Comprehensive Addiction and Recovery Act of 2016

Comprehensive Addiction and Recovery Act of 2016

TITLE I--PREVENTION AND EDUCATION

(Sec. 101) This bill requires the Department of Health and Human Services (HHS) to convene a Pain Management Best Practices Inter-Agency Task Force to review best practices for pain management developed or adopted by federal agencies. The task force must propose updates to best practices and recommendations for addressing gaps or inconsistencies.

(Sec. 102) HHS must advance education and awareness regarding the risk of abuse of prescription opioids if they are not taken as prescribed. (Opioids are drugs with effects similar to opium, such as certain pain medications and heroin.)

(Sec. 103) The Office of National Drug Control Policy, in coordination with the Substance Abuse and Mental Health Services Administration, may award grants to implement community-wide strategies to address a high rate of, or sudden increase in, opioid or methamphetamine abuse or a sudden increase in opioid-related deaths.

(Sec. 104) HHS must report on the availability of information regarding the prescription of opioids after youth sports injury, including information on opioid use and misuse, injury treatments that do not involve opioids, and treatment for opioid addiction. The report must determine the extent this information is available to teenagers and adolescents who play youth sports, their families, youth sports groups, and health care providers. Taking into consideration the findings of the report, HHS may facilitate the development of such information.

(Sec. 105) This bill amends the Public Health Service Act to require HHS to award grants to states to: (1) streamline state requirements and procedures to assist certain veterans to meet state certification, licensure, and other requirements applicable to civilian health care professions; and (2) develop or expand career pathways at institutions of higher education to support veterans in meeting such requirements.

(Sec. 106) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

The FDA must finalize the draft guidance entitled "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

(Sec. 107) HHS must award grants to expand access to drugs or devices approved by the FDA for emergency treatment of opioid overdose (e.g., naloxone). Grant recipients may use the funds to purchase such treatments, establish a program for prescribing such treatments, train health care providers and pharmacists, offset patient cost sharing, and connect patients to treatment.

HHS may provide information to prescribers in federally qualified health centers and Indian Health Service facilities on best practices for prescribing such treatments. The Department of Defense and the Department of Veterans Affairs may provide such information to prescribers in their medical facilities.

(Sec. 108) The National Institutes of Health (NIH) may intensify and coordinate NIH research into the understanding of pain, therapies for chronic pain, and alternatives to opioids for pain treatments. The prioritization and direction of federally funded pain research must consider recommendations made by the Interagency Pain Research Coordinating Committee.

(Sec. 109) The grant program for state prescription drug monitoring programs is extended through FY2021 and revised, including to:

• allow grants to be used to maintain and operate existing state prescription drug monitoring programs,

• require HHS to redistribute any returned funds among the remaining grantees,

• require a state to provide HHS with aggregate data to enable HHS to evaluate the success of the state's program, and

• expand the program to include any commonwealth or territory of the United States.

The Drug Enforcement Administration (DEA), HHS, a state Medicaid program, a state health department, or a state substance abuse agency receiving nonidentifiable information from a prescription drug monitoring database for research purposes may make that information available to other entities for research purposes.

A state receiving a grant must: (1) facilitate prescriber and dispenser use of the state's prescription drug monitoring system, and (2) educate prescribers and dispensers on the benefits of the system both to them and society.

(Sec. 110) HHS must make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for drugs or devices for emergency treatment of opioid overdose (e.g., naloxone). Grants may be used for:

• implementing strategies for pharmacists to dispense such treatments pursuant to a standing order,

• encouraging pharmacies to dispense such treatments pursuant to a standing order,

• developing or providing training materials for prescribers to use in educating the public on administration of such treatments, and

• educating the public on the availability of such treatments.

States must report on pharmacies that dispense such treatments under a standing order.

TITLE II--LAW ENFORCEMENT AND TREATMENT

(Sec. 201) This bill amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize the Department of Justice (DOJ) to award grants to state, local, and tribal governments to provide opioid abuse services, including:

• developing, implementing, or expanding a treatment alternative to incarceration program;

• enhancing collaboration between criminal justice and substance abuse agencies;

• developing, implementing, or expanding programs to prevent, treat, or respond to opioid abuse;

• training first responders to administer opioid overdose treatments; and

• investigating unlawful opioid distribution activities.

This bill amends the Justice Assistance Act of 1984 to eliminate existing authority for DOJ to award grants under the Emergency Federal Law Enforcement Assistance Program through FY2021.

The Family-Based Substance Abuse Treatment Program is expanded to include prison-based family treatment programs for pregnant women.

