohibiting Federal financial participation for medical assistance for items or services that are provided to the woman outside of the institution. . (b) Effective date (1) In general Except as provided in paragraph (2), the amendment made by subsection (a) shall take effect on the date of enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendment made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 1013. Securing flexibility to treat substance use disorders Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) Payment shall be made under this title to a State for expenditures for capitation payments described in section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation). . 1014. MACPAC study and report on MAT utilization controls under State Medicaid programs (a) Study The Medicaid and CHIP Payment and Access Commission shall conduct a study and analysis of utilization control policies applied to medication-assisted treatment for substance use disorders under State Medicaid programs, including policies and procedures applied both in fee-for-service Medicaid and in risk-based managed care Medicaid, which shall— (1) include an inventory of such utilization control policies and related protocols for ensuring access to medically necessary treatment; (2) determine whether managed care utilization control policies and procedures for medication-assisted treatment for substance use disorders are consistent with section 438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and (3) identify policies that— (A) limit an individual's access to medication-assisted treatment for a substance use disorder by limiting the quantity of medication-assisted treatment prescriptions, or the number of refills for such prescriptions, available to the individual as part of a prior authorization process or similar utilization protocols; and (B) apply without evaluating individual instances of fraud, waste, or abuse. (b) Report Not later than 1 year after the date of the enactment of this Act, the Medicaid and CHIP Payment and Access Commission shall make publicly available a report containing the results of the study conducted under subsection (a). 1015. Opioid addiction treatment programs enhancement (a) T–MSIS substance use disorder data book (1) In general Not later than the date that is 12 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall publish on the public website of the Centers for Medicare & Medicaid Services a report with comprehensive data on the prevalence of substance use disorders in the Medicaid beneficiary population and services provided for the treatment of substance use disorders under Medicaid. (2) Content of report The report required under paragraph (1) shall include, at a minimum, the following data for each State (including, to the extent available, for the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa): (A) The number and percentage of individuals enrolled in the State Medicaid plan or waiver of such plan in each of the major enrollment categories (as defined in a public letter from the Medicaid and CHIP Payment and Access Commission to the Secretary) who have been diagnosed with a substance use disorder and whether such individuals are enrolled under the State Medicaid plan or a waiver of such plan, including the specific waiver authority under which they are enrolled, to the extent available. (B) A list of the substance use disorder treatment services by each major type of service, such as counseling, medication-assisted treatment, peer support, residential treatment, and inpatient care, for which beneficiaries in each State received at least 1 service under the State Medicaid plan or a waiver of such plan. (C) The number and percentage of individuals with a substance use disorder diagnosis enrolled in the State Medicaid plan or waiver of such plan who received substance use disorder treatment services under such plan or waiver by each major type of service under subparagraph (B) within each major setting type, such as outpatient, inpatient, residential, and other home-based and community-based settings. (D) The number of services provided under the State Medicaid plan or waiver of such plan per individual with a substance use disorder diagnosis enrolled in such plan or waiver for each major type of service under subparagraph (B). (E) The number and percentage of individuals enrolled in the State Medicaid plan or waiver, by major enrollment category, who received substance use disorder treatment through— (i) a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act ( 42 U.S.C. 1396u–2(a)(1)(B) )), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan; (ii) a fee-for-service payment model; or (iii) an alternative payment model, to the extent available. (F) The number and percentage of individuals with a substance use disorder who receive substance use disorder treatment services in an outpatient or home-based and community-based setting after receiving treatment in an inpatient or residential setting, and the number of services received by such individuals in the outpatient or home-based and community-based setting. (3) Annual updates The Secretary shall issue an updated version of the report required under paragraph (1) not later than January 1 of each calendar year through 2024. (4) Use of T–MSIS data The report required under paragraph (1) and updates required under paragraph (3) shall— (A) use data and definitions from the Transformed Medicaid Statistical Information System ( T–MSIS ) data set that is no more than 12 months old on the date that the report or update is published; and (B) as appropriate, include a description with respect to each State of the quality and completeness of the data and caveats describing the limitations of the data reported to the Secretary by the State that is sufficient to communicate the appropriate uses for the information. (b) Making T–MSIS data on substance use disorders available to researchers (1) In general The Secretary shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System. (2) Required data The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings. (3) Initiation of data-sharing activities Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1). 1016. Better data sharing to combat the opioid crisis (a) In general Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ), as amended by section 1013, is further amended by adding at the end the following new paragraph: (8) (A) The State agency administering the State plan under this title may have reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State to the extent the State agency is permitted to access such databases under State law. (B) Such State agency may facilitate reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State, to same extent that the State agency is permitted under State law to access such databases, for— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). (C) Such State agency may share information in such databases, to the same extent that the State agency is permitted under State law to share information in such databases, with— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). . (b) Security and privacy All applicable State and Federal security and privacy protections and laws shall apply to any State agency, individual, or entity accessing 1 or more prescription drug monitoring program databases or obtaining information in such databases in accordance with section 1903(m)(8) of the Social Security Act (as added by subsection (a)). (c) Effective date The amendment made by subsection (a) shall take effect on the date of enactment of this Act. 1017. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to Congress describing innovative State initiatives and strategies for providing housing-related services and supports under a State Medicaid program to individuals with substance use disorders who are experiencing or at risk of experiencing homelessness. (b) Content of report The report required under subsection (a) shall describe the following: (1) Existing methods and innovative strategies developed and adopted by State Medicaid programs that have achieved positive outcomes in increasing housing stability among Medicaid beneficiaries with substance use disorders who are experiencing or at risk of experiencing homelessness, including Medicaid beneficiaries with substance use disorders who are— (A) receiving treatment for substance use disorders in inpatient, residential, outpatient, or home-based and community-based settings; (B) transitioning between substance use disorder treatment settings; or (C) living in supportive housing or another model of affordable housing. (2) Strategies employed by Medicaid managed care organizations, primary care case managers, hospitals, accountable care organizations, and other care coordination providers to deliver housing-related services and supports and to coordinate services provided under State Medicaid programs across different treatment settings. (3) Innovative strategies and lessons learned by States with Medicaid waivers approved under section 1115 or 1915 of the Social Security Act ( 42 U.S.C. 1315 , 1396n), including— (A) challenges experienced by States in designing, securing, and implementing such waivers or plan amendments; (B) how States developed partnerships with other organizations such as behavioral health agencies, State housing agencies, housing providers, health care services agencies and providers, community-based organizations, and health insurance plans to implement waivers or State plan amendments; and (C) how and whether States plan to provide Medicaid coverage for housing-related services and supports in the future, including by covering such services and supports under State Medicaid plans or waivers. (4) Existing opportunities for States to provide housing-related services and supports through a Medicaid waiver under sections 1115 or 1915 of the Social Security Act ( 42 U.S.C. 1315 , 1396n) or through a State Medicaid plan amendment, such as the Assistance in Community Integration Service pilot program, which promotes supportive housing and other housing-related supports under Medicaid for individuals with substance use disorders and for which Maryland has a waiver approved under such section 1115 to conduct the program. (5) Innovative strategies and partnerships developed and implemented by State Medicaid programs or other entities to identify and enroll eligible individuals with substance use disorders who are experiencing or at risk of experiencing homelessness in State Medicaid programs. 1018. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid (a) In general The Secretary of Health and Human Services shall provide technical assistance and support to States regarding the development and expansion of innovative State strategies (including through State Medicaid demonstration projects) to provide housing-related supports and services and care coordination services under Medicaid to individuals with substance use disorders. (b) Report Not later than 180 days after the date of enactment of this Act, the Secretary shall issue a report to Congress detailing a plan of action to carry out the requirements of subsection (a). II Medicare Provisions to Address the Opioid Crisis 2001. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders (a) In general Section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) is amended— (1) in paragraph (2)(B)— (A) in clause (i), in the matter preceding subclause (I), by striking clause (ii) and inserting clause (ii) and paragraph (6)(C) ; and (B) in clause (ii), in the heading, by striking for home dialysis therapy ; (2) in paragraph (4)(C)— (A) in clause (i), by striking paragraph (6) and inserting paragraphs (5), (6), and (7) ; and (B) in clause (ii)(X), by inserting or telehealth services described in paragraph (7) before the period at the end; and (3) by adding at the end the following new paragraph: (7) Treatment of substance use disorder services furnished through telehealth The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph). . (b) Implementation The Secretary of Health and Human Services (in this section referred to as the Secretary ) may implement the amendments made by this section by interim final rule. (c) Report (1) In general Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) on— (A) the utilization of health care items and services under title XVIII of such Act ( 42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and (B) health outcomes related to substance use disorders, such as opioid overdose deaths. (2) Funding For purposes of carrying out paragraph (1), in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended. 2002. Comprehensive screenings for seniors (a) Initial preventive physical examination Section 1861(ww) of the Social Security Act ( 42 U.S.C. 1395x(ww) ) is amended— (1) in paragraph (1)— (A) by striking paragraph (2) and and inserting paragraph (2), ; and (B) by inserting and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)), after upon the agreement with the individual, ; and (2) in paragraph (2)— (A) by redesignating subparagraph (N) as subparagraph (O); and (B) by inserting after subparagraph (M) the following new subparagraph: (N) Screening for potential substance use disorders. ; and (3) by adding at the end the following new paragraph: (4) For purposes of paragraph (1), the term a review of any current opioid prescriptions means, with respect to an individual determined to have a current prescription for opioids— (A) a review of the potential risk factors to the individual for opioid use disorder; (B) an evaluation of the individual's severity of pain and current treatment plan; (C) the provision of information on non-opioid treatment options; and (D) a referral to a specialist, as appropriate. . (b) Annual wellness visit Section 1861(hhh)(2) of the Social Security Act ( 42 U.S.C. 1395x(hhh)(2) ) is amended— (1) by redesignating subparagraph (G) as subparagraph (I); and (2) by inserting after subparagraph (F) the following new subparagraphs: (G) Screening for potential substance use disorders and referral for treatment as appropriate. (H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)). . (c) Rule of construction Nothing in the amendments made by subsection (a) or (b) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination or an annual wellness visit. (d) Effective date The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2020. 2003. Every prescription conveyed securely (a) In general Section 1860D–4(e) of the Social Security Act ( 42 U.S.C. 1395w–104(e) ) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispensing pharmacy are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner prescribing a drug under a research protocol; (vi) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use; (vii) a prescription issued by a practitioner— (I) for an individual who receives hospice care under this title; and (II) that is not covered under the hospice benefit under this title; and (viii) a prescription issued by a practitioner for an individual who is— (I) a resident of a nursing facility (as defined in section 1919(a)); and (II) dually eligible for benefits under this title and title XIX. (C) Dispensing (i) Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). (ii) Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral, or fax prescriptions that are consistent with laws and regulations. (iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. (c) Update of Biometric Component of Multifactor Authentication Not later than 1 year after the date of enactment of this Act, the Attorney General shall update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances. 2004. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended— (1) in paragraph (1), by inserting after subparagraph (E) the following new subparagraph: (F) With respect to plan years beginning on or after January 1, 2022, a drug management program for at-risk beneficiaries described in paragraph (5). ; and (2) in paragraph (5)(A), by inserting (and for plan years beginning on or after January 1, 2022, a PDP sponsor shall) after A PDP sponsor may . 2005. Medicare coverage of certain services furnished by opioid treatment programs (a) Coverage Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (FF), by striking at the end and ; (2) in subparagraph (GG), by inserting at the end and ; and (3) by adding at the end the following new subparagraph: (HH) opioid use disorder treatment services (as defined in subsection (jjj)). . (b) Opioid use disorder treatment services and opioid treatment program defined Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended by adding at the end the following new subsection: (jjj) Opioid use disorder treatment services; opioid treatment program (1) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for use in the treatment of opioid use disorder; (B) dispensing and administration of such medications, if applicable; (C) substance use counseling by a professional to the extent authorized under State law to furnish such services; (D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (E) toxicology testing, and (F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation). (2) Opioid treatment program The term opioid treatment program means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (A) is enrolled under section 1866(j); (B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and (D) meets such additional conditions as the Secretary may find necessary to ensure— (i) the health and safety of individuals being furnished services under such program; and (ii) the effective and efficient furnishing of such services. . (c) Payment (1) In general Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (A) by striking and (BB) and inserting (BB) ; and (B) by inserting before the semicolon at the end the following , and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary . (2) Payment determination Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (w) Opioid use disorder treatment services (1) In general The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program. (2) Considerations The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (3) Annual updates The Secretary shall provide an update each year to the bundled payment amounts under this subsection. . (d) Including opioid treatment programs as Medicare providers Section 1866(e) of the Social Security Act ( 42 U.S.C. 1395cc(e) ) is amended— (1) in paragraph (1), by striking at the end and ; (2) in paragraph (2), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new paragraph: (3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section). . 2006. Encouraging appropriate prescribing under Medicare for victims of opioid overdose Section 1860D–4(c)(5)(C) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(5)(C) ) is amended— (1) in clause (i), in the matter preceding subclause (I), by striking For purposes and inserting Except as provided in clause (v), for purposes ; and (2) by adding at the end the following new clause: (v) Treatment of enrollees with a history of opioid-related overdose (I) In general For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph. (II) Identification and notice For purposes of this clause, the Secretary shall— (aa) identify part D eligible individuals with a history of opioid-related overdose (as so defined); and (bb) notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification. . 2007. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries (a) In general Section 1860D–4(c)(5) of the Social Security Act ( 42 U.S.C. 1395ww–10(c)(5) ) is amended— (1) in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking and the option of an automatic escalation to external review and inserting , including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution ; and (2) in subparagraph (E), by striking and the option and all that follows and inserting the following: and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution. . (b) Effective date The amendments made by subsection (a) shall apply beginning not later January 1, 2021. 2008. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies (a) In general Section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended by adding at the end the following new paragraph: (7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies (A) In general Section 1862(o)(1) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such section applies with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. A PDP sponsor shall notify the Secretary regarding the imposition of any payment suspension pursuant to the previous sentence, such as through the secure internet website portal (or other successor technology) established under section 1859(i). (B) Rule of construction Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review. . (b) Application to MA–PD plans Section 1857(f)(3) of the Social Security Act ( 42 U.S.C. 1395w–27(f)(3) ) is amended by adding at the end the following new subparagraph: (D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies Section 1860D–12(b)(7). . (c) Conforming amendment Section 1862(o)(3) of the Social Security Act ( 42 U.S.C. 1395y(o)(3) ) is amended by inserting , section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), after this subsection . (d) Clarification relating to credible allegation of fraud Section 1862(o) of the Social Security Act ( 42 U.S.C. 1395y(o) ) is amended by adding at the end the following new paragraph: (4) Credible allegation of fraud In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud. . (e) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020. III FDA and Controlled Substance Provisions A FDA provisions 1 In general 3001. Clarifying FDA regulation of non-addictive pain products (a) Public meetings Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction, which may include— (1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), section 510(k) of such Act ( 21 U.S.C. 360(k) ), or section 515(c) of such Act ( 21 U.S.C. 360e(c) ), as applicable; (2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c )) for the development of non-addictive medical products intended to treat pain or addiction; (3) the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and (4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence; (3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including— (A) alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), including patient registries and patient reported outcomes, as appropriate, to support product labeling; (B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit; (C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use; (D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and (E) the appropriate format in which to submit such data results to the Secretary; and (4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section. (c) Definitions In this section— (1) the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )); and (2) the term opioid-sparing means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain. 3002. Evidence-based opioid analgesic prescribing guidelines and report (a) Guidelines The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist. (b) Public input In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall— (1) consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate; (2) collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and (3) provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h) ) for the submission of comments by the public. (c) Report Not later than 1 year after the date of enactment of this Act, or, if earlier, at the time the guidelines under subsection (a) are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection (a) to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline. (d) Updates The Commissioner of Food and Drugs shall periodically— (1) update the guidelines under subsection (a), informed by public input described in subsection (b); and (2) submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection. (e) Statement To accompany guidelines and recommendations The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable— (1) are intended to help inform clinical decisionmaking by prescribers and patients; and (2) are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 2 Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now 3011. Short title This chapter may be cited as the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act . 3012. Notification, nondistribution, and recall of controlled substances (a) Prohibited Acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (eee) The failure to comply with any order issued under section 569D. . (b) Notification, nondistribution, and recall of controlled substances Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: 569D. Notification, nondistribution, and recall of controlled substances (a) Order To cease distribution and recall (1) In general If the Secretary determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substance to immediately cease distribution of such controlled substance. (2) Hearing An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3). (3) Order resolution After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)— (A) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order; (B) continue the order ceasing distribution of the controlled substance until a date specified in such order; or (C) amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall. (4) Risk assessment If the Secretary determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substance, as applicable. (5) Action following order Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substance and provide notification as required by such order. (b) Notice to persons affected If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances. (c) Nondelegation An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Director. (d) Savings clause Nothing contained in this section shall be construed as limiting— (1) the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this Act or the Public Health Service Act; or (2) the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act. . (c) Controlled substances subject to refusal The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by inserting , or is a controlled substance subject to an order under section 569D before , or (4) . (d) Effective date Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act. 3013. Single source pattern of imported illegal drugs Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended by section 3012, is further amended by adding at the end the following: (t) Single source pattern of imported illegal drugs If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 306(b)(3)(D), and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise. . 3014. Strengthening FDA and CBP coordination and capacity (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection. (b) FDA import facilities and inspection capacity (1) In general In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include— (A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate— (i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies; (ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction; (iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods; (iv) upgrades to the security of import facilities; and (v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and (B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate. (2) Innovative technology Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable. (c) Report Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies. 3 Stop Illicit Drug Importation 3021. Short title This chapter may be cited as the Stop Illicit Drug Importation Act of 2018 . 3022. Restricting entrance of illicit drugs (a) Food and Drug Administration and U.S. Customs and Border Protection Cooperation (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act ( 21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act ( 21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act ( 21 U.S.C. 801 et seq.). (2) Report Not later than 9 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section. (b) Debarment, temporary denial of approval, and suspension (1) Prohibited act Section 301(cc) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(cc) ) is amended— (A) by inserting or a drug after food ; and (B) by inserting from such activity after person debarred . (2) Debarment Section 306(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a(b) ) is amended— (A) in paragraph (1)— (i) in the matter preceding subparagraph (A), by inserting or (3) after paragraph (2) ; (ii) in subparagraph (A), by striking the comma at the end and inserting a semicolon; (iii) in subparagraph (B), by striking , or and inserting a semicolon; (iv) in subparagraph (C), by striking the period and inserting ; or ; and (v) by adding at the end the following: (D) a person from importing or offering for import into the United States a drug. ; (B) in paragraph (3)— (i) in the heading, by inserting or drug after Food ; (ii) in subparagraph (A), by striking ; or and inserting a semicolon; (iii) in subparagraph (B), by striking the period and inserting a semicolon; and (iv) by adding at the end the following: (C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); (D) the person has engaged in a pattern of importing or offering for import— (i) controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 ( 19 U.S.C. 1401(m) ); or (ii) adulterated or misbranded drugs that are— (I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or (II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. ; and (C) by adding at the end the following: (5) Definition For purposes of paragraph (3)(D), the term pattern of importing or offering for import means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer. . (c) Imports and exports Section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ), as amended, is further amended— (1) by striking , then such article shall be refused admission inserting or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission ; (2) by inserting If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission. before With respect to an article of food, if importation ; and (3) by striking Clause (2) of the third sentence and all that follows through the period at the end and inserting the following: Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act. . (d) Certain illicit articles Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended, is amended by adding at the end the following— (u) Illicit articles containing active pharmaceutical ingredients (1) In general For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article— (A) is not— (i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and (ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this Act); and (B) is an ingredient that presents significant public health concern and is, or contains— (i) an active ingredient in a drug— (I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or (II) for which— (aa) an investigational use exemption has been authorized under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and (bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or (ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i). (2) Effect This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1). . 4 Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging 3031. Short title This chapter may be cited as the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act . 3032. Safety-enhancing packaging and disposal features (a) Deliberate disposal and packaging elements of strategy Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(e) ) is amended by adding at the end the following: (4) Packaging and disposal The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that— (A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or (B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available. . (b) Assuring access and minimizing burden Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(f)(2)(C) ) is amended— (1) in clause (i) by striking and at the end; and (2) by adding at the end the following: (iii) patients with functional limitations; and . (c) Application to abbreviated new drug applications Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(i) ) is amended— (1) in paragraph (1)— (A) by redesignating subparagraph (B) as subparagraph (C); and (B) inserting after subparagraph (A) the following: (B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug. ; and (2) in paragraph (2)— (A) in subparagraph (A), by striking and at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: (B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and . (d) GAO report Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing— (1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies; (2) an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies; (3) identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act ( 21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products; (4) identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies; (5) a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including— (A) identification of the Federal agencies that oversee such products; (B) identification of the methods of disposal of controlled substances recommended by such agencies for site-of-use, in-home disposal; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; (6) a description of current Federal oversight, if any, of controlled substance packaging technologies, including— (A) identification of the Federal agencies that oversee such technologies; (B) identification of the technologies recommended by such agencies, including unit dose packaging, packaging that provides a set duration, and other packaging systems that may mitigate abuse or misuse; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and (7) recommendations, as appropriate, on— (A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agency or agencies should be responsible for such oversight and, as applicable, review of such products or technologies; and (B) whether there are applicable standards that should be considered to ensure the effectiveness of such products. 5 Postapproval study requirements 3041. Clarifying FDA postmarket authorities (a) Definition of adverse drug experience Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(b)(1)(E) ) is amended by striking of the drug and inserting of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling . (b) Safety labeling changes Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(4) ) is amended— (1) in subparagraph (A) by— (A) striking Safety information and inserting Safety or new effectiveness information ; and (B) by striking If the Secretary becomes and all that follows through in the labeling of the drug and inserting If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug ; (2) in clause (i) of subparagraph (B), by inserting before the semicolon , or new effectiveness information ; (3) in subparagraph (C) by striking safety information and inserting safety or new effectiveness information ; and (4) in subparagraph (E) by striking safety information and inserting safety or new effectiveness information . (c) Guidance Not less than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain. B Controlled substance provisions 1 More flexibility with respect to medication-Assisted treatment for opioid use disorders 3201. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders (a) Conforming applicable number Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(B)(iii) ) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; (bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); (cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)); or (dd) 275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations). . (b) Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended— (1) in subclause (I), by striking or at the end; and (2) by amending subclause (II) to read as follows: (II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or . (c) Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ), as amended by subsection (b), is further amended by adding at the end the following: (III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife. . (d) Definition of qualifying other practitioner Section 303(g)(2)(G)(iv) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iv) ) is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant . (e) Report by Secretary Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iii) )) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment— (1) the average frequency with which qualifying practitioners see their patients; (2) the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral; (3) the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered; (4) the average monthly patient caseload for each type of qualifying practitioner; (5) the treatment retention rates for patients; (6) overdose and mortality rates; and (7) any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner. 3202. Medication-assisted treatment for recovery from substance use disorder (a) Waivers for Maintenance Treatment or Detoxification Section 303(g)(2)(G)(ii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(ii) ) is amended by adding at the end the following: (VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that— (aa) included not less than 8 hours of training on treating and managing opioid-dependent patients; and (bb) included, at a minimum— (AA) the training described in items (aa) through (gg) of subclause (IV); and (BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. . (b) Treatment for children The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ), who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders. (c) Technical Amendment Section 102(24) of the Controlled Substances Act ( 21 U.S.C. 802(24) ) is amended by striking Health, Education, and Welfare and inserting Health and Human Services . 3203. Grants to enhance access to substance use disorder treatment (a) In general The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 3202(a) of this Act. (b) Authorization of appropriations There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023. 3204. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation (a) In general The Controlled Substances Act is amended by inserting after section 309 ( 21 U.S.C. 829 ) the following: 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this title and the regulations issued by the Attorney General under this title, for the purpose of administering the controlled substance by the practitioner if— (1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this title; (2) the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2) and— (A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and (B) the controlled substance is to be administered by injection or implantation; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and (6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General. (b) Modification of number of days before which controlled substance shall be administered (1) Initial 2-year period During the 2-year period beginning on the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will— (A) reduce the risk of diversion; or (B) protect the public health. (2) Modifications after submission of report After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5). (3) Minimum number of days Any modification under this subsection shall be for a period of not less than 7 days. . (b) Study and report Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation. (c) Technical and conforming amendment The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following: Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner. . 2 Empowering Pharmacists in the Fight Against Opioid Abuse 3211. Short title This chapter may be cited as the Empowering Pharmacists in the Fight Against Opioid Abuse Act . 3212. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate, as appropriate, materials for pharmacists, health care providers, and patients on— (1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act ( 21 U.S.C. 829 ) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and (2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances. (b) Materials included In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for— (1) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and (2) other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)). (c) Stakeholder input In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain. 3 Safe Disposal of Unused Medication 3221. Short title This chapter may be cited as the Safe Disposal of Unused Medication Act . 3222. Disposal of controlled substances of a hospice patient by employees of a qualified hospice program (a) In general Subsection (g) of section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ) is amended by adding at the end the following: (5) (A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and— (i) the disposal occurs after the death of a person receiving hospice care; (ii) the controlled substance is expired; or (iii) (I) the employee is— (aa) the physician of the person receiving hospice care; and (bb) registered under section 303(f); and (II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified. (B) For the purposes of this paragraph: (i) The terms hospice care and hospice program have the meanings given to those terms in section 1861(dd) of the Social Security Act. (ii) The term employee of a qualified hospice program means a physician, physician assistant, nurse, or other person who— (I) is employed by, or pursuant to arrangements made by, a qualified hospice program; (II) (aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and (bb) is acting within the scope of such employment in accordance with applicable State law; and (III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion. (iii) The term qualified hospice program means a hospice program that— (I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death; (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the patient or patient representative and family; (bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and (cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and (III) at the time following the disposal of the controlled substances— (aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and (bb) the time, date, and manner in which that disposal occurred. . (b) Guidance The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act ( 21 U.S.C. 822(g) ), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5). (c) Rule of construction relating to State and local law Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs. 3223. GAO study and report on hospice safe drug management (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study on the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual. (2) Contents In conducting the study under paragraph (1), the Comptroller General shall include— (A) an overview of any challenges encountered by selected hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and (B) a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements. (b) Report Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate. 4 Special Registration for Telemedicine Clarification 3231. Short title This chapter may be cited as the Special Registration for Telemedicine Clarification Act of 2018 . 3232. Regulations relating to a special registration for telemedicine Section 311(h)(2) of the Controlled Substances Act ( 21 U.S.C. 831(h)(2) ) is amended to read as follows: (2) Regulations Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying— (A) the limited circumstances in which a special registration under this subsection may be issued; and (B) the procedure for obtaining a special registration under this subsection. . 5 Synthetic Abuse and Labeling of Toxic Substances 3241. Controlled substance analogues Section 203 of the Controlled Substances Act ( 21 U.S.C. 813 ) is amended— (1) by striking A controlled and inserting (a) In general .—A controlled ; and (2) by adding at the end the following: (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws. (c) Limitation For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption. . 6 Access to Increased Drug Disposal 3251. Short title This chapter may be cited as the Access to Increased Drug Disposal Act of 2018 . 3252. Definitions In this chapter— (1) the term Attorney General means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs; (2) the term authorized collector means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation); (3) the term covered grant means a grant awarded under section 3003; and (4) the term eligible collector means a person who is eligible to be an authorized collector. 3253. Authority to make grants The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors. 3254. Application A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum— (1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant; (2) details a plan to increase participation rates of eligible collectors as authorized collectors; and (3) describes how the State will select eligible collectors to be served under the grant. 3255. Use of grant funds A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors. 3256. Eligibility for grant The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General. 3257. Duration of grants The Attorney General shall determine the period of years for which a covered grant is made to a State. 3258. Accountability and oversight A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that— (1) lists the ultimate recipients of the grant amounts; (2) describes the activities undertaken by the State using the grant amounts; and (3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors. 3259. Duration of program The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act. 3260. Authorization of appropriations There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter. 7 Using Data To Prevent Opioid Diversion 3271. Short title This chapter may be cited as the Using Data To Prevent Opioid Diversion Act of 2018 . 3272. Purpose (a) In general The purpose of this chapter is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates. (b) Rule of construction Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to— (1) identify, stop, and report suspicious orders; or (2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) or any successor law or associated regulation. 3273. Amendments (a) Records and reports of registrants Section 307 of the Controlled Substances Act ( 21 U.S.C. 827 ) is amended— (1) by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively; (2) by inserting after subsection (e) the following: (f) (1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances: (A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant. (B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A). (2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates. (3) (A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection. (B) In determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant. ; and (3) by inserting after subsection (i), as so redesignated, the following: (j) All of the reports required under this section shall be provided in an electronic format. . (b) Cooperative arrangements Section 503 of the Controlled Substances Act ( 21 U.S.C. 873 ) is amended by striking subsection (c) and inserting the following: (c) (1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse. (2) If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection. . (c) Civil and criminal penalties Section 402 of the Controlled Substances Act ( 21 U.S.C. 842 ) is amended— (1) in subsection (a)— (A) in paragraph (15), by striking or at the end; (B) in paragraph (16), by striking the period at the end and inserting ; or ; and (C) by inserting after paragraph (16) the following: (17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f). ; and (2) in subsection (c)— (A) in paragraph (1), by striking subparagraph (B) and inserting the following: (B) (i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000. (ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000. ; and (B) in paragraph (2)— (i) in subparagraph (A), by inserting or (D) after subparagraph (B) ; and (ii) by adding at the end the following: (D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000. . 3274. Report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor. 8 Opioid Quota Reform 3281. Short title This chapter may be cited as the Opioid Quota Reform Act . 3282. Strengthening considerations for DEA opioid quotas (a) In general Section 306 of the Controlled Substances Act ( 21 U.S.C. 826 ) is amended— (1) in subsection (a)— (A) by inserting (1) after (a) ; (B) in the second sentence, by striking Production and inserting Except as provided in paragraph (2), production ; and (C) by adding at the end the following: (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance. ; (2) in subsection (b), in the first sentence, by striking production and inserting manufacturing ; (3) in subsection (c), by striking October and inserting December ; and (4) by adding at the end the following: (i) (1) (A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a covered controlled substance ), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States. (B) In estimating diversion under this paragraph, the Attorney General— (i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the Attorney General determines reliable. (C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. (2) (A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States. (B) Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance: (i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance. (ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year. (3) Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will— (A) take into consideration changes in the accepted medical use of the covered controlled substances; and (B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events. . (b) Conforming change The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking production and inserting manufacturing . 9 Preventing Drug Diversion 3291. Short title This chapter may be cited as the Preventing Drug Diversion Act of 2018 . 3292. Improvements to prevent drug diversion (a) Definition Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended by adding at the end the following: (57) The term suspicious order may include, but is not limited to— (A) an order of a controlled substance of unusual size; (B) an order of a controlled substance deviating substantially from a normal pattern; and (C) orders of controlled substances of unusual frequency. . (b) Suspicious orders Part C of the Controlled Substances Act ( 21 U.S.C. 821 et seq.) is amended by adding at the end the following: 312. Suspicious orders (a) Reporting Each registrant shall— (1) design and operate a system to identify suspicious orders for the registrant; (2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and (3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (b) Suspicious order database (1) In general Not later than 1 year after the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders. (2) Satisfaction of reporting requirements If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (c) Sharing information with the States (1) In general The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State. (2) Timing The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information. (3) Coordination In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law. . (c) Reports to Congress (1) Definition In this subsection, the term suspicious order has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this chapter. (2) One-time report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include— (A) a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders; (B) a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States; (C) information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and (D) descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity. (3) Additional reports Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year— (A) the number of reports of suspicious orders; (B) a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and (C) a description of the information shared with States based on reports of suspicious orders. (4) One-time GAO report Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms— (A) would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real time to suppliers before orders are filled; (B) may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and (C) would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids. IV Offsets 4001. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ), as amended by sections 1013 and 1016, is further amended by adding at the end the following new paragraph: (9) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). . 4002. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program Clause (i) of section 1862(b)(7)(A) of the Social Security Act ( 42 U.S.C. 1395y(b)(7)(A) ) is amended to read as follows: (i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been— (I) a primary plan to the program under this title; or (II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and . 4003. Additional religious exemption from health coverage responsibility requirement (a) In general Section 5000A(d)(2)(A) of the Internal Revenue Code of 1986 is amended to read as follows: (A) Religious conscience exemptions (i) In general Such term shall not include any individual for any month if such individual has in effect an exemption under section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act which certifies that— (I) such individual is a member of a recognized religious sect or division thereof which is described in section 1402(g)(1), and is adherent of established tenets or teachings of such sect or division as described in such section; or (II) such individual is a member of a religious sect or division thereof which is not described in section 1402(g)(1), who relies solely on a religious method of healing, and for whom the acceptance of medical health services would be inconsistent with the religious beliefs of the individual. (ii) Special rules (I) Medical health services defined For purposes of this subparagraph, the term medical health services does not include routine dental, vision and hearing services, midwifery services, vaccinations, necessary medical services provided to children, services required by law or by a third party, and such other services as the Secretary of Health and Human Services may provide in implementing section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act. (II) Attestation required Clause (i)(II) shall apply to an individual for months in a taxable year only if the information provided by the individual under section 1411(b)(5)(A) of such Act includes an attestation that the individual has not received medical health services during the preceding taxable year. . (b) Effective date The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2018. (c) Construction Nothing in the amendment made by subsection (a) shall preempt any State law requiring the provision of medical treatment for children, especially those who are seriously ill. 4004. Modernizing the reporting of biological and biosimilar products Subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ) is amended— (1) in section 1111, as amended by section 3(1) of the Patient Right to Know Drug Prices Act— (A) in the paragraph (3) inserted by such section 3(1), by striking an application and inserting a biosimilar biological product application ; (B) in the paragraph (4) inserted by such section 3(1), by inserting application before under section 351(k) of the Public Health Service Act ; (C) in the paragraph (5) inserted by such section 3(1), by striking for licensure of a biological product under section 351(k) of the Public Health Service Act and inserting under section 351(k) of the Public Health Service Act for licensure of a biological product as biosimilar to, or interchangeable with, a reference product ; (D) in paragraph (7), as redesignated and amended by such section 3(1), by striking or under section 351(a) of the Public Health Service Act and inserting or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act ; and (E) in the paragraph (12) added by such section 3(1), by striking means a brand name drug for which a license is in effect under section 351(a) and inserting has the meaning given such term in section 351(i) ; and (2) in section 1112, as amended by section 3(2) of the Patient Right to Know Drug Prices Act— (A) in subsection (a)— (i) in paragraph (1), by striking for which a statement under section 351(l)(3)(B)(ii)(I) of the Public Health Service Act has been provided ; (ii) in paragraph (2)— (I) in subparagraph (C)(i), by striking brand name and inserting listed ; and (II) by amending clause (ii) of subparagraph (C) to read as follows: (ii) any of the time periods referred to in section 351(k)(6) of the Public Health Service Act as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product. ; (B) in subsection (b)— (i) in the subsection heading, by inserting or Biosimilar Biological Product Applicant after Applicant ; (ii) in paragraph (1)(B), by striking the first sentence and inserting the following: A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c). ; and (iii) in paragraph (2)— (I) by striking 2 generic drug applicants and inserting 2 or more generic drug applicants ; and (II) by striking or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned and inserting , an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product ; and (C) in subsection (c)(2), by inserting were entered into within 30 days of, after condition for, . V Other Medicaid Provisions A Mandatory reporting with respect to adult behavioral health measures 5001. Mandatory reporting with respect to adult behavioral health measures Section 1139B of the Social Security Act ( 42 U.S.C. 1320b–9b ) is amended— (1) in subsection (b)— (A) in paragraph (3)— (i) by striking Not later than January 1, 2013 and inserting the following: (A) Voluntary reporting Not later than January 1, 2013 ; and (ii) by adding at the end the following: (B) Mandatory reporting with respect to behavioral health measures Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults. ; and (B) in paragraph (5), by adding at the end the following new subparagraph: (C) Behavioral health measures Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures. ; and (2) in subsection (d)(1)(A)— (A) by striking the such plan and inserting such plan ; and (B) by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)) . B Medicaid IMD Additional Info 5011. Short title This subtitle may be cited as the Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act . 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid (a) In general Not later than January 1, 2020, the Medicaid and CHIP Payment and Access Commission established under section 1900 of the Social Security Act ( 42 U.S.C. 1396 ) shall conduct an exploratory study, using data from a representative sample of States, and submit to Congress a report on at least the following information, with respect to services furnished to individuals enrolled under State plans under the Medicaid program under title XIX of such Act ( 42 U.S.C. 1396 et seq.) (or waivers of such plans) who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such State plans (or waivers): (1) A description of such institutions for mental diseases in each such State, including at a minimum— (A) the number of such institutions in the State; (B) the facility type of such institutions in the State; and (C) any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services. (2) With respect to each such institution for mental diseases in each such State, a description of— (A) such services provided at such institution; (B) the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and (C) the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process. (3) A description of— (A) any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and (B) any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments. (4) A summary of State requirements (such as certification, licensure, and accreditation) applied by each such State to such institutions in order for such institutions to receive payment under the State plan (or waiver) and how each such State determines if such requirements have been met. (5) A summary of State standards (such as quality standards, clinical standards, and facility standards) that such institutions must meet to receive payment under such State plans (or waivers) and how each such State determines if such standards have been met. (6) If determined appropriate by the Commission, recommendations for policies and actions by Congress and the Centers for Medicare & Medicaid Services, such as on how State Medicaid programs may improve care and improve standards and including a recommendation for how the Centers for Medicare & Medicaid Services can improve data collection from such programs to address any gaps in information. (b) Stakeholder input In carrying out subsection (a), the Medicaid and CHIP Payment and Access Commission shall seek input from State Medicaid directors and stakeholders, including at a minimum the Substance Abuse and Mental Health Services Administration, Centers for Medicare & Medicaid Services, State Medicaid officials, State mental health authorities, Medicaid beneficiary advocates, health care providers, and Medicaid managed care organizations. (c) Definitions In this section: (1) Representative sample of States The term representative sample of States means a non-probability sample in which at least two States are selected based on the knowledge and professional judgment of the selector. (2) State The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (3) Institution for mental diseases The term institution for mental diseases has the meaning given such term in section 435.1010 of title 42, Code of Federal Regulations, or any successor regulation. C CHIP Mental Health and Substance Use Disorder Parity 5021. Short title This subtitle may be cited as the CHIP Mental Health and Substance Use Disorder Parity Act . 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program (a) In general Section 2103(c)(1) of the Social Security Act ( 42 U.S.C. 1397cc(c)(1) ) is amended by adding at the end the following new subparagraph: (E) Mental health and substance use disorder services (as defined in paragraph (5)). . (b) Mental health and substance use disorder services (1) In general Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended— (A) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and (B) by inserting after paragraph (4) the following new paragraph: (5) Mental health and substance use disorder services Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income pregnant women (as defined in section 2112(d)) shall— (A) include coverage of mental health services (including behavioral health treatment) necessary to prevent, diagnose, and treat a broad range of mental health symptoms and disorders, including substance use disorders; and (B) be delivered in a culturally and linguistically appropriate manner. . (2) Conforming amendments (A) Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ) is amended, in the matter before paragraph (1), by striking paragraphs (5), (6), and (7) and inserting paragraphs (5), (6), (7), and (8) . (B) Section 2110(a) of the Social Security Act ( 42 U.S.C. 1397jj(a) ) is amended— (i) in paragraph (18), by striking substance abuse each place it appears and inserting substance use ; and (ii) in paragraph (19), by striking substance abuse and inserting substance use . (C) Section 2110(b)(5)(A)(i) of the Social Security Act ( 42 U.S.C. 1397jj(b)(5)(A)(i) ) is amended by striking subsection (c)(5) and inserting subsection (c)(6) . (c) Assuring access to care Section 2102(a)(7)(B) of the Social Security Act ( 42 U.S.C. 1397bb(c)(2) ) is amended by striking section 2103(c)(5) and inserting paragraphs (5) and (6) of section 2103(c) . (d) Mental health services parity Subparagraph (A) of paragraph (7) of section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) (as redesignated by subsection (b)(1)) is amended to read as follows: (A) In general A State child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services (as described in paragraph (5)) provided under such plan comply with the requirements of section 2726(a) of the Public Health Service Act in the same manner as such requirements or limitations apply to a group health plan under such section. . (e) Effective date (1) In general Subject to paragraph (2), the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is 1 year after the date of the enactment of this Act. (2) Exception for State legislation In the case of a State child health plan under title XXI of the Social Security Act (or a waiver of such plan), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan (or waiver) to meet any requirement imposed by the amendments made by this section, the respective plan (or waiver) shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this section. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. D Medicaid Reentry 5031. Short title This subtitle may be cited as the Medicaid Reentry Act . 5032. Promoting State innovations to ease transitions integration to the community for certain individuals (a) Stakeholder group development of best practices; State Medicaid program innovation (1) Stakeholder group best practices Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a stakeholder group of representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, and other relevant representatives from local, State, and Federal jail and prison systems to develop best practices (and submit to the Secretary and Congress a report on such best practices) for States— (A) to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and (B) to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution. (2) State Medicaid program innovation The Secretary of Health and Human Services shall work with States on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the Medicaid program under title XIX of the Social Security Act transition, with respect to enrollment for medical assistance under such program, seamlessly to the community. (b) Guidance on innovative service delivery systems demonstration project opportunities Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a State Medicaid Director letter, based on best practices developed under subsection (a)(1), regarding opportunities to design demonstration projects under section 1115 of the Social Security Act ( 42 U.S.C. 1315 ) to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title XIX of such Act, including systems for, with respect to a period (not to exceed 30 days) immediately prior to the day on which such individuals are expected to be released from such institution— (1) providing assistance and education for enrollment under a State plan under the Medicaid program under title XIX of such Act for such individuals during such period; and (2) providing health care services for such individuals during such period. (c) Rule of construction Nothing under title XIX of the Social Security Act or any other provision of law precludes a State from reclassifying or suspending (rather than terminating) eligibility of an individual for medical assistance under title XIX of the Social Security Act while such individual is an inmate of a public institution. E Medicaid Partnership 5041. Short title This subtitle may be cited as the Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act . 5042. Medicaid providers are required to note experiences in record systems to help in-need patients (a) Requirements under the Medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) is amended by inserting after section 1943 the following new section: 1944. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances (a) In general Subject to subsection (d), beginning October 1, 2021, a State— (1) shall require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance; and (2) in the case that such a provider is not able to conduct such a check despite a good faith effort by such provider— (A) shall require the provider to document such good faith effort, including the reasons why the provider was not able to conduct the check; and (B) may require the provider to submit, upon request, such documentation to the State. (b) Qualified prescription drug monitoring program described A qualified prescription drug monitoring program described in this subsection is, with respect to a State, a prescription drug monitoring program administered by the State that, at a minimum, satisfies each of the following criteria: (1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible: (A) Information regarding the prescription drug history of a covered individual with respect to controlled substances. (B) The number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period. (C) The name, location, and contact information (or other identifying number selected by the State, such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent 12-month period. (2) The program facilitates the integration of information described in paragraph (1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe controlled substances. A qualified prescription drug monitoring program described in this subsection, with respect to a State, may have in place, in accordance with applicable State and Federal law, a data-sharing agreement with the State Medicaid program that allows the medical director and pharmacy director of such program (and any designee of such a director who reports directly to such director) to access the information described in paragraph (1) in an electronic format. The State Medicaid program under this title may facilitate reasonable and limited access, as determined by the State and ensuring documented beneficiary protections regarding the use of such data, to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under section 1903(m) or under section 1905(t)(3), or the medical director or pharmacy director of any entity that has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the State plan (or under a waiver of the State plan). All applicable State and Federal security and privacy laws shall apply to the directors or designees of such directors of any State Medicaid program or entity accessing a qualified prescription drug monitoring program under this section. (c) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (d) Ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the application of the requirement under subsection (a), with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (e) Reports (1) State reports Each State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2023, information including, at a minimum, the following information for the most recent 12-month period: (A) The percentage of covered providers (as determined pursuant to a process established by the State) who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance. (B) Aggregate trends with respect to prescribing controlled substances such as— (i) the quantity of daily morphine milligram equivalents prescribed for controlled substances; (ii) the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and (iii) the types of controlled substances prescribed, including the dates of such prescriptions, the supplies authorized (including the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this title and title XVIII). (C) Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before dispensing a controlled substance to such individual. (D) An accounting of any data or privacy breach of a qualified prescription drug monitoring program described in subsection (b), the number of covered individuals impacted by each such breach, and a description of the steps the State has taken to address each such breach, including, to the extent required by State or Federal law or otherwise determined appropriate by the State, alerting any such impacted individual and law enforcement of the breach. (2) Report by CMS Not later than October 1, 2023, the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information: (A) Guidance for States on how States can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection (b). (B) Best practices for how States and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances. (f) Increase to FMAP and Federal matching rates for certain expenditures relating to qualified prescription drug monitoring programs (1) In general With respect to a State that meets the condition described in paragraph (2) and any quarter occurring during fiscal year 2019 or fiscal year 2020, the Federal medical assistance percentage or Federal matching rate that would otherwise apply to such State under section 1903(a) for such quarter, with respect to expenditures by the State for activities under the State plan (or a waiver of such plan) to design, develop, or implement a prescription drug monitoring program (and to make connections to such program) that satisfies the criteria described in paragraphs (1) and (2) of subsection (b), shall be equal to 100 percent. (2) Condition The condition described in this paragraph, with respect to a State, is that the State (in this paragraph referred to as the administering State ) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug monitoring program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program. (g) Rule of construction Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified prescription drug monitoring program before dispensing controlled substances to such individuals. (h) Definitions In this section: (1) Controlled substance The term controlled substance means a drug that is included in schedule II of section 202(c) of the Controlled Substances Act and, at the option of the State involved, a drug included in schedule III or IV of such section. (2) Covered individual The term covered individual means, with respect to a State, an individual who is enrolled in the State plan (or under a waiver of such plan). Such term does not include an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as exempted from such term. (3) Covered provider (A) In general The term covered provider means, subject to subparagraph (B), with respect to a State, a health care provider who is participating under the State plan (or waiver of the State plan) and licensed, registered, or otherwise permitted by the State to prescribe a controlled substance (or the designee of such provider). (B) Exceptions (i) In general Beginning October 1, 2021, for purposes of this section, such term does not include a health care provider included in any type of health care provider determined by the Secretary to be exempt from application of this section under clause (ii). (ii) Exceptions process Not later than October 1, 2020, the Secretary, after consultation with the National Association of Medicaid Directors, national health care provider associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of health care providers (if any) that should be exempted from the definition of the term covered provider for purposes of this section. . (b) Guidance Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs. (c) Development of model State practices (1) In general Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data-sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act, as added by subsection (a), for the following purposes: (A) Monitoring and preventing fraud, waste, and abuse. (B) Improving health care for individuals enrolled in a State plan under title XIX of such Act (or under a waiver of such plan) who— (i) transition in and out of coverage under such title; (ii) may have sources of health care coverage in addition to coverage under such title; or (iii) pay for prescription drugs with cash. (C) Any other purposes specified by the Secretary. (2) Elements of model practices The model practices described in paragraph (1)— (A) shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and (B) shall include any appropriate beneficiary protections and privacy guidelines. (3) Consultation In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act) with contracts with States pursuant to section 1903(m) of such Act, pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records. (d) Report by Comptroller General Not later than October 1, 2020, the Comptroller General of the United States shall issue a report examining the operation of prescription drug monitoring programs administered by States, including data security and access standards used by such programs. F IMD CARE Act 5051. Short title This title may be cited as the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act . 5052. State option to provide Medicaid coverage for certain individuals with substance use disorders who are patients in certain institutions for mental diseases (a) In general Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.), as amended by preceding sections of this Act, is further amended— (1) in section 1905(a), in the subdivision (B) that follows paragraph (30), by inserting (except in the case of services provided under a State plan amendment described in section 1915(l)) before the period; and (2) in section 1915, by adding at the end the following new subsection: (l) State plan amendment option to provide medical assistance for certain individuals who are patients in certain institutions for mental diseases (1) In general With respect to calendar quarters beginning during the period beginning October 1, 2019, and ending September 30, 2023, a State may elect, through a State plan amendment, to provide medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection. (2) Payments Subject to paragraphs (3) and (4), amounts expended under a State plan amendment under paragraph (1) for services described in such paragraph furnished, with respect to a 12-month period, to an eligible individual who is a patient in an eligible institution for mental diseases shall be treated as medical assistance for which payment is made under section 1903(a) but only to the extent that such services are furnished for not more than a period of 30 days (whether or not consecutive) during such 12-month period. (3) Maintenance of effort (A) In general As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall (during the period in which it so furnished such medical assistance through a State plan amendment under this subsection) maintain on an annual basis a level of funding expended by the State (and political subdivisions thereof) other than under this title from non-Federal funds for— (i) items and services furnished to eligible individuals who are patients in eligible institutions for mental diseases that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection; and (ii) items and services (including services described in subparagraph (B)) furnished to eligible individuals in outpatient and community-based settings that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection. (B) Services described For purposes of subparagraph (A)(ii), services described in this subparagraph are the following: (i) Outpatient and community-based substance use disorder treatment. (ii) Evidence-based recovery and support services. (iii) Clinically-directed therapeutic treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. (iv) Outpatient medication-assisted treatment, related therapies, and pharmacology. (v) Counseling and clinical monitoring. (vi) Outpatient withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or occurring with, an individual’s use of alcohol and other drugs. (vii) Routine monitoring of medication adherence. (viii) Other outpatient and community-based services for the treatment of substance use disorders, as designated by the Secretary. (C) State reporting requirement (i) In general Prior to approval of a State plan amendment under this subsection, as a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall report to the Secretary, in accordance with the process established by the Secretary under clause (ii), the information deemed necessary by the Secretary under such clause. (ii) Process Not later than the date that is 8 months after the date of enactment of this subsection, the Secretary shall establish a process for States to report to the Secretary, at such time and in such manner as the Secretary deems appropriate, such information as the Secretary deems necessary to verify a State’s compliance with subparagraph (A). (4) Ensuring a continuum of services (A) In general As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall carry out each of the requirements described in subparagraphs (B) through (D). (B) Notification Prior to approval of a State plan amendment under this subsection, the State shall notify the Secretary of how the State will ensure that eligible individuals receive appropriate evidence-based clinical screening prior to being furnished with items and services in an eligible institution for mental diseases, including initial and periodic assessments to determine the appropriate level of care, length of stay, and setting for such care for each individual. (C) Outpatient services; inpatient and residential services (i) Outpatient services The State shall, at a minimum, provide medical assistance for services that could otherwise be covered under the State plan, consistent with each of the following outpatient levels of care: (I) Early intervention for individuals who, for a known reason, are at risk of developing substance-related problems and for individuals for whom there is not yet sufficient information to document a diagnosable substance use disorder. (II) Outpatient services for less than 9 hours per week for adults, and for less than 6 hours per week for adolescents, for recovery or motivational enhancement therapies and strategies. (III) Intensive outpatient services for 9 hours or more per week for adults, and for 6 hours or more per week for adolescents, to treat multidimensional instability. (IV) Partial hospitalization services for 20 hours or more per week for adults and adolescents to treat multidimensional instability that does not require 24-hour care. (ii) Inpatient and residential services The State shall provide medical assistance for services that could otherwise be covered under the State plan, consistent with at least 2 of the following inpatient and residential levels of care: (I) Clinically managed, low-intensity residential services that provide adults and adolescents with 24-hour living support and structure with trained personnel and at least 5 hours of clinical service per week per individual. (II) Clinically managed, population-specific, high-intensity residential services that provide adults with 24-hour care with trained counselors to stabilize multidimensional imminent danger along with less intense milieu and group treatment for those with cognitive or other impairments unable to use full active milieu or therapeutic community. (III) Clinically managed, medium-intensity residential services for adolescents, and clinically managed, high-intensity residential services for adults, that provide 24-hour care with trained counselors to stabilize multidimensional imminent danger and preparation for outpatient treatment. (IV) Medically monitored, high-intensity inpatient services for adolescents, and medically monitored, intensive inpatient services withdrawal management for adults, that provide 24-hour nursing care, make physicians available for significant problems in Dimensions 1, 2, or 3, and provide counseling services 16 hours per day. (V) Medically managed, intensive inpatient services for adolescents and adults that provide 24-hour nursing care and daily physician care for severe, unstable problems in Dimensions 1, 2 or 3. (D) Transition of care In order to ensure an appropriate transition for an eligible individual from receiving care in an eligible institution for mental diseases to receiving care at a lower level of clinical intensity within the continuum of care (including outpatient services), the State shall ensure that— (i) a placement in such eligible institution for mental diseases would allow for an eligible individual’s successful transition to the community, considering such factors as proximity to an individual’s support network (such as family members, employment, and counseling and other services near an individual’s residence); and (ii) all eligible institutions for mental diseases that furnish items and services to individuals for which medical assistance is provided under the State plan— (I) are able to provide care at such lower level of clinical intensity; or (II) have an established relationship with another facility or provider that is able to provide care at such lower level of clinical intensity and accepts patients receiving medical assistance under this title under which the eligible institution for mental diseases may arrange for individuals to receive such care from such other facility or provider. (5) Application to managed care Payments for, and limitations to, medical assistance furnished in accordance with this subsection shall be in addition to and shall not be construed to limit or supersede the ability of States to make monthly capitation payments to managed care organizations for individuals receiving treatment in institutions for mental diseases in accordance with section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation). (6) Other medical assistance The provision of medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection shall not prohibit Federal financial participation for medical assistance for items or services that are provided to such eligible individual in or away from the eligible institution for mental disease during any period in which the eligible individual is receiving items or services in accordance with this subsection. (7) Definitions In this subsection: (A) Dimensions 1, 2, or 3 The term Dimensions 1, 2, or 3 has the meaning given that term for purposes of the publication of the American Society of Addiction Medicine entitled The ASAM Criteria: Treatment Criteria for Addictive Substance-Related, and Co-Occurring Conditions, 2013 . (B) Eligible individual The term eligible individual means an individual who— (i) with respect to a State, is enrolled for medical assistance under the State plan or a waiver of such plan; (ii) is at least 21 years of age; (iii) has not attained 65 years of age; and (iv) has at least 1 substance use disorder. (C) Eligible institution for mental diseases The term eligible institution for mental diseases means an institution for mental diseases that— (i) follows reliable, evidence-based practices; and (ii) offers at least 2 forms of medication-assisted treatment for substance use disorders on site, including, in the case of medication-assisted treatment for opioid use disorder, at least 1 antagonist and 1 partial agonist. (D) Institution for mental diseases The term institution for mental diseases has the meaning given that term in section 1905(i). . (b) Rule of construction Nothing in the amendments made by subsection (a) shall be construed as encouraging a State to place an individual in an inpatient or a residential care setting where a home or community-based care setting would be more appropriate for the individual, or as preventing a State from conducting or pursuing a demonstration project under section 1115 of the Social Security Act to improve access to, and the quality of, substance use disorder treatment for eligible populations. G Medicaid Improvement Fund 5061. Medicaid Improvement Fund Section 1941(b)(1) of the Social Security Act ( 42 U.S.C. 1396w–1(b)(1) ) is amended by striking $0 and inserting $31,000,000 . VI Other Medicare Provisions A Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ) is amended by adding at the end the following new clause: (xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))). . B Abuse Deterrent Access 6011. Short title This subtitle may be cited at the Abuse Deterrent Access Act of 2018 . 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare (a) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on— (1) the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an MA–PD plan under part C of title XVIII of the Social Security Act or a prescription drug plan under part D of such title of such Act, taking into account any barriers preventing such individuals from accessing such formulations under such MA–PD or part D plans, such as cost-sharing tiers, fail-first requirements, the price of such formulations, and prior authorization requirements; and (2) the effectiveness of abuse-deterrent opioid formulations in preventing opioid abuse or misuse; the impact of the use of abuse-deterrent opioid formulations on the use or abuse of other prescription or illicit opioids (including changes in deaths from such opioids); and other public health consequences of the use of abuse-deterrent opioid formulations, such as an increase in rates of human immunodeficiency virus. (b) Definition of Abuse-Deterrent opioid formulation In this section, the term abuse-deterrent opioid formulation means an opioid that is a prodrug or that has certain abuse-deterrent properties, such as physical or chemical barriers, agonist or antagonist combinations, aversion properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid. C Medicare Opioid Safety Education 6021. Medicare opioid safety education (a) In general Section 1804 of the Social Security Act ( 42 U.S.C. 1395b–2 ) is amended by adding at the end the following new subsection: (d) The notice provided under subsection (a) shall include— (1) references to educational resources regarding opioid use and pain management; (2) a description of categories of alternative, non-opioid pain management treatments covered under this title; and (3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management. . (b) Effective date The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019. D Opioid Addiction Action Plan 6031. Short title This subtitle may be cited as the Opioid Addiction Action Plan Act . 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment (a) In general Not later than January 1, 2020, the Secretary of Health and Human Services (in this section referred to as the “Secretary”), in collaboration with the Pain Management Best Practices Inter-Agency Task Force convened under section 101(b) of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), shall develop an action plan as described in subsection (b). (b) Action plan components The action plan shall include a review by the Secretary of Medicare and Medicaid payment and coverage policies that may be viewed as potential obstacles to an effective response to the opioid crisis, and recommendations, as determined appropriate by the Secretary, on the following: (1) A review of payment and coverage policies under the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act, including a review of coverage and payment under such programs of all medication-assisted treatment approved by the Food and Drug Administration related to the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including in such review, payment under the Medicare prospective payment system for inpatient hospital services under section 1886(d) of such Act ( 42 U.S.C. 1395ww(d) ) and the Medicare prospective payment system for hospital outpatient department services under section 1833(t) of such Act ( 42 U.S.C. 1395I(t) ), to determine whether those payment policies resulted in incentives or disincentives that have contributed to the opioid crisis. (2) Recommendations for payment and service delivery models to be tested as appropriate by the Center for Medicare and Medicaid Innovation and other federally authorized demonstration projects, including value-based models, that may encourage the use of appropriate medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse. (3) Recommendations for data collection that could facilitate research and policy-making regarding prevention of opioid use disorder as well as data that would aid the Secretary in making coverage and payment decisions under the Medicare and Medicaid programs related to the access to appropriate opioid dependence treatments. (4) A review of Medicare and Medicaid beneficiaries’ access to the full range of medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including access of beneficiaries residing in rural or medically underserved communities. (5) A review of payment and coverage policies under the Medicare program and the Medicaid program related to medical devices that are non-opioid based treatments approved by the Food and Drug Administration for the management of acute pain and chronic pain, for monitoring substance use withdrawal and preventing overdoses of controlled substances, and for treating substance use disorder, including barriers to patient access. (c) Stakeholder meetings (1) In general Beginning not later than 3 months after the date of the enactment of this section, the Secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan described in subsection (b). (2) Participants Participants of meetings described in paragraph (1) shall include representatives from the Food and Drug Administration and National Institutes of Health, biopharmaceutical industry members, medical researchers, health care providers, the medical device industry, the Medicare program, the Medicaid program, and patient advocates. (d) Request for information Not later than 3 months after the date of the enactment of this section, the Secretary shall issue a request for information seeking public feedback regarding ways in which the Centers for Medicare & Medicaid Services can help address the opioid crisis through the development of and application of the action plan. (e) Report to Congress Not later than June 1, 2020, the Secretary shall submit to Congress, and make public, a report that includes— (1) a summary of the results of the Secretary’s review and any recommendations under the action plan; (2) the Secretary’s planned next steps with respect to the action plan; and (3) an evaluation of price trends for drugs used to reverse opioid overdoses (such as naloxone), including recommendations on ways to lower such prices for consumers. (f) Definition of Medication-Assisted treatment In this section, the term medication-assisted treatment includes opioid treatment programs, behavioral therapy, and medications to treat substance abuse disorder. E Advancing High Quality Treatment for Opioid Use Disorders in Medicare 6041. Short title This subtitle may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 6042. Opioid use disorder treatment demonstration program Title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E ( 42 U.S.C. 1395cc–5 ) the following new section: 1866F. Opioid use disorder treatment demonstration program (a) Implementation of 4-Year demonstration program (1) In general Not later than January 1, 2021, the Secretary shall implement a 4-year demonstration program under this title (in this section referred to as the Program ) to increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce expenditures under this title. Under the Program, the Secretary shall make payments under subsection (e) to participants (as defined in subsection (c)(1)(A)) for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams, or arranging for such services to be furnished, to applicable beneficiaries participating in the Program. (2) Opioid use disorder treatment services For purposes of this section, the term opioid use disorder treatment services — (A) means, with respect to an applicable beneficiary, services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act for the treatment of opioid use disorders in an outpatient setting; and (B) includes— (i) medication-assisted treatment; (ii) treatment planning; (iii) psychiatric, psychological, or counseling services (or any combination of such services), as appropriate; (iv) social support services, as appropriate; and (v) care management and care coordination services, including coordination with other providers of services and suppliers not on an opioid use disorder care team. (b) Program design (1) In general The Secretary shall design the Program in such a manner to allow for the evaluation of the extent to which the Program accomplishes the following purposes: (A) Reduces hospitalizations and emergency department visits. (B) Increases use of medication-assisted treatment for opioid use disorders. (C) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV). (D) Does not increase the total spending on items and services under this title. (E) Reduces deaths from opioid overdose. (F) Reduces the utilization of inpatient residential treatment. (2) Consultation In designing the Program, including the criteria under subsection (e)(2)(A), the Secretary shall, not later than 3 months after the date of the enactment of this section, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups. (c) Participants; opioid use disorder care teams (1) Participants (A) Definition In this section, the term participant means an entity or individual— (i) that is otherwise enrolled under this title and that is— (I) a physician (as defined in section 1861(r)(1)); (II) a group practice comprised of at least one physician described in subclause (I); (III) a hospital outpatient department; (IV) a federally qualified health center (as defined in section 1861(aa)(4)); (V) a rural health clinic (as defined in section 1861(aa)(2)); (VI) a community mental health center (as defined in section 1861(ff)(3)(B)); (VII) a clinic certified as a certified community behavioral health clinic pursuant to section 223 of the Protecting Access to Medicare Act of 2014; or (VIII) any other individual or entity specified by the Secretary; (ii) that applied for and was selected to participate in the Program pursuant to an application and selection process established by the Secretary; and (iii) that establishes an opioid use disorder care team (as defined in paragraph (2)) through employing or contracting with health care practitioners described in paragraph (2)(A), and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the Program. (B) Preference In selecting participants for the Program, the Secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence. (2) Opioid use disorder care teams (A) In general For purposes of this section, the term opioid use disorder care team means a team of health care practitioners established by a participant described in paragraph (1)(A) that— (i) shall include— (I) at least one physician (as defined in section 1861(r)(1)) furnishing primary care services or addiction treatment services to an applicable beneficiary; and (II) at least one eligible practitioner (as defined in paragraph (3)), who may be a physician who meets the criterion in subclause (I); and (ii) may include other practitioners licensed under State law to furnish psychiatric, psychological, counseling, and social services to applicable beneficiaries. (B) Requirements for receipt of payment under Program In order to receive payments under subsection (e), each participant in the Program shall— (i) furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services; (ii) meet minimum criteria, as established by the Secretary; and (iii) submit to the Secretary, in such form, manner, and frequency as specified by the Secretary, with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team, data and such other information as the Secretary determines appropriate to— (I) monitor and evaluate the Program; (II) determine if minimum criteria are met under clause (ii); and (III) determine the incentive payment under subsection (e). (3) Eligible practitioner defined For purposes of this section, the term eligible practitioner means a physician or other health care practitioner, such as a nurse practitioner, that— (A) is enrolled under section 1866(j)(1); (B) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and (C) has in effect a waiver in accordance with section 303(g) of the Controlled Substances Act for such purpose and is otherwise in compliance with regulations promulgated by the Substance Abuse and Mental Health Services Administration to carry out such section. (d) Participation of applicable beneficiaries (1) Applicable beneficiary defined In this section, the term applicable beneficiary means an individual who— (A) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B; (B) is not enrolled in a Medicare Advantage plan under part C; (C) has a current diagnosis for an opioid use disorder; and (D) meets such other criteria as the Secretary determines appropriate. Such term shall include an individual who is dually eligible for benefits under this title and title XIX if such individual satisfies the criteria described in subparagraphs (A) through (D). (2) Voluntary beneficiary participation; limitation on number of beneficiaries An applicable beneficiary may participate in the Program on a voluntary basis and may terminate participation in the Program at any time. Not more than 20,000 applicable beneficiaries may participate in the Program at any time. (3) Services In order to participate in the Program, an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant. Participation under the Program shall not affect coverage of or payment for any other item or service under this title for the applicable beneficiary. (4) Beneficiary access to services Nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this title, and applicable beneficiaries shall not be required to relinquish access to any benefit under this title as a condition of receiving services from a participant in the Program. (e) Payments (1) Per applicable beneficiary per month care management fee (A) In general The Secretary shall establish a schedule of per applicable beneficiary per month care management fees. Such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this title to the health care practitioners in the participant’s opioid use disorder care team or, if applicable, to the participant. A participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries, including services not otherwise eligible for payment under this title. (B) Payment amounts In carrying out subparagraph (A), the Secretary may— (i) consider payments otherwise payable under this title for opioid use disorder treatment services and the needs of applicable beneficiaries; (ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care; (iii) pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months, to reflect the greater time and costs required for the planning and initiation of treatment, as compared to maintenance of treatment; and (iv) take into account whether a participant’s opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services. (C) No duplicate payment The Secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month. (2) Incentive payments (A) In general Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid (using a methodology established and at a time determined appropriate by the Secretary) to participants based on the performance of participants with respect to criteria, as determined appropriate by the Secretary, in accordance with subparagraph (B). (B) Criteria (i) In general Criteria described in subparagraph (A) may include consideration of the following: (I) Patient engagement and retention in treatment. (II) Evidence-based medication-assisted treatment. (III) Other criteria established by the Secretary. (ii) Required consultation and consideration In determining criteria described in subparagraph (A), the Secretary shall— (I) consult with stakeholders, including clinicians in the primary care community and in the field of addiction medicine; and (II) consider existing clinical guidelines for the treatment of opioid use disorders. (C) No duplicate payment The Secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary. (f) Multipayer strategy In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the Program under subsection (e)(2)(C). The Secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the Program. (g) Evaluation (1) In general The Secretary shall conduct an intermediate and final evaluation of the program. Each such evaluation shall determine the extent to which each of the purposes described in subsection (b) have been accomplished under the Program. (2) Reports The Secretary shall submit to Congress— (A) a report with respect to the intermediate evaluation under paragraph (1) not later than 3 years after the date of the implementation of the Program; and (B) a report with respect to the final evaluation under paragraph (1) not later than 6 years after such date. (h) Funding (1) Administrative funding For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841. (2) Care management fees and incentives For the purposes of making payments under subsection (e), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 for each of fiscal years 2021 through 2024. (3) Availability Amounts transferred under this subsection for a fiscal year shall be available until expended. (i) Waivers The Secretary may waive any provision of this title as may be necessary to carry out the Program under this section. . F Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment 6051. Short title This subtitle may be cited as the Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Act of 2018 or the REACH OUT Act of 2018 . 6052. Grants to provide technical assistance to outlier prescribers of opioids (a) Grants authorized The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, through the Centers for Medicare & Medicaid Services, award grants, contracts, or cooperative agreements to eligible entities for the purposes described in subsection (b). (b) Use of funds Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance— (1) to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids; (2) to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and (3) to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids. (c) Application Each eligible entity seeking to receive a grant, contract, or cooperative agreement under subsection (a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. (d) Geographic distribution In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State. (e) Definitions In this section: (1) Eligible entity The term eligible entity means— (A) an organization— (i) that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and (ii) that has at least— (I) one individual who is a representative of consumers on its governing body; and (II) one individual who is a representative of health care providers on its governing body; or (B) an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act ( 42 U.S.C. 1320c et seq.). (2) Outlier prescriber of opioids The term outlier prescriber of opioids means, with respect to a period, a prescriber identified by the Secretary under subparagraph (D)(ii) of section 1860D–4(c)(4) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4) ), as added by section 6065 of this Act, to be an outlier prescriber of opioids for such period. (3) Prescribers The term prescriber means any health care professional, including a nurse practitioner or physician assistant, who is licensed to prescribe opioids by the State or territory in which such professional practices. (f) Funding For purposes of implementing this section, $75,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act ( 42 U.S.C. 1395t ), to remain available until expended. G Preventing Addiction for Susceptible Seniors 6061. Short title This subtitle may be cited as the Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018 . 6062. Electronic prior authorization for covered part D drugs Section 1860D–4(e)(2) of the Social Security Act ( 42 U.S.C. 1395w–104(e)(2) ) is amended by adding at the end the following new subparagraph: (E) Electronic prior authorization (i) In general Not later than January 1, 2021, the program shall provide for the secure electronic transmission of— (I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and (II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional. (ii) Electronic transmission (I) Exclusions For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i). (II) Standards In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors. (III) Application Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual. . 6063. Program integrity transparency measures under Medicare parts C and D (a) In general Section 1859 of the Social Security Act ( 42 U.S.C. 1395w–28 ) is amended by adding at the end the following new subsection: (i) Program integrity transparency measures (1) Program integrity portal (A) In general Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure internet website portal (or other successor technology) that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or an entity responsible for carrying out program integrity activities under this part and part D) for the purpose of enabling through such portal (or other successor technology)— (i) the referral by such plans of substantiated or suspicious activities, as defined by the Secretary, of a provider of services (including a prescriber) or supplier related to fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and (ii) data sharing among such MA plans, prescription drug plans, and the Secretary. (B) Required uses of portal The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure internet website portal (or other successor technology) established under subparagraph (A): (i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period. (ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise. (iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation. (iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal (or other successor technology) with respect to activities of substantiated or suspicious activities of fraud, waste, or abuse of a provider of services (including a prescriber) or supplier, if such provider (including a prescriber) or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken. (C) Rulemaking For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes substantiated or suspicious activities of fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.8. In carrying out this subsection, a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for substantiated fraud, waste, or abuse. (D) HIPAA compliant information only For purposes of this subsection, communications may only occur if the communications are permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (2) Quarterly reports Beginning not later than 2 years after the date of the enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal (or other successor technology) described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall— (A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and (B) be anonymized information submitted by plans without identifying the source of such information. (3) Clarification Nothing in this subsection shall preclude or otherwise affect referrals to the Inspector General of the Department of Health and Human Services or other law enforcement entities. . (b) Contract requirement to communicate plan corrective actions against opioids over-prescribers Section 1857(e) of the Social Security Act ( 42 U.S.C. 1395w–27(e) ) is amended by adding at the end the following new paragraph: (5) Communicating plan corrective actions against opioids over-prescribers (A) In general Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on the investigations, credible evidence of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud, and other actions taken by such plans related to inappropriate prescribing of opioids. (B) Process Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A). (C) Regulations For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking— (i) specify a definition for the term inappropriate prescribing and a method for determining if a provider of services prescribes inappropriate prescribing; and (ii) establish the process described in subparagraph (B) and the types of information that shall be submitted through such process. . (c) Reference under part D to program integrity transparency measures Section 1860D–4 of the Social Security Act ( 42 U.S.C. 1395w–104 ) is amended by adding at the end the following new subsection: (m) Program integrity transparency measures For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i). . 6064. Expanding eligibility for medication therapy management programs under part D Section 1860D–4(c)(2)(A)(ii) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(A)(ii) ) is amended— (1) by redesignating subclauses (I) through (III) as items (aa) through (cc), respectively, and adjusting the margins accordingly; (2) by striking are part D eligible individuals who— and inserting are the following: (I) Part D eligible individuals who— ; and (3) by adding at the end the following new subclause: (II) Beginning January 1, 2021, at-risk beneficiaries for prescription drug abuse (as defined in paragraph (5)(C)). . 6065. Commit to opioid medical prescriber accountability and safety for seniors Section 1860D–4(c)(4) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4) ) is amended by adding at the end the following new subparagraph: (D) Notification and additional requirements with respect to outlier prescribers of opioids (i) Notification Not later than January 1, 2021, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be an outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified and that includes resources on proper prescribing methods and other information as specified in accordance with clause (iii). (ii) Identification of outlier prescribers of opioids (I) In general The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the thresholds established under subclause (II), identify prescribers that are outlier opioids prescribers for a period of time specified by the Secretary. (II) Establishment of thresholds For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish thresholds, based on prescriber specialty and geographic area, for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area. (III) Exclusions The following shall not be included in the analysis for identifying outlier prescribers of opioids under this clause: (aa) Claims for covered part D drugs for part D eligible individuals who are receiving hospice care under this title. (bb) Claims for covered part D drugs for part D eligible individuals who are receiving oncology services under this title. (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Inspector General of the Department of Health and Human Services. (iii) Contents of notification The Secretary shall include the following information in the notifications provided under clause (i): (I) Information on how such prescriber compares to other prescribers within the same specialty and geographic area. (II) Information on opioid prescribing guidelines, based on input from stakeholders, that may include the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain and guidelines developed by physician organizations. (III) Other information determined appropriate by the Secretary. (iv) Modifications and expansions (I) Frequency Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input and changes in opioid prescribing utilization and trends. (II) Expansion to other prescriptions The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary. (v) Additional requirements for persistent outlier prescribers In the case of a prescriber who the Secretary determines is persistently identified under clause (ii) as an outlier prescriber of opioids, the following shall apply: (I) Such prescriber may be required to enroll in the program under this title under section 1866(j) if such prescriber is not otherwise required to enroll, but only after other appropriate remedies have been provided, such as the provision of education funded through section 6052 of the SUPPORT for Patients and Communities Act, for a period determined by the Secretary as sufficient to correct the prescribing patterns that lead to identification of such prescriber as a persistent outlier prescriber of opioids. The Secretary shall determine the length of the period for which such prescriber is required to maintain such enrollment, which shall be the minimum period necessary to correct such prescribing patterns. (II) Not less frequently than annually (and in a form and manner determined appropriate by the Secretary), the Secretary, consistent with clause(iv)(I), shall communicate information on such prescribers to sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA–PD plan. (vi) Public availability of information The Secretary shall make aggregate information under this subparagraph available on the internet website of the Centers for Medicare & Medicaid Services. Such information shall be in a form and manner determined appropriate by the Secretary and shall not identify any specific prescriber. In carrying out this clause, the Secretary shall consult with interested stakeholders. (vii) Opioids defined For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary. (viii) Other activities Nothing in this subparagraph shall preclude the Secretary from conducting activities that provide prescribers with information as to how they compare to other prescribers that are in addition to the activities under this subparagraph, including activities that were being conducted as of the date of the enactment of this subparagraph. . 6066. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle and the amendments made by this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. H Expanding Oversight of Opioid Prescribing and Payment 6071. Short title This subtitle may be cited as the Expanding Oversight of Opioid Prescribing and Payment Act of 2018 . 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program Not later than March 15, 2019, the Medicare Payment Advisory Commission shall submit to Congress a report on, with respect to the Medicare program under title XVIII of the Social Security Act, the following: (1) A description of how the Medicare program pays for pain management treatments (both opioid and non-opioid pain management alternatives) in both inpatient and outpatient hospital settings. (2) The identification of incentives under the hospital inpatient prospective payment system under section 1886 of the Social Security Act ( 42 U.S.C. 1395ww ) and incentives under the hospital outpatient prospective payment system under section 1833(t) of such Act ( 42 U.S.C. 1395l(t) ) for prescribing opioids and incentives under each such system for prescribing non-opioid treatments, and recommendations as the Commission deems appropriate for addressing any of such incentives that are adverse incentives. (3) A description of how opioid use is tracked and monitored through Medicare claims data and other mechanisms and the identification of any areas in which further data and methods are needed for improving data and understanding of opioid use. 6073. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. I Dr. Todd Graham Pain Management, Treatment, and Recovery 6081. Short title This subtitle may be cited as the Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 . 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments (a) Outpatient prospective payment system Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended by adding at the end the following new paragraph: (22) Review and revisions of payments for non-opioid alternative treatments (A) In general With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary— (i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives; (ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and (iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management. (B) Priority In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management. (C) Revisions If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B). (D) Rules of construction Nothing in this paragraph shall be construed to preclude the Secretary— (i) from conducting a demonstration before making the revisions described in subparagraph (C); or (ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management. . (b) Ambulatory surgical centers Section 1833(i) of the Social Security Act ( 42 U.S.C. 1395l(i) ) is amended by adding at the end the following new paragraph: (8) The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1833(t)), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary). . 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics (a) Federally qualified health centers Section 1834(o) of the Social Security Act ( 42 U.S.C. 1395m(o) ) is amended by adding at the end the following new paragraph: (3) Additional payments for certain FQHCs with physicians or other practitioners receiving DATA 2000 waivers (A) In general In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally qualified health center services (as defined in section 1861(aa)(3)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph (C), the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Federally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practitioner. (B) Application In order to receive a payment described in subparagraph (A), a Federally qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center. (C) Requirements For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following: (i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B). (ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (D) Funding For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended. . (b) Rural health clinic Section 1833 of the Social Security Act ( 42 U.S.C. 1395l ) is amended— (1) by redesignating the subsection (z) relating to medical review of spinal subluxation services as subsection (aa); and (2) by adding at the end the following new subsection: (bb) Additional payments for certain rural health clinics with physicians or practitioners receiving DATA 2000 waivers (1) In general In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in section 1861(aa)(1)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner. (2) Application In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic. (3) Requirements For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following: (A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2). (B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (4) Funding For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended. . 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans (a) In general Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall submit to Congress a report on the availability of supplemental health care benefits (as described in section 1852(a)(3)(A) of the Social Security Act ( 42 U.S.C. 1395w–22(a)(3)(A) )) designed to treat or prevent substance use disorders under Medicare Advantage plans offered under part C of title XVIII of such Act. Such report shall include the analysis described in subsection (c) and any differences in the availability of such benefits under specialized MA plans for special needs individuals (as defined in section 1859(b)(6) of such Act ( 42 U.S.C. 1395w–28(b)(6) )) offered to individuals entitled to medical assistance under title XIX of such Act and other such Medicare Advantage plans. (b) Consultation The Secretary shall develop the report described in subsection (a) in consultation with relevant stakeholders, including— (1) individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act; (2) entities who advocate on behalf of such individuals; (3) Medicare Advantage organizations; (4) pharmacy benefit managers; and (5) providers of services and suppliers (as such terms are defined in section 1861 of such Act ( 42 U.S.C. 1395x )). (c) Contents The report described in subsection (a) shall include an analysis on the following: (1) The extent to which plans described in such subsection offer supplemental health care benefits relating to coverage of— (A) medication-assisted treatments for opioid use, substance use disorder counseling, peer recovery support services, or other forms of substance use disorder treatments (whether furnished in an inpatient or outpatient setting); and (B) non-opioid alternatives for the treatment of pain. (2) Challenges associated with such plans offering supplemental health care benefits relating to coverage of items and services described in subparagraph (A) or (B) of paragraph (1). (3) The impact, if any, of increasing the applicable rebate percentage determined under section 1854(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395w–24(b)(1)(C) ) for plans offering such benefits relating to such coverage would have on the availability of such benefits relating to such coverage offered under Medicare Advantage plans. (4) Potential ways to improve upon such coverage or to incentivize such plans to offer additional supplemental health care benefits relating to such coverage. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report (a) CMI models Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ), as amended by section 6001, is further amended by adding at the end the following new clauses: (xxvi) Supporting ways to familiarize individuals with the availability of coverage under part B of title XVIII for qualified psychologist services (as defined in section 1861(ii)). (xxvii) Exploring ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services (such as for treating depression) through use of a 24-hour, 7-day a week help line that may inform individuals about the availability of treatment options, including the availability of qualified psychologist services (as defined in section 1861(ii)). . (b) GAO study and report Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, on mental and behavioral health services under the Medicare program under title XVIII of the Social Security Act, including an examination of the following: (1) Information about services furnished by psychiatrists, clinical psychologists, and other professionals. (2) Information about ways that Medicare beneficiaries familiarize themselves about the availability of Medicare payment for qualified psychologist services (as defined in section 1861(ii) of the Social Security Act ( 42 U.S.C. 1395x(ii) ) and ways that the provision of such information could be improved. 6086. Dr. Todd Graham pain management study (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a study analyzing best practices as well as payment and coverage for pain management services under title XVIII of the Social Security Act and submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report containing options for revising payment to providers and suppliers of services and coverage related to the use of multi-disciplinary, evidence-based, non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act. The Secretary shall make such report available on the public website of the Centers for Medicare & Medicaid Services. (b) Consultation In developing the report described in subsection (a), the Secretary shall consult with— (1) relevant agencies within the Department of Health and Human Services; (2) licensed and practicing osteopathic and allopathic physicians, behavioral health practitioners, physician assistants, nurse practitioners, dentists, pharmacists, and other providers of health services; (3) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (4) substance abuse and mental health professional organizations; (5) pain management professional organizations and advocacy entities, including individuals who personally suffer chronic pain; (6) medical professional organizations and medical specialty organizations; (7) licensed health care providers who furnish alternative pain management services; (8) organizations with expertise in the development of innovative medical technologies for pain management; (9) beneficiary advocacy organizations; and (10) other organizations with expertise in the assessment, diagnosis, treatment, and management of pain, as determined appropriate by the Secretary. (c) Contents The report described in subsection (a) shall include the following: (1) An analysis of payment and coverage under title XVIII of the Social Security Act with respect to the following: (A) Evidence-based treatments and technologies for chronic or acute pain, including such treatments that are covered, not covered, or have limited coverage under such title. (B) Evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids. (C) Evidence-based treatments and technologies that treat substance use disorders. (D) Items and services furnished by practitioners through a multi-disciplinary treatment model for pain management, including the patient-centered medical home. (E) Items and services furnished to beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, or have comorbidities and require consultation or management of pain with one or more specialists in pain management, mental health, or addiction treatment. (2) An evaluation of the following: (A) Barriers inhibiting individuals entitled to benefits under part A or enrolled under part B of such title from accessing treatments and technologies described in subparagraphs (A) through (E) of paragraph (1). (B) Costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain, such as acupuncture, therapeutic massage, and items and services furnished by integrated pain management programs. (C) Pain management guidance published by the Federal Government that may be relevant to coverage determinations or other coverage requirements under title XVIII of the Social Security Act. (3) An assessment of all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids. Such assessment shall consider incorporating into such guidance relevant elements of the Va/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain published in February 2017 by the Department of Veterans Affairs and Department of Defense, including adoption of elements of the Department of Defense and Department of Veterans Affairs pain rating scale. (4) The options described in subsection (d). (5) The impact analysis described in subsection (e). (d) Options The options described in this subsection are, with respect to individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act, legislative and administrative options for accomplishing the following: (1) Improving coverage of and payment for pain management therapies without the use of opioids, including interventional pain therapies, and options to augment opioid therapy with other clinical and complementary, integrative health services to minimize the risk of substance use disorder, including in a hospital setting. (2) Improving coverage of and payment for medical devices and non-opioid based pharmacological and non-pharmacological therapies approved or cleared by the Food and Drug Administration for the treatment of pain as an alternative or augment to opioid therapy. (3) Improving and disseminating treatment strategies for beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, and treatment strategies to address health disparities related to opioid use and opioid abuse treatment. (4) Improving and disseminating treatment strategies for beneficiaries with comorbidities who require a consultation or comanagement of pain with one or more specialists in pain management, mental health, or addiction treatment, including in a hospital setting. (5) Educating providers on risks of coadministration of opioids and other drugs, particularly benzodiazepines. (6) Ensuring appropriate case management for beneficiaries who transition between inpatient and outpatient hospital settings, or between opioid therapy to non-opioid therapy, which may include the use of care transition plans. (7) Expanding outreach activities designed to educate providers of services and suppliers under the Medicare program and individuals entitled to benefits under part A or under part B of such title on alternative, non-opioid therapies to manage and treat acute and chronic pain. (8) Creating a beneficiary education tool on alternatives to opioids for chronic pain management. (e) Impact analysis The impact analysis described in this subsection consists of an analysis of any potential effects implementing the options described in subsection (d) would have— (1) on expenditures under the Medicare program; and (2) on preventing or reducing opioid addiction for individuals receiving benefits under the Medicare program. J Combating Opioid Abuse for Care in Hospitals 6091. Short title This subtitle may be cited as the Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018 . 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program (a) In general Not later than July 1, 2019, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall develop and publish on the public website of the Centers for Medicare & Medicaid Services guidance for hospitals receiving payment under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) on pain management strategies and opioid use disorder prevention strategies with respect to individuals entitled to benefits under such part. (b) Consultation In developing the guidance described in subsection (a), the Secretary shall consult with relevant stakeholders, including— (1) medical professional organizations; (2) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (3) health care consumers or groups representing such consumers; and (4) other entities determined appropriate by the Secretary. (c) Contents The guidance described in subsection (a) shall include, with respect to hospitals and individuals described in such subsection, the following: (1) Best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder, including— (A) methods to identify such individuals at-risk of opioid use disorder, including risk stratification; (B) ways to prevent, recognize, and treat opioid overdoses; and (C) resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs. (2) Best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders, including education on— (A) the adverse effects of prolonged opioid use; (B) non-opioid, evidence-based, non-pharmacological pain management treatments; (C) monitoring programs for individuals who have been prescribed opioids; and (D) the prescribing of naloxone along with an initial opioid prescription. (3) Best practices for such hospitals to make such individuals aware of the risks associated with opioid use (which may include use of the notification template described in paragraph (4)). (4) A notification template developed by the Secretary, for use as appropriate, for such individuals who are prescribed an opioid that— (A) explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely; (B) highlights multimodal and evidence-based non-opioid alternatives for pain management; (C) encourages such individuals to talk to their health care providers about such alternatives; (D) provides for a method (through signature or otherwise) for such an individual, or person acting on such individual’s behalf, to acknowledge receipt of such notification template; (E) is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and (F) includes any other information determined appropriate by the Secretary. (5) Best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital, including— (A) ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners; (B) guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs; (C) strategies to reduce long-term opioid prescriptions; and (D) methods to identify such practitioners who may be over-prescribing opioids. (6) Other information the Secretary determines appropriate, including any such information from the Opioid Safety Initiative established by the Department of Veterans Affairs or the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs Section 1890A of the Social Security Act ( 42 U.S.C. 1395aaa–1 ) is amended by adding at the end the following new subsection: (g) Technical expert panel review of opioid and opioid use disorder quality measures (1) In general Not later than 180 days after the date of the enactment of this subsection, the Secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders, including care, prevention, diagnosis, health outcomes, and treatment furnished to individuals with opioid use disorders. The Secretary may use the entity with a contract under section 1890(a) and amend such contract as necessary to provide for the establishment of such technical expert panel. (2) Review and assessment Not later than 1 year after the date the technical expert panel described in paragraph (1) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall— (A) review quality measures that relate to opioids and opioid use disorders, including existing measures and those under development; (B) identify gaps in areas of quality measurement that relate to opioids and opioid use disorders, and identify measure development priorities for such measure gaps; and (C) make recommendations to the Secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System under section 1848(q), the alternative payment models under section 1833(z)(3)(C), the shared savings program under section 1899, the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and the hospital value-based purchasing program under section 1886(o). (3) Consideration of measures by secretary The Secretary shall consider— (A) using opioid and opioid use disorder measures (including measures used under the Merit-Based Incentive Payment System under section 1848(q), measures recommended under paragraph (2)(C), and other such measures identified by the Secretary) in alternative payment models under section 1833(z)(3)(C) and in the shared savings program under section 1899; and (B) using opioid measures described in subparagraph (A), as applicable, in the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and in the hospital value-based purchasing program under section 1886(o). (4) Prioritization of measure development The Secretary shall prioritize for measure development the gaps in quality measures identified under paragraph (2)(B). (5) Prioritization of measure endorsement The Secretary— (A) during the period beginning on the date of the enactment of this subsection and ending on December 31, 2023, shall prioritize the endorsement of measures relating to opioids and opioid use disorders by the entity with a contract under subsection (a) of section 1890 in connection with endorsement of measures described in subsection (b)(2) of such section; and (B) on and after January 1, 2024, may prioritize the endorsement of such measures by such entity. . 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use (a) Technical expert panel on reducing surgical setting opioid use (1) In general Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a technical expert panel, including medical and surgical specialty societies and hospital organizations, to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings and on best practices for pain management, including with respect to the following: (A) Approaches that limit patient exposure to opioids during the perioperative period, including pre-surgical and post-surgical injections, and that identify such patients at risk of opioid use disorder pre-operation. (B) Shared decision making with patients and families on pain management, including a review of payment to ensure payment under the Medicare program under title XVIII of the Social Security Act accounts for time spent on shared decision making. (C) Education on the safe use, storage, and disposal of opioids. (D) Prevention of opioid misuse and abuse after discharge. (E) Development of a clinical algorithm to identify and treat at-risk, opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period. (2) Report Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress and make public a report containing the recommendations developed under paragraph (1) and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge from such setting. (b) Data collection on perioperative opioid use Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains the following: (1) The diagnosis-related group codes identified by the Secretary as having the highest volume of surgeries. (2) With respect to each of such diagnosis-related group codes so identified, a determination by the Secretary of the data that is both available and reported on opioid use following such surgeries, such as with respect to— (A) surgical volumes, practices, and opioid prescribing patterns; (B) opioid consumption, including— (i) perioperative days of therapy; (ii) average daily dose at the hospital, including dosage greater than 90 milligram morphine equivalent; (iii) post-discharge prescriptions and other combination drugs that are used before intervention and after intervention; (iv) quantity and duration of opioid prescription at discharge; and (v) quantity consumed and number of refills; (C) regional anesthesia and analgesia practices, including pre-surgical and post-surgical injections; (D) naloxone reversal; (E) post-operative respiratory failure; (F) information about storage and disposal; and (G) such other information as the Secretary may specify. (3) Recommendations for improving data collection on perioperative opioid use, including an analysis to identify and reduce barriers to collecting, reporting, and analyzing the data described in paragraph (2), including barriers related to technological availability. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall post on the public website of the Centers for Medicare & Medicaid Services all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids and applicable to opioid prescriptions for individuals entitled to benefits under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) or enrolled under part B of such title of such Act ( 42 U.S.C. 1395j et seq.). (b) Update of guidance (1) Periodic update The Secretary shall, in consultation with the entities specified in paragraph (2), periodically (as determined appropriate by the Secretary) update guidance described in subsection (a) and revise the posting of such guidance on the website described in such subsection. (2) Consultation The entities specified in this paragraph are the following: (A) Medical professional organizations. (B) Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )). (C) Health care consumers or groups representing such consumers. (D) Other entities determined appropriate by the Secretary. K Providing Reliable Options for Patients and Educational Resources 6101. Short title This subtitle may be cited as the Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018 . 6102. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain Section 1860D–4(a)(1) of the Social Security Act ( 42 U.S.C. 1395w–104(a)(1) ) is amended— (1) in subparagraph (A), by inserting , subject to subparagraph (C), before including ; (2) in subparagraph (B), by adding at the end the following new clause: (vi) For plan year 2021 and each subsequent plan year, subject to subparagraph (C), with respect to the treatment of pain— (I) the risks associated with prolonged opioid use; and (II) coverage of nonpharmacological therapies, devices, and nonopioid medications— (aa) in the case of an MA–PD plan under part C, under such plan; and (bb) in the case of a prescription drug plan, under such plan and under parts A and B. ; and (3) by adding at the end the following new subparagraph: (C) Targeted provision of information A PDP sponsor of a prescription drug plan may, in lieu of disclosing the information described in subparagraph (B)(vi) to each enrollee under the plan, disclose such information through mail or electronic communications to a subset of enrollees under the plan, such as enrollees who have been prescribed an opioid in the previous 2-year period. . 6103. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs (a) Medicare Advantage Section 1852 of the Social Security Act ( 42 U.S.C. 1395w–22 ) is amended by adding at the end the following new subsection: (n) Provision of information relating to the safe disposal of certain prescription drugs (1) In general In the case of an individual enrolled under an MA or MA–PD plan who is furnished an in-home health risk assessment on or after January 1, 2021, such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal. (2) Criteria The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances. . (b) Prescription drug plans Section 1860D–4(c)(2)(B) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(B) ) is amended— (1) by striking may include elements that promote ; (2) by redesignating clauses (i) through (iii) as subclauses (I) through (III) and adjusting the margins accordingly; (3) by inserting before subclause (I), as so redesignated, the following new clause: (i) may include elements that promote— ; (4) in subclause (III), as so redesignated, by striking the period at the end and inserting ; and ; and (5) by adding at the end the following new clause: (ii) with respect to plan years beginning on or after January 1, 2021, shall provide for— (I) the provision of information to the enrollee on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under section 1852(n)(2), including information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal; and (II) cost-effective means by which an enrollee may so safely dispose of such drugs. . 6104. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management (a) Restriction on the use of pain questions in HCAHPS Section 1886(b)(3)(B)(viii) of the Social Security Act ( 42 U.S.C. 1395ww(b)(3)(B)(viii) ) is amended by adding at the end the following new subclause: (XII) (aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2020, such survey may not include questions about communication by hospital staff with an individual about such individual’s pain unless such questions take into account, as applicable, whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain. (bb) The Secretary shall not include on the Hospital Compare internet website any measures based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 or 2019 about communication by hospital staff with an individual about such individual’s pain. . (b) Restriction on use of 2018 and 2019 pain questions in the hospital value-based purchasing program Section 1886(o)(2)(B) of the Social Security Act ( 42 U.S.C. 1395ww(o)(2)(B) ) is amended by adding at the end the following new clause: (iii) HCAHPS pain questions The Secretary may not include under subparagraph (A) a measure that is based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 or 2019 about communication by hospital staff with an individual about the individual’s pain. . L Fighting the Opioid Epidemic With Sunshine 6111. Fighting the opioid epidemic with sunshine (a) Inclusion of information regarding payments to additional practitioners (1) In general Section 1128G(e)(6) of the Social Security Act (42 U.S.C. 1320a–7h(e)(6)) is amended— (A) in subparagraph (A), by adding at the end the following new clauses: (iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1861(aa)(5)). (iv) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)). (v) A certified nurse-midwife (as defined in section 1861(gg)(2)). ; and (B) in subparagraph (B), by inserting , physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife after physician . (2) Effective date The amendments made by this subsection shall apply with respect to information required to be submitted under section 1128G of the Social Security Act ( 42 U.S.C. 1320a–7h ) on or after January 1, 2022. (b) Sunset of exclusion of National Provider Identifier of covered recipient in information made publicly available Section 1128G(c)(1)(C)(viii) of the Social Security Act (42 U.S.C. 1320a–7h(c)(1)(C)(viii)) is amended by striking does not contain and inserting in the case of information made available under this subparagraph prior to January 1, 2022, does not contain . (c) Administration Chapter 35 of title 44, United States Code, shall not apply to this section or the amendments made by this section. VII Public Health Provisions A Awareness and training 7001. Report on effects on public health of synthetic drug use (a) In general Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Surgeon General of the Public Health Service, shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the health effects of new psychoactive substances, including synthetic drugs, used by adolescents and young adults. (b) New psychoactive substance defined For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act ( 21 U.S.C. 802(32) ). 7002. First responder training Section 546 of the Public Health Service Act ( 42 U.S.C. 290ee–1 ) is amended— (1) in subsection (c)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3), by striking the period and inserting ; and ; and (C) by adding at the end the following: (4) train and provide resources for first responders and members of other key community sectors on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure to such drugs and respond appropriately when exposure occurs. ; (2) in subsection (d), by striking and mechanisms for referral to appropriate treatment for an entity receiving a grant under this section and inserting mechanisms for referral to appropriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs ; (3) in subsection (f)— (A) in paragraph (3), by striking and at the end; (B) in paragraph (4), by striking the period and inserting ; and ; and (C) by adding at the end the following: (5) the number of first responders and members of other key community sectors trained on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs. ; (4) by redesignating subsection (g) as subsection (h); (5) by inserting after subsection (f) the following: (g) Other key community sectors In this section, the term other key community sectors includes substance use disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and jail populations and offender reentry programs, health care providers, harm reduction groups, pharmacies, community health centers, tribal health facilities, and mental health providers. ; and (6) in subsection (h), as so redesignated, by striking $12,000,000 for each of fiscal years 2017 through 2021 and inserting $36,000,000 for each of fiscal years 2019 through 2023 . B Pilot program for public health laboratories To detect fentanyl and other synthetic opioids 7011. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids (a) Grants The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall award grants to, or enter into cooperative agreements with, Federal, State, and local agencies to improve coordination between public health laboratories and laboratories operated by law enforcement agencies, such as Customs and Border Protection and the Drug Enforcement Administration, to improve detection of synthetic opioids, including fentanyl and its analogues, as described in subsection (b). (b) Detection activities The Secretary, in consultation with the Director of the National Institute of Standards and Technology, the Director of the Centers for Disease Control and Prevention, the Attorney General of the United States, and the Administrator of the Drug Enforcement Administration, shall, for purposes of this section, develop or identify— (1) best practices for safely handling and testing synthetic opioids, including fentanyl and its analogues, including with respect to reference materials, instrument calibration, and quality control protocols; (2) reference materials and quality control standards related to synthetic opioids, including fentanyl and its analogues, to enhance— (A) clinical diagnostics; (B) postmortem data collection; and (C) portable testing equipment utilized by law enforcement and public health officials; and (3) procedures for the identification of new and emerging synthetic opioid formulations and procedures for reporting those findings to appropriate law enforcement agencies and Federal, State, and local public health laboratories and health departments, as appropriate. (c) Laboratories The Secretary shall require recipients of grants or cooperative agreements under subsection (a) to— (1) follow the best practices established under subsection (b) and have the appropriate capabilities to provide laboratory testing of controlled substances, such as synthetic fentanyl, and biospecimens for the purposes of aggregating and reporting public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate; (2) work with law enforcement agencies and public health authorities, as practicable; (3) provide early warning information to Federal, State, and local law enforcement agencies and public health authorities regarding trends or other data related to the supply of synthetic opioids, including fentanyl and its analogues; (4) provide biosurveillance capabilities with respect to identifying trends in adverse health outcomes associated with non-fatal exposures; and (5) provide diagnostic testing, as appropriate and practicable, for non-fatal exposures of emergency personnel, first responders, and other individuals. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023. C Indexing Narcotics, Fentanyl, and Opioids 7021. Establishment of substance use disorder information dashboard Title XVII of the Public Health Service Act ( 42 U.S.C. 300u et seq.) is amended by adding at the end the following new section: 1711. Establishment of substance use disorder information dashboard (a) In general Not later than 6 months after the date of the enactment of this section, the Secretary of Health and Human Services shall, in consultation with the Director of National Drug Control Policy, establish and periodically update, on the Internet website of the Department of Health and Human Services, a public information dashboard that— (1) provides links to information on programs within the Department of Health and Human Services related to the reduction of opioid and other substance use disorders; (2) provides access, to the extent practicable and appropriate, to publicly available data, which may include data from agencies within the Department of Health and Human Services and— (A) other Federal agencies; (B) State, local, and Tribal governments; (C) nonprofit organizations; (D) law enforcement; (E) medical experts; (F) public health educators; and (G) research institutions regarding prevention, treatment, recovery, and other services for opioid and other substance use disorders; (3) provides data on substance use disorder prevention and treatment strategies in different regions of and populations in the United States; (4) identifies information on alternatives to controlled substances for pain management, such as approaches studied by the National Institutes of Health Pain Consortium, the National Center for Complimentary and Integrative Health, and other institutes and centers at the National Institutes of Health, as appropriate; and (5) identifies guidelines and best practices for health care providers regarding treatment of substance use disorders. (b) Controlled substance defined In this section, the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ). . 7022. Interdepartmental Substance Use Disorders Coordinating Committee (a) Establishment Not later than 3 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, in coordination with the Director of National Drug Control Policy, establish a committee, to be known as the Interdepartmental Substance Use Disorders Coordinating Committee (in this section referred to as the Committee ), to coordinate Federal activities related to substance use disorders. (b) Membership (1) Federal members The Committee shall be composed of the following Federal representatives, or the designees of such representatives: (A) The Secretary, who shall serve as the Chair of the Committee. (B) The Attorney General of the United States. (C) The Secretary of Labor. (D) The Secretary of Housing and Urban Development. (E) The Secretary of Education. (F) The Secretary of Veterans Affairs. (G) The Commissioner of Social Security. (H) The Assistant Secretary for Mental Health and Substance Use. (I) The Director of National Drug Control Policy. (J) Representatives of other Federal agencies that support or conduct activities or programs related to substance use disorders, as determined appropriate by the Secretary. (2) Non-Federal members The Committee shall include a minimum of 15 non-Federal members appointed by the Secretary, of which— (A) at least two such members shall be an individual who has received treatment for a diagnosis of a substance use disorder; (B) at least two such members shall be a director of a State substance abuse agency; (C) at least two such members shall be a representative of a leading research, advocacy, or service organization for adults with substance use disorder; (D) at least two such members shall— (i) be a physician, licensed mental health professional, advance practice registered nurse, or physician assistant; and (ii) have experience in treating individuals with substance use disorders; (E) at least one such member shall be a substance use disorder treatment professional who provides treatment services at a certified opioid treatment program; (F) at least one such member shall be a substance use disorder treatment professional who has research or clinical experience in working with racial and ethnic minority populations; (G) at least one such member shall be a substance use disorder treatment professional who has research or clinical mental health experience in working with medically underserved populations; (H) at least one such member shall be a State-certified substance use disorder peer support specialist; (I) at least one such member shall be a drug court judge or a judge with experience in adjudicating cases related to substance use disorder; (J) at least one such member shall be a public safety officer with extensive experience in interacting with adults with a substance use disorder; and (K) at least one such member shall be an individual with experience providing services for homeless individuals with a substance use disorder. (c) Terms (1) In general A member of the Committee appointed under subsection (b)(2) shall be appointed for a term of 3 years and may be reappointed for one or more 3-year terms. (2) Vacancies A vacancy on the Committee shall be filled in the same manner in which the original appointment was made. Any individual appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and may serve after the expiration of such term until a successor has been appointed. (d) Meetings The Committee shall meet not fewer than two times each year. (e) Duties The Committee shall— (1) identify areas for improved coordination of activities, if any, related to substance use disorders, including research, services, supports, and prevention activities across all relevant Federal agencies; (2) identify and provide to the Secretary recommendations for improving Federal programs for the prevention and treatment of, and recovery from, substance use disorders, including by expanding access to prevention, treatment, and recovery services; (3) analyze substance use disorder prevention and treatment strategies in different regions of and populations in the United States and evaluate the extent to which Federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies; (4) make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in paragraphs (1) through (3); (5) make recommendations to the Secretary regarding public participation in decisions relating to substance use disorders and the process by which public feedback can be better integrated into such decisions; and (6) make recommendations to ensure that substance use disorder research, services, supports, and prevention activities of the Department of Health and Human Services and other Federal agencies are not unnecessarily duplicative. (f) Annual report Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the life of the Committee, the Committee shall publish on the Internet website of the Department of Health and Human Services, which may include the public information dashboard established under section 1711 of the Public Health Service Act, as added by section 7021, a report summarizing the activities carried out by the Committee pursuant to subsection (e), including any findings resulting from such activities. (g) Working groups The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to enable the working group to carry out the duties delegated to the working group. (h) Federal Advisory Committee Act The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee only to the extent that the provisions of such Act do not conflict with the requirements of this section. (i) Sunset The Committee shall terminate on the date that is 6 years after the date on which the Committee is established under subsection (a). 