Public Law 114-198

On July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (P.L. 114-198). This is the first major federal addiction legislation in 40 years and the most comprehensive effort undertaken to address the opioid epidemic, encompassing all six pillars necessary for such a coordinated response – prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. While it authorizes over $181 million each year in new funding to fight the opioid epidemic, monies must be appropriated every year through the regular appropriations process in order for it to be distributed in accordance with the law.

The Comprehensive Addiction and Recovery Act (CARA)

Public Law 114-198 (Original Bills as Introduced in 114th Congress: S.524/H.R.953)

The Comprehensive Addiction and Recovery Act (CARA) establishes a comprehensive, coordinated, balanced strategy through enhanced grant programs that would expand prevention and education efforts while also promoting treatment and recovery.

Brief Summary of Provisions of CARA

• Expand prevention and educational efforts—particularly aimed at teens, parents and other caretakers, and aging populations—to prevent the use of methamphetamines, opioids and heroin, and to promote treatment and recovery.
• Expand the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives.
• Expand resources to identify and treat incarcerated individuals suffering from addiction disorders promptly by collaborating with criminal justice stakeholders and by providing evidence-based treatment.
• Expand disposal sites for unwanted prescription medications to keep them out of the hands of our children and adolescents.
• Launch an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country.
• Launch a medication-assisted treatment and intervention demonstration program.
• Strengthen prescription drug monitoring programs to help states monitor and track prescription drug diversion and to help at-risk individuals access services.

Section-by-Section Summary of Provisions of CARA

Title I: Prevention and Education

Sec. 101 – Task Force on Pain Management: This section establishes an interagency task force, led by the Department of Health and Human Services, to develop a set of best practices for chronic and acute pain management and prescribing pain medication.

Sec. 102 – Awareness Campaigns:  This section requires HHS and the Attorney General to advance the education and awareness of the public of the risk of misuse of prescription opioid drugs if they are not taken properly. It also will aim to bring attention to the association between prescription opioid misuse and heroin use, as well as focus on the dangers of fentanyl.

Sec. 103–Authorizes a $5 million enhancement grant program in ONDCP for current and former Drug-Free Communities (DFC) grantees to apply for supplemental funds of up to $50,000 for 3 years to deal with their community’s prescription drug and/or methamphetamine epidemic in a comprehensive, community-wide fashion.

Sec. 104 – Information Materials and Resources to Prevent Addiction Related to Youth Sports Injuries: Requires HHS to publish a report regarding the availability of resources for teens and their families for sports injuries which may require prescription opioids to treat.

Sec. 105 – Assisting Veterans with Military Emergency Medical Training to Meet Requirements for Becoming Civilian Health Care Professionals: Requires the Secretary of HHS, in coordination with the Secretary of Labor, to award demonstration grants to States that will help veterans with certain medical specialties to gain civilian certification and other medical licensing as civilians.

Sec. 106 – FDA Opioid Action Plan: Requires any new application for an opioid drug to be referred to an FDA advisory committee for recommendations prior to FDA approval. The Secretary of HHS has certain flexibility in requiring this referral process to take place, however.

Sec. 107 – Improving Access to Overdose Treatment: Amends part D of Title V of the Public Health Service Act to add a new section titled “Grants for Reducing Overdose Deaths.” This new section of the PHS Act would allow HHS to award grants to eligible entities (federally qualified health centers, opioid treatment programs, etc.) in order to expand access to opioid overdose reversal drugs or devices (such as Naloxone). Grantees would have broad latitude to use the funding in various ways to achieve this goal.

Sec. 108 – NIH Opioid Research: Authorizes the Director of the National Institutes of Health to coordinate research done by or funded through NIH, to focus on scientific understanding of pain, alternatives to opioids for pain treatment, and development of chronic pain therapies.

Sec. 109 – National All Schedules Prescription Electronic Reporting Reauthorization: Amends the Public Health Service Act to require that grants concerning state Prescription Drug Monitoring Programs (PDMPs) be administered by HHS in consultation with SAMHSA and CDC. This section also includes language aimed at increasing and improving state-level coordination and efficiency of PDMPs.

