Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
(Sec. 1001) The bill prohibits termination of Medicaid eligibility for juveniles who are inmates of public institutions.
(Sec. 1003) The Centers for Medicare & Medicaid Services (CMS) must establish a demonstration project to increase provider treatment capacity for substance-use disorders.
(Sec. 1004) State Medicaid programs must establish drug-review and utilization requirements, including safety measures for subsequent prescriptions of opioids.
(Sec. 1006) The bill extends the enhanced federal matching rate for expenditures regarding substance-use disorder health-home services under Medicaid.
The bill also temporarily requires coverage of medication-assisted treatment under Medicaid.
(Sec. 1007) The bill allows state Medicaid programs to cover residential pediatric recovery center services for infants with neonatal abstinence syndrome.
(Sec. 1012) States may also receive federal payment under Medicaid for outside services that are provided to pregnant and postpartum women who are substance-use disorder patients at institutions for mental diseases (IMDs).
(Sec. 1016) State Medicaid agencies, to the extent permitted under state law, may also access prescription drug monitoring programs (PDMPs), facilitate access to PDMPs for Medicaid providers and managed care entities, and share accessed information with such providers and entities.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
(Sec. 2001) The bill exempts substance-use disorder telehealth services from specified requirements, such as geographic restrictions, under Medicare.
(Sec. 2002) The initial examination for new enrollees and annual wellness visits under Medicare must include a substance-use disorder screening and a review of any current opioid prescriptions.
(Sec. 2003) In general, prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs.
(Sec. 2004) Medicare prescription drug plan sponsors must establish drug-management programs for at-risk beneficiaries.
(Sec. 2005) The bill also requires coverage for services provided by certified opioid-treatment programs under Medicare.
(Sec. 2006) The CMS must notify Medicare prescription drug plan sponsors about individuals who have a history of opioid-related overdoses, so that such individuals are included in drug-management programs for at-risk beneficiaries.
(Sec. 2008) The bill authorizes the suspension of payments to a pharmacy under the Medicare prescription drug benefit and Medicare Advantage (MA) prescription drug plans pending the investigation of a credible allegation of fraud by the pharmacy.
TITLE III--FDA AND CONTROLLED SUBSTANCE PROVISIONS
Subtitle A--FDA Provisions
Chapter 1--In General
(Sec. 3001) The Food and Drug Administration (FDA) must issue guidance that addresses the challenges of developing nonaddictive products to treat pain and addiction.
(Sec. 3002) The FDA must also issue guidance regarding the prescription of opioid analgesics for pain management.
Chapter 2--Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act
(Sec. 3012) The bill requires the FDA to halt the distribution of a controlled substance that is found to be a public hazard and, if appropriate, order the controlled substance to be recalled.
(Sec. 3013) The FDA may consider all drugs from a single manufacturer, distributor, or importer as adulterated or misbranded if a pattern emerges, unless otherwise shown.
(Sec. 3014) The FDA must coordinate with the Department of Homeland Security and the U.S. Postal Service to improve screening and identification of unlawful controlled substances at international drug import facilities.
Chapter 3--Stop Illicit Drug Importation
Stop Illicit Drug Importation Act of 2018
(Sec. 3022) The FDA may prohibit a person from importing drugs or controlled substances under specified circumstances, including if the person has shown a pattern of importing adulterated or misbranded drugs that pose a serious health threat.
The bill also prohibits the importation, in accordance with specified criteria, of counterfeit drugs and drugs that pose a significant public health concern.
Chapter 4--Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging
Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act
(Sec. 3032) The FDA may require certain packaging and disposal measures to mitigate the risk of abuse or misuse of a drug.
Chapter 5--Postapproval Study Requirements
(Sec. 3041) The FDA may also require a post-approval study for certain drugs in order to assess potential reduced effectiveness.
Subtitle B--Controlled Substance Provisions
Chapter 1--More Flexibility with Respect to Medication-Assisted Treatment for Opioid Use Disorders
(Sec. 3201) The bill increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).
(Sec. 3204) The bill amends the Controlled Substances Act to allow a pharmacy to deliver a controlled substance to a practitioner, in accordance with a prescription, to be administered to a specific patient for maintenance or detoxification treatment.
Chapter 2--Empowering Pharmacists in the Fight Against Opioid Abuse
Empowering Pharmacists in the Fight Against Opioid Abuse Act
(Sec. 3212) The Department of Health and Human Services (HHS) must develop training programs and materials on the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or of suspicious origin.
Chapter 3--Safe Disposal of Unused Medication
Safe Disposal of Unused Medication Act
(Sec. 3222) The bill allows a hospice employee, under specified circumstances, to handle lawfully dispensed controlled substances of a hospice patient in order to assist with disposal of the controlled substances, so long as such disposal occurs onsite in accordance with applicable law.
Chapter 4--Special Registration for Telemedicine Clarification
Special Registration for Telemedicine Clarification Act of 2018
(Sec. 3232) The bill establishes a deadline for the Drug Enforcement Administration (DEA) to promulgate regulations for the special registration of practitioners to practice telemedicine.
Chapter 5--Synthetic Abuse and Labeling of Toxic Substances
(Sec. 3241) The bill also sets forth factors that may be considered to determine whether a controlled substance analogue is intended for human consumption. Under current law, a controlled substance analogue that is intended for human consumption is treated as a schedule I controlled substance and is subject to certain regulatory controls.
Chapter 6--Access to Increased Drug Disposal
Access to Increased Drug Disposal Act of 2018
(Sec. 3252) The bill directs the Office of Justice Programs in the Department of Justice (DOJ) to award grants to states to increase the number of pharmacies and other eligible entities (e.g., narcotic treatment programs) that collect unused prescription drugs for disposal. Grants must be used for costs associated with the collection and disposal of such drugs.
Chapter 7--Using Data to Prevent Opioid Diversion
Using Data to Prevent Opioid Diversion Act of 2018
(Sec. 3272) In order to identify and prevent drug diversion, the DEA must use an automated data system to inform drug manufacturers and distributors about the quantity and type of opioids that are distributed to pharmacies and practitioners.
Chapter 8--Opioid Quota Reform
Opioid Quota Reform Act
(Sec. 3282) The DEA must also estimate the extent of any diversion of specified controlled substances (e.g., fentanyl) when determining manufacturing quotas for such substances. In estimating diversion rates, the DEA must consider information relating to overdose deaths and abuse of such substances.
Chapter 9--Preventing Drug Diversion
Preventing Drug Diversion Act of 2018
(Sec. 3292) The bill also establishes reporting requirements regarding suspicious orders of controlled substances; information must be collected in a centralized DEA database and shared with states.
TITLE IV--OFFSETS
(Sec. 4001) The bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.
(Sec. 4003) The bill amends the Internal Revenue Code to expand the religious conscience exemption under the Patient Protection and Affordable Care Act to exempt individuals who rely solely on a religious method of healing and for whom the acceptance of medical health services would be inconsistent with their religious beliefs from the requirement to purchase and maintain minimum essential health care coverage.
TITLE V--OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting with Respect to Adult Behavioral Health Measures
(Sec. 5001) The bill requires certain Medicaid quality health measures to include behavioral health measures.
Subtitle B--Medicaid IMD Additional Info
Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act or the Medicaid IMD ADDITIONAL INFO Act
(Sec. 5012) The Medicaid and Children's Health Insurance Program (CHIP) Payment and Access Commission must report on information relating to services for Medicaid enrollees who are patients in IMDs, including the number and type of IMDs in each sampled state, services offered, and funding sources.
Subtitle C--CHIP Mental Health and Substance Use Disorder Parity
CHIP Mental Health and Substance Use Disorder Parity Act
(Sec. 5022) CHIP plans must cover mental health and substance-use disorder services. Financial requirements and treatment limitations applicable to such services shall not differ from those applicable to other medical services under CHIP.
Subtitle D--Medicaid Reentry
Medicaid Reentry Act
(Sec. 5032) The CMS must convene a stakeholder workgroup in order to develop best practices for states to help inmates released from public institutions transition to the community with health care (such as by ensuring continuity of health insurance or Medicaid coverage). The CMS must also issue a letter to states outlining opportunities for Medicaid demonstration waivers based on identified best practices.
Subtitle E--Medicaid Partnership
Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act or the Medicaid PARTNERSHIP Act
(Sec. 5042) Each state must establish a qualifying PDMP and require health care providers to check the PDMP for a Medicaid enrollee's prescription drug history before prescribing controlled substances to the enrollee.
Subtitle F--IMD CARE Act
Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act
(Sec. 5052) The bill temporarily allows states to apply to receive federal Medicaid payment for specified services provided in IMDs for enrollees (aged 21 to 64) with substance-use disorders. Services may be covered for a total of up to 30 days in a 12-month period for an eligible enrollee.
Current law generally prohibits federal payment under Medicaid for services provided in IMDs for individuals under the age of 65 (although states may receive payment through certain mechanisms, such as through a Medicaid demonstration waiver).
Subtitle G--Medicaid Improvement Fund
(Sec. 5061) The bill reauthorizes annual funding for the Medicaid Improvement Fund beginning in FY2021. (The fund is used to improve management of the Medicaid program by the CMS, such as through demonstration project evaluations.)
TITLE VI--OTHER MEDICARE PROVISIONS
Subtitle A--Testing of Incentive Payments for Behavioral Health Providers for Adoption and Use of Certified Electronic Health Record Technology
(Sec. 6001) The Center for Medicare and Medicaid Innovation may test models to provide incentive payments to behavioral health providers for adopting electronic health records technology and for using that technology to improve the quality and coordination of care.
Subtitle B--Abuse Deterrent Access
Abuse Deterrent Access Act of 2018
(Sec. 6012) The CMS must report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in a prescription drug plan under Medicare or MA, as well as the effectiveness and impact of such formulations.
Subtitle C--Medicare Opioid Safety Education
(Sec. 6021) The CMS must provide Medicare beneficiaries with educational resources regarding opioid use and pain management, as well as descriptions of covered alternative (non-opioid) pain-management treatments.
Subtitle D--Opioid Addiction Action Plan
Opioid Addiction Action Plan Act
(Sec. 6032) The CMS must develop an action plan to provide recommendations on changes to the Medicare and Medicaid programs to enhance the treatment and prevention of opioid addiction, as well as coverage and payment of medication-assisted treatment.
The CMS must also publish a report that includes an evaluation of price trends for opioid overdose-reversal drugs (e.g., naloxone) and recommendations on ways to lower consumer prices for such drugs.
Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders in Medicare
Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act
(Sec. 6042) The CMS must carry out a demonstration program to increase access to opioid-use disorder treatment services for Medicare beneficiaries, improve physical and mental health outcomes for such beneficiaries, and reduce Medicare expenditures.
Subtitle F--Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment
Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act of 2018 or the REACH OUT Act of 2018
(Sec. 6052) The CMS must also award grants, contracts, or cooperative agreements to qualifying organizations in order to support efforts to curb outlier prescribers of opioids under the Medicare prescription drug benefit and MA prescription drug plans.
Subtitle G--Preventing Addiction for Susceptible Seniors
Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018
(Sec. 6062) The bill requires electronic prescription programs to be able to securely transmit prior authorization requests for covered drugs under Medicare.
(Sec. 6063) The CMS must also establish a secure online portal to allow data sharing among the CMS, Medicare prescription drug benefit plans, and MA plans. The portal must also support referrals by such plans of substantiated fraud, waste, or abuse.
(Sec. 6064) The bill also establishes individuals who are identified as at-risk beneficiaries for prescription drug abuse as qualifying participants in medication therapy management programs under the Medicare prescription drug benefit.
(Sec. 6065) The CMS must also identify outlier prescribers of opioids under Medicare prescription drug benefit plans and MA plans, based on specialty and geographic area, and annually notify such prescribers of their status.
Subtitle H--Expanding Oversight of Opioid Prescribing and Payment
Expanding Oversight of Opioid Prescribing and Payment Act of 2018
(Sec. 6072) The Medicare Payment Advisory Commission must report on Medicare payment for opioid and non-opioid pain management treatments, current incentives for prescribing opioid and non-opioid treatments, and how opioid use is currently tracked and monitored.
Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery
Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018
(Sec. 6082) The CMS must review payments under Medicare for opioid and non-opioid pain-management procedures, specifically with respect to ambulatory outpatient surgical procedures and hospital outpatient department services. The CMS must ensure that there are no payment incentives for using opioids instead of non-opioid alternatives and must make revisions accordingly.
(Sec. 6083) The bill also requires payment under Medicare to federally qualified health centers and rural health clinics that have health care practitioners who are newly certified to provide medication-assisted treatment (e.g., buprenorphine).
(Sec. 6085) The Center for Medicare and Medicaid Innovation may test models to help individuals learn about the availability of psychologist services under Medicare, as well as to explore the use of a behavioral health help-line that is available 24-7 to prevent unnecessary hospitalizations and emergency department visits.
Subtitle J--Combating Opioid Abuse for Care in Hospitals
Combating Opioid Abuse for Care in Hospitals Act of 2018 or the COACH Act of 2018
(Sec. 6092) The CMS must publish guidance for hospitals on pain management and opioid-use disorder prevention strategies for Medicare beneficiaries.
Technical expert panels must also recommend opioid-use disorder quality measures for hospital reports, methods to reduce opioid use in surgical settings, and pain-management strategies.
Subtitle K--Providing Reliable Options for Patients and Educational Resources
Providing Reliable Options for Patients and Educational Resources Act of 2018 or the PROPER Act of 2018
(Sec. 6102) Medicare and MA prescription drug plan sponsors must annually disclose information to enrollees about the risks of prolonged opioid use, as well as coverage of nonpharmacological therapies, devices, and non-opioid medications.
(Sec. 6103) The bill also requires Medicare medication therapy management programs and MA in-home health-risk assessments to include information about the safe disposal of prescription drugs.
(Sec. 6104) The bill prohibits inclusion of pain-management questions in certain health care system surveys, unless the questions address the risks of opioid use and the availability of non-opioid alternatives.
Subtitle L--Fighting the Opioid Epidemic With Sunshine
(Sec. 6111) The bill expands Medicaid and Medicare reporting requirements related to the transparency of physician ownership or investment interests by including additional health care practitioners (e.g., physician assistants and nurses) in such requirements.
TITLE VII--PUBLIC HEALTH PROVISIONS
Subtitle A--Awareness and Training
(Sec. 7001) The bill requires HHS and the Surgeon General to report on the health effects of new psychoactive substances (also known as "synthetic drugs") that are used by adolescents and young adults. Examples of synthetic drugs include synthetic marijuana (also known as "spice") and synthetic amphetamines (also known as "bath salts").
(Sec. 7002) The bill also reauthorizes through FY2023 and revises the grant program for first responders regarding opioid overdose treatment, which is administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). The bill includes safety training for handling specified drugs (e.g., fentanyl) as a component of the grant program.
Subtitle B--Pilot Program for Public Health Laboratories to Detect Fentanyl and Other Synthetic Opioids
(Sec. 7011) HHS must establish a grant program to improve coordination between public health laboratories and law enforcement regarding synthetic opioid detection.
Subtitle C-- Indexing Narcotics, Fentanyl, and Opioids
(Sec. 7021) HHS must establish a public information dashboard that coordinates programs related to opioid-abuse reduction, allows data sharing between different programs and regions of the country, and provides information on alternatives to controlled substances for pain management.
(Sec. 7023) HHS must also develop national milestones to measure progress in reducing the opioid crisis over a five-year period based on certain metrics.
Subtitle D--Ensuring Access to Quality Sober Living
(Sec. 7031) The bill amends the Public Health Service Act to require SAMHSA to develop best practices for operating recovery housing (shared living environments free from alcohol and illegal drug use and centered on peer support and connection to services that promote recovery from substance-use disorders).
Subtitle E--Advancing Cutting Edge Research
(Sec. 7041) The bill expands the National Institutes of Health's unique research initiatives to include cutting-edge research that is urgently required to respond to a public health threat. (Unique research initiatives may be supported through transactions other than contracts, grants, or cooperative agreements.)
Subtitle F--Jessie's Law
(Sec. 7051) HHS must develop best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records.
(Sec. 7052) The bill also requires the CMS and the Health Resources and Services Administration to notify annually health care providers about health information that may be disclosed under federal privacy laws to families, caregivers, and health care providers during emergencies, including overdoses.
Subtitle G--Protecting Pregnant Women and Infants
(Sec. 7061) The bill requires HHS to issue several reports relating to pregnant and postpartum women with substance-use disorders, including non-opioid pain management practices.
(Sec. 7065) The bill also authorizes a grant program that supports the care of infants who are affected by substance-use disorders (e.g., infants with neonatal abstinence syndrome).
Subtitle H--Substance Use Disorder Treatment Workforce
(Sec. 7071) The bill creates a loan repayment program for individuals who complete a period of service in a substance-use disorder treatment job in a mental health professional shortage area or a county where the drug overdose death rate is higher than the national average.
(Sec. 7073) The bill also reauthorizes through FY2023 and revises a grant program regarding pain care training for health care professionals. The bill specifically requires information about opioid misuse and nonaddictive treatments to be incorporated into the grant program.
Subtitle I--Preventing Overdoses While in Emergency Rooms
(Sec. 7081) HHS must establish a grant program to implement best practices (as developed by HHS) regarding treatment for individuals who experience a drug overdose, including emergency treatment and the use of recovery coaches.
Subtitle J--Alternatives to Opioids in the Emergency Department
(Sec. 7091) HHS must also establish a demonstration program through which hospitals and emergency departments receive grants to support alternatives to opioids for pain management.
Subtitle K--Treatment, Education, and Community Help to Combat Addiction
(Sec. 7101) The bill requires SAMHSA to designate Regional Centers of Excellence in Substance Use Disorder Education. Such centers must improve substance-use disorder training through the distribution of evidence-based resources for health care professional schools.
(Sec. 7102) HHS must also award grants to support substance-use disorder prevention and treatment programs for children, adolescents, and young adults.
Subtitle L--Information from National Mental Health and Substance Use Policy Laboratory
(Sec. 7111) The National Mental Health and Substance Use Policy Laboratory within SAMHSA must issue guidance for SAMHSA grant applicants in order to encourage funding of evidence-based practices and to help applicants properly articulate funding rationales.
Subtitle M--Comprehensive Opioid Recovery Centers
(Sec. 7121) The bill also requires SAMHSA to award grants to establish or operate at least 10 comprehensive opioid recovery centers across the country. Such centers must conduct outreach and provide specified treatment and recovery services, including approved drug treatments (e.g., methadone), counseling, residential rehabilitation, and job-placement assistance.
Subtitle N--Trauma-Informed Care
(Sec. 7131) The Centers for Disease Control and Prevention (CDC) may collect and report data using specified surveys regarding adverse childhood experiences, particularly with respect to rural and tribal areas.
(Sec. 7135) HHS must provide resources to early childhood care and education providers and other professionals working with young children on ways to recognize and respond to children who may be affected by a family member's or other adult's substance abuse.
Subtitle O--Eliminating Opioid Related Infectious Diseases
(Sec. 7141) The bill expands the CDC grant program for combating hepatitis C infections to include other infections associated with illicit drug use (e.g., HIV). The bill also includes Indian tribes in the program.
Subtitle P--Peer Support Communities of Recovery
(Sec. 7151) SAMHSA must award grants to support recovery community organizations (nonprofit organizations that are wholly or principally governed by individuals in recovery for substance-use disorders).
Subtitle Q--Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigation Strategies
(Sec. 7161) The CDC may provide technical assistance and award grants in order to improve PDMPs, promote new approaches for responding to emerging public health crises, and improve overdose data reporting.
(Sec. 7162) The bill also alters requirements relating to PDMPs. Among other changes, the bill authorizes federal support for specific PDMP improvements regarding use, data reporting, and intrastate and interstate interoperability.
Subtitle R--Review of Substance Use Disorder Treatment Providers Receiving Federal Funding
(Sec. 7171) HHS must review entities that receive federal funds for substance-use disorder treatment services; the scope of the review must include the types of services provided, the populations served, and the adequacy of services.
Subtitle S--Other Health Provisions
(Sec. 7183) HHS must establish a grant program to help individuals who are in substance-use disorder treatment or recovery to live independently and to participate in the workforce.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018
(Sec. 8002) The bill increases shipment-tracking responsibilities and coordination between the U.S. Postal Service and the U.S. Customs and Border Protection regarding international shipments of controlled substances, such as through communication requirements and the development of technology to detect illicit fentanyl.
Subtitle B--Opioid Addiction Recovery Fraud Prevention
Opioid Addiction Recovery Fraud Prevention Act of 2018
(Sec. 8022) The bill prohibits unfair or deceptive trade practices regarding substance-use disorder treatment services or products.
Subtitle C--Addressing Economic and Workforce Impacts of the Opioid Crisis
(Sec. 8041) The Department of Labor must establish a pilot program that awards grants in order to address the economic and workforce impacts of substance-use disorders, such as through treatment services for employees.
Subtitle D--Peer Support Counseling Program for Women Veterans
(Sec. 8051) The Department of Veterans Affairs (VA) must also emphasize appointing peer-support counselors for women veterans. The VA shall recruit women peer-support counselors with expertise in gender-specific issues and services, VA services and benefits, and employment mentoring.
Subtitle E--Treating Barriers to Prosperity
Treating Barriers to Prosperity Act of 2018
(Sec. 8062) The bill allows the Appalachian Regional Commission to support projects and activities addressing drug abuse, such as infrastructure development for telemedicine.
Subtitle F--Pilot Program to Help Individuals in Recovery from a Substance Use Disorder Become Stably Housed
(Sec. 8071) The bill authorizes a grant program, based on funding formulas determined by the Department of Housing and Urban Development, to help states provide temporary housing for individuals who are in recovery from a substance-use disorder.
Subtitle G--Human Services
(Sec. 8081) HHS must develop guidance for states on ways to support family-focused residential treatment programs (substance-use disorder treatment programs for pregnant and postpartum women, as well as parents and guardians, which allow their children to remain with them during treatment). The guidance must include descriptions of funding opportunities under Medicaid and federal foster care and adoption assistance programs.
Subtitle H--Reauthorizing and Extending Grants for Recovery from Opioid Use Programs
Reauthorizing and Extending Grants for Recovery from Opioid Use Programs Act of 2018 or the REGROUP Act of 2018
(Sec. 8092) The bill reauthorizes through FY2023 the comprehensive opioid abuse grant program administered by DOJ.
Subtitle I--Fighting Opioid Abuse in Transportation
Fighting Opioid Abuse in Transportation Act
(Sec. 8102) The bill institutes a series of requirements relating to transportation workplace drug- and alcohol-testing. Among other things, the bill requires the Department of Transportation (DOT) to establish a public database with testing results for each mode of transportation; DOT must also include fentanyl in drug-testing policies, if HHS determines that inclusion is justified based on the reliability and cost-effectiveness of available testing.
Subtitle J--Eliminating Kickbacks in Recovery
Eliminating Kickbacks in Recovery Act of 2018
(Sec.8122) The bill amends the federal criminal code make it a crime to knowingly and willfully solicit, receive, pay, or offer payment for referrals to a recovery home, clinical treatment facility, or laboratory, subject to limitations.
Subtitle K--Substance Abuse Prevention
Substance Abuse Prevention Act of 2018
(Sec. 8202) The bill reauthorizes several programs relating to drug control through FY2023, including the Office of National Drug Control Policy, the Drug-Free Communities Program, and the High-Intensity Drug Trafficking Area Program.
The bill also reauthorizes and establishes several other judicial, treatment, and administrative programs relating to controlled substances. Among other things, the bill reauthorizes funding for drug courts, authorizes grants to support the safe handling of fentanyl by first responders, and authorizes grants for family substance-use disorder treatment services.
[115th Congress Public Law 271]
[From the U.S. Government Publishing Office]
[[Page 3893]]
SUBSTANCE USE-DISORDER PREVENTION THAT PROMOTES OPIOID RECOVERY AND
TREATMENT FOR PATIENTS AND COMMUNITIES ACT
[[Page 132 STAT. 3894]]
Public Law 115-271
115th Congress
An Act
To provide for opioid use disorder prevention, recovery, and treatment,
and for other purposes. <<NOTE: Oct. 24, 2018 - [H.R. 6]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act.>>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This Act may be cited
as the ``Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act'' or the ``SUPPORT for
Patients and Communities Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 1001. At-risk youth Medicaid protection.
Sec. 1002. Health insurance for former foster youth.
Sec. 1003. Demonstration project to increase substance use provider
capacity under the Medicaid program.
Sec. 1004. Medicaid drug review and utilization.
Sec. 1005. Guidance to improve care for infants with neonatal abstinence
syndrome and their mothers; GAO study on gaps in Medicaid
coverage for pregnant and postpartum women with substance use
disorder.
Sec. 1006. Medicaid health homes for substance-use-disorder Medicaid
enrollees.
Sec. 1007. Caring recovery for infants and babies.
Sec. 1008. Peer support enhancement and evaluation review.
Sec. 1009. Medicaid substance use disorder treatment via telehealth.
Sec. 1010. Enhancing patient access to non-opioid treatment options.
Sec. 1011. Assessing barriers to opioid use disorder treatment.
Sec. 1012. Help for moms and babies.
Sec. 1013. Securing flexibility to treat substance use disorders.
Sec. 1014. MACPAC study and report on MAT utilization controls under
State Medicaid programs.
Sec. 1015. Opioid addiction treatment programs enhancement.
Sec. 1016. Better data sharing to combat the opioid crisis.
Sec. 1017. Report on innovative State initiatives and strategies to
provide housing-related services and supports to individuals
struggling with substance use disorders under Medicaid.
Sec. 1018. Technical assistance and support for innovative State
strategies to provide housing-related supports under
Medicaid.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 2001. Expanding the use of telehealth services for the treatment of
opioid use disorder and other substance use disorders.
Sec. 2002. Comprehensive screenings for seniors.
Sec. 2003. Every prescription conveyed securely.
Sec. 2004. Requiring prescription drug plan sponsors under Medicare to
establish drug management programs for at-risk beneficiaries.
Sec. 2005. Medicare coverage of certain services furnished by opioid
treatment programs.
Sec. 2006. Encouraging appropriate prescribing under Medicare for
victims of opioid overdose.
[[Page 132 STAT. 3895]]
Sec. 2007. Automatic escalation to external review under a Medicare part
D drug management program for at-risk beneficiaries.
Sec. 2008. Suspension of payments by Medicare prescription drug plans
and MA-PD plans pending investigations of credible
allegations of fraud by pharmacies.
TITLE III--FDA AND CONTROLLED SUBSTANCE PROVISIONS
Subtitle A--FDA Provisions
Chapter 1--In General
Sec. 3001. Clarifying FDA regulation of non-addictive pain products.
Sec. 3002. Evidence-based opioid analgesic prescribing guidelines and
report.
Chapter 2--Stop Counterfeit Drugs by Regulating and Enhancing
Enforcement Now
Sec. 3011. Short title.
Sec. 3012. Notification, nondistribution, and recall of controlled
substances.
Sec. 3013. Single source pattern of imported illegal drugs.
Sec. 3014. Strengthening FDA and CBP coordination and capacity.
Chapter 3--Stop Illicit Drug Importation
Sec. 3021. Short title.
Sec. 3022. Restricting entrance of illicit drugs.
Chapter 4--Securing Opioids and Unused Narcotics With Deliberate
Disposal and Packaging
Sec. 3031. Short title.
Sec. 3032. Safety-enhancing packaging and disposal features.
Chapter 5--Postapproval Study Requirements
Sec. 3041. Clarifying FDA postmarket authorities.
Subtitle B--Controlled Substance Provisions
Chapter 1--More Flexibility With Respect to Medication-Assisted
Treatment for Opioid Use Disorders
Sec. 3201. Allowing for more flexibility with respect to medication-
assisted treatment for opioid use disorders.
Sec. 3202. Medication-assisted treatment for recovery from substance use
disorder.
Sec. 3203. Grants to enhance access to substance use disorder treatment.
Sec. 3204. Delivery of a controlled substance by a pharmacy to be
administered by injection or implantation.
Chapter 2--Empowering Pharmacists in the Fight Against Opioid Abuse
Sec. 3211. Short title.
Sec. 3212. Programs and materials for training on certain circumstances
under which a pharmacist may decline to fill a prescription.
Chapter 3--Safe Disposal of Unused Medication
Sec. 3221. Short title.
Sec. 3222. Disposal of controlled substances of a hospice patient by
employees of a qualified hospice program.
Sec. 3223. GAO study and report on hospice safe drug management.
Chapter 4--Special Registration for Telemedicine Clarification
Sec. 3231. Short title.
Sec. 3232. Regulations relating to a special registration for
telemedicine.
Chapter 5--Synthetic Abuse and Labeling of Toxic Substances
Sec. 3241. Controlled substance analogues.
Chapter 6--Access to Increased Drug Disposal
Sec. 3251. Short title.
Sec. 3252. Definitions.
Sec. 3253. Authority to make grants.
Sec. 3254. Application.
Sec. 3255. Use of grant funds.
Sec. 3256. Eligibility for grant.
[[Page 132 STAT. 3896]]
Sec. 3257. Duration of grants.
Sec. 3258. Accountability and oversight.
Sec. 3259. Duration of program.
Sec. 3260. Authorization of appropriations.
Chapter 7--Using Data To Prevent Opioid Diversion
Sec. 3271. Short title.
Sec. 3272. Purpose.
Sec. 3273. Amendments.
Sec. 3274. Report.
Chapter 8--Opioid Quota Reform
Sec. 3281. Short title.
Sec. 3282. Strengthening considerations for DEA opioid quotas.
Chapter 9--Preventing Drug Diversion
Sec. 3291. Short title.
Sec. 3292. Improvements to prevent drug diversion.
TITLE IV--OFFSETS
Sec. 4001. Promoting value in Medicaid managed care.
Sec. 4002. Requiring reporting by group health plans of prescription
drug coverage information for purposes of identifying primary
payer situations under the Medicare program.
Sec. 4003. Additional religious exemption from health coverage
responsibility requirement.
Sec. 4004. Modernizing the reporting of biological and biosimilar
products.