7023. National milestones to measure success in curtailing the opioid crisis (a) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), in coordination with the Administrator of the Drug Enforcement Administration and the Director of the Office of National Drug Control Policy, shall develop or identify existing national indicators (referred to in this section as the national milestones ) to measure success in curtailing the opioid crisis, with the goal of significantly reversing the incidence and prevalence of opioid misuse and abuse, and opioid-related morbidity and mortality in the United States within 5 years of such date of enactment. (b) National milestones to end the opioid crisis The national milestones under subsection (a) shall include the following: (1) Not fewer than 10 indicators or metrics to accurately and expediently measure progress in meeting the goal described in subsection (a), which shall, as appropriate, include, indicators or metrics related to— (A) the number of fatal and non-fatal opioid overdoses; (B) the number of emergency room visits related to opioid misuse and abuse; (C) the number of individuals in sustained recovery from opioid use disorder; (D) the number of infections associated with illicit drug use, such as HIV, viral hepatitis, and infective endocarditis, and available capacity for treating such infections; (E) the number of providers prescribing medication-assisted treatment for opioid use disorders, including in primary care settings, community health centers, jails, and prisons; (F) the number of individuals receiving treatment for opioid use disorder; and (G) additional indicators or metrics, as appropriate, such as metrics pertaining to specific populations, including women and children, American Indians and Alaskan Natives, individuals living in rural and non-urban areas, and justice-involved populations, that would further clarify the progress made in addressing the opioid crisis. (2) A reasonable goal, such as a percentage decrease or other specified metric, that signifies progress in meeting the goal described in subsection (a), and annual targets to help achieve that goal. (c) Consideration of other substance use disorders In developing the national milestones under subsection (b), the Secretary shall, as appropriate, consider other substance use disorders in addition to opioid use disorder. (d) Extension of period If the Secretary determines that the goal described in subsection (a) will not be achieved with respect to any indicator or metric established under subsection (b)(2) within 5 years of the date of enactment of this Act, the Secretary may extend the timeline for meeting such goal with respect to that indicator or metric. The Secretary shall include with any such extension a rationale for why additional time is needed and information on whether significant changes are needed in order to achieve such goal with respect to the indicator or metric. (e) Annual status update Not later than one year after the date of enactment of this Act, the Secretary shall make available on the Internet website of the Department of Health and Human Services, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an update on the progress, including expected progress in the subsequent year, in achieving the goals detailed in the national milestones. Each such update shall include the progress made in the first year or since the previous report, as applicable, in meeting each indicator or metric in the national milestones. 7024. Study on prescribing limits Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Attorney General of the United States, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the impact of Federal and State laws and regulations that limit the length, quantity, or dosage of opioid prescriptions. Such report shall address— (1) the impact of such limits on— (A) the incidence and prevalence of overdose related to prescription opioids; (B) the incidence and prevalence of overdose related to illicit opioids; (C) the prevalence of opioid use disorders; (D) medically appropriate use of, and access to, opioids, including any impact on travel expenses and pain management outcomes for patients, whether such limits are associated with significantly higher rates of negative health outcomes, including suicide, and whether the impact of such limits differs based on the clinical indication for which opioids are prescribed; (2) whether such limits lead to a significant increase in burden for prescribers of opioids or prescribers of treatments for opioid use disorder, including any impact on patient access to treatment, and whether any such burden is mitigated by any factors such as electronic prescribing or telemedicine; and (3) the impact of such limits on diversion or misuse of any controlled substance in schedule II, III, or IV of section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ). D Ensuring Access to Quality Sober Living 7031. National recovery housing best practices Part D of title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.) is amended by adding at the end the following new section: 550. National recovery housing best practices (a) Best practices for operating recovery housing (1) In general The Secretary, in consultation with the individuals and entities specified in paragraph (2), shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing. (2) Consultation In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate— (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services; (B) the Secretary of Housing and Urban Development; (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies; (D) representatives of health insurance issuers; (E) national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable; (F) individuals with a history of substance use disorder; and (G) other stakeholders identified by the Secretary. (b) Identification of fraudulent recovery housing operators (1) In general The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of common indicators that could be used to identify potentially fraudulent recovery housing operators. (2) Consultation In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate, the individuals and entities specified in subsection (a)(2) and the Attorney General of the United States. (3) Requirements (A) Practices for identification and reporting In carrying out the activities described in paragraph (1), the Secretary shall consider how law enforcement, public and private payers, and the public can best identify and report fraudulent recovery housing operators. (B) Factors to be considered In carrying out the activities described in paragraph (1), the Secretary shall identify or develop indicators, which may include indicators related to— (i) unusual billing practices; (ii) average lengths of stays; (iii) excessive levels of drug testing (in terms of cost or frequency); and (iv) unusually high levels of recidivism. (c) Dissemination The Secretary shall, as appropriate, disseminate the best practices identified or developed under subsection (a) and the common indicators identified or developed under subsection (b) to— (1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices; (2) Indian tribes, tribal organizations, and tribally designated housing entities; (3) the Attorney General of the United States; (4) the Secretary of Labor; (5) the Secretary of Housing and Urban Development; (6) State and local law enforcement agencies; (7) health insurance issuers; (8) recovery housing entities; and (9) the public. (d) Requirements In carrying out the activities described in subsections (a) and (b), the Secretary, in consultation with appropriate individuals and entities described in subsections (a)(2) and (b)(2), shall consider how recovery housing is able to support recovery and prevent relapse, recidivism, or overdose (including overdose death), including by improving access and adherence to treatment, including medication-assisted treatment. (e) Rule of construction Nothing in this section shall be construed to provide the Secretary with the authority to require States to adhere to minimum standards in the State oversight of recovery housing. (f) Definitions In this section: (1) The term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders. (2) The terms Indian tribe and tribal organization have the meanings given those terms in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (3) The term tribally designated housing entity has the meaning given that term in section 4 of the Native American Housing Assistance and Self-Determination Act of 1996 ( 25 U.S.C. 4103 ). (g) Authorization of appropriations To carry out this section, there is authorized to be appropriated $3,000,000 for the period of fiscal years 2019 through 2021. . E Advancing Cutting Edge Research 7041. Unique research initiatives Section 402(n)(1) of the Public Health Service Act ( 42 U.S.C. 282(n)(1) ) is amended— (1) in subparagraph (A), by striking or ; (2) in subparagraph (B), by striking the period and inserting ; or ; and (3) by adding at the end the following: (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat. . 7042. Pain research Section 409J(b) of the Public Health Service Act ( 42 U.S.C. 284q(b) ) is amended— (1) in paragraph (5)— (A) in subparagraph (A), by striking and treatment of pain and diseases and disorders associated with pain and inserting treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration ; (B) in subparagraph (B), by striking on the symptoms and causes of pain; and inserting the following: “on— (i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain; (ii) the diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and (iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain; and ; and (C) by striking subparagraphs (C) through (E) and inserting the following: (C) make recommendations to the Director of NIH— (i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and (iii) on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research. ; (2) by redesignating paragraph (6) as paragraph (7); and (3) by inserting after paragraph (5) the following: (6) Report The Secretary shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress. . F Jessie’s Law 7051. Inclusion of opioid addiction history in patient records (a) Best practices (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ), in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding— (A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient; (B) what constitutes the patient’s request for the purpose described in subparagraph (A); and (C) the process and methods by which the information should be so displayed. (2) Dissemination The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies. (b) Requirements In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following: (1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder. (2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications. (3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers. (4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, having access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations. (5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations. (6) All applicable Federal and State laws and regulations. 7052. Communication with families during emergencies (a) Promoting awareness of authorized disclosures during emergencies The Secretary of Health and Human Services shall annually notify health care providers regarding permitted disclosures under Federal health care privacy law during emergencies, including overdoses, of certain health information to families, caregivers, and health care providers. (b) Use of material For the purposes of carrying out subsection (a), the Secretary of Health and Human Services may use material produced under section 7053 of this Act or section 11004 of the 21st Century Cures Act ( 42 U.S.C. 1320d–2 note). 7053. Development and dissemination of model training programs for substance use disorder patient records (a) Initial programs and materials Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ), in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials): (1) Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) for the confidentiality of patient records. (2) Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in paragraph (1). (b) Requirements The model programs and materials described in paragraphs (1) and (2) of subsection (a) shall address circumstances under which disclosure of substance use disorder patient records is needed to— (1) facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care; (2) avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and (3) notify and involve families and caregivers when individuals experience an overdose. (c) Periodic updates The Secretary shall— (1) periodically review and update the model program and materials identified or developed under subsection (a); and (2) disseminate such updated programs and materials to the individuals described in subsection (a)(1). (d) Input of certain entities In identifying, reviewing, or updating the model programs and materials under this section, the Secretary shall solicit the input of relevant stakeholders. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section— (1) $4,000,000 for fiscal year 2019; (2) $2,000,000 for each of fiscal years 2020 and 2021; and (3) $1,000,000 for each of fiscal years 2022 and 2023. G Protecting Pregnant Women and Infants 7061. Report on addressing maternal and infant health in the opioid crisis (a) In general Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Centers for Disease Control and Prevention, the National Institutes of Health, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration, shall develop and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— (1) information on opioid, non-opioid, and non-pharmacologic pain management practices during pregnancy and after pregnancy; (2) recommendations for increasing public awareness and education about substance use disorders, including opioid use disorders, during and after pregnancy, including available treatment resources in urban and rural areas; (3) recommendations to prevent, identify, and reduce substance use disorders, including opioid use disorders, during pregnancy to improve care for pregnant women with substance use disorders and their infants; and (4) an identification of areas in need of further research with respect to acute and chronic pain management during and after pregnancy. (b) No additional funds No additional funds are authorized to be appropriated for purposes of carrying out subsection (a). 7062. Protecting moms and infants (a) Report (1) In general Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make available to the public on the Internet website of the Department of Health and Human Services, a report regarding the implementation of the recommendations in the strategy relating to prenatal opioid use, including neonatal abstinence syndrome, developed pursuant to section 2 of the Protecting Our Infants Act of 2015 ( Public Law 114–91 ). Such report shall include— (A) an update on the implementation of the recommendations in the strategy, including information regarding the agencies involved in the implementation; and (B) information on additional funding or authority the Secretary requires, if any, to implement the strategy, which may include authorities needed to coordinate implementation of such strategy across the Department of Health and Human Services. (2) Periodic updates The Secretary shall periodically update the report under paragraph (1). (b) Residential treatment programs for pregnant and postpartum women Section 508(s) of the Public Health Service Act ( 42 U.S.C. 290bb–1(s) ) is amended by striking $16,900,000 for each of fiscal years 2017 through 2021 and inserting $29,931,000 for each of fiscal years 2019 through 2023 . 7063. Early interventions for pregnant women and infants (a) Development of educational materials by Center for Substance Abuse Prevention Section 515(b) of the Public Health Service Act ( 42 U.S.C. 290bb–21(b) ) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (15) in consultation with relevant stakeholders and in collaboration with the Director of the Centers for Disease Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared decision making regarding pain management and the prevention of substance use disorders during pregnancy. . (b) Guidelines and recommendations by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act ( 42 U.S.C. 290bb(b) ) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting a semicolon; and (3) by adding at the end the following: (15) in cooperation with the Secretary, implement and disseminate, as appropriate, the recommendations in the report entitled Protecting Our Infants Act: Final Strategy issued by the Department of Health and Human Services in 2017; and . (c) Support of partnerships by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act ( 42 U.S.C. 290bb(b) ), as amended by subsection (b), is further amended by adding at the end the following: (16) in cooperation with relevant stakeholders, and through public-private partnerships, encourage education about substance use disorders for pregnant women and health care providers who treat pregnant women and babies. . 7064. Prenatal and postnatal health Section 317L of the Public Health Service Act ( 42 U.S.C. 247b–13 ) is amended— (1) in subsection (a)— (A) by amending paragraph (1) to read as follows: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including— (A) data on— (i) the incidence, prevalence, and implications of such activities; and (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and (B) additional information or data, as appropriate, on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis; ; (B) in paragraph (2)— (i) by striking prevention of and inserting prevention and long-term outcomes associated with ; and (ii) by striking illegal drug use and inserting other substance abuse and misuse ; (C) in paragraph (3), by striking and cessation programs; and and inserting , treatment, and cessation programs; ; (D) in paragraph (4), by striking illegal drug use. and inserting other substance abuse and misuse; and ; and (E) by adding at the end the following: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of— (A) long-term outcomes of children affected by neonatal abstinence syndrome; (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and (C) relevant studies, evaluations, or information the Secretary determines to be appropriate. ; (2) in subsection (b), by inserting tribal entities, after local governments, ; (3) by redesignating subsection (c) as subsection (d); (4) by inserting after subsection (b) the following: (c) Coordinating activities To carry out this section, the Secretary may— (1) provide technical and consultative assistance to entities receiving grants under subsection (b); (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention; (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and (4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology. ; and (5) in subsection (d), as so redesignated, by striking 2001 through 2005 and inserting 2019 through 2023 . 7065. Plans of safe care (a) In general Section 105(a) of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5106(a) ) is amended by adding at the end the following: (7) Grants to States to improve and coordinate their response to ensure the safety, permanency, and well-being of infants affected by substance use (A) Program authorized The Secretary is authorized to make grants to States for the purpose of assisting child welfare agencies, social services agencies, substance use disorder treatment agencies, hospitals with labor and delivery units, medical staff, public health and mental health agencies, and maternal and child health agencies to facilitate collaboration in developing, updating, implementing, and monitoring plans of safe care described in section 106(b)(2)(B)(iii). Section 112(a)(2) shall not apply to the program authorized under this paragraph. (B) Distribution of funds (i) Reservations Of the amounts made available to carry out subparagraph (A), the Secretary shall reserve— (I) no more than 3 percent for the purposes described in subparagraph (G); and (II) up to 3 percent for grants to Indian Tribes and tribal organizations to address the needs of infants born with, and identified as being affected by, substance abuse or withdrawal symptoms resulting from prenatal drug exposure or a fetal alcohol spectrum disorder and their families or caregivers, which to the extent practicable, shall be consistent with the uses of funds described under subparagraph (D). (ii) Allotments to States and territories The Secretary shall allot the amount made available to carry out subparagraph (A) that remains after application of clause (i) to each State that applies for such a grant, in an amount equal to the sum of— (I) $500,000; and (II) an amount that bears the same relationship to any funds made available to carry out subparagraph (A) and remaining after application of clause (i), as the number of live births in the State in the previous calendar year bears to the number of live births in all States in such year. (iii) Ratable reduction If the amount made available to carry out subparagraph (A) is insufficient to satisfy the requirements of clause (ii), the Secretary shall ratably reduce each allotment to a State. (C) Application A State desiring a grant under this paragraph shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (i) a description of— (I) the impact of substance use disorder in such State, including with respect to the substance or class of substances with the highest incidence of abuse in the previous year in such State, including— (aa) the prevalence of substance use disorder in such State; (bb) the aggregate rate of births in the State of infants affected by substance abuse or withdrawal symptoms or a fetal alcohol spectrum disorder (as determined by hospitals, insurance claims, claims submitted to the State Medicaid program, or other records), if available and to the extent practicable; and (cc) the number of infants identified, for whom a plan of safe care was developed, and for whom a referral was made for appropriate services, as reported under section 106(d)(18); (II) the challenges the State faces in developing, implementing, and monitoring plans of safe care in accordance with section 106(b)(2)(B)(iii); (III) the State’s lead agency for the grant program and how that agency will coordinate with relevant State entities and programs, including the child welfare agency, the substance use disorder treatment agency, hospitals with labor and delivery units, health care providers, the public health and mental health agencies, programs funded by the Substance Abuse and Mental Health Services Administration that provide substance use disorder treatment for women, the State Medicaid program, the State agency administering the block grant program under title V of the Social Security Act ( 42 U.S.C. 701 et seq.), the State agency administering the programs funded under part C of the Individuals with Disabilities Education Act ( 20 U.S.C. 1431 et seq.), the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act ( 42 U.S.C. 711 ), the State judicial system, and other agencies, as determined by the Secretary, and Indian Tribes and tribal organizations, as appropriate, to implement the activities under this paragraph; (IV) how the State will monitor local development and implementation of plans of safe care, in accordance with section 106(b)(2)(B)(iii)(II), including how the State will monitor to ensure plans of safe care address differences between substance use disorder and medically supervised substance use, including for the treatment of a substance use disorder; (V) if applicable, how the State plans to utilize funding authorized under part E of title IV of the Social Security Act ( 42 U.S.C. 670 et seq.) to assist in carrying out any plan of safe care, including such funding authorized under section 471(e) of such Act (as in effect on October 1, 2018) for mental health and substance abuse prevention and treatment services and in-home parent skill-based programs and funding authorized under such section 472(j) (as in effect on October 1, 2018) for children with a parent in a licensed residential family-based treatment facility for substance abuse; and (VI) an assessment of the treatment and other services and programs available in the State to effectively carry out any plan of safe care developed, including identification of needed treatment, and other services and programs to ensure the well-being of young children and their families affected by substance use disorder, such as programs carried out under part C of the Individuals with Disabilities Education Act ( 20 U.S.C. 1431 et seq.) and comprehensive early childhood development services and programs such as Head Start programs; (ii) a description of how the State plans to use funds for activities described in subparagraph (D) for the purposes of ensuring State compliance with requirements under clauses (ii) and (iii) of section 106(b)(2)(B); and (iii) an assurance that the State will comply with requirements to refer a child identified as substance-exposed to early intervention services as required pursuant to a grant under part C of the Individuals with Disabilities Education Act ( 20 U.S.C. 1431 et seq.). (D) Uses of funds Funds awarded to a State under this paragraph may be used for the following activities, which may be carried out by the State directly, or through grants or subgrants, contracts, or cooperative agreements: (i) Improving State and local systems with respect to the development and implementation of plans of safe care, which— (I) shall include parent and caregiver engagement, as required under section 106(b)(2)(B)(iii)(I), regarding available treatment and service options, which may include resources available for pregnant, perinatal, and postnatal women; and (II) may include activities such as— (aa) developing policies, procedures, or protocols for the administration or development of evidence-based and validated screening tools for infants who may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder and pregnant, perinatal, and postnatal women whose infants may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder; (bb) improving assessments used to determine the needs of the infant and family; (cc) improving ongoing case management services; (dd) improving access to treatment services, which may be prior to the pregnant woman’s delivery date; and (ee) keeping families safely together when it is in the best interest of the child. (ii) Developing policies, procedures, or protocols in consultation and coordination with health professionals, public and private health facilities, and substance use disorder treatment agencies to ensure that— (I) appropriate notification to child protective services is made in a timely manner, as required under section 106(b)(2)(B)(ii); (II) a plan of safe care is in place, in accordance with section 106(b)(2)(B)(iii), before the infant is discharged from the birth or health care facility; and (III) such health and related agency professionals are trained on how to follow such protocols and are aware of the supports that may be provided under a plan of safe care. (iii) Training health professionals and health system leaders, child welfare workers, substance use disorder treatment agencies, and other related professionals such as home visiting agency staff and law enforcement in relevant topics including— (I) State mandatory reporting laws established under section 106(b)(2)(B)(i) and the referral and process requirements for notification to child protective services when child abuse or neglect reporting is not mandated; (II) the co-occurrence of pregnancy and substance use disorder, and implications of prenatal exposure; (III) the clinical guidance about treating substance use disorder in pregnant and postpartum women; (IV) appropriate screening and interventions for infants affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder and the requirements under section 106(b)(2)(B)(iii); and (V) appropriate multigenerational strategies to address the mental health needs of the parent and child together. (iv) Establishing partnerships, agreements, or memoranda of understanding between the lead agency and other entities (including health professionals, health facilities, child welfare professionals, juvenile and family court judges, substance use and mental disorder treatment programs, early childhood education programs, maternal and child health and early intervention professionals (including home visiting providers), peer-to-peer recovery programs such as parent mentoring programs, and housing agencies) to facilitate the implementation of, and compliance with, section 106(b)(2) and clause (ii) of this subparagraph, in areas which may include— (I) developing a comprehensive, multi-disciplinary assessment and intervention process for infants, pregnant women, and their families who are affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder, that includes meaningful engagement with and takes into account the unique needs of each family and addresses differences between medically supervised substance use, including for the treatment of substance use disorder, and substance use disorder; (II) ensuring that treatment approaches for serving infants, pregnant women, and perinatal and postnatal women whose infants may be affected by substance use, withdrawal symptoms, or a fetal alcohol spectrum disorder, are designed to, where appropriate, keep infants with their mothers during both inpatient and outpatient treatment; and (III) increasing access to all evidence-based medication-assisted treatment approved by the Food and Drug Administration, behavioral therapy, and counseling services for the treatment of substance use disorders, as appropriate. (v) Developing and updating systems of technology for improved data collection and monitoring under section 106(b)(2)(B)(iii), including existing electronic medical records, to measure the outcomes achieved through the plans of safe care, including monitoring systems to meet the requirements of this Act and submission of performance measures. (E) Reporting Each State that receives funds under this paragraph, for each year such funds are received, shall submit a report to the Secretary, disaggregated by geographic location, economic status, and major racial and ethnic groups, except that such disaggregation shall not be required if the results would reveal personally identifiable information on, with respect to infants identified under section 106(b)(2)(B)(ii)— (i) the number who experienced removal associated with parental substance use; (ii) the number who experienced removal and subsequently are reunified with parents, and the length of time between such removal and reunification; (iii) the number who are referred to community providers without a child protection case; (iv) the number who receive services while in the care of their birth parents; (v) the number who receive post-reunification services within 1 year after a reunification has occurred; and (vi) the number who experienced a return to out-of-home care within 1 year after reunification. (F) Secretary’s report to Congress The Secretary shall submit an annual report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Education and the Workforce and the Committee on Appropriations of the House of Representatives that includes the information described in subparagraph (E) and recommendations or observations on the challenges, successes, and lessons derived from implementation of the grant program. (G) Assisting States’ implementation The Secretary shall use the amount reserved under subparagraph (B)(i)(I) to provide written guidance and technical assistance to support States in complying with and implementing this paragraph, which shall include— (i) technical assistance, including programs of in-depth technical assistance, to additional States, territories, and Indian Tribes and tribal organizations in accordance with the substance-exposed infant initiative developed by the National Center on Substance Abuse and Child Welfare; (ii) guidance on the requirements of this Act with respect to infants born with and identified as being affected by substance use or withdrawal symptoms or fetal alcohol spectrum disorder, as described in clauses (ii) and (iii) of section 106(b)(2)(B), including by— (I) enhancing States’ understanding of requirements and flexibilities under the law, including by clarifying key terms; (II) addressing state-identified challenges with developing, implementing, and monitoring plans of safe care, including those reported under subparagraph (C)(i)(II); (III) disseminating best practices on implementation of plans of safe care, on such topics as differential response, collaboration and coordination, and identification and delivery of services for different populations, while recognizing needs of different populations and varying community approaches across States; and (IV) helping States improve the long-term safety and well-being of young children and their families; (iii) supporting State efforts to develop information technology systems to manage plans of safe care; and (iv) preparing the Secretary’s report to Congress described in subparagraph (F). (H) Sunset The authority under this paragraph shall sunset on September 30, 2023. . (b) Repeal The Abandoned Infants Assistance Act of 1988 ( 42 U.S.C. 5117aa et seq.) is repealed. H Substance Use Disorder Treatment Workforce 7071. Loan repayment program for substance use disorder treatment workforce Title VII of the Public Health Service Act is amended— (1) by redesignating part F as part G; and (2) by inserting after part E ( 42 U.S.C. 294n et seq.) the following: F Substance Use Disorder Treatment Workforce 781. Loan repayment program for substance use disorder treatment workforce (a) In general The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a program under which— (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection (b) on the principal of and interest on any eligible loan; and (2) the individuals each agree to the requirements of service in substance use disorder treatment employment, as described in subsection (d). (b) Payments For each year of obligated service by an individual pursuant to an agreement under subsection (a), the Secretary shall make a payment to such individual as follows: (1) Service in a shortage area The Secretary shall pay— (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1/6 of the principal of and interest on each eligible loan of the individual which is outstanding on the date the individual began service pursuant to the agreement; and (B) for completion of the sixth and final year of such service, the remainder of such principal and interest. (2) Maximum amount The total amount of payments under this section to any individual shall not exceed $250,000. (c) Eligible loans The loans eligible for repayment under this section are each of the following: (1) Any loan for education or training for a substance use disorder treatment employment. (2) Any loan under part E of title VIII (relating to nursing student loans). (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965). (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965. (5) Any other Federal loan as determined appropriate by the Secretary. (d) Requirements of service Any individual receiving payments under this program as required by an agreement under subsection (a) shall agree to an annual commitment to full-time employment, with no more than 1 year passing between any 2 years of covered employment, in substance use disorder treatment employment in the United States in— (1) a Mental Health Professional Shortage Area, as designated under section 332; or (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per 100,000 people over the past 3 years for which official data is available from the State, is higher than the most recent available national average overdose death rate per 100,000 people, as reported by the Centers for Disease Control and Prevention. (e) Ineligibility for double benefits No borrower may, for the same service, receive a reduction of loan obligations or a loan repayment under both— (1) this section; and (2) any Federally supported loan forgiveness program, including under section 338B, 338I, or 846 of this Act, or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965. (f) Breach (1) Liquidated damages formula The Secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under subsection (a). (2) Limitation The failure by an individual to complete the full period of service obligated pursuant to such an agreement, taken alone, shall not constitute a breach of the agreement, so long as the individual completed in good faith the years of service for which payments were made to the individual under this section. (g) Additional criteria The Secretary— (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed and in addition to the criteria and rules specified in this section; and (2) shall give notice to the committees specified in subsection (h) of any criteria and rules so established. (h) Report to Congress Not later than 5 years after the date of enactment of this section, and every other year thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on— (1) the number and location of borrowers who have qualified for loan repayments under this section; and (2) the impact of this section on the availability of substance use disorder treatment employees nationally and in shortage areas and counties described in subsection (d). (i) Definition In this section: (1) The terms Indian tribe and tribal organization have the meanings given those terms in section 4 of the Indian Self-Determination and Education Assistance Act. (2) The term municipality means a city, town, or other public body created by or pursuant to State law, or an Indian tribe. (3) The term substance use disorder treatment employment means full-time employment (including a fellowship)— (A) where the primary intent and function of the position is the direct treatment or recovery support of patients with or in recovery from a substance use disorder, including master’s level social workers, psychologists, counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists, psychology doctoral interns, and behavioral health paraprofessionals and physicians, physician assistants, and nurses, who are licensed or certified in accordance with applicable State and Federal laws; and (B) which is located at a substance use disorder treatment program, private physician practice, hospital or health system-affiliated inpatient treatment center or outpatient clinic (including an academic medical center-affiliated treatment program), correctional facility or program, youth detention center or program, inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or other specialty community behavioral health center, recovery center, school, community-based organization, telehealth platform, migrant health center, health program or facility operated by an Indian tribe or tribal organization, Federal medical facility, or any other facility as determined appropriate for purposes of this section by the Secretary. (j) Authorization of appropriations There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2023. . 7072. Clarification regarding service in schools and other community-based settings Subpart III of part D of title III of the Public Health Service Act ( 42 U.S.C. 254l et seq.) is amended by adding at the end the following: 338N. Clarification regarding service in schools and other community-based settings (a) Schools and community-based settings An entity to which a participant in the Scholarship Program or the Loan Repayment Program (referred to in this section as a participant ) is assigned under section 333 may direct such participant to provide service as a behavioral or mental health professional at a school or other community-based setting located in a health professional shortage area. (b) Obligated service (1) In general Any service described in subsection (a) that a participant provides may count towards such participant's completion of any obligated service requirements under the Scholarship Program or the Loan Repayment Program, subject to any limitation imposed under paragraph (2). (2) Limitation The Secretary may impose a limitation on the number of hours of service described in subsection (a) that a participant may credit towards completing obligated service requirements, provided that the limitation allows a member to credit service described in subsection (a) for not less than 50 percent of the total hours required to complete such obligated service requirements. (c) Rule of construction The authorization under subsection (a) shall be notwithstanding any other provision of this subpart or subpart II. . 7073. Programs for health care workforce (a) Program for education and training in pain care Section 759 of the Public Health Service Act ( 42 U.S.C. 294i ) is amended— (1) in subsection (a), by striking hospices, and other public and private entities and inserting hospices, tribal health programs (as defined in section 4 of the Indian Health Care Improvement Act), and other public and nonprofit private entities ; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking award may be made under subsection (a) only if the applicant for the award agrees that the program carried out with the award will include and inserting entity receiving an award under this section shall develop a comprehensive education and training plan that includes ; (B) in paragraph (1)— (i) by inserting preventing, after diagnosing, ; and (ii) by inserting non-addictive medical products and non-pharmacologic treatments and after including ; (C) in paragraph (2)— (i) by inserting Federal, State, and local after applicable ; and (ii) by striking the degree to which and all that follows through effective pain care and inserting opioids ; (D) in paragraph (3), by inserting , integrated, evidence-based pain management, and, as appropriate, non-pharmacotherapy before the semicolon; (E) in paragraph (4), by striking ; and and inserting ; ; and (F) by striking paragraph (5) and inserting the following: (5) recent findings, developments, and advancements in pain care research and the provision of pain care, which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which may include best practices related to screening for opioid use disorders, training on screening, brief intervention, and referral to treatment), and safe disposal options for prescription medications (including such options provided by law enforcement or other innovative deactivation mechanisms). ; (3) in subsection (d), by inserting prevention, after diagnosis, ; and (4) in subsection (e), by striking 2010 through 2012 and inserting 2019 through 2023 . (b) Mental and behavioral health education and training program Section 756 of the Public Health Service Act ( 42 U.S.C. 294e–1 ) is amended— (1) in subsection (a)— (A) in paragraph (1), by inserting , trauma, after focus on child and adolescent mental health ; and (B) in paragraphs (2) and (3), by inserting trauma-informed care and before substance use disorder prevention and treatment services ; and (2) in subsection (f), by striking 2018 through 2022 and inserting 2019 through 2023 . I Preventing Overdoses While in Emergency Rooms 7081. Program to support coordination and continuation of care for drug overdose patients (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall identify or facilitate the development of best practices for— (1) emergency treatment of known or suspected drug overdose; (2) the use of recovery coaches, as appropriate, to encourage individuals who experience a non-fatal overdose to seek treatment for substance use disorder and to support coordination and continuation of care; (3) coordination and continuation of care and treatment, including, as appropriate, through referrals, of individuals after a drug overdose; and (4) the provision or prescribing of overdose reversal medication, as appropriate. (b) Grant establishment and participation (1) In general The Secretary shall award grants on a competitive basis to eligible entities to support implementation of voluntary programs for care and treatment of individuals after a drug overdose, as appropriate, which may include implementation of the best practices described in subsection (a). (2) Eligible entity In this section, the term eligible entity means— (A) a State substance abuse agency; (B) an Indian Tribe or tribal organization; or (C) an entity that offers treatment or other services for individuals in response to, or following, drug overdoses or a drug overdose, such as an emergency department, in consultation with a State substance abuse agency. (3) Application An eligible entity desiring a grant under this section shall submit an application to the Secretary, at such time and in such manner as the Secretary may require, that includes— (A) evidence that such eligible entity carries out, or is capable of contracting and coordinating with other community entities to carry out, the activities described in paragraph (4); (B) evidence that such eligible entity will work with a recovery community organization to recruit, train, hire, mentor, and supervise recovery coaches and fulfill the requirements described in paragraph (4)(A); and (C) such additional information as the Secretary may require. (4) Use of grant funds An eligible entity awarded a grant under this section shall use such grant funds to— (A) hire or utilize recovery coaches to help support recovery, including by— (i) connecting patients to a continuum of care services, such as— (I) treatment and recovery support programs; (II) programs that provide non-clinical recovery support services; (III) peer support networks; (IV) recovery community organizations; (V) health care providers, including physicians and other providers of behavioral health and primary care; (VI) education and training providers; (VII) employers; (VIII) housing services; and (IX) child welfare agencies; (ii) providing education on overdose prevention and overdose reversal to patients and families, as appropriate; (iii) providing follow-up services for patients after an overdose to ensure continued recovery and connection to support services; (iv) collecting and evaluating outcome data for patients receiving recovery coaching services; and (v) providing other services the Secretary determines necessary to help ensure continued connection with recovery support services, including culturally appropriate services, as applicable; (B) establish policies and procedures, pursuant to Federal and State law, that address the provision of overdose reversal medication, the administration of all drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat substance use disorder, and subsequent continuation of, or referral to, evidence-based treatment for patients with a substance use disorder who have experienced a non-fatal drug overdose, in order to support long-term treatment, prevent relapse, and reduce recidivism and future overdose; and (C) establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment, follow up, and transportation to and from treatment facilities. (5) Additional permissible uses In addition to the uses described in paragraph (4), a grant awarded under this section may be used, directly or through contractual arrangements, to provide— (A) all drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat substance use disorders or reverse overdose, pursuant to Federal and State law; (B) withdrawal and detoxification services that include patient evaluation, stabilization, and preparation for treatment of substance use disorder, including treatment described in subparagraph (A), as appropriate; or (C) mental health services provided by a certified professional who is licensed and qualified by education, training, or experience to assess the psychosocial background of patients, to contribute to the appropriate treatment plan for patients with substance use disorder, and to monitor patient progress. (6) Preference In awarding grants under this section, the Secretary shall give preference to eligible entities that meet any or all of the following criteria: (A) The eligible entity is a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act ( 42 U.S.C. 1395x(mm)(1) )), a low volume hospital (as defined in section 1886(d)(12)(C)(i) of such Act ( 42 U.S.C. 1395ww(d)(12)(C)(i) )), a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act ( 42 U.S.C. 1395ww(d)(5)(D)(iii) )), or a hospital that receives disproportionate share hospital payments under section 1886(d)(5)(F) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5)(F) ). (B) The eligible entity is located in a State with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention, or under the jurisdiction of an Indian Tribe with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined through appropriate mechanisms as determined by the Secretary in consultation with Indian Tribes. (C) The eligible entity demonstrates that recovery coaches will be placed in both health care settings and community settings. (7) Period of grant A grant awarded to an eligible entity under this section shall be for a period of not more than 5 years. (c) Definitions In this section: (1) Indian Tribe; tribal organization The terms Indian Tribe and tribal organization have the meanings given the terms Indian tribe and tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (2) Recovery coach the term recovery coach means an individual— (A) with knowledge of, or experience with, recovery from a substance use disorder; and (B) who has completed training from, and is determined to be in good standing by, a recovery services organization capable of conducting such training and making such determination. (3) Recovery community organization The term recovery community organization has the meaning given such term in section 547(a) of the Public Health Service Act ( 42 U.S.C. 290ee–2(a) ). (d) Reporting requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the entity has received such grant that includes information on— (A) the number of individuals treated by the entity for non-fatal overdoses, including the number of non-fatal overdoses where overdose reversal medication was administered; (B) the number of individuals administered medication-assisted treatment by the entity; (C) the number of individuals referred by the entity to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals; and (D) the frequency and number of patients with reoccurrences, including readmissions for non-fatal overdoses and evidence of relapse related to substance use disorder. (2) Report by Secretary Not later than 5 years after the date of enactment of this Act, the Secretary shall submit to Congress a report that includes an evaluation of the effectiveness of the grant program carried out under this section with respect to long term health outcomes of the population of individuals who have experienced a drug overdose, the percentage of patients treated or referred to treatment by grantees, and the frequency and number of patients who experienced relapse, were readmitted for treatment, or experienced another overdose. (e) Privacy The requirements of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2019 through 2023. J Alternatives to Opioids in the Emergency Department 7091. Emergency department alternatives to opioids demonstration program (a) Demonstration program grants (1) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall carry out a demonstration program for purposes of awarding grants to hospitals and emergency departments, including freestanding emergency departments, to develop, implement, enhance, or study alternatives to opioids for pain management in such settings. (2) Eligibility To be eligible to receive a grant under paragraph (1), a hospital or emergency department shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (3) Geographic distribution In awarding grants under this section, the Secretary shall seek to ensure geographical distribution among grant recipients. (4) Use of funds Grants under paragraph (1) shall be used to— (A) target treatment approaches for painful conditions frequently treated in such settings; (B) train providers and other hospital personnel on protocols or best practices related to the use and prescription of opioids and alternatives to opioids for pain management in the emergency department; and (C) develop or continue strategies to provide alternatives to opioids, as appropriate. (b) Additional demonstration program The Secretary may carry out a demonstration program similar to the program under subsection (a) for other acute care settings. (c) Consultation The Secretary shall implement a process for recipients of grants under subsection (a) or (b) to share evidence-based and best practices and promote consultation with persons having robust knowledge, including emergency departments and physicians that have successfully implemented programs that use alternatives to opioids for pain management, as appropriate, such as approaches studied through the National Center for Complimentary and Integrative Health or other institutes and centers at the National Institutes of Health, as appropriate. The Secretary shall offer to each recipient of a grant under subsection (a) or (b) technical assistance as necessary. (d) Technical assistance The Secretary shall identify or facilitate the development of best practices on alternatives to opioids for pain management and provide technical assistance to hospitals and other acute care settings on alternatives to opioids for pain management. The technical assistance provided shall be for the purpose of— (1) utilizing information from recipients of a grant under subsection (a) or (b) that have successfully implemented alternatives to opioids programs; (2) identifying or facilitating the development of best practices on the use of alternatives to opioids, which may include pain-management strategies that involve non-addictive medical products, non-pharmacologic treatments, and technologies or techniques to identify patients at risk for opioid use disorder; (3) identifying or facilitating the development of best practices on the use of alternatives to opioids that target common painful conditions and include certain patient populations, such as geriatric patients, pregnant women, and children; and (4) disseminating information on the use of alternatives to opioids to providers in acute care settings, which may include emergency departments, outpatient clinics, critical access hospitals, Federally qualified health centers, Indian Health Service health facilities, and tribal hospitals. (e) Report to the Secretary Each recipient of a grant under this section shall submit to the Secretary (during the period of such grant) annual reports on the progress of the program funded through the grant. These reports shall include, in accordance with all applicable State and Federal privacy laws— (1) a description of and specific information about the opioid alternative pain management programs, including the demographic characteristics of patients who were treated with an alternative pain management protocol, implemented in hospitals, emergency departments, and other acute care settings; (2) data on the opioid alternative pain management strategies used, including the number of opioid prescriptions written— (A) during a baseline period before the program began; or (B) at various stages of the program; and (3) data on patients who were eventually prescribed opioids after alternative pain management protocols and treatments were utilized; and (4) any other information the Secretary determines appropriate. (f) Report to Congress Not later than 1 year after completion of the demonstration program under this section, the Secretary shall submit a report to the Congress on the results of the demonstration program and include in the report— (1) the number of applications received and the number funded; (2) a summary of the reports described in subsection (e), including data that allows for comparison of programs; and (3) recommendations for broader implementation of pain management strategies that encourage the use of alternatives to opioids in hospitals, emergency departments, or other acute care settings. (g) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2021. K Treatment, Education, and Community Help To Combat Addiction 7101. Establishment of regional centers of excellence in substance use disorder education Part D of title V of the Public Health Service Act, as amended by section 7031, is further amended by adding at the end the following new section: 551. Regional centers of excellence in substance use disorder education (a) In general The Secretary, in consultation with appropriate agencies, shall award cooperative agreements to eligible entities for the designation of such entities as Regional Centers of Excellence in Substance Use Disorder Education for purposes of improving health professional training resources with respect to substance use disorder prevention, treatment, and recovery. (b) Eligibility To be eligible to receive a cooperative agreement under subsection (a), an entity shall— (1) be an accredited entity that offers education to students in various health professions, which may include— (A) a teaching hospital; (B) a medical school; (C) a certified behavioral health clinic; or (D) any other health professions school, school of public health, or Cooperative Extension Program at institutions of higher education, as defined in section 101 of the Higher Education Act of 1965, engaged in the prevention, treatment, or recovery of substance use disorders; (2) demonstrate community engagement and partnerships with community stakeholders, including entities that train health professionals, mental health counselors, social workers, peer recovery specialists, substance use treatment programs, community health centers, physician offices, certified behavioral health clinics, research institutions, and law enforcement; and (3) submit to the Secretary an application containing such information, at such time, and in such manner, as the Secretary may require. (c) Activities An entity receiving an award under this section shall develop, evaluate, and distribute evidence-based resources regarding the prevention and treatment of, and recovery from, substance use disorders. Such resources may include information on— (1) the neurology and pathology of substance use disorders; (2) advancements in the treatment of substance use disorders; (3) techniques and best practices to support recovery from substance use disorders; (4) strategies for the prevention and treatment of, and recovery from substance use disorders across patient populations; and (5) other topic areas that are relevant to the objectives described in subsection (a). (d) Geographic distribution In awarding cooperative agreements under subsection (a), the Secretary shall take into account regional differences among eligible entities and shall make an effort to ensure geographic distribution. (e) Evaluation The Secretary shall evaluate each project carried out by an entity receiving an award under this section and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities. (f) Funding There is authorized to be appropriated to carry out this section, $4,000,000 for each of fiscal years 2019 through 2023. . 7102. Youth prevention and recovery (a) Substance abuse treatment services for children, adolescents, and young adults Section 514 of the Public Health Service Act ( 42 U.S.C. 290bb–7 ) is amended— (1) in the section heading, by striking children and adolescents and inserting children, adolescents, and young adults ; (2) in subsection (a)(2), by striking children, including and inserting children, adolescents, and young adults, including ; and (3) by striking children and adolescents each place it appears and inserting children, adolescents, and young adults . (b) Resource center The Secretary of Health and Human Services (referred to in this section as the Secretary , except as otherwise provided), in consultation with the Secretary of Education and other heads of agencies, including the Assistant Secretary for Mental Health and Substance Use and the Administrator of the Health Resources and Services Administration, as appropriate, shall establish a resource center to provide technical support to recipients of grants under subsection (c). (c) Youth prevention and recovery initiative (1) In general The Secretary, in consultation with the Secretary of Education, shall administer a program to provide support for communities to support the prevention of, treatment of, and recovery from, substance use disorders for children, adolescents, and young adults. (2) Definitions In this subsection: (A) Eligible entity The term eligible entity means— (i) a local educational agency that is seeking to establish or expand substance use prevention or recovery support services at one or more high schools; (ii) a State educational agency; (iii) an institution of higher education (or consortia of such institutions), which may include a recovery program at an institution of higher education; (iv) a local board or one-stop operator; (v) a nonprofit organization with appropriate expertise in providing services or programs for children, adolescents, or young adults, excluding a school; (vi) a State, political subdivision of a State, Indian tribe, or tribal organization; or (vii) a high school or dormitory serving high school students that receives funding from the Bureau of Indian Education. (B) Foster care The term foster care has the meaning given such term in section 1355.20(a) of title 45, Code of Federal Regulations (or any successor regulations). (C) High school The term high school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (D) Homeless youth The term homeless youth has the meaning given the term homeless children or youths in section 725 of the McKinney-Vento Homeless Assistance Act ( 42 U.S.C. 11434a ). (E) Indian tribe; tribal organization The terms Indian tribe and tribal organization have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (F) Institution of higher education The term institution of higher education has the meaning given such term in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ) and includes a postsecondary vocational institution as defined in section 102(c) of such Act ( 20 U.S.C. 1002(c) ). (G) Local educational agency The term local educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (H) Local board; one-stop operator The terms local board and one-stop operator have the meanings given such terms in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ). (I) Out-of-school youth The term out-of-school youth has the meaning given such term in section 129(a)(1)(B) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3164(a)(1)(B) ). (J) Recovery program The term recovery program means a program— (i) to help children, adolescents, or young adults who are recovering from substance use disorders to initiate, stabilize, and maintain healthy and productive lives in the community; and (ii) that includes peer-to-peer support delivered by individuals with lived experience in recovery, and communal activities to build recovery skills and supportive social networks. (K) State educational agency The term State educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act ( 20 U.S.C. 7801 ). (3) Best practices The Secretary, in consultation with the Secretary of Education, shall— (A) identify or facilitate the development of evidence-based best practices for prevention of substance misuse and abuse by children, adolescents, and young adults, including for specific populations such as youth in foster care, homeless youth, out-of-school youth, and youth who are at risk of or have experienced trafficking that address— (i) primary prevention; (ii) appropriate recovery support services; (iii) appropriate use of medication-assisted treatment for such individuals, if applicable, and ways of overcoming barriers to the use of medication-assisted treatment in such population; and (iv) efficient and effective communication, which may include the use of social media, to maximize outreach efforts; (B) disseminate such best practices to State educational agencies, local educational agencies, schools and dormitories funded by the Bureau of Indian Education, institutions of higher education, recovery programs at institutions of higher education, local boards, one-stop operators, family and youth homeless providers, and nonprofit organizations, as appropriate; (C) conduct a rigorous evaluation of each grant funded under this subsection, particularly its impact on the indicators described in paragraph (7)(B); and (D) provide technical assistance for grantees under this subsection. (4) Grants authorized The Secretary, in consultation with the Secretary of Education, shall award 3-year grants, on a competitive basis, to eligible entities to enable such entities, in coordination with Indian tribes, if applicable, and State agencies responsible for carrying out substance use disorder prevention and treatment programs, to carry out evidence-based programs for— (A) prevention of substance misuse and abuse by children, adolescents, and young adults, which may include primary prevention; (B) recovery support services for children, adolescents, and young adults, which may include counseling, job training, linkages to community-based services, family support groups, peer mentoring, and recovery coaching; or (C) treatment or referrals for treatment of substance use disorders, which may include the use of medication-assisted treatment, as appropriate. (5) Special consideration In awarding grants under this subsection, the Secretary shall give special consideration to the unique needs of tribal, urban, suburban, and rural populations. (6) Application To be eligible for a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. Such application shall include— (A) a description of— (i) the impact of substance use disorders in the population that will be served by the grant program; (ii) how the eligible entity has solicited input from relevant stakeholders, which may include faculty, teachers, staff, families, students, and experts in substance use disorder prevention, treatment, and recovery in developing such application; (iii) the goals of the proposed project, including the intended outcomes; (iv) how the eligible entity plans to use grant funds for evidence-based activities, in accordance with this subsection to prevent, provide recovery support for, or treat substance use disorders amongst such individuals, or a combination of such activities; and (v) how the eligible entity will collaborate with relevant partners, which may include State educational agencies, local educational agencies, institutions of higher education, juvenile justice agencies, prevention and recovery support providers, local service providers, including substance use disorder treatment programs, providers of mental health services, youth serving organizations, family and youth homeless providers, child welfare agencies, and primary care providers, in carrying out the grant program; and (B) an assurance that the eligible entity will participate in the evaluation described in paragraph (3)(C). (7) Reports to the Secretary Each eligible entity awarded a grant under this subsection shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include— (A) a description of how the eligible entity used grant funds, in accordance with this subsection, including the number of children, adolescents, and young adults reached through programming; and (B) a description, including relevant data, of how the grant program has made an impact on the intended outcomes described in paragraph (6)(A)(iii), including— (i) indicators of student success, which, if the eligible entity is an educational institution, shall include student well-being and academic achievement; (ii) substance use disorders amongst children, adolescents, and young adults, including the number of overdoses and deaths amongst children, adolescents, and young adults served by the grant during the grant period; and (iii) other indicators, as the Secretary determines appropriate. (8) Report to Congress The Secretary shall, not later than October 1, 2022, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives a report summarizing the effectiveness of the grant program under this subsection, based on the information submitted in reports required under paragraph (7). (9) Authorization of appropriations There is authorized to be appropriated $10,000,000 to carry out this subsection for each of fiscal years 2019 through 2023. L Information from National Mental Health and Substance Use Policy Laboratory 7111. Information from National Mental Health and Substance Use Policy Laboratory Section 501A(b) of the Public Health Service Act ( 42 U.S.C. 290aa–0(b) ) is amended— (1) in paragraph (5)(C), by striking ; and at the end and inserting a semicolon; (2) by redesignating paragraph (6) as paragraph (7); and (3) by inserting after paragraph (5) the following: (6) issue and periodically update information for entities applying for grants or cooperative agreements from the Substance Abuse and Mental Health Services Administration in order to— (A) encourage the implementation and replication of evidence-based practices; and (B) provide technical assistance to applicants for funding, including with respect to justifications for such programs and activities; and . M Comprehensive Opioid Recovery Centers 7121. Comprehensive opioid recovery centers (a) In general Part D of title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.), as amended by sections 7031 and 7101, is further amended by adding at the end the following new section: 552. Comprehensive opioid recovery centers (a) In general The Secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center (referred to in this section as a Center ). A Center may be a single entity or an integrated delivery network. (b) Grant period (1) In general A grant awarded under subsection (a) shall be for a period of not less than 3 years and not more than 5 years. (2) Renewal A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph, the Secretary shall consider the data submitted under subsection (h). (c) Minimum number of Centers The Secretary shall allocate the amounts made available under subsection (j) such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a single State for any one period. (d) Application (1) Eligible entity An entity is eligible for a grant under this section if the entity offers treatment and other services for individuals with a substance use disorder. (2) Submission of application In order to be eligible for a grant under subsection (a), an entity shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activities described in subsection (g); and (B) such other information as the Secretary may require. (e) Priority In awarding grants under subsection (a), the Secretary shall give priority to eligible entities— (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or (2) serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined through appropriate mechanisms determined by the Secretary in consultation with Indian Tribes. (f) Preference In awarding grants under subsection (a), the Secretary may give preference to eligible entities utilizing technology-enabled collaborative learning and capacity building models, including such models as defined in section 2 of the Expanding Capacity for Health Outcomes Act ( Public Law 114–270 ; 130 Stat. 1395), to conduct the activities described in this section. (g) Center activities Each Center shall, at a minimum, carry out the following activities directly, through referral, or through contractual arrangements, which may include carrying out such activities through technology-enabled collaborative learning and capacity building models described in subsection (f): (1) Treatment and recovery services Each Center shall— (A) Ensure that intake, evaluations, and periodic patient assessments meet the individualized clinical needs of patients, including by reviewing patient placement in treatment settings to support meaningful recovery. (B) Provide the full continuum of treatment services, including— (i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all biological products licensed under section 351 of this Act to treat substance use disorders or reverse overdoses, pursuant to Federal and State law; (ii) medically supervised withdrawal management, that includes patient evaluation, stabilization, and readiness for and entry into treatment; (iii) counseling provided by a program counselor or other certified professional who is licensed and qualified by education, training, or experience to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan for the patient, and to monitor patient progress; (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders; (v) testing, as appropriate, for infections commonly associated with illicit drug use; (vi) residential rehabilitation, and outpatient and intensive outpatient programs; (vii) recovery housing; (viii) community-based and peer recovery support services; (ix) job training, job placement assistance, and continuing education assistance to support reintegration into the workforce; and (x) other best practices to provide the full continuum of treatment and services, as determined by the Secretary. (C) Ensure that all programs covered by the Center include medication-assisted treatment, as appropriate, and do not exclude individuals receiving medication-assisted treatment from any service. (D) Periodically conduct patient assessments to support sustained and clinically significant recovery, as defined by the Assistant Secretary for Mental Health and Substance Use. (E) Provide onsite access to medication, as appropriate, and toxicology services; for purposes of carrying out this section. (F) Operate a secure, confidential, and interoperable electronic health information system. (G) Offer family support services such as child care, family counseling, and parenting interventions to help stabilize families impacted by substance use disorder, as appropriate. (2) Outreach Each Center shall carry out outreach activities regarding the services offered through the Centers, which may include— (A) training and supervising outreach staff, as appropriate, to work with State and local health departments, health care providers, the Indian Health Service, State and local educational agencies, schools funded by the Indian Bureau of Education, institutions of higher education, State and local workforce development boards, State and local community action agencies, public safety officials, first responders, Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including patients, to identify and respond to community needs; (B) ensuring that the entities described in subparagraph (A) are aware of the services of the Center; and (C) disseminating and making publicly available, including through the internet, evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders, including co-occurring substance use and mental disorders. (h) Data reporting and program oversight With respect to a grant awarded under subsection (a), not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period (including the duration of any renewal period for such grant), the entity shall submit data, as appropriate, to the Secretary regarding— (1) the programs and activities funded by the grant; (2) health outcomes of the population of individuals with a substance use disorder who received services from the Center, evaluated by an independent program evaluator through the use of outcomes measures, as determined by the Secretary; (3) the retention rate of program participants; and (4) any other information that the Secretary may require for the purpose of—ensuring that the Center is complying with all the requirements of the grant, including providing the full continuum of services described in subsection (g)(1)(B). (i) Privacy The provisions of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (j) Authorization of appropriations There is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. . (b) Reports to Congress (1) Preliminary report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a preliminary report that analyzes data submitted under section 552(h) of the Public Health Service Act, as added by subsection (a). (2) Final report Not later than 2 years after submitting the preliminary report required under paragraph (1), the Secretary of Health and Human Services shall submit to Congress a final report that includes— (A) an evaluation of the effectiveness of the comprehensive services provided by the Centers established or operated pursuant to section 552 of the Public Health Service Act, as added by subsection (a), with respect to health outcomes of the population of individuals with substance use disorder who receive services from the Center, which shall include an evaluation of the effectiveness of services for treatment and recovery support and to reduce relapse, recidivism, and overdose; and (B) recommendations, as appropriate, regarding ways to improve Federal programs related to substance use disorders, which may include dissemination of best practices for the treatment of substance use disorders to health care professionals. N Trauma-Informed Care 7131. CDC surveillance and data collection for child, youth, and adult trauma (a) Data collection The Director of the Centers for Disease Control and Prevention (referred to in this section as the Director ) may, in cooperation with the States, collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, and other relevant public health surveys or questionnaires. (b) Timing The collection of data under subsection (a) may occur biennially. (c) Data from rural areas The Director shall encourage each State that participates in collecting and reporting data under subsection (a) to collect and report data from rural areas within such State, in order to generate a statistically reliable representation of such areas. (d) Data from tribal areas The Director may, in cooperation with Indian Tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) and pursuant to a written request from an Indian Tribe, provide technical assistance to such Indian Tribe to collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, or another relevant public health survey or questionnaire. (e) Authorization of appropriations To carry out this section, there is authorized to be appropriated $2,000,000 for each of fiscal years 2019 through 2023. 7132. Task force to develop best practices for trauma-informed identification, referral, and support (a) Establishment There is established a task force, to be known as the Interagency Task Force on Trauma-Informed Care (in this section referred to as the task force ) that shall identify, evaluate, and make recommendations regarding— (1) best practices with respect to children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (2) ways in which Federal agencies can better coordinate to improve the Federal response to families impacted by substance use disorders and other forms of trauma. (b) Membership (1) Composition The task force shall be composed of the heads of the following Federal departments and agencies, or their designees: (A) The Centers for Medicare & Medicaid Services. (B) The Substance Abuse and Mental Health Services Administration. (C) The Agency for Healthcare Research and Quality. (D) The Centers for Disease Control and Prevention. (E) The Indian Health Service. (F) The Department of Veterans Affairs. (G) The National Institutes of Health. (H) The Food and Drug Administration. (I) The Health Resources and Services Administration. (J) The Department of Defense. (K) The Office of Minority Health of the Department of Health and Human Services. (L) The Administration for Children and Families. (M) The Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services. (N) The Office for Civil Rights of the Department of Health and Human Services. (O) The Office of Juvenile Justice and Delinquency Prevention of the Department of Justice. (P) The Office of Community Oriented Policing Services of the Department of Justice. (Q) The Office on Violence Against Women of the Department of Justice. (R) The National Center for Education Evaluation and Regional Assistance of the Department of Education. (S) The National Center for Special Education Research of the Institute of Education Science. (T) The Office of Elementary and Secondary Education of the Department of Education. (U) The Office for Civil Rights of the Department of Education. (V) The Office of Special Education and Rehabilitative Services of the Department of Education. (W) The Bureau of Indian Affairs of the Department of the Interior. (X) The Veterans Health Administration of the Department of Veterans Affairs. (Y) The Office of Special Needs Assistance Programs of the Department of Housing and Urban Development. (Z) The Office of Head Start of the Administration for Children and Families. (AA) The Children’s Bureau of the Administration for Children and Families. (BB) The Bureau of Indian Education of the Department of the Interior. (CC) Such other Federal agencies as the Secretaries determine to be appropriate. (2) Date of appointments The heads of Federal departments and agencies shall appoint the corresponding members of the task force not later than 60 days after the date of enactment of this Act. (3) Chairperson The task force shall be chaired by the Assistant Secretary for Mental Health and Substance Use, or the Assistant Secretary's designee. (c) Task force duties The task force shall— (1) solicit input from stakeholders, including frontline service providers, educators, mental health professionals, researchers, experts in infant, child, and youth trauma, child welfare professionals, and the public, in order to inform the activities under paragraph (2); and (2) identify, evaluate, make recommendations, and update such recommendations not less than annually, to the general public, the Secretary of Education, the Secretary of Health and Human Services, the Secretary of Labor, the Secretary of the Interior, the Attorney General, and other relevant cabinet Secretaries, and Congress regarding— (A) a set of evidence-based, evidence-informed, and promising best practices with respect to— (i) prevention strategies for individuals at risk of experiencing or being exposed to trauma, including trauma as a result of exposure to substance use; (ii) the identification of infants, children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; (iii) the expeditious referral to and implementation of trauma-informed practices and supports that prevent and mitigate the effects of trauma, which may include whole-family and multi-generational approaches; and (iv) community based or multi-generational practices that support children and their families; (B) a national strategy on how the task force and member agencies will collaborate, prioritize options for, and implement a coordinated approach, which may include— (i) data sharing; (ii) providing support to infants, children, and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; (iii) identifying options for coordinating existing grants that support infants, children, and youth, and their families as appropriate, who have experienced, or are at risk of experiencing, exposure to substance use or other trauma, including trauma related to substance use; and (iv) other ways to improve coordination, planning, and communication within and across Federal agencies, offices, and programs, to better serve children and families impacted by substance use disorders; and (C) existing Federal authorities at the Department of Education, Department of Health and Human Services, Department of Justice, Department of Labor, Department of the Interior, and other relevant agencies, and specific Federal grant programs to disseminate best practices on, provide training in, or deliver services through, trauma-informed practices, and disseminate such information— (i) in writing to relevant program offices at such agencies to encourage grant applicants in writing to use such funds, where appropriate, for trauma-informed practices; and (ii) to the general public through the internet website of the task force. (d) Best practices In identifying, evaluating, and recommending the set of best practices under subsection (c), the task force shall— (1) include guidelines for providing professional development and education for front-line services providers, including school personnel, early childhood education program providers, providers from child- or youth-serving organizations, housing and homeless providers, primary and behavioral health care providers, child welfare and social services providers, juvenile and family court personnel, health care providers, individuals who are mandatory reporters of child abuse or neglect, trained nonclinical providers (including peer mentors and clergy), and first responders, in— (A) understanding and identifying early signs and risk factors of trauma in infants, children, and youth, and their families as appropriate, including through screening processes and services; (B) providing practices to prevent and mitigate the impact of trauma, including by fostering safe and stable environments and relationships; and (C) developing and implementing policies, procedures, or systems that— (i) are designed to quickly refer infants, children, youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma to the appropriate trauma-informed screening and support and age-appropriate treatment, and to ensure such infants, children, youth, and family members receive such support; (ii) utilize and develop partnerships with early childhood education programs, local social services organizations, such as organizations serving youth, and clinical mental health or other health care providers with expertise in providing support services and age-appropriate trauma-informed and evidence-based treatment aimed at preventing or mitigating the effects of trauma; (iii) educate children and youth to— (I) understand and identify the signs, effects, or symptoms of trauma; and (II) build the resilience and coping skills to mitigate the effects of experiencing trauma; (iv) promote and support multi-generational practices that assist parents, foster parents, and kinship and other caregivers in accessing resources related to, and developing environments conducive to, the prevention and mitigation of trauma; and (v) collect and utilize data from screenings, referrals, or the provision of services and supports to evaluate outcomes and improve processes for trauma-informed services and supports that are culturally sensitive, linguistically appropriate, and specific to age ranges and sex, as applicable; (2) recommend best practices that are designed to avoid unwarranted custody loss or criminal penalties for parents or guardians in connection with infants, children, and youth who have experienced or are at risk of experiencing trauma; and (3) recommend opportunities for local- and State-level partnerships that— (A) are designed to quickly identify and refer children and families, as appropriate, who have experienced or are at risk of experiencing exposure to trauma, including related to substance use; (B) utilize and develop partnerships with early childhood education programs, local social services organizations, and health care services aimed at preventing or mitigating the effects of exposure to trauma, including related to substance use; (C) offer community-based prevention activities, including educating families and children on the effects of exposure to trauma, such as trauma related to substance use, and how to build resilience and coping skills to mitigate those effects; (D) in accordance with Federal privacy protections, utilize non-personally-identifiable data from screenings, referrals, or the provision of services and supports to evaluate and improve processes addressing exposure to trauma, including related to substance use; and (E) are designed to prevent separation and support reunification of families if in the best interest of the child. (e) Operating plan Not later than 120 days after the date of enactment of this Act, the task force shall hold the first meeting. Not later than 2 years after such date of enactment, the task force shall submit to the Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, and Congress an operating plan for carrying out the activities of the task force described in subsection (c)(2). Such operating plan shall include— (1) a list of specific activities that the task force plans to carry out for purposes of carrying out duties described in subsection (c)(2), which may include public engagement; (2) a plan for carrying out the activities under subsection (c)(2); (3) a list of members of the task force and other individuals who are not members of the task force that may be consulted to carry out such activities; (4) an explanation of Federal agency involvement and coordination needed to carry out such activities, including any statutory or regulatory barriers to such coordination; (5) a budget for carrying out such activities; (6) a proposed timeline for implementing recommendations and efforts identified under subsection (c); and (7) other information that the task force determines appropriate as related to its duties. (f) Final report Not later than 3 years after the date of the first meeting of the task force, the task force shall submit to the general public, Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, other relevant cabinet Secretaries, the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and Congress, a final report containing all of the findings and recommendations required under this section, and shall make such report available online in an accessible format. (g) Additional reports In addition to the final report under subsection (f). the task force shall submit— (1) a report to Congress identifying any recommendations identified under subsection (c) that require additional legislative authority to implement; and (2) a report to the Governors describing the opportunities for local- and State-level partnerships, professional development, or best practices recommended under subsection (d)(3). (h) Definitions In this section— (1) the term early childhood education program has the meaning given such term in section 103 of the Higher Education Act of 1965 ( 20 U.S.C. 1003 ); (2) The term Governor means the chief executive officer of a State; and (3) the term State means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. (i) Sunset The task force shall sunset on the date that is 60 days after the submission of the final report under subsection (f), but not later than September 30, 2023. 7133. National Child Traumatic Stress Initiative Section 582(j) of the Public Health Service Act ( 42 U.S.C. 290hh–1(j) ) (relating to grants to address the problems of persons who experience violence-related stress) is amended by striking $46,887,000 for each of fiscal years 2018 through 2022 and inserting $63,887,000 for each of fiscal years 2019 through 2023 . 7134. Grants to improve trauma support services and mental health care for children and youth in educational settings (a) Grants, contracts, and cooperative agreements authorized The Secretary, in coordination with the Assistant Secretary for Mental Health and Substance Use, is authorized to award grants to, or enter into contracts or cooperative agreements with, State educational agencies, local educational agencies, Indian Tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) or their tribal educational agencies, a school operated by the Bureau of Indian Education, a Regional Corporation, or a Native Hawaiian educational organization, for the purpose of increasing student access to evidence-based trauma support services and mental health care by developing innovative initiatives, activities, or programs to link local school systems with local trauma-informed support and mental health systems, including those under the Indian Health Service. (b) Duration With respect to a grant, contract, or cooperative agreement awarded or entered into under this section, the period during which payments under such grant, contract or agreement are made to the recipient may not exceed 4 years. (c) Use of funds An entity that receives a grant, contract, or cooperative agreement under this section shall use amounts made available through such grant, contract, or cooperative agreement for evidence-based activities, which shall include any of the following: (1) Collaborative efforts between school-based service systems and trauma-informed support and mental health service systems to provide, develop, or improve prevention, screening, referral, and treatment and support services to students, such as providing trauma screenings to identify students in need of specialized support. (2) To implement schoolwide positive behavioral interventions and supports, or other trauma-informed models of support. (3) To provide professional development to teachers, teacher assistants, school leaders, specialized instructional support personnel, and mental health professionals that— (A) fosters safe and stable learning environments that prevent and mitigate the effects of trauma, including through social and emotional learning; (B) improves school capacity to identify, refer, and provide services to students in need of trauma support or behavioral health services; or (C) reflects the best practices for trauma-informed identification, referral, and support developed by the Task Force under section 7132. (4) Services at a full-service community school that focuses on trauma-informed supports, which may include a full-time site coordinator, or other activities consistent with section 4625 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7275 ). (5) Engaging families and communities in efforts to increase awareness of child and youth trauma, which may include sharing best practices with law enforcement regarding trauma-informed care and working with mental health professionals to provide interventions, as well as longer term coordinated care within the community for children and youth who have experienced trauma and their families. (6) To provide technical assistance to school systems and mental health agencies. (7) To evaluate the effectiveness of the program carried out under this section in increasing student access to evidence-based trauma support services and mental health care. (8) To establish partnerships with or provide subgrants to Head Start agencies (including Early Head Start agencies), public and private preschool programs, child care programs (including home-based providers), or other entities described in subsection (a), to include such entities described in this paragraph in the evidence-based trauma initiatives, activities, support services, and mental health systems established under this section in order to provide, develop, or improve prevention, screening, referral, and treatment and support services to young children and their families. (d) Applications To be eligible to receive a grant, contract, or cooperative agreement under this section, an entity described in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include the following: (1) A description of the innovative initiatives, activities, or programs to be funded under the grant, contract, or cooperative agreement, including how such program will increase access to evidence-based trauma support services and mental health care for students, and, as applicable, the families of such students. (2) A description of how the program will provide linguistically appropriate and culturally competent services. (3) A description of how the program will support students and the school in improving the school climate in order to support an environment conducive to learning. (4) An assurance that— (A) persons providing services under the grant, contract, or cooperative agreement are adequately trained to provide such services; and (B) teachers, school leaders, administrators, specialized instructional support personnel, representatives of local Indian Tribes or tribal organizations as appropriate, other school personnel, and parents or guardians of students participating in services under this section will be engaged and involved in the design and implementation of the services. (5) A description of how the applicant will support and integrate existing school-based services with the program in order to provide mental health services for students, as appropriate. (6) A description of the entities in the community with which the applicant will partner or to which the applicant will provide subgrants in accordance with subsection (c)(8). (e) Interagency agreements (1) Local interagency agreements To ensure the provision of the services described in subsection (c), a recipient of a grant, contract, or cooperative agreement under this section, or their designee, shall establish a local interagency agreement among local educational agencies, agencies responsible for early childhood education programs, Head Start agencies (including Early Head Start agencies), juvenile justice authorities, mental health agencies, child welfare agencies, and other relevant agencies, authorities, or entities in the community that will be involved in the provision of such services. (2) Contents In ensuring the provision of the services described in subsection (c), the local interagency agreement shall specify with respect to each agency, authority, or entity that is a party to such agreement— (A) the financial responsibility for the services; (B) the conditions and terms of responsibility for the services, including quality, accountability, and coordination of the services; and (C) the conditions and terms of reimbursement among such agencies, authorities, or entities, including procedures for dispute resolution. (f) Evaluation The Secretary shall reserve not more than 3 percent of the funds made available under subsection (l) for each fiscal year to— (1) conduct a rigorous, independent evaluation of the activities funded under this section; and (2) disseminate and promote the utilization of evidence-based practices regarding trauma support services and mental health care. (g) Distribution of awards The Secretary shall ensure that grants, contracts, and cooperative agreements awarded or entered into under this section are equitably distributed among the geographical regions of the United States and among tribal, urban, suburban, and rural populations. (h) Rule of construction Nothing in this section shall be construed— (1) to prohibit an entity involved with a program carried out under this section from reporting a crime that is committed by a student to appropriate authorities; or (2) to prevent Federal, State, and tribal law enforcement and judicial authorities from exercising their responsibilities with regard to the application of Federal, tribal, and State law to crimes committed by a student. (i) Supplement, not supplant Any services provided through programs carried out under this section shall supplement, and not supplant, existing mental health services, including any special education and related services provided under the Individuals with Disabilities Education Act ( 20 U.S.C. 1400 et seq.). (j) Consultation with Indian Tribes In carrying out subsection (a), the Secretary shall, in a timely manner, meaningfully consult with Indian Tribes and their representatives to ensure notice of eligibility. (k) Definitions In this section: (1) Elementary school The term elementary school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (2) Evidence-based The term evidence-based has the meaning given such term in section 8101(21)(A)(i) of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801(21)(A)(i) ). (3) Native Hawaiian educational organization The term Native Hawaiian educational organization has the meaning given such term in section 6207 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7517 ). (4) Local educational agency The term local educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (5) Regional Corporation The term Regional Corporation has the meaning given the term in section 3 of the Alaska Native Claims Settlement Act ( 43 U.S.C. 1602 )). (6) School The term school means a public elementary school or public secondary school. (7) School leader The term school leader has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (8) Secondary school The term secondary school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (9) Secretary The term Secretary means the Secretary of Education. (10) Specialized instructional support personnel The term specialized instructional support personnel has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (11) State educational agency The term State educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (l) Authorization of appropriations There is authorized to be appropriated to carry out this section, $50,000,000 for each of fiscal years 2019 through 2023. 7135. Recognizing early childhood trauma related to substance abuse (a) Dissemination of information The Secretary of Health and Human Services shall disseminate information, resources, and, if requested, technical assistance to early childhood care and education providers and professionals working with young children on— (1) ways to properly recognize children who may be impacted by trauma, including trauma related to substance use by a family member or other adult; and (2) how to respond appropriately in order to provide for the safety and well-being of young children and their families. (b) Goals The information, resources, and technical assistance provided under subsection (a) shall— (1) educate early childhood care and education providers and professionals working with young children on understanding and identifying the early signs and risk factors of children who might be impacted by trauma, including trauma due to exposure to substance use; (2) suggest age-appropriate communication tools, procedures, and practices for trauma-informed care, including ways to prevent or mitigate the effects of trauma; (3) provide options for responding to children impacted by trauma, including due to exposure to substance use, that consider the needs of the child and family, including recommending resources and referrals for evidence-based services to support such family; and (4) promote whole-family and multi-generational approaches to keep families safely together when it is in the best interest of the child. (c) Coordination The Secretary of Health and Human Services shall coordinate with the task force to develop best practices for trauma-informed identification, referral, and support authorized under section 7132 in disseminating the information, resources, and technical assistance described under subsection (b). (d) Rule of construction Such information, resources, and if applicable, technical assistance, shall not be construed to amend the requirements under— (1) the Child Care and Development Block Grant Act of 1990 ( 42 U.S.C. 9858 et seq.); (2) the Head Start Act ( 42 U.S.C. 9831 et seq.); or (3) the Individuals with Disabilities Education Act ( 20 U.S.C. 1400 et seq.). O Eliminating Opioid Related Infectious Diseases 7141. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors Section 317N of the Public Health Service Act ( 42 U.S.C. 247b–15 ) is amended to read as follows: 317N. Surveillance and education regarding infections associated with illicit drug use and other risk factors (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may (directly or through grants to public and nonprofit private entities) provide for programs for the following: (1) To cooperate with States and Indian tribes in implementing or maintaining a national system to determine the incidence of infections commonly associated with illicit drug use, such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections. (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph (1) resulting from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors. (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services. (4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary. (5) To improve the education, training, and skills of health professionals in the detection and control of infections described in paragraph (1), including to improve coordination of treatment of substance use disorders and infectious diseases, with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, and infectious disease clinicians, including HIV clinicians. (b) Laboratory procedures The Secretary may (directly or through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection (a)(1). (c) Definition In this section, the term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023. . P Peer Support Communities of Recovery 7151. Building communities of recovery Section 547 of the Public Health Service Act ( 42 U.S.C. 290ee–2 ) is amended to read as follows: 547. Building communities of recovery (a) Definition In this section, the term recovery community organization means an independent nonprofit organization that— (1) mobilizes resources within and outside of the recovery community, which may include through a peer support network, to increase the prevalence and quality of long-term recovery from substance use disorders; and (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community served. (b) Grants authorized The Secretary shall award grants to recovery community organizations to enable such organizations to develop, expand, and enhance recovery services. (c) Federal share The Federal share of the costs of a program funded by a grant under this section may not exceed 85 percent. (d) Use of funds Grants awarded under subsection (b)— (1) shall be used to develop, expand, and enhance community and statewide recovery support services; and (2) may be used to— (A) build connections between recovery networks, including between recovery community organizations and peer support networks, and with other recovery support services, including— (i) behavioral health providers; (ii) primary care providers and physicians; (iii) educational and vocational schools; (iv) employers; (v) housing services; (vi) child welfare agencies; and (vii) other recovery support services that facilitate recovery from substance use disorders, including non-clinical community services; (B) reduce stigma associated with substance use disorders; and (C) conduct outreach on issues relating to substance use disorders and recovery, including— (i) identifying the signs of substance use disorder; (ii) the resources available to individuals with substance use disorder and to families of an individual with a substance use disorder, including programs that mentor and provide support services to children; (iii) the resources available to help support individuals in recovery; and (iv) related medical outcomes of substance use disorders, the potential of acquiring an infection commonly associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during pregnancy. (e) Special consideration In carrying out this section, the Secretary shall give special consideration to the unique needs of rural areas, including areas with an age-adjusted rate of drug overdose deaths that is above the national average and areas with a shortage of prevention and treatment services. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2019 through 2023. . 7152. Peer support technical assistance center Title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.) is amended by inserting after section 547 the following: 547A. Peer support technical assistance center (a) Establishment The Secretary, acting through the Assistant Secretary, shall establish or operate a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this section as the Center ). (b) Functions The Center established under subsection (a) shall provide technical assistance and support to recovery community organizations and peer support networks, including such assistance and support related to— (1) training on identifying— (A) signs of substance use disorder; (B) resources to assist individuals with a substance use disorder, or resources for families of an individual with a substance use disorder; and (C) best practices for the delivery of recovery support services; (2) the provision of translation services, interpretation, or other such services for clients with limited English speaking proficiency; (3) data collection to support research, including for translational research; (4) capacity building; and (5) evaluation and improvement, as necessary, of the effectiveness of such services provided by recovery community organizations. (c) Best practices The Center established under subsection (a) shall periodically issue best practices for use by recovery community organizations and peer support networks. (d) Recovery community organization In this section, the term recovery community organization has the meaning given such term in section 547. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2019 through 2023. . Q Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies 7161. Preventing overdoses of controlled substances (a) In general Part J of title III of the Public Health Service Act ( 42 U.S.C. 280b et seq.) is amended by inserting after section 392 ( 42 U.S.C. 280b–1 ) the following: 392A. Preventing overdoses of controlled substances (a) Evidence-Based prevention grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out and expand any evidence-based prevention activities described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying out such activity; and (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity. (2) Evidence-based prevention activities An evidence-based prevention activity described in this paragraph is any of the following activities: (A) Improving the efficiency and use of a new or currently operating prescription drug monitoring program, including by— (i) encouraging all authorized users (as specified by the State or other entity) to register with and use the program; (ii) enabling such users to access any updates to information collected by the program in as close to real-time as possible; (iii) improving the ease of use of such program; (iv) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing or dispensing practices relating to such substances; (v) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identified, aggregate reports based on such analysis to State public health agencies, State substance abuse agencies, State licensing boards, and other appropriate State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug monitoring program and not containing any protected health information, to prevent inappropriate prescribing, drug diversion, or abuse and misuse of controlled substances, and to facilitate better coordination among agencies; (vi) enhancing interoperability between the program and any health information technology (including certified health information technology), including by integrating program data into such technology; (vii) updating program capabilities to respond to technological innovation for purposes of appropriately addressing the occurrence and evolution of controlled substance overdoses; (viii) facilitating and encouraging data exchange between the program and the prescription drug monitoring programs of other States; (ix) enhancing data collection and quality, including improving patient matching and proactively monitoring data quality; (x) providing prescriber and dispenser practice tools, including prescriber practice insight reports for practitioners to review their prescribing patterns in comparison to such patterns of other practitioners in the specialty; and (xi) meeting the purpose of the program established under section 399O, as described in section 399O(a). (B) Promoting community or health system interventions. (C) Evaluating interventions to prevent controlled substance overdoses. (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging public health crises and opportunities to address such crises, such as enhancing public education and awareness on the risks associated with opioids. (3) Additional grants The Director may award grants to States, localities, and Indian Tribes— (A) to carry out innovative projects for grantees to rapidly respond to controlled substance misuse, abuse, and overdoses, including changes in patterns of controlled substance use; and (B) for any other evidence-based activity for preventing controlled substance misuse, abuse, and overdoses as the Director determines appropriate. (4) Research The Director, in coordination with the Assistant Secretary for Mental Health and Substance Use and the National Mental Health and Substance Use Policy Laboratory established under section 501A, as appropriate and applicable, may conduct studies and evaluations to address substance use disorders, including preventing substance use disorders or other related topics the Director determines appropriate. (b) Enhanced controlled substance overdose data collection, analysis, and dissemination grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out any controlled substance overdose data collection activities described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying out such activity; (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity; and (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to section 505(d)(1)(A) (relating to the number of individuals admitted to emergency departments as a result of the abuse of alcohol or other drugs). (2) Controlled substance overdose data collection and analysis activities A controlled substance overdose data collection, analysis, and dissemination activity described in this paragraph is any of the following activities: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal overdoses of controlled substances. (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on such overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and emergency departments. (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an electronic-based system. (D) Using data to help identify risk factors associated with controlled substance overdoses. (E) Supporting entities involved in providing information on controlled substance overdoses, such as coroners, medical examiners, and public health laboratories to improve accurate testing and standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of various opioid analogues to controlled substance overdoses. (F) Working to enable and encourage the access, exchange, and use of information regarding controlled substance overdoses among data sources and entities. (c) Definitions In this section: (1) Controlled substance The term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act. (2) Indian tribe The term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations For purposes of carrying out this section, section 399O of this Act, and section 102 of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), there is authorized to be appropriated $496,000,000 for each of fiscal years 2019 through 2023. . (b) Education and awareness Section 102 of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ) is amended— (1) by amending subsection (a) to read as follows: (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in coordination with the heads of other departments and agencies, shall advance education and awareness regarding the risks related to misuse and abuse of opioids, as appropriate, which may include developing or improving existing programs, conducting activities, and awarding grants that advance the education and awareness of— (1) the public, including patients and consumers— (A) generally; and (B) regarding such risks related to unused opioids and the dispensing options under section 309(f) of the Controlled Substances Act, as applicable; and (2) providers, which may include— (A) providing for continuing education on appropriate prescribing practices; (B) education related to applicable State or local prescriber limit laws, information on the use of non-addictive alternatives for pain management, and the use of overdose reversal drugs, as appropriate; (C) disseminating and improving the use of evidence-based opioid prescribing guidelines across relevant health care settings, as appropriate, and updating guidelines as necessary; (D) implementing strategies, such as best practices, to encourage and facilitate the use of prescriber guidelines, in accordance with State and local law; (E) disseminating information to providers about prescribing options for controlled substances, including such options under section 309(f) of the Controlled Substances Act, as applicable; and (F) disseminating information, as appropriate, on the National Pain Strategy developed by or in consultation with the Assistant Secretary for Health; and (3) other appropriate entities. ; and (2) in subsection (b)— (A) by striking opioid abuse each place such term appears and inserting opioid misuse and abuse ; and (B) in paragraph (2), by striking safe disposal of prescription medications and other and inserting non-addictive treatment options, safe disposal options for prescription medications, and other applicable . 7162. Prescription drug monitoring program Section 399O of the Public Health Service Act ( 42 U.S.C. 280g–3 ) is amended to read as follows: 399O. Prescription drug monitoring program (a) Program (1) In general Each fiscal year, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, in coordination with the heads of other departments and agencies as appropriate, shall support States or localities for the purpose of improving the efficiency and use of PDMPs, including— (A) establishment and implementation of a PDMP; (B) maintenance of a PDMP; (C) improvements to a PDMP by— (i) enhancing functional components to work toward— (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow; (II) more timely inclusion of data within a PDMP; (III) active management of the PDMP, in part by sending proactive or unsolicited reports to providers to inform prescribing; and (IV) ensuring the highest level of ease in use of and access to PDMPs by providers and their delegates, to the extent that State laws allow; (ii) in consultation with the Office of the National Coordinator for Health Information Technology, improving the intrastate interoperability of PDMPs by— (I) making PDMPs more actionable by integrating PDMPs within electronic health records and health information technology infrastructure; and (II) linking PDMP data to other data systems within the State, including— (aa) the data of pharmacy benefit managers, medical examiners and coroners, and the State’s Medicaid program; (bb) worker’s compensation data; and (cc) prescribing data of providers of the Department of Veterans Affairs and the Indian Health Service within the State; (iii) in consultation with the Office of the National Coordinator for Health Information Technology, improving the interstate interoperability of PDMPs through— (I) sharing of dispensing data in near-real time across State lines; and (II) integration of automated queries for multistate PDMP data and analytics into clinical workflow to improve the use of such data and analytics by practitioners and dispensers; or (iv) improving the ability to include treatment availability resources and referral capabilities within the PDMP. (2) Legislation As a condition on the receipt of support under this section, the Secretary shall require a State or locality to demonstrate that it has enacted legislation or regulations— (A) to provide for the implementation of the PDMP; and (B) to permit the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained by the PDMP. (b) PDMP strategies The Secretary shall encourage a State or locality, in establishing, improving, or maintaining a PDMP, to implement strategies that improve— (1) the reporting of dispensing in the State or locality of a controlled substance to an ultimate user so the reporting occurs not later than 24 hours after the dispensing event; (2) the consultation of the PDMP by each prescribing practitioner, or their designee, in the State or locality before initiating treatment with a controlled substance, or any substance as required by the State to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event; (3) the consultation of the PDMP before dispensing a controlled substance, or any substance as required by the State to be reported to the PDMP; (4) the proactive notification to a practitioner when patterns indicative of controlled substance misuse by a patient, including opioid misuse, are detected; (5) the availability of data in the PDMP to other States, as allowable under State law; and (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for surveillance, epidemiology, statistical research, or educational purposes. (c) Drug misuse and abuse In consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State receiving support under this section— (1) shall establish a program to notify practitioners and dispensers of information that will help to identify and prevent the unlawful diversion or misuse of controlled substances; (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for carrying out drug diversion investigations if the State determines that information in the PDMP maintained by the State indicates an unlawful diversion or abuse of a controlled substance; (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State agencies with aggregate reports based on such analyses in as close to real-time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse, addiction, overdose, and other aggregate information, as appropriate and in compliance with applicable Federal and State laws and provided that such reports shall not include protected health information; and (4) may access information about prescriptions, such as claims data, to ensure that such prescribing and dispensing history is updated in as close to real-time as practicable, in compliance with applicable Federal and State laws and provided that such information shall not include protected health information. (d) Evaluation and reporting As a condition on receipt of support under this section, the State shall report on interoperability with PDMPs of other States and Federal agencies, where appropriate, intrastate interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient. (e) Evaluation and reporting A State receiving support under this section shall provide the Secretary with aggregate nonidentifiable information, as permitted by State law, to enable the Secretary— (1) to evaluate the success of the State’s program in achieving the purpose described in subsection (a); or (2) to prepare and submit to the Congress the report required by subsection (i)(2). (f) Education and access to the monitoring system A State receiving support under this section shall take steps to— (1) facilitate prescribers and dispensers, and their delegates, as permitted by State law, to use the PDMP, to the extent practicable; and (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs. (g) Electronic format The Secretary may issue guidelines specifying a uniform electronic format for the reporting, sharing, and disclosure of information pursuant to PDMPs. To the extent possible, such guidelines shall be consistent with standards recognized by the Office of the National Coordinator for Health Information Technology. (h) Rules of construction (1) Functions otherwise authorized by law Nothing in this section shall be construed to restrict the ability of any authority, including any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, to perform functions otherwise authorized by law. (2) Additional privacy protections Nothing in this section shall be construed as preempting any State from imposing any additional privacy protections. (3) Federal privacy requirements Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( Public Law 104–191 ; 110 Stat. 2033) and section 543 of this Act. (4) No Federal private cause of action Nothing in this section shall be construed to create a Federal private cause of action. (i) Progress report Not later than 3 years after the date of enactment of this section, the Secretary shall— (1) complete a study that— (A) determines the progress of grantees in establishing and implementing PDMPs consistent with this section; (B) provides an analysis of the extent to which the operation of PDMPs has— (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances; (ii) established or strengthened initiatives to ensure linkages to substance use disorder treatment services; or (iii) affected patient access to appropriate care in States operating PDMPs; (C) determine the progress of grantees in achieving interstate interoperability and intrastate interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress and recommendations for addressing these barriers; (D) determines the progress of grantees in implementing near real-time electronic PDMPs; (E) provides an analysis of the privacy protections in place for the information reported to the PDMP in each State or locality receiving support under this section and any recommendations of the Secretary for additional Federal or State requirements for protection of this information; (F) determines the progress of States or localities in implementing technological alternatives to centralized data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such alternatives to enhance the privacy and security of individually identifiable data; and (G) evaluates the penalties that States or localities have enacted for the unauthorized use and disclosure of information maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify as appropriate for purposes of subsection (a)(2); and (2) submit a report to the Congress on the results of the study. (j) Advisory council (1) Establishment A State or locality may establish an advisory council to assist in the establishment, improvement, or maintenance of a PDMP consistent with this section. (2) Limitation A State or locality may not use Federal funds for the operations of an advisory council to assist in the establishment, improvement, or maintenance of a PDMP. (3) Sense of Congress It is the sense of the Congress that, in establishing an advisory council to assist in the establishment, improvement, or maintenance of a PDMP, a State or locality should consult with appropriate professional boards and other interested parties. (k) Definitions For purposes of this section: (1) The term controlled substance means a controlled substance (as defined in section 102 of the Controlled Substances Act) in schedule II, III, or IV of section 202 of such Act. (2) The term dispense means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, irrespective of whether the dispenser uses the Internet or other means to effect such delivery. (3) The term dispenser means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user. (4) The term interstate interoperability with respect to a PDMP means the ability of the PDMP to electronically share reported information with another State if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing of a controlled substance prescribed by a practitioner whose principal place of business is located in such other State. (5) The term intrastate interoperability with respect to a PDMP means the integration of PDMP data within electronic health records and health information technology infrastructure or linking of a PDMP to other data systems within the State, including the State’s Medicaid program, workers’ compensation programs, and medical examiners or coroners. (6) The term nonidentifiable information means information that does not identify a practitioner, dispenser, or an ultimate user and with respect to which there is no reasonable basis to believe that the information can be used to identify a practitioner, dispenser, or an ultimate user. (7) The term PDMP means a prescription drug monitoring program that is State-controlled. (8) The term practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the individual practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. (9) The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (10) The term ultimate user means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the person’s household, or for the use of an animal owned by the person or by a member of the person’s household. (11) The term clinical workflow means the integration of automated queries for prescription drug monitoring programs data and analytics into health information technologies such as electronic health record systems, health information exchanges, and/or pharmacy dispensing software systems, thus streamlining provider access through automated queries. . R Review of substance use disorder treatment providers receiving Federal funding 7171. Review of substance use disorder treatment providers receiving Federal funding (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall conduct a review of entities that receive Federal funding for the provision of substance use disorder treatment services. The review shall include: (1) The length of time the entity has provided substance use disorder treatment services and the geographic area served by the entity. (2) A detailed analysis of the patient population served by the entity, including but not limited to the number of patients, types of diagnosed substance use disorders and the demographic information of such patients, including sex, race, ethnicity, and socioeconomic status. (3) Detailed information on the types of substance use disorders for which the entity has the experience, capability, and capacity to provide such services. (4) An analysis of how the entity handles patients requiring treatment for a substance use disorder that the organization is not able to treat. (5) An analysis of what is needed in order to improve the entity’s ability to meet the addiction treatment needs of the communities served by that entity. (6) Based on the identified needs of the communities served, a description of unmet needs and inadequate services and how such needs and services could be better addressed to treat individuals with methamphetamine, cocaine, including crack cocaine, heroin, opioid, and other substance use disorders. (b) Report Not later than 2 years after the date of the enactment of this Act, the Secretary shall develop and submit to Congress a plan to direct appropriate resources to entities that provide substance use disorder treatment services in order to address inadequacies in services or funding identified through the survey described in subsection (a). S Other health provisions 7181. State response to the opioid abuse crisis (a) In general Section 1003 of the 21st Century Cures Act ( Public Law 114–255 ) is amended— (1) in subsection (a)— (A) by striking the authorization of appropriations under subsection (b) to carry out the grant program described in subsection (c) and inserting subsection (h) to carry out the grant program described in subsection (b) ; and (B) by inserting and Indian Tribes after States ; (2) by striking subsection (b); (3) by redesignating subsections (c) through (e) as subsections (b) through (d), respectively; (4) by redesignating subsection (f) as subsection (j); (5) in subsection (b), as so redesignated— (A) in paragraph (1)— (i) in the paragraph heading, by inserting and tribal after State ; (ii) by striking States for the purpose of addressing the opioid abuse crisis within such States and inserting States and Indian Tribes for the purpose of addressing the opioid abuse crisis within such States and Indian Tribes ; (iii) by inserting or Indian Tribes after preference to States ; and (iv) by inserting before the period of the second sentence or other Indian Tribes, as applicable ; and (B) in paragraph (2)— (i) in the matter preceding subparagraph (A), by striking to a State ; (ii) in subparagraph (A), by striking Improving State and inserting Establishing or improving ; (iii) in subparagraph (C), by inserting preventing diversion of controlled substances, after treatment programs, ; and (iv) in subparagraph (E), by striking as the State determines appropriate, related to addressing the opioid abuse crisis within the State and inserting as the State or Indian Tribe determines appropriate, related to addressing the opioid abuse crisis within the State or Indian Tribe, including directing resources in accordance with local needs related to substance use disorders ; (6) in subsection (c), as so redesignated, by striking subsection (c) and inserting subsection (b) ; (7) in subsection (d), as so redesignated— (A) in the matter preceding paragraph (1), by striking the authorization of appropriations under subsection (b) and inserting subsection (h) ; and (B) in paragraph (1), by striking subsection (c) and inserting subsection (b) ; and (8) by inserting after subsection (d), as so redesignated, the following: (e) Indian Tribes (1) Definition For purposes of this section, the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (2) Appropriate mechanisms The Secretary, in consultation with Indian Tribes, shall identify and establish appropriate mechanisms for Tribes to demonstrate or report the information as required under subsections (b), (c), and (d). (f) Report to Congress Not later than 1 year after the date on which amounts are first awarded after the date of enactment of this subsection, pursuant to subsection (b), and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing the information provided to the Secretary in reports made pursuant to subsection (c), including the purposes for which grant funds are awarded under this section and the activities of such grant recipients. (g) Technical Assistance The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, shall provide State agencies and Indian Tribes, as applicable, with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing the opioid crisis. (h) Authorization of appropriations For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $500,000,000 for each of fiscal years 2019 through 2021, to remain available until expended. (i) Set aside Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, 5 percent of such amount for such fiscal year shall be made available to Indian Tribes, and up to 15 percent of such amount for such fiscal year may be set aside for States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention. . (b) Conforming amendment Section 1004(c) of the 21st Century Cures Act ( Public Law 114–255 ) is amended by striking , the FDA Innovation Account, or the Account For the State Response to the Opioid Abuse Crisis and inserting or the FDA Innovation Account . 7182. Report on investigations regarding parity in mental health and substance use disorder benefits (a) In general Section 13003 of the 21st Century Cures Act ( Public Law 114–255 ) is amended— (1) in subsection (a)— (A) by striking with findings of any serious violation regarding and inserting concerning ; and (B) by inserting and the Committee on Education and the Workforce after Energy and Commerce ; and (2) in subsection (b)(1)— (A) by inserting complaints received and number of before closed ; and (B) by inserting before the period , and, for each such investigation closed, which agency conducted the investigation, whether the health plan that is the subject of the investigation is fully insured or not fully insured and a summary of any coordination between the applicable State regulators and the Department of Labor, the Department of Health and Human Services, or the Department of the Treasury, and references to any guidance provided by the agencies addressing the category of violation committed . (b) Applicability The amendments made by subsection (a) shall apply with respect to the second annual report required under such section 13003 and each such annual report thereafter. 7183. CAREER Act (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), in consultation with the Secretary of Labor, shall continue or establish a program to support individuals in substance use disorder treatment and recovery to live independently and participate in the workforce. (b) Grants authorized In carrying out the activities under this section, the Secretary shall, on a competitive basis, award grants for a period of not more than 5 years to entities to enable such entities to carry out evidence-based programs to help individuals in substance use disorder treatment and recovery to live independently and participate in the workforce. Such entities shall coordinate, as applicable, with Indian tribes or tribal organizations (as applicable), State boards and local boards (as defined in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ), lead State agencies with responsibility for a workforce investment activity (as defined in such section 3), and State agencies responsible for carrying out substance use disorder prevention and treatment programs. (c) Priority (1) In general In awarding grants under this section, the Secretary shall give priority based on the State in which the entity is located. Priority shall be given among States according to a formula based on the rates described in paragraph (2) and weighted as described in paragraph (3). (2) Rates The rates described in this paragraph are the following: (A) The amount by which the rate of drug overdose deaths in the State, adjusted for age, is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention. (B) The amount by which the rate of unemployment for the State, based on data provided by the Bureau of Labor Statistics for the preceding 5 calendar years for which there is available data, is above the national average. (C) The amount by which rate of labor force participation in the State, based on data provided by the Bureau of Labor Statistics for the preceding 5 calendar years for which there is available data, is below the national average. (3) Weighting The rates described in paragraph (2) shall be weighted as follows: (A) The rate described in paragraph (2)(A) shall be weighted 70 percent. (B) The rate described in paragraph (2)(B) shall be weighted 15 percent. (C) The rate described in paragraph (2)(C) shall be weighted 15 percent. (d) Preference In awarding grants under this section, the Secretary shall give preference to entities located in areas within States with the greatest need, with such need based on the highest mortality rate related to substance use disorder. (e) Definitions In this section: (1) Eligible entity The term eligible entity means an entity that offers treatment or recovery services for individuals with substance use disorders, and partners with one or more local or State stakeholders, which may include local employers, community organizations, the local workforce development board, local and State governments, and Indian Tribes or tribal organizations, to support recovery, independent living, and participation in the workforce. (2) Indian Tribes; tribal organization The terms Indian Tribe and tribal organization have the meanings given the terms Indian tribe and tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (3) State The term State includes only the several States and the District of Columbia. (f) Applications An eligible entity shall submit an application at such time and in such manner as the Secretary may require. In submitting an application, the entity shall demonstrate the ability to partner with local stakeholders, which may include local employers, community stakeholders, the local workforce development board, local and State governments, and Indian Tribes or tribal organizations, as applicable, to— (1) identify gaps in the workforce due to the prevalence of substance use disorders; (2) in coordination with statewide employment and training activities, including coordination and alignment of activities carried out by entities provided grant funds under section 8041, help individuals in recovery from a substance use disorder transition into the workforce, including by providing career services, training services as described in paragraph (2) of section 134(c) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3174(c) ), and related services described in section 134(a)(3) of such Act ( 42 U.S.C. 3174(a) ); and (3) assist employers with informing their employees of the resources, such as resources related to substance use disorders that are available to their employees. (g) Use of funds An entity receiving a grant under this section shall use the funds to conduct one or more of the following activities: (1) Hire case managers, care coordinators, providers of peer recovery support services, as described in section 547(a) of the Public Health Service Act ( 42 U.S.C. 290ee–2(a) ), or other professionals, as appropriate, to provide services that support treatment, recovery, and rehabilitation, and prevent relapse, recidivism, and overdose, including by encouraging— (A) the development and strengthening of daily living skills; and (B) the use of counseling, care coordination, and other services, as appropriate, to support recovery from substance use disorders. (2) Implement or utilize innovative technologies, which may include the use of telemedicine. (3) In coordination with the lead State agency with responsibility for a workforce investment activity or local board described in subsection (b), provide— (A) short-term prevocational training services; and (B) training services that are directly linked to the employment opportunities in the local area or the planning region. (h) Support for State strategy An eligible entity shall include in its application under subsection (f) information describing how the services and activities proposed in such application are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing issues described in such application and how such entity will coordinate with existing systems to deliver services as described in such application. (i) Data reporting and program oversight Each eligible entity awarded a grant under this section shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include a description of— (1) the programs and activities funded by the grant; (2) outcomes of the population of individuals with a substance use disorder the grantee served through activities described in subsection (g); and (3) any other information that the Secretary may require for the purpose of ensuring that the grantee is complying with all of the requirements of the grant. (j) Reports to Congress (1) Preliminary report Not later than 2 years after the end of the first year of the grant period under this section, the Secretary shall submit to Congress a preliminary report that analyzes reports submitted under subsection (i). (2) Final report Not later than 2 years after submitting the preliminary report required under paragraph (1), the Secretary shall submit to Congress a final report that includes— (A) a description of how the grant funding was used, including the number of individuals who received services under subsection (g)(3) and an evaluation of the effectiveness of the activities conducted by the grantee with respect to outcomes of the population of individuals with substance use disorder who receive services from the grantee; and (B) recommendations related to best practices for health care professionals to support individuals in substance use disorder treatment or recovery to live independently and participate in the workforce. (k) Authorization of appropriations There is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. VIII Miscellaneous A Synthetics Trafficking and Overdose Prevention 8001. Short title This subtitle may be cited as the Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 . 8002. Customs fees (a) In general Section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(b)(9) ) is amended by adding at the end the following: (D) (i) With respect to the processing of items that are sent to the United States through the international postal network by Inbound Express Mail service or Inbound EMS (as that service is described in the mail classification schedule referred to in section 3631 of title 39, United States Code), the following payments are required: (I) $1 per Inbound EMS item. (II) If an Inbound EMS item is formally entered, the fee provided for under subsection (a)(9), if applicable. (ii) Notwithstanding section 451 of the Tariff Act of 1930 ( 19 U.S.C. 1451 ), the payments required by clause (i), as allocated pursuant to clause (iii)(I), shall be the only payments required for reimbursement of U.S. Customs and Border Protection for customs services provided in connection with the processing of an Inbound EMS item. (iii) (I) The payments required by clause (i)(I) shall be allocated as follows: (aa) 50 percent of the amount of the payments shall be paid on a quarterly basis by the United States Postal Service to the Commissioner of U.S. Customs and Border Protection in accordance with regulations prescribed by the Secretary of the Treasury to reimburse U.S. Customs and Border Protection for customs services provided in connection with the processing of Inbound EMS items. (bb) 50 percent of the amount of the payments shall be retained by the Postal Service to reimburse the Postal Service for services provided in connection with the customs processing of Inbound EMS items. (II) Payments received by U.S. Customs and Border Protection under subclause (I)(aa) shall, in accordance with section 524 of the Tariff Act of 1930 ( 19 U.S.C. 1524 ), be deposited in the Customs User Fee Account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities. Amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services. (III) Payments retained by the Postal Service under subclause (I)(bb) shall be used to directly reimburse the Postal Service for the costs incurred in providing services in connection with the customs processing of Inbound EMS items. (iv) Beginning in fiscal year 2021, the Secretary, in consultation with the Postmaster General, may adjust, not more frequently than once each fiscal year, the amount described in clause (i)(I) to an amount commensurate with the costs of services provided in connection with the customs processing of Inbound EMS items, consistent with the obligations of the United States under international agreements. . (b) Conforming amendments Section 13031(a) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(a) ) is amended— (1) in paragraph (6), by inserting (other than an item subject to a fee under subsection (b)(9)(D)) after customs officer ; and (2) in paragraph (10)— (A) in subparagraph (C), in the matter preceding clause (i), by inserting (other than Inbound EMS items described in subsection (b)(9)(D)) after release ; and (B) in the flush at the end, by inserting or of Inbound EMS items described in subsection (b)(9)(D), after (C), . (c) Effective date The amendments made by this section shall take effect on January 1, 2020. 8003. Mandatory advance electronic information for postal shipments (a) Mandatory advance electronic information (1) In general Section 343(a)(3)(K) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended to read as follows: (K) (i) The Secretary shall prescribe regulations requiring the United States Postal Service to transmit the information described in paragraphs (1) and (2) to the Commissioner of U.S. Customs and Border Protection for international mail shipments by the Postal Service (including shipments to the Postal Service from foreign postal operators that are transported by private carrier) consistent with the requirements of this subparagraph. (ii) In prescribing regulations under clause (i), the Secretary shall impose requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo, taking into account the parameters set forth in subparagraphs (A) through (J). (iii) The regulations prescribed under clause (i) shall require the transmission of the information described in paragraphs (1) and (2) with respect to a shipment as soon as practicable in relation to the transportation of the shipment, consistent with subparagraph (H). (iv) Regulations prescribed under clause (i) shall allow for the requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) to be implemented in phases, as appropriate, by— (I) setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the Commissioner; and (II) taking into consideration— (aa) the risk posed by such shipments; (bb) the volume of mail shipped to the United States by or through a particular country; and (cc) the capacities of foreign postal operators to provide that information to the Postal Service. (v) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2018, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for not less than 70 percent of the aggregate number of mail shipments, including 100 percent of mail shipments from the People’s Republic of China, described in clause (i). (II) If the requirements of subclause (I) are not met, the Comptroller General of the United States shall submit to the appropriate congressional committees, not later than June 30, 2019, a report— (aa) assessing the reasons for the failure to meet those requirements; and (bb) identifying recommendations to improve the collection by the Postal Service of the information described in paragraphs (1) and (2). (vi)(I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2020, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for 100 percent of the aggregate number of mail shipments described in clause (i). (II) The Commissioner, in consultation with the Postmaster General, may determine to exclude a country from the requirement described in subclause (I) to transmit information for mail shipments described in clause (i) from the country if the Commissioner determines that the country— (aa) does not have the capacity to collect and transmit such information; (bb) represents a low risk for mail shipments that violate relevant United States laws and regulations; and (cc) accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant United States laws and regulations through an alternate means. (III) The Commissioner shall, at a minimum on an annual basis, re-evaluate any determination made under subclause (II) to exclude a country from the requirement described in subclause (I). If, at any time, the Commissioner determines that a country no longer meets the requirements under subclause (II), the Commissioner may not further exclude the country from the requirement described in subclause (I). (IV) The Commissioner shall, on an annual basis, submit to the appropriate congressional committees— (aa) a list of countries with respect to which the Commissioner has made a determination under subclause (II) to exclude the countries from the requirement described in subclause (I); and (bb) information used to support such determination with respect to such countries. (vii) (I) The Postmaster General shall, in consultation with the Commissioner, refuse any shipments received after December 31, 2020, for which the information described in paragraphs (1) and (2) is not transmitted as required under this subparagraph, except as provided in subclause (II). (II) If remedial action is warranted in lieu of refusal of shipments pursuant to subclause (I), the Postmaster General and the Commissioner shall take remedial action with respect to the shipments, including destruction, seizure, controlled delivery or other law enforcement initiatives, or correction of the failure to provide the information described in paragraphs (1) and (2) with respect to the shipments. (viii) Nothing in this subparagraph shall be construed to limit the authority of the Secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties. (ix) In this subparagraph, the term appropriate congressional committees means— (I) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (II) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. . (2) Joint strategic plan on mandatory advance information Not later than 60 days after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving— (A) the transmission of information as required by section 343(a)(3)(K) of the Trade Act of 2002, as amended by paragraph (1); and (B) the presentation by the Postal Service to U.S. Customs and Border Protection of all mail targeted by U.S. Customs and Border Protection for inspection. (b) Capacity building (1) In general Section 343(a) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended by adding at the end the following: (5) Capacity building (A) In general The Secretary, with the concurrence of the Secretary of State, and in coordination with the Postmaster General and the heads of other Federal agencies, as appropriate, may provide technical assistance, equipment, technology, and training to enhance the capacity of foreign postal operators— (i) to gather and provide the information required by paragraph (3)(K); and (ii) to otherwise gather and provide postal shipment information related to— (I) terrorism; (II) items the importation or introduction of which into the United States is prohibited or restricted, including controlled substances; and (III) such other concerns as the Secretary determines appropriate. (B) Provision of equipment and technology With respect to the provision of equipment and technology under subparagraph (A), the Secretary may lease, loan, provide, or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the Secretary may prescribe, including nonreimbursable loans or the transfer of ownership of equipment and technology. . (2) Joint strategic plan on capacity building Not later than 1 year after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly develop and submit to the appropriate congressional committees a joint strategic plan— (A) detailing the extent to which U.S. Customs and Border Protection and the United States Postal Service are engaged in capacity building efforts under section 343(a)(5) of the Trade Act of 2002, as added by paragraph (1); (B) describing plans for future capacity building efforts; and (C) assessing how capacity building has increased the ability of U.S. Customs and Border Protection and the Postal Service to advance the goals of this subtitle and the amendments made by this subtitle. (c) Report and consultations by Secretary of Homeland Security and Postmaster General (1) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 3 years after the Postmaster General has met the requirement under clause (vi) of subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following: (A) An assessment of the status of the regulations required to be promulgated under that subparagraph. (B) An update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph. (C) A summary of deliberations between the United States Postal Service and foreign postal operators with respect to issues relating to the transmission of that information. (D) A summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph. (E) An assessment of the quality of that information being received by foreign postal operators, as determined by the Secretary of Homeland Security, and actions taken to improve the quality of that information. (F) A summary of policies established by the Universal Postal Union that may affect the ability of the Postmaster General to obtain the transmission of that information. (G) A summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology. (H) Such other information as the Secretary of Homeland Security and the Postmaster General consider appropriate with respect to obtaining the transmission of information required by that subparagraph. (2) Consultations Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the Postmaster General has met the requirement under clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as amended by subsection (a)(1), to arrange for the transmission of information with respect to 100 percent of the aggregate number of mail shipments described in clause (i) of that section, the Secretary of Homeland Security and the Postmaster General shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments. (d) Government Accountability Office report Not later than June 30, 2019, the Comptroller General of the United States shall submit to the appropriate congressional committees a report— (1) assessing the progress of the United States Postal Service in achieving the transmission of the information required by subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), for the percentage of shipments required by that subparagraph; (2) assessing the quality of the information received from foreign postal operators for targeting purposes; (3) assessing the specific percentage of targeted mail presented by the Postal Service to U.S. Customs and Border Protection for inspection; (4) describing the costs of collecting the information required by such subparagraph (K) from foreign postal operators and the costs of implementing the use of that information; (5) assessing the benefits of receiving that information with respect to international mail shipments; (6) assessing the feasibility of assessing a customs fee under section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 8002, on international mail shipments other than Inbound Express Mail service in a manner consistent with the obligations of the United States under international agreements; and (7) identifying recommendations, including recommendations for legislation, to improve the compliance of the Postal Service with such subparagraph (K), including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by— (A) requiring the Postal Service to serve as the consignee for international mail shipments containing goods; or (B) designating a customs broker to act as an importer of record for international mail shipments containing goods. (e) Technical correction Section 343 of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended in the section heading by striking advanced and inserting advance . (f) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8004. International postal agreements (a) Existing agreements (1) In general In the event that any provision of this subtitle, or any amendment made by this subtitle, is determined to be in violation of obligations of the United States under any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, the Secretary of State should negotiate to amend the relevant provisions of the agreement so that the United States is no longer in violation of the agreement. (2) Rule of construction Nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle. (b) Future agreements (1) Consultations Before entering into, on or after the date of the enactment of this Act, any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, that is related to the ability of the United States to secure the provision of advance electronic information by foreign postal operators, the Secretary of State should consult with the appropriate congressional committees (as defined in section 8003(f)). (2) Expedited negotiation of new agreement To the extent that any new postal treaty, convention, or other international agreement related to international postal services would improve the ability of the United States to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section 343(a)(3)(K) of the Trade Act of 2002, as amended by section 8003(a)(1), the Secretary of State should expeditiously conclude such an agreement. 