Sec. 110 – Opioid Overdose Reversal Medication Access and Education Grant Programs: Creates grant programs within HHS to encourage pharmacies to implement strategies to dispense opioid overdose reversal drugs pursuant to a standing order; develop and provide training on how to administer opioid overdose reversal drugs and devices; and to educate the public concerning the availability of overdose reversal drugs or devices. Grants are only awarded to States that have already authorized standing orders for overdose reversal drugs and devices.

Title II: Law Enforcement and Treatment

Sec. 201 – Comprehensive Opioid Abuse Grant Program: Creates a grant program within the Department of Justice for States, local governments, and Indian tribes to develop, implement, or expand a program for treatment alternatives to incarceration; enhance collaboration between state criminal justice agencies and substance misuse agencies in order to enhance efforts to combat opioid misuse; provide training and resources for first responders on opioid overdose reversal drugs and devices; enhancing law enforcement efforts to combat illegal distribution of opioids; developing, implementing, or expanding medication-assisted treatment (MAT) programs and PDMPs; developing, implementing, or expanding programs to prevent youth opioid misuse, encouraging innovation for development of secure containers for prescription drugs, creating drug take-back programs, and creating comprehensive opioid misuse response programs.

Sec. 202 – First Responder Training:  This section authorizes HHS, in coordination with the Attorney General, to make grants to state, local, and tribal law enforcement agencies for training in the use of naloxone and for the purchase of naloxone.

Sec. 203 – Prescription Drug Take Back Expansion:  This section authorizes the Attorney General, in coordination with the Administrator of the Drug Enforcement Administration (DEA), the Secretary of HHS, and the Director of ONDCP, to coordinate with State, local, or tribal law enforcement agencies, as well as pharmacies and others, to develop or expand disposal sites for unwanted prescription medications.

Title III:  Treatment and Recovery

Sec. 301 – Evidence-Based Prescription Opioid and Heroin Treatment and Interventions Demonstration: This section authorizes HHS to award grants to State substance misuse agencies, units of local government, Indian tribes or tribal organizations, or nonprofit organizations in geographic areas that have a high rate of —or have had rapid increases in — heroin or other opioids to expand activities (including those making available medication assisted treatment) in the relevant areas.

Sec. 302 – Building Communities of Recovery:  This section authorizes HHS to award grants to certain independent nonprofit organizations for the development and expansion of recovery services.

Sec. 303 – Medication-Assisted Treatment for Recovery from Addiction: This section amends the Controlled Substances Act to, under certain conditions and restrictions, raise the total number of patients a prescriber can have for the purposes of dispensing buprenorphine from 30 up to 100 per year.

Title IV: Addressing Collateral Consequences

Sec. 401 – GAO Report on Recovery and Collateral Consequences: This section requires the Comptroller General to submit a report to Congress that will identify the background, analysis, and perspectives on collateral consequences faced by individuals with state or federal drug convictions.

Title V:  Addiction and Treatment Services for Women, Families, and Veterans

Sec. 501 – Improving Treatment for Pregnant and Postpartum Women:  This section reauthorizes the Residential Treatment Program for Pregnant and Postpartum Women. It also authorizes the creation of grants within CSAT for a pilot program to enhance a State’s services for women who are pregnant and postpartum while suffering from substance use disorder.

Sec. 502 – Veterans’ Treatment Courts:  This section amends the Omnibus Crime Control and Safe Streets Act of 1968 to allow DOJ, in consultation with the Secretary of Veterans Affairs, to award grants that expand veterans treatment courts, substance use treatment programs for veterans, as well as other programs for the treatment and rehabilitation of veterans with substance use disorders.

Sec. 503 – Infant Plan of Safe Care: Requires HHS to produce information concerning best practices on developing plans for the safe care of infants born with substance use disorders or showing withdrawal symptoms. This section also requires that a State plan addresses the health and SUD treatment needs of the infant, among others.

