114th CONGRESS 2d Session S. 524 IN THE SENATE OF THE UNITED STATES AN ACT To authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use.

1. Short title; table of contents (a) Short title This Act may be cited as the Comprehensive Addiction and Recovery Act of 2016 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings. Sec. 3. Definitions. TITLE I—Prevention and education Sec. 101. Development of best practices for the prescribing of prescription opioids. Sec. 102. Awareness campaigns. Sec. 103. Community-based coalition enhancement grants to address local drug crises. TITLE II—Law enforcement and treatment Sec. 201. Treatment alternative to incarceration programs. Sec. 202. First responder training for the use of drugs and devices that rapidly reverse the effects of opioids. Sec. 203. Prescription drug take back expansion. Sec. 204. Heroin and methamphetamine task forces. TITLE III—Treatment and recovery Sec. 301. Evidence-based prescription opioid and heroin treatment and interventions demonstration. Sec. 302. Criminal justice medication assisted treatment and interventions demonstration. Sec. 303. National youth recovery initiative. Sec. 304. Building communities of recovery. TITLE IV—Addressing collateral consequences Sec. 401. Correctional education demonstration grant program. Sec. 402. National Task Force on Recovery and Collateral Consequences. TITLE V—Addiction and treatment services for women, families, and veterans Sec. 501. Improving treatment for pregnant and postpartum women. Sec. 502. Report on grants for family-based substance abuse treatment. Sec. 503. Veterans’ treatment courts. TITLE VI—Incentivizing State comprehensive initiatives to address prescription opioid and heroin abuse Sec. 601. State demonstration grants for comprehensive opioid abuse response. TITLE VII—Miscellaneous Sec. 701. GAO report on IMD exclusion. Sec. 702. Funding. Sec. 703. Conforming amendments. Sec. 704. Grant accountability. Sec. 705. Programs to prevent prescription drug abuse under the Medicare program. TITLE VIII—Transnational Drug Trafficking Act Sec. 801. Short title. Sec. 802. Possession, manufacture or distribution for purposes of unlawful importations. Sec. 803. Trafficking in counterfeit goods or services. 2. Findings Congress finds the following: (1) The abuse of heroin and prescription opioid painkillers is having a devastating effect on public health and safety in communities across the United States. According to the Centers for Disease Control and Prevention, drug overdose deaths now surpass traffic accidents in the number of deaths caused by injury in the United States. In 2014, an average of more than 120 people in the United States died from drug overdoses every day. (2) According to the National Institute on Drug Abuse (commonly known as NIDA ), the number of prescriptions for opioids increased from approximately 76,000,000 in 1991 to nearly 207,000,000 in 2013, and the United States is the biggest consumer of opioids globally, accounting for almost 100 percent of the world total for hydrocodone and 81 percent for oxycodone. (3) Opioid pain relievers are the most widely misused or abused controlled prescription drugs (commonly referred to as CPDs ) and are involved in most CPD-related overdose incidents. According to the Drug Abuse Warning Network (commonly known as DAWN ), the estimated number of emergency department visits involving nonmedical use of prescription opiates or opioids increased by 112 percent between 2006 and 2010, from 84,671 to 179,787. (4) The use of heroin in the United States has also spiked sharply in recent years. According to the most recent National Survey on Drug Use and Health, more than 900,000 people in the United States reported using heroin in 2014, nearly a 35 percent increase from the previous year. Heroin overdose deaths more than tripled from 2010 to 2014. (5) The supply of cheap heroin available in the United States has increased dramatically as well, largely due to the activity of Mexican drug trafficking organizations. The Drug Enforcement Administration (commonly known as the DEA ) estimates that heroin seizures at the Mexican border have more than doubled since 2010, and heroin production in Mexico increased 62 percent from 2013 to 2014. While only 8 percent of State and local law enforcement officials across the United States identified heroin as the greatest drug threat in their area in 2008, that number rose to 38 percent in 2015. (6) Law enforcement officials and treatment experts throughout the country report that many people who have misused prescription opioids have turned to heroin as a cheaper or more easily obtained alternative to prescription opioids. (7) According to a report by the National Association of State Alcohol and Drug Abuse Directors (commonly referred to as NASADAD ), 37 States reported an increase in admissions to treatment for heroin use during the past 2 years, while admissions to treatment for prescription opiates increased 500 percent from 2000 to 2012. (8) Research indicates that combating the opioid crisis, including abuse of prescription painkillers and, increasingly, heroin, requires a multipronged approach that involves prevention, education, monitoring, law enforcement initiatives, reducing drug diversion and the supply of illicit drugs, expanding delivery of existing treatments (including medication assisted treatments), expanding access to overdose medications and interventions, and the development of new medications for pain that can augment the existing treatment arsenal. (9) Substance use disorders are a treatable disease. Discoveries in the science of addiction have led to advances in the treatment of substance use disorders that help people stop abusing drugs and prescription medications and resume their productive lives. (10) According to the National Survey on Drug Use and Health, approximately 22,700,000 people in the United States needed substance use disorder treatment in 2013, but only 2,500,000 people received it. Furthermore, current treatment services are not adequate to meet demand. According to a report commissioned by the Substance Abuse and Mental Health Services Administration (commonly known as SAMHSA ), there are approximately 32 providers for every 1,000 individuals needing substance use disorder treatment. In some States, the ratio is much lower. (11) The overall cost of drug abuse, from health care- and criminal justice-related costs to lost productivity, is steep, totaling more than $700,000,000,000 a year, according to NIDA. Effective substance abuse prevention can yield major economic dividends. (12) According to NIDA, when schools and communities properly implement science-validated substance abuse prevention programs, abuse of alcohol, tobacco, and illicit drugs is reduced. Such programs help teachers, parents, and healthcare professionals shape the perceptions of youths about the risks of drug abuse. (13) Diverting certain individuals with substance use disorders from criminal justice systems into community-based treatment can save billions of dollars and prevent sizeable numbers of crimes, arrests, and re-incarcerations over the course of those individuals’ lives. (14) According to the DEA, more than 2,700 tons of expired, unwanted prescription medications have been collected since the enactment of the Secure and Responsible Drug Disposal Act of 2010 ( Public Law 111–273 ; 124 Stat. 2858). (15) Faith-based, holistic, or drug-free models can provide a critical path to successful recovery for a number of people in the United States. The 2015 membership survey conducted by Alcoholics Anonymous (commonly known as AA ) found that 73 percent of AA members were sober longer than 1 year and attended 2.5 meetings per week. (16) Research shows that combining treatment medications with behavioral therapy is an effective way to facilitate success for some patients. Treatment approaches must be tailored to address the drug abuse patterns and drug-related medical, psychiatric, and social problems of each individual. Different types of medications may be useful at different stages of treatment or recovery to help a patient stop using drugs, stay in treatment, and avoid relapse. Patients have a range of options regarding their path to recovery and many have also successfully addressed drug abuse through the use of faith-based, holistic, or drug-free models. (17) Individuals with mental illness, especially severe mental illness, are at considerably higher risk for substance abuse than the general population, and the presence of a mental illness complicates recovery from substance abuse. (18) Rural communities are especially susceptible to heroin and opioid abuse. Individuals in rural counties have higher rates of drug poisoning deaths, including deaths from opioids. According to the American Journal of Public Health, [O]pioid poisonings in nonmetropolitan counties have increased at a rate greater than threefold the increase in metropolitan counties. According to a February 19, 2016, report from the Maine Rural Health Research Center, [M]ultiple studies document a higher prevalence [of abuse] among specific vulnerable rural populations, particularly among youth, women who are pregnant or experiencing partner violence, and persons with co-occurring disorders. 3. Definitions In this Act— (1) the term first responder includes a firefighter, law enforcement officer, paramedic, emergency medical technician, or other individual (including an employee of a legally organized and recognized volunteer organization, whether compensated or not), who, in the course of professional duties, responds to fire, medical, hazardous material, or other similar emergencies; (2) the term medication assisted treatment means the use, for problems relating to heroin and other opioids, of medications approved by the Food and Drug Administration in combination with counseling and behavioral therapies; (3) the term opioid means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability; and (4) the term State means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, and any territory or possession of the United States. I Prevention and education 101. Development of best practices for the prescribing of prescription opioids (a) Definitions In this section— (1) the term Secretary means the Secretary of Health and Human Services; and (2) the term task force means the Pain Management Best Practices Interagency Task Force convened under subsection (b). (b) Interagency Task Force Not later than December 14, 2018, the Secretary, in cooperation with the Secretary of Veterans Affairs, the Secretary of Defense, and the Administrator of the Drug Enforcement Administration, shall convene a Pain Management Best Practices Interagency Task Force to review, modify, and update, as appropriate, best practices for pain management (including chronic and acute pain) and prescribing pain medication. (c) Membership The task force shall be comprised of— (1) representatives of— (A) the Department of Health and Human Services; (B) the Department of Veterans Affairs; (C) the Food and Drug Administration; (D) the Department of Defense; (E) the Drug Enforcement Administration; (F) the Centers for Disease Control and Prevention; (G) the National Academy of Medicine; (H) the National Institutes of Health; (I) the Office of National Drug Control Policy; and (J) the Office of Rural Health Policy of the Department of Health and Human Services; (2) physicians, dentists, and nonphysician prescribers; (3) pharmacists; (4) experts in the fields of pain research and addiction research; (5) representatives of— (A) pain management professional organizations; (B) the mental health treatment community; (C) the addiction treatment community; (D) pain advocacy groups; and (E) groups with expertise around overdose reversal; and (6) other stakeholders, as the Secretary determines appropriate. (d) Duties The task force shall— (1) not later than 180 days after the date on which the task force is convened under subsection (b), review, modify, and update, as appropriate, best practices for pain management (including chronic and acute pain) and prescribing pain medication, taking into consideration— (A) existing pain management research; (B) recommendations from relevant conferences and existing relevant evidence-based guidelines; (C) ongoing efforts at the State and local levels and by medical professional organizations to develop improved pain management strategies, including consideration of alternatives to opioids to reduce opioid monotherapy in appropriate cases; (D) the management of high-risk populations, other than populations who suffer pain, who— (i) may use or be prescribed benzodiazepines, alcohol, and diverted opioids; or (ii) receive opioids in the course of medical care; and (E) the Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention (80 Fed. Reg. 77351 (December 14, 2015)) and any final guidelines issued by the Centers for Disease Control and Prevention; (2) solicit and take into consideration public comment on the practices developed under paragraph (1), amending such best practices if appropriate; and (3) develop a strategy for disseminating information about the best practices to stakeholders, as appropriate. (e) Limitation The task force shall not have rulemaking authority. (f) Report Not later than 270 days after the date on which the task force is convened under subsection (b), the task force shall submit to Congress a report that includes— (1) the strategy for disseminating best practices for pain management (including chronic and acute pain) and prescribing pain medication, as reviewed, modified, or updated under subsection (d); and (2) recommendations for effectively applying the best practices described in paragraph (1) to improve prescribing practices at medical facilities, including medical facilities of the Veterans Health Administration. 