8005. Cost recoupment (a) In general The United States Postal Service shall, to the extent practicable and otherwise recoverable by law, ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators. (b) Costs not considered revenue The recovery of costs under subsection (a) shall not be deemed revenue for purposes of subchapter I and II of chapter 36 of title 39, United States Code, or regulations prescribed under that chapter. 8006. Development of technology to detect illicit narcotics (a) In general The Postmaster General and the Commissioner of U.S. Customs and Border Protection, in coordination with the heads of other agencies as appropriate, shall collaborate to identify and develop technology for the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States by mail. (b) Outreach to private sector The Postmaster General and the Commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States. 8007. Civil penalties for postal shipments Section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ) is amended by adding at the end the following new subsection: (e) Civil penalties for postal shipments (1) Civil penalty A civil penalty shall be imposed against the United States Postal Service if the Postal Service accepts a shipment in violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (2) Modification of civil penalty (A) In general U.S. Customs and Border Protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph (1) if U.S. Customs and Border Protection determines that the United States Postal Service— (i) has a low error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002; (ii) is cooperating with U.S. Customs and Border Protection with respect to the violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or (iii) has taken remedial action to prevent future violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (B) Written notification U.S. Customs and Border Protection shall issue a written notification to the Postal Service with respect to each exercise of the authority of subparagraph (A) to reduce or dismiss a civil penalty imposed pursuant to paragraph (1). (3) Ongoing lack of compliance If U.S. Customs and Border Protection determines that the United States Postal Service— (A) has repeatedly committed violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, (B) has failed to cooperate with U.S. Customs and Border Protection with respect to violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and (C) has an increasing error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002, civil penalties may be imposed against the United States Postal Service until corrective action, satisfactory to U.S. Customs and Border Protection, is taken. . 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest (a) In general The Commissioner of U.S. Customs and Border Protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection (b) with respect to each violation of section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ), as amended by section 8007, and section 584 of such Act ( 19 U.S.C. 1584 ) that occurred during the previous year. (b) Information described The information described in this subsection is the following: (1) The name and address of the violator. (2) The specific violation that was committed. (3) The location or port of entry through which the items were transported. (4) An inventory of the items seized, including a description of the items and the quantity seized. (5) The location from which the items originated. (6) The entity responsible for the apprehension or seizure, organized by location or port of entry. (7) The amount of penalties assessed by U.S. Customs and Border Protection, organized by name of the violator and location or port of entry. (8) The amount of penalties that U.S. Customs and Border Protection could have levied, organized by name of the violator and location or port of entry. (9) The rationale for negotiating lower penalties, organized by name of the violator and location or port of entry. (c) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8009. Effective date; regulations (a) Effective date This subtitle and the amendments made by this subtitle (other than the amendments made by section 8002) shall take effect on the date of the enactment of this Act. (b) Regulations Not later than 1 year after the date of the enactment of this Act, such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed. B Opioid Addiction Recovery Fraud Prevention 8021. Short title This subtitle may be cited as the Opioid Addiction Recovery Fraud Prevention Act of 2018 . 8022. Definitions For purposes of this subtitle only, and not be construed or applied as to challenge or affect the characterization, definition, or treatment under any other statute, regulation, or rule: (1) Substance use disorder treatment product The term substance use disorder treatment product means a product for use or marketed for use in the treatment, cure, or prevention of a substance use disorder, including an opioid use disorder. (2) Substance use disorder treatment service The term substance use disorder treatment service means a service that purports to provide referrals to treatment, treatment, or recovery housing for people diagnosed with, having, or purporting to have a substance use disorder, including an opioid use disorder. 8023. Unfair or deceptive acts or practices with respect to substance use disorder treatment service and products (a) Unlawful activity It is unlawful to engage in an unfair or deceptive act or practice with respect to any substance use disorder treatment service or substance use disorder treatment product. (b) Enforcement by the Federal Trade Commission (1) Unfair or deceptive acts or practices A violation of subsection (a) shall be treated as a violation of a rule under section 18 of the Federal Trade Commission Act ( 15 U.S.C. 57a ) regarding unfair or deceptive acts or practices. (2) Powers of the Federal Trade Commission (A) In general The Federal Trade Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act ( 15 U.S.C. 41 et seq.) were incorporated into and made a part of this section. (B) Privileges and immunities Any person who violates subsection (a) shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act as though all applicable terms and provisions of the Federal Trade Commission Act ( 15 U.S.C. 41 et seq.) were incorporated and made part of this section. (c) Authority preserved Nothing in this subtitle shall be construed to limit the authority of the Federal Trade Commission or the Food and Drug Administration under any other provision of law. C Addressing economic and workforce impacts of the opioid crisis 8041. Addressing economic and workforce impacts of the opioid crisis (a) Definitions Except as otherwise expressly provided, in this section: (1) WIOA definitions The terms core program , individual with a barrier to employment , local area , local board , one-stop operator , outlying area , State , State board , and supportive services have the meanings given the terms in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ). (2) Education provider The term education provider means— (A) an institution of higher education, as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ); or (B) a postsecondary vocational institution, as defined in section 102(c) of such Act ( 20 U.S.C. 1002(c) ). (3) Eligible entity The term eligible entity means— (A) a State workforce agency; (B) an outlying area; or (C) a Tribal entity. (4) Participating partnership The term participating partnership means a partnership— (A) evidenced by a written contract or agreement; and (B) including, as members of the partnership, a local board receiving a subgrant under subsection (d) and 1 or more of the following: (i) The eligible entity. (ii) A treatment provider. (iii) An employer or industry organization. (iv) An education provider. (v) A legal service or law enforcement organization. (vi) A faith-based or community-based organization. (vii) Other State or local agencies, including counties or local governments. (viii) Other organizations, as determined to be necessary by the local board. (ix) Indian Tribes or tribal organizations. (5) Program participant The term program participant means an individual who— (A) is a member of a population of workers described in subsection (e)(2) that is served by a participating partnership through the pilot program under this section; and (B) enrolls with the applicable participating partnership to receive any of the services described in subsection (e)(3). (6) Provider of peer recovery support services The term provider of peer recovery support services means a provider that delivers peer recovery support services through an organization described in section 547(a) of the Public Health Service Act ( 42 U.S.C. 290ee–2(a) ). (7) Secretary The term Secretary means the Secretary of Labor. (8) State workforce agency The term State workforce agency means the lead State agency with responsibility for the administration of a program under chapter 2 or 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3161 et seq., 3171 et seq.). (9) Substance use disorder The term substance use disorder has the meaning given such term by the Assistant Secretary for Mental Health and Substance Use. (10) Treatment provider The term treatment provider — (A) means a health care provider that— (i) offers services for treating substance use disorders and is licensed in accordance with applicable State law to provide such services; and (ii) accepts health insurance for such services, including coverage under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.); and (B) may include— (i) a nonprofit provider of peer recovery support services; (ii) a community health care provider; (iii) a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act ( 42 U.S.C. 1395x )); (iv) an Indian health program (as defined in section 3 of the Indian Health Care Improvement Act ( 25 U.S.C. 1603 )), including an Indian health program that serves an urban center (as defined in such section); and (v) a Native Hawaiian health center (as defined in section 12 of the Native Hawaiian Health Care Improvement Act ( 42 U.S.C. 11711 )). (11) Tribal entity The term Tribal entity includes any Indian Tribe, tribal organization, Indian-controlled organization serving Indians, Native Hawaiian organization, or Alaska Native entity, as such terms are defined or used in section 166 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3221 ). (b) Pilot program and grants authorized (1) In general The Secretary, in consultation with the Secretary of Health and Human Services, shall carry out a pilot program to address economic and workforce impacts associated with a high rate of a substance use disorder. In carrying out the pilot program, the Secretary shall make grants, on a competitive basis, to eligible entities to enable such entities to make subgrants to local boards to address the economic and workforce impacts associated with a high rate of a substance use disorder. (2) Grant amounts The Secretary shall make each such grant in an amount that is not less than $500,000, and not more than $5,000,000, for a fiscal year. (c) Grant applications (1) In general An eligible entity applying for a grant under this section shall submit an application to the Secretary at such time and in such form and manner as the Secretary may reasonably require, including the information described in this subsection. (2) Significant impact on community by opioid and substance use disorder-related problems (A) Demonstration An eligible entity shall include in the application— (i) information that demonstrates significant impact on the community by problems related to opioid abuse or another substance use disorder, by— (I) identifying the counties, communities, regions, or local areas that have been significantly impacted and will be served through the grant (each referred to in this section as a service area ); and (II) demonstrating for each such service area, an increase equal to or greater than the national increase in such problems, between— (aa) 1999; and (bb) 2016 or the latest year for which data are available; and (ii) a description of how the eligible entity will prioritize support for significantly impacted service areas described in clause (i)(I). (B) Information To meet the requirements described in subparagraph (A)(i)(II), the eligible entity may use information including data on— (i) the incidence or prevalence of opioid abuse and other substance use disorders; (ii) the age-adjusted rate of drug overdose deaths, as determined by the Director of the Centers for Disease Control and Prevention; (iii) the rate of non-fatal hospitalizations related to opioid abuse or other substance use disorders; (iv) the number of arrests or convictions, or a relevant law enforcement statistic, that reasonably shows an increase in opioid abuse or another substance use disorder; or (v) in the case of an eligible entity described in subsection (a)(3)(C), other alternative relevant data as determined appropriate by the Secretary. (C) Support for state strategy The eligible entity may include in the application information describing how the proposed services and activities are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing problems described in subparagraph (A) in specific service areas or across the State, outlying area, or Tribal land. (3) Economic and employment conditions demonstrate additional Federal support needed (A) Demonstration An eligible entity shall include in the application information that demonstrates that a high rate of a substance use disorder has caused, or is coincident to— (i) an economic or employment downturn in the service area; or (ii) persistent economically depressed conditions in such service area. (B) Information To meet the requirements of subparagraph (A), an eligible entity may use information including— (i) documentation of any layoff, announced future layoff, legacy industry decline, decrease in an employment or labor market participation rate, or economic impact, whether or not the result described in this clause is overtly related to a high rate of a substance use disorder; (ii) documentation showing decreased economic activity related to, caused by, or contributing to a high rate of a substance use disorder, including a description of how the service area has been impacted, or will be impacted, by such a decrease; (iii) information on economic indicators, labor market analyses, information from public announcements, and demographic and industry data; (iv) information on rapid response activities (as defined in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 )) that have been or will be conducted, including demographic data gathered by employer or worker surveys or through other methods; (v) data or documentation, beyond anecdotal evidence, showing that employers face challenges filling job vacancies due to a lack of skilled workers able to pass a drug test; or (vi) any additional relevant data or information on the economy, workforce, or another aspect of the service area to support the application. (d) Subgrant authorization and application process (1) Subgrants authorized (A) In general An eligible entity receiving a grant under subsection (b)— (i) may use not more than 5 percent of the grant funds for the administrative costs of carrying out the grant; (ii) in the case of an eligible entity described in subparagraph (A) or (B) of subsection (a)(3), shall use the remaining grant funds to make subgrants to local entities in the service area to carry out the services and activities described in subsection (e); and (iii) in the case of an eligible entity described in subsection (a)(3)(C), shall use the remaining grant funds to carry out the services and activities described in subsection (e). (B) Equitable distribution In making subgrants under this subsection, an eligible entity shall ensure, to the extent practicable, the equitable distribution of subgrants, based on— (i) geography (such as urban and rural distribution); and (ii) significantly impacted service areas as described in subsection (c)(2). (C) Timing of subgrant funds distribution An eligible entity making subgrants under this subsection shall disburse subgrant funds to a local board receiving a subgrant from the eligible entity by the later of— (i) the date that is 90 days after the date on which the Secretary makes the funds available to the eligible entity; or (ii) the date that is 15 days after the date that the eligible entity makes the subgrant under subparagraph (A)(ii). (2) Subgrant application (A) In general A local board desiring to receive a subgrant under this subsection from an eligible entity shall submit an application at such time and in such manner as the eligible entity may reasonably require, including the information described in this paragraph. (B) Contents Each application described in subparagraph (A) shall include— (i) an analysis of the estimated performance of the local board in carrying out the proposed services and activities under the subgrant— (I) based on— (aa) primary indicators of performance described in section 116(c)(1)(A)(i) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3141(c)(1)(A)(i) , to assess estimated effectiveness of the proposed services and activities, including the estimated number of individuals with a substance use disorder who may be served by the proposed services and activities; (bb) the record of the local board in serving individuals with a barrier to employment; and (cc) the ability of the local board to establish a participating partnership; and (II) which may include or utilize— (aa) data from the National Center for Health Statistics of the Centers for Disease Control and Prevention; (bb) data from the Center for Behavioral Health Statistics and Quality of the Substance Abuse and Mental Health Services Administration; (cc) State vital statistics; (dd) municipal police department records; (ee) reports from local coroners; or (ff) other relevant data; and (ii) in the case of a local board proposing to serve a population described in subsection (e)(2)(B), a demonstration of the workforce shortage in the professional area to be addressed under the subgrant (which may include substance use disorder treatment and related services, non-addictive pain therapy and pain management services, mental health care treatment services, emergency response services, or mental health care), which shall include information that can demonstrate such a shortage, such as— (I) the distance between— (aa) communities affected by opioid abuse or another substance use disorder; and (bb) facilities or professionals offering services in the professional area; or (II) the maximum capacity of facilities or professionals to serve individuals in an affected community, or increases in arrests related to opioid or another substance use disorder, overdose deaths, or nonfatal overdose emergencies in the community. (e) Subgrant services and activities (1) In general Each local board that receives a subgrant under subsection (d) shall carry out the services and activities described in this subsection through a participating partnership. (2) Selection of Population to be served A participating partnership shall elect to provide services and activities under the subgrant to one or both of the following populations of workers: (A) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), each of whom— (i) is directly or indirectly affected by a high rate of a substance use disorder; and (ii) voluntarily confirms that the worker, or a friend or family member of the worker, has a history of opioid abuse or another substance use disorder. (B) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), who— (i) seek to transition to professions that support individuals with a substance use disorder or at risk for developing such disorder, such as professions that provide— (I) substance use disorder treatment and related services; (II) services offered through providers of peer recovery support services; (III) non-addictive pain therapy and pain management services; (IV) emergency response services; or (V) mental health care; and (ii) need new or upgraded skills to better serve such a population of struggling or at-risk individuals. (3) Services and activities Each participating partnership shall use funds available through a subgrant under this subsection to carry out 1 or more of the following: (A) Engaging employers Engaging with employers to— (i) learn about the skill and hiring requirements of employers; (ii) learn about the support needed by employers to hire and retain program participants, and other individuals with a substance use disorder, and the support needed by such employers to obtain their commitment to testing creative solutions to employing program participants and such individuals; (iii) connect employers and workers to on-the-job or customized training programs before or after layoff to help facilitate reemployment; (iv) connect employers with an education provider to develop classroom instruction to complement on-the-job learning for program participants and such individuals; (v) help employers develop the curriculum design of a work-based learning program for program participants and such individuals; (vi) help employers employ program participants or such individuals engaging in a work-based learning program for a transitional period before hiring such a program participant or individual for full-time employment of not less than 30 hours a week; or (vii) connect employers to program participants receiving concurrent outpatient treatment and job training services. (B) Screening services Providing screening services, which may include— (i) using an evidence-based screening method to screen each individual seeking participation in the pilot program to determine whether the individual has a substance use disorder; (ii) conducting an assessment of each such individual to determine the services needed for such individual to obtain or retain employment, including an assessment of strengths and general work readiness; or (iii) accepting walk-ins or referrals from employers, labor organizations, or other entities recommending individuals to participate in such program. (C) Individual treatment and employment plan Developing an individual treatment and employment plan for each program participant— (i) in coordination, as appropriate, with other programs serving the participant such as the core programs within the workforce development system under the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3101 et seq.); and (ii) which shall include providing a case manager to work with each participant to develop the plan, which may include— (I) identifying employment and career goals; (II) exploring career pathways that lead to in-demand industries and sectors, as determined by the State board and the head of the State workforce agency or, as applicable, the Tribal entity; (III) setting appropriate achievement objectives to attain the employment and career goals identified under subclause (I); or (IV) developing the appropriate combination of services to enable the participant to achieve the employment and career goals identified under subclause (I). (D) Outpatient treatment and recovery care In the case of a participating partnership serving program participants described in paragraph (2)(A) with a substance use disorder, providing individualized and group outpatient treatment and recovery services for such program participants that are offered during the day and evening, and on weekends. Such treatment and recovery services— (i) shall be based on a model that utilizes combined behavioral interventions and other evidence-based or evidence-informed interventions; and (ii) may include additional services such as— (I) health, mental health, addiction, or other forms of outpatient treatment that may impact a substance use disorder and co-occurring conditions; (II) drug testing for a current substance use disorder prior to enrollment in career or training services or prior to employment; (III) linkages to community services, including services offered by partner organizations designed to support program participants; or (IV) referrals to health care, including referrals to substance use disorder treatment and mental health services. (E) Supportive services Providing supportive services, which shall include services such as— (i) coordinated wraparound services to provide maximum support for program participants to assist the program participants in maintaining employment and recovery for not less than 12 months, as appropriate; (ii) assistance in establishing eligibility for assistance under Federal, State, Tribal, and local programs providing health services, mental health services, vocational services, housing services, transportation services, social services, or services through early childhood education programs (as defined in section 103 of the Higher Education Act of 1965 ( 20 U.S.C. 1003 )); (iii) services offered through providers of peer recovery support services; (iv) networking and mentorship opportunities; or (v) any supportive services determined necessary by the local board. (F) Career and job training services Offering career services and training services, and related services, concurrently or sequentially with the services provided under subparagraphs (B) through (E). Such services shall include the following: (i) Services provided to program participants who are in a pre-employment stage of the program, which may include— (I) initial education and skills assessments; (II) traditional classroom training funded through individual training accounts under chapter 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3171 et seq.); (III) services to promote employability skills such as punctuality, personal maintenance skills, and professional conduct; (IV) in-depth interviewing and evaluation to identify employment barriers and to develop individual employment plans; (V) career planning that includes— (aa) career pathways leading to in-demand, high-wage jobs; and (bb) job coaching, job matching, and job placement services; (VI) provision of payments and fees for employment and training-related applications, tests, and certifications; or (VII) any other appropriate career service or training service described in section 134(c) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3174(c) ). (ii) Services provided to program participants during their first 6 months of employment to ensure job retention, which may include— (I) case management and support services, including a continuation of the services described in clause (i); (II) a continuation of skills training, and career and technical education, described in clause (i) that is conducted in collaboration with the employers of such participants; (III) mentorship services and job retention support for such participants; or (IV) targeted training for managers and workers working with such participants (such as mentors), and human resource representatives in the business in which such participants are employed. (iii) Services to assist program participants in maintaining employment for not less than 12 months, as appropriate. (G) Proven and promising practices Leading efforts in the service area to identify and promote proven and promising strategies and initiatives for meeting the needs of employers and program participants. (4) Limitations A participating partnership may not use— (A) more than 10 percent of the funds received under a subgrant under subsection (d) for the administrative costs of the partnership; (B) more than 10 percent of the funds received under such subgrant for the provision of treatment and recovery services, as described in paragraph (3)(D); and (C) more than 10 percent of the funds received under such subgrant for the provision of supportive services described in paragraph (3)(E) to program participants. (f) Performance accountability (1) Reports The Secretary shall establish quarterly reporting requirements for recipients of grants and subgrants under this section that, to the extent practicable, are based on the performance accountability system under section 116 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3141 ) and, in the case of a grant awarded to an eligible entity described in subsection (a)(3)(C), section 166(h) of such Act ( 29 U.S.C. 3221(h) ), including the indicators described in subsection (c)(1)(A)(i) of such section 116 and the requirements for local area performance reports under subsection (d) of such section 116. (2) Evaluations (A) Authority to enter into agreements The Secretary shall ensure that an independent evaluation is conducted on the pilot program carried out under this section to determine the impact of the program on employment of individuals with substance use disorders. The Secretary shall enter into an agreement with eligible entities receiving grants under this section to pay for all or part of such evaluation. (B) Methodologies to be used The independent evaluation required under this paragraph shall use experimental designs using random assignment or, when random assignment is not feasible, other reliable, evidence-based research methodologies that allow for the strongest possible causal inferences. (g) Funding (1) Covered fiscal year In this subsection, the term covered fiscal year means any of fiscal years 2019 through 2023. (2) Using funding for national dislocated worker grants Subject to paragraph (4) and notwithstanding section 132(a)(2)(A) and subtitle D of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3172(a)(2)(A) , 3221 et seq.), the Secretary may use, to carry out the pilot program under this section for a covered fiscal year— (A) funds made available to carry out section 170 of such Act ( 29 U.S.C. 3225 ) for that fiscal year; (B) funds made available to carry out section 170 of such Act that remain available for that fiscal year; and (C) funds that remain available under section 172(f) of such Act ( 29 U.S.C. 3227(f) ). (3) Availability of funds Funds appropriated under section 136(c) of such Act ( 29 U.S.C. 3181(c) ) and made available to carry out section 170 of such Act for a fiscal year shall remain available for use under paragraph (2) for a subsequent fiscal year until expended. (4) Limitation The Secretary may not use more than $100,000,000 of the funds described in paragraph (2) for any covered fiscal year under this section. D Peer support counseling program for women veterans 8051. Peer support counseling program for women veterans (a) In general Section 1720F(j) of title 38, United States Code, is amended by adding at the end the following new paragraph: (4) (A) As part of the counseling program under this subsection, the Secretary shall emphasize appointing peer support counselors for women veterans. To the degree practicable, the Secretary shall seek to recruit women peer support counselors with expertise in— (i) female gender-specific issues and services; (ii) the provision of information about services and benefits provided under laws administered by the Secretary; or (iii) employment mentoring. (B) To the degree practicable, the Secretary shall emphasize facilitating peer support counseling for women veterans who are eligible for counseling and services under section 1720D of this title, have post-traumatic stress disorder or suffer from another mental health condition, are homeless or at risk of becoming homeless, or are otherwise at increased risk of suicide, as determined by the Secretary. (C) The Secretary shall conduct outreach to inform women veterans about the program and the assistance available under this paragraph. (D) In carrying out this paragraph, the Secretary shall coordinate with such community organizations, State and local governments, institutions of higher education, chambers of commerce, local business organizations, organizations that provide legal assistance, and other organizations as the Secretary considers appropriate. (E) In carrying out this paragraph, the Secretary shall provide adequate training for peer support counselors, including training carried out under the national program of training required by section 304(c) of the Caregivers and Veterans Omnibus Health Services Act of 2010 ( 38 U.S.C. 1712A note). . (b) Funding The Secretary of Veterans Affairs shall carry out paragraph (4) of section 1720F(j) of title 38, United States Code, as added by subsection (a), using funds otherwise made available to the Secretary. No additional funds are authorized to be appropriated by reason of such paragraph. (c) Report to Congress Not later than 2 years after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on the peer support counseling program under section 1720F(j) of title 38, United States Code, as amended by this section. Such report shall include— (1) the number of peer support counselors in the program; (2) an assessment of the effectiveness of the program; and (3) a description of the oversight of the program. E Treating Barriers to Prosperity 8061. Short title This subtitle may be cited as the Treating Barriers to Prosperity Act of 2018 . 8062. Drug abuse mitigation initiative (a) In general Chapter 145 of title 40, United States Code, is amended by inserting after section 14509 the following: 14510. Drug abuse mitigation initiative (a) In general The Appalachian Regional Commission may provide technical assistance to, make grants to, enter into contracts with, or otherwise provide amounts to individuals or entities in the Appalachian region for projects and activities to address drug abuse, including opioid abuse, in the region, including projects and activities— (1) to facilitate the sharing of best practices among States, counties, and other experts in the region with respect to reducing such abuse; (2) to initiate or expand programs designed to eliminate or reduce the harm to the workforce and economic growth of the region that results from such abuse; (3) to attract and retain relevant health care services, businesses, and workers; and (4) to develop relevant infrastructure, including broadband infrastructure that supports the use of telemedicine. (b) Limitation on available amounts Of the cost of any activity eligible for a grant under this section— (1) not more than 50 percent may be provided from amounts appropriated to carry out this section; and (2) notwithstanding paragraph (1)— (A) in the case of a project to be carried out in a county for which a distressed county designation is in effect under section 14526, not more than 80 percent may be provided from amounts appropriated to carry out this section; and (B) in the case of a project to be carried out in a county for which an at-risk designation is in effect under section 14526, not more than 70 percent may be provided from amounts appropriated to carry out this section. (c) Sources of assistance Subject to subsection (b), a grant provided under this section may be provided from amounts made available to carry out this section in combination with amounts made available— (1) under any other Federal program (subject to the availability of subsequent appropriations); or (2) from any other source. (d) Federal share Notwithstanding any provision of law limiting the Federal share under any other Federal program, amounts made available to carry out this section may be used to increase that Federal share, as the Appalachian Regional Commission determines to be appropriate. . (b) Clerical amendment The analysis for chapter 145 of title 40, United States Code, is amended by inserting after the item relating to section 14509 the following: 14510. Drug abuse mitigation initiative. . F Pilot program to help individuals in recovery from a substance use disorder become stably housed 8071. Pilot program to help individuals in recovery from a substance use disorder become stably housed (a) Authorization of appropriations There is authorized to be appropriated under this section such sums as may be necessary for each of fiscal years 2019 through 2023 for assistance to States to provide individuals in recovery from a substance use disorder stable, temporary housing for a period of not more than 2 years or until the individual secures permanent housing, whichever is earlier. (b) Allocation of appropriated amounts (1) In general The amounts appropriated or otherwise made available to States under this section shall be allocated based on a funding formula established by the Secretary of Housing and Urban Development (referred to in this section as the Secretary ) not later than 60 days after the date of enactment of this Act. (2) Criteria (A) In general The funding formula required under paragraph (1) shall ensure that any amounts appropriated or otherwise made available under this section are allocated to States with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, according to the Centers for Disease Control and Prevention. (B) Priority (i) In general Among such States, priority shall be given to States with the greatest need, as such need is determined by the Secretary based on the following factors, and weighting such factors as described in clause (ii): (I) The highest average rates of unemployment based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017. (II) The lowest average labor force participation rates based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017. (III) The highest age-adjusted rates of drug overdose deaths based on data from the Centers for Disease Control and Prevention. (ii) Weighting The factors described in clause (i) shall be weighted as follows: (I) The rate described in clause (i)(I) shall be weighted at 15 percent. (II) The rate described in clause (i)(II) shall be weighted at 15 percent. (III) The rate described in clause (i)(III) shall be weighted at 70 percent. (3) Distribution Amounts appropriated or otherwise made available under this section shall be distributed according to the funding formula established by the Secretary under paragraph (1) not later than 30 days after the establishment of such formula. (c) Use of funds (1) In general Any State that receives amounts pursuant to this section shall expend at least 30 percent of such funds within one year of the date funds become available to the grantee for obligation. (2) Priority Any State that receives amounts pursuant to this section shall distribute such amounts giving priority to entities with the greatest need and ability to deliver effective assistance in a timely manner. (3) Administrative costs Any State that receives amounts pursuant to this section may use up to 5 percent of any grant for administrative costs. (d) Rules of construction (1) In general Except as otherwise provided by this section, amounts appropriated, or amounts otherwise made available to States under this section shall be treated as though such funds were community development block grant funds under title I of the Housing and Community Development Act of 1974 ( 42 U.S.C. 5301 et seq.). (2) No match No matching funds shall be required in order for a State to receive any amounts under this section. (e) Authority to waive or specify alternative requirements (1) In general In administering any amounts appropriated or otherwise made available under this section, the Secretary may waive or specify alternative requirements to any provision under title I of the Housing and Community Development Act of 1974 ( 42 U.S.C. 5301 et seq.) except for requirements related to fair housing, nondiscrimination, labor standards, the environment, and requirements that activities benefit persons of low- and moderate-income, upon a finding that such a waiver is necessary to expedite or facilitate the use of such funds. (2) Notice of intent The Secretary shall provide written notice of its intent to exercise the authority to specify alternative requirements under paragraph (1) to the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives not later than 15 business days before such exercise of authority occurs. (3) Notice to the public The Secretary shall provide written notice of its intent to exercise the authority to specify alternative requirements under paragraph (1) to the public via notice, on the internet website of the Department of Housing and Urban Development, and by other appropriate means, not later than 15 business days before such exercise of authority occurs. (f) Technical assistance For the 2-year period following the date of enactment of this Act, the Secretary may use not more than 2 percent of the funds made available under this section for technical assistance to grantees. (g) State For purposes of this section the term State includes any State as defined in section 102 of the Housing and Community Development Act of 1974 ( 42 U.S.C. 5302 ) and the District of Columbia. G Human Services 8081. Supporting family-focused residential treatment (a) Definitions In this section: (1) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (2) Medicaid program The term Medicaid program means the program established under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Title IV–E program The term title IV–E program means the program for foster care, prevention, and permanency established under part E of title IV of the Social Security Act ( 42 U.S.C. 670 et seq.). (b) Guidance on family-focused residential treatment programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with divisions of the Department of Health and Human Services administering substance use disorder or child welfare programs, shall develop and issue guidance to States identifying opportunities to support family-focused residential treatment programs for the provision of substance use disorder treatment. Before issuing such guidance, the Secretary shall solicit input from representatives of States, health care providers with expertise in addiction medicine, obstetrics and gynecology, neonatology, child trauma, and child development, health plans, recipients of family-focused treatment services, and other relevant stakeholders. (2) Additional requirements The guidance required under paragraph (1) shall include descriptions of the following: (A) Existing opportunities and flexibilities under the Medicaid program, including under waivers authorized under section 1115 or 1915 of the Social Security Act ( 42 U.S.C. 1315 , 1396n), for States to receive Federal Medicaid funding for the provision of substance use disorder treatment for pregnant and postpartum women and parents and guardians and, to the extent applicable, their children, in family-focused residential treatment programs. (B) How States can employ and coordinate funding provided under the Medicaid program, the title IV-E program, and other programs administered by the Secretary to support the provision of treatment and services provided by a family-focused residential treatment facility such as substance use disorder treatment and services, including medication-assisted treatment, family, group, and individual counseling, case management, parenting education and skills development, the provision, assessment, or coordination of care and services for children, including necessary assessments and appropriate interventions, non-emergency transportation for necessary care provided at or away from a program site, transitional services and supports for families leaving treatment, and other services. (C) How States can employ and coordinate funding provided under the Medicaid program and the title IV–E program (including as amended by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123 , and particularly with respect to the authority under subsections (a)(2)(C) and (j) of section 472 and section 474(a)(1) of the Social Security Act ( 42 U.S.C. 672 , 674(a)(1)) (as amended by section 50712 of Public Law 115–123 ) to provide foster care maintenance payments for a child placed with a parent who is receiving treatment in a licensed residential family-based treatment facility for a substance use disorder) to support placing children with their parents in family-focused residential treatment programs. 8082. Improving recovery and reunifying families (a) Family Recovery and Reunification Program Replication Project Section 435 of the Social Security Act ( 42 U.S.C. 629e ) is amended by adding at the end the following: (e) Family Recovery and Reunification Program Replication Project (1) Purpose The purpose of this subsection is to provide resources to the Secretary to support the conduct and evaluation of a family recovery and reunification program replication project (referred to in this subsection as the project ) and to determine the extent to which such programs may be appropriate for use at different intervention points (such as when a child is at risk of entering foster care or when a child is living with a guardian while a parent is in treatment). The family recovery and reunification program conducted under the project shall use a recovery coach model that is designed to help reunify families and protect children by working with parents or guardians with a substance use disorder who have temporarily lost custody of their children. (2) Program components The family recovery and reunification program conducted under the project shall adhere closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children and, consistent with such elements and protocol, shall provide such items and services as— (A) assessments to evaluate the needs of the parent or guardian; (B) assistance in receiving the appropriate benefits to aid the parent or guardian in recovery; (C) services to assist the parent or guardian in prioritizing issues identified in assessments, establishing goals for resolving such issues that are consistent with the goals of the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children, and making a coordinated plan for achieving such goals; (D) home visiting services coordinated with the child welfare agency and treatment provider involved with the parent or guardian or their children; (E) case management services to remove barriers for the parent or guardian to participate and continue in treatment, as well as to re-engage a parent or guardian who is not participating or progressing in treatment; (F) access to services needed to monitor the parent’s or guardian's compliance with program requirements; (G) frequent reporting between the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children to ensure appropriate information on the parent’s or guardian's status is available to inform decision-making; and (H) assessments and recommendations provided by a recovery coach to the child welfare caseworker responsible for documenting the parent’s or guardian's progress in treatment and recovery as well as the status of other areas identified in the treatment plan for the parent or guardian, including a recommendation regarding the expected safety of the child if the child is returned to the custody of the parent or guardian that can be used by the caseworker and a court to make permanency decisions regarding the child. (3) Responsibilities of the secretary (A) In general The Secretary shall, through a grant or contract with 1 or more entities, conduct and evaluate the family recovery and reunification program under the project. (B) Requirements In identifying 1 or more entities to conduct the evaluation of the family recovery and reunification program, the Secretary shall— (i) determine that the area or areas in which the program will be conducted have sufficient substance use disorder treatment providers and other resources (other than those provided with funds made available to carry out the project) to successfully conduct the program; (ii) determine that the area or areas in which the program will be conducted have enough potential program participants, and will serve a sufficient number of parents or guardians and their children, so as to allow for the formation of a control group, evaluation results to be adequately powered, and preliminary results of the evaluation to be available within 4 years of the program's implementation; (iii) provide the entity or entities with technical assistance for the program design, including by working with 1 or more entities that are or have been involved in recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children so as to make sure the program conducted under the project adheres closely to the elements and protocol determined to be most effective in such other recovery coaching programs; (iv) assist the entity or entities in securing adequate coaching, treatment, child welfare, court, and other resources needed to successfully conduct the family recovery and reunification program under the project; and (v) ensure the entity or entities will be able to monitor the impacts of the program in the area or areas in which it is conducted for at least 5 years after parents or guardians and their children are randomly assigned to participate in the program or to be part of the program's control group. (4) Evaluation requirements (A) In general The Secretary, in consultation with the entity or entities conducting the family recovery and reunification program under the project, shall conduct an evaluation to determine whether the program has been implemented effectively and resulted in improvements for children and families. The evaluation shall have 3 components: a pilot phase, an impact study, and an implementation study. (B) Pilot phase The pilot phase component of the evaluation shall consist of the Secretary providing technical assistance to the entity or entities conducting the family recovery and reunification program under the project to ensure— (i) the program's implementation adheres closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) random assignment of parents or guardians and their children to be participants in the program or to be part of the program's control group is being carried out. (C) Impact study The impact study component of the evaluation shall determine the impacts of the family recovery and reunification program conducted under the project on the parents and guardians and their children participating in the program. The impact study component shall— (i) be conducted using an experimental design that uses a random assignment research methodology; (ii) consistent with previous studies of other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children, measure outcomes for parents and guardians and their children over multiple time periods, including for a period of 5 years; and (iii) include measurements of family stability and parent, guardian, and child safety for program participants and the program control group that are consistent with measurements of such factors for participants and control groups from previous studies of other recovery coaching programs so as to allow results of the impact study to be compared with the results of such prior studies, including with respect to comparisons between program participants and the program control group regarding— (I) safe family reunification; (II) time to reunification; (III) permanency (such as through measures of reunification, adoption, or placement with guardians); (IV) safety (such as through measures of subsequent maltreatment); (V) parental or guardian treatment persistence and engagement; (VI) parental or guardian substance use; (VII) juvenile delinquency; (VIII) cost; and (IX) other measurements agreed upon by the Secretary and the entity or entities operating the family recovery and reunification program under the project. (D) Implementation study The implementation study component of the evaluation shall be conducted concurrently with the conduct of the impact study component and shall include, in addition to such other information as the Secretary may determine, descriptions and analyses of— (i) the adherence of the family recovery and reunification program conducted under the project to other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) the difference in services received or proposed to be received by the program participants and the program control group. (E) Report The Secretary shall publish on an internet website maintained by the Secretary the following information: (i) A report on the pilot phase component of the evaluation. (ii) A report on the impact study component of the evaluation. (iii) A report on the implementation study component of the evaluation. (iv) A report that includes— (I) analyses of the extent to which the program has resulted in increased reunifications, increased permanency, case closures, net savings to the State or States involved (taking into account both costs borne by States and the Federal government), or other outcomes, or if the program did not produce such outcomes, an analysis of why the replication of the program did not yield such results; (II) if, based on such analyses, the Secretary determines the program should be replicated, a replication plan; and (III) such recommendations for legislation and administrative action as the Secretary determines appropriate. (5) Appropriation In addition to any amounts otherwise made available to carry out this subpart, out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated $15,000,000 for fiscal year 2019 to carry out the project, which shall remain available through fiscal year 2026. . (b) Clarification of payer of last resort application to child welfare prevention and family services Section 471(e)(10) of the Social Security Act ( 42 U.S.C. 671(e)(10) ), as added by section 50711(a)(2) of division E of Public Law 115–123 , is amended— (1) in subparagraph (A), by inserting , nor shall the provision of such services or programs be construed to permit the State to reduce medical or other assistance available to a recipient of such services or programs after under this Act ; and (2) by adding at the end the following: (C) Payer of last resort In carrying out its responsibilities to ensure access to services or programs under this subsection, the State agency shall not be considered to be a legally liable third party for purposes of satisfying a financial commitment for the cost of providing such services or programs with respect to any individual for whom such cost would have been paid for from another public or private source but for the enactment of this subsection (except that whenever considered necessary to prevent a delay in the receipt of appropriate early intervention services by a child or family in a timely fashion, funds provided under section 474(a)(6) may be used to pay the provider of services or programs pending reimbursement from the public or private source that has ultimate responsibility for the payment). . (c) Effective date The amendments made by subsection (b) shall take effect as if included in section 50711 of division E of Public Law 115–123 . 8083. Building capacity for family-focused residential treatment (a) Definitions In this section: (1) Eligible entity The term eligible entity means a State, county, local, or tribal health or child welfare agency, a private nonprofit organization, a research organization, a treatment service provider, an institution of higher education (as defined under section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 )), or another entity specified by the Secretary. (2) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (3) Secretary The term Secretary means the Secretary of Health and Human Services. (b) Support for the development of evidence-based family-focused residential treatment programs (1) Authority to award grants The Secretary shall award grants to eligible entities for purposes of developing, enhancing, or evaluating family-focused residential treatment programs to increase the availability of such programs that meet the requirements for promising, supported, or well-supported practices specified in section 471(e)(4)(C) of the Social Security Act ( 42 U.S.C. 671(e)(4)(C) )) (as added by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123 ). (2) Evaluation requirement The Secretary shall require any evaluation of a family-focused residential treatment program by an eligible entity that uses funds awarded under this section for all or part of the costs of the evaluation be designed to assist in the determination of whether the program may qualify as a promising, supported, or well-supported practice in accordance with the requirements of such section 471(e)(4)(C). (c) Authorization of appropriations There is authorized to be appropriated to the Secretary to carry out this section, $20,000,000 for fiscal year 2019, which shall remain available through fiscal year 2023. H Reauthorizing and Extending Grants for Recovery from Opioid Use Programs 8091. Short title This subtitle may be cited as the Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018 . 8092. Reauthorization of the comprehensive opioid abuse grant program Section 1001(a)(27) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10261(a)(27) ) is amended by striking through 2021 and inserting and 2018, and $330,000,000 for each of fiscal years 2019 through 2023 . I Fighting Opioid Abuse in Transportation 8101. Short title This subtitle may be cited as the Fighting Opioid Abuse in Transportation Act . 8102. Alcohol and controlled substance testing of mechanical employees (a) In general Not later than 2 years after the date of enactment of this Act, the Secretary of Transportation shall publish a rule in the Federal Register revising the regulations promulgated under section 20140 of title 49, United States Code, to cover all employees of railroad carriers who perform mechanical activities. (b) Definition of mechanical activities For the purposes of the rule under subsection (a), the Secretary shall define the term mechanical activities by regulation. 8103. Department of Transportation public drug and alcohol testing database (a) In general Subject to subsection (c), the Secretary of Transportation shall— (1) not later than March 31, 2019, establish and make publicly available on its website a database of the drug and alcohol testing data reported by employers for each mode of transportation; and (2) update the database annually. (b) Contents The database under subsection (a) shall include, for each mode of transportation— (1) the total number of drug and alcohol tests by type of substance tested; (2) the drug and alcohol test results by type of substance tested; (3) the reason for the drug or alcohol test, such as pre-employment, random, post-accident, reasonable suspicion or cause, return-to-duty, or follow-up, by type of substance tested; and (4) the number of individuals who refused testing. (c) Commercially sensitive data The Department of Transportation shall not release any commercially sensitive data or personally identifiable data furnished by an employer under this section unless the data is aggregated or otherwise in a form that does not identify the employer providing the data. (d) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the requirements of the Secretary of Transportation to adhere to requirements applicable to confidential business information and sensitive security information, consistent with applicable law. 8104. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data (a) In general Not later than 2 years after the date the Department of Transportation public drug and alcohol testing database is established under section 8103, the Comptroller General of the United States shall— (1) review the Department of Transportation Drug and Alcohol Testing Management Information System; and (2) submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on the review, including recommendations under subsection (c). (b) Contents The report under subsection (a) shall include— (1) a description of the process the Department of Transportation uses to collect and record drug and alcohol testing data submitted by employers for each mode of transportation; (2) an assessment of whether and, if so, how the Department of Transportation uses the data described in paragraph (1) in carrying out its responsibilities; and (3) an assessment of the Department of Transportation public drug and alcohol testing database under section 8103. (c) Recommendations The report under subsection (a) may include recommendations regarding— (1) how the Department of Transportation can best use the data described in subsection (b)(1); (2) any improvements that could be made to the process described in subsection (b)(1); (3) whether and, if so, how the Department of Transportation public drug and alcohol testing database under section 8103 could be made more effective; and (4) such other recommendations as the Comptroller General considers appropriate. 8105. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl and other substances (a) Mandatory Guidelines for Federal Workplace Drug Testing Programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall— (A) determine whether a revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the opiate category on the list of authorized substance testing to include fentanyl is justified, based on the reliability and cost-effectiveness of available testing; and (B) consider whether to include with the determination under subparagraph (A) a separate determination on whether a revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the list of substances authorized for testing to include any other drugs or other substances listed in schedule I and II of section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ) is justified based on the criteria described in subparagraph (A). (2) Revision of guidelines If an expansion of the substance list is determined to be justified under paragraph (1), the Secretary of Health and Human Services shall— (A) notify the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives of the determination; and (B) publish in the Federal Register, not later than 18 months after the date of the determination under that paragraph, a final notice of the revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the list of substances authorized to be tested to include the substance or substances determined to be justified for inclusion. (3) Report If an expansion of the substance list is determined not to be justified under paragraph (1), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report explaining, in detail, the reasons the expansion of the list of authorized substances is not justified. (b) Department of Transportation drug-testing panel If an expansion is determined to be justified under subsection (a)(1), the Secretary of Transportation shall publish in the Federal Register, not later than 18 months after the date the final notice is published under subsection (a)(2), a final rule revising part 40 of title 49, Code of Federal Regulations, to include such substances in the Department of Transportation's drug-testing panel, consistent with the Mandatory Guidelines for Federal Workplace Drug Testing Programs as revised by the Secretary of Health and Human Services under subsection (a). (c) Savings provision Nothing in this section may be construed as— (1) delaying the publication of the notices described in sections 8106 and 8107 of this Act until the Secretary of Health and Human Services makes a determination or publishes a notice under this section; or (2) limiting or otherwise affecting any authority of the Secretary of Health and Human Services or the Secretary of Transportation to expand the list of authorized substance testing to include an additional substance. 8106. Status reports on hair testing guidelines (a) In general Not later than 60 days after the date of enactment of this Act, and annually thereafter until the date that the Secretary of Health and Human Services publishes in the Federal Register a final notice of scientific and technical guidelines for hair testing in accordance with section 5402(b) of the Fixing America's Surface Transportation Act ( Public Law 114–94 ; 129 Stat. 1312), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on— (1) the status of the hair testing guidelines; (2) an explanation for why the hair testing guidelines have not been issued; and (3) an estimated date of completion of the hair testing guidelines. (b) Requirement To the extent practicable and consistent with the objective of the hair testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results, of the individual being tested, caused solely by the drug use of others and not caused by the drug use of the individual being tested. 8107. Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (a) Deadline Not later than December 31, 2018, the Secretary of Health and Human Services shall publish in the Federal Register a final notice of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, based on the notice of proposed mandatory guidelines published in the Federal Register on May 15, 2015 (94 FR 28054). (b) Requirement To the extent practicable and consistent with the objective of the testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results, of the individual being tested, caused solely by the drug use of others and not caused by the drug use of the individual being tested. (c) Rule of construction Nothing in this section may be construed as requiring the Secretary of Health and Human Services to reissue a notice of proposed mandatory guidelines to carry out subsection (a). 8108. Electronic recordkeeping (a) Deadline Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) ensure that each certified laboratory that requests approval for the use of completely paperless electronic Federal Drug Testing Custody and Control Forms from the National Laboratory Certification Program’s Electronic Custody and Control Form systems receives approval for those completely paperless electronic forms instead of forms that include any combination of electronic traditional handwritten signatures executed on paper forms; and (2) establish a deadline for a certified laboratory to request approval under paragraph (1). (b) Savings clause Nothing in this section may be construed as limiting or otherwise affecting any authority of the Secretary of Health and Human Services to grant approval to a certified laboratory for use of completely paperless electronic Federal Drug Testing Custody and Control Forms, including to grant approval outside of the process under subsection (a). (c) Electronic signatures Not later than 18 months after the date of the deadline under subsection (a)(2), the Secretary of Transportation shall issue a final rule revising part 40 of title 49, Code of Federal Regulations, to authorize, to the extent practicable, the use of electronic signatures or digital signatures executed to electronic forms instead of traditional handwritten signatures executed on paper forms. 8109. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse (a) In general Not later than 60 days after the date of enactment of this Act, and annually thereafter until the compliance date, the Administrator of the Federal Motor Carrier Safety Administration shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a status report on implementation of the final rule for the Commercial Driver's License Drug and Alcohol Clearinghouse (81 FR 87686), including— (1) an updated schedule, including benchmarks, for implementing the final rule as soon as practicable, but not later than the compliance date; and (2) a description of each action the Federal Motor Carrier Safety Administration is taking to implement the final rule before the compliance date. (b) Definition of compliance date In this section, the term compliance date means the earlier of— (1) January 6, 2020; or (2) the date that the national clearinghouse required under section 31306a of title 49, United States Code, is operational. J Eliminating Kickbacks in Recovery 8121. Short title This subtitle may be cited as the Eliminating Kickbacks in Recovery Act of 2018 . 8122. Criminal penalties (a) In general Chapter 11 of title 18, United States Code, is amended by inserting after section 219 the following: 220. Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories (a) Offense Except as provided in subsection (b), whoever, with respect to services covered by a health care benefit program, in or affecting interstate or foreign commerce, knowingly and willfully— (1) solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or (2) pays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or (B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory, shall be fined not more than $200,000, imprisoned not more than 10 years, or both, for each occurrence. (b) Applicability Subsection (a) shall not apply to— (1) a discount or other reduction in price obtained by a provider of services or other entity under a health care benefit program if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity; (2) a payment made by an employer to an employee or independent contractor (who has a bona fide employment or contractual relationship with such employer) for employment, if the employee’s payment is not determined by or does not vary by— (A) the number of individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (B) the number of tests or procedures performed; or (C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (3) a discount in the price of an applicable drug of a manufacturer that is furnished to an applicable beneficiary under the Medicare coverage gap discount program under section 1860D–14A(g) of the Social Security Act (42 U.S.C. 1395w–114a(g)); (4) a payment made by a principal to an agent as compensation for the services of the agent under a personal services and management contract that meets the requirements of section 1001.952(d) of title 42, Code of Federal Regulations, as in effect on the date of enactment of this section; (5) a waiver or discount (as defined in section 1001.952(h)(5) of title 42, Code of Federal Regulations, or any successor regulation) of any coinsurance or copayment by a health care benefit program if— (A) the waiver or discount is not routinely provided; and (B) the waiver or discount is provided in good faith; (6) a remuneration described in section 1128B(b)(3)(I) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)(I)); (7) a remuneration made pursuant to an alternative payment model (as defined in section 1833(z)(3)(C) of the Social Security Act) or pursuant to a payment arrangement used by a State, health insurance issuer, or group health plan if the Secretary of Health and Human Services has determined that such arrangement is necessary for care coordination or value-based care; or (8) any other payment, remuneration, discount, or reduction as determined by the Attorney General, in consultation with the Secretary of Health and Human Services, by regulation. (c) Regulations The Attorney General, in consultation with the Secretary of Health and Human Services, may promulgate regulations to clarify the exceptions described in subsection (b). (d) Preemption (1) Federal law This section shall not apply to conduct that is prohibited under section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b ). (2) State law Nothing in this section shall be construed to occupy the field in which any provisions of this section operate to the exclusion of State laws on the same subject matter. (e) Definitions In this section— (1) the terms applicable beneficiary and applicable drug have the meanings given those terms in section 1860D–14A(g) of the Social Security Act (42 U.S.C. 1395w–114a(g)); (2) the term clinical treatment facility means a medical setting , other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law; (3) the term health care benefit program has the meaning given the term in section 24(b); (4) the term laboratory has the meaning given the term in section 353 of the Public Health Service Act ( 42 U.S.C. 263a ); and (5) the term recovery home means a shared living environment that is, or purports to be, free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders. . (b) Clerical amendment The table of sections for chapter 11 of title 18, United States Code, is amended by inserting after the item related to section 219 the following: 220. Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories. . K Substance Abuse Prevention 8201. Short title This subtitle may be cited as the Substance Abuse Prevention Act of 2018 . 8202. Reauthorization of the Office of National Drug Control Policy (a) Office of National Drug Control Policy Reauthorization Act of 1998 (1) In general The Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 et seq.), as in effect on September 29, 2003, and as amended by the laws described in paragraph (2), is revived and restored. (2) Laws described The laws described in this paragraph are: (A) The Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3502). (B) The Presidential Appointment Efficiency and Streamlining Act of 2011 ( Public Law 112–166 ; 126 Stat. 1283). (b) Reauthorization (1) In general Section 714 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1711 ) is amended by striking such sums as may be necessary for each of fiscal years 2006 through 2010 and inserting $18,400,000 for each of fiscal years 2018 through 2023 . (2) Repeal of termination The Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 et seq.) is amended by striking section 715 ( 21 U.S.C. 1712 ). 8203. Reauthorization of the Drug-Free Communities Program (a) Revival of national narcotics leadership act of 1988 (1) In general Chapter 2 of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1521 et seq.), except for subchapter II ( 21 U.S.C. 1541 et seq.), as in effect on September 29, 1997, and as amended by the laws described in paragraph (2), is revived and restored. (2) Laws described The laws described in this paragraph are: (A) Public Law 107–82 (115 Stat. 814). (B) The Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 : 120 Stat. 3502), as amended by paragraph (4). (3) Amendment to termination provision Section 1009 of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1056 ) is amended by inserting and sections 1021 through 1035 after section 1007 . (4) Technical correction (A) In general Title VIII of the Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3535) is amended by striking Drug-Free Communities Act of 1997 each place it appears and inserting National Narcotics Leadership Act of 1988 . (B) Effective date The amendments made by subparagraph (A) shall take effect as though enacted as part of the Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3502). (b) Amendment to National Narcotics Leadership Act of 1988 Chapter 2 of subtitle A of title I of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1521 et seq.) is amended— (1) in section 1022 ( 21 U.S.C. 1522 ), by striking substance abuse each place it appears and inserting substance use and misuse ; (2) in section 1023 ( 21 U.S.C. 1523 ), by striking paragraph (9) and inserting the following: (9) Substance use and misuse The term substance use and misuse means— (A) the illegal use or misuse of drugs, including substances for which a listing is effect under any of schedules I through V under section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ); (B) the misuse of inhalants or over-the-counter drugs; or (C) the use of alcohol, tobacco, or other related product as such use is prohibited by State or local law. ; (3) in section 1024 ( 21 U.S.C. 1524 ), by striking subsections (a) and (b) and inserting the following: (a) In general There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this chapter $99,000,000 for each of fiscal years 2018 through 2023. (b) Administrative costs Not more than 8 percent of the funds appropriated to carry out this chapter may be used by the Office of National Drug Control Policy to pay administrative costs associated with the responsibilities of the Office under this chapter. ; (4) in subchapter I ( 21 U.S.C. 1531 et seq.)— (A) by striking substance abuse each place it appears and inserting substance use and misuse ; and (B) in section 1032(b)(1)(A) ( 21 U.S.C. 1532(b)(1)(A) ), by striking clause (iii) and inserting the following: (iii) Renewal grants Subject to clause (iv), the Administrator may award a renewal grant to a grant recipient under this subparagraph for each fiscal year of the 4-fiscal-year period following the first fiscal year for which the initial additional grant is awarded in an amount not to exceed the following: (I) For the first and second fiscal years of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 125 percent of the amount awarded. (II) For the third and fourth fiscal tears of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 150 percent of the amount awarded. ; and (5) by striking subchapter II ( 21 U.S.C. 1541 et seq.). 8204. Reauthorization of the National Community Anti-Drug Coalition Institute Section 4 of Public Law 107–82 ( 21 U.S.C. 1521 note) is amended to read as follows: 4. Authorization for National Community Antidrug Coalition Institute (a) In general The Director shall, using amounts authorized to be appropriated by subsection (d), make a competitive grant to provide for the continuation of the National Community Anti-drug Coalition Institute. (b) Eligible organizations An organization eligible for the grant under subsection (a) is any national nonprofit organization that represents, provides technical assistance and training to, and has special expertise and broad, national-level experience in community antidrug coalitions under this subchapter. (c) Use of grant amount The organization that receives the grant under subsection (a) shall continue a National Community Anti-Drug Coalition Institute to— (1) provide education, training, and technical assistance for coalition leaders and community teams, with emphasis on the development of coalitions serving economically disadvantaged areas; (2) develop and disseminate evaluation tools, mechanisms, and measures to better assess and document coalition performance measures and outcomes; and (3) bridge the gap between research and practice by translating knowledge from research into practical information. (d) Authorization of appropriations The Director shall, using amounts authorized to be appropriated by section 1032 of the National Narcotics Leadership Act of 1988 ( 15 U.S.C. 1532 ), make a grant of $2 million under subsection (a), for each of the fiscal years 2018 through 2023. . 8205. Reauthorization of the High-Intensity Drug Trafficking Area Program Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1706 ) is amended— (1) in subsection (f), by striking no Federal and all that follows through programs. and inserting the following: not more than a total of 5 percent of Federal funds appropriated for the Program are expended for substance use disorder treatment programs and drug prevention programs. ; (2) in subsection (p)— (A) in paragraph (4), by striking and at the end; (B) in paragraph (5), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following: (6) $280,000,000 for each of fiscal years 2018 through 2023. ; and (3) in subsection (q)— (A) by striking paragraph (2) and inserting the following: (2) Required uses The funds used under paragraph (1) shall be used to ensure the safety of neighborhoods and the protection of communities, including the prevention of the intimidation of witnesses of illegal drug distribution and related activities and the establishment of, or support for, programs that provide protection or assistance to witnesses in court proceedings. ; and (B) by adding at the end the following: (3) Best practice models The Director shall work with HIDTAs to develop and maintain best practice models to assist State, local, and Tribal governments in addressing witness safety, relocation, financial and housing assistance, or any other services related to witness protection or assistance in cases of illegal drug distribution and related activities. The Director shall ensure dissemination of the best practice models to each HIDTA. . 8206. Reauthorization of drug court program Section 1001(a)(25)(A) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10261(a)(25)(A) ) is amended by striking Except as provided and all that follows and inserting the following: Except as provided in subparagraph (C), there is authorized to be appropriated to carry out part EE $75,000,000 for each of fiscal years 2018 through 2023. . 8207. Drug court training and technical assistance Section 705 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1704 ) is amended by adding at the end the following: (e) Drug court training and technical assistance program (1) Grants authorized The Director may make a grant to a nonprofit organization for the purpose of providing training and technical assistance to drug courts. (2) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2018 through 2023. . 8208. Drug overdose response strategy Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1706 ) is amended by adding at the end the following: (r) Drug overdose response strategy implementation The Director may use funds appropriated to carry out this section to implement a drug overdose response strategy in high intensity drug trafficking areas on a nationwide basis by— (1) coordinating multi-disciplinary efforts to prevent, reduce, and respond to drug overdoses, including the uniform reporting of fatal and non-fatal overdoses to public health and safety officials; (2) increasing data sharing among public safety and public health officials concerning drug-related abuse trends, including new psychoactive substances, and related crime; and (3) enabling collaborative deployment of prevention, intervention, and enforcement resources to address substance use addiction and narcotics trafficking. . 8209. Protecting law enforcement officers from accidental exposure Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1706 ), as amended by section 8208, is amended by adding at the end the following: (s) Supplemental grants The Director is authorized to use not more than $10,000,000 of the amounts otherwise appropriated to carry out this section to provide supplemental competitive grants to high intensity drug trafficking areas that have experienced high seizures of fentanyl and new psychoactive substances for the purposes of— (1) purchasing portable equipment to test for fentanyl and other substances; (2) training law enforcement officers and other first responders on best practices for handling fentanyl and other substances; and (3) purchasing protective equipment, including overdose reversal drugs. . 8210. COPS Anti-Meth Program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10381 ) is amended— (1) by redesignating subsection (k) as subsection (l); and (2) by inserting after subsection (j) the following: (k) COPS Anti-Meth Program The Attorney General shall use amounts otherwise appropriated to carry out this section for a fiscal year (beginning with fiscal year 2019) to make competitive grants, in amounts of not less than $1,000,000 for such fiscal year, to State law enforcement agencies with high seizures of precursor chemicals, finished methamphetamine, laboratories, and laboratory dump seizures for the purpose of locating or investigating illicit activities, such as precursor diversion, laboratories, or methamphetamine traffickers. . 8211. COPS anti-heroin task force program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10381 ) is amended— (1) by redesignating subsection (l), as so redesignated by section 8210, as subsection (m); and (2) by inserting after subsection (k), as added by section 8210, the following: (l) Cops anti-heroin task force program The Attorney General shall use amounts otherwise appropriated to carry out this section, or other amounts as appropriated, for a fiscal year (beginning with fiscal year 2019) to make competitive grants to State law enforcement agencies in States with high per capita rates of primary treatment admissions, for the purpose of locating or investigating illicit activities, through Statewide collaboration, relating to the distribution of heroin, fentanyl, or carfentanil or relating to the unlawful distribution of prescription opioids. . 8212. Comprehensive Addiction and Recovery Act education and awareness Title VII of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ; 130 Stat. 735) is amended by adding at the end the following: 709. Services for families and patients in crisis (a) In general The Secretary of Health and Human Services may make grants to entities that focus on addiction and substance use disorders and specialize in family and patient services, advocacy for patients and families, and educational information. (b) Allowable uses A grant awarded under this section may be used for nonprofit national, State, or local organizations that engage in the following activities: (1) Expansion of resource center services with professional, clinical staff that provide, for families and individuals impacted by a substance use disorder, support, access to treatment resources, brief assessments, medication and overdose prevention education, compassionate listening services, recovery support or peer specialists, bereavement and grief support, and case management. (2) Continued development of health information technology systems that leverage new and upcoming technology and techniques for prevention, intervention, and filling resource gaps in communities that are underserved. (3) Enhancement and operation of treatment and recovery resources, easy-to-read scientific and evidence-based education on addiction and substance use disorders, and other informational tools for families and individuals impacted by a substance use disorder and community stakeholders, such as law enforcement agencies. (4) Provision of training and technical assistance to State and local governments, law enforcement agencies, health care systems, research institutions, and other stakeholders. (5) Expanding upon and implementing educational information using evidence-based information on substance use disorders. (6) Expansion of training of community stakeholders, law enforcement officers, and families across a broad-range of addiction, health, and related topics on substance use disorders, local issues and community-specific issues related to the drug epidemic. (7) Program evaluation. . 8213. Reimbursement of substance use disorder treatment professionals Not later than January 1, 2020, the Comptroller General of the United States shall submit to Congress a report examining how substance use disorder services are reimbursed. 8214. Sobriety Treatment and Recovery Teams (START) Title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.) is amended by adding at the end the following: 550. Sobriety Treatment and Recovery Teams (a) In general The Secretary may make grants to States, units of local government, or tribal governments to establish or expand Sobriety Treatment And Recovery Team (referred to in this section as START ) or other similar programs to determine the effectiveness of pairing social workers or mentors with families that are struggling with a substance use disorder and child abuse or neglect in order to help provide peer support, intensive treatment, and child welfare services to such families. (b) Allowable uses A grant awarded under this section may be used for one or more of the following activities: (1) Training eligible staff, including social workers, social services coordinators, child welfare specialists, substance use disorder treatment professionals, and mentors. (2) Expanding access to substance use disorder treatment services and drug testing. (3) Enhancing data sharing with law enforcement agencies, child welfare agencies, substance use disorder treatment providers, judges, and court personnel. (4) Program evaluation and technical assistance. (c) Program requirements A State, unit of local government, or tribal government receiving a grant under this section shall— (1) serve only families for which— (A) there is an open record with the child welfare agency; and (B) substance use disorder was a reason for the record or finding described in paragraph (1); and (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social Security Act focused on improving outcomes for children affected by substance abuse. (d) Technical assistance The Secretary may reserve not more than 5 percent of funds provided under this section to provide technical assistance on the establishment or expansion of programs funded under this section from the National Center on Substance Abuse and Child Welfare. . 8215. Provider education Not later than 60 days after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall complete the plan related to medical registration coordination required by Senate Report 114–239, which accompanied the Veterans Care Financial Protection Act of 2017 ( Public Law 115–131 ; 132 Stat. 334). 8216. Definitions Section 702 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 ) is amended— (1) by striking paragraphs (5), (12), and (13); (2) by redesignating paragraph (11) as paragraph (17); (3) by redesignating paragraphs (9) and (10) as paragraphs (14) and (15), respectively; (4) by redesignating paragraphs (6), (7), and (8) as paragraphs (10), (11), and (12), respectively; (5) by redesignating paragraphs (1), (2), (3), and (4) as paragraphs (3), (4), (5), and (6), respectively; (6) by inserting before paragraph (3), as so redesignated, the following: (1) Agency The term agency has the meaning given the term executive agency in section 102 of title 31, United States Code. (2) Appropriate congressional committees (A) In general The term appropriate congressional committees means— (i) the Committee on the Judiciary, the Committee on Appropriations, and the Committee on Health, Education, Labor, and Pensions of the Senate; and (ii) the Committee on Oversight and Government Reform, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives. (B) Submission to Congress Any submission to Congress shall mean submission to the appropriate congressional committees. ; (7) by amending paragraph (3), as so redesignated, to read as follows: (3) Demand reduction The term demand reduction means any activity conducted by a National Drug Control Program Agency, other than an enforcement activity, that is intended to reduce or prevent the use of drugs or support, expand, or provide treatment and recovery efforts, including— (A) education about the dangers of illicit drug use; (B) services, programs, or strategies to prevent substance use disorder, including evidence-based education campaigns, community-based prevention programs, collection and disposal of unused prescription drugs, and services to at-risk populations to prevent or delay initial use of an illicit drug; (C) substance use disorder treatment; (D) support for long-term recovery from substance use disorders; (E) drug-free workplace programs; (F) drug testing, including the testing of employees; (G) interventions for illicit drug use and dependence; (H) expanding availability of access to health care services for the treatment of substance use disorders; (I) international drug control coordination and cooperation with respect to activities described in this paragraph; (J) pre- and post-arrest criminal justice interventions such as diversion programs, drug courts, and the provision of evidence-based treatment to individuals with substance use disorders who are arrested or under some form of criminal justice supervision, including medication assisted treatment; (K) other coordinated and joint initiatives among Federal, State, local, and Tribal agencies to promote comprehensive drug control strategies designed to reduce the demand for, and the availability of, illegal drugs; (L) international illicit drug use education, prevention, treatment, recovery, research, rehabilitation activities, and interventions for illicit drug use and dependence; and (M) research related to illicit drug use and any of the activities described in this paragraph. ; (8) by inserting after paragraph (6), as so redesignated, the following: (7) Emerging drug threat The term emerging drug threat means the occurrence of a new and growing trend in the use of an illicit drug or class of drugs, including rapid expansion in the supply of or demand for such drug. (8) Illicit drug use; illicit drugs; illegal drugs The terms illicit drug use , illicit drugs , and illegal drugs include the illegal or illicit use of prescription drugs. (9) Law enforcement The term law enforcement or drug law enforcement means all efforts by a Federal, State, local, or Tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties. ; (9) by amending paragraph (11), as so redesignated, to read as follows: (11) National drug control program agency The term National Drug Control Program Agency means any agency (or bureau, office, independent agency, board, division, commission, subdivision, unit, or other component thereof) that is responsible for implementing any aspect of the National Drug Control Strategy, including any agency that receives Federal funds to implement any aspect of the National Drug Control Strategy, but does not include any agency that receives funds for drug control activity solely under the National Intelligence Program or the Joint Military Intelligence Program. ; (10) in paragraph (12), as so redesignated— (A) by inserting or Strategy before means ; and (B) by inserting , including any report, plan, or strategy required to be incorporated into or issued concurrently with such strategy before the period at the end; (11) by inserting after paragraph (12), as so redesignated, the following: (13) Nonprofit organization The term nonprofit organization means an organization that is described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code. ; (12) in paragraph (14), as so redesignated, by striking Unless the context clearly indicates otherwise, the and inserting The ; (13) by inserting after paragraph (15), as so redesignated, the following: (16) Substance use disorder treatment The term substance use disorder treatment means an evidence-based, professionally directed, deliberate, and planned regimen including evaluation, observation, medical monitoring, and rehabilitative services and interventions such as pharmacotherapy, behavioral therapy, and individual and group counseling, on an inpatient or outpatient basis, to help patients with substance use disorder reach recovery. ; and (14) in paragraph (17), as so redesignated— (A) by redesignating subparagraphs (B), (C), (D), and (E), as subparagraphs (C), (D), (E), and (F), respectively; (B) by inserting after subparagraph (A) the following: (B) domestic law enforcement; ; (C) in subparagraph (E), as so redesignated, by striking and at the end; (D) in subparagraph (F), as so redesignated, by striking the period at the end and inserting a semicolon; and (E) by adding at the end the following: (G) activities to prevent the diversion of drugs for their illicit use; and (H) research related to any of the activities described in this paragraph. . 8217. Amendments to administration of the Office (a) Responsibilities of Office Section 703(a) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1702(a) ) is amended— (1) by striking paragraph (1) and inserting the following: (1) lead the national drug control effort, including coordinating with the National Drug Control Program Agencies; ; (2) in paragraph (2), by inserting before the semicolon the following: , including the National Drug Control Strategy ; (3) in paragraph (3), by striking and at the end; and (4) by striking paragraph (4) and all that follows through the National Academy of Sciences. and inserting the following: (4) evaluate the effectiveness of national drug control policy efforts, including the National Drug Control Program Agencies’ program, by developing and applying specific goals and performance measurements and monitoring the agencies’ program-level spending; (5) identify and respond to emerging drug threats related to illicit drug use; (6) administer the Drug-Free Communities Program, the High-Intensity Drug Trafficking Areas Program, and other grant programs directly authorized to be administered by the Office in furtherance of the National Drug Control Strategy; and (7) facilitate broad-scale information sharing and data standardization among Federal, State, and local entities to support the national drug control efforts. . (b) Ethics guidelines Section 703(d) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1702(d) ) is amended by adding at the end the following: (4) Ethics guidelines The Director shall establish written guidelines setting forth the criteria to be used in determining whether a gift or donation should be declined under this subsection because the acceptance of the gift or donation would— (A) reflect unfavorably upon the ability of the Director or the Office, or any employee of the Office, to carry out responsibilities or official duties under this chapter in a fair and objective manner; or (B) compromise the integrity or the appearance of integrity of programs or services provided under this chapter or of any official involved in those programs or services. (5) Registry of gifts The Director shall maintain a list of— (A) the source and amount of each gift or donation accepted by the Office; and (B) the source and amount of each gift or donation accepted by a contractor to be used in its performance of a contract for the Office. (6) Report to Congress The Director shall include in the annual assessment under section 706(g) a copy of the registry maintained under paragraph (5). . (c) Appointment of Director and Deputy Director Section 704(a) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(a) ) is amended— (1) in paragraph (1), by striking subparagraphs (A), (B), and (C), and inserting the following: (A) Director (i) In general There shall be at the head of the Office a Director who shall hold the same rank and status as the head of an executive department listed in section 101 of title 5, United States Code. (ii) Appointment The Director shall be appointed by the President, by and with the advice and consent of the Senate, and shall serve at the pleasure of the President. (B) Deputy Director There shall be a Deputy Director who shall report directly to the Director, and who shall be appointed by the President, and shall serve at the pleasure of the President. (C) Coordinators The following coordinators shall be appointed by the Director: (i) Performance Budget Coordinator, as described in section 704(c)(4). (ii) Interdiction Coordinator, as described in section 711. (iii) Emerging and Continuing Threats Coordinator, as described in section 709. (iv) State, Local, and Tribal Affairs Coordinator, to carry out the activities described in section 704(j). (v) Demand Reduction Coordinator, as described in subparagraph (D). (D) Demand Reduction Coordinator The Director shall designate or appoint a United States Demand Reduction Coordinator to be responsible for the activities described in section 702(3). The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). ; (2) in paragraph (5), by striking such official and inserting such officer or employee ; and (3) by adding at the end the following: (6) Prohibition on the use of funds for ballot initiatives No funds authorized under this title may be obligated for the purpose of expressly advocating the passage or defeat of a State or local ballot initiative. . (d) Consultation Section 704(b) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(b) ) is amended— (1) in paragraph (19), by striking ; and and inserting a semicolon; (2) in paragraph (20), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (21) in order to formulate the national drug control policies, goals, objectives, and priorities— (A) shall consult with and assist— (i) State and local governments; (ii) National Drug Control Program Agencies; (iii) each committee, working group, council, or other entity established under this chapter, as appropriate; (iv) the public; (v) appropriate congressional committees; and (vi) any other person in the discretion of the Director; and (B) may— (i) establish advisory councils; (ii) acquire data from agencies; and (iii) request data from any other entity. . (e) National Drug Control Program Budget Section 704(c) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(c) ) is amended— (1) in paragraph (2)— (A) in subparagraph (A), by striking paragraph (1)(C); and inserting the following: paragraph (1)(C) and include— (i) the funding level for each National Drug Control Program agency; and (ii) alternative funding structures that could improve progress on achieving the goals fo the National Drug Control Strategy; and ; (B) in subparagraph (B), strike the President; and and inserting the President and Congress. ; and (C) by striking subparagraph (C); (2) in paragraph (3)(E), by striking clause (ii) and inserting the following: (ii) Certification The Director shall— (I) review each budget submission submitted under subparagraph (A); (II) based on the review under clause (i), make a determination as to whether the budget submission of a National Drug Control Program agency includes the funding levels and initiatives described in subparagraph (B); and (III) submit to the appropriate congressional committees— (aa) a written statement that either— (AA) certifies that the budget submission includes sufficient funding; or (BB) decertifies the budget submission as not including sufficient funding; (bb) a copy of the description made under subparagraph (B); and (cc) the budget recommendations made under subsection (b)(8). ; and (3) by adding at the end the following: (5) Performance-budget coordinator (A) Designation The Director shall designate or appoint a United States Performance-Budget Coordinator to— (i) ensure the Director has sufficient information necessary to analyze the performance of each National Drug Control Program Agency, the impact Federal funding has had on the goals in the Strategy, and the likely contributions to the goals of the Strategy based on funding levels of each National Drug Control Program Agency, to make an independent assessment of the budget request of each agency under this subsection; (ii) advise the Director on agency budgets, performance measures and targets, and additional data and research needed to make informed policy decisions under this section and section 706; and (iii) other duties as may be determined by the Director with respect to measuring or assessing performance or agency budgets. (B) Determination of position The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). (6) Budget estimate or request submission to Congress Whenever the Director submits any budget estimate or request to the President or the Office of Management and Budget, the Director shall concurrently transmit to the appropriate congressional committees a detailed statement of the budgetary needs of the Office to execute its mission based on the good-faith assessment of the Director. . (f) Powers and responsibilities of the Director Section 704 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703 ) is amended— (1) in subsection (d)(8)— (A) in subparagraph (D), by striking and at the end; (B) in subparagraph (E)— (i) in clause (i)— (I) by striking Congress, including to the Committees on Appropriations of the Senate and the House of Representatives, the authorizing committees for the Office, and inserting the appropriate congressional committees ; and (II) by striking or agencies ; (ii) in clause (ii)— (I) by striking Congress and inserting the appropriate congressional committees ; and (II) by adding and at the end; and (iii) by adding at the end the following: (iii) funds may only be used for— (I) expansion of demand reduction activities; (II) interdiction of illicit drugs on the high seas, in United States territorial waters, and at United States ports of entry by officers and employees of National Drug Control Program Agencies and domestic and foreign law enforcement officers; (III) accurate assessment and monitoring of international drug production and interdiction programs and policies; (IV) activities to facilitate and enhance the sharing of domestic and foreign intelligence information among National Drug Control Program Agencies related to the production and trafficking of drugs in the United States and foreign countries; and (V) research related to any of these activities. ; (2) in subsection (e)(2)(A), by striking Notwithstanding any other provision of law and inserting Subject to the availability of appropriations ; and (3) by adding at the end the following: (i) Model Acts Program (1) In general The Director shall provide for or shall enter into an agreement with a nonprofit organization to— (A) advise States on establishing laws and policies to address illicit drug use issues; and (B) revise such model State drug laws and draft supplementary model State laws to take into consideration changes in illicit drug use issues in the State involved. (2) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $1,250,000 for each of fiscal years 2018 through 2023. (j) State, Local, and Tribal Affairs Coordinator The Director shall designate or appoint a United States State, Local, and Tribal Affairs Coordinator to perform the duties of the Office outlined in this section and 706 and such other duties as may be determined by the Director with respect to coordination of drug control efforts between agencies and State, local, and Tribal governments. The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). (k) Harm reduction programs When developing the national drug control policy, any policy of the Director, including policies relating to syringe exchange programs for intravenous drug users, shall be based on the best available medical and scientific evidence regarding the effectiveness of such policy in promoting individual health and preventing the spread of infectious disease and the impact of such policy on drug addiction and use. In making any policy relating to harm reduction programs, the Director shall consult with the National Institutes of Health and the National Academy of Sciences. . (g) Accounting of funds expended Section 705 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1704(d) ), as amended by section 8207 is further amended— (1) by amending subsection (d) to read as follows: (d) Accounting of Funds Expended (1) In general Not later than February 1 of each year, in accordance with guidance issued by the Director, the head of each National Drug Control Program Agency shall submit to the Director a detailed accounting of all funds expended by the agency for National Drug Control Program activities during the previous fiscal year and shall ensure such detailed accounting is authenticated for the previous fiscal year by the Inspector General for such agency prior to the submission to the Director as frequently as determined by the Inspector General but not less frequently that every 3 years. (2) Submission to Congress The Director shall submit to Congress not later than April 1 of each year the information submitted to the Director under paragraph (1). ; and (2) by adding at the end the following: (f) Tracking system for federally funded grant programs (1) Establishment The Director, or the head of an agency designated by the Director, in coordination with the Secretary of Health and Human Services, shall track federally-funded grant programs to— (A) ensure the public has electronic access to information identifying: (i) all drug control grants and pertinent identifying information for each grant; (ii) any available performance metrics, evaluations, or other information indicating the effectiveness of such programs; (B) facilitate efforts to identify duplication, overlap, or gaps in funding to provide increased accountability of Federally-funded grants for substance use disorder treatment, prevention, and enforcement; and (C) identify barriers in the grant application process impediments that applicants currently have in the grant application process with applicable agencies. (2) National Drug Control Agencies The head of each National Drug Control Program Agency shall provide to the Director a complete list of all drug control program grant programs and any other relevant information for inclusion in the system developed under paragraph (1) and annually update such list. (3) Updating existing systems The Director may meet the requirements of this subsection by utilizing, updating, or improving existing Federal information systems to ensure they meet the requirements of this subsection. (4) Report Not later than 3 years after the date of enactment of this subsection, the Comptroller General of the United States shall submit to Congress a report examining implementation of this subsection. . (h) Technical and conforming amendment Section 1105 of the Office of National Drug Control Policy Reauthorization Act of 2006 ( 21 U.S.C. 1701 note) is repealed. 8218. Emerging threats committee, plan, and media campaign (a) In general Section 709 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1708 ) is amended to read as follows: 709. Emerging threats committee, plan, and media campaign (a) Emerging threats coordinator The Director shall designate or appoint a United States Emerging and Continuing Threats Coordinator to perform the duties of that position described in this section and such other duties as may be determined by the Director. The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). (b) Emerging threats committee (1) In general The Emerging Threats Committee shall— (A) monitor evolving and emerging drug threats in the United States; (B) identify and discuss evolving and emerging drug trends in the United States using the criteria required to be established under paragraph (6); (C) assist in the formulation of and oversee implementation of any plan described in subsection (d); (D) provide such other advice to the Coordinator and Director concerning strategy and policies for emerging drug threats and trends as the Committee determines to be appropriate; and (E) disseminate and facilitate the sharing with Federal, State, local, and Tribal officials and other entities as determined by the Director of pertinent information and data relating to— (i) recent trends in drug supply and demand; (ii) fatal and nonfatal overdoses; (iii) demand for and availability of evidence-based substance use disorder treatment, including the extent of the unmet treatment need, and treatment admission trends; (iv) recent trends in drug interdiction, supply, and demand from State, local, and Tribal law enforcement agencies; and (v) other subject matter as determined necessary by the Director. (2) Chairperson The Director shall designate one of the members of the Emerging Threats Committee to serve as Chairperson. (3) Members The Director shall appoint other members of the Committee, which shall include— (A) representatives from National Drug Control Program Agencies or other agencies; (B) representatives from State, local, and Tribal governments; and (C) representatives from other entities as designated by the Director. (4) Meetings The members of the Emerging Threats Committee shall meet, in person and not through any delegate or representative, not less frequently than once per calendar year, before June 1. At the call of the Director or the Chairperson, the Emerging Threats Committee may hold additional meetings as the members may choose. (5) Contract, agreement, and other authority The Director may award contracts, enter into interagency agreements, manage individual projects, and conduct other activities in support of the identification of emerging drug threats and in support of the development, implementation, and assessment of any Emerging Threat Response Plan. (6) Criteria to identify emerging drug threats Not later than 180 days after the date on which the Committee first meets, the Committee shall develop and recommend to the Director criteria to be used to identify an emerging drug threat or the termination of an emerging drug threat designation based on information gathered by the Committee, statistical data, and other evidence. (c) Designation (1) In general The Director, in consultation with the Coordinator, the Committee, and the head of each National Drug Control Program Agency, may designate an emerging drug threat in the United States. (2) Standards for designation The Director, in consultation with the Coordinator, shall promulgate and make publicly available standards by which a designation under paragraph (1) and the termination of such designation may be made. In developing such standards, the Director shall consider the recommendations of the committee and other criteria the Director considers to be appropriate. (3) Public statement required The Director shall publish a public written statement on the portal of the Office explaining the designation of an emerging drug threat or the termination of such designation and shall notify the appropriate congressional committees of the availability of such statement when a designation or termination of such designation has been made. (d) Plan (1) Public availability of plan Not later than 90 days after making a designation under subsection (c), the Director shall publish and make publicly available an Emerging Threat Response Plan and notify the President and the appropriate congressional committees of such plan’s availability. (2) Timing Concurrently with the annual submissions under section 706(g), the Director shall update the plan and report on implementation of the plan, until the Director issues the public statement required under subsection (c)(3) to terminate the emerging drug threat designation. (3) Contents of an emerging threat response plan The Director shall include in the plan required under this subsection— (A) a comprehensive strategic assessment of the emerging drug threat, including the current availability of, demand for, and effectiveness of evidence-based prevention, treatment, and enforcement programs and efforts to respond to the emerging drug threat; (B) comprehensive, research-based, short- and long-term, quantifiable goals for addressing the emerging drug threat, including for reducing the supply of the drug designated as the emerging drug threat and for expanding the availability and effectiveness of evidence-based substance use disorder treatment and prevention programs to reduce the demand for the emerging drug threat; (C) performance measures pertaining to the plan’s goals, including quantifiable and measurable objectives and specific targets; (D) the level of funding needed to implement the plan, including whether funding is available to be reprogrammed or transferred to support implementation of the plan or whether additional appropriations are necessary to implement the plan; (E) an implementation strategy for the media campaign under subsection (f), including goals as described under subparagraph (B) of this paragraph and performance measures, objectives, and targets, as described under subparagraph (C) of this paragraph; and (F) any other information necessary to inform the public of the status, progress, or response of an emerging drug threat. (4) Implementation (A) In general Not later than 120 days after the date on which a designation is made under subsection (c), the Director, in consultation with the President, the appropriate congressional committees, and the head of each National Drug Control Program Agency, shall issue guidance on implementation of the plan described in this subsection to the National Drug Control Program Agencies and any other relevant agency determined to be necessary by the Director. (B) Coordinator’s responsibilities The Coordinator shall— (i) direct the implementation of the plan among the agencies identified in the plan, State, local, and Tribal governments, and other relevant entities; (ii) facilitate information-sharing between agencies identified in the plan, State, local, and Tribal governments, and other relevant entities; and (iii) monitor implementation of the plan by coordinating the development and implementation of collection and reporting systems to support performance measurement and adherence to the plan by agencies identified in plan, where appropriate. (C) Reporting Not later than 180 days after the date on which a designation is made under subsection (c) and in accordance with subparagraph (A), the head of each agency identified in the plan shall submit to the Coordinator a report on implementation of the plan. (e) Evaluation of media campaign Upon designation of an emerging drug threat, the Director shall evaluate whether a media campaign would be appropriate to address that threat. (f) National anti-drug media campaign (1) In general The Director shall, to the extent feasible and appropriate, conduct a national anti-drug media campaign (referred to in this subtitle as the national media campaign ) in accordance with this subsection for the purposes of— (A) preventing substance abuse among people in the United States; (B) educating the public about the dangers and negative consequences of substance use and abuse, including patient and family education about the characteristics and hazards of substance abuse and methods to safeguard against substance use, to include the safe disposal of prescription medications; (C) supporting evidence-based prevention programs targeting the attitudes, perception, and beliefs of persons concerning substance use and intentions to initiate or continue such use; (D) encouraging individuals affected by substance use disorders to seek treatment and providing such individuals with information on— (i) how to recognize addiction issues; (ii) what forms of evidence-based treatment options are available; and (iii) how to access such treatment; (E) combating the stigma of addiction and substance use disorders, including the stigma of treating such disorders with medication-assisted treatment therapies; and (F) informing the public about the dangers of any drug identified by the Director as an emerging drug threat as appropriate. (2) Use of funds (A) In general Amounts made available to carry out this subsection for the national media campaign may only be used for the following: (i) The purchase of media time and space, including the strategic planning for, tracking, and accounting of, such purchases. (ii) Creative and talent costs, consistent with subparagraph (B)(i). (iii) Advertising production costs, which may include television, radio, internet, social media, and other commercial marketing venues. (iv) Testing and evaluation of advertising. (v) Evaluation of the effectiveness of the national media campaign. (vi) Costs of contracts to carry out activities authorized by this subsection. (vii) Partnerships with professional and civic groups, community-based organizations, including faith-based organizations, and government organizations related to the national media campaign. (viii) Entertainment industry outreach, interactive outreach, media projects and activities, public information, news media outreach, and corporate sponsorship and participation. (ix) Operational and management expenses. (B) Specific requirements (i) Creative services In using amounts for creative and talent costs under subparagraph (A)(ii), the Director shall use creative services donated at no cost to the Government wherever feasible and may only procure creative services for advertising— (I) responding to high-priority or emergent campaign needs that cannot timely be obtained at no cost; or (II) intended to reach a minority, ethnic, or other special audience that cannot reasonably be obtained at no cost. (ii) Testing and evaluation of advertising In using amounts for testing and evaluation of advertising under subparagraph (A)(iv), the Director shall test all advertisements prior to use in the national media campaign to ensure that the advertisements are effective with the target audience and meet industry-accepted standards. The Director may waive this requirement for advertisements using no more than 10 percent of the purchase of advertising time purchased under this subsection in a fiscal year and no more than 10 percent of the advertising space purchased under this subsection in a fiscal year, if the advertisements respond to emergent and time-sensitive campaign needs or the advertisements will not be widely utilized in the national media campaign. (iii) Consultation For the planning of the campaign under paragraph (1), the Director may consult with— (I) the head of any appropriate National Drug Control Program Agency; (II) experts on the designated drug; (III) State, local, and Tribal government officials and relevant agencies; (IV) communications professionals; (V) the public; and (VI) appropriate congressional committees. (iv) Evaluation of effectiveness of national media campaign In using amounts for the evaluation of the effectiveness of the national media campaign under subparagraph (A)(v), the Director shall— (I) designate an independent entity to evaluate by April 20 of each year the effectiveness of the national media campaign based on data from— (aa) the Monitoring the Future Study published by the Department of Health and Human Services; (bb) the National Survey on Drug Use and Health; and (cc) other relevant studies or publications, as determined by the Director, including tracking and evaluation data collected according to marketing and advertising industry standards; and (II) ensure that the effectiveness of the national media campaign is evaluated in a manner that enables consideration of whether the national media campaign has contributed to changes in attitude or behaviors among the target audience with respect to substance use and such other measures of evaluation as the Director determines are appropriate. (3) Advertising In carrying out this subsection, the Director shall ensure that sufficient funds are allocated to meet the stated goals of the national media campaign. (4) Responsibilities and functions under the program (A) In general The Director shall determine the overall purposes and strategy of the national media campaign. (B) Director (i) In general The Director shall approve— (I) the strategy of the national media campaign; (II) all advertising and promotional material used in the national media campaign; and (III) the plan for the purchase of advertising time and space for the national media campaign. (ii) Implementation The Director shall be responsible for implementing a focused national media campaign to meet the purposes set forth in paragraph (1) and shall ensure— (I) information disseminated through the campaign is accurate and scientifically valid; and (II) the campaign is designed using strategies demonstrated to be the most effective at achieving the goals and requirements of paragraph (1), which may include— (aa) a media campaign, as described in paragraph (2); (bb) local, regional, or population specific messaging; (cc) the development of websites to publicize and disseminate information; (dd) conducting outreach and providing educational resources for parents; (ee) collaborating with law enforcement agencies; and (ff) providing support for school-based public health education classes to improve teen knowledge about the effects of substance use. (5) Prohibitions None of the amounts made available under paragraph (2) may be obligated or expended for any of the following: (A) To supplant current anti-drug community-based coalitions. (B) To supplant pro bono public service time donated by national and local broadcasting networks for other public service campaigns. (C) For partisan political purposes, or to express advocacy in support of or to defeat any clearly identified candidate, clearly identified ballot initiative, or clearly identified legislative or regulatory proposal. (D) To fund advertising that features any elected officials, persons seeking elected office, cabinet level officials, or other Federal officials employed pursuant to section 213 of Schedule C of title 5, Code of Federal Regulations. (E) To fund advertising that does not contain a primary message intended to reduce or prevent substance use. (F) To fund advertising containing a primary message intended to promote support for the national media campaign or private sector contributions to the national media campaign. (6) Matching requirement (A) In general Amounts made available under paragraph (2) for media time and space shall be matched by an equal amount of non-Federal funds for the national media campaign, or be matched with in-kind contributions of the same value. (B) No-cost match advertising direct relationship requirement The Director shall ensure that not less than 85 percent of no-cost match advertising directly relates to substance abuse prevention consistent with the specific purposes of the national media campaign. (C) No-cost match advertising not directly related The Director shall ensure that no-cost match advertising that does not directly relate to substance abuse prevention consistent with the purposes of the national media campaign includes a clear anti-drug message. Such message is not required to be the primary message of the match advertising. (7) Financial and performance accountability The Director shall cause to be performed— (A) audits and reviews of costs of the national media campaign pursuant to section 4706 of title 41, United States Code; and (B) an audit to determine whether the costs of the national media campaign are allowable under chapter 43 of title 41, United States Code. (8) Report to congress The Director shall submit on an annual basis a report to Congress that describes— (A) the strategy of the national media campaign and whether specific objectives of the national media campaign were accomplished; (B) steps taken to ensure that the national media campaign operates in an effective and efficient manner consistent with the overall strategy and focus of the national media campaign; (C) plans to purchase advertising time and space; (D) policies and practices implemented to ensure that Federal funds are used responsibly to purchase advertising time and space and eliminate the potential for waste, fraud, and abuse; (E) all contracts entered into with a corporation, partnership, or individual working on behalf of the national media campaign; (F) the results of any financial audit of the national media campaign; (G) a description of any evidence used to develop the national media campaign; (H) specific policies and steps implemented to ensure compliance with this section; (I) a detailed accounting of the amount of funds obligated during the previous fiscal year for carrying out the national media campaign, including each recipient of funds, the purpose of each expenditure, the amount of each expenditure, any available outcome information, and any other information necessary to provide a complete accounting of the funds expended; and (J) a review and evaluation of the effectiveness of the national media campaign strategy for the past year. (9) Required notice for communication from the office Any communication, including an advertisement, paid for or otherwise disseminated by the Office directly or through a contract awarded by the Office shall include a prominent notice informing the audience that the communication was paid for by the Office. (g) Authorization of Appropriations There is authorized to be appropriated to the Office to carry out this section, $25,000,000 for each of fiscal years 2018 through 2023. . (b) Technical and conforming amendment Subsection (a) of section 203 of the Office of National Drug Control Policy Reauthorization Act of 2006 ( 21 U.S.C. 1708a ) is repealed. 8219. Drug interdiction (a) Repeal This first section 711 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1710 ) is repealed. (b) Amendments Section 711 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1710 ), as added by Public Law 109–469 (120 Stat. 3507), is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking The United and inserting The Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent) as the United ; and (ii) by striking shall and inserting to ; (B) in paragraph (2)(B)— (i) by striking March 1 and inserting September 1 ; and (ii) by striking paragraph (3) and inserting paragraph (4) ; (C) in paragraph (3)— (i) by striking also, at his discretion, ; and (ii) by striking the Office of Supply Reduction for that purpose and inserting assist in carrying out such responsibilities ; and (D) in paragraph (4)— (i) in subparagraph (B), by striking The United and inserting Before submission of the National Drug Control Strategy or annual assessment required under section 706, as applicable, the United ; (ii) by striking subparagraphs (C) and (E); (iii) by redesignating subparagraph (D) as subparagraph (C); (iv) in subparagraph (C), as so redesignated— (I) in the matter preceding clause (i)— (aa) by striking March 1 and inserting September 1 ; (bb) by inserting the Director, acting through before the United States ; (cc) by inserting a comma after Coordinator ; (dd) by striking a report on behalf of the Director ; and (ee) by striking , which shall include and inserting a report that ; (II) by redesignating clauses (i), (ii), and (iii) as subclauses (I), (II), and (III), and adjusting the margins accordingly; (III) by inserting before subclause (I), as so redesignated, the following: (i) includes— ; (IV) in clause (i), as so redesignated— (aa) in subclause (I), as so redesignated, by inserting , including information about how each National Drug Control Program agency conducting drug interdiction activities is engaging with relevant international partners after Plan ; (bb) in subclause (II), as so redesignated, by striking , as well as and inserting and ; (cc) in subclause III, as so redesignated— (AA) by striking , as well as and inserting and ; and (BB) by striking the period at the end and inserting ; and ; and (V) by adding at the end the following: (ii) may include recommendations for changes to existing agency authorities or laws governing interagency relationships. ; and (v) by adding at the end the following: (D) Classified annex Each report required to be submitted under subparagraph (C) shall be in unclassified form, but may include a classified annex. ; (2) in subsection (b)— (A) in paragraph (1)(B), by inserting and how to strengthen international partnerships to better achieve the goals of that plan after that plan ; (B) in paragraph (2)— (i) in the paragraph heading, by striking Chairman and inserting Chairperson ; and (ii) by striking chairman and inserting Chairperson ; (C) in paragraph (3)— (i) by striking prior to March 1 and inserting before June 1 ; (ii) by striking either each place it appears; (iii) by striking current chairman and inserting Chairperson ; and (iv) by striking they and inserting the members ; and (D) in paragraph (4)— (i) by striking chairman each place it appears and inserting Chairperson ; (ii) in the first sentence, by striking a report ; (iii) by inserting a report after committees ; and (iv) by striking the second sentence and inserting the following: The report required under this paragraph shall be in unclassified form, but may include a classified annex. ; and (3) by adding at the end the following: (c) International coordination The Director may facilitate international drug control coordination efforts. . 8220. GAO Audit Not later than 4 years after the date of enactment of this Act, and every 4 years thereafter, the Comptroller General of the United States shall— (1) conduct an audit relating to the programs and operations of— (A) the Office; and (B) certain programs within the Office, including— (i) the High Intensity Drug Trafficking Areas Program; (ii) the Drug-Free Communities Program; and (iii) the campaign under section 709(f) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1708(f) ); and (2) submit to the Director and the appropriate congressional committees a report containing an evaluation of and recommendations on the— (A) policies and activities of the programs and operations subject to the audit; (B) economy, efficiency, and effectiveness in the administration of the reviewed programs and operations; and (C) policy or management changes needed to prevent and detect fraud and abuse in such programs and operations. 8221. National Drug Control Strategy (a) In general Section 706 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1705 ) is amended to read as follows: 706. National drug control strategy (a) In general (1) Statement of drug policy priorities The Director shall release a statement of drug control policy priorities in the calendar year of a Presidential inauguration following the inauguration, but not later than April 1. (2) National drug control strategy submitted by the president Not later than the first Monday in February following the year in which the term of the President commences, and every 2 years thereafter, the President shall submit to Congress a National Drug Control Strategy. (b) Development of the national drug control strategy (1) Promulgation The Director shall promulgate the National Drug Control Strategy, which shall set forth a comprehensive plan to reduce illicit drug use and the consequences of such illicit drug use in the United States by limiting the availability of and reducing the demand for illegal drugs and promoting prevention, early intervention, treatment, and recovery support for individuals with substance use disorders. (2) State and local commitment The Director shall seek the support and commitment of State, local, and Tribal officials in the formulation and implementation of the National Drug Control Strategy. (3) Strategy based on evidence The Director shall ensure the National Drug Control Strategy is based on the best available evidence regarding the policies that are most effective in reducing the demand for and supply of illegal drugs. (4) Process for development and submission of national drug control strategy In developing and effectively implementing the National Drug Control Strategy, the Director— (A) shall consult with— (i) the heads of the National Drug Control Program Agencies; (ii) each Coordinator listed in section 704; (iii) the Interdiction Committee and the Emerging Threats Committee; (iv) the appropriate congressional committees and any other committee of jurisdiction; (v) State, local, and Tribal officials; (vi) private citizens and organizations, including community and faith-based organizations, with experience and expertise in demand reduction; (vii) private citizens and organizations with experience and expertise in supply reduction; and (viii) appropriate representatives of foreign governments; and (B) in satisfying the requirements of subparagraph (A), shall ensure, to the maximum extent possible, that State, local, and Tribal officials and relevant private organizations commit to support and take steps to achieve the goals and objectives of the National Drug Control Strategy. (c) Contents of the national drug control strategy (1) In general The National Drug Control Strategy submitted under subsection (a)(2) shall include the following: (A) A mission statement detailing the major functions of the National Drug Control Program. (B) Comprehensive, research-based, long-range, quantifiable goals for reducing illicit drug use, and the consequences of illicit drug use in the United States. (C) Annual quantifiable and measurable objectives and specific targets to accomplish long-term quantifiable goals that the Director determines may be achieved during each year beginning on the date on which the National Drug Control Strategy is submitted. (D) A 5-year projection for the National Drug Control Program and budget priorities. (E) A review of international, State, local, and private sector drug control activities to ensure that the United States pursues coordinated and effective drug control at all levels of government. (F) A description of how each goal established under subparagraph (B) will be achieved, including for each goal— (i) a list of each relevant National Drug Control Program Agency and each such agency’s related programs, activities, and available assets and the role of each such program, activity, and asset in achieving such goal; (ii) a list of relevant stakeholders and each such stakeholder’s role in achieving such goal; (iii) an estimate of Federal funding and other resources needed to achieve such goal; (iv) a list of each existing or new coordinating mechanism needed to achieve such goal; and (v) a description of the Office’s role in facilitating the achievement of such goal. (G) For each year covered by the Strategy, a performance evaluation plan for each goal established under subparagraph (B) for each National Drug Control Program Agency, including— (i) specific performance measures for each National Drug Control Program Agency; (ii) annual and, to the extent practicable, quarterly objectives and targets for each performance measure; and (iii) an estimate of Federal funding and other resources needed to achieve each performance objective and target. (H) A list identifying existing data sources or a description of data collection needed to evaluate performance, including a description of how the Director will obtain such data. (I) A list of any anticipated challenges to achieving the National Drug Control Strategy goals and planned actions to address such challenges. (J) A description of how each goal established under subparagraph (B) was determined, including— (i) a description of each required consultation and a description of how such consultation was incorporated; and (ii) data, research, or other information used to inform the determination to establish the goal. (K) A description of the current prevalence of illicit drug use in the United States, including both the availability of illicit drugs and the prevalence of substance use disorders. (L) Such other statistical data and information as the Director considers appropriate to demonstrate and assess trends relating to illicit drug use, the effects and consequences of illicit drug use (including the effects on children), supply reduction, demand reduction, drug-related law enforcement, and the implementation of the National Drug Control Strategy. (M) A systematic plan for increasing data collection to enable real time surveillance of drug control threats, developing analysis and monitoring capabilities, and identifying and addressing policy questions related to the National Drug Control Strategy and Program, which shall include— (i) a list of policy-relevant questions for which the Director and each National Drug Control Program Agency intends to develop evidence to support the National Drug Control Program and Strategy; (ii) a list of data the Director and each National Drug Control Program Agency intends to collect, use, or acquire to facilitate the use of evidence in drug control policymaking and monitoring; (iii) a list of methods and analytical approaches that may be used to develop evidence to support the National Drug Control Program and Strategy and related policy; (iv) a list of any challenges to developing evidence to support policymaking, including any barriers to accessing, collecting, or using relevant data; (v) a description of the steps the Director and the head of each National Drug Control Program Agency will take to effectuate the plan; and (vi) any other relevant information as determined by the Director. (N) A plan to expand treatment of substance use disorders, which shall— (i) identify unmet needs for treatment for substance use disorders and a strategy for closing the gap between available and needed treatment; (ii) describe the specific roles and responsibilities of the relevant National Drug Control Programs for implementing the plan; (iii) identify the specific resources required to enable the relevant National Drug Control Agencies to implement that strategy; and (iv) identify the resources, including private sources, required to eliminate the unmet need for evidence-based substance use disorder treatment. (2) Consultation In developing the plan required under paragraph (1), the Director shall consult with the following: (A) The public. (B) Any evaluation or analysis units and personnel of the Office. (C) Office officials responsible for implementing privacy policy. (D) Office officials responsible for data governance. (E) The appropriate congressional committees. (F) Any other individual or entity as determined by the Director. (3) Additional strategies (A) In general The Director shall include in the National Drug Control Strategy the additional strategies described under this paragraph and shall comply with the following: (i) Provide a copy of the additional strategies to the appropriate congressional committees and to the Committee on Armed Services and the Committee on Homeland Security of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs and the Committee on Armed Services of the Senate. (ii) Issue the additional strategies in consultation with the head of each relevant National Drug Control Program Agency, any relevant official of a State, local, or Tribal government, and the government of other relevant countries. (iii) Not change any existing agency authority or construe any strategy described under this paragraph to amend or modify any law governing interagency relationship but may include recommendations about changes to such authority or law. (iv) Present separately from the rest of any strategy described under this paragraph any information classified under criteria established by an Executive order, or whose public disclosure, as determined by the Director or the head of any relevant National Drug Control Program Agency, would be detrimental to the law enforcement or national security activities of any Federal, State, local, or Tribal agency. (B) Requirement for southwest border counternarcotics strategy (i) Purposes The Southwest Border Counternarcotics Strategy shall— (I) set forth the Government’s strategy for preventing the illegal trafficking of drugs across the international border between the United States and Mexico, including through ports of entry and between ports of entry on that border; (II) state the specific roles and responsibilities of the relevant National Drug Control Program Agencies for implementing that strategy; and (III) identify the specific resources required to enable the relevant National Drug Control Program Agencies to implement that strategy. (ii) Specific content related to drug tunnels between the United States and Mexico The Southwest Border Counternarcotics Strategy shall include— (I) a strategy to end the construction and use of tunnels and subterranean passages that cross the international border between the United States and Mexico for the purpose of illegal trafficking of drugs across such border; and (II) recommendations for criminal penalties for persons who construct or use such a tunnel or subterranean passage for such a purpose. (C) Requirement for Northern Border Counternarcotics Strategy (i) Purposes The Northern Border Counternarcotics Strategy shall— (I) set forth the strategy of the Federal Government for preventing the illegal trafficking of drugs across the international border between the United States and Canada, including through ports of entry and between ports of entry on the border; (II) state the specific roles and responsibilities of each relevant National Drug Control Program Agency for implementing the strategy; (III) identify the specific resources required to enable the relevant National Drug Control Program Agencies to implement the strategy; (IV) be designed to promote, and not hinder, legitimate trade and travel; and (V) reflect the unique nature of small communities along the international border between the United States and Canada, ongoing cooperation and coordination with Canadian law, enforcement authorities, and variations in the volumes of vehicles and pedestrians crossing through ports of entry along the international border between the United States and Canada. (ii) Specific content related to cross-border Indian reservations The Northern Border Counternarcotics Strategy shall include— (I) a strategy to end the illegal trafficking of drugs to or through Indian reservations on or near the international border between the United States and Canada; and (II) recommendations for additional assistance, if any, needed by Tribal law enforcement agencies relating to the strategy, including an evaluation of Federal technical and financial assistance, infrastructure capacity building, and interoperability deficiencies. (4) Classified information Any contents of the National Drug Control Strategy that involve information properly classified under criteria established by an Executive order shall be presented to Congress separately from the rest of the National Drug Control Strategy. (5) Selection of data and information In selecting data and information for inclusion in the Strategy, the Director shall ensure— (A) the inclusion of data and information that will permit analysis of current trends against previously compiled data and information where the Director believes such analysis enhances long-term assessment of the National Drug Control Strategy; and (B) the inclusion of data and information to permit a standardized and uniform assessment of the effectiveness of drug treatment programs in the United States. (d) Submission of revised strategy The President may submit to Congress a revised National Drug Control Strategy that meets the requirements of this section— (1) at any time, upon a determination of the President, in consultation with the Director, that the National Drug Control Strategy in effect is not sufficiently effective; or (2) if a new President or Director takes office. (e) Failure of Director to submit National Drug Control Strategy If the Director does not submit a National Drug Control Strategy to Congress in accordance with subsection (a)(2), not later than five days after the first Monday in February following the year in which the term of the President commences, the Director shall send a notification to the appropriate congressional committees— (1) explaining why the Strategy was not submitted; and (2) specifying the date by which the Strategy will be submitted. (f) Drug control data dashboard (1) In general The Director shall collect and disseminate, as appropriate, such information as the Director determines is appropriate, but not less than the information described in this subsection. The data shall be publicly available in a machine-readable format on the online portal of the Office, and to the extent practicable on the Drug Control Data Dashboard. (2) Establishment The Director shall publish to the online portal of the office in a machine-readable, sortable, and searchable format, or to the extent practicable, establish and maintain a data dashboard on the online portal of the Office to be known as the Drug Control Data Dashboard . To the extent practicable, when establishing the Drug Control Dashboard, the Director shall ensure the user interface of the dashboard is constructed with modern design standards. To the extent practicable, the data made available on the dashboard shall be publicly available in a machine-readable format and searchable by year, agency, drug, and location. (3) Data The data included in the Drug Control Data Dashboard shall be updated quarterly to the extent practicable, but not less frequently than annually and shall include, at a minimum, the following: (A) For each substance identified by the Director as having a significant impact on the prevalence of illicit drug use— (i) data sufficient to show the quantities of such substance available in the United States, including— (I) the total amount seized and disrupted in the calendar year and each of the previous 3 calendar years, including to the extent practicable the amount seized by State, local, and Tribal governments; (II) the known and estimated flows into the United States from all sources in the calendar year and each of the previous 3 calendar years; (III) the total amount of known flows that could not be interdicted or disrupted in the calendar year and each of the previous 3 calendar years; (IV) the known and estimated levels of domestic production in the calendar year and each of the previous three calendar years, including the levels of domestic production if the drug is a prescription drug, as determined under the Federal Food, Drug, and Cosmetic Act, for which a listing is in effect under section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ); (V) the average street price for the calendar year and the highest known street price during the preceding 10-year period; and (VI) to the extent practicable, related prosecutions by State, local, and Tribal governments; (ii) data sufficient to show the frequency of use of such substance, including— (I) use of such substance in the workplace and productivity lost by such use; (II) use of such substance by arrestees, probationers, and parolees; (III) crime and criminal activity related to such substance; (IV) to the extent practicable, related prosecutions by State, local, and Tribal governments; (B) For the calendar year and each of the previous three years data sufficient to show, disaggregated by State and, to the extent feasible, by region within a State, county, or city, the following: (i) The number of fatal and non-fatal overdoses caused by each drug identified under subparagraph (A)(i). (ii) The prevalence of substance use disorders. (iii) The number of individuals who have received substance use disorder treatment, including medication assisted treatment, for a substance use disorder, including treatment provided through publicly-financed health care programs. (iv) The extent of the unmet need for substance use disorder treatment, including the unmet need for medication-assisted treatment. (C) Data sufficient to show the extent of prescription drug diversion, trafficking, and misuse in the calendar year and each of the previous 3 calendar years. (D) Any quantifiable measures the Director determines to be appropriate to detail progress toward the achievement of the goals of the National Drug Control Strategy. (g) Development of an annual national drug control assessment (1) Timing Not later than the first Monday in February of each year, the Director shall submit to the President, Congress, and the appropriate congressional committees, a report assessing the progress of each National Drug Control Program Agency toward achieving each goal, objective, and target contained in the National Drug Control Strategy applicable to the prior fiscal year. (2) Process for development of the annual assessment Not later than November 1 of each year, the head of each National Drug Control Program Agency shall submit, in accordance with guidance issued by the Director, to the Director an evaluation of progress by the agency with respect to the National Drug Control Strategy goals using the performance measures for the agency developed under this title, including progress with respect to— (A) success in achieving the goals of the National Drug Control Strategy; (B) success in reducing domestic and foreign sources of illegal drugs; (C) success in expanding access to and increasing the effectiveness of substance use disorder treatment; (D) success in protecting the borders of the United States (and in particular the Southwestern border of the United States) from penetration by illegal narcotics; (E) success in reducing crime associated with drug use in the United States; (F) success in reducing the negative health and social consequences of drug use in the United States; (G) implementation of evidence-based substance use disorder treatment and prevention programs in the United States and improvements in the adequacy and effectiveness of such programs; and (H) success in increasing the prevention of illicit drug use. (3) Contents of the annual assessment The Director shall include in the annual assessment required under paragraph (1)— (A) a summary of each evaluation received by the Director under paragraph (2); (B) a summary of the progress of each National Drug Control Program Agency toward the National Drug Control Strategy goals of the agency using the performance measures for the agency developed under this chapter; (C) an assessment of the effectiveness of each National Drug Control Program Agency and program in achieving the National Drug Control Strategy for the previous year, including a specific evaluation of whether the applicable goals, measures, objectives, and targets for the previous year were met; and (D) the assessments required under this subsection shall be based on the Performance Measurement System. . (b) Technical and conforming amendments (1) Section 704(b) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(b) ) is amended— (A) by striking paragraphs (13) and (17); and (B) in paragraph (14)(A), by striking paragraph (13) and inserting section 706(g)(2) . (2) The Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3502) is amended by striking sections 1110 and 1110A. 8222. Technical and conforming amendments to the Office of National Drug Control Policy Reauthorization Act of 1998 The Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 et seq.) is amended— (1) by striking section 703(b) ( 21 U.S.C. 1702(b) ); (2) in section 704 ( 21 U.S.C. 1703 )— (A) in subsection (c)— (i) in paragraph (3)(C)— (I) in the matter before clause (i), by inserting requests a level of funding that will not enable achievement of the goals of the National Drug Control Strategy, including after request that ; (II) in clause (iii)— (aa) by striking drug treatment and inserting substance use disorder prevention and treatment ; and (bb) by striking the semicolon at the end and inserting ; and ; (III) by striking clauses (iv), (vi), and (vii); (IV) by redesignating clause (v) as clause (iv); and (V) in clause (iv), as so redesignated, by striking the semicolon and inserting a period; (ii) in paragraph (4)(A), by striking $1,000,000 and inserting $5,000,000 or 10 percent of a specific program or account ; and (B) in subsection (f)— (i) by striking the first paragraph (5); and (ii) by striking the second paragraph (4); and (3) by striking section 708 ( 21 U.S.C. 1707 ). L Budgetary effects 8231. Budgetary effect (a) In General The budgetary effects of this Act shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010 ( 2 U.S.C. 933(d) ). (b) Senate PAYGO Scorecards The budgetary effects of this Act shall not be entered on any PAYGO scorecard maintained for purposes of section 4106 of H. Con. Res. 71 (115th Congress).

Karen L. Haas Clerk.