The Government Accountability Office (GAO) must report on how federal grant programs address substance use and substance use disorders among adolescents and young adults.

(Sec. 202) HHS must make grants to states, local governmental entities, Indian tribes, and tribal organizations to enable first responders and others to administer drugs or devices for emergency treatment of opioid overdose. Grants may be used to make such treatments available, train first responders and others on the use of such treatments, and establish processes to refer individuals receiving treatment to follow-up care.

(Sec. 203) DOJ must coordinate with law enforcement agencies, pharmacies, distributors of prescription medications, and others to expand or make available disposal sites for unwanted prescription medications.

TITLE III--TREATMENT AND RECOVERY

(Sec. 301) HHS must provide support to state substance abuse agencies, units of local government, nonprofit organizations, and Indian tribes and tribal organizations that have a high rate of, or a rapid increase in, use of opioids to expand treatment of addiction in the areas affected.

(Sec. 302) HHS must award grants to enable recovery community organizations to develop, expand, and enhance substance use disorder recovery services. A recovery community organization is a nonprofit organization governed by people in recovery for substance use disorders that mobilizes resources to increase the prevalence and quality of long-term recovery.

(Sec. 303) This bill amends the Controlled Substances Act to revise the qualifications required for a practitioner to administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment in an office-based opioid treatment program.

The bill expands qualifying practitioners to include licensed nurse practitioners and physician assistants who have expertise and prescribe medications for opioid use disorder in collaboration with or under the supervision of a qualifying physician if state law requires physician oversight of prescribing authority. Qualifying practitioners must comply with reporting requirements and have the capacity to provide all FDA-approved drugs for opioid use disorder and other ancillary services.

HHS may change the maximum patient limit for qualifying practitioners.

HHS must update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings.

TITLE IV--ADDRESSING COLLATERAL CONSEQUENCES

(Sec. 401) The GAO must report on the collateral consequences for individuals with convictions for nonviolent drug-related offenses, including the effect of those consequences on individuals resuming their personal and professional activities and the justifications for imposing those consequences. Collateral consequences are penalties or disadvantages imposed on such individuals by law, an administrative agency, or a court, not including consequences imposed at sentencing.

TITLE V--ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, AND VETERANS

(Sec. 501) Support for residential substance abuse treatment programs for pregnant and postpartum women is expanded to include outpatient treatment and extended through FY2021. Such programs must provide services to the children of participants, including therapeutic, comprehensive child care. Priority for support must be given to programs serving rural areas, health professional shortage areas, or areas with a shortage of family-based substance use disorder treatment options.

The Center for Substance Abuse Treatment must carry out a pilot program to make grants to state substance abuse agencies to support services for pregnant and postpartum women who have a primary diagnosis of a substance use disorder, including opioid use disorders. The Center for Behavioral Health Statistics and Quality must evaluate the pilot program.

(Sec. 502) DOJ may award grants to state, local, and tribal governments to establish or expand programs for veterans, including veterans treatment courts, peer-to-peer services, and treatment, rehabilitation, legal, or transitional services for incarcerated veterans.

(Sec. 503) This bill amends the Child Abuse Prevention and Treatment Act to require the national clearinghouse for information relating to child abuse to maintain and disseminate information about requirements and best practices relating to the development of plans of safe care for infants born affected by substance abuse symptoms, withdrawal symptoms, or a Fetal Alcohol Spectrum Disorder.

The plan of safe care for such infants that is required for a state to receive a grant to improve its child protective services system must: (1) address the health and substance use disorder treatment needs of the infant and affected family or caregiver, and (2) specify a system for monitoring whether and in what manner local entities are providing services in accordance with state requirements.

Annual state data reports must include the number of such infants, the number for whom a plan of safe care was developed, and the number for whom referrals are made for services, including services for the affected family or caregiver.

HHS must monitor state compliance with child protective services system grant requirements.

(Sec. 504) The GAO must report on:

• the prevalence of neonatal abstinence syndrome (NAS), which is the symptoms of withdrawal in a newborn;

• NAS treatment services for which coverage is available under state Medicaid programs;

• the care settings and reimbursement for NAS treatment;

• the prevalence of use of various care settings for NAS treatment under state Medicaid programs;

• any federal barriers to treating infants with NAS under state Medicaid programs;

• what is known about best practices for treating infants with NAS; and

• its recommendations for improvements that will ensure access to NAS treatment under state Medicaid programs.

