H. Res. 1099 

In the House of Representatives, U. S., 

September 28, 2018. 

Resolved, That upon the adoption of this resolution the 

House shall be considered to have taken from the Speaker’s 

table the bill, H.R. 6, with the Senate amendment thereto, 

and to have concurred in the Senate amendment with the following amendment: 

In lieu of the matter proposed to be inserted by the 

amendment of the Senate to the text of the bill, insert 

the following: 

SECTION 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. 
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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
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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. 
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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 
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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. 
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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. 
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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. 
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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. 
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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. 
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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. 
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Subtitle L—Budgetary Effects 

Sec. 8231. Budgetary effect. 

TITLE I—MEDICAID PROVISIONS 

TO ADDRESS THE OPIOID CRISIS 

SEC. 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 
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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 
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‘‘(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. 
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(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 pre-
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vious 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. 

SEC. 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. 
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(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. 

SEC. 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 appro-
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priate, 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. 
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‘‘(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 
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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); 
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‘‘(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 
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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 pro-
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viders 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. 
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‘‘(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 par-
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ticular 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 
25 

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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. 
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‘‘(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. 
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‘‘(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 pro-
28 

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viders, 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) 
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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. 
30 

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‘‘(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. 
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‘‘(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 
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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 
33 

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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.’’. 

SEC. 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 
34 

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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 
35 

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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 
36 

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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 
37 

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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 auto-
38 

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mated 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 
39 

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‘‘(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.— 
40 

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(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 retrospec-
41 

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tive drug use reviews conducted on or after October 1, 

2020. 

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. 

(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 
42 

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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. 
43 

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SEC. 1006. MEDICAID HEALTH HOMES FOR SUBSTANCE-USEDISORDER 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 
44 

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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. 
45 

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‘‘(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 
46 

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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 
47 

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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 
48 

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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 
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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. 

SEC. 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.— 
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‘‘(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. 
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SEC. 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. 
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(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. 

SEC. 1009. MEDICAID SUBSTANCE USE DISORDER TREATMENT 

VIA TELEHEALTH. 

(a) DEFINITIONS.—In this section: 
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(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: 
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(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. 
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(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 
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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 treat-
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ment 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. 

SEC. 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 
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and management of pain, including, but not limited to, evidence-based, non-opioid pharmacological therapies and nonpharmacological therapies. 

SEC. 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. 
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(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. 

SEC. 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 
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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 
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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. 

SEC. 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).’’. 

SEC. 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 
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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 medicationassisted 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 
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containing the results of the study conducted under subsection (a). 

SEC. 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 Med-
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icaid 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 indi-
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vidual 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. 
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(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. 
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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). 

SEC. 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: 
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‘‘(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).’’. 
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(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. 

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. 

(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: 
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(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 homebased 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— 
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(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. 
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(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. 

SEC. 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). 
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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. 

(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 serv-
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ices 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 cooccurring 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. 
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(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. 

SEC. 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 
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(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)).’’. 
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(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. 

SEC. 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 rule-
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making, 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 
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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— 
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‘‘(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 
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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. 

SEC. 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 pro-
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gram 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’’. 

SEC. 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’ 
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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 
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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 
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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 
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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).’’. 

SEC. 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— 
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(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 
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such an individual is enrolled of such 

identification.’’. 

SEC. 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. 
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SEC. 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 
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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.’’. 
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(e) EFFECTIVE DATE.—The amendments made by this 

section shall apply with respect to plan years beginning on or 

after January 1, 2020. 

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. 

(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 
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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 ad-
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diction. 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; 
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(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 
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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. 
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SEC. 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. 
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(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— 
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(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. 

CHAPTER 2—STOP COUNTERFEIT DRUGS BY 

REGULATING AND ENHANCING ENFORCEMENT NOW 

SEC. 3011. SHORT TITLE. 

This chapter may be cited as the ‘‘Stop Counterfeit 

Drugs by Regulating and Enhancing Enforcement Now Act’’ 

or the ‘‘SCREEN Act’’. 

SEC. 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. 
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360bbb et seq.) is amended by adding at the end the following: 

‘‘SEC. 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)— 
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‘‘(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. 
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‘‘(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 
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‘‘(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. 