tv_txt: 115th CONGRESS 2d Session H.R. 6 In the Senate of the United States, September 17, 2018. Amendment:

That the bill from the House of Representatives (H.R. 6) entitled An Act to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. , do pass with the following Strike all after the enacting clause and insert the following: 1. Short title; table of contents (a) Short title This Act may be cited as the Opioid Crisis Response Act of 2018 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—Opioid Crisis Response Act Sec. 1001. Definitions. Subtitle A—Reauthorization of Cures Funding Sec. 1101. State response to the opioid abuse crisis. Subtitle B—Research and Innovation Sec. 1201. Advancing cutting-edge research. Sec. 1202. Pain research. Sec. 1203. Report on synthetic drug use. Subtitle C—Medical Products and Controlled Substances Safety Sec. 1301. Clarifying FDA regulation of non-addictive pain products. Sec. 1302. Clarifying FDA packaging authorities. Sec. 1303. Strengthening FDA and CBP coordination and capacity. Sec. 1304. Clarifying FDA post-market authorities. Sec. 1305. Restricting entrance of illicit drugs. Sec. 1306. First responder training. Sec. 1307. Disposal of controlled substances of hospice patients. Sec. 1308. GAO study and report on hospice safe drug management. Sec. 1309. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation. Subtitle D—Treatment and Recovery Sec. 1401. Comprehensive opioid recovery centers. Sec. 1402. Program to support coordination and continuation of care for drug overdose patients. Sec. 1403. Alternatives to opioids. Sec. 1404. Building communities of recovery. Sec. 1405. Peer support technical assistance center. Sec. 1406. Medication-assisted treatment for recovery from addiction. Sec. 1407. Grant program. Sec. 1408. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Sec. 1409. National recovery housing best practices. Sec. 1410. Addressing economic and workforce impacts of the opioid crisis. Sec. 1411. Career Act. Sec. 1412. Pilot program to help individuals in recovery from a substance use disorder become stably housed. Sec. 1413. Youth prevention and recovery. Sec. 1414. Plans of safe care. Sec. 1415. Regulations relating to special registration for telemedicine. Sec. 1416. National Health Service Corps behavioral and mental health professionals providing obligated service in schools and other community-based settings. Sec. 1417. Loan repayment for substance use disorder treatment providers. Sec. 1418. Protecting moms and infants. Sec. 1419. Early interventions for pregnant women and infants. Sec. 1420. Report on investigations regarding parity in mental health and substance use disorder benefits. Subtitle E—Prevention Sec. 1501. Study on prescribing limits. Sec. 1502. Programs for health care workforce. Sec. 1503. Education and awareness campaigns. Sec. 1504. Enhanced controlled substance overdoses data collection, analysis, and dissemination. Sec. 1505. Preventing overdoses of controlled substances. Sec. 1506. CDC surveillance and data collection for child, youth, and adult trauma. Sec. 1507. Reauthorization of NASPER. Sec. 1508. Jessie’s law. Sec. 1509. Development and dissemination of model training programs for substance use disorder patient records. Sec. 1510. Communication with families during emergencies. Sec. 1511. Prenatal and postnatal health. Sec. 1512. Surveillance and education regarding infections associated with illicit drug use and other risk factors. Sec. 1513. Task force to develop best practices for trauma-informed identification, referral, and support. Sec. 1514. Grants to improve trauma support services and mental health care for children and youth in educational settings. Sec. 1515. National Child Traumatic Stress Initiative. Sec. 1516. National milestones to measure success in curtailing the opioid crisis. TITLE II—Finance Sec. 2001. Short title. Subtitle A—Medicare Sec. 2101. Medicare opioid safety education. Sec. 2102. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders. Sec. 2103. Comprehensive screenings for seniors. Sec. 2104. Every prescription conveyed securely. Sec. 2105. Standardizing electronic prior authorization for safe prescribing. Sec. 2106. Strengthening partnerships to prevent opioid abuse. Sec. 2107. Commit to opioid medical prescriber accountability and safety for seniors. Sec. 2108. Fighting the opioid epidemic with sunshine. Sec. 2109. Demonstration testing coverage of certain services furnished by opioid treatment programs. Sec. 2110. Encouraging appropriate prescribing under Medicare for victims of opioid overdose. Sec. 2111. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries. Sec. 2112. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. Sec. 2113. Medicare Improvement Fund. Subtitle B—Medicaid Sec. 2201. Caring recovery for infants and babies. Sec. 2202. Peer support enhancement and evaluation review. Sec. 2203. Medicaid substance use disorder treatment via telehealth. Sec. 2204. Enhancing patient access to non-opioid treatment options. Sec. 2205. Assessing barriers to opioid use disorder treatment. Sec. 2206. Help for moms and babies. Sec. 2207. Securing flexibility to treat substance use disorders. Sec. 2208. MACPAC study and report on MAT utilization controls under State Medicaid programs. Sec. 2209. Opioid addiction treatment programs enhancement. Sec. 2210. Better data sharing to combat the opioid crisis. Sec. 2211. Mandatory reporting with respect to adult behavioral health measures. Sec. 2212. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid. Sec. 2213. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid. Subtitle C—Human Services Sec. 2301. Supporting family-focused residential treatment. Sec. 2302. Improving recovery and reunifying families. Sec. 2303. Building capacity for family-focused residential treatment. Subtitle D—Synthetics Trafficking and Overdose Prevention Sec. 2401. Short title. Sec. 2402. Customs fees. Sec. 2403. Mandatory advance electronic information for postal shipments. Sec. 2404. International postal agreements. Sec. 2405. Cost recoupment. Sec. 2406. Development of technology to detect illicit narcotics. Sec. 2407. Civil penalties for postal shipments. Sec. 2408. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest. Sec. 2409. Effective date; regulations. TITLE III—Judiciary Subtitle A—Access to Increased Drug Disposal Sec. 3101. Short title. Sec. 3102. Definitions. Sec. 3103. Authority to make grants. Sec. 3104. Application. Sec. 3105. Use of grant funds. Sec. 3106. Eligibility for grant. Sec. 3107. Duration of grants. Sec. 3108. Accountability and oversight. Sec. 3109. Duration of program. Sec. 3110. Authorization of appropriations. Subtitle B—Using Data To Prevent Opioid Diversion Sec. 3201. Short title. Sec. 3202. Purpose. Sec. 3203. Amendments. Sec. 3204. Report. Subtitle C—Substance Abuse Prevention Sec. 3301. Short title. Sec. 3302. Reauthorization of the Office of National Drug Control Policy. Sec. 3303. Reauthorization of the Drug-Free Communities Program. Sec. 3304. Reauthorization of the National Community Anti-Drug Coalition Institute. Sec. 3305. Reauthorization of the High-Intensity Drug Trafficking Area Program. Sec. 3306. Reauthorization of drug court program. Sec. 3307. Drug court training and technical assistance. Sec. 3308. Drug overdose response strategy. Sec. 3309. Protecting law enforcement officers from accidental exposure. Sec. 3310. COPS Anti-Meth Program. Sec. 3311. COPS anti-heroin task force program. Sec. 3312. Comprehensive Addiction and Recovery Act education and awareness. Sec. 3313. Protecting children with addicted parents. Sec. 3314. Reimbursement of substance use disorder treatment professionals. Sec. 3315. Sobriety Treatment and Recovery Teams (START). Sec. 3316. Provider education. Sec. 3317. Demand reduction. Sec. 3318. Anti-drug media campaign. Sec. 3319. Technical corrections to the office of national drug control policy reauthorization act of 1998. Subtitle D—Synthetic Abuse and Labeling of Toxic Substances Sec. 3401. Short title. Sec. 3402. Controlled substance analogues. Subtitle E—Opioid Quota Reform Sec. 3501. Short title. Sec. 3502. Strengthening considerations for DEA opioid quotas. Subtitle F—Preventing Drug Diversion Sec. 3601. Short title. Sec. 3602. Improvements to prevent drug diversion. Subtitle G—Sense of Congress Sec. 3701. Sense of Congress. TITLE IV—Commerce Subtitle A—Fighting Opioid Abuse in Transportation Sec. 4101. Short title. Sec. 4102. Rail mechanical employee controlled substances and alcohol testing. Sec. 4103. Rail yardmaster controlled substances and alcohol testing. Sec. 4104. Department of Transportation public drug and alcohol testing database. Sec. 4105. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data. Sec. 4106. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl. Sec. 4107. Status reports on hair testing guidelines. Sec. 4108. Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid. Sec. 4109. Electronic recordkeeping. Sec. 4110. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse. Subtitle B—Opioid Addiction Recovery Fraud Prevention Sec. 4201. Short title. Sec. 4202. Definitions. Sec. 4203. False or misleading representations with respect to opioid treatment programs and products. I Opioid Crisis Response Act 1001. Definitions In this title— (1) the terms Indian Tribe and tribal organization have the meanings given the terms Indian tribe and tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); and (2) the term Secretary means the Secretary of Health and Human Services, unless otherwise specified. A Reauthorization of Cures Funding 1101. State response to the opioid abuse crisis (a) In general Section 1003 of the 21st Century Cures Act (Public Law 114–255) is amended— (1) in subsection (a)— (A) by striking the authorization of appropriations under subsection (b) to carry out the grant program described in subsection (c) and inserting subsection (h) to carry out the grant program described in subsection (b) ; and (B) by inserting and Indian Tribes after States ; (2) by striking subsection (b); (3) by redesignating subsections (c) through (e) as subsections (b) through (d), respectively; (4) by redesignating subsection (f) as subsection (j); (5) in subsection (b), as so redesignated— (A) in paragraph (1)— (i) in the paragraph heading, by inserting and Indian Tribe after State ; (ii) by striking States for the purpose of addressing the opioid abuse crisis within such States and inserting States and Indian Tribes for the purpose of addressing the opioid abuse crisis within such States and Indian Tribes ; (iii) by inserting or Indian Tribes after preference to States ; and (iv) by inserting before the period of the second sentence or other Indian Tribes, as applicable ; (B) in paragraph (2)— (i) in the matter preceding subparagraph (A), by striking to a State ; (ii) in subparagraph (A), by striking State ; (iii) in subparagraph (C), by inserting preventing diversion of controlled substances, after treatment programs, ; and (iv) in subparagraph (E), by striking as the State determines appropriate, related to addressing the opioid abuse crisis within the State and inserting as the State or Indian Tribe determines appropriate, related to addressing the opioid abuse crisis within the State, including directing resources in accordance with local needs related to substance use disorders ; (6) in subsection (c), as so redesignated, by striking subsection (c) and inserting subsection (b) ; (7) in subsection (d), as so redesignated— (A) in the matter preceding paragraph (1), by striking the authorization of appropriations under subsection (b) and inserting subsection (h) ; and (B) in paragraph (1), by striking subsection (c) and inserting subsection (b) ; and (8) by inserting after subsection (d), as so redesignated, the following: (e) Indian Tribes (1) Definition For purposes of this section, the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304). (2) Appropriate mechanisms The Secretary, in consultation with Indian Tribes, shall identify and establish appropriate mechanisms for Tribes to demonstrate or report the information as required under subsections (b), (c), and (d). (f) Report to Congress Not later than 1 year after the date on which amounts are first awarded after the date of enactment of the Opioid Crisis Response Act of 2018 , pursuant to subsection (b), and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing the information provided to the Secretary in reports made pursuant to subsection (c), including the purposes for which grant funds are awarded under this section and the activities of such grant recipients. (g) Technical Assistance The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, shall provide State agencies and Indian Tribes, as applicable, with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing the opioid crisis. (h) Authorization of appropriations For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $500,000,000 for each of fiscal years 2019 through 2021, to remain available until expended. (i) Set aside Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, 5 percent of such amount for such fiscal year shall be made available to Indian Tribes, and up to 15 percent of such amount for such fiscal year may be set aside for States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention. . (b) Conforming amendment Section 1004(c) of the 21st Century Cures Act (Public Law 114–255) is amended by striking , the FDA Innovation Account, or the Account For the State Response to the Opioid Abuse Crisis and inserting or the FDA Innovation Account . B Research and Innovation 1201. Advancing cutting-edge research Section 402(n)(1) of the Public Health Service Act (42 U.S.C. 282(n)(1)) is amended— (1) in subparagraph (A), by striking or ; (2) in subparagraph (B), by striking the period and inserting ; or ; and (3) by adding at the end the following: (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat. . 1202. Pain research Section 409J(b) of the Public Health Service Act (42 U.S.C. 284q(b)) is amended— (1) in paragraph (5)— (A) in subparagraph (A), by striking and treatment of pain and diseases and disorders associated with pain and inserting treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration ; (B) in subparagraph (B), by striking on the symptoms and causes of pain; and inserting the following: “on— (i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain; (ii) the diagnosis, prevention, treatment, and management of acute or chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and (iii) risk factors for, and early warning signs of, substance use disorders; and ; and (C) by striking subparagraphs (C) through (E) and inserting the following: (C) make recommendations to the Director of NIH— (i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and (iii) on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research. ; (2) by redesignating paragraph (6) as paragraph (7); and (3) by inserting after paragraph (5) the following: (6) Report The Director of NIH shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress. . 1203. Report on synthetic drug use (a) In general Not later than 3 years after the date of the enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the health effects of new psychoactive substances, including synthetic drugs, by adolescents and young adults. (b) New psychoactive substance defined For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act (21 U.S.C. 802(32))). C Medical Products and Controlled Substances Safety 1301. Clarifying FDA regulation of non-addictive pain products (a) Public Meetings Not later than one year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction, which may include— (1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable; (2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction; (3) the evidentiary standards and the development of opioid sparing data for inclusion in the labeling of medical products; and (4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence; (3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid sparing data in the labeling of non-addictive medical products intended to treat pain, including— (A) data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), as appropriate, to support product labeling; (B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit; (C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use; (D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and (E) the appropriate format in which to submit such data results to the Secretary; and (4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section. (c) Definitions In this section— (1) the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and (2) the term opioid sparing means reducing, replacing, or avoiding the use of opioids or other controlled substances. 1302. Clarifying FDA packaging authorities (a) Additional potential elements of strategy Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)) is amended by adding at the end the following: (4) Packaging and disposal The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug packaging, which may include requiring that— (A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or (B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs non-retrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary has determines that such safe disposal packaging or system may mitigate such serious risk and exists in sufficient quantities. . (b) Assuring access and minimizing burden Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)(2)(C)) is amended— (1) in clause (i) by striking and at the end; and (2) by adding at the end the following: (iii) patients with functional needs; and . (c) Application to abbreviated new drug applications Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(i)) is amended— (1) in paragraph (1)— (A) by redesignating subparagraph (B) as subparagraph (C); and (B) inserting after subparagraph (A) the following: (B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug. ; and (2) in paragraph (2)— (A) in subparagraph (A), by striking and at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: (B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and . 1303. Strengthening FDA and CBP coordination and capacity (a) In general The Secretary, acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities). Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection. (b) FDA import facilities and inspection capacity (1) In general In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include— (A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate— (i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies; (ii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods; (iii) upgrades to the security of import facilities; and (iv) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and (B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate. (2) Innovative technology Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate. (c) Report Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the relevant committees of Congress on the implementation of this section, including a summary of progress made towards near-real-time information sharing and the interoperability of such technologies. (d) Authorization of appropriations Out of amounts otherwise available to the Secretary, the Secretary may allocate such sums as may be necessary for purposes of carrying out this section. 1304. Clarifying FDA post-market authorities Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by striking of the drug and inserting of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling . 1305. Restricting entrance of illicit drugs (a) In general The Secretary, acting through the Commissioner of Food and Drugs, upon discovering or receiving, in a package being offered for import, a controlled substance that is offered for import in violation of any requirement of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law, shall transfer such package to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.). (b) Debarment, temporary denial of approval, and suspension (1) In general Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended— (A) in paragraph (1)— (i) in the matter preceding subparagraph (A), by inserting or (3) after paragraph (2) ; (ii) in subparagraph (A), by striking the comma at the end and inserting a semicolon; (iii) in subparagraph (B), by striking , or and inserting a semicolon; (iv) in subparagraph (C), by striking the period and inserting ; or ; and (v) by adding at the end the following: (D) a person from importing or offering for import into the United States a drug. ; and (B) in paragraph (3)— (i) in the heading, by striking Food ; (ii) in subparagraph (A), by striking ; or and inserting a semicolon; (iii) in subparagraph (B), by striking the period and inserting a semicolon; and (iv) by adding at the end the following: (C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); (D) the person has engaged in a pattern of importing or offering for import— (i) controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or (ii) adulterated or misbranded drugs that are— (I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or (II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. . (2) Prohibited act Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended by inserting or a drug after food . (c) Imports and exports Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— (1) by striking the second sentence; (2) by striking If it appears and inserting Subject to subsection (b), if it appears ; (3) by striking regarding such article, then such article shall be refused and inserting the following: regarding such article, or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) may be refused admission. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission. ; (4) by striking this Act, then such article shall be refused admission and inserting this Act, then such article may be refused admission ; and (5) by striking Clause (2) of the third sentence and all that follows through the period at the end and inserting the following: Neither clause (2) nor clause (5) of the second sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act. . (d) Certain illicit articles Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following— (t) Illicit articles containing active pharmaceutical ingredients (1) In general For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article— (A) is not— (i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and (ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, or a dietary supplement; and (B) is an ingredient that presents significant public health concern and is, or contains— (i) an active ingredient in a drug— (I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or (II) for which— (aa) an investigational use exemption is in effect under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and (bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or (ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i). (2) Effect This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1). . 1306. First responder training Section 546 of the Public Health Service Act (42 U.S.C. 290ee–1) is amended— (1) in subsection (c)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3), by striking the period and inserting ; and ; and (C) by adding at the end the following: (4) train and provide resources for first responders and members of other key community sectors on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure to such drugs and respond appropriately when exposure occurs. ; (2) in subsection (d), by striking and mechanisms for referral to appropriate treatment for an entity receiving a grant under this section and inserting mechanisms for referral to appropriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs ; (3) in subsection (f)— (A) in paragraph (3), by striking and at the end; (B) in paragraph (4), by striking the period and inserting ; and ; and (C) by adding at the end the following: (5) the number of first responders and members of other key community sectors trained on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs. ; (4) by redesignating subsection (g) as subsection (h); (5) by inserting after subsection (f) the following: (g) Other key community sectors In this section, the term other key community sectors includes substance abuse treatment providers, emergency medical services agencies, agencies and organizations working with prison and jail populations and offender reentry programs, health care providers, harm reduction groups, pharmacies, community health centers, tribal health facilities, and mental health providers. ; and (6) in subsection (h), as so redesignated, by striking $12,000,000 for each of fiscal years 2017 through 2021 and inserting $36,000,000 for each of fiscal years 2019 through 2023 . 1307. Disposal of controlled substances of hospice patients (a) In general Section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)) is amended by adding at the end the following: (5) (A) An employee of a qualified hospice program acting within the scope of employment may handle, in the place of residence of a hospice patient, any controlled substance that was lawfully dispensed to the hospice patient, for the purpose of assisting in the disposal of the controlled substance— (i) after the hospice patient's death; (ii) if the controlled substance is expired; or (iii) if— (I) the employee is— (aa) the physician of the hospice patient; and (bb) registered under section 303(f); and (II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified. (B) In this paragraph: (i) The term employee of a qualified hospice program means a physician, physician assistant, registered nurse, or nurse practitioner who— (I) is employed by, or is acting pursuant to arrangements made with, a qualified hospice program; and (II) is licensed or certified to perform such employment, or such activities arranged by the qualified hospice program, in accordance with applicable State law. (ii) The terms hospice care and hospice program have the meanings given those terms in section 1861(dd) of the Social Security Act (42 U.S.C. 1395x(dd)). (iii) The term hospice patient means an individual receiving hospice care. (iv) The term qualified hospice program means a hospice program that— (I) has written policies and procedures for employees of the hospice program to use when assisting in the disposal of the controlled substances of a hospice patient in a circumstance described in clause (i), (ii), or (iii) of subparagraph (A); (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the hospice patient or hospice patient representative and the family of the hospice patient; (bb) discusses the policies and procedures with the hospice patient or hospice patient's representative and the hospice patient's family in a language and manner that such individuals understand to ensure that such individuals are informed regarding the safe disposal of controlled substances; and (cc) documents in the clinical record of the hospice patient that the written policies and procedures were provided and discussed with the hospice patient or hospice patient's representative; and (III) at the time when an employee of the hospice program assists in the disposal of controlled substances of a hospice patient, documents in the clinical record of the hospice patient a list of all controlled substances disposed of. (C) The Attorney General may, by regulation, include additional types of licensed medical professionals in the definition of the term employee of a qualified hospice program under subparagraph (B). . (b) No registration required Section 302(c) of the Controlled Substances Act (21 U.S.C. 822(c)) is amended by adding at the end the following: (4) An employee of a qualified hospice program for the purpose of assisting in the disposal of a controlled substance in accordance with subsection (g)(5), except as provided in subparagraph (A)(iii) of that subsection. . (c) Guidance The Attorney General may issue guidance to qualified hospice programs to assist the programs in satisfying the requirements under paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a). (d) State and local authority Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs. 1308. GAO study and report on hospice safe drug management (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study on the requirements applicable to and challenges of hospice programs with regard to the management and disposal of controlled substances in the home of an individual. (2) Contents In conducting the study under paragraph (1), the Comptroller General shall include— (A) an overview of challenges encountered by hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and (B) a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements. (b) Report Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate. 1309. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation (a) In general The Controlled Substances Act is amended by inserting after section 309 (21 U.S.C. 829) the following: 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this title and the regulations issued by the Attorney General under this title, for the purpose of administering the controlled substance by the practitioner if— (1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this title; (2) in the case of administering of the controlled substance for the purpose of maintenance or detoxification treatment under section 303(g)(2)— (A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and (B) the controlled substance is to be administered by injection or implantation; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and (6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General. (b) Modification of number of days before which controlled substance shall be administered (1) Initial 2-year period During the 2-year period beginning on the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will— (A) reduce the risk of diversion; or (B) protect the public health. (2) Modifications after submission of report After the date on which the report described in subsection (c) is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5). (3) Minimum number of days Any modification under this subsection shall be for a period of not less than 7 days. . (b) Study and report Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation. (c) Technical and conforming amendment The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following: Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner. . D Treatment and Recovery 1401. Comprehensive opioid recovery centers (a) In general The Secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center (referred to in this section as a Center ). A Center may be a single entity or an integrated delivery network. (b) Grant period (1) In general A grant awarded under subsection (a) shall be for a period not more than 5 years. (2) Renewal A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph, the Secretary shall consider the data submitted under subsection (h). (c) Minimum number of grants The Secretary shall allocate the amounts made available under subsection (j) such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a single State for any one period. (d) Application (1) Eligible entity An entity is eligible for a grant under this section if the entity offers treatment and other services for individuals with a substance use disorder. (2) Submission of application In order to be eligible for a grant under subsection (a), an entity shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activities described in subsection (g); and (B) such other information as the Secretary may require. (e) Priority In awarding grants under subsection (a), the Secretary shall give priority to eligible entities located in a State or Indian Tribe with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention. (f) Preference In awarding grants under subsection (a), the Secretary may give preference to eligible entities utilizing technology-enabled collaborative learning and capacity building models, including such models as defined in section 2 of the Expanding Capacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395), to conduct the activities described in this section. (g) Center activities Each Center shall, at a minimum, carry out the following activities directly, through referral, or through contractual arrangements, which may include carrying out such activities through technology-enabled collaborative learning and capacity building models described in subsection (f): (1) Treatment and recovery services Each Center shall— (A) ensure that intake and evaluations meet the individualized clinical needs of patients, including by offering assessments for services and care recommendations through independent, evidence-based verification processes for reviewing patient placement in treatment settings; (B) provide the full continuum of treatment services, including— (i) all drugs approved by the Food and Drug Administration to treat substance use disorders, pursuant to Federal and State law; (ii) medically supervised withdrawal management that includes patient evaluation, stabilization, and readiness for and entry into treatment; (iii) counseling provided by a program counselor or other certified professional who is licensed and qualified by education, training, or experience to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan for the patient, and to monitor patient progress; (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders; (v) testing, as appropriate, for infections commonly associated with illicit drug use; (vi) residential rehabilitation, and outpatient and intensive outpatient programs; (vii) recovery housing; (viii) community-based and peer recovery support services; (ix) job training, job placement assistance, and continuing education assistance to support reintegration into the workforce; and (x) other best practices to provide the full continuum of treatment and services, as determined by the Secretary; (C) ensure that all programs covered by the Center include medication-assisted treatment, as appropriate, and do not exclude individuals receiving medication-assisted treatment from any service; (D) periodically conduct patient assessments to support sustained and clinically significant recovery, as defined by the Assistant Secretary for Mental Health and Substance Use; (E) administer an onsite pharmacy and provide toxicology services, for purposes of carrying out this section; and (F) operate a secure, confidential, and interoperable electronic health information system. (2) Outreach Each Center shall carry out outreach activities to publicize the services offered through the Centers, which may include— (A) training and supervising outreach staff, as appropriate, to work with State and local health departments, health care providers, the Indian Health Service, State and local educational agencies, schools funded by the Indian Bureau of Education, institutions of higher education, State and local workforce development boards, State and local community action agencies, public safety officials, first responders, Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including patients, to identify and respond to community needs; (B) ensuring that the entities described in subparagraph (A) are aware of the services of the Center; and (C) disseminating and making publicly available, including through the internet, evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders, including co-occurring substance use and mental disorders. (h) Data reporting and program oversight With respect to a grant awarded under subsection (a), not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period (including the duration of any renewal period for such grant), the entity shall submit data, as appropriate, to the Secretary regarding— (1) the programs and activities funded by the grant; (2) health outcomes of the population of individuals with a substance use disorder who received services from the Center, evaluated by an independent program evaluator through the use of outcomes measures, as determined by the Secretary; (3) the retention rate of program participants; and (4) any other information that the Secretary may require for the purpose of ensuring that the Center is complying with all the requirements of the grant, including providing the full continuum of services described in subsection (g)(1)(B). (i) Privacy The provisions of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (j) Authorization of appropriations There is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. (k) Reports to Congress (1) Preliminary report Not later than 3 years after the date of the enactment of this Act, the Secretary shall submit to Congress a preliminary report that analyzes data submitted under subsection (h). (2) Final report Not later than 2 years after submitting the preliminary report required under paragraph (1), the Secretary shall submit to Congress a final report that includes— (A) an evaluation of the effectiveness of the comprehensive services provided by the Centers established or operated pursuant to this section with respect to health outcomes of the population of individuals with substance use disorder who receive services from the Center, which shall include an evaluation of the effectiveness of services for treatment and recovery support and to reduce relapse, recidivism, and overdose; and (B) recommendations, as appropriate, regarding ways to improve Federal programs related to substance use disorders, which may include dissemination of best practices for the treatment of substance use disorders to health care professionals. 1402. Program to support coordination and continuation of care for drug overdose patients (a) In general The Secretary shall identify or facilitate the development of best practices for— (1) emergency treatment of known or suspected drug overdose; (2) the use of recovery coaches, as appropriate, to encourage individuals who experience a non-fatal overdose to seek treatment for substance use disorder and to support coordination and continuation of care; (3) coordination and continuation of care and treatment, including, as appropriate, through referrals, of individuals after an opioid overdose; and (4) the provision of overdose reversal medication, as appropriate. (b) Grant establishment and participation (1) In general The Secretary shall award grants on a competitive basis to eligible entities to support implementation of voluntary programs for care and treatment of individuals after an opioid overdose, as appropriate, which may include implementation of the best practices described in subsection (a). (2) Eligible entity In this section, the term eligible entity means— (A) a State alcohol or drug agency; (B) an Indian Tribe or tribal organization; or (C) an entity that offers treatment or other services for individuals in response to, or following, drug overdoses or a drug overdose, in consultation with a State alcohol and drug agency. (3) Application An eligible entity desiring a grant under this section shall submit an application to the Secretary, at such time and in such manner as the Secretary may require, that includes— (A) evidence that such eligible entity carries out, or is capable of contracting and coordinating with other community entities to carry out, the activities described in paragraph (4); (B) evidence that such eligible entity will work with a recovery community organization to recruit, train, hire, mentor, and supervise recovery coaches and fulfill the requirements described in paragraph (4)(A); and (C) such additional information as the Secretary may require. (4) Use of grant funds An eligible entity awarded a grant under this section shall use such grant funds to— (A) hire or utilize recovery coaches to help support recovery, including by— (i) connecting patients to a continuum of care services, such as— (I) treatment and recovery support programs; (II) programs that provide non-clinical recovery support services; (III) peer support networks; (IV) recovery community organizations; (V) health care providers, including physicians and other providers of behavioral health and primary care; (VI) education and training providers; (VII) employers; (VIII) housing services; and (IX) child welfare agencies; (ii) providing education on overdose prevention and overdose reversal to patients and families, as appropriate; (iii) providing follow-up services for patients after an overdose to ensure continued recovery and connection to support services; (iv) collecting and evaluating outcome data for patients receiving recovery coaching services; and (v) providing other services the Secretary determines necessary to help ensure continued connection with recovery support services, including culturally appropriate services, as applicable; (B) establish policies and procedures, pursuant to Federal and State law, that address the provision of overdose reversal medication, the administration of all drugs approved by the Food and Drug Administration to treat substance use disorder, and subsequent continuation of, or referral to, evidence-based treatment for patients with a substance use disorder who have experienced a non-fatal drug overdose, in order to support long-term treatment, prevent relapse, and reduce recidivism and future overdose; and (C) establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment, follow up, and transportation to and from treatment facilities. (5) Additional permissible uses In addition to the uses described in paragraph (4), a grant awarded under this section may be used, directly or through contractual arrangements, to provide— (A) all drugs approved by the Food and Drug Administration to treat substance use disorders, pursuant to Federal and State law; (B) withdrawal and detoxification services that include patient evaluation, stabilization, and preparation for treatment of substance use disorder, including treatment described in subparagraph (A), as appropriate; or (C) mental health services provided by a program counselor, social worker, therapist, or other certified professional who is licensed and qualified by education, training, or experience to assess the psychosocial background of patients, to contribute to the appropriate treatment plan for patients with substance use disorder, and to monitor patient progress. (6) Preference In awarding grants under this section, the Secretary shall give preference to eligible entities that meet any or all of the following criteria: (A) The eligible entity is a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act (42 U.S.C. 1395x(mm)(1))), a low volume hospital (as defined in section 1886(d)(12)(C)(i) of such Act (42 U.S.C. 1395ww(d)(12)(C)(i))), or a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act (42 U.S.C. 1395ww(d)(5)(D)(iii))). (B) The eligible entity is located in a State, or under the jurisdiction of an Indian Tribe, with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention. (C) The eligible entity demonstrates that recovery coaches will be placed in both health care settings and community settings. (7) Period of grant A grant awarded to an eligible entity under this section shall be for a period of not more than 5 years. (c) Definitions In this section: (1) Recovery coach the term recovery coach means an individual— (A) with knowledge of, or experience with, recovery from a substance use disorder; and (B) who has completed training from, and is determined to be in good standing by, a recovery services organization capable of conducting such training and making such determination. (2) Recovery community organization The term recovery community organization has the meaning given such term in section 547(a) of the Public Health Service Act (42 U.S.C. 290ee–2(a)). (3) State alcohol and drug agency The term State alcohol and drug agency means the principal agency of a State that is responsible for carrying out the block grant for prevention and treatment of substance abuse under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.) (d) Reporting requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the entity has received such grant that includes information on— (A) the number of individuals treated by the entity for non-fatal overdoses, including the number of non-fatal overdoses where overdose reversal medication was administered; (B) the number of individuals administered medication-assisted treatment by the entity; (C) the number of individuals referred by the entity to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals; and (D) the frequency and number of patients with reoccurrences, including readmissions for non-fatal overdoses and evidence of relapse related to substance use disorder. (2) Report by Secretary Not later than 5 years after the date of enactment of this Act, the Secretary shall submit to Congress a report that includes an evaluation of the effectiveness of the grant program carried out under this section with respect to long term health outcomes of the population of individuals who have experienced a drug overdose, the percentage of patients treated or referred to treatment by grantees, and the frequency and number of patients who experienced relapse, were readmitted for treatment, or experienced another overdose. (e) Privacy The requirements of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2019 through 2023. 1403. Alternatives to opioids (a) In general The Secretary shall, directly or through grants to, or contracts with, public and private entities, provide technical assistance to hospitals and other acute care settings on alternatives to opioids for pain management. The technical assistance provided shall be for the purpose of— (1) utilizing information from acute care providers including emergency departments and other providers that have successfully implemented alternatives to opioids programs, promoting non-addictive protocols and medications while appropriately limiting the use of opioids; (2) identifying or facilitating the development of best practices on the use of alternatives to opioids, which may include pain-management strategies that involve non-addictive medical products, non-pharmacologic treatments, and technologies or techniques to identify patients at risk for opioid use disorder; (3) identifying or facilitating the development of best practices on the use of alternatives to opioids that target common painful conditions and include certain patient populations, such as geriatric patients, pregnant women, and children; (4) disseminating information on the use of alternatives to opioids to providers in acute care settings, which may include emergency departments, outpatient clinics, critical access hospitals, Federally qualified health centers, Indian Health Service health facilities, and tribal hospitals; and (5) collecting data and reporting on health outcomes associated with the use of alternatives to opioids. (b) Pain management and funding (1) In general The Secretary shall award grants to hospitals and other acute care settings relating to alternatives to opioids for pain management. (2) Authorization of appropriations There is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. 1404. Building communities of recovery Section 547 of the Public Health Service Act (42 U.S.C. 290ee–2) is amended to read as follows: 547. Building communities of recovery (a) Definition In this section, the term recovery community organization means an independent nonprofit organization that— (1) mobilizes resources within and outside of the recovery community, which may include through a peer support network, to increase the prevalence and quality of long-term recovery from substance use disorders; and (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community served. (b) Grants authorized The Secretary shall award grants to recovery community organizations to enable such organizations to develop, expand, and enhance recovery services. (c) Federal share The Federal share of the costs of a program funded by a grant under this section may not exceed 85 percent. (d) Use of funds Grants awarded under subsection (b)— (1) shall be used to develop, expand, and enhance community and statewide recovery support services; and (2) may be used to— (A) build connections between recovery networks, including between recovery community organizations and peer support networks, and with other recovery support services, including— (i) behavioral health providers; (ii) primary care providers and physicians; (iii) educational and vocational schools; (iv) employers; (v) housing services; (vi) child welfare agencies; and (vii) other recovery support services that facilitate recovery from substance use disorders, including non-clinical community services; (B) reduce the stigma associated with substance use disorders; and (C) conduct outreach on issues relating to substance use disorders and recovery, including— (i) identifying the signs of substance use disorder; (ii) the resources available to individuals with substance use disorder and to families of an individual with a substance use disorder, including programs that mentor and provide support services to children; (iii) the resources available to help support individuals in recovery; and (iv) related medical outcomes of substance use disorders, the potential of acquiring an infection commonly associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during pregnancy. (e) Special consideration In carrying out this section, the Secretary shall give special consideration to the unique needs of rural areas, including areas with an age-adjusted rate of drug overdose deaths that is above the national average and areas with a shortage of prevention and treatment services. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2019 through 2023. . 1405. Peer support technical assistance center (a) Establishment The Secretary, acting through the Assistant Secretary for Mental Health and Substance Abuse, shall establish or operate a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this subsection as the Center ). (b) Functions The Center established under subsection (a) shall provide technical assistance and support to recovery community organizations and peer support networks, including such assistance and support related to— (1) training on identifying— (A) signs of substance use disorder; (B) resources to assist individuals with a substance use disorder, or resources for families of an individual with a substance use disorder; and (C) best practices for the delivery of recovery support services; (2) the provision of translation services, interpretation, or other such services for clients with limited English speaking proficiency; (3) data collection to support research, including for translational research; (4) capacity building; and (5) evaluation and improvement, as necessary, of the effectiveness of such services provided by recovery community organizations (as defined in section 547 of the Public Health Service Act). (c) Best practices The Center established under subsection (a) shall periodically issue best practices for use by recovery community organizations and peer support networks. (d) Recovery community organization In this section, the term recovery community organization has the meaning given such term in section 547 of the Public Health Service Act. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2019 through 2023. 1406. Medication-assisted treatment for recovery from addiction (a) Waivers for maintenance treatment or detoxification Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following: (VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that— (aa) included not less than 24 hours of training on treating and managing opioid-dependent patients; and (bb) included, at a minimum— (AA) the training described in items (aa) through (gg) of subclause (IV); and (BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. . (b) Treatment for children The Secretary shall consider ways to ensure that an adequate number of physicians who meet the requirements under the amendment made by subsection (a) and have a specialty in pediatrics, or the treatment of children or of adolescents, are granted a waiver under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) to treat children and adolescents with substance use disorders. (c) Technical amendment Section 102(24) of the Controlled Substances Act (21 U.S.C. 802(24)) is amended by striking Health, Education, and Welfare and inserting Health and Human Services . 1407. Grant program (a) In general The Secretary shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 1406(a) of this Act. (b) Authorization of appropriations There is authorized to be appropriated for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023. 1408. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; or (bb) 275 if the practitioner meets the requirements specified in section 8.610 of title 42, Code of Federal Regulations (or successor regulations). . 1409. National recovery housing best practices (a) Best practices for operating recovery housing (1) In general The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing. (2) Consultation In carrying out the activities described in paragraph (1) the Secretary shall consult with, as appropriate— (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services; (B) the Secretary of Housing and Urban Development; (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies; (D) representatives of health insurance issuers; (E) national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian Tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable; (F) individuals with a history of substance use disorder; and (G) other stakeholders identified by the Secretary. (b) Identification of fraudulent recovery housing operators (1) In general The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of common indicators that could be used to identify potentially fraudulent recovery housing operators. (2) Consultation In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate— (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services; (B) the Attorney General; (C) the Secretary of Housing and Urban Development; (D) directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies; (E) representatives of health insurance issuers; (F) national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian Tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable; (G) individuals with a history of substance use disorder; and (H) other stakeholders identified by the Secretary. (3) Requirements (A) Practices for identification and reporting In carrying out the activities described in this subsection, the Secretary shall consider how law enforcement, public and private payers, and the public can best identify and report fraudulent recovery housing operators. (B) Factors to be considered In carrying out the activities described in this subsection, the Secretary shall consider identifying or developing indicators regarding— (i) unusual billing practices; (ii) average lengths of stays; (iii) excessive levels of drug testing (in terms of cost or frequency); (iv) unusually high levels of recidivism; and (v) any other factors identified by the Secretary. (c) Dissemination The Secretary shall, as appropriate, disseminate the best practices identified or developed under subsection (a), and the common indicators identified or developed under subsection (b), to— (1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices; (2) Indian Tribes, tribal organizations, and tribally designated housing entities; (3) the Attorney General; (4) the Secretary of Labor; (5) the Secretary of Housing and Urban Development; (6) State and local law enforcement agencies; (7) health insurance issuers; (8) recovery housing entities; and (9) the public. (d) Requirements In carrying out the activities under subsections (a) and (b), the Secretary, in consultation with appropriate stakeholders as described in each such subsection, shall consider how recovery housing is able to support recovery and prevent relapse, recidivism, or overdose (including overdose death), including by improving access and adherence to treatment, including medication-assisted treatment. (e) Rule of construction Nothing in this section shall be construed to provide the Secretary with the authority to require States to adhere to minimum standards in the State oversight of recovery housing. (f) Definitions In this section— (1) the term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders; and (2) the term tribally designated housing entity has the meaning given such term in section 4 of the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4103). 1410. Addressing economic and workforce impacts of the opioid crisis (a) Definitions Except as otherwise expressly provided, in this section: (1) WIOA definitions The terms core program , individual with a barrier to employment , local area , local board , one-stop operator , outlying area , State , State board , and supportive services have the meanings given the terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102). (2) Education provider The term education provider means— (A) an institution of higher education, as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001); or (B) a postsecondary vocational institution, as defined in section 102(c) of such Act (20 U.S.C. 1002(c)). (3) Eligible entity The term eligible entity means— (A) a State workforce agency; (B) an outlying area; or (C) a Tribal entity. (4) Participating partnership The term participating partnership means a partnership— (A) evidenced by a written contract or agreement; and (B) including, as members of the partnership, a local board receiving a subgrant under subsection (d) and 1 or more of the following: (i) The eligible entity. (ii) A treatment provider. (iii) An employer or industry organization. (iv) An education provider. (v) A legal service or law enforcement organization. (vi) A faith-based or community-based organization. (vii) Other State or local agencies, including counties or local governments. (viii) Other organizations, as determined to be necessary by the local board. (ix) Indian Tribes or tribal organizations. (5) Program participant The term program participant means an individual who— (A) is a member of a population of workers described in subsection (e)(2) that is served by a participating partnership through the pilot program under this section; and (B) enrolls with the applicable participating partnership to receive any of the services described in subsection (e)(3). (6) Provider of peer recovery support services The term provider of peer recovery support services means a provider that delivers peer recovery support services through an organization described in section 547(a) of the Public Health Service Act (42 U.S.C. 290ee–2(a)). (7) Secretary The term Secretary means the Secretary of Labor. (8) State workforce agency The term State workforce agency means the lead State agency with responsibility for the administration of a program under chapter 2 or 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act (29 U.S.C. 3161 et seq., 3171 et seq.). (9) Substance use disorder The term substance use disorder has the meaning given such term by the Assistant Secretary for Mental Health and Substance Use. (10) Treatment provider The term treatment provider — (A) means a health care provider that— (i) offers services for treating substance use disorders and is licensed in accordance with applicable State law to provide such services; and (ii) accepts health insurance for such services, including coverage under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.); and (B) may include— (i) a nonprofit provider of peer recovery support services; (ii) a community health care provider; (iii) a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x)); (iv) an Indian health program (as defined in section 3 of the Indian Health Care Improvement Act (25 U.S.C. 1603)), including an Indian health program that serves an urban center (as defined in such section); and (v) a Native Hawaiian health center (as defined in section 12 of the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11711)). (11) Tribal entity The term Tribal entity includes any Indian Tribe, tribal organization, Indian-controlled organization serving Indians, Native Hawaiian organization, or Alaska Native entity, as such terms are defined or used in section 166 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3221). (b) Pilot program and grants authorized (1) In general The Secretary, in consultation with the Secretary of Health and Human Services, shall carry out a pilot program to address economic and workforce impacts associated with a high rate of a substance use disorder. In carrying out the pilot program, the Secretary shall make grants, on a competitive basis, to eligible entities to enable such entities to make subgrants to local boards to address the economic and workforce impacts associated with a high rate of a substance use disorder. (2) Grant amounts The Secretary shall make each such grant in an amount that is not less than $500,000, and not more than $5,000,000, for a fiscal year. (c) Grant applications (1) In general An eligible entity applying for a grant under this section shall submit an application to the Secretary at such time and in such form and manner as the Secretary may reasonably require, including the information described in this subsection. (2) Significant impact on community by opioid and substance use disorder-related problems (A) Demonstration An eligible entity shall include in the application— (i) information that demonstrates significant impact on the community by problems related to opioid abuse or another substance use disorder, by— (I) identifying the counties, communities, regions, or local areas that have been significantly impacted and will be served through the grant (each referred to in this section as a service area ); and (II) demonstrating for each such service area, an increase equal to or greater than the national increase in such problems, between— (aa) 1999; and (bb) 2016 or the latest year for which data are available; and (ii) a description of how the eligible entity will prioritize support for significantly impacted service areas described in clause (i)(I). (B) Information To meet the requirements described in subparagraph (A)(i)(II), the eligible entity may use information including data on— (i) the incidence or prevalence of opioid abuse and other substance use disorders; (ii) the age-adjusted rate of drug overdose deaths, as determined by the Director of the Centers for Disease Control and Prevention; (iii) the rate of non-fatal hospitalizations related to opioid abuse or other substance use disorders; (iv) the number of arrests or convictions, or a relevant law enforcement statistic, that reasonably shows an increase in opioid abuse or another substance use disorder; or (v) in the case of an eligible entity described in subsection (a)(3)(C), other alternative relevant data as determined appropriate by the Secretary. (C) Support for state strategy The eligible entity may include in the application information describing how the proposed services and activities are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing problems described in subparagraph (A) in specific service areas or across the State, outlying area, or Tribal land. (3) Economic and employment conditions demonstrate additional Federal support needed (A) Demonstration An eligible entity shall include in the application information that demonstrates that a high rate of a substance use disorder has caused, or is coincident to— (i) an economic or employment downturn in the service area; or (ii) persistent economically depressed conditions in such service area. (B) Information To meet the requirements of subparagraph (A), an eligible entity may use information including— (i) documentation of any layoff, announced future layoff, legacy industry decline, decrease in an employment or labor market participation rate, or economic impact, whether or not the result described in this clause is overtly related to a high rate of a substance use disorder; (ii) documentation showing decreased economic activity related to, caused by, or contributing to a high rate of a substance use disorder, including a description of how the service area has been impacted, or will be impacted, by such a decrease; (iii) information on economic indicators, labor market analyses, information from public announcements, and demographic and industry data; (iv) information on rapid response activities (as defined in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102)) that have been or will be conducted, including demographic data gathered by employer or worker surveys or through other methods; (v) data or documentation, beyond anecdotal evidence, showing that employers face challenges filling job vacancies due to a lack of skilled workers able to pass a drug test; or (vi) any additional relevant data or information on the economy, workforce, or another aspect of the service area to support the application. (d) Subgrant authorization and application process (1) Subgrants authorized (A) In general An eligible entity receiving a grant under subsection (b)— (i) may use not more than 5 percent of the grant funds for the administrative costs of carrying out the grant; (ii) in the case of an eligible entity described in subparagraph (A) or (B) of subsection (a)(3), shall use the remaining grant funds to make subgrants to local entities in the service area to carry out the services and activities described in subsection (e); and (iii) in the case of an eligible entity described in subsection (a)(3)(C), shall use the remaining grant funds to carry out the services and activities described in subsection (e). (B) Equitable distribution In making subgrants under this subsection, an eligible entity shall ensure, to the extent practicable, the equitable distribution of subgrants, based on— (i) geography (such as urban and rural distribution); and (ii) significantly impacted service areas as described in subsection (c)(2). (C) Timing of subgrant funds distribution An eligible entity making subgrants under this subsection shall disburse subgrant funds to a local board receiving a subgrant from the eligible entity by the later of— (i) the date that is 90 days after the date on which the Secretary makes the funds available to the eligible entity; or (ii) the date that is 15 days after the date that the eligible entity makes the subgrant under subparagraph (A)(ii). (2) Subgrant application (A) In general A local board desiring to receive a subgrant under this subsection from an eligible entity shall submit an application at such time and in such manner as the eligible entity may reasonably require, including the information described in this paragraph. (B) Contents Each application described in subparagraph (A) shall include— (i) an analysis of the estimated performance of the local board in carrying out the proposed services and activities under the subgrant— (I) based on— (aa) primary indicators of performance described in section 116(c)(1)(A)(i) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3141(c)(1)(A)(i), to assess estimated effectiveness of the proposed services and activities, including the estimated number of individuals with a substance use disorder who may be served by the proposed services and activities; (bb) the record of the local board in serving individuals with a barrier to employment; and (cc) the ability of the local board to establish a participating partnership; and (II) which may include or utilize— (aa) data from the National Center for Health Statistics of the Centers for Disease Control and Prevention; (bb) data from the Center for Behavioral Health Statistics and Quality of the Substance Abuse and Mental Health Services Administration; (cc) State vital statistics; (dd) municipal police department records; (ee) reports from local coroners; or (ff) other relevant data; and (ii) in the case of a local board proposing to serve a population described in subsection (e)(2)(B), a demonstration of the workforce shortage in the professional area to be addressed under the subgrant (which may include substance use disorder treatment and related services, non-addictive pain therapy and pain management services, mental health care treatment services, emergency response services, or mental health care), which shall include information that can demonstrate such a shortage, such as— (I) the distance between— (aa) communities affected by opioid abuse or another substance use disorder; and (bb) facilities or professionals offering services in the professional area; or (II) the maximum capacity of facilities or professionals to serve individuals in an affected community, or increases in arrests related to opioid or another substance use disorder, overdose deaths, or nonfatal overdose emergencies in the community. (e) Subgrant services and activities (1) In general Each local board that receives a subgrant under subsection (d) shall carry out the services and activities described in this subsection through a participating partnership. (2) Selection of Population to be served A participating partnership shall elect to provide services and activities under the subgrant to one or both of the following populations of workers: (A) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), each of whom— (i) is directly or indirectly affected by a high rate of a substance use disorder; and (ii) voluntarily confirms that the worker, or a friend or family member of the worker, has a history of opioid abuse or another substance use disorder. (B) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), who— (i) seek to transition to professions that support individuals with a substance use disorder or at risk for developing such disorder, such as professions that provide— (I) substance use disorder treatment and related services; (II) services offered through providers of peer recovery support services; (III) non-addictive pain therapy and pain management services; (IV) emergency response services; or (V) mental health care; and (ii) need new or upgraded skills to better serve such a population of struggling or at-risk individuals. (3) Services and activities Each participating partnership shall use funds available through a subgrant under this subsection to carry out 1 or more of the following: (A) Engaging employers Engaging with employers to— (i) learn about the skill and hiring requirements of employers; (ii) learn about the support needed by employers to hire and retain program participants, and other individuals with a substance use disorder, and the support needed by such employers to obtain their commitment to testing creative solutions to employing program participants and such individuals; (iii) connect employers and workers to on-the-job or customized training programs before or after layoff to help facilitate reemployment; (iv) connect employers with an education provider to develop classroom instruction to complement on-the-job learning for program participants and such individuals; (v) help employers develop the curriculum design of a work-based learning program for program participants and such individuals; (vi) help employers employ program participants or such individuals engaging in a work-based learning program for a transitional period before hiring such a program participant or individual for full-time employment of not less than 30 hours a week; or (vii) connect employers to program participants receiving concurrent outpatient treatment and job training services. (B) Screening services Providing screening services, which may include— (i) using an evidence-based screening method to screen each individual seeking participation in the pilot program to determine whether the individual has a substance use disorder; (ii) conducting an assessment of each such individual to determine the services needed for such individual to obtain or retain employment, including an assessment of strengths and general work readiness; or (iii) accepting walk-ins or referrals from employers, labor organizations, or other entities recommending individuals to participate in such program. (C) Individual treatment and employment plan Developing an individual treatment and employment plan for each program participant— (i) in coordination, as appropriate, with other programs serving the participant such as the core programs within the workforce development system under the Workforce Innovation and Opportunity Act (29 U.S.C. 3101 et seq.); and (ii) which shall include providing a case manager to work with each participant to develop the plan, which may include— (I) identifying employment and career goals; (II) exploring career pathways that lead to in-demand industries and sectors, as determined by the State board and the head of the State workforce agency or, as applicable, the Tribal entity; (III) setting appropriate achievement objectives to attain the employment and career goals identified under subclause (I); or (IV) developing the appropriate combination of services to enable the participant to achieve the employment and career goals identified under subclause (I). (D) Outpatient treatment and recovery care In the case of a participating partnership serving program participants described in paragraph (2)(A) with a substance use disorder, providing individualized and group outpatient treatment and recovery services for such program participants that are offered during the day and evening, and on weekends. Such treatment and recovery services— (i) shall be based on a model that utilizes combined behavioral interventions and other evidence-based or evidence-informed interventions; and (ii) may include additional services such as— (I) health, mental health, addiction, or other forms of outpatient treatment that may impact a substance use disorder and co-occurring conditions; (II) drug testing for a current substance use disorder prior to enrollment in career or training services or prior to employment; (III) linkages to community services, including services offered by partner organizations designed to support program participants; or (IV) referrals to health care, including referrals to substance use disorder treatment and mental health services. (E) Supportive services Providing supportive services, which shall include services such as— (i) coordinated wraparound services to provide maximum support for program participants to assist the program participants in maintaining employment and recovery for not less than 12 months, as appropriate; (ii) assistance in establishing eligibility for assistance under Federal, State, Tribal, and local programs providing health services, mental health services, vocational services, housing services, transportation services, social services, or services through early childhood education programs (as defined in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003)); (iii) services offered through providers of peer recovery support services; (iv) networking and mentorship opportunities; or (v) any supportive services determined necessary by the local board. (F) Career and job training services Offering career services and training services, and related services, concurrently or sequentially with the services provided under subparagraphs (B) through (E). Such services shall include the following: (i) Services provided to program participants who are in a pre-employment stage of the program, which may include— (I) initial education and skills assessments; (II) traditional classroom training funded through individual training accounts under chapter 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act (29 U.S.C. 3171 et seq.); (III) services to promote employability skills such as punctuality, personal maintenance skills, and professional conduct; (IV) in-depth interviewing and evaluation to identify employment barriers and to develop individual employment plans; (V) career planning that includes— (aa) career pathways leading to in-demand, high-wage jobs; and (bb) job coaching, job matching, and job placement services; (VI) provision of payments and fees for employment and training-related applications, tests, and certifications; or (VII) any other appropriate career service or training service described in section 134(c) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3174(c)). (ii) Services provided to program participants during their first 6 months of employment to ensure job retention, which may include— (I) case management and support services, including a continuation of the services described in clause (i); (II) a continuation of skills training, and career and technical education, described in clause (i) that is conducted in collaboration with the employers of such participants; (III) mentorship services and job retention support for such participants; or (IV) targeted training for managers and workers working with such participants (such as mentors), and human resource representatives in the business in which such participants are employed. (iii) Services to assist program participants in maintaining employment for not less than 12 months, as appropriate. (G) Proven and promising practices Leading efforts in the service area to identify and promote proven and promising strategies and initiatives for meeting the needs of employers and program participants. (4) Limitations A participating partnership may not use— (A) more than 10 percent of the funds received under a subgrant under subsection (d) for the administrative costs of the partnership; (B) more than 10 percent of the funds received under such subgrant for the provision of treatment and recovery services, as described in paragraph (3)(D); and (C) more than 10 percent of the funds received under such subgrant for the provision of supportive services described in paragraph (3)(E) to program participants. (f) Performance accountability (1) Reports The Secretary shall establish quarterly reporting requirements for recipients of grants and subgrants under this section that, to the extent practicable, are based on the performance accountability system under section 116 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3141) and, in the case of a grant awarded to an eligible entity described in subsection (a)(3)(C), section 166(h) of such Act (29 U.S.C. 3221(h)), including the indicators described in subsection (c)(1)(A)(i) of such section 116 and the requirements for local area performance reports under subsection (d) of such section 116. (2) Evaluations (A) Authority to enter into agreements The Secretary shall ensure that an independent evaluation is conducted on the pilot program carried out under this section to determine the impact of the program on employment of individuals with substance use disorders. The Secretary shall enter into an agreement with eligible entities receiving grants under this section to pay for all or part of such evaluation. (B) Methodologies to be used The independent evaluation required under this paragraph shall use experimental designs using random assignment or, when random assignment is not feasible, other reliable, evidence-based research methodologies that allow for the strongest possible causal inferences. (g) Funding (1) Covered fiscal year In this subsection, the term covered fiscal year means any of fiscal years 2018 through 2023. (2) Using funding for national dislocated worker grants Subject to paragraph (4) and notwithstanding section 132(a)(2)(A) and subtitle D of the Workforce Innovation and Opportunity Act (29 U.S.C. 3172(a)(2)(A), 3221 et seq.), the Secretary may use, to carry out the pilot program under this section for a covered fiscal year— (A) funds made available to carry out section 170 of such Act (29 U.S.C. 3225) for that fiscal year; (B) funds made available to carry out section 170 of such Act that remain available for that fiscal year; and (C) funds that remain available under section 172(f) of such Act (29 U.S.C. 3227(f)). (3) Availability of funds Funds appropriated under section 136(c) of such Act (29 U.S.C. 3181(c)) and made available to carry out section 170 of such Act for a fiscal year shall remain available for use under paragraph (2) for a subsequent fiscal year until expended. (4) Limitation The Secretary may not use more than $100,000,000 of the funds described in paragraph (2) for any covered fiscal year under this section. 1411. Career Act (a) In general The Secretary, in consultation with the Secretary of Labor, shall continue or establish a program to support individuals in recovery from a substance use disorder transition to independent living and the workforce. (b) Grants authorized In carrying out the activities under this section, the Secretary shall, on a competitive basis, award grants for a period of not more than 5 years to entities to enable such entities to carry out evidence-based programs to help individuals in recovery from a substance use disorder transition from treatment to independent living and the workforce. Such entities shall coordinate, as applicable, with Indian tribes or tribal organizations (as applicable), State boards and local boards (as defined in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102), lead State agencies with responsibility for a workforce investment activity (as defined in such section 3), and State agencies responsible for carrying out substance use disorder prevention and treatment programs. (c) Priority In awarding grants under this section, the Secretary shall give priority to entities located in a State with— (1) an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; (2) a rate of unemployment, based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017, that is above the national average; and (3) a rate of labor force participation, based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017, that is below the national average. (d) Preference In awarding grants under this section, the Secretary shall, as appropriate, give preference to entities located in an area with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate. (e) Applications An eligible entity shall submit an application at such time and in such manner as the Secretary may require. In submitting an application, the entity shall demonstrate the ability to partner with local stakeholders, which may include local employers, community stakeholders, the local workforce development board, and local and State governments, to— (1) identify gaps in the workforce due to the prevalence of substance use disorders; (2) in coordination with statewide employment and training activities, including coordination and alignment of activities carried out by entities provided grant funds under section 1410, help individuals in recovery from a substance use disorder transition into the workforce, including by providing career services, training services as described in paragraph (2) of section 134(c) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3174(c)), and related services described in section 134(a)(3) of such Act (42 U.S.C. 3174(a)); and (3) assist employers with informing their employees of the resources, such as resources related to substance use disorders that are available to their employees. (f) Use of funds An entity receiving a grant under this section shall use the funds to conduct one or more of the following activities: (1) Hire case managers, care coordinators, providers of peer recovery support services, as described in section 547(a) of the Public Health Service Act (42 U.S.C. 290ee–2(a)), or other professionals, as appropriate, to provide services that support treatment, recovery, and rehabilitation, and prevent relapse, recidivism, and overdose, including by encouraging— (A) the development of daily living skills; and (B) the use of counseling, care coordination, and other services, as appropriate, to support recovery from substance use disorders. (2) Implement or utilize innovative technologies, which may include the use of telemedicine. (3) In coordination with the lead State agency with responsibility for a workforce investment activity or local board described in subsection (b), provide— (A) short-term prevocational training services; and (B) training services that are directly linked to the employment opportunities in the local area or the planning region. (g) Support for State strategy An eligible entity shall include in its application under subsection (e) information describing how the services and activities proposed in such application are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing issues described in such application and how such entity will coordinate with existing systems to deliver services as described in such application. (h) Authorization of appropriations There is authorized to be appropriated such sums as may be necessary for each of fiscal years 2019 through 2023 for purposes of carrying out this section. 1412. Pilot program to help individuals in recovery from a substance use disorder become stably housed (a) Authorization of appropriations There is authorized to be appropriated under this section such sums as may be necessary for each of fiscal years 2019 through 2023 for assistance to States to provide individuals in recovery from a substance use disorder stable, temporary housing for a period of not more than 2 years or until the individual secures permanent housing, whichever is earlier. (b) Allocation of appropriated amounts (1) In general The amounts appropriated or otherwise made available to States under this section shall be allocated based on a funding formula established by the Secretary of Housing and Urban Development (referred to in this section as the Secretary ) not later than 60 days after the date of enactment of this Act. (2) Criteria The funding formula required under paragraph (1) shall ensure that any amounts appropriated or otherwise made available under this section are allocated to States with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, according to the Centers for Disease Control and Prevention. Among such States, priority shall be given to States with the greatest need, as such need is determined by the Secretary based on— (A) the highest average rates of unemployment based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017; (B) the lowest average labor force participation rates based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017; and (C) the highest prevalence of opioid use disorder based on data provided by the Substance Abuse and Mental Health Services Administration for calendar years 2013 through 2017. (3) Distribution Amounts appropriated or otherwise made available under this section shall be distributed according to the funding formula established by the Secretary under paragraph (1) not later than 30 days after the establishment of such formula. (c) Use of funds (1) In general Any State that receives amounts pursuant to this section shall expend at least 30 percent of such funds within one year of the date funds become available to the grantee for obligation. (2) Priority Any State that receives amounts pursuant to this section shall distribute such amounts giving priority to entities with the greatest need and ability to deliver effective assistance in a timely manner. (3) Administrative costs Any State that receives amounts pursuant to this section may use up to 5 percent of any grant for administrative costs. (d) Rules of construction (1) In general Except as otherwise provided by this section, amounts appropriated, or amounts otherwise made available to States under this section shall be treated as though such funds were community development block grant funds under title I of the Housing and Community Development Act of 1974 (42 U.S.C. 5301 et seq.). (2) No match No matching funds shall be required in order for a State to receive any amounts under this section. (e) Authority to waive or specify alternative requirements (1) In general In administering any amounts appropriated or otherwise made available under this section, the Secretary may waive or specify alternative requirements for any provision of any statute or regulation in connection with the obligation by the Secretary or the use of funds except for requirements related to fair housing, nondiscrimination, labor standards, and the environment, upon a finding that such a waiver is necessary to expedite or facilitate the use of such funds. (2) Notice The Secretary shall provide written notice of its intent to exercise the authority to specify alternative requirements under paragraph (1) to the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives not later than 5 business days before such exercise of authority occurs. (f) Technical assistance For the 2-year period following the date of enactment of this Act, the Secretary may use not more than 2 percent of the funds made available under this section for technical assistance to grantees. (g) State For purposes of this section the term State includes any State as defined in section 102 of the Housing and Community Development Act of 1974 (42 U.S.C. 5302) and the District of Columbia. 1413. Youth prevention and recovery (a) Substance abuse treatment services for children, adolescents, and young adults Section 514 of the Public Health Service Act (42 U.S.C. 290bb–7) is amended— (1) in the section heading, by striking children and adolescents and inserting children, adolescents, and young adults ; (2) in subsection (a)(2), by striking children, including and inserting children, adolescents, and young adults, including ; and (3) by striking children and adolescents each place it appears and inserting children, adolescents, and young adults . (b) Resource center The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use and, as appropriate, in consultation with the Secretary of Education and other agencies, shall establish a resource center to provide technical support to recipients of grants under subsection (c). (c) Youth prevention and recovery initiative (1) In general The Secretary, in consultation with the Secretary of Education, shall administer a program to provide support for communities to support the prevention of, treatment of, and recovery from, substance use disorders for children, adolescents, and young adults. (2) Definitions In this subsection: (A) Eligible entity The term eligible entity means— (i) a local educational agency that is seeking to establish or expand substance use prevention or recovery support services at one or more high schools; (ii) a State educational agency; (iii) an institution of higher education (or consortia of such institutions), which may include a recovery program at an institution of higher education; (iv) a local board or one-stop operator; (v) a nonprofit organization with appropriate expertise in providing services or programs for children, adolescents, or young adults, excluding a school; (vi) a State, political subdivision of a State, Indian Tribe, or tribal organization; or (vii) a high school or dormitory serving high school students that receives funding from the Bureau of Indian Education. (B) Evidence-based The term evidence-based has the meaning given such term in section 8101 of the Elementary and Secondary Education Act (20 U.S.C. 7801). (C) Foster care The term foster care has the meaning given such term in section 1355.20(a) of title 45, Code of Federal Regulations (or any successor regulations). (D) High school The term high school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (E) Homeless youth The term homeless youth has the meaning given the term homeless children or youths in section 725 of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11434a); (F) Institution of higher education The term institution of higher education has the meaning given such term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001) and includes a postsecondary vocational institution as defined in section 102(c) of such Act (20 U.S.C. 1002(c)). (G) Local educational agency The term local educational agency has the meaning given the term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (H) Local board; one-stop operator The terms local board and one-stop operator have the meanings given such terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102). (I) Out of School Youth The term out-of-school youth has the meaning given such term in section 129(a)(1)(B) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3164(a)(1)(B)). (J) Recovery program The term recovery program means a program— (i) to help children, adolescents, or young adults who are recovering from substance use disorders to initiate, stabilize, and maintain healthy and productive lives in the community; and (ii) that includes peer-to-peer support delivered by individuals with lived experience in recovery, and communal activities to build recovery skills and supportive social networks. (K) State Educational Agency The term State educational agency has the meaning given the term in section 8101 of the Elementary and Secondary Education Act (20 U.S.C. 7801). (3) Best practices The Secretary, in consultation with the Secretary of Education, shall— (A) identify or facilitate the development of evidence-based best practices for prevention of substance misuse and abuse by children, adolescents, and young adults, including for specific populations such as youth in foster care, homeless youth, out-of-school youth, and youth who are at risk of or have experienced trafficking that address— (i) primary prevention; (ii) appropriate recovery support services; (iii) appropriate use of medication-assisted treatment for such individuals, if applicable, and ways of overcoming barriers to the use of medication-assisted treatment in such population; and (iv) efficient and effective communication, which may include the use of social media, to maximize outreach efforts; (B) disseminate such best practices to State educational agencies, local educational agencies, schools and dormitories funded by the Bureau of Indian Education, institutions of higher education, recovery programs at institutions of higher education, local boards, one-stop operators, family and youth homeless providers, and nonprofit organizations, as appropriate; (C) conduct a rigorous evaluation of each grant funded under this subsection, particularly its impact on the indicators described in paragraph (8)(B); and (D) provide technical assistance for grantees under this subsection. (4) Grants authorized The Secretary, in consultation with the Secretary of Education, shall award 3-year grants, on a competitive basis, to eligible entities to enable such entities, in coordination with Indian Tribes, if applicable, and State agencies responsible for carrying out substance use disorder prevention and treatment programs, to carry out evidence-based programs for— (A) prevention of substance misuse and abuse by children, adolescents, and young adults, which may include primary prevention; (B) recovery support services for children, adolescents, and young adults, which may include counseling, job training, linkages to community-based services, family support groups, peer mentoring, and recovery coaching; or (C) treatment or referrals for treatment of substance use disorders, which may include the use of medication-assisted treatment, as appropriate. (5) Special consideration In awarding grants under this subsection, the Secretary shall give special consideration to the unique needs of tribal, urban, suburban, and rural populations. (6) Application To be eligible for a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. Such application shall include— (A) a description of— (i) the impact of substance use disorders in the population that will be served by the grant program; (ii) how the eligible entity has solicited input from relevant stakeholders, which may include faculty, teachers, staff, families, students, and experts in substance use prevention and treatment in developing such application; (iii) the goals of the proposed project, including the intended outcomes; (iv) how the eligible entity plans to use grant funds for evidence-based activities, in accordance with this subsection to prevent, provide recovery support for, or treat substance use disorders amongst such individuals, or a combination of such activities; and (v) how the eligible entity will collaborate with relevant partners, which may include State educational agencies, local educational agencies, institutions of higher education, juvenile justice agencies, prevention and recovery support providers, local service providers, including substance use disorder treatment programs, providers of mental health services, youth serving organizations, family and youth homeless providers, child welfare agencies, and primary care providers, in carrying out the grant program; and (B) an assurance that the eligible entity will participate in the evaluation described in paragraph (3)(C). (7) Priority In awarding grants under this subsection, the Secretary shall give priority to eligible entities that propose to use grant funds for activities that meet the criteria described in subclauses (I) and (II) of section 8101(21)(A)(i) of the Elementary and Secondary Education Act (20 U.S.C. 7801(21)(A)(i)). (8) Reports to the Secretary Each eligible entity awarded a grant under this subsection shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include— (A) a description of how the eligible entity used grant funds, in accordance with this subsection, including the number of children, adolescents, and young adults reached through programming; and (B) a description, including relevant data, of how the grant program has made an impact on the intended outcomes described in paragraph (6)(A)(iii), including— (i) indicators of student success, which, if the eligible entity is an educational institution, shall include student well-being and academic achievement; (ii) substance use disorders amongst children, adolescents, and young adults, including the number of overdoses and deaths amongst children, adolescents, and young adults during the grant period; and (iii) other indicators, as the Secretary determines appropriate. (9) Report to Congress The Secretary shall, not later than October 1, 2022, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives, a report summarizing the effectiveness of the grant program under this subsection, based on the information submitted in reports required under paragraph (8). (10) Authorization of appropriations There is authorized to be appropriated such sums as may be necessary to carry out this subsection for each of fiscal years 2019 through 2023. 1414. Plans of safe care Section 105(a) of the Child Abuse Prevention and Treatment Act (42 U.S.C. 5106(a)) is amended by adding at the end the following: (7) Grants to States to improve and coordinate their response to ensure the safety, permanency, and well-being of infants affected by substance use (A) Program authorized The Secretary shall make grants to States for the purpose of assisting child welfare agencies, social services agencies, substance use disorder treatment agencies, hospitals with labor and delivery units, medical staff, public health and mental health agencies, and maternal and child health agencies to facilitate collaboration in developing, updating, implementing, and monitoring plans of safe care described in section 106(b)(2)(B)(iii). (B) Distribution of funds (i) Reservations Of the amounts appropriated under subparagraph (H), the Secretary shall reserve— (I) no more than 3 percent for the purposes described in subparagraph (G); and (II) up to 3 percent for grants to Indian Tribes and tribal organizations to address the needs of infants born with, and identified as being affected by, substance abuse or withdrawal symptoms resulting from prenatal drug exposure or a fetal alcohol spectrum disorder and their families or caregivers, which to the extent practicable, shall be consistent with the uses of funds described under subparagraph (D). (ii) Allotments to States and territories The Secretary shall allot the amount appropriated under subparagraph (H) that remains after application of clause (i) to each State that applies for such a grant, in an amount equal to the sum of— (I) $500,000; and (II) an amount that bears the same relationship to any funds appropriated under subparagraph (H) and remaining after application of clause (i), as the number of live births in the State in the previous calendar year bears to the number of live births in all States in such year. (iii) Ratable reduction If the amount appropriated under subparagraph (H) is insufficient to satisfy the requirements of clause (ii), the Secretary shall ratably reduce each allotment to a State. (C) Application A State desiring a grant under this paragraph shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (i) a description of— (I) the impact of substance use disorder in such State, including with respect to the substance or class of substances with the highest incidence of abuse in the previous year in such State, including— (aa) the prevalence of substance use disorder in such State; (bb) the aggregate rate of births in the State of infants affected by substance abuse or withdrawal symptoms or a fetal alcohol spectrum disorder (as determined by hospitals, insurance claims, claims submitted to the State Medicaid program, or other records), if available and to the extent practicable; and (cc) the number of infants identified, for whom a plan of safe care was developed, and for whom a referral was made for appropriate services, as reported under section 106(d)(18); (II) the challenges the State faces in developing, implementing, and monitoring plans of safe care in accordance with section 106(b)(2)(B)(iii); (III) the State’s lead agency for the grant program and how that agency will coordinate with relevant State entities and programs, including the child welfare agency, the substance use disorder treatment agency, hospitals with labor and delivery units, health care providers, the public health and mental health agencies, programs funded by the Substance Abuse and Mental Health Services Administration that provide substance use disorder treatment for women, the State Medicaid program, the State agency administering the block grant program under title V of the Social Security Act (42 U.S.C. 701 et seq.), the State agency administering the programs funded under part C of the Individuals with Disabilities Education Act (20 U.S.C. 1431 et seq.), the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act (42 U.S.C. 711), the State judicial system, and other agencies, as determined by the Secretary, and Indian Tribes and tribal organizations, as appropriate; (IV) how the State will monitor local development and implementation of plans of safe care, in accordance with section 106(b)(2)(B)(iii)(II), including how the State will monitor to ensure plans of safe care address differences between substance use disorder and medically supervised substance use, including for the treatment of a substance use disorder; (V) how the State meets the requirements of section 1927 of the Public Health Service Act (42 U.S.C. 300x–27); (VI) how the State plans to utilize funding authorized under part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.) to assist in carrying out any plan of safe care, including such funding authorized under section 471(e) of such Act (as in effect on October 1, 2018) for mental health and substance abuse prevention and treatment services and in-home parent skill-based programs and funding authorized under such section 472(j) (as in effect on October 1, 2018) for children with a parent in a licensed residential family-based treatment facility for substance abuse; and (VII) an assessment of the treatment and other services and programs available in the State, to effectively carry out any plan of safe care developed, including identification of needed treatment, and other services and programs to ensure the well-being of young children and their families affected by substance use disorder, such as programs carried out under part C of the Individuals with Disabilities Education Act and comprehensive early childhood development services and programs such as Head Start programs; (ii) a description of how the State plans to use funds for activities described in subparagraph (D) for the purposes of ensuring State compliance with requirements under clauses (ii) and (iii) of section 106(b)(2)(B); and (iii) an assurance that the State will— (I) comply with this Act and parts B and E of title IV of the Social Security Act (42 U.S.C. 621 et seq., 670 et seq.); and (II) comply with requirements to refer a child identified as substance-exposed to early intervention services as required pursuant to a grant under part C of the Individuals with Disabilities Education Act (20 U.S.C. 1431 et seq.). (D) Uses of funds Funds awarded to a State under this paragraph may be used for the following activities, which may be carried out by the State directly, or through grants or subgrants, contracts, or cooperative agreements: (i) Improving State and local systems with respect to the development and implementation of plans of safe care, which— (I) shall include parent and caregiver engagement, as required under section 106(b)(2)(B)(iii)(I), regarding available treatment and service options, which may include resources available for pregnant, perinatal, and postnatal women; and (II) may include activities such as— (aa) developing policies, procedures, or protocols for the administration or development of evidence-based and validated screening tools for infants who may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder and pregnant, perinatal, and postnatal women whose infants may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder; (bb) improving assessments used to determine the needs of the infant and family; (cc) improving ongoing case management services; and (dd) improving access to treatment services, which may be prior to the pregnant woman’s delivery date. (ii) Developing policies, procedures, or protocols in consultation and coordination with health professionals, public and private health facilities, and substance use disorder treatment agencies to ensure that— (I) appropriate notification to child protective services is made in a timely manner; (II) a plan of safe care is in place, in accordance with section 106(b)(2)(B)(iii), before the infant is discharged from the birth or health care facility; and (III) such health and related agency professionals are trained on how to follow such protocols and are aware of the supports that may be provided under a plan of safe care. (iii) Training health professionals and health system leaders, child welfare workers, substance use disorder treatment agencies, and other related professionals such as home visiting agency staff and law enforcement in relevant topics including— (I) State mandatory reporting laws and the referral and process requirements for notification to child protective services when child abuse or neglect reporting is not mandated; (II) the co-occurrence of pregnancy and substance use disorder, and implications of prenatal exposure; (III) the clinical guidance about treating substance use disorder in pregnant and postpartum women; (IV) appropriate screening and interventions for infants affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder and the requirements under section 106(b)(2)(B)(iii); and (V) appropriate multigenerational strategies to address the mental health needs of the parent and child together. (iv) Establishing partnerships, agreements, or memoranda of understanding between the lead agency and health professionals, health facilities, child welfare professionals, juvenile and family court judges, substance use and mental disorder treatment programs, early childhood education programs, and maternal and child health and early intervention professionals, including home visiting providers, peer-to-peer recovery programs such as parent mentoring programs, and housing agencies to facilitate the implementation of, and compliance with section 106(b)(2) and clause (ii) of this subparagraph, in areas which may include— (I) developing a comprehensive, multi-disciplinary assessment and intervention process for infants, pregnant women, and their families who are affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder, that includes meaningful engagement with and takes into account the unique needs of each family and addresses differences between medically supervised substance use, including for the treatment of substance use disorder, and substance use disorder; (II) ensuring that treatment approaches for serving infants, pregnant women, and perinatal and postnatal women whose infants may be affected by substance use, withdrawal symptoms, or a fetal alcohol spectrum disorder, are designed to, where appropriate, keep infants with their mothers during both inpatient and outpatient treatment; and (III) increasing access to all evidence-based medication-assisted treatment approved by the Food and Drug Administration, behavioral therapy, and counseling services for the treatment of substance use disorders, as appropriate. (v) Developing and updating systems of technology for improved data collection and monitoring under section 106(b)(2)(B)(iii), including existing electronic medical records, to measure the outcomes achieved through the plans of safe care, including monitoring systems to meet the requirements of this Act and submission of performance measures. (E) Reporting Each State that receives funds under this paragraph, for each year such funds are received, shall submit a report to the Secretary, disaggregated by geographic location, economic status, and major racial and ethnic groups, except that such disaggregation shall not be required if the results would reveal personally identifiable information on, with respect to infants identified under section 106(b)(2)(B)(ii)— (i) the number who experienced removal associated with parental substance use; (ii) the number who experienced removal and subsequently are reunified with parents, and the length of time between such removal and reunification; (iii) the number who are referred to community providers without a child protection case; (iv) the number who receive services while in the care of their birth parents; (v) the number who receive post-reunification services within 1 year after a reunification has occurred; and (vi) the number who experienced a return to out-of-home care within 1 year after reunification. (F) Secretary’s report to congress The Secretary shall submit an annual report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Education and the Workforce and the Committee on Appropriations of the House of Representatives that includes the information described in subparagraph (E) and recommendations or observations on the challenges, successes, and lessons derived from implementation of the grant program. (G) Reservation of funds The Secretary shall use the amount reserved under subparagraph (B)(i)(I) for the purposes of— (i) providing technical assistance, including programs of in-depth technical assistance, to additional States, territories, and Indian Tribes and tribal organizations in accordance with the substance-exposed infant initiative developed by the National Center on Substance Abuse and Child Welfare; (ii) issuing guidance on the requirements of this Act with respect to infants born with and identified as being affected by substance use or withdrawal symptoms or fetal alcohol spectrum disorder, as described in clauses (ii) and (iii) of section 106(b)(2)(B), including by— (I) clarifying key terms; and (II) disseminating best practices on implementation of plans of safe care, on such topics as differential response, collaboration and coordination, and identification and delivery of services for different populations; (iii) supporting State efforts to develop information technology systems to manage plans of safe care; and (iv) preparing the Secretary’s report to Congress described in subparagraph (F). (H) Authorization of appropriations To carry out the program under this paragraph, there is authorized to be appropriated $60,000,000 for each of fiscal years 2019 through 2023. . 1415. Regulations relating to special registration for telemedicine Section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) is amended by striking paragraph (2) and inserting the following: (2) Regulations (A) In general Not later than 1 year after the date of enactment of the Opioid Crisis Response Act of 2018 , in consultation with the Secretary, and in accordance with the procedure described in subparagraph (B), the Attorney General shall promulgate final regulations specifying— (i) the limited circumstances in which a special registration under this subsection may be issued; and (ii) the procedure for obtaining a special registration under this subsection. (B) Procedure In promulgating final regulations under subparagraph (A), the Attorney General shall— (i) issue a notice of proposed rulemaking that includes a copy of the proposed regulations; (ii) provide a period of not less than 60 days for comments on the proposed regulations; (iii) finalize the proposed regulation not later than 6 months after the close of the comment period; and (iv) publish the final regulations not later than 30 days before the effective date of the final regulations. . 1416. National Health Service Corps behavioral and mental health professionals providing obligated service in schools and other community-based settings Subpart III of part D of title III of the Public Health Service Act (42 U.S.C. 254 l et seq.) is amended by adding at the end the following: 338N. Behavioral and mental health professionals providing obligated service in schools and other community-based settings (a) Schools and community-based settings An entity to which a participant in the Scholarship Program or the Loan Repayment Program (referred to in this section as a participant ) is assigned under section 333 may direct such participant to provide service as a behavioral or mental health professional at a school or other community-based setting located in a health professional shortage area. (b) Obligated service (1) In general Any service described in subsection (a) that a participant provides may count towards such participant's completion of any obligated service requirements under the Scholarship Program or the Loan Repayment Program, subject to any limitation imposed under paragraph (2). (2) Limitation The Secretary may impose a limitation on the number of hours of service described in subsection (a) that a participant may credit towards completing obligated service requirements, provided that the limitation allows a member to credit service described in subsection (a) for not less than 50 percent of the total hours required to complete such obligated service requirements. (c) Rule of construction The authorization under subsection (a) shall be notwithstanding any other provision of this subpart or subpart II. . 1417. Loan repayment for substance use disorder treatment providers (a) Loan repayment for substance use treatment providers The Secretary shall enter into contracts under section 338B of the Public Health Service Act (42 U.S.C. 254l–1) with eligible health professionals providing substance use disorder treatment services in substance use disorder treatment facilities, as defined by the Secretary. (b) Provision of substance use disorder treatment In carrying out the activities described in subsection (a)— (1) each such facility shall be located in or serving a mental health professional shortage area designated under section 332 of the Public Health Service Act (42 U.S.C. 254e), or, as the Secretary determines appropriate, an area with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate; (2) section 331(a)(3)(D) of such Act (42 U.S.C. 254d(a)(3)(D)) shall be applied as if the term primary health services includes health services regarding substance use disorder treatment and infections associated with illicit drug use; (3) section 331(a)(3)(E)(i) of such Act (42 U.S.C. 254d(a)(3)(E)(i)) shall be applied as if the term behavioral and mental health professionals includes master's level, licensed substance use disorder treatment counselors, and other relevant professionals or paraprofessionals, as the Secretary determines appropriate; and (4) such professionals and facilities shall provide— (A) directly, or through the use of telehealth technology, and pursuant to Federal and State law, counseling by a program counselor or other certified professional who is licensed and qualified by education, training, or experience to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan for the patient, and to monitor progress; and (B) medication-assisted treatment, including, to the extent practicable, all drugs approved by the Food and Drug Administration to treat substance use disorders, pursuant to Federal and State law. (c) Authorization of appropriations There is authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2023. 1418. Protecting moms and infants (a) Report (1) In general Not later than 60 days after the date of enactment of this Act, the Secretary shall submit to the appropriate committees of Congress and make available to the public on the internet website of the Department of Health and Human Services a report regarding the implementation of the recommendations in the strategy relating to prenatal opioid use, including neonatal abstinence syndrome, developed pursuant to section 2 of the Protecting Our Infants Act of 2015 (Public Law 114–91). Such report shall include— (A) an update on the implementation of the recommendations in the strategy, including information regarding the agencies involved in the implementation; and (B) information on additional funding or authority the Secretary requires, if any, to implement the strategy, which may include authorities needed to coordinate implementation of such strategy across the Department of Health and Human Services. (2) Periodic updates The Secretary shall periodically update the report under paragraph (1). (b) Residential treatment programs for pregnant and postpartum women Section 508(s) of the Public Health Service Act (42 U.S.C. 290bb–1(s)) is amended by striking $16,900,000 for each of fiscal years 2017 through 2021 and inserting $29,931,000 for each of fiscal years 2019 through 2023 . 1419. Early interventions for pregnant women and infants (a) Development of educational materials by Center for Substance Abuse Prevention Section 515(b) of the Public Health Service Act (42 U.S.C. 290bb–21(b)) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (15) in cooperation with relevant stakeholders and the Director of the Centers for Disease Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared decisionmaking regarding pain management during pregnancy. . (b) Guidelines and recommendations by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act (42 U.S.C. 290bb(b)) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting a semicolon; and (3) by adding at the end the following: (15) in cooperation with the Secretary, implement and disseminate, as appropriate, the recommendations in the report entitled Protecting Our Infants Act: Final Strategy issued by the Department of Health and Human Services in 2017; and . (c) Support of partnerships by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act (42 U.S.C. 290bb(b)), as amended by subsection (b), is further amended by adding at the end the following: (16) in cooperation with relevant stakeholders, support public-private partnerships to assist with education about, and support with respect to, substance use disorder for pregnant women and health care providers who treat pregnant women and babies. . 1420. Report on investigations regarding parity in mental health and substance use disorder benefits (a) In general Section 13003 of the 21st Century Cures Act (Public Law 114–255) is amended— (1) in subsection (a), by striking with findings of any serious violation regarding and inserting concerning ; and (2) in subsection (b)(1)— (A) by inserting complaints received and number of before closed ; and (B) by inserting before the period , and, for each such investigation closed, which agency conducted the investigation, whether the health plan that is the subject of the investigation is fully insured or not fully insured and a summary of any coordination between the applicable State regulators and the Department of Labor, the Department of Health and Human Services, or the Department of the Treasury, and references to any guidance provided by the agencies addressing the category of violation committed . (b) Applicability The amendments made by subsection (a) shall apply with respect to the second annual report required under such section 13003 and each such annual report thereafter. E Prevention 1501. Study on prescribing limits Not later than 2 years after the date of enactment of this Act, the Secretary, in consultation with the Attorney General, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the impact of Federal and State laws and regulations that limit the length, quantity, or dosage of opioid prescriptions. Such report shall address— (1) the impact of such limits on— (A) the incidence and prevalence of overdose related to prescription opioids; (B) the incidence and prevalence of overdose related to illicit opioids; (C) the prevalence of opioid use disorders; (D) medically appropriate use of, and access to, opioids, including any impact on travel expenses and pain management outcomes for patients, whether such limits are associated with significantly higher rates of negative health outcomes, including suicide, and whether the impact of such limits differs based on the clinical indication for which opioids are prescribed; (2) whether such limits lead to a significant increase in burden for prescribers of opioids or prescribers of treatments for opioid use disorder, including any impact on patient access to treatment, and whether any such burden is mitigated by any factors such as electronic prescribing or telemedicine; and (3) the impact of such limits on diversion or misuse of any controlled substance in schedule II, III, or IV of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)). 1502. Programs for health care workforce (a) Program for education and training in pain care Section 759 of the Public Health Service Act (42 U.S.C. 294i) is amended— (1) in subsection (a), by striking hospices, and other public and private entities and inserting hospices, tribal health programs (as defined in section 4 of the Indian Health Care Improvement Act), and other public and nonprofit private entities ; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking award may be made under subsection (a) only if the applicant for the award agrees that the program carried out with the award will include and inserting entity receiving an award under this section shall develop a comprehensive education and training plan that includes ; (B) in paragraph (1)— (i) by inserting preventing, after diagnosing, ; and (ii) by inserting non-addictive medical products and non-pharmacologic treatments and after including ; (C) in paragraph (2)— (i) by inserting Federal, State, and local after applicable ; and (ii) by striking the degree to which and all that follows through effective pain care and inserting opioids ; (D) in paragraph (3), by inserting , integrated, evidence-based pain management, and, as appropriate, non-pharmacotherapy before the semicolon; (E) in paragraph (4), by striking ; and and inserting ; ; and (F) by striking paragraph (5) and inserting the following: (5) recent findings, developments, and advancements in pain care research and the provision of pain care, which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which may include best practices related to screening for opioid use disorders, training on screening, brief intervention, and referral to treatment), and safe disposal options for prescription medications (including such options provided by law enforcement or other innovative deactivation mechanisms). ; (3) in subsection (d), by inserting prevention, after diagnosis, ; and (4) in subsection (e), by striking 2010 through 2012 and inserting 2019 through 2023 . (b) Mental and behavioral health education and training program Section 756(a) of the Public Health Service Act (42 U.S.C. 294e–1(a)) is amended— (1) in paragraph (1), by inserting , trauma, after focus on child and adolescent mental health ; and (2) in paragraphs (2) and (3), by inserting trauma-informed care and before substance use disorder prevention and treatment services . 1503. Education and awareness campaigns Section 102 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198) is amended— (1) by amending subsection (a) to read as follows: (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in coordination with the heads of other departments and agencies, shall advance education and awareness regarding the risks related to misuse and abuse of opioids, as appropriate, which may include developing or improving existing programs, conducting activities, and awarding grants that advance the education and awareness of— (1) the public, including patients and consumers; (2) patients, consumers, and other appropriate members of the public, regarding such risks related to unused opioids and the dispensing options under section 309(f) of the Controlled Substances Act, as applicable; (3) providers, which may include— (A) providing for continuing education on appropriate prescribing practices; (B) education related to applicable State or local prescriber limit laws, information on the use of non-addictive alternatives for pain management, and the use of overdose reversal drugs, as appropriate; (C) disseminating and improving the use of evidence-based opioid prescribing guidelines across relevant health care settings, as appropriate, and updating guidelines as necessary; (D) implementing strategies, such as best practices, to encourage and facilitate the use of prescriber guidelines, in accordance with State and local law; (E) disseminating information to providers about prescribing options for controlled substances, including such options under section 309(f) of the Controlled Substances Act, as applicable; and (F) disseminating information, as appropriate, on the National Pain Strategy developed by or in consultation with the Assistant Secretary for Health; and (4) other appropriate entities. ; and (2) in subsection (b)— (A) by striking opioid abuse each place such term appears and inserting opioid misuse and abuse ; and (B) in paragraph (2), by striking safe disposal of prescription medications and other and inserting non-addictive treatment options, safe disposal options for prescription medications, and other applicable . 1504. Enhanced controlled substance overdoses data collection, analysis, and dissemination Part J of title III of the Public Health Service Act is amended by inserting after section 392 (42 U.S.C. 280b–1) the following: 392A. Enhanced controlled substance overdoses data collection, analysis, and dissemination (a) In general The Director of the Centers for Disease Control and Prevention, using the authority provided to the Director under section 392, may— (1) to the extent practicable, carry out and expand any controlled substance overdose data collection, analysis, and dissemination activity described in subsection (b); (2) provide training and technical assistance to States, localities, and Indian Tribes for the purpose of carrying out any such activity; and (3) award grants to States, localities, and Indian Tribes for the purpose of carrying out any such activity. (b) Controlled substance overdose data collection and analysis activities A controlled substance overdose data collection, analysis, and dissemination activity described in this subsection is any of the following activities: (1) Improving the timeliness of reporting aggregate data to the public, including data on fatal and nonfatal controlled substance overdoses. (2) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on such overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and emergency department services. (3) Modernizing the system for coding causes of death related to controlled substance overdoses to use an electronic-based system. (4) Using data to help identify risk factors associated with controlled substance overdoses, including the delivery of certain health care services. (5) Supporting entities involved in reporting information on controlled substance overdoses, such as coroners and medical examiners, to improve accurate testing and standardized reporting of causes and contributing factors of such overdoses, and analysis of various opioid analogues to controlled substance overdoses. (6) Working to enable and encourage the access, exchange, and use of data regarding controlled substances overdoses among data sources and entities. (c) Definitions In this section— (1) the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act; and (2) the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act. . 1505. Preventing overdoses of controlled substances Part J of title III of the Public Health Service Act (42 U.S.C. 280b et seq.), as amended by section 504, is further amended by inserting after section 392A the following: 392B. Preventing overdoses of controlled substances (a) Prevention activities (1) In general The Director of the Centers for Disease Control and Prevention (referred to in this section as the Director ), using the authority provided to the Director under section 392, may— (A) to the extent practicable, carry out and expand any prevention activity described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian Tribes to carry out any such activity; and (C) award grants to States, localities, and Indian Tribes for the purpose of carrying out any such activity. (2) Prevention activities A prevention activity described in this paragraph is an activity to improve the efficiency and use of a new or currently operating prescription drug monitoring program, such as— (A) encouraging all authorized users (as specified by the State or other entity) to register with and use the program; (B) enabling such users to access any data updates in as close to real-time as practicable; (C) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing or dispensing practices relating to such substances; (D) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identified, aggregate reports based on such analysis to State public health agencies, State alcohol and drug agencies, State licensing boards, and other appropriate State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug monitoring program and not containing any protected health information, to prevent inappropriate prescribing, drug diversion, or abuse and misuse of controlled substances, and to facilitate better coordination among agencies; (E) enhancing interoperability between the program and any health information technology (including certified health information technology), including by integrating program data into such technology; (F) updating program capabilities to respond to technological innovation for purposes of appropriately addressing the occurrence and evolution of controlled substance overdoses; (G) developing or enhancing data exchange with other sources such as the Medicaid agency, the Medicare program, pharmacy benefit managers, coroners’ reports, and workers’ compensation data; (H) facilitating and encouraging data exchange between the program and the prescription drug monitoring programs of other States; (I) enhancing data collection and quality, including improving patient matching and proactively monitoring data quality; and (J) providing prescriber and dispenser practice tools, including prescriber practice insight reports for practitioners to review their prescribing patterns in comparison to such patters of other practitioners in the specialty. (b) Additional grants The Director may award grants to States, localities, and Indian Tribes— (1) to carry out innovative projects for grantees to rapidly respond to controlled substance misuse, abuse, and overdoses, including changes in patterns of controlled substance use; and (2) for any other evidence-based activity for preventing controlled substance misuse, abuse, and overdoses as the Director determines appropriate. (c) Research The Director, in coordination with the Assistant Secretary for Mental Health and Substance Use and the National Mental Health and Substance Use Policy Laboratory established under section 501A, as appropriate and applicable, may conduct studies and evaluations to address substance use disorders, including preventing substance use disorders or other related topics the Director determines appropriate. (d) Public and prescriber education Pursuant to section 102 of the Comprehensive Addiction and Recovery Act of 2016, the Director may advance the education and awareness of prescribers and the public regarding the risk of abuse and misuse of prescription opioids. (e) Definitions In this section— (1) the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act; and (2) the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act. (f) Authorization of appropriations For purposes of carrying out this section, section 392A of this Act, and section 102 of the Comprehensive Addiction and Recovery Act of 2016, there is authorized to be appropriated $486,000,000 for each of fiscal years 2019 through 2024. . 1506. CDC surveillance and data collection for child, youth, and adult trauma (a) Data collection The Director of the Centers for Disease Control and Prevention (referred to in this section as the Director ) may, in cooperation with the States, collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, and other relevant public health surveys or questionnaires. (b) Timing The collection of data under subsection (a) may occur in fiscal year 2019 and every 2 years thereafter. (c) Data from rural areas The Director shall encourage each State that participates in collecting and reporting data under subsection (a) to collect and report data from tribal and rural areas within such State, in order to generate a statistically reliable representation of such areas. (d) Data from tribal areas The Director may, in cooperation with Indian Tribes and pursuant to a written request from an Indian Tribe, provide technical assistance to such Indian Tribe to collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, or another relevant public health survey or questionnaire. (e) Authorization of appropriations To carry out this section, there is authorized to be appropriated such sums as may be necessary for the period of fiscal years 2019 through 2021. 1507. Reauthorization of NASPER Section 399O of the Public Health Service Act (42 U.S.C. 280g–3) is amended— (1) in subsection (a)— (A) in paragraph (1), in the matter preceding subparagraph (A), by striking in consultation with the Administrator of the Substance Abuse and Mental Health Services Administration and Director of the Centers for Disease Control and Prevention and inserting in coordination with the Director of the Centers for Disease Control and the heads of other departments and agencies as appropriate ; and (B) by adding at the end the following: (4) States and local governments (A) In general In the case of a State that does not have a prescription drug monitoring program, a county or other unit of local government within the State that has a prescription drug monitoring program shall be treated as a State for purposes of this section, including for purposes of eligibility for grants under paragraph (1). (B) Plan for interoperability For purposes of meeting the interoperability requirements under subsection (c)(3), a county or other unit of local government shall submit a plan outlining the methods such county or unit of local government will use to ensure the capability of data sharing with other counties and units of local government within the State and with other States, as applicable. ; (2) in subsection (c)— (A) in paragraph (1)(A)(iii)— (i) by inserting as such standards become available, after interoperability standards, ; and (ii) by striking generated or identified by the Secretary or his or her designee and inserting recognized by the Office of the National Coordinator for Health Information Technology ; and (B) in paragraph (3)(A), by inserting including electronic health records, after technology systems, ; (3) in subsection (d)(1), by striking not later than 1 week after the date of such dispensing and inserting in as close to real time as practicable ; (4) in subsection (f)— (A) in paragraph (1)(D), by striking medicaid and inserting Medicaid ; and (B) in paragraph (2)— (i) in subparagraph (A), by striking and at the end; (ii) in subparagraph (B), by striking the period and inserting a semicolon; and (iii) by adding at the end the following: (C) may conduct analyses of controlled substance program data for purposes of providing appropriate State agencies with aggregate reports based on such analyses in as close to real-time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse, addiction, overdose, and other aggregate information, as appropriate and in compliance with applicable Federal and State laws and provided that such reports shall not include protected health information; and (D) may access information about prescriptions, such as claims data, to ensure that such prescribing and dispensing history is updated in as close to real-time as practicable, in compliance with applicable Federal and State laws and provided that such information shall not include protected health information. ; (5) in subsection (i), by inserting , in collaboration with the National Coordinator for Health Information Technology and the Director of the National Institute of Standards and Technology, after The Secretary ; and (6) in subsection (n), by striking 2021 and inserting 2026 . 1508. Jessie’s law (a) Best practices (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding— (A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient; (B) what constitutes the patient’s request for the purpose described in subparagraph (A); and (C) the process and methods by which the information should be so displayed. (2) Dissemination The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies. (b) Requirements In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following: (1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder. (2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications. (3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers. (4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, having access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations. (5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations. (6) All applicable Federal and State laws and regulations. 1509. Development and dissemination of model training programs for substance use disorder patient records (a) Initial programs and materials Not later than 1 year after the date of the enactment of this Act, the Secretary, in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials): (1) Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) for the confidentiality of patient records. (2) Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in paragraph (1). (b) Requirements The model programs and materials described in paragraphs (1) and (2) of subsection (a) shall address circumstances under which disclosure of substance use disorder patient records is needed to— (1) facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care; (2) avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and (3) notify and involve families and caregivers when individuals experience an overdose. (c) Periodic updates The Secretary shall— (1) periodically review and update the model program and materials identified or developed under subsection (a); and (2) disseminate such updated programs and materials to the individuals described in subsection (a)(1). (d) Input of certain entities In identifying, reviewing, or updating the model programs and materials under this section, the Secretary shall solicit the input of relevant stakeholders. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2019 through 2023. 1510. Communication with families during emergencies (a) Promoting Awareness of Authorized Disclosures during Emergencies The Secretary shall annually notify health care providers regarding permitted disclosures during emergencies, including overdoses, of certain health information to families and caregivers under Federal health care privacy laws and regulations. (b) Use of material For the purposes of carrying out subsection (a), the Secretary may use material produced under section 1509 of this Act or under section 11004 of the 21st Century Cures Act (42 U.S.C. 1320d–2 note). 1511. Prenatal and postnatal health Section 317L of the Public Health Service Act (42 U.S.C. 247b–13) is amended— (1) in subsection (a)— (A) by amending paragraph (1) to read as follows: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and substance abuse and misuse, including— (A) data on— (i) the incidence, prevalence, and implications of such activities; and (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and (B) to inform such analysis, additional information or data on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, as appropriate; ; (B) in paragraph (2)— (i) by striking prevention of and inserting prevention and long-term outcomes associated with ; and (ii) by striking illegal drug use and inserting substance abuse and misuse ; (C) in paragraph (3), by striking and cessation programs; and and inserting , treatment, and cessation programs; ; (D) in paragraph (4), by striking illegal drug use. and inserting substance abuse and misuse; and ; and (E) by adding at the end the following: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of— (A) long-term outcomes of children affected by neonatal abstinence syndrome; (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and (C) relevant studies, evaluations, or information the Secretary determines to be appropriate. ; (2) in subsection (b), by inserting tribal entities, after local governments, ; (3) by redesignating subsection (c) as subsection (d); (4) by inserting after subsection (b) the following: (c) Coordinating activities To carry out this section, the Secretary may— (1) provide technical and consultative assistance to entities receiving grants under subsection (b); (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention; (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and (4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology. ; and (5) in subsection (d), as so redesignated, by striking 2001 through 2005 and inserting 2019 through 2023 . 1512. Surveillance and education regarding infections associated with illicit drug use and other risk factors Section 317N of the Public Health Service Act (42 U.S.C. 247b–15) is amended— (1) by amending the section heading to read as follows: Surveillance and education regarding infections associated with illicit drug use and other risk factors ; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by inserting activities before the colon; (B) in paragraph (1)— (i) by inserting or maintaining after implementing ; (ii) by striking hepatitis C virus infection (in this section referred to as HCV infection ) and inserting infections commonly associated with illicit drug use, which may include viral hepatitis, human immunodeficiency virus, and infective endocarditis, ; and (iii) by striking such infection and all that follows through the period at the end and inserting such infections, which may include the reporting of cases of such infections. ; (C) in paragraph (2), by striking HCV infection and all that follows through the period at the end and inserting infections as a result of illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors. ; (D) in paragraphs (4) and (5), by striking HCV infection each place such term appears and inserting infections described in paragraph (1) ; and (E) in paragraph (5), by striking pediatricians and other primary care physicians, and obstetricians and gynecologists and inserting substance use disorder treatment providers, pediatricians, other primary care providers, and obstetrician-gynecologists ; (3) in subsection (b)— (A) by striking directly and and inserting directly or ; and (B) by striking hepatitis C, and all that follows through the period at the end and inserting infections described in subsection (a)(1). ; and (4) in subsection (c), by striking such sums as may be necessary for each of the fiscal years 2001 through 2005 and inserting $40,000,000 for each of fiscal years 2019 through 2023 . 