TITLE V--OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting With Respect to Adult Behavioral Health
Measures
Sec. 5001. Mandatory reporting with respect to adult behavioral health
measures.
Subtitle B--Medicaid IMD Additional Info
Sec. 5011. Short title.
Sec. 5012. MACPAC exploratory study and report on institutions for
mental diseases requirements and practices under Medicaid.
Subtitle C--CHIP Mental Health and Substance Use Disorder Parity
Sec. 5021. Short title.
Sec. 5022. Ensuring access to mental health and substance use disorder
services for children and pregnant women under the Children's
Health Insurance Program.
Subtitle D--Medicaid Reentry
Sec. 5031. Short title.
Sec. 5032. Promoting State innovations to ease transitions integration
to the community for certain individuals.
Subtitle E--Medicaid Partnership
Sec. 5041. Short title.
Sec. 5042. Medicaid providers are required to note experiences in record
systems to help in-need patients.
Subtitle F--IMD CARE Act
Sec. 5051. Short title.
Sec. 5052. State option to provide Medicaid coverage for certain
individuals with substance use disorders who are patients in
certain institutions for mental diseases.
Subtitle G--Medicaid Improvement Fund
Sec. 5061. Medicaid Improvement Fund.
TITLE VI--OTHER MEDICARE PROVISIONS
Subtitle A--Testing of Incentive Payments for Behavioral Health
Providers for Adoption and Use of Certified Electronic Health Record
Technology
Sec. 6001. Testing of incentive payments for behavioral health providers
for adoption and use of certified electronic health record
technology.
[[Page 132 STAT. 3897]]
Subtitle B--Abuse Deterrent Access
Sec. 6011. Short title.
Sec. 6012. Study on abuse-deterrent opioid formulations access barriers
under Medicare.
Subtitle C--Medicare Opioid Safety Education
Sec. 6021. Medicare opioid safety education.
Subtitle D--Opioid Addiction Action Plan
Sec. 6031. Short title.
Sec. 6032. Action plan on recommendations for changes under Medicare and
Medicaid to prevent opioids addictions and enhance access to
medication-assisted treatment.
Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders in
Medicare
Sec. 6041. Short title.
Sec. 6042. Opioid use disorder treatment demonstration program.
Subtitle F--Responsible Education Achieves Care and Healthy Outcomes for
Users' Treatment
Sec. 6051. Short title.
Sec. 6052. Grants to provide technical assistance to outlier prescribers
of opioids.
Subtitle G--Preventing Addiction for Susceptible Seniors
Sec. 6061. Short title.
Sec. 6062. Electronic prior authorization for covered part D drugs.
Sec. 6063. Program integrity transparency measures under Medicare parts
C and D.
Sec. 6064. Expanding eligibility for medication therapy management
programs under part D.
Sec. 6065. Commit to opioid medical prescriber accountability and safety
for seniors.
Sec. 6066. No additional funds authorized.
Subtitle H--Expanding Oversight of Opioid Prescribing and Payment
Sec. 6071. Short title.
Sec. 6072. Medicare Payment Advisory Commission report on opioid
payment, adverse incentives, and data under the Medicare
program.
Sec. 6073. No additional funds authorized.
Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery
Sec. 6081. Short title.
Sec. 6082. Review and adjustment of payments under the Medicare
outpatient prospective payment system to avoid financial
incentives to use opioids instead of non-opioid alternative
treatments.
Sec. 6083. Expanding access under the Medicare program to addiction
treatment in Federally qualified health centers and rural
health clinics.
Sec. 6084. Studying the availability of supplemental benefits designed
to treat or prevent substance use disorders under Medicare
Advantage plans.
Sec. 6085. Clinical psychologist services models under the Center for
Medicare and Medicaid Innovation; GAO study and report.
Sec. 6086. Dr. Todd Graham pain management study.
Subtitle J--Combating Opioid Abuse for Care in Hospitals
Sec. 6091. Short title.
Sec. 6092. Developing guidance on pain management and opioid use
disorder prevention for hospitals receiving payment under
part A of the Medicare program.
Sec. 6093. Requiring the review of quality measures relating to opioids
and opioid use disorder treatments furnished under the
medicare program and other federal health care programs.
Sec. 6094. Technical expert panel on reducing surgical setting opioid
use; Data collection on perioperative opioid use.
Sec. 6095. Requiring the posting and periodic update of opioid
prescribing guidance for Medicare beneficiaries.
Subtitle K--Providing Reliable Options for Patients and Educational
Resources
Sec. 6101. Short title.
[[Page 132 STAT. 3898]]
Sec. 6102. Requiring Medicare Advantage plans and part D prescription
drug plans to include information on risks associated with
opioids and coverage of nonpharmacological therapies and
nonopioid medications or devices used to treat pain.
Sec. 6103. Requiring Medicare Advantage plans and prescription drug
plans to provide information on the safe disposal of
prescription drugs.
Sec. 6104. Revising measures used under the Hospital Consumer Assessment
of Healthcare Providers and Systems survey relating to pain
management.
Subtitle L--Fighting the Opioid Epidemic With Sunshine
Sec. 6111. Fighting the opioid epidemic with sunshine.
TITLE VII--PUBLIC HEALTH PROVISIONS
Subtitle A--Awareness and Training
Sec. 7001. Report on effects on public health of synthetic drug use.
Sec. 7002. First responder training.
Subtitle B--Pilot Program for Public Health Laboratories To Detect
Fentanyl and Other Synthetic Opioids
Sec. 7011. Pilot program for public health laboratories to detect
fentanyl and other synthetic opioids.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
Sec. 7021. Establishment of substance use disorder information
dashboard.
Sec. 7022. Interdepartmental Substance Use Disorders Coordinating
Committee.
Sec. 7023. National milestones to measure success in curtailing the
opioid crisis.
Sec. 7024. Study on prescribing limits.
Subtitle D--Ensuring Access to Quality Sober Living
Sec. 7031. National recovery housing best practices.
Subtitle E--Advancing Cutting Edge Research
Sec. 7041. Unique research initiatives.
Sec. 7042. Pain research.
Subtitle F--Jessie's Law
Sec. 7051. Inclusion of opioid addiction history in patient records.
Sec. 7052. Communication with families during emergencies.
Sec. 7053. Development and dissemination of model training programs for
substance use disorder patient records.
Subtitle G--Protecting Pregnant Women and Infants
Sec. 7061. Report on addressing maternal and infant health in the opioid
crisis.
Sec. 7062. Protecting moms and infants.
Sec. 7063. Early interventions for pregnant women and infants.
Sec. 7064. Prenatal and postnatal health.
Sec. 7065. Plans of safe care.
Subtitle H--Substance Use Disorder Treatment Workforce
Sec. 7071. Loan repayment program for substance use disorder treatment
workforce.
Sec. 7072. Clarification regarding service in schools and other
community-based settings.
Sec. 7073. Programs for health care workforce.
Subtitle I--Preventing Overdoses While in Emergency Rooms
Sec. 7081. Program to support coordination and continuation of care for
drug overdose patients.
Subtitle J--Alternatives to Opioids in the Emergency Department
Sec. 7091. Emergency department alternatives to opioids demonstration
program.
Subtitle K--Treatment, Education, and Community Help To Combat Addiction
Sec. 7101. Establishment of regional centers of excellence in substance
use disorder education.
Sec. 7102. Youth prevention and recovery.
Subtitle L--Information From National Mental Health and Substance Use
Policy Laboratory
Sec. 7111. Information from National Mental Health and Substance Use
Policy Laboratory.
[[Page 132 STAT. 3899]]
Subtitle M--Comprehensive Opioid Recovery Centers
Sec. 7121. Comprehensive opioid recovery centers.
Subtitle N--Trauma-Informed Care
Sec. 7131. CDC surveillance and data collection for child, youth, and
adult trauma.
Sec. 7132. Task force to develop best practices for trauma-informed
identification, referral, and support.
Sec. 7133. National Child Traumatic Stress Initiative.
Sec. 7134. Grants to improve trauma support services and mental health
care for children and youth in educational settings.
Sec. 7135. Recognizing early childhood trauma related to substance
abuse.
Subtitle O--Eliminating Opioid Related Infectious Diseases
Sec. 7141. Reauthorization and expansion of program of surveillance and
education regarding infections associated with illicit drug
use and other risk factors.
Subtitle P--Peer Support Communities of Recovery
Sec. 7151. Building communities of recovery.
Sec. 7152. Peer support technical assistance center.
Subtitle Q--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
Sec. 7161. Preventing overdoses of controlled substances.
Sec. 7162. Prescription drug monitoring program.
Subtitle R--Review of Substance Use Disorder Treatment Providers
Receiving Federal Funding
Sec. 7171. Review of substance use disorder treatment providers
receiving Federal funding.
Subtitle S--Other Health Provisions
Sec. 7181. State response to the opioid abuse crisis.
Sec. 7182. Report on investigations regarding parity in mental health
and substance use disorder benefits.
Sec. 7183. CAREER Act.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
Sec. 8001. Short title.
Sec. 8002. Customs fees.
Sec. 8003. Mandatory advance electronic information for postal
shipments.
Sec. 8004. International postal agreements.
Sec. 8005. Cost recoupment.
Sec. 8006. Development of technology to detect illicit narcotics.
Sec. 8007. Civil penalties for postal shipments.
Sec. 8008. Report on violations of arrival, reporting, entry, and
clearance requirements and falsity or lack of manifest.
Sec. 8009. Effective date; regulations.
Subtitle B--Opioid Addiction Recovery Fraud Prevention
Sec. 8021. Short title.
Sec. 8022. Definitions.
Sec. 8023. Unfair or deceptive acts or practices with respect to
substance use disorder treatment service and products.
Subtitle C--Addressing Economic and Workforce Impacts of the Opioid
Crisis
Sec. 8041. Addressing economic and workforce impacts of the opioid
crisis.
Subtitle D--Peer Support Counseling Program for Women Veterans
Sec. 8051. Peer support counseling program for women veterans.
Subtitle E--Treating Barriers to Prosperity
Sec. 8061. Short title.
Sec. 8062. Drug abuse mitigation initiative.
Subtitle F--Pilot Program to Help Individuals in Recovery From a
Substance Use Disorder Become Stably Housed
Sec. 8071. Pilot program to help individuals in recovery from a
substance use disorder become stably housed.
[[Page 132 STAT. 3900]]
Subtitle G--Human Services
Sec. 8081. Supporting family-focused residential treatment.
Sec. 8082. Improving recovery and reunifying families.
Sec. 8083. Building capacity for family-focused residential treatment.
Subtitle H--Reauthorizing and Extending Grants for Recovery From Opioid
Use Programs
Sec. 8091. Short title.
Sec. 8092. Reauthorization of the comprehensive opioid abuse grant
program.
Subtitle I--Fighting Opioid Abuse in Transportation
Sec. 8101. Short title.
Sec. 8102. Alcohol and controlled substance testing of mechanical
employees.
Sec. 8103. Department of Transportation public drug and alcohol testing
database.
Sec. 8104. GAO report on Department of Transportation's collection and
use of drug and alcohol testing data.
Sec. 8105. Transportation Workplace Drug and Alcohol Testing Program;
addition of fentanyl and other substances.
Sec. 8106. Status reports on hair testing guidelines.
Sec. 8107. Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Oral Fluid.
Sec. 8108. Electronic recordkeeping.
Sec. 8109. Status reports on Commercial Driver's License Drug and
Alcohol Clearinghouse.
Subtitle J--Eliminating Kickbacks in Recovery
Sec. 8121. Short title.
Sec. 8122. Criminal penalties.
Subtitle K--Substance Abuse Prevention
Sec. 8201. Short title.
Sec. 8202. Reauthorization of the Office of National Drug Control
Policy.
Sec. 8203. Reauthorization of the Drug-Free Communities Program.
Sec. 8204. Reauthorization of the National Community Anti-Drug Coalition
Institute.
Sec. 8205. Reauthorization of the High-Intensity Drug Trafficking Area
Program.
Sec. 8206. Reauthorization of drug court program.
Sec. 8207. Drug court training and technical assistance.
Sec. 8208. Drug overdose response strategy.
Sec. 8209. Protecting law enforcement officers from accidental exposure.
Sec. 8210. COPS Anti-Meth Program.
Sec. 8211. COPS anti-heroin task force program.
Sec. 8212. Comprehensive Addiction and Recovery Act education and
awareness.
Sec. 8213. Reimbursement of substance use disorder treatment
professionals.
Sec. 8214. Sobriety Treatment and Recovery Teams (START).
Sec. 8215. Provider education.
Sec. 8216. Definitions.
Sec. 8217. Amendments to administration of the Office.
Sec. 8218. Emerging threats committee, plan, and media campaign.
Sec. 8219. Drug interdiction.
Sec. 8220. GAO Audit.
Sec. 8221. National Drug Control Strategy.
Sec. 8222. Technical and conforming amendments to the Office of National
Drug Control Policy Reauthorization Act of 1998.
Subtitle L--Budgetary Effects
Sec. 8231. Budgetary effect.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 1001. AT-RISK YOUTH MEDICAID PROTECTION.
(a) In General.--Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended--
(1) in subsection (a)--
(A) by striking ``and'' at the end of paragraph
(82);
[[Page 132 STAT. 3901]]
(B) by striking the period at the end of paragraph
(83) and inserting ``; and''; and
(C) by inserting after paragraph (83) the following
new paragraph:
``(84) provide that--
``(A) the State shall not terminate eligibility for
medical assistance under the State plan for an
individual who is an eligible juvenile (as defined in
subsection (nn)(2)) because the juvenile is an inmate of
a public institution (as defined in subsection (nn)(3)),
but may suspend coverage during the period the juvenile
is such an inmate;
``(B) in the case of an individual who is an
eligible juvenile described in paragraph (2)(A) of
subsection (nn), the State shall, prior to the
individual's release from such a public institution,
conduct a redetermination of eligibility for such
individual with respect to such medical assistance
(without requiring a new application from the
individual) and, if the State determines pursuant to
such redetermination that the individual continues to
meet the eligibility requirements for such medical
assistance, the State shall restore coverage for such
medical assistance to such an individual upon the
individual's release from such public institution; and
``(C) in the case of an individual who is an
eligible juvenile described in paragraph (2)(B) of
subsection (nn), the State shall process any application
for medical assistance submitted by, or on behalf of,
such individual such that the State makes a
determination of eligibility for such individual with
respect to such medical assistance upon release of such
individual from such public institution.''; and
(2) by adding at the end the following new subsection:
``(nn) Juvenile; Eligible Juvenile; Public Institution.--For
purposes of subsection (a)(84) and this subsection:
``(1) Juvenile.--The term `juvenile' means an individual who
is--
``(A) under 21 years of age; or
``(B) described in subsection (a)(10)(A)(i)(IX).
``(2) Eligible juvenile.--The term `eligible juvenile' means
a juvenile who is an inmate of a public institution and who--
``(A) was determined eligible for medical assistance
under the State plan immediately before becoming an
inmate of such a public institution; or
``(B) is determined eligible for such medical
assistance while an inmate of a public institution.
``(3) Inmate of a public institution.--The term `inmate of a
public institution' has the meaning given such term for purposes
of applying the subdivision (A) following paragraph (30) of
section 1905(a), taking into account the exception in such
subdivision for a patient of a medical institution.''.
(b) <<NOTE: 42 USC 1396a note.>> No Change in Exclusion From
Medical Assistance for Inmates of Public Institutions.--Nothing in this
section shall be construed as changing the exclusion from medical
assistance under the subdivision (A) following paragraph (30) of section
1905(a) of the Social Security Act (42 U.S.C. 1396d(a)), as redesignated
[[Page 132 STAT. 3902]]
by section 1006(b)(2)(B) of this Act, including any applicable
restrictions on a State submitting claims for Federal financial
participation under title XIX of such Act for such assistance.
(c) <<NOTE: 42 USC 1396a note.>> No Change in Continuity of
Eligibility Before Adjudication or Sentencing.--Nothing in this section
shall be construed to mandate, encourage, or suggest that a State
suspend or terminate coverage for individuals before they have been
adjudicated or sentenced.
(d) <<NOTE: 42 USC 1396a note.>> Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by subsection (a) shall apply to eligibility of
juveniles who become inmates of public institutions on or after
the date that is 1 year after the date of the enactment of this
Act.
(2) Rule for changes requiring state legislation.--In the
case of a State plan for medical assistance under title XIX of
the Social Security Act which the Secretary of Health and Human
Services determines requires State legislation (other than
legislation appropriating funds) in order for the plan to meet
the additional requirements imposed by the amendments made by
subsection (a), the State plan shall not be regarded as failing
to comply with the requirements of such title solely on the
basis of its failure to meet these additional requirements
before the first day of the first calendar quarter beginning
after the close of the first regular session of the State
legislature that begins after the date of the enactment of this
Act. For purposes of the previous sentence, in the case of a
State that has a 2-year legislative session, each year of such
session shall be deemed to be a separate regular session of the
State legislature.
SEC. 1002. HEALTH INSURANCE FOR FORMER FOSTER YOUTH.
(a) Coverage Continuity for Former Foster Care Children up to Age
26.--
(1) In general.--Section 1902(a)(10)(A)(i)(IX) of the Social
Security Act (42 U.S.C. 1396a(a)(10)(A)(i)(IX)) is amended--
(A) in item (bb), by striking ``are not described in
or enrolled under'' and inserting ``are not described in
and are not enrolled under'';
(B) in item (cc), by striking ``responsibility of
the State'' and inserting ``responsibility of a State'';
and
(C) in item (dd), by striking ``the State plan under
this title or under a waiver of the'' and inserting ``a
State plan under this title or under a waiver of such
a''.
(2) <<NOTE: 42 USC 1396a note.>> Effective date.--The
amendments made by this subsection shall take effect with
respect to foster youth who attain 18 years of age on or after
January 1, 2023.
(b) <<NOTE: 42 USC 1396a note.>> Guidance.--Not later than 1 year
after the date of the enactment of this Act, the Secretary of Health and
Human Services shall issue guidance to States, with respect to the State
Medicaid programs of such States--
(1) on best practices for--
(A) removing barriers and ensuring streamlined,
timely access to Medicaid coverage for former foster
youth up to age 26; and
[[Page 132 STAT. 3903]]
(B) conducting outreach and raising awareness among
such youth regarding Medicaid coverage options for such
youth; and
(2) which shall include examples of States that have
successfully extended Medicaid coverage to former foster youth
up to age 26.
SEC. 1003. DEMONSTRATION PROJECT TO INCREASE SUBSTANCE USE
PROVIDER CAPACITY UNDER THE MEDICAID
PROGRAM.
Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended
by adding at the end the following new subsection:
``(aa) Demonstration Project To Increase Substance Use Provider
Capacity.--
``(1) In general.--Not later than the date that is 180 days
after the date of the enactment of this subsection, the
Secretary shall, in consultation, as appropriate, with the
Director of the Agency for Healthcare Research and Quality and
the Assistant Secretary for Mental Health and Substance Use,
conduct a 54-month demonstration project for the purpose
described in paragraph (2) under which the Secretary shall--
``(A) for the first 18-month period of such project,
award planning grants described in paragraph (3); and
``(B) for the remaining 36-month period of such
project, provide to each State selected under paragraph
(4) payments in accordance with paragraph (5).
``(2) Purpose.--The purpose described in this paragraph is
for each State selected under paragraph (4) to increase the
treatment capacity of providers participating under the State
plan (or a waiver of such plan) to provide substance use
disorder treatment or recovery services under such plan (or
waiver) through the following activities:
``(A) For the purpose described in paragraph
(3)(C)(i), activities that support an ongoing assessment
of the behavioral health treatment needs of the State,
taking into account the matters described in subclauses
(I) through (IV) of such paragraph.
``(B) Activities that, taking into account the
results of the assessment described in subparagraph (A),
support the recruitment, training, and provision of
technical assistance for providers participating under
the State plan (or a waiver of such plan) that offer
substance use disorder treatment or recovery services.
``(C) Improved reimbursement for and expansion of,
through the provision of education, training, and
technical assistance, the number or treatment capacity
of providers participating under the State plan (or
waiver) that--
``(i) are authorized to dispense drugs
approved by the Food and Drug Administration for
individuals with a substance use disorder who need
withdrawal management or maintenance treatment for
such disorder;
``(ii) have in effect a registration or waiver
under section 303(g) of the Controlled Substances
Act for purposes of dispensing narcotic drugs to
individuals for maintenance treatment or
detoxification treatment and are in compliance
with any regulation promulgated
[[Page 132 STAT. 3904]]
by the Assistant Secretary for Mental Health and
Substance Use for purposes of carrying out the
requirements of such section 303(g); and
``(iii) are qualified under applicable State
law to provide substance use disorder treatment or
recovery services.
``(D) Improved reimbursement for and expansion of,
through the provision of education, training, and
technical assistance, the number or treatment capacity
of providers participating under the State plan (or
waiver) that have the qualifications to address the
treatment or recovery needs of--
``(i) individuals enrolled under the State
plan (or a waiver of such plan) who have neonatal
abstinence syndrome, in accordance with guidelines
issued by the American Academy of Pediatrics and
American College of Obstetricians and
Gynecologists relating to maternal care and infant
care with respect to neonatal abstinence syndrome;
``(ii) pregnant women, postpartum women, and
infants, particularly the concurrent treatment, as
appropriate, and comprehensive case management of
pregnant women, postpartum women and infants,
enrolled under the State plan (or a waiver of such
plan);
``(iii) adolescents and young adults between
the ages of 12 and 21 enrolled under the State
plan (or a waiver of such plan); or
``(iv) American Indian and Alaska Native
individuals enrolled under the State plan (or a
waiver of such plan).
``(3) Planning grants.--
``(A) In general.--The Secretary shall, with respect
to the first 18-month period of the demonstration
project conducted under paragraph (1), award planning
grants to at least 10 States selected in accordance with
subparagraph (B) for purposes of preparing an
application described in paragraph (4)(C) and carrying
out the activities described in subparagraph (C).
``(B) Selection.--In selecting States for purposes
of this paragraph, the Secretary shall--
``(i) select States that have a State plan (or
waiver of the State plan) approved under this
title;
``(ii) select States in a manner that ensures
geographic diversity; and
``(iii) give preference to States with a
prevalence of substance use disorders (in
particular opioid use disorders) that is
comparable to or higher than the national average
prevalence, as measured by aggregate per capita
drug overdoses, or any other measure that the
Secretary deems appropriate.
``(C) Activities described.--Activities described in
this subparagraph are, with respect to a State, each of
the following:
``(i) Activities that support the development
of an initial assessment of the behavioral health
treatment needs of the State to determine the
extent to which
[[Page 132 STAT. 3905]]
providers are needed (including the types of such
providers and geographic area of need) to improve
the network of providers that treat substance use
disorders under the State plan (or waiver),
including the following:
``(I) An estimate of the number of
individuals enrolled under the State
plan (or a waiver of such plan) who have
a substance use disorder.
``(II) Information on the capacity
of providers to provide substance use
disorder treatment or recovery services
to individuals enrolled under the State
plan (or waiver), including information
on providers who provide such services
and their participation under the State
plan (or waiver).
``(III) Information on the gap in
substance use disorder treatment or
recovery services under the State plan
(or waiver) based on the information
described in subclauses (I) and (II).
``(IV) Projections regarding the
extent to which the State participating
under the demonstration project would
increase the number of providers
offering substance use disorder
treatment or recovery services under the
State plan (or waiver) during the period
of the demonstration project.
``(ii) Activities that, taking into account
the results of the assessment described in clause
(i), support the development of State
infrastructure to, with respect to the provision
of substance use disorder treatment or recovery
services under the State plan (or a waiver of such
plan), recruit prospective providers and provide
training and technical assistance to such
providers.
``(D) Funding.--For purposes of subparagraph (A),
there is appropriated, out of any funds in the Treasury
not otherwise appropriated, $50,000,000, to remain
available until expended.
``(4) Post-planning states.--
``(A) In general.--The Secretary shall, with respect
to the remaining 36-month period of the demonstration
project conducted under paragraph (1), select not more
than 5 States in accordance with subparagraph (B) for
purposes of carrying out the activities described in
paragraph (2) and receiving payments in accordance with
paragraph (5).
``(B) Selection.--In selecting States for purposes
of this paragraph, the Secretary shall--
``(i) select States that received a planning
grant under paragraph (3);
``(ii) select States that submit to the
Secretary an application in accordance with the
requirements in subparagraph (C), taking into
consideration the quality of each such
application;
``(iii) select States in a manner that ensures
geographic diversity; and
``(iv) give preference to States with a
prevalence of substance use disorders (in
particular opioid use disorders) that is
comparable to or higher than the national average
prevalence, as measured by aggregate
[[Page 132 STAT. 3906]]
per capita drug overdoses, or any other measure
that the Secretary deems appropriate.
``(C) Applications.--
``(i) In general.--A State seeking to be
selected for purposes of this paragraph shall
submit to the Secretary, at such time and in such
form and manner as the Secretary requires, an
application that includes such information,
provisions, and assurances, as the Secretary may
require, in addition to the following:
``(I) A proposed process for
carrying out the ongoing assessment
described in paragraph (2)(A), taking
into account the results of the initial
assessment described in paragraph
(3)(C)(i).
``(II) A review of reimbursement
methodologies and other policies related
to substance use disorder treatment or
recovery services under the State plan
(or waiver) that may create barriers to
increasing the number of providers
delivering such services.
``(III) The development of a plan,
taking into account activities carried
out under paragraph (3)(C)(ii), that
will result in long-term and sustainable
provider networks under the State plan
(or waiver) that will offer a continuum
of care for substance use disorders.
Such plan shall include the following:
``(aa) Specific activities
to increase the number of
providers (including providers
that specialize in providing
substance use disorder treatment
or recovery services, hospitals,
health care systems, Federally
qualified health centers, and,
as applicable, certified
community behavioral health
clinics) that offer substance
use disorder treatment,
recovery, or support services,
including short-term
detoxification services,
outpatient substance use
disorder services, and evidence-
based peer recovery services.
``(bb) Strategies that will
incentivize providers described
in subparagraphs (C) and (D) of
paragraph (2) to obtain the
necessary training, education,
and support to deliver substance
use disorder treatment or
recovery services in the State.
``(cc) Milestones and
timeliness for implementing
activities set forth in the
plan.
``(dd) Specific measurable
targets for increasing the
substance use disorder treatment
and recovery provider network
under the State plan (or a
waiver of such plan).
``(IV) A proposed process for
reporting the information required under
paragraph (6)(A), including information
to assess the effectiveness of the
efforts of the State to expand the
capacity of providers to deliver
substance use disorder treatment or
recovery services during the period of
the demonstration project under this
subsection.
[[Page 132 STAT. 3907]]
``(V) The expected financial impact
of the demonstration project under this
subsection on the State.
``(VI) A description of all funding
sources available to the State to
provide substance use disorder treatment
or recovery services in the State.
``(VII) A preliminary plan for how
the State will sustain any increase in
the capacity of providers to deliver
substance use disorder treatment or
recovery services resulting from the
demonstration project under this
subsection after the termination of such
demonstration project.
``(VIII) A description of how the
State will coordinate the goals of the
demonstration project with any waiver
granted (or submitted by the State and
pending) pursuant to section 1115 for
the delivery of substance use services
under the State plan, as applicable.
``(ii) Consultation.--In completing an
application under clause (i), a State shall
consult with relevant stakeholders, including
Medicaid managed care plans, health care
providers, and Medicaid beneficiary advocates, and
include in such application a description of such
consultation.
``(5) Payment.--
``(A) In general.--For each quarter occurring during
the period for which the demonstration project is
conducted (after the first 18 months of such period),
the Secretary shall pay under this subsection, subject
to subparagraph (C), to each State selected under
paragraph (4) an amount equal to 80 percent of so much
of the qualified sums expended during such quarter.
``(B) Qualified sums defined.--For purposes of
subparagraph (A), the term `qualified sums' means, with
respect to a State and a quarter, the amount equal to
the amount (if any) by which the sums expended by the
State during such quarter attributable to substance use
disorder treatment or recovery services furnished by
providers participating under the State plan (or a
waiver of such plan) exceeds 1/4 of such sums expended
by the State during fiscal year 2018 attributable to
substance use disorder treatment or recovery services.
``(C) Non-duplication of payment.--In the case that
payment is made under subparagraph (A) with respect to
expenditures for substance use disorder treatment or
recovery services furnished by providers participating
under the State plan (or a waiver of such plan), payment
may not also be made under subsection (a) with respect
to expenditures for the same services so furnished.
``(6) Reports.--
``(A) State reports.--A State receiving payments
under paragraph (5) shall, for the period of the
demonstration project under this subsection, submit to
the Secretary a quarterly report, with respect to
expenditures for substance use disorder treatment or
recovery services for which payment is made to the State
under this subsection, on the following:
[[Page 132 STAT. 3908]]
``(i) The specific activities with respect to
which payment under this subsection was provided.
``(ii) The number of providers that delivered
substance use disorder treatment or recovery
services in the State under the demonstration
project compared to the estimated number of
providers that would have otherwise delivered such
services in the absence of such demonstration
project.
``(iii) The number of individuals enrolled
under the State plan (or a waiver of such plan)
who received substance use disorder treatment or
recovery services under the demonstration project
compared to the estimated number of such
individuals who would have otherwise received such
services in the absence of such demonstration
project.
``(iv) Other matters as determined by the
Secretary.
``(B) CMS reports.--
``(i) Initial report.--Not later than October
1, 2020, the Administrator of the Centers for
Medicare & Medicaid Services shall, in
consultation with the Director of the Agency for
Healthcare Research and Quality and the Assistant
Secretary for Mental Health and Substance Use,
submit to Congress an initial report on--
``(I) the States awarded planning
grants under paragraph (3);
``(II) the criteria used in such
selection; and
``(III) the activities carried out
by such States under such planning
grants.