SEC. 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 
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from such person as adulterated or misbranded, unless such 

person can provide evidence otherwise.’’. 

SEC. 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— 
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(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 
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(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. 
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CHAPTER 3—STOP ILLICIT DRUG 

IMPORTATION 

SEC. 3021. SHORT TITLE. 

This chapter may be cited as the ‘‘Stop Illicit Drug Importation Act of 2018’’. 

SEC. 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 addi-
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tional 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’’. 
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(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: 
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‘‘(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 
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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.’’. 
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(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 
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‘‘(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).’’. 
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CHAPTER 4—SECURING OPIOIDS AND UNUSED NARCOTICS WITH DELIBERATE DISPOSAL AND PACKAGING 

SEC. 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’’. 

SEC. 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 pack-
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aging 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: 
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‘‘(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 organiza-
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tion, 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— 
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(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. 

CHAPTER 5—POSTAPPROVAL STUDY 

REQUIREMENTS 

SEC. 3041. CLARIFYING FDA POSTMARKET AUTHORITIES. 

(a) DEFINITION OF ADVERSE DRUG EXPERIENCE.— 

Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cos-
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metic 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 
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(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. 
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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. 

(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 
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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. 
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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 
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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. 

SEC. 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: 
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‘‘(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 
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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’’. 

SEC. 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. 
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SEC. 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: 

‘‘DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY

TO AN ADMINISTERING PRACTITIONER

‘‘SEC. 309A. (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 
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‘‘(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. 
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‘‘(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 
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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.’’. 

CHAPTER 2—EMPOWERING PHARMACISTS IN 

THE FIGHT AGAINST OPIOID ABUSE 

SEC. 3211. SHORT TITLE. 

This chapter may be cited as the ‘‘Empowering Pharmacists in the Fight Against Opioid Abuse Act’’. 

SEC. 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— 
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(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 
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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. 

CHAPTER 3—SAFE DISPOSAL OF UNUSED 

MEDICATION 

SEC. 3221. SHORT TITLE. 

This chapter may be cited as the ‘‘Safe Disposal of Unused Medication Act’’. 

SEC. 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; 
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‘‘(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 
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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— 
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‘‘(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. 

SEC. 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 
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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. 
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CHAPTER 4—SPECIAL REGISTRATION FOR 

TELEMEDICINE CLARIFICATION 

SEC. 3231. SHORT TITLE. 

This chapter may be cited as the ‘‘Special Registration 

for Telemedicine Clarification Act of 2018’’. 

SEC. 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.’’. 

CHAPTER 5—SYNTHETIC ABUSE AND 

LABELING OF TOXIC SUBSTANCES 

SEC. 3241. CONTROLLED SUBSTANCE ANALOGUES. 

Section 203 of the Controlled Substances Act (21 U.S.C. 

813) is amended— 
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(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. 
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‘‘(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.’’. 

CHAPTER 6—ACCESS TO INCREASED DRUG 

DISPOSAL 

SEC. 3251. SHORT TITLE. 

This chapter may be cited as the ‘‘Access to Increased 

Drug Disposal Act of 2018’’. 

SEC. 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 onsite 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. 
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SEC. 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. 

SEC. 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. 

SEC. 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. 

SEC. 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. 
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SEC. 3257. DURATION OF GRANTS. 

The Attorney General shall determine the period of 

years for which a covered grant is made to a State. 

SEC. 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. 

SEC. 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. 

SEC. 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. 
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CHAPTER 7—USING DATA TO PREVENT 

OPIOID DIVERSION 

SEC. 3271. SHORT TITLE. 

This chapter may be cited as the ‘‘Using Data To Prevent Opioid Diversion Act of 2018’’. 

SEC. 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. 
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SEC. 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. 
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‘‘(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 
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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 
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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 
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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.’’. 

SEC. 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. 

CHAPTER 8—OPIOID QUOTA REFORM 

SEC. 3281. SHORT TITLE. 

This chapter may be cited as the ‘‘Opioid Quota Reform 

Act’’. 