102. Awareness campaigns (a) In general The Secretary of Health and Human Services, in coordination with the Attorney General, shall advance the education and awareness of the public, providers, patients, consumers, and other appropriate entities regarding the risk of abuse of prescription opioid drugs if such products are not taken as prescribed, including opioid and methadone abuse. Such education and awareness campaigns shall include information on the dangers of opioid abuse, how to prevent opioid abuse including through safe disposal of prescription medications and other safety precautions, and detection of early warning signs of addiction. (b) Drug-Free Media Campaign (1) In general The Office of National Drug Control Policy, in coordination with the Secretary of Health and Human Services and the Attorney General, shall establish a national drug awareness campaign. (2) Requirements The national drug awareness campaign required under paragraph (1) shall— (A) take into account the association between prescription opioid abuse and heroin use; (B) emphasize the similarities between heroin and prescription opioids and the effects of heroin and prescription opioids on the human body; and (C) bring greater public awareness to the dangerous effects of fentanyl when mixed with heroin or abused in a similar manner. 103. Community-based coalition enhancement grants to address local drug crises Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ) is amended by striking section 2997 and inserting the following: 2997. Community-based coalition enhancement grants to address local drug crises (a) Definitions In this section— (1) the term Drug-Free Communities Act of 1997 means chapter 2 of the National Narcotics Leadership Act of 1988 ( 21 U.S.C. 1521 et seq. ); (2) the term eligible entity means an organization that— (A) on or before the date of submitting an application for a grant under this section, receives or has received a grant under the Drug-Free Communities Act of 1997; and (B) has documented, using local data, rates of abuse of opioids or methamphetamines at levels that are— (i) significantly higher than the national average as determined by the Secretary (including appropriate consideration of the results of the Monitoring the Future Survey published by the National Institute on Drug Abuse and the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration); or (ii) higher than the national average, as determined by the Secretary (including appropriate consideration of the results of the surveys described in clause (i)), over a sustained period of time; (3) the term local drug crisis means, with respect to the area served by an eligible entity— (A) a sudden increase in the abuse of opioids or methamphetamines, as documented by local data; (B) the abuse of prescription medications, specifically opioids or methamphetamines, that is significantly higher than the national average, over a sustained period of time, as documented by local data; or (C) a sudden increase in opioid-related deaths, as documented by local data; (4) the term opioid means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability; and (5) the term Secretary means the Secretary of Health and Human Services. (b) Program authorized The Secretary, in coordination with the Director of the Office of National Drug Control Policy, may make grants to eligible entities to implement comprehensive community-wide strategies that address local drug crises within the area served by the eligible entity. (c) Application (1) In general An eligible entity seeking a grant under this section shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may require. (2) Criteria As part of an application for a grant under this section, the Secretary shall require an eligible entity to submit a detailed, comprehensive, multisector plan for addressing the local drug crisis within the area served by the eligible entity. (d) Use of funds An eligible entity shall use a grant received under this section— (1) for programs designed to implement comprehensive community-wide prevention strategies to address the local drug crisis in the area served by the eligible entity, in accordance with the plan submitted under subsection (c)(2); and (2) to obtain specialized training and technical assistance from the organization funded under section 4 of Public Law 107–82 ( 21 U.S.C. 1521 note). (e) Supplement not supplant An eligible entity shall use Federal funds received under this section only to supplement the funds that would, in the absence of those Federal funds, be made available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds. (f) Evaluation A grant under this section shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipient of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effectiveness at reducing abuse of opioids, methadone, or methamphetamines. (g) Limitation on administrative expenses Not more than 8 percent of the amounts made available to carry out this section for a fiscal year may be used by the Secretary to pay for administrative expenses. . II Law enforcement and treatment 201. Treatment alternative to incarceration programs (a) Definitions In this section: (1) Eligible entity The term eligible entity means a State, unit of local government, Indian tribe, or nonprofit organization. (2) Eligible participant The term eligible participant means an individual who— (A) comes into contact with the juvenile justice system or criminal justice system or is arrested or charged with an offense that is not— (i) a crime of violence, as defined under applicable State law or section 3156 of title 18, United States Code; or (ii) a serious drug offense, as defined under section 924(e)(2)(A) of title 18, United States Code; (B) has been screened by a qualified mental health professional and determined to suffer from a substance use disorder, or co-occurring mental illness and substance use disorder, that there is a reasonable basis to believe is related to the commission of the offense; and (C) has been, after consideration of any potential risk of violence to any person in the program or the public if the individual were selected to participate in the program, unanimously approved for participation in a program funded under this section by, as applicable depending on the stage of the criminal justice process— (i) the relevant law enforcement agency; (ii) the prosecuting attorney; (iii) the defense attorney; (iv) the pretrial, probation, or correctional officer; (v) the judge; and (vi) a representative from the relevant mental health or substance abuse agency. (b) Program authorized The Secretary of Health and Human Services, in coordination with the Attorney General, may make grants to eligible entities to— (1) develop, implement, or expand a treatment alternative to incarceration program for eligible participants, including— (A) pre-booking, including pre-arrest, treatment alternative to incarceration programs, including— (i) law enforcement training on substance use disorders and co-occurring mental illness and substance use disorders; (ii) receiving centers as alternatives to incarceration of eligible participants; (iii) specialized response units for calls related to substance use disorders and co-occurring mental illness and substance use disorders; and (iv) other pre-arrest or pre-booking treatment alternative to incarceration models; and (B) post-booking treatment alternative to incarceration programs, including— (i) specialized clinical case management; (ii) pretrial services related to substance use disorders and co-occurring mental illness and substance use disorders; (iii) prosecutor and defender based programs; (iv) specialized probation; (v) programs utilizing the American Society of Addiction Medicine patient placement criteria; (vi) treatment and rehabilitation programs and recovery support services; and (vii) drug courts, DWI courts, and veterans treatment courts; and (2) facilitate or enhance planning and collaboration between State criminal justice systems and State substance abuse systems in order to more efficiently and effectively carry out programs described in paragraph (1) that address problems related to the use of heroin and misuse of prescription drugs among eligible participants. (c) Application (1) In general An eligible entity seeking a grant under this section shall submit an application to the Secretary of Health and Human Services— (A) that meets the criteria under paragraph (2); and (B) at such time, in such manner, and accompanied by such information as the Secretary of Health and Human Services may require. (2) Criteria An eligible entity, in submitting an application under paragraph (1), shall— (A) provide extensive evidence of collaboration with State and local government agencies overseeing health, community corrections, courts, prosecution, substance abuse, mental health, victims services, and employment services, and with local law enforcement agencies; (B) demonstrate consultation with the Single State Authority for Substance Abuse (as defined in section 201(e) of the Second Chance Act of 2007 ( 42 U.S.C. 17521(e) )); (C) demonstrate consultation with the Single State criminal justice planning agency; (D) demonstrate that evidence-based treatment practices, including if applicable the use of medication assisted treatment, will be utilized; and (E) demonstrate that evidenced-based screening and assessment tools will be utilized to place participants in the treatment alternative to incarceration program. (d) Requirements Each eligible entity awarded a grant for a treatment alternative to incarceration program under this section shall— (1) determine the terms and conditions of participation in the program by eligible participants, taking into consideration the collateral consequences of an arrest, prosecution, or criminal conviction; (2) ensure that each substance abuse and mental health treatment component is licensed and qualified by the relevant jurisdiction; (3) for programs described in subsection (b)(2), organize an enforcement unit comprised of appropriately trained law enforcement professionals under the supervision of the State, tribal, or local criminal justice agency involved, the duties of which shall include— (A) the verification of addresses and other contacts of each eligible participant who participates or desires to participate in the program; and (B) if necessary, the location, apprehension, arrest, and return to court of an eligible participant in the program who has absconded from the facility of a treatment provider or has otherwise violated the terms and conditions of the program, consistent with Federal and State confidentiality requirements; (4) notify the relevant criminal justice entity if any eligible participant in the program absconds from the facility of the treatment provider or otherwise violates the terms and conditions of the program, consistent with Federal and State confidentiality requirements; (5) submit periodic reports on the progress of treatment or other measured outcomes from participation in the program of each eligible participant in the program to the relevant State, tribal, or local criminal justice agency; (6) describe the evidence-based methodology and outcome measurements that will be used to evaluate the program, and specifically explain how such measurements will provide valid measures of the impact of the program; and (7) describe how the program could be broadly replicated if demonstrated to be effective. (e) Use of funds An eligible entity shall use a grant received under this section for expenses of a treatment alternative to incarceration program, including— (1) salaries, personnel costs, equipment costs, and other costs directly related to the operation of the program, including the enforcement unit; (2) payments for treatment providers that are approved by the relevant State or tribal jurisdiction and licensed, if necessary, to provide needed treatment to eligible participants in the program, including medication assisted treatment, aftercare supervision, vocational training, education, and job placement; (3) payments to public and nonprofit private entities that are approved by the State or tribal jurisdiction and licensed, if necessary, to provide alcohol and drug addiction treatment and mental health treatment to eligible participants in the program; and (4) salaries, personnel costs, and other costs related to strategic planning among State and local government agencies. (f) Supplement not supplant An eligible entity shall use Federal funds received under this section only to supplement the funds that would, in the absence of those Federal funds, be made available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds. (g) Geographic distribution The Secretary of Health and Human Services shall ensure that, to the extent practicable, the geographical distribution of grants under this section is equitable and includes a grant to an eligible entity in— (1) each State; (2) rural, suburban, and urban areas; and (3) tribal jurisdictions. (h) Priority consideration with respect to States In awarding grants to States under this section, the Secretary of Health and Human Services shall give priority to— (1) a State that submits a joint application from the substance abuse agencies and criminal justice agencies of the State that proposes to use grant funds to facilitate or enhance planning and collaboration between the agencies, including coordination to better address the needs of incarcerated populations; and (2) a State that— (A) provides civil liability protection for first responders, health professionals, and family members who have received appropriate training in the administration of naloxone in administering naloxone to counteract opioid overdoses; and (B) submits to the Secretary a certification by the attorney general of the State that the attorney general has— (i) reviewed any applicable civil liability protection law to determine the applicability of the law with respect to first responders, health care professionals, family members, and other individuals who— (I) have received appropriate training in the administration of naloxone; and (II) may administer naloxone to individuals reasonably believed to be suffering from opioid overdose; and (ii) concluded that the law described in subparagraph (A) provides adequate civil liability protection applicable to such persons. (i) Reports and evaluations (1) In general Each fiscal year, each recipient of a grant under this section during that fiscal year shall submit to the Secretary of Health and Human Services a report on the outcomes of activities carried out using that grant in such form, containing such information, and on such dates as the Secretary of Health and Human Services shall specify. (2) Contents A report submitted under paragraph (1) shall— (A) describe best practices for treatment alternatives; and (B) identify training requirements for law enforcement officers who participate in treatment alternative to incarceration programs. (j) Funding During the 5-year period beginning on the date of enactment of this Act, the Secretary of Health and Human Services may carry out this section using not more than $5,000,000 each fiscal year of amounts appropriated to the Substance Abuse and Mental Health Services Administration for Criminal Justice Activities. No additional funds are authorized to be appropriated to carry out this section. 