``(ii) Interim report.--Not later than October
1, 2022, the Administrator of the Centers for
Medicare & Medicaid Services shall, in
consultation with the Director of the Agency for
Healthcare Research and Quality and the Assistant
Secretary for Mental Health and Substance Use,
submit to Congress an interim report--
``(I) on activities carried out
under the demonstration project under
this subsection;
``(II) on the extent to which States
selected under paragraph (4) have
achieved the stated goals submitted in
their applications under subparagraph
(C) of such paragraph;
``(III) with a description of the
strengths and limitations of such
demonstration project; and
``(IV) with a plan for the
sustainability of such project.
``(iii) Final report.--Not later than October
1, 2024, the Administrator of the Centers for
Medicare & Medicaid Services shall, in
consultation with the Director of the Agency for
Healthcare Research and Quality and the Assistant
Secretary for Mental Health and Substance Use,
submit to Congress a final report--
``(I) providing updates on the
matters reported in the interim report
under clause (ii);
``(II) including a description of
any changes made with respect to the
demonstration project
[[Page 132 STAT. 3909]]
under this subsection after the
submission of such interim report; and
``(III) evaluating such
demonstration project.
``(C) AHRQ report.--Not later than 3 years after the
date of the enactment of this subsection, the Director
of the Agency for Healthcare Research and Quality, in
consultation with the Administrator of the Centers for
Medicare & Medicaid Services, shall submit to Congress a
summary on the experiences of States awarded planning
grants under paragraph (3) and States selected under
paragraph (4).
``(7) Data sharing and best practices.--During the period of
the demonstration project under this subsection, the Secretary
shall, in collaboration with States selected under paragraph
(4), facilitate data sharing and the development of best
practices between such States and States that were not so
selected.
``(8) CMS funding.--There is appropriated, out of any funds
in the Treasury not otherwise appropriated, $5,000,000 to the
Centers for Medicare & Medicaid Services for purposes of
implementing this subsection. Such amount shall remain available
until expended.''.
SEC. 1004. MEDICAID DRUG REVIEW AND UTILIZATION.
(a) Medicaid Drug Utilization Review.--
(1) State plan requirement.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)), as amended by section 1001,
is further amended--
(A) in paragraph (83), at the end, by striking
``and'';
(B) in paragraph (84), at the end, by striking the
period and inserting ``; and''; and
(C) by inserting after paragraph (84) the following
new paragraph:
``(85) provide that the State is in compliance with the drug
review and utilization requirements under subsection (oo)(1).''.
(2) Drug review and utilization requirements.--Section 1902
of the Social Security Act (42 U.S.C. 1396a), as amended by
section 1001, is further amended by adding at the end the
following new subsection:
``(oo) Drug Review and Utilization Requirements.--
``(1) In general.--For purposes of subsection (a)(85), the
drug review and utilization requirements under this subsection
are, subject to paragraph (3) and beginning October 1, 2019, the
following:
``(A) Claims review limitations.--
``(i) In general.--The State has in place--
``(I) safety edits (as specified by
the State) for subsequent fills for
opioids and a claims review automated
process (as designed and implemented by
the State) that indicates when an
individual enrolled under the State plan
(or under a waiver of the State plan) is
prescribed a subsequent fill of opioids
in excess of any limitation that may be
identified by the State;
``(II) safety edits (as specified by
the State) on the maximum daily morphine
equivalent that
[[Page 132 STAT. 3910]]
can be prescribed to an individual
enrolled under the State plan (or under
a waiver of the State plan) for
treatment of chronic pain and a claims
review automated process (as designed
and implemented by the State) that
indicates when an individual enrolled
under the plan (or waiver) is prescribed
the morphine equivalent for such
treatment in excess of any limitation
that may be identified by the State; and
``(III) a claims review automated
process (as designed and implemented by
the State) that monitors when an
individual enrolled under the State plan
(or under a waiver of the State plan) is
concurrently prescribed opioids and--
``(aa) benzodiazepines; or
``(bb) antipsychotics.
``(ii) Managed care entities.--The State
requires each managed care entity (as defined in
section 1932(a)(1)(B)) with respect to which the
State has a contract under section 1903(m) or
under section 1905(t)(3) to have in place, subject
to paragraph (3), with respect to individuals who
are eligible for medical assistance under the
State plan (or under a waiver of the State plan)
and who are enrolled with the entity, the
limitations described in subclauses (I) and (II)
of clause (i) and a claims review automated
process described in subclause (III) of such
clause.
``(iii) Rules of construction.--Nothing in
this subparagraph may be construed as prohibiting
a State or managed care entity from designing and
implementing a claims review automated process
under this subparagraph that provides for
prospective or retrospective reviews of claims.
Nothing in this subparagraph shall be understood
as prohibiting the exercise of clinical judgment
from a provider enrolled as a participating
provider in a State plan (or waiver of the State
plan) or contracting with a managed care entity
regarding the best items and services for an
individual enrolled under such State plan (or
waiver).
``(B) Program to monitor antipsychotic medications
by children.--The State has in place a program (as
designed and implemented by the State) to monitor and
manage the appropriate use of antipsychotic medications
by children enrolled under the State plan (or under a
waiver of the State plan) and submits annually to the
Secretary such information as the Secretary may require
on activities carried out under such program for
individuals not more than the age of 18 years generally
and children in foster care specifically.
``(C) Fraud and abuse identification.--The State has
in place a process (as designed and implemented by the
State) that identifies potential fraud or abuse of
controlled substances by individuals enrolled under the
State plan (or under a waiver of the State plan), health
care providers prescribing drugs to individuals so
enrolled, and pharmacies dispensing drugs to individuals
so enrolled.
[[Page 132 STAT. 3911]]
``(D) Reports.--The State shall include in the
annual report submitted to the Secretary under section
1927(g)(3)(D) information on the limitations,
requirement, program, and processes applied by the State
under subparagraphs (A) through (C) in accordance with
such manner and time as specified by the Secretary.
``(E) Clarification.--Nothing shall prevent a State
from satisfying the requirement--
``(i) described in subparagraph (A) by having
safety edits or a claims review automated process
described in such subparagraph that was in place
before October 1, 2019;
``(ii) described in subparagraph (B) by having
a program described in such subparagraph that was
in place before such date; or
``(iii) described in subparagraph (C) by
having a process described in such subparagraph
that was in place before such date.
``(2) Annual report by secretary.--For each fiscal year
beginning with fiscal year 2020, the Secretary shall submit to
Congress a report on the most recent information submitted by
States under paragraph (1)(D).
``(3) Exceptions.--
``(A) Certain individuals exempted.--The drug review
and utilization requirements under this subsection shall
not apply with respect to an individual who--
``(i) is receiving--
``(I) hospice or palliative care; or
``(II) treatment for cancer;
``(ii) is a resident of a long-term care
facility, of a facility described in section
1905(d), or of another facility for which
frequently abused drugs are dispensed for
residents through a contract with a single
pharmacy; or
``(iii) the State elects to treat as exempted
from such requirements.
``(B) Exception relating to ensuring access.--In
order to ensure reasonable access to health care, the
Secretary shall waive the drug review and utilization
requirements under this subsection, with respect to a
State, in the case of natural disasters and similar
situations, and in the case of the provision of
emergency services (as defined for purposes of section
1860D-4(c)(5)(D)(ii)(II)).''.
(3) Managed care entities.--Section 1932 of the Social
Security Act (42 U.S.C. 1396u-2) is amended by adding at the end
the following new subsection:
``(i) Drug Utilization Review Activities and Requirements.--
Beginning not later than October 1, 2019, each contract under a State
plan with a managed care entity (other than a primary care case manager)
under section 1903(m) shall provide that the entity is in compliance
with the applicable provisions of section 438.3(s)(2) of title 42, Code
of Federal Regulations, section 483.3(s)(4)) of such title, and section
483.3(s)(5) of such title, as such provisions were in effect on March
31, 2018.''.
(b) Identifying and Addressing Inappropriate Prescribing and Billing
Practices Under Medicaid.--
[[Page 132 STAT. 3912]]
(1) In general.--Section 1927(g) of the Social Security Act
(42 U.S.C. 1396r-8(g)) is amended--
(A) in paragraph (1)(A)--
(i) by striking ``of section 1903(i)(10)(B)''
and inserting ``of section 1902(a)(54)'';
(ii) by striking ``, by not later than January
1, 1993,'';
(iii) by inserting after ``gross overuse,''
the following: ``excessive utilization,''; and
(iv) by striking ``or inappropriate or
medically unnecessary care'' and inserting
``inappropriate or medically unnecessary care, or
prescribing or billing practices that indicate
abuse or excessive utilization''; and
(B) in paragraph (2)(B)--
(i) by inserting after ``gross overuse,'' the
following: ``excessive utilization,''; and
(ii) by striking ``or inappropriate or
medically unnecessary care'' and inserting
``inappropriate or medically unnecessary care, or
prescribing or billing practices that indicate
abuse or excessive utilization''.
(2) <<NOTE: 42 USC 1396r-8 note.>> Effective date.--The
amendments made by paragraph (1) shall take effect with respect
to retrospective drug use reviews conducted on or after October
1, 2020.
SEC. 1005. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH NEONATAL
ABSTINENCE SYNDROME AND THEIR MOTHERS;
GAO STUDY ON GAPS IN MEDICAID COVERAGE
FOR PREGNANT AND POSTPARTUM WOMEN WITH
SUBSTANCE USE DISORDER.
(a) <<NOTE: 42 USC 1396a note.>> Guidance.--Not later than 1 year
after the date of the enactment of this Act, the Secretary of Health and
Human Services shall issue guidance to improve care for infants with
neonatal abstinence syndrome and their families. Such guidance shall
include--
(1) best practices from States with respect to innovative or
evidenced-based payment models that focus on prevention,
screening, treatment, plans of safe care, and postdischarge
services for mothers and fathers with substance use disorders
and babies with neonatal abstinence syndrome that improve care
and clinical outcomes;
(2) recommendations for States on available financing
options under the Medicaid program under title XIX of such Act
and under the Children's Health Insurance Program under title
XXI of such Act for Children's Health Insurance Program Health
Services Initiative funds for parents with substance use
disorders, infants with neonatal abstinence syndrome, and home-
visiting services;
(3) guidance and technical assistance to State Medicaid
agencies regarding additional flexibilities and incentives
related to screening, prevention, and postdischarge services,
including parenting supports, and infant-caregiver bonding,
including breastfeeding when it is appropriate; and
(4) guidance regarding suggested terminology and ICD codes
to identify infants with neonatal abstinence syndrome and
neonatal opioid withdrawal syndrome, which could include opioid-
exposure, opioid withdrawal not requiring
[[Page 132 STAT. 3913]]
pharmacotherapy, and opioid withdrawal requiring
pharmacotherapy.
(b) GAO Study.--Not later than 1 year after the date of the
enactment of this Act, the Comptroller General of the United States
shall conduct a study, and submit to Congress a report, addressing gaps
in coverage for pregnant women with substance use disorder under the
Medicaid program under title XIX of the Social Security Act, and gaps in
coverage for postpartum women with substance use disorder who had
coverage during their pregnancy under the Medicaid program under such
title.
SEC. 1006. MEDICAID HEALTH HOMES FOR SUBSTANCE-USE-DISORDER
MEDICAID ENROLLEES.
(a) Extension of Enhanced FMAP for Certain Health Homes for
Individuals With Substance Use Disorders.--Section 1945(c) of the Social
Security Act (42 U.S.C. 1396w-4(c)) is amended--
(1) in paragraph (1), by inserting ``subject to paragraph
(4),'' after ``except that,''; and
(2) by adding at the end the following new paragraph:
``(4) Special rule relating to substance use disorder health
homes.--
``(A) In general.--In the case of a State with an
SUD-focused State plan amendment approved by the
Secretary on or after October 1, 2018, the Secretary
may, at the request of the State, extend the application
of the Federal medical assistance percentage described
in paragraph (1) to payments for the provision of health
home services to SUD-eligible individuals under such
State plan amendment, in addition to the first 8 fiscal
year quarters the State plan amendment is in effect, for
the subsequent 2 fiscal year quarters that the State
plan amendment is in effect. Nothing in this section
shall be construed as prohibiting a State with a State
plan amendment that is approved under this section and
that is not an SUD-focused State plan amendment from
additionally having approved on or after such date an
SUD-focused State plan amendment under this section,
including for purposes of application of this paragraph.
``(B) Report requirements.--In the case of a State
with an SUD-focused State plan amendment for which the
application of the Federal medical assistance percentage
has been extended under subparagraph (A), such State
shall, at the end of the period of such State plan
amendment, submit to the Secretary a report on the
following, with respect to SUD-eligible individuals
provided health home services under such State plan
amendment:
``(i) The quality of health care provided to
such individuals, with a focus on outcomes
relevant to the recovery of each such individual.
``(ii) The access of such individuals to
health care.
``(iii) The total expenditures of such
individuals for health care.
For purposes of this subparagraph, the Secretary shall
specify all applicable measures for determining quality,
access, and expenditures.
[[Page 132 STAT. 3914]]
``(C) Best practices.--Not later than October 1,
2020, the Secretary shall make publicly available on the
internet website of the Centers for Medicare & Medicaid
Services best practices for designing and implementing
an SUD-focused State plan amendment, based on the
experiences of States that have State plan amendments
approved under this section that include SUD-eligible
individuals.
``(D) Definitions.--For purposes of this paragraph:
``(i) SUD-eligible individuals.--The term
`SUD-eligible individual' means, with respect to a
State, an individual who satisfies all of the
following:
``(I) The individual is an eligible
individual with chronic conditions.
``(II) The individual is an
individual with a substance use
disorder.
``(III) The individual has not
previously received health home services
under any other State plan amendment
approved for the State under this
section by the Secretary.
``(ii) SUD-focused state plan amendment.--The
term `SUD-focused State plan amendment' means a
State plan amendment under this section that is
designed to provide health home services primarily
to SUD-eligible individuals.''.
(b) Requirement for State Medicaid Plans To Provide Coverage for
Medication-Assisted Treatment.--
(1) Requirement for state medicaid plans to provide coverage
for medication-assisted treatment.--Section 1902(a)(10)(A) of
the Social Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended,
in the matter preceding clause (i), by striking ``and (28)'' and
inserting ``(28), and (29)''.
(2) Inclusion of medication-assisted treatment as medical
assistance.--Section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)) is amended--
(A) in paragraph (28), by striking ``and'' at the
end;
(B) by redesignating paragraph (29) as paragraph
(30); and
(C) by inserting after paragraph (28) the following
new paragraph:
``(29) subject to paragraph (2) of subsection (ee), for the
period beginning October 1, 2020, and ending September 30, 2025,
medication-assisted treatment (as defined in paragraph (1) of
such subsection); and''.
(3) Medication-assisted treatment defined; waivers.--Section
1905 of the Social Security Act (42 U.S.C. 1396d) is amended by
adding at the end the following new subsection:
``(ee) Medication-Assisted Treatment.--
``(1) Definition.--For purposes of subsection (a)(29), the
term `medication-assisted treatment'--
``(A) means all drugs approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), including methadone, and all biological products
licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262) to treat opioid use disorders; and
``(B) includes, with respect to the provision of
such drugs and biological products, counseling services
and behavioral therapy.
[[Page 132 STAT. 3915]]
``(2) Exception.--The provisions of paragraph (29) of
subsection (a) shall not apply with respect to a State for the
period specified in such paragraph, if before the beginning of
such period the State certifies to the satisfaction of the
Secretary that implementing such provisions statewide for all
individuals eligible to enroll in the State plan (or waiver of
the State plan) would not be feasible by reason of a shortage of
qualified providers of medication-assisted treatment, or
facilities providing such treatment, that will contract with the
State or a managed care entity with which the State has a
contract under section 1903(m) or under section 1905(t)(3).''.
(4) <<NOTE: 42 USC 1396a note.>> Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with
respect to medical assistance provided on or after
October 1, 2020, and before October 1, 2025.
(B) Exception for state legislation.--In the case of
a State plan under title XIX of the Social Security Act
(42 U.S.C. 1396 et seq.) that the Secretary of Health
and Human Services determines requires State legislation
in order for the respective plan to meet any requirement
imposed by the amendments made by this subsection, the
respective plan shall not be regarded as failing to
comply with the requirements of such title solely on the
basis of its failure to meet such an additional
requirement before the first day of the first calendar
quarter beginning after the close of the first regular
session of the State legislature that begins after the
date of the enactment of this Act. For purposes of the
previous sentence, in the case of a State that has a 2-
year legislative session, each year of the session shall
be considered to be a separate regular session of the
State legislature.
SEC. 1007. CARING RECOVERY FOR INFANTS AND BABIES.
(a) State Plan Amendment.--Section 1902(a) of the Social Security
Act (42 U.S.C. 1396a(a)), as amended by sections 1001 and 1004, is
further amended--
(1) in paragraph (84)(C), by striking ``and'' after the
semicolon;
(2) in paragraph (85), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after paragraph (85), the following new
paragraph:
``(86) provide, at the option of the State, for making
medical assistance available on an inpatient or outpatient basis
at a residential pediatric recovery center (as defined in
subsection (pp)) to infants with neonatal abstinence
syndrome.''.
(b) Residential Pediatric Recovery Center Defined.--Section 1902 of
such Act (42 U.S.C. 1396a), as amended by sections 1001 and 1004, is
further amended by adding at the end the following new subsection:
``(pp) Residential Pediatric Recovery Center Defined.--
``(1) In general.--For purposes of section 1902(a)(86), the
term `residential pediatric recovery center' means a center or
facility that furnishes items and services for which medical
assistance is available under the State plan to infants with
[[Page 132 STAT. 3916]]
the diagnosis of neonatal abstinence syndrome without any other
significant medical risk factors.
``(2) Counseling and services.--A residential pediatric
recovery center may offer counseling and other services to
mothers (and other appropriate family members and caretakers) of
infants receiving treatment at such centers if such services are
otherwise covered under the State plan under this title or under
a waiver of such plan. Such other services may include the
following:
``(A) Counseling or referrals for services.
``(B) Activities to encourage caregiver-infant
bonding.
``(C) Training on caring for such infants.''.
(c) <<NOTE: 42 USC 1396a note.>> Effective Date.--The amendments
made by this section take effect on the date of enactment of this Act
and shall apply to medical assistance furnished on or after that date,
without regard to final regulations to carry out such amendments being
promulgated as of such date.
SEC. 1008. PEER SUPPORT ENHANCEMENT AND EVALUATION REVIEW.
(a) In General.--Not later than 2 years after the date of the
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Energy and Commerce of the House of
Representatives, the Committee on Finance of the Senate, and the
Committee on Health, Education, Labor and Pensions of the Senate a
report on the provision of peer support services under the Medicaid
program.
(b) Content of Report.--
(1) In general.--The report required under subsection (a)
shall include the following information:
(A) Information on State coverage of peer support
services under Medicaid, including--
(i) the mechanisms through which States may
provide such coverage, including through existing
statutory authority or through waivers;
(ii) the populations to which States have
provided such coverage;
(iii) the payment models, including any
alternative payment models, used by States to pay
providers of such services; and
(iv) where available, information on Federal
and State spending under Medicaid for peer support
services.
(B) Information on selected State experiences in
providing medical assistance for peer support services
under State Medicaid plans and whether States measure
the effects of providing such assistance with respect
to--
(i) improving access to behavioral health
services;
(ii) improving early detection, and preventing
worsening, of behavioral health disorders;
(iii) reducing chronic and comorbid
conditions; and
(iv) reducing overall health costs.
(2) Recommendations.--The report required under subsection
(a) shall include recommendations, including recommendations for
such legislative and administrative actions related to improving
services, including peer support services, and access to peer
support services under Medicaid as the
[[Page 132 STAT. 3917]]
Comptroller General of the United States determines appropriate.
SEC. 1009. MEDICAID SUBSTANCE USE DISORDER TREATMENT VIA
TELEHEALTH.
(a) <<NOTE: 42 USC 1396a note.>> Definitions.--In this section:
(1) Comptroller general.--The term ``Comptroller General''
means the Comptroller General of the United States.
(2) School-based health center.--The term ``school-based
health center'' has the meaning given that term in section
2110(c)(9) of the Social Security Act (42 U.S.C. 1397jj(c)(9)).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(4) Underserved area.--The term ``underserved area'' means a
health professional shortage area (as defined in section
332(a)(1)(A) of the Public Health Service Act (42 U.S.C.
254e(a)(1)(A))) and a medically underserved area (according to a
designation under section 330(b)(3)(A) of the Public Health
Service Act (42 U.S.C. 254b(b)(3)(A))).
(b) <<NOTE: 42 USC 1396a note.>> Guidance to States Regarding
Federal Reimbursement for Furnishing Services and Treatment for
Substance Use Disorders Under Medicaid Using Services Delivered Via
Telehealth, Including in School-Based Health Centers.--Not later than 1
year after the date of enactment of this Act, the Secretary, acting
through the Administrator of the Centers for Medicare & Medicaid
Services, shall issue guidance to States on the following:
(1) State options for Federal reimbursement of expenditures
under Medicaid for furnishing services and treatment for
substance use disorders, including assessment, medication-
assisted treatment, counseling, medication management, and
medication adherence with prescribed medication regimes, using
services delivered via telehealth. Such guidance shall also
include guidance on furnishing services and treatments that
address the needs of high-risk individuals, including at least
the following groups:
(A) American Indians and Alaska Natives.
(B) Adults under the age of 40.
(C) Individuals with a history of non-fatal
overdose.
(D) Individuals with a co-occurring serious mental
illness and substance use disorder.
(2) State options for Federal reimbursement of expenditures
under Medicaid for education directed to providers serving
Medicaid beneficiaries with substance use disorders using the
hub and spoke model, through contracts with managed care
entities, through administrative claiming for disease management
activities, and under Delivery System Reform Incentive Payment
(``DSRIP'') programs.
(3) State options for Federal reimbursement of expenditures
under Medicaid for furnishing services and treatment for
substance use disorders for individuals enrolled in Medicaid in
a school-based health center using services delivered via
telehealth.
(c) GAO Evaluation of Children's Access to Services and Treatment
for Substance Use Disorders Under Medicaid.--
(1) Study.--The Comptroller General shall evaluate
children's access to services and treatment for substance use
disorders under Medicaid. The evaluation shall include an
analysis
[[Page 132 STAT. 3918]]
of State options for improving children's access to such
services and treatment and for improving outcomes, including by
increasing the number of Medicaid providers who offer services
or treatment for substance use disorders in a school-based
health center using services delivered via telehealth,
particularly in rural and underserved areas. The evaluation
shall include an analysis of Medicaid provider reimbursement
rates for services and treatment for substance use disorders.
(2) Report.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General shall submit to
Congress a report containing the results of the evaluation
conducted under paragraph (1), together with recommendations for
such legislation and administrative action as the Comptroller
General determines appropriate.
(d) Report on Reducing Barriers to Using Services Delivered Via
Telehealth and Remote Patient Monitoring for Pediatric Populations Under
Medicaid.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the
Administrator of the Centers for Medicare & Medicaid Services,
shall issue a report to the Committee on Finance of the Senate
and the Committee on Energy and Commerce of the House of
Representatives identifying best practices and potential
solutions for reducing barriers to using services delivered via
telehealth to furnish services and treatment for substance use
disorders among pediatric populations under Medicaid. The report
shall include--
(A) analyses of the best practices, barriers, and
potential solutions for using services delivered via
telehealth to diagnose and provide services and
treatment for children with substance use disorders,
including opioid use disorder; and
(B) identification and analysis of the differences,
if any, in furnishing services and treatment for
children with substance use disorders using services
delivered via telehealth and using services delivered in
person, such as, and to the extent feasible, with
respect to--
(i) utilization rates;
(ii) costs;
(iii) avoidable inpatient admissions and
readmissions;
(iv) quality of care; and
(v) patient, family, and provider
satisfaction.
(2) Publication.--The Secretary shall publish the report
required under paragraph (1) on a public internet website of the
Department of Health and Human Services.
SEC. 1010. <<NOTE: 42 USC 1396a note.>> ENHANCING PATIENT ACCESS
TO NON-OPIOID TREATMENT OPTIONS.
Not later than January 1, 2019, the Secretary of Health and Human
Services, acting through the Administrator of the Centers for Medicare &
Medicaid Services, shall issue 1 or more final guidance documents, or
update existing guidance documents, to States regarding mandatory and
optional items and services that may be provided under a State plan
under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or
under a waiver of such a plan, for non-opioid treatment and management
of pain, including,
[[Page 132 STAT. 3919]]
but not limited to, evidence-based, non-opioid pharmacological therapies
and non-pharmacological therapies.
SEC. 1011. ASSESSING BARRIERS TO OPIOID USE DISORDER TREATMENT.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study regarding the barriers to
providing medication used in the treatment of substance use
disorders under Medicaid distribution models such as the ``buy-
and-bill'' model, and options for State Medicaid programs to
remove or reduce such barriers. The study shall include analyses
of each of the following models of distribution of substance use
disorder treatment medications, particularly buprenorphine,
naltrexone, and buprenorphine-naloxone combinations:
(A) The purchasing, storage, and administration of
substance use disorder treatment medications by
providers.
(B) The dispensing of substance use disorder
treatment medications by pharmacists.
(C) The ordering, prescribing, and obtaining
substance use disorder treatment medications on demand
from specialty pharmacies by providers.
(2) Requirements.--For each model of distribution specified
in paragraph (1), the Comptroller General shall evaluate how
each model presents barriers or could be used by selected State
Medicaid programs to reduce the barriers related to the
provision of substance use disorder treatment by examining what
is known about the effects of the model of distribution on--
(A) Medicaid beneficiaries' access to substance use
disorder treatment medications;
(B) the differential cost to the program between
each distribution model for medication-assisted
treatment; and
(C) provider willingness to provide or prescribe
substance use disorder treatment medications.
(b) Report.--Not later than 15 months after the date of the
enactment of this Act, the Comptroller General shall submit to Congress
a report containing the results of the study conducted under subsection
(a), together with recommendations for such legislation and
administrative action as the Comptroller General determines appropriate.
SEC. 1012. HELP FOR MOMS AND BABIES.
(a) Medicaid State Plan.--Section 1905(a) of the Social Security Act
(42 U.S.C. 1396d(a)), as amended by section 1006, is further amended by
adding at the end the following new sentence: ``In the case of a woman
who is eligible for medical assistance on the basis of being pregnant
(including through the end of the month in which the 60-day period
beginning on the last day of her pregnancy ends), who is a patient in an
institution for mental diseases for purposes of receiving treatment for
a substance use disorder, and who was enrolled for medical assistance
under the State plan immediately before becoming a patient in an
institution for mental diseases or who becomes eligible to enroll for
such medical assistance while such a patient, the exclusion from the
definition of `medical assistance' set forth in the subdivision (B)
following paragraph (30) of the first sentence of this subsection
[[Page 132 STAT. 3920]]
shall not be construed as prohibiting Federal financial participation
for medical assistance for items or services that are provided to the
woman outside of the institution.''.
(b) <<NOTE: 42 USC 1396d note.>> Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendment made by subsection (a) shall take effect on the date
of enactment of this Act.
(2) Rule for changes requiring state legislation.--In the
case of a State plan under title XIX of the Social Security Act
which the Secretary of Health and Human Services determines
requires State legislation (other than legislation appropriating
funds) in order for the plan to meet the additional requirements
imposed by the amendment made by subsection (a), the State plan
shall not be regarded as failing to comply with the requirements
of such title solely on the basis of its failure to meet these
additional requirements before the first day of the first
calendar quarter beginning after the close of the first regular
session of the State legislature that begins after the date of
the enactment of this Act. For purposes of the previous
sentence, in the case of a State that has a 2-year legislative
session, each year of such session shall be deemed to be a
separate regular session of the State legislature.
SEC. 1013. SECURING FLEXIBILITY TO TREAT SUBSTANCE USE DISORDERS.
Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)) is
amended by adding at the end the following new paragraph:
``(7) Payment shall be made under this title to a State for
expenditures for capitation payments described in section 438.6(e) of
title 42, Code of Federal Regulations (or any successor regulation).''.
SEC. 1014. MACPAC STUDY AND REPORT ON MAT UTILIZATION CONTROLS
UNDER STATE MEDICAID PROGRAMS.
(a) Study.--The Medicaid and CHIP Payment and Access Commission
shall conduct a study and analysis of utilization control policies
applied to medication-assisted treatment for substance use disorders
under State Medicaid programs, including policies and procedures applied
both in fee-for-service Medicaid and in risk-based managed care
Medicaid, which shall--
(1) include an inventory of such utilization control
policies and related protocols for ensuring access to medically
necessary treatment;
(2) determine whether managed care utilization control
policies and procedures for medication-assisted treatment for
substance use disorders are consistent with section
438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and
(3) identify policies that--
(A) limit an individual's access to medication-
assisted treatment for a substance use disorder by
limiting the quantity of medication-assisted treatment
prescriptions, or the number of refills for such
prescriptions, available to the individual as part of a
prior authorization process or similar utilization
protocols; and
(B) apply without evaluating individual instances of
fraud, waste, or abuse.
(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Medicaid and CHIP Payment and Access
[[Page 132 STAT. 3921]]
Commission shall make publicly available a report containing the results
of the study conducted under subsection (a).
SEC. 1015. OPIOID ADDICTION TREATMENT PROGRAMS ENHANCEMENT.
(a) T-MSIS Substance Use Disorder Data Book.--
(1) In general.--Not later than the date that is 12 months
after the date of enactment of this Act, the Secretary of Health
and Human Services (in this section referred to as the
``Secretary'') shall publish on the public website of the
Centers for Medicare & Medicaid Services a report with
comprehensive data on the prevalence of substance use disorders
in the Medicaid beneficiary population and services provided for
the treatment of substance use disorders under Medicaid.
(2) Content of report.--The report required under paragraph
(1) shall include, at a minimum, the following data for each
State (including, to the extent available, for the District of
Columbia, Puerto Rico, the United States Virgin Islands, Guam,
the Northern Mariana Islands, and American Samoa):
(A) The number and percentage of individuals
enrolled in the State Medicaid plan or waiver of such
plan in each of the major enrollment categories (as
defined in a public letter from the Medicaid and CHIP
Payment and Access Commission to the Secretary) who have
been diagnosed with a substance use disorder and whether
such individuals are enrolled under the State Medicaid
plan or a waiver of such plan, including the specific
waiver authority under which they are enrolled, to the
extent available.