SEC. 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)’’; 
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(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— 
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‘‘(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. 
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‘‘(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 
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‘‘(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’’. 

CHAPTER 9—PREVENTING DRUG DIVERSION 

SEC. 3291. SHORT TITLE. 

This chapter may be cited as the ‘‘Preventing Drug Diversion Act of 2018’’. 

SEC. 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 
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‘‘(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: 

‘‘SEC. 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 
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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 informa-
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tion, 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 
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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 
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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. 

TITLE IV—OFFSETS 

SEC. 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) 
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(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. 
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‘‘(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 
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‘‘(II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation).’’. 

SEC. 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’’. 
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SEC. 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.— 
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‘‘(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 
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provision of medical treatment for children, especially those 

who are seriously ill. 

SEC. 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 
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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 
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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 
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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,’’. 

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. 

Section 1139B of the Social Security Act (42 U.S.C. 

1320b–9b) is amended— 
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(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 
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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))’’. 

Subtitle B—Medicaid IMD Additional 

Info 

SEC. 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’’. 
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SEC. 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— 
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(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. 
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(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 nonprobability sample in which at least two States are selected based on the knowledge and professional judgment 

of the selector. 
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(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. 

Subtitle C—CHIP Mental Health and 

Substance Use Disorder Parity 

SEC. 5021. SHORT TITLE. 

This subtitle may be cited as the ‘‘CHIP Mental Health 

and Substance Use Disorder Parity Act’’. 

SEC. 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— 
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(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 lowincome 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), 
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(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 
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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 
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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. 

Subtitle D—Medicaid Reentry 

SEC. 5031. SHORT TITLE. 

This subtitle may be cited as the ‘‘Medicaid Reentry 

Act’’. 

SEC. 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, 
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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 
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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. 

Subtitle E—Medicaid Partnership 

SEC. 5041. SHORT TITLE. 

This subtitle may be cited as the ‘‘Medicaid Providers 

Are Required To Note Experiences in Record Systems to 
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Help In-need Patients Act’’ or the ‘‘Medicaid PARTNERSHIP Act’’. 

SEC. 5042. MEDICAID PROVIDERS ARE REQUIRED TO NOTE EXPERIENCES IN RECORD SYSTEMS TO HELP INNEED 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: 

‘‘SEC. 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 
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‘‘(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 realtime 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. 
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‘‘(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 datasharing 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 
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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 situa-
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tions, 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 
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‘‘(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 
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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 
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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 Sub-
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stances 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). 
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‘‘(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 
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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. 
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(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 
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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. 

Subtitle F—IMD CARE Act 

SEC. 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’’. 

SEC. 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
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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 
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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 communitybased 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 
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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. 
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‘‘(viii) Other outpatient and communitybased 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 med-
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ical 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 
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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 
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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, populationspecific, 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, mediumintensity 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 
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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 
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‘‘(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). 
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‘‘(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; 
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‘‘(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 medicationassisted 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 
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improve access to, and the quality of, substance use disorder 

treatment for eligible populations. 

Subtitle G—Medicaid Improvement 

Fund 

SEC. 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’’. 

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. 

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 co-
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ordination 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))).’’. 

Subtitle B—Abuse Deterrent Access 

SEC. 6011. SHORT TITLE. 

This subtitle may be cited at the ‘‘Abuse Deterrent Access Act of 2018’’. 

SEC. 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 
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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 
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properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid. 

Subtitle C—Medicare Opioid Safety 

Education 

SEC. 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, nonopioid 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. 
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Subtitle D—Opioid Addiction Action 

Plan 

SEC. 6031. SHORT TITLE. 

This subtitle may be cited as the ‘‘Opioid Addiction Action Plan Act’’. 

SEC. 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 
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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 valuebased 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. 
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(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, 
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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 
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(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. 

Subtitle E—Advancing High Quality 

Treatment for Opioid Use Disorders in Medicare 

SEC. 6041. SHORT TITLE. 

This subtitle may be cited as the ‘‘Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act’’. 