202. First responder training for the use of drugs and devices that rapidly reverse the effects of opioids Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 103, is amended by adding at the end the following: 2998. First responder training for the use of drugs and devices that rapidly reverse the effects of opioids (a) Definition In this section— (1) the terms drug and device have the meanings given those terms in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ); (2) the term eligible entity means a State, a unit of local government, or an Indian tribal government; (3) the term first responder includes a firefighter, law enforcement officer, paramedic, emergency medical technician, or other individual (including an employee of a legally organized and recognized volunteer organization, whether compensated or not), who, in the course of professional duties, responds to fire, medical, hazardous material, or other similar emergencies; (4) the term opioid means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability; and (5) the term Secretary means the Secretary of Health and Human Services. (b) Program authorized The Secretary, in coordination with the Attorney General, may make grants to eligible entities to allow appropriately trained first responders to administer an opioid overdose reversal drug to an individual who has— (1) experienced a prescription opioid or heroin overdose; or (2) been determined to have likely experienced a prescription opioid or heroin overdose. (c) Application (1) In general An eligible entity seeking a grant under this section shall submit an application to the Secretary— (A) that meets the criteria under paragraph (2); and (B) at such time, in such manner, and accompanied by such information as the Secretary may require. (2) Criteria An eligible entity, in submitting an application under paragraph (1), shall— (A) describe the evidence-based methodology and outcome measurements that will be used to evaluate the program funded with a grant under this section, and specifically explain how such measurements will provide valid measures of the impact of the program; (B) describe how the program could be broadly replicated if demonstrated to be effective; (C) identify the governmental and community agencies that the program will coordinate; and (D) describe how law enforcement agencies will coordinate with their corresponding State substance abuse and mental health agencies to identify protocols and resources that are available to overdose victims and families, including information on treatment and recovery resources. (d) Use of funds An eligible entity shall use a grant received under this section to— (1) make such opioid overdose reversal drugs or devices that are approved by the Food and Drug Administration, such as naloxone, available to be carried and administered by first responders; (2) train and provide resources for first responders on carrying an opioid overdose reversal drug or device approved by the Food and Drug Administration, such as naloxone, and administering the drug or device to an individual who has experienced, or has been determined to have likely experienced, a prescription opioid or heroin overdose; and (3) establish processes, protocols, and mechanisms for referral to appropriate treatment, which may include an outreach coordinator or team to connect individuals receiving opioid overdose reversal drugs to follow-up services. (e) Technical assistance grants The Secretary shall make a grant for the purpose of providing technical assistance and training on the use of an opioid overdose reversal drug, such as naloxone, to respond to an individual who has experienced, or has been determined to have likely experienced, a prescription opioid or heroin overdose, and mechanisms for referral to appropriate treatment for an eligible entity receiving a grant under this section. (f) Evaluation The Secretary shall conduct an evaluation of grants made under this section to determine— (1) the number of first responders equipped with naloxone, or another opioid overdose reversal drug, for the prevention of fatal opioid and heroin overdose; (2) the number of opioid and heroin overdoses reversed by first responders receiving training and supplies of naloxone, or another opioid overdose reversal drug, through a grant received under this section; (3) the number of calls for service related to opioid and heroin overdose; (4) the extent to which overdose victims and families receive information about treatment services and available data describing treatment admissions; and (5) the research, training, and naloxone, or another opioid overdose reversal drug, supply needs of first responder agencies, including those agencies that are not receiving grants under this section. (g) Rural areas with limited access to emergency medical services In making grants under this section, the Secretary shall ensure that not less than 25 percent of grant funds are awarded to eligible entities that are not located in metropolitan statistical areas, as defined by the Office of Management and Budget. . 203. Prescription drug take back expansion (a) Definition of covered entity In this section, the term covered entity means— (1) a State, local, or tribal law enforcement agency; (2) a manufacturer, distributor, or reverse distributor of prescription medications; (3) a retail pharmacy; (4) a registered narcotic treatment program; (5) a hospital or clinic with an onsite pharmacy; (6) an eligible long-term care facility; or (7) any other entity authorized by the Drug Enforcement Administration to dispose of prescription medications. (b) Program authorized The Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, shall coordinate with covered entities in expanding or making available disposal sites for unwanted prescription medications. 204. Heroin and methamphetamine task forces Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 202, is amended by adding at the end the following: 2999. Heroin and methamphetamine task forces (a) Definition of opioid In this section, the term opioid means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. (b) Authority The Attorney General may make grants to State law enforcement agencies for investigative purposes— (1) to locate or investigate illicit activities through statewide collaboration, including activities related to— (A) the distribution of heroin or fentanyl, or the unlawful distribution of prescription opioids; or (B) unlawful heroin, fentanyl, and prescription opioid traffickers; and (2) to locate or investigate illicit activities, including precursor diversion, laboratories, or methamphetamine traffickers. . III Treatment and recovery 301. Evidence-based prescription opioid and heroin treatment and interventions demonstration Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 204, is amended by adding at the end the following: 2999A. Evidence-based prescription opioid and heroin treatment and interventions demonstration (a) Definitions In this section— (1) the terms Indian tribe and tribal organization have the meaning given those terms in section 4 of the Indian Health Care Improvement Act ( 25 U.S.C. 1603 )); (2) the term medication assisted treatment means the use, for problems relating to heroin and other opioids, of medications approved by the Food and Drug Administration in combination with counseling and behavioral therapies; (3) the term opioid means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability; (4) the term Secretary means the Secretary of Health and Human Services; and (5) the term State substance abuse agency means the agency of a State responsible for the State prevention, treatment, and recovery system, including management of the Substance Abuse Prevention and Treatment Block Grant under subpart II of part B of title XIX of the Public Health Service Act ( 42 U.S.C. 300x–21 et seq. ). (b) Grants (1) Authority to make grants The Secretary, acting through the Director of the Center for Substance Abuse Treatment of the Substance Abuse and Mental Health Services Administration, and in coordination with the Attorney General and other departments or agencies, as appropriate, may award grants to State substance abuse agencies, units of local government, nonprofit organizations, and Indian tribes or tribal organizations that have a high rate, or have had a rapid increase, in the use of heroin or other opioids, in order to permit such entities to expand activities, including an expansion in the availability of medication assisted treatment and other clinically appropriate services, with respect to the treatment of addiction in the specific geographical areas of such entities where there is a high rate or rapid increase in the use of heroin or other opioids. (2) Nature of activities The grant funds awarded under paragraph (1) shall be used for activities that are based on reliable scientific evidence of efficacy in the treatment of problems related to heroin or other opioids. (c) Geographic distribution The Secretary shall ensure that grants awarded under subsection (b) are distributed equitably among the various regions of the United States and among rural, urban, and suburban areas that are affected by the use of heroin or other opioids. (d) Additional activities In administering grants under subsection (b), the Secretary shall— (1) evaluate the activities supported by grants awarded under subsection (b); (2) disseminate information, as appropriate, derived from the evaluation as the Secretary considers appropriate; (3) provide States, Indian tribes and tribal organizations, and providers with technical assistance in connection with the provision of treatment of problems related to heroin and other opioids; and (4) fund only those applications that specifically support recovery services as a critical component of the grant program. . 302. Criminal justice medication assisted treatment and interventions demonstration (a) Definitions In this section— (1) the term criminal justice agency means a State, local, or tribal— (A) court; (B) prison; (C) jail; or (D) other agency that performs the administration of criminal justice, including prosecution, pretrial services, and community supervision; (2) the term eligible entity means a State, unit of local government, or Indian tribe; and (3) the term Secretary means the Secretary of Health and Human Services. (b) Program authorized The Secretary, in coordination with the Attorney General, may make grants to eligible entities to implement medication assisted treatment programs through criminal justice agencies. (c) Application (1) In general An eligible entity seeking a grant under this section shall submit an application to the Secretary— (A) that meets the criteria under paragraph (2); and (B) at such time, in such manner, and accompanied by such information as the Secretary may require. (2) Criteria An eligible entity, in submitting an application under paragraph (1), shall— (A) certify that each medication assisted treatment program funded with a grant under this section has been developed in consultation with the Single State Authority for Substance Abuse (as defined in section 201(e) of the Second Chance Act of 2007 ( 42 U.S.C. 17521(e) )); and (B) describe how data will be collected and analyzed to determine the effectiveness of the program described in subparagraph (A). (d) Use of funds An eligible entity shall use a grant received under this section for expenses of— (1) a medication assisted treatment program, including the expenses of prescribing medications recognized by the Food and Drug Administration for opioid treatment in conjunction with psychological and behavioral therapy; (2) training criminal justice agency personnel and treatment providers on medication assisted treatment; (3) cross-training personnel providing behavioral health and health services, administration of medicines, and other administrative expenses, including required reports; and (4) the provision of recovery coaches who are responsible for providing mentorship and transition plans to individuals reentering society following incarceration or alternatives to incarceration. (e) Priority consideration with respect to States In awarding grants to States under this section, the Secretary shall give priority to a State that— (1) provides civil liability protection for first responders, health professionals, and family members who have received appropriate training in the administration of naloxone in administering naloxone to counteract opioid overdoses; and (2) submits to the Secretary a certification by the attorney general of the State that the attorney general has— (A) reviewed any applicable civil liability protection law to determine the applicability of the law with respect to first responders, health care professionals, family members, and other individuals who— (i) have received appropriate training in the administration of naloxone; and (ii) may administer naloxone to individuals reasonably believed to be suffering from opioid overdose; and (B) concluded that the law described in subparagraph (A) provides adequate civil liability protection applicable to such persons. (f) Technical assistance The Secretary, in coordination with the Director of the National Institute on Drug Abuse and the Attorney General, shall provide technical assistance and training for an eligible entity receiving a grant under this section. (g) Reports (1) In general An eligible entity receiving a grant under this section shall submit a report to the Secretary on the outcomes of each grant received under this section for individuals receiving medication assisted treatment, based on— (A) the recidivism of the individuals; (B) the treatment outcomes of the individuals, including maintaining abstinence from illegal, unauthorized, and unprescribed or undispensed opioids and heroin; (C) a comparison of the cost of providing medication assisted treatment to the cost of incarceration or other participation in the criminal justice system; (D) the housing status of the individuals; and (E) the employment status of the individuals. (2) Contents and timing Each report described in paragraph (1) shall be submitted annually in such form, containing such information, and on such dates as the Secretary shall specify. (h) Funding During the 5-year period beginning on the date of enactment of this Act, the Secretary may carry out this section using not more than $5,000,000 each fiscal year of amounts appropriated to the Substance Abuse and Mental Health Services Administration for Criminal Justice Activities. No additional funds are authorized to be appropriated to carry out this section. 