(B) A list of the substance use disorder treatment
services by each major type of service, such as
counseling, medication-assisted treatment, peer support,
residential treatment, and inpatient care, for which
beneficiaries in each State received at least 1 service
under the State Medicaid plan or a waiver of such plan.
(C) The number and percentage of individuals with a
substance use disorder diagnosis enrolled in the State
Medicaid plan or waiver of such plan who received
substance use disorder treatment services under such
plan or waiver by each major type of service under
subparagraph (B) within each major setting type, such as
outpatient, inpatient, residential, and other home-based
and community-based settings.
(D) The number of services provided under the State
Medicaid plan or waiver of such plan per individual with
a substance use disorder diagnosis enrolled in such plan
or waiver for each major type of service under
subparagraph (B).
(E) The number and percentage of individuals
enrolled in the State Medicaid plan or waiver, by major
enrollment category, who received substance use disorder
treatment through--
(i) a medicaid managed care entity (as defined
in section 1932(a)(1)(B) of the Social Security
Act (42 U.S.C. 1396u-2(a)(1)(B))), including the
number of such individuals who received such
assistance through a prepaid inpatient health plan
or a prepaid ambulatory health plan;
[[Page 132 STAT. 3922]]
(ii) a fee-for-service payment model; or
(iii) an alternative payment model, to the
extent available.
(F) The number and percentage of individuals with a
substance use disorder who receive substance use
disorder treatment services in an outpatient or home-
based and community-based setting after receiving
treatment in an inpatient or residential setting, and
the number of services received by such individuals in
the outpatient or home-based and community-based
setting.
(3) Annual updates.--The Secretary shall issue an updated
version of the report required under paragraph (1) not later
than January 1 of each calendar year through 2024.
(4) Use of t-msis data.--The report required under paragraph
(1) and updates required under paragraph (3) shall--
(A) use data and definitions from the Transformed
Medicaid Statistical Information System (``T-MSIS'')
data set that is no more than 12 months old on the date
that the report or update is published; and
(B) as appropriate, include a description with
respect to each State of the quality and completeness of
the data and caveats describing the limitations of the
data reported to the Secretary by the State that is
sufficient to communicate the appropriate uses for the
information.
(b) <<NOTE: 42 USC 1320d-2 note.>> Making T-MSIS Data on Substance
Use Disorders Available to Researchers.--
(1) In general.--The Secretary shall publish in the Federal
Register a system of records notice for the data specified in
paragraph (2) for the Transformed Medicaid Statistical
Information System, in accordance with section 552a(e)(4) of
title 5, United States Code. The notice shall outline policies
that protect the security and privacy of the data that, at a
minimum, meet the security and privacy policies of SORN 09-70-
0541 for the Medicaid Statistical Information System.
(2) Required data.--The data covered by the systems of
records notice required under paragraph (1) shall be sufficient
for researchers and States to analyze the prevalence of
substance use disorders in the Medicaid beneficiary population
and the treatment of substance use disorders under Medicaid
across all States (including the District of Columbia, Puerto
Rico, the United States Virgin Islands, Guam, the Northern
Mariana Islands, and American Samoa), forms of treatment, and
treatment settings.
(3) Initiation of data-sharing activities.--Not later than
January 1, 2019, the Secretary shall initiate the data-sharing
activities outlined in the notice required under paragraph (1).
SEC. 1016. BETTER DATA SHARING TO COMBAT THE OPIOID CRISIS.
(a) In General.--Section 1903(m) of the Social Security Act (42
U.S.C. 1396b(m)), as amended by section 1013, is further amended by
adding at the end the following new paragraph:
``(8)(A) The State agency administering the State plan under this
title may have reasonable access, as determined by the State, to 1 or
more prescription drug monitoring program databases administered or
accessed by the State to the extent the State agency is permitted to
access such databases under State law.
[[Page 132 STAT. 3923]]
``(B) Such State agency may facilitate reasonable access, as
determined by the State, to 1 or more prescription drug monitoring
program databases administered or accessed by the State, to same extent
that the State agency is permitted under State law to access such
databases, for--
``(i) any provider enrolled under the State plan to provide
services to Medicaid beneficiaries; and
``(ii) any managed care entity (as defined under section
1932(a)(1)(B)) that has a contract with the State under this
subsection or under section 1905(t)(3).
``(C) Such State agency may share information in such databases, to
the same extent that the State agency is permitted under State law to
share information in such databases, with--
``(i) any provider enrolled under the State plan to provide
services to Medicaid beneficiaries; and
``(ii) any managed care entity (as defined under section
1932(a)(1)(B)) that has a contract with the State under this
subsection or under section 1905(t)(3).''.
(b) <<NOTE: 42 USC 1396b note.>> Security and Privacy.--All
applicable State and Federal security and privacy protections and laws
shall apply to any State agency, individual, or entity accessing 1 or
more prescription drug monitoring program databases or obtaining
information in such databases in accordance with section 1903(m)(8) of
the Social Security Act (as added by subsection (a)).
(c) <<NOTE: 42 USC 1396b note.>> Effective Date.--The amendment
made by subsection (a) shall take effect on the date of enactment of
this Act.
SEC. 1017. REPORT ON INNOVATIVE STATE INITIATIVES AND STRATEGIES
TO PROVIDE HOUSING-RELATED SERVICES AND
SUPPORTS TO INDIVIDUALS STRUGGLING WITH
SUBSTANCE USE DISORDERS UNDER MEDICAID.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services shall issue a
report to Congress describing innovative State initiatives and
strategies for providing housing-related services and supports under a
State Medicaid program to individuals with substance use disorders who
are experiencing or at risk of experiencing homelessness.
(b) Content of Report.--The report required under subsection (a)
shall describe the following:
(1) Existing methods and innovative strategies developed and
adopted by State Medicaid programs that have achieved positive
outcomes in increasing housing stability among Medicaid
beneficiaries with substance use disorders who are experiencing
or at risk of experiencing homelessness, including Medicaid
beneficiaries with substance use disorders who are--
(A) receiving treatment for substance use disorders
in inpatient, residential, outpatient, or home-based and
community-based settings;
(B) transitioning between substance use disorder
treatment settings; or
(C) living in supportive housing or another model of
affordable housing.
(2) Strategies employed by Medicaid managed care
organizations, primary care case managers, hospitals,
accountable care organizations, and other care coordination
providers
[[Page 132 STAT. 3924]]
to deliver housing-related services and supports and to
coordinate services provided under State Medicaid programs
across different treatment settings.
(3) Innovative strategies and lessons learned by States with
Medicaid waivers approved under section 1115 or 1915 of the
Social Security Act (42 U.S.C. 1315, 1396n), including--
(A) challenges experienced by States in designing,
securing, and implementing such waivers or plan
amendments;
(B) how States developed partnerships with other
organizations such as behavioral health agencies, State
housing agencies, housing providers, health care
services agencies and providers, community-based
organizations, and health insurance plans to implement
waivers or State plan amendments; and
(C) how and whether States plan to provide Medicaid
coverage for housing-related services and supports in
the future, including by covering such services and
supports under State Medicaid plans or waivers.
(4) Existing opportunities for States to provide housing-
related services and supports through a Medicaid waiver under
sections 1115 or 1915 of the Social Security Act (42 U.S.C.
1315, 1396n) or through a State Medicaid plan amendment, such as
the Assistance in Community Integration Service pilot program,
which promotes supportive housing and other housing-related
supports under Medicaid for individuals with substance use
disorders and for which Maryland has a waiver approved under
such section 1115 to conduct the program.
(5) Innovative strategies and partnerships developed and
implemented by State Medicaid programs or other entities to
identify and enroll eligible individuals with substance use
disorders who are experiencing or at risk of experiencing
homelessness in State Medicaid programs.
SEC. 1018. <<NOTE: 42 USC 1396a note.>> TECHNICAL ASSISTANCE AND
SUPPORT FOR INNOVATIVE STATE STRATEGIES
TO PROVIDE HOUSING-RELATED SUPPORTS
UNDER MEDICAID.
(a) In General.--The Secretary of Health and Human Services shall
provide technical assistance and support to States regarding the
development and expansion of innovative State strategies (including
through State Medicaid demonstration projects) to provide housing-
related supports and services and care coordination services under
Medicaid to individuals with substance use disorders.
(b) Report.--Not later than 180 days after the date of enactment of
this Act, the Secretary shall issue a report to Congress detailing a
plan of action to carry out the requirements of subsection (a).
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 2001. EXPANDING THE USE OF TELEHEALTH SERVICES FOR THE
TREATMENT OF OPIOID USE DISORDER AND
OTHER SUBSTANCE USE DISORDERS.
(a) In General.--Section 1834(m) of the Social Security Act (42
U.S.C. 1395m(m)) is amended--
[[Page 132 STAT. 3925]]
(1) in paragraph (2)(B)--
(A) in clause (i), in the matter preceding subclause
(I), by striking ``clause (ii)'' and inserting ``clause
(ii) and paragraph (6)(C)''; and
(B) in clause (ii), in the heading, by striking
``for home dialysis therapy'';
(2) in paragraph (4)(C)--
(A) in clause (i), by striking ``paragraph (6)'' and
inserting ``paragraphs (5), (6), and (7)''; and
(B) in clause (ii)(X), by inserting ``or telehealth
services described in paragraph (7)'' before the period
at the end; and
(3) by adding at the end the following new paragraph:
``(7) Treatment of substance use disorder services furnished
through telehealth.--The geographic requirements described in
paragraph (4)(C)(i) shall not apply with respect to telehealth
services furnished on or after July 1, 2019, to an eligible
telehealth individual with a substance use disorder diagnosis
for purposes of treatment of such disorder or co-occurring
mental health disorder, as determined by the Secretary, at an
originating site described in paragraph (4)(C)(ii) (other than
an originating site described in subclause (IX) of such
paragraph).''.
(b) <<NOTE: 42 USC 1395m note.>> Implementation.--The Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') may implement the amendments made by this section by
interim final rule.
(c) Report.--
(1) In general.--Not later than 5 years after the date of
the enactment of this Act, the Secretary shall submit to
Congress a report on the impact of the implementation of the
amendments made by this section with respect to telehealth
services under section 1834(m) of the Social Security Act (42
U.S.C. 1395m(m)) on--
(A) the utilization of health care items and
services under title XVIII of such Act (42 U.S.C. 1395
et seq.) related to substance use disorders, including
emergency department visits; and
(B) health outcomes related to substance use
disorders, such as opioid overdose deaths.
(2) Funding.--For purposes of carrying out paragraph (1), in
addition to funds otherwise available, the Secretary shall
provide for the transfer, from the Federal Supplementary Medical
Insurance Trust Fund under section 1841, of $3,000,000 to the
Centers for Medicare & Medicaid Services Program Management
Account to remain available until expended.
SEC. 2002. COMPREHENSIVE SCREENINGS FOR SENIORS.
(a) Initial Preventive Physical Examination.--Section 1861(ww) of
the Social Security Act (42 U.S.C. 1395x(ww)) is amended--
(1) in paragraph (1)--
(A) by striking ``paragraph (2) and'' and inserting
``paragraph (2),''; and
(B) by inserting ``and the furnishing of a review of
any current opioid prescriptions (as defined in
paragraph (4)),'' after ``upon the agreement with the
individual,''; and
(2) in paragraph (2)--
[[Page 132 STAT. 3926]]
(A) by redesignating subparagraph (N) as
subparagraph (O); and
(B) by inserting after subparagraph (M) the
following new subparagraph:
``(N) Screening for potential substance use
disorders.''; and
(3) by adding at the end the following new paragraph:
``(4) For purposes of paragraph (1), the term `a review of any
current opioid prescriptions' means, with respect to an individual
determined to have a current prescription for opioids--
``(A) a review of the potential risk factors to the
individual for opioid use disorder;
``(B) an evaluation of the individual's severity of pain and
current treatment plan;
``(C) the provision of information on non-opioid treatment
options; and
``(D) a referral to a specialist, as appropriate.''.
(b) Annual Wellness Visit.--Section 1861(hhh)(2) of the Social
Security Act (42 U.S.C. 1395x(hhh)(2)) is amended--
(1) by redesignating subparagraph (G) as subparagraph (I);
and
(2) by inserting after subparagraph (F) the following new
subparagraphs:
``(G) Screening for potential substance use
disorders and referral for treatment as appropriate.
``(H) The furnishing of a review of any current
opioid prescriptions (as defined in subsection
(ww)(4)).''.
(c) <<NOTE: 42 USC 1395x note.>> Rule of Construction.--Nothing in
the amendments made by subsection (a) or (b) shall be construed to
prohibit separate payment for structured assessment and intervention
services for substance abuse furnished to an individual on the same day
as an initial preventive physical examination or an annual wellness
visit.
(d) <<NOTE: 42 USC 1395x note.>> Effective Date.--The amendments
made by this section shall apply to examinations and visits furnished on
or after January 1, 2020.
SEC. 2003. EVERY PRESCRIPTION CONVEYED SECURELY.
(a) In General.--Section 1860D-4(e) of the Social Security Act (42
U.S.C. 1395w-104(e)) is amended by adding at the end the following:
``(7) Requirement of e-prescribing for controlled
substances.--
``(A) In general.--Subject to subparagraph (B), a
prescription for a covered part D drug under a
prescription drug plan (or under an MA-PD plan) for a
schedule II, III, IV, or V controlled substance shall be
transmitted by a health care practitioner electronically
in accordance with an electronic prescription drug
program that meets the requirements of paragraph (2).
``(B) Exception for certain circumstances.--The
Secretary shall, through rulemaking, specify
circumstances and processes by which the Secretary may
waive the requirement under subparagraph (A), with
respect to a covered part D drug, including in the case
of--
``(i) a prescription issued when the
practitioner and dispensing pharmacy are the same
entity;
[[Page 132 STAT. 3927]]
``(ii) a prescription issued that cannot be
transmitted electronically under the most recently
implemented version of the National Council for
Prescription Drug Programs SCRIPT Standard;
``(iii) a prescription issued by a
practitioner who received a waiver or a renewal
thereof for a period of time as determined by the
Secretary, not to exceed one year, from the
requirement to use electronic prescribing due to
demonstrated economic hardship, technological
limitations that are not reasonably within the
control of the practitioner, or other exceptional
circumstance demonstrated by the practitioner;
``(iv) a prescription issued by a practitioner
under circumstances in which, notwithstanding the
practitioner's ability to submit a prescription
electronically as required by this subsection,
such practitioner reasonably determines that it
would be impractical for the individual involved
to obtain substances prescribed by electronic
prescription in a timely manner, and such delay
would adversely impact the individual's medical
condition involved;
``(v) a prescription issued by a practitioner
prescribing a drug under a research protocol;
``(vi) a prescription issued by a practitioner
for a drug for which the Food and Drug
Administration requires a prescription to contain
elements that are not able to be included in
electronic prescribing, such as a drug with risk
evaluation and mitigation strategies that include
elements to assure safe use;
``(vii) a prescription issued by a
practitioner--
``(I) for an individual who receives
hospice care under this title; and
``(II) that is not covered under the
hospice benefit under this title; and
``(viii) a prescription issued by a
practitioner for an individual who is--
``(I) a resident of a nursing
facility (as defined in section
1919(a)); and
``(II) dually eligible for benefits
under this title and title XIX.
``(C) Dispensing.--(i) Nothing in this paragraph
shall be construed as requiring a sponsor of a
prescription drug plan under this part, MA organization
offering an MA-PD plan under part C, or a pharmacist to
verify that a practitioner, with respect to a
prescription for a covered part D drug, has a waiver (or
is otherwise exempt) under subparagraph (B) from the
requirement under subparagraph (A).
``(ii) Nothing in this paragraph shall be construed
as affecting the ability of the plan to cover or the
pharmacists' ability to continue to dispense covered
part D drugs from otherwise valid written, oral, or fax
prescriptions that are consistent with laws and
regulations.
``(iii) Nothing in this paragraph shall be construed
as affecting the ability of an individual who is being
prescribed a covered part D drug to designate a
particular pharmacy to dispense the covered part D drug
to the extent
[[Page 132 STAT. 3928]]
consistent with the requirements under subsection (b)(1)
and under this paragraph.
``(D) Enforcement.--The Secretary shall, through
rulemaking, have authority to enforce and specify
appropriate penalties for non-compliance with the
requirement under subparagraph (A).''.
(b) <<NOTE: 42 USC 1395w-104 note.>> Effective Date.--The amendment
made by subsection (a) shall apply to coverage of drugs prescribed on or
after January 1, 2021.
(c) <<NOTE: 42 USC 1395w-104 note.>> Update of Biometric Component
of Multifactor Authentication.--Not later than 1 year after the date of
enactment of this Act, the Attorney General shall update the
requirements for the biometric component of multifactor authentication
with respect to electronic prescriptions of controlled substances.
SEC. 2004. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS UNDER
MEDICARE TO ESTABLISH DRUG MANAGEMENT
PROGRAMS FOR AT-RISK BENEFICIARIES.
Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (E)
the following new subparagraph:
``(F) With respect to plan years beginning on or
after January 1, 2022, a drug management program for at-
risk beneficiaries described in paragraph (5).''; and
(2) in paragraph (5)(A), by inserting ``(and for plan years
beginning on or after January 1, 2022, a PDP sponsor shall)''
after ``A PDP sponsor may''.
SEC. 2005. MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY
OPIOID TREATMENT PROGRAMS.
(a) Coverage.--Section 1861(s)(2) of the Social Security Act (42
U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (FF), by striking at the end ``and'';
(2) in subparagraph (GG), by inserting at the end ``and'';
and
(3) by adding at the end the following new subparagraph:
``(HH) opioid use disorder treatment services (as defined in
subsection (jjj)).''.
(b) Opioid Use Disorder Treatment Services and Opioid Treatment
Program Defined.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended by adding at the end the following new subsection:
``(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment
Program.--
``(1) Opioid use disorder treatment services.--The term
`opioid use disorder treatment services' means items and
services that are furnished by an opioid treatment program for
the treatment of opioid use disorder, including--
``(A) opioid agonist and antagonist treatment
medications (including oral, injected, or implanted
versions) that are approved by the Food and Drug
Administration under section 505 of the Federal Food,
Drug, and Cosmetic Act for use in the treatment of
opioid use disorder;
``(B) dispensing and administration of such
medications, if applicable;
``(C) substance use counseling by a professional to
the extent authorized under State law to furnish such
services;
[[Page 132 STAT. 3929]]
``(D) individual and group therapy with a physician
or psychologist (or other mental health professional to
the extent authorized under State law);
``(E) toxicology testing, and
``(F) other items and services that the Secretary
determines are appropriate (but in no event to include
meals or transportation).
``(2) Opioid treatment program.--The term `opioid treatment
program' means an entity that is an opioid treatment program (as
defined in section 8.2 of title 42 of the Code of Federal
Regulations, or any successor regulation) that--
``(A) is enrolled under section 1866(j);
``(B) has in effect a certification by the Substance
Abuse and Mental Health Services Administration for such
a program;
``(C) is accredited by an accrediting body approved
by the Substance Abuse and Mental Health Services
Administration; and
``(D) meets such additional conditions as the
Secretary may find necessary to ensure--
``(i) the health and safety of individuals
being furnished services under such program; and
``(ii) the effective and efficient furnishing
of such services.''.
(c) Payment.--
(1) In general.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (bb)'' and inserting ``(bb)'';
and
(B) by inserting before the semicolon at the end the
following ``, and (cc) with respect to opioid use
disorder treatment services furnished during an episode
of care, the amount paid shall be equal to the amount
payable under section 1834(w) less any copayment
required as specified by the Secretary''.
(2) Payment determination.--Section 1834 of the Social
Security Act (42 U.S.C. 1395m) is amended by adding at the end
the following new subsection:
``(w) Opioid Use Disorder Treatment Services.--
``(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of section
1861(jjj)) an amount that is equal to 100 percent of a bundled
payment under this part for opioid use disorder treatment
services (as defined in paragraph (1) of such section) that are
furnished by such program to an individual during an episode of
care (as defined by the Secretary) beginning on or after January
1, 2020. The Secretary shall ensure, as determined appropriate
by the Secretary, that no duplicative payments are made under
this part or part D for items and services furnished by an
opioid treatment program.
``(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the type of
medication provided (such as buprenorphine, methadone,
naltrexone, or a new innovative drug), the frequency of
services, the scope of services furnished, characteristics of
the individuals furnished such services, or other factors as the
Secretary determine appropriate. In developing such bundles, the
Secretary may consider payment rates paid to opioid treatment
programs
[[Page 132 STAT. 3930]]
for comparable services under State plans under title XIX or
under the TRICARE program under chapter 55 of title 10 of the
United States Code.
``(3) Annual updates.--The Secretary shall provide an update
each year to the bundled payment amounts under this
subsection.''.
(d) Including Opioid Treatment Programs as Medicare Providers.--
Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is
amended--
(1) in paragraph (1), by striking at the end ``and'';
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(3) opioid treatment programs (as defined in paragraph (2)
of section 1861(jjj)), but only with respect to the furnishing
of opioid use disorder treatment services (as defined in
paragraph (1) of such section).''.
SEC. 2006. ENCOURAGING APPROPRIATE PRESCRIBING UNDER MEDICARE FOR
VICTIMS OF OPIOID OVERDOSE.
Section 1860D-4(c)(5)(C) of the Social Security Act (42 U.S.C.
1395w-104(c)(5)(C)) is amended--
(1) in clause (i), in the matter preceding subclause (I), by
striking ``For purposes'' and inserting ``Except as provided in
clause (v), for purposes''; and
(2) by adding at the end the following new clause:
``(v) Treatment of enrollees with a history of
opioid-related overdose.--
``(I) In general.--For plan years
beginning not later than January 1,
2021, a part D eligible individual who
is not an exempted individual described
in clause (ii) and who is identified
under this clause as a part D eligible
individual with a history of opioid-
related overdose (as defined by the
Secretary) shall be included as a
potentially at-risk beneficiary for
prescription drug abuse under the drug
management program under this paragraph.
``(II) Identification and notice.--
For purposes of this clause, the
Secretary shall--
``(aa) identify part D
eligible individuals with a
history of opioid-related
overdose (as so defined); and
``(bb) notify the PDP
sponsor of the prescription drug
plan in which such an individual
is enrolled of such
identification.''.
SEC. 2007. AUTOMATIC ESCALATION TO EXTERNAL REVIEW UNDER A
MEDICARE PART D DRUG MANAGEMENT PROGRAM
FOR AT-RISK BENEFICIARIES.
(a) In General.--Section 1860D-4(c)(5) of the Social Security Act
(42 U.S.C. 1395ww-10(c)(5)) is amended--
(1) in subparagraph (B), in each of clauses (ii)(III) and
(iii)(IV), by striking ``and the option of an automatic
escalation to external review'' and inserting ``, including
notice that if on reconsideration a PDP sponsor affirms its
denial, in whole or in part, the case shall be automatically
forwarded to the
[[Page 132 STAT. 3931]]
independent, outside entity contracted with the Secretary for
review and resolution''; and
(2) in subparagraph (E), by striking ``and the option'' and
all that follows and inserting the following: ``and if on
reconsideration a PDP sponsor affirms its denial, in whole or in
part, the case shall be automatically forwarded to the
independent, outside entity contracted with the Secretary for
review and resolution.''.
(b) <<NOTE: 42 USC 1395w-104 note.>> Effective Date.--The
amendments made by subsection (a) shall apply beginning not later
January 1, 2021.
SEC. 2008. SUSPENSION OF PAYMENTS BY MEDICARE PRESCRIPTION DRUG
PLANS AND MA-PD PLANS PENDING
INVESTIGATIONS OF CREDIBLE ALLEGATIONS
OF FRAUD BY PHARMACIES.
(a) In General.--Section 1860D-12(b) of the Social Security Act (42
U.S.C. 1395w-112(b)) is amended by adding at the end the following new
paragraph:
``(7) Suspension of payments pending investigation of
credible allegations of fraud by pharmacies.--
``(A) In general.--Section 1862(o)(1) shall apply
with respect to a PDP sponsor with a contract under this
part, a pharmacy, and payments to such pharmacy under
this part in the same manner as such section applies
with respect to the Secretary, a provider of services or
supplier, and payments to such provider of services or
supplier under this title. A PDP sponsor shall notify
the Secretary regarding the imposition of any payment
suspension pursuant to the previous sentence, such as
through the secure internet website portal (or other
successor technology) established under section 1859(i).
``(B) Rule of construction.--Nothing in this
paragraph shall be construed as limiting the authority
of a PDP sponsor to conduct postpayment review.''.
(b) Application to MA-PD Plans.--Section 1857(f)(3) of the Social
Security Act (42 U.S.C. 1395w-27(f)(3)) is amended by adding at the end
the following new subparagraph:
``(D) Suspension of payments pending investigation
of credible allegations of fraud by pharmacies.--Section
1860D-12(b)(7).''.
(c) Conforming Amendment.--Section 1862(o)(3) of the Social Security
Act (42 U.S.C. 1395y(o)(3)) is amended by inserting ``, section 1860D-
12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)),''
after ``this subsection''.
(d) Clarification Relating to Credible Allegation of Fraud.--Section
1862(o) of the Social Security Act (42 U.S.C. 1395y(o)) is amended by
adding at the end the following new paragraph:
``(4) Credible allegation of fraud.--In carrying out this
subsection, section 1860D-12(b)(7) (including as applied
pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a
fraud hotline tip (as defined by the Secretary) without further
evidence shall not be treated as sufficient evidence for a
credible allegation of fraud.''.
(e) <<NOTE: 42 USC 1395w-27 note.>> Effective Date.--The amendments
made by this section shall apply with respect to plan years beginning on
or after January 1, 2020.
[[Page 132 STAT. 3932]]
TITLE III--FDA AND CONTROLLED SUBSTANCE PROVISIONS
Subtitle A--FDA Provisions
CHAPTER 1--IN GENERAL
SEC. 3001. <<NOTE: 21 USC 355 note.>> CLARIFYING FDA REGULATION
OF NON-ADDICTIVE PAIN PRODUCTS.
(a) Public Meetings.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through the
Commissioner of Food and Drugs, shall hold not less than one public
meeting to address the challenges and barriers of developing non-
addictive medical products intended to treat acute or chronic pain or
addiction, which may include--
(1) the manner by which the Secretary may incorporate the
risks of misuse and abuse of a controlled substance (as defined
in section 102 of the Controlled Substances Act (21 U.S.C. 802))
into the risk benefit assessments under subsections (d) and (e)
of section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or
section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;
(2) the application of novel clinical trial designs
(consistent with section 3021 of the 21st Century Cures Act
(Public Law 114-255)), use of real world evidence (consistent
with section 505F of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355g)), and use of patient experience data
(consistent with section 569C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8c)) for the development of non-
addictive medical products intended to treat pain or addiction;
(3) the evidentiary standards and the development of opioid-
sparing data for inclusion in the labeling of medical products
intended to treat acute or chronic pain; and
(4) the application of eligibility criteria under sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) for non-addictive medical products intended
to treat pain or addiction.
(b) Guidance.--Not less than one year after the public meetings are
conducted under subsection (a) the Secretary shall issue one or more
final guidance documents, or update existing guidance documents, to help
address challenges to developing non-addictive medical products to treat
pain or addiction. Such guidance documents shall include information
regarding--
(1) how the Food and Drug Administration may apply sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) to non-addictive medical products intended
to treat pain or addiction, including the circumstances under
which the Secretary--
(A) may apply the eligibility criteria under such
sections 506 and 515B to non-addictive medical products
intended to treat pain or addiction;
[[Page 132 STAT. 3933]]
(B) considers the risk of addiction of controlled
substances approved to treat pain when establishing
unmet medical need; and
(C) considers pain, pain control, or pain management
in assessing whether a disease or condition is a serious
or life-threatening disease or condition;
(2) the methods by which sponsors may evaluate acute and
chronic pain, endpoints for non-addictive medical products
intended to treat pain, the manner in which endpoints and
evaluations of efficacy will be applied across and within review
divisions, taking into consideration the etiology of the
underlying disease, and the manner in which sponsors may use
surrogate endpoints, intermediate endpoints, and real world
evidence;
(3) the manner in which the Food and Drug Administration
will assess evidence to support the inclusion of opioid-sparing
data in the labeling of non-addictive medical products intended
to treat acute or chronic pain, including--
(A) alternative data collection methodologies,
including the use of novel clinical trial designs
(consistent with section 3021 of the 21st Century Cures
Act (Public Law 114-255)) and real world evidence
(consistent with section 505F of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355g)), including patient
registries and patient reported outcomes, as
appropriate, to support product labeling;
(B) ethical considerations of exposing subjects to
controlled substances in clinical trials to develop
opioid-sparing data and considerations on data
collection methods that reduce harm, which may include
the reduction of opioid use as a clinical benefit;
(C) endpoints, including primary, secondary, and
surrogate endpoints, to evaluate the reduction of opioid
use;
(D) best practices for communication between
sponsors and the agency on the development of data
collection methods, including the initiation of data
collection; and
(E) the appropriate format in which to submit such
data results to the Secretary; and
(4) the circumstances under which the Food and Drug
Administration considers misuse and abuse of a controlled
substance (as defined in section 102 of the Controlled
Substances Act (21 U.S.C. 802)) in making the risk benefit
assessment under paragraphs (2) and (4) of subsection (d) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) and in finding that a drug is unsafe under paragraph
(1) or (2) of subsection (e) of such section.
(c) Definitions.--In this section--
(1) the term ``medical product'' means a drug (as defined in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1))), biological product (as defined in
section 351(i) of the Public Health Service Act (42 U.S.C.
262(i))), or device (as defined in section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and
(2) the term ``opioid-sparing'' means reducing, replacing,
or avoiding the use of opioids or other controlled substances
intended to treat acute or chronic pain.