SEC. 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: 

‘‘SEC. 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 demonstra-
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tion 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; 
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‘‘(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. 
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‘‘(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)); 
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‘‘(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 
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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 pay-
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ments 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’ 
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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. 
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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.— 
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‘‘(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 
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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 appro-
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priate 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. 
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‘‘(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 
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‘‘(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.’’. 
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Subtitle F—Responsible Education 

Achieves Care and Healthy Outcomes for Users’ Treatment 

SEC. 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’’. 

SEC. 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 
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(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 
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(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. 
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Subtitle G—Preventing Addiction for 

Susceptible Seniors 

SEC. 6061. SHORT TITLE. 

This subtitle may be cited as the ‘‘Preventing Addiction 

for Susceptible Seniors Act of 2018’’ or the ‘‘PASS Act of 

2018’’. 

SEC. 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 spon-
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sor 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. 
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‘‘(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.’’. 

SEC. 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 
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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. 
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‘‘(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 
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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 
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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 
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(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 
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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).’’. 

SEC. 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, atrisk beneficiaries for prescription drug 

abuse (as defined in paragraph (5)(C)).’’. 
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SEC. 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 
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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. 
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‘‘(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. 
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‘‘(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) 
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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 
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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.’’. 
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SEC. 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. 

Subtitle H—Expanding Oversight of 

Opioid Prescribing and Payment 

SEC. 6071. SHORT TITLE. 

This subtitle may be cited as the ‘‘Expanding Oversight 

of Opioid Prescribing and Payment Act of 2018’’. 

SEC. 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 
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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. 

SEC. 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. 

Subtitle I—Dr. Todd Graham Pain 

Management, Treatment, and Recovery 

SEC. 6081. SHORT TITLE. 

This subtitle may be cited as the ‘‘Dr. Todd Graham 

Pain Management, Treatment, and Recovery Act of 2018’’. 
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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. 

(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; 
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‘‘(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 nonopioid 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 appro-
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priate, 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).’’. 
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SEC. 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 Sec-
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retary, 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). 
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‘‘(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 
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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). 
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‘‘(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.’’. 

SEC. 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 
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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 
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(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. 

SEC. 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 
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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 
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U.S.C. 1395x(ii)) and ways that the provision of such information could be improved. 

SEC. 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, nonopioid 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, 
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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: 
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(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 patientcentered 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). 
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(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 
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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 nonpharmacological 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. 
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(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, nonopioid 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. 
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Subtitle J—Combating Opioid Abuse 

for Care in Hospitals 

SEC. 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’’. 

SEC. 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; 
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(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— 
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(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; 
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(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. 
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(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. 

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. 

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 
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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 
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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 valuebased 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— 
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‘‘(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.’’. 

SEC. 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: 
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(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 
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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 
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(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. 

SEC. 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 appli-
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cable 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. 
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Subtitle K—Providing Reliable Options for Patients and Educational 

Resources 

SEC. 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’’. 

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. 

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 
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‘‘(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.’’. 
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SEC. 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.’’. 
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(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 appro-
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priate 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.’’. 

SEC. 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 
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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.’’. 

Subtitle L—Fighting the Opioid 

Epidemic With Sunshine 

SEC. 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— 
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(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 
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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. 

TITLE VII—PUBLIC HEALTH 

PROVISIONS 

Subtitle A—Awareness and Training 

SEC. 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)). 
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SEC. 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 
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(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’’. 
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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. 

(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, 
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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, labora-
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tories, 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. 

Subtitle C—Indexing Narcotics, 

Fentanyl, and Opioids 

SEC. 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: 
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‘‘SEC. 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; 
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‘‘(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).’’. 

SEC. 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 
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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. 
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(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 
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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 Statecertified 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. 
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(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; 
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(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 
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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). 

SEC. 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. 
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(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 popu-
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lations, 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 
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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. 

SEC. 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; 
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(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)). 

Subtitle D—Ensuring Access to 

Quality Sober Living 

SEC. 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: 
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‘‘SEC. 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; 
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‘‘(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 
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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; 
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‘‘(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 
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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.’’. 

Subtitle E—Advancing Cutting Edge 

Research 

SEC. 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.’’. 
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SEC. 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 
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‘‘(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.’’. 
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Subtitle F—Jessie’s Law 

SEC. 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. 
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(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. 
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(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. 