1513. Task force to develop best practices for trauma-informed identification, referral, and support (a) Establishment There is established a task force, to be known as the Interagency Task Force on Trauma-Informed Care (in this section referred to as the task force ) that shall identify, evaluate, and make recommendations regarding best practices with respect to children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma. (b) Membership (1) Composition The task force shall be composed of the heads of the following Federal departments and agencies, or their designees: (A) The Centers for Medicare & Medicaid Services. (B) The Substance Abuse and Mental Health Services Administration. (C) The Agency for Healthcare Research and Quality. (D) The Centers for Disease Control and Prevention. (E) The Indian Health Service. (F) The Department of Veterans Affairs. (G) The National Institutes of Health. (H) The Food and Drug Administration. (I) The Health Resources and Services Administration. (J) The Department of Defense. (K) The Office of Minority Health. (L) The Administration for Children and Families. (M) The Office of the Assistant Secretary for Planning and Evaluation. (N) The Office for Civil Rights of the Department of Health and Human Services. (O) The Office of Juvenile Justice and Delinquency Prevention of the Department of Justice. (P) The Office of Community Oriented Policing Services of the Department of Justice. (Q) The Office on Violence Against Women of the Department of Justice. (R) The National Center for Education Evaluation and Regional Assistance of the Department of Education. (S) The National Center for Special Education Research of the Institute of Education Science. (T) The Office of Elementary and Secondary Education of the Department of Education. (U) The Office for Civil Rights of the Department of Education. (V) The Office of Special Education and Rehabilitative Services of the Department of Education. (W) The Bureau of Indian Affairs of the Department of the Interior. (X) The Veterans Health Administration of the Department of Veterans Affairs. (Y) The Office of Special Needs Assistance Programs of the Department of Housing and Urban Development. (Z) The Office of Head Start of the Administration for Children and Families. (AA) The Children’s Bureau of the Administration for Children and Families. (BB) The Bureau of Indian Education of the Department of the Interior. (CC) Such other Federal agencies as the Secretaries determine to be appropriate. (2) Date of appointments The heads of Federal departments and agencies shall appoint the corresponding members of the task force not later than 6 months after the date of enactment of this Act. (3) Chairperson The task force shall be chaired by the Assistant Secretary for Mental Health and Substance Use. (c) Task force duties The task force shall— (1) solicit input from stakeholders, including frontline service providers, educators, mental health professionals, researchers, experts in infant, child, and youth trauma, child welfare professionals, and the public, in order to inform the activities under paragraph (2); and (2) identify, evaluate, make recommendations, and update such recommendations not less than annually, to the general public, the Secretary of Education, the Secretary of Health and Human Services, the Secretary of Labor, the Secretary of the Interior, the Attorney General, and other relevant cabinet Secretaries, and Congress regarding— (A) a set of evidence-based, evidence-informed, and promising best practices with respect to— (i) the identification of infants, children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (ii) the expeditious referral to and implementation of trauma-informed practices and supports that prevent and mitigate the effects of trauma; (B) a national strategy on how the task force and member agencies will collaborate, prioritize options for, and implement a coordinated approach which may include data sharing and the awarding of grants that support infants, children, and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (C) existing Federal authorities at the Department of Education, Department of Health and Human Services, Department of Justice, Department of Labor, Department of the Interior, and other relevant agencies, and specific Federal grant programs to disseminate best practices on, provide training in, or deliver services through, trauma-informed practices, and disseminate such information— (i) in writing to relevant program offices at such agencies to encourage grant applicants in writing to use such funds, where appropriate, for trauma-informed practices; and (ii) to the general public through the internet website of the task force. (d) Best practices In identifying, evaluating, and recommending the set of best practices under subsection (c), the task force shall— (1) include guidelines for providing professional development for front-line services providers, including school personnel, early childhood education program providers, providers from child- or youth-serving organizations, housing and homeless providers, primary and behavioral health care providers, child welfare and social services providers, juvenile and family court personnel, health care providers, individuals who are mandatory reporters of child abuse or neglect, trained nonclinical providers (including peer mentors and clergy), and first responders, in— (A) understanding and identifying early signs and risk factors of trauma in infants, children, and youth, and their families as appropriate, including through screening processes; (B) providing practices to prevent and mitigate the impact of trauma, including by fostering safe and stable environments and relationships; and (C) developing and implementing policies, procedures, or systems that— (i) are designed to quickly refer infants, children, youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma to the appropriate trauma-informed screening and support, including age-appropriate treatment, and to ensure such infants, children, youth, and family members receive such support; (ii) utilize and develop partnerships with early childhood education programs, local social services organizations, such as organizations serving youth, and clinical mental health or health care service providers with expertise in providing support services (including age-appropriate trauma-informed and evidence-based treatment) aimed at preventing or mitigating the effects of trauma; (iii) educate children and youth to— (I) understand and identify the signs, effects, or symptoms of trauma; and (II) build the resilience and coping skills to mitigate the effects of experiencing trauma; (iv) promote and support multi-generational practices that assist parents, foster parents, and kinship and other caregivers in accessing resources related to, and developing environments conducive to, the prevention and mitigation of trauma; and (v) collect and utilize data from screenings, referrals, or the provision of services and supports to evaluate and improve processes for trauma-informed support and outcomes that are culturally sensitive, linguistically appropriate, and specific to age ranges and sex, as applicable; and (2) recommend best practices that are designed to avoid unwarranted custody loss or criminal penalties for parents or guardians in connection with infants, children, and youth who have experienced or are at risk of experiencing trauma. (e) Operating plan Not later than 1 year after the date of enactment of this Act, the task force shall hold the first meeting. Not later than 2 years after such date of enactment, the task force shall submit to the Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, and Congress an operating plan for carrying out the activities of the task force described in subsection (c)(2). Such operating plan shall include— (1) a list of specific activities that the task force plans to carry out for purposes of carrying out duties described in subsection (c)(2), which may include public engagement; (2) a plan for carrying out the activities under subsection (c)(2); (3) a list of members of the task force and other individuals who are not members of the task force that may be consulted to carry out such activities; (4) an explanation of Federal agency involvement and coordination needed to carry out such activities, including any statutory or regulatory barriers to such coordination; (5) a budget for carrying out such activities; and (6) other information that the task force determines appropriate. (f) Final report Not later than 3 years after the date of the first meeting of the task force, the task force shall submit to the general public, Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, and other relevant cabinet Secretaries, and Congress, a final report containing all of the findings and recommendations required under this section. (g) Definition In this section, the term early childhood education program has the meaning given such term in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003). (h) Authorization of appropriations To carry out this section, there is authorized to be appropriated such sums as may be necessary for each of fiscal years 2019 through 2022. (i) Sunset The task force shall on the date that is 60 days after the submission of the final report under subsection (f), but not later than September 30, 2022. 1514. Grants to improve trauma support services and mental health care for children and youth in educational settings (a) Grants, contracts, and cooperative agreements authorized The Secretary, in coordination with the Assistant Secretary for Mental Health and Substance Use, is authorized to award grants to, or enter into contracts or cooperative agreements with, State educational agencies, local educational agencies, Head Start agencies (including Early Head Start agencies), State or local agencies that administer public preschool programs, Indian Tribes or their tribal educational agencies, a school operated by the Bureau of Indian Education, a Regional Corporation (as defined in section 3 of the Alaska Native Claims Settlement Act (43 U.S.C. 1602)), or a Native Hawaiian educational organization (as defined in section 6207 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517)), for the purpose of increasing student access to evidence-based trauma support services and mental health care by developing innovative initiatives, activities, or programs to link local school systems with local trauma-informed support and mental health systems, including those under the Indian Health Service. (b) Duration With respect to a grant, contract, or cooperative agreement awarded or entered into under this section, the period during which payments under such grant, contract or agreement are made to the recipient may not exceed 4 years. (c) Use of funds An entity that receives a grant, contract, or cooperative agreement under this section shall use amounts made available through such grant, contract, or cooperative agreement for evidence-based activities, which shall include any of the following: (1) Collaborative efforts between school-based service systems and trauma-informed support and mental health service systems to provide, develop, or improve prevention, screening, referral, and treatment and support services to students, such as by providing universal trauma screenings to identify students in need of specialized support. (2) To implement schoolwide multi-tiered positive behavioral interventions and supports, or other trauma-informed models of support. (3) To provide professional development to teachers, teacher assistants, school leaders, specialized instructional support personnel, and mental health professionals that— (A) fosters safe and stable learning environments that prevent and mitigate the effects of trauma, including through social and emotional learning; (B) improves school capacity to identify, refer, and provide services to students in need of trauma support or behavioral health services; or (C) reflects the best practices developed by the Interagency Task Force on Trauma-Informed Care established under section 513. (4) To create or enhance services at a full-service community school that focuses on trauma-informed supports, which may include establishing a school-site advisory team, managing, coordinating, or delivering pipeline services, hiring a full-time site coordinator, or other activities consistent with section 4625 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7275). (5) Engaging families and communities in efforts to increase awareness of child and youth trauma, which may include sharing best practices with law enforcement regarding trauma-informed care and working with mental health professionals to provide interventions, as well as longer term coordinated care within the community for children and youth who have experienced trauma and their families. (6) To provide technical assistance to school systems and mental health agencies. (7) To evaluate the effectiveness of the program carried out under this section in increasing student access to evidence-based trauma support services and mental health care. (d) Applications To be eligible to receive a grant, contract, or cooperative agreement under this section, an entity described in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include the following: (1) A description of the innovative initiatives, activities, or programs to be funded under the grant, contract, or cooperative agreement, including how such program will increase access to evidence-based trauma support services and mental health care for students, and, as applicable, the families of such students. (2) A description of how the program will provide linguistically appropriate and culturally competent services. (3) A description of how the program will support students and the school in improving the school climate in order to support an environment conducive to learning. (4) An assurance that— (A) persons providing services under the grant, contract, or cooperative agreement are adequately trained to provide such services; and (B) teachers, school leaders, administrators, specialized instructional support personnel, representatives of local Indian Tribes or tribal organizations as appropriate, other school personnel, and parents or guardians of students participating in services under this section will be engaged and involved in the design and implementation of the services. (5) A description of how the applicant will support and integrate existing school-based services with the program in order to provide mental health services for students, as appropriate. (e) Interagency agreements (1) Designation of lead agency A recipient of a grant, contract, or cooperative agreement under this section shall designate a lead agency to direct the establishment of an interagency agreement among local educational agencies, agencies responsible for early childhood education programs, juvenile justice authorities, mental health agencies, child welfare agencies, and other relevant entities in the State or Indian Tribe, in collaboration with local entities. (2) Contents The interagency agreement shall ensure the provision of the services described in subsection (c), specifying with respect to each agency, authority, or entity— (A) the financial responsibility for the services; (B) the conditions and terms of responsibility for the services, including quality, accountability, and coordination of the services; and (C) the conditions and terms of reimbursement among the agencies, authorities, or entities that are parties to the interagency agreement, including procedures for dispute resolution. (f) Evaluation The Secretary shall reserve not to exceed 3 percent of the funds made available under subsection (l) for each fiscal year to— (1) conduct a rigorous, independent evaluation of the activities funded under this section; and (2) disseminate and promote the utilization of evidence-based practices regarding trauma support services and mental health care. (g) Distribution of awards The Secretary shall ensure that grants, contracts, and cooperative agreements awarded or entered into under this section are equitably distributed among the geographical regions of the United States and among tribal, urban, suburban, and rural populations. (h) Rule of construction Nothing in this section shall be construed— (1) to prohibit an entity involved with a program carried out under this section from reporting a crime that is committed by a student to appropriate authorities; or (2) to prevent Federal, State, and tribal law enforcement and judicial authorities from exercising their responsibilities with regard to the application of Federal, tribal, and State law to crimes committed by a student. (i) Supplement, not supplant Any services provided through programs carried out under this section shall supplement, and not supplant, existing mental health services, including any special education and related services provided under the Individuals with Disabilities Education Act (20 U.S.C. 1400 et seq.). (j) Consultation with indian Tribes In carrying out subsection (a), the Secretary shall, in a timely manner, meaningfully consult, engage, and cooperate with Indian Tribes and their representatives to ensure notice of eligibility. (k) Definitions In this section: (1) Elementary or secondary school The term elementary or secondary school means a public elementary and secondary school as such term is defined in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (2) Evidence-based The term evidence-based has the meaning given such term in section 8101(21)(A)(i) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801(21)(A)(i)). (3) Native Hawaiian educational organization The term Native Hawaiian educational organization has the meaning given such term in section 6207 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517). (4) Pipeline services The term pipeline services has the meaning given such term in section 4622 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517). (5) School leader The term school leader has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (6) Secretary The term Secretary means the Secretary of Education. (7) Specialized instructional support personnel The term specialized instructional support personnel has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (l) Authorization of appropriations There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2019 through 2023. 1515. National Child Traumatic Stress Initiative Section 582(j) of the Public Health Service Act (42 U.S.C. 290hh–1(j)) (relating to grants to address the problems of persons who experience violence-related stress) is amended by striking $46,887,000 for each of fiscal years 2018 through 2022 and inserting $53,887,000 for each of fiscal years 2019 through 2023 . 1516. National milestones to measure success in curtailing the opioid crisis (a) In general Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with the Administrator of the Drug Enforcement Administration and the Director of the Office of National Drug Control Policy, shall develop or identify existing national indicators (referred to in this section as the national milestones ) to measure success in curtailing the opioid crisis, with the goal of significantly reversing the incidence and prevalence of opioid misuse and abuse, and opioid-related morbidity and mortality in the United States within 5 years of such date of enactment. (b) National milestones to end the opioid crisis The national milestones under subsection (a) shall include the following: (1) Not fewer than 10 indicators or metrics to accurately and expediently measure progress in meeting the goal described in subsection (a), which shall, as appropriate, include, indicators or metrics related to— (A) the number of fatal and non-fatal opioid overdoses; (B) the number of emergency room visits related to opioid misuse and abuse; (C) the number of individuals in sustained recovery from opioid use disorder; (D) the number of infections associated with illicit drug use, such as HIV, viral hepatitis, and infective endocarditis, and available capacity for treating such infections; (E) the number of providers prescribing medication assisted treatment for opioid use disorders, including in primary care settings, community health centers, jails, and prisons; (F) the number of individuals receiving treatment for opioid use disorder; and (G) additional indicators or metrics, as appropriate, such as metrics pertaining to specific populations, including women and children, American Indians and Alaskan Natives, individuals living in rural and non-urban areas, and justice-involved populations, that would further clarify the progress made in addressing the opioid misuse and abuse crisis. (2) A reasonable goal, such as a percentage decrease or other specified metric, that signifies progress in meeting the goal described in subsection (a), and annual targets to help achieve that goal. (c) Consideration of other substance use disorders In developing the national milestones under subsection (b), the Secretary shall, as appropriate, consider other substance use disorders in addition to opioid use disorder. (d) Extension of period If the Secretary determines that the goal described in subsection (a) will not be achieved with respect to any indicator or metric established under subsection (b)(2) within 5 years of the date of enactment of this Act, the Secretary may extend the timeline for meeting such goal with respect to that indicator or metric. The Secretary shall include with any such extension a rationale for why additional time is needed and information on whether significant changes are needed in order to achieve such goal with respect to the indicator or metric. (e) Annual status update Not later than one year after the enactment of this Act, the Secretary shall make available on the internet website of the Department of Health and Human Services, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an update on the progress, including expected progress in the subsequent year, in achieving the goals detailed in the national milestones. Each such update shall include the progress made in the first year or since the previous report, as applicable, in meeting each indicator or metric in the national milestones. II Finance 2001. Short title This title may be cited as the Helping to End Addiction and Lessen Substance Use Disorders Act of 2018 or the HEAL Act of 2018 . A Medicare 2101. Medicare opioid safety education (a) In general Section 1804 of the Social Security Act (42 U.S.C. 1395b–2) is amended by adding at the end the following new subsection: (d) The notice provided under subsection (a) shall include— (1) references to educational resources regarding opioid use and pain management; (2) a description of categories of alternative, non-opioid pain management treatments covered under this title; and (3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management. . (b) Effective date The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019. 2102. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders (a) In general Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended— (1) in paragraph (2)(B)— (A) in clause (i), in the matter preceding subclause (I), by striking clause (ii) and inserting clause (ii) and paragraph (6)(C) ; and (B) in clause (ii), in the heading, by striking for home dialysis therapy ; (2) in paragraph (4)(C)— (A) in clause (i), by striking paragraph (6) and inserting paragraphs (5), (6), and (7) ; and (B) in clause (ii)(X), by inserting or telehealth services described in paragraph (7) before the period at the end; and (3) by adding at the end the following new paragraph: (7) Treatment of substance use disorder services furnished through telehealth The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after January 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph). . (b) Implementation The Secretary of Health and Human Services (in this section referred to as the Secretary ) may implement the amendments made by this section by interim final rule. (c) Report Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) on— (1) the utilization of health care items and services under title XVIII of such Act (42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and (2) health outcomes related to substance use disorders, such as opioid overdose deaths. 2103. Comprehensive screenings for seniors (a) Initial preventive physical examination Section 1861(ww) of the Social Security Act (42 U.S.C. 1395x(ww)) is amended— (1) in paragraph (1)— (A) by striking paragraph (2) and and inserting paragraph (2), ; and (B) by inserting and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)), after ‘‘upon the agreement with the individual,”; and (2) in paragraph (2)— (A) by redesignating subparagraph (N) as subparagraph (O); and (B) by inserting after subparagraph (M) the following new subparagraph: (N) Screening for potential substance use disorders. ; and (3) by adding at the end the following new paragraph: (4) For purposes of paragraph (1), the term a review of any current opioid prescriptions means, with respect to an individual determined to have a current prescription for opioids— (A) a review of the potential risk factors to the individual for opioid use disorder; (B) an evaluation of the individual's severity of pain and current treatment plan; (C) the provision of information on non-opioid treatment options; and (D) a referral to a pain management specialist, as appropriate. . (b) Annual wellness visit Section 1861(hhh)(2) of the Social Security Act (42 U.S.C. 1395x(hhh)(2)) is amended— (1) by redesignating subparagraph (G) as subparagraph (I); and (2) by inserting after subparagraph (F) the following new subparagraphs: (G) Screening for potential substance use disorders and referral for treatment as appropriate. (H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)). . (c) Effective date The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2019. 2104. Every prescription conveyed securely (a) In general Section 1860D–4(e) of the Social Security Act (42 U.S.C. 1395w–104(e)) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispensing pharmacy are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner prescribing a drug under a research protocol; (vi) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing such as, a drug with risk evaluation and mitigation strategies that include elements to assure safe use; (vii) a prescription issued by a practitioner— (I) for an individual who receives hospice care under this title; and (II) that is not covered under the hospice benefit under this title; and (viii) a prescription issued by a practitioner for an individual who is— (I) a resident of a nursing facility (as defined in section 1919(a)); and (II) dually eligible for benefits under this title and title XIX. (C) Dispensing (i) Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). (ii) Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral or fax prescriptions that are consistent with laws and regulations. (iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. 2105. Standardizing electronic prior authorization for safe prescribing Section 1860D–4(e)(2) of the Social Security Act (42 U.S.C. 1395w–104(e)(2)) is amended by adding at the end the following new subparagraph: (E) Electronic prior authorization (i) In general Not later than January 1, 2021, the program shall provide for the secure electronic transmittal of— (I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and (II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional. (ii) Electronic transmission (I) Exclusions For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i). (II) Standards In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors. (III) Application Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual. . 2106. Strengthening partnerships to prevent opioid abuse (a) In general Section 1859 of the Social Security Act (42 U.S.C. 1395w–28) is amended by adding at the end the following new subsection: (i) Program integrity transparency measures (1) Program integrity portal (A) In general Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure Internet website portal that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or any successor entity to a Medicare drug integrity contractor), in accordance with subsection (j)(3) of such section, for the purpose of enabling through such portal— (i) the referral by such plans of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and (ii) data sharing among such MA plans, prescription drug plans, and the Secretary. (B) Required uses of portal The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure Internet website portal established under subparagraph (A): (i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period. (ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise. (iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation. (iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal with respect to suspicious activities of a provider of services (including a prescriber) or supplier, if such provider (or prescriber) or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken. (C) Rulemaking For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes suspicious activities related to fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.7.1. (2) Quarterly reports Beginning not later than 2 years after the date of the enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall— (A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and (B) be anonymized information submitted by plans without identifying the source of such information. (3) Clarification Nothing in this subsection shall preclude or otherwise affect referrals to the Inspector General of the Department of Health and Human Services or other law enforcement entities. . (b) Contract requirement to communicate plan corrective actions against opioids over-prescribers Section 1857(e)(4)(C) of the Social Security Act (42 U.S.C. 1395w–27(e)(4)(C)) is amended by adding at the end the following new paragraph: (5) Communicating plan corrective actions against opioids over-prescribers (A) In general Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on credible evidence of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud and other actions taken by such plans related to inappropriate prescribing of opioids. (B) Process Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A). (C) Regulations For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking— (i) specify a definition for the term inappropriate prescribing of opioids and a method for determining if a provider of services prescribes such a high volume; and (ii) establish the process described in subparagraph (B) and the types of information that may be submitted through such process. . (c) Reference under part D to program integrity transparency measures Section 1860D–4 of the Social Security Act (42 U.S.C. 1395w–104) is amended by adding at the end the following new subsection: (m) Program integrity transparency measures For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i). . 2107. Commit to opioid medical prescriber accountability and safety for seniors Section 1860D–4(c)(4) of the Social Security Act (42 U.S.C. 1395w–104(c)(4)) is amended by adding at the end the following new subparagraph: (D) Notification and additional requirements with respect to statistical outlier prescribers of opioids (i) Notification Not later than January 1, 2021, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be a statistical outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified that includes resources on proper prescribing methods and other information as specified in accordance with clause (iii). (ii) Identification of statistical outlier prescribers of opioids (I) In general The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the thresholds established under subclause (II), identify prescribers that are statistical outlier opioids prescribers for a period of time specified by the Secretary. (II) Establishment of thresholds For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish thresholds, based on prescriber specialty and, as determined appropriate by the Secretary, geographic area, for identifying whether a prescriber in a specialty and geographic area is a statistical outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area. (III) Exclusions The following shall not be included in the analysis for identifying statistical outlier prescribers of opioids under this clause: (aa) Claims for covered part D drugs for part D eligible individuals who are receiving hospice care under this title. (bb) Claims for covered part D drugs for part D eligible individuals who are receiving oncology services under this title. (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Inspector General of the Department of Health and Human Services. (iii) Contents of notification The Secretary shall include the following information in the notifications provided under clause (i): (I) Information on how such prescriber compares to other prescribers within the same specialty and, if determined appropriate by the Secretary, geographic area. (II) Information on opioid prescribing guidelines, based on input from stakeholders, that may include the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain and guidelines developed by physician organizations. (III) Other information determined appropriate by the Secretary. (iv) Modifications and expansions (I) Frequency Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input and changes in opioid prescribing utilization and trends. (II) Expansion to other prescriptions The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary. (v) Additional requirements for persistent statistical outlier prescribers In the case of a prescriber who the Secretary determines is persistently identified under clause (ii) as a statistical outlier prescriber of opioids, the following shall apply: (I) The Secretary shall provide an opportunity for such prescriber to receive technical assistance or educational resources on opioid prescribing guidelines (such as the guidelines described in clause (iii)(II)) from an entity that furnishes such assistance or resources, which may include a quality improvement organization under part B of title XI, as available and appropriate. (II) Such prescriber may be required to enroll in the program under this title under section 1866(j) if such prescriber is not otherwise required to enroll. The Secretary shall determine the length of the period for which such prescriber is required to maintain such enrollment. (III) Not less frequently than annually (and in a form and manner determined appropriate by the Secretary), the Secretary shall communicate information on such prescribers to sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA–PD plan. (vi) Public availability of information The Secretary shall make aggregate information under this subparagraph available on the Internet website of the Centers for Medicare & Medicaid Services. Such information shall be in a form and manner determined appropriate by the Secretary and shall not identify any specific prescriber. In carrying out this clause, the Secretary shall consult with interested stakeholders. (vii) Opioids defined For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary. (viii) Other activities Nothing in this subparagraph shall preclude the Secretary from conducting activities that provide prescribers with information as to how they compare to other prescribers that are in addition to the activities under this subparagraph, including activities that were being conducted as of the date of the enactment of this subparagraph. . 2108. Fighting the opioid epidemic with sunshine (a) Inclusion of information regarding payments to advance practice nurses (1) In general Section 1128G(e)(6) of the Social Security Act (42 U.S.C. 1320a–7h(e)(6)) is amended— (A) in subparagraph (A), by adding at the end the following new clauses: (iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1861(aa)(5)). (iv) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)). (v) A certified nurse-midwife (as defined in section 1861(gg)(2)). ; and (B) in subparagraph (B), by inserting , physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife after physician . (2) Effective date The amendments made by this subsection shall apply with respect to information required to be submitted under section 1128G of the Social Security Act (42 U.S.C. 1320a–7h) on or after January 1, 2022. (b) Sunset of exclusion of National Provider Identifier of covered recipient in information made publicly available Section 1128G(c)(1)(C)(viii) of the Social Security Act (42 U.S.C. 1320a–7h(c)(1)(C)(viii))) is amended by striking does not contain and inserting in the case of information made available under this subparagraph prior to January 1, 2022, does not contain . (c) Administration Chapter 35 of title 44, United States Code, shall not apply to this section or the amendments made by this section. 2109. Demonstration testing coverage of certain services furnished by opioid treatment programs Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E the following: 1866F. Demonstration testing coverage of certain services furnished by opioid treatment programs (a) Establishment (1) In general The Secretary shall conduct a demonstration (in this section referred to as the demonstration ) to test coverage of and payment for opioid use disorder treatment services (as defined in paragraph (2)(B)) furnished by opioid treatment programs (as defined in paragraph (2)(A)) to individuals under part B using a bundled payment as described in paragraph (3). (2) Definitions In this section: (A) Opioid treatment program The term opioid treatment program means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (i) is selected for participation in the demonstration; (ii) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (iii) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; (iv) submits to the Secretary data and information needed to monitor the quality of services furnished and conduct the evaluation described in subsection (c); and (v) meets such additional requirements as the Secretary may find necessary. (B) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (i) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act for use in the treatment of opioid use disorder; (ii) dispensing and administration of such medications, if applicable; (iii) substance use counseling by a professional to the extent authorized under State law to furnish such services; (iv) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (v) toxicology testing; and (vi) other items and services that the Secretary determines are appropriate (but in no case to include meals or transportation). (3) Bundled payment under part B (A) In general The Secretary shall pay, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, to an opioid treatment program participating in the demonstration a bundled payment as determined by the Secretary for opioid use disorder treatment services that are furnished by such treatment program to an individual under part B during an episode of care (as defined by the Secretary). (B) Considerations The Secretary may implement this paragraph through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services furnished, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determines appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (b) Implementation (1) Duration The demonstration shall be conducted for a period of 5 years, beginning not later than January 1, 2021. (2) Scope In carrying out the demonstration, the Secretary shall limit the number of beneficiaries that may participate at any one time in the demonstration to 2,000. (3) Waiver The Secretary may waive such provisions of this title and title XI as the Secretary determines necessary in order to implement the demonstration. (4) Administration Chapter 35 of title 44, United States Code, shall not apply to this section. (c) Evaluation and report (1) Evaluation The Secretary shall conduct an evaluation of the demonstration. Such evaluation shall include analyses of— (A) the impact of the demonstration on— (i) utilization of health care items and services related to opioid use disorder, including hospitalizations and emergency department visits; (ii) beneficiary health outcomes related to opioid use disorder, including opioid overdose deaths; and (iii) overall expenditures under this title; and (B) the performance of opioid treatment programs participating in the demonstration with respect to applicable quality and cost metrics, including whether any additional quality measures related to opioid use disorder treatment are needed with respect to such programs under this title. (2) Report Not later than 2 years after the completion of the demonstration, the Secretary shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Secretary determines appropriate. (d) Funding For purposes of administering and carrying out the demonstration, in addition to funds otherwise appropriated, there shall be transferred to the Secretary for the Center for Medicare & Medicaid Services Program Management Account from the Federal Supplementary Medical Insurance Trust Fund under section 1841 $5,000,000, to remain available until expended. . 2110. Encouraging appropriate prescribing under Medicare for victims of opioid overdose Section 1860D–4(c)(5)(C) of the Social Security Act (42 U.S.C. 1395w–104(c)(5)(C)) is amended— (1) in clause (i), in the matter preceding subclause (I), by striking For purposes and inserting Except as provided in clause (v), for purposes ; and (2) by adding at the end the following new clause: (v) Treatment of enrollees with a history of opioid-related overdose (I) In general For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph. (II) Identification and notice For purposes of this clause, the Secretary shall— (aa) identify part D eligible individuals with a history of opioid-related overdose (as so defined); and (bb) notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification. . 2111. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries (a) In general Section 1860D–4(c)(5) of the Social Security Act (42 U.S.C. 1395ww–10(c)(5)) is amended— (1) in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking and the option of an automatic escalation to external review and inserting , including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution ; and (2) in subparagraph (E), by striking and the option and all that follows and inserting the following: and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution. . (b) Effective date The amendments made by subsection (a) shall apply beginning not later January 1, 2021. 2112. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the following new clause: (xxv) Providing incentive payments to behavioral health providers for the adoption and use of certified electronic health record technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information. Behavioral health providers may include— (I) psychiatric hospitals (as defined in section 1861(f)); (II) community mental health centers (as defined in section 1861(ff)(3)(B)); (III) clinical psychologists (as defined in section 1861(ii)); (IV) clinical social workers (as defined in section 1861(hh)(1)); and (V) hospitals, treatment facilities, and mental health or substance use disorder providers that participate in a State plan under title XIX or a waiver of such plan. . 2113. Medicare Improvement Fund Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking fiscal year 2021, $0 and inserting fiscal year 2024, $65,000,000 . B Medicaid 2201. Caring recovery for infants and babies (a) State plan amendment Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended— (1) in paragraph (82), by striking and after the semicolon; (2) in paragraph (83), by striking the period at the end and inserting ; and ; and (3) by inserting after paragraph (83), the following new paragraph: (84) provide, at the option of the State, for making medical assistance available on an inpatient or outpatient basis at a residential pediatric recovery center (as defined in subsection (nn)) to infants with neonatal abstinence syndrome. . (b) Residential pediatric recovery center defined Section 1902 of such Act (42 U.S.C. 1396a) is amended by adding at the end the following new subsection: (nn) Residential pediatric recovery center defined (1) In general For purposes of section 1902(a)(84), the term residential pediatric recovery center means a center or facility that furnishes items and services for which medical assistance is available under the State plan to infants with the diagnosis of neonatal abstinence syndrome without any other significant medical risk factors. (2) Counseling and services A residential pediatric recovery center may offer counseling and other services to mothers (and other appropriate family members and caretakers) of infants receiving treatment at such centers if such services are otherwise covered under the State plan under this title or under a waiver of such plan. Such other services may include the following: (A) Counseling or referrals for services. (B) Activities to encourage caregiver-infant bonding. (C) Training on caring for such infants. . (c) Effective date The amendments made by this section take effect on the date of enactment of this Act and shall apply to medical assistance furnished on or after that date, without regard to final regulations to carry out such amendments being promulgated as of such date. 2202. Peer support enhancement and evaluation review (a) In general Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the provision of peer support services under the Medicaid program. (b) Content of report (1) In general The report required under subsection (a) shall include the following information: (A) Information on State coverage of peer support services under Medicaid, including— (i) the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers; (ii) the populations to which States have provided such coverage; (iii) the payment models, including any alternative payment models, used by States to pay providers of such services; and (iv) where available, information on Federal and State spending under Medicaid for peer support services. (B) Information on selected State experiences in providing medical assistance for peer support services under State Medicaid plans and whether States measure the effects of providing such assistance with respect to— (i) improving access to behavioral health services; (ii) improving early detection, and preventing worsening, of behavioral health disorders; (iii) reducing chronic and comorbid conditions; and (iv) reducing overall health costs. (2) Recommendations The report required under subsection (a) shall include recommendations, including recommendations for such legislative and administrative actions related to improving services, including peer support services, and access to peer support services under Medicaid as the Comptroller General of the United States determines appropriate. 2203. Medicaid substance use disorder treatment via telehealth (a) Definitions In this section: (1) Comptroller General The term Comptroller General means the Comptroller General of the United States. (2) School-based health center The term school-based health center has the meaning given that term in section 2110(c)(9) of the Social Security Act (42 U.S.C. 1397jj(c)(9)). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Teleheath services The term telehealth services includes remote patient monitoring and other key modalities such as live video or synchronous telehealth, store-and-forward or asynchronous telehealth, mobile health, telephonic consultation, and electronic consult including provider-to-provider e-consults. (5) Underserved area The term underserved area means a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A))) and a medically underserved area (according to a designation under section 330(b)(3)(A) of the Public Health Service Act (42 U.S.C. 254b(b)(3)(A))). (b) Guidance to States regarding Federal reimbursement for furnishing services and treatment for substance use disorders under Medicaid using telehealth services, including in school-based health centers Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue guidance to States on the following: (1) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders, including assessment, medication-assisted treatment, counseling, and medication management, using telehealth services. Such guidance shall also include guidance on furnishing services and treatments that address the needs of high risk individuals, including at least the following groups: (A) American Indians and Alaska Natives. (B) Adults under the age of 40. (C) Individuals with a history of nonfatal overdose. (2) State options for Federal reimbursement of expenditures under Medicaid for education directed to providers serving Medicaid beneficiaries with substance use disorders using the hub and spoke model, through contracts with managed care entities, through administrative claiming for disease management activities, and under Delivery System Reform Incentive Payment ( DSRIP ) programs. (3) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders for individuals enrolled in Medicaid in a school-based health center using telehealth services. (c) GAO evaluation of children's access to services and treatment for substance use disorders under Medicaid (1) Study The Comptroller General shall evaluate children's access to services and treatment for substance use disorders under Medicaid. The evaluation shall include an analysis of State options for improving children's access to such services and treatment and for improving outcomes, including by increasing the number of Medicaid providers who offer services or treatment for substance use disorders in a school-based health center using telehealth services, particularly in rural and underserved areas. The evaluation shall include an analysis of Medicaid provider reimbursement rates for services and treatment for substance use disorders. (2) Report Not later than 1 year after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. (d) Report on reducing barriers to using telehealth services and remote patient monitoring for pediatric populations under Medicaid (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a report to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representative identifying best practices and potential solutions for reducing barriers to using telehealth services to furnish services and treatment for substance use disorders among pediatric populations under Medicaid. The report shall include— (A) analyses of the best practices, barriers, and potential solutions for using telehealth services to diagnose and provide services and treatment for children with substance use disorders, including opioid use disorder; and (B) identification and analysis of the differences, if any, in furnishing services and treatment for children with substance use disorders using telehealth services and using services delivered in person, such as, and to the extent feasible, with respect to— (i) utilization rates; (ii) costs; (iii) avoidable inpatient admissions and readmissions; (iv) quality of care; and (v) patient, family, and provider satisfaction. (2) Publication The Secretary shall publish the report required under paragraph (1) on a public Internet website of the Department of Health and Human Services. 2204. Enhancing patient access to non-opioid treatment options Not later than January 1, 2019, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue 1 or more final guidance documents, or update existing guidance documents, to States regarding mandatory and optional items and services that may be provided under a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or under a waiver of such a plan, for non-opioid treatment and management of pain, including, but not limited to, evidence-based non-opioid pharmacological therapies and non-pharmacological therapies. 2205. Assessing barriers to opioid use disorder treatment (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study regarding the barriers to providing medication used in the treatment of substance use disorders under Medicaid distribution models such as the buy-and-bill model, and options for State Medicaid programs to remove or reduce such barriers. The study shall include analyses of each of the following models of distribution of substance use disorder treatment medications, particularly buprenorphine, naltrexone, and buprenorphine-naloxone combinations: (A) The purchasing, storage, and administration of substance use disorder treatment medications by providers. (B) The dispensing of substance use disorder treatment medications by pharmacists. (C) The ordering, prescribing, and obtaining substance use disorder treatment medications on demand from specialty pharmacies by providers. (2) Requirements For each model of distribution specified in paragraph (1), the Comptroller General shall evaluate how each model presents barriers or could be used by selected State Medicaid programs to reduce the barriers related to the provision of substance use disorder treatment by examining what is known about the effects of the model of distribution on— (A) Medicaid beneficiaries’ access to substance use disorder treatment medications; (B) the differential cost to the program between each distribution model for medication assisted treatment; and (C) provider willingness to provide or prescribe substance use disorder treatment medications. (b) Report Not later than 15 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. 2206. Help for moms and babies (a) Medicaid state plan Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended by adding at the end the following new sentence: In the case of a woman who is eligible for medical assistance on the basis of being pregnant (including through the end of the month in which the 60-day period beginning on the last day of her pregnancy ends), who is a patient in an institution for mental diseases for purposes of receiving treatment for a substance use disorder, and who was enrolled for medical assistance under the State plan immediately before becoming a patient in an institution for mental diseases or who becomes eligible to enroll for such medical assistance while such a patient, the exclusion from the definition of medical assistance set forth in the subdivision (B) following paragraph (29) of the first sentence of this subsection shall not be construed as prohibiting Federal financial participation for medical assistance for items or services that are provided to the woman outside of the institution. . (b) Effective date (1) In general Except as provided in paragraph (2), the amendment made by subsection (a) shall take effect on the date of enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendment made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 2207. Securing flexibility to treat substance use disorders Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)) is amended by adding at the end the following new paragraph: (7) Payment shall be made under this title to a State for expenditures for capitation payments described in section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation). . 2208. MACPAC study and report on MAT utilization controls under State Medicaid programs (a) Study The Medicaid and CHIP Payment and Access Commission shall conduct a study and analysis of utilization control policies applied to medication-assisted treatment for substance use disorders under State Medicaid programs, including policies and procedures applied both in fee-for-service Medicaid and in risk-based managed care Medicaid, which shall— (1) include an inventory of such utilization control policies and related protocols for ensuring access to medically necessary treatment; (2) determine whether managed care utilization control policies and procedures for medication assisted treatment for substance use disorders are consistent with section 438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and (3) identify policies that— (A) limit an individual's access to medication-assisted treatment for a substance use disorder by limiting the quantity of medication-assisted treatment prescriptions, or the number of refills for such prescriptions, available to the individual as part of a prior authorization process or similar utilization protocols; and (B) apply without evaluating individual instances of fraud, waste, or abuse. (b) Report Not later than 1 year after the date of the enactment of this Act, the Medicaid and CHIP Payment and Access Commission shall make publicly available a report containing the results of the study conducted under subsection (a). 2209. Opioid addiction treatment programs enhancement (a) T–MSIS substance use disorder data book (1) In general Not later than the date that is 12 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall publish on the public website of the Centers for Medicare & Medicaid Services a report with comprehensive data on the prevalence of substance use disorders in the Medicaid beneficiary population and services provided for the treatment of substance use disorders under Medicaid. (2) Content of report The report required under paragraph (1) shall include, at a minimum, the following data for each State (including, to the extent available, for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa): (A) The number and percentage of individuals enrolled in the State Medicaid plan or waiver of such plan in each of the major enrollment categories (as defined in a public letter from the Medicaid and CHIP Payment and Access Commission to the Secretary) who have been diagnosed with a substance use disorder and whether such individuals are enrolled under the State Medicaid plan or a waiver of such plan, including the specific waiver authority under which they are enrolled, to the extent available. (B) A list of the substance use disorder treatment services by each major type of service, such as counseling, medication assisted treatment, peer support, residential treatment, and inpatient care, for which beneficiaries in each State received at least 1 service under the State Medicaid plan or a waiver of such plan. (C) The number and percentage of individuals with a substance use disorder diagnosis enrolled in the State Medicaid plan or waiver of such plan who received substance use disorder treatment services under such plan or waiver by each major type of service under subparagraph (B) within each major setting type, such as outpatient, inpatient, residential, and other home and community-based settings. (D) The number of services provided under the State Medicaid plan or waiver of such plan per individual with a substance use disorder diagnosis enrolled in such plan or waiver for each major type of service under subparagraph (B). (E) The number and percentage of individuals enrolled in the State Medicaid plan or waiver, by major enrollment category, who received substance use disorder treatment through— (i) a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act (42 U.S.C. 1396u–2(a)(1)(B))), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan; (ii) a fee-for-service payment model; or (iii) an alternative payment model, to the extent available. (F) The number and percentage of individuals with a substance use disorder who receive substance use disorder treatment services in an outpatient or home and community-based setting after receiving treatment in an inpatient or residential setting, and the number of services received by such individuals in the outpatient or home and community-based setting. (3) Annual updates The Secretary shall issue an updated version of the report required under paragraph (1) not later than January 1 of each calendar year through 2024. (4) Use of T–MSIS data The report required under paragraph (1) and updates required under paragraph (3) shall— (A) use data and definitions from the Transformed Medicaid Statistical Information System ( T–MSIS ) data set that is no more than 12 months old on the date that the report or update is published; and (B) as appropriate, include a description with respect to each State of the quality and completeness of the data and caveats describing the limitations of the data reported to the Secretary by the State that is sufficient to communicate the appropriate uses for the information. (b) Making T–MSIS data on substance use disorders available to researchers (1) In general The Secretary shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System. (2) Required data The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings. (3) Initiation of data-sharing activities Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1). 2210. Better data sharing to combat the opioid crisis (a) In general Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by section 2207, is amended by adding at the end the following new paragraph: (8) (A) The State agency administering the State plan under this title may have reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State to the extent the State agency is permitted to access such databases under State law. (B) Such State agency may facilitate reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State, to same extent that the State agency is permitted under State law to access such databases, for— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). (C) Such State agency may share information in such databases, to the same extent that the State agency is permitted under State law to share information in such databases, with— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). . (b) Security and privacy All applicable State and Federal security and privacy protections and laws shall apply to any State agency, individual, or entity accessing 1 or more prescription drug monitoring program databases or obtaining information in such databases in accordance with section 1903(m)(8) of the Social Security Act (42 U.S.C. 1396b(m)(8)) (as added by subsection (a)). (c) Effective date The amendment made by subsection (a) shall take effect on the date of enactment of this Act. 2211. Mandatory reporting with respect to adult behavioral health measures Section 1139B of the Social Security Act (42 U.S.C. 1320b–9b) is amended— (1) in subsection (b)— (A) in paragraph (3)— (i) by striking Not later than January 1, 2013 and inserting the following: (A) Voluntary reporting Not later than January 1, 2013 ; and (ii) by adding at the end the following: (B) Mandatory reporting with respect to behavioral health measures Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults. ; (B) in paragraph (5), by adding at the end the following new subparagraph: (C) Behavioral health measures Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures. ; and (2) in subsection (d)(1)(A)— (A) by striking the such plan and inserting such plan ; and (B) by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)) . 2212. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to Congress describing innovative State initiatives and strategies for providing housing-related services and supports under a State Medicaid program to individuals with substance use disorders who are experiencing or at risk of experiencing homelessness. (b) Content of report The report required under subsection (a) shall describe the following: (1) Existing methods and innovative strategies developed and adopted by State Medicaid programs that have achieved positive outcomes in increasing housing stability among Medicaid beneficiaries with substance use disorders who are experiencing or at risk of experiencing homelessness, including Medicaid beneficiaries with substance use disorders who are— (A) receiving treatment for substance use disorders in inpatient, residential, outpatient, or home and community-based settings; (B) transitioning between substance use disorder treatment settings; or (C) living in supportive housing or another model of affordable housing. (2) Strategies employed by Medicaid managed care organizations, primary care case managers, hospitals, accountable care organizations, and other care coordination providers to deliver housing-related services and supports and to coordinate services provided under State Medicaid programs across different treatment settings. (3) Innovative strategies and lessons learned by States with Medicaid waivers approved under section 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n), including— (A) challenges experienced by States in designing, securing, and implementing such waivers or plan amendments; (B) how States developed partnerships with other organizations such as behavioral health agencies, State housing agencies, housing providers, health care services agencies and providers, community-based organizations, and health insurance plans to implement waivers or State plan amendments; and (C) how and whether States plan to provide Medicaid coverage for housing-related services and supports in the future, including by covering such services and supports under State Medicaid plans or waivers. (4) Existing opportunities for States to provide housing-related services and supports through a Medicaid waiver under sections 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n) or through a State Medicaid plan amendment, such as the Assistance in Community Integration Service pilot program, which promotes supportive housing and other housing-related supports under Medicaid for individuals with substance use disorders and for which Maryland has a waiver approved under such section 1115 to conduct the program. (5) Innovative strategies and partnerships developed and implemented by State Medicaid programs or other entities to identify and enroll eligible individuals with substance use disorders who are experiencing or at risk of experiencing homelessness in State Medicaid programs. 2213. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid (a) In general The Secretary of Health and Human Services shall provide technical assistance and support to States regarding the development and expansion of innovative State strategies (including through State Medicaid demonstration projects) to provide housing-related supports and services and care coordination services under Medicaid to individuals with substance use disorders. (b) Report Not later than 180 days after the date of enactment of this Act, the Secretary shall issue a report to Congress detailing a plan of action to carry out the requirements of subsection (a). C Human Services 2301. Supporting family-focused residential treatment (a) Definitions In this section: (1) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (2) Medicaid program The term Medicaid program means the program established under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Title IV–E program The term title IV–E program means the program for foster care, prevention, and permanency established under part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.). (b) Guidance on family-focused residential treatment programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with divisions of the Department of Health and Human Services administering substance use disorder or child welfare programs, shall develop and issue guidance to States identifying opportunities to support family-focused residential treatment programs for the provision of substance use disorder treatment. Before issuing such guidance, the Secretary shall solicit input from representatives of States, health care providers with expertise in addiction medicine, obstetrics and gynecology, neonatology, child trauma, and child development, health plans, recipients of family-focused treatment services, and other relevant stakeholders. (2) Additional requirements The guidance required under paragraph (1) shall include descriptions of the following: (A) Existing opportunities and flexibilities under the Medicaid program, including under waivers authorized under section 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n), for States to receive Federal Medicaid funding for the provision of substance use disorder treatment for pregnant and postpartum women and parents and guardians and, to the extent applicable, their children, in family-focused residential treatment programs. (B) How States can employ and coordinate funding provided under the Medicaid program, the title IV-E program, and other programs administered by the Secretary to support the provision of treatment and services provided by a family-focused residential treatment facility such as substance use disorder treatment and services, including medication-assisted treatment, family, group, and individual counseling, case management, parenting education and skills development, the provision, assessment, or coordination of care and services for children, including necessary assessments and appropriate interventions, non-emergency transportation for necessary care provided at or away from a program site, transitional services and supports for families leaving treatment, and other services. (C) How States can employ and coordinate funding provided under the Medicaid program and the title IV–E program (including as amended by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123, and particularly with respect to the authority under subsections (a)(2)(C) and (j) of section 472 and section 474(a)(1) of the Social Security Act (42 U.S.C. 672, 674(a)(1)) (as amended by section 50712 of Public Law 115–123) to provide foster care maintenance payments for a child placed with a parent who is receiving treatment in a licensed residential family-based treatment facility for a substance use disorder) to support placing children with their parents in family-focused residential treatment programs. 2302. Improving recovery and reunifying families (a) Family Recovery and Reunification Program Replication Project Section 435 of the Social Security Act (42 U.S.C. 629e) is amended by adding at the end the following: (e) Family Recovery and Reunification Program Replication Project (1) Purpose The purpose of this subsection is to provide resources to the Secretary to support the conduct and evaluation of a family recovery and reunification program replication project (referred to in this subsection as the project ) and to determine the extent to which such programs may be appropriate for use at different intervention points (such as when a child is at risk of entering foster care or when a child is living with a guardian while a parent is in treatment). The family recovery and reunification program conducted under the project shall use a recovery coach model that is designed to help reunify families and protect children by working with parents or guardians with a substance use disorder who have temporarily lost custody of their children. (2) Program components The family recovery and reunification program conducted under the project shall adhere closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children and, consistent with such elements and protocol, shall provide such items and services as— (A) assessments to evaluate the needs of the parent or guardian; (B) assistance in receiving the appropriate benefits to aid the parent or guardian in recovery; (C) services to assist the parent or guardian in prioritizing issues identified in assessments, establishing goals for resolving such issues that are consistent with the goals of the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children, and making a coordinated plan for achieving such goals; (D) home visiting services coordinated with the child welfare agency and treatment provider involved with the parent or guardian or their children; (E) case management services to remove barriers for the parent or guardian to participate and continue in treatment, as well as to re-engage a parent or guardian who is not participating or progressing in treatment; (F) access to services needed to monitor the parent’s or guardian's compliance with program requirements; (G) frequent reporting between the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children to ensure appropriate information on the parent’s or guardian's status is available to inform decision-making; and (H) assessments and recommendations provided by a recovery coach to the child welfare caseworker responsible for documenting the parent’s or guardian's progress in treatment and recovery as well as the status of other areas identified in the treatment plan for the parent or guardian, including a recommendation regarding the expected safety of the child if the child is returned to the custody of the parent or guardian that can be used by the caseworker and a court to make permanency decisions regarding the child. (3) Responsibilities of the secretary (A) In general The Secretary shall, through a grant or contract with 1 or more entities, conduct and evaluate the family recovery and reunification program under the project. (B) Requirements In identifying 1 or more entities to conduct the evaluation of the family recovery and reunification program, the Secretary shall— (i) determine that the area or areas in which the program will be conducted have sufficient substance use disorder treatment providers and other resources (other than those provided with funds made available to carry out the project) to successfully conduct the program; (ii) determine that the area or areas in which the program will be conducted have enough potential program participants, and will serve a sufficient number of parents or guardians and their children, so as to allow for the formation of a control group, evaluation results to be adequately powered, and preliminary results of the evaluation to be available within 4 years of the program's implementation; (iii) provide the entity or entities with technical assistance for the program design, including by working with 1 or more entities that are or have been involved in recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children so as to make sure the program conducted under the project adheres closely to the elements and protocol determined to be most effective in such other recovery coaching programs; (iv) assist the entity or entities in securing adequate coaching, treatment, child welfare, court, and other resources needed to successfully conduct the family recovery and reunification program under the project; and (v) ensure the entity or entities will be able to monitor the impacts of the program in the area or areas in which it is conducted for at least 5 years after parents or guardians and their children are randomly assigned to participate in the program or to be part of the program's control group. (4) Evaluation requirements (A) In general The Secretary, in consultation with the entity or entities conducting the family recovery and reunification program under the project, shall conduct an evaluation to determine whether the program has been implemented effectively and resulted in improvements for children and families. The evaluation shall have 3 components: a pilot phase, an impact study, and an implementation study. (B) Pilot phase The pilot phase component of the evaluation shall consist of the Secretary providing technical assistance to the entity or entities conducting the family recovery and reunification program under the project to ensure— (i) the program's implementation adheres closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) random assignment of parents or guardians and their children to be participants in the program or to be part of the program's control group is being carried out. (C) Impact study The impact study component of the evaluation shall determine the impacts of the family recovery and reunification program conducted under the project on the parents and guardians and their children participating in the program. The impact study component shall— (i) be conducted using an experimental design that uses a random assignment research methodology; (ii) consistent with previous studies of other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children, measure outcomes for parents and guardians and their children over multiple time periods, including for a period of 5 years; and (iii) include measurements of family stability and parent, guardian, and child safety for program participants and the program control group that are consistent with measurements of such factors for participants and control groups from previous studies of other recovery coaching programs so as to allow results of the impact study to be compared with the results of such prior studies, including with respect to comparisons between program participants and the program control group regarding— (I) safe family reunification; (II) time to reunification; (III) permanency (such as through measures of reunification, adoption, or placement with guardians); (IV) safety (such as through measures of subsequent maltreatment); (V) parental or guardian treatment persistence and engagement; (VI) parental or guardian substance use; (VII) juvenile delinquency; (VIII) cost; and (IX) other measurements agreed upon by the Secretary and the entity or entities operating the family recovery and reunification program under the project. (D) Implementation study The implementation study component of the evaluation shall be conducted concurrently with the conduct of the impact study component and shall include, in addition to such other information as the Secretary may determine, descriptions and analyses of— (i) the adherence of the family recovery and reunification program conducted under the project to other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) the difference in services received or proposed to be received by the program participants and the program control group. (E) Report The Secretary shall publish on an internet website maintained by the Secretary the following information: (i) A report on the pilot phase component of the evaluation. (ii) A report on the impact study component of the evaluation. (iii) A report on the implementation study component of the evaluation. (iv) A report that includes— (I) analyses of the extent to which the program has resulted in increased reunifications, increased permanency, case closures, net savings to the State or States involved (taking into account both costs borne by States and the Federal government), or other outcomes, or if the program did not produce such outcomes, an analysis of why the replication of the program did not yield such results; (II) if, based on such analyses, the Secretary determines the program should be replicated, a replication plan; and (III) such recommendations for legislation and administrative action as the Secretary determines appropriate. (5) Appropriation In addition to any amounts otherwise made available to carry out this subpart, out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated $15,000,000 for fiscal year 2019 to carry out the project, which shall remain available through fiscal year 2026. . (b) Clarification of payer of last resort application to child welfare prevention and family services Section 471(e)(10) of the Social Security Act (42 U.S.C. 671(e)(10)), as added by section 50711(a)(2) of division E of Public Law 115–123, is amended— (1) in subparagraph (A), by inserting , nor shall the provision of such services or programs be construed to permit the State to reduce medical or other assistance available to a recipient of such services or programs after under this Act ; and (2) by adding at the end the following: (C) Payer of last resort In carrying out its responsibilities to ensure access to services or programs under this subsection, the State agency shall not be considered to be a legally liable third party for purposes of satisfying a financial commitment for the cost of providing such services or programs with respect to any individual for whom such cost would have been paid for from another public or private source but for the enactment of this subsection (except that whenever considered necessary to prevent a delay in the receipt of appropriate early intervention services by a child or family in a timely fashion, funds provided under section 474(a)(6) may be used to pay the provider of services or programs pending reimbursement from the public or private source that has ultimate responsibility for the payment). . (c) Effective date The amendments made by subsection (b) shall take effect as if included in section 50711 of division E of Public Law 115–123. 2303. Building capacity for family-focused residential treatment (a) Definitions In this section: (1) Eligible entity The term eligible entity means a State, county, local, or tribal health or child welfare agency, a private nonprofit organization, a research organization, a treatment service provider, an institution of higher education (as defined under section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), or another entity specified by the Secretary. (2) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (3) Secretary The term Secretary means the Secretary of Health and Human Services. (b) Support for the development of evidence-based family-focused residential treatment programs (1) Authority to award grants The Secretary shall award grants to eligible entities for purposes of developing, enhancing, or evaluating family-focused residential treatment programs to increase the availability of such programs that meet the requirements for promising, supported, or well-supported practices specified in section 471(e)(4)(C) of the Social Security Act (42 U.S.C. 671(e)(4)(C))) (as added by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123). (2) Evaluation requirement The Secretary shall require any evaluation of a family-focused residential treatment program by an eligible entity that uses funds awarded under this section for all or part of the costs of the evaluation be designed to assist in the determination of whether the program may qualify as a promising, supported, or well-supported practice in accordance with the requirements of such section 471(e)(4)(C). (c) Authorization of appropriations There is authorized to be appropriated to the Secretary to carry out this section, $20,000,000 for fiscal year 2019, which shall remain available through fiscal year 2023. D Synthetics Trafficking and Overdose Prevention 2401. Short title This subtitle may be cited as the Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 . 2402. Customs fees (a) In general Section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(b)(9)) is amended by adding at the end the following: (D) (i) With respect to the processing of items that are sent to the United States through the international postal network by Inbound Express Mail service or Inbound EMS (as that service is described in the mail classification schedule referred to in section 3631 of title 39, United States Code), the following payments are required: (I) $1 per Inbound EMS item. (II) If an Inbound EMS item is formally entered, the fee provided for under subsection (a)(9), if applicable. (ii) Notwithstanding section 451 of the Tariff Act of 1930 (19 U.S.C. 1451), the payments required by clause (i), as allocated pursuant to clause (iii)(I), shall be the only payments required for reimbursement of U.S. Customs and Border Protection for customs services provided in connection with the processing of an Inbound EMS item. (iii) (I) The payments required by clause (i)(I) shall be allocated as follows: (aa) 50 percent of the amount of the payments shall be paid on a quarterly basis by the United States Postal Service to the Commissioner of U.S. Customs and Border Protection in accordance with regulations prescribed by the Secretary of the Treasury to reimburse U.S. Customs and Border Protection for customs services provided in connection with the processing of Inbound EMS items. (bb) 50 percent of the amount of the payments shall be retained by the Postal Service to reimburse the Postal Service for services provided in connection with the customs processing of Inbound EMS items. (II) Payments received by U.S. Customs and Border Protection under subclause (I)(aa) shall, in accordance with section 524 of the Tariff Act of 1930 (19 U.S.C. 1524), be deposited in the Customs User Fee Account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities. Amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services. (III) Payments retained by the Postal Service under subclause (I)(bb) shall be used to directly reimburse the Postal Service for the costs incurred in providing services in connection with the customs processing of Inbound EMS items. (iv) Beginning in fiscal year 2021, the Secretary, in consultation with the Postmaster General, may adjust, not more frequently than once each fiscal year, the amount described in clause (i)(I) to an amount commensurate with the costs of services provided in connection with the customs processing of Inbound EMS items, consistent with the obligations of the United States under international agreements. . (b) Conforming amendments Section 13031(a) of the Consolidated Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(a)) is amended— (1) in paragraph (6), by inserting (other than an item subject to a fee under subsection (b)(9)(D)) after customs officer ; and (2) in paragraph (10)— (A) in subparagraph (C), in the matter preceding clause (i), by inserting (other than Inbound EMS items described in subsection (b)(9)(D)) after release ; and (B) in the flush at the end, by inserting or of Inbound EMS items described in subsection (b)(9)(D), after (C), . (c) Effective date The amendments made by this section shall take effect on January 1, 2020. 2403. Mandatory advance electronic information for postal shipments (a) Mandatory advance electronic information (1) In general Section 343(a)(3)(K) of the Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 note) is amended to read as follows: (K) (i) The Secretary shall prescribe regulations requiring the United States Postal Service to transmit the information described in paragraphs (1) and (2) to the Commissioner of U.S. Customs and Border Protection for international mail shipments by the Postal Service (including shipments to the Postal Service from foreign postal operators that are transported by private carrier) consistent with the requirements of this subparagraph. (ii) In prescribing regulations under clause (i), the Secretary shall impose requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo, taking into account the parameters set forth in subparagraphs (A) through (J). (iii) The regulations prescribed under clause (i) shall require the transmission of the information described in paragraphs (1) and (2) with respect to a shipment as soon as practicable in relation to the transportation of the shipment, consistent with subparagraph (H). (iv) Regulations prescribed under clause (i) shall allow for the requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) to be implemented in phases, as appropriate, by— (I) setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the Commissioner; and (II) taking into consideration— (aa) the risk posed by such shipments; (bb) the volume of mail shipped to the United States by or through a particular country; and (cc) the capacities of foreign postal operators to provide that information to the Postal Service. (v) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2018, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for not less than 70 percent of the aggregate number of mail shipments, including 100 percent of mail shipments from the People’s Republic of China, described in clause (i). (II) If the requirements of subclause (I) are not met, the Comptroller General of the United States shall submit to the appropriate congressional committees, not later than June 30, 2019, a report— (aa) assessing the reasons for the failure to meet those requirements; and (bb) identifying recommendations to improve the collection by the Postal Service of the information described in paragraphs (1) and (2). (vi) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2020, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for 100 percent of the aggregate number of mail shipments described in clause (i). (II) The Commissioner, in consultation with the Postmaster General, may determine to exclude a country from the requirement described in subclause (I) to transmit information for mail shipments described in clause (i) from the country if the Commissioner determines that the country— (aa) does not have the capacity to collect and transmit such information; (bb) represents a low risk for mail shipments that violate relevant United States laws and regulations; and (cc) accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant United States laws and regulations through an alternate means. (III) The Commissioner shall, at a minimum on an annual basis, re-evaluate any determination made under subclause (II) to exclude a country from the requirement described in subclause (I). If, at any time, the Commissioner determines that a country no longer meets the requirements under subclause (II), the Commissioner may not further exclude the country from the requirement described in subclause (I). (IV) The Commissioner shall, on an annual basis, submit to the appropriate congressional committees— (aa) a list of countries with respect to which the Commissioner has made a determination under subclause (II) to exclude the countries from the requirement described in subclause (I); and (bb) information used to support such determination with respect to such countries. (vii) (I) The Postmaster General shall, in consultation with the Commissioner, refuse any shipments received after December 31, 2020, for which the information described in paragraphs (1) and (2) is not transmitted as required under this subparagraph, except as provided in subclause (II). (II) If remedial action is warranted in lieu of refusal of shipments pursuant to subclause (I), the Postmaster General and the Commissioner shall take remedial action with respect to the shipments, including destruction, seizure, controlled delivery or other law enforcement initiatives, or correction of the failure to provide the information described in paragraphs (1) and (2) with respect to the shipment. (viii) Nothing in this subparagraph shall be construed to limit the authority of the Secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties. (ix) In this subparagraph, the term appropriate congressional committees means— (I) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (II) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. . (2) Joint strategic plan on mandatory advance information Not later than 60 days after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving— (A) the transmission of information as required by section 343(a)(3)(K) of the Trade Act of 2002, as amended by paragraph (1); and (B) the presentation by the Postal Service to U.S. Customs and Border Protection of all mail targeted by U.S. Customs and Border Protection for inspection. (b) Capacity building (1) In general Section 343(a) of the Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 note) is amended by adding at the end the following: (5) Capacity building (A) In general The Secretary, with the concurrence of the Secretary of State, and in coordination with the Postmaster General and the heads of other Federal agencies, as appropriate, may provide technical assistance, equipment, technology, and training to enhance the capacity of foreign postal operators— (i) to gather and provide the information required by paragraph (3)(K); and (ii) to otherwise gather and provide postal shipment information related to— (I) terrorism; (II) items the importation or introduction of which into the United States is prohibited or restricted, including controlled substances; and (III) such other concerns as the Secretary determines appropriate. (B) Provision of equipment and technology With respect to the provision of equipment and technology under subparagraph (A), the Secretary may lease, loan, provide, or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the Secretary may prescribe, including nonreimbursable loans or the transfer of ownership of equipment and technology. . (2) Joint strategic plan on capacity building Not later than one year after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly develop and submit to the appropriate congressional committees a joint strategic plan— (A) detailing the extent to which U.S. Customs and Border Protection and the United States Postal Service are engaged in capacity building efforts under section 343(a)(5) of the Trade Act of 2002, as added by paragraph (1); (B) describing plans for future capacity building efforts; and (C) assessing how capacity building has increased the ability of U.S. Customs and Border Protection and the Postal Service to advance the goals of this subtitle and the amendments made by this subtitle. (c) Report and consultations by Secretary of Homeland Security and Postmaster General (1) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 3 years after the Postmaster General has met the requirement under clause (vi) of subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following: (A) An assessment of the status of the regulations required to be promulgated under that subparagraph. (B) An update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph. (C) A summary of deliberations between the United States Postal Service and foreign postal operators with respect to issues relating to the transmission of that information. (D) A summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph. (E) An assessment of the quality of that information being received by foreign postal operators, as determined by the Secretary of Homeland Security, and actions taken to improve the quality of that information. (F) A summary of policies established by the Universal Postal Union that may affect the ability of the Postmaster General to obtain the transmission of that information. (G) A summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology. (H) Such other information as the Secretary of Homeland Security and the Postmaster General consider appropriate with respect to obtaining the transmission of information required by that subparagraph. (2) Consultations Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the Postmaster General has met the requirement under clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as amended by subsection (a)(1), to arrange for the transmission of information with respect to 100 percent of the aggregate number of mail shipments described in clause (i) of that section, the Secretary of Homeland Security and the Postmaster General shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments. (d) Government Accountability Office report Not later than June 30, 2019, the Comptroller General of the United States shall submit to the appropriate congressional committees a report— (1) assessing the progress of the United States Postal Service in achieving the transmission of the information required by subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), for the percentage of shipments required by that subparagraph; (2) assessing the quality of the information received from foreign postal operators for targeting purposes; (3) assessing the specific percentage of targeted mail presented by the Postal Service to U.S. Customs and Border Protection for inspection; (4) describing the costs of collecting the information required by such subparagraph (K) from foreign postal operators and the costs of implementing the use of that information; (5) assessing the benefits of receiving that information with respect to international mail shipments; (6) assessing the feasibility of assessing a customs fee under section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 2402, on international mail shipments other than Inbound Express Mail service in a manner consistent with the obligations of the United States under international agreements; and (7) identifying recommendations, including recommendations for legislation, to improve the compliance of the Postal Service with such subparagraph (K), including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by— (A) requiring the Postal Service to serve as the consignee for international mail shipments containing goods; or (B) designating a customs broker to act as an importer of record for international mail shipments containing goods. (e) Technical correction Section 343 of the Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 note) is amended in the section heading by striking advanced and inserting advance . (f) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 2404. International postal agreements (a) Existing agreements (1) In general In the event that any provision of this subtitle, or any amendment made by this subtitle, is determined to be in violation of obligations of the United States under any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, the Secretary of State should negotiate to amend the relevant provisions of the agreement so that the United States is no longer in violation of the agreement. (2) Rule of construction Nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle. (b) Future agreements (1) Consultations Before entering into, on or after the date of the enactment of this Act, any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, that is related to the ability of the United States to secure the provision of advance electronic information by foreign postal operators, the Secretary of State should consult with the appropriate congressional committees (as defined in section 2403(f)). (2) Expedited negotiation of new agreement To the extent that any new postal treaty, convention, or other international agreement related to international postal services would improve the ability of the United States to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section 343(a)(3)(K) of the Trade Act of 2002, as amended by section 2403(a)(1), the Secretary of State should expeditiously conclude such an agreement. 2405. Cost recoupment (a) In general The United States Postal Service shall, to the extent practicable and otherwise recoverable by law, ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators. (b) Costs not considered revenue The recovery of costs under subsection (a) shall not be deemed revenue for purposes of subchapter I and II of chapter 36 of title 39, United States Code, or regulations prescribed under that chapter. 2406. Development of technology to detect illicit narcotics (a) In general The Postmaster General and the Commissioner of U.S. Customs and Border Protection, in coordination with the heads of other agencies as appropriate, shall collaborate to identify and develop technology for the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States by mail. (b) Outreach to private sector The Postmaster General and the Commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States. 2407. Civil penalties for postal shipments Section 436 of the Tariff Act of 1930 (19 U.S.C. 1436) is amended by adding at the end the following new subsection: (e) Civil penalties for postal shipments (1) Civil penalty A civil penalty shall be imposed against the United States Postal Service if the Postal Service accepts a shipment in violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (2) Modification of civil penalty (A) In general U.S. Customs and Border Protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph (1) if U.S. Customs and Border Protection determines that the United States Postal Service— (i) has a low error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002; (ii) is cooperating with U.S. Customs and Border Protection with respect to the violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or (iii) has taken remedial action to prevent future violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (B) Written notification U.S. Customs and Border Protection shall issue a written notification to the Postal Service with respect to each exercise of the authority of subparagraph (A) to reduce or dismiss a civil penalty imposed pursuant to paragraph (1). (3) Ongoing lack of compliance If U.S. Customs and Border Protection determines that the United States Postal Service— (A) has repeatedly committed violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, (B) has failed to cooperate with U.S. Customs and Border Protection with respect to violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and (C) has an increasing error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002, civil penalties may be imposed against the United States Postal Service until corrective action, satisfactory to U.S. Customs and Border Protection, is taken. . 2408. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest (a) In general The Commissioner of U.S. Customs and Border Protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection (b) with respect to each violation of section 436 of the Tariff Act of 1930 (19 U.S.C. 1436), as amended by section 7, and section 584 of such Act (19 U.S.C. 1584) that occurred during the previous year. (b) Information described The information described in this subsection is the following: (1) The name and address of the violator. (2) The specific violation that was committed. (3) The location or port of entry through which the items were transported. (4) An inventory of the items seized, including a description of the items and the quantity seized. (5) The location from which the items originated. (6) The entity responsible for the apprehension or seizure, organized by location or port of entry. (7) The amount of penalties assessed by U.S. Customs and Border Protection, organized by name of the violator and location or port of entry. (8) The amount of penalties that U.S. Customs and Border Protection could have levied, organized by name of the violator and location or port of entry. (9) The rationale for negotiating lower penalties, organized by name of the violator and location or port of entry. (c) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 2409. Effective date; regulations (a) Effective date This subtitle and the amendments made by this subtitle (other than the amendments made by section 2402) shall take effect on the date of the enactment of this Act. (b) Regulations Not later than one year after the date of the enactment of this Act, such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed. III Judiciary A Access to Increased Drug Disposal 3101. Short title This subtitle may be cited as the Access to Increased Drug Disposal Act of 2018 . 3102. Definitions In this subtitle— (1) the term Attorney General means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs; (2) the term authorized collector means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation); (3) the term covered grant means a grant awarded under section 3003; and (4) the term eligible collector means a person who is eligible to be an authorized collector. 3103. Authority to make grants The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors. 3104. Application A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum— (1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant; (2) details a plan to increase participation rates of eligible collectors as authorized collectors; and (3) describes how the State will select eligible collectors to be served under the grant. 3105. Use of grant funds A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors. 3106. Eligibility for grant The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General. 3107. Duration of grants The Attorney General shall determine the period of years for which a covered grant is made to a State. 3108. Accountability and oversight A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that— (1) lists the ultimate recipients of the grant amounts; (2) describes the activities undertaken by the State using the grant amounts; and (3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors. 3109. Duration of program The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act. 3110. Authorization of appropriations There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this subtitle. B Using Data To Prevent Opioid Diversion 3201. Short title This subtitle may be cited as the Using Data to Prevent Opioid Diversion Act of 2018 . 3202. Purpose (a) In general The purpose of this subtitle is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates. (b) Rule of construction Nothing in this subtitle should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to— (1) identify, stop, and report suspicious orders; or (2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation. 3203. Amendments (a) Records and reports of registrants Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended— (1) by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively; (2) by inserting after subsection (e) the following: (f) (1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances: (A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant. (B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A). (2) The information required to be made available under paragraph (1) shall be made available not later than the 15th day of the first month following the quarter to which the information relates. (3) (A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection. (B) In determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant. ; and (3) by inserting after subsection (i), as so redesignated, the following: (j) All of the reports required under this section shall be provided in an electronic format. . (b) Cooperative arrangements Section 503 of the Controlled Substances Act (21 U.S.C. 873) is amended— (1) by striking subsection (c) and inserting the following: (c) (1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse. (2) If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection. . (c) Civil and criminal penalties Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended— (1) in subsection (a)— (A) in paragraph (15), by striking or at the end; (B) in paragraph (16), by striking the period at the end and inserting ; or ; and (C) by inserting after paragraph (16) the following: (17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f). ; and (2) in subsection (c)— (A) in paragraph (1), by striking subparagraph (B) and inserting the following: (B) (i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the penalty shall not exceed $10,000. (ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000. ; and (B) in paragraph (2)— (i) in subparagraph (A), by inserting or (D) after subparagraph (B) ; and (ii) by adding at the end the following: (D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000. . 3204. Report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor. C Substance Abuse Prevention 3301. Short title This subtitle may be cited as the Substance Abuse Prevention Act of 2018 . 3302. Reauthorization of the Office of National Drug Control Policy (a) Office of National Drug Control Policy Reauthorization Act of 1998 (1) In general The Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.), as in effect on September 29, 2003, and as amended by the laws described in paragraph (2), is revived and restored. (2) Laws described The laws described in this paragraph are: (A) The Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469; 120 Stat. 3502). (B) The Presidential Appointment Efficiency and Streamlining Act of 2011 (Public Law 112–166; 126 Stat. 1283). (b) Reauthorization Section 715(a) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1712(a)) is amended by striking 2010 and inserting 2022 . 3303. Reauthorization of the Drug-Free Communities Program Section 1024 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1524(a)) is amended by striking subsections (a) and (b) and inserting the following: (a) In general There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this chapter $99,000,000 for each of fiscal years 2018 through 2022. (b) Administrative costs Not more than 8 percent of the funds appropriated to carry out this chapter may be used by the Office of National Drug Control Policy to pay administrative costs associated with the responsibilities of the Office under this chapter. . 3304. Reauthorization of the National Community Anti-Drug Coalition Institute Section 4(c)(4) of Public Law 107–82 (21 U.S.C. 1521 note) is amended by striking 2008 through 2012 and inserting 2018 through 2022 . 3305. Reauthorization of the High-Intensity Drug Trafficking Area Program Section 707(p) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1706(p)) is amended— (1) in paragraph (4), by striking and at the end; (2) in paragraph (5), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (6) $280,000,000 for each of fiscal years 2018 through 2022. . 3306. Reauthorization of drug court program Section 1001(a)(25)(A) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10261(a)(25)(A)) is amended by striking Except as provided and all that follows and inserting the following: Except as provided in subparagraph (C), there is authorized to be appropriated to carry out part EE $75,000,000 for each of fiscal years 2018 through 2022. . 3307. Drug court training and technical assistance Section 705 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1704) is amended by adding at the end the following— (e) Drug Court Training and Technical Assistance Program Using funds appropriated to carry out this title, the Director may make grants to nonprofit organizations for the purpose of providing training and technical assistance to drug courts. . 3308. Drug overdose response strategy Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1706) is amended by adding at the end the following: (r) Drug overdose response strategy implementation The Director may use funds appropriated to carry out this section to implement a drug overdose response strategy in high intensity drug trafficking areas on a nationwide basis by— (1) coordinating multi-disciplinary efforts to prevent, reduce, and respond to drug overdoses, including the uniform reporting of fatal and non-fatal overdoses to public health and safety officials; (2) increasing data sharing among public safety and public health officials concerning drug-related abuse trends, including new psychoactive substances, and related crime; and (3) enabling collaborative deployment of prevention, intervention, and enforcement resources to address substance use addiction and narcotics trafficking. . 3309. Protecting law enforcement officers from accidental exposure Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1706), as amended by section 3308, is amended by adding at the end the following: (s) Supplemental grants The Director is authorized to use not more than $10,000,000 of the amounts otherwise appropriated to carry out this section to provide supplemental competitive grants to high intensity drug trafficking areas that have experienced high seizures of fentanyl and new psychoactive substances for the purposes of— (1) purchasing portable equipment to test for fentanyl and other substances; (2) training law enforcement officers and other first responders on best practices for handling fentanyl and other substances; and (3) purchasing protective equipment, including overdose reversal drugs. . 3310. COPS Anti-Meth Program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10381) is amended— (1) by redesignating subsection (k) as subsection (l); and (2) by inserting after subsection (j) the following: (k) COPS Anti-Meth Program The Attorney General shall use amounts otherwise appropriated to carry out this section to make competitive grants, in amounts of not less than $1,000,000 for a fiscal year, to State law enforcement agencies with high seizures of precursor chemicals, finished methamphetamine, laboratories, and laboratory dump seizures for the purpose of locating or investigating illicit activities, such as precursor diversion, laboratories, or methamphetamine traffickers. . 3311. COPS anti-heroin task force program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10381) is amended— (1) by redesignating subsection (l), as so redesignated by section 3310, as subsection (m); and (2) by inserting after subsection (k), as added by section 3310, the following: (l) Cops anti-heroin task force program The Attorney General shall use amounts otherwise appropriated to carry out this section, or other amounts as appropriated, to make competitive grants to State law enforcement agencies in States with high per capita rates of primary treatment admissions, for the purpose of locating or investigating illicit activities, through Statewide collaboration, relating to the distribution of heroin, fentanyl, or carfentanil or relating to the unlawful distribution of prescription opioids. . 3312. Comprehensive Addiction and Recovery Act education and awareness Title VII of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198; 130 Stat. 735) is amended by adding at the end the following: 709. Services for families and patients in crisis (a) In general The Attorney General may make grants to entities that focus on addiction and substance use disorders and specialize in family and patient services, advocacy for patients and families, and educational information. (b) Allowable uses A grant awarded under this section may be used for private, nonprofit national organizations that engage in all of the following activities: (1) Expansion of phone line or call center services with professional, clinical staff that provide, for families and individuals impacted by a substance use disorder, support, access to treatment resources, brief assessments, medication and overdose prevention education, compassionate listening services, recovery support or peer specialists, bereavement and grief support, and case management. (2) Continued development of health information technology systems that leverage new and upcoming technology and techniques for prevention, intervention, and filling resource gaps in communities that are underserved. (3) Enhancement and operation of treatment and recovery resources, easy-to-read scientific and evidence-based education on addiction and substance use disorders, and other informational tools for families and individuals impacted by a substance use disorder and community stakeholders, such as law enforcement agencies. (4) Provision of training and technical assistance to State and local governments, law enforcement agencies, health care systems, research institutions, and other stakeholders. (5) Expanding upon and implementing educational information using evidence-based information on substance use disorders. (6) Expansion of training of community stakeholders, law enforcement officers, and families across a broad-range of addiction, health, and related topics on substance use disorders, local issues and community-specific issues related to the drug epidemic. (7) Program evaluation. (c) Authorization of appropriations For each of fiscal years 2018 through 2022, the Attorney General is authorized to award not more than $10,000,000 of amounts otherwise appropriated to the Attorney General for comprehensive opioid abuse reduction activities for purposes of carrying out this section. . 3313. Protecting children with addicted parents Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is amended by adding at the end the following: 550. Protecting children with addicted parents (a) Best practices The Secretary, acting through the Assistant Secretary and in cooperation with the Commissioner of the Administration on Children, Youth and Families, shall collect and disseminate best practices for States regarding interventions and strategies to keep families affected by a substance use disorder together, when it can be done safely. Such best practices shall— (1) utilize comprehensive family-centered approaches; (2) ensure that families have access to drug screening, substance use disorder treatment, medication-assisted treatment approved by the Food and Drug Administration, and parental support; and (3) build upon lessons learned from— (A) programs such as the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act; and (B) identifying substance abuse prevention and treatment services that meet the requirements for promising, supported, or well-supported practices specified in section 471(e)(4)(C) of the Social Security Act (as such section shall be in effect beginning on October 1, 2018). (b) Grant program The Secretary shall award grants to States, units of local government, and tribal governments to— (1) develop programs and models designed to keep pregnant and post-partum women who have a substance use disorder together with their newborns, including programs and models that provide for screenings of pregnant and post-partum women for substance use disorders, treatment interventions, supportive housing, nonpharmacological interventions for children born with neonatal abstinence syndrome, medication assisted treatment, and other recovery supports; and (2) support the attendance of children who have a family member living with a substance use disorder at therapeutic camps or other therapeutic programs aimed at addiction prevention education and delaying the onset of first use, providing trusted mentors and education on coping strategies that these children can use in their daily lives, and family support initiatives aimed at keeping these families together. . 3314. Reimbursement of substance use disorder treatment professionals Not later than January 1, 2020, the Comptroller General of the United States shall submit to Congress a report examining how substance use disorder services are reimbursed. 3315. Sobriety Treatment and Recovery Teams (START) Title V of the Public Health Service Act (42 U.S.C. 290dd et seq.), as amended by section 3313, is further amended by adding at the end the following: 551. Sobriety Treatment and Recovery Teams (a) In general The Secretary may make grants to States, units of local government, or tribal governments to establish or expand Sobriety Treatment And Recovery Team (referred to in this section as START ) or other similar programs to determine the effectiveness of pairing social workers or mentors with families that are struggling with a substance use disorder and child abuse or neglect in order to help provide peer support, intensive treatment, and child welfare services to such families. (b) Allowable uses A grant awarded under this section may be used for one or more of the following activities: (1) Training eligible staff, including social workers, social services coordinators, child welfare specialists, substance use disorder treatment professionals, and mentors. (2) Expanding access to substance use disorder treatment services and drug testing. (3) Enhancing data sharing with law enforcement agencies, child welfare agencies, substance use disorder treatment providers, judges, and court personnel. (4) Program evaluation and technical assistance. (c) Program requirements A State, unit of local government, or tribal government receiving a grant under this section shall— (1) serve only families for which— (A) there is an open record with the child welfare agency; and (B) substance use disorder was a reason for the record or finding described in paragraph (1); and (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social Security Act focused on improving outcomes for children affected by substance abuse. (d) Technical assistance The Secretary may reserve not more than 5 percent of funds provided under this section to provide technical assistance on the establishment or expansion of programs funded under this section from the National Center on Substance Abuse and Child Welfare. (e) Authorization of appropriations For each of fiscal years 2018 through 2022, the Secretary is authorized to award not more than $10,000,000 of amounts otherwise appropriated to the Secretary for comprehensive opioid abuse reduction activities for purposes of carrying out this section. . 3316. Provider education Not later than 60 days after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall complete the plan related to medical registration coordination required by Senate Report 114–239, which accompanied the Veterans Care Financial Protection Act of 2017 (Public Law 115–131; 132 Stat. 334). 3317. Demand reduction Section 702(1) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701(1)) is amended— (1) by redesignating subparagraphs (F) through (J) as subparagraphs (G) through (K), respectively; and (2) by inserting after subparagraph (E) the following: (F) support for long-term recovery from substance use disorders; . 3318. Anti-drug media campaign Section 709 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1708) is amended— (1) in the section heading, by striking youth ; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking youth ; (B) in paragraph (1), by striking young ; (C) in paragraph (2), by striking of adults of the impact of drug abuse on young people and inserting among the population about the impact of drug abuse ; and (D) in paragraph (3), by striking parents and other interested adults to discuss with young people and inserting interested persons to discuss ; and (3) in subsection (b)(2)(C)(ii), by striking among youth . 3319. Technical corrections to the office of national drug control policy reauthorization act of 1998 The Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.) is amended— (1) in section 703(b)(3)(E) (21 U.S.C. 1702(b)(3)(E))— (A) in clause (i), by adding and at the end; (B) in clause (ii), by striking ; and and inserting a period; and (C) by striking clause (iii); (2) in section 704 (21 U.S.C. 1703)— (A) in subsection (c)(3)(C)— (i) in clause (v), by adding and at the end; (ii) in clause (vi), by striking ; and and inserting a period; and (iii) by striking clause (vii); and (B) in subsection (f)— (i) by striking the first paragraph (5); and (ii) by striking the second paragraph (4); (3) in section 706(a)(2)(A) (21 U.S.C. 1705(a)(2)(A))— (A) by striking clause (ix); and (B) by redesignating clauses (x) through (xiv) as clauses (ix) through (xiii), respectively; and (4) by striking section 708 (21 U.S.C. 1707). D Synthetic Abuse and Labeling of Toxic Substances 3401. Short title This subtitle may be cited as the Synthetic Abuse and Labeling of Toxic Substances Act of 2017 or the SALTS Act . 3402. Controlled substance analogues Section 203 of the Controlled Substances Act (21 U.S.C. 813) is amended— (1) by striking A controlled and inserting (a) In general .—A controlled ; and (2) by adding at the end the following: (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), evidence related to the following factors may be considered, along with all other relevant evidence: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (c) Limitation For purposes of this section, the existence of evidence that a substance was not marketed, advertised, or labeled for human consumption shall not preclude the Government from establishing, based on all the evidence, that the substance was intended for human consumption. . E Opioid Quota Reform 3501. Short title This subtitle may be cited as the Opioid Quota Reform Act . 3502. Strengthening considerations for DEA opioid quotas (a) In general Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended— (1) in subsection (a)— (A) by inserting (1) after (a) ; (B) in the second sentence, by striking Production and inserting Except as provided in paragraph (2), production ; and (C) by adding at the end the following: (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance. ; (2) in subsection (b), in the first sentence, by striking production and inserting manufacturing ; (3) in subsection (c), by striking October and inserting December ; and (4) by adding at the end the following: (i) (1) (A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a covered controlled substance ), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States. (B) In estimating diversion under this paragraph, the Attorney General— (i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the Attorney General determines reliable. (C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. (2) (A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States. (B) Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Caucus on International Narcotics Control, the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance: (i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance. (ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year. (3) Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will— (A) take into consideration changes in the accepted medical use of the covered controlled substances; and (B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events. . (b) Conforming change The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking production and inserting manufacturing . F Preventing Drug Diversion 3601. Short title This subtitle may be cited as the Preventing Drug Diversion Act of 2018 . 3602. Improvements to prevent drug diversion (a) Definition Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following: (57) The term suspicious order includes— (A) an order of a controlled substance of unusual size; (B) an order of a controlled substance deviating substantially from a normal pattern; (C) orders of controlled substances of unusual frequency; and (D) an order having any characteristic that would indicate to a reasonable registrant that it is suspicious or not legitimate. . (b) Suspicious orders Part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) is amended by adding at the end the following: 312. Suspicious orders (a) Reporting Each registrant shall— (1) design and operate a system to identify suspicious orders for the registrant; (2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and (3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (b) Suspicious order database (1) In general Not later than 1 year after the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders. (2) Satisfaction of reporting requirements If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (c) Sharing information with the States (1) In general The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State. (2) Timing The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information. (3) Coordination In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law. . (c) Reports to Congress (1) Definition In this subsection, the term suspicious order has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this subtitle. (2) One time report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include— (A) a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders; (B) a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States; (C) information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and (D) descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity. (3) Additional reports Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year— (A) the number of reports of suspicious orders; (B) a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and (C) a description of the information shared with States based on reports of suspicious orders. (4) One time GAO report Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms— (A) would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real-time to suppliers before orders are filled; (B) may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and (C) would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids. G Sense of Congress 3701. Sense of Congress It is the sense of Congress that: (1) Americans with substance use disorders often seek treatment through recovery homes and clinical treatment facilities that offer detoxification, risk reduction, outpatient treatment, residential treatment, or rehabilitation for substance use. Most of those facilities provide a critical function in addressing substance misuse and abuse, particularly as the incidence and prevalence of substance use disorders, and drug overdose numbers continue to rise. (2) Despite the necessity of such treatment facilities and the important services most provide, there are some bad actors in the industry who, through telemarketing and other schemes, actively recruit patients with private insurance so that programs can bill the insurers without providing the necessary treatment services. Often these patient brokers are paid for each patient successfully recruited. Payments are also made as a percentage of billings, which incentivizes brokers to recommend patients even at low risk levels to the most aggressive and most expensive treatment programs. (3) Unless the patient is enrolled in a Federal health care program, a gap in Federal law exists with respect to patient brokers who are improperly recruiting unsuspecting patients to defraud insurance companies. (4) It is important that Congress provide a mechanism to penalize these bad actors, while minding legitimate entities who continue to help patients find reputable treatment programs. IV Commerce A Fighting Opioid Abuse in Transportation 4101. Short title This subtitle may be cited as the Fighting Opioid Abuse in Transportation Act . 4102. Rail mechanical employee controlled substances and alcohol testing (a) Rail mechanical employees Not later than 2 years after the date of enactment of this Act, the Secretary of Transportation shall publish a final rule in the Federal Register revising the regulations promulgated under section 20140 of title 49, United States Code, to designate a rail mechanical employee as a railroad employee responsible for safety-sensitive functions for purposes of that section. (b) Definition of rail mechanical employee The Secretary shall define the term rail mechanical employee by regulation under subsection (a). (c) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the discretion of the Secretary of Transportation to set different requirements by railroad size or other factors, consistent with applicable law. 4103. Rail yardmaster controlled substances and alcohol testing (a) Yardmasters Not later than 2 years after the date of enactment of this Act, the Secretary of Transportation shall publish a final rule in the Federal Register revising the regulations promulgated under section 20140 of title 49, United States Code, to designate a yardmaster as a railroad employee responsible for safety-sensitive functions for purposes of that section. (b) Definition of yardmaster The Secretary shall define the term yardmaster by regulation under subsection (a). (c) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the discretion of the Secretary of Transportation to set different requirements by railroad size or other factors, consistent with applicable law. 4104. Department of Transportation public drug and alcohol testing database (a) In general Subject to subsection (c), the Secretary of Transportation shall— (1) not later than March 31, 2019, establish and make publicly available on its website a database of the drug and alcohol testing data reported by employers for each mode of transportation; and (2) update the database annually. (b) Contents The database under subsection (a) shall include, for each mode of transportation— (1) the total number of drug and alcohol tests by type of substance tested; (2) the drug and alcohol test results by type of substance tested; (3) the reason for the drug or alcohol test, such as pre-employment, random, post-accident, reasonable suspicion or cause, return-to-duty, or follow-up, by type of substance tested; and (4) the number of individuals who refused testing. (c) Commercially sensitive data The Department of Transportation shall not release any commercially sensitive data furnished by an employer under this section unless the data is aggregated or otherwise in a form that does not identify the employer providing the data. (d) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the requirements of the Secretary of Transportation to adhere to requirements applicable to confidential business information and sensitive security information, consistent with applicable law. 4105. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data (a) In general Not later than 2 years after the date the Department of Transportation public drug and alcohol testing database is established under section 4104, the Comptroller General of the United States shall— (1) review the Department of Transportation Drug and Alcohol Testing Management Information System; and (2) submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on the review, including recommendations under subsection (c). (b) Contents The report under subsection (a) shall include— (1) a description of the process the Department of Transportation uses to collect and record drug and alcohol testing data submitted by employers for each mode of transportation; (2) an assessment of whether and, if so, how the Department of Transportation uses the data described in paragraph (1) in carrying out its responsibilities; and (3) an assessment of the Department of Transportation public drug and alcohol testing database under section 4104. (c) Recommendations The report under subsection (a) may include recommendations regarding— (1) how the Department of Transportation can best use the data described in subsection (b)(1); (2) any improvements that could be made to the process described in subsection (b)(1); (3) whether and, if so, how the Department of Transportation public drug and alcohol testing database under section 4104 could be made more effective; and (4) such other recommendations as the Comptroller General considers appropriate. 4106. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl (a) Mandatory Guidelines for Federal Workplace Drug Testing Programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall determine whether a revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the opioid category on the list of authorized drug testing to include fentanyl is justified, based on the reliability and cost-effectiveness of available testing. (2) Revision of guidelines If the expansion of the opioid category is determined to be justified under paragraph (1), the Secretary of Health and Human Services shall— (A) notify the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives of the determination; and (B) publish in the Federal Register, not later than 18 months after the date of the determination under that paragraph, a final notice of the revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the opioid category on the list of authorized drug testing to include fentanyl. (3) Report If the expansion of the opioid category is determined not to be justified under paragraph (1), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report explaining, in detail, the reasons the expansion of the opioid category on the list of authorized drugs to include fentanyl is not justified. (b) Department of Transportation drug-testing panel If the expansion of the opioid category is determined to be justified under subsection (a)(1), the Secretary of Transportation shall publish in the Federal Register, not later than 18 months after the date the final notice is published under subsection (a)(2), a final rule revising part 40 of title 49, Code of Federal Regulations, to include fentanyl in the Department of Transportation's drug-testing panel, consistent with the Mandatory Guidelines for Federal Workplace Drug Testing Programs as revised by the Secretary of Health and Human Services under subsection (a). (c) Savings provision Nothing in this section may be construed as— (1) delaying the publication of the notices described in sections 4107 and 4108 until the Secretary of Health and Human Services makes a determination or publishes a notice under this section; or (2) limiting or otherwise affecting any authority of the Secretary of Health and Human Services or the Secretary of Transportation to expand the list of authorized drug testing to include an additional substance. 4107. Status reports on hair testing guidelines (a) In general Not later than 30 days after the date of enactment of this Act, and every 180 days thereafter until the date that the Secretary of Health and Human Services publishes in the Federal Register a final notice of scientific and technical guidelines for hair testing in accordance with section 5402(b) of the Fixing America's Surface Transportation Act (Public Law 114–94; 129 Stat. 1312), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on— (1) the status of the hair testing guidelines; (2) an explanation for why the hair testing guidelines have not been issued; (3) a schedule, including benchmarks, for the completion of the hair testing guidelines; and (4) an estimated date of completion of the hair testing guidelines. (b) Requirement To the extent practicable and consistent with the objective of the hair testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results of the individual being tested caused solely by the drug use of others and not caused by the drug use of the individual being tested. 4108. Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (a) Deadline Not later than December 31, 2018, the Secretary of Health and Human Services shall publish in the Federal Register a final notice of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, based on the notice of proposed mandatory guidelines published in the Federal Register on May 15, 2015 (80 Fed. Reg. 28054). (b) Requirement To the extent practicable and consistent with the objective of the testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results of the individual being tested caused solely by the drug use of others and not caused by the drug use of the individual being tested. (c) Rule of construction Nothing in this section may be construed as requiring the Secretary of Health and Human Services to reissue a notice of proposed mandatory guidelines to carry out subsection (a). 4109. Electronic recordkeeping (a) Deadline Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) ensure that each certified laboratory that requests approval for the use of completely paperless electronic Federal Drug Testing Custody and Control Forms from the National Laboratory Certification Program’s Electronic Custody and Control Form systems receives approval for those completely paperless electronic forms instead of forms that include any combination of electronic traditional handwritten signatures executed on paper forms; and (2) establish a deadline for a certified laboratory to request approval under paragraph (1). (b) Savings clause Nothing in this section may be construed as limiting or otherwise affecting any authority of the Secretary of Health and Human Services to grant approval to a certified laboratory for use of completely paperless electronic Federal Drug Testing Custody and Control Forms, including to grant approval outside of the process under subsection (a). (c) Electronic signatures Not later than 18 months after the date of the deadline under subsection (a)(2), the Secretary of Transportation shall issue a final rule revising part 40 of title 49, Code of Federal Regulations, to authorize, to the extent practicable, the use of electronic signatures or digital signatures executed to electronic forms instead of traditional handwritten signatures executed on paper forms. 4110. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse (a) In general Not later than 180 days after the date of enactment of this Act, and biannually thereafter until the compliance date, the Administrator of the Federal Motor Carrier Safety Administration shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a status report on implementation of the final rule for the Commercial Driver's License Drug and Alcohol Clearinghouse (81 Fed. Reg. 87686), including— (1) an updated schedule, including benchmarks, for implementing the final rule as soon as practicable, but not later than the compliance date; and (2) a description of each action the Federal Motor Carrier Safety Administration is taking to implement the final rule before the compliance date. (b) Definition of compliance date In this section, the term compliance date means the earlier of— (1) January 6, 2020; or (2) the date that the national clearinghouse required under section 31306a of title 49, United States Code, is operational. B Opioid Addiction Recovery Fraud Prevention 4201. Short title This subtitle may be cited as the Opioid Addiction Recovery Fraud Prevention Act of 2018 . 4202. Definitions In this subtitle: (1) Opioid treatment product The term opioid treatment product means a product, including any supplement or medication, for use or marketed for use in the treatment, cure, or prevention of an opioid use disorder. (2) Opioid treatment program The term opioid treatment program means a program that provides treatment for people diagnosed with, having, or purporting to have an opioid use disorder. (3) Opioid use disorder The term opioid use disorder means a cluster of cognitive, behavioral, or physiological symptoms in which the individual continues use of opioids despite significant opioid-induced problems, such as adverse health effects. 4203. False or misleading representations with respect to opioid treatment programs and products (a) Unlawful activity It is unlawful to make any deceptive representation with respect to the cost, price, efficacy, performance, benefit, risk, or safety of any opioid treatment program or opioid treatment product. (b) Enforcement by the Federal Trade Commission (1) Unfair or deceptive acts or practices A violation of subsection (a) shall be treated as a violation of a rule under section 18 of the Federal Trade Commission Act (15 U.S.C. 57a) regarding unfair or deceptive acts or practices. (2) Powers of the Federal Trade Commission (A) In general The Federal Trade Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and made a part of this section. (B) Privileges and immunities Any person who violates subsection (a) shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated and made part of this section. (c) Enforcement by States (1) In general Except as provided in paragraph (4), in any case in which the attorney general of a State has reason to believe that an interest of the residents of the State has been or is threatened or adversely affected by any person who violates subsection (a), the attorney general of the State, as parens patriae, may bring a civil action on behalf of the residents of the State in an appropriate district court of the United States to obtain appropriate relief. (2) Rights of Federal Trade Commission (A) Notice to Federal Trade Commission (i) In general Except as provided in clause (iii), the attorney general of a State shall notify the Federal Trade Commission in writing that the attorney general intends to bring a civil action under paragraph (1) before initiating the civil action. (ii) Contents The notification required by clause (i) with respect to a civil action shall include a copy of the complaint to be filed to initiate the civil action. (iii) Exception If it is not feasible for the attorney general of a State to provide the notification required by clause (i) before initiating a civil action under paragraph (1), the attorney general shall notify the Federal Trade Commission immediately upon instituting the civil action. (B) Intervention by Federal Trade Commission The Federal Trade Commission may— (i) intervene in any civil action brought by the attorney general of a State under paragraph (1); and (ii) upon intervening— (I) be heard on all matters arising in the civil action; and (II) file petitions for appeal. (3) Investigatory powers Nothing in this subsection shall be construed to prevent the attorney general of a State from exercising the powers conferred on the attorney general by the laws of the State to conduct investigations, to administer oaths or affirmations, or to compel the attendance of witnesses or the production of documentary or other evidence. (4) Preemptive action by Federal Trade Commission If the Federal Trade Commission or the Attorney General on behalf of the Commission institutes a civil action, or the Federal Trade Commission institutes an administrative action, with respect to a violation of subsection (a), the attorney general of a State may not, during the pendency of that action, bring a civil action under paragraph (1) against any defendant or respondent named in the complaint of the Commission for the violation with respect to which the Commission instituted such action. (5) Venue; service of process (A) Venue Any action brought under paragraph (1) may be brought in any district court of the United States that meets applicable requirements relating to venue under section 1391 of title 28, United States Code. (B) Service of process In an action brought under paragraph (1), process may be served in any district in which the defendant— (i) is an inhabitant; or (ii) may be found. (6) Actions by other State officials In addition to civil actions brought by attorneys general under paragraph (1), any other consumer protection officer of a State who is authorized by the State to do so may bring a civil action under paragraph (1), subject to the same requirements and limitations that apply under this subsection to civil actions brought by attorneys general. (d) Authority preserved Nothing in this title shall be construed to limit the authority of the Federal Trade Commission or the Food and Drug Administration under any other provision of law.

