Shown Here:
Passed House amended (05/13/2016)

TITLE I--PAIN MANAGEMENT BEST PRACTICES INTER-AGENCY TASK FORCE

(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: (1) review, modify, and update best practices for pain management and prescribing pain medication; and (2) examine and identify the need for, development of, and availability of medical alternatives to opioids (drugs with effects similar to opium, such as heroin and certain pain medications).

TITLE II--COMPREHENSIVE OPIOID ABUSE REDUCTION ACT

Comprehensive Opioid Abuse Reduction Act of 2016

(Sec. 202) 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:

• 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 reversal drugs; and
• investigating unlawful opioid distribution activities.

(Sec. 203) DOJ's Office of the Inspector General must audit a number of DOJ grant recipients each year. Grants may not be awarded to nonprofit organizations that hold money in offshore accounts to avoid tax liability.

(Sec. 204) DOJ must 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. 205) As an offset, this title 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.

(Sec. 206) The Family-Based Substance Abuse Treatment Program is expanded to include prison-based family treatment programs for pregnant women.

(Sec. 207) The Government Accountability Office (GAO) must report on how DOJ grant programs address substance use and substance use disorders among adolescents and young adults.

TITLE III--JASON SIMCAKOSKI PROMISE ACT

Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act or the Jason Simcakoski PROMISE Act

(Sec. 302) 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 VA 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, (3) information on controlled substances prescribed to a patient outside the VA, (4) the most recent time the tool was accessed by a VA health care provider regarding a patient, (5) the results of a patient's most recent drug test, and (6) the ability to determine whether a health care provider prescribed an opioid to a patient without checking information in the tool.

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. The VA must establish standard protocols for the designation of pain management teams. The protocols must ensure that a health care provider without expertise or training in prescribing pain medications does not prescribe opioids unless the health care provider: (1) consults with a provider who has pain management expertise or who is on the pain management team; and (2) refers the patient to the pain management team for subsequent prescriptions and therapy.

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 report on improving the Opioid Therapy Risk Report tool to allow for improved real-time tracking and access to data on certain clinical indicators, concurrent prescribing of opioids by VA health care providers, and mail-order opioid prescriptions.

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 opioid abuse.

(Sec. 303) 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. 304) 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 the prescription of opioids to certain patients at each VA facility and notify Congress and investigate if a provider's or facility's prescription rate is inconsistent with safe care standards.

(Sec. 305) VA disclosure of certain information to a state prescription drug monitoring program in order to prevent misuse of prescription medicines by a veteran or dependent is made mandatory.

(Sec. 306) 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.

TITLE IV--KINGPIN DESIGNATION IMPROVEMENT ACT

Kingpin Designation Improvement Act of 2016

(Sec. 402) 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 V--GOOD SAMARITAN ASSESSMENT ACT

Good Samaritan Assessment Act of 2016

(Sec. 503) 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.

TITLE VI--OPEN ACT

Opioid Program Evaluation Act or the OPEN Act

(Sec. 602) DOJ and HHS must each enter into an arrangement with the National Academy of Sciences to identify outcomes and develop metrics to evaluate: (1) the incidence of opioid abuse and illegal opioid distribution, and (2) the effectiveness of department grant programs regarding opioid abuse. DOJ and HHS must each publish outcomes and metrics and require grant recipients to collect and report data. The National Academy of Sciences must publish the evaluations.

(Sec. 606) As an offset, this title reduces the authorization of appropriations for financial assistance under the Emergency Federal Law Enforcement Assistance program for FY2022.

TITLE VII--INFANT PLAN OF SAFE CARE IMPROVEMENT ACT

Infant Plan of Safe Care Improvement Act

(Sec. 702) 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 illegal substance abuse symptoms, withdrawal symptoms, or a Fetal Alcohol Spectrum Disorder.

(Sec. 703) 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.

(Sec. 704) 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.

(Sec. 705) HHS must monitor state compliance with child protective services system grant requirements.

TITLE VIII--NAS HEALTHY BABIES ACT

Nurturing and Supporting Healthy Babies Act or the NAS Healthy Babies Act

(Sec. 802) 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; and
• its recommendations for improvements that will ensure access to NAS treatment under state Medicaid programs.

(Sec. 803) This bill amends title XIX (Medicaid) of the Social Security Act 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. 804) Under current law, the Centers for Medicare & Medicaid Services 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. 805) The bill places $5 million in the Medicaid Improvement Fund to be available beginning in FY2021.

TITLE IX--CO-PRESCRIBING TO REDUCE OVERDOSES ACT

Co-Prescribing to Reduce Overdoses Act of 2016

(Sec. 902) HHS may establish a grant program to support prescribing opioid overdose reversal drugs (e.g., naloxone) for patients at an elevated risk of overdose, including patients prescribed an opioid.