[[Page 132 STAT. 3934]]
SEC. 3002. <<NOTE: 21 USC 355-1 note.>> EVIDENCE-BASED OPIOID
ANALGESIC PRESCRIBING GUIDELINES AND
REPORT.
(a) Guidelines.--The Commissioner of Food and Drugs shall develop
evidence-based opioid analgesic prescribing guidelines for the
indication-specific treatment of acute pain only for the relevant
therapeutic areas where such guidelines do not exist.
(b) Public Input.--In developing the guidelines under subsection
(a), the Commissioner of Food and Drugs shall--
(1) consult with stakeholders, which may include conducting
a public meeting of medical professional societies (including
any State-based societies), health care providers, State medical
boards, medical specialties including pain medicine specialty
societies, patient groups, pharmacists, academic or medical
research entities, and other entities with experience in health
care, as appropriate;
(2) collaborate with the Director of the Centers for Disease
Control and Prevention, as applicable and appropriate, and other
Federal agencies with relevant expertise as appropriate; and
(3) provide for a notice and comment period consistent with
section 701(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 371(h)) for the submission of comments by the public.
(c) Report.--Not later than 1 year after the date of enactment of
this Act, or, if earlier, at the time the guidelines under subsection
(a) are finalized, the Commissioner of Food and Drugs shall submit to
the Committee on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions of the Senate,
and post on the public website of the Food and Drug Administration, a
report on how the Food and Drug Administration will utilize the
guidelines under subsection (a) to protect the public health and a
description of the public health need with respect to each such
indication-specific treatment guideline.
(d) Updates.--The Commissioner of Food and Drugs shall
periodically--
(1) update the guidelines under subsection (a), informed by
public input described in subsection (b); and
(2) submit to the committees specified in subsection (c) and
post on the public website of the Food and Drug Administration
an updated report under such subsection.
(e) Statement To Accompany Guidelines and Recommendations.--The
Commissioner of Food and Drugs shall ensure that opioid analgesic
prescribing guidelines and other recommendations developed under this
section are accompanied by a clear statement that such guidelines or
recommendations, as applicable--
(1) are intended to help inform clinical decisionmaking by
prescribers and patients; and
(2) are not intended to be used for the purposes of
restricting, limiting, delaying, or denying coverage for, or
access to, a prescription issued for a legitimate medical
purpose by an individual practitioner acting in the usual course
of professional practice.
[[Page 132 STAT. 3935]]
CHAPTER 2-- <<NOTE: Stop Counterfeit Drugs by Regulating and Enhancing
Enforcement Now Act.>> STOP COUNTERFEIT DRUGS BY REGULATING AND
ENHANCING ENFORCEMENT NOW
SEC. 3011. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This chapter may be cited as the ``Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act'' or the ``SCREEN Act''.
SEC. 3012. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CONTROLLED
SUBSTANCES.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(eee) The failure to comply with any order issued under section
569D.''.
(b) Notification, Nondistribution, and Recall of Controlled
Substances.--Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end
the following:
``SEC. 569D. <<NOTE: 21 USC 360bbb-8d.>> NOTIFICATION,
NONDISTRIBUTION, AND RECALL OF
CONTROLLED SUBSTANCES.
``(a) Order To Cease Distribution and Recall.--
``(1) In general.--If the Secretary determines there is a
reasonable probability that a controlled substance would cause
serious adverse health consequences or death, the Secretary may,
after providing the appropriate person with an opportunity to
consult with the agency, issue an order requiring manufacturers,
importers, distributors, or pharmacists, who distribute such
controlled substance to immediately cease distribution of such
controlled substance.
``(2) Hearing.--An order under paragraph (1) shall provide
the person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days after the
date of issuance of the order, on whether adequate evidence
exists to justify an amendment to the order, and what actions
are required by such amended order pursuant to subparagraph (3).
``(3) Order resolution.--After an order is issued according
to the process under paragraphs (1) and (2), the Secretary
shall, except as provided in paragraph (4)--
``(A) vacate the order, if the Secretary determines
that inadequate grounds exist to support the actions
required by the order;
``(B) continue the order ceasing distribution of the
controlled substance until a date specified in such
order; or
``(C) amend the order to require a recall of the
controlled substance, including any requirements to
notify appropriate persons, a timetable for the recall
to occur, and a schedule for updates to be provided to
the Secretary regarding such recall.
``(4) Risk assessment.--If the Secretary determines that the
risk of recalling a controlled substance presents a greater
health risk than the health risk of not recalling such
controlled substance from use, an amended order under
subparagraph (B) or (C) of paragraph (3) shall not include
either a recall
[[Page 132 STAT. 3936]]
order for, or an order to cease distribution of, such controlled
substance, as applicable.
``(5) Action following order.--Any person who is subject to
an order pursuant to subparagraph (B) or (C) of paragraph (3)
shall immediately cease distribution of or recall, as
applicable, the controlled substance and provide notification as
required by such order.
``(b) Notice to Persons Affected.--If the Secretary determines
necessary, the Secretary may require the person subject to an order
pursuant to paragraph (1) or an amended order pursuant to subparagraph
(B) or (C) of paragraph (3) to provide either a notice of a recall order
for, or an order to cease distribution of, such controlled substance, as
applicable, under this section to appropriate persons, including persons
who manufacture, distribute, import, or offer for sale such product that
is the subject of an order and to the public. In providing such notice,
the Secretary may use the assistance of health professionals who
prescribed or dispensed such controlled substances.
``(c) Nondelegation.--An order described in subsection (a)(3) shall
be ordered by the Secretary or an official designated by the Secretary.
An official may not be so designated under this section unless the
official is the Director of the Center for Drug Evaluation and Research
or an official senior to such Director.
``(d) Savings Clause.--Nothing contained in this section shall be
construed as limiting--
``(1) the authority of the Secretary to issue an order to
cease distribution of, or to recall, any drug under any other
provision of this Act or the Public Health Service Act; or
``(2) the ability of the Secretary to request any person to
perform a voluntary activity related to any drug subject to this
Act or the Public Health Service Act.''.
(c) Controlled Substances Subject to Refusal.--The third sentence of
section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)) is amended by inserting ``, or is a controlled substance subject
to an order under section 569D'' before ``, or (4)''.
(d) <<NOTE: 21 USC 331 note.>> Effective Date.--Sections 301(eee)
and 569D of the Federal Food, Drug, and Cosmetic Act, as added by
subsections (a) and (b), shall be effective beginning on the date of
enactment of this Act.
SEC. 3013. SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL DRUGS.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381), as amended by section 3012, is further amended by adding at the
end the following:
``(t) Single Source Pattern of Imported Illegal Drugs.--If the
Secretary determines that a person subject to debarment as a result of
engaging in a pattern of importing or offering for import controlled
substances or drugs as described in section 306(b)(3)(D), and such
pattern is identified by the Secretary as being offered for import from
the same manufacturer, distributor, or importer, the Secretary may by
order determine all drugs being offered for import from such person as
adulterated or misbranded, unless such person can provide evidence
otherwise.''.
[[Page 132 STAT. 3937]]
SEC. 3014. <<NOTE: 21 USC 384f.>> STRENGTHENING FDA AND CBP
COORDINATION AND CAPACITY.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through the
Commissioner of Food and Drugs, shall coordinate with the Secretary of
Homeland Security to carry out activities related to customs and border
protection and in response to illegal controlled substances and drug
imports, including at sites of import (such as international mail
facilities), that will provide improvements to such facilities,
technologies, and inspection capacity. Such Secretaries may carry out
such activities through a memorandum of understanding between the Food
and Drug Administration and the U.S. Customs and Border Protection.
(b) FDA Import Facilities and Inspection Capacity.--
(1) In general.--In carrying out this section, the Secretary
shall, in collaboration with the Secretary of Homeland Security
and the Postmaster General of the United States Postal Service,
provide that import facilities in which the Food and Drug
Administration operates or carries out activities related to
drug imports within the international mail facilities include--
(A) facility upgrades and improved capacity in order
to increase and improve inspection and detection
capabilities, which may include, as the Secretary
determines appropriate--
(i) improvements to facilities, such as
upgrades or renovations, and support for the
maintenance of existing import facilities and
sites to improve coordination between Federal
agencies;
(ii) improvements in equipment and information
technology enhancement to identify unapproved,
counterfeit, or other unlawful controlled
substances for destruction;
(iii) the construction of, or upgrades to,
laboratory capacity for purposes of detection and
testing of imported goods;
(iv) upgrades to the security of import
facilities; and
(v) innovative technology and equipment to
facilitate improved and near-real-time information
sharing between the Food and Drug Administration,
the Department of Homeland Security, and the
United States Postal Service; and
(B) innovative technology, including controlled
substance detection and testing equipment and other
applicable technology, in order to collaborate with the
U.S. Customs and Border Protection to share near-real-
time information, including information about test
results, as appropriate.
(2) Innovative technology.--Any technology used in
accordance with paragraph (1)(B) shall be interoperable with
technology used by other relevant Federal agencies, including
the U.S. Customs and Border Protection, as the Secretary
determines appropriate and practicable.
(c) Report.--Not later than 6 months after the date of enactment of
this Act, the Secretary, in consultation with the Secretary of Homeland
Security and the Postmaster General of the United States Postal Service,
shall report to the Committee on Energy
[[Page 132 STAT. 3938]]
and Commerce and the Committee on Homeland Security of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions and the Committee on Homeland Security and Governmental Affairs
of the Senate on the implementation of this section, including a summary
of progress made toward near-real-time information sharing and the
interoperability of such technologies.
CHAPTER 3-- <<NOTE: Stop Illicit Drug Importation Act of 2018.>> STOP
ILLICIT DRUG IMPORTATION
SEC. 3021. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This chapter may be cited as the ``Stop Illicit Drug Importation Act
of 2018''.
SEC. 3022. <<NOTE: 21 USC 384g.>> RESTRICTING ENTRANCE OF ILLICIT
DRUGS.
(a) Food and Drug Administration and U.S. Customs and Border
Protection Cooperation.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs and in consultation
with the U.S. Customs and Border Protection, shall develop and
periodically update a mutually agreed upon list of the
controlled substances that the Secretary will refer to U.S.
Customs and Border Protection, unless the Secretary and U.S.
Customs and Border Protection agree otherwise, when such
substances are offered for import via international mail and
appear to violate the Controlled Substances Act (21 U.S.C. 801
et seq.), the Controlled Substances Import and Export Act (21
U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), or any other applicable law. The
Secretary shall transfer controlled substances on such list to
the U.S. Customs and Border Protection. If the Secretary
identifies additional packages that appear to be the same as
such package containing a controlled substance, such additional
packages may also be transferred to U.S. Customs and Border
Protection. The U.S. Customs and Border Protection shall receive
such packages consistent with the requirements of the Controlled
Substances Act (21 U.S.C. 801 et seq.).
(2) Report.--Not later than 9 months after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs and in consultation with the
Secretary of Homeland Security, shall report to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate on the implementation of this section.
(b) Debarment, Temporary Denial of Approval, and Suspension.--
(1) Prohibited act.--Section 301(cc) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended--
(A) by inserting ``or a drug'' after ``food''; and
(B) by inserting ``from such activity'' after
``person debarred''.
(2) Debarment.--Section 306(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A),
by inserting ``or (3)'' after ``paragraph (2)'';
[[Page 132 STAT. 3939]]
(ii) in subparagraph (A), by striking the
comma at the end and inserting a semicolon;
(iii) in subparagraph (B), by striking ``,
or'' and inserting a semicolon;
(iv) in subparagraph (C), by striking the
period and inserting ``; or''; and
(v) by adding at the end the following:
``(D) a person from importing or offering for import
into the United States a drug.'';
(B) in paragraph (3)--
(i) in the heading, by inserting ``or drug''
after ``Food'';
(ii) in subparagraph (A), by striking ``; or''
and inserting a semicolon;
(iii) in subparagraph (B), by striking the
period and inserting a semicolon; and
(iv) by adding at the end the following:
``(C) the person has been convicted of a felony for
conduct relating to the importation into the United
States of any drug or controlled substance (as defined
in section 102 of the Controlled Substances Act);
``(D) the person has engaged in a pattern of
importing or offering for import--
``(i) controlled substances that are
prohibited from importation under section 401(m)
of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or
``(ii) adulterated or misbranded drugs that
are--
``(I) not designated in an
authorized electronic data interchange
system as a product that is regulated by
the Secretary; or
``(II) knowingly or intentionally
falsely designated in an authorized
electronic data interchange system as a
product that is regulated by the
Secretary.''; and
(C) by adding at the end the following:
``(5) Definition.--For purposes of paragraph (3)(D), the
term `pattern of importing or offering for import' means
importing or offering for import a drug described in clause (i)
or (ii) of paragraph (3)(D) in an amount, frequency, or dosage
that is inconsistent with personal or household use by the
importer.''.
(c) Imports and Exports.--Section 801(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(a)), as amended, is further amended--
(1) by striking ``, then such article shall be refused
admission'' inserting ``or (5) such article is being imported or
offered for import in violation of section 301(cc), then any
such article described in any of clauses (1) through (5) shall
be refused admission'';
(2) by inserting ``If it appears from the examination of
such samples or otherwise that the article is a counterfeit
drug, such article shall be refused admission.'' before ``With
respect to an article of food, if importation''; and
(3) by striking ``Clause (2) of the third sentence'' and all
that follows through the period at the end and inserting the
following: ``Neither clause (2) nor clause (5) of the third
sentence of this subsection shall be construed to prohibit the
admission
[[Page 132 STAT. 3940]]
of narcotic drugs, the importation of which is permitted under
the Controlled Substances Import and Export Act.''.
(d) Certain Illicit Articles.--Section 801 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is amended by adding
at the end the following--
``(u) Illicit Articles Containing Active Pharmaceutical
Ingredients.--
``(1) In general.--For purposes of this section, an article
that is being imported or offered for import into the United
States may be treated by the Secretary as a drug if the
article--
``(A) is not--
``(i) accompanied by an electronic import
entry for such article submitted using an
authorized electronic data interchange system; and
``(ii) designated in such a system as an
article regulated by the Secretary (which may
include regulation as a drug, a device, a dietary
supplement, or other product that is regulated
under this Act); and
``(B) is an ingredient that presents significant
public health concern and is, or contains--
``(i) an active ingredient in a drug--
``(I) that is approved under section
505 or licensed under section 351 of the
Public Health Service Act; or
``(II) for which--
``(aa) an investigational
use exemption has been
authorized under section 505(i)
of this Act or section 351(a) of
the Public Health Service Act;
and
``(bb) a substantial
clinical investigation has been
instituted, and such
investigation has been made
public; or
``(ii) a substance that has a chemical
structure that is substantially similar to the
chemical structure of an active ingredient in a
drug or biological product described in subclause
(I) or (II) of clause (i).
``(2) Effect.--This subsection shall not be construed to
bear upon any determination of whether an article is a drug
within the meaning of section 201(g), other than for the
purposes described in paragraph (1).''.
CHAPTER 4 <<NOTE: Securing Opioids and Unused Narcotics with Deliberate
Disposal and Packaging Act of 2018.>> --SECURING OPIOIDS AND UNUSED
NARCOTICS WITH DELIBERATE DISPOSAL AND PACKAGING
SEC. 3031. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This chapter may be cited as the ``Securing Opioids and Unused
Narcotics with Deliberate Disposal and Packaging Act of 2018'' or the
``SOUND Disposal and Packaging Act''.
SEC. 3032. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.
(a) Deliberate Disposal and Packaging Elements of Strategy.--
Section 505-1(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355-1(e)) is amended by adding at the end the following:
``(4) Packaging and disposal.--The Secretary may require a
risk evaluation mitigation strategy for a drug for which
[[Page 132 STAT. 3941]]
there is a serious risk of an adverse drug experience described
in subparagraph (B) or (C) of subsection (b)(1), taking into
consideration the factors described in subparagraphs (C) and (D)
of subsection (f)(2) and in consultation with other relevant
Federal agencies with authorities over drug disposal packaging,
which may include requiring that--
``(A) the drug be made available for dispensing to
certain patients in unit dose packaging, packaging that
provides a set duration, or another packaging system
that the Secretary determines may mitigate such serious
risk; or
``(B) the drug be dispensed to certain patients with
a safe disposal packaging or safe disposal system for
purposes of rendering drugs nonretrievable (as defined
in section 1300.05 of title 21, Code of Federal
Regulations (or any successor regulation)) if the
Secretary determines that such safe disposal packaging
or system may mitigate such serious risk and is
sufficiently available.''.
(b) Assuring Access and Minimizing Burden.--Section 505-1(f)(2)(C)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(2)(C))
is amended--
(1) in clause (i) by striking ``and'' at the end; and
(2) by adding at the end the following:
``(iii) patients with functional limitations;
and''.
(c) Application to Abbreviated New Drug Applications.--Section 505-
1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(i)) is
amended--
(1) in paragraph (1)--
(A) by redesignating subparagraph (B) as
subparagraph (C); and
(B) inserting after subparagraph (A) the following:
``(B) A packaging or disposal requirement, if
required under subsection (e)(4) for the applicable
listed drug.''; and
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) by redesignating subparagraph (B) as
subparagraph (C); and
(C) by inserting after subparagraph (A) the
following:
``(B) shall permit packaging systems and safe
disposal packaging or safe disposal systems that are
different from those required for the applicable listed
drug under subsection (e)(4); and''.
(d) GAO Report.--Not later than 12 months after the date of
enactment of this Act, the Comptroller General of the United States
shall prepare and submit to Congress a report containing--
(1) a description of available evidence, if any, on the
effectiveness of site-of-use, in-home controlled substance
disposal products and packaging technologies;
(2) an evaluation of existing reference standards with
respect to controlled substance disposal products and packaging
technologies, including any such standards established by a
standards development organization, and how such standards
should be considered in ensuring effectiveness of such products
and technologies;
(3) identification of ways in which such disposal products
intended for use by patients, consumers, and other end users
that are not registrants under the Controlled Substances Act
[[Page 132 STAT. 3942]]
(21 U.S.C. 801 et seq.), are made available to the public and
any barriers to the use of such disposal products;
(4) identification of ways in which packaging technologies
are made available to the public and any barriers to the use of
such technologies;
(5) a description of current Federal oversight, if any, of
site-of-use, in-home controlled substance disposal products,
including--
(A) identification of the Federal agencies that
oversee such products;
(B) identification of the methods of disposal of
controlled substances recommended by such agencies for
site-of-use, in-home disposal; and
(C) a description of the effectiveness of such
recommendations at preventing the diversion of legally
prescribed controlled substances;
(6) a description of current Federal oversight, if any, of
controlled substance packaging technologies, including--
(A) identification of the Federal agencies that
oversee such technologies;
(B) identification of the technologies recommended
by such agencies, including unit dose packaging,
packaging that provides a set duration, and other
packaging systems that may mitigate abuse or misuse; and
(C) a description of the effectiveness of such
recommendations at preventing the diversion of legally
prescribed controlled substances; and
(7) recommendations, as appropriate, on--
(A) whether site-of-use, in-home controlled
substance disposal products and packaging technologies
require Federal oversight and, if so, which agency or
agencies should be responsible for such oversight and,
as applicable, review of such products or technologies;
and
(B) whether there are applicable standards that
should be considered to ensure the effectiveness of such
products.
CHAPTER 5--POSTAPPROVAL STUDY REQUIREMENTS
SEC. 3041. CLARIFYING FDA POSTMARKET AUTHORITIES.
(a) Definition of Adverse Drug Experience.--Section 505-1(b)(1)(E)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(b)(1)(E))
is amended by striking ``of the drug'' and inserting ``of the drug,
which may include reduced effectiveness under the conditions of use
prescribed in the labeling of such drug, but which may not include
reduced effectiveness that is in accordance with such labeling''.
(b) Safety Labeling Changes.--Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is amended--
(1) in subparagraph (A) by--
(A) striking ``Safety information'' and inserting
``Safety or new effectiveness information''; and
(B) by striking ``If the Secretary becomes'' and all
that follows through ``in the labeling of the drug'' and
inserting ``If the Secretary becomes aware of new
information, including any new safety information or
information related
[[Page 132 STAT. 3943]]
to reduced effectiveness, that the Secretary determines
should be included in the labeling of the drug'';
(2) in clause (i) of subparagraph (B), by inserting before
the semicolon ``, or new effectiveness information'';
(3) in subparagraph (C) by striking ``safety information''
and inserting ``safety or new effectiveness information''; and
(4) in subparagraph (E) by striking ``safety information''
and inserting ``safety or new effectiveness information''.
(c) <<NOTE: 21 USC 355 note.>> Guidance.--Not less than one year
after the date of enactment of this Act, the Secretary of Health and
Human Services shall issue guidance regarding the circumstances under
which the Food and Drug Administration may require postmarket studies or
clinical trials to assess the potential reduction in effectiveness of a
drug and how such reduction in effectiveness could result in a change to
the benefits of the drug and the risks to the patient. Such guidance
shall also address how the Food and Drug Administration may apply this
section and the amendments made thereby with respect to circumstances
under which the Food and Drug Administration may require postmarket
studies or clinical trials and safety labeling changes related to the
use of controlled substances for acute or chronic pain.
Subtitle B--Controlled Substance Provisions
CHAPTER 1--MORE FLEXIBILITY WITH RESPECT TO MEDICATION-ASSISTED
TREATMENT FOR OPIOID USE DISORDERS
SEC. 3201. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO
MEDICATION-ASSISTED TREATMENT FOR OPIOID
USE DISORDERS.
(a) Conforming Applicable Number.--Subclause (II) of section
303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(B)(iii)) is amended to read as follows:
``(II) The applicable number is--
``(aa) 100 if, not sooner than 1 year after the date
on which the practitioner submitted the initial
notification, the practitioner submits a second
notification to the Secretary of the need and intent of
the practitioner to treat up to 100 patients;
``(bb) 100 if the practitioner holds additional
credentialing, as defined in section 8.2 of title 42,
Code of Federal Regulations (or successor regulations);
``(cc) 100 if the practitioner provides medication-
assisted treatment (MAT) using covered medications (as
such terms are defined in section 8.2 of title 42, Code
of Federal Regulations (or successor regulations)) in a
qualified practice setting (as described in section
8.615 of title 42, Code of Federal Regulations (or
successor regulations)); or
``(dd) 275 if the practitioner meets the
requirements specified in sections 8.610 through 8.655
of title 42, Code of Federal Regulations (or successor
regulations).''.
(b) Eliminating Any Time Limitation for Nurse Practitioners and
Physician Assistants To Become Qualifying
[[Page 132 STAT. 3944]]
Practitioners.--Clause (iii) of section 303(g)(2)(G) of the Controlled
Substances Act (21 U.S.C. 823(g)(2)(G)) is amended--
(1) in subclause (I), by striking ``or'' at the end; and
(2) by amending subclause (II) to read as follows:
``(II) a qualifying other practitioner, as defined
in clause (iv), who is a nurse practitioner or physician
assistant; or''.
(c) Imposing a Time Limitation for Clinical Nurse Specialists,
Certified Registered Nurse Anesthetists, and Certified Nurse Midwifes To
Become Qualifying Practitioners.--Clause (iii) of section 303(g)(2)(G)
of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)), as amended by
subsection (b), is further amended by adding at the end the following:
``(III) for the period beginning on October 1, 2018,
and ending on October 1, 2023, a qualifying other
practitioner, as defined in clause (iv), who is a
clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife.''.
(d) Definition of Qualifying Other Practitioner.--Section
303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)(iv)) is amended by striking ``nurse practitioner or
physician assistant'' each place it appears and inserting ``nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, certified nurse midwife, or physician assistant''.
(e) Report by Secretary.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human Services,
in consultation with the Drug Enforcement Administration, shall submit
to Congress a report that assesses the care provided by qualifying
practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled
Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are treating, in the
case of physicians, more than 100 patients, and in the case of
qualifying practitioners who are not physicians, more than 30 patients.
Such report shall include recommendations on future applicable patient
number levels and limits. In preparing such report, the Secretary shall
study, with respect to opioid use disorder treatment--
(1) the average frequency with which qualifying
practitioners see their patients;
(2) the average frequency with which patients receive
counseling, including the rates by which such counseling is
provided by such a qualifying practitioner directly, or by
referral;
(3) the frequency of toxicology testing, including the
average frequency with which random toxicology testing is
administered;
(4) the average monthly patient caseload for each type of
qualifying practitioner;
(5) the treatment retention rates for patients;
(6) overdose and mortality rates; and
(7) any available information regarding the diversion of
drugs by patients receiving such treatment from such a
qualifying practitioner.
SEC. 3202. MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM
SUBSTANCE USE DISORDER.
(a) Waivers for Maintenance Treatment or Detoxification.--Section
303(g)(2)(G)(ii) of the Controlled Substances Act (21
[[Page 132 STAT. 3945]]
U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following:
``(VIII) The physician graduated in good standing from an
accredited school of allopathic medicine or osteopathic medicine
in the United States during the 5-year period immediately
preceding the date on which the physician submits to the
Secretary a written notification under subparagraph (B) and
successfully completed a comprehensive allopathic or osteopathic
medicine curriculum or accredited medical residency that--
``(aa) included not less than 8 hours of training on
treating and managing opioid-dependent patients; and
``(bb) included, at a minimum--
``(AA) the training described in items (aa)
through (gg) of subclause (IV); and
``(BB) training with respect to any other best
practice the Secretary determines should be
included in the curriculum, which may include
training on pain management, including assessment
and appropriate use of opioid and non-opioid
alternatives.''.
(b) <<NOTE: 21 USC 823 note.>> Treatment for Children.--The
Secretary of Health and Human Services shall consider ways to ensure
that an adequate number of qualified practitioners, as defined in
subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances
Act (21 U.S.C. 823(g)(2)), who have a specialty in pediatrics or the
treatment of children or adolescents, are granted a waiver under such
section 303(g)(2) to treat children and adolescents with substance use
disorders.
(c) Technical Amendment.--Section 102(24) of the Controlled
Substances Act (21 U.S.C. 802(24)) is amended by striking ``Health,
Education, and Welfare'' and inserting ``Health and Human Services''.
SEC. 3203. <<NOTE: 21 USC 823 note.>> GRANTS TO ENHANCE ACCESS TO
SUBSTANCE USE DISORDER TREATMENT.
(a) In General.--The Secretary of Health and Human Services shall
establish a grant program under which the Secretary may make grants to
accredited schools of allopathic medicine or osteopathic medicine and
teaching hospitals located in the United States to support the
development of curricula that meet the requirements under subclause
(VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as
added by section 3202(a) of this Act.
(b) Authorization of Appropriations.--There is authorized to be
appropriated, for grants under subsection (a), $4,000,000 for each of
fiscal years 2019 through 2023.
SEC. 3204. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO BE
ADMINISTERED BY INJECTION OR
IMPLANTATION.
(a) In General.--The Controlled Substances Act is amended by
inserting after section 309 (21 U.S.C. 829) the following:
``delivery of a controlled substance by a pharmacy to an administering
practitioner
``Sec. 309A. <<NOTE: 21 USC 829a.>> (a) In General.--
Notwithstanding section 102(10), a pharmacy may deliver a controlled
substance to a practitioner in accordance with a prescription that meets
the requirements of this title and the regulations issued by the
Attorney General
[[Page 132 STAT. 3946]]
under this title, for the purpose of administering the controlled
substance by the practitioner if--
``(1) the controlled substance is delivered by the pharmacy
to the prescribing practitioner or the practitioner
administering the controlled substance, as applicable, at the
location listed on the practitioner's certificate of
registration issued under this title;
``(2) the controlled substance is to be administered for the
purpose of maintenance or detoxification treatment under section
303(g)(2) and--
``(A) the practitioner who issued the prescription
is a qualifying practitioner authorized under, and
acting within the scope of that section; and
``(B) the controlled substance is to be administered
by injection or implantation;
``(3) the pharmacy and the practitioner are authorized to
conduct the activities specified in this section under the law
of the State in which such activities take place;
``(4) the prescription is not issued to supply any
practitioner with a stock of controlled substances for the
purpose of general dispensing to patients;
``(5) except as provided in subsection (b), the controlled
substance is to be administered only to the patient named on the
prescription not later than 14 days after the date of receipt of
the controlled substance by the practitioner; and
``(6) notwithstanding any exceptions under section 307, the
prescribing practitioner, and the practitioner administering the
controlled substance, as applicable, maintain complete and
accurate records of all controlled substances delivered,
received, administered, or otherwise disposed of under this
section, including the persons to whom controlled substances
were delivered and such other information as may be required by
regulations of the Attorney General.
``(b) Modification of Number of Days Before Which Controlled
Substance Shall Be Administered.--
``(1) Initial 2-year period.--During the 2-year period
beginning on the date of enactment of this section, the Attorney
General, in coordination with the Secretary, may reduce the
number of days described in subsection (a)(5) if the Attorney
General determines that such reduction will--
``(A) reduce the risk of diversion; or
``(B) protect the public health.
``(2) Modifications after submission of report.--After the
date on which the report described in section 3204(b) of the
SUPPORT for Patients and Communities Act is submitted, the
Attorney General, in coordination with the Secretary, may modify
the number of days described in subsection (a)(5).
``(3) Minimum number of days.--Any modification under this
subsection shall be for a period of not less than 7 days.''.
(b) Study and Report.--Not later than 2 years after the date of
enactment of this section, the Comptroller General of the United States
shall conduct a study and submit to Congress a report on access to and
potential diversion of controlled substances administered by injection
or implantation.
(c) Technical and Conforming Amendment.--The table of contents for
the Comprehensive Drug Abuse Prevention and Control
[[Page 132 STAT. 3947]]
Act of 1970 is amended by inserting after the item relating to section
309 the following:
``Sec. 309A. Delivery of a controlled substance by a pharmacy to an
administering practitioner.''.
CHAPTER 2-- <<NOTE: Empowering Pharmacists in the Fight Against Opioid
Abuse Act.>> EMPOWERING PHARMACISTS IN THE FIGHT AGAINST OPIOID ABUSE
SEC. 3211. <<NOTE: 21 USC 801 note.>> SHORT TITLE.