303. National youth recovery initiative Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 301, is amended by adding at the end the following: 2999B. National youth recovery initiative (a) Definitions In this section: (1) Eligible entity The term eligible entity means— (A) a high school that has been accredited as a recovery high school by the Association of Recovery Schools; (B) an accredited high school that is seeking to establish or expand recovery support services; (C) an institution of higher education; (D) a recovery program at a nonprofit collegiate institution; or (E) a nonprofit organization. (2) Institution of higher education The term institution of higher education has the meaning given the term in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ). (3) Recovery program The term recovery program — (A) means a program to help individuals who are recovering from substance use disorders to initiate, stabilize, and maintain healthy and productive lives in the community; and (B) includes peer-to-peer support and communal activities to build recovery skills and supportive social networks. (b) Grants authorized The Secretary of Health and Human Services, in coordination with the Secretary of Education, may award grants to eligible entities to enable the entities to— (1) provide substance use disorder recovery support services to young people in high school and enrolled in institutions of higher education; (2) help build communities of support for young people in recovery through a spectrum of activities such as counseling and health- and wellness-oriented social activities; and (3) encourage initiatives designed to help young people achieve and sustain recovery from substance use disorders. (c) Use of funds Grants awarded under subsection (b) may be used for activities to develop, support, and maintain youth recovery support services, including— (1) the development and maintenance of a dedicated physical space for recovery programs; (2) dedicated staff for the provision of recovery programs; (3) health- and wellness-oriented social activities and community engagement; (4) establishment of recovery high schools; (5) coordination of recovery programs with— (A) substance use disorder treatment programs and systems; (B) providers of mental health services; (C) primary care providers and physicians; (D) the criminal justice system, including the juvenile justice system; (E) employers; (F) housing services; (G) child welfare services; (H) high schools and institutions of higher education; and (I) other programs or services related to the welfare of an individual in recovery from a substance use disorder; (6) the development of peer-to-peer support programs or services; and (7) additional activities that help youths and young adults to achieve recovery from substance use disorders. . 304. Building communities of recovery Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 303, is amended by adding at the end the following: 2999C. 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 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 of Health and Human Services may 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 50 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) advocate for individuals in recovery from substance use disorders; (B) build connections between recovery networks, between recovery community organizations, and with other recovery support services, including— (i) substance use disorder treatment programs and systems; (ii) providers of mental health services; (iii) primary care providers and physicians; (iv) the criminal justice system; (v) employers; (vi) housing services; (vii) child welfare agencies; and (viii) other recovery support services that facilitate recovery from substance use disorders; (C) reduce the stigma associated with substance use disorders; (D) conduct public education and outreach on issues relating to substance use disorders and recovery, including— (i) how to identify the signs of addiction; (ii) the resources that are available to individuals struggling with addiction and families who have a family member struggling with or being treated for addiction, including programs that mentor and provide support services to children; (iii) the resources that are available to help support individuals in recovery; and (iv) information on the medical consequences of substance use disorders, including neonatal abstinence syndrome and potential infection with human immunodeficiency virus and viral hepatitis; and (E) carry out other activities that strengthen the network of community support for individuals in recovery. . IV Addressing collateral consequences 401. Correctional education demonstration grant program Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 304, is amended by adding at the end the following: 2999D. Correctional education demonstration grant program (a) Definition In this section, the term eligible entity means a State, unit of local government, nonprofit organization, or Indian tribe. (b) Grant program authorized The Attorney General may make grants to eligible entities to design, implement, and expand educational programs for offenders in prisons, jails, and juvenile facilities, including to pay for— (1) basic education, secondary level academic education, high school equivalency examination preparation, career technical education, and English language learner instruction at the basic, secondary, or post-secondary levels, for adult and juvenile populations; (2) screening and assessment of inmates to assess education level and needs, occupational interest or aptitude, risk level, and other needs, and case management services; (3) hiring and training of instructors and aides, reimbursement of non-corrections staff and experts, reimbursement of stipends paid to inmate tutors or aides, and the costs of training inmate tutors and aides; (4) instructional supplies and equipment, including occupational program supplies and equipment to the extent that the supplies and equipment are used for instructional purposes; (5) partnerships and agreements with community colleges, universities, and career technology education program providers; (6) certification programs providing recognized high school equivalency certificates and industry recognized credentials; and (7) technology solutions to— (A) meet the instructional, assessment, and information needs of correctional populations; and (B) facilitate the continued participation of incarcerated students in community-based education programs after the students are released from incarceration. (c) Application An eligible entity seeking a grant under this section shall submit to the Attorney General an application in such form and manner, at such time, and accompanied by such information as the Attorney General specifies. (d) Priority considerations In awarding grants under this section, the Attorney General shall give priority to applicants that— (1) assess the level of risk and need of inmates, including by— (A) assessing the need for English language learner instruction; (B) conducting educational assessments; and (C) assessing occupational interests and aptitudes; (2) target educational services to assessed needs, including academic and occupational at the basic, secondary, or post-secondary level; (3) target career and technology education programs to— (A) areas of identified occupational demand; and (B) employment opportunities in the communities in which students are reasonably expected to reside post-release; (4) include a range of appropriate educational opportunities at the basic, secondary, and post-secondary levels; (5) include opportunities for students to attain industry recognized credentials; (6) include partnership or articulation agreements linking institutional education programs with community sited programs provided by adult education program providers and accredited institutions of higher education, community colleges, and vocational training institutions; and (7) explicitly include career pathways models offering opportunities for incarcerated students to develop academic skills, in-demand occupational skills and credentials, occupational experience in institutional work programs or work release programs, and linkages with employers in the community, so that incarcerated students have opportunities to embark on careers with strong prospects for both post-release employment and advancement in a career ladder over time. (e) Requirements An eligible entity seeking a grant under this section shall— (1) describe the evidence-based methodology and outcome measurements that will be used to evaluate each program funded with a grant under this section, and specifically explain how such measurements will provide valid measures of the impact of the program; and (2) describe how each program described in paragraph (1) could be broadly replicated if demonstrated to be effective. (f) Control of Internet access An entity that receives a grant under this section may restrict access to the Internet by prisoners, as appropriate and in accordance with Federal and State law, to ensure public safety. . 402. National Task Force on Recovery and Collateral Consequences (a) Definition In this section, the term collateral consequence means a penalty, disability, or disadvantage imposed on an individual who is in recovery for a substance use disorder (including by an administrative agency, official, or civil court ) as a result of a Federal or State conviction for a drug-related offense but not as part of the judgment of the court that imposes the conviction. (b) Establishment (1) In general Not later than 30 days after the date of enactment of this Act, the Attorney General shall establish a bipartisan task force to be known as the Task Force on Recovery and Collateral Consequences (in this section referred to as the Task Force ). (2) Membership (A) Total number of members The Task Force shall include 10 members, who shall be appointed by the Attorney General in accordance with subparagraphs (B) and (C). (B) Members of the task force The Task Force shall include— (i) members who have national recognition and significant expertise in areas such as health care, housing, employment, substance use disorders, mental health, law enforcement, and law; (ii) not fewer than 2 members— (I) who have personally experienced a substance abuse disorder or addiction and are in recovery; and (II) not fewer than 1 of whom has benefitted from medication assisted treatment; and (iii) to the extent practicable, members who formerly served as elected officials at the State and Federal levels. (C) Timing The Attorney General shall appoint the members of the Task Force not later than 60 days after the date on which the Task Force is established under paragraph (1). (3) Chairperson The Task Force shall select a chairperson or co-chairpersons from among the members of the Task Force. (c) Duties of the task force (1) In general The Task Force shall— (A) identify collateral consequences for individuals with Federal or State convictions for drug-related offenses who are in recovery for substance use disorder; and (B) examine any policy basis for the imposition of collateral consequences identified under subparagraph (A) and the effect of the collateral consequences on individuals in recovery in resuming their personal and professional activities. (2) Recommendations Not later than 180 days after the date of the first meeting of the Task Force, the Task Force shall develop recommendations, as it considers appropriate, for proposed legislative and regulatory changes related to the collateral consequences identified under paragraph (1). (3) Collection of information The Task Force shall hold hearings, require the testimony and attendance of witnesses, and secure information from any department or agency of the United States in performing the duties under paragraphs (1) and (2). (4) Report (A) Submission to executive branch Not later than 1 year after the date of the first meeting of the Task Force, the Task Force shall submit a report detailing the findings and recommendations of the Task Force to— (i) the head of each relevant department or agency of the United States; (ii) the President; and (iii) the Vice President. (B) Submission to Congress The individuals who receive the report under subparagraph (A) shall submit to Congress such legislative recommendations, if any, as those individuals consider