Grant recipients may use the funds to purchase opioid overdose reversal drugs, establish a program for prescribing such drugs, train health care providers and pharmacists, track patients and outcomes, offset patient cost sharing, conduct community outreach, and connect patients to treatment.

(Sec. 903) HHS may provide information to prescribers in federally qualified health centers and Indian Health Service facilities on best practices for prescribing opioid overdose reversal drugs for patients at an elevated risk of overdose.

(Sec. 904) This title amends the Public Health Service Act to reduce, as an offset, the authorization of appropriations for Centers for Disease Control and Prevention facilities for FY2018.

TITLE X--IMPROVING TREATMENT FOR PREGNANT AND POSTPARTUM WOMEN ACT

Improving Treatment for Pregnant and Postpartum Women Act of 2016

(Sec. 1002) Support for residential substance abuse treatment programs for pregnant and postpartum women is extended through FY2021.

(Sec. 1003) 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 fund an evaluation of the pilot program.

(Sec. 1004) As an offset, this title reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities for FY2017.

TITLE XI--VETERAN EMERGENCY MEDICAL TECHNICIAN SUPPORT ACT

Veteran Emergency Medical Technician Support Act of 2016

(Sec. 1102) HHS must establish a demonstration program for states with a shortage of emergency medical technicians (EMTs) to streamline state requirements and procedures to assist veterans who completed military EMT training to meet state EMT certification, licensure, and other requirements.

TITLE XII--JOHN THOMAS DECKER ACT

John Thomas Decker Act of 2016

(Sec. 1202) HHS must report on the availability of information regarding 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 must develop and disseminate such information.

TITLE XIII--LALI'S LAW

Lali's Law

(Sec. 1302) HHS may 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 opioid overdose reversal drugs (e.g., naloxone). Grants may be used for:

• developing standing orders for opioid overdose reversal drugs for pharmacies,
• encouraging pharmacies to dispense drugs pursuant to such a standing order,
• implementing best practices for prescribing opioids and prescribing and discussing with patients opioid overdose reversal drugs,
• developing training for prescribers to use in educating the public on administration of opioid overdose reversal drugs, and
• educating the public on the availability and public health benefits of opioid overdose reversal drugs.

States must report on pharmacies that dispense opioid overdose reversal drugs under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal drugs.

(Sec. 1303) As an offset, this title reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities for FY2017.

TITLE XIV--REDUCING UNUSED MEDICATIONS ACT

Reducing Unused Medications Act of 2016

(Sec. 1402) 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. Such prescriptions may also be partially filled in accordance with existing Drug Enforcement Administration (DEA) regulations that permit partial fills when a pharmacist cannot supply a full quantity, a patient resides in a long-term care facility, or a patient is terminally ill.

The bill specifies time limits for filling the remaining portion of a partially filled prescription.

TITLE XV--OPIOID REVIEW MODERNIZATION ACT

Opioid Review Modernization Act of 2016

(Sec. 1502) 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.

(Sec. 1503) 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.

(Sec. 1504) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

TITLE XVI--EXAMINING OPIOID TREATMENT INFRASTRUCTURE ACT

Examining Opioid Treatment Infrastructure Act of 2016

(Sec. 1602) The GAO must report on inpatient and outpatient treatment capacity, availability, and needs, including detoxification programs, clinical stabilization programs, transitional residential support services, rehabilitation programs, treatment programs for pregnant women or adolescents, and treatment through Indian health programs. The report must include the barriers to real-time reporting of drug overdoses at the federal, state, and local level and ways to overcome those barriers.

TITLE XVII--OPIOID USE DISORDER TREATMENT EXPANSION AND MODERNIZATION ACT

Opioid Use Disorder Treatment Expansion and Modernization Act

(Sec. 1703) This bill revises 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.

HHS may change the maximum patient limit for qualifying practitioners. If HHS increases the limit, then a qualifying practitioner must obtain written consent from each patient regarding assessment and treatment.

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

HHS may recommend revoking or suspending the registration of a practitioner who fails to comply with the requirements of the Controlled Substances Act.

(Sec. 1705) This section repeats section 1402.

TITLE XVIII--NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING REAUTHORIZATION ACT

National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015

(Sec. 1802) This bill amends the National All Schedules Prescription Electronic Reporting Act of 2005 to include as a purpose of state prescription drug monitoring systems ensuring access to prescription history information for the investigative purposes of law enforcement, regulatory, and state professional licensing authorities.

(Sec. 1803) The grant program for state prescription drug monitoring programs is extended through FY2020 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 and other information 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 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.