Secretary

tv_txt: I One Hundred Fifteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Wednesday, the third day of January, two thousand and eighteen H. R. 6 AN ACT To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Title I—Medicaid Provisions to Address the Opioid Crisis Sec. 1001. At-risk youth Medicaid protection. Sec. 1002. Health insurance for former foster youth. Sec. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program. Sec. 1004. Medicaid drug review and utilization. Sec. 1005. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder. Sec. 1006. Medicaid health homes for substance-use-disorder Medicaid enrollees. Sec. 1007. Caring recovery for infants and babies. Sec. 1008. Peer support enhancement and evaluation review. Sec. 1009. Medicaid substance use disorder treatment via telehealth. Sec. 1010. Enhancing patient access to non-opioid treatment options. Sec. 1011. Assessing barriers to opioid use disorder treatment. Sec. 1012. Help for moms and babies. Sec. 1013. Securing flexibility to treat substance use disorders. Sec. 1014. MACPAC study and report on MAT utilization controls under State Medicaid programs. Sec. 1015. Opioid addiction treatment programs enhancement. Sec. 1016. Better data sharing to combat the opioid crisis. Sec. 1017. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid. Sec. 1018. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid. Title II—Medicare Provisions to Address the Opioid Crisis Sec. 2001. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders. Sec. 2002. Comprehensive screenings for seniors. Sec. 2003. Every prescription conveyed securely. Sec. 2004. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries. Sec. 2005. Medicare coverage of certain services furnished by opioid treatment programs. Sec. 2006. Encouraging appropriate prescribing under Medicare for victims of opioid overdose. Sec. 2007. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries. Sec. 2008. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies. Title III—FDA and Controlled Substance Provisions Subtitle A—FDA provisions Chapter 1—In general Sec. 3001. Clarifying FDA regulation of non-addictive pain products. Sec. 3002. Evidence-based opioid analgesic prescribing guidelines and report. Chapter 2—Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Sec. 3011. Short title. Sec. 3012. Notification, nondistribution, and recall of controlled substances. Sec. 3013. Single source pattern of imported illegal drugs. Sec. 3014. Strengthening FDA and CBP coordination and capacity. Chapter 3—Stop Illicit Drug Importation Sec. 3021. Short title. Sec. 3022. Restricting entrance of illicit drugs. Chapter 4—Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Sec. 3031. Short title. Sec. 3032. Safety-enhancing packaging and disposal features. Chapter 5—Postapproval study requirements Sec. 3041. Clarifying FDA postmarket authorities. Subtitle B—Controlled substance provisions Chapter 1—More flexibility with respect to medication-Assisted treatment for opioid use disorders Sec. 3201. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Sec. 3202. Medication-assisted treatment for recovery from substance use disorder. Sec. 3203. Grants to enhance access to substance use disorder treatment. Sec. 3204. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation. Chapter 2—Empowering Pharmacists in the Fight Against Opioid Abuse Sec. 3211. Short title. Sec. 3212. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription. Chapter 3—Safe Disposal of Unused Medication Sec. 3221. Short title. Sec. 3222. Disposal of controlled substances of a hospice patient by employees of a qualified hospice program. Sec. 3223. GAO study and report on hospice safe drug management. Chapter 4—Special Registration for Telemedicine Clarification Sec. 3231. Short title. Sec. 3232. Regulations relating to a special registration for telemedicine. Chapter 5—Synthetic Abuse and Labeling of Toxic Substances Sec. 3241. Controlled substance analogues. Chapter 6—Access to Increased Drug Disposal Sec. 3251. Short title. Sec. 3252. Definitions. Sec. 3253. Authority to make grants. Sec. 3254. Application. Sec. 3255. Use of grant funds. Sec. 3256. Eligibility for grant. Sec. 3257. Duration of grants. Sec. 3258. Accountability and oversight. Sec. 3259. Duration of program. Sec. 3260. Authorization of appropriations. Chapter 7—Using Data To Prevent Opioid Diversion Sec. 3271. Short title. Sec. 3272. Purpose. Sec. 3273. Amendments. Sec. 3274. Report. Chapter 8—Opioid Quota Reform Sec. 3281. Short title. Sec. 3282. Strengthening considerations for DEA opioid quotas. Chapter 9—Preventing Drug Diversion Sec. 3291. Short title. Sec. 3292. Improvements to prevent drug diversion. Title IV—Offsets Sec. 4001. Promoting value in Medicaid managed care. Sec. 4002. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program. Sec. 4003. Additional religious exemption from health coverage responsibility requirement. Sec. 4004. Modernizing the reporting of biological and biosimilar products. Title V—Other Medicaid Provisions Subtitle A—Mandatory reporting with respect to adult behavioral health measures Sec. 5001. Mandatory reporting with respect to adult behavioral health measures. Subtitle B—Medicaid IMD Additional Info Sec. 5011. Short title. Sec. 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid. Subtitle C—CHIP Mental Health and Substance Use Disorder Parity Sec. 5021. Short title. Sec. 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program. Subtitle D—Medicaid Reentry Sec. 5031. Short title. Sec. 5032. Promoting State innovations to ease transitions integration to the community for certain individuals. Subtitle E—Medicaid Partnership Sec. 5041. Short title. Sec. 5042. Medicaid providers are required to note experiences in record systems to help in-need patients. Subtitle F—IMD CARE Act Sec. 5051. Short title. Sec. 5052. State option to provide Medicaid coverage for certain individuals with substance use disorders who are patients in certain institutions for mental diseases. Subtitle G—Medicaid Improvement Fund Sec. 5061. Medicaid Improvement Fund. Title VI—Other Medicare Provisions Subtitle A—Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Sec. 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. Subtitle B—Abuse Deterrent Access Sec. 6011. Short title. Sec. 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare. Subtitle C—Medicare Opioid Safety Education Sec. 6021. Medicare opioid safety education. Subtitle D—Opioid Addiction Action Plan Sec. 6031. Short title. Sec. 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment. Subtitle E—Advancing High Quality Treatment for Opioid Use Disorders in Medicare Sec. 6041. Short title. Sec. 6042. Opioid use disorder treatment demonstration program. Subtitle F—Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Sec. 6051. Short title. Sec. 6052. Grants to provide technical assistance to outlier prescribers of opioids. Subtitle G—Preventing Addiction for Susceptible Seniors Sec. 6061. Short title. Sec. 6062. Electronic prior authorization for covered part D drugs. Sec. 6063. Program integrity transparency measures under Medicare parts C and D. Sec. 6064. Expanding eligibility for medication therapy management programs under part D. Sec. 6065. Commit to opioid medical prescriber accountability and safety for seniors. Sec. 6066. No additional funds authorized. Subtitle H—Expanding Oversight of Opioid Prescribing and Payment Sec. 6071. Short title. Sec. 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program. Sec. 6073. No additional funds authorized. Subtitle I—Dr. Todd Graham Pain Management, Treatment, and Recovery Sec. 6081. Short title. Sec. 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments. Sec. 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics. Sec. 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans. Sec. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report. Sec. 6086. Dr. Todd Graham pain management study. Subtitle J—Combating Opioid Abuse for Care in Hospitals Sec. 6091. Short title. Sec. 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program. Sec. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs. Sec. 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use. Sec. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries. Subtitle K—Providing Reliable Options for Patients and Educational Resources Sec. 6101. Short title. Sec. 6102. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. Sec. 6103. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs. Sec. 6104. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management. Subtitle L—Fighting the Opioid Epidemic With Sunshine Sec. 6111. Fighting the opioid epidemic with sunshine. Title VII—Public Health Provisions Subtitle A—Awareness and training Sec. 7001. Report on effects on public health of synthetic drug use. Sec. 7002. First responder training. Subtitle B—Pilot program for public health laboratories To detect fentanyl and other synthetic opioids Sec. 7011. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids. Subtitle C—Indexing Narcotics, Fentanyl, and Opioids Sec. 7021. Establishment of substance use disorder information dashboard. Sec. 7022. Interdepartmental Substance Use Disorders Coordinating Committee. Sec. 7023. National milestones to measure success in curtailing the opioid crisis. Sec. 7024. Study on prescribing limits. Subtitle D—Ensuring Access to Quality Sober Living Sec. 7031. National recovery housing best practices. Subtitle E—Advancing Cutting Edge Research Sec. 7041. Unique research initiatives. Sec. 7042. Pain research. Subtitle F—Jessie’s Law Sec. 7051. Inclusion of opioid addiction history in patient records. Sec. 7052. Communication with families during emergencies. Sec. 7053. Development and dissemination of model training programs for substance use disorder patient records. Subtitle G—Protecting Pregnant Women and Infants Sec. 7061. Report on addressing maternal and infant health in the opioid crisis. Sec. 7062. Protecting moms and infants. Sec. 7063. Early interventions for pregnant women and infants. Sec. 7064. Prenatal and postnatal health. Sec. 7065. Plans of safe care. Subtitle H—Substance Use Disorder Treatment Workforce Sec. 7071. Loan repayment program for substance use disorder treatment workforce. Sec. 7072. Clarification regarding service in schools and other community-based settings. Sec. 7073. Programs for health care workforce. Subtitle I—Preventing Overdoses While in Emergency Rooms Sec. 7081. Program to support coordination and continuation of care for drug overdose patients. Subtitle J—Alternatives to Opioids in the Emergency Department Sec. 7091. Emergency department alternatives to opioids demonstration program. Subtitle K—Treatment, Education, and Community Help To Combat Addiction Sec. 7101. Establishment of regional centers of excellence in substance use disorder education. Sec. 7102. Youth prevention and recovery. Subtitle L—Information from National Mental Health and Substance Use Policy Laboratory Sec. 7111. Information from National Mental Health and Substance Use Policy Laboratory. Subtitle M—Comprehensive Opioid Recovery Centers Sec. 7121. Comprehensive opioid recovery centers. Subtitle N—Trauma-Informed Care Sec. 7131. CDC surveillance and data collection for child, youth, and adult trauma. Sec. 7132. Task force to develop best practices for trauma-informed identification, referral, and support. Sec. 7133. National Child Traumatic Stress Initiative. Sec. 7134. Grants to improve trauma support services and mental health care for children and youth in educational settings. Sec. 7135. Recognizing early childhood trauma related to substance abuse. Subtitle O—Eliminating Opioid Related Infectious Diseases Sec. 7141. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors. Subtitle P—Peer Support Communities of Recovery Sec. 7151. Building communities of recovery. Sec. 7152. Peer support technical assistance center. Subtitle Q—Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Sec. 7161. Preventing overdoses of controlled substances. Sec. 7162. Prescription drug monitoring program. Subtitle R—Review of substance use disorder treatment providers receiving Federal funding Sec. 7171. Review of substance use disorder treatment providers receiving Federal funding. Subtitle S—Other health provisions Sec. 7181. State response to the opioid abuse crisis. Sec. 7182. Report on investigations regarding parity in mental health and substance use disorder benefits. Sec. 7183. CAREER Act. Title VIII—Miscellaneous Subtitle A—Synthetics Trafficking and Overdose Prevention Sec. 8001. Short title. Sec. 8002. Customs fees. Sec. 8003. Mandatory advance electronic information for postal shipments. Sec. 8004. International postal agreements. Sec. 8005. Cost recoupment. Sec. 8006. Development of technology to detect illicit narcotics. Sec. 8007. Civil penalties for postal shipments. Sec. 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest. Sec. 8009. Effective date; regulations. Subtitle B—Opioid Addiction Recovery Fraud Prevention Sec. 8021. Short title. Sec. 8022. Definitions. Sec. 8023. Unfair or deceptive acts or practices with respect to substance use disorder treatment service and products. Subtitle C—Addressing economic and workforce impacts of the opioid crisis Sec. 8041. Addressing economic and workforce impacts of the opioid crisis. Subtitle D—Peer support counseling program for women veterans Sec. 8051. Peer support counseling program for women veterans. Subtitle E—Treating Barriers to Prosperity Sec. 8061. Short title. Sec. 8062. Drug abuse mitigation initiative. Subtitle F—Pilot program to help individuals in recovery from a substance use disorder become stably housed Sec. 8071. Pilot program to help individuals in recovery from a substance use disorder become stably housed. Subtitle G—Human Services Sec. 8081. Supporting family-focused residential treatment. Sec. 8082. Improving recovery and reunifying families. Sec. 8083. Building capacity for family-focused residential treatment. Subtitle H—Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Sec. 8091. Short title. Sec. 8092. Reauthorization of the comprehensive opioid abuse grant program. Subtitle I—Fighting Opioid Abuse in Transportation Sec. 8101. Short title. Sec. 8102. Alcohol and controlled substance testing of mechanical employees. Sec. 8103. Department of Transportation public drug and alcohol testing database. Sec. 8104. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data. Sec. 8105. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl and other substances. Sec. 8106. Status reports on hair testing guidelines. Sec. 8107. Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid. Sec. 8108. Electronic recordkeeping. Sec. 8109. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse. Subtitle J—Eliminating Kickbacks in Recovery Sec. 8121. Short title. Sec. 8122. Criminal penalties. Subtitle K—Substance Abuse Prevention Sec. 8201. Short title. Sec. 8202. Reauthorization of the Office of National Drug Control Policy. Sec. 8203. Reauthorization of the Drug-Free Communities Program. Sec. 8204. Reauthorization of the National Community Anti-Drug Coalition Institute. Sec. 8205. Reauthorization of the High-Intensity Drug Trafficking Area Program. Sec. 8206. Reauthorization of drug court program. Sec. 8207. Drug court training and technical assistance. Sec. 8208. Drug overdose response strategy. Sec. 8209. Protecting law enforcement officers from accidental exposure. Sec. 8210. COPS Anti-Meth Program. Sec. 8211. COPS anti-heroin task force program. Sec. 8212. Comprehensive Addiction and Recovery Act education and awareness. Sec. 8213. Reimbursement of substance use disorder treatment professionals. Sec. 8214. Sobriety Treatment and Recovery Teams (START). Sec. 8215. Provider education. Sec. 8216. Definitions. Sec. 8217. Amendments to administration of the Office. Sec. 8218. Emerging threats committee, plan, and media campaign. Sec. 8219. Drug interdiction. Sec. 8220. GAO Audit. Sec. 8221. National Drug Control Strategy. Sec. 8222. Technical and conforming amendments to the Office of National Drug Control Policy Reauthorization Act of 1998. Subtitle L—Budgetary effects Sec. 8231. Budgetary effect. I Medicaid Provisions to Address the Opioid Crisis 1001. At-risk youth Medicaid protection (a) In general Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ) is amended— (1) in subsection (a)— (A) by striking and at the end of paragraph (82); (B) by striking the period at the end of paragraph (83) and inserting ; and ; and (C) by inserting after paragraph (83) the following new paragraph: (84) provide that— (A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate; (B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and (C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, such individual such that the State makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution. ; and (2) by adding at the end the following new subsection: (nn) Juvenile; eligible juvenile; public institution For purposes of subsection (a)(84) and this subsection: (1) Juvenile The term juvenile means an individual who is— (A) under 21 years of age; or (B) described in subsection (a)(10)(A)(i)(IX). (2) Eligible juvenile The term eligible juvenile means a juvenile who is an inmate of a public institution and who— (A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or (B) is determined eligible for such medical assistance while an inmate of a public institution. (3) Inmate of a public institution The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (30) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution. . (b) No change in exclusion from medical assistance for inmates of public institutions Nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision (A) following paragraph (30) of section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), as redesignated by section 1006(b)(2)(B) of this Act, including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance. (c) No change in continuity of eligibility before adjudication or sentencing Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced. (d) Effective date (1) In general Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 1002. Health insurance for former foster youth (a) Coverage continuity for former foster care children up to age 26 (1) In general Section 1902(a)(10)(A)(i)(IX) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A)(i)(IX) ) is amended— (A) in item (bb), by striking are not described in or enrolled under and inserting are not described in and are not enrolled under ; (B) in item (cc), by striking responsibility of the State and inserting responsibility of a State ; and (C) in item (dd), by striking the State plan under this title or under a waiver of the and inserting a State plan under this title or under a waiver of such a . (2) Effective date The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023. (b) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States— (1) on best practices for— (A) removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and (B) conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and (2) which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program Section 1903 of the Social Security Act ( 42 U.S.C. 1396b ) is amended by adding at the end the following new subsection: (aa) Demonstration project To increase substance use provider capacity (1) In general Not later than the date that is 180 days after the date of the enactment of this subsection, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall— (A) for the first 18-month period of such project, award planning grants described in paragraph (3); and (B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5). (2) Purpose The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities: (A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph. (B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services. (C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that— (i) are authorized to dispense drugs approved by the Food and Drug Administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder; (ii) have in effect a registration or waiver under section 303(g) of the Controlled Substances Act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the Assistant Secretary for Mental Health and Substance Use for purposes of carrying out the requirements of such section 303(g); and (iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services. (D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of— (i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, in accordance with guidelines issued by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome; (ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan); (iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or (iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan). (3) Planning grants (A) In general The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that have a State plan (or waiver of the State plan) approved under this title; (ii) select States in a manner that ensures geographic diversity; and (iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Activities described Activities described in this subparagraph are, with respect to a State, each of the following: (i) Activities that support the development of an initial assessment of the behavioral health treatment needs of the State to determine the extent to which providers are needed (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following: (I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder. (II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver). (III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II). (IV) Projections regarding the extent to which the State participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the State plan (or waiver) during the period of the demonstration project. (ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers. (D) Funding For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended. (4) Post-planning States (A) In general The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5). (B) Selection In selecting States for purposes of this paragraph, the Secretary shall— (i) select States that received a planning grant under paragraph (3); (ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application; (iii) select States in a manner that ensures geographic diversity; and (iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate. (C) Applications (i) In general A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following: (I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i). (II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services. (III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following: (aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services. (bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State. (cc) Milestones and timeliness for implementing activities set forth in the plan. (dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan). (IV) A proposed process for reporting the information required under paragraph (6)(A), including information to assess the effectiveness of the efforts of the State to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection. (V) The expected financial impact of the demonstration project under this subsection on the State. (VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State. (VII) A preliminary plan for how the State will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project. (VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable. (ii) Consultation In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation. (5) Payment (A) In general For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter. (B) Qualified sums defined For purposes of subparagraph (A), the term qualified sums means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use disorder treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use disorder treatment or recovery services. (C) Non-duplication of payment In the case that payment is made under subparagraph (A) with respect to expenditures for substance use disorder treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished. (6) Reports (A) State reports A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use disorder treatment or recovery services for which payment is made to the State under this subsection, on the following: (i) The specific activities with respect to which payment under this subsection was provided. (ii) The number of providers that delivered substance use disorder treatment or recovery services in the State under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project. (iii) The number of individuals enrolled under the State plan (or a waiver of such plan) who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project. (iv) Other matters as determined by the Secretary. (B) CMS reports (i) Initial report Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on— (I) the States awarded planning grants under paragraph (3); (II) the criteria used in such selection; and (III) the activities carried out by such States under such planning grants. (ii) Interim report Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report— (I) on activities carried out under the demonstration project under this subsection; (II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph; (III) with a description of the strengths and limitations of such demonstration project; and (IV) with a plan for the sustainability of such project. (iii) Final report Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report— (I) providing updates on the matters reported in the interim report under clause (ii); (II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and (III) evaluating such demonstration project. (C) AHRQ report Not later than 3 years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4). (7) Data sharing and best practices During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected. (8) CMS funding There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended. . 1004. Medicaid drug review and utilization (a) Medicaid drug utilization review (1) State plan requirement Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by section 1001, is further amended— (A) in paragraph (83), at the end, by striking and ; (B) in paragraph (84), at the end, by striking the period and inserting ; and ; and (C) by inserting after paragraph (84) the following new paragraph: (85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1). . (2) Drug review and utilization requirements Section 1902 of the Social Security Act ( 42 U.S.C. 1396a ), as amended by section 1001, is further amended by adding at the end the following new subsection: (oo) Drug review and utilization requirements (1) In general For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following: (A) Claims review limitations (i) In general The State has in place— (I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State; (II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and (III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and— (aa) benzodiazepines; or (bb) antipsychotics. (ii) Managed care entities The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause. (iii) Rules of construction Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver). (B) Program to monitor antipsychotic medications by children The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically. (C) Fraud and abuse identification The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled. (D) Reports The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary. (E) Clarification Nothing shall prevent a State from satisfying the requirement— (i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019; (ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or (iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date. (2) Annual report by Secretary For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D). (3) Exceptions (A) Certain individuals exempted The drug review and utilization requirements under this subsection shall not apply with respect to an individual who— (i) is receiving— (I) hospice or palliative care; or (II) treatment for cancer; (ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (iii) the State elects to treat as exempted from such requirements. (B) Exception relating to ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). . (3) Managed care entities Section 1932 of the Social Security Act ( 42 U.S.C. 1396u–2 ) is amended by adding at the end the following new subsection: (i) Drug utilization review activities and requirements Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42, Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018. . (b) Identifying and addressing inappropriate prescribing and billing practices under Medicaid (1) In general Section 1927(g) of the Social Security Act ( 42 U.S.C. 1396r–8(g) ) is amended— (A) in paragraph (1)(A)— (i) by striking of section 1903(i)(10)(B) and inserting of section 1902(a)(54) ; (ii) by striking , by not later than January 1, 1993, ; (iii) by inserting after gross overuse, the following: excessive utilization, ; and (iv) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization ; and (B) in paragraph (2)(B)— (i) by inserting after gross overuse, the following: excessive utilization, ; and (ii) by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization . (2) Effective date The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020. 1005. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder (a) Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include— (1) best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and postdischarge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes; (2) recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home-visiting services; (3) guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and postdischarge services, including parenting supports, and infant-caregiver bonding, including breastfeeding when it is appropriate; and (4) guidance regarding suggested terminology and ICD codes to identify infants with neonatal abstinence syndrome and neonatal opioid withdrawal syndrome, which could include opioid-exposure, opioid withdrawal not requiring pharmacotherapy, and opioid withdrawal requiring pharmacotherapy. (b) GAO study Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title. 1006. Medicaid health homes for substance-use-disorder Medicaid enrollees (a) Extension of enhanced FMAP for certain health homes for individuals with substance use disorders Section 1945(c) of the Social Security Act ( 42 U.S.C. 1396w–4(c) ) is amended— (1) in paragraph (1), by inserting subject to paragraph (4), after except that, ; and (2) by adding at the end the following new paragraph: (4) Special rule relating to substance use disorder health homes (A) In general In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. Nothing in this section shall be construed as prohibiting a State with a State plan amendment that is approved under this section and that is not an SUD-focused State plan amendment from additionally having approved on or after such date an SUD-focused State plan amendment under this section, including for purposes of application of this paragraph. (B) Report requirements In the case of a State with an SUD-focused State plan amendment for which the application of the Federal medical assistance percentage has been extended under subparagraph (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment: (i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual. (ii) The access of such individuals to health care. (iii) The total expenditures of such individuals for health care. For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures. (C) Best practices Not later than October 1, 2020, the Secretary shall make publicly available on the internet website of the Centers for Medicare & Medicaid Services best practices for designing and implementing an SUD-focused State plan amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals. (D) Definitions For purposes of this paragraph: (i) SUD-eligible individuals The term SUD-eligible individual means, with respect to a State, an individual who satisfies all of the following: (I) The individual is an eligible individual with chronic conditions. (II) The individual is an individual with a substance use disorder. (III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary. (ii) SUD-focused State plan amendment The term SUD-focused State plan amendment means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals. . (b) Requirement for State Medicaid plans To provide coverage for medication-Assisted treatment (1) Requirement for State Medicaid plans to provide coverage for medication-assisted treatment Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29) . (2) Inclusion of medication-assisted treatment as medical assistance Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (28), by striking and at the end; (B) by redesignating paragraph (29) as paragraph (30); and (C) by inserting after paragraph (28) the following new paragraph: (29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and . (3) Medication-assisted treatment defined; Waivers Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended by adding at the end the following new subsection: (ee) Medication-Assisted treatment (1) Definition For purposes of subsection (a)(29), the term medication-assisted treatment — (A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), including methadone, and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat opioid use disorders; and (B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy. (2) Exception The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, if before the beginning of such period the State certifies to the satisfaction of the Secretary that implementing such provisions statewide for all individuals eligible to enroll in the State plan (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3). . (4) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025. (B) Exception for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. 1007. Caring recovery for infants and babies (a) State plan amendment Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ), as amended by sections 1001 and 1004, is further amended— (1) in paragraph (84)(C), by striking and after the semicolon; (2) in paragraph (85), by striking the period at the end and inserting ; and ; and (3) by inserting after paragraph (85), the following new paragraph: (86) provide, at the option of the State, for making medical assistance available on an inpatient or outpatient basis at a residential pediatric recovery center (as defined in subsection (pp)) to infants with neonatal abstinence syndrome. . (b) Residential pediatric recovery center defined Section 1902 of such Act ( 42 U.S.C. 1396a ), as amended by sections 1001 and 1004, is further amended by adding at the end the following new subsection: (pp) Residential pediatric recovery center defined (1) In general For purposes of section 1902(a)(86), the term residential pediatric recovery center means a center or facility that furnishes items and services for which medical assistance is available under the State plan to infants with the diagnosis of neonatal abstinence syndrome without any other significant medical risk factors. (2) Counseling and services A residential pediatric recovery center may offer counseling and other services to mothers (and other appropriate family members and caretakers) of infants receiving treatment at such centers if such services are otherwise covered under the State plan under this title or under a waiver of such plan. Such other services may include the following: (A) Counseling or referrals for services. (B) Activities to encourage caregiver-infant bonding. (C) Training on caring for such infants. . (c) Effective date The amendments made by this section take effect on the date of enactment of this Act and shall apply to medical assistance furnished on or after that date, without regard to final regulations to carry out such amendments being promulgated as of such date. 1008. Peer support enhancement and evaluation review (a) In general Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Committee on Health, Education, Labor and Pensions of the Senate a report on the provision of peer support services under the Medicaid program. (b) Content of report (1) In general The report required under subsection (a) shall include the following information: (A) Information on State coverage of peer support services under Medicaid, including— (i) the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers; (ii) the populations to which States have provided such coverage; (iii) the payment models, including any alternative payment models, used by States to pay providers of such services; and (iv) where available, information on Federal and State spending under Medicaid for peer support services. (B) Information on selected State experiences in providing medical assistance for peer support services under State Medicaid plans and whether States measure the effects of providing such assistance with respect to— (i) improving access to behavioral health services; (ii) improving early detection, and preventing worsening, of behavioral health disorders; (iii) reducing chronic and comorbid conditions; and (iv) reducing overall health costs. (2) Recommendations The report required under subsection (a) shall include recommendations, including recommendations for such legislative and administrative actions related to improving services, including peer support services, and access to peer support services under Medicaid as the Comptroller General of the United States determines appropriate. 1009. Medicaid substance use disorder treatment via telehealth (a) Definitions In this section: (1) Comptroller General The term Comptroller General means the Comptroller General of the United States. (2) School-based health center The term school-based health center has the meaning given that term in section 2110(c)(9) of the Social Security Act ( 42 U.S.C. 1397jj(c)(9) ). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Underserved area The term underserved area means a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act ( 42 U.S.C. 254e(a)(1)(A) )) and a medically underserved area (according to a designation under section 330(b)(3)(A) of the Public Health Service Act ( 42 U.S.C. 254b(b)(3)(A) )). (b) Guidance to States regarding Federal reimbursement for furnishing services and treatment for substance use disorders under Medicaid using services delivered via telehealth, including in school-Based health centers Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue guidance to States on the following: (1) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders, including assessment, medication-assisted treatment, counseling, medication management, and medication adherence with prescribed medication regimes, using services delivered via telehealth. Such guidance shall also include guidance on furnishing services and treatments that address the needs of high-risk individuals, including at least the following groups: (A) American Indians and Alaska Natives. (B) Adults under the age of 40. (C) Individuals with a history of non-fatal overdose. (D) Individuals with a co-occurring serious mental illness and substance use disorder. (2) State options for Federal reimbursement of expenditures under Medicaid for education directed to providers serving Medicaid beneficiaries with substance use disorders using the hub and spoke model, through contracts with managed care entities, through administrative claiming for disease management activities, and under Delivery System Reform Incentive Payment ( DSRIP ) programs. (3) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders for individuals enrolled in Medicaid in a school-based health center using services delivered via telehealth. (c) GAO evaluation of children's access to services and treatment for substance use disorders under Medicaid (1) Study The Comptroller General shall evaluate children’s access to services and treatment for substance use disorders under Medicaid. The evaluation shall include an analysis of State options for improving children's access to such services and treatment and for improving outcomes, including by increasing the number of Medicaid providers who offer services or treatment for substance use disorders in a school-based health center using services delivered via telehealth, particularly in rural and underserved areas. The evaluation shall include an analysis of Medicaid provider reimbursement rates for services and treatment for substance use disorders. (2) Report Not later than 1 year after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. (d) Report on reducing barriers to using services delivered via telehealth and remote patient monitoring for pediatric populations under Medicaid (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a report to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives identifying best practices and potential solutions for reducing barriers to using services delivered via telehealth to furnish services and treatment for substance use disorders among pediatric populations under Medicaid. The report shall include— (A) analyses of the best practices, barriers, and potential solutions for using services delivered via telehealth to diagnose and provide services and treatment for children with substance use disorders, including opioid use disorder; and (B) identification and analysis of the differences, if any, in furnishing services and treatment for children with substance use disorders using services delivered via telehealth and using services delivered in person, such as, and to the extent feasible, with respect to— (i) utilization rates; (ii) costs; (iii) avoidable inpatient admissions and readmissions; (iv) quality of care; and (v) patient, family, and provider satisfaction. (2) Publication The Secretary shall publish the report required under paragraph (1) on a public internet website of the Department of Health and Human Services. 1010. Enhancing patient access to non-opioid treatment options Not later than January 1, 2019, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue 1 or more final guidance documents, or update existing guidance documents, to States regarding mandatory and optional items and services that may be provided under a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.), or under a waiver of such a plan, for non-opioid treatment and management of pain, including, but not limited to, evidence-based, non-opioid pharmacological therapies and non-pharmacological therapies. 1011. Assessing barriers to opioid use disorder treatment (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study regarding the barriers to providing medication used in the treatment of substance use disorders under Medicaid distribution models such as the buy-and-bill model, and options for State Medicaid programs to remove or reduce such barriers. The study shall include analyses of each of the following models of distribution of substance use disorder treatment medications, particularly buprenorphine, naltrexone, and buprenorphine-naloxone combinations: (A) The purchasing, storage, and administration of substance use disorder treatment medications by providers. (B) The dispensing of substance use disorder treatment medications by pharmacists. (C) The ordering, prescribing, and obtaining substance use disorder treatment medications on demand from specialty pharmacies by providers. (2) Requirements For each model of distribution specified in paragraph (1), the Comptroller General shall evaluate how each model presents barriers or could be used by selected State Medicaid programs to reduce the barriers related to the provision of substance use disorder treatment by examining what is known about the effects of the model of distribution on— (A) Medicaid beneficiaries’ access to substance use disorder treatment medications; (B) the differential cost to the program between each distribution model for medication-assisted treatment; and (C) provider willingness to provide or prescribe substance use disorder treatment medications. (b) Report Not later than 15 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. 1012. Help for moms and babies (a) Medicaid State plan Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ), as amended by section 1006, is further amended by adding at the end the following new sentence: In the case of a woman who is eligible for medical assistance on the basis of being pregnant (including through the end of the month in which the 60-day period beginning on the last day of her pregnancy ends), who is a patient in an institution for mental diseases for purposes of receiving treatment for a substance use disorder, and who was enrolled for medical assistance under the State plan immediately before becoming a patient in an institution for mental diseases or who becomes eligible to enroll for such medical assistance while such a patient, the exclusion from the definition of medical assistance set forth in the subdivision (B) following paragraph (30) of the first sentence of this subsection shall not be construed as prohibiting Federal financial participation for medical assistance for items or services that are provided to the woman outside of the institution. . (b) Effective date (1) In general Except as provided in paragraph (2), the amendment made by subsection (a) shall take effect on the date of enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendment made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 1013. Securing flexibility to treat substance use disorders Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ) is amended by adding at the end the following new paragraph: (7) Payment shall be made under this title to a State for expenditures for capitation payments described in section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation). . 1014. MACPAC study and report on MAT utilization controls under State Medicaid programs (a) Study The Medicaid and CHIP Payment and Access Commission shall conduct a study and analysis of utilization control policies applied to medication-assisted treatment for substance use disorders under State Medicaid programs, including policies and procedures applied both in fee-for-service Medicaid and in risk-based managed care Medicaid, which shall— (1) include an inventory of such utilization control policies and related protocols for ensuring access to medically necessary treatment; (2) determine whether managed care utilization control policies and procedures for medication-assisted treatment for substance use disorders are consistent with section 438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and (3) identify policies that— (A) limit an individual's access to medication-assisted treatment for a substance use disorder by limiting the quantity of medication-assisted treatment prescriptions, or the number of refills for such prescriptions, available to the individual as part of a prior authorization process or similar utilization protocols; and (B) apply without evaluating individual instances of fraud, waste, or abuse. (b) Report Not later than 1 year after the date of the enactment of this Act, the Medicaid and CHIP Payment and Access Commission shall make publicly available a report containing the results of the study conducted under subsection (a). 1015. Opioid addiction treatment programs enhancement (a) T–MSIS substance use disorder data book (1) In general Not later than the date that is 12 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall publish on the public website of the Centers for Medicare & Medicaid Services a report with comprehensive data on the prevalence of substance use disorders in the Medicaid beneficiary population and services provided for the treatment of substance use disorders under Medicaid. (2) Content of report The report required under paragraph (1) shall include, at a minimum, the following data for each State (including, to the extent available, for the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa): (A) The number and percentage of individuals enrolled in the State Medicaid plan or waiver of such plan in each of the major enrollment categories (as defined in a public letter from the Medicaid and CHIP Payment and Access Commission to the Secretary) who have been diagnosed with a substance use disorder and whether such individuals are enrolled under the State Medicaid plan or a waiver of such plan, including the specific waiver authority under which they are enrolled, to the extent available. (B) A list of the substance use disorder treatment services by each major type of service, such as counseling, medication-assisted treatment, peer support, residential treatment, and inpatient care, for which beneficiaries in each State received at least 1 service under the State Medicaid plan or a waiver of such plan. (C) The number and percentage of individuals with a substance use disorder diagnosis enrolled in the State Medicaid plan or waiver of such plan who received substance use disorder treatment services under such plan or waiver by each major type of service under subparagraph (B) within each major setting type, such as outpatient, inpatient, residential, and other home-based and community-based settings. (D) The number of services provided under the State Medicaid plan or waiver of such plan per individual with a substance use disorder diagnosis enrolled in such plan or waiver for each major type of service under subparagraph (B). (E) The number and percentage of individuals enrolled in the State Medicaid plan or waiver, by major enrollment category, who received substance use disorder treatment through— (i) a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act ( 42 U.S.C. 1396u–2(a)(1)(B) )), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan; (ii) a fee-for-service payment model; or (iii) an alternative payment model, to the extent available. (F) The number and percentage of individuals with a substance use disorder who receive substance use disorder treatment services in an outpatient or home-based and community-based setting after receiving treatment in an inpatient or residential setting, and the number of services received by such individuals in the outpatient or home-based and community-based setting. (3) Annual updates The Secretary shall issue an updated version of the report required under paragraph (1) not later than January 1 of each calendar year through 2024. (4) Use of T–MSIS data The report required under paragraph (1) and updates required under paragraph (3) shall— (A) use data and definitions from the Transformed Medicaid Statistical Information System ( T–MSIS ) data set that is no more than 12 months old on the date that the report or update is published; and (B) as appropriate, include a description with respect to each State of the quality and completeness of the data and caveats describing the limitations of the data reported to the Secretary by the State that is sufficient to communicate the appropriate uses for the information. (b) Making T–MSIS data on substance use disorders available to researchers (1) In general The Secretary shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System. (2) Required data The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings. (3) Initiation of data-sharing activities Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1). 1016. Better data sharing to combat the opioid crisis (a) In general Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ), as amended by section 1013, is further amended by adding at the end the following new paragraph: (8) (A) The State agency administering the State plan under this title may have reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State to the extent the State agency is permitted to access such databases under State law. (B) Such State agency may facilitate reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State, to same extent that the State agency is permitted under State law to access such databases, for— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). (C) Such State agency may share information in such databases, to the same extent that the State agency is permitted under State law to share information in such databases, with— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). . (b) Security and privacy All applicable State and Federal security and privacy protections and laws shall apply to any State agency, individual, or entity accessing 1 or more prescription drug monitoring program databases or obtaining information in such databases in accordance with section 1903(m)(8) of the Social Security Act (as added by subsection (a)). (c) Effective date The amendment made by subsection (a) shall take effect on the date of enactment of this Act. 1017. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to Congress describing innovative State initiatives and strategies for providing housing-related services and supports under a State Medicaid program to individuals with substance use disorders who are experiencing or at risk of experiencing homelessness. (b) Content of report The report required under subsection (a) shall describe the following: (1) Existing methods and innovative strategies developed and adopted by State Medicaid programs that have achieved positive outcomes in increasing housing stability among Medicaid beneficiaries with substance use disorders who are experiencing or at risk of experiencing homelessness, including Medicaid beneficiaries with substance use disorders who are— (A) receiving treatment for substance use disorders in inpatient, residential, outpatient, or home-based and community-based settings; (B) transitioning between substance use disorder treatment settings; or (C) living in supportive housing or another model of affordable housing. (2) Strategies employed by Medicaid managed care organizations, primary care case managers, hospitals, accountable care organizations, and other care coordination providers to deliver housing-related services and supports and to coordinate services provided under State Medicaid programs across different treatment settings. (3) Innovative strategies and lessons learned by States with Medicaid waivers approved under section 1115 or 1915 of the Social Security Act ( 42 U.S.C. 1315 , 1396n), including— (A) challenges experienced by States in designing, securing, and implementing such waivers or plan amendments; (B) how States developed partnerships with other organizations such as behavioral health agencies, State housing agencies, housing providers, health care services agencies and providers, community-based organizations, and health insurance plans to implement waivers or State plan amendments; and (C) how and whether States plan to provide Medicaid coverage for housing-related services and supports in the future, including by covering such services and supports under State Medicaid plans or waivers. (4) Existing opportunities for States to provide housing-related services and supports through a Medicaid waiver under sections 1115 or 1915 of the Social Security Act ( 42 U.S.C. 1315 , 1396n) or through a State Medicaid plan amendment, such as the Assistance in Community Integration Service pilot program, which promotes supportive housing and other housing-related supports under Medicaid for individuals with substance use disorders and for which Maryland has a waiver approved under such section 1115 to conduct the program. (5) Innovative strategies and partnerships developed and implemented by State Medicaid programs or other entities to identify and enroll eligible individuals with substance use disorders who are experiencing or at risk of experiencing homelessness in State Medicaid programs. 1018. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid (a) In general The Secretary of Health and Human Services shall provide technical assistance and support to States regarding the development and expansion of innovative State strategies (including through State Medicaid demonstration projects) to provide housing-related supports and services and care coordination services under Medicaid to individuals with substance use disorders. (b) Report Not later than 180 days after the date of enactment of this Act, the Secretary shall issue a report to Congress detailing a plan of action to carry out the requirements of subsection (a). II Medicare Provisions to Address the Opioid Crisis 2001. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders (a) In general Section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) is amended— (1) in paragraph (2)(B)— (A) in clause (i), in the matter preceding subclause (I), by striking clause (ii) and inserting clause (ii) and paragraph (6)(C) ; and (B) in clause (ii), in the heading, by striking for home dialysis therapy ; (2) in paragraph (4)(C)— (A) in clause (i), by striking paragraph (6) and inserting paragraphs (5), (6), and (7) ; and (B) in clause (ii)(X), by inserting or telehealth services described in paragraph (7) before the period at the end; and (3) by adding at the end the following new paragraph: (7) Treatment of substance use disorder services furnished through telehealth The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph). . (b) Implementation The Secretary of Health and Human Services (in this section referred to as the Secretary ) may implement the amendments made by this section by interim final rule. (c) Report (1) In general Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act ( 42 U.S.C. 1395m(m) ) on— (A) the utilization of health care items and services under title XVIII of such Act ( 42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and (B) health outcomes related to substance use disorders, such as opioid overdose deaths. (2) Funding For purposes of carrying out paragraph (1), in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended. 2002. Comprehensive screenings for seniors (a) Initial preventive physical examination Section 1861(ww) of the Social Security Act ( 42 U.S.C. 1395x(ww) ) is amended— (1) in paragraph (1)— (A) by striking paragraph (2) and and inserting paragraph (2), ; and (B) by inserting and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)), after upon the agreement with the individual, ; and (2) in paragraph (2)— (A) by redesignating subparagraph (N) as subparagraph (O); and (B) by inserting after subparagraph (M) the following new subparagraph: (N) Screening for potential substance use disorders. ; and (3) by adding at the end the following new paragraph: (4) For purposes of paragraph (1), the term a review of any current opioid prescriptions means, with respect to an individual determined to have a current prescription for opioids— (A) a review of the potential risk factors to the individual for opioid use disorder; (B) an evaluation of the individual's severity of pain and current treatment plan; (C) the provision of information on non-opioid treatment options; and (D) a referral to a specialist, as appropriate. . (b) Annual wellness visit Section 1861(hhh)(2) of the Social Security Act ( 42 U.S.C. 1395x(hhh)(2) ) is amended— (1) by redesignating subparagraph (G) as subparagraph (I); and (2) by inserting after subparagraph (F) the following new subparagraphs: (G) Screening for potential substance use disorders and referral for treatment as appropriate. (H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)). . (c) Rule of construction Nothing in the amendments made by subsection (a) or (b) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination or an annual wellness visit. (d) Effective date The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2020. 2003. Every prescription conveyed securely (a) In general Section 1860D–4(e) of the Social Security Act ( 42 U.S.C. 1395w–104(e) ) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispensing pharmacy are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner prescribing a drug under a research protocol; (vi) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use; (vii) a prescription issued by a practitioner— (I) for an individual who receives hospice care under this title; and (II) that is not covered under the hospice benefit under this title; and (viii) a prescription issued by a practitioner for an individual who is— (I) a resident of a nursing facility (as defined in section 1919(a)); and (II) dually eligible for benefits under this title and title XIX. (C) Dispensing (i) Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). (ii) Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral, or fax prescriptions that are consistent with laws and regulations. (iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. (c) Update of Biometric Component of Multifactor Authentication Not later than 1 year after the date of enactment of this Act, the Attorney General shall update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances. 2004. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended— (1) in paragraph (1), by inserting after subparagraph (E) the following new subparagraph: (F) With respect to plan years beginning on or after January 1, 2022, a drug management program for at-risk beneficiaries described in paragraph (5). ; and (2) in paragraph (5)(A), by inserting (and for plan years beginning on or after January 1, 2022, a PDP sponsor shall) after A PDP sponsor may . 2005. Medicare coverage of certain services furnished by opioid treatment programs (a) Coverage Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (FF), by striking at the end and ; (2) in subparagraph (GG), by inserting at the end and ; and (3) by adding at the end the following new subparagraph: (HH) opioid use disorder treatment services (as defined in subsection (jjj)). . (b) Opioid use disorder treatment services and opioid treatment program defined Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended by adding at the end the following new subsection: (jjj) Opioid use disorder treatment services; opioid treatment program (1) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for use in the treatment of opioid use disorder; (B) dispensing and administration of such medications, if applicable; (C) substance use counseling by a professional to the extent authorized under State law to furnish such services; (D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (E) toxicology testing, and (F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation). (2) Opioid treatment program The term opioid treatment program means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (A) is enrolled under section 1866(j); (B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and (D) meets such additional conditions as the Secretary may find necessary to ensure— (i) the health and safety of individuals being furnished services under such program; and (ii) the effective and efficient furnishing of such services. . (c) Payment (1) In general Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (A) by striking and (BB) and inserting (BB) ; and (B) by inserting before the semicolon at the end the following , and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary . (2) Payment determination Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (w) Opioid use disorder treatment services (1) In general The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program. (2) Considerations The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (3) Annual updates The Secretary shall provide an update each year to the bundled payment amounts under this subsection. . (d) Including opioid treatment programs as Medicare providers Section 1866(e) of the Social Security Act ( 42 U.S.C. 1395cc(e) ) is amended— (1) in paragraph (1), by striking at the end and ; (2) in paragraph (2), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new paragraph: (3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section). . 2006. Encouraging appropriate prescribing under Medicare for victims of opioid overdose Section 1860D–4(c)(5)(C) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(5)(C) ) is amended— (1) in clause (i), in the matter preceding subclause (I), by striking For purposes and inserting Except as provided in clause (v), for purposes ; and (2) by adding at the end the following new clause: (v) Treatment of enrollees with a history of opioid-related overdose (I) In general For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph. (II) Identification and notice For purposes of this clause, the Secretary shall— (aa) identify part D eligible individuals with a history of opioid-related overdose (as so defined); and (bb) notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification. . 2007. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries (a) In general Section 1860D–4(c)(5) of the Social Security Act ( 42 U.S.C. 1395ww–10(c)(5) ) is amended— (1) in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking and the option of an automatic escalation to external review and inserting , including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution ; and (2) in subparagraph (E), by striking and the option and all that follows and inserting the following: and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution. . (b) Effective date The amendments made by subsection (a) shall apply beginning not later January 1, 2021. 2008. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies (a) In general Section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended by adding at the end the following new paragraph: (7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies (A) In general Section 1862(o)(1) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such section applies with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. A PDP sponsor shall notify the Secretary regarding the imposition of any payment suspension pursuant to the previous sentence, such as through the secure internet website portal (or other successor technology) established under section 1859(i). (B) Rule of construction Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review. . (b) Application to MA–PD plans Section 1857(f)(3) of the Social Security Act ( 42 U.S.C. 1395w–27(f)(3) ) is amended by adding at the end the following new subparagraph: (D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies Section 1860D–12(b)(7). . (c) Conforming amendment Section 1862(o)(3) of the Social Security Act ( 42 U.S.C. 1395y(o)(3) ) is amended by inserting , section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), after this subsection . (d) Clarification relating to credible allegation of fraud Section 1862(o) of the Social Security Act ( 42 U.S.C. 1395y(o) ) is amended by adding at the end the following new paragraph: (4) Credible allegation of fraud In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud. . (e) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020. III FDA and Controlled Substance Provisions A FDA provisions 1 In general 3001. Clarifying FDA regulation of non-addictive pain products (a) Public meetings Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction, which may include— (1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), section 510(k) of such Act ( 21 U.S.C. 360(k) ), or section 515(c) of such Act ( 21 U.S.C. 360e(c) ), as applicable; (2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c )) for the development of non-addictive medical products intended to treat pain or addiction; (3) the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and (4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence; (3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including— (A) alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), including patient registries and patient reported outcomes, as appropriate, to support product labeling; (B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit; (C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use; (D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and (E) the appropriate format in which to submit such data results to the Secretary; and (4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section. (c) Definitions In this section— (1) the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )); and (2) the term opioid-sparing means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain. 3002. Evidence-based opioid analgesic prescribing guidelines and report (a) Guidelines The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist. (b) Public input In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall— (1) consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate; (2) collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and (3) provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h) ) for the submission of comments by the public. (c) Report Not later than 1 year after the date of enactment of this Act, or, if earlier, at the time the guidelines under subsection (a) are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection (a) to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline. (d) Updates The Commissioner of Food and Drugs shall periodically— (1) update the guidelines under subsection (a), informed by public input described in subsection (b); and (2) submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection. (e) Statement To accompany guidelines and recommendations The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable— (1) are intended to help inform clinical decisionmaking by prescribers and patients; and (2) are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 2 Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now 3011. Short title This chapter may be cited as the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act . 3012. Notification, nondistribution, and recall of controlled substances (a) Prohibited Acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (eee) The failure to comply with any order issued under section 569D. . (b) Notification, nondistribution, and recall of controlled substances Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: 569D. Notification, nondistribution, and recall of controlled substances (a) Order To cease distribution and recall (1) In general If the Secretary determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substance to immediately cease distribution of such controlled substance. (2) Hearing An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3). (3) Order resolution After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)— (A) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order; (B) continue the order ceasing distribution of the controlled substance until a date specified in such order; or (C) amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall. (4) Risk assessment If the Secretary determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substance, as applicable. (5) Action following order Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substance and provide notification as required by such order. (b) Notice to persons affected If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances. (c) Nondelegation An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Director. (d) Savings clause Nothing contained in this section shall be construed as limiting— (1) the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this Act or the Public Health Service Act; or (2) the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act. . (c) Controlled substances subject to refusal The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by inserting , or is a controlled substance subject to an order under section 569D before , or (4) . (d) Effective date Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act. 3013. Single source pattern of imported illegal drugs Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended by section 3012, is further amended by adding at the end the following: (t) Single source pattern of imported illegal drugs If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 306(b)(3)(D), and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise. . 3014. Strengthening FDA and CBP coordination and capacity (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection. (b) FDA import facilities and inspection capacity (1) In general In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include— (A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate— (i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies; (ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction; (iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods; (iv) upgrades to the security of import facilities; and (v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and (B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate. (2) Innovative technology Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable. (c) Report Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies. 3 Stop Illicit Drug Importation 3021. Short title This chapter may be cited as the Stop Illicit Drug Importation Act of 2018 . 3022. Restricting entrance of illicit drugs (a) Food and Drug Administration and U.S. Customs and Border Protection Cooperation (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act ( 21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act ( 21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act ( 21 U.S.C. 801 et seq.). (2) Report Not later than 9 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section. (b) Debarment, temporary denial of approval, and suspension (1) Prohibited act Section 301(cc) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(cc) ) is amended— (A) by inserting or a drug after food ; and (B) by inserting from such activity after person debarred . (2) Debarment Section 306(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a(b) ) is amended— (A) in paragraph (1)— (i) in the matter preceding subparagraph (A), by inserting or (3) after paragraph (2) ; (ii) in subparagraph (A), by striking the comma at the end and inserting a semicolon; (iii) in subparagraph (B), by striking , or and inserting a semicolon; (iv) in subparagraph (C), by striking the period and inserting ; or ; and (v) by adding at the end the following: (D) a person from importing or offering for import into the United States a drug. ; (B) in paragraph (3)— (i) in the heading, by inserting or drug after Food ; (ii) in subparagraph (A), by striking ; or and inserting a semicolon; (iii) in subparagraph (B), by striking the period and inserting a semicolon; and (iv) by adding at the end the following: (C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); (D) the person has engaged in a pattern of importing or offering for import— (i) controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 ( 19 U.S.C. 1401(m) ); or (ii) adulterated or misbranded drugs that are— (I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or (II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. ; and (C) by adding at the end the following: (5) Definition For purposes of paragraph (3)(D), the term pattern of importing or offering for import means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer. . (c) Imports and exports Section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ), as amended, is further amended— (1) by striking , then such article shall be refused admission inserting or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission ; (2) by inserting If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission. before With respect to an article of food, if importation ; and (3) by striking Clause (2) of the third sentence and all that follows through the period at the end and inserting the following: Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act. . (d) Certain illicit articles Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended, is amended by adding at the end the following— (u) Illicit articles containing active pharmaceutical ingredients (1) In general For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article— (A) is not— (i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and (ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this Act); and (B) is an ingredient that presents significant public health concern and is, or contains— (i) an active ingredient in a drug— (I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or (II) for which— (aa) an investigational use exemption has been authorized under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and (bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or (ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i). (2) Effect This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1). . 4 Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging 3031. Short title This chapter may be cited as the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act . 3032. Safety-enhancing packaging and disposal features (a) Deliberate disposal and packaging elements of strategy Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(e) ) is amended by adding at the end the following: (4) Packaging and disposal The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that— (A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or (B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available. . (b) Assuring access and minimizing burden Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(f)(2)(C) ) is amended— (1) in clause (i) by striking and at the end; and (2) by adding at the end the following: (iii) patients with functional limitations; and . (c) Application to abbreviated new drug applications Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(i) ) is amended— (1) in paragraph (1)— (A) by redesignating subparagraph (B) as subparagraph (C); and (B) inserting after subparagraph (A) the following: (B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug. ; and (2) in paragraph (2)— (A) in subparagraph (A), by striking and at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: (B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and . (d) GAO report Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing— (1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies; (2) an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies; (3) identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act ( 21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products; (4) identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies; (5) a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including— (A) identification of the Federal agencies that oversee such products; (B) identification of the methods of disposal of controlled substances recommended by such agencies for site-of-use, in-home disposal; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; (6) a description of current Federal oversight, if any, of controlled substance packaging technologies, including— (A) identification of the Federal agencies that oversee such technologies; (B) identification of the technologies recommended by such agencies, including unit dose packaging, packaging that provides a set duration, and other packaging systems that may mitigate abuse or misuse; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and (7) recommendations, as appropriate, on— (A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agency or agencies should be responsible for such oversight and, as applicable, review of such products or technologies; and (B) whether there are applicable standards that should be considered to ensure the effectiveness of such products. 5 Postapproval study requirements 3041. Clarifying FDA postmarket authorities (a) Definition of adverse drug experience Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(b)(1)(E) ) is amended by striking of the drug and inserting of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling . (b) Safety labeling changes Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(4) ) is amended— (1) in subparagraph (A) by— (A) striking Safety information and inserting Safety or new effectiveness information ; and (B) by striking If the Secretary becomes and all that follows through in the labeling of the drug and inserting If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug ; (2) in clause (i) of subparagraph (B), by inserting before the semicolon , or new effectiveness information ; (3) in subparagraph (C) by striking safety information and inserting safety or new effectiveness information ; and (4) in subparagraph (E) by striking safety information and inserting safety or new effectiveness information . (c) Guidance Not less than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain. B Controlled substance provisions 1 More flexibility with respect to medication-Assisted treatment for opioid use disorders 3201. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders (a) Conforming applicable number Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(B)(iii) ) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; (bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); (cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)); or (dd) 275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations). . (b) Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended— (1) in subclause (I), by striking or at the end; and (2) by amending subclause (II) to read as follows: (II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or . (c) Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ), as amended by subsection (b), is further amended by adding at the end the following: (III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife. . (d) Definition of qualifying other practitioner Section 303(g)(2)(G)(iv) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iv) ) is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant . (e) Report by Secretary Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iii) )) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment— (1) the average frequency with which qualifying practitioners see their patients; (2) the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral; (3) the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered; (4) the average monthly patient caseload for each type of qualifying practitioner; (5) the treatment retention rates for patients; (6) overdose and mortality rates; and (7) any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner. 3202. Medication-assisted treatment for recovery from substance use disorder (a) Waivers for Maintenance Treatment or Detoxification Section 303(g)(2)(G)(ii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(ii) ) is amended by adding at the end the following: (VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that— (aa) included not less than 8 hours of training on treating and managing opioid-dependent patients; and (bb) included, at a minimum— (AA) the training described in items (aa) through (gg) of subclause (IV); and (BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. . (b) Treatment for children The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ), who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders. (c) Technical Amendment Section 102(24) of the Controlled Substances Act ( 21 U.S.C. 802(24) ) is amended by striking Health, Education, and Welfare and inserting Health and Human Services . 3203. Grants to enhance access to substance use disorder treatment (a) In general The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 3202(a) of this Act. (b) Authorization of appropriations There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023. 3204. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation (a) In general The Controlled Substances Act is amended by inserting after section 309 ( 21 U.S.C. 829 ) the following: 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this title and the regulations issued by the Attorney General under this title, for the purpose of administering the controlled substance by the practitioner if— (1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this title; (2) the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2) and— (A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and (B) the controlled substance is to be administered by injection or implantation; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and (6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General. (b) Modification of number of days before which controlled substance shall be administered (1) Initial 2-year period During the 2-year period beginning on the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will— (A) reduce the risk of diversion; or (B) protect the public health. (2) Modifications after submission of report After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5). (3) Minimum number of days Any modification under this subsection shall be for a period of not less than 7 days. . (b) Study and report Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation. (c) Technical and conforming amendment The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following: Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner. . 2 Empowering Pharmacists in the Fight Against Opioid Abuse 3211. Short title This chapter may be cited as the Empowering Pharmacists in the Fight Against Opioid Abuse Act . 3212. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate, as appropriate, materials for pharmacists, health care providers, and patients on— (1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act ( 21 U.S.C. 829 ) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and (2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances. (b) Materials included In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for— (1) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and (2) other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)). (c) Stakeholder input In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain. 3 Safe Disposal of Unused Medication 3221. Short title This chapter may be cited as the Safe Disposal of Unused Medication Act . 3222. Disposal of controlled substances of a hospice patient by employees of a qualified hospice program (a) In general Subsection (g) of section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ) is amended by adding at the end the following: (5) (A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and— (i) the disposal occurs after the death of a person receiving hospice care; (ii) the controlled substance is expired; or (iii) (I) the employee is— (aa) the physician of the person receiving hospice care; and (bb) registered under section 303(f); and (II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified. (B) For the purposes of this paragraph: (i) The terms hospice care and hospice program have the meanings given to those terms in section 1861(dd) of the Social Security Act. (ii) The term employee of a qualified hospice program means a physician, physician assistant, nurse, or other person who— (I) is employed by, or pursuant to arrangements made by, a qualified hospice program; (II) (aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and (bb) is acting within the scope of such employment in accordance with applicable State law; and (III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion. (iii) The term qualified hospice program means a hospice program that— (I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death; (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the patient or patient representative and family; (bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and (cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and (III) at the time following the disposal of the controlled substances— (aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and (bb) the time, date, and manner in which that disposal occurred. . (b) Guidance The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act ( 21 U.S.C. 822(g) ), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5). (c) Rule of construction relating to State and local law Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs. 3223. GAO study and report on hospice safe drug management (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study on the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual. (2) Contents In conducting the study under paragraph (1), the Comptroller General shall include— (A) an overview of any challenges encountered by selected hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and (B) a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements. (b) Report Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate. 4 Special Registration for Telemedicine Clarification 3231. Short title This chapter may be cited as the Special Registration for Telemedicine Clarification Act of 2018 . 3232. Regulations relating to a special registration for telemedicine Section 311(h)(2) of the Controlled Substances Act ( 21 U.S.C. 831(h)(2) ) is amended to read as follows: (2) Regulations Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying— (A) the limited circumstances in which a special registration under this subsection may be issued; and (B) the procedure for obtaining a special registration under this subsection. . 5 Synthetic Abuse and Labeling of Toxic Substances 3241. Controlled substance analogues Section 203 of the Controlled Substances Act ( 21 U.S.C. 813 ) is amended— (1) by striking A controlled and inserting (a) In general .—A controlled ; and (2) by adding at the end the following: (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws. (c) Limitation For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption. . 6 Access to Increased Drug Disposal 3251. Short title This chapter may be cited as the Access to Increased Drug Disposal Act of 2018 . 3252. Definitions In this chapter— (1) the term Attorney General means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs; (2) the term authorized collector means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation); (3) the term covered grant means a grant awarded under section 3003; and (4) the term eligible collector means a person who is eligible to be an authorized collector. 3253. Authority to make grants The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors. 3254. Application A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum— (1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant; (2) details a plan to increase participation rates of eligible collectors as authorized collectors; and (3) describes how the State will select eligible collectors to be served under the grant. 3255. Use of grant funds A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors. 3256. Eligibility for grant The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General. 3257. Duration of grants The Attorney General shall determine the period of years for which a covered grant is made to a State. 3258. Accountability and oversight A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that— (1) lists the ultimate recipients of the grant amounts; (2) describes the activities undertaken by the State using the grant amounts; and (3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors. 3259. Duration of program The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act. 3260. Authorization of appropriations There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter. 7 Using Data To Prevent Opioid Diversion 3271. Short title This chapter may be cited as the Using Data To Prevent Opioid Diversion Act of 2018 . 3272. Purpose (a) In general The purpose of this chapter is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates. (b) Rule of construction Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to— (1) identify, stop, and report suspicious orders; or (2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) or any successor law or associated regulation. 3273. Amendments (a) Records and reports of registrants Section 307 of the Controlled Substances Act ( 21 U.S.C. 827 ) is amended— (1) by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively; (2) by inserting after subsection (e) the following: (f) (1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances: (A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant. (B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A). (2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates. (3) (A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection. (B) In determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant. ; and (3) by inserting after subsection (i), as so redesignated, the following: (j) All of the reports required under this section shall be provided in an electronic format. . (b) Cooperative arrangements Section 503 of the Controlled Substances Act ( 21 U.S.C. 873 ) is amended by striking subsection (c) and inserting the following: (c) (1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse. (2) If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection. . (c) Civil and criminal penalties Section 402 of the Controlled Substances Act ( 21 U.S.C. 842 ) is amended— (1) in subsection (a)— (A) in paragraph (15), by striking or at the end; (B) in paragraph (16), by striking the period at the end and inserting ; or ; and (C) by inserting after paragraph (16) the following: (17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f). ; and (2) in subsection (c)— (A) in paragraph (1), by striking subparagraph (B) and inserting the following: (B) (i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000. (ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000. ; and (B) in paragraph (2)— (i) in subparagraph (A), by inserting or (D) after subparagraph (B) ; and (ii) by adding at the end the following: (D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000. . 3274. Report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor. 8 Opioid Quota Reform 3281. Short title This chapter may be cited as the Opioid Quota Reform Act . 3282. Strengthening considerations for DEA opioid quotas (a) In general Section 306 of the Controlled Substances Act ( 21 U.S.C. 826 ) is amended— (1) in subsection (a)— (A) by inserting (1) after (a) ; (B) in the second sentence, by striking Production and inserting Except as provided in paragraph (2), production ; and (C) by adding at the end the following: (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance. ; (2) in subsection (b), in the first sentence, by striking production and inserting manufacturing ; (3) in subsection (c), by striking October and inserting December ; and (4) by adding at the end the following: (i) (1) (A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a covered controlled substance ), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States. (B) In estimating diversion under this paragraph, the Attorney General— (i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the Attorney General determines reliable. (C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. (2) (A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States. (B) Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance: (i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance. (ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year. (3) Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will— (A) take into consideration changes in the accepted medical use of the covered controlled substances; and (B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events. . (b) Conforming change The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking production and inserting manufacturing . 9 Preventing Drug Diversion 3291. Short title This chapter may be cited as the Preventing Drug Diversion Act of 2018 . 3292. Improvements to prevent drug diversion (a) Definition Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended by adding at the end the following: (57) The term suspicious order may include, but is not limited to— (A) an order of a controlled substance of unusual size; (B) an order of a controlled substance deviating substantially from a normal pattern; and (C) orders of controlled substances of unusual frequency. . (b) Suspicious orders Part C of the Controlled Substances Act ( 21 U.S.C. 821 et seq.) is amended by adding at the end the following: 312. Suspicious orders (a) Reporting Each registrant shall— (1) design and operate a system to identify suspicious orders for the registrant; (2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and (3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (b) Suspicious order database (1) In general Not later than 1 year after the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders. (2) Satisfaction of reporting requirements If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (c) Sharing information with the States (1) In general The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State. (2) Timing The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information. (3) Coordination In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law. . (c) Reports to Congress (1) Definition In this subsection, the term suspicious order has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this chapter. (2) One-time report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include— (A) a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders; (B) a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States; (C) information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and (D) descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity. (3) Additional reports Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year— (A) the number of reports of suspicious orders; (B) a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and (C) a description of the information shared with States based on reports of suspicious orders. (4) One-time GAO report Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms— (A) would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real time to suppliers before orders are filled; (B) may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and (C) would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids. IV Offsets 4001. Promoting value in Medicaid managed care Section 1903(m) of the Social Security Act ( 42 U.S.C. 1396b(m) ), as amended by sections 1013 and 1016, is further amended by adding at the end the following new paragraph: (9) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y). (B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State— (i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing— (I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or (II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and (ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio. (C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent. (D) For purposes of this paragraph: (i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i). (ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan). (iii) The term other specified entity means— (I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and (II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation). . 4002. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program Clause (i) of section 1862(b)(7)(A) of the Social Security Act ( 42 U.S.C. 1395y(b)(7)(A) ) is amended to read as follows: (i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been— (I) a primary plan to the program under this title; or (II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and . 4003. Additional religious exemption from health coverage responsibility requirement (a) In general Section 5000A(d)(2)(A) of the Internal Revenue Code of 1986 is amended to read as follows: (A) Religious conscience exemptions (i) In general Such term shall not include any individual for any month if such individual has in effect an exemption under section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act which certifies that— (I) such individual is a member of a recognized religious sect or division thereof which is described in section 1402(g)(1), and is adherent of established tenets or teachings of such sect or division as described in such section; or (II) such individual is a member of a religious sect or division thereof which is not described in section 1402(g)(1), who relies solely on a religious method of healing, and for whom the acceptance of medical health services would be inconsistent with the religious beliefs of the individual. (ii) Special rules (I) Medical health services defined For purposes of this subparagraph, the term medical health services does not include routine dental, vision and hearing services, midwifery services, vaccinations, necessary medical services provided to children, services required by law or by a third party, and such other services as the Secretary of Health and Human Services may provide in implementing section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act. (II) Attestation required Clause (i)(II) shall apply to an individual for months in a taxable year only if the information provided by the individual under section 1411(b)(5)(A) of such Act includes an attestation that the individual has not received medical health services during the preceding taxable year. . (b) Effective date The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2018. (c) Construction Nothing in the amendment made by subsection (a) shall preempt any State law requiring the provision of medical treatment for children, especially those who are seriously ill. 4004. Modernizing the reporting of biological and biosimilar products Subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ) is amended— (1) in section 1111, as amended by section 3(1) of the Patient Right to Know Drug Prices Act— (A) in the paragraph (3) inserted by such section 3(1), by striking an application and inserting a biosimilar biological product application ; (B) in the paragraph (4) inserted by such section 3(1), by inserting application before under section 351(k) of the Public Health Service Act ; (C) in the paragraph (5) inserted by such section 3(1), by striking for licensure of a biological product under section 351(k) of the Public Health Service Act and inserting under section 351(k) of the Public Health Service Act for licensure of a biological product as biosimilar to, or interchangeable with, a reference product ; (D) in paragraph (7), as redesignated and amended by such section 3(1), by striking or under section 351(a) of the Public Health Service Act and inserting or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act ; and (E) in the paragraph (12) added by such section 3(1), by striking means a brand name drug for which a license is in effect under section 351(a) and inserting has the meaning given such term in section 351(i) ; and (2) in section 1112, as amended by section 3(2) of the Patient Right to Know Drug Prices Act— (A) in subsection (a)— (i) in paragraph (1), by striking for which a statement under section 351(l)(3)(B)(ii)(I) of the Public Health Service Act has been provided ; (ii) in paragraph (2)— (I) in subparagraph (C)(i), by striking brand name and inserting listed ; and (II) by amending clause (ii) of subparagraph (C) to read as follows: (ii) any of the time periods referred to in section 351(k)(6) of the Public Health Service Act as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product. ; (B) in subsection (b)— (i) in the subsection heading, by inserting or Biosimilar Biological Product Applicant after Applicant ; (ii) in paragraph (1)(B), by striking the first sentence and inserting the following: A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c). ; and (iii) in paragraph (2)— (I) by striking 2 generic drug applicants and inserting 2 or more generic drug applicants ; and (II) by striking or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned and inserting , an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product ; and (C) in subsection (c)(2), by inserting were entered into within 30 days of, after condition for, . V Other Medicaid Provisions A Mandatory reporting with respect to adult behavioral health measures 5001. Mandatory reporting with respect to adult behavioral health measures Section 1139B of the Social Security Act ( 42 U.S.C. 1320b–9b ) is amended— (1) in subsection (b)— (A) in paragraph (3)— (i) by striking Not later than January 1, 2013 and inserting the following: (A) Voluntary reporting Not later than January 1, 2013 ; and (ii) by adding at the end the following: (B) Mandatory reporting with respect to behavioral health measures Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults. ; and (B) in paragraph (5), by adding at the end the following new subparagraph: (C) Behavioral health measures Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures. ; and (2) in subsection (d)(1)(A)— (A) by striking the such plan and inserting such plan ; and (B) by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)) . B Medicaid IMD Additional Info 5011. Short title This subtitle may be cited as the Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act . 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid (a) In general Not later than January 1, 2020, the Medicaid and CHIP Payment and Access Commission established under section 1900 of the Social Security Act ( 42 U.S.C. 1396 ) shall conduct an exploratory study, using data from a representative sample of States, and submit to Congress a report on at least the following information, with respect to services furnished to individuals enrolled under State plans under the Medicaid program under title XIX of such Act ( 42 U.S.C. 1396 et seq.) (or waivers of such plans) who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such State plans (or waivers): (1) A description of such institutions for mental diseases in each such State, including at a minimum— (A) the number of such institutions in the State; (B) the facility type of such institutions in the State; and (C) any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services. (2) With respect to each such institution for mental diseases in each such State, a description of— (A) such services provided at such institution; (B) the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and (C) the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process. (3) A description of— (A) any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and (B) any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments. (4) A summary of State requirements (such as certification, licensure, and accreditation) applied by each such State to such institutions in order for such institutions to receive payment under the State plan (or waiver) and how each such State determines if such requirements have been met. (5) A summary of State standards (such as quality standards, clinical standards, and facility standards) that such institutions must meet to receive payment under such State plans (or waivers) and how each such State determines if such standards have been met. (6) If determined appropriate by the Commission, recommendations for policies and actions by Congress and the Centers for Medicare & Medicaid Services, such as on how State Medicaid programs may improve care and improve standards and including a recommendation for how the Centers for Medicare & Medicaid Services can improve data collection from such programs to address any gaps in information. (b) Stakeholder input In carrying out subsection (a), the Medicaid and CHIP Payment and Access Commission shall seek input from State Medicaid directors and stakeholders, including at a minimum the Substance Abuse and Mental Health Services Administration, Centers for Medicare & Medicaid Services, State Medicaid officials, State mental health authorities, Medicaid beneficiary advocates, health care providers, and Medicaid managed care organizations. (c) Definitions In this section: (1) Representative sample of States The term representative sample of States means a non-probability sample in which at least two States are selected based on the knowledge and professional judgment of the selector. (2) State The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (3) Institution for mental diseases The term institution for mental diseases has the meaning given such term in section 435.1010 of title 42, Code of Federal Regulations, or any successor regulation. C CHIP Mental Health and Substance Use Disorder Parity 5021. Short title This subtitle may be cited as the CHIP Mental Health and Substance Use Disorder Parity Act . 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program (a) In general Section 2103(c)(1) of the Social Security Act ( 42 U.S.C. 1397cc(c)(1) ) is amended by adding at the end the following new subparagraph: (E) Mental health and substance use disorder services (as defined in paragraph (5)). . (b) Mental health and substance use disorder services (1) In general Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended— (A) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and (B) by inserting after paragraph (4) the following new paragraph: (5) Mental health and substance use disorder services Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income pregnant women (as defined in section 2112(d)) shall— (A) include coverage of mental health services (including behavioral health treatment) necessary to prevent, diagnose, and treat a broad range of mental health symptoms and disorders, including substance use disorders; and (B) be delivered in a culturally and linguistically appropriate manner. . (2) Conforming amendments (A) Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ) is amended, in the matter before paragraph (1), by striking paragraphs (5), (6), and (7) and inserting paragraphs (5), (6), (7), and (8) . (B) Section 2110(a) of the Social Security Act ( 42 U.S.C. 1397jj(a) ) is amended— (i) in paragraph (18), by striking substance abuse each place it appears and inserting substance use ; and (ii) in paragraph (19), by striking substance abuse and inserting substance use . (C) Section 2110(b)(5)(A)(i) of the Social Security Act ( 42 U.S.C. 1397jj(b)(5)(A)(i) ) is amended by striking subsection (c)(5) and inserting subsection (c)(6) . (c) Assuring access to care Section 2102(a)(7)(B) of the Social Security Act ( 42 U.S.C. 1397bb(c)(2) ) is amended by striking section 2103(c)(5) and inserting paragraphs (5) and (6) of section 2103(c) . (d) Mental health services parity Subparagraph (A) of paragraph (7) of section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) (as redesignated by subsection (b)(1)) is amended to read as follows: (A) In general A State child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services (as described in paragraph (5)) provided under such plan comply with the requirements of section 2726(a) of the Public Health Service Act in the same manner as such requirements or limitations apply to a group health plan under such section. . (e) Effective date (1) In general Subject to paragraph (2), the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is 1 year after the date of the enactment of this Act. (2) Exception for State legislation In the case of a State child health plan under title XXI of the Social Security Act (or a waiver of such plan), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan (or waiver) to meet any requirement imposed by the amendments made by this section, the respective plan (or waiver) shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this section. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. D Medicaid Reentry 5031. Short title This subtitle may be cited as the Medicaid Reentry Act . 5032. Promoting State innovations to ease transitions integration to the community for certain individuals (a) Stakeholder group development of best practices; State Medicaid program innovation (1) Stakeholder group best practices Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a stakeholder group of representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, and other relevant representatives from local, State, and Federal jail and prison systems to develop best practices (and submit to the Secretary and Congress a report on such best practices) for States— (A) to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and (B) to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution. (2) State Medicaid program innovation The Secretary of Health and Human Services shall work with States on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the Medicaid program under title XIX of the Social Security Act transition, with respect to enrollment for medical assistance under such program, seamlessly to the community. (b) Guidance on innovative service delivery systems demonstration project opportunities Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a State Medicaid Director letter, based on best practices developed under subsection (a)(1), regarding opportunities to design demonstration projects under section 1115 of the Social Security Act ( 42 U.S.C. 1315 ) to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title XIX of such Act, including systems for, with respect to a period (not to exceed 30 days) immediately prior to the day on which such individuals are expected to be released from such institution— (1) providing assistance and education for enrollment under a State plan under the Medicaid program under title XIX of such Act for such individuals during such period; and (2) providing health care services for such individuals during such period. (c) Rule of construction Nothing under title XIX of the Social Security Act or any other provision of law precludes a State from reclassifying or suspending (rather than terminating) eligibility of an individual for medical assistance under title XIX of the Social Security Act while such individual is an inmate of a public institution. E Medicaid Partnership 5041. Short title This subtitle may be cited as the Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act . 5042. Medicaid providers are required to note experiences in record systems to help in-need patients (a) Requirements under the Medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) is amended by inserting after section 1943 the following new section: 1944. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances (a) In general Subject to subsection (d), beginning October 1, 2021, a State— (1) shall require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance; and (2) in the case that such a provider is not able to conduct such a check despite a good faith effort by such provider— (A) shall require the provider to document such good faith effort, including the reasons why the provider was not able to conduct the check; and (B) may require the provider to submit, upon request, such documentation to the State. (b) Qualified prescription drug monitoring program described A qualified prescription drug monitoring program described in this subsection is, with respect to a State, a prescription drug monitoring program administered by the State that, at a minimum, satisfies each of the following criteria: (1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible: (A) Information regarding the prescription drug history of a covered individual with respect to controlled substances. (B) The number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period. (C) The name, location, and contact information (or other identifying number selected by the State, such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent 12-month period. (2) The program facilitates the integration of information described in paragraph (1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe controlled substances. A qualified prescription drug monitoring program described in this subsection, with respect to a State, may have in place, in accordance with applicable State and Federal law, a data-sharing agreement with the State Medicaid program that allows the medical director and pharmacy director of such program (and any designee of such a director who reports directly to such director) to access the information described in paragraph (1) in an electronic format. The State Medicaid program under this title may facilitate reasonable and limited access, as determined by the State and ensuring documented beneficiary protections regarding the use of such data, to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under section 1903(m) or under section 1905(t)(3), or the medical director or pharmacy director of any entity that has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the State plan (or under a waiver of the State plan). All applicable State and Federal security and privacy laws shall apply to the directors or designees of such directors of any State Medicaid program or entity accessing a qualified prescription drug monitoring program under this section. (c) Application of privacy rules clarification The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph. (d) Ensuring access In order to ensure reasonable access to health care, the Secretary shall waive the application of the requirement under subsection (a), with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)). (e) Reports (1) State reports Each State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2023, information including, at a minimum, the following information for the most recent 12-month period: (A) The percentage of covered providers (as determined pursuant to a process established by the State) who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance. (B) Aggregate trends with respect to prescribing controlled substances such as— (i) the quantity of daily morphine milligram equivalents prescribed for controlled substances; (ii) the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and (iii) the types of controlled substances prescribed, including the dates of such prescriptions, the supplies authorized (including the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this title and title XVIII). (C) Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before dispensing a controlled substance to such individual. (D) An accounting of any data or privacy breach of a qualified prescription drug monitoring program described in subsection (b), the number of covered individuals impacted by each such breach, and a description of the steps the State has taken to address each such breach, including, to the extent required by State or Federal law or otherwise determined appropriate by the State, alerting any such impacted individual and law enforcement of the breach. (2) Report by CMS Not later than October 1, 2023, the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information: (A) Guidance for States on how States can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection (b). (B) Best practices for how States and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances. (f) Increase to FMAP and Federal matching rates for certain expenditures relating to qualified prescription drug monitoring programs (1) In general With respect to a State that meets the condition described in paragraph (2) and any quarter occurring during fiscal year 2019 or fiscal year 2020, the Federal medical assistance percentage or Federal matching rate that would otherwise apply to such State under section 1903(a) for such quarter, with respect to expenditures by the State for activities under the State plan (or a waiver of such plan) to design, develop, or implement a prescription drug monitoring program (and to make connections to such program) that satisfies the criteria described in paragraphs (1) and (2) of subsection (b), shall be equal to 100 percent. (2) Condition The condition described in this paragraph, with respect to a State, is that the State (in this paragraph referred to as the administering State ) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug monitoring program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program. (g) Rule of construction Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified prescription drug monitoring program before dispensing controlled substances to such individuals. (h) Definitions In this section: (1) Controlled substance The term controlled substance means a drug that is included in schedule II of section 202(c) of the Controlled Substances Act and, at the option of the State involved, a drug included in schedule III or IV of such section. (2) Covered individual The term covered individual means, with respect to a State, an individual who is enrolled in the State plan (or under a waiver of such plan). Such term does not include an individual who— (A) is receiving— (i) hospice or palliative care; or (ii) treatment for cancer; (B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or (C) the State elects to treat as exempted from such term. (3) Covered provider (A) In general The term covered provider means, subject to subparagraph (B), with respect to a State, a health care provider who is participating under the State plan (or waiver of the State plan) and licensed, registered, or otherwise permitted by the State to prescribe a controlled substance (or the designee of such provider). (B) Exceptions (i) In general Beginning October 1, 2021, for purposes of this section, such term does not include a health care provider included in any type of health care provider determined by the Secretary to be exempt from application of this section under clause (ii). (ii) Exceptions process Not later than October 1, 2020, the Secretary, after consultation with the National Association of Medicaid Directors, national health care provider associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of health care providers (if any) that should be exempted from the definition of the term covered provider for purposes of this section. . (b) Guidance Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs. (c) Development of model State practices (1) In general Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data-sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act, as added by subsection (a), for the following purposes: (A) Monitoring and preventing fraud, waste, and abuse. (B) Improving health care for individuals enrolled in a State plan under title XIX of such Act (or under a waiver of such plan) who— (i) transition in and out of coverage under such title; (ii) may have sources of health care coverage in addition to coverage under such title; or (iii) pay for prescription drugs with cash. (C) Any other purposes specified by the Secretary. (2) Elements of model practices The model practices described in paragraph (1)— (A) shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and (B) shall include any appropriate beneficiary protections and privacy guidelines. (3) Consultation In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act) with contracts with States pursuant to section 1903(m) of such Act, pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records. (d) Report by Comptroller General Not later than October 1, 2020, the Comptroller General of the United States shall issue a report examining the operation of prescription drug monitoring programs administered by States, including data security and access standards used by such programs. F IMD CARE Act 5051. Short title This title may be cited as the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act . 5052. State option to provide Medicaid coverage for certain individuals with substance use disorders who are patients in certain institutions for mental diseases (a) In general Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.), as amended by preceding sections of this Act, is further amended— (1) in section 1905(a), in the subdivision (B) that follows paragraph (30), by inserting (except in the case of services provided under a State plan amendment described in section 1915(l)) before the period; and (2) in section 1915, by adding at the end the following new subsection: (l) State plan amendment option to provide medical assistance for certain individuals who are patients in certain institutions for mental diseases (1) In general With respect to calendar quarters beginning during the period beginning October 1, 2019, and ending September 30, 2023, a State may elect, through a State plan amendment, to provide medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection. (2) Payments Subject to paragraphs (3) and (4), amounts expended under a State plan amendment under paragraph (1) for services described in such paragraph furnished, with respect to a 12-month period, to an eligible individual who is a patient in an eligible institution for mental diseases shall be treated as medical assistance for which payment is made under section 1903(a) but only to the extent that such services are furnished for not more than a period of 30 days (whether or not consecutive) during such 12-month period. (3) Maintenance of effort (A) In general As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall (during the period in which it so furnished such medical assistance through a State plan amendment under this subsection) maintain on an annual basis a level of funding expended by the State (and political subdivisions thereof) other than under this title from non-Federal funds for— (i) items and services furnished to eligible individuals who are patients in eligible institutions for mental diseases that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection; and (ii) items and services (including services described in subparagraph (B)) furnished to eligible individuals in outpatient and community-based settings that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection. (B) Services described For purposes of subparagraph (A)(ii), services described in this subparagraph are the following: (i) Outpatient and community-based substance use disorder treatment. (ii) Evidence-based recovery and support services. (iii) Clinically-directed therapeutic treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. (iv) Outpatient medication-assisted treatment, related therapies, and pharmacology. (v) Counseling and clinical monitoring. (vi) Outpatient withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or occurring with, an individual’s use of alcohol and other drugs. (vii) Routine monitoring of medication adherence. (viii) Other outpatient and community-based services for the treatment of substance use disorders, as designated by the Secretary. (C) State reporting requirement (i) In general Prior to approval of a State plan amendment under this subsection, as a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall report to the Secretary, in accordance with the process established by the Secretary under clause (ii), the information deemed necessary by the Secretary under such clause. (ii) Process Not later than the date that is 8 months after the date of enactment of this subsection, the Secretary shall establish a process for States to report to the Secretary, at such time and in such manner as the Secretary deems appropriate, such information as the Secretary deems necessary to verify a State’s compliance with subparagraph (A). (4) Ensuring a continuum of services (A) In general As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall carry out each of the requirements described in subparagraphs (B) through (D). (B) Notification Prior to approval of a State plan amendment under this subsection, the State shall notify the Secretary of how the State will ensure that eligible individuals receive appropriate evidence-based clinical screening prior to being furnished with items and services in an eligible institution for mental diseases, including initial and periodic assessments to determine the appropriate level of care, length of stay, and setting for such care for each individual. (C) Outpatient services; inpatient and residential services (i) Outpatient services The State shall, at a minimum, provide medical assistance for services that could otherwise be covered under the State plan, consistent with each of the following outpatient levels of care: (I) Early intervention for individuals who, for a known reason, are at risk of developing substance-related problems and for individuals for whom there is not yet sufficient information to document a diagnosable substance use disorder. (II) Outpatient services for less than 9 hours per week for adults, and for less than 6 hours per week for adolescents, for recovery or motivational enhancement therapies and strategies. (III) Intensive outpatient services for 9 hours or more per week for adults, and for 6 hours or more per week for adolescents, to treat multidimensional instability. (IV) Partial hospitalization services for 20 hours or more per week for adults and adolescents to treat multidimensional instability that does not require 24-hour care. (ii) Inpatient and residential services The State shall provide medical assistance for services that could otherwise be covered under the State plan, consistent with at least 2 of the following inpatient and residential levels of care: (I) Clinically managed, low-intensity residential services that provide adults and adolescents with 24-hour living support and structure with trained personnel and at least 5 hours of clinical service per week per individual. (II) Clinically managed, population-specific, high-intensity residential services that provide adults with 24-hour care with trained counselors to stabilize multidimensional imminent danger along with less intense milieu and group treatment for those with cognitive or other impairments unable to use full active milieu or therapeutic community. (III) Clinically managed, medium-intensity residential services for adolescents, and clinically managed, high-intensity residential services for adults, that provide 24-hour care with trained counselors to stabilize multidimensional imminent danger and preparation for outpatient treatment. (IV) Medically monitored, high-intensity inpatient services for adolescents, and medically monitored, intensive inpatient services withdrawal management for adults, that provide 24-hour nursing care, make physicians available for significant problems in Dimensions 1, 2, or 3, and provide counseling services 16 hours per day. (V) Medically managed, intensive inpatient services for adolescents and adults that provide 24-hour nursing care and daily physician care for severe, unstable problems in Dimensions 1, 2 or 3. (D) Transition of care In order to ensure an appropriate transition for an eligible individual from receiving care in an eligible institution for mental diseases to receiving care at a lower level of clinical intensity within the continuum of care (including outpatient services), the State shall ensure that— (i) a placement in such eligible institution for mental diseases would allow for an eligible individual’s successful transition to the community, considering such factors as proximity to an individual’s support network (such as family members, employment, and counseling and other services near an individual’s residence); and (ii) all eligible institutions for mental diseases that furnish items and services to individuals for which medical assistance is provided under the State plan— (I) are able to provide care at such lower level of clinical intensity; or (II) have an established relationship with another facility or provider that is able to provide care at such lower level of clinical intensity and accepts patients receiving medical assistance under this title under which the eligible institution for mental diseases may arrange for individuals to receive such care from such other facility or provider. (5) Application to managed care Payments for, and limitations to, medical assistance furnished in accordance with this subsection shall be in addition to and shall not be construed to limit or supersede the ability of States to make monthly capitation payments to managed care organizations for individuals receiving treatment in institutions for mental diseases in accordance with section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation). (6) Other medical assistance The provision of medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection shall not prohibit Federal financial participation for medical assistance for items or services that are provided to such eligible individual in or away from the eligible institution for mental disease during any period in which the eligible individual is receiving items or services in accordance with this subsection. (7) Definitions In this subsection: (A) Dimensions 1, 2, or 3 The term Dimensions 1, 2, or 3 has the meaning given that term for purposes of the publication of the American Society of Addiction Medicine entitled The ASAM Criteria: Treatment Criteria for Addictive Substance-Related, and Co-Occurring Conditions, 2013 . (B) Eligible individual The term eligible individual means an individual who— (i) with respect to a State, is enrolled for medical assistance under the State plan or a waiver of such plan; (ii) is at least 21 years of age; (iii) has not attained 65 years of age; and (iv) has at least 1 substance use disorder. (C) Eligible institution for mental diseases The term eligible institution for mental diseases means an institution for mental diseases that— (i) follows reliable, evidence-based practices; and (ii) offers at least 2 forms of medication-assisted treatment for substance use disorders on site, including, in the case of medication-assisted treatment for opioid use disorder, at least 1 antagonist and 1 partial agonist. (D) Institution for mental diseases The term institution for mental diseases has the meaning given that term in section 1905(i). . (b) Rule of construction Nothing in the amendments made by subsection (a) shall be construed as encouraging a State to place an individual in an inpatient or a residential care setting where a home or community-based care setting would be more appropriate for the individual, or as preventing a State from conducting or pursuing a demonstration project under section 1115 of the Social Security Act to improve access to, and the quality of, substance use disorder treatment for eligible populations. G Medicaid Improvement Fund 5061. Medicaid Improvement Fund Section 1941(b)(1) of the Social Security Act ( 42 U.S.C. 1396w–1(b)(1) ) is amended by striking $0 and inserting $31,000,000 . VI Other Medicare Provisions A Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology 6001. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ) is amended by adding at the end the following new clause: (xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))). . B Abuse Deterrent Access 6011. Short title This subtitle may be cited at the Abuse Deterrent Access Act of 2018 . 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare (a) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on— (1) the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an MA–PD plan under part C of title XVIII of the Social Security Act or a prescription drug plan under part D of such title of such Act, taking into account any barriers preventing such individuals from accessing such formulations under such MA–PD or part D plans, such as cost-sharing tiers, fail-first requirements, the price of such formulations, and prior authorization requirements; and (2) the effectiveness of abuse-deterrent opioid formulations in preventing opioid abuse or misuse; the impact of the use of abuse-deterrent opioid formulations on the use or abuse of other prescription or illicit opioids (including changes in deaths from such opioids); and other public health consequences of the use of abuse-deterrent opioid formulations, such as an increase in rates of human immunodeficiency virus. (b) Definition of Abuse-Deterrent opioid formulation In this section, the term abuse-deterrent opioid formulation means an opioid that is a prodrug or that has certain abuse-deterrent properties, such as physical or chemical barriers, agonist or antagonist combinations, aversion properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid. C Medicare Opioid Safety Education 6021. Medicare opioid safety education (a) In general Section 1804 of the Social Security Act ( 42 U.S.C. 1395b–2 ) is amended by adding at the end the following new subsection: (d) The notice provided under subsection (a) shall include— (1) references to educational resources regarding opioid use and pain management; (2) a description of categories of alternative, non-opioid pain management treatments covered under this title; and (3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management. . (b) Effective date The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019. D Opioid Addiction Action Plan 6031. Short title This subtitle may be cited as the Opioid Addiction Action Plan Act . 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment (a) In general Not later than January 1, 2020, the Secretary of Health and Human Services (in this section referred to as the “Secretary”), in collaboration with the Pain Management Best Practices Inter-Agency Task Force convened under section 101(b) of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), shall develop an action plan as described in subsection (b). (b) Action plan components The action plan shall include a review by the Secretary of Medicare and Medicaid payment and coverage policies that may be viewed as potential obstacles to an effective response to the opioid crisis, and recommendations, as determined appropriate by the Secretary, on the following: (1) A review of payment and coverage policies under the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act, including a review of coverage and payment under such programs of all medication-assisted treatment approved by the Food and Drug Administration related to the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including in such review, payment under the Medicare prospective payment system for inpatient hospital services under section 1886(d) of such Act ( 42 U.S.C. 1395ww(d) ) and the Medicare prospective payment system for hospital outpatient department services under section 1833(t) of such Act ( 42 U.S.C. 1395I(t) ), to determine whether those payment policies resulted in incentives or disincentives that have contributed to the opioid crisis. (2) Recommendations for payment and service delivery models to be tested as appropriate by the Center for Medicare and Medicaid Innovation and other federally authorized demonstration projects, including value-based models, that may encourage the use of appropriate medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse. (3) Recommendations for data collection that could facilitate research and policy-making regarding prevention of opioid use disorder as well as data that would aid the Secretary in making coverage and payment decisions under the Medicare and Medicaid programs related to the access to appropriate opioid dependence treatments. (4) A review of Medicare and Medicaid beneficiaries’ access to the full range of medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including access of beneficiaries residing in rural or medically underserved communities. (5) A review of payment and coverage policies under the Medicare program and the Medicaid program related to medical devices that are non-opioid based treatments approved by the Food and Drug Administration for the management of acute pain and chronic pain, for monitoring substance use withdrawal and preventing overdoses of controlled substances, and for treating substance use disorder, including barriers to patient access. (c) Stakeholder meetings (1) In general Beginning not later than 3 months after the date of the enactment of this section, the Secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan described in subsection (b). (2) Participants Participants of meetings described in paragraph (1) shall include representatives from the Food and Drug Administration and National Institutes of Health, biopharmaceutical industry members, medical researchers, health care providers, the medical device industry, the Medicare program, the Medicaid program, and patient advocates. (d) Request for information Not later than 3 months after the date of the enactment of this section, the Secretary shall issue a request for information seeking public feedback regarding ways in which the Centers for Medicare & Medicaid Services can help address the opioid crisis through the development of and application of the action plan. (e) Report to Congress Not later than June 1, 2020, the Secretary shall submit to Congress, and make public, a report that includes— (1) a summary of the results of the Secretary’s review and any recommendations under the action plan; (2) the Secretary’s planned next steps with respect to the action plan; and (3) an evaluation of price trends for drugs used to reverse opioid overdoses (such as naloxone), including recommendations on ways to lower such prices for consumers. (f) Definition of Medication-Assisted treatment In this section, the term medication-assisted treatment includes opioid treatment programs, behavioral therapy, and medications to treat substance abuse disorder. E Advancing High Quality Treatment for Opioid Use Disorders in Medicare 6041. Short title This subtitle may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 6042. Opioid use disorder treatment demonstration program Title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E ( 42 U.S.C. 1395cc–5 ) the following new section: 1866F. Opioid use disorder treatment demonstration program (a) Implementation of 4-Year demonstration program (1) In general Not later than January 1, 2021, the Secretary shall implement a 4-year demonstration program under this title (in this section referred to as the Program ) to increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce expenditures under this title. Under the Program, the Secretary shall make payments under subsection (e) to participants (as defined in subsection (c)(1)(A)) for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams, or arranging for such services to be furnished, to applicable beneficiaries participating in the Program. (2) Opioid use disorder treatment services For purposes of this section, the term opioid use disorder treatment services — (A) means, with respect to an applicable beneficiary, services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act for the treatment of opioid use disorders in an outpatient setting; and (B) includes— (i) medication-assisted treatment; (ii) treatment planning; (iii) psychiatric, psychological, or counseling services (or any combination of such services), as appropriate; (iv) social support services, as appropriate; and (v) care management and care coordination services, including coordination with other providers of services and suppliers not on an opioid use disorder care team. (b) Program design (1) In general The Secretary shall design the Program in such a manner to allow for the evaluation of the extent to which the Program accomplishes the following purposes: (A) Reduces hospitalizations and emergency department visits. (B) Increases use of medication-assisted treatment for opioid use disorders. (C) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV). (D) Does not increase the total spending on items and services under this title. (E) Reduces deaths from opioid overdose. (F) Reduces the utilization of inpatient residential treatment. (2) Consultation In designing the Program, including the criteria under subsection (e)(2)(A), the Secretary shall, not later than 3 months after the date of the enactment of this section, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups. (c) Participants; opioid use disorder care teams (1) Participants (A) Definition In this section, the term participant means an entity or individual— (i) that is otherwise enrolled under this title and that is— (I) a physician (as defined in section 1861(r)(1)); (II) a group practice comprised of at least one physician described in subclause (I); (III) a hospital outpatient department; (IV) a federally qualified health center (as defined in section 1861(aa)(4)); (V) a rural health clinic (as defined in section 1861(aa)(2)); (VI) a community mental health center (as defined in section 1861(ff)(3)(B)); (VII) a clinic certified as a certified community behavioral health clinic pursuant to section 223 of the Protecting Access to Medicare Act of 2014; or (VIII) any other individual or entity specified by the Secretary; (ii) that applied for and was selected to participate in the Program pursuant to an application and selection process established by the Secretary; and (iii) that establishes an opioid use disorder care team (as defined in paragraph (2)) through employing or contracting with health care practitioners described in paragraph (2)(A), and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the Program. (B) Preference In selecting participants for the Program, the Secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence. (2) Opioid use disorder care teams (A) In general For purposes of this section, the term opioid use disorder care team means a team of health care practitioners established by a participant described in paragraph (1)(A) that— (i) shall include— (I) at least one physician (as defined in section 1861(r)(1)) furnishing primary care services or addiction treatment services to an applicable beneficiary; and (II) at least one eligible practitioner (as defined in paragraph (3)), who may be a physician who meets the criterion in subclause (I); and (ii) may include other practitioners licensed under State law to furnish psychiatric, psychological, counseling, and social services to applicable beneficiaries. (B) Requirements for receipt of payment under Program In order to receive payments under subsection (e), each participant in the Program shall— (i) furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services; (ii) meet minimum criteria, as established by the Secretary; and (iii) submit to the Secretary, in such form, manner, and frequency as specified by the Secretary, with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team, data and such other information as the Secretary determines appropriate to— (I) monitor and evaluate the Program; (II) determine if minimum criteria are met under clause (ii); and (III) determine the incentive payment under subsection (e). (3) Eligible practitioner defined For purposes of this section, the term eligible practitioner means a physician or other health care practitioner, such as a nurse practitioner, that— (A) is enrolled under section 1866(j)(1); (B) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and (C) has in effect a waiver in accordance with section 303(g) of the Controlled Substances Act for such purpose and is otherwise in compliance with regulations promulgated by the Substance Abuse and Mental Health Services Administration to carry out such section. (d) Participation of applicable beneficiaries (1) Applicable beneficiary defined In this section, the term applicable beneficiary means an individual who— (A) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B; (B) is not enrolled in a Medicare Advantage plan under part C; (C) has a current diagnosis for an opioid use disorder; and (D) meets such other criteria as the Secretary determines appropriate. Such term shall include an individual who is dually eligible for benefits under this title and title XIX if such individual satisfies the criteria described in subparagraphs (A) through (D). (2) Voluntary beneficiary participation; limitation on number of beneficiaries An applicable beneficiary may participate in the Program on a voluntary basis and may terminate participation in the Program at any time. Not more than 20,000 applicable beneficiaries may participate in the Program at any time. (3) Services In order to participate in the Program, an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant. Participation under the Program shall not affect coverage of or payment for any other item or service under this title for the applicable beneficiary. (4) Beneficiary access to services Nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this title, and applicable beneficiaries shall not be required to relinquish access to any benefit under this title as a condition of receiving services from a participant in the Program. (e) Payments (1) Per applicable beneficiary per month care management fee (A) In general The Secretary shall establish a schedule of per applicable beneficiary per month care management fees. Such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this title to the health care practitioners in the participant’s opioid use disorder care team or, if applicable, to the participant. A participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries, including services not otherwise eligible for payment under this title. (B) Payment amounts In carrying out subparagraph (A), the Secretary may— (i) consider payments otherwise payable under this title for opioid use disorder treatment services and the needs of applicable beneficiaries; (ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care; (iii) pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months, to reflect the greater time and costs required for the planning and initiation of treatment, as compared to maintenance of treatment; and (iv) take into account whether a participant’s opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services. (C) No duplicate payment The Secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month. (2) Incentive payments (A) In general Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid (using a methodology established and at a time determined appropriate by the Secretary) to participants based on the performance of participants with respect to criteria, as determined appropriate by the Secretary, in accordance with subparagraph (B). (B) Criteria (i) In general Criteria described in subparagraph (A) may include consideration of the following: (I) Patient engagement and retention in treatment. (II) Evidence-based medication-assisted treatment. (III) Other criteria established by the Secretary. (ii) Required consultation and consideration In determining criteria described in subparagraph (A), the Secretary shall— (I) consult with stakeholders, including clinicians in the primary care community and in the field of addiction medicine; and (II) consider existing clinical guidelines for the treatment of opioid use disorders. (C) No duplicate payment The Secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary. (f) Multipayer strategy In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the Program under subsection (e)(2)(C). The Secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the Program. (g) Evaluation (1) In general The Secretary shall conduct an intermediate and final evaluation of the program. Each such evaluation shall determine the extent to which each of the purposes described in subsection (b) have been accomplished under the Program. (2) Reports The Secretary shall submit to Congress— (A) a report with respect to the intermediate evaluation under paragraph (1) not later than 3 years after the date of the implementation of the Program; and (B) a report with respect to the final evaluation under paragraph (1) not later than 6 years after such date. (h) Funding (1) Administrative funding For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841. (2) Care management fees and incentives For the purposes of making payments under subsection (e), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 for each of fiscal years 2021 through 2024. (3) Availability Amounts transferred under this subsection for a fiscal year shall be available until expended. (i) Waivers The Secretary may waive any provision of this title as may be necessary to carry out the Program under this section. . F Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment 6051. Short title This subtitle may be cited as the Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Act of 2018 or the REACH OUT Act of 2018 . 6052. Grants to provide technical assistance to outlier prescribers of opioids (a) Grants authorized The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, through the Centers for Medicare & Medicaid Services, award grants, contracts, or cooperative agreements to eligible entities for the purposes described in subsection (b). (b) Use of funds Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance— (1) to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids; (2) to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and (3) to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids. (c) Application Each eligible entity seeking to receive a grant, contract, or cooperative agreement under subsection (a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. (d) Geographic distribution In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State. (e) Definitions In this section: (1) Eligible entity The term eligible entity means— (A) an organization— (i) that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and (ii) that has at least— (I) one individual who is a representative of consumers on its governing body; and (II) one individual who is a representative of health care providers on its governing body; or (B) an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act ( 42 U.S.C. 1320c et seq.). (2) Outlier prescriber of opioids The term outlier prescriber of opioids means, with respect to a period, a prescriber identified by the Secretary under subparagraph (D)(ii) of section 1860D–4(c)(4) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4) ), as added by section 6065 of this Act, to be an outlier prescriber of opioids for such period. (3) Prescribers The term prescriber means any health care professional, including a nurse practitioner or physician assistant, who is licensed to prescribe opioids by the State or territory in which such professional practices. (f) Funding For purposes of implementing this section, $75,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act ( 42 U.S.C. 1395t ), to remain available until expended. G Preventing Addiction for Susceptible Seniors 6061. Short title This subtitle may be cited as the Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018 . 6062. Electronic prior authorization for covered part D drugs Section 1860D–4(e)(2) of the Social Security Act ( 42 U.S.C. 1395w–104(e)(2) ) is amended by adding at the end the following new subparagraph: (E) Electronic prior authorization (i) In general Not later than January 1, 2021, the program shall provide for the secure electronic transmission of— (I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and (II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional. (ii) Electronic transmission (I) Exclusions For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i). (II) Standards In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors. (III) Application Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual. . 6063. Program integrity transparency measures under Medicare parts C and D (a) In general Section 1859 of the Social Security Act ( 42 U.S.C. 1395w–28 ) is amended by adding at the end the following new subsection: (i) Program integrity transparency measures (1) Program integrity portal (A) In general Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure internet website portal (or other successor technology) that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or an entity responsible for carrying out program integrity activities under this part and part D) for the purpose of enabling through such portal (or other successor technology)— (i) the referral by such plans of substantiated or suspicious activities, as defined by the Secretary, of a provider of services (including a prescriber) or supplier related to fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and (ii) data sharing among such MA plans, prescription drug plans, and the Secretary. (B) Required uses of portal The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure internet website portal (or other successor technology) established under subparagraph (A): (i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period. (ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise. (iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation. (iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal (or other successor technology) with respect to activities of substantiated or suspicious activities of fraud, waste, or abuse of a provider of services (including a prescriber) or supplier, if such provider (including a prescriber) or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken. (C) Rulemaking For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes substantiated or suspicious activities of fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.8. In carrying out this subsection, a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for substantiated fraud, waste, or abuse. (D) HIPAA compliant information only For purposes of this subsection, communications may only occur if the communications are permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (2) Quarterly reports Beginning not later than 2 years after the date of the enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal (or other successor technology) described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall— (A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and (B) be anonymized information submitted by plans without identifying the source of such information. (3) Clarification Nothing in this subsection shall preclude or otherwise affect referrals to the Inspector General of the Department of Health and Human Services or other law enforcement entities. . (b) Contract requirement to communicate plan corrective actions against opioids over-prescribers Section 1857(e) of the Social Security Act ( 42 U.S.C. 1395w–27(e) ) is amended by adding at the end the following new paragraph: (5) Communicating plan corrective actions against opioids over-prescribers (A) In general Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on the investigations, credible evidence of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud, and other actions taken by such plans related to inappropriate prescribing of opioids. (B) Process Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A). (C) Regulations For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking— (i) specify a definition for the term inappropriate prescribing and a method for determining if a provider of services prescribes inappropriate prescribing; and (ii) establish the process described in subparagraph (B) and the types of information that shall be submitted through such process. . (c) Reference under part D to program integrity transparency measures Section 1860D–4 of the Social Security Act ( 42 U.S.C. 1395w–104 ) is amended by adding at the end the following new subsection: (m) Program integrity transparency measures For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i). . 6064. Expanding eligibility for medication therapy management programs under part D Section 1860D–4(c)(2)(A)(ii) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(A)(ii) ) is amended— (1) by redesignating subclauses (I) through (III) as items (aa) through (cc), respectively, and adjusting the margins accordingly; (2) by striking are part D eligible individuals who— and inserting are the following: (I) Part D eligible individuals who— ; and (3) by adding at the end the following new subclause: (II) Beginning January 1, 2021, at-risk beneficiaries for prescription drug abuse (as defined in paragraph (5)(C)). . 6065. Commit to opioid medical prescriber accountability and safety for seniors Section 1860D–4(c)(4) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(4) ) is amended by adding at the end the following new subparagraph: (D) Notification and additional requirements with respect to outlier prescribers of opioids (i) Notification Not later than January 1, 2021, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be an outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified and that includes resources on proper prescribing methods and other information as specified in accordance with clause (iii). (ii) Identification of outlier prescribers of opioids (I) In general The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the thresholds established under subclause (II), identify prescribers that are outlier opioids prescribers for a period of time specified by the Secretary. (II) Establishment of thresholds For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish thresholds, based on prescriber specialty and geographic area, for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area. (III) Exclusions The following shall not be included in the analysis for identifying outlier prescribers of opioids under this clause: (aa) Claims for covered part D drugs for part D eligible individuals who are receiving hospice care under this title. (bb) Claims for covered part D drugs for part D eligible individuals who are receiving oncology services under this title. (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Inspector General of the Department of Health and Human Services. (iii) Contents of notification The Secretary shall include the following information in the notifications provided under clause (i): (I) Information on how such prescriber compares to other prescribers within the same specialty and geographic area. (II) Information on opioid prescribing guidelines, based on input from stakeholders, that may include the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain and guidelines developed by physician organizations. (III) Other information determined appropriate by the Secretary. (iv) Modifications and expansions (I) Frequency Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input and changes in opioid prescribing utilization and trends. (II) Expansion to other prescriptions The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary. (v) Additional requirements for persistent outlier prescribers In the case of a prescriber who the Secretary determines is persistently identified under clause (ii) as an outlier prescriber of opioids, the following shall apply: (I) Such prescriber may be required to enroll in the program under this title under section 1866(j) if such prescriber is not otherwise required to enroll, but only after other appropriate remedies have been provided, such as the provision of education funded through section 6052 of the SUPPORT for Patients and Communities Act, for a period determined by the Secretary as sufficient to correct the prescribing patterns that lead to identification of such prescriber as a persistent outlier prescriber of opioids. The Secretary shall determine the length of the period for which such prescriber is required to maintain such enrollment, which shall be the minimum period necessary to correct such prescribing patterns. (II) Not less frequently than annually (and in a form and manner determined appropriate by the Secretary), the Secretary, consistent with clause(iv)(I), shall communicate information on such prescribers to sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA–PD plan. (vi) Public availability of information The Secretary shall make aggregate information under this subparagraph available on the internet website of the Centers for Medicare & Medicaid Services. Such information shall be in a form and manner determined appropriate by the Secretary and shall not identify any specific prescriber. In carrying out this clause, the Secretary shall consult with interested stakeholders. (vii) Opioids defined For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary. (viii) Other activities Nothing in this subparagraph shall preclude the Secretary from conducting activities that provide prescribers with information as to how they compare to other prescribers that are in addition to the activities under this subparagraph, including activities that were being conducted as of the date of the enactment of this subparagraph. . 6066. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle and the amendments made by this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. H Expanding Oversight of Opioid Prescribing and Payment 6071. Short title This subtitle may be cited as the Expanding Oversight of Opioid Prescribing and Payment Act of 2018 . 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program Not later than March 15, 2019, the Medicare Payment Advisory Commission shall submit to Congress a report on, with respect to the Medicare program under title XVIII of the Social Security Act, the following: (1) A description of how the Medicare program pays for pain management treatments (both opioid and non-opioid pain management alternatives) in both inpatient and outpatient hospital settings. (2) The identification of incentives under the hospital inpatient prospective payment system under section 1886 of the Social Security Act ( 42 U.S.C. 1395ww ) and incentives under the hospital outpatient prospective payment system under section 1833(t) of such Act ( 42 U.S.C. 1395l(t) ) for prescribing opioids and incentives under each such system for prescribing non-opioid treatments, and recommendations as the Commission deems appropriate for addressing any of such incentives that are adverse incentives. (3) A description of how opioid use is tracked and monitored through Medicare claims data and other mechanisms and the identification of any areas in which further data and methods are needed for improving data and understanding of opioid use. 6073. No additional funds authorized No additional funds are authorized to be appropriated to carry out the requirements of this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated. I Dr. Todd Graham Pain Management, Treatment, and Recovery 6081. Short title This subtitle may be cited as the Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 . 6082. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments (a) Outpatient prospective payment system Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended by adding at the end the following new paragraph: (22) Review and revisions of payments for non-opioid alternative treatments (A) In general With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary— (i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives; (ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and (iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management. (B) Priority In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management. (C) Revisions If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B). (D) Rules of construction Nothing in this paragraph shall be construed to preclude the Secretary— (i) from conducting a demonstration before making the revisions described in subparagraph (C); or (ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management. . (b) Ambulatory surgical centers Section 1833(i) of the Social Security Act ( 42 U.S.C. 1395l(i) ) is amended by adding at the end the following new paragraph: (8) The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1833(t)), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary). . 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics (a) Federally qualified health centers Section 1834(o) of the Social Security Act ( 42 U.S.C. 1395m(o) ) is amended by adding at the end the following new paragraph: (3) Additional payments for certain FQHCs with physicians or other practitioners receiving DATA 2000 waivers (A) In general In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally qualified health center services (as defined in section 1861(aa)(3)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph (C), the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Federally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practitioner. (B) Application In order to receive a payment described in subparagraph (A), a Federally qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center. (C) Requirements For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following: (i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B). (ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (D) Funding For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended. . (b) Rural health clinic Section 1833 of the Social Security Act ( 42 U.S.C. 1395l ) is amended— (1) by redesignating the subsection (z) relating to medical review of spinal subluxation services as subsection (aa); and (2) by adding at the end the following new subsection: (bb) Additional payments for certain rural health clinics with physicians or practitioners receiving DATA 2000 waivers (1) In general In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in section 1861(aa)(1)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner. (2) Application In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic. (3) Requirements For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following: (A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2). (B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (4) Funding For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended. . 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans (a) In general Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall submit to Congress a report on the availability of supplemental health care benefits (as described in section 1852(a)(3)(A) of the Social Security Act ( 42 U.S.C. 1395w–22(a)(3)(A) )) designed to treat or prevent substance use disorders under Medicare Advantage plans offered under part C of title XVIII of such Act. Such report shall include the analysis described in subsection (c) and any differences in the availability of such benefits under specialized MA plans for special needs individuals (as defined in section 1859(b)(6) of such Act ( 42 U.S.C. 1395w–28(b)(6) )) offered to individuals entitled to medical assistance under title XIX of such Act and other such Medicare Advantage plans. (b) Consultation The Secretary shall develop the report described in subsection (a) in consultation with relevant stakeholders, including— (1) individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act; (2) entities who advocate on behalf of such individuals; (3) Medicare Advantage organizations; (4) pharmacy benefit managers; and (5) providers of services and suppliers (as such terms are defined in section 1861 of such Act ( 42 U.S.C. 1395x )). (c) Contents The report described in subsection (a) shall include an analysis on the following: (1) The extent to which plans described in such subsection offer supplemental health care benefits relating to coverage of— (A) medication-assisted treatments for opioid use, substance use disorder counseling, peer recovery support services, or other forms of substance use disorder treatments (whether furnished in an inpatient or outpatient setting); and (B) non-opioid alternatives for the treatment of pain. (2) Challenges associated with such plans offering supplemental health care benefits relating to coverage of items and services described in subparagraph (A) or (B) of paragraph (1). (3) The impact, if any, of increasing the applicable rebate percentage determined under section 1854(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395w–24(b)(1)(C) ) for plans offering such benefits relating to such coverage would have on the availability of such benefits relating to such coverage offered under Medicare Advantage plans. (4) Potential ways to improve upon such coverage or to incentivize such plans to offer additional supplemental health care benefits relating to such coverage. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report (a) CMI models Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ), as amended by section 6001, is further amended by adding at the end the following new clauses: (xxvi) Supporting ways to familiarize individuals with the availability of coverage under part B of title XVIII for qualified psychologist services (as defined in section 1861(ii)). (xxvii) Exploring ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services (such as for treating depression) through use of a 24-hour, 7-day a week help line that may inform individuals about the availability of treatment options, including the availability of qualified psychologist services (as defined in section 1861(ii)). . (b) GAO study and report Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, on mental and behavioral health services under the Medicare program under title XVIII of the Social Security Act, including an examination of the following: (1) Information about services furnished by psychiatrists, clinical psychologists, and other professionals. (2) Information about ways that Medicare beneficiaries familiarize themselves about the availability of Medicare payment for qualified psychologist services (as defined in section 1861(ii) of the Social Security Act ( 42 U.S.C. 1395x(ii) ) and ways that the provision of such information could be improved. 