appropriate based on the report. V Addiction and treatment services for women, families, and veterans 501. Improving treatment for pregnant and postpartum women (a) In general Section 508 of the Public Health Service Act ( 42 U.S.C. 290bb–1 ) is amended— (1) in subsection (a), by inserting (referred to in this section as the Director ) after Director of the Center for Substance Abuse Treatment ; and (2) in subsection (p), in the first sentence— (A) by striking Committee on Labor and Human Resources and inserting Committee on Health, Education, Labor, and Pensions ; and (B) by inserting (other than subsection (r)) after this section . (b) Pilot program grants for State substance abuse agencies Section 508 of the Public Health Service Act ( 42 U.S.C. 290bb–1 ) is amended— (1) by striking subsection (r); and (2) by inserting after subsection (q) the following: (r) Pilot program for state substance abuse agencies (1) In general The Director shall carry out a pilot program under which the Director makes competitive grants to State substance abuse agencies to— (A) enhance flexibility in the use of funds designed to support family-based services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid use disorders; (B) help State substance abuse agencies address identified gaps in services furnished to such women along the continuum of care, including services provided to women in non-residential based settings; and (C) promote a coordinated, effective, and efficient State system managed by State substance abuse agencies by encouraging new approaches and models of service delivery that are evidence-based, including effective family-based programs for women involved with the criminal justice system. (2) Requirements In carrying out the pilot program under this subsection, the Director— (A) shall require State substance abuse agencies to submit to the Director applications, in such form and manner and containing such information as specified by the Director, to be eligible to receive a grant under the program; (B) shall identify, based on such submitted applications, State substance abuse agencies that are eligible for such grants; (C) shall require services proposed to be furnished through such a grant to support family-based treatment and other services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid use disorders; (D) notwithstanding subsection (a)(1), shall not require that services furnished through such a grant be provided solely to women that reside in facilities; and (E) shall not require that grant recipients under the program make available all services described in subsection (d). (3) Required services (A) In general The Director shall specify minimum services required to be made available to eligible women through a grant awarded under the pilot program under this subsection. Such minimum services— (i) shall include the requirements described in subsection (c); (ii) may include any of the services described in subsection (d); (iii) may include other services, as appropriate; and (iv) shall be based on the recommendations submitted under subparagraph (B) (B) Stakeholder input The Director shall convene and solicit recommendations from stakeholders, including State substance abuse agencies, health care providers, persons in recovery from a substance use disorder, and other appropriate individuals, for the minimum services described in subparagraph (A). (4) Duration The pilot program under this subsection shall not exceed 5 years. (5) Evaluation and report to Congress (A) In general Out of amounts made available to the Center for Behavioral Health Statistics and Quality, the Director of the Center for Behavioral Health Statistics and Quality, in cooperation with the recipients of grants under this subsection, shall conduct an evaluation of the pilot program under this subsection, beginning 1 year after the date on which a grant is first awarded under this subsection. The Director of the Center for Behavioral Health Statistics and Quality, in coordination with the Director of the Center for Substance Abuse Treatment, not later than 120 days after completion of such evaluation, shall submit to the relevant Committees of the Senate and the House of Representatives a report on such evaluation. (B) Contents The report to Congress under subparagraph (A) shall include, at a minimum, outcomes information from the pilot program, including any resulting reductions in the use of alcohol and other drugs, engagement in treatment services, retention in the appropriate level and duration of services, increased access to the use of drugs approved by the Food and Drug Administration for the treatment of substance use disorders in combination with counseling, and other appropriate measures. (6) Definition of State substance abuse agency For purposes of this subsection, the term State substance abuse agency means, with respect to a State, the agency in such State that manages the substance abuse prevention and treatment block grant program under part B of title XIX. (s) Funding (1) In general For the purpose of carrying out this section, there are authorized to be appropriated $15,900,000 for each of fiscal years 2016 through 2020. (2) Limitation Of the amounts made available under paragraph (1) to carry out this section, not more than 25 percent may be used each fiscal year to carry out subsection (r). . 502. Report on grants for family-based substance abuse treatment Section 2925 of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797s–4 ) is amended— (1) by striking An entity and inserting (a) Entity Reports .—An entity ; and (2) by adding at the end the following: (b) Attorney general report on family-Based substance abuse treatment The Attorney General shall submit to Congress an annual report that describes the number of grants awarded under section 2921(1) and how such grants are used by the recipients for family-based substance abuse treatment programs that serve as alternatives to incarceration for custodial parents to receive treatment and services as a family. . 503. Veterans’ treatment courts Section 2991(j)(1)(B)(ii) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797aa(j)(1)(B)(ii) ), as amended by the Comprehensive Justice and Mental Health Act of 2015 (S. 993, 114th Congress), is amended— (1) by inserting (I) after (ii) ; (2) in subclause (I), as so designated, by striking the period and inserting ; or ; and (3) by adding at the end the following: (II) was discharged or released from such service under dishonorable conditions, if the reason for that discharge or release, if known, is attributable to a substance use disorder. . VI Incentivizing State comprehensive initiatives to address prescription opioid and heroin abuse 601. State demonstration grants for comprehensive opioid abuse response (a) Definitions In this section— (1) the term dispenser has the meaning given the term in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ); (2) the term prescriber means a dispenser who prescribes a controlled substance, or the agent of such a dispenser; (3) the term prescriber of a schedule II, III, or IV controlled substance does not include a prescriber of a schedule II, III, or IV controlled substance that dispenses the substance— (A) for use on the premises on which the substance is dispensed; (B) in a hospital emergency room, when the substance is in short supply; (C) for a certified opioid treatment program; or (D) in other situations as the Attorney General may reasonably determine; and (4) the term schedule II, III, or IV controlled substance means a controlled substance that is listed on schedule II, schedule III, or schedule IV of section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ). (b) Planning and implementation grants (1) In general The Attorney General, in coordination with the Secretary of Health and Human Services and in consultation with the Director of the Office of National Drug Control Policy, may award grants to States, and combinations thereof, to prepare a comprehensive plan for and implement an integrated opioid abuse response initiative. (2) Purposes A State receiving a grant under this section shall establish a comprehensive response to opioid abuse, which shall include— (A) prevention and education efforts around heroin and opioid use, treatment, and recovery, including education of residents, medical students, and physicians and other prescribers of schedule II, III, or IV controlled substances on relevant prescribing guidelines and the prescription drug monitoring program of the State; (B) a comprehensive prescription drug monitoring program to track dispensing of schedule II, III, or IV controlled substances, which shall— (i) provide for data sharing with other States by statute, regulation, or interstate agreement; and (ii) allow for access to all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled substances on the prescription drug monitoring program of the State; (C) developing, implementing, or expanding prescription drug and opioid addiction treatment programs by— (i) expanding programs for medication assisted treatment of prescription drug and opioid addiction, including training for treatment and recovery support providers; (ii) developing, implementing, or expanding programs for behavioral health therapy for individuals who are in treatment for prescription drug and opioid addiction; (iii) developing, implementing, or expanding programs to screen individuals who are in treatment for prescription drug and opioid addiction for hepatitis C and HIV, and provide treatment for those individuals if clinically appropriate; or (iv) developing, implementing, or expanding programs that provide screening, early intervention, and referral to treatment (commonly known as SBIRT ) to teenagers and young adults in primary care, middle schools, high schools, universities, school-based health centers, and other community-based health care settings frequently accessed by teenagers or young adults; and (D) developing, implementing, and expanding programs to prevent overdose death from prescription medications and opioids. (3) Planning grant applications (A) Application (i) In general A State seeking a planning grant under this section to prepare a comprehensive plan for an integrated opioid abuse response initiative shall submit to the Attorney General an application in such form, and containing such information, as the Attorney General may require. (ii) Requirements An application for a planning grant under this section shall, at a minimum, include— (I) a budget and a budget justification for the activities to be carried out using the grant; (II) a description of the activities proposed to be carried out using the grant, including a schedule for completion of such activities; (III) outcome measures that will be used to measure the effectiveness of the programs and initiatives to address opioids; and (IV) a description of the personnel necessary to complete such activities. (B) Period; nonrenewability A planning grant under this section shall be for a period of 1 year. A State may not receive more than 1 planning grant under this section. (C) Strategic plan and program implementation plan A State receiving a planning grant under this section shall develop a strategic plan and a program implementation plan. (4) Implementation grants (A) Application A State seeking an implementation grant under this section to implement a comprehensive strategy for addressing opioid abuse shall submit to the Attorney General an application in such form, and containing such information, as the Attorney General may require. (B) Use of funds A State that receives an implementation grant under this section shall use the grant for the cost of carrying out an integrated opioid abuse response program in accordance with this section, including for technical assistance, training, and administrative expenses. (C) Requirements An integrated opioid abuse response program carried out using an implementation grant under this section shall— (i) require that each prescriber of a schedule II, III, or IV controlled substance in the State— (I) registers with the prescription drug monitoring program of the State; and (II) consults the prescription drug monitoring program database of the State before prescribing a schedule II, III, or IV controlled substance; (ii) require that each dispenser of a schedule II, III, or IV controlled substance in the State— (I) registers with the prescription drug monitoring program of the State; (II) consults the prescription drug monitoring program database of the State before dispensing a schedule II, III, or IV controlled substance; and (III) reports to the prescription drug monitoring program of the State, at a minimum, each instance in which a schedule II, III, or IV controlled substance is dispensed, with limited exceptions, as defined by the State, which shall indicate the prescriber by name and National Provider Identifier; (iii) require that, not fewer than 4 times each year, the State agency or agencies that administer the prescription drug monitoring program of the State prepare and provide to each prescriber of a schedule II, III, or IV controlled substance an informational report that shows how the prescribing patterns of the prescriber compare to prescribing practices of the peers of the prescriber and expected norms; (iv) if informational reports provided to a prescriber under clause (iii) indicate that the prescriber is repeatedly falling outside of expected norms or standard practices for the prescriber's field, direct the prescriber to educational resources on appropriate prescribing of controlled substances; (v) ensure that the prescriber licensing board of the State receives a report describing any prescribers that repeatedly fall outside of expected norms or standard practices for the prescriber's field, as described in clause (iii); (vi) require consultation with the Single State Authority for Substance Abuse (as defined in section 201(e) of the Second Chance Act of 2007 ( 42 U.S.C. 17521(e) )); and (vii) establish requirements for how data will be collected and