SEC. 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). 

SEC. 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 
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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). 
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(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; 
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(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. 

Subtitle G—Protecting Pregnant 

Women and Infants 

SEC. 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 nonpharmacologic 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, 
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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). 

SEC. 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 pre-
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natal 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’’. 
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SEC. 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 
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(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.’’. 

SEC. 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— 
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‘‘(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;’’; 
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(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; 
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‘‘(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’’. 

SEC. 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 serv-
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ices 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 
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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 
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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); 
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‘‘(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 
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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 
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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 
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‘‘(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 evidencebased and validated screening tools 
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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— 
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‘‘(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 
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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 
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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 
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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 identifi-
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able 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 
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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— 
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‘‘(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). 
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‘‘(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. 

Subtitle H—Substance Use Disorder 

Treatment Workforce 

SEC. 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: 

‘‘PART F—SUBSTANCE USE DISORDER TREATMENT 

WORKFORCE 

‘‘SEC. 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 
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‘‘(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. 
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‘‘(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 
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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 
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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. 
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‘‘(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, tele-
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health 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.’’. 

SEC. 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: 

‘‘SEC. 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 to-
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wards 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.’’. 

SEC. 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)— 
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(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 
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(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)— 
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(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’’. 

Subtitle I—Preventing Overdoses 

While in Emergency Rooms 

SEC. 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 
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(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 
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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; 
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(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 
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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 nonfatal 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 
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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 
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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). 
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(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; 
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(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. 
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(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. 

Subtitle J—Alternatives to Opioids in 

the Emergency Department 

SEC. 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— 
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(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. 
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(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 
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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. 
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(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. 
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Subtitle K—Treatment, Education, 

and Community Help To Combat 

Addiction 

SEC. 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: 

‘‘SEC. 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; 
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‘‘(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 evidencebased 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; 
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‘‘(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.’’. 

SEC. 7102. YOUTH PREVENTION AND RECOVERY. 

(a) SUBSTANCE ABUSE TREATMENT SERVICES FOR

CHILDREN, ADOLESCENTS, AND YOUNG ADULTS.—Section 
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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, sub-
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stance 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. 
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(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 McKinneyVento 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)). 
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(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 ‘‘outof-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. 
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(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, outof-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, 
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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 
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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; 
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(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 sub-
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mit 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 
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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. 

Subtitle L—Information From National Mental Health and Substance Use Policy Laboratory 

SEC. 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 
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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’’. 

Subtitle M—Comprehensive Opioid 

Recovery Centers 

SEC. 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: 

‘‘SEC. 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. 
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‘‘(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 
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‘‘(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 in-
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clude 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, 
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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. 
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‘‘(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 agen-
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cies, 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 
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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 para-
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graph (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. 

Subtitle N—Trauma-Informed Care 

SEC. 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 
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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. 
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SEC. 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. 
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(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. 
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(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. 
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(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— 
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(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 multigenerational 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; 
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(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 
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(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— 
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(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 ageappropriate 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 multigenerational practices that assist parents, fos-
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ter 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 Statelevel 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 
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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— 
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(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 
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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 
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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. 

SEC. 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’’. 

SEC. 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 
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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. 
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(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 
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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 
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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 
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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 
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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— 
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(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 
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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). 
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(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. 

SEC. 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 
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(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, refer-
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ral, 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.). 

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. 

Section 317N of the Public Health Service Act (42 

U.S.C. 247b–15) is amended to read as follows: 

‘‘SEC. 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, 
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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 in-
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fections 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.’’. 

Subtitle P—Peer Support 

Communities of Recovery 

SEC. 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: 
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‘‘SEC. 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 orga-
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nizations 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; 
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‘‘(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.’’. 

SEC. 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: 

‘‘SEC. 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 Ad-
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diction 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 
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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.’’. 