6086. Dr. Todd Graham pain management study (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a study analyzing best practices as well as payment and coverage for pain management services under title XVIII of the Social Security Act and submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report containing options for revising payment to providers and suppliers of services and coverage related to the use of multi-disciplinary, evidence-based, non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act. The Secretary shall make such report available on the public website of the Centers for Medicare & Medicaid Services. (b) Consultation In developing the report described in subsection (a), the Secretary shall consult with— (1) relevant agencies within the Department of Health and Human Services; (2) licensed and practicing osteopathic and allopathic physicians, behavioral health practitioners, physician assistants, nurse practitioners, dentists, pharmacists, and other providers of health services; (3) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (4) substance abuse and mental health professional organizations; (5) pain management professional organizations and advocacy entities, including individuals who personally suffer chronic pain; (6) medical professional organizations and medical specialty organizations; (7) licensed health care providers who furnish alternative pain management services; (8) organizations with expertise in the development of innovative medical technologies for pain management; (9) beneficiary advocacy organizations; and (10) other organizations with expertise in the assessment, diagnosis, treatment, and management of pain, as determined appropriate by the Secretary. (c) Contents The report described in subsection (a) shall include the following: (1) An analysis of payment and coverage under title XVIII of the Social Security Act with respect to the following: (A) Evidence-based treatments and technologies for chronic or acute pain, including such treatments that are covered, not covered, or have limited coverage under such title. (B) Evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids. (C) Evidence-based treatments and technologies that treat substance use disorders. (D) Items and services furnished by practitioners through a multi-disciplinary treatment model for pain management, including the patient-centered medical home. (E) Items and services furnished to beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, or have comorbidities and require consultation or management of pain with one or more specialists in pain management, mental health, or addiction treatment. (2) An evaluation of the following: (A) Barriers inhibiting individuals entitled to benefits under part A or enrolled under part B of such title from accessing treatments and technologies described in subparagraphs (A) through (E) of paragraph (1). (B) Costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain, such as acupuncture, therapeutic massage, and items and services furnished by integrated pain management programs. (C) Pain management guidance published by the Federal Government that may be relevant to coverage determinations or other coverage requirements under title XVIII of the Social Security Act. (3) An assessment of all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids. Such assessment shall consider incorporating into such guidance relevant elements of the Va/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain published in February 2017 by the Department of Veterans Affairs and Department of Defense, including adoption of elements of the Department of Defense and Department of Veterans Affairs pain rating scale. (4) The options described in subsection (d). (5) The impact analysis described in subsection (e). (d) Options The options described in this subsection are, with respect to individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act, legislative and administrative options for accomplishing the following: (1) Improving coverage of and payment for pain management therapies without the use of opioids, including interventional pain therapies, and options to augment opioid therapy with other clinical and complementary, integrative health services to minimize the risk of substance use disorder, including in a hospital setting. (2) Improving coverage of and payment for medical devices and non-opioid based pharmacological and non-pharmacological therapies approved or cleared by the Food and Drug Administration for the treatment of pain as an alternative or augment to opioid therapy. (3) Improving and disseminating treatment strategies for beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, and treatment strategies to address health disparities related to opioid use and opioid abuse treatment. (4) Improving and disseminating treatment strategies for beneficiaries with comorbidities who require a consultation or comanagement of pain with one or more specialists in pain management, mental health, or addiction treatment, including in a hospital setting. (5) Educating providers on risks of coadministration of opioids and other drugs, particularly benzodiazepines. (6) Ensuring appropriate case management for beneficiaries who transition between inpatient and outpatient hospital settings, or between opioid therapy to non-opioid therapy, which may include the use of care transition plans. (7) Expanding outreach activities designed to educate providers of services and suppliers under the Medicare program and individuals entitled to benefits under part A or under part B of such title on alternative, non-opioid therapies to manage and treat acute and chronic pain. (8) Creating a beneficiary education tool on alternatives to opioids for chronic pain management. (e) Impact analysis The impact analysis described in this subsection consists of an analysis of any potential effects implementing the options described in subsection (d) would have— (1) on expenditures under the Medicare program; and (2) on preventing or reducing opioid addiction for individuals receiving benefits under the Medicare program. J Combating Opioid Abuse for Care in Hospitals 6091. Short title This subtitle may be cited as the Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018 . 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program (a) In general Not later than July 1, 2019, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall develop and publish on the public website of the Centers for Medicare & Medicaid Services guidance for hospitals receiving payment under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) on pain management strategies and opioid use disorder prevention strategies with respect to individuals entitled to benefits under such part. (b) Consultation In developing the guidance described in subsection (a), the Secretary shall consult with relevant stakeholders, including— (1) medical professional organizations; (2) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (3) health care consumers or groups representing such consumers; and (4) other entities determined appropriate by the Secretary. (c) Contents The guidance described in subsection (a) shall include, with respect to hospitals and individuals described in such subsection, the following: (1) Best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder, including— (A) methods to identify such individuals at-risk of opioid use disorder, including risk stratification; (B) ways to prevent, recognize, and treat opioid overdoses; and (C) resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs. (2) Best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders, including education on— (A) the adverse effects of prolonged opioid use; (B) non-opioid, evidence-based, non-pharmacological pain management treatments; (C) monitoring programs for individuals who have been prescribed opioids; and (D) the prescribing of naloxone along with an initial opioid prescription. (3) Best practices for such hospitals to make such individuals aware of the risks associated with opioid use (which may include use of the notification template described in paragraph (4)). (4) A notification template developed by the Secretary, for use as appropriate, for such individuals who are prescribed an opioid that— (A) explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely; (B) highlights multimodal and evidence-based non-opioid alternatives for pain management; (C) encourages such individuals to talk to their health care providers about such alternatives; (D) provides for a method (through signature or otherwise) for such an individual, or person acting on such individual’s behalf, to acknowledge receipt of such notification template; (E) is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and (F) includes any other information determined appropriate by the Secretary. (5) Best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital, including— (A) ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners; (B) guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs; (C) strategies to reduce long-term opioid prescriptions; and (D) methods to identify such practitioners who may be over-prescribing opioids. (6) Other information the Secretary determines appropriate, including any such information from the Opioid Safety Initiative established by the Department of Veterans Affairs or the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration. 6093. Requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs Section 1890A of the Social Security Act ( 42 U.S.C. 1395aaa–1 ) is amended by adding at the end the following new subsection: (g) Technical expert panel review of opioid and opioid use disorder quality measures (1) In general Not later than 180 days after the date of the enactment of this subsection, the Secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders, including care, prevention, diagnosis, health outcomes, and treatment furnished to individuals with opioid use disorders. The Secretary may use the entity with a contract under section 1890(a) and amend such contract as necessary to provide for the establishment of such technical expert panel. (2) Review and assessment Not later than 1 year after the date the technical expert panel described in paragraph (1) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall— (A) review quality measures that relate to opioids and opioid use disorders, including existing measures and those under development; (B) identify gaps in areas of quality measurement that relate to opioids and opioid use disorders, and identify measure development priorities for such measure gaps; and (C) make recommendations to the Secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System under section 1848(q), the alternative payment models under section 1833(z)(3)(C), the shared savings program under section 1899, the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and the hospital value-based purchasing program under section 1886(o). (3) Consideration of measures by secretary The Secretary shall consider— (A) using opioid and opioid use disorder measures (including measures used under the Merit-Based Incentive Payment System under section 1848(q), measures recommended under paragraph (2)(C), and other such measures identified by the Secretary) in alternative payment models under section 1833(z)(3)(C) and in the shared savings program under section 1899; and (B) using opioid measures described in subparagraph (A), as applicable, in the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and in the hospital value-based purchasing program under section 1886(o). (4) Prioritization of measure development The Secretary shall prioritize for measure development the gaps in quality measures identified under paragraph (2)(B). (5) Prioritization of measure endorsement The Secretary— (A) during the period beginning on the date of the enactment of this subsection and ending on December 31, 2023, shall prioritize the endorsement of measures relating to opioids and opioid use disorders by the entity with a contract under subsection (a) of section 1890 in connection with endorsement of measures described in subsection (b)(2) of such section; and (B) on and after January 1, 2024, may prioritize the endorsement of such measures by such entity. . 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use (a) Technical expert panel on reducing surgical setting opioid use (1) In general Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a technical expert panel, including medical and surgical specialty societies and hospital organizations, to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings and on best practices for pain management, including with respect to the following: (A) Approaches that limit patient exposure to opioids during the perioperative period, including pre-surgical and post-surgical injections, and that identify such patients at risk of opioid use disorder pre-operation. (B) Shared decision making with patients and families on pain management, including a review of payment to ensure payment under the Medicare program under title XVIII of the Social Security Act accounts for time spent on shared decision making. (C) Education on the safe use, storage, and disposal of opioids. (D) Prevention of opioid misuse and abuse after discharge. (E) Development of a clinical algorithm to identify and treat at-risk, opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period. (2) Report Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress and make public a report containing the recommendations developed under paragraph (1) and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge from such setting. (b) Data collection on perioperative opioid use Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains the following: (1) The diagnosis-related group codes identified by the Secretary as having the highest volume of surgeries. (2) With respect to each of such diagnosis-related group codes so identified, a determination by the Secretary of the data that is both available and reported on opioid use following such surgeries, such as with respect to— (A) surgical volumes, practices, and opioid prescribing patterns; (B) opioid consumption, including— (i) perioperative days of therapy; (ii) average daily dose at the hospital, including dosage greater than 90 milligram morphine equivalent; (iii) post-discharge prescriptions and other combination drugs that are used before intervention and after intervention; (iv) quantity and duration of opioid prescription at discharge; and (v) quantity consumed and number of refills; (C) regional anesthesia and analgesia practices, including pre-surgical and post-surgical injections; (D) naloxone reversal; (E) post-operative respiratory failure; (F) information about storage and disposal; and (G) such other information as the Secretary may specify. (3) Recommendations for improving data collection on perioperative opioid use, including an analysis to identify and reduce barriers to collecting, reporting, and analyzing the data described in paragraph (2), including barriers related to technological availability. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall post on the public website of the Centers for Medicare & Medicaid Services all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids and applicable to opioid prescriptions for individuals entitled to benefits under part A of title XVIII of the Social Security Act ( 42 U.S.C. 1395c et seq.) or enrolled under part B of such title of such Act ( 42 U.S.C. 1395j et seq.). (b) Update of guidance (1) Periodic update The Secretary shall, in consultation with the entities specified in paragraph (2), periodically (as determined appropriate by the Secretary) update guidance described in subsection (a) and revise the posting of such guidance on the website described in such subsection. (2) Consultation The entities specified in this paragraph are the following: (A) Medical professional organizations. (B) Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )). (C) Health care consumers or groups representing such consumers. (D) Other entities determined appropriate by the Secretary. K Providing Reliable Options for Patients and Educational Resources 6101. Short title This subtitle may be cited as the Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018 . 6102. Requiring Medicare Advantage plans and part D prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain Section 1860D–4(a)(1) of the Social Security Act ( 42 U.S.C. 1395w–104(a)(1) ) is amended— (1) in subparagraph (A), by inserting , subject to subparagraph (C), before including ; (2) in subparagraph (B), by adding at the end the following new clause: (vi) For plan year 2021 and each subsequent plan year, subject to subparagraph (C), with respect to the treatment of pain— (I) the risks associated with prolonged opioid use; and (II) coverage of nonpharmacological therapies, devices, and nonopioid medications— (aa) in the case of an MA–PD plan under part C, under such plan; and (bb) in the case of a prescription drug plan, under such plan and under parts A and B. ; and (3) by adding at the end the following new subparagraph: (C) Targeted provision of information A PDP sponsor of a prescription drug plan may, in lieu of disclosing the information described in subparagraph (B)(vi) to each enrollee under the plan, disclose such information through mail or electronic communications to a subset of enrollees under the plan, such as enrollees who have been prescribed an opioid in the previous 2-year period. . 6103. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs (a) Medicare Advantage Section 1852 of the Social Security Act ( 42 U.S.C. 1395w–22 ) is amended by adding at the end the following new subsection: (n) Provision of information relating to the safe disposal of certain prescription drugs (1) In general In the case of an individual enrolled under an MA or MA–PD plan who is furnished an in-home health risk assessment on or after January 1, 2021, such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal. (2) Criteria The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances. . (b) Prescription drug plans Section 1860D–4(c)(2)(B) of the Social Security Act ( 42 U.S.C. 1395w–104(c)(2)(B) ) is amended— (1) by striking may include elements that promote ; (2) by redesignating clauses (i) through (iii) as subclauses (I) through (III) and adjusting the margins accordingly; (3) by inserting before subclause (I), as so redesignated, the following new clause: (i) may include elements that promote— ; (4) in subclause (III), as so redesignated, by striking the period at the end and inserting ; and ; and (5) by adding at the end the following new clause: (ii) with respect to plan years beginning on or after January 1, 2021, shall provide for— (I) the provision of information to the enrollee on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under section 1852(n)(2), including information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal; and (II) cost-effective means by which an enrollee may so safely dispose of such drugs. . 6104. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management (a) Restriction on the use of pain questions in HCAHPS Section 1886(b)(3)(B)(viii) of the Social Security Act ( 42 U.S.C. 1395ww(b)(3)(B)(viii) ) is amended by adding at the end the following new subclause: (XII) (aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2020, such survey may not include questions about communication by hospital staff with an individual about such individual’s pain unless such questions take into account, as applicable, whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain. (bb) The Secretary shall not include on the Hospital Compare internet website any measures based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 or 2019 about communication by hospital staff with an individual about such individual’s pain. . (b) Restriction on use of 2018 and 2019 pain questions in the hospital value-based purchasing program Section 1886(o)(2)(B) of the Social Security Act ( 42 U.S.C. 1395ww(o)(2)(B) ) is amended by adding at the end the following new clause: (iii) HCAHPS pain questions The Secretary may not include under subparagraph (A) a measure that is based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 or 2019 about communication by hospital staff with an individual about the individual’s pain. . L Fighting the Opioid Epidemic With Sunshine 6111. Fighting the opioid epidemic with sunshine (a) Inclusion of information regarding payments to additional practitioners (1) In general Section 1128G(e)(6) of the Social Security Act (42 U.S.C. 1320a–7h(e)(6)) is amended— (A) in subparagraph (A), by adding at the end the following new clauses: (iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1861(aa)(5)). (iv) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)). (v) A certified nurse-midwife (as defined in section 1861(gg)(2)). ; and (B) in subparagraph (B), by inserting , physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife after physician . (2) Effective date The amendments made by this subsection shall apply with respect to information required to be submitted under section 1128G of the Social Security Act ( 42 U.S.C. 1320a–7h ) on or after January 1, 2022. (b) Sunset of exclusion of National Provider Identifier of covered recipient in information made publicly available Section 1128G(c)(1)(C)(viii) of the Social Security Act (42 U.S.C. 1320a–7h(c)(1)(C)(viii)) is amended by striking does not contain and inserting in the case of information made available under this subparagraph prior to January 1, 2022, does not contain . (c) Administration Chapter 35 of title 44, United States Code, shall not apply to this section or the amendments made by this section. VII Public Health Provisions A Awareness and training 7001. Report on effects on public health of synthetic drug use (a) In general Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Surgeon General of the Public Health Service, shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the health effects of new psychoactive substances, including synthetic drugs, used by adolescents and young adults. (b) New psychoactive substance defined For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act ( 21 U.S.C. 802(32) ). 7002. First responder training Section 546 of the Public Health Service Act ( 42 U.S.C. 290ee–1 ) is amended— (1) in subsection (c)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3), by striking the period and inserting ; and ; and (C) by adding at the end the following: (4) train and provide resources for first responders and members of other key community sectors on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure to such drugs and respond appropriately when exposure occurs. ; (2) in subsection (d), by striking and mechanisms for referral to appropriate treatment for an entity receiving a grant under this section and inserting mechanisms for referral to appropriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs ; (3) in subsection (f)— (A) in paragraph (3), by striking and at the end; (B) in paragraph (4), by striking the period and inserting ; and ; and (C) by adding at the end the following: (5) the number of first responders and members of other key community sectors trained on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs. ; (4) by redesignating subsection (g) as subsection (h); (5) by inserting after subsection (f) the following: (g) Other key community sectors In this section, the term other key community sectors includes substance use disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and jail populations and offender reentry programs, health care providers, harm reduction groups, pharmacies, community health centers, tribal health facilities, and mental health providers. ; and (6) in subsection (h), as so redesignated, by striking $12,000,000 for each of fiscal years 2017 through 2021 and inserting $36,000,000 for each of fiscal years 2019 through 2023 . B Pilot program for public health laboratories To detect fentanyl and other synthetic opioids 7011. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids (a) Grants The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall award grants to, or enter into cooperative agreements with, Federal, State, and local agencies to improve coordination between public health laboratories and laboratories operated by law enforcement agencies, such as Customs and Border Protection and the Drug Enforcement Administration, to improve detection of synthetic opioids, including fentanyl and its analogues, as described in subsection (b). (b) Detection activities The Secretary, in consultation with the Director of the National Institute of Standards and Technology, the Director of the Centers for Disease Control and Prevention, the Attorney General of the United States, and the Administrator of the Drug Enforcement Administration, shall, for purposes of this section, develop or identify— (1) best practices for safely handling and testing synthetic opioids, including fentanyl and its analogues, including with respect to reference materials, instrument calibration, and quality control protocols; (2) reference materials and quality control standards related to synthetic opioids, including fentanyl and its analogues, to enhance— (A) clinical diagnostics; (B) postmortem data collection; and (C) portable testing equipment utilized by law enforcement and public health officials; and (3) procedures for the identification of new and emerging synthetic opioid formulations and procedures for reporting those findings to appropriate law enforcement agencies and Federal, State, and local public health laboratories and health departments, as appropriate. (c) Laboratories The Secretary shall require recipients of grants or cooperative agreements under subsection (a) to— (1) follow the best practices established under subsection (b) and have the appropriate capabilities to provide laboratory testing of controlled substances, such as synthetic fentanyl, and biospecimens for the purposes of aggregating and reporting public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate; (2) work with law enforcement agencies and public health authorities, as practicable; (3) provide early warning information to Federal, State, and local law enforcement agencies and public health authorities regarding trends or other data related to the supply of synthetic opioids, including fentanyl and its analogues; (4) provide biosurveillance capabilities with respect to identifying trends in adverse health outcomes associated with non-fatal exposures; and (5) provide diagnostic testing, as appropriate and practicable, for non-fatal exposures of emergency personnel, first responders, and other individuals. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023. C Indexing Narcotics, Fentanyl, and Opioids 7021. Establishment of substance use disorder information dashboard Title XVII of the Public Health Service Act ( 42 U.S.C. 300u et seq.) is amended by adding at the end the following new section: 1711. Establishment of substance use disorder information dashboard (a) In general Not later than 6 months after the date of the enactment of this section, the Secretary of Health and Human Services shall, in consultation with the Director of National Drug Control Policy, establish and periodically update, on the Internet website of the Department of Health and Human Services, a public information dashboard that— (1) provides links to information on programs within the Department of Health and Human Services related to the reduction of opioid and other substance use disorders; (2) provides access, to the extent practicable and appropriate, to publicly available data, which may include data from agencies within the Department of Health and Human Services and— (A) other Federal agencies; (B) State, local, and Tribal governments; (C) nonprofit organizations; (D) law enforcement; (E) medical experts; (F) public health educators; and (G) research institutions regarding prevention, treatment, recovery, and other services for opioid and other substance use disorders; (3) provides data on substance use disorder prevention and treatment strategies in different regions of and populations in the United States; (4) identifies information on alternatives to controlled substances for pain management, such as approaches studied by the National Institutes of Health Pain Consortium, the National Center for Complimentary and Integrative Health, and other institutes and centers at the National Institutes of Health, as appropriate; and (5) identifies guidelines and best practices for health care providers regarding treatment of substance use disorders. (b) Controlled substance defined In this section, the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ). . 7022. Interdepartmental Substance Use Disorders Coordinating Committee (a) Establishment Not later than 3 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall, in coordination with the Director of National Drug Control Policy, establish a committee, to be known as the Interdepartmental Substance Use Disorders Coordinating Committee (in this section referred to as the Committee ), to coordinate Federal activities related to substance use disorders. (b) Membership (1) Federal members The Committee shall be composed of the following Federal representatives, or the designees of such representatives: (A) The Secretary, who shall serve as the Chair of the Committee. (B) The Attorney General of the United States. (C) The Secretary of Labor. (D) The Secretary of Housing and Urban Development. (E) The Secretary of Education. (F) The Secretary of Veterans Affairs. (G) The Commissioner of Social Security. (H) The Assistant Secretary for Mental Health and Substance Use. (I) The Director of National Drug Control Policy. (J) Representatives of other Federal agencies that support or conduct activities or programs related to substance use disorders, as determined appropriate by the Secretary. (2) Non-Federal members The Committee shall include a minimum of 15 non-Federal members appointed by the Secretary, of which— (A) at least two such members shall be an individual who has received treatment for a diagnosis of a substance use disorder; (B) at least two such members shall be a director of a State substance abuse agency; (C) at least two such members shall be a representative of a leading research, advocacy, or service organization for adults with substance use disorder; (D) at least two such members shall— (i) be a physician, licensed mental health professional, advance practice registered nurse, or physician assistant; and (ii) have experience in treating individuals with substance use disorders; (E) at least one such member shall be a substance use disorder treatment professional who provides treatment services at a certified opioid treatment program; (F) at least one such member shall be a substance use disorder treatment professional who has research or clinical experience in working with racial and ethnic minority populations; (G) at least one such member shall be a substance use disorder treatment professional who has research or clinical mental health experience in working with medically underserved populations; (H) at least one such member shall be a State-certified substance use disorder peer support specialist; (I) at least one such member shall be a drug court judge or a judge with experience in adjudicating cases related to substance use disorder; (J) at least one such member shall be a public safety officer with extensive experience in interacting with adults with a substance use disorder; and (K) at least one such member shall be an individual with experience providing services for homeless individuals with a substance use disorder. (c) Terms (1) In general A member of the Committee appointed under subsection (b)(2) shall be appointed for a term of 3 years and may be reappointed for one or more 3-year terms. (2) Vacancies A vacancy on the Committee shall be filled in the same manner in which the original appointment was made. Any individual appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and may serve after the expiration of such term until a successor has been appointed. (d) Meetings The Committee shall meet not fewer than two times each year. (e) Duties The Committee shall— (1) identify areas for improved coordination of activities, if any, related to substance use disorders, including research, services, supports, and prevention activities across all relevant Federal agencies; (2) identify and provide to the Secretary recommendations for improving Federal programs for the prevention and treatment of, and recovery from, substance use disorders, including by expanding access to prevention, treatment, and recovery services; (3) analyze substance use disorder prevention and treatment strategies in different regions of and populations in the United States and evaluate the extent to which Federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies; (4) make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in paragraphs (1) through (3); (5) make recommendations to the Secretary regarding public participation in decisions relating to substance use disorders and the process by which public feedback can be better integrated into such decisions; and (6) make recommendations to ensure that substance use disorder research, services, supports, and prevention activities of the Department of Health and Human Services and other Federal agencies are not unnecessarily duplicative. (f) Annual report Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the life of the Committee, the Committee shall publish on the Internet website of the Department of Health and Human Services, which may include the public information dashboard established under section 1711 of the Public Health Service Act, as added by section 7021, a report summarizing the activities carried out by the Committee pursuant to subsection (e), including any findings resulting from such activities. (g) Working groups The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to enable the working group to carry out the duties delegated to the working group. (h) Federal Advisory Committee Act The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee only to the extent that the provisions of such Act do not conflict with the requirements of this section. (i) Sunset The Committee shall terminate on the date that is 6 years after the date on which the Committee is established under subsection (a). 7023. National milestones to measure success in curtailing the opioid crisis (a) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), in coordination with the Administrator of the Drug Enforcement Administration and the Director of the Office of National Drug Control Policy, shall develop or identify existing national indicators (referred to in this section as the national milestones ) to measure success in curtailing the opioid crisis, with the goal of significantly reversing the incidence and prevalence of opioid misuse and abuse, and opioid-related morbidity and mortality in the United States within 5 years of such date of enactment. (b) National milestones to end the opioid crisis The national milestones under subsection (a) shall include the following: (1) Not fewer than 10 indicators or metrics to accurately and expediently measure progress in meeting the goal described in subsection (a), which shall, as appropriate, include, indicators or metrics related to— (A) the number of fatal and non-fatal opioid overdoses; (B) the number of emergency room visits related to opioid misuse and abuse; (C) the number of individuals in sustained recovery from opioid use disorder; (D) the number of infections associated with illicit drug use, such as HIV, viral hepatitis, and infective endocarditis, and available capacity for treating such infections; (E) the number of providers prescribing medication-assisted treatment for opioid use disorders, including in primary care settings, community health centers, jails, and prisons; (F) the number of individuals receiving treatment for opioid use disorder; and (G) additional indicators or metrics, as appropriate, such as metrics pertaining to specific populations, including women and children, American Indians and Alaskan Natives, individuals living in rural and non-urban areas, and justice-involved populations, that would further clarify the progress made in addressing the opioid crisis. (2) A reasonable goal, such as a percentage decrease or other specified metric, that signifies progress in meeting the goal described in subsection (a), and annual targets to help achieve that goal. (c) Consideration of other substance use disorders In developing the national milestones under subsection (b), the Secretary shall, as appropriate, consider other substance use disorders in addition to opioid use disorder. (d) Extension of period If the Secretary determines that the goal described in subsection (a) will not be achieved with respect to any indicator or metric established under subsection (b)(2) within 5 years of the date of enactment of this Act, the Secretary may extend the timeline for meeting such goal with respect to that indicator or metric. The Secretary shall include with any such extension a rationale for why additional time is needed and information on whether significant changes are needed in order to achieve such goal with respect to the indicator or metric. (e) Annual status update Not later than one year after the date of enactment of this Act, the Secretary shall make available on the Internet website of the Department of Health and Human Services, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an update on the progress, including expected progress in the subsequent year, in achieving the goals detailed in the national milestones. Each such update shall include the progress made in the first year or since the previous report, as applicable, in meeting each indicator or metric in the national milestones. 7024. Study on prescribing limits Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Attorney General of the United States, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the impact of Federal and State laws and regulations that limit the length, quantity, or dosage of opioid prescriptions. Such report shall address— (1) the impact of such limits on— (A) the incidence and prevalence of overdose related to prescription opioids; (B) the incidence and prevalence of overdose related to illicit opioids; (C) the prevalence of opioid use disorders; (D) medically appropriate use of, and access to, opioids, including any impact on travel expenses and pain management outcomes for patients, whether such limits are associated with significantly higher rates of negative health outcomes, including suicide, and whether the impact of such limits differs based on the clinical indication for which opioids are prescribed; (2) whether such limits lead to a significant increase in burden for prescribers of opioids or prescribers of treatments for opioid use disorder, including any impact on patient access to treatment, and whether any such burden is mitigated by any factors such as electronic prescribing or telemedicine; and (3) the impact of such limits on diversion or misuse of any controlled substance in schedule II, III, or IV of section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ). D Ensuring Access to Quality Sober Living 7031. National recovery housing best practices Part D of title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.) is amended by adding at the end the following new section: 550. National recovery housing best practices (a) Best practices for operating recovery housing (1) In general The Secretary, in consultation with the individuals and entities specified in paragraph (2), shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing. (2) Consultation In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate— (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services; (B) the Secretary of Housing and Urban Development; (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies; (D) representatives of health insurance issuers; (E) national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable; (F) individuals with a history of substance use disorder; and (G) other stakeholders identified by the Secretary. (b) Identification of fraudulent recovery housing operators (1) In general The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of common indicators that could be used to identify potentially fraudulent recovery housing operators. (2) Consultation In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate, the individuals and entities specified in subsection (a)(2) and the Attorney General of the United States. (3) Requirements (A) Practices for identification and reporting In carrying out the activities described in paragraph (1), the Secretary shall consider how law enforcement, public and private payers, and the public can best identify and report fraudulent recovery housing operators. (B) Factors to be considered In carrying out the activities described in paragraph (1), the Secretary shall identify or develop indicators, which may include indicators related to— (i) unusual billing practices; (ii) average lengths of stays; (iii) excessive levels of drug testing (in terms of cost or frequency); and (iv) unusually high levels of recidivism. (c) Dissemination The Secretary shall, as appropriate, disseminate the best practices identified or developed under subsection (a) and the common indicators identified or developed under subsection (b) to— (1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices; (2) Indian tribes, tribal organizations, and tribally designated housing entities; (3) the Attorney General of the United States; (4) the Secretary of Labor; (5) the Secretary of Housing and Urban Development; (6) State and local law enforcement agencies; (7) health insurance issuers; (8) recovery housing entities; and (9) the public. (d) Requirements In carrying out the activities described in subsections (a) and (b), the Secretary, in consultation with appropriate individuals and entities described in subsections (a)(2) and (b)(2), shall consider how recovery housing is able to support recovery and prevent relapse, recidivism, or overdose (including overdose death), including by improving access and adherence to treatment, including medication-assisted treatment. (e) Rule of construction Nothing in this section shall be construed to provide the Secretary with the authority to require States to adhere to minimum standards in the State oversight of recovery housing. (f) Definitions In this section: (1) The term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders. (2) The terms Indian tribe and tribal organization have the meanings given those terms in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (3) The term tribally designated housing entity has the meaning given that term in section 4 of the Native American Housing Assistance and Self-Determination Act of 1996 ( 25 U.S.C. 4103 ). (g) Authorization of appropriations To carry out this section, there is authorized to be appropriated $3,000,000 for the period of fiscal years 2019 through 2021. . E Advancing Cutting Edge Research 7041. Unique research initiatives Section 402(n)(1) of the Public Health Service Act ( 42 U.S.C. 282(n)(1) ) is amended— (1) in subparagraph (A), by striking or ; (2) in subparagraph (B), by striking the period and inserting ; or ; and (3) by adding at the end the following: (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat. . 7042. Pain research Section 409J(b) of the Public Health Service Act ( 42 U.S.C. 284q(b) ) is amended— (1) in paragraph (5)— (A) in subparagraph (A), by striking and treatment of pain and diseases and disorders associated with pain and inserting treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration ; (B) in subparagraph (B), by striking on the symptoms and causes of pain; and inserting the following: “on— (i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain; (ii) the diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and (iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain; and ; and (C) by striking subparagraphs (C) through (E) and inserting the following: (C) make recommendations to the Director of NIH— (i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and (iii) on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research. ; (2) by redesignating paragraph (6) as paragraph (7); and (3) by inserting after paragraph (5) the following: (6) Report The Secretary shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress. . F Jessie’s Law 7051. Inclusion of opioid addiction history in patient records (a) Best practices (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ), in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding— (A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient; (B) what constitutes the patient’s request for the purpose described in subparagraph (A); and (C) the process and methods by which the information should be so displayed. (2) Dissemination The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies. (b) Requirements In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following: (1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder. (2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications. (3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers. (4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, having access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations. (5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations. (6) All applicable Federal and State laws and regulations. 7052. Communication with families during emergencies (a) Promoting awareness of authorized disclosures during emergencies The Secretary of Health and Human Services shall annually notify health care providers regarding permitted disclosures under Federal health care privacy law during emergencies, including overdoses, of certain health information to families, caregivers, and health care providers. (b) Use of material For the purposes of carrying out subsection (a), the Secretary of Health and Human Services may use material produced under section 7053 of this Act or section 11004 of the 21st Century Cures Act ( 42 U.S.C. 1320d–2 note). 7053. Development and dissemination of model training programs for substance use disorder patient records (a) Initial programs and materials Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ), in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials): (1) Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) for the confidentiality of patient records. (2) Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in paragraph (1). (b) Requirements The model programs and materials described in paragraphs (1) and (2) of subsection (a) shall address circumstances under which disclosure of substance use disorder patient records is needed to— (1) facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care; (2) avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and (3) notify and involve families and caregivers when individuals experience an overdose. (c) Periodic updates The Secretary shall— (1) periodically review and update the model program and materials identified or developed under subsection (a); and (2) disseminate such updated programs and materials to the individuals described in subsection (a)(1). (d) Input of certain entities In identifying, reviewing, or updating the model programs and materials under this section, the Secretary shall solicit the input of relevant stakeholders. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section— (1) $4,000,000 for fiscal year 2019; (2) $2,000,000 for each of fiscal years 2020 and 2021; and (3) $1,000,000 for each of fiscal years 2022 and 2023. G Protecting Pregnant Women and Infants 7061. Report on addressing maternal and infant health in the opioid crisis (a) In general Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Centers for Disease Control and Prevention, the National Institutes of Health, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration, shall develop and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— (1) information on opioid, non-opioid, and non-pharmacologic pain management practices during pregnancy and after pregnancy; (2) recommendations for increasing public awareness and education about substance use disorders, including opioid use disorders, during and after pregnancy, including available treatment resources in urban and rural areas; (3) recommendations to prevent, identify, and reduce substance use disorders, including opioid use disorders, during pregnancy to improve care for pregnant women with substance use disorders and their infants; and (4) an identification of areas in need of further research with respect to acute and chronic pain management during and after pregnancy. (b) No additional funds No additional funds are authorized to be appropriated for purposes of carrying out subsection (a). 7062. Protecting moms and infants (a) Report (1) In general Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make available to the public on the Internet website of the Department of Health and Human Services, a report regarding the implementation of the recommendations in the strategy relating to prenatal opioid use, including neonatal abstinence syndrome, developed pursuant to section 2 of the Protecting Our Infants Act of 2015 ( Public Law 114–91 ). Such report shall include— (A) an update on the implementation of the recommendations in the strategy, including information regarding the agencies involved in the implementation; and (B) information on additional funding or authority the Secretary requires, if any, to implement the strategy, which may include authorities needed to coordinate implementation of such strategy across the Department of Health and Human Services. (2) Periodic updates The Secretary shall periodically update the report under paragraph (1). (b) Residential treatment programs for pregnant and postpartum women Section 508(s) of the Public Health Service Act ( 42 U.S.C. 290bb–1(s) ) is amended by striking $16,900,000 for each of fiscal years 2017 through 2021 and inserting $29,931,000 for each of fiscal years 2019 through 2023 . 7063. Early interventions for pregnant women and infants (a) Development of educational materials by Center for Substance Abuse Prevention Section 515(b) of the Public Health Service Act ( 42 U.S.C. 290bb–21(b) ) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (15) in consultation with relevant stakeholders and in collaboration with the Director of the Centers for Disease Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared decision making regarding pain management and the prevention of substance use disorders during pregnancy. . (b) Guidelines and recommendations by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act ( 42 U.S.C. 290bb(b) ) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting a semicolon; and (3) by adding at the end the following: (15) in cooperation with the Secretary, implement and disseminate, as appropriate, the recommendations in the report entitled Protecting Our Infants Act: Final Strategy issued by the Department of Health and Human Services in 2017; and . (c) Support of partnerships by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act ( 42 U.S.C. 290bb(b) ), as amended by subsection (b), is further amended by adding at the end the following: (16) in cooperation with relevant stakeholders, and through public-private partnerships, encourage education about substance use disorders for pregnant women and health care providers who treat pregnant women and babies. . 7064. Prenatal and postnatal health Section 317L of the Public Health Service Act ( 42 U.S.C. 247b–13 ) is amended— (1) in subsection (a)— (A) by amending paragraph (1) to read as follows: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including— (A) data on— (i) the incidence, prevalence, and implications of such activities; and (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and (B) additional information or data, as appropriate, on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis; ; (B) in paragraph (2)— (i) by striking prevention of and inserting prevention and long-term outcomes associated with ; and (ii) by striking illegal drug use and inserting other substance abuse and misuse ; (C) in paragraph (3), by striking and cessation programs; and and inserting , treatment, and cessation programs; ; (D) in paragraph (4), by striking illegal drug use. and inserting other substance abuse and misuse; and ; and (E) by adding at the end the following: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of— (A) long-term outcomes of children affected by neonatal abstinence syndrome; (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and (C) relevant studies, evaluations, or information the Secretary determines to be appropriate. ; (2) in subsection (b), by inserting tribal entities, after local governments, ; (3) by redesignating subsection (c) as subsection (d); (4) by inserting after subsection (b) the following: (c) Coordinating activities To carry out this section, the Secretary may— (1) provide technical and consultative assistance to entities receiving grants under subsection (b); (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention; (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and (4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology. ; and (5) in subsection (d), as so redesignated, by striking 2001 through 2005 and inserting 2019 through 2023 . 7065. Plans of safe care (a) In general Section 105(a) of the Child Abuse Prevention and Treatment Act ( 42 U.S.C. 5106(a) ) is amended by adding at the end the following: (7) Grants to States to improve and coordinate their response to ensure the safety, permanency, and well-being of infants affected by substance use (A) Program authorized The Secretary is authorized to make grants to States for the purpose of assisting child welfare agencies, social services agencies, substance use disorder treatment agencies, hospitals with labor and delivery units, medical staff, public health and mental health agencies, and maternal and child health agencies to facilitate collaboration in developing, updating, implementing, and monitoring plans of safe care described in section 106(b)(2)(B)(iii). Section 112(a)(2) shall not apply to the program authorized under this paragraph. (B) Distribution of funds (i) Reservations Of the amounts made available to carry out subparagraph (A), the Secretary shall reserve— (I) no more than 3 percent for the purposes described in subparagraph (G); and (II) up to 3 percent for grants to Indian Tribes and tribal organizations to address the needs of infants born with, and identified as being affected by, substance abuse or withdrawal symptoms resulting from prenatal drug exposure or a fetal alcohol spectrum disorder and their families or caregivers, which to the extent practicable, shall be consistent with the uses of funds described under subparagraph (D). (ii) Allotments to States and territories The Secretary shall allot the amount made available to carry out subparagraph (A) that remains after application of clause (i) to each State that applies for such a grant, in an amount equal to the sum of— (I) $500,000; and (II) an amount that bears the same relationship to any funds made available to carry out subparagraph (A) and remaining after application of clause (i), as the number of live births in the State in the previous calendar year bears to the number of live births in all States in such year. (iii) Ratable reduction If the amount made available to carry out subparagraph (A) is insufficient to satisfy the requirements of clause (ii), the Secretary shall ratably reduce each allotment to a State. (C) Application A State desiring a grant under this paragraph shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (i) a description of— (I) the impact of substance use disorder in such State, including with respect to the substance or class of substances with the highest incidence of abuse in the previous year in such State, including— (aa) the prevalence of substance use disorder in such State; (bb) the aggregate rate of births in the State of infants affected by substance abuse or withdrawal symptoms or a fetal alcohol spectrum disorder (as determined by hospitals, insurance claims, claims submitted to the State Medicaid program, or other records), if available and to the extent practicable; and (cc) the number of infants identified, for whom a plan of safe care was developed, and for whom a referral was made for appropriate services, as reported under section 106(d)(18); (II) the challenges the State faces in developing, implementing, and monitoring plans of safe care in accordance with section 106(b)(2)(B)(iii); (III) the State’s lead agency for the grant program and how that agency will coordinate with relevant State entities and programs, including the child welfare agency, the substance use disorder treatment agency, hospitals with labor and delivery units, health care providers, the public health and mental health agencies, programs funded by the Substance Abuse and Mental Health Services Administration that provide substance use disorder treatment for women, the State Medicaid program, the State agency administering the block grant program under title V of the Social Security Act ( 42 U.S.C. 701 et seq.), the State agency administering the programs funded under part C of the Individuals with Disabilities Education Act ( 20 U.S.C. 1431 et seq.), the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act ( 42 U.S.C. 711 ), the State judicial system, and other agencies, as determined by the Secretary, and Indian Tribes and tribal organizations, as appropriate, to implement the activities under this paragraph; (IV) how the State will monitor local development and implementation of plans of safe care, in accordance with section 106(b)(2)(B)(iii)(II), including how the State will monitor to ensure plans of safe care address differences between substance use disorder and medically supervised substance use, including for the treatment of a substance use disorder; (V) if applicable, how the State plans to utilize funding authorized under part E of title IV of the Social Security Act ( 42 U.S.C. 670 et seq.) to assist in carrying out any plan of safe care, including such funding authorized under section 471(e) of such Act (as in effect on October 1, 2018) for mental health and substance abuse prevention and treatment services and in-home parent skill-based programs and funding authorized under such section 472(j) (as in effect on October 1, 2018) for children with a parent in a licensed residential family-based treatment facility for substance abuse; and (VI) an assessment of the treatment and other services and programs available in the State to effectively carry out any plan of safe care developed, including identification of needed treatment, and other services and programs to ensure the well-being of young children and their families affected by substance use disorder, such as programs carried out under part C of the Individuals with Disabilities Education Act ( 20 U.S.C. 1431 et seq.) and comprehensive early childhood development services and programs such as Head Start programs; (ii) a description of how the State plans to use funds for activities described in subparagraph (D) for the purposes of ensuring State compliance with requirements under clauses (ii) and (iii) of section 106(b)(2)(B); and (iii) an assurance that the State will comply with requirements to refer a child identified as substance-exposed to early intervention services as required pursuant to a grant under part C of the Individuals with Disabilities Education Act ( 20 U.S.C. 1431 et seq.). (D) Uses of funds Funds awarded to a State under this paragraph may be used for the following activities, which may be carried out by the State directly, or through grants or subgrants, contracts, or cooperative agreements: (i) Improving State and local systems with respect to the development and implementation of plans of safe care, which— (I) shall include parent and caregiver engagement, as required under section 106(b)(2)(B)(iii)(I), regarding available treatment and service options, which may include resources available for pregnant, perinatal, and postnatal women; and (II) may include activities such as— (aa) developing policies, procedures, or protocols for the administration or development of evidence-based and validated screening tools for infants who may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder and pregnant, perinatal, and postnatal women whose infants may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder; (bb) improving assessments used to determine the needs of the infant and family; (cc) improving ongoing case management services; (dd) improving access to treatment services, which may be prior to the pregnant woman’s delivery date; and (ee) keeping families safely together when it is in the best interest of the child. (ii) Developing policies, procedures, or protocols in consultation and coordination with health professionals, public and private health facilities, and substance use disorder treatment agencies to ensure that— (I) appropriate notification to child protective services is made in a timely manner, as required under section 106(b)(2)(B)(ii); (II) a plan of safe care is in place, in accordance with section 106(b)(2)(B)(iii), before the infant is discharged from the birth or health care facility; and (III) such health and related agency professionals are trained on how to follow such protocols and are aware of the supports that may be provided under a plan of safe care. (iii) Training health professionals and health system leaders, child welfare workers, substance use disorder treatment agencies, and other related professionals such as home visiting agency staff and law enforcement in relevant topics including— (I) State mandatory reporting laws established under section 106(b)(2)(B)(i) and the referral and process requirements for notification to child protective services when child abuse or neglect reporting is not mandated; (II) the co-occurrence of pregnancy and substance use disorder, and implications of prenatal exposure; (III) the clinical guidance about treating substance use disorder in pregnant and postpartum women; (IV) appropriate screening and interventions for infants affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder and the requirements under section 106(b)(2)(B)(iii); and (V) appropriate multigenerational strategies to address the mental health needs of the parent and child together. (iv) Establishing partnerships, agreements, or memoranda of understanding between the lead agency and other entities (including health professionals, health facilities, child welfare professionals, juvenile and family court judges, substance use and mental disorder treatment programs, early childhood education programs, maternal and child health and early intervention professionals (including home visiting providers), peer-to-peer recovery programs such as parent mentoring programs, and housing agencies) to facilitate the implementation of, and compliance with, section 106(b)(2) and clause (ii) of this subparagraph, in areas which may include— (I) developing a comprehensive, multi-disciplinary assessment and intervention process for infants, pregnant women, and their families who are affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder, that includes meaningful engagement with and takes into account the unique needs of each family and addresses differences between medically supervised substance use, including for the treatment of substance use disorder, and substance use disorder; (II) ensuring that treatment approaches for serving infants, pregnant women, and perinatal and postnatal women whose infants may be affected by substance use, withdrawal symptoms, or a fetal alcohol spectrum disorder, are designed to, where appropriate, keep infants with their mothers during both inpatient and outpatient treatment; and (III) increasing access to all evidence-based medication-assisted treatment approved by the Food and Drug Administration, behavioral therapy, and counseling services for the treatment of substance use disorders, as appropriate. (v) Developing and updating systems of technology for improved data collection and monitoring under section 106(b)(2)(B)(iii), including existing electronic medical records, to measure the outcomes achieved through the plans of safe care, including monitoring systems to meet the requirements of this Act and submission of performance measures. (E) Reporting Each State that receives funds under this paragraph, for each year such funds are received, shall submit a report to the Secretary, disaggregated by geographic location, economic status, and major racial and ethnic groups, except that such disaggregation shall not be required if the results would reveal personally identifiable information on, with respect to infants identified under section 106(b)(2)(B)(ii)— (i) the number who experienced removal associated with parental substance use; (ii) the number who experienced removal and subsequently are reunified with parents, and the length of time between such removal and reunification; (iii) the number who are referred to community providers without a child protection case; (iv) the number who receive services while in the care of their birth parents; (v) the number who receive post-reunification services within 1 year after a reunification has occurred; and (vi) the number who experienced a return to out-of-home care within 1 year after reunification. (F) Secretary’s report to Congress The Secretary shall submit an annual report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Education and the Workforce and the Committee on Appropriations of the House of Representatives that includes the information described in subparagraph (E) and recommendations or observations on the challenges, successes, and lessons derived from implementation of the grant program. (G) Assisting States’ implementation The Secretary shall use the amount reserved under subparagraph (B)(i)(I) to provide written guidance and technical assistance to support States in complying with and implementing this paragraph, which shall include— (i) technical assistance, including programs of in-depth technical assistance, to additional States, territories, and Indian Tribes and tribal organizations in accordance with the substance-exposed infant initiative developed by the National Center on Substance Abuse and Child Welfare; (ii) guidance on the requirements of this Act with respect to infants born with and identified as being affected by substance use or withdrawal symptoms or fetal alcohol spectrum disorder, as described in clauses (ii) and (iii) of section 106(b)(2)(B), including by— (I) enhancing States’ understanding of requirements and flexibilities under the law, including by clarifying key terms; (II) addressing state-identified challenges with developing, implementing, and monitoring plans of safe care, including those reported under subparagraph (C)(i)(II); (III) disseminating best practices on implementation of plans of safe care, on such topics as differential response, collaboration and coordination, and identification and delivery of services for different populations, while recognizing needs of different populations and varying community approaches across States; and (IV) helping States improve the long-term safety and well-being of young children and their families; (iii) supporting State efforts to develop information technology systems to manage plans of safe care; and (iv) preparing the Secretary’s report to Congress described in subparagraph (F). (H) Sunset The authority under this paragraph shall sunset on September 30, 2023. . (b) Repeal The Abandoned Infants Assistance Act of 1988 ( 42 U.S.C. 5117aa et seq.) is repealed. H Substance Use Disorder Treatment Workforce 7071. Loan repayment program for substance use disorder treatment workforce Title VII of the Public Health Service Act is amended— (1) by redesignating part F as part G; and (2) by inserting after part E ( 42 U.S.C. 294n et seq.) the following: F Substance Use Disorder Treatment Workforce 781. Loan repayment program for substance use disorder treatment workforce (a) In general The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a program under which— (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection (b) on the principal of and interest on any eligible loan; and (2) the individuals each agree to the requirements of service in substance use disorder treatment employment, as described in subsection (d). (b) Payments For each year of obligated service by an individual pursuant to an agreement under subsection (a), the Secretary shall make a payment to such individual as follows: (1) Service in a shortage area The Secretary shall pay— (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1/6 of the principal of and interest on each eligible loan of the individual which is outstanding on the date the individual began service pursuant to the agreement; and (B) for completion of the sixth and final year of such service, the remainder of such principal and interest. (2) Maximum amount The total amount of payments under this section to any individual shall not exceed $250,000. (c) Eligible loans The loans eligible for repayment under this section are each of the following: (1) Any loan for education or training for a substance use disorder treatment employment. (2) Any loan under part E of title VIII (relating to nursing student loans). (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965). (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965. (5) Any other Federal loan as determined appropriate by the Secretary. (d) Requirements of service Any individual receiving payments under this program as required by an agreement under subsection (a) shall agree to an annual commitment to full-time employment, with no more than 1 year passing between any 2 years of covered employment, in substance use disorder treatment employment in the United States in— (1) a Mental Health Professional Shortage Area, as designated under section 332; or (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per 100,000 people over the past 3 years for which official data is available from the State, is higher than the most recent available national average overdose death rate per 100,000 people, as reported by the Centers for Disease Control and Prevention. (e) Ineligibility for double benefits No borrower may, for the same service, receive a reduction of loan obligations or a loan repayment under both— (1) this section; and (2) any Federally supported loan forgiveness program, including under section 338B, 338I, or 846 of this Act, or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965. (f) Breach (1) Liquidated damages formula The Secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under subsection (a). (2) Limitation The failure by an individual to complete the full period of service obligated pursuant to such an agreement, taken alone, shall not constitute a breach of the agreement, so long as the individual completed in good faith the years of service for which payments were made to the individual under this section. (g) Additional criteria The Secretary— (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed and in addition to the criteria and rules specified in this section; and (2) shall give notice to the committees specified in subsection (h) of any criteria and rules so established. (h) Report to Congress Not later than 5 years after the date of enactment of this section, and every other year thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on— (1) the number and location of borrowers who have qualified for loan repayments under this section; and (2) the impact of this section on the availability of substance use disorder treatment employees nationally and in shortage areas and counties described in subsection (d). (i) Definition In this section: (1) The terms Indian tribe and tribal organization have the meanings given those terms in section 4 of the Indian Self-Determination and Education Assistance Act. (2) The term municipality means a city, town, or other public body created by or pursuant to State law, or an Indian tribe. (3) The term substance use disorder treatment employment means full-time employment (including a fellowship)— (A) where the primary intent and function of the position is the direct treatment or recovery support of patients with or in recovery from a substance use disorder, including master’s level social workers, psychologists, counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists, psychology doctoral interns, and behavioral health paraprofessionals and physicians, physician assistants, and nurses, who are licensed or certified in accordance with applicable State and Federal laws; and (B) which is located at a substance use disorder treatment program, private physician practice, hospital or health system-affiliated inpatient treatment center or outpatient clinic (including an academic medical center-affiliated treatment program), correctional facility or program, youth detention center or program, inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or other specialty community behavioral health center, recovery center, school, community-based organization, telehealth platform, migrant health center, health program or facility operated by an Indian tribe or tribal organization, Federal medical facility, or any other facility as determined appropriate for purposes of this section by the Secretary. (j) Authorization of appropriations There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2023. . 7072. Clarification regarding service in schools and other community-based settings Subpart III of part D of title III of the Public Health Service Act ( 42 U.S.C. 254 l et seq.) is amended by adding at the end the following: 338N. Clarification regarding service in schools and other community-based settings (a) Schools and community-based settings An entity to which a participant in the Scholarship Program or the Loan Repayment Program (referred to in this section as a participant ) is assigned under section 333 may direct such participant to provide service as a behavioral or mental health professional at a school or other community-based setting located in a health professional shortage area. (b) Obligated service (1) In general Any service described in subsection (a) that a participant provides may count towards such participant's completion of any obligated service requirements under the Scholarship Program or the Loan Repayment Program, subject to any limitation imposed under paragraph (2). (2) Limitation The Secretary may impose a limitation on the number of hours of service described in subsection (a) that a participant may credit towards completing obligated service requirements, provided that the limitation allows a member to credit service described in subsection (a) for not less than 50 percent of the total hours required to complete such obligated service requirements. (c) Rule of construction The authorization under subsection (a) shall be notwithstanding any other provision of this subpart or subpart II. . 7073. Programs for health care workforce (a) Program for education and training in pain care Section 759 of the Public Health Service Act ( 42 U.S.C. 294i ) is amended— (1) in subsection (a), by striking hospices, and other public and private entities and inserting hospices, tribal health programs (as defined in section 4 of the Indian Health Care Improvement Act), and other public and nonprofit private entities ; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking award may be made under subsection (a) only if the applicant for the award agrees that the program carried out with the award will include and inserting entity receiving an award under this section shall develop a comprehensive education and training plan that includes ; (B) in paragraph (1)— (i) by inserting preventing, after diagnosing, ; and (ii) by inserting non-addictive medical products and non-pharmacologic treatments and after including ; (C) in paragraph (2)— (i) by inserting Federal, State, and local after applicable ; and (ii) by striking the degree to which and all that follows through effective pain care and inserting opioids ; (D) in paragraph (3), by inserting , integrated, evidence-based pain management, and, as appropriate, non-pharmacotherapy before the semicolon; (E) in paragraph (4), by striking ; and and inserting ; ; and (F) by striking paragraph (5) and inserting the following: (5) recent findings, developments, and advancements in pain care research and the provision of pain care, which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which may include best practices related to screening for opioid use disorders, training on screening, brief intervention, and referral to treatment), and safe disposal options for prescription medications (including such options provided by law enforcement or other innovative deactivation mechanisms). ; (3) in subsection (d), by inserting prevention, after diagnosis, ; and (4) in subsection (e), by striking 2010 through 2012 and inserting 2019 through 2023 . (b) Mental and behavioral health education and training program Section 756 of the Public Health Service Act ( 42 U.S.C. 294e–1 ) is amended— (1) in subsection (a)— (A) in paragraph (1), by inserting , trauma, after focus on child and adolescent mental health ; and (B) in paragraphs (2) and (3), by inserting trauma-informed care and before substance use disorder prevention and treatment services ; and (2) in subsection (f), by striking 2018 through 2022 and inserting 2019 through 2023 . I Preventing Overdoses While in Emergency Rooms 7081. Program to support coordination and continuation of care for drug overdose patients (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall identify or facilitate the development of best practices for— (1) emergency treatment of known or suspected drug overdose; (2) the use of recovery coaches, as appropriate, to encourage individuals who experience a non-fatal overdose to seek treatment for substance use disorder and to support coordination and continuation of care; (3) coordination and continuation of care and treatment, including, as appropriate, through referrals, of individuals after a drug overdose; and (4) the provision or prescribing of overdose reversal medication, as appropriate. (b) Grant establishment and participation (1) In general The Secretary shall award grants on a competitive basis to eligible entities to support implementation of voluntary programs for care and treatment of individuals after a drug overdose, as appropriate, which may include implementation of the best practices described in subsection (a). (2) Eligible entity In this section, the term eligible entity means— (A) a State substance abuse agency; (B) an Indian Tribe or tribal organization; or (C) an entity that offers treatment or other services for individuals in response to, or following, drug overdoses or a drug overdose, such as an emergency department, in consultation with a State substance abuse agency. (3) Application An eligible entity desiring a grant under this section shall submit an application to the Secretary, at such time and in such manner as the Secretary may require, that includes— (A) evidence that such eligible entity carries out, or is capable of contracting and coordinating with other community entities to carry out, the activities described in paragraph (4); (B) evidence that such eligible entity will work with a recovery community organization to recruit, train, hire, mentor, and supervise recovery coaches and fulfill the requirements described in paragraph (4)(A); and (C) such additional information as the Secretary may require. (4) Use of grant funds An eligible entity awarded a grant under this section shall use such grant funds to— (A) hire or utilize recovery coaches to help support recovery, including by— (i) connecting patients to a continuum of care services, such as— (I) treatment and recovery support programs; (II) programs that provide non-clinical recovery support services; (III) peer support networks; (IV) recovery community organizations; (V) health care providers, including physicians and other providers of behavioral health and primary care; (VI) education and training providers; (VII) employers; (VIII) housing services; and (IX) child welfare agencies; (ii) providing education on overdose prevention and overdose reversal to patients and families, as appropriate; (iii) providing follow-up services for patients after an overdose to ensure continued recovery and connection to support services; (iv) collecting and evaluating outcome data for patients receiving recovery coaching services; and (v) providing other services the Secretary determines necessary to help ensure continued connection with recovery support services, including culturally appropriate services, as applicable; (B) establish policies and procedures, pursuant to Federal and State law, that address the provision of overdose reversal medication, the administration of all drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat substance use disorder, and subsequent continuation of, or referral to, evidence-based treatment for patients with a substance use disorder who have experienced a non-fatal drug overdose, in order to support long-term treatment, prevent relapse, and reduce recidivism and future overdose; and (C) establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment, follow up, and transportation to and from treatment facilities. (5) Additional permissible uses In addition to the uses described in paragraph (4), a grant awarded under this section may be used, directly or through contractual arrangements, to provide— (A) all drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and all biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to treat substance use disorders or reverse overdose, pursuant to Federal and State law; (B) withdrawal and detoxification services that include patient evaluation, stabilization, and preparation for treatment of substance use disorder, including treatment described in subparagraph (A), as appropriate; or (C) mental health services provided by a certified professional who is licensed and qualified by education, training, or experience to assess the psychosocial background of patients, to contribute to the appropriate treatment plan for patients with substance use disorder, and to monitor patient progress. (6) Preference In awarding grants under this section, the Secretary shall give preference to eligible entities that meet any or all of the following criteria: (A) The eligible entity is a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act ( 42 U.S.C. 1395x(mm)(1) )), a low volume hospital (as defined in section 1886(d)(12)(C)(i) of such Act ( 42 U.S.C. 1395ww(d)(12)(C)(i) )), a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act ( 42 U.S.C. 1395ww(d)(5)(D)(iii) )), or a hospital that receives disproportionate share hospital payments under section 1886(d)(5)(F) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5)(F) ). (B) The eligible entity is located in a State with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention, or under the jurisdiction of an Indian Tribe with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined through appropriate mechanisms as determined by the Secretary in consultation with Indian Tribes. (C) The eligible entity demonstrates that recovery coaches will be placed in both health care settings and community settings. (7) Period of grant A grant awarded to an eligible entity under this section shall be for a period of not more than 5 years. (c) Definitions In this section: (1) Indian Tribe; tribal organization The terms Indian Tribe and tribal organization have the meanings given the terms Indian tribe and tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (2) Recovery coach the term recovery coach means an individual— (A) with knowledge of, or experience with, recovery from a substance use disorder; and (B) who has completed training from, and is determined to be in good standing by, a recovery services organization capable of conducting such training and making such determination. (3) Recovery community organization The term recovery community organization has the meaning given such term in section 547(a) of the Public Health Service Act ( 42 U.S.C. 290ee–2(a) ). (d) Reporting requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the entity has received such grant that includes information on— (A) the number of individuals treated by the entity for non-fatal overdoses, including the number of non-fatal overdoses where overdose reversal medication was administered; (B) the number of individuals administered medication-assisted treatment by the entity; (C) the number of individuals referred by the entity to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals; and (D) the frequency and number of patients with reoccurrences, including readmissions for non-fatal overdoses and evidence of relapse related to substance use disorder. (2) Report by Secretary Not later than 5 years after the date of enactment of this Act, the Secretary shall submit to Congress a report that includes an evaluation of the effectiveness of the grant program carried out under this section with respect to long term health outcomes of the population of individuals who have experienced a drug overdose, the percentage of patients treated or referred to treatment by grantees, and the frequency and number of patients who experienced relapse, were readmitted for treatment, or experienced another overdose. (e) Privacy The requirements of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2019 through 2023. J Alternatives to Opioids in the Emergency Department 7091. Emergency department alternatives to opioids demonstration program (a) Demonstration program grants (1) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall carry out a demonstration program for purposes of awarding grants to hospitals and emergency departments, including freestanding emergency departments, to develop, implement, enhance, or study alternatives to opioids for pain management in such settings. (2) Eligibility To be eligible to receive a grant under paragraph (1), a hospital or emergency department shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (3) Geographic distribution In awarding grants under this section, the Secretary shall seek to ensure geographical distribution among grant recipients. (4) Use of funds Grants under paragraph (1) shall be used to— (A) target treatment approaches for painful conditions frequently treated in such settings; (B) train providers and other hospital personnel on protocols or best practices related to the use and prescription of opioids and alternatives to opioids for pain management in the emergency department; and (C) develop or continue strategies to provide alternatives to opioids, as appropriate. (b) Additional demonstration program The Secretary may carry out a demonstration program similar to the program under subsection (a) for other acute care settings. (c) Consultation The Secretary shall implement a process for recipients of grants under subsection (a) or (b) to share evidence-based and best practices and promote consultation with persons having robust knowledge, including emergency departments and physicians that have successfully implemented programs that use alternatives to opioids for pain management, as appropriate, such as approaches studied through the National Center for Complimentary and Integrative Health or other institutes and centers at the National Institutes of Health, as appropriate. The Secretary shall offer to each recipient of a grant under subsection (a) or (b) technical assistance as necessary. (d) Technical assistance The Secretary shall identify or facilitate the development of best practices on alternatives to opioids for pain management and provide technical assistance to hospitals and other acute care settings on alternatives to opioids for pain management. The technical assistance provided shall be for the purpose of— (1) utilizing information from recipients of a grant under subsection (a) or (b) that have successfully implemented alternatives to opioids programs; (2) identifying or facilitating the development of best practices on the use of alternatives to opioids, which may include pain-management strategies that involve non-addictive medical products, non-pharmacologic treatments, and technologies or techniques to identify patients at risk for opioid use disorder; (3) identifying or facilitating the development of best practices on the use of alternatives to opioids that target common painful conditions and include certain patient populations, such as geriatric patients, pregnant women, and children; and (4) disseminating information on the use of alternatives to opioids to providers in acute care settings, which may include emergency departments, outpatient clinics, critical access hospitals, Federally qualified health centers, Indian Health Service health facilities, and tribal hospitals. (e) Report to the Secretary Each recipient of a grant under this section shall submit to the Secretary (during the period of such grant) annual reports on the progress of the program funded through the grant. These reports shall include, in accordance with all applicable State and Federal privacy laws— (1) a description of and specific information about the opioid alternative pain management programs, including the demographic characteristics of patients who were treated with an alternative pain management protocol, implemented in hospitals, emergency departments, and other acute care settings; (2) data on the opioid alternative pain management strategies used, including the number of opioid prescriptions written— (A) during a baseline period before the program began; or (B) at various stages of the program; and (3) data on patients who were eventually prescribed opioids after alternative pain management protocols and treatments were utilized; and (4) any other information the Secretary determines appropriate. (f) Report to Congress Not later than 1 year after completion of the demonstration program under this section, the Secretary shall submit a report to the Congress on the results of the demonstration program and include in the report— (1) the number of applications received and the number funded; (2) a summary of the reports described in subsection (e), including data that allows for comparison of programs; and (3) recommendations for broader implementation of pain management strategies that encourage the use of alternatives to opioids in hospitals, emergency departments, or other acute care settings. (g) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2021. K Treatment, Education, and Community Help To Combat Addiction 7101. Establishment of regional centers of excellence in substance use disorder education Part D of title V of the Public Health Service Act, as amended by section 7031, is further amended by adding at the end the following new section: 551. Regional centers of excellence in substance use disorder education (a) In general The Secretary, in consultation with appropriate agencies, shall award cooperative agreements to eligible entities for the designation of such entities as Regional Centers of Excellence in Substance Use Disorder Education for purposes of improving health professional training resources with respect to substance use disorder prevention, treatment, and recovery. (b) Eligibility To be eligible to receive a cooperative agreement under subsection (a), an entity shall— (1) be an accredited entity that offers education to students in various health professions, which may include— (A) a teaching hospital; (B) a medical school; (C) a certified behavioral health clinic; or (D) any other health professions school, school of public health, or Cooperative Extension Program at institutions of higher education, as defined in section 101 of the Higher Education Act of 1965, engaged in the prevention, treatment, or recovery of substance use disorders; (2) demonstrate community engagement and partnerships with community stakeholders, including entities that train health professionals, mental health counselors, social workers, peer recovery specialists, substance use treatment programs, community health centers, physician offices, certified behavioral health clinics, research institutions, and law enforcement; and (3) submit to the Secretary an application containing such information, at such time, and in such manner, as the Secretary may require. (c) Activities An entity receiving an award under this section shall develop, evaluate, and distribute evidence-based resources regarding the prevention and treatment of, and recovery from, substance use disorders. Such resources may include information on— (1) the neurology and pathology of substance use disorders; (2) advancements in the treatment of substance use disorders; (3) techniques and best practices to support recovery from substance use disorders; (4) strategies for the prevention and treatment of, and recovery from substance use disorders across patient populations; and (5) other topic areas that are relevant to the objectives described in subsection (a). (d) Geographic distribution In awarding cooperative agreements under subsection (a), the Secretary shall take into account regional differences among eligible entities and shall make an effort to ensure geographic distribution. (e) Evaluation The Secretary shall evaluate each project carried out by an entity receiving an award under this section and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities. (f) Funding There is authorized to be appropriated to carry out this section, $4,000,000 for each of fiscal years 2019 through 2023. . 7102. Youth prevention and recovery (a) Substance abuse treatment services for children, adolescents, and young adults Section 514 of the Public Health Service Act ( 42 U.S.C. 290bb–7 ) is amended— (1) in the section heading, by striking children and adolescents and inserting children, adolescents, and young adults ; (2) in subsection (a)(2), by striking children, including and inserting children, adolescents, and young adults, including ; and (3) by striking children and adolescents each place it appears and inserting children, adolescents, and young adults . (b) Resource center The Secretary of Health and Human Services (referred to in this section as the Secretary , except as otherwise provided), in consultation with the Secretary of Education and other heads of agencies, including the Assistant Secretary for Mental Health and Substance Use and the Administrator of the Health Resources and Services Administration, as appropriate, shall establish a resource center to provide technical support to recipients of grants under subsection (c). (c) Youth prevention and recovery initiative (1) In general The Secretary, in consultation with the Secretary of Education, shall administer a program to provide support for communities to support the prevention of, treatment of, and recovery from, substance use disorders for children, adolescents, and young adults. (2) Definitions In this subsection: (A) Eligible entity The term eligible entity means— (i) a local educational agency that is seeking to establish or expand substance use prevention or recovery support services at one or more high schools; (ii) a State educational agency; (iii) an institution of higher education (or consortia of such institutions), which may include a recovery program at an institution of higher education; (iv) a local board or one-stop operator; (v) a nonprofit organization with appropriate expertise in providing services or programs for children, adolescents, or young adults, excluding a school; (vi) a State, political subdivision of a State, Indian tribe, or tribal organization; or (vii) a high school or dormitory serving high school students that receives funding from the Bureau of Indian Education. (B) Foster care The term foster care has the meaning given such term in section 1355.20(a) of title 45, Code of Federal Regulations (or any successor regulations). (C) High school The term high school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (D) Homeless youth The term homeless youth has the meaning given the term homeless children or youths in section 725 of the McKinney-Vento Homeless Assistance Act ( 42 U.S.C. 11434a ). (E) Indian tribe; tribal organization The terms Indian tribe and tribal organization have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (F) Institution of higher education The term institution of higher education has the meaning given such term in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ) and includes a postsecondary vocational institution as defined in section 102(c) of such Act ( 20 U.S.C. 1002(c) ). (G) Local educational agency The term local educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (H) Local board; one-stop operator The terms local board and one-stop operator have the meanings given such terms in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ). (I) Out-of-school youth The term out-of-school youth has the meaning given such term in section 129(a)(1)(B) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3164(a)(1)(B) ). (J) Recovery program The term recovery program means a program— (i) to help children, adolescents, or young adults who are recovering from substance use disorders to initiate, stabilize, and maintain healthy and productive lives in the community; and (ii) that includes peer-to-peer support delivered by individuals with lived experience in recovery, and communal activities to build recovery skills and supportive social networks. (K) State educational agency The term State educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act ( 20 U.S.C. 7801 ). (3) Best practices The Secretary, in consultation with the Secretary of Education, shall— (A) identify or facilitate the development of evidence-based best practices for prevention of substance misuse and abuse by children, adolescents, and young adults, including for specific populations such as youth in foster care, homeless youth, out-of-school youth, and youth who are at risk of or have experienced trafficking that address— (i) primary prevention; (ii) appropriate recovery support services; (iii) appropriate use of medication-assisted treatment for such individuals, if applicable, and ways of overcoming barriers to the use of medication-assisted treatment in such population; and (iv) efficient and effective communication, which may include the use of social media, to maximize outreach efforts; (B) disseminate such best practices to State educational agencies, local educational agencies, schools and dormitories funded by the Bureau of Indian Education, institutions of higher education, recovery programs at institutions of higher education, local boards, one-stop operators, family and youth homeless providers, and nonprofit organizations, as appropriate; (C) conduct a rigorous evaluation of each grant funded under this subsection, particularly its impact on the indicators described in paragraph (7)(B); and (D) provide technical assistance for grantees under this subsection. (4) Grants authorized The Secretary, in consultation with the Secretary of Education, shall award 3-year grants, on a competitive basis, to eligible entities to enable such entities, in coordination with Indian tribes, if applicable, and State agencies responsible for carrying out substance use disorder prevention and treatment programs, to carry out evidence-based programs for— (A) prevention of substance misuse and abuse by children, adolescents, and young adults, which may include primary prevention; (B) recovery support services for children, adolescents, and young adults, which may include counseling, job training, linkages to community-based services, family support groups, peer mentoring, and recovery coaching; or (C) treatment or referrals for treatment of substance use disorders, which may include the use of medication-assisted treatment, as appropriate. (5) Special consideration In awarding grants under this subsection, the Secretary shall give special consideration to the unique needs of tribal, urban, suburban, and rural populations. (6) Application To be eligible for a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. Such application shall include— (A) a description of— (i) the impact of substance use disorders in the population that will be served by the grant program; (ii) how the eligible entity has solicited input from relevant stakeholders, which may include faculty, teachers, staff, families, students, and experts in substance use disorder prevention, treatment, and recovery in developing such application; (iii) the goals of the proposed project, including the intended outcomes; (iv) how the eligible entity plans to use grant funds for evidence-based activities, in accordance with this subsection to prevent, provide recovery support for, or treat substance use disorders amongst such individuals, or a combination of such activities; and (v) how the eligible entity will collaborate with relevant partners, which may include State educational agencies, local educational agencies, institutions of higher education, juvenile justice agencies, prevention and recovery support providers, local service providers, including substance use disorder treatment programs, providers of mental health services, youth serving organizations, family and youth homeless providers, child welfare agencies, and primary care providers, in carrying out the grant program; and (B) an assurance that the eligible entity will participate in the evaluation described in paragraph (3)(C). (7) Reports to the Secretary Each eligible entity awarded a grant under this subsection shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include— (A) a description of how the eligible entity used grant funds, in accordance with this subsection, including the number of children, adolescents, and young adults reached through programming; and (B) a description, including relevant data, of how the grant program has made an impact on the intended outcomes described in paragraph (6)(A)(iii), including— (i) indicators of student success, which, if the eligible entity is an educational institution, shall include student well-being and academic achievement; (ii) substance use disorders amongst children, adolescents, and young adults, including the number of overdoses and deaths amongst children, adolescents, and young adults served by the grant during the grant period; and (iii) other indicators, as the Secretary determines appropriate. (8) Report to Congress The Secretary shall, not later than October 1, 2022, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives a report summarizing the effectiveness of the grant program under this subsection, based on the information submitted in reports required under paragraph (7). (9) Authorization of appropriations There is authorized to be appropriated $10,000,000 to carry out this subsection for each of fiscal years 2019 through 2023. L Information from National Mental Health and Substance Use Policy Laboratory 7111. Information from National Mental Health and Substance Use Policy Laboratory Section 501A(b) of the Public Health Service Act ( 42 U.S.C. 290aa–0(b) ) is amended— (1) in paragraph (5)(C), by striking ; and at the end and inserting a semicolon; (2) by redesignating paragraph (6) as paragraph (7); and (3) by inserting after paragraph (5) the following: (6) issue and periodically update information for entities applying for grants or cooperative agreements from the Substance Abuse and Mental Health Services Administration in order to— (A) encourage the implementation and replication of evidence-based practices; and (B) provide technical assistance to applicants for funding, including with respect to justifications for such programs and activities; and . M Comprehensive Opioid Recovery Centers 7121. Comprehensive opioid recovery centers (a) In general Part D of title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.), as amended by sections 7031 and 7101, is further amended by adding at the end the following new section: 552. Comprehensive opioid recovery centers (a) In general The Secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center (referred to in this section as a Center ). A Center may be a single entity or an integrated delivery network. (b) Grant period (1) In general A grant awarded under subsection (a) shall be for a period of not less than 3 years and not more than 5 years. (2) Renewal A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph, the Secretary shall consider the data submitted under subsection (h). (c) Minimum number of Centers The Secretary shall allocate the amounts made available under subsection (j) such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a single State for any one period. (d) Application (1) Eligible entity An entity is eligible for a grant under this section if the entity offers treatment and other services for individuals with a substance use disorder. (2) Submission of application In order to be eligible for a grant under subsection (a), an entity shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activities described in subsection (g); and (B) such other information as the Secretary may require. (e) Priority In awarding grants under subsection (a), the Secretary shall give priority to eligible entities— (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or (2) serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined through appropriate mechanisms determined by the Secretary in consultation with Indian Tribes. (f) Preference In awarding grants under subsection (a), the Secretary may give preference to eligible entities utilizing technology-enabled collaborative learning and capacity building models, including such models as defined in section 2 of the Expanding Capacity for Health Outcomes Act ( Public Law 114–270 ; 130 Stat. 1395), to conduct the activities described in this section. (g) Center activities Each Center shall, at a minimum, carry out the following activities directly, through referral, or through contractual arrangements, which may include carrying out such activities through technology-enabled collaborative learning and capacity building models described in subsection (f): (1) Treatment and recovery services Each Center shall— (A) Ensure that intake, evaluations, and periodic patient assessments meet the individualized clinical needs of patients, including by reviewing patient placement in treatment settings to support meaningful recovery. (B) Provide the full continuum of treatment services, including— (i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all biological products licensed under section 351 of this Act to treat substance use disorders or reverse overdoses, pursuant to Federal and State law; (ii) medically supervised withdrawal management, that includes patient evaluation, stabilization, and readiness for and entry into treatment; (iii) counseling provided by a program counselor or other certified professional who is licensed and qualified by education, training, or experience to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan for the patient, and to monitor patient progress; (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders; (v) testing, as appropriate, for infections commonly associated with illicit drug use; (vi) residential rehabilitation, and outpatient and intensive outpatient programs; (vii) recovery housing; (viii) community-based and peer recovery support services; (ix) job training, job placement assistance, and continuing education assistance to support reintegration into the workforce; and (x) other best practices to provide the full continuum of treatment and services, as determined by the Secretary. (C) Ensure that all programs covered by the Center include medication-assisted treatment, as appropriate, and do not exclude individuals receiving medication-assisted treatment from any service. (D) Periodically conduct patient assessments to support sustained and clinically significant recovery, as defined by the Assistant Secretary for Mental Health and Substance Use. (E) Provide onsite access to medication, as appropriate, and toxicology services; for purposes of carrying out this section. (F) Operate a secure, confidential, and interoperable electronic health information system. (G) Offer family support services such as child care, family counseling, and parenting interventions to help stabilize families impacted by substance use disorder, as appropriate. (2) Outreach Each Center shall carry out outreach activities regarding the services offered through the Centers, which may include— (A) training and supervising outreach staff, as appropriate, to work with State and local health departments, health care providers, the Indian Health Service, State and local educational agencies, schools funded by the Indian Bureau of Education, institutions of higher education, State and local workforce development boards, State and local community action agencies, public safety officials, first responders, Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including patients, to identify and respond to community needs; (B) ensuring that the entities described in subparagraph (A) are aware of the services of the Center; and (C) disseminating and making publicly available, including through the internet, evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders, including co-occurring substance use and mental disorders. (h) Data reporting and program oversight With respect to a grant awarded under subsection (a), not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period (including the duration of any renewal period for such grant), the entity shall submit data, as appropriate, to the Secretary regarding— (1) the programs and activities funded by the grant; (2) health outcomes of the population of individuals with a substance use disorder who received services from the Center, evaluated by an independent program evaluator through the use of outcomes measures, as determined by the Secretary; (3) the retention rate of program participants; and (4) any other information that the Secretary may require for the purpose of—ensuring that the Center is complying with all the requirements of the grant, including providing the full continuum of services described in subsection (g)(1)(B). (i) Privacy The provisions of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (j) Authorization of appropriations There is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. . (b) Reports to Congress (1) Preliminary report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a preliminary report that analyzes data submitted under section 552(h) of the Public Health Service Act, as added by subsection (a). (2) Final report Not later than 2 years after submitting the preliminary report required under paragraph (1), the Secretary of Health and Human Services shall submit to Congress a final report that includes— (A) an evaluation of the effectiveness of the comprehensive services provided by the Centers established or operated pursuant to section 552 of the Public Health Service Act, as added by subsection (a), with respect to health outcomes of the population of individuals with substance use disorder who receive services from the Center, which shall include an evaluation of the effectiveness of services for treatment and recovery support and to reduce relapse, recidivism, and overdose; and (B) recommendations, as appropriate, regarding ways to improve Federal programs related to substance use disorders, which may include dissemination of best practices for the treatment of substance use disorders to health care professionals. N Trauma-Informed Care 7131. CDC surveillance and data collection for child, youth, and adult trauma (a) Data collection The Director of the Centers for Disease Control and Prevention (referred to in this section as the Director ) may, in cooperation with the States, collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, and other relevant public health surveys or questionnaires. (b) Timing The collection of data under subsection (a) may occur biennially. (c) Data from rural areas The Director shall encourage each State that participates in collecting and reporting data under subsection (a) to collect and report data from rural areas within such State, in order to generate a statistically reliable representation of such areas. (d) Data from tribal areas The Director may, in cooperation with Indian Tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) and pursuant to a written request from an Indian Tribe, provide technical assistance to such Indian Tribe to collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, or another relevant public health survey or questionnaire. (e) Authorization of appropriations To carry out this section, there is authorized to be appropriated $2,000,000 for each of fiscal years 2019 through 2023. 7132. Task force to develop best practices for trauma-informed identification, referral, and support (a) Establishment There is established a task force, to be known as the Interagency Task Force on Trauma-Informed Care (in this section referred to as the task force ) that shall identify, evaluate, and make recommendations regarding— (1) best practices with respect to children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (2) ways in which Federal agencies can better coordinate to improve the Federal response to families impacted by substance use disorders and other forms of trauma. (b) Membership (1) Composition The task force shall be composed of the heads of the following Federal departments and agencies, or their designees: (A) The Centers for Medicare & Medicaid Services. (B) The Substance Abuse and Mental Health Services Administration. (C) The Agency for Healthcare Research and Quality. (D) The Centers for Disease Control and Prevention. (E) The Indian Health Service. (F) The Department of Veterans Affairs. (G) The National Institutes of Health. (H) The Food and Drug Administration. (I) The Health Resources and Services Administration. (J) The Department of Defense. (K) The Office of Minority Health of the Department of Health and Human Services. (L) The Administration for Children and Families. (M) The Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services. (N) The Office for Civil Rights of the Department of Health and Human Services. (O) The Office of Juvenile Justice and Delinquency Prevention of the Department of Justice. (P) The Office of Community Oriented Policing Services of the Department of Justice. (Q) The Office on Violence Against Women of the Department of Justice. (R) The National Center for Education Evaluation and Regional Assistance of the Department of Education. (S) The National Center for Special Education Research of the Institute of Education Science. (T) The Office of Elementary and Secondary Education of the Department of Education. (U) The Office for Civil Rights of the Department of Education. (V) The Office of Special Education and Rehabilitative Services of the Department of Education. (W) The Bureau of Indian Affairs of the Department of the Interior. (X) The Veterans Health Administration of the Department of Veterans Affairs. (Y) The Office of Special Needs Assistance Programs of the Department of Housing and Urban Development. (Z) The Office of Head Start of the Administration for Children and Families. (AA) The Children’s Bureau of the Administration for Children and Families. (BB) The Bureau of Indian Education of the Department of the Interior. (CC) Such other Federal agencies as the Secretaries determine to be appropriate. (2) Date of appointments The heads of Federal departments and agencies shall appoint the corresponding members of the task force not later than 60 days after the date of enactment of this Act. (3) Chairperson The task force shall be chaired by the Assistant Secretary for Mental Health and Substance Use, or the Assistant Secretary's designee. (c) Task force duties The task force shall— (1) solicit input from stakeholders, including frontline service providers, educators, mental health professionals, researchers, experts in infant, child, and youth trauma, child welfare professionals, and the public, in order to inform the activities under paragraph (2); and (2) identify, evaluate, make recommendations, and update such recommendations not less than annually, to the general public, the Secretary of Education, the Secretary of Health and Human Services, the Secretary of Labor, the Secretary of the Interior, the Attorney General, and other relevant cabinet Secretaries, and Congress regarding— (A) a set of evidence-based, evidence-informed, and promising best practices with respect to— (i) prevention strategies for individuals at risk of experiencing or being exposed to trauma, including trauma as a result of exposure to substance use; (ii) the identification of infants, children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; (iii) the expeditious referral to and implementation of trauma-informed practices and supports that prevent and mitigate the effects of trauma, which may include whole-family and multi-generational approaches; and (iv) community based or multi-generational practices that support children and their families; (B) a national strategy on how the task force and member agencies will collaborate, prioritize options for, and implement a coordinated approach, which may include— (i) data sharing; (ii) providing support to infants, children, and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; (iii) identifying options for coordinating existing grants that support infants, children, and youth, and their families as appropriate, who have experienced, or are at risk of experiencing, exposure to substance use or other trauma, including trauma related to substance use; and (iv) other ways to improve coordination, planning, and communication within and across Federal agencies, offices, and programs, to better serve children and families impacted by substance use disorders; and (C) existing Federal authorities at the Department of Education, Department of Health and Human Services, Department of Justice, Department of Labor, Department of the Interior, and other relevant agencies, and specific Federal grant programs to disseminate best practices on, provide training in, or deliver services through, trauma-informed practices, and disseminate such information— (i) in writing to relevant program offices at such agencies to encourage grant applicants in writing to use such funds, where appropriate, for trauma-informed practices; and (ii) to the general public through the internet website of the task force. (d) Best practices In identifying, evaluating, and recommending the set of best practices under subsection (c), the task force shall— (1) include guidelines for providing professional development and education for front-line services providers, including school personnel, early childhood education program providers, providers from child- or youth-serving organizations, housing and homeless providers, primary and behavioral health care providers, child welfare and social services providers, juvenile and family court personnel, health care providers, individuals who are mandatory reporters of child abuse or neglect, trained nonclinical providers (including peer mentors and clergy), and first responders, in— (A) understanding and identifying early signs and risk factors of trauma in infants, children, and youth, and their families as appropriate, including through screening processes and services; (B) providing practices to prevent and mitigate the impact of trauma, including by fostering safe and stable environments and relationships; and (C) developing and implementing policies, procedures, or systems that— (i) are designed to quickly refer infants, children, youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma to the appropriate trauma-informed screening and support and age-appropriate treatment, and to ensure such infants, children, youth, and family members receive such support; (ii) utilize and develop partnerships with early childhood education programs, local social services organizations, such as organizations serving youth, and clinical mental health or other health care providers with expertise in providing support services and age-appropriate trauma-informed and evidence-based treatment aimed at preventing or mitigating the effects of trauma; (iii) educate children and youth to— (I) understand and identify the signs, effects, or symptoms of trauma; and (II) build the resilience and coping skills to mitigate the effects of experiencing trauma; (iv) promote and support multi-generational practices that assist parents, foster parents, and kinship and other caregivers in accessing resources related to, and developing environments conducive to, the prevention and mitigation of trauma; and (v) collect and utilize data from screenings, referrals, or the provision of services and supports to evaluate outcomes and improve processes for trauma-informed services and supports that are culturally sensitive, linguistically appropriate, and specific to age ranges and sex, as applicable; (2) recommend best practices that are designed to avoid unwarranted custody loss or criminal penalties for parents or guardians in connection with infants, children, and youth who have experienced or are at risk of experiencing trauma; and (3) recommend opportunities for local- and State-level partnerships that— (A) are designed to quickly identify and refer children and families, as appropriate, who have experienced or are at risk of experiencing exposure to trauma, including related to substance use; (B) utilize and develop partnerships with early childhood education programs, local social services organizations, and health care services aimed at preventing or mitigating the effects of exposure to trauma, including related to substance use; (C) offer community-based prevention activities, including educating families and children on the effects of exposure to trauma, such as trauma related to substance use, and how to build resilience and coping skills to mitigate those effects; (D) in accordance with Federal privacy protections, utilize non-personally-identifiable data from screenings, referrals, or the provision of services and supports to evaluate and improve processes addressing exposure to trauma, including related to substance use; and (E) are designed to prevent separation and support reunification of families if in the best interest of the child. (e) Operating plan Not later than 120 days after the date of enactment of this Act, the task force shall hold the first meeting. Not later than 2 years after such date of enactment, the task force shall submit to the Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, and Congress an operating plan for carrying out the activities of the task force described in subsection (c)(2). Such operating plan shall include— (1) a list of specific activities that the task force plans to carry out for purposes of carrying out duties described in subsection (c)(2), which may include public engagement; (2) a plan for carrying out the activities under subsection (c)(2); (3) a list of members of the task force and other individuals who are not members of the task force that may be consulted to carry out such activities; (4) an explanation of Federal agency involvement and coordination needed to carry out such activities, including any statutory or regulatory barriers to such coordination; (5) a budget for carrying out such activities; (6) a proposed timeline for implementing recommendations and efforts identified under subsection (c); and (7) other information that the task force determines appropriate as related to its duties. (f) Final report Not later than 3 years after the date of the first meeting of the task force, the task force shall submit to the general public, Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, other relevant cabinet Secretaries, the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and Congress, a final report containing all of the findings and recommendations required under this section, and shall make such report available online in an accessible format. (g) Additional reports In addition to the final report under subsection (f). the task force shall submit— (1) a report to Congress identifying any recommendations identified under subsection (c) that require additional legislative authority to implement; and (2) a report to the Governors describing the opportunities for local- and State-level partnerships, professional development, or best practices recommended under subsection (d)(3). (h) Definitions In this section— (1) the term early childhood education program has the meaning given such term in section 103 of the Higher Education Act of 1965 ( 20 U.S.C. 1003 ); (2) The term Governor means the chief executive officer of a State; and (3) the term State means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. (i) Sunset The task force shall sunset on the date that is 60 days after the submission of the final report under subsection (f), but not later than September 30, 2023. 7133. National Child Traumatic Stress Initiative Section 582(j) of the Public Health Service Act ( 42 U.S.C. 290hh–1(j) ) (relating to grants to address the problems of persons who experience violence-related stress) is amended by striking $46,887,000 for each of fiscal years 2018 through 2022 and inserting $63,887,000 for each of fiscal years 2019 through 2023 . 7134. Grants to improve trauma support services and mental health care for children and youth in educational settings (a) Grants, contracts, and cooperative agreements authorized The Secretary, in coordination with the Assistant Secretary for Mental Health and Substance Use, is authorized to award grants to, or enter into contracts or cooperative agreements with, State educational agencies, local educational agencies, Indian Tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) or their tribal educational agencies, a school operated by the Bureau of Indian Education, a Regional Corporation, or a Native Hawaiian educational organization, for the purpose of increasing student access to evidence-based trauma support services and mental health care by developing innovative initiatives, activities, or programs to link local school systems with local trauma-informed support and mental health systems, including those under the Indian Health Service. (b) Duration With respect to a grant, contract, or cooperative agreement awarded or entered into under this section, the period during which payments under such grant, contract or agreement are made to the recipient may not exceed 4 years. (c) Use of funds An entity that receives a grant, contract, or cooperative agreement under this section shall use amounts made available through such grant, contract, or cooperative agreement for evidence-based activities, which shall include any of the following: (1) Collaborative efforts between school-based service systems and trauma-informed support and mental health service systems to provide, develop, or improve prevention, screening, referral, and treatment and support services to students, such as providing trauma screenings to identify students in need of specialized support. (2) To implement schoolwide positive behavioral interventions and supports, or other trauma-informed models of support. (3) To provide professional development to teachers, teacher assistants, school leaders, specialized instructional support personnel, and mental health professionals that— (A) fosters safe and stable learning environments that prevent and mitigate the effects of trauma, including through social and emotional learning; (B) improves school capacity to identify, refer, and provide services to students in need of trauma support or behavioral health services; or (C) reflects the best practices for trauma-informed identification, referral, and support developed by the Task Force under section 7132. (4) Services at a full-service community school that focuses on trauma-informed supports, which may include a full-time site coordinator, or other activities consistent with section 4625 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7275 ). (5) Engaging families and communities in efforts to increase awareness of child and youth trauma, which may include sharing best practices with law enforcement regarding trauma-informed care and working with mental health professionals to provide interventions, as well as longer term coordinated care within the community for children and youth who have experienced trauma and their families. (6) To provide technical assistance to school systems and mental health agencies. (7) To evaluate the effectiveness of the program carried out under this section in increasing student access to evidence-based trauma support services and mental health care. (8) To establish partnerships with or provide subgrants to Head Start agencies (including Early Head Start agencies), public and private preschool programs, child care programs (including home-based providers), or other entities described in subsection (a), to include such entities described in this paragraph in the evidence-based trauma initiatives, activities, support services, and mental health systems established under this section in order to provide, develop, or improve prevention, screening, referral, and treatment and support services to young children and their families. (d) Applications To be eligible to receive a grant, contract, or cooperative agreement under this section, an entity described in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include the following: (1) A description of the innovative initiatives, activities, or programs to be funded under the grant, contract, or cooperative agreement, including how such program will increase access to evidence-based trauma support services and mental health care for students, and, as applicable, the families of such students. (2) A description of how the program will provide linguistically appropriate and culturally competent services. (3) A description of how the program will support students and the school in improving the school climate in order to support an environment conducive to learning. (4) An assurance that— (A) persons providing services under the grant, contract, or cooperative agreement are adequately trained to provide such services; and (B) teachers, school leaders, administrators, specialized instructional support personnel, representatives of local Indian Tribes or tribal organizations as appropriate, other school personnel, and parents or guardians of students participating in services under this section will be engaged and involved in the design and implementation of the services. (5) A description of how the applicant will support and integrate existing school-based services with the program in order to provide mental health services for students, as appropriate. (6) A description of the entities in the community with which the applicant will partner or to which the applicant will provide subgrants in accordance with subsection (c)(8). (e) Interagency agreements (1) Local interagency agreements To ensure the provision of the services described in subsection (c), a recipient of a grant, contract, or cooperative agreement under this section, or their designee, shall establish a local interagency agreement among local educational agencies, agencies responsible for early childhood education programs, Head Start agencies (including Early Head Start agencies), juvenile justice authorities, mental health agencies, child welfare agencies, and other relevant agencies, authorities, or entities in the community that will be involved in the provision of such services. (2) Contents In ensuring the provision of the services described in subsection (c), the local interagency agreement shall specify with respect to each agency, authority, or entity that is a party to such agreement— (A) the financial responsibility for the services; (B) the conditions and terms of responsibility for the services, including quality, accountability, and coordination of the services; and (C) the conditions and terms of reimbursement among such agencies, authorities, or entities, including procedures for dispute resolution. (f) Evaluation The Secretary shall reserve not more than 3 percent of the funds made available under subsection (l) for each fiscal year to— (1) conduct a rigorous, independent evaluation of the activities funded under this section; and (2) disseminate and promote the utilization of evidence-based practices regarding trauma support services and mental health care. (g) Distribution of awards The Secretary shall ensure that grants, contracts, and cooperative agreements awarded or entered into under this section are equitably distributed among the geographical regions of the United States and among tribal, urban, suburban, and rural populations. (h) Rule of construction Nothing in this section shall be construed— (1) to prohibit an entity involved with a program carried out under this section from reporting a crime that is committed by a student to appropriate authorities; or (2) to prevent Federal, State, and tribal law enforcement and judicial authorities from exercising their responsibilities with regard to the application of Federal, tribal, and State law to crimes committed by a student. (i) Supplement, not supplant Any services provided through programs carried out under this section shall supplement, and not supplant, existing mental health services, including any special education and related services provided under the Individuals with Disabilities Education Act ( 20 U.S.C. 1400 et seq.). (j) Consultation with Indian Tribes In carrying out subsection (a), the Secretary shall, in a timely manner, meaningfully consult with Indian Tribes and their representatives to ensure notice of eligibility. (k) Definitions In this section: (1) Elementary school The term elementary school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (2) Evidence-based The term evidence-based has the meaning given such term in section 8101(21)(A)(i) of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801(21)(A)(i) ). (3) Native Hawaiian educational organization The term Native Hawaiian educational organization has the meaning given such term in section 6207 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7517 ). (4) Local educational agency The term local educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (5) Regional Corporation The term Regional Corporation has the meaning given the term in section 3 of the Alaska Native Claims Settlement Act ( 43 U.S.C. 1602 )). (6) School The term school means a public elementary school or public secondary school. (7) School leader The term school leader has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (8) Secondary school The term secondary school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (9) Secretary The term Secretary means the Secretary of Education. (10) Specialized instructional support personnel The term specialized instructional support personnel has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (11) State educational agency The term State educational agency has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). (l) Authorization of appropriations There is authorized to be appropriated to carry out this section, $50,000,000 for each of fiscal years 2019 through 2023. 7135. Recognizing early childhood trauma related to substance abuse (a) Dissemination of information The Secretary of Health and Human Services shall disseminate information, resources, and, if requested, technical assistance to early childhood care and education providers and professionals working with young children on— (1) ways to properly recognize children who may be impacted by trauma, including trauma related to substance use by a family member or other adult; and (2) how to respond appropriately in order to provide for the safety and well-being of young children and their families. (b) Goals The information, resources, and technical assistance provided under subsection (a) shall— (1) educate early childhood care and education providers and professionals working with young children on understanding and identifying the early signs and risk factors of children who might be impacted by trauma, including trauma due to exposure to substance use; (2) suggest age-appropriate communication tools, procedures, and practices for trauma-informed care, including ways to prevent or mitigate the effects of trauma; (3) provide options for responding to children impacted by trauma, including due to exposure to substance use, that consider the needs of the child and family, including recommending resources and referrals for evidence-based services to support such family; and (4) promote whole-family and multi-generational approaches to keep families safely together when it is in the best interest of the child. (c) Coordination The Secretary of Health and Human Services shall coordinate with the task force to develop best practices for trauma-informed identification, referral, and support authorized under section 7132 in disseminating the information, resources, and technical assistance described under subsection (b). (d) Rule of construction Such information, resources, and if applicable, technical assistance, shall not be construed to amend the requirements under— (1) the Child Care and Development Block Grant Act of 1990 ( 42 U.S.C. 9858 et seq.); (2) the Head Start Act ( 42 U.S.C. 9831 et seq.); or (3) the Individuals with Disabilities Education Act ( 20 U.S.C. 1400 et seq.). O Eliminating Opioid Related Infectious Diseases 7141. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors Section 317N of the Public Health Service Act ( 42 U.S.C. 247b–15 ) is amended to read as follows: 317N. Surveillance and education regarding infections associated with illicit drug use and other risk factors (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may (directly or through grants to public and nonprofit private entities) provide for programs for the following: (1) To cooperate with States and Indian tribes in implementing or maintaining a national system to determine the incidence of infections commonly associated with illicit drug use, such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections. (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph (1) resulting from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors. (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services. (4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary. (5) To improve the education, training, and skills of health professionals in the detection and control of infections described in paragraph (1), including to improve coordination of treatment of substance use disorders and infectious diseases, with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, and infectious disease clinicians, including HIV clinicians. (b) Laboratory procedures The Secretary may (directly or through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection (a)(1). (c) Definition In this section, the term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023. . P Peer Support Communities of Recovery 7151. Building communities of recovery Section 547 of the Public Health Service Act ( 42 U.S.C. 290ee–2 ) is amended to read as follows: 547. Building communities of recovery (a) Definition In this section, the term recovery community organization means an independent nonprofit organization that— (1) mobilizes resources within and outside of the recovery community, which may include through a peer support network, to increase the prevalence and quality of long-term recovery from substance use disorders; and (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community served. (b) Grants authorized The Secretary shall award grants to recovery community organizations to enable such organizations to develop, expand, and enhance recovery services. (c) Federal share The Federal share of the costs of a program funded by a grant under this section may not exceed 85 percent. (d) Use of funds Grants awarded under subsection (b)— (1) shall be used to develop, expand, and enhance community and statewide recovery support services; and (2) may be used to— (A) build connections between recovery networks, including between recovery community organizations and peer support networks, and with other recovery support services, including— (i) behavioral health providers; (ii) primary care providers and physicians; (iii) educational and vocational schools; (iv) employers; (v) housing services; (vi) child welfare agencies; and (vii) other recovery support services that facilitate recovery from substance use disorders, including non-clinical community services; (B) reduce stigma associated with substance use disorders; and (C) conduct outreach on issues relating to substance use disorders and recovery, including— (i) identifying the signs of substance use disorder; (ii) the resources available to individuals with substance use disorder and to families of an individual with a substance use disorder, including programs that mentor and provide support services to children; (iii) the resources available to help support individuals in recovery; and (iv) related medical outcomes of substance use disorders, the potential of acquiring an infection commonly associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during pregnancy. (e) Special consideration In carrying out this section, the Secretary shall give special consideration to the unique needs of rural areas, including areas with an age-adjusted rate of drug overdose deaths that is above the national average and areas with a shortage of prevention and treatment services. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2019 through 2023. . 7152. Peer support technical assistance center Title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.) is amended by inserting after section 547 the following: 547A. Peer support technical assistance center (a) Establishment The Secretary, acting through the Assistant Secretary, shall establish or operate a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this section as the Center ). (b) Functions The Center established under subsection (a) shall provide technical assistance and support to recovery community organizations and peer support networks, including such assistance and support related to— (1) training on identifying— (A) signs of substance use disorder; (B) resources to assist individuals with a substance use disorder, or resources for families of an individual with a substance use disorder; and (C) best practices for the delivery of recovery support services; (2) the provision of translation services, interpretation, or other such services for clients with limited English speaking proficiency; (3) data collection to support research, including for translational research; (4) capacity building; and (5) evaluation and improvement, as necessary, of the effectiveness of such services provided by recovery community organizations. (c) Best practices The Center established under subsection (a) shall periodically issue best practices for use by recovery community organizations and peer support networks. (d) Recovery community organization In this section, the term recovery community organization has the meaning given such term in section 547. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2019 through 2023. . Q Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies 7161. Preventing overdoses of controlled substances (a) In general Part J of title III of the Public Health Service Act ( 42 U.S.C. 280b et seq.) is amended by inserting after section 392 ( 42 U.S.C. 280b–1 ) the following: 392A. Preventing overdoses of controlled substances (a) Evidence-Based prevention grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out and expand any evidence-based prevention activities described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying out such activity; and (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity. (2) Evidence-based prevention activities An evidence-based prevention activity described in this paragraph is any of the following activities: (A) Improving the efficiency and use of a new or currently operating prescription drug monitoring program, including by— (i) encouraging all authorized users (as specified by the State or other entity) to register with and use the program; (ii) enabling such users to access any updates to information collected by the program in as close to real-time as possible; (iii) improving the ease of use of such program; (iv) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing or dispensing practices relating to such substances; (v) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identified, aggregate reports based on such analysis to State public health agencies, State substance abuse agencies, State licensing boards, and other appropriate State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug monitoring program and not containing any protected health information, to prevent inappropriate prescribing, drug diversion, or abuse and misuse of controlled substances, and to facilitate better coordination among agencies; (vi) enhancing interoperability between the program and any health information technology (including certified health information technology), including by integrating program data into such technology; (vii) updating program capabilities to respond to technological innovation for purposes of appropriately addressing the occurrence and evolution of controlled substance overdoses; (viii) facilitating and encouraging data exchange between the program and the prescription drug monitoring programs of other States; (ix) enhancing data collection and quality, including improving patient matching and proactively monitoring data quality; (x) providing prescriber and dispenser practice tools, including prescriber practice insight reports for practitioners to review their prescribing patterns in comparison to such patterns of other practitioners in the specialty; and (xi) meeting the purpose of the program established under section 399O, as described in section 399O(a). (B) Promoting community or health system interventions. (C) Evaluating interventions to prevent controlled substance overdoses. (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging public health crises and opportunities to address such crises, such as enhancing public education and awareness on the risks associated with opioids. (3) Additional grants The Director may award grants to States, localities, and Indian Tribes— (A) to carry out innovative projects for grantees to rapidly respond to controlled substance misuse, abuse, and overdoses, including changes in patterns of controlled substance use; and (B) for any other evidence-based activity for preventing controlled substance misuse, abuse, and overdoses as the Director determines appropriate. (4) Research The Director, in coordination with the Assistant Secretary for Mental Health and Substance Use and the National Mental Health and Substance Use Policy Laboratory established under section 501A, as appropriate and applicable, may conduct studies and evaluations to address substance use disorders, including preventing substance use disorders or other related topics the Director determines appropriate. (b) Enhanced controlled substance overdose data collection, analysis, and dissemination grants (1) In general The Director of the Centers for Disease Control and Prevention may— (A) to the extent practicable, carry out any controlled substance overdose data collection activities described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying out such activity; (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity; and (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to section 505(d)(1)(A) (relating to the number of individuals admitted to emergency departments as a result of the abuse of alcohol or other drugs). (2) Controlled substance overdose data collection and analysis activities A controlled substance overdose data collection, analysis, and dissemination activity described in this paragraph is any of the following activities: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal overdoses of controlled substances. (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on such overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and emergency departments. (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an electronic-based system. (D) Using data to help identify risk factors associated with controlled substance overdoses. (E) Supporting entities involved in providing information on controlled substance overdoses, such as coroners, medical examiners, and public health laboratories to improve accurate testing and standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of various opioid analogues to controlled substance overdoses. (F) Working to enable and encourage the access, exchange, and use of information regarding controlled substance overdoses among data sources and entities. (c) Definitions In this section: (1) Controlled substance The term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act. (2) Indian tribe The term Indian tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations For purposes of carrying out this section, section 399O of this Act, and section 102 of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), there is authorized to be appropriated $496,000,000 for each of fiscal years 2019 through 2023. . (b) Education and awareness Section 102 of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ) is amended— (1) by amending subsection (a) to read as follows: (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in coordination with the heads of other departments and agencies, shall advance education and awareness regarding the risks related to misuse and abuse of opioids, as appropriate, which may include developing or improving existing programs, conducting activities, and awarding grants that advance the education and awareness of— (1) the public, including patients and consumers— (A) generally; and (B) regarding such risks related to unused opioids and the dispensing options under section 309(f) of the Controlled Substances Act, as applicable; and (2) providers, which may include— (A) providing for continuing education on appropriate prescribing practices; (B) education related to applicable State or local prescriber limit laws, information on the use of non-addictive alternatives for pain management, and the use of overdose reversal drugs, as appropriate; (C) disseminating and improving the use of evidence-based opioid prescribing guidelines across relevant health care settings, as appropriate, and updating guidelines as necessary; (D) implementing strategies, such as best practices, to encourage and facilitate the use of prescriber guidelines, in accordance with State and local law; (E) disseminating information to providers about prescribing options for controlled substances, including such options under section 309(f) of the Controlled Substances Act, as applicable; and (F) disseminating information, as appropriate, on the National Pain Strategy developed by or in consultation with the Assistant Secretary for Health; and (3) other appropriate entities. ; and (2) in subsection (b)— (A) by striking opioid abuse each place such term appears and inserting opioid misuse and abuse ; and (B) in paragraph (2), by striking safe disposal of prescription medications and other and inserting non-addictive treatment options, safe disposal options for prescription medications, and other applicable . 7162. Prescription drug monitoring program Section 399O of the Public Health Service Act ( 42 U.S.C. 280g–3 ) is amended to read as follows: 399O. Prescription drug monitoring program (a) Program (1) In general Each fiscal year, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, in coordination with the heads of other departments and agencies as appropriate, shall support States or localities for the purpose of improving the efficiency and use of PDMPs, including— (A) establishment and implementation of a PDMP; (B) maintenance of a PDMP; (C) improvements to a PDMP by— (i) enhancing functional components to work toward— (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow; (II) more timely inclusion of data within a PDMP; (III) active management of the PDMP, in part by sending proactive or unsolicited reports to providers to inform prescribing; and (IV) ensuring the highest level of ease in use of and access to PDMPs by providers and their delegates, to the extent that State laws allow; (ii) in consultation with the Office of the National Coordinator for Health Information Technology, improving the intrastate interoperability of PDMPs by— (I) making PDMPs more actionable by integrating PDMPs within electronic health records and health information technology infrastructure; and (II) linking PDMP data to other data systems within the State, including— (aa) the data of pharmacy benefit managers, medical examiners and coroners, and the State’s Medicaid program; (bb) worker’s compensation data; and (cc) prescribing data of providers of the Department of Veterans Affairs and the Indian Health Service within the State; (iii) in consultation with the Office of the National Coordinator for Health Information Technology, improving the interstate interoperability of PDMPs through— (I) sharing of dispensing data in near-real time across State lines; and (II) integration of automated queries for multistate PDMP data and analytics into clinical workflow to improve the use of such data and analytics by practitioners and dispensers; or (iv) improving the ability to include treatment availability resources and referral capabilities within the PDMP. (2) Legislation As a condition on the receipt of support under this section, the Secretary shall require a State or locality to demonstrate that it has enacted legislation or regulations— (A) to provide for the implementation of the PDMP; and (B) to permit the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained by the PDMP. (b) PDMP strategies The Secretary shall encourage a State or locality, in establishing, improving, or maintaining a PDMP, to implement strategies that improve— (1) the reporting of dispensing in the State or locality of a controlled substance to an ultimate user so the reporting occurs not later than 24 hours after the dispensing event; (2) the consultation of the PDMP by each prescribing practitioner, or their designee, in the State or locality before initiating treatment with a controlled substance, or any substance as required by the State to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event; (3) the consultation of the PDMP before dispensing a controlled substance, or any substance as required by the State to be reported to the PDMP; (4) the proactive notification to a practitioner when patterns indicative of controlled substance misuse by a patient, including opioid misuse, are detected; (5) the availability of data in the PDMP to other States, as allowable under State law; and (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for surveillance, epidemiology, statistical research, or educational purposes. (c) Drug misuse and abuse In consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State receiving support under this section— (1) shall establish a program to notify practitioners and dispensers of information that will help to identify and prevent the unlawful diversion or misuse of controlled substances; (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for carrying out drug diversion investigations if the State determines that information in the PDMP maintained by the State indicates an unlawful diversion or abuse of a controlled substance; (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State agencies with aggregate reports based on such analyses in as close to real-time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse, addiction, overdose, and other aggregate information, as appropriate and in compliance with applicable Federal and State laws and provided that such reports shall not include protected health information; and (4) may access information about prescriptions, such as claims data, to ensure that such prescribing and dispensing history is updated in as close to real-time as practicable, in compliance with applicable Federal and State laws and provided that such information shall not include protected health information. (d) Evaluation and reporting As a condition on receipt of support under this section, the State shall report on interoperability with PDMPs of other States and Federal agencies, where appropriate, intrastate interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient. (e) Evaluation and reporting A State receiving support under this section shall provide the Secretary with aggregate nonidentifiable information, as permitted by State law, to enable the Secretary— (1) to evaluate the success of the State’s program in achieving the purpose described in subsection (a); or (2) to prepare and submit to the Congress the report required by subsection (i)(2). (f) Education and access to the monitoring system A State receiving support under this section shall take steps to— (1) facilitate prescribers and dispensers, and their delegates, as permitted by State law, to use the PDMP, to the extent practicable; and (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs. (g) Electronic format The Secretary may issue guidelines specifying a uniform electronic format for the reporting, sharing, and disclosure of information pursuant to PDMPs. To the extent possible, such guidelines shall be consistent with standards recognized by the Office of the National Coordinator for Health Information Technology. (h) Rules of construction (1) Functions otherwise authorized by law Nothing in this section shall be construed to restrict the ability of any authority, including any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, to perform functions otherwise authorized by law. (2) Additional privacy protections Nothing in this section shall be construed as preempting any State from imposing any additional privacy protections. (3) Federal privacy requirements Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( Public Law 104–191 ; 110 Stat. 2033) and section 543 of this Act. (4) No Federal private cause of action Nothing in this section shall be construed to create a Federal private cause of action. (i) Progress report Not later than 3 years after the date of enactment of this section, the Secretary shall— (1) complete a study that— (A) determines the progress of grantees in establishing and implementing PDMPs consistent with this section; (B) provides an analysis of the extent to which the operation of PDMPs has— (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances; (ii) established or strengthened initiatives to ensure linkages to substance use disorder treatment services; or (iii) affected patient access to appropriate care in States operating PDMPs; (C) determine the progress of grantees in achieving interstate interoperability and intrastate interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress and recommendations for addressing these barriers; (D) determines the progress of grantees in implementing near real-time electronic PDMPs; (E) provides an analysis of the privacy protections in place for the information reported to the PDMP in each State or locality receiving support under this section and any recommendations of the Secretary for additional Federal or State requirements for protection of this information; (F) determines the progress of States or localities in implementing technological alternatives to centralized data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such alternatives to enhance the privacy and security of individually identifiable data; and (G) evaluates the penalties that States or localities have enacted for the unauthorized use and disclosure of information maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify as appropriate for purposes of subsection (a)(2); and (2) submit a report to the Congress on the results of the study. (j) Advisory council (1) Establishment A State or locality may establish an advisory council to assist in the establishment, improvement, or maintenance of a PDMP consistent with this section. (2) Limitation A State or locality may not use Federal funds for the operations of an advisory council to assist in the establishment, improvement, or maintenance of a PDMP. (3) Sense of Congress It is the sense of the Congress that, in establishing an advisory council to assist in the establishment, improvement, or maintenance of a PDMP, a State or locality should consult with appropriate professional boards and other interested parties. (k) Definitions For purposes of this section: (1) The term controlled substance means a controlled substance (as defined in section 102 of the Controlled Substances Act) in schedule II, III, or IV of section 202 of such Act. (2) The term dispense means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, irrespective of whether the dispenser uses the Internet or other means to effect such delivery. (3) The term dispenser means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user. (4) The term interstate interoperability with respect to a PDMP means the ability of the PDMP to electronically share reported information with another State if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing of a controlled substance prescribed by a practitioner whose principal place of business is located in such other State. (5) The term intrastate interoperability with respect to a PDMP means the integration of PDMP data within electronic health records and health information technology infrastructure or linking of a PDMP to other data systems within the State, including the State’s Medicaid program, workers’ compensation programs, and medical examiners or coroners. (6) The term nonidentifiable information means information that does not identify a practitioner, dispenser, or an ultimate user and with respect to which there is no reasonable basis to believe that the information can be used to identify a practitioner, dispenser, or an ultimate user. (7) The term PDMP means a prescription drug monitoring program that is State-controlled. (8) The term practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the individual practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. (9) The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States. (10) The term ultimate user means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the person’s household, or for the use of an animal owned by the person or by a member of the person’s household. (11) The term clinical workflow means the integration of automated queries for prescription drug monitoring programs data and analytics into health information technologies such as electronic health record systems, health information exchanges, and/or pharmacy dispensing software systems, thus streamlining provider access through automated queries. . R Review of substance use disorder treatment providers receiving Federal funding 7171. Review of substance use disorder treatment providers receiving Federal funding (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall conduct a review of entities that receive Federal funding for the provision of substance use disorder treatment services. The review shall include: (1) The length of time the entity has provided substance use disorder treatment services and the geographic area served by the entity. (2) A detailed analysis of the patient population served by the entity, including but not limited to the number of patients, types of diagnosed substance use disorders and the demographic information of such patients, including sex, race, ethnicity, and socioeconomic status. (3) Detailed information on the types of substance use disorders for which the entity has the experience, capability, and capacity to provide such services. (4) An analysis of how the entity handles patients requiring treatment for a substance use disorder that the organization is not able to treat. (5) An analysis of what is needed in order to improve the entity’s ability to meet the addiction treatment needs of the communities served by that entity. (6) Based on the identified needs of the communities served, a description of unmet needs and inadequate services and how such needs and services could be better addressed to treat individuals with methamphetamine, cocaine, including crack cocaine, heroin, opioid, and other substance use disorders. (b) Report Not later than 2 years after the date of the enactment of this Act, the Secretary shall develop and submit to Congress a plan to direct appropriate resources to entities that provide substance use disorder treatment services in order to address inadequacies in services or funding identified through the survey described in subsection (a). S Other health provisions 7181. State response to the opioid abuse crisis (a) In general Section 1003 of the 21st Century Cures Act ( Public Law 114–255 ) is amended— (1) in subsection (a)— (A) by striking the authorization of appropriations under subsection (b) to carry out the grant program described in subsection (c) and inserting subsection (h) to carry out the grant program described in subsection (b) ; and (B) by inserting and Indian Tribes after States ; (2) by striking subsection (b); (3) by redesignating subsections (c) through (e) as subsections (b) through (d), respectively; (4) by redesignating subsection (f) as subsection (j); (5) in subsection (b), as so redesignated— (A) in paragraph (1)— (i) in the paragraph heading, by inserting and tribal after State ; (ii) by striking States for the purpose of addressing the opioid abuse crisis within such States and inserting States and Indian Tribes for the purpose of addressing the opioid abuse crisis within such States and Indian Tribes ; (iii) by inserting or Indian Tribes after preference to States ; and (iv) by inserting before the period of the second sentence or other Indian Tribes, as applicable ; and (B) in paragraph (2)— (i) in the matter preceding subparagraph (A), by striking to a State ; (ii) in subparagraph (A), by striking Improving State and inserting Establishing or improving ; (iii) in subparagraph (C), by inserting preventing diversion of controlled substances, after treatment programs, ; and (iv) in subparagraph (E), by striking as the State determines appropriate, related to addressing the opioid abuse crisis within the State and inserting as the State or Indian Tribe determines appropriate, related to addressing the opioid abuse crisis within the State or Indian Tribe, including directing resources in accordance with local needs related to substance use disorders ; (6) in subsection (c), as so redesignated, by striking subsection (c) and inserting subsection (b) ; (7) in subsection (d), as so redesignated— (A) in the matter preceding paragraph (1), by striking the authorization of appropriations under subsection (b) and inserting subsection (h) ; and (B) in paragraph (1), by striking subsection (c) and inserting subsection (b) ; and (8) by inserting after subsection (d), as so redesignated, the following: (e) Indian Tribes (1) Definition For purposes of this section, the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (2) Appropriate mechanisms The Secretary, in consultation with Indian Tribes, shall identify and establish appropriate mechanisms for Tribes to demonstrate or report the information as required under subsections (b), (c), and (d). (f) Report to Congress Not later than 1 year after the date on which amounts are first awarded after the date of enactment of this subsection, pursuant to subsection (b), and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing the information provided to the Secretary in reports made pursuant to subsection (c), including the purposes for which grant funds are awarded under this section and the activities of such grant recipients. (g) Technical Assistance The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, shall provide State agencies and Indian Tribes, as applicable, with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing the opioid crisis. (h) Authorization of appropriations For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $500,000,000 for each of fiscal years 2019 through 2021, to remain available until expended. (i) Set aside Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, 5 percent of such amount for such fiscal year shall be made available to Indian Tribes, and up to 15 percent of such amount for such fiscal year may be set aside for States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention. . (b) Conforming amendment Section 1004(c) of the 21st Century Cures Act ( Public Law 114–255 ) is amended by striking , the FDA Innovation Account, or the Account For the State Response to the Opioid Abuse Crisis and inserting or the FDA Innovation Account . 7182. Report on investigations regarding parity in mental health and substance use disorder benefits (a) In general Section 13003 of the 21st Century Cures Act ( Public Law 114–255 ) is amended— (1) in subsection (a)— (A) by striking with findings of any serious violation regarding and inserting concerning ; and (B) by inserting and the Committee on Education and the Workforce after Energy and Commerce ; and (2) in subsection (b)(1)— (A) by inserting complaints received and number of before closed ; and (B) by inserting before the period , and, for each such investigation closed, which agency conducted the investigation, whether the health plan that is the subject of the investigation is fully insured or not fully insured and a summary of any coordination between the applicable State regulators and the Department of Labor, the Department of Health and Human Services, or the Department of the Treasury, and references to any guidance provided by the agencies addressing the category of violation committed . (b) Applicability The amendments made by subsection (a) shall apply with respect to the second annual report required under such section 13003 and each such annual report thereafter. 7183. CAREER Act (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), in consultation with the Secretary of Labor, shall continue or establish a program to support individuals in substance use disorder treatment and recovery to live independently and participate in the workforce. (b) Grants authorized In carrying out the activities under this section, the Secretary shall, on a competitive basis, award grants for a period of not more than 5 years to entities to enable such entities to carry out evidence-based programs to help individuals in substance use disorder treatment and recovery to live independently and participate in the workforce. Such entities shall coordinate, as applicable, with Indian tribes or tribal organizations (as applicable), State boards and local boards (as defined in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ), lead State agencies with responsibility for a workforce investment activity (as defined in such section 3), and State agencies responsible for carrying out substance use disorder prevention and treatment programs. (c) Priority (1) In general In awarding grants under this section, the Secretary shall give priority based on the State in which the entity is located. Priority shall be given among States according to a formula based on the rates described in paragraph (2) and weighted as described in paragraph (3). (2) Rates The rates described in this paragraph are the following: (A) The amount by which the rate of drug overdose deaths in the State, adjusted for age, is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention. (B) The amount by which the rate of unemployment for the State, based on data provided by the Bureau of Labor Statistics for the preceding 5 calendar years for which there is available data, is above the national average. (C) The amount by which rate of labor force participation in the State, based on data provided by the Bureau of Labor Statistics for the preceding 5 calendar years for which there is available data, is below the national average. (3) Weighting The rates described in paragraph (2) shall be weighted as follows: (A) The rate described in paragraph (2)(A) shall be weighted 70 percent. (B) The rate described in paragraph (2)(B) shall be weighted 15 percent. (C) The rate described in paragraph (2)(C) shall be weighted 15 percent. (d) Preference In awarding grants under this section, the Secretary shall give preference to entities located in areas within States with the greatest need, with such need based on the highest mortality rate related to substance use disorder. (e) Definitions In this section: (1) Eligible entity The term eligible entity means an entity that offers treatment or recovery services for individuals with substance use disorders, and partners with one or more local or State stakeholders, which may include local employers, community organizations, the local workforce development board, local and State governments, and Indian Tribes or tribal organizations, to support recovery, independent living, and participation in the workforce. (2) Indian Tribes; tribal organization The terms Indian Tribe and tribal organization have the meanings given the terms Indian tribe and tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (3) State The term State includes only the several States and the District of Columbia. (f) Applications An eligible entity shall submit an application at such time and in such manner as the Secretary may require. In submitting an application, the entity shall demonstrate the ability to partner with local stakeholders, which may include local employers, community stakeholders, the local workforce development board, local and State governments, and Indian Tribes or tribal organizations, as applicable, to— (1) identify gaps in the workforce due to the prevalence of substance use disorders; (2) in coordination with statewide employment and training activities, including coordination and alignment of activities carried out by entities provided grant funds under section 8041, help individuals in recovery from a substance use disorder transition into the workforce, including by providing career services, training services as described in paragraph (2) of section 134(c) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3174(c) ), and related services described in section 134(a)(3) of such Act ( 42 U.S.C. 3174(a) ); and (3) assist employers with informing their employees of the resources, such as resources related to substance use disorders that are available to their employees. (g) Use of funds An entity receiving a grant under this section shall use the funds to conduct one or more of the following activities: (1) Hire case managers, care coordinators, providers of peer recovery support services, as described in section 547(a) of the Public Health Service Act ( 42 U.S.C. 290ee–2(a) ), or other professionals, as appropriate, to provide services that support treatment, recovery, and rehabilitation, and prevent relapse, recidivism, and overdose, including by encouraging— (A) the development and strengthening of daily living skills; and (B) the use of counseling, care coordination, and other services, as appropriate, to support recovery from substance use disorders. (2) Implement or utilize innovative technologies, which may include the use of telemedicine. (3) In coordination with the lead State agency with responsibility for a workforce investment activity or local board described in subsection (b), provide— (A) short-term prevocational training services; and (B) training services that are directly linked to the employment opportunities in the local area or the planning region. (h) Support for State strategy An eligible entity shall include in its application under subsection (f) information describing how the services and activities proposed in such application are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing issues described in such application and how such entity will coordinate with existing systems to deliver services as described in such application. (i) Data reporting and program oversight Each eligible entity awarded a grant under this section shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include a description of— (1) the programs and activities funded by the grant; (2) outcomes of the population of individuals with a substance use disorder the grantee served through activities described in subsection (g); and (3) any other information that the Secretary may require for the purpose of ensuring that the grantee is complying with all of the requirements of the grant. (j) Reports to Congress (1) Preliminary report Not later than 2 years after the end of the first year of the grant period under this section, the Secretary shall submit to Congress a preliminary report that analyzes reports submitted under subsection (i). (2) Final report Not later than 2 years after submitting the preliminary report required under paragraph (1), the Secretary shall submit to Congress a final report that includes— (A) a description of how the grant funding was used, including the number of individuals who received services under subsection (g)(3) and an evaluation of the effectiveness of the activities conducted by the grantee with respect to outcomes of the population of individuals with substance use disorder who receive services from the grantee; and (B) recommendations related to best practices for health care professionals to support individuals in substance use disorder treatment or recovery to live independently and participate in the workforce. (k) Authorization of appropriations There is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. VIII Miscellaneous A Synthetics Trafficking and Overdose Prevention 8001. Short title This subtitle may be cited as the Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 . 