This chapter may be cited as the ``Empowering Pharmacists in the
Fight Against Opioid Abuse Act''.
SEC. 3212. <<NOTE: 21 USC 829 note.>> PROGRAMS AND MATERIALS FOR
TRAINING ON CERTAIN CIRCUMSTANCES UNDER
WHICH A PHARMACIST MAY DECLINE TO FILL A
PRESCRIPTION.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, in consultation
with the Administrator of the Drug Enforcement Administration,
Commissioner of Food and Drugs, Director of the Centers for Disease
Control and Prevention, and Assistant Secretary for Mental Health and
Substance Use, shall develop and disseminate, as appropriate, materials
for pharmacists, health care providers, and patients on--
(1) circumstances under which a pharmacist may, consistent
with section 309 of the Controlled Substances Act (21 U.S.C.
829) and regulations thereunder, including section 1306.04 of
title 21, Code of Federal Regulations, decline to fill a
prescription for a controlled substance because the pharmacist
suspects the prescription is fraudulent, forged, or of doubtful,
questionable, or suspicious origin; and
(2) other Federal requirements pertaining to declining to
fill a prescription under such circumstances, including the
partial fill of prescriptions for certain controlled substances.
(b) Materials Included.--In developing materials under subsection
(a), the Secretary of Health and Human Services shall include
information for--
(1) pharmacists on how to decline to fill a prescription and
actions to take after declining to fill a prescription; and
(2) other health care practitioners and the public on a
pharmacist's ability to decline to fill prescriptions in certain
circumstances and a description of those circumstances (as
described in the materials developed under subsection (a)(1)).
(c) Stakeholder Input.--In developing the programs and materials
required under subsection (a), the Secretary of Health and Human
Services shall seek input from relevant national, State, and local
associations, boards of pharmacy, medical societies, licensing boards,
health care practitioners, and patients, including individuals with
chronic pain.
CHAPTER 3-- <<NOTE: Safe Disposal of Unused Medication Act.>> SAFE
DISPOSAL OF UNUSED MEDICATION
SEC. 3221. <<NOTE: 21 USC 801 note.>> SHORT TITLE.
This chapter may be cited as the ``Safe Disposal of Unused
Medication Act''.
[[Page 132 STAT. 3948]]
SEC. 3222. DISPOSAL OF CONTROLLED SUBSTANCES OF A HOSPICE PATIENT
BY EMPLOYEES OF A QUALIFIED HOSPICE
PROGRAM.
(a) In General.--Subsection (g) of section 302 of the Controlled
Substances Act (21 U.S.C. 822) is amended by adding at the end the
following:
``(5)(A) In the case of a person receiving hospice care, an employee
of a qualified hospice program, acting within the scope of employment,
may handle, without being registered under this section, any controlled
substance that was lawfully dispensed to the person receiving hospice
care, for the purpose of disposal of the controlled substance so long as
such disposal occurs onsite in accordance with all applicable Federal,
State, Tribal, and local law and--
``(i) the disposal occurs after the death of a person
receiving hospice care;
``(ii) the controlled substance is expired; or
``(iii)(I) the employee is--
``(aa) the physician of the person receiving
hospice care; and
``(bb) registered under section 303(f); and
``(II) the hospice patient no longer requires the
controlled substance because the plan of care of the
hospice patient has been modified.
``(B) For the purposes of this paragraph:
``(i) The terms `hospice care' and `hospice program' have
the meanings given to those terms in section 1861(dd) of the
Social Security Act.
``(ii) The term `employee of a qualified hospice program'
means a physician, physician assistant, nurse, or other person
who--
``(I) is employed by, or pursuant to arrangements
made by, a qualified hospice program;
``(II)(aa) is licensed to perform medical or nursing
services by the jurisdiction in which the person
receiving hospice care was located; and
``(bb) is acting within the scope of such employment
in accordance with applicable State law; and
``(III) has completed training through the qualified
hospice program regarding the disposal of controlled
substances in a secure and responsible manner so as to
discourage abuse, misuse, or diversion.
``(iii) The term `qualified hospice program' means a hospice
program that--
``(I) has written policies and procedures for
assisting in the disposal of the controlled substances
of a person receiving hospice care after the person's
death;
``(II) at the time when the controlled substances
are first ordered--
``(aa) provides a copy of the written policies
and procedures to the patient or patient
representative and family;
``(bb) discusses the policies and procedures
with the patient or representative and the family
in a language and manner that they understand to
ensure that these parties are educated regarding
the safe disposal of controlled substances; and
[[Page 132 STAT. 3949]]
``(cc) documents in the patient's clinical
record that the written policies and procedures
were provided and discussed; and
``(III) at the time following the disposal of the
controlled substances--
``(aa) documents in the patient's clinical
record the type of controlled substance, dosage,
route of administration, and quantity so disposed;
and
``(bb) the time, date, and manner in which
that disposal occurred.''.
(b) <<NOTE: 21 USC 822 note.>> Guidance.--The Attorney General may
issue guidance to hospice programs (as defined in paragraph (5) of
section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as
added by subsection (a)) to assist the programs in satisfying the
requirements under such paragraph (5).
(c) <<NOTE: 21 USC 822 note.>> Rule of Construction Relating to
State and Local Law.--Nothing in this section or the amendments made by
this section shall be construed to prevent a State or local government
from imposing additional controls or restrictions relating to the
regulation of the disposal of controlled substances in hospice care or
hospice programs.
SEC. 3223. GAO STUDY AND REPORT ON HOSPICE SAFE DRUG MANAGEMENT.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study on the requirements applicable
to, and challenges of, hospice programs with regard to the
management and disposal of controlled substances in the home of
an individual.
(2) Contents.--In conducting the study under paragraph (1),
the Comptroller General shall include--
(A) an overview of any challenges encountered by
selected hospice programs regarding the disposal of
controlled substances, such as opioids, in a home
setting, including any key changes in policies,
procedures, or best practices for the disposal of
controlled substances over time; and
(B) a description of Federal requirements, including
requirements under the Medicare program, for hospice
programs regarding the disposal of controlled substances
in a home setting, and oversight of compliance with
those requirements.
(b) Report.--Not later than 18 months after the date of enactment of
this Act, the Comptroller General shall submit to Congress a report
containing the results of the study conducted under subsection (a),
together with recommendations, if any, for such legislation and
administrative action as the Comptroller General determines appropriate.
CHAPTER 4 <<NOTE: Special Registration for Telemedicine Clarification
Act of 2018.>> --SPECIAL REGISTRATION FOR TELEMEDICINE CLARIFICATION
SEC. 3231. <<NOTE: 21 USC 801 note.>> SHORT TITLE.
This chapter may be cited as the ``Special Registration for
Telemedicine Clarification Act of 2018''.
[[Page 132 STAT. 3950]]
SEC. 3232. REGULATIONS RELATING TO A SPECIAL REGISTRATION FOR
TELEMEDICINE.
Section 311(h)(2) of the Controlled Substances Act (21 U.S.C.
831(h)(2)) is amended to read as follows:
``(2) Regulations.--Not later than 1 year after the date of
enactment of the SUPPORT for Patients and Communities Act, in
consultation with the Secretary, the Attorney General shall
promulgate final regulations specifying--
``(A) the limited circumstances in which a special
registration under this subsection may be issued; and
``(B) the procedure for obtaining a special
registration under this subsection.''.
CHAPTER 5--SYNTHETIC ABUSE AND LABELING OF TOXIC SUBSTANCES
SEC. 3241. CONTROLLED SUBSTANCE ANALOGUES.
Section 203 of the Controlled Substances Act (21 U.S.C. 813) is
amended--
(1) by striking ``A controlled'' and inserting ``(a) In
General.--A controlled''; and
(2) by adding at the end the following:
``(b) Determination.--In determining whether a controlled substance
analogue was intended for human consumption under subsection (a), the
following factors may be considered, along with any other relevant
factors:
``(1) The marketing, advertising, and labeling of the
substance.
``(2) The known efficacy or usefulness of the substance for
the marketed, advertised, or labeled purpose.
``(3) The difference between the price at which the
substance is sold and the price at which the substance it is
purported to be or advertised as is normally sold.
``(4) The diversion of the substance from legitimate
channels and the clandestine importation, manufacture, or
distribution of the substance.
``(5) Whether the defendant knew or should have known the
substance was intended to be consumed by injection, inhalation,
ingestion, or any other immediate means.
``(6) Any controlled substance analogue that is
manufactured, formulated, sold, distributed, or marketed with
the intent to avoid the provisions of existing drug laws.
``(c) Limitation.--For purposes of this section, evidence that a
substance was not marketed, advertised, or labeled for human
consumption, by itself, shall not be sufficient to establish that the
substance was not intended for human consumption.''.
CHAPTER 6 <<NOTE: Access to Increased Drug Disposal Act of 2018.>> --
ACCESS TO INCREASED DRUG DISPOSAL
SEC. 3251. <<NOTE: 21 USC 822a note.>> SHORT TITLE.
This chapter may be cited as the ``Access to Increased Drug Disposal
Act of 2018''.
SEC. 3252. DEFINITIONS.
In this chapter--
[[Page 132 STAT. 3951]]
(1) the term ``Attorney General'' means the Attorney
General, acting through the Assistant Attorney General for the
Office of Justice Programs;
(2) the term ``authorized collector'' means a narcotic
treatment program, a hospital or clinic with an on-site
pharmacy, a retail pharmacy, or a reverse distributor, that is
authorized as a collector under section 1317.40 of title 21,
Code of Federal Regulations (or any successor regulation);
(3) the term ``covered grant'' means a grant awarded under
section 3003; and
(4) the term ``eligible collector'' means a person who is
eligible to be an authorized collector.
SEC. 3253. AUTHORITY TO MAKE GRANTS.
The Attorney General shall award grants to States to enable the
States to increase the participation of eligible collectors as
authorized collectors.
SEC. 3254. APPLICATION.
A State desiring a covered grant shall submit to the Attorney
General an application that, at a minimum--
(1) identifies the single State agency that oversees
pharmaceutical care and will be responsible for complying with
the requirements of the grant;
(2) details a plan to increase participation rates of
eligible collectors as authorized collectors; and
(3) describes how the State will select eligible collectors
to be served under the grant.
SEC. 3255. USE OF GRANT FUNDS.
A State that receives a covered grant, and any subrecipient of the
grant, may use the grant amounts only for the costs of installation,
maintenance, training, purchasing, and disposal of controlled substances
associated with the participation of eligible collectors as authorized
collectors.
SEC. 3256. ELIGIBILITY FOR GRANT.
The Attorney General shall award a covered grant to 5 States, not
less than 3 of which shall be States in the lowest quartile of States
based on the participation rate of eligible collectors as authorized
collectors, as determined by the Attorney General.
SEC. 3257. DURATION OF GRANTS.
The Attorney General shall determine the period of years for which a
covered grant is made to a State.
SEC. 3258. ACCOUNTABILITY AND OVERSIGHT.
A State that receives a covered grant shall submit to the Attorney
General a report, at such time and in such manner as the Attorney
General may reasonably require, that--
(1) lists the ultimate recipients of the grant amounts;
(2) describes the activities undertaken by the State using
the grant amounts; and
(3) contains performance measures relating to the
effectiveness of the grant, including changes in the
participation rate of eligible collectors as authorized
collectors.
[[Page 132 STAT. 3952]]
SEC. 3259. <<NOTE: 21 USC 822a note.>> DURATION OF PROGRAM.
The Attorney General may award covered grants for each of the first
5 fiscal years beginning after the date of enactment of this Act.
SEC. 3260. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to the Attorney General such
sums as may be necessary to carry out this chapter.
CHAPTER 7-- <<NOTE: Using Data To Prevent Opioid Diversion Act of
2018.>> USING DATA TO PREVENT OPIOID DIVERSION
SEC. 3271. <<NOTE: 21 USC 801 note.>> SHORT TITLE.
This chapter may be cited as the ``Using Data To Prevent Opioid
Diversion Act of 2018''.
SEC. 3272. <<NOTE: 21 USC 827 note.>> PURPOSE.
(a) In General.--The purpose of this chapter is to provide drug
manufacturers and distributors with access to anonymized information
through the Automated Reports and Consolidated Orders System to help
drug manufacturers and distributors identify, report, and stop
suspicious orders of opioids and reduce diversion rates.
(b) Rule of Construction.--Nothing in this chapter should be
construed to absolve a drug manufacturer, drug distributor, or other
Drug Enforcement Administration registrant from the responsibility of
the manufacturer, distributor, or other registrant to--
(1) identify, stop, and report suspicious orders; or
(2) maintain effective controls against diversion in
accordance with section 303 of the Controlled Substances Act (21
U.S.C. 823) or any successor law or associated regulation.
SEC. 3273. AMENDMENTS.
(a) Records and Reports of Registrants.--Section 307 of the
Controlled Substances Act (21 U.S.C. 827) is amended--
(1) by redesignating subsections (f), (g), and (h) as
subsections (g), (h), and (i), respectively;
(2) by inserting after subsection (e) the following:
``(f)(1) The Attorney General shall, not less frequently than
quarterly, make the following information available to manufacturer and
distributor registrants through the Automated Reports and Consolidated
Orders System, or any subsequent automated system developed by the Drug
Enforcement Administration to monitor selected controlled substances:
``(A) The total number of distributor registrants that
distribute controlled substances to a pharmacy or practitioner
registrant, aggregated by the name and address of each pharmacy
and practitioner registrant.
``(B) The total quantity and type of opioids distributed,
listed by Administration Controlled Substances Code Number, to
each pharmacy and practitioner registrant described in
subparagraph (A).
``(2) The information required to be made available under paragraph
(1) shall be made available not later than the 30th day of the first
month following the quarter to which the information relates.
[[Page 132 STAT. 3953]]
``(3)(A) All registered manufacturers and distributors shall be
responsible for reviewing the information made available by the Attorney
General under this subsection.
``(B) In determining whether to initiate proceedings under this
title against a registered manufacturer or distributor based on the
failure of the registrant to maintain effective controls against
diversion or otherwise comply with the requirements of this title or the
regulations issued thereunder, the Attorney General may take into
account that the information made available under this subsection was
available to the registrant.''; and
(3) by inserting after subsection (i), as so redesignated,
the following:
``(j) All of the reports required under this section shall be
provided in an electronic format.''.
(b) Cooperative Arrangements.--Section 503 of the Controlled
Substances Act (21 U.S.C. 873) is amended by striking subsection (c) and
inserting the following:
``(c)(1) The Attorney General shall, once every 6 months, prepare
and make available to regulatory, licensing, attorneys general, and law
enforcement agencies of States a standardized report containing
descriptive and analytic information on the actual distribution
patterns, as gathered through the Automated Reports and Consolidated
Orders System, or any subsequent automated system, pursuant to section
307 and which includes detailed amounts, outliers, and trends of
distributor and pharmacy registrants, in such States for the controlled
substances contained in schedule II, which, in the discretion of the
Attorney General, are determined to have the highest abuse.
``(2) If the Attorney General publishes the report described in
paragraph (1) once every 6 months as required under paragraph (1),
nothing in this subsection shall be construed to bring an action in any
court to challenge the sufficiency of the information or to compel the
Attorney General to produce any documents or reports referred to in this
subsection.''.
(c) Civil and Criminal Penalties.--Section 402 of the Controlled
Substances Act (21 U.S.C. 842) is amended--
(1) in subsection (a)--
(A) in paragraph (15), by striking ``or'' at the
end;
(B) in paragraph (16), by striking the period at the
end and inserting ``; or''; and
(C) by inserting after paragraph (16) the following:
``(17) in the case of a registered manufacturer or
distributor of opioids, to fail to review the most recent
information, directly related to the customers of the
manufacturer or distributor, made available by the Attorney
General in accordance with section 307(f).''; and
(2) in subsection (c)--
(A) in paragraph (1), by striking subparagraph (B)
and inserting the following:
``(B)(i) Except as provided in clause (ii), in the case of a
violation of paragraph (5), (10), or (17) of subsection (a), the civil
penalty shall not exceed $10,000.
``(ii) In the case of a violation described in clause (i) committed
by a registered manufacturer or distributor of opioids and related to
the reporting of suspicious orders for opioids, failing to maintain
effective controls against diversion of opioids, or failing to review
the most recent information made available by the Attorney General
[[Page 132 STAT. 3954]]
in accordance with section 307(f), the penalty shall not exceed
$100,000.''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``or
(D)'' after ``subparagraph (B)''; and
(ii) by adding at the end the following:
``(D) In the case of a violation described in subparagraph (A) that
was a violation of paragraph (5), (10), or (17) of subsection (a)
committed by a registered manufacturer or distributor of opioids that
relates to the reporting of suspicious orders for opioids, failing to
maintain effective controls against diversion of opioids, or failing to
review the most recent information made available by the Attorney
General in accordance with section 307(f), the criminal fine under title
18, United States Code, shall not exceed $500,000.''.
SEC. 3274. REPORT.
Not later than 1 year after the date of enactment of this Act, the
Attorney General shall submit to Congress a report that provides
information about how the Attorney General is using data in the
Automation of Reports and Consolidated Orders System to identify and
stop suspicious activity, including whether the Attorney General is
looking at aggregate orders from individual pharmacies to multiple
distributors that in total are suspicious, even if no individual order
rises to the level of a suspicious order to a given distributor.
CHAPTER 8-- <<NOTE: Opioid Quota Reform Act.>> OPIOID QUOTA REFORM
SEC. 3281. <<NOTE: 21 USC 801 note.>> SHORT TITLE.
This chapter may be cited as the ``Opioid Quota Reform Act''.
SEC. 3282. STRENGTHENING CONSIDERATIONS FOR DEA OPIOID QUOTAS.
(a) In General.--Section 306 of the Controlled Substances Act (21
U.S.C. 826) is amended--
(1) in subsection (a)--
(A) by inserting ``(1)'' after ``(a)'';
(B) in the second sentence, by striking
``Production'' and inserting ``Except as provided in
paragraph (2), production''; and
(C) by adding at the end the following:
``(2) The Attorney General may, if the Attorney General determines
it will assist in avoiding the overproduction, shortages, or diversion
of a controlled substance, establish an aggregate or individual
production quota under this subsection, or a procurement quota
established by the Attorney General by regulation, in terms of
pharmaceutical dosage forms prepared from or containing the controlled
substance.'';
(2) in subsection (b), in the first sentence, by striking
``production'' and inserting ``manufacturing'';
(3) in subsection (c), by striking ``October'' and inserting
``December''; and
(4) by adding at the end the following:
``(i)(1)(A) In establishing any quota under this section, or any
procurement quota established by the Attorney General by regulation, for
fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this
subsection referred to as a `covered controlled substance'), the
Attorney General shall estimate the amount
[[Page 132 STAT. 3955]]
of diversion of the covered controlled substance that occurs in the
United States.
``(B) In estimating diversion under this paragraph, the Attorney
General--
``(i) shall consider information the Attorney General, in
consultation with the Secretary of Health and Human Services,
determines reliable on rates of overdose deaths and abuse and
overall public health impact related to the covered controlled
substance in the United States; and
``(ii) may take into consideration whatever other sources of
information the Attorney General determines reliable.
``(C) After estimating the amount of diversion of a covered
controlled substance, the Attorney General shall make appropriate quota
reductions, as determined by the Attorney General, from the quota the
Attorney General would have otherwise established had such diversion not
been considered.
``(2)(A) For any year for which the approved aggregate production
quota for a covered controlled substance is higher than the approved
aggregate production quota for the covered controlled substance for the
previous year, the Attorney General, in consultation with the Secretary
of Health and Human Services, shall include in the final order an
explanation of why the public health benefits of increasing the quota
clearly outweigh the consequences of having an increased volume of the
covered controlled substance available for sale, and potential
diversion, in the United States.
``(B) Not later than 1 year after the date of enactment of this
subsection, and every year thereafter, the Attorney General shall submit
to the Committee on the Judiciary, the Committee on Health, Education,
Labor, and Pensions, and the Committee on Appropriations of the Senate
and the Committee on the Judiciary, the Committee on Energy and
Commerce, and the Committee on Appropriations of the House of
Representatives the following information with regard to each covered
controlled substance:
``(i) An anonymized count of the total number of
manufacturers issued individual manufacturing quotas that year
for the covered controlled substance.
``(ii) An anonymized count of how many such manufacturers
were issued an approved manufacturing quota that was higher than
the quota issued to that manufacturer for the covered controlled
substance in the previous year.
``(3) Not later than 1 year after the date of enactment of this
subsection, the Attorney General shall submit to Congress a report on
how the Attorney General, when fixing and adjusting production and
manufacturing quotas under this section for covered controlled
substances, will--
``(A) take into consideration changes in the accepted
medical use of the covered controlled substances; and
``(B) work with the Secretary of Health and Human Services
on methods to appropriately and anonymously estimate the type
and amount of covered controlled substances that are submitted
for collection from approved drug collection receptacles, mail-
back programs, and take-back events.''.
(b) Conforming Change. <<NOTE: 21 USC 826 note.>> --The Law Revision
Counsel is directed to amend the heading for subsection (b) of section
826 of title 21, United States Code, by striking ``Production'' and
inserting ``Manufacturing''.
[[Page 132 STAT. 3956]]
CHAPTER 9 <<NOTE: Preventing Drug Diversion Act of 2018.>> --PREVENTING
DRUG DIVERSION
SEC. 3291. <<NOTE: 21 USC 801 note.>> SHORT TITLE.
This chapter may be cited as the ``Preventing Drug Diversion Act of
2018''.
SEC. 3292. IMPROVEMENTS TO PREVENT DRUG DIVERSION.
(a) Definition.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by adding at the end the following:
``(57) The term `suspicious order' may include, but is not
limited to--
``(A) an order of a controlled substance of unusual
size;
``(B) an order of a controlled substance deviating
substantially from a normal pattern; and
``(C) orders of controlled substances of unusual
frequency.''.
(b) Suspicious Orders.--Part C of the Controlled Substances Act (21
U.S.C. 821 et seq.) is amended by adding at the end the following:
``SEC. 312. <<NOTE: 21 USC 832.>> SUSPICIOUS ORDERS.
``(a) Reporting.--Each registrant shall--
``(1) design and operate a system to identify suspicious
orders for the registrant;
``(2) ensure that the system designed and operated under
paragraph (1) by the registrant complies with applicable Federal
and State privacy laws; and
``(3) upon discovering a suspicious order or series of
orders, notify the Administrator of the Drug Enforcement
Administration and the Special Agent in Charge of the Division
Office of the Drug Enforcement Administration for the area in
which the registrant is located or conducts business.
``(b) Suspicious Order Database.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Attorney General shall establish
a centralized database for collecting reports of suspicious
orders.
``(2) Satisfaction of reporting requirements.--If a
registrant reports a suspicious order to the centralized
database established under paragraph (1), the registrant shall
be considered to have complied with the requirement under
subsection (a)(3) to notify the Administrator of the Drug
Enforcement Administration and the Special Agent in Charge of
the Division Office of the Drug Enforcement Administration for
the area in which the registrant is located or conducts
business.
``(c) Sharing Information With the States.--
``(1) In general.--The Attorney General shall prepare and
make available information regarding suspicious orders in a
State, including information in the database established under
subsection (b)(1), to the point of contact for purposes of
administrative, civil, and criminal oversight relating to the
diversion of controlled substances for the State, as designated
by the Governor or chief executive officer of the State.
``(2) Timing.--The Attorney General shall provide
information in accordance with paragraph (1) within a reasonable
period of time after obtaining the information.
[[Page 132 STAT. 3957]]
``(3) Coordination.--In establishing the process for the
provision of information under this subsection, the Attorney
General shall coordinate with States to ensure that the Attorney
General has access to information, as permitted under State law,
possessed by the States relating to prescriptions for controlled
substances that will assist in enforcing Federal law.''.
(c) Reports to Congress.--
(1) Definition.--In this subsection, the term ``suspicious
order'' has the meaning given that term in section 102 of the
Controlled Substances Act, as amended by this chapter.
(2) One-time report.--Not later than 1 year after the date
of enactment of this Act, the Attorney General shall submit to
Congress a report on the reporting of suspicious orders, which
shall include--
(A) a description of the centralized database
established under section 312 of the Controlled
Substances Act, as added by this section, to collect
reports of suspicious orders;
(B) a description of the system and reports
established under section 312 of the Controlled
Substances Act, as added by this section, to share
information with States;
(C) information regarding how the Attorney General
used reports of suspicious orders before the date of
enactment of this Act and after the date of enactment of
this Act, including how the Attorney General received
the reports and what actions were taken in response to
the reports; and
(D) descriptions of the data analyses conducted on
reports of suspicious orders to identify, analyze, and
stop suspicious activity.
(3) Additional reports.--Not later than 1 year after the
date of enactment of this Act, and annually thereafter until the
date that is 5 years after the date of enactment of this Act,
the Attorney General shall submit to Congress a report
providing, for the previous year--
(A) the number of reports of suspicious orders;
(B) a summary of actions taken in response to
reports, in the aggregate, of suspicious orders; and
(C) a description of the information shared with
States based on reports of suspicious orders.
(4) One-time gao report.--Not later than 1 year after the
date of enactment of this Act, the Comptroller General of the
United States, in consultation with the Administrator of the
Drug Enforcement Administration, shall submit to Congress a
report on the reporting of suspicious orders, which shall
include an evaluation of the utility of real-time reporting of
potential suspicious orders of opioids on a national level using
computerized algorithms, including the extent to which such
algorithms--
(A) would help ensure that potentially suspicious
orders are more accurately captured, identified, and
reported in real time to suppliers before orders are
filled;
(B) may produce false positives of suspicious order
reports that could result in market disruptions for
legitimate orders of opioids; and
[[Page 132 STAT. 3958]]
(C) would reduce the overall length of an
investigation that prevents the diversion of suspicious
orders of opioids.
TITLE IV--OFFSETS
SEC. 4001. PROMOTING VALUE IN MEDICAID MANAGED CARE.
Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as
amended by sections 1013 and 1016, is further amended by adding at the
end the following new paragraph:
``(9)(A) With respect to expenditures described in subparagraph (B)
that are incurred by a State for any fiscal year after fiscal year 2020
(and before fiscal year 2024), in determining the pro rata share to
which the United States is equitably entitled under subsection (d)(3),
the Secretary shall substitute the Federal medical assistance percentage
that applies for such fiscal year to the State under section 1905(b)
(without regard to any adjustments to such percentage applicable under
such section or any other provision of law) for the percentage that
applies to such expenditures under section 1905(y).
``(B) Expenditures described in this subparagraph, with respect to a
fiscal year to which subparagraph (A) applies, are expenditures incurred
by a State for payment for medical assistance provided to individuals
described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed
care entity, or other specified entity (as defined in subparagraph
(D)(iii)), that are treated as remittances because the State--
``(i) has satisfied the requirement of section 438.8 of
title 42, Code of Federal Regulations (or any successor
regulation), by electing--
``(I) in the case of a State described in
subparagraph (C), to apply a minimum medical loss ratio
(as defined in subparagraph (D)(ii)) that is at least 85
percent but not greater than the minimum medical loss
ratio (as so defined) that such State applied as of May
31, 2018; or
``(II) in the case of a State not described in
subparagraph (C), to apply a minimum medical loss ratio
that is equal to 85 percent; and
``(ii) recovered all or a portion of the expenditures as a
result of the entity's failure to meet such ratio.
``(C) For purposes of subparagraph (B), a State described in this
subparagraph is a State that as of May 31, 2018, applied a minimum
medical loss ratio (as calculated under subsection (d) of section 438.8
of title 42, Code of Federal Regulations (as in effect on June 1, 2018))
for payment for services provided by entities described in such
subparagraph under the State plan under this title (or a waiver of the
plan) that is equal to or greater than 85 percent.
``(D) For purposes of this paragraph:
``(i) The term `managed care entity' means a medicaid
managed care organization described in section 1932(a)(1)(B)(i).
``(ii) The term `minimum medical loss ratio' means, with
respect to a State, a minimum medical loss ratio (as calculated
under subsection (d) of section 438.8 of title 42, Code of
Federal Regulations (as in effect on June 1, 2018)) for payment
for services provided by entities described in subparagraph (B)
under the State plan under this title (or a waiver of the plan).
[[Page 132 STAT. 3959]]
``(iii) The term `other specified entity' means--
``(I) a prepaid inpatient health plan, as defined in
section 438.2 of title 42, Code of Federal Regulations
(or any successor regulation); and
``(II) a prepaid ambulatory health plan, as defined
in such section (or any successor regulation).''.
SEC. 4002. REQUIRING REPORTING BY GROUP HEALTH PLANS OF
PRESCRIPTION DRUG COVERAGE INFORMATION
FOR PURPOSES OF IDENTIFYING PRIMARY
PAYER SITUATIONS UNDER THE MEDICARE
PROGRAM.
Clause (i) of section 1862(b)(7)(A) of the Social Security Act (42
U.S.C. 1395y(b)(7)(A)) is amended to read as follows:
``(i) secure from the plan sponsor and plan
participants such information as the Secretary
shall specify for the purpose of identifying
situations where the group health plan is or has
been--
``(I) a primary plan to the program
under this title; or
``(II) for calendar quarters
beginning on or after January 1, 2020, a
primary payer with respect to benefits
relating to prescription drug coverage
under part D; and''.
SEC. 4003. ADDITIONAL RELIGIOUS EXEMPTION FROM HEALTH COVERAGE
RESPONSIBILITY REQUIREMENT.
(a) In General.--Section 5000A(d)(2)(A) of the Internal Revenue Code
of 1986 is amended to read as follows:
``(A) Religious conscience exemptions.--
``(i) In general.--Such term shall not include
any individual for any month if such individual
has in effect an exemption under section
1311(d)(4)(H) of the Patient Protection and
Affordable Care Act which certifies that--
``(I) such individual is a member of
a recognized religious sect or division
thereof which is described in section
1402(g)(1), and is adherent of
established tenets or teachings of such
sect or division as described in such
section; or
``(II) such individual is a member
of a religious sect or division thereof
which is not described in section
1402(g)(1), who relies solely on a
religious method of healing, and for
whom the acceptance of medical health
services would be inconsistent with the
religious beliefs of the individual.