analyzed to determine the effectiveness of the program. (D) Period An implementation grant under this section shall be for a period of 2 years. (5) Priority considerations In awarding planning and implementation grants under this section, the Attorney General shall give priority to a State that— (A) (i) provides civil liability protection for first responders, health professionals, and family members who have received appropriate training in the administration of naloxone in administering naloxone to counteract opioid overdoses; and (ii) submits to the Attorney General a certification by the attorney general of the State that the attorney general has— (I) reviewed any applicable civil liability protection law to determine the applicability of the law with respect to first responders, health care professionals, family members, and other individuals who— (aa) have received appropriate training in the administration of naloxone; and (bb) may administer naloxone to individuals reasonably believed to be suffering from opioid overdose; and (II) concluded that the law described in subclause (I) provides adequate civil liability protection applicable to such persons; (B) has in effect legislation or implements a policy under which the State shall not terminate, but may suspend, enrollment under the State plan for medical assistance under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq. ) for an individual who is incarcerated for a period of fewer than 2 years; (C) has a process for enrollment in services and benefits necessary by criminal justice agencies to initiate or continue treatment in the community, under which an individual who is incarcerated may, while incarcerated, enroll in services and benefits that are necessary for the individual to continue treatment upon release from incarceration; (D) ensures the capability of data sharing with other States, such as by making data available to a prescription monitoring hub; (E) ensures that data recorded in the prescription drug monitoring program database of the State is available within 24 hours, to the extent possible; and (F) ensures that the prescription drug monitoring program of the State notifies prescribers and dispensers of schedule II, III, or IV controlled substances when overuse or misuse of such controlled substances by patients is suspected. (c) Authorization of Funding For each of fiscal years 2016 through 2020, the Attorney General may use, from any unobligated balances made available under the heading GENERAL ADMINISTRATION to the Department of Justice in an appropriation Act, such amounts as are necessary to carry out this section, not to exceed $5,000,000 per fiscal year. VII Miscellaneous 701. GAO report on IMD exclusion (a) Definition In this section, the term Medicaid Institutions for Mental Disease exclusion means the prohibition on Federal matching payments under Medicaid for patients who have attained age 22, but have not attained age 65, in an institution for mental diseases under subparagraph (B) of the matter following subsection (a) of section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) and subsection (i) of such section. (b) Report required Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the impact that the Medicaid Institutions for Mental Disease exclusion has on access to treatment for individuals with a substance use disorder. (c) Elements The report required under subsection (b) shall include a review of what is known regarding— (1) Medicaid beneficiary access to substance use disorder treatments in institutions for mental disease; and (2) the quality of care provided to Medicaid beneficiaries treated in and outside of institutions for mental disease for substance use disorders. 702. Funding Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ), as amended by section 401, is amended by adding at the end the following: 2999E. Funding There are authorized to be appropriated to the Attorney General and the Secretary of Health and Human Services to carry out this part $62,000,000 for each of fiscal years 2016 through 2020. . 703. Conforming amendments Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ) is amended— (1) in the part heading, by striking CONFRONTING USE OF METHAMPHETAMINE and inserting COMPREHENSIVE ADDICTION AND RECOVERY ; and (2) in section 2996(a)(1), by striking this part and inserting this section . 704. Grant accountability (a) Grants under part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 Part II of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3797cc et seq. ); as amended by section 702, is amended by adding at the end the following: 2999F. Grant accountability (a) Definitions In this section— (1) the term applicable committees — (A) with respect to the Attorney General and any other official of the Department of Justice, means— (i) the Committee on the Judiciary of the Senate; and (ii) the Committee on the Judiciary of the House of Representatives; and (B) with respect to the Secretary of Health and Human Services and any other official of the Department of Health and Human Services, means— (i) the Committee on Health, Education, Labor, and Pensions of the Senate; and (ii) the Committee on Energy and Commerce of the House of Representatives; (2) the term covered agency means— (A) the Department of Justice; and (B) the Department of Health and Human Services; and (3) the term covered official means— (A) the Attorney General; and (B) the Secretary of Health and Human Services. (b) Accountability All grants awarded by a covered official under this part shall be subject to the following accountability provisions: (1) Audit requirement (A) Definition In this paragraph, the term unresolved audit finding means a finding in the final audit report of the Inspector General of a covered agency that the audited grantee has utilized grant funds for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved within 12 months after the date on which the final audit report is issued. (B) Audit Beginning in the first fiscal year beginning after the date of enactment of this section, and in each fiscal year thereafter, the Inspector General of a covered agency shall conduct audits of recipients of grants awarded by the applicable covered official under this part to prevent waste, fraud, and abuse of funds by grantees. The Inspector General shall determine the appropriate number of grantees to be audited each year. (C) Mandatory exclusion A recipient of grant funds under this part that is found to have an unresolved audit finding shall not be eligible to receive grant funds under this part during the first 2 fiscal years beginning after the end of the 12-month period described in subparagraph (A). (D) Priority In awarding grants under this part, a covered official shall give priority to eligible applicants that did not have an unresolved audit finding during the 3 fiscal years before submitting an application for a grant under this part. (E) Reimbursement If an entity is awarded grant funds under this part during the 2-fiscal-year period during which the entity is barred from receiving grants under subparagraph (C), the covered official that awarded the grant funds shall— (i) deposit an amount equal to the amount of the grant funds that were improperly awarded to the grantee into the General Fund of the Treasury; and (ii) seek to recoup the costs of the repayment to the fund from the grant recipient that was erroneously awarded grant funds. (2) Nonprofit organization requirements (A) Definition For purposes of this paragraph and the grant programs under this part, the term nonprofit organization means an organization that is described in section 501(c)(3) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of such Code. (B) Prohibition A covered official may not award a grant under this part to a nonprofit organization that holds money in offshore accounts for the purpose of avoiding paying the tax described in section 511(a) of the Internal Revenue Code of 1986. (C) Disclosure Each nonprofit organization that is awarded a grant under this part and uses the procedures prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, directors, trustees, and key employees, shall disclose to the applicable covered official, in the application for the grant, the process for determining such compensation, including the independent persons involved in reviewing and approving such compensation, the comparability data used, and contemporaneous substantiation of the deliberation and decision. Upon request, a covered official shall make the information disclosed under this subparagraph available for public inspection. (3) Conference expenditures (A) Limitation No amounts made available to a covered official under this part may be used by the covered official, or by any individual or entity awarded discretionary funds through a cooperative agreement under this part, to host or support any expenditure for conferences that uses more than $20,000 in funds made available by the covered official, unless the covered official provides prior written authorization that the funds may be expended to host the conference. (B) Written authorization Written authorization under subparagraph (A) shall include a written estimate of all costs associated with the conference, including the cost of all food, beverages, audio-visual equipment, honoraria for speakers, and entertainment. (C) Report (i) Department of Justice The Deputy Attorney General shall submit to the applicable committees an annual report on all conference expenditures approved by the Attorney General under this paragraph. (ii) Department of Health and Human Services The Deputy Secretary of Health and Human Services shall submit to the applicable committees an annual report on all conference expenditures approved by the Secretary of Health and Human Services under this paragraph. (4) Annual certification Beginning in the first fiscal year beginning after the date of enactment of this section, each covered official shall submit to the applicable committees an annual certification— (A) indicating whether— (i) all audits issued by the Office of the Inspector General of the applicable agency under paragraph (1) have been completed and reviewed by the appropriate Assistant Attorney General or Director, or the appropriate official of the Department of Health and Human Services, as applicable; (ii) all mandatory exclusions required under paragraph (1)(C) have been issued; and (iii) all reimbursements required under paragraph (1)(E) have been made; and (B) that includes a list of any grant recipients excluded under paragraph (1) from the previous year. (c) Preventing duplicative grants (1) In general Before a covered official awards a grant to an applicant under this part, the covered official shall compare potential grant awards with other grants awarded under this part by the covered official to determine if duplicate grant awards are awarded for the same purpose. (2) Report If a covered official awards duplicate grants to the same applicant for the same purpose, the covered official shall submit to the applicable committees a report that includes— (A) a list of all duplicate grants awarded, including the total dollar amount of any duplicate grants awarded; and (B) the reason the covered official awarded the duplicate grants. . (b) Other grants (1) Definitions In this subsection— (A) the term applicable committees — (i) with respect to the Attorney General and any other official of the Department of Justice, means— (I) the Committee on the Judiciary of the Senate; and (II) the Committee on the Judiciary of the House of Representatives; and (ii) with respect to the Secretary of Health and Human Services and any other official of the Department of Health and Human Services, means— (I) the Committee on Health, Education, Labor, and Pensions of the Senate; and (II) the Committee on Energy and Commerce of the House of Representatives; (B) the term covered agency means— (i) the Department of Justice; and (ii) the Department of Health and Human Services; (C) the term covered grant means a grant under section 201, 302, or 601 of this Act or section 508 of the Public Health Service Act ( 42 U.S.C. 290bb–1 ) (as amended by section 501 of this Act); and (D) the term covered official means— (i) the Attorney General; and (ii) the Secretary of Health and Human Services. (2) Accountability All covered grants awarded by a covered official shall be subject to the following accountability provisions: (A) Audit requirement (i) Definition In this subparagraph, the term unresolved audit finding means a finding in the final audit report of the Inspector General of a covered agency that the audited grantee has utilized grant funds for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved within 12 months after the date on which the final audit report is issued. (ii) Audit Beginning in the first fiscal year beginning after the date of enactment of this Act, and in each fiscal year thereafter, the Inspector General of a covered agency shall conduct audits of recipients of covered grants awarded by the applicable covered official to prevent waste, fraud, and abuse of funds by grantees. The Inspector General shall determine the appropriate number of grantees to be audited each year. (iii) Mandatory exclusion A recipient of covered grant funds that is found to have an unresolved audit finding shall not be eligible to receive covered grant funds during the first 2 fiscal years beginning after the end of the 12-month period described in clause (i). (iv) Priority In awarding covered grants, a covered official shall give priority to eligible applicants that did not have an unresolved audit finding during the 3 fiscal years before submitting an application for a covered grant. (v) Reimbursement If an entity is awarded covered grant funds during the 2-fiscal-year period during which the entity is barred from receiving grants under clause (iii), the covered official that awarded the funds shall— (I) deposit an amount equal to the amount of the grant funds that were improperly awarded to the grantee into the General