8002. Customs fees (a) In general Section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(b)(9) ) is amended by adding at the end the following: (D) (i) With respect to the processing of items that are sent to the United States through the international postal network by Inbound Express Mail service or Inbound EMS (as that service is described in the mail classification schedule referred to in section 3631 of title 39, United States Code), the following payments are required: (I) $1 per Inbound EMS item. (II) If an Inbound EMS item is formally entered, the fee provided for under subsection (a)(9), if applicable. (ii) Notwithstanding section 451 of the Tariff Act of 1930 ( 19 U.S.C. 1451 ), the payments required by clause (i), as allocated pursuant to clause (iii)(I), shall be the only payments required for reimbursement of U.S. Customs and Border Protection for customs services provided in connection with the processing of an Inbound EMS item. (iii) (I) The payments required by clause (i)(I) shall be allocated as follows: (aa) 50 percent of the amount of the payments shall be paid on a quarterly basis by the United States Postal Service to the Commissioner of U.S. Customs and Border Protection in accordance with regulations prescribed by the Secretary of the Treasury to reimburse U.S. Customs and Border Protection for customs services provided in connection with the processing of Inbound EMS items. (bb) 50 percent of the amount of the payments shall be retained by the Postal Service to reimburse the Postal Service for services provided in connection with the customs processing of Inbound EMS items. (II) Payments received by U.S. Customs and Border Protection under subclause (I)(aa) shall, in accordance with section 524 of the Tariff Act of 1930 ( 19 U.S.C. 1524 ), be deposited in the Customs User Fee Account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities. Amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services. (III) Payments retained by the Postal Service under subclause (I)(bb) shall be used to directly reimburse the Postal Service for the costs incurred in providing services in connection with the customs processing of Inbound EMS items. (iv) Beginning in fiscal year 2021, the Secretary, in consultation with the Postmaster General, may adjust, not more frequently than once each fiscal year, the amount described in clause (i)(I) to an amount commensurate with the costs of services provided in connection with the customs processing of Inbound EMS items, consistent with the obligations of the United States under international agreements. . (b) Conforming amendments Section 13031(a) of the Consolidated Omnibus Budget Reconciliation Act of 1985 ( 19 U.S.C. 58c(a) ) is amended— (1) in paragraph (6), by inserting (other than an item subject to a fee under subsection (b)(9)(D)) after customs officer ; and (2) in paragraph (10)— (A) in subparagraph (C), in the matter preceding clause (i), by inserting (other than Inbound EMS items described in subsection (b)(9)(D)) after release ; and (B) in the flush at the end, by inserting or of Inbound EMS items described in subsection (b)(9)(D), after (C), . (c) Effective date The amendments made by this section shall take effect on January 1, 2020. 8003. Mandatory advance electronic information for postal shipments (a) Mandatory advance electronic information (1) In general Section 343(a)(3)(K) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended to read as follows: (K) (i) The Secretary shall prescribe regulations requiring the United States Postal Service to transmit the information described in paragraphs (1) and (2) to the Commissioner of U.S. Customs and Border Protection for international mail shipments by the Postal Service (including shipments to the Postal Service from foreign postal operators that are transported by private carrier) consistent with the requirements of this subparagraph. (ii) In prescribing regulations under clause (i), the Secretary shall impose requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo, taking into account the parameters set forth in subparagraphs (A) through (J). (iii) The regulations prescribed under clause (i) shall require the transmission of the information described in paragraphs (1) and (2) with respect to a shipment as soon as practicable in relation to the transportation of the shipment, consistent with subparagraph (H). (iv) Regulations prescribed under clause (i) shall allow for the requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) to be implemented in phases, as appropriate, by— (I) setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the Commissioner; and (II) taking into consideration— (aa) the risk posed by such shipments; (bb) the volume of mail shipped to the United States by or through a particular country; and (cc) the capacities of foreign postal operators to provide that information to the Postal Service. (v) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2018, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for not less than 70 percent of the aggregate number of mail shipments, including 100 percent of mail shipments from the People’s Republic of China, described in clause (i). (II) If the requirements of subclause (I) are not met, the Comptroller General of the United States shall submit to the appropriate congressional committees, not later than June 30, 2019, a report— (aa) assessing the reasons for the failure to meet those requirements; and (bb) identifying recommendations to improve the collection by the Postal Service of the information described in paragraphs (1) and (2). (vi)(I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2020, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for 100 percent of the aggregate number of mail shipments described in clause (i). (II) The Commissioner, in consultation with the Postmaster General, may determine to exclude a country from the requirement described in subclause (I) to transmit information for mail shipments described in clause (i) from the country if the Commissioner determines that the country— (aa) does not have the capacity to collect and transmit such information; (bb) represents a low risk for mail shipments that violate relevant United States laws and regulations; and (cc) accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant United States laws and regulations through an alternate means. (III) The Commissioner shall, at a minimum on an annual basis, re-evaluate any determination made under subclause (II) to exclude a country from the requirement described in subclause (I). If, at any time, the Commissioner determines that a country no longer meets the requirements under subclause (II), the Commissioner may not further exclude the country from the requirement described in subclause (I). (IV) The Commissioner shall, on an annual basis, submit to the appropriate congressional committees— (aa) a list of countries with respect to which the Commissioner has made a determination under subclause (II) to exclude the countries from the requirement described in subclause (I); and (bb) information used to support such determination with respect to such countries. (vii) (I) The Postmaster General shall, in consultation with the Commissioner, refuse any shipments received after December 31, 2020, for which the information described in paragraphs (1) and (2) is not transmitted as required under this subparagraph, except as provided in subclause (II). (II) If remedial action is warranted in lieu of refusal of shipments pursuant to subclause (I), the Postmaster General and the Commissioner shall take remedial action with respect to the shipments, including destruction, seizure, controlled delivery or other law enforcement initiatives, or correction of the failure to provide the information described in paragraphs (1) and (2) with respect to the shipments. (viii) Nothing in this subparagraph shall be construed to limit the authority of the Secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties. (ix) In this subparagraph, the term appropriate congressional committees means— (I) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (II) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. . (2) Joint strategic plan on mandatory advance information Not later than 60 days after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving— (A) the transmission of information as required by section 343(a)(3)(K) of the Trade Act of 2002, as amended by paragraph (1); and (B) the presentation by the Postal Service to U.S. Customs and Border Protection of all mail targeted by U.S. Customs and Border Protection for inspection. (b) Capacity building (1) In general Section 343(a) of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended by adding at the end the following: (5) Capacity building (A) In general The Secretary, with the concurrence of the Secretary of State, and in coordination with the Postmaster General and the heads of other Federal agencies, as appropriate, may provide technical assistance, equipment, technology, and training to enhance the capacity of foreign postal operators— (i) to gather and provide the information required by paragraph (3)(K); and (ii) to otherwise gather and provide postal shipment information related to— (I) terrorism; (II) items the importation or introduction of which into the United States is prohibited or restricted, including controlled substances; and (III) such other concerns as the Secretary determines appropriate. (B) Provision of equipment and technology With respect to the provision of equipment and technology under subparagraph (A), the Secretary may lease, loan, provide, or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the Secretary may prescribe, including nonreimbursable loans or the transfer of ownership of equipment and technology. . (2) Joint strategic plan on capacity building Not later than 1 year after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly develop and submit to the appropriate congressional committees a joint strategic plan— (A) detailing the extent to which U.S. Customs and Border Protection and the United States Postal Service are engaged in capacity building efforts under section 343(a)(5) of the Trade Act of 2002, as added by paragraph (1); (B) describing plans for future capacity building efforts; and (C) assessing how capacity building has increased the ability of U.S. Customs and Border Protection and the Postal Service to advance the goals of this subtitle and the amendments made by this subtitle. (c) Report and consultations by Secretary of Homeland Security and Postmaster General (1) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 3 years after the Postmaster General has met the requirement under clause (vi) of subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following: (A) An assessment of the status of the regulations required to be promulgated under that subparagraph. (B) An update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph. (C) A summary of deliberations between the United States Postal Service and foreign postal operators with respect to issues relating to the transmission of that information. (D) A summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph. (E) An assessment of the quality of that information being received by foreign postal operators, as determined by the Secretary of Homeland Security, and actions taken to improve the quality of that information. (F) A summary of policies established by the Universal Postal Union that may affect the ability of the Postmaster General to obtain the transmission of that information. (G) A summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology. (H) Such other information as the Secretary of Homeland Security and the Postmaster General consider appropriate with respect to obtaining the transmission of information required by that subparagraph. (2) Consultations Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the Postmaster General has met the requirement under clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as amended by subsection (a)(1), to arrange for the transmission of information with respect to 100 percent of the aggregate number of mail shipments described in clause (i) of that section, the Secretary of Homeland Security and the Postmaster General shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments. (d) Government Accountability Office report Not later than June 30, 2019, the Comptroller General of the United States shall submit to the appropriate congressional committees a report— (1) assessing the progress of the United States Postal Service in achieving the transmission of the information required by subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), for the percentage of shipments required by that subparagraph; (2) assessing the quality of the information received from foreign postal operators for targeting purposes; (3) assessing the specific percentage of targeted mail presented by the Postal Service to U.S. Customs and Border Protection for inspection; (4) describing the costs of collecting the information required by such subparagraph (K) from foreign postal operators and the costs of implementing the use of that information; (5) assessing the benefits of receiving that information with respect to international mail shipments; (6) assessing the feasibility of assessing a customs fee under section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 8002, on international mail shipments other than Inbound Express Mail service in a manner consistent with the obligations of the United States under international agreements; and (7) identifying recommendations, including recommendations for legislation, to improve the compliance of the Postal Service with such subparagraph (K), including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by— (A) requiring the Postal Service to serve as the consignee for international mail shipments containing goods; or (B) designating a customs broker to act as an importer of record for international mail shipments containing goods. (e) Technical correction Section 343 of the Trade Act of 2002 ( Public Law 107–210 ; 19 U.S.C. 2071 note) is amended in the section heading by striking advanced and inserting advance . (f) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8004. International postal agreements (a) Existing agreements (1) In general In the event that any provision of this subtitle, or any amendment made by this subtitle, is determined to be in violation of obligations of the United States under any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, the Secretary of State should negotiate to amend the relevant provisions of the agreement so that the United States is no longer in violation of the agreement. (2) Rule of construction Nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle. (b) Future agreements (1) Consultations Before entering into, on or after the date of the enactment of this Act, any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, that is related to the ability of the United States to secure the provision of advance electronic information by foreign postal operators, the Secretary of State should consult with the appropriate congressional committees (as defined in section 8003(f)). (2) Expedited negotiation of new agreement To the extent that any new postal treaty, convention, or other international agreement related to international postal services would improve the ability of the United States to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section 343(a)(3)(K) of the Trade Act of 2002, as amended by section 8003(a)(1), the Secretary of State should expeditiously conclude such an agreement. 8005. Cost recoupment (a) In general The United States Postal Service shall, to the extent practicable and otherwise recoverable by law, ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators. (b) Costs not considered revenue The recovery of costs under subsection (a) shall not be deemed revenue for purposes of subchapter I and II of chapter 36 of title 39, United States Code, or regulations prescribed under that chapter. 8006. Development of technology to detect illicit narcotics (a) In general The Postmaster General and the Commissioner of U.S. Customs and Border Protection, in coordination with the heads of other agencies as appropriate, shall collaborate to identify and develop technology for the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States by mail. (b) Outreach to private sector The Postmaster General and the Commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States. 8007. Civil penalties for postal shipments Section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ) is amended by adding at the end the following new subsection: (e) Civil penalties for postal shipments (1) Civil penalty A civil penalty shall be imposed against the United States Postal Service if the Postal Service accepts a shipment in violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (2) Modification of civil penalty (A) In general U.S. Customs and Border Protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph (1) if U.S. Customs and Border Protection determines that the United States Postal Service— (i) has a low error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002; (ii) is cooperating with U.S. Customs and Border Protection with respect to the violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or (iii) has taken remedial action to prevent future violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (B) Written notification U.S. Customs and Border Protection shall issue a written notification to the Postal Service with respect to each exercise of the authority of subparagraph (A) to reduce or dismiss a civil penalty imposed pursuant to paragraph (1). (3) Ongoing lack of compliance If U.S. Customs and Border Protection determines that the United States Postal Service— (A) has repeatedly committed violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, (B) has failed to cooperate with U.S. Customs and Border Protection with respect to violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and (C) has an increasing error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002, civil penalties may be imposed against the United States Postal Service until corrective action, satisfactory to U.S. Customs and Border Protection, is taken. . 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest (a) In general The Commissioner of U.S. Customs and Border Protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection (b) with respect to each violation of section 436 of the Tariff Act of 1930 ( 19 U.S.C. 1436 ), as amended by section 8007, and section 584 of such Act ( 19 U.S.C. 1584 ) that occurred during the previous year. (b) Information described The information described in this subsection is the following: (1) The name and address of the violator. (2) The specific violation that was committed. (3) The location or port of entry through which the items were transported. (4) An inventory of the items seized, including a description of the items and the quantity seized. (5) The location from which the items originated. (6) The entity responsible for the apprehension or seizure, organized by location or port of entry. (7) The amount of penalties assessed by U.S. Customs and Border Protection, organized by name of the violator and location or port of entry. (8) The amount of penalties that U.S. Customs and Border Protection could have levied, organized by name of the violator and location or port of entry. (9) The rationale for negotiating lower penalties, organized by name of the violator and location or port of entry. (c) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 8009. Effective date; regulations (a) Effective date This subtitle and the amendments made by this subtitle (other than the amendments made by section 8002) shall take effect on the date of the enactment of this Act. (b) Regulations Not later than 1 year after the date of the enactment of this Act, such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed. B Opioid Addiction Recovery Fraud Prevention 8021. Short title This subtitle may be cited as the Opioid Addiction Recovery Fraud Prevention Act of 2018 . 8022. Definitions For purposes of this subtitle only, and not be construed or applied as to challenge or affect the characterization, definition, or treatment under any other statute, regulation, or rule: (1) Substance use disorder treatment product The term substance use disorder treatment product means a product for use or marketed for use in the treatment, cure, or prevention of a substance use disorder, including an opioid use disorder. (2) Substance use disorder treatment service The term substance use disorder treatment service means a service that purports to provide referrals to treatment, treatment, or recovery housing for people diagnosed with, having, or purporting to have a substance use disorder, including an opioid use disorder. 8023. Unfair or deceptive acts or practices with respect to substance use disorder treatment service and products (a) Unlawful activity It is unlawful to engage in an unfair or deceptive act or practice with respect to any substance use disorder treatment service or substance use disorder treatment product. (b) Enforcement by the Federal Trade Commission (1) Unfair or deceptive acts or practices A violation of subsection (a) shall be treated as a violation of a rule under section 18 of the Federal Trade Commission Act ( 15 U.S.C. 57a ) regarding unfair or deceptive acts or practices. (2) Powers of the Federal Trade Commission (A) In general The Federal Trade Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act ( 15 U.S.C. 41 et seq.) were incorporated into and made a part of this section. (B) Privileges and immunities Any person who violates subsection (a) shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act as though all applicable terms and provisions of the Federal Trade Commission Act ( 15 U.S.C. 41 et seq.) were incorporated and made part of this section. (c) Authority preserved Nothing in this subtitle shall be construed to limit the authority of the Federal Trade Commission or the Food and Drug Administration under any other provision of law. C Addressing economic and workforce impacts of the opioid crisis 8041. Addressing economic and workforce impacts of the opioid crisis (a) Definitions Except as otherwise expressly provided, in this section: (1) WIOA definitions The terms core program , individual with a barrier to employment , local area , local board , one-stop operator , outlying area , State , State board , and supportive services have the meanings given the terms in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ). (2) Education provider The term education provider means— (A) an institution of higher education, as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ); or (B) a postsecondary vocational institution, as defined in section 102(c) of such Act ( 20 U.S.C. 1002(c) ). (3) Eligible entity The term eligible entity means— (A) a State workforce agency; (B) an outlying area; or (C) a Tribal entity. (4) Participating partnership The term participating partnership means a partnership— (A) evidenced by a written contract or agreement; and (B) including, as members of the partnership, a local board receiving a subgrant under subsection (d) and 1 or more of the following: (i) The eligible entity. (ii) A treatment provider. (iii) An employer or industry organization. (iv) An education provider. (v) A legal service or law enforcement organization. (vi) A faith-based or community-based organization. (vii) Other State or local agencies, including counties or local governments. (viii) Other organizations, as determined to be necessary by the local board. (ix) Indian Tribes or tribal organizations. (5) Program participant The term program participant means an individual who— (A) is a member of a population of workers described in subsection (e)(2) that is served by a participating partnership through the pilot program under this section; and (B) enrolls with the applicable participating partnership to receive any of the services described in subsection (e)(3). (6) Provider of peer recovery support services The term provider of peer recovery support services means a provider that delivers peer recovery support services through an organization described in section 547(a) of the Public Health Service Act ( 42 U.S.C. 290ee–2(a) ). (7) Secretary The term Secretary means the Secretary of Labor. (8) State workforce agency The term State workforce agency means the lead State agency with responsibility for the administration of a program under chapter 2 or 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3161 et seq., 3171 et seq.). (9) Substance use disorder The term substance use disorder has the meaning given such term by the Assistant Secretary for Mental Health and Substance Use. (10) Treatment provider The term treatment provider — (A) means a health care provider that— (i) offers services for treating substance use disorders and is licensed in accordance with applicable State law to provide such services; and (ii) accepts health insurance for such services, including coverage under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.); and (B) may include— (i) a nonprofit provider of peer recovery support services; (ii) a community health care provider; (iii) a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act ( 42 U.S.C. 1395x )); (iv) an Indian health program (as defined in section 3 of the Indian Health Care Improvement Act ( 25 U.S.C. 1603 )), including an Indian health program that serves an urban center (as defined in such section); and (v) a Native Hawaiian health center (as defined in section 12 of the Native Hawaiian Health Care Improvement Act ( 42 U.S.C. 11711 )). (11) Tribal entity The term Tribal entity includes any Indian Tribe, tribal organization, Indian-controlled organization serving Indians, Native Hawaiian organization, or Alaska Native entity, as such terms are defined or used in section 166 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3221 ). (b) Pilot program and grants authorized (1) In general The Secretary, in consultation with the Secretary of Health and Human Services, shall carry out a pilot program to address economic and workforce impacts associated with a high rate of a substance use disorder. In carrying out the pilot program, the Secretary shall make grants, on a competitive basis, to eligible entities to enable such entities to make subgrants to local boards to address the economic and workforce impacts associated with a high rate of a substance use disorder. (2) Grant amounts The Secretary shall make each such grant in an amount that is not less than $500,000, and not more than $5,000,000, for a fiscal year. (c) Grant applications (1) In general An eligible entity applying for a grant under this section shall submit an application to the Secretary at such time and in such form and manner as the Secretary may reasonably require, including the information described in this subsection. (2) Significant impact on community by opioid and substance use disorder-related problems (A) Demonstration An eligible entity shall include in the application— (i) information that demonstrates significant impact on the community by problems related to opioid abuse or another substance use disorder, by— (I) identifying the counties, communities, regions, or local areas that have been significantly impacted and will be served through the grant (each referred to in this section as a service area ); and (II) demonstrating for each such service area, an increase equal to or greater than the national increase in such problems, between— (aa) 1999; and (bb) 2016 or the latest year for which data are available; and (ii) a description of how the eligible entity will prioritize support for significantly impacted service areas described in clause (i)(I). (B) Information To meet the requirements described in subparagraph (A)(i)(II), the eligible entity may use information including data on— (i) the incidence or prevalence of opioid abuse and other substance use disorders; (ii) the age-adjusted rate of drug overdose deaths, as determined by the Director of the Centers for Disease Control and Prevention; (iii) the rate of non-fatal hospitalizations related to opioid abuse or other substance use disorders; (iv) the number of arrests or convictions, or a relevant law enforcement statistic, that reasonably shows an increase in opioid abuse or another substance use disorder; or (v) in the case of an eligible entity described in subsection (a)(3)(C), other alternative relevant data as determined appropriate by the Secretary. (C) Support for state strategy The eligible entity may include in the application information describing how the proposed services and activities are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing problems described in subparagraph (A) in specific service areas or across the State, outlying area, or Tribal land. (3) Economic and employment conditions demonstrate additional Federal support needed (A) Demonstration An eligible entity shall include in the application information that demonstrates that a high rate of a substance use disorder has caused, or is coincident to— (i) an economic or employment downturn in the service area; or (ii) persistent economically depressed conditions in such service area. (B) Information To meet the requirements of subparagraph (A), an eligible entity may use information including— (i) documentation of any layoff, announced future layoff, legacy industry decline, decrease in an employment or labor market participation rate, or economic impact, whether or not the result described in this clause is overtly related to a high rate of a substance use disorder; (ii) documentation showing decreased economic activity related to, caused by, or contributing to a high rate of a substance use disorder, including a description of how the service area has been impacted, or will be impacted, by such a decrease; (iii) information on economic indicators, labor market analyses, information from public announcements, and demographic and industry data; (iv) information on rapid response activities (as defined in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 )) that have been or will be conducted, including demographic data gathered by employer or worker surveys or through other methods; (v) data or documentation, beyond anecdotal evidence, showing that employers face challenges filling job vacancies due to a lack of skilled workers able to pass a drug test; or (vi) any additional relevant data or information on the economy, workforce, or another aspect of the service area to support the application. (d) Subgrant authorization and application process (1) Subgrants authorized (A) In general An eligible entity receiving a grant under subsection (b)— (i) may use not more than 5 percent of the grant funds for the administrative costs of carrying out the grant; (ii) in the case of an eligible entity described in subparagraph (A) or (B) of subsection (a)(3), shall use the remaining grant funds to make subgrants to local entities in the service area to carry out the services and activities described in subsection (e); and (iii) in the case of an eligible entity described in subsection (a)(3)(C), shall use the remaining grant funds to carry out the services and activities described in subsection (e). (B) Equitable distribution In making subgrants under this subsection, an eligible entity shall ensure, to the extent practicable, the equitable distribution of subgrants, based on— (i) geography (such as urban and rural distribution); and (ii) significantly impacted service areas as described in subsection (c)(2). (C) Timing of subgrant funds distribution An eligible entity making subgrants under this subsection shall disburse subgrant funds to a local board receiving a subgrant from the eligible entity by the later of— (i) the date that is 90 days after the date on which the Secretary makes the funds available to the eligible entity; or (ii) the date that is 15 days after the date that the eligible entity makes the subgrant under subparagraph (A)(ii). (2) Subgrant application (A) In general A local board desiring to receive a subgrant under this subsection from an eligible entity shall submit an application at such time and in such manner as the eligible entity may reasonably require, including the information described in this paragraph. (B) Contents Each application described in subparagraph (A) shall include— (i) an analysis of the estimated performance of the local board in carrying out the proposed services and activities under the subgrant— (I) based on— (aa) primary indicators of performance described in section 116(c)(1)(A)(i) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3141(c)(1)(A)(i) , to assess estimated effectiveness of the proposed services and activities, including the estimated number of individuals with a substance use disorder who may be served by the proposed services and activities; (bb) the record of the local board in serving individuals with a barrier to employment; and (cc) the ability of the local board to establish a participating partnership; and (II) which may include or utilize— (aa) data from the National Center for Health Statistics of the Centers for Disease Control and Prevention; (bb) data from the Center for Behavioral Health Statistics and Quality of the Substance Abuse and Mental Health Services Administration; (cc) State vital statistics; (dd) municipal police department records; (ee) reports from local coroners; or (ff) other relevant data; and (ii) in the case of a local board proposing to serve a population described in subsection (e)(2)(B), a demonstration of the workforce shortage in the professional area to be addressed under the subgrant (which may include substance use disorder treatment and related services, non-addictive pain therapy and pain management services, mental health care treatment services, emergency response services, or mental health care), which shall include information that can demonstrate such a shortage, such as— (I) the distance between— (aa) communities affected by opioid abuse or another substance use disorder; and (bb) facilities or professionals offering services in the professional area; or (II) the maximum capacity of facilities or professionals to serve individuals in an affected community, or increases in arrests related to opioid or another substance use disorder, overdose deaths, or nonfatal overdose emergencies in the community. (e) Subgrant services and activities (1) In general Each local board that receives a subgrant under subsection (d) shall carry out the services and activities described in this subsection through a participating partnership. (2) Selection of Population to be served A participating partnership shall elect to provide services and activities under the subgrant to one or both of the following populations of workers: (A) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), each of whom— (i) is directly or indirectly affected by a high rate of a substance use disorder; and (ii) voluntarily confirms that the worker, or a friend or family member of the worker, has a history of opioid abuse or another substance use disorder. (B) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), who— (i) seek to transition to professions that support individuals with a substance use disorder or at risk for developing such disorder, such as professions that provide— (I) substance use disorder treatment and related services; (II) services offered through providers of peer recovery support services; (III) non-addictive pain therapy and pain management services; (IV) emergency response services; or (V) mental health care; and (ii) need new or upgraded skills to better serve such a population of struggling or at-risk individuals. (3) Services and activities Each participating partnership shall use funds available through a subgrant under this subsection to carry out 1 or more of the following: (A) Engaging employers Engaging with employers to— (i) learn about the skill and hiring requirements of employers; (ii) learn about the support needed by employers to hire and retain program participants, and other individuals with a substance use disorder, and the support needed by such employers to obtain their commitment to testing creative solutions to employing program participants and such individuals; (iii) connect employers and workers to on-the-job or customized training programs before or after layoff to help facilitate reemployment; (iv) connect employers with an education provider to develop classroom instruction to complement on-the-job learning for program participants and such individuals; (v) help employers develop the curriculum design of a work-based learning program for program participants and such individuals; (vi) help employers employ program participants or such individuals engaging in a work-based learning program for a transitional period before hiring such a program participant or individual for full-time employment of not less than 30 hours a week; or (vii) connect employers to program participants receiving concurrent outpatient treatment and job training services. (B) Screening services Providing screening services, which may include— (i) using an evidence-based screening method to screen each individual seeking participation in the pilot program to determine whether the individual has a substance use disorder; (ii) conducting an assessment of each such individual to determine the services needed for such individual to obtain or retain employment, including an assessment of strengths and general work readiness; or (iii) accepting walk-ins or referrals from employers, labor organizations, or other entities recommending individuals to participate in such program. (C) Individual treatment and employment plan Developing an individual treatment and employment plan for each program participant— (i) in coordination, as appropriate, with other programs serving the participant such as the core programs within the workforce development system under the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3101 et seq.); and (ii) which shall include providing a case manager to work with each participant to develop the plan, which may include— (I) identifying employment and career goals; (II) exploring career pathways that lead to in-demand industries and sectors, as determined by the State board and the head of the State workforce agency or, as applicable, the Tribal entity; (III) setting appropriate achievement objectives to attain the employment and career goals identified under subclause (I); or (IV) developing the appropriate combination of services to enable the participant to achieve the employment and career goals identified under subclause (I). (D) Outpatient treatment and recovery care In the case of a participating partnership serving program participants described in paragraph (2)(A) with a substance use disorder, providing individualized and group outpatient treatment and recovery services for such program participants that are offered during the day and evening, and on weekends. Such treatment and recovery services— (i) shall be based on a model that utilizes combined behavioral interventions and other evidence-based or evidence-informed interventions; and (ii) may include additional services such as— (I) health, mental health, addiction, or other forms of outpatient treatment that may impact a substance use disorder and co-occurring conditions; (II) drug testing for a current substance use disorder prior to enrollment in career or training services or prior to employment; (III) linkages to community services, including services offered by partner organizations designed to support program participants; or (IV) referrals to health care, including referrals to substance use disorder treatment and mental health services. (E) Supportive services Providing supportive services, which shall include services such as— (i) coordinated wraparound services to provide maximum support for program participants to assist the program participants in maintaining employment and recovery for not less than 12 months, as appropriate; (ii) assistance in establishing eligibility for assistance under Federal, State, Tribal, and local programs providing health services, mental health services, vocational services, housing services, transportation services, social services, or services through early childhood education programs (as defined in section 103 of the Higher Education Act of 1965 ( 20 U.S.C. 1003 )); (iii) services offered through providers of peer recovery support services; (iv) networking and mentorship opportunities; or (v) any supportive services determined necessary by the local board. (F) Career and job training services Offering career services and training services, and related services, concurrently or sequentially with the services provided under subparagraphs (B) through (E). Such services shall include the following: (i) Services provided to program participants who are in a pre-employment stage of the program, which may include— (I) initial education and skills assessments; (II) traditional classroom training funded through individual training accounts under chapter 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3171 et seq.); (III) services to promote employability skills such as punctuality, personal maintenance skills, and professional conduct; (IV) in-depth interviewing and evaluation to identify employment barriers and to develop individual employment plans; (V) career planning that includes— (aa) career pathways leading to in-demand, high-wage jobs; and (bb) job coaching, job matching, and job placement services; (VI) provision of payments and fees for employment and training-related applications, tests, and certifications; or (VII) any other appropriate career service or training service described in section 134(c) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3174(c) ). (ii) Services provided to program participants during their first 6 months of employment to ensure job retention, which may include— (I) case management and support services, including a continuation of the services described in clause (i); (II) a continuation of skills training, and career and technical education, described in clause (i) that is conducted in collaboration with the employers of such participants; (III) mentorship services and job retention support for such participants; or (IV) targeted training for managers and workers working with such participants (such as mentors), and human resource representatives in the business in which such participants are employed. (iii) Services to assist program participants in maintaining employment for not less than 12 months, as appropriate. (G) Proven and promising practices Leading efforts in the service area to identify and promote proven and promising strategies and initiatives for meeting the needs of employers and program participants. (4) Limitations A participating partnership may not use— (A) more than 10 percent of the funds received under a subgrant under subsection (d) for the administrative costs of the partnership; (B) more than 10 percent of the funds received under such subgrant for the provision of treatment and recovery services, as described in paragraph (3)(D); and (C) more than 10 percent of the funds received under such subgrant for the provision of supportive services described in paragraph (3)(E) to program participants. (f) Performance accountability (1) Reports The Secretary shall establish quarterly reporting requirements for recipients of grants and subgrants under this section that, to the extent practicable, are based on the performance accountability system under section 116 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3141 ) and, in the case of a grant awarded to an eligible entity described in subsection (a)(3)(C), section 166(h) of such Act ( 29 U.S.C. 3221(h) ), including the indicators described in subsection (c)(1)(A)(i) of such section 116 and the requirements for local area performance reports under subsection (d) of such section 116. (2) Evaluations (A) Authority to enter into agreements The Secretary shall ensure that an independent evaluation is conducted on the pilot program carried out under this section to determine the impact of the program on employment of individuals with substance use disorders. The Secretary shall enter into an agreement with eligible entities receiving grants under this section to pay for all or part of such evaluation. (B) Methodologies to be used The independent evaluation required under this paragraph shall use experimental designs using random assignment or, when random assignment is not feasible, other reliable, evidence-based research methodologies that allow for the strongest possible causal inferences. (g) Funding (1) Covered fiscal year In this subsection, the term covered fiscal year means any of fiscal years 2019 through 2023. (2) Using funding for national dislocated worker grants Subject to paragraph (4) and notwithstanding section 132(a)(2)(A) and subtitle D of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3172(a)(2)(A) , 3221 et seq.), the Secretary may use, to carry out the pilot program under this section for a covered fiscal year— (A) funds made available to carry out section 170 of such Act ( 29 U.S.C. 3225 ) for that fiscal year; (B) funds made available to carry out section 170 of such Act that remain available for that fiscal year; and (C) funds that remain available under section 172(f) of such Act ( 29 U.S.C. 3227(f) ). (3) Availability of funds Funds appropriated under section 136(c) of such Act ( 29 U.S.C. 3181(c) ) and made available to carry out section 170 of such Act for a fiscal year shall remain available for use under paragraph (2) for a subsequent fiscal year until expended. (4) Limitation The Secretary may not use more than $100,000,000 of the funds described in paragraph (2) for any covered fiscal year under this section. D Peer support counseling program for women veterans 8051. Peer support counseling program for women veterans (a) In general Section 1720F(j) of title 38, United States Code, is amended by adding at the end the following new paragraph: (4) (A) As part of the counseling program under this subsection, the Secretary shall emphasize appointing peer support counselors for women veterans. To the degree practicable, the Secretary shall seek to recruit women peer support counselors with expertise in— (i) female gender-specific issues and services; (ii) the provision of information about services and benefits provided under laws administered by the Secretary; or (iii) employment mentoring. (B) To the degree practicable, the Secretary shall emphasize facilitating peer support counseling for women veterans who are eligible for counseling and services under section 1720D of this title, have post-traumatic stress disorder or suffer from another mental health condition, are homeless or at risk of becoming homeless, or are otherwise at increased risk of suicide, as determined by the Secretary. (C) The Secretary shall conduct outreach to inform women veterans about the program and the assistance available under this paragraph. (D) In carrying out this paragraph, the Secretary shall coordinate with such community organizations, State and local governments, institutions of higher education, chambers of commerce, local business organizations, organizations that provide legal assistance, and other organizations as the Secretary considers appropriate. (E) In carrying out this paragraph, the Secretary shall provide adequate training for peer support counselors, including training carried out under the national program of training required by section 304(c) of the Caregivers and Veterans Omnibus Health Services Act of 2010 ( 38 U.S.C. 1712A note). . (b) Funding The Secretary of Veterans Affairs shall carry out paragraph (4) of section 1720F(j) of title 38, United States Code, as added by subsection (a), using funds otherwise made available to the Secretary. No additional funds are authorized to be appropriated by reason of such paragraph. (c) Report to Congress Not later than 2 years after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on the peer support counseling program under section 1720F(j) of title 38, United States Code, as amended by this section. Such report shall include— (1) the number of peer support counselors in the program; (2) an assessment of the effectiveness of the program; and (3) a description of the oversight of the program. E Treating Barriers to Prosperity 8061. Short title This subtitle may be cited as the Treating Barriers to Prosperity Act of 2018 . 8062. Drug abuse mitigation initiative (a) In general Chapter 145 of title 40, United States Code, is amended by inserting after section 14509 the following: 14510. Drug abuse mitigation initiative (a) In general The Appalachian Regional Commission may provide technical assistance to, make grants to, enter into contracts with, or otherwise provide amounts to individuals or entities in the Appalachian region for projects and activities to address drug abuse, including opioid abuse, in the region, including projects and activities— (1) to facilitate the sharing of best practices among States, counties, and other experts in the region with respect to reducing such abuse; (2) to initiate or expand programs designed to eliminate or reduce the harm to the workforce and economic growth of the region that results from such abuse; (3) to attract and retain relevant health care services, businesses, and workers; and (4) to develop relevant infrastructure, including broadband infrastructure that supports the use of telemedicine. (b) Limitation on available amounts Of the cost of any activity eligible for a grant under this section— (1) not more than 50 percent may be provided from amounts appropriated to carry out this section; and (2) notwithstanding paragraph (1)— (A) in the case of a project to be carried out in a county for which a distressed county designation is in effect under section 14526, not more than 80 percent may be provided from amounts appropriated to carry out this section; and (B) in the case of a project to be carried out in a county for which an at-risk designation is in effect under section 14526, not more than 70 percent may be provided from amounts appropriated to carry out this section. (c) Sources of assistance Subject to subsection (b), a grant provided under this section may be provided from amounts made available to carry out this section in combination with amounts made available— (1) under any other Federal program (subject to the availability of subsequent appropriations); or (2) from any other source. (d) Federal share Notwithstanding any provision of law limiting the Federal share under any other Federal program, amounts made available to carry out this section may be used to increase that Federal share, as the Appalachian Regional Commission determines to be appropriate. . (b) Clerical amendment The analysis for chapter 145 of title 40, United States Code, is amended by inserting after the item relating to section 14509 the following: 14510. Drug abuse mitigation initiative. . F Pilot program to help individuals in recovery from a substance use disorder become stably housed 8071. Pilot program to help individuals in recovery from a substance use disorder become stably housed (a) Authorization of appropriations There is authorized to be appropriated under this section such sums as may be necessary for each of fiscal years 2019 through 2023 for assistance to States to provide individuals in recovery from a substance use disorder stable, temporary housing for a period of not more than 2 years or until the individual secures permanent housing, whichever is earlier. (b) Allocation of appropriated amounts (1) In general The amounts appropriated or otherwise made available to States under this section shall be allocated based on a funding formula established by the Secretary of Housing and Urban Development (referred to in this section as the Secretary ) not later than 60 days after the date of enactment of this Act. (2) Criteria (A) In general The funding formula required under paragraph (1) shall ensure that any amounts appropriated or otherwise made available under this section are allocated to States with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, according to the Centers for Disease Control and Prevention. (B) Priority (i) In general Among such States, priority shall be given to States with the greatest need, as such need is determined by the Secretary based on the following factors, and weighting such factors as described in clause (ii): (I) The highest average rates of unemployment based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017. (II) The lowest average labor force participation rates based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017. (III) The highest age-adjusted rates of drug overdose deaths based on data from the Centers for Disease Control and Prevention. (ii) Weighting The factors described in clause (i) shall be weighted as follows: (I) The rate described in clause (i)(I) shall be weighted at 15 percent. (II) The rate described in clause (i)(II) shall be weighted at 15 percent. (III) The rate described in clause (i)(III) shall be weighted at 70 percent. (3) Distribution Amounts appropriated or otherwise made available under this section shall be distributed according to the funding formula established by the Secretary under paragraph (1) not later than 30 days after the establishment of such formula. (c) Use of funds (1) In general Any State that receives amounts pursuant to this section shall expend at least 30 percent of such funds within one year of the date funds become available to the grantee for obligation. (2) Priority Any State that receives amounts pursuant to this section shall distribute such amounts giving priority to entities with the greatest need and ability to deliver effective assistance in a timely manner. (3) Administrative costs Any State that receives amounts pursuant to this section may use up to 5 percent of any grant for administrative costs. (d) Rules of construction (1) In general Except as otherwise provided by this section, amounts appropriated, or amounts otherwise made available to States under this section shall be treated as though such funds were community development block grant funds under title I of the Housing and Community Development Act of 1974 ( 42 U.S.C. 5301 et seq.). (2) No match No matching funds shall be required in order for a State to receive any amounts under this section. (e) Authority to waive or specify alternative requirements (1) In general In administering any amounts appropriated or otherwise made available under this section, the Secretary may waive or specify alternative requirements to any provision under title I of the Housing and Community Development Act of 1974 ( 42 U.S.C. 5301 et seq.) except for requirements related to fair housing, nondiscrimination, labor standards, the environment, and requirements that activities benefit persons of low- and moderate-income, upon a finding that such a waiver is necessary to expedite or facilitate the use of such funds. (2) Notice of intent The Secretary shall provide written notice of its intent to exercise the authority to specify alternative requirements under paragraph (1) to the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives not later than 15 business days before such exercise of authority occurs. (3) Notice to the public The Secretary shall provide written notice of its intent to exercise the authority to specify alternative requirements under paragraph (1) to the public via notice, on the internet website of the Department of Housing and Urban Development, and by other appropriate means, not later than 15 business days before such exercise of authority occurs. (f) Technical assistance For the 2-year period following the date of enactment of this Act, the Secretary may use not more than 2 percent of the funds made available under this section for technical assistance to grantees. (g) State For purposes of this section the term State includes any State as defined in section 102 of the Housing and Community Development Act of 1974 ( 42 U.S.C. 5302 ) and the District of Columbia. G Human Services 8081. Supporting family-focused residential treatment (a) Definitions In this section: (1) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (2) Medicaid program The term Medicaid program means the program established under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Title IV–E program The term title IV–E program means the program for foster care, prevention, and permanency established under part E of title IV of the Social Security Act ( 42 U.S.C. 670 et seq.). (b) Guidance on family-focused residential treatment programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with divisions of the Department of Health and Human Services administering substance use disorder or child welfare programs, shall develop and issue guidance to States identifying opportunities to support family-focused residential treatment programs for the provision of substance use disorder treatment. Before issuing such guidance, the Secretary shall solicit input from representatives of States, health care providers with expertise in addiction medicine, obstetrics and gynecology, neonatology, child trauma, and child development, health plans, recipients of family-focused treatment services, and other relevant stakeholders. (2) Additional requirements The guidance required under paragraph (1) shall include descriptions of the following: (A) Existing opportunities and flexibilities under the Medicaid program, including under waivers authorized under section 1115 or 1915 of the Social Security Act ( 42 U.S.C. 1315 , 1396n), for States to receive Federal Medicaid funding for the provision of substance use disorder treatment for pregnant and postpartum women and parents and guardians and, to the extent applicable, their children, in family-focused residential treatment programs. (B) How States can employ and coordinate funding provided under the Medicaid program, the title IV-E program, and other programs administered by the Secretary to support the provision of treatment and services provided by a family-focused residential treatment facility such as substance use disorder treatment and services, including medication-assisted treatment, family, group, and individual counseling, case management, parenting education and skills development, the provision, assessment, or coordination of care and services for children, including necessary assessments and appropriate interventions, non-emergency transportation for necessary care provided at or away from a program site, transitional services and supports for families leaving treatment, and other services. (C) How States can employ and coordinate funding provided under the Medicaid program and the title IV–E program (including as amended by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123 , and particularly with respect to the authority under subsections (a)(2)(C) and (j) of section 472 and section 474(a)(1) of the Social Security Act ( 42 U.S.C. 672 , 674(a)(1)) (as amended by section 50712 of Public Law 115–123 ) to provide foster care maintenance payments for a child placed with a parent who is receiving treatment in a licensed residential family-based treatment facility for a substance use disorder) to support placing children with their parents in family-focused residential treatment programs. 8082. Improving recovery and reunifying families (a) Family Recovery and Reunification Program Replication Project Section 435 of the Social Security Act ( 42 U.S.C. 629e ) is amended by adding at the end the following: (e) Family Recovery and Reunification Program Replication Project (1) Purpose The purpose of this subsection is to provide resources to the Secretary to support the conduct and evaluation of a family recovery and reunification program replication project (referred to in this subsection as the project ) and to determine the extent to which such programs may be appropriate for use at different intervention points (such as when a child is at risk of entering foster care or when a child is living with a guardian while a parent is in treatment). The family recovery and reunification program conducted under the project shall use a recovery coach model that is designed to help reunify families and protect children by working with parents or guardians with a substance use disorder who have temporarily lost custody of their children. (2) Program components The family recovery and reunification program conducted under the project shall adhere closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children and, consistent with such elements and protocol, shall provide such items and services as— (A) assessments to evaluate the needs of the parent or guardian; (B) assistance in receiving the appropriate benefits to aid the parent or guardian in recovery; (C) services to assist the parent or guardian in prioritizing issues identified in assessments, establishing goals for resolving such issues that are consistent with the goals of the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children, and making a coordinated plan for achieving such goals; (D) home visiting services coordinated with the child welfare agency and treatment provider involved with the parent or guardian or their children; (E) case management services to remove barriers for the parent or guardian to participate and continue in treatment, as well as to re-engage a parent or guardian who is not participating or progressing in treatment; (F) access to services needed to monitor the parent’s or guardian's compliance with program requirements; (G) frequent reporting between the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children to ensure appropriate information on the parent’s or guardian's status is available to inform decision-making; and (H) assessments and recommendations provided by a recovery coach to the child welfare caseworker responsible for documenting the parent’s or guardian's progress in treatment and recovery as well as the status of other areas identified in the treatment plan for the parent or guardian, including a recommendation regarding the expected safety of the child if the child is returned to the custody of the parent or guardian that can be used by the caseworker and a court to make permanency decisions regarding the child. (3) Responsibilities of the secretary (A) In general The Secretary shall, through a grant or contract with 1 or more entities, conduct and evaluate the family recovery and reunification program under the project. (B) Requirements In identifying 1 or more entities to conduct the evaluation of the family recovery and reunification program, the Secretary shall— (i) determine that the area or areas in which the program will be conducted have sufficient substance use disorder treatment providers and other resources (other than those provided with funds made available to carry out the project) to successfully conduct the program; (ii) determine that the area or areas in which the program will be conducted have enough potential program participants, and will serve a sufficient number of parents or guardians and their children, so as to allow for the formation of a control group, evaluation results to be adequately powered, and preliminary results of the evaluation to be available within 4 years of the program's implementation; (iii) provide the entity or entities with technical assistance for the program design, including by working with 1 or more entities that are or have been involved in recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children so as to make sure the program conducted under the project adheres closely to the elements and protocol determined to be most effective in such other recovery coaching programs; (iv) assist the entity or entities in securing adequate coaching, treatment, child welfare, court, and other resources needed to successfully conduct the family recovery and reunification program under the project; and (v) ensure the entity or entities will be able to monitor the impacts of the program in the area or areas in which it is conducted for at least 5 years after parents or guardians and their children are randomly assigned to participate in the program or to be part of the program's control group. (4) Evaluation requirements (A) In general The Secretary, in consultation with the entity or entities conducting the family recovery and reunification program under the project, shall conduct an evaluation to determine whether the program has been implemented effectively and resulted in improvements for children and families. The evaluation shall have 3 components: a pilot phase, an impact study, and an implementation study. (B) Pilot phase The pilot phase component of the evaluation shall consist of the Secretary providing technical assistance to the entity or entities conducting the family recovery and reunification program under the project to ensure— (i) the program's implementation adheres closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) random assignment of parents or guardians and their children to be participants in the program or to be part of the program's control group is being carried out. (C) Impact study The impact study component of the evaluation shall determine the impacts of the family recovery and reunification program conducted under the project on the parents and guardians and their children participating in the program. The impact study component shall— (i) be conducted using an experimental design that uses a random assignment research methodology; (ii) consistent with previous studies of other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children, measure outcomes for parents and guardians and their children over multiple time periods, including for a period of 5 years; and (iii) include measurements of family stability and parent, guardian, and child safety for program participants and the program control group that are consistent with measurements of such factors for participants and control groups from previous studies of other recovery coaching programs so as to allow results of the impact study to be compared with the results of such prior studies, including with respect to comparisons between program participants and the program control group regarding— (I) safe family reunification; (II) time to reunification; (III) permanency (such as through measures of reunification, adoption, or placement with guardians); (IV) safety (such as through measures of subsequent maltreatment); (V) parental or guardian treatment persistence and engagement; (VI) parental or guardian substance use; (VII) juvenile delinquency; (VIII) cost; and (IX) other measurements agreed upon by the Secretary and the entity or entities operating the family recovery and reunification program under the project. (D) Implementation study The implementation study component of the evaluation shall be conducted concurrently with the conduct of the impact study component and shall include, in addition to such other information as the Secretary may determine, descriptions and analyses of— (i) the adherence of the family recovery and reunification program conducted under the project to other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) the difference in services received or proposed to be received by the program participants and the program control group. (E) Report The Secretary shall publish on an internet website maintained by the Secretary the following information: (i) A report on the pilot phase component of the evaluation. (ii) A report on the impact study component of the evaluation. (iii) A report on the implementation study component of the evaluation. (iv) A report that includes— (I) analyses of the extent to which the program has resulted in increased reunifications, increased permanency, case closures, net savings to the State or States involved (taking into account both costs borne by States and the Federal government), or other outcomes, or if the program did not produce such outcomes, an analysis of why the replication of the program did not yield such results; (II) if, based on such analyses, the Secretary determines the program should be replicated, a replication plan; and (III) such recommendations for legislation and administrative action as the Secretary determines appropriate. (5) Appropriation In addition to any amounts otherwise made available to carry out this subpart, out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated $15,000,000 for fiscal year 2019 to carry out the project, which shall remain available through fiscal year 2026. . (b) Clarification of payer of last resort application to child welfare prevention and family services Section 471(e)(10) of the Social Security Act ( 42 U.S.C. 671(e)(10) ), as added by section 50711(a)(2) of division E of Public Law 115–123 , is amended— (1) in subparagraph (A), by inserting , nor shall the provision of such services or programs be construed to permit the State to reduce medical or other assistance available to a recipient of such services or programs after under this Act ; and (2) by adding at the end the following: (C) Payer of last resort In carrying out its responsibilities to ensure access to services or programs under this subsection, the State agency shall not be considered to be a legally liable third party for purposes of satisfying a financial commitment for the cost of providing such services or programs with respect to any individual for whom such cost would have been paid for from another public or private source but for the enactment of this subsection (except that whenever considered necessary to prevent a delay in the receipt of appropriate early intervention services by a child or family in a timely fashion, funds provided under section 474(a)(6) may be used to pay the provider of services or programs pending reimbursement from the public or private source that has ultimate responsibility for the payment). . (c) Effective date The amendments made by subsection (b) shall take effect as if included in section 50711 of division E of Public Law 115–123 . 8083. Building capacity for family-focused residential treatment (a) Definitions In this section: (1) Eligible entity The term eligible entity means a State, county, local, or tribal health or child welfare agency, a private nonprofit organization, a research organization, a treatment service provider, an institution of higher education (as defined under section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 )), or another entity specified by the Secretary. (2) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (3) Secretary The term Secretary means the Secretary of Health and Human Services. (b) Support for the development of evidence-based family-focused residential treatment programs (1) Authority to award grants The Secretary shall award grants to eligible entities for purposes of developing, enhancing, or evaluating family-focused residential treatment programs to increase the availability of such programs that meet the requirements for promising, supported, or well-supported practices specified in section 471(e)(4)(C) of the Social Security Act ( 42 U.S.C. 671(e)(4)(C) )) (as added by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123 ). (2) Evaluation requirement The Secretary shall require any evaluation of a family-focused residential treatment program by an eligible entity that uses funds awarded under this section for all or part of the costs of the evaluation be designed to assist in the determination of whether the program may qualify as a promising, supported, or well-supported practice in accordance with the requirements of such section 471(e)(4)(C). (c) Authorization of appropriations There is authorized to be appropriated to the Secretary to carry out this section, $20,000,000 for fiscal year 2019, which shall remain available through fiscal year 2023. H Reauthorizing and Extending Grants for Recovery from Opioid Use Programs 8091. Short title This subtitle may be cited as the Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018 . 8092. Reauthorization of the comprehensive opioid abuse grant program Section 1001(a)(27) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10261(a)(27) ) is amended by striking through 2021 and inserting and 2018, and $330,000,000 for each of fiscal years 2019 through 2023 . I Fighting Opioid Abuse in Transportation 8101. Short title This subtitle may be cited as the Fighting Opioid Abuse in Transportation Act . 8102. Alcohol and controlled substance testing of mechanical employees (a) In general Not later than 2 years after the date of enactment of this Act, the Secretary of Transportation shall publish a rule in the Federal Register revising the regulations promulgated under section 20140 of title 49, United States Code, to cover all employees of railroad carriers who perform mechanical activities. (b) Definition of mechanical activities For the purposes of the rule under subsection (a), the Secretary shall define the term mechanical activities by regulation. 8103. Department of Transportation public drug and alcohol testing database (a) In general Subject to subsection (c), the Secretary of Transportation shall— (1) not later than March 31, 2019, establish and make publicly available on its website a database of the drug and alcohol testing data reported by employers for each mode of transportation; and (2) update the database annually. (b) Contents The database under subsection (a) shall include, for each mode of transportation— (1) the total number of drug and alcohol tests by type of substance tested; (2) the drug and alcohol test results by type of substance tested; (3) the reason for the drug or alcohol test, such as pre-employment, random, post-accident, reasonable suspicion or cause, return-to-duty, or follow-up, by type of substance tested; and (4) the number of individuals who refused testing. (c) Commercially sensitive data The Department of Transportation shall not release any commercially sensitive data or personally identifiable data furnished by an employer under this section unless the data is aggregated or otherwise in a form that does not identify the employer providing the data. (d) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the requirements of the Secretary of Transportation to adhere to requirements applicable to confidential business information and sensitive security information, consistent with applicable law. 8104. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data (a) In general Not later than 2 years after the date the Department of Transportation public drug and alcohol testing database is established under section 8103, the Comptroller General of the United States shall— (1) review the Department of Transportation Drug and Alcohol Testing Management Information System; and (2) submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on the review, including recommendations under subsection (c). (b) Contents The report under subsection (a) shall include— (1) a description of the process the Department of Transportation uses to collect and record drug and alcohol testing data submitted by employers for each mode of transportation; (2) an assessment of whether and, if so, how the Department of Transportation uses the data described in paragraph (1) in carrying out its responsibilities; and (3) an assessment of the Department of Transportation public drug and alcohol testing database under section 8103. (c) Recommendations The report under subsection (a) may include recommendations regarding— (1) how the Department of Transportation can best use the data described in subsection (b)(1); (2) any improvements that could be made to the process described in subsection (b)(1); (3) whether and, if so, how the Department of Transportation public drug and alcohol testing database under section 8103 could be made more effective; and (4) such other recommendations as the Comptroller General considers appropriate. 8105. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl and other substances (a) Mandatory Guidelines for Federal Workplace Drug Testing Programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall— (A) determine whether a revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the opiate category on the list of authorized substance testing to include fentanyl is justified, based on the reliability and cost-effectiveness of available testing; and (B) consider whether to include with the determination under subparagraph (A) a separate determination on whether a revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the list of substances authorized for testing to include any other drugs or other substances listed in schedule I and II of section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ) is justified based on the criteria described in subparagraph (A). (2) Revision of guidelines If an expansion of the substance list is determined to be justified under paragraph (1), the Secretary of Health and Human Services shall— (A) notify the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives of the determination; and (B) publish in the Federal Register, not later than 18 months after the date of the determination under that paragraph, a final notice of the revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the list of substances authorized to be tested to include the substance or substances determined to be justified for inclusion. (3) Report If an expansion of the substance list is determined not to be justified under paragraph (1), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report explaining, in detail, the reasons the expansion of the list of authorized substances is not justified. (b) Department of Transportation drug-testing panel If an expansion is determined to be justified under subsection (a)(1), the Secretary of Transportation shall publish in the Federal Register, not later than 18 months after the date the final notice is published under subsection (a)(2), a final rule revising part 40 of title 49, Code of Federal Regulations, to include such substances in the Department of Transportation's drug-testing panel, consistent with the Mandatory Guidelines for Federal Workplace Drug Testing Programs as revised by the Secretary of Health and Human Services under subsection (a). (c) Savings provision Nothing in this section may be construed as— (1) delaying the publication of the notices described in sections 8106 and 8107 of this Act until the Secretary of Health and Human Services makes a determination or publishes a notice under this section; or (2) limiting or otherwise affecting any authority of the Secretary of Health and Human Services or the Secretary of Transportation to expand the list of authorized substance testing to include an additional substance. 8106. Status reports on hair testing guidelines (a) In general Not later than 60 days after the date of enactment of this Act, and annually thereafter until the date that the Secretary of Health and Human Services publishes in the Federal Register a final notice of scientific and technical guidelines for hair testing in accordance with section 5402(b) of the Fixing America's Surface Transportation Act ( Public Law 114–94 ; 129 Stat. 1312), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on— (1) the status of the hair testing guidelines; (2) an explanation for why the hair testing guidelines have not been issued; and (3) an estimated date of completion of the hair testing guidelines. (b) Requirement To the extent practicable and consistent with the objective of the hair testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results, of the individual being tested, caused solely by the drug use of others and not caused by the drug use of the individual being tested. 8107. Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (a) Deadline Not later than December 31, 2018, the Secretary of Health and Human Services shall publish in the Federal Register a final notice of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, based on the notice of proposed mandatory guidelines published in the Federal Register on May 15, 2015 (94 FR 28054). (b) Requirement To the extent practicable and consistent with the objective of the testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results, of the individual being tested, caused solely by the drug use of others and not caused by the drug use of the individual being tested. (c) Rule of construction Nothing in this section may be construed as requiring the Secretary of Health and Human Services to reissue a notice of proposed mandatory guidelines to carry out subsection (a). 8108. Electronic recordkeeping (a) Deadline Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) ensure that each certified laboratory that requests approval for the use of completely paperless electronic Federal Drug Testing Custody and Control Forms from the National Laboratory Certification Program’s Electronic Custody and Control Form systems receives approval for those completely paperless electronic forms instead of forms that include any combination of electronic traditional handwritten signatures executed on paper forms; and (2) establish a deadline for a certified laboratory to request approval under paragraph (1). (b) Savings clause Nothing in this section may be construed as limiting or otherwise affecting any authority of the Secretary of Health and Human Services to grant approval to a certified laboratory for use of completely paperless electronic Federal Drug Testing Custody and Control Forms, including to grant approval outside of the process under subsection (a). (c) Electronic signatures Not later than 18 months after the date of the deadline under subsection (a)(2), the Secretary of Transportation shall issue a final rule revising part 40 of title 49, Code of Federal Regulations, to authorize, to the extent practicable, the use of electronic signatures or digital signatures executed to electronic forms instead of traditional handwritten signatures executed on paper forms. 8109. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse (a) In general Not later than 60 days after the date of enactment of this Act, and annually thereafter until the compliance date, the Administrator of the Federal Motor Carrier Safety Administration shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a status report on implementation of the final rule for the Commercial Driver's License Drug and Alcohol Clearinghouse (81 FR 87686), including— (1) an updated schedule, including benchmarks, for implementing the final rule as soon as practicable, but not later than the compliance date; and (2) a description of each action the Federal Motor Carrier Safety Administration is taking to implement the final rule before the compliance date. (b) Definition of compliance date In this section, the term compliance date means the earlier of— (1) January 6, 2020; or (2) the date that the national clearinghouse required under section 31306a of title 49, United States Code, is operational. J Eliminating Kickbacks in Recovery 8121. Short title This subtitle may be cited as the Eliminating Kickbacks in Recovery Act of 2018 . 8122. Criminal penalties (a) In general Chapter 11 of title 18, United States Code, is amended by inserting after section 219 the following: 220. Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories (a) Offense Except as provided in subsection (b), whoever, with respect to services covered by a health care benefit program, in or affecting interstate or foreign commerce, knowingly and willfully— (1) solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or (2) pays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or (B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory, shall be fined not more than $200,000, imprisoned not more than 10 years, or both, for each occurrence. (b) Applicability Subsection (a) shall not apply to— (1) a discount or other reduction in price obtained by a provider of services or other entity under a health care benefit program if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity; (2) a payment made by an employer to an employee or independent contractor (who has a bona fide employment or contractual relationship with such employer) for employment, if the employee’s payment is not determined by or does not vary by— (A) the number of individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (B) the number of tests or procedures performed; or (C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (3) a discount in the price of an applicable drug of a manufacturer that is furnished to an applicable beneficiary under the Medicare coverage gap discount program under section 1860D–14A(g) of the Social Security Act (42 U.S.C. 1395w–114a(g)); (4) a payment made by a principal to an agent as compensation for the services of the agent under a personal services and management contract that meets the requirements of section 1001.952(d) of title 42, Code of Federal Regulations, as in effect on the date of enactment of this section; (5) a waiver or discount (as defined in section 1001.952(h)(5) of title 42, Code of Federal Regulations, or any successor regulation) of any coinsurance or copayment by a health care benefit program if— (A) the waiver or discount is not routinely provided; and (B) the waiver or discount is provided in good faith; (6) a remuneration described in section 1128B(b)(3)(I) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)(I)); (7) a remuneration made pursuant to an alternative payment model (as defined in section 1833(z)(3)(C) of the Social Security Act) or pursuant to a payment arrangement used by a State, health insurance issuer, or group health plan if the Secretary of Health and Human Services has determined that such arrangement is necessary for care coordination or value-based care; or (8) any other payment, remuneration, discount, or reduction as determined by the Attorney General, in consultation with the Secretary of Health and Human Services, by regulation. (c) Regulations The Attorney General, in consultation with the Secretary of Health and Human Services, may promulgate regulations to clarify the exceptions described in subsection (b). (d) Preemption (1) Federal law This section shall not apply to conduct that is prohibited under section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b ). (2) State law Nothing in this section shall be construed to occupy the field in which any provisions of this section operate to the exclusion of State laws on the same subject matter. (e) Definitions In this section— (1) the terms applicable beneficiary and applicable drug have the meanings given those terms in section 1860D–14A(g) of the Social Security Act (42 U.S.C. 1395w–114a(g)); (2) the term clinical treatment facility means a medical setting , other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law; (3) the term health care benefit program has the meaning given the term in section 24(b); (4) the term laboratory has the meaning given the term in section 353 of the Public Health Service Act ( 42 U.S.C. 263a ); and (5) the term recovery home means a shared living environment that is, or purports to be, free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders. . (b) Clerical amendment The table of sections for chapter 11 of title 18, United States Code, is amended by inserting after the item related to section 219 the following: 220. Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories. . K Substance Abuse Prevention 8201. Short title This subtitle may be cited as the Substance Abuse Prevention Act of 2018 . 8202. Reauthorization of the Office of National Drug Control Policy (a) Office of National Drug Control Policy Reauthorization Act of 1998 (1) In general The Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 et seq.), as in effect on September 29, 2003, and as amended by the laws described in paragraph (2), is revived and restored. (2) Laws described The laws described in this paragraph are: (A) The Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3502). (B) The Presidential Appointment Efficiency and Streamlining Act of 2011 ( Public Law 112–166 ; 126 Stat. 1283). (b) Reauthorization (1) In general Section 714 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1711 ) is amended by striking such sums as may be necessary for each of fiscal years 2006 through 2010 and inserting $18,400,000 for each of fiscal years 2018 through 2023 . (2) Repeal of termination The Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 et seq.) is amended by striking section 715 ( 21 U.S.C. 1712 ). 8203. Reauthorization of the Drug-Free Communities Program (a) Revival of national narcotics leadership act of 1988 (1) In general Chapter 2 of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1521 et seq.), except for subchapter II ( 21 U.S.C. 1541 et seq.), as in effect on September 29, 1997, and as amended by the laws described in paragraph (2), is revived and restored. (2) Laws described The laws described in this paragraph are: (A) Public Law 107–82 (115 Stat. 814). (B) The Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 : 120 Stat. 3502), as amended by paragraph (4). (3) Amendment to termination provision Section 1009 of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1056 ) is amended by inserting and sections 1021 through 1035 after section 1007 . (4) Technical correction (A) In general Title VIII of the Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3535) is amended by striking Drug-Free Communities Act of 1997 each place it appears and inserting National Narcotics Leadership Act of 1988 . (B) Effective date The amendments made by subparagraph (A) shall take effect as though enacted as part of the Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3502). (b) Amendment to National Narcotics Leadership Act of 1988 Chapter 2 of subtitle A of title I of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1521 et seq.) is amended— (1) in section 1022 ( 21 U.S.C. 1522 ), by striking substance abuse each place it appears and inserting substance use and misuse ; (2) in section 1023 ( 21 U.S.C. 1523 ), by striking paragraph (9) and inserting the following: (9) Substance use and misuse The term substance use and misuse means— (A) the illegal use or misuse of drugs, including substances for which a listing is effect under any of schedules I through V under section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ); (B) the misuse of inhalants or over-the-counter drugs; or (C) the use of alcohol, tobacco, or other related product as such use is prohibited by State or local law. ; (3) in section 1024 ( 21 U.S.C. 1524 ), by striking subsections (a) and (b) and inserting the following: (a) In general There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this chapter $99,000,000 for each of fiscal years 2018 through 2023. (b) Administrative costs Not more than 8 percent of the funds appropriated to carry out this chapter may be used by the Office of National Drug Control Policy to pay administrative costs associated with the responsibilities of the Office under this chapter. ; (4) in subchapter I ( 21 U.S.C. 1531 et seq.)— (A) by striking substance abuse each place it appears and inserting substance use and misuse ; and (B) in section 1032(b)(1)(A) ( 21 U.S.C. 1532(b)(1)(A) ), by striking clause (iii) and inserting the following: (iii) Renewal grants Subject to clause (iv), the Administrator may award a renewal grant to a grant recipient under this subparagraph for each fiscal year of the 4-fiscal-year period following the first fiscal year for which the initial additional grant is awarded in an amount not to exceed the following: (I) For the first and second fiscal years of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 125 percent of the amount awarded. (II) For the third and fourth fiscal tears of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 150 percent of the amount awarded. ; and (5) by striking subchapter II ( 21 U.S.C. 1541 et seq.). 8204. Reauthorization of the National Community Anti-Drug Coalition Institute Section 4 of Public Law 107–82 ( 21 U.S.C. 1521 note) is amended to read as follows: 4. Authorization for National Community Antidrug Coalition Institute (a) In general The Director shall, using amounts authorized to be appropriated by subsection (d), make a competitive grant to provide for the continuation of the National Community Anti-drug Coalition Institute. (b) Eligible organizations An organization eligible for the grant under subsection (a) is any national nonprofit organization that represents, provides technical assistance and training to, and has special expertise and broad, national-level experience in community antidrug coalitions under this subchapter. (c) Use of grant amount The organization that receives the grant under subsection (a) shall continue a National Community Anti-Drug Coalition Institute to— (1) provide education, training, and technical assistance for coalition leaders and community teams, with emphasis on the development of coalitions serving economically disadvantaged areas; (2) develop and disseminate evaluation tools, mechanisms, and measures to better assess and document coalition performance measures and outcomes; and (3) bridge the gap between research and practice by translating knowledge from research into practical information. (d) Authorization of appropriations The Director shall, using amounts authorized to be appropriated by section 1032 of the National Narcotics Leadership Act of 1988 ( 15 U.S.C. 1532 ), make a grant of $2 million under subsection (a), for each of the fiscal years 2018 through 2023. . 8205. Reauthorization of the High-Intensity Drug Trafficking Area Program Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1706 ) is amended— (1) in subsection (f), by striking no Federal and all that follows through programs. and inserting the following: not more than a total of 5 percent of Federal funds appropriated for the Program are expended for substance use disorder treatment programs and drug prevention programs. ; (2) in subsection (p)— (A) in paragraph (4), by striking and at the end; (B) in paragraph (5), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following: (6) $280,000,000 for each of fiscal years 2018 through 2023. ; and (3) in subsection (q)— (A) by striking paragraph (2) and inserting the following: (2) Required uses The funds used under paragraph (1) shall be used to ensure the safety of neighborhoods and the protection of communities, including the prevention of the intimidation of witnesses of illegal drug distribution and related activities and the establishment of, or support for, programs that provide protection or assistance to witnesses in court proceedings. ; and (B) by adding at the end the following: (3) Best practice models The Director shall work with HIDTAs to develop and maintain best practice models to assist State, local, and Tribal governments in addressing witness safety, relocation, financial and housing assistance, or any other services related to witness protection or assistance in cases of illegal drug distribution and related activities. The Director shall ensure dissemination of the best practice models to each HIDTA. . 8206. Reauthorization of drug court program Section 1001(a)(25)(A) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10261(a)(25)(A) ) is amended by striking Except as provided and all that follows and inserting the following: Except as provided in subparagraph (C), there is authorized to be appropriated to carry out part EE $75,000,000 for each of fiscal years 2018 through 2023. . 8207. Drug court training and technical assistance Section 705 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1704 ) is amended by adding at the end the following: (e) Drug court training and technical assistance program (1) Grants authorized The Director may make a grant to a nonprofit organization for the purpose of providing training and technical assistance to drug courts. (2) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2018 through 2023. . 8208. Drug overdose response strategy Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1706 ) is amended by adding at the end the following: (r) Drug overdose response strategy implementation The Director may use funds appropriated to carry out this section to implement a drug overdose response strategy in high intensity drug trafficking areas on a nationwide basis by— (1) coordinating multi-disciplinary efforts to prevent, reduce, and respond to drug overdoses, including the uniform reporting of fatal and non-fatal overdoses to public health and safety officials; (2) increasing data sharing among public safety and public health officials concerning drug-related abuse trends, including new psychoactive substances, and related crime; and (3) enabling collaborative deployment of prevention, intervention, and enforcement resources to address substance use addiction and narcotics trafficking. . 8209. Protecting law enforcement officers from accidental exposure Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1706 ), as amended by section 8208, is amended by adding at the end the following: (s) Supplemental grants The Director is authorized to use not more than $10,000,000 of the amounts otherwise appropriated to carry out this section to provide supplemental competitive grants to high intensity drug trafficking areas that have experienced high seizures of fentanyl and new psychoactive substances for the purposes of— (1) purchasing portable equipment to test for fentanyl and other substances; (2) training law enforcement officers and other first responders on best practices for handling fentanyl and other substances; and (3) purchasing protective equipment, including overdose reversal drugs. . 8210. COPS Anti-Meth Program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10381 ) is amended— (1) by redesignating subsection (k) as subsection (l); and (2) by inserting after subsection (j) the following: (k) COPS Anti-Meth Program The Attorney General shall use amounts otherwise appropriated to carry out this section for a fiscal year (beginning with fiscal year 2019) to make competitive grants, in amounts of not less than $1,000,000 for such fiscal year, to State law enforcement agencies with high seizures of precursor chemicals, finished methamphetamine, laboratories, and laboratory dump seizures for the purpose of locating or investigating illicit activities, such as precursor diversion, laboratories, or methamphetamine traffickers. . 8211. COPS anti-heroin task force program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10381 ) is amended— (1) by redesignating subsection (l), as so redesignated by section 8210, as subsection (m); and (2) by inserting after subsection (k), as added by section 8210, the following: (l) Cops anti-heroin task force program The Attorney General shall use amounts otherwise appropriated to carry out this section, or other amounts as appropriated, for a fiscal year (beginning with fiscal year 2019) to make competitive grants to State law enforcement agencies in States with high per capita rates of primary treatment admissions, for the purpose of locating or investigating illicit activities, through Statewide collaboration, relating to the distribution of heroin, fentanyl, or carfentanil or relating to the unlawful distribution of prescription opioids. . 8212. Comprehensive Addiction and Recovery Act education and awareness Title VII of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ; 130 Stat. 735) is amended by adding at the end the following: 709. Services for families and patients in crisis (a) In general The Secretary of Health and Human Services may make grants to entities that focus on addiction and substance use disorders and specialize in family and patient services, advocacy for patients and families, and educational information. (b) Allowable uses A grant awarded under this section may be used for nonprofit national, State, or local organizations that engage in the following activities: (1) Expansion of resource center services with professional, clinical staff that provide, for families and individuals impacted by a substance use disorder, support, access to treatment resources, brief assessments, medication and overdose prevention education, compassionate listening services, recovery support or peer specialists, bereavement and grief support, and case management. (2) Continued development of health information technology systems that leverage new and upcoming technology and techniques for prevention, intervention, and filling resource gaps in communities that are underserved. (3) Enhancement and operation of treatment and recovery resources, easy-to-read scientific and evidence-based education on addiction and substance use disorders, and other informational tools for families and individuals impacted by a substance use disorder and community stakeholders, such as law enforcement agencies. (4) Provision of training and technical assistance to State and local governments, law enforcement agencies, health care systems, research institutions, and other stakeholders. (5) Expanding upon and implementing educational information using evidence-based information on substance use disorders. (6) Expansion of training of community stakeholders, law enforcement officers, and families across a broad-range of addiction, health, and related topics on substance use disorders, local issues and community-specific issues related to the drug epidemic. (7) Program evaluation. . 8213. Reimbursement of substance use disorder treatment professionals Not later than January 1, 2020, the Comptroller General of the United States shall submit to Congress a report examining how substance use disorder services are reimbursed. 8214. Sobriety Treatment and Recovery Teams (START) Title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq.) is amended by adding at the end the following: 550. Sobriety Treatment and Recovery Teams (a) In general The Secretary may make grants to States, units of local government, or tribal governments to establish or expand Sobriety Treatment And Recovery Team (referred to in this section as START ) or other similar programs to determine the effectiveness of pairing social workers or mentors with families that are struggling with a substance use disorder and child abuse or neglect in order to help provide peer support, intensive treatment, and child welfare services to such families. (b) Allowable uses A grant awarded under this section may be used for one or more of the following activities: (1) Training eligible staff, including social workers, social services coordinators, child welfare specialists, substance use disorder treatment professionals, and mentors. (2) Expanding access to substance use disorder treatment services and drug testing. (3) Enhancing data sharing with law enforcement agencies, child welfare agencies, substance use disorder treatment providers, judges, and court personnel. (4) Program evaluation and technical assistance. (c) Program requirements A State, unit of local government, or tribal government receiving a grant under this section shall— (1) serve only families for which— (A) there is an open record with the child welfare agency; and (B) substance use disorder was a reason for the record or finding described in paragraph (1); and (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social Security Act focused on improving outcomes for children affected by substance abuse. (d) Technical assistance The Secretary may reserve not more than 5 percent of funds provided under this section to provide technical assistance on the establishment or expansion of programs funded under this section from the National Center on Substance Abuse and Child Welfare. . 8215. Provider education Not later than 60 days after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall complete the plan related to medical registration coordination required by Senate Report 114–239, which accompanied the Veterans Care Financial Protection Act of 2017 ( Public Law 115–131 ; 132 Stat. 334). 8216. Definitions Section 702 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 ) is amended— (1) by striking paragraphs (5), (12), and (13); (2) by redesignating paragraph (11) as paragraph (17); (3) by redesignating paragraphs (9) and (10) as paragraphs (14) and (15), respectively; (4) by redesignating paragraphs (6), (7), and (8) as paragraphs (10), (11), and (12), respectively; (5) by redesignating paragraphs (1), (2), (3), and (4) as paragraphs (3), (4), (5), and (6), respectively; (6) by inserting before paragraph (3), as so redesignated, the following: (1) Agency The term agency has the meaning given the term executive agency in section 102 of title 31, United States Code. (2) Appropriate congressional committees (A) In general The term appropriate congressional committees means— (i) the Committee on the Judiciary, the Committee on Appropriations, and the Committee on Health, Education, Labor, and Pensions of the Senate; and (ii) the Committee on Oversight and Government Reform, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives. (B) Submission to Congress Any submission to Congress shall mean submission to the appropriate congressional committees. ; (7) by amending paragraph (3), as so redesignated, to read as follows: (3) Demand reduction The term demand reduction means any activity conducted by a National Drug Control Program Agency, other than an enforcement activity, that is intended to reduce or prevent the use of drugs or support, expand, or provide treatment and recovery efforts, including— (A) education about the dangers of illicit drug use; (B) services, programs, or strategies to prevent substance use disorder, including evidence-based education campaigns, community-based prevention programs, collection and disposal of unused prescription drugs, and services to at-risk populations to prevent or delay initial use of an illicit drug; (C) substance use disorder treatment; (D) support for long-term recovery from substance use disorders; (E) drug-free workplace programs; (F) drug testing, including the testing of employees; (G) interventions for illicit drug use and dependence; (H) expanding availability of access to health care services for the treatment of substance use disorders; (I) international drug control coordination and cooperation with respect to activities described in this paragraph; (J) pre- and post-arrest criminal justice interventions such as diversion programs, drug courts, and the provision of evidence-based treatment to individuals with substance use disorders who are arrested or under some form of criminal justice supervision, including medication assisted treatment; (K) other coordinated and joint initiatives among Federal, State, local, and Tribal agencies to promote comprehensive drug control strategies designed to reduce the demand for, and the availability of, illegal drugs; (L) international illicit drug use education, prevention, treatment, recovery, research, rehabilitation activities, and interventions for illicit drug use and dependence; and (M) research related to illicit drug use and any of the activities described in this paragraph. ; (8) by inserting after paragraph (6), as so redesignated, the following: (7) Emerging drug threat The term emerging drug threat means the occurrence of a new and growing trend in the use of an illicit drug or class of drugs, including rapid expansion in the supply of or demand for such drug. (8) Illicit drug use; illicit drugs; illegal drugs The terms illicit drug use , illicit drugs , and illegal drugs include the illegal or illicit use of prescription drugs. (9) Law enforcement The term law enforcement or drug law enforcement means all efforts by a Federal, State, local, or Tribal government agency to enforce the drug laws of the United States or any State, including investigation, arrest, prosecution, and incarceration or other punishments or penalties. ; (9) by amending paragraph (11), as so redesignated, to read as follows: (11) National drug control program agency The term National Drug Control Program Agency means any agency (or bureau, office, independent agency, board, division, commission, subdivision, unit, or other component thereof) that is responsible for implementing any aspect of the National Drug Control Strategy, including any agency that receives Federal funds to implement any aspect of the National Drug Control Strategy, but does not include any agency that receives funds for drug control activity solely under the National Intelligence Program or the Joint Military Intelligence Program. ; (10) in paragraph (12), as so redesignated— (A) by inserting or Strategy before means ; and (B) by inserting , including any report, plan, or strategy required to be incorporated into or issued concurrently with such strategy before the period at the end; (11) by inserting after paragraph (12), as so redesignated, the following: (13) Nonprofit organization The term nonprofit organization means an organization that is described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code. ; (12) in paragraph (14), as so redesignated, by striking Unless the context clearly indicates otherwise, the and inserting The ; (13) by inserting after paragraph (15), as so redesignated, the following: (16) Substance use disorder treatment The term substance use disorder treatment means an evidence-based, professionally directed, deliberate, and planned regimen including evaluation, observation, medical monitoring, and rehabilitative services and interventions such as pharmacotherapy, behavioral therapy, and individual and group counseling, on an inpatient or outpatient basis, to help patients with substance use disorder reach recovery. ; and (14) in paragraph (17), as so redesignated— (A) by redesignating subparagraphs (B), (C), (D), and (E), as subparagraphs (C), (D), (E), and (F), respectively; (B) by inserting after subparagraph (A) the following: (B) domestic law enforcement; ; (C) in subparagraph (E), as so redesignated, by striking and at the end; (D) in subparagraph (F), as so redesignated, by striking the period at the end and inserting a semicolon; and (E) by adding at the end the following: (G) activities to prevent the diversion of drugs for their illicit use; and (H) research related to any of the activities described in this paragraph. . 8217. Amendments to administration of the Office (a) Responsibilities of Office Section 703(a) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1702(a) ) is amended— (1) by striking paragraph (1) and inserting the following: (1) lead the national drug control effort, including coordinating with the National Drug Control Program Agencies; ; (2) in paragraph (2), by inserting before the semicolon the following: , including the National Drug Control Strategy ; (3) in paragraph (3), by striking and at the end; and (4) by striking paragraph (4) and all that follows through the National Academy of Sciences. and inserting the following: (4) evaluate the effectiveness of national drug control policy efforts, including the National Drug Control Program Agencies’ program, by developing and applying specific goals and performance measurements and monitoring the agencies’ program-level spending; (5) identify and respond to emerging drug threats related to illicit drug use; (6) administer the Drug-Free Communities Program, the High-Intensity Drug Trafficking Areas Program, and other grant programs directly authorized to be administered by the Office in furtherance of the National Drug Control Strategy; and (7) facilitate broad-scale information sharing and data standardization among Federal, State, and local entities to support the national drug control efforts. . (b) Ethics guidelines Section 703(d) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1702(d) ) is amended by adding at the end the following: (4) Ethics guidelines The Director shall establish written guidelines setting forth the criteria to be used in determining whether a gift or donation should be declined under this subsection because the acceptance of the gift or donation would— (A) reflect unfavorably upon the ability of the Director or the Office, or any employee of the Office, to carry out responsibilities or official duties under this chapter in a fair and objective manner; or (B) compromise the integrity or the appearance of integrity of programs or services provided under this chapter or of any official involved in those programs or services. (5) Registry of gifts The Director shall maintain a list of— (A) the source and amount of each gift or donation accepted by the Office; and (B) the source and amount of each gift or donation accepted by a contractor to be used in its performance of a contract for the Office. (6) Report to Congress The Director shall include in the annual assessment under section 706(g) a copy of the registry maintained under paragraph (5). . (c) Appointment of Director and Deputy Director Section 704(a) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(a) ) is amended— (1) in paragraph (1), by striking subparagraphs (A), (B), and (C), and inserting the following: (A) Director (i) In general There shall be at the head of the Office a Director who shall hold the same rank and status as the head of an executive department listed in section 101 of title 5, United States Code. (ii) Appointment The Director shall be appointed by the President, by and with the advice and consent of the Senate, and shall serve at the pleasure of the President. (B) Deputy Director There shall be a Deputy Director who shall report directly to the Director, and who shall be appointed by the President, and shall serve at the pleasure of the President. (C) Coordinators The following coordinators shall be appointed by the Director: (i) Performance Budget Coordinator, as described in section 704(c)(4). (ii) Interdiction Coordinator, as described in section 711. (iii) Emerging and Continuing Threats Coordinator, as described in section 709. (iv) State, Local, and Tribal Affairs Coordinator, to carry out the activities described in section 704(j). (v) Demand Reduction Coordinator, as described in subparagraph (D). (D) Demand Reduction Coordinator The Director shall designate or appoint a United States Demand Reduction Coordinator to be responsible for the activities described in section 702(3). The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). ; (2) in paragraph (5), by striking such official and inserting such officer or employee ; and (3) by adding at the end the following: (6) Prohibition on the use of funds for ballot initiatives No funds authorized under this title may be obligated for the purpose of expressly advocating the passage or defeat of a State or local ballot initiative. . (d) Consultation Section 704(b) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(b) ) is amended— (1) in paragraph (19), by striking ; and and inserting a semicolon; (2) in paragraph (20), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (21) in order to formulate the national drug control policies, goals, objectives, and priorities— (A) shall consult with and assist— (i) State and local governments; (ii) National Drug Control Program Agencies; (iii) each committee, working group, council, or other entity established under this chapter, as appropriate; (iv) the public; (v) appropriate congressional committees; and (vi) any other person in the discretion of the Director; and (B) may— (i) establish advisory councils; (ii) acquire data from agencies; and (iii) request data from any other entity. . (e) National Drug Control Program Budget Section 704(c) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(c) ) is amended— (1) in paragraph (2)— (A) in subparagraph (A), by striking paragraph (1)(C); and inserting the following: paragraph (1)(C) and include— (i) the funding level for each National Drug Control Program agency; and (ii) alternative funding structures that could improve progress on achieving the goals fo the National Drug Control Strategy; and ; (B) in subparagraph (B), strike the President; and and inserting the President and Congress. ; and (C) by striking subparagraph (C); (2) in paragraph (3)(E), by striking clause (ii) and inserting the following: (ii) Certification The Director shall— (I) review each budget submission submitted under subparagraph (A); (II) based on the review under clause (i), make a determination as to whether the budget submission of a National Drug Control Program agency includes the funding levels and initiatives described in subparagraph (B); and (III) submit to the appropriate congressional committees— (aa) a written statement that either— (AA) certifies that the budget submission includes sufficient funding; or (BB) decertifies the budget submission as not including sufficient funding; (bb) a copy of the description made under subparagraph (B); and (cc) the budget recommendations made under subsection (b)(8). ; and (3) by adding at the end the following: (5) Performance-budget coordinator (A) Designation The Director shall designate or appoint a United States Performance-Budget Coordinator to— (i) ensure the Director has sufficient information necessary to analyze the performance of each National Drug Control Program Agency, the impact Federal funding has had on the goals in the Strategy, and the likely contributions to the goals of the Strategy based on funding levels of each National Drug Control Program Agency, to make an independent assessment of the budget request of each agency under this subsection; (ii) advise the Director on agency budgets, performance measures and targets, and additional data and research needed to make informed policy decisions under this section and section 706; and (iii) other duties as may be determined by the Director with respect to measuring or assessing performance or agency budgets. (B) Determination of position The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). (6) Budget estimate or request submission to Congress Whenever the Director submits any budget estimate or request to the President or the Office of Management and Budget, the Director shall concurrently transmit to the appropriate congressional committees a detailed statement of the budgetary needs of the Office to execute its mission based on the good-faith assessment of the Director. . (f) Powers and responsibilities of the Director Section 704 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703 ) is amended— (1) in subsection (d)(8)— (A) in subparagraph (D), by striking and at the end; (B) in subparagraph (E)— (i) in clause (i)— (I) by striking Congress, including to the Committees on Appropriations of the Senate and the House of Representatives, the authorizing committees for the Office, and inserting the appropriate congressional committees ; and (II) by striking or agencies ; (ii) in clause (ii)— (I) by striking Congress and inserting the appropriate congressional committees ; and (II) by adding and at the end; and (iii) by adding at the end the following: (iii) funds may only be used for— (I) expansion of demand reduction activities; (II) interdiction of illicit drugs on the high seas, in United States territorial waters, and at United States ports of entry by officers and employees of National Drug Control Program Agencies and domestic and foreign law enforcement officers; (III) accurate assessment and monitoring of international drug production and interdiction programs and policies; (IV) activities to facilitate and enhance the sharing of domestic and foreign intelligence information among National Drug Control Program Agencies related to the production and trafficking of drugs in the United States and foreign countries; and (V) research related to any of these activities. ; (2) in subsection (e)(2)(A), by striking Notwithstanding any other provision of law and inserting Subject to the availability of appropriations ; and (3) by adding at the end the following: (i) Model Acts Program (1) In general The Director shall provide for or shall enter into an agreement with a nonprofit organization to— (A) advise States on establishing laws and policies to address illicit drug use issues; and (B) revise such model State drug laws and draft supplementary model State laws to take into consideration changes in illicit drug use issues in the State involved. (2) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $1,250,000 for each of fiscal years 2018 through 2023. (j) State, Local, and Tribal Affairs Coordinator The Director shall designate or appoint a United States State, Local, and Tribal Affairs Coordinator to perform the duties of the Office outlined in this section and 706 and such other duties as may be determined by the Director with respect to coordination of drug control efforts between agencies and State, local, and Tribal governments. The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). (k) Harm reduction programs When developing the national drug control policy, any policy of the Director, including policies relating to syringe exchange programs for intravenous drug users, shall be based on the best available medical and scientific evidence regarding the effectiveness of such policy in promoting individual health and preventing the spread of infectious disease and the impact of such policy on drug addiction and use. In making any policy relating to harm reduction programs, the Director shall consult with the National Institutes of Health and the National Academy of Sciences. . (g) Accounting of funds expended Section 705 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1704(d) ), as amended by section 8207 is further amended— (1) by amending subsection (d) to read as follows: (d) Accounting of Funds Expended (1) In general Not later than February 1 of each year, in accordance with guidance issued by the Director, the head of each National Drug Control Program Agency shall submit to the Director a detailed accounting of all funds expended by the agency for National Drug Control Program activities during the previous fiscal year and shall ensure such detailed accounting is authenticated for the previous fiscal year by the Inspector General for such agency prior to the submission to the Director as frequently as determined by the Inspector General but not less frequently that every 3 years. (2) Submission to Congress The Director shall submit to Congress not later than April 1 of each year the information submitted to the Director under paragraph (1). ; and (2) by adding at the end the following: (f) Tracking system for federally funded grant programs (1) Establishment The Director, or the head of an agency designated by the Director, in coordination with the Secretary of Health and Human Services, shall track federally-funded grant programs to— (A) ensure the public has electronic access to information identifying: (i) all drug control grants and pertinent identifying information for each grant; (ii) any available performance metrics, evaluations, or other information indicating the effectiveness of such programs; (B) facilitate efforts to identify duplication, overlap, or gaps in funding to provide increased accountability of Federally-funded grants for substance use disorder treatment, prevention, and enforcement; and (C) identify barriers in the grant application process impediments that applicants currently have in the grant application process with applicable agencies. (2) National Drug Control Agencies The head of each National Drug Control Program Agency shall provide to the Director a complete list of all drug control program grant programs and any other relevant information for inclusion in the system developed under paragraph (1) and annually update such list. (3) Updating existing systems The Director may meet the requirements of this subsection by utilizing, updating, or improving existing Federal information systems to ensure they meet the requirements of this subsection. (4) Report Not later than 3 years after the date of enactment of this subsection, the Comptroller General of the United States shall submit to Congress a report examining implementation of this subsection. . (h) Technical and conforming amendment Section 1105 of the Office of National Drug Control Policy Reauthorization Act of 2006 ( 21 U.S.C. 1701 note) is repealed. 8218. Emerging threats committee, plan, and media campaign (a) In general Section 709 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1708 ) is amended to read as follows: 709. Emerging threats committee, plan, and media campaign (a) Emerging threats coordinator The Director shall designate or appoint a United States Emerging and Continuing Threats Coordinator to perform the duties of that position described in this section and such other duties as may be determined by the Director. The Director shall determine whether the coordinator position is a noncareer appointee in the Senior Executive Service or a career appointee in a position at level 15 of the General Schedule (or equivalent). (b) Emerging threats committee (1) In general The Emerging Threats Committee shall— (A) monitor evolving and emerging drug threats in the United States; (B) identify and discuss evolving and emerging drug trends in the United States using the criteria required to be established under paragraph (6); (C) assist in the formulation of and oversee implementation of any plan described in subsection (d); (D) provide such other advice to the Coordinator and Director concerning strategy and policies for emerging drug threats and trends as the Committee determines to be appropriate; and (E) disseminate and facilitate the sharing with Federal, State, local, and Tribal officials and other entities as determined by the Director of pertinent information and data relating to— (i) recent trends in drug supply and demand; (ii) fatal and nonfatal overdoses; (iii) demand for and availability of evidence-based substance use disorder treatment, including the extent of the unmet treatment need, and treatment admission trends; (iv) recent trends in drug interdiction, supply, and demand from State, local, and Tribal law enforcement agencies; and (v) other subject matter as determined necessary by the Director. (2) Chairperson The Director shall designate one of the members of the Emerging Threats Committee to serve as Chairperson. (3) Members The Director shall appoint other members of the Committee, which shall include— (A) representatives from National Drug Control Program Agencies or other agencies; (B) representatives from State, local, and Tribal governments; and (C) representatives from other entities as designated by the Director. (4) Meetings The members of the Emerging Threats Committee shall meet, in person and not through any delegate or representative, not less frequently than once per calendar year, before June 1. At the call of the Director or the Chairperson, the Emerging Threats Committee may hold additional meetings as the members may choose. (5) Contract, agreement, and other authority The Director may award contracts, enter into interagency agreements, manage individual projects, and conduct other activities in support of the identification of emerging drug threats and in support of the development, implementation, and assessment of any Emerging Threat Response Plan. (6) Criteria to identify emerging drug threats Not later than 180 days after the date on which the Committee first meets, the Committee shall develop and recommend to the Director criteria to be used to identify an emerging drug threat or the termination of an emerging drug threat designation based on information gathered by the Committee, statistical data, and other evidence. (c) Designation (1) In general The Director, in consultation with the Coordinator, the Committee, and the head of each National Drug Control Program Agency, may designate an emerging drug threat in the United States. (2) Standards for designation The Director, in consultation with the Coordinator, shall promulgate and make publicly available standards by which a designation under paragraph (1) and the termination of such designation may be made. In developing such standards, the Director shall consider the recommendations of the committee and other criteria the Director considers to be appropriate. (3) Public statement required The Director shall publish a public written statement on the portal of the Office explaining the designation of an emerging drug threat or the termination of such designation and shall notify the appropriate congressional committees of the availability of such statement when a designation or termination of such designation has been made. (d) Plan (1) Public availability of plan Not later than 90 days after making a designation under subsection (c), the Director shall publish and make publicly available an Emerging Threat Response Plan and notify the President and the appropriate congressional committees of such plan’s availability. (2) Timing Concurrently with the annual submissions under section 706(g), the Director shall update the plan and report on implementation of the plan, until the Director issues the public statement required under subsection (c)(3) to terminate the emerging drug threat designation. (3) Contents of an emerging threat response plan The Director shall include in the plan required under this subsection— (A) a comprehensive strategic assessment of the emerging drug threat, including the current availability of, demand for, and effectiveness of evidence-based prevention, treatment, and enforcement programs and efforts to respond to the emerging drug threat; (B) comprehensive, research-based, short- and long-term, quantifiable goals for addressing the emerging drug threat, including for reducing the supply of the drug designated as the emerging drug threat and for expanding the availability and effectiveness of evidence-based substance use disorder treatment and prevention programs to reduce the demand for the emerging drug threat; (C) performance measures pertaining to the plan’s goals, including quantifiable and measurable objectives and specific targets; (D) the level of funding needed to implement the plan, including whether funding is available to be reprogrammed or transferred to support implementation of the plan or whether additional appropriations are necessary to implement the plan; (E) an implementation strategy for the media campaign under subsection (f), including goals as described under subparagraph (B) of this paragraph and performance measures, objectives, and targets, as described under subparagraph (C) of this paragraph; and (F) any other information necessary to inform the public of the status, progress, or response of an emerging drug threat. (4) Implementation (A) In general Not later than 120 days after the date on which a designation is made under subsection (c), the Director, in consultation with the President, the appropriate congressional committees, and the head of each National Drug Control Program Agency, shall issue guidance on implementation of the plan described in this subsection to the National Drug Control Program Agencies and any other relevant agency determined to be necessary by the Director. (B) Coordinator’s responsibilities The Coordinator shall— (i) direct the implementation of the plan among the agencies identified in the plan, State, local, and Tribal governments, and other relevant entities; (ii) facilitate information-sharing between agencies identified in the plan, State, local, and Tribal governments, and other relevant entities; and (iii) monitor implementation of the plan by coordinating the development and implementation of collection and reporting systems to support performance measurement and adherence to the plan by agencies identified in plan, where appropriate. (C) Reporting Not later than 180 days after the date on which a designation is made under subsection (c) and in accordance with subparagraph (A), the head of each agency identified in the plan shall submit to the Coordinator a report on implementation of the plan. (e) Evaluation of media campaign Upon designation of an emerging drug threat, the Director shall evaluate whether a media campaign would be appropriate to address that threat. (f) National anti-drug media campaign (1) In general The Director shall, to the extent feasible and appropriate, conduct a national anti-drug media campaign (referred to in this subtitle as the national media campaign ) in accordance with this subsection for the purposes of— (A) preventing substance abuse among people in the United States; (B) educating the public about the dangers and negative consequences of substance use and abuse, including patient and family education about the characteristics and hazards of substance abuse and methods to safeguard against substance use, to include the safe disposal of prescription medications; (C) supporting evidence-based prevention programs targeting the attitudes, perception, and beliefs of persons concerning substance use and intentions to initiate or continue such use; (D) encouraging individuals affected by substance use disorders to seek treatment and providing such individuals with information on— (i) how to recognize addiction issues; (ii) what forms of evidence-based treatment options are available; and (iii) how to access such treatment; (E) combating the stigma of addiction and substance use disorders, including the stigma of treating such disorders with medication-assisted treatment therapies; and (F) informing the public about the dangers of any drug identified by the Director as an emerging drug threat as appropriate. (2) Use of funds (A) In general Amounts made available to carry out this subsection for the national media campaign may only be used for the following: (i) The purchase of media time and space, including the strategic planning for, tracking, and accounting of, such purchases. (ii) Creative and talent costs, consistent with subparagraph (B)(i). (iii) Advertising production costs, which may include television, radio, internet, social media, and other commercial marketing venues. (iv) Testing and evaluation of advertising. (v) Evaluation of the effectiveness of the national media campaign. (vi) Costs of contracts to carry out activities authorized by this subsection. (vii) Partnerships with professional and civic groups, community-based organizations, including faith-based organizations, and government organizations related to the national media campaign. (viii) Entertainment industry outreach, interactive outreach, media projects and activities, public information, news media outreach, and corporate sponsorship and participation. (ix) Operational and management expenses. (B) Specific requirements (i) Creative services In using amounts for creative and talent costs under subparagraph (A)(ii), the Director shall use creative services donated at no cost to the Government wherever feasible and may only procure creative services for advertising— (I) responding to high-priority or emergent campaign needs that cannot timely be obtained at no cost; or (II) intended to reach a minority, ethnic, or other special audience that cannot reasonably be obtained at no cost. (ii) Testing and evaluation of advertising In using amounts for testing and evaluation of advertising under subparagraph (A)(iv), the Director shall test all advertisements prior to use in the national media campaign to ensure that the advertisements are effective with the target audience and meet industry-accepted standards. The Director may waive this requirement for advertisements using no more than 10 percent of the purchase of advertising time purchased under this subsection in a fiscal year and no more than 10 percent of the advertising space purchased under this subsection in a fiscal year, if the advertisements respond to emergent and time-sensitive campaign needs or the advertisements will not be widely utilized in the national media campaign. (iii) Consultation For the planning of the campaign under paragraph (1), the Director may consult with— (I) the head of any appropriate National Drug Control Program Agency; (II) experts on the designated drug; (III) State, local, and Tribal government officials and relevant agencies; (IV) communications professionals; (V) the public; and (VI) appropriate congressional committees. (iv) Evaluation of effectiveness of national media campaign In using amounts for the evaluation of the effectiveness of the national media campaign under subparagraph (A)(v), the Director shall— (I) designate an independent entity to evaluate by April 20 of each year the effectiveness of the national media campaign based on data from— (aa) the Monitoring the Future Study published by the Department of Health and Human Services; (bb) the National Survey on Drug Use and Health; and (cc) other relevant studies or publications, as determined by the Director, including tracking and evaluation data collected according to marketing and advertising industry standards; and (II) ensure that the effectiveness of the national media campaign is evaluated in a manner that enables consideration of whether the national media campaign has contributed to changes in attitude or behaviors among the target audience with respect to substance use and such other measures of evaluation as the Director determines are appropriate. (3) Advertising In carrying out this subsection, the Director shall ensure that sufficient funds are allocated to meet the stated goals of the national media campaign. (4) Responsibilities and functions under the program (A) In general The Director shall determine the overall purposes and strategy of the national media campaign. (B) Director (i) In general The Director shall approve— (I) the strategy of the national media campaign; (II) all advertising and promotional material used in the national media campaign; and (III) the plan for the purchase of advertising time and space for the national media campaign. (ii) Implementation The Director shall be responsible for implementing a focused national media campaign to meet the purposes set forth in paragraph (1) and shall ensure— (I) information disseminated through the campaign is accurate and scientifically valid; and (II) the campaign is designed using strategies demonstrated to be the most effective at achieving the goals and requirements of paragraph (1), which may include— (aa) a media campaign, as described in paragraph (2); (bb) local, regional, or population specific messaging; (cc) the development of websites to publicize and disseminate information; (dd) conducting outreach and providing educational resources for parents; (ee) collaborating with law enforcement agencies; and (ff) providing support for school-based public health education classes to improve teen knowledge about the effects of substance use. (5) Prohibitions None of the amounts made available under paragraph (2) may be obligated or expended for any of the following: (A) To supplant current anti-drug community-based coalitions. (B) To supplant pro bono public service time donated by national and local broadcasting networks for other public service campaigns. (C) For partisan political purposes, or to express advocacy in support of or to defeat any clearly identified candidate, clearly identified ballot initiative, or clearly identified legislative or regulatory proposal. (D) To fund advertising that features any elected officials, persons seeking elected office, cabinet level officials, or other Federal officials employed pursuant to section 213 of Schedule C of title 5, Code of Federal Regulations. (E) To fund advertising that does not contain a primary message intended to reduce or prevent substance use. (F) To fund advertising containing a primary message intended to promote support for the national media campaign or private sector contributions to the national media campaign. (6) Matching requirement (A) In general Amounts made available under paragraph (2) for media time and space shall be matched by an equal amount of non-Federal funds for the national media campaign, or be matched with in-kind contributions of the same value. (B) No-cost match advertising direct relationship requirement The Director shall ensure that not less than 85 percent of no-cost match advertising directly relates to substance abuse prevention consistent with the specific purposes of the national media campaign. (C) No-cost match advertising not directly related The Director shall ensure that no-cost match advertising that does not directly relate to substance abuse prevention consistent with the purposes of the national media campaign includes a clear anti-drug message. Such message is not required to be the primary message of the match advertising. (7) Financial and performance accountability The Director shall cause to be performed— (A) audits and reviews of costs of the national media campaign pursuant to section 4706 of title 41, United States Code; and (B) an audit to determine whether the costs of the national media campaign are allowable under chapter 43 of title 41, United States Code. (8) Report to congress The Director shall submit on an annual basis a report to Congress that describes— (A) the strategy of the national media campaign and whether specific objectives of the national media campaign were accomplished; (B) steps taken to ensure that the national media campaign operates in an effective and efficient manner consistent with the overall strategy and focus of the national media campaign; (C) plans to purchase advertising time and space; (D) policies and practices implemented to ensure that Federal funds are used responsibly to purchase advertising time and space and eliminate the potential for waste, fraud, and abuse; (E) all contracts entered into with a corporation, partnership, or individual working on behalf of the national media campaign; (F) the results of any financial audit of the national media campaign; (G) a description of any evidence used to develop the national media campaign; (H) specific policies and steps implemented to ensure compliance with this section; (I) a detailed accounting of the amount of funds obligated during the previous fiscal year for carrying out the national media campaign, including each recipient of funds, the purpose of each expenditure, the amount of each expenditure, any available outcome information, and any other information necessary to provide a complete accounting of the funds expended; and (J) a review and evaluation of the effectiveness of the national media campaign strategy for the past year. (9) Required notice for communication from the office Any communication, including an advertisement, paid for or otherwise disseminated by the Office directly or through a contract awarded by the Office shall include a prominent notice informing the audience that the communication was paid for by the Office. (g) Authorization of Appropriations There is authorized to be appropriated to the Office to carry out this section, $25,000,000 for each of fiscal years 2018 through 2023. . (b) Technical and conforming amendment Subsection (a) of section 203 of the Office of National Drug Control Policy Reauthorization Act of 2006 ( 21 U.S.C. 1708a ) is repealed. 8219. Drug interdiction (a) Repeal This first section 711 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1710 ) is repealed. (b) Amendments Section 711 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1710 ), as added by Public Law 109–469 (120 Stat. 3507), is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking The United and inserting The Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent) as the United ; and (ii) by striking shall and inserting to ; (B) in paragraph (2)(B)— (i) by striking March 1 and inserting September 1 ; and (ii) by striking paragraph (3) and inserting paragraph (4) ; (C) in paragraph (3)— (i) by striking also, at his discretion, ; and (ii) by striking the Office of Supply Reduction for that purpose and inserting assist in carrying out such responsibilities ; and (D) in paragraph (4)— (i) in subparagraph (B), by striking The United and inserting Before submission of the National Drug Control Strategy or annual assessment required under section 706, as applicable, the United ; (ii) by striking subparagraphs (C) and (E); (iii) by redesignating subparagraph (D) as subparagraph (C); (iv) in subparagraph (C), as so redesignated— (I) in the matter preceding clause (i)— (aa) by striking March 1 and inserting September 1 ; (bb) by inserting the Director, acting through before the United States ; (cc) by inserting a comma after Coordinator ; (dd) by striking a report on behalf of the Director ; and (ee) by striking , which shall include and inserting a report that ; (II) by redesignating clauses (i), (ii), and (iii) as subclauses (I), (II), and (III), and adjusting the margins accordingly; (III) by inserting before subclause (I), as so redesignated, the following: (i) includes— ; (IV) in clause (i), as so redesignated— (aa) in subclause (I), as so redesignated, by inserting , including information about how each National Drug Control Program agency conducting drug interdiction activities is engaging with relevant international partners after Plan ; (bb) in subclause (II), as so redesignated, by striking , as well as and inserting and ; (cc) in subclause III, as so redesignated— (AA) by striking , as well as and inserting and ; and (BB) by striking the period at the end and inserting ; and ; and (V) by adding at the end the following: (ii) may include recommendations for changes to existing agency authorities or laws governing interagency relationships. ; and (v) by adding at the end the following: (D) Classified annex Each report required to be submitted under subparagraph (C) shall be in unclassified form, but may include a classified annex. ; (2) in subsection (b)— (A) in paragraph (1)(B), by inserting and how to strengthen international partnerships to better achieve the goals of that plan after that plan ; (B) in paragraph (2)— (i) in the paragraph heading, by striking Chairman and inserting Chairperson ; and (ii) by striking chairman and inserting Chairperson ; (C) in paragraph (3)— (i) by striking prior to March 1 and inserting before June 1 ; (ii) by striking either each place it appears; (iii) by striking current chairman and inserting Chairperson ; and (iv) by striking they and inserting the members ; and (D) in paragraph (4)— (i) by striking chairman each place it appears and inserting Chairperson ; (ii) in the first sentence, by striking a report ; (iii) by inserting a report after committees ; and (iv) by striking the second sentence and inserting the following: The report required under this paragraph shall be in unclassified form, but may include a classified annex. ; and (3) by adding at the end the following: (c) International coordination The Director may facilitate international drug control coordination efforts. . 8220. GAO Audit Not later than 4 years after the date of enactment of this Act, and every 4 years thereafter, the Comptroller General of the United States shall— (1) conduct an audit relating to the programs and operations of— (A) the Office; and (B) certain programs within the Office, including— (i) the High Intensity Drug Trafficking Areas Program; (ii) the Drug-Free Communities Program; and (iii) the campaign under section 709(f) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1708(f) ); and (2) submit to the Director and the appropriate congressional committees a report containing an evaluation of and recommendations on the— (A) policies and activities of the programs and operations subject to the audit; (B) economy, efficiency, and effectiveness in the administration of the reviewed programs and operations; and (C) policy or management changes needed to prevent and detect fraud and abuse in such programs and operations. 8221. National Drug Control Strategy (a) In general Section 706 of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1705 ) is amended to read as follows: 706. National drug control strategy (a) In general (1) Statement of drug policy priorities The Director shall release a statement of drug control policy priorities in the calendar year of a Presidential inauguration following the inauguration, but not later than April 1. (2) National drug control strategy submitted by the president Not later than the first Monday in February following the year in which the term of the President commences, and every 2 years thereafter, the President shall submit to Congress a National Drug Control Strategy. (b) Development of the national drug control strategy (1) Promulgation The Director shall promulgate the National Drug Control Strategy, which shall set forth a comprehensive plan to reduce illicit drug use and the consequences of such illicit drug use in the United States by limiting the availability of and reducing the demand for illegal drugs and promoting prevention, early intervention, treatment, and recovery support for individuals with substance use disorders. (2) State and local commitment The Director shall seek the support and commitment of State, local, and Tribal officials in the formulation and implementation of the National Drug Control Strategy. (3) Strategy based on evidence The Director shall ensure the National Drug Control Strategy is based on the best available evidence regarding the policies that are most effective in reducing the demand for and supply of illegal drugs. (4) Process for development and submission of national drug control strategy In developing and effectively implementing the National Drug Control Strategy, the Director— (A) shall consult with— (i) the heads of the National Drug Control Program Agencies; (ii) each Coordinator listed in section 704; (iii) the Interdiction Committee and the Emerging Threats Committee; (iv) the appropriate congressional committees and any other committee of jurisdiction; (v) State, local, and Tribal officials; (vi) private citizens and organizations, including community and faith-based organizations, with experience and expertise in demand reduction; (vii) private citizens and organizations with experience and expertise in supply reduction; and (viii) appropriate representatives of foreign governments; and (B) in satisfying the requirements of subparagraph (A), shall ensure, to the maximum extent possible, that State, local, and Tribal officials and relevant private organizations commit to support and take steps to achieve the goals and objectives of the National Drug Control Strategy. (c) Contents of the national drug control strategy (1) In general The National Drug Control Strategy submitted under subsection (a)(2) shall include the following: (A) A mission statement detailing the major functions of the National Drug Control Program. (B) Comprehensive, research-based, long-range, quantifiable goals for reducing illicit drug use, and the consequences of illicit drug use in the United States. (C) Annual quantifiable and measurable objectives and specific targets to accomplish long-term quantifiable goals that the Director determines may be achieved during each year beginning on the date on which the National Drug Control Strategy is submitted. (D) A 5-year projection for the National Drug Control Program and budget priorities. (E) A review of international, State, local, and private sector drug control activities to ensure that the United States pursues coordinated and effective drug control at all levels of government. (F) A description of how each goal established under subparagraph (B) will be achieved, including for each goal— (i) a list of each relevant National Drug Control Program Agency and each such agency’s related programs, activities, and available assets and the role of each such program, activity, and asset in achieving such goal; (ii) a list of relevant stakeholders and each such stakeholder’s role in achieving such goal; (iii) an estimate of Federal funding and other resources needed to achieve such goal; (iv) a list of each existing or new coordinating mechanism needed to achieve such goal; and (v) a description of the Office’s role in facilitating the achievement of such goal. (G) For each year covered by the Strategy, a performance evaluation plan for each goal established under subparagraph (B) for each National Drug Control Program Agency, including— (i) specific performance measures for each National Drug Control Program Agency; (ii) annual and, to the extent practicable, quarterly objectives and targets for each performance measure; and (iii) an estimate of Federal funding and other resources needed to achieve each performance objective and target. (H) A list identifying existing data sources or a description of data collection needed to evaluate performance, including a description of how the Director will obtain such data. (I) A list of any anticipated challenges to achieving the National Drug Control Strategy goals and planned actions to address such challenges. (J) A description of how each goal established under subparagraph (B) was determined, including— (i) a description of each required consultation and a description of how such consultation was incorporated; and (ii) data, research, or other information used to inform the determination to establish the goal. (K) A description of the current prevalence of illicit drug use in the United States, including both the availability of illicit drugs and the prevalence of substance use disorders. (L) Such other statistical data and information as the Director considers appropriate to demonstrate and assess trends relating to illicit drug use, the effects and consequences of illicit drug use (including the effects on children), supply reduction, demand reduction, drug-related law enforcement, and the implementation of the National Drug Control Strategy. (M) A systematic plan for increasing data collection to enable real time surveillance of drug control threats, developing analysis and monitoring capabilities, and identifying and addressing policy questions related to the National Drug Control Strategy and Program, which shall include— (i) a list of policy-relevant questions for which the Director and each National Drug Control Program Agency intends to develop evidence to support the National Drug Control Program and Strategy; (ii) a list of data the Director and each National Drug Control Program Agency intends to collect, use, or acquire to facilitate the use of evidence in drug control policymaking and monitoring; (iii) a list of methods and analytical approaches that may be used to develop evidence to support the National Drug Control Program and Strategy and related policy; (iv) a list of any challenges to developing evidence to support policymaking, including any barriers to accessing, collecting, or using relevant data; (v) a description of the steps the Director and the head of each National Drug Control Program Agency will take to effectuate the plan; and (vi) any other relevant information as determined by the Director. (N) A plan to expand treatment of substance use disorders, which shall— (i) identify unmet needs for treatment for substance use disorders and a strategy for closing the gap between available and needed treatment; (ii) describe the specific roles and responsibilities of the relevant National Drug Control Programs for implementing the plan; (iii) identify the specific resources required to enable the relevant National Drug Control Agencies to implement that strategy; and (iv) identify the resources, including private sources, required to eliminate the unmet need for evidence-based substance use disorder treatment. (2) Consultation In developing the plan required under paragraph (1), the Director shall consult with the following: (A) The public. (B) Any evaluation or analysis units and personnel of the Office. (C) Office officials responsible for implementing privacy policy. (D) Office officials responsible for data governance. (E) The appropriate congressional committees. (F) Any other individual or entity as determined by the Director. (3) Additional strategies (A) In general The Director shall include in the National Drug Control Strategy the additional strategies described under this paragraph and shall comply with the following: (i) Provide a copy of the additional strategies to the appropriate congressional committees and to the Committee on Armed Services and the Committee on Homeland Security of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs and the Committee on Armed Services of the Senate. (ii) Issue the additional strategies in consultation with the head of each relevant National Drug Control Program Agency, any relevant official of a State, local, or Tribal government, and the government of other relevant countries. (iii) Not change any existing agency authority or construe any strategy described under this paragraph to amend or modify any law governing interagency relationship but may include recommendations about changes to such authority or law. (iv) Present separately from the rest of any strategy described under this paragraph any information classified under criteria established by an Executive order, or whose public disclosure, as determined by the Director or the head of any relevant National Drug Control Program Agency, would be detrimental to the law enforcement or national security activities of any Federal, State, local, or Tribal agency. (B) Requirement for southwest border counternarcotics strategy (i) Purposes The Southwest Border Counternarcotics Strategy shall— (I) set forth the Government’s strategy for preventing the illegal trafficking of drugs across the international border between the United States and Mexico, including through ports of entry and between ports of entry on that border; (II) state the specific roles and responsibilities of the relevant National Drug Control Program Agencies for implementing that strategy; and (III) identify the specific resources required to enable the relevant National Drug Control Program Agencies to implement that strategy. (ii) Specific content related to drug tunnels between the United States and Mexico The Southwest Border Counternarcotics Strategy shall include— (I) a strategy to end the construction and use of tunnels and subterranean passages that cross the international border between the United States and Mexico for the purpose of illegal trafficking of drugs across such border; and (II) recommendations for criminal penalties for persons who construct or use such a tunnel or subterranean passage for such a purpose. (C) Requirement for Northern Border Counternarcotics Strategy (i) Purposes The Northern Border Counternarcotics Strategy shall— (I) set forth the strategy of the Federal Government for preventing the illegal trafficking of drugs across the international border between the United States and Canada, including through ports of entry and between ports of entry on the border; (II) state the specific roles and responsibilities of each relevant National Drug Control Program Agency for implementing the strategy; (III) identify the specific resources required to enable the relevant National Drug Control Program Agencies to implement the strategy; (IV) be designed to promote, and not hinder, legitimate trade and travel; and (V) reflect the unique nature of small communities along the international border between the United States and Canada, ongoing cooperation and coordination with Canadian law, enforcement authorities, and variations in the volumes of vehicles and pedestrians crossing through ports of entry along the international border between the United States and Canada. (ii) Specific content related to cross-border Indian reservations The Northern Border Counternarcotics Strategy shall include— (I) a strategy to end the illegal trafficking of drugs to or through Indian reservations on or near the international border between the United States and Canada; and (II) recommendations for additional assistance, if any, needed by Tribal law enforcement agencies relating to the strategy, including an evaluation of Federal technical and financial assistance, infrastructure capacity building, and interoperability deficiencies. (4) Classified information Any contents of the National Drug Control Strategy that involve information properly classified under criteria established by an Executive order shall be presented to Congress separately from the rest of the National Drug Control Strategy. (5) Selection of data and information In selecting data and information for inclusion in the Strategy, the Director shall ensure— (A) the inclusion of data and information that will permit analysis of current trends against previously compiled data and information where the Director believes such analysis enhances long-term assessment of the National Drug Control Strategy; and (B) the inclusion of data and information to permit a standardized and uniform assessment of the effectiveness of drug treatment programs in the United States. (d) Submission of revised strategy The President may submit to Congress a revised National Drug Control Strategy that meets the requirements of this section— (1) at any time, upon a determination of the President, in consultation with the Director, that the National Drug Control Strategy in effect is not sufficiently effective; or (2) if a new President or Director takes office. (e) Failure of Director to submit National Drug Control Strategy If the Director does not submit a National Drug Control Strategy to Congress in accordance with subsection (a)(2), not later than five days after the first Monday in February following the year in which the term of the President commences, the Director shall send a notification to the appropriate congressional committees— (1) explaining why the Strategy was not submitted; and (2) specifying the date by which the Strategy will be submitted. (f) Drug control data dashboard (1) In general The Director shall collect and disseminate, as appropriate, such information as the Director determines is appropriate, but not less than the information described in this subsection. The data shall be publicly available in a machine-readable format on the online portal of the Office, and to the extent practicable on the Drug Control Data Dashboard. (2) Establishment The Director shall publish to the online portal of the office in a machine-readable, sortable, and searchable format, or to the extent practicable, establish and maintain a data dashboard on the online portal of the Office to be known as the Drug Control Data Dashboard . To the extent practicable, when establishing the Drug Control Dashboard, the Director shall ensure the user interface of the dashboard is constructed with modern design standards. To the extent practicable, the data made available on the dashboard shall be publicly available in a machine-readable format and searchable by year, agency, drug, and location. (3) Data The data included in the Drug Control Data Dashboard shall be updated quarterly to the extent practicable, but not less frequently than annually and shall include, at a minimum, the following: (A) For each substance identified by the Director as having a significant impact on the prevalence of illicit drug use— (i) data sufficient to show the quantities of such substance available in the United States, including— (I) the total amount seized and disrupted in the calendar year and each of the previous 3 calendar years, including to the extent practicable the amount seized by State, local, and Tribal governments; (II) the known and estimated flows into the United States from all sources in the calendar year and each of the previous 3 calendar years; (III) the total amount of known flows that could not be interdicted or disrupted in the calendar year and each of the previous 3 calendar years; (IV) the known and estimated levels of domestic production in the calendar year and each of the previous three calendar years, including the levels of domestic production if the drug is a prescription drug, as determined under the Federal Food, Drug, and Cosmetic Act, for which a listing is in effect under section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ); (V) the average street price for the calendar year and the highest known street price during the preceding 10-year period; and (VI) to the extent practicable, related prosecutions by State, local, and Tribal governments; (ii) data sufficient to show the frequency of use of such substance, including— (I) use of such substance in the workplace and productivity lost by such use; (II) use of such substance by arrestees, probationers, and parolees; (III) crime and criminal activity related to such substance; (IV) to the extent practicable, related prosecutions by State, local, and Tribal governments; (B) For the calendar year and each of the previous three years data sufficient to show, disaggregated by State and, to the extent feasible, by region within a State, county, or city, the following: (i) The number of fatal and non-fatal overdoses caused by each drug identified under subparagraph (A)(i). (ii) The prevalence of substance use disorders. (iii) The number of individuals who have received substance use disorder treatment, including medication assisted treatment, for a substance use disorder, including treatment provided through publicly-financed health care programs. (iv) The extent of the unmet need for substance use disorder treatment, including the unmet need for medication-assisted treatment. (C) Data sufficient to show the extent of prescription drug diversion, trafficking, and misuse in the calendar year and each of the previous 3 calendar years. (D) Any quantifiable measures the Director determines to be appropriate to detail progress toward the achievement of the goals of the National Drug Control Strategy. (g) Development of an annual national drug control assessment (1) Timing Not later than the first Monday in February of each year, the Director shall submit to the President, Congress, and the appropriate congressional committees, a report assessing the progress of each National Drug Control Program Agency toward achieving each goal, objective, and target contained in the National Drug Control Strategy applicable to the prior fiscal year. (2) Process for development of the annual assessment Not later than November 1 of each year, the head of each National Drug Control Program Agency shall submit, in accordance with guidance issued by the Director, to the Director an evaluation of progress by the agency with respect to the National Drug Control Strategy goals using the performance measures for the agency developed under this title, including progress with respect to— (A) success in achieving the goals of the National Drug Control Strategy; (B) success in reducing domestic and foreign sources of illegal drugs; (C) success in expanding access to and increasing the effectiveness of substance use disorder treatment; (D) success in protecting the borders of the United States (and in particular the Southwestern border of the United States) from penetration by illegal narcotics; (E) success in reducing crime associated with drug use in the United States; (F) success in reducing the negative health and social consequences of drug use in the United States; (G) implementation of evidence-based substance use disorder treatment and prevention programs in the United States and improvements in the adequacy and effectiveness of such programs; and (H) success in increasing the prevention of illicit drug use. (3) Contents of the annual assessment The Director shall include in the annual assessment required under paragraph (1)— (A) a summary of each evaluation received by the Director under paragraph (2); (B) a summary of the progress of each National Drug Control Program Agency toward the National Drug Control Strategy goals of the agency using the performance measures for the agency developed under this chapter; (C) an assessment of the effectiveness of each National Drug Control Program Agency and program in achieving the National Drug Control Strategy for the previous year, including a specific evaluation of whether the applicable goals, measures, objectives, and targets for the previous year were met; and (D) the assessments required under this subsection shall be based on the Performance Measurement System. . (b) Technical and conforming amendments (1) Section 704(b) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(b) ) is amended— (A) by striking paragraphs (13) and (17); and (B) in paragraph (14)(A), by striking paragraph (13) and inserting section 706(g)(2) . (2) The Office of National Drug Control Policy Reauthorization Act of 2006 ( Public Law 109–469 ; 120 Stat. 3502) is amended by striking sections 1110 and 1110A. 8222. Technical and conforming amendments to the Office of National Drug Control Policy Reauthorization Act of 1998 The Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1701 et seq.) is amended— (1) by striking section 703(b) ( 21 U.S.C. 1702(b) ); (2) in section 704 ( 21 U.S.C. 1703 )— (A) in subsection (c)— (i) in paragraph (3)(C)— (I) in the matter before clause (i), by inserting requests a level of funding that will not enable achievement of the goals of the National Drug Control Strategy, including after request that ; (II) in clause (iii)— (aa) by striking drug treatment and inserting substance use disorder prevention and treatment ; and (bb) by striking the semicolon at the end and inserting ; and ; (III) by striking clauses (iv), (vi), and (vii); (IV) by redesignating clause (v) as clause (iv); and (V) in clause (iv), as so redesignated, by striking the semicolon and inserting a period; (ii) in paragraph (4)(A), by striking $1,000,000 and inserting $5,000,000 or 10 percent of a specific program or account ; and (B) in subsection (f)— (i) by striking the first paragraph (5); and (ii) by striking the second paragraph (4); and (3) by striking section 708 ( 21 U.S.C. 1707 ). L Budgetary effects 8231. Budgetary effect (a) In General The budgetary effects of this Act shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010 ( 2 U.S.C. 933(d) ). (b) Senate PAYGO Scorecards The budgetary effects of this Act shall not be entered on any PAYGO scorecard maintained for purposes of section 4106 of H. Con. Res. 71 (115th Congress).

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.