``(ii) Special rules.--
``(I) Medical health services
defined.--For purposes of this
subparagraph, the term `medical health
services' does not include routine
dental, vision and hearing services,
midwifery services, vaccinations,
necessary medical services provided to
children, services required by law or by
a third party, and such other services
as the Secretary of Health and Human
Services may provide in implementing
section 1311(d)(4)(H) of the Patient
Protection and Affordable Care Act.
``(II) Attestation required.--Clause
(i)(II) shall apply to an individual for
months in a taxable
[[Page 132 STAT. 3960]]
year only if the information provided by
the individual under section
1411(b)(5)(A) of such Act includes an
attestation that the individual has not
received medical health services during
the preceding taxable year.''.
(b) <<NOTE: 26 USC 5000A note.>> Effective Date.--The amendment
made by subsection (a) shall apply to taxable years beginning after
December 31, 2018.
(c) <<NOTE: 26 USC 5000A note.>> Construction.--Nothing in the
amendment made by subsection (a) shall preempt any State law requiring
the provision of medical treatment for children, especially those who
are seriously ill.
SEC. 4004. MODERNIZING THE REPORTING OF BIOLOGICAL AND BIOSIMILAR
PRODUCTS.
Subtitle B of title XI of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-173) is
amended--
(1) in section 1111 <<NOTE: 21 USC 355 note.>> , as amended
by section 3(1) of the Patient Right to Know Drug Prices Act--
(A) in the paragraph (3) inserted by such section
3(1), by striking ``an application'' and inserting ``a
biosimilar biological product application'';
(B) in the paragraph (4) inserted by such section
3(1), by inserting ``application'' before ``under
section 351(k) of the Public Health Service Act'';
(C) in the paragraph (5) inserted by such section
3(1), by striking ``for licensure of a biological
product under section 351(k) of the Public Health
Service Act'' and inserting ``under section 351(k) of
the Public Health Service Act for licensure of a
biological product as biosimilar to, or interchangeable
with, a reference product'';
(D) in paragraph (7), as redesignated and amended by
such section 3(1), by striking ``or under section 351(a)
of the Public Health Service Act'' and inserting ``or
the owner, or exclusive licensee, of a patent included
in a list provided under section 351(l)(3) of the Public
Health Service Act''; and
(E) in the paragraph (12) added by such section
3(1), by striking ``means a brand name drug for which a
license is in effect under section 351(a)'' and
inserting ``has the meaning given such term in section
351(i)''; and
(2) in section 1112, as amended by section 3(2) of the
Patient Right to Know Drug Prices Act--
(A) in subsection (a)--
(i) in paragraph (1), by striking ``for which
a statement under section 351(l)(3)(B)(ii)(I) of
the Public Health Service Act has been provided'';
(ii) in paragraph (2)--
(I) in subparagraph (C)(i), by
striking ``brand name'' and inserting
``listed''; and
(II) by amending clause (ii) of
subparagraph (C) to read as follows:
``(ii) any of the time periods referred to in
section 351(k)(6) of the Public Health Service Act
as such period applies to such biosimilar
biological product application or to any other
biosimilar biological product application based on
the same reference product.'';
[[Page 132 STAT. 3961]]
(B) in subsection (b)--
(i) in the subsection heading, by inserting
``or Biosimilar Biological Product Applicant''
after ``Applicant'';
(ii) in paragraph (1)(B), by striking the
first sentence and inserting the following: ``A
biosimilar biological product applicant that has
submitted a biosimilar biological product
application that references a reference product
and another biosimilar biological product
applicant that has submitted a biosimilar
biological product application that references the
same reference product shall each file the
agreement in accordance with subsection (c).'';
and
(iii) in paragraph (2)--
(I) by striking ``2 generic drug
applicants'' and inserting ``2 or more
generic drug applicants''; and
(II) by striking ``or an agreement
between 2 biosimilar biological product
applicants regarding the 1-year period
referred to in section 351(k)(6)(A) of
the Public Health Service Act as it
applies to the biosimilar biological
product applications with which the
agreement is concerned'' and inserting
``, an agreement between 2 or more
biosimilar biological product applicants
regarding a time period referred to in
section 351(k)(6) of the Public Health
Service Act as it applies to the
biosimilar biological product, or an
agreement between 2 or more biosimilar
biological product applicants regarding
the manufacture, marketing, or sale of a
biosimilar biological product''; and
(C) in subsection (c)(2), by inserting ``were
entered into within 30 days of,'' after ``condition
for,''.
TITLE V <<NOTE: Individuals in Medicaid Deserve Care that is Appropriate
and Responsible in its Execution Act.>> --OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting With Respect to Adult Behavioral Health
Measures
SEC. 5001. MANDATORY REPORTING WITH RESPECT TO ADULT BEHAVIORAL
HEALTH MEASURES.
Section 1139B of the Social Security Act (42 U.S.C. 1320b-9b) is
amended--
(1) in subsection (b)--
(A) in paragraph (3)--
(i) by striking ``Not later than January 1,
2013'' and inserting the following:
``(A) Voluntary reporting.--Not later than January
1, 2013''; and
(ii) by adding at the end the following:
``(B) Mandatory reporting with respect to behavioral
health measures.--Beginning with the State report
required under subsection (d)(1) for 2024, the Secretary
[[Page 132 STAT. 3962]]
shall require States to use all behavioral health
measures included in the core set of adult health
quality measures and any updates or changes to such
measures to report information, using the standardized
format for reporting information and procedures
developed under subparagraph (A), regarding the quality
of behavioral health care for Medicaid eligible
adults.''; and
(B) in paragraph (5), by adding at the end the
following new subparagraph:
``(C) Behavioral health measures.--Beginning with
respect to State reports required under subsection
(d)(1) for 2024, the core set of adult health quality
measures maintained under this paragraph (and any
updates or changes to such measures) shall include
behavioral health measures.''; and
(2) in subsection (d)(1)(A)--
(A) by striking ``the such plan'' and inserting
``such plan''; and
(B) by striking ``subsection (a)(5)'' and inserting
``subsection (b)(5) and, beginning with the report for
2024, all behavioral health measures included in the
core set of adult health quality measures maintained
under such subsection (b)(5) and any updates or changes
to such measures (as required under subsection
(b)(3))''.
Subtitle B <<NOTE: Medicaid Institutes for Mental Disease Are Decisive
in Delivering Inpatient Treatment for Individuals but Opportunities for
Needed Access are Limited without Information Needed about Facility
Obligations Act.>> --Medicaid IMD Additional Info
SEC. 5011. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Institutes for Mental
Disease Are Decisive in Delivering Inpatient Treatment for Individuals
but Opportunities for Needed Access are Limited without Information
Needed about Facility Obligations Act'' or the ``Medicaid IMD ADDITIONAL
INFO Act''.
SEC. 5012. MACPAC EXPLORATORY STUDY AND REPORT ON INSTITUTIONS FOR
MENTAL DISEASES REQUIREMENTS AND
PRACTICES UNDER MEDICAID.
(a) In General.--Not later than January 1, 2020, the Medicaid and
CHIP Payment and Access Commission established under section 1900 of the
Social Security Act (42 U.S.C. 1396) shall conduct an exploratory study,
using data from a representative sample of States, and submit to
Congress a report on at least the following information, with respect to
services furnished to individuals enrolled under State plans under the
Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.)
(or waivers of such plans) who are patients in institutions for mental
diseases and for which payment is made through fee-for-service or
managed care arrangements under such State plans (or waivers):
(1) A description of such institutions for mental diseases
in each such State, including at a minimum--
(A) the number of such institutions in the State;
(B) the facility type of such institutions in the
State; and
(C) any coverage limitations under each such State
plan (or waiver) on scope, duration, or frequency of
such services.
[[Page 132 STAT. 3963]]
(2) With respect to each such institution for mental
diseases in each such State, a description of--
(A) such services provided at such institution;
(B) the process, including any timeframe, used by
such institution to clinically assess and reassess such
individuals; and
(C) the discharge process used by such institution,
including any care continuum of relevant services or
facilities provided or used in such process.
(3) A description of--
(A) any Federal waiver that each such State has for
such institutions and the Federal statutory authority
for such waiver; and
(B) any other Medicaid funding sources used by each
such State for funding such institutions, such as
supplemental payments.
(4) A summary of State requirements (such as certification,
licensure, and accreditation) applied by each such State to such
institutions in order for such institutions to receive payment
under the State plan (or waiver) and how each such State
determines if such requirements have been met.
(5) A summary of State standards (such as quality standards,
clinical standards, and facility standards) that such
institutions must meet to receive payment under such State plans
(or waivers) and how each such State determines if such
standards have been met.
(6) If determined appropriate by the Commission,
recommendations for policies and actions by Congress and the
Centers for Medicare & Medicaid Services, such as on how State
Medicaid programs may improve care and improve standards and
including a recommendation for how the Centers for Medicare &
Medicaid Services can improve data collection from such programs
to address any gaps in information.
(b) Stakeholder Input.--In carrying out subsection (a), the Medicaid
and CHIP Payment and Access Commission shall seek input from State
Medicaid directors and stakeholders, including at a minimum the
Substance Abuse and Mental Health Services Administration, Centers for
Medicare & Medicaid Services, State Medicaid officials, State mental
health authorities, Medicaid beneficiary advocates, health care
providers, and Medicaid managed care organizations.
(c) Definitions.--In this section:
(1) Representative sample of states.--The term
``representative sample of States'' means a non-probability
sample in which at least two States are selected based on the
knowledge and professional judgment of the selector.
(2) State.--The term ``State'' means each of the 50 States,
the District of Columbia, and any commonwealth or territory of
the United States.
(3) Institution for mental diseases.--The term ``institution
for mental diseases'' has the meaning given such term in section
435.1010 of title 42, Code of Federal Regulations, or any
successor regulation.
[[Page 132 STAT. 3964]]
Subtitle C <<NOTE: CHIP Mental Health and Substance Use Disorder Parity
Act.>> --CHIP Mental Health and Substance Use Disorder Parity
SEC. 5021. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This subtitle may be cited as the ``CHIP Mental Health and Substance
Use Disorder Parity Act''.
SEC. 5022. ENSURING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE
DISORDER SERVICES FOR CHILDREN AND
PREGNANT WOMEN UNDER THE CHILDREN'S
HEALTH INSURANCE PROGRAM.
(a) In General.--Section 2103(c)(1) of the Social Security Act (42
U.S.C. 1397cc(c)(1)) is amended by adding at the end the following new
subparagraph:
``(E) Mental health and substance use disorder
services (as defined in paragraph (5)).''.
(b) Mental Health and Substance Use Disorder Services.--
(1) In general.--Section 2103(c) of the Social Security Act
(42 U.S.C. 1397cc(c)) is amended--
(A) by redesignating paragraphs (5), (6), (7), and
(8) as paragraphs (6), (7), (8), and (9), respectively;
and
(B) by inserting after paragraph (4) the following
new paragraph:
``(5) Mental health and substance use disorder services.--
Regardless of the type of coverage elected by a State under
subsection (a), child health assistance provided under such
coverage for targeted low-income children and, in the case that
the State elects to provide pregnancy-related assistance under
such coverage pursuant to section 2112, such pregnancy-related
assistance for targeted low-income pregnant women (as defined in
section 2112(d)) shall--
``(A) include coverage of mental health services
(including behavioral health treatment) necessary to
prevent, diagnose, and treat a broad range of mental
health symptoms and disorders, including substance use
disorders; and
``(B) be delivered in a culturally and
linguistically appropriate manner.''.
(2) Conforming amendments.--
(A) Section 2103(a) of the Social Security Act (42
U.S.C. 1397cc(a)) is amended, in the matter before
paragraph (1), by striking ``paragraphs (5), (6), and
(7)'' and inserting ``paragraphs (5), (6), (7), and
(8)''.
(B) Section 2110(a) of the Social Security Act (42
U.S.C. 1397jj(a)) is amended--
(i) in paragraph (18), by striking ``substance
abuse'' each place it appears and inserting
``substance use''; and
(ii) in paragraph (19), by striking
``substance abuse'' and inserting ``substance
use''.
(C) Section 2110(b)(5)(A)(i) of the Social Security
Act (42 U.S.C. 1397jj(b)(5)(A)(i)) is amended by
striking ``subsection (c)(5)'' and inserting
``subsection (c)(6)''.
(c) Assuring Access to Care.--Section 2102(a)(7)(B) of the Social
Security Act (42 U.S.C. 1397bb(c)(2)) is amended by striking
[[Page 132 STAT. 3965]]
``section 2103(c)(5)'' and inserting ``paragraphs (5) and (6) of section
2103(c)''.
(d) Mental Health Services Parity.--Subparagraph (A) of paragraph
(7) of section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c))
(as redesignated by subsection (b)(1)) is amended to read as follows:
``(A) In general.--A State child health plan shall
ensure that the financial requirements and treatment
limitations applicable to mental health and substance
use disorder services (as described in paragraph (5))
provided under such plan comply with the requirements of
section 2726(a) of the Public Health Service Act in the
same manner as such requirements or limitations apply to
a group health plan under such section.''.
(e) <<NOTE: 42 USC 1397bb note.>> Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect with respect to child
health assistance provided on or after the date that is 1 year
after the date of the enactment of this Act.
(2) Exception for state legislation.--In the case of a State
child health plan under title XXI of the Social Security Act (or
a waiver of such plan), which the Secretary of Health and Human
Services determines requires State legislation in order for the
respective plan (or waiver) to meet any requirement imposed by
the amendments made by this section, the respective plan (or
waiver) shall not be regarded as failing to comply with the
requirements of such title solely on the basis of its failure to
meet such an additional requirement before the first day of the
first calendar quarter beginning after the close of the first
regular session of the State legislature that begins after the
date of enactment of this section. For purposes of the previous
sentence, in the case of a State that has a 2-year legislative
session, each year of the session shall be considered to be a
separate regular session of the State legislature.
Subtitle D <<NOTE: Medicaid Reentry Act.>> --Medicaid Reentry
SEC. 5031 <<NOTE: 42 USC 1396a note.>> . SHORT TITLE.
This subtitle may be cited as the ``Medicaid Reentry Act''.
SEC. 5032 <<NOTE: 42 USC 1396a note.>> . PROMOTING STATE
INNOVATIONS TO EASE TRANSITIONS
INTEGRATION TO THE COMMUNITY FOR CERTAIN
INDIVIDUALS.
(a) Stakeholder Group Development of Best Practices; State Medicaid
Program Innovation.--
(1) Stakeholder group best practices.--Not later than 6
months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall convene a
stakeholder group of representatives of managed care
organizations, Medicaid beneficiaries, health care providers,
the National Association of Medicaid Directors, and other
relevant representatives from local, State, and Federal jail and
prison systems to develop best practices (and submit to the
Secretary and Congress a report on such best practices) for
States--
[[Page 132 STAT. 3966]]
(A) to ease the health care-related transition of an
individual who is an inmate of a public institution from
the public institution to the community, including best
practices for ensuring continuity of health insurance
coverage or coverage under the State Medicaid plan under
title XIX of the Social Security Act, as applicable, and
relevant social services; and
(B) to carry out, with respect to such an
individual, such health care-related transition not
later than 30 days after such individual is released
from the public institution.
(2) State medicaid program innovation.--The Secretary of
Health and Human Services shall work with States on innovative
strategies to help individuals who are inmates of public
institutions and otherwise eligible for medical assistance under
the Medicaid program under title XIX of the Social Security Act
transition, with respect to enrollment for medical assistance
under such program, seamlessly to the community.
(b) Guidance on Innovative Service Delivery Systems Demonstration
Project Opportunities.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services,
through the Administrator of the Centers for Medicare & Medicaid
Services, shall issue a State Medicaid Director letter, based on best
practices developed under subsection (a)(1), regarding opportunities to
design demonstration projects under section 1115 of the Social Security
Act (42 U.S.C. 1315) to improve care transitions for certain individuals
who are soon-to-be former inmates of a public institution and who are
otherwise eligible to receive medical assistance under title XIX of such
Act, including systems for, with respect to a period (not to exceed 30
days) immediately prior to the day on which such individuals are
expected to be released from such institution--
(1) providing assistance and education for enrollment under
a State plan under the Medicaid program under title XIX of such
Act for such individuals during such period; and
(2) providing health care services for such individuals
during such period.
(c) Rule of Construction.--Nothing under title XIX of the Social
Security Act or any other provision of law precludes a State from
reclassifying or suspending (rather than terminating) eligibility of an
individual for medical assistance under title XIX of the Social Security
Act while such individual is an inmate of a public institution.
Subtitle E <<NOTE: Medicaid Providers Are Required To Note Experiences
in Record Systems to Help In-need Patients Act.>> --Medicaid Partnership
SEC. 5041. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This subtitle may be cited as the ``Medicaid Providers Are Required
To Note Experiences in Record Systems to Help In-need Patients Act'' or
the ``Medicaid PARTNERSHIP Act''.
SEC. 5042. MEDICAID PROVIDERS ARE REQUIRED TO NOTE EXPERIENCES IN
RECORD SYSTEMS TO HELP IN-NEED PATIENTS.
(a) Requirements Under the Medicaid Program Relating to Qualified
Prescription Drug Monitoring Programs and Prescribing Certain Controlled
Substances.--Title XIX of the
[[Page 132 STAT. 3967]]
Social Security Act (42 U.S.C. 1396 et seq.) is amended by inserting
after section 1943 the following new section:
``SEC. 1944. <<NOTE: 42 USC 1396w-3a.>> REQUIREMENTS RELATING TO
QUALIFIED PRESCRIPTION DRUG MONITORING
PROGRAMS AND PRESCRIBING CERTAIN
CONTROLLED SUBSTANCES.
``(a) In General.--Subject to subsection (d), beginning October 1,
2021, a State--
``(1) shall require each covered provider to check, in
accordance with such timing, manner, and form as specified by
the State, the prescription drug history of a covered individual
being treated by the covered provider through a qualified
prescription drug monitoring program described in subsection (b)
before prescribing to such individual a controlled substance;
and
``(2) in the case that such a provider is not able to
conduct such a check despite a good faith effort by such
provider--
``(A) shall require the provider to document such
good faith effort, including the reasons why the
provider was not able to conduct the check; and
``(B) may require the provider to submit, upon
request, such documentation to the State.
``(b) Qualified Prescription Drug Monitoring Program Described.--A
qualified prescription drug monitoring program described in this
subsection is, with respect to a State, a prescription drug monitoring
program administered by the State that, at a minimum, satisfies each of
the following criteria:
``(1) The program facilitates access by a covered provider
to, at a minimum, the following information with respect to a
covered individual, in as close to real-time as possible:
``(A) Information regarding the prescription drug
history of a covered individual with respect to
controlled substances.
``(B) The number and type of controlled substances
prescribed to and filled for the covered individual
during at least the most recent 12-month period.
``(C) The name, location, and contact information
(or other identifying number selected by the State, such
as a national provider identifier issued by the National
Plan and Provider Enumeration System of the Centers for
Medicare & Medicaid Services) of each covered provider
who prescribed a controlled substance to the covered
individual during at least the most recent 12-month
period.
``(2) The program facilitates the integration of information
described in paragraph (1) into the workflow of a covered
provider, which may include the electronic system the covered
provider uses to prescribe controlled substances.
A qualified prescription drug monitoring program described in this
subsection, with respect to a State, may have in place, in accordance
with applicable State and Federal law, a data-sharing agreement with the
State Medicaid program that allows the medical director and pharmacy
director of such program (and any designee of such a director who
reports directly to such director) to access the information described
in paragraph (1) in an electronic format. The State Medicaid program
under this title may facilitate reasonable and limited access, as
determined by the State and ensuring documented beneficiary protections
regarding the use of such data,
[[Page 132 STAT. 3968]]
to such qualified prescription drug monitoring program for the medical
director or pharmacy director of any managed care entity (as defined
under section 1932(a)(1)(B)) that has a contract with the State under
section 1903(m) or under section 1905(t)(3), or the medical director or
pharmacy director of any entity that has a contract to manage the
pharmaceutical benefit with respect to individuals enrolled in the State
plan (or under a waiver of the State plan). All applicable State and
Federal security and privacy laws shall apply to the directors or
designees of such directors of any State Medicaid program or entity
accessing a qualified prescription drug monitoring program under this
section.
``(c) Application of Privacy Rules Clarification.--The Secretary
shall clarify privacy requirements, including requirements under the
regulations promulgated pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note), related to the sharing of data under subsection (b) in the same
manner as the Secretary is required under subparagraph (J) of section
1860D-4(c)(5) to clarify privacy requirements related to the sharing of
data described in such subparagraph.
``(d) Ensuring Access.--In order to ensure reasonable access to
health care, the Secretary shall waive the application of the
requirement under subsection (a), with respect to a State, in the case
of natural disasters and similar situations, and in the case of the
provision of emergency services (as defined for purposes of section
1860D-4(c)(5)(D)(ii)(II)).
``(e) Reports.--
``(1) State reports.--Each State shall include in the annual
report submitted to the Secretary under section 1927(g)(3)(D),
beginning with such reports submitted for 2023, information
including, at a minimum, the following information for the most
recent 12-month period:
``(A) The percentage of covered providers (as
determined pursuant to a process established by the
State) who checked the prescription drug history of a
covered individual through a qualified prescription drug
monitoring program described in subsection (b) before
prescribing to such individual a controlled substance.
``(B) Aggregate trends with respect to prescribing
controlled substances such as--
``(i) the quantity of daily morphine milligram
equivalents prescribed for controlled substances;
``(ii) the number and quantity of daily
morphine milligram equivalents prescribed for
controlled substances per covered individual; and
``(iii) the types of controlled substances
prescribed, including the dates of such
prescriptions, the supplies authorized (including
the duration of such supplies), and the period of
validity of such prescriptions, in different
populations (such as individuals who are elderly,
individuals with disabilities, and individuals who
are enrolled under both this title and title
XVIII).
``(C) Whether or not the State requires (and a
detailed explanation as to why the State does or does
not require) pharmacists to check the prescription drug
history of a covered individual through a qualified
prescription drug
[[Page 132 STAT. 3969]]
monitoring program described in subsection (b) before
dispensing a controlled substance to such individual.
``(D) An accounting of any data or privacy breach of
a qualified prescription drug monitoring program
described in subsection (b), the number of covered
individuals impacted by each such breach, and a
description of the steps the State has taken to address
each such breach, including, to the extent required by
State or Federal law or otherwise determined appropriate
by the State, alerting any such impacted individual and
law enforcement of the breach.
``(2) Report by cms.--Not later than October 1, 2023, the
Administrator of the Centers for Medicare & Medicaid Services
shall publish on the publicly available website of the Centers
for Medicare & Medicaid Services a report including the
following information:
``(A) Guidance for States on how States can increase
the percentage of covered providers who use qualified
prescription drug monitoring programs described in
subsection (b).
``(B) Best practices for how States and covered
providers should use such qualified prescription drug
monitoring programs to reduce the occurrence of abuse of
controlled substances.
``(f) Increase to FMAP and Federal Matching Rates for Certain
Expenditures Relating to Qualified Prescription Drug Monitoring
Programs.--
``(1) In general.--With respect to a State that meets the
condition described in paragraph (2) and any quarter occurring
during fiscal year 2019 or fiscal year 2020, the Federal medical
assistance percentage or Federal matching rate that would
otherwise apply to such State under section 1903(a) for such
quarter, with respect to expenditures by the State for
activities under the State plan (or a waiver of such plan) to
design, develop, or implement a prescription drug monitoring
program (and to make connections to such program) that satisfies
the criteria described in paragraphs (1) and (2) of subsection
(b), shall be equal to 100 percent.
``(2) Condition.--The condition described in this paragraph,
with respect to a State, is that the State (in this paragraph
referred to as the `administering State') has in place
agreements with all States that are contiguous to such
administering State that, when combined, enable covered
providers in all such contiguous States to access, through the
prescription drug monitoring program, the information that is
described in subsection (b)(1) of covered individuals of such
administering State and that covered providers in such
administering State are able to access through such program.
``(g) Rule of Construction.--Nothing in this section prevents a
State from requiring pharmacists to check the prescription drug history
of covered individuals through a qualified prescription drug monitoring
program before dispensing controlled substances to such individuals.
``(h) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled substance'
means a drug that is included in schedule II of section 202(c)
of the Controlled Substances Act and, at the option
[[Page 132 STAT. 3970]]
of the State involved, a drug included in schedule III or IV of
such section.
``(2) Covered individual.--The term `covered individual'
means, with respect to a State, an individual who is enrolled in
the State plan (or under a waiver of such plan). Such term does
not include an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility, of
a facility described in section 1905(d), or of another
facility for which frequently abused drugs are dispensed
for residents through a contract with a single pharmacy;
or
``(C) the State elects to treat as exempted from
such term.
``(3) Covered provider.--
``(A) In general.--The term `covered provider'
means, subject to subparagraph (B), with respect to a
State, a health care provider who is participating under
the State plan (or waiver of the State plan) and
licensed, registered, or otherwise permitted by the
State to prescribe a controlled substance (or the
designee of such provider).
``(B) Exceptions.--
``(i) In general.--Beginning October 1, 2021,
for purposes of this section, such term does not
include a health care provider included in any
type of health care provider determined by the
Secretary to be exempt from application of this
section under clause (ii).
``(ii) Exceptions process.--Not later than
October 1, 2020, the Secretary, after consultation
with the National Association of Medicaid
Directors, national health care provider
associations, Medicaid beneficiary advocates, and
advocates for individuals with rare diseases,
shall determine, based on such consultations, the
types of health care providers (if any) that
should be exempted from the definition of the term
`covered provider' for purposes of this
section.''.
(b) <<NOTE: 42 USC 1396w-3a note.>> Guidance.--Not later than
October 1, 2019, the Administrator of the Centers for Medicare &
Medicaid Services, in consultation with the Director of the Centers for
Disease Control and Prevention, shall issue guidance on best practices
on the uses of prescription drug monitoring programs required of
prescribers and on protecting the privacy of Medicaid beneficiary
information maintained in and accessed through prescription drug
monitoring programs.
(c) <<NOTE: 42 USC 1396w-3a note.>> Development of Model State
Practices.--
(1) In general.--Not later than October 1, 2020, the
Secretary of Health and Human Services shall develop and publish
model practices to assist State Medicaid program operations in
identifying and implementing strategies to utilize data-sharing
agreements described in the matter following paragraph (2) of
section 1944(b) of the Social Security Act, as added by
subsection (a), for the following purposes:
(A) Monitoring and preventing fraud, waste, and
abuse.
(B) Improving health care for individuals enrolled
in a State plan under title XIX of such Act (or under a
waiver of such plan) who--
[[Page 132 STAT. 3971]]
(i) transition in and out of coverage under
such title;
(ii) may have sources of health care coverage
in addition to coverage under such title; or
(iii) pay for prescription drugs with cash.
(C) Any other purposes specified by the Secretary.
(2) Elements of model practices.--The model practices
described in paragraph (1)--
(A) shall include strategies for assisting States in
allowing the medical director or pharmacy director (or
designees of such a director) of managed care
organizations or pharmaceutical benefit managers to
access information with respect to all covered
individuals served by such managed care organizations or
pharmaceutical benefit managers to access as a single
data set, in an electronic format; and
(B) shall include any appropriate beneficiary
protections and privacy guidelines.
(3) Consultation.--In developing model practices under this
subsection, the Secretary shall consult with the National
Association of Medicaid Directors, managed care entities (as
defined in section 1932(a)(1)(B) of the Social Security Act)
with contracts with States pursuant to section 1903(m) of such
Act, pharmaceutical benefit managers, physicians and other
health care providers, beneficiary advocates, and individuals
with expertise in health care technology related to prescription
drug monitoring programs and electronic health records.
(d) Report by Comptroller General.--Not later than October 1, 2020,
the Comptroller General of the United States shall issue a report
examining the operation of prescription drug monitoring programs
administered by States, including data security and access standards
used by such programs.
Subtitle F--IMD CARE Act
SEC. 5051. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This title may be cited as the ``Individuals in Medicaid Deserve
Care that is Appropriate and Responsible in its Execution Act'' or the
``IMD CARE Act''.
SEC. 5052. STATE OPTION TO PROVIDE MEDICAID COVERAGE FOR CERTAIN
INDIVIDUALS WITH SUBSTANCE USE DISORDERS
WHO ARE PATIENTS IN CERTAIN INSTITUTIONS
FOR MENTAL DISEASES.
(a) In General.--Title XIX of the Social Security Act (42 U.S.C.
1396 et seq.), as amended by preceding sections of this Act, is further
amended--
(1) in section 1905(a), in the subdivision (B) that follows
paragraph (30), by inserting ``(except in the case of services
provided under a State plan amendment described in section
1915(l))'' before the period; and
(2) in section 1915, by adding at the end the following new
subsection:
``(l) State Plan Amendment Option to Provide Medical Assistance for
Certain Individuals Who Are Patients in Certain Institutions for Mental
Diseases.--
[[Page 132 STAT. 3972]]
``(1) In general.--With respect to calendar quarters
beginning during the period beginning October 1, 2019, and
ending September 30, 2023, a State may elect, through a State
plan amendment, to provide medical assistance for items and
services furnished to an eligible individual who is a patient in
an eligible institution for mental diseases in accordance with
the requirements of this subsection.
``(2) Payments.--Subject to paragraphs (3) and (4), amounts
expended under a State plan amendment under paragraph (1) for
services described in such paragraph furnished, with respect to
a 12-month period, to an eligible individual who is a patient in
an eligible institution for mental diseases shall be treated as
medical assistance for which payment is made under section
1903(a) but only to the extent that such services are furnished
for not more than a period of 30 days (whether or not
consecutive) during such 12-month period.