TITLE VI--INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS PRESCRIPTION OPIOID ABUSE

(Sec. 601) HHS must award grants to establish and implement a comprehensive state and local response to opioid abuse that includes education efforts, a prescription drug monitoring program, prescription drug and opioid addiction treatment programs, and overdose death prevention efforts. HHS must give priority to entities that: (1) provide civil liability protection for first responders, health professionals, or family members who are trained in administering an opioid overdose treatment; (2) enroll incarcerated drug offenders in community-based treatment services prior to reentry; (3) ensure that data from their prescription drug monitoring program can be shared with other states and is regularly updated; and (4) maximize use of prescription drug monitoring programs and ensure programs notify prescribers and dispensers of suspected abuse of controlled substances by patients.

TITLE VII--MISCELLANEOUS

(Sec. 701) Each fiscal year, DOJ's Office of the Inspector General must audit a number of opioid abuse services grant recipients. Grant recipients with unresolved audit findings are not eligible to receive grant funds for two years. Nonprofit organizations that hold money in offshore accounts to avoid tax liability may not receive grant funds.

DOJ and HHS must each enter into an arrangement with the National Academy of Sciences or a nonfederal entity to evaluate the effectiveness of grants pertaining to opioid abuse established by this bill. The bill limits expenditures for conferences under these grants.

(Sec. 702) This bill amends the Controlled Substances Act to allow a pharmacist to partially fill a prescription for a schedule II controlled substance (such as an opioid) if: (1) such partial fills are not prohibited by state law, (2) a partial fill is requested by the patient or prescribing practitioner, and (3) the total quantity dispensed in partial fillings does not exceed the quantity prescribed.

(Sec. 703) The GAO must report on the Office of National Drug Control Policy's review of state and local Good Samaritan laws that exempt from criminal or civil liability any individual who administers an opioid overdose reversal drug or device (e.g., naloxone) or who contacts emergency services providers in response to an overdose.

(Sec. 704) This bill amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSAct) to authorize prescription drug plan (PDP) sponsors to establish a drug management program for beneficiaries at-risk for prescription drug abuse. PDP sponsors with drug management programs must provide to the Centers for Medicare and Medicaid Services (CMS) data on limitations imposed on beneficiaries and data to identify patterns of drug use that may indicate fraudulent, medically unnecessary, or unsafe use.

PDP sponsors must have in place a utilization management tool designed to prevent the abuse and diversion of frequently abused drugs.

Medicare drug integrity contractors (MEDICs) may accept an individual's prescription and necessary medical records from pharmacies, PDPs, and physicians in order to provide information relevant to determining whether the individual is an at-risk beneficiary.

The Inspector General of HHS must study the effectiveness of MEDICs in identifying, combating, and preventing Medicare fraud.

Funds are made available to the Medicare Improvement Fund for services provided during and after FY2021.

(Sec. 705) This bill amends title XIX (Medicaid) of the SSAct to exclude abuse-deterrent prescription drugs from the requirement that manufacturers of single-source or innovator drugs pay additional rebates to state Medicaid programs.

(Sec. 706) Under current law, the CMS must use analytic technologies to identify improper Medicaid claims. The bill prohibits a state agency from using or disclosing such technologies except for purposes of administering a state Medicaid program or Children's Health Insurance Program (CHIP). State agencies must have adequate data security and control policies to ensure that access to such information is restricted to authorized persons for authorized uses.

(Sec. 707) The bill places $5 million in the Medicaid Improvement Fund to be available beginning in FY2021.

TITLE VIII--KINGPIN DESIGNATION IMPROVEMENT

(Sec. 801) This bill amends the Foreign Narcotics Kingpin Designation Act to allow classified information to be submitted to a reviewing court ex parte (without all parties present) or in camera (in private) in a judicial review of a determination by the President that a foreign person is subject to sanctions as a significant foreign narcotics trafficker.

TITLE IX--DEPARTMENT OF VETERANS AFFAIRS

Jason Simcakoski Memorial and Promise Act

Subtitle A--Opioid Therapy and Pain Management

(Sec. 911) This bill directs the Department of Veterans Affairs (VA) to expand its Opioid Safety Initiative to include all VA medical facilities.

The VA must direct its health care providers, before initiating opioid therapy, to use the VA's Opioid Therapy Risk Report tool, which must include: (1) information from state prescription drug monitoring programs, (2) a patient's most recent information, and (3) information on controlled substances prescribed to a patient outside the VA.

The VA must establish enhanced standards for urine drug tests before and during opioid therapy to help prevent substance abuse, dependence, and diversion.

The VA must use the Interdisciplinary Chronic Pain Management Training Team Program to provide education and training on pain management and safe opioid prescribing practices.