Fund of the Treasury; and (II) seek to recoup the costs of the repayment to the fund from the grant recipient that was erroneously awarded grant funds. (B) Nonprofit organization requirements (i) Definition For purposes of this subparagraph and the covered grant programs, the term nonprofit organization means an organization that is described in section 501(c)(3) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of such Code. (ii) Prohibition A covered official may not award a covered grant to a nonprofit organization that holds money in offshore accounts for the purpose of avoiding paying the tax described in section 511(a) of the Internal Revenue Code of 1986. (iii) Disclosure Each nonprofit organization that is awarded a covered grant and uses the procedures prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, directors, trustees, and key employees, shall disclose to the applicable covered official, in the application for the grant, the process for determining such compensation, including the independent persons involved in reviewing and approving such compensation, the comparability data used, and contemporaneous substantiation of the deliberation and decision. Upon request, a covered official shall make the information disclosed under this clause available for public inspection. (C) Conference expenditures (i) Limitation No amounts made available to a covered official under a covered grant program may be used by the covered official, or by any individual or entity awarded discretionary funds through a cooperative agreement under a covered grant program, to host or support any expenditure for conferences that uses more than $20,000 in funds made available by the covered official, unless the covered official provides prior written authorization that the funds may be expended to host the conference. (ii) Written authorization Written authorization under clause (i) shall include a written estimate of all costs associated with the conference, including the cost of all food, beverages, audio-visual equipment, honoraria for speakers, and entertainment. (iii) Report (I) Department of Justice The Deputy Attorney General shall submit to the applicable committees an annual report on all conference expenditures approved by the Attorney General under this subparagraph. (II) Department of Health and Human Services The Deputy Secretary of Health and Human Services shall submit to the applicable committees an annual report on all conference expenditures approved by the Secretary of Health and Human Services under this subparagraph. (D) Annual certification Beginning in the first fiscal year beginning after the date of enactment of this Act, each covered official shall submit to the applicable committees an annual certification— (i) indicating whether— (I) all audits issued by the Office of the Inspector General of the applicable agency under subparagraph (A) have been completed and reviewed by the appropriate Assistant Attorney General or Director, or the appropriate official of the Department of Health and Human Services, as applicable; (II) all mandatory exclusions required under subparagraph (A)(iii) have been issued; and (III) all reimbursements required under subparagraph (A)(v) have been made; and (ii) that includes a list of any grant recipients excluded under subparagraph (A) from the previous year. (3) Preventing duplicative grants (A) In general Before a covered official awards a covered grant to an applicant, the covered official shall compare potential grant awards with other covered grants awarded by the covered official to determine if duplicate grant awards are awarded for the same purpose. (B) Report If a covered official awards duplicate grants to the same applicant for the same purpose, the covered official shall submit to the applicable committees a report that includes— (i) a list of all duplicate grants awarded, including the total dollar amount of any duplicate grants awarded; and (ii) the reason the covered official awarded the duplicate grants. 705. Programs to prevent prescription drug abuse under the Medicare program (a) Drug Management Program for At-Risk Beneficiaries (1) In general Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended by adding at the end the following: (5) Drug management program for at-risk beneficiaries (A) Authority to establish A PDP sponsor may establish a drug management program for at-risk beneficiaries under which, subject to subparagraph (B) , the PDP sponsor may, in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such PDP sponsor, limit such beneficiary’s access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by a prescriber (or prescribers) selected under subparagraph (D), and dispensed for such beneficiary by a pharmacy (or pharmacies) selected under such subparagraph. (B) Requirement for notices (i) In general A PDP sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor— (I) provides to the beneficiary an initial notice described in clause (ii) and a second notice described in clause (iii); and (II) verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse, as described in subparagraph (C)(iv). (ii) Initial notice An initial written notice described in this clause is a notice that provides to the beneficiary— (I) notice that the PDP sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse; (II) information, when possible, describing State and Federal public health resources that are designed to address prescription drug abuse to which the beneficiary may have access, including substance use disorder treatment services, addiction treatment services, mental health services, and other counseling services; (III) a request for the beneficiary to submit to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor to select under subparagraph (D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause (iii)(I); (IV) an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse, including an explanation of the drug management program established by the PDP sponsor pursuant to subparagraph (A); (V) clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (IV) and any other communications relating to the drug management program for at-risk beneficiaries established by the PDP sponsor; (VI) contact information for other organizations that can provide the beneficiary with information regarding drug management program for at-risk beneficiaries (similar to the information provided by the Secretary in other standardized notices to part D eligible individuals enrolled in prescription drug plans under this part); and (VII) notice that the beneficiary has a right to an appeal pursuant to subparagraph (E). (iii) Second notice A second written notice described in this clause is a notice that provides to the beneficiary notice— (I) that the PDP sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse; (II) that such beneficiary has been sent, or informed of, such identification in the initial notice and is now subject to the requirements of the drug management program for at-risk beneficiaries established by such PDP sponsor for such plan; (III) of the prescriber and pharmacy selected for such individual under subparagraph (D) ; (IV) of, and information about, the right of the beneficiary to a reconsideration and an appeal under subsection (h) of such identification and the prescribers and pharmacies selected; (V) that the beneficiary can, in the case that the beneficiary has not previously submitted to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor select under subparagraph (D), submit such preferences to the PDP sponsor; and (VI) that includes clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (V). (iv) Timing of notices (I) In general Subject to subclause (II), a second written notice described in clause (iii) shall be provided to the beneficiary on a date that is not less than 30 days after an initial notice described in clause (ii) is provided to the beneficiary. (II) Exception In the case that the PDP sponsor, in conjunction with the Secretary, determines that concerns identified through rulemaking by the Secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the PDP sponsor to provide a second notice described in clause (iii) to the beneficiary on a date that is earlier than the date described in subclause (II), the PDP sponsor may provide such second notice on such earlier date. (III) Form of notice The written notices under clauses (ii) and (iii) shall be in a format determined appropriate by the Secretary, taking into account beneficiary preferences. (C) At-risk beneficiary for prescription drug abuse (i) In general For purposes of this paragraph, the term at-risk beneficiary for prescription drug abuse means a part D eligible individual who is not an exempted individual described in clause (ii) and— (I) who is identified through criteria developed by the Secretary in consultation with PDP sponsors and other stakeholders described in subsection section __(g)(2)(A) of the Comprehensive Addiction and Recovery Act of 2016 based on clinical factors indicating misuse or abuse of prescription drugs described in subparagraph (G), including dosage, quantity, duration of use, number of and reasonable access to prescribers, and number of and reasonable access to pharmacies used to obtain such drug; or (II) with respect to whom the PDP sponsor of a prescription drug plan, upon enrolling such individual in such plan, received notice from the Secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug abuse under a prescription drug plan in which such individual was previously enrolled and such identification has not been terminated under subparagraph (F). (ii) Exempted individual described An exempted individual described in this clause is an individual who— (I) receives hospice care under this title; (II) resides in a long-term care facility, a facility described in section 1905(d), or other facility under contract with a single pharmacy; or (III) the Secretary elects to treat as an exempted individual for purposes of clause (i). (iii) Program size The Secretary shall establish policies, including the criteria developed under clause (i)(I) and the exemptions under clause (ii)(III), to ensure that the population of enrollees in a drug management program for at-risk beneficiaries operated by a prescription drug plan can be effectively managed by such plans. (iv) Clinical contact With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by a PDP sponsor, the PDP sponsor shall contact the beneficiary's providers who have prescribed frequently abused drugs regarding whether prescribed medications are appropriate for such beneficiary’s medical conditions. (D) Selection of prescribers (i) In general With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor, a PDP sponsor shall, based on the preferences submitted to the PDP sponsor by the beneficiary pursuant to clauses (ii)(III) and (iii)(V) of subparagraph (B) if applicable, select— (I) one, or, if the PDP sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause (ii), more than one, individual who is authorized to prescribe frequently abused drugs (referred to in this paragraph as a prescriber ) who may write prescriptions for such drugs for such beneficiary; and (II) one, or, if the PDP sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause (ii), more than one, pharmacy that may dispense such drugs to such beneficiary. (ii) Reasonable access In making the selection under this subparagraph, a PDP sponsor shall ensure, taking into account geographic location, beneficiary preference, impact on cost-sharing, and reasonable travel time, that the beneficiary continues to have reasonable access to drugs described in subparagraph (G), including— (I) for individuals with multiple residences; and (II) in the case of natural disasters and similar emergency situations. (iii) Beneficiary preferences (I) In general If an at-risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the PDP sponsor select in response to a notice under subparagraph (B), the PDP sponsor shall— (aa) review such preferences; (bb) select or change the selection of a prescriber or pharmacy for the beneficiary based on such preferences; and (cc) inform the beneficiary of such selection or change of selection. (II) Exception In the case that the PDP sponsor determines that a change to the selection of a prescriber or pharmacy under item (bb) by the PDP sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary, the PDP sponsor may change the selection of a prescriber or pharmacy for the beneficiary. If the PDP sponsor changes the selection pursuant to the preceding sentence, the PDP sponsor shall provide the beneficiary with— (aa) at least 30 days written notice of the change of selection; and (bb) a rationale for the change. (III) Timing An at-risk beneficiary for prescription drug abuse may choose to express their prescriber and pharmacy preference and communicate such preference to their PDP sponsor at any date while enrolled in the program, including after a second notice under subparagraph (B)(iii) has been provided. (iv) Confirmation Before selecting a prescriber or pharmacy under this subparagraph, a PDP sponsor must notify the prescriber and pharmacy that the beneficiary involved has been identified for inclusion in the drug management program for at-risk beneficiaries and that the prescriber and pharmacy has been selected as the beneficiary’s designated prescriber and pharmacy. (E) Appeals The identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph, a coverage determination made under a drug management program for at-risk beneficiaries, and the selection of a prescriber or pharmacy under subparagraph (D) with respect to such individual shall be subject to an expedited reconsideration and appeal pursuant to subsection (h). (F) Termination of identification (i) In general The Secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph. Under such standards such identification shall terminate as of the earlier of— (I) the date the individual demonstrates that the individual is no longer likely, in the absence of the restrictions under this