Subtitle Q—Creating Opportunities 

That Necessitate New and Enhanced Connections That Improve 

Opioid Navigation Strategies 

SEC. 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: 

‘‘SEC. 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); 
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‘‘(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 pre-
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scribing 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; 
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‘‘(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 
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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— 
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‘‘(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 infor-
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mation 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. 
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‘‘(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 
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‘‘(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 
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‘‘(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’’. 

SEC. 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: 

‘‘SEC. 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— 
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‘‘(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 
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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 
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‘‘(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; 
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‘‘(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; 
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‘‘(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 
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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.— 
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‘‘(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; 
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‘‘(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; 
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‘‘(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. 
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‘‘(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 
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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 con-
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trolled 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.’’. 

Subtitle R—Review of Substance Use 

Disorder Treatment Providers Receiving Federal Funding 

SEC. 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 
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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 meth-
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amphetamine, 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). 

Subtitle S—Other Health Provisions 

SEC. 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— 
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(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 
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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 dem-
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onstrate 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 
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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’’. 

SEC. 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 
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(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. 

SEC. 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 
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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). 
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(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. 
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(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 
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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 
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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 
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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— 
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(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. 

TITLE VIII—MISCELLANEOUS 

Subtitle A—Synthetics Trafficking 

and Overdose Prevention 

SEC. 8001. SHORT TITLE. 

This subtitle may be cited as the ‘‘Synthetics Trafficking 

and Overdose Prevention Act of 2018’’ or ‘‘STOP Act of 

2018’’. 
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SEC. 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 
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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 pro-
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viding 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),’’. 
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(c) EFFECTIVE DATE.—The amendments made by this 

section shall take effect on January 1, 2020. 

SEC. 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 
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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 
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‘‘(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 
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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 
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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 
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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— 
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(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; 
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‘‘(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 
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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. 
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(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. 
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(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 
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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 
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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. 

SEC. 8004. INTERNATIONAL POSTAL AGREEMENTS. 

(a) EXISTING AGREEMENTS.— 
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(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, con-
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vention, 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. 

SEC. 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. 

SEC. 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 
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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. 

SEC. 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— 
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‘‘(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 
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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.’’. 

SEC. 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. 
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(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. 

SEC. 8009. EFFECTIVE DATE; REGULATIONS. 

(a) EFFECTIVE DATE.—This subtitle and the amendments made by this subtitle (other than the amendments 
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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. 

Subtitle B—Opioid Addiction 

Recovery Fraud Prevention 

SEC. 8021. SHORT TITLE. 

This subtitle may be cited as the ‘‘Opioid Addiction Recovery Fraud Prevention Act of 2018’’. 

SEC. 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 
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diagnosed with, having, or purporting to have a substance use disorder, including an opioid use disorder. 

SEC. 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. 
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(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. 

Subtitle C—Addressing Economic and 

Workforce Impacts of the Opioid 

Crisis 

SEC. 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 
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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. 
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(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)). 
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(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— 
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(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, Indiancontrolled 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 work-
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force 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— 
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(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; 
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(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 dem-
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onstrates 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 
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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; 
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(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— 
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(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 es-
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timated 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; 
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(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 ar-
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rests 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 
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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; 
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(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 onthe-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 
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(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 
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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 para-
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graph (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 
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(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 
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(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 
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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 
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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 
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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 indi-
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viduals 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; 
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(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. 

Subtitle D—Peer Support Counseling 

Program for Women Veterans 

SEC. 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 prac-
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ticable, 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, includ-
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ing 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. 
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Subtitle E—Treating Barriers to 

Prosperity 

SEC. 8061. SHORT TITLE. 

This subtitle may be cited as the ‘‘Treating Barriers to 

Prosperity Act of 2018’’. 

SEC. 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 
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‘‘(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. 
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‘‘(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.’’. 

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. 

(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 
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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. 
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(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 
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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 re-
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quirements 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. 
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(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. 

Subtitle G—Human Services 

SEC. 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. 
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(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 waiv-
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ers 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. 
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(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. 

SEC. 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 con-
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duct 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; 
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‘‘(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 
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‘‘(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 
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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 wel-
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fare, 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— 
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‘‘(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 
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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; 
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‘‘(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: 
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‘‘(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 
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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 sub-
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section (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. 