Sec. 504 – GAO Report on Neonatal Abstinence Syndrome (NAS): Requires the GAO to submit a report to Congress on Neonatal Abstinence Syndrome that will include information on prevalence, treatment, costs, and recommendations for improvements for NAS.

Title VI:  Incentivizing State Comprehensive Initiatives to Address Opioid and Heroin Abuse

Sec. 601 – State Demonstration Grants for Comprehensive Opioid Abuse Response:  This section authorizes the Secretary of Health and Human Services to award planning and implementation grants to eligible state, units of local government, territories, or Indian Tribes, or combination thereof, to prepare a comprehensive plan for, and implement, an integrated opioid misuse response initiative.  The comprehensive response must include state prescription drug monitoring programs, as well as prevention/education efforts, expanded treatment programs, and plans for reversing opioid overdoses.

Title VII: Miscellaneous

Sec. 701 – Grant Accountability and Evaluations: Grant Accountability: This section requires all grants awarded under the provisions of the bill to be subject to audits and other accountability measures.

Sec. 702 – Partial Fills of Schedule II Controlled Substances: Amends the Controlled Substances Act by allowing schedule II substances to be partially filled if certain conditions and restrictions are met.

Sec. 703 – Good Samaritan Assessment: Allows the GAO to submit a report to Congress which will review the impact of Good Samaritan laws, any efforts undertaken by ONDCP to support enactment of Good Samaritan laws, and a summary of all such laws within the U.S.

Sec. 704 – Programs to Prevent Prescription Drug Abuse under Medicare Parts C and D: This section authorizes amendments to the Social Security Act to ensure the prevention of prescription drug misuse within Medicare Parts C and D among at-risk individuals. It also requires a GAO report on the effectiveness of programs authorized by this section.

Sec. 705 – Excluding Abuse-Deterrent Formulations of Prescription Drugs from the Medicaid Additional Rebate Requirement for New Formulations of Prescription Drugs: Clarifies certain regulations pertaining to misuse-deterrent formulations of prescription drugs.

Sec. 706 – Limiting Disclosure of Predictive Modeling and Other Analytics Technologies to Identify and Prevent Waste, Fraud, and Abuse: Amends the Social Security Act by adding a new section titled “Disclosure of Predictive Modeling and Other Analytics Technologies to Identify and Prevent Waste, Fraud, and Abuse.” This section exempts certain algorithms used by States to target waste, fraud, and abuse from being disclosed.

Sec. 707 – Medicaid Improvement Fund: Amends the Social Security Act to add $5 million to the Medicaid Improvement Fund for FY 2021 and on.

Sec. 708 – Sense of Congress Regarding Treatment of Substance Abuse Epidemics: The Sense of Congress states that experience and research demonstrate that a fiscally responsible way to handle substance use disorder epidemics is to treat them as a public health emergency that requires prevention, treatment, and recovery.

Title VIII: Kingpin Designation Improvement

Sec. 801 – Protection of Classified Information in Federal Court Challenges Relating to Designations under the Narcotics Kingpin Designation Act: Amends the Foreign Narcotics Kingpin Designation Act to allow for information gathered based on classified information to be submitted to the reviewing court in a judicial review.

Title IX: Department of Veterans Affairs

Sec. 901 – Short Title: Titles this part of the bill as the Jason Simcakoski Memorial and Promise Act.

Sec. 902 – Definitions: Provides definitions for the following terms: controlled substance, State, complementary and integrative health, and opioid receptor antagonist.

Subtitle A – Opioid Therapy and Pain Management

Sec. 911 – Improvement of Opioid Safety Measures by Department of Veterans Affairs: Requires HHS to establish guidance to ensure that VA health care providers use responsible opioid therapy strategies in treating patients, and to implement provisions of the Opioid Safety Initiative to ensure responsible prescribing practices within the VA.