Each VA medical facility must designate a pain management team of health care professionals to coordinate pain management therapy for patients experiencing pain that is not related to cancer.

VA health care providers to must provide information on prescriptions of controlled substances received by veterans to state prescription drug monitoring programs.

The VA must: (1) maximize the availability to veterans of opioid overdose reversal drugs, such as naloxone; (2) equip each VA pharmacy with such medications for outpatient use; and (3) expand the Overdose Education and Naloxone Distribution program to ensure that veterans receiving VA health care who are at risk of opioid overdose may access such drugs and training on the proper administration of such drugs.

The VA must modify its patient record system to ensure that health care providers who access a veteran's record will be immediately notified about whether the veteran is receiving opioid therapy, has a history of substance use disorder or overdose, or is at risk of developing an opioid use disorder.

(Sec. 912) The VA and the Department of Defense (DOD) must ensure that the VA/DOD Pain Management Working Group: (1) includes a focus on specified practices, (2) coordinates with other working groups, (3) consults with other federal agencies, and (4) and consults with the VA and DOD regarding proposed updates to the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain.

The VA and DOD must update the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain.

(Sec. 913) The GAO must report on the VA's Opioid Safety Initiative and the opioid prescribing practices of VA health care providers.

The VA must report on opioid therapy and prescription rates for VA patients and notify Congress and investigate if a provider's or facility's prescription rate is inconsistent with safe care standards.

(Sec. 914) The bill makes mandatory the disclosure by the VA of certain information to a state prescription drug monitoring program in order to prevent misuse of prescription medicines by a veteran or dependent.

(Sec. 915) Veterans at high risk of an opioid overdose are exempt from paying a copayment to the VA for opioid overdose treatments. Veterans are exempt from paying a copayment to the VA for education on the use of such treatments.

Subtitle B--Patient Advocacy

(Sec. 921) At least once every 90 days, each VA medical facility must host a public meeting on improving health care furnished by the VA. Community-based VA outpatient clinics must host such meetings at least once every year.

(Sec. 922) Not more than 90 days after enactment of this bill, the VA must display: (1) the purposes of the Patient Advocacy Program and patient advocate contact information at VA medical facilities, and (2) the rights and responsibilities of patients and family members at medical and residential facilities.

(Sec. 923) The GAO must report on the Patient Advocacy Program and include an assessment of staffing, staff training, and awareness and use of the program.

(Sec. 924) The Office of Patient Advocacy is established in the VA's Office of the Under Secretary for Health. The office must carry out the Patient Advocacy Program and ensure that patient advocates are trained and advocate on behalf of veterans receiving or seeking health care through the VA.

Subtitle C--Complementary and Integrative Health

(Sec. 931) The bill establishes the Creating Options for Veterans' Expedited Recovery Commission or the COVER Commission to examine the evidence-based therapy treatment model used by the VA for treating mental health conditions of veterans and the potential benefits of incorporating complementary and integrative treatments including music, acupuncture, yoga, meditation, and sports.

Not more than 90 days after receiving a report from the commission with recommendations, the VA must submit a report that includes: (1) an action plan for implementing recommendations and a time frame for implementing complementary and integrative treatments, and (2) a justification for any determination that a recommendation is not appropriate or feasible and an alternative solution to improve the therapy model.

(Sec. 932) The VA must develop a plan to expand the scope of its research and education on, and delivery and integration of, complementary and integrative health services.

(Sec. 933) The VA must carry out a pilot program to assess the feasibility and advisability of using complementary and integrative health and wellness-based services by complementing the provision of pain management and related health care services with such services. In selecting the medical centers for this pilot program, the VA must give priority to centers where the prescription rate of opioids conflicts or is inconsistent with the standards of appropriate and safe care.

Subtitle D--Fitness of Health Care Providers

(Sec. 941) As part of the VA's hiring process for health care providers, the VA must require from each medical board that licensed the provider information on any violation of the license and any settlement agreement for a disciplinary charge relating to the provider's practice of medicine.

(Sec. 942) The VA must provide information on any violation of a medical license by a VA health care provider to each medical board licensing that provider.

(Sec. 943) Not later than 180 days after enactment of this bill, the VA must report on its compliance with its policy to review each health care provider who transfers, resigns, retires, or is terminated to determine whether there are any concerns, complaints, or allegations of violations relating to the medical practice of the provider and take appropriate action.

Subtitle E--Other Matters

(Sec. 951) This bill amends the Veterans Access, Choice, and Accountability Act of 2014 to reduce the aggregate amount of awards and bonuses that may be paid by the VA in each of FY2017-FY2021.