SEC. 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 
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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 EVIDENCEBASED 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 prom-
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ising, 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. 

Subtitle H—Reauthorizing and Extending Grants for Recovery From 

Opioid Use Programs 

SEC. 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’’. 

SEC. 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’’. 

Subtitle I—Fighting Opioid Abuse in 

Transportation 

SEC. 8101. SHORT TITLE. 

This subtitle may be cited as the ‘‘Fighting Opioid 

Abuse in Transportation Act’’. 
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SEC. 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. 

SEC. 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; 
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(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. 

SEC. 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— 
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(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); 
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(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. 

SEC. 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 
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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), 
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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 
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(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. 

SEC. 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 
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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. 

SEC. 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. 
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(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). 

SEC. 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, 
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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. 

SEC. 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 
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(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. 

Subtitle J—Eliminating Kickbacks in 

Recovery 

SEC. 8121. SHORT TITLE. 

This subtitle may be cited as the ‘‘Eliminating Kickbacks in Recovery Act of 2018’’. 

SEC. 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— 
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‘‘(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 
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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, 
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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 valuebased 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). 
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‘‘(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 
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‘‘(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.’’. 

Subtitle K—Substance Abuse 

Prevention 

SEC. 8201. SHORT TITLE. 

This subtitle may be cited as the ‘‘Substance Abuse Prevention Act of 2018’’. 

SEC. 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: 
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(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). 

SEC. 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 
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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). 
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(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-thecounter 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 
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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 co-
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alition 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.). 

SEC. 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: 

‘‘SEC. 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 assist-
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ance 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.’’. 
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SEC. 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 
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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.’’. 

SEC. 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.’’. 
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SEC. 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.’’. 

SEC. 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 
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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.’’. 

SEC. 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; 
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‘‘(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.’’. 

SEC. 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.’’. 
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SEC. 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.’’. 

SEC. 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: 

‘‘SEC. 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 
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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 evidencebased 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. 
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‘‘(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.’’. 

SEC. 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. 

SEC. 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: 
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‘‘SEC. 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— 
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‘‘(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.’’. 

SEC. 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). 
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SEC. 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 
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‘‘(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 evidencebased 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; 
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‘‘(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; 
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‘‘(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: 
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‘‘(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 
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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; 
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(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.’’. 

SEC. 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: 
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‘‘(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— 
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‘‘(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: 
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‘‘(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). 
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‘‘(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; 
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(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 
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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 in-
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cludes 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 PerformanceBudget Coordinator to— 

‘‘(i) ensure the Director has sufficient information necessary to analyze the performance of each National Drug Control Program 
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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 commit-
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tees 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: 
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‘‘(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 
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(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 
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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 fis-
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cal 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 ac-
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countability 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. 
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SEC. 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: 

‘‘SEC. 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); 
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‘‘(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. 
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‘‘(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. 
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‘‘(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 
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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; 
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‘‘(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. 
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‘‘(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 ad-
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herence 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 antidrug 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 
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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: 
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‘‘(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. 
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‘‘(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 
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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 timesensitive 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— 
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‘‘(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. 
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‘‘(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— 
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‘‘(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. 
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‘‘(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. 
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‘‘(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— 
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‘‘(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; 
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‘‘(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 
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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. 

SEC. 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)— 
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(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)— 
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(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 
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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 bet-
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ter 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 
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(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.’’. 

SEC. 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 
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(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. 

SEC. 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: 

‘‘SEC. 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 
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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 
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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 
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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, longrange, 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 
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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— 
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‘‘(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. 
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‘‘(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 in-
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tends 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; 
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‘‘(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. 
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‘‘(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. 
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‘‘(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 
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‘‘(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 inter-
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national 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. 
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‘‘(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— 
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‘‘(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— 
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‘‘(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. 
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‘‘(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 
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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; 
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‘‘(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 
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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— 
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‘‘(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. 
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‘‘(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 
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(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. 

SEC. 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 
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(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). 

Subtitle L—Budgetary Effects 

SEC. 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 score-
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card maintained for purposes of section 4106 of H. Con. Res. 

71 (115th Congress). 

Attest: 

Clerk.