Sec. 912 – Strengthening of Joint Working Group on Pain Management of the Department of Veterans Affairs and the Department of Defense: This section proposes various ways that the VA and DOD joint Pain Management Working Group can improve collaboration.

Sec. 913 – Review, Investigation, and Report on Use of Opioids in Treatment by Department of Veterans Affairs: Requires a GAO report to be submitted to the House and Senate Committee on Veterans’ Affairs that reviews the Opioid Safety Initiative of the VA, as well as the prescribing practices of providers within the department.

Sec. 914 – Mandatory Disclosure of Certain Veteran Information to State Controlled Substance Monitoring Programs: Requires disclosure of certain veteran information to State PDMP programs.

Sec. 915 – Elimination of Copayment Requirement for Veterans Receiving Opioid Antagonists or Education on Use of Opioid Antagonists: Clarifies that co-payments do not apply to opioid antagonists for veterans at high risk for overdose from a specific medication or substance in order to reverse the effect of an overdose.

Subtitle B – Patient Advocacy

Sec. 921 – Community Meetings on Improving Care Furnished by Department of Veterans Affairs: HHS should ensure that each VA medical facility and community-based outpatient clinic will convene a public community meeting every 90 days with the goal of discussing ways to improve health care.

Sec. 922 – Improvement of Awareness of Patient Advocacy Program and Patient Bill of Rights of Department of Veterans Affairs: Requires the VA to publicly display the purposes of the Patient Advocacy Program within the department, as well as contact information for the patient advocate.

Sec. 923 – Comptroller General Report on Patient Advocacy Program of Department of Veterans Affairs: Requires a GAO report on the Patient Advocacy Program of the VA to be submitted to the House and Senate Committee on Veterans’ Affairs.

Sec. 924 – Establishment of Office of Patient Advocacy of the Department of Veterans Affairs: Establishes the Office of Patient Advocacy within the Department of Veterans Affairs, which will be led by the Director of the Office of Patient Advocacy. The Director will ensure that patient advocates advocate on behalf of veterans with respect to their health care, receive training in patient advocacy, and carry out the responsibilities detailed in the bill.

Subtitle C – Complementary and Integrative Health

Sec. 931 – Expansion of Research and Education on and Delivery of Complementary and Integrative Health to Veterans: Establishes a commission titled the “Creating Options for Veterans’ Expedited Recovery (COVER) Commission”, which will examine the therapy treatment model used by the VA for treating veterans’ mental health, among other purposes.

Sec. 932 – Expansion of Research and Education on and Delivery of Complementary and Integrative Health to Veterans: Requires the VA to develop a plan to improve the effectiveness of complementary and integrative health services for veterans.

Sec. 933 – Pilot Program on Integration of Complementary and Integrative Health and Related Issues for Veterans and Family Members of Veterans: This section establishes a pilot program within HHS to determine the feasibility of whether complementary and integrative health programs could add to the existing system of pain management and other health care services for veterans. Also requires HHS to submit a report to Congress on the findings of this pilot program within 30 months of the start of the program.

Subtitle D – Fitness of Health Care Providers

Sec. 941 – Additional Requirements for Hiring of Health Care Providers by Department of Veterans Affairs: Clarifies what requirements health care providers need when applying for a job at the VA.

Sec. 942 – Provision of Information on Health Care Providers of Department of Veterans Affairs to State Medical Boards: Requires the Secretary of the VA to disclose to the relevant State medical board any violation of a VA health care provider’s medical license.

Sec. 943 – Report on Compliance by Department of Veterans Affairs with Reviews of Health Care Providers Leaving the Department or Transferring to Other Facilities: Requires the VA to submit a report to Congress on how well the VA has complied with its own policy in conducting reviews of the VA health care providers who transfer to another VA medical facility, resign, retire, or are terminated.

Subtitle E – Other Matters

Sec. 951 – Modification to Limitation on Awards and Bonuses: This section amends the Veterans Access, Choice, and Accountability Act of 2014 to require that the Secretary of the VA ensures that awards and bonuses paid out to employees do not exceed a certain amount in any fiscal year.