paragraph, to be an at-risk beneficiary for prescription drug abuse described in subparagraph (C)(i); or (II) the end of such maximum period of identification as the Secretary may specify. (ii) Rule of construction Nothing in clause (i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph (C)(i) after such termination on the basis of additional information on drug use occurring after the date of notice of such termination. (G) Frequently abused drug For purposes of this subsection, the term frequently abused drug means a drug that is determined by the Secretary to be frequently abused or diverted and that is— (i) a Controlled Drug Substance in Schedule CII; or (ii) within the same class or category of drugs as a Controlled Drug Substance in Schedule CII, as determined through notice and comment rulemaking. (H) Data disclosure (i) Data on decision to impose limitation In the case of an at-risk beneficiary for prescription drug abuse (or an individual who is a potentially at-risk beneficiary for prescription drug abuse) whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a PDP sponsor under this paragraph, the Secretary shall establish rules and procedures to require such PDP sponsor to disclose data, including necessary individually identifiable health information, about the decision to impose such limitations and the limitations imposed by the PDP sponsor under this part. (ii) Data to reduce fraud, abuse, and waste The Secretary shall establish rules and procedures to require PDP sponsors operating a drug management program for at-risk beneficiaries under this paragraph to provide the Secretary with such data as the Secretary determines appropriate for purposes of identifying patterns of prescription drug utilization for plan enrollees that are outside normal patterns and that may indicate fraudulent, medically unnecessary, or unsafe use. (I) Sharing of information for subsequent plan enrollments The Secretary shall establish procedures under which PDP sponsors who offer prescription drug plans shall share information with respect to individuals who are at-risk beneficiaries for prescription drug abuse (or individuals who are potentially at-risk beneficiaries for prescription drug abuse) and enrolled in a prescription drug plan and who subsequently disenroll from such plan and enroll in another prescription drug plan offered by another PDP sponsor. (J) Privacy issues Prior to the implementation of the rules and procedures under this paragraph, 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 subparagraphs (H) and (I) by PDP sponsors. Such clarification shall provide that the sharing of such data shall be considered to be protected health information in accordance with the requirements of the regulations promulgated pursuant to such section 264(c). (K) Education The Secretary shall provide education to enrollees in prescription drug plans of PDP sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph, including education— (i) provided through the improper payment outreach and education program described in section 1874A(h); and (ii) through current education efforts (such as State health insurance assistance programs described in subsection (a)(1)(A) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 ( 42 U.S.C. 1395b–3 note)) and materials directed toward such enrollees. (L) CMS compliance review The Secretary shall ensure that existing plan sponsor compliance reviews and audit processes include the drug management programs for at-risk beneficiaries under this paragraph, including appeals processes under such programs. . (2) Information for consumers Section 1860D–4(a)(1)(B) of the Social Security Act ( 42 U.S.C. 1395w–104(a)(1)(B) ) is amended by adding at the end the following: (v) The drug management program for at-risk beneficiaries under subsection (c)(5). . (3) Dual eligibles Section 1860D–1(b)(3)(D) of the Social Security Act ( 42 U.S.C. 1395w–101(b)(3)(D) ) is amended by inserting , subject to such limits as the Secretary may establish for individuals identified pursuant to section 1860D–4(c)(5) after the Secretary . (b) Utilization management programs Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ), as amended by subsection (a)(1), is amended— (1) in paragraph (1), by inserting after subparagraph (D) the following new subparagraph: (E) A utilization management tool to prevent drug abuse (as described in paragraph (5)(A)). ; and (2) by adding at the end the following new paragraph: (6) Utilization management tool to prevent drug abuse (A) In general A tool described in this paragraph is any of the following: (i) A utilization tool designed to prevent the abuse of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies. (ii) Retrospective utilization review to identify— (I) individuals that receive frequently abused drugs at a frequency or in amounts that are not clinically appropriate; and (II) providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries. (iii) Consultation with the contractor described in subparagraph (B) to verify if an individual enrolling in a prescription drug plan offered by a PDP sponsor has been previously identified by another PDP sponsor as an individual described in clause (ii)(I). (B) Reporting A PDP sponsor offering a prescription drug plan in a State shall submit to the Secretary and the Medicare drug integrity contractor with which the Secretary has entered into a contract under section 1893 with respect to such State a report, on a monthly basis, containing information on— (i) any provider of services or supplier described in subparagraph (A)(ii)(II) that is identified by such plan sponsor during the 30-day period before such report is submitted; and (ii) the name and prescription records of individuals described in paragraph (5)(C). (C) CMS compliance review The Secretary shall ensure that plan sponsor annual compliance reviews and program audits include a certification that utilization management tools under this paragraph are in compliance with the requirements for such tools. . (c) Treatment of certain complaints for purposes of quality or performance assessment Section 1860D–42 of the Social Security Act ( 42 U.S.C. 1395w–152 ) is amended by adding at the end the following new subsection: (d) Treatment of certain complaints for purposes of quality or performance assessment In conducting a quality or performance assessment of a PDP sponsor, the Secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such PDP sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries. . (d) Sense of Congress regarding use of technology tools To combat fraud It is the sense of Congress that MA organizations and PDP sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under MA–PD plans and prescription drug plans under parts C and D of the Medicare Program. (e) GAO study and report (1) Study The Comptroller General of the United States shall conduct a study on the implementation of the amendments made by this section, including the effectiveness of the at-risk beneficiaries for prescription drug abuse drug management programs authorized by section 1860D–4(c)(5) of the Social Security Act ( 42 U.S.C. 1395w–10(c)(5) ), as added by subsection (a)(1). Such study shall include an analysis of— (A) the impediments, if any, that impair the ability of individuals described in subparagraph (C) of such section 1860D–4(c)(5) to access clinically appropriate levels of prescription drugs; (B) the effectiveness of the reasonable access protections under subparagraph (D)(ii) of such section 1860D–4(c)(5), including the impact on beneficiary access and health; (C) how best to define the term designated pharmacy , including whether the definition of such term should include an entity that is comprised of a number of locations that are under common ownership and that electronically share a real-time, online database and whether such a definition would help to protect and improve beneficiary access; (D) the types of— (i) individuals who, in the implementation of such section, are determined to be individuals described in such subparagraph; and (ii) prescribers and pharmacies that are selected under subparagraph (D) of such section; (E) the extent of prescription drug abuse beyond Controlled Drug Substances in Schedule CII in parts C and D of the Medicare program; and (F) other areas determined appropriate by the Comptroller General. (2) Report Not later than July 1, 2019, the Comptroller General of the United States shall submit to the appropriate committees of jurisdiction of Congress a report on the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines to be appropriate. (f) Report by Secretary (1) In general Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the appropriate committees of jurisdiction of Congress a report on ways to improve upon the appeals process for Medicare beneficiaries with respect to prescription drug coverage under part D of title XVIII of the Social Security Act. Such report shall include an analysis comparing appeals processes under parts C and D of such title XVIII. (2) Feedback In development of the report described in paragraph (1), the Secretary of Health and Human Services shall solicit feedback on the current appeals process from stakeholders, such as beneficiaries, consumer advocates, plan sponsors, pharmacy benefit managers, pharmacists, providers, independent review entity evaluators, and pharmaceutical manufacturers. (g) Effective date (1) In general Except as provided in subsection (d)(2), the amendments made by this section shall apply to prescription drug plans for plan years beginning on or after January 1, 2018. (2) Stakeholder meetings prior to effective date (A) In general Not later than January 1, 2017, the Secretary of Health and Human Services shall convene stakeholders, including individuals entitled to benefits under part A of title XVIII of the Social Security Act or enrolled under part B of such title of such Act, advocacy groups representing such individuals, clinicians, plan sponsors, pharmacists, retail pharmacies, entities delegated by plan sponsors, and biopharmaceutical manufacturers for input regarding the topics described in subparagraph (B). The input described in the preceding sentence shall be provided to the Secretary in sufficient time in order for the Secretary to take such input into account in promulgating the regulations pursuant to subparagraph (C). (B) Topics described The topics described in this subparagraph are the topics of— (i) the impact on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans of PDP sponsors who are at-risk beneficiaries for prescription drug abuse (as defined in paragraph (5)(C) of section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–10(c) )); (ii) the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug abuse under such paragraph (similar to the processes established under the Medicare Advantage program under part C of title XVIII of the Social Security Act); (iii) the types of enrollees that should be treated as exempted individuals, as described in clause (ii) of such paragraph; (iv) the manner in which terms and definitions in paragraph (5) of such section 1860D–4(c) should be applied, such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in subparagraph (C) of such paragraph (5); (v) the information to be included in the notices described in subparagraph (B) of such section and the standardization of such notices; (vi) with respect to a PDP sponsor that establishes a drug management program for at-risk beneficiaries under such paragraph (5), the responsibilities of such PDP sponsor with respect to the implementation of such program; (vii) notices for plan enrollees at the point of sale that would explain why an at-risk beneficiary has been prohibited from receiving a prescription at a location outside of the designated pharmacy; (viii) evidence-based prescribing guidelines for opiates; and (ix) the sharing of claims data under parts A and B with PDP sponsors. (C) Rulemaking The Secretary of Health and Human Services shall, taking into account the input gathered pursuant to subparagraph (A) and after providing notice and an opportunity to comment, promulgate regulations to carry out the provisions of, and amendments made by subsections (a) and (b). VIII Transnational Drug Trafficking Act 801. Short title This title may be cited as the Transnational Drug Trafficking Act of 2015 . 802. Possession, manufacture or distribution for purposes of unlawful importations Section 1009 of the Controlled Substances Import and Export Act ( 21 U.S.C. 959 ) is amended— (1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (2) in subsection (a), by striking It shall and all that follows and inserting the following: “It shall be unlawful for any person to manufacture or distribute a controlled substance in schedule I or II or flunitrazepam or a listed chemical intending, knowing, or having reasonable cause to believe that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States. (b) It shall be unlawful for any person to manufacture or distribute a listed chemical— (1) intending or knowing that the listed chemical will be used to manufacture a controlled substance; and (2) intending, knowing, or having reasonable cause to believe that the controlled substance will be unlawfully imported into the United States. . 803. Trafficking in counterfeit goods or services Chapter 113 of title 18, United States Code, is amended— (1) in section 2318(b)(2), by striking section 2320(e) and inserting section 2320(f) ; and (2) in section 2320— (A) in subsection (a), by striking paragraph (4) and inserting the following: (4) traffics in a drug and knowingly uses a counterfeit mark on or in connection with such drug, ; (B) in subsection (b)(3), in the matter preceding subparagraph (A), by striking counterfeit drug and inserting drug that uses a counterfeit mark on or in connection with the drug ; and (C) in subsection (f), by striking paragraph (6) and inserting the following: (6) the term drug means a drug, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). .

Passed the Senate March 10, 2016. Secretary