``(3) Maintenance of effort.--
``(A) In general.--As a condition for a State
receiving payments under section 1903(a) for medical
assistance provided in accordance with this subsection,
the State shall (during the period in which it so
furnished such medical assistance through a State plan
amendment under this subsection) maintain on an annual
basis a level of funding expended by the State (and
political subdivisions thereof) other than under this
title from non-Federal funds for--
``(i) items and services furnished to eligible
individuals who are patients in eligible
institutions for mental diseases that is not less
than the level of such funding for such items and
services for the most recently ended fiscal year
as of the date of enactment of this subsection or,
if higher, for the most recently ended fiscal year
as of the date the State submits a State plan
amendment to the Secretary to provide such medical
assistance in accordance with this subsection; and
``(ii) items and services (including services
described in subparagraph (B)) furnished to
eligible individuals in outpatient and community-
based settings that is not less than the level of
such funding for such items and services for the
most recently ended fiscal year as of the date of
enactment of this subsection or, if higher, for
the most recently ended fiscal year as of the date
the State submits a State plan amendment to the
Secretary to provide such medical assistance in
accordance with this subsection.
``(B) Services described.--For purposes of
subparagraph (A)(ii), services described in this
subparagraph are the following:
``(i) Outpatient and community-based substance
use disorder treatment.
``(ii) Evidence-based recovery and support
services.
``(iii) Clinically-directed therapeutic
treatment to facilitate recovery skills, relapse
prevention, and emotional coping strategies.
``(iv) Outpatient medication-assisted
treatment, related therapies, and pharmacology.
``(v) Counseling and clinical monitoring.
[[Page 132 STAT. 3973]]
``(vi) Outpatient withdrawal management and
related treatment designed to alleviate acute
emotional, behavioral, cognitive, or biomedical
distress resulting from, or occurring with, an
individual's use of alcohol and other drugs.
``(vii) Routine monitoring of medication
adherence.
``(viii) Other outpatient and community-based
services for the treatment of substance use
disorders, as designated by the Secretary.
``(C) State reporting requirement.--
``(i) In general.--Prior to approval of a
State plan amendment under this subsection, as a
condition for a State receiving payments under
section 1903(a) for medical assistance provided in
accordance with this subsection, the State shall
report to the Secretary, in accordance with the
process established by the Secretary under clause
(ii), the information deemed necessary by the
Secretary under such clause.
``(ii) Process.--Not later than the date that
is 8 months after the date of enactment of this
subsection, the Secretary shall establish a
process for States to report to the Secretary, at
such time and in such manner as the Secretary
deems appropriate, such information as the
Secretary deems necessary to verify a State's
compliance with subparagraph (A).
``(4) Ensuring a continuum of services.--
``(A) In general.--As a condition for a State
receiving payments under section 1903(a) for medical
assistance provided in accordance with this subsection,
the State shall carry out each of the requirements
described in subparagraphs (B) through (D).
``(B) Notification.--Prior to approval of a State
plan amendment under this subsection, the State shall
notify the Secretary of how the State will ensure that
eligible individuals receive appropriate evidence-based
clinical screening prior to being furnished with items
and services in an eligible institution for mental
diseases, including initial and periodic assessments to
determine the appropriate level of care, length of stay,
and setting for such care for each individual.
``(C) Outpatient services; inpatient and residential
services.--
``(i) Outpatient services.--The State shall,
at a minimum, provide medical assistance for
services that could otherwise be covered under the
State plan, consistent with each of the following
outpatient levels of care:
``(I) Early intervention for
individuals who, for a known reason, are
at risk of developing substance-related
problems and for individuals for whom
there is not yet sufficient information
to document a diagnosable substance use
disorder.
``(II) Outpatient services for less
than 9 hours per week for adults, and
for less than 6 hours per week for
adolescents, for recovery or
motivational enhancement therapies and
strategies.
[[Page 132 STAT. 3974]]
``(III) Intensive outpatient
services for 9 hours or more per week
for adults, and for 6 hours or more per
week for adolescents, to treat
multidimensional instability.
``(IV) Partial hospitalization
services for 20 hours or more per week
for adults and adolescents to treat
multidimensional instability that does
not require 24-hour care.
``(ii) Inpatient and residential services.--
The State shall provide medical assistance for
services that could otherwise be covered under the
State plan, consistent with at least 2 of the
following inpatient and residential levels of
care:
``(I) Clinically managed, low-
intensity residential services that
provide adults and adolescents with 24-
hour living support and structure with
trained personnel and at least 5 hours
of clinical service per week per
individual.
``(II) Clinically managed,
population-specific, high-intensity
residential services that provide adults
with 24-hour care with trained
counselors to stabilize multidimensional
imminent danger along with less intense
milieu and group treatment for those
with cognitive or other impairments
unable to use full active milieu or
therapeutic community.
``(III) Clinically managed, medium-
intensity residential services for
adolescents, and clinically managed,
high-intensity residential services for
adults, that provide 24-hour care with
trained counselors to stabilize
multidimensional imminent danger and
preparation for outpatient treatment.
``(IV) Medically monitored, high-
intensity inpatient services for
adolescents, and medically monitored,
intensive inpatient services withdrawal
management for adults, that provide 24-
hour nursing care, make physicians
available for significant problems in
Dimensions 1, 2, or 3, and provide
counseling services 16 hours per day.
``(V) Medically managed, intensive
inpatient services for adolescents and
adults that provide 24-hour nursing care
and daily physician care for severe,
unstable problems in Dimensions 1, 2 or
3.
``(D) Transition of care.--In order to ensure an
appropriate transition for an eligible individual from
receiving care in an eligible institution for mental
diseases to receiving care at a lower level of clinical
intensity within the continuum of care (including
outpatient services), the State shall ensure that--
``(i) a placement in such eligible institution
for mental diseases would allow for an eligible
individual's successful transition to the
community, considering such factors as proximity
to an individual's support network (such as family
members, employment, and counseling and other
services near an individual's residence); and
[[Page 132 STAT. 3975]]
``(ii) all eligible institutions for mental
diseases that furnish items and services to
individuals for which medical assistance is
provided under the State plan--
``(I) are able to provide care at
such lower level of clinical intensity;
or
``(II) have an established
relationship with another facility or
provider that is able to provide care at
such lower level of clinical intensity
and accepts patients receiving medical
assistance under this title under which
the eligible institution for mental
diseases may arrange for individuals to
receive such care from such other
facility or provider.
``(5) Application to managed care.--Payments for, and
limitations to, medical assistance furnished in accordance with
this subsection shall be in addition to and shall not be
construed to limit or supersede the ability of States to make
monthly capitation payments to managed care organizations for
individuals receiving treatment in institutions for mental
diseases in accordance with section 438.6(e) of title 42, Code
of Federal Regulations (or any successor regulation).
``(6) Other medical assistance.--The provision of medical
assistance for items and services furnished to an eligible
individual who is a patient in an eligible institution for
mental diseases in accordance with the requirements of this
subsection shall not prohibit Federal financial participation
for medical assistance for items or services that are provided
to such eligible individual in or away from the eligible
institution for mental disease during any period in which the
eligible individual is receiving items or services in accordance
with this subsection.
``(7) Definitions.--In this subsection:
``(A) Dimensions 1, 2, or 3.--The term `Dimensions
1, 2, or 3' has the meaning given that term for purposes
of the publication of the American Society of Addiction
Medicine entitled `The ASAM Criteria: Treatment Criteria
for Addictive Substance-Related, and Co-Occurring
Conditions, 2013'.
``(B) Eligible individual.--The term `eligible
individual' means an individual who--
``(i) with respect to a State, is enrolled for
medical assistance under the State plan or a
waiver of such plan;
``(ii) is at least 21 years of age;
``(iii) has not attained 65 years of age; and
``(iv) has at least 1 substance use disorder.
``(C) Eligible institution for mental diseases.--The
term `eligible institution for mental diseases' means an
institution for mental diseases that--
``(i) follows reliable, evidence-based
practices; and
``(ii) offers at least 2 forms of medication-
assisted treatment for substance use disorders on
site, including, in the case of medication-
assisted treatment for opioid use disorder, at
least 1 antagonist and 1 partial agonist.
``(D) Institution for mental diseases.--The term
`institution for mental diseases' has the meaning given
that term in section 1905(i).''.
[[Page 132 STAT. 3976]]
(b) <<NOTE: 42 USC 1396n note.>> Rule of Construction.--Nothing in
the amendments made by subsection (a) shall be construed as encouraging
a State to place an individual in an inpatient or a residential care
setting where a home or community-based care setting would be more
appropriate for the individual, or as preventing a State from conducting
or pursuing a demonstration project under section 1115 of the Social
Security Act to improve access to, and the quality of, substance use
disorder treatment for eligible populations.
Subtitle G--Medicaid Improvement Fund
SEC. 5061. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w-
1(b)(1)) is amended by striking ``$0'' and inserting ``$31,000,000''.
TITLE VI--OTHER MEDICARE PROVISIONS
Subtitle A--Testing of Incentive Payments for Behavioral Health
Providers for Adoption and Use of Certified Electronic Health Record
Technology
SEC. 6001. TESTING OF INCENTIVE PAYMENTS FOR BEHAVIORAL HEALTH
PROVIDERS FOR ADOPTION AND USE OF
CERTIFIED ELECTRONIC HEALTH RECORD
TECHNOLOGY.
Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C.
1315a(b)(2)(B)) is amended by adding at the end the following new
clause:
``(xxv) Providing, for the adoption and use of
certified EHR technology (as defined in section
1848(o)(4)) to improve the quality and
coordination of care through the electronic
documentation and exchange of health information,
incentive payments to behavioral health providers
(such as psychiatric hospitals (as defined in
section 1861(f)), community mental health centers
(as defined in section 1861(ff)(3)(B)), hospitals
that participate in a State plan under title XIX
or a waiver of such plan, treatment facilities
that participate in such a State plan or such a
waiver, mental health or substance use disorder
providers that participate in such a State plan or
such a waiver, clinical psychologists (as defined
in section 1861(ii)), nurse practitioners (as
defined in section 1861(aa)(5)) with respect to
the provision of psychiatric services, and
clinical social workers (as defined in section
1861(hh)(1))).''.
Subtitle B <<NOTE: Abuse Deterrent Access Act of 2018.>> --Abuse
Deterrent Access
SEC. 6011. SHORT TITLE.
This subtitle may be cited at the ``Abuse Deterrent Access Act of
2018''.
[[Page 132 STAT. 3977]]
SEC. 6012. STUDY ON ABUSE-DETERRENT OPIOID FORMULATIONS ACCESS
BARRIERS UNDER MEDICARE.
(a) In General.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
conduct a study and submit to Congress a report on--
(1) the adequacy of access to abuse-deterrent opioid
formulations for individuals with chronic pain enrolled in an
MA-PD plan under part C of title XVIII of the Social Security
Act or a prescription drug plan under part D of such title of
such Act, taking into account any barriers preventing such
individuals from accessing such formulations under such MA-PD or
part D plans, such as cost-sharing tiers, fail-first
requirements, the price of such formulations, and prior
authorization requirements; and
(2) the effectiveness of abuse-deterrent opioid formulations
in preventing opioid abuse or misuse; the impact of the use of
abuse-deterrent opioid formulations on the use or abuse of other
prescription or illicit opioids (including changes in deaths
from such opioids); and other public health consequences of the
use of abuse-deterrent opioid formulations, such as an increase
in rates of human immunodeficiency virus.
(b) Definition of Abuse-Deterrent Opioid Formulation.--In this
section, the term ``abuse-deterrent opioid formulation'' means an opioid
that is a prodrug or that has certain abuse-deterrent properties, such
as physical or chemical barriers, agonist or antagonist combinations,
aversion properties, delivery system mechanisms, or other features
designed to prevent abuse of such opioid.
Subtitle C--Medicare Opioid Safety Education
SEC. 6021. MEDICARE OPIOID SAFETY EDUCATION.
(a) In General.--Section 1804 of the Social Security Act (42 U.S.C.
1395b-2) is amended by adding at the end the following new subsection:
``(d) The notice provided under subsection (a) shall include--
``(1) references to educational resources regarding opioid
use and pain management;
``(2) a description of categories of alternative, non-opioid
pain management treatments covered under this title; and
``(3) a suggestion for the beneficiary to talk to a
physician regarding opioid use and pain management.''.
(b) <<NOTE: 42 USC 1395b-2 note.>> Effective Date.--The amendment
made by subsection (a) shall apply to notices distributed prior to each
Medicare open enrollment period beginning after January 1, 2019.
Subtitle D <<NOTE: Opioid Addiction Action Plan Act.>> --Opioid
Addiction Action Plan
SEC. 6031. SHORT TITLE.
This subtitle may be cited as the ``Opioid Addiction Action Plan
Act''.
[[Page 132 STAT. 3978]]
SEC. 6032. ACTION PLAN ON RECOMMENDATIONS FOR CHANGES UNDER
MEDICARE AND MEDICAID TO PREVENT OPIOIDS
ADDICTIONS AND ENHANCE ACCESS TO
MEDICATION-ASSISTED TREATMENT.
(a) In General.--Not later than January 1, 2020, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary''), in collaboration with the Pain Management Best Practices
Inter-Agency Task Force convened under section 101(b) of the
Comprehensive Addiction and Recovery Act of 2016 (Public Law 114-198),
shall develop an action plan as described in subsection (b).
(b) Action Plan Components.--The action plan shall include a review
by the Secretary of Medicare and Medicaid payment and coverage policies
that may be viewed as potential obstacles to an effective response to
the opioid crisis, and recommendations, as determined appropriate by the
Secretary, on the following:
(1) A review of payment and coverage policies under the
Medicare program under title XVIII of the Social Security Act
and the Medicaid program under title XIX of such Act, including
a review of coverage and payment under such programs of all
medication-assisted treatment approved by the Food and Drug
Administration related to the treatment of opioid use disorder
and other therapies that manage chronic and acute pain and treat
and minimize risk of opioid misuse and abuse, including in such
review, payment under the Medicare prospective payment system
for inpatient hospital services under section 1886(d) of such
Act (42 U.S.C. 1395ww(d)) and the Medicare prospective payment
system for hospital outpatient department services under section
1833(t) of such Act (42 U.S.C. 1395I(t)), to determine whether
those payment policies resulted in incentives or disincentives
that have contributed to the opioid crisis.
(2) Recommendations for payment and service delivery models
to be tested as appropriate by the Center for Medicare and
Medicaid Innovation and other federally authorized demonstration
projects, including value-based models, that may encourage the
use of appropriate medication-assisted treatment approved by the
Food and Drug Administration for the treatment of opioid use
disorder and other therapies that manage chronic and acute pain
and treat and minimize risk of opioid misuse and abuse.
(3) Recommendations for data collection that could
facilitate research and policy-making regarding prevention of
opioid use disorder as well as data that would aid the Secretary
in making coverage and payment decisions under the Medicare and
Medicaid programs related to the access to appropriate opioid
dependence treatments.
(4) A review of Medicare and Medicaid beneficiaries' access
to the full range of medication-assisted treatment approved by
the Food and Drug Administration for the treatment of opioid use
disorder and other therapies that manage chronic and acute pain
and treat and minimize risk of opioid misuse and abuse,
including access of beneficiaries residing in rural or medically
underserved communities.
(5) A review of payment and coverage policies under the
Medicare program and the Medicaid program related to medical
devices that are non-opioid based treatments approved by the
[[Page 132 STAT. 3979]]
Food and Drug Administration for the management of acute pain
and chronic pain, for monitoring substance use withdrawal and
preventing overdoses of controlled substances, and for treating
substance use disorder, including barriers to patient access.
(c) Stakeholder Meetings.--
(1) In general.--Beginning not later than 3 months after the
date of the enactment of this section, the Secretary shall
convene a public stakeholder meeting to solicit public comment
on the components of the action plan described in subsection
(b).
(2) Participants.--Participants of meetings described in
paragraph (1) shall include representatives from the Food and
Drug Administration and National Institutes of Health,
biopharmaceutical industry members, medical researchers, health
care providers, the medical device industry, the Medicare
program, the Medicaid program, and patient advocates.
(d) Request for Information.--Not later than 3 months after the date
of the enactment of this section, the Secretary shall issue a request
for information seeking public feedback regarding ways in which the
Centers for Medicare & Medicaid Services can help address the opioid
crisis through the development of and application of the action plan.
(e) Report to Congress.--Not later than June 1, 2020, the Secretary
shall submit to Congress, and make public, a report that includes--
(1) a summary of the results of the Secretary's review and
any recommendations under the action plan;
(2) the Secretary's planned next steps with respect to the
action plan; and
(3) an evaluation of price trends for drugs used to reverse
opioid overdoses (such as naloxone), including recommendations
on ways to lower such prices for consumers.
(f) Definition of Medication-Assisted Treatment.--In this section,
the term ``medication-assisted treatment'' includes opioid treatment
programs, behavioral therapy, and medications to treat substance abuse
disorder.
Subtitle E <<NOTE: Advancing High Quality Treatment for Opioid Use
Disorders in Medicare Act.>> --Advancing High Quality Treatment for
Opioid Use Disorders in Medicare
SEC. 6041 <<NOTE: 42 USC 1305 note.>> . SHORT TITLE.
This subtitle may be cited as the ``Advancing High Quality Treatment
for Opioid Use Disorders in Medicare Act''.
SEC. 6042. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.
Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is
amended by inserting after section 1866E (42 U.S.C. 1395cc-5) the
following new section:
``SEC. 1866F. <<NOTE: 42 USC 1395cc-6.>> OPIOID USE DISORDER
TREATMENT DEMONSTRATION PROGRAM.
``(a) Implementation of 4-Year Demonstration Program.--
[[Page 132 STAT. 3980]]
``(1) In general.--Not later than January 1, 2021, the
Secretary shall implement a 4-year demonstration program under
this title (in this section referred to as the `Program') to
increase access of applicable beneficiaries to opioid use
disorder treatment services, improve physical and mental health
outcomes for such beneficiaries, and to the extent possible,
reduce expenditures under this title. Under the Program, the
Secretary shall make payments under subsection (e) to
participants (as defined in subsection (c)(1)(A)) for furnishing
opioid use disorder treatment services delivered through opioid
use disorder care teams, or arranging for such services to be
furnished, to applicable beneficiaries participating in the
Program.
``(2) Opioid use disorder treatment services.--For purposes
of this section, the term `opioid use disorder treatment
services'--
``(A) means, with respect to an applicable
beneficiary, services that are furnished for the
treatment of opioid use disorders and that utilize drugs
approved under section 505 of the Federal Food, Drug,
and Cosmetic Act for the treatment of opioid use
disorders in an outpatient setting; and
``(B) includes--
``(i) medication-assisted treatment;
``(ii) treatment planning;
``(iii) psychiatric, psychological, or
counseling services (or any combination of such
services), as appropriate;
``(iv) social support services, as
appropriate; and
``(v) care management and care coordination
services, including coordination with other
providers of services and suppliers not on an
opioid use disorder care team.
``(b) Program Design.--
``(1) In general.--The Secretary shall design the Program in
such a manner to allow for the evaluation of the extent to which
the Program accomplishes the following purposes:
``(A) Reduces hospitalizations and emergency
department visits.
``(B) Increases use of medication-assisted treatment
for opioid use disorders.
``(C) Improves health outcomes of individuals with
opioid use disorders, including by reducing the
incidence of infectious diseases (such as hepatitis C
and HIV).
``(D) Does not increase the total spending on items
and services under this title.
``(E) Reduces deaths from opioid overdose.
``(F) Reduces the utilization of inpatient
residential treatment.
``(2) Consultation.--In designing the Program, including the
criteria under subsection (e)(2)(A), the Secretary shall, not
later than 3 months after the date of the enactment of this
section, consult with specialists in the field of addiction,
clinicians in the primary care community, and beneficiary
groups.
``(c) Participants; Opioid Use Disorder Care Teams.--
``(1) Participants.--
``(A) Definition.--In this section, the term
`participant' means an entity or individual--
[[Page 132 STAT. 3981]]
``(i) that is otherwise enrolled under this
title and that is--
``(I) a physician (as defined in
section 1861(r)(1));
``(II) a group practice comprised of
at least one physician described in
subclause (I);
``(III) a hospital outpatient
department;
``(IV) a federally qualified health
center (as defined in section
1861(aa)(4));
``(V) a rural health clinic (as
defined in section 1861(aa)(2));
``(VI) a community mental health
center (as defined in section
1861(ff)(3)(B));
``(VII) a clinic certified as a
certified community behavioral health
clinic pursuant to section 223 of the
Protecting Access to Medicare Act of
2014; or
``(VIII) any other individual or
entity specified by the Secretary;
``(ii) that applied for and was selected to
participate in the Program pursuant to an
application and selection process established by
the Secretary; and
``(iii) that establishes an opioid use
disorder care team (as defined in paragraph (2))
through employing or contracting with health care
practitioners described in paragraph (2)(A), and
uses such team to furnish or arrange for opioid
use disorder treatment services in the outpatient
setting under the Program.
``(B) Preference.--In selecting participants for the
Program, the Secretary shall give preference to
individuals and entities that are located in areas with
a prevalence of opioid use disorders that is higher than
the national average prevalence.
``(2) Opioid use disorder care teams.--
``(A) In general.--For purposes of this section, the
term `opioid use disorder care team' means a team of
health care practitioners established by a participant
described in paragraph (1)(A) that--
``(i) shall include--
``(I) at least one physician (as
defined in section 1861(r)(1))
furnishing primary care services or
addiction treatment services to an
applicable beneficiary; and
``(II) at least one eligible
practitioner (as defined in paragraph
(3)), who may be a physician who meets
the criterion in subclause (I); and
``(ii) may include other practitioners
licensed under State law to furnish psychiatric,
psychological, counseling, and social services to
applicable beneficiaries.
``(B) Requirements for receipt of payment under
program.--In order to receive payments under subsection
(e), each participant in the Program shall--
``(i) furnish opioid use disorder treatment
services through opioid use disorder care teams to
applicable beneficiaries who agree to receive the
services;
``(ii) meet minimum criteria, as established
by the Secretary; and
[[Page 132 STAT. 3982]]
``(iii) submit to the Secretary, in such form,
manner, and frequency as specified by the
Secretary, with respect to each applicable
beneficiary for whom opioid use disorder treatment
services are furnished by the opioid use disorder
care team, data and such other information as the
Secretary determines appropriate to--
``(I) monitor and evaluate the
Program;
``(II) determine if minimum criteria
are met under clause (ii); and
``(III) determine the incentive
payment under subsection (e).
``(3) Eligible practitioner defined.--For purposes of this
section, the term `eligible practitioner' means a physician or
other health care practitioner, such as a nurse practitioner,
that--
``(A) is enrolled under section 1866(j)(1);
``(B) is authorized to prescribe or dispense
narcotic drugs to individuals for maintenance treatment
or detoxification treatment; and
``(C) has in effect a waiver in accordance with
section 303(g) of the Controlled Substances Act for such
purpose and is otherwise in compliance with regulations
promulgated by the Substance Abuse and Mental Health
Services Administration to carry out such section.
``(d) Participation of Applicable Beneficiaries.--
``(1) Applicable beneficiary defined.--In this section, the
term `applicable beneficiary' means an individual who--
``(A) is entitled to, or enrolled for, benefits
under part A and enrolled for benefits under part B;
``(B) is not enrolled in a Medicare Advantage plan
under part C;
``(C) has a current diagnosis for an opioid use
disorder; and
``(D) meets such other criteria as the Secretary
determines appropriate.
Such term shall include an individual who is dually eligible for
benefits under this title and title XIX if such individual
satisfies the criteria described in subparagraphs (A) through
(D).
``(2) Voluntary beneficiary participation; limitation on
number of beneficiaries.--An applicable beneficiary may
participate in the Program on a voluntary basis and may
terminate participation in the Program at any time. Not more
than 20,000 applicable beneficiaries may participate in the
Program at any time.
``(3) Services.--In order to participate in the Program, an
applicable beneficiary shall agree to receive opioid use
disorder treatment services from a participant. Participation
under the Program shall not affect coverage of or payment for
any other item or service under this title for the applicable
beneficiary.
``(4) Beneficiary access to services.--Nothing in this
section shall be construed as encouraging providers to limit
applicable beneficiary access to services covered under this
[[Page 132 STAT. 3983]]
title, and applicable beneficiaries shall not be required to
relinquish access to any benefit under this title as a condition
of receiving services from a participant in the Program.
``(e) Payments.--
``(1) Per applicable beneficiary per month care management
fee.--
``(A) In general.--The Secretary shall establish a
schedule of per applicable beneficiary per month care
management fees. Such a per applicable beneficiary per
month care management fee shall be paid to a participant
in addition to any other amount otherwise payable under
this title to the health care practitioners in the
participant's opioid use disorder care team or, if
applicable, to the participant. A participant may use
such per applicable beneficiary per month care
management fee to deliver additional services to
applicable beneficiaries, including services not
otherwise eligible for payment under this title.
``(B) Payment amounts.--In carrying out subparagraph
(A), the Secretary may--
``(i) consider payments otherwise payable
under this title for opioid use disorder treatment
services and the needs of applicable
beneficiaries;
``(ii) pay a higher per applicable beneficiary
per month care management fee for an applicable
beneficiary who receives more intensive treatment
services from a participant and for whom those
services are appropriate based on clinical
guidelines for opioid use disorder care;
``(iii) pay a higher per applicable
beneficiary per month care management fee for the
month in which the applicable beneficiary begins
treatment with a participant than in subsequent
months, to reflect the greater time and costs
required for the planning and initiation of
treatment, as compared to maintenance of
treatment; and
``(iv) take into account whether a
participant's opioid use disorder care team refers
applicable beneficiaries to other suppliers or
providers for any opioid use disorder treatment
services.
``(C) No duplicate payment.--The Secretary shall
make payments under this paragraph to only one
participant for services furnished to an applicable
beneficiary during a calendar month.
``(2) Incentive payments.--
``(A) In general.--Under the Program, the Secretary
shall establish a performance-based incentive payment,
which shall be paid (using a methodology established and
at a time determined appropriate by the Secretary) to
participants based on the performance of participants
with respect to criteria, as determined appropriate by
the Secretary, in accordance with subparagraph (B).
``(B) Criteria.--
``(i) In general.--Criteria described in
subparagraph (A) may include consideration of the
following:
``(I) Patient engagement and
retention in treatment.
[[Page 132 STAT. 3984]]
``(II) Evidence-based medication-
assisted treatment.
``(III) Other criteria established
by the Secretary.
``(ii) Required consultation and
consideration.--In determining criteria described
in subparagraph (A), the Secretary shall--
``(I) consult with stakeholders,
including clinicians in the primary care
community and in the field of addiction
medicine; and
``(II) consider existing clinical
guidelines for the treatment of opioid
use disorders.
``(C) No duplicate payment.--The Secretary shall
ensure that no duplicate payments under this paragraph
are made with respect to an applicable beneficiary.
``(f) Multipayer Strategy.--In carrying out the Program, the
Secretary shall encourage other payers to provide similar payments and
to use similar criteria as applied under the Program under subsection
(e)(2)(C). The Secretary may enter into a memorandum of understanding
with other payers to align the methodology for payment provided by such
a payer related to opioid use disorder treatment services with such
methodology for payment under the Program.
``(g) Evaluation.--
``(1) In general.--The Secretary shall conduct an
intermediate and final evaluation of the program. Each such
evaluation shall determine the extent to which each of the
purposes described in subsection (b) have been accomplished
under the Program.
``(2) Reports.--The Secretary shall submit to Congress--
``(A) a report with respect to the intermediate
evaluation under paragraph (1) not later than 3 years
after the date of the implementation of the Program; and
``(B) a report with respect to the final evaluation
under paragraph (1) not later than 6 years after such
date.
``(h) Funding.--
``(1) Administrative funding.--For the purposes of
implementing, administering, and carrying out the Program (other
than for purposes described in paragraph (2)), $5,000,000 shall
be available from the Federal Supplementary Medical Insurance
Trust Fund under section 1841.
``(2) Care management fees and incentives.--For the purposes
of making payments under subsection (e), $10,000,000 shall be
available from the Federal Supplementary Medical Insurance Trust
Fund under section 1841 for each of fiscal years 2021 through
2024.
``(3) Availability.--Amounts transferred under this
subsection for a fiscal year shall be available until expended.
``(i) Waivers.--The Secretary may waive any provision of this title
as may be necessary to carry out the Program under this section.''.
[[Page 132 STAT. 3985]]
Subtitle F-- <<NOTE: Responsible Education Achieves Care and Healthy
Outcomes for Users' Treatment Act of 2018.>> Responsible Education
Achieves Care and Healthy Outcomes for Users' Treatment
SEC. 6051. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This subtitle may be cited as the ``Responsible Education Achieves
Care and Healthy Outcomes for Users' Treatment Act of 2018'' or the
``REACH OUT Act of 2018''.
SEC. 6052. GRANTS TO PROVIDE TECHNICAL ASSISTANCE TO OUTLIER
PRESCRIBERS OF OPIOIDS.
(a) Grants Authorized.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall, through the
Centers for Medicare & Medicaid Services, award grants, contracts, or
cooperative agreements to eligible entities for the purposes described
in subsection (b).
(b) Use of Funds.--Grants, contracts, and cooperative agreements
awarded under subsection (a) shall be used to support eligible entities
through technical assistance--
(1) to educate and provide outreach to outlier prescribers
of opioids about best practices for prescribing opioids;
(2) to educate and provide outreach to outlier prescribers
of opioids about non-opioid pain management therapies; and
(3) to reduce the amount of opioid prescriptions prescribed
by outlier prescribers of opioids.
(c) <<NOTE: 42 USC 1395w-104 note.>> Application.--Each eligible
entity seeking to receive a grant, contract, or cooperative agreement
under subsection (a) shall submit to the Secretary an application, at
such time, in such manner, and containing such information as the
Secretary may require.
(d) Geographic Distribution.--In awarding grants, contracts, and
cooperative agreements under this section, the Secretary shall
prioritize establishing technical assistance resources in each State.
(e) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means--
(A) an organization--
(i) that has demonstrated experience providing
technical assistance to health care professionals
on a State or regional basis; and
(ii) that has at least--
(I) one individual who is a
representative of consumers on its
governing body; and
(II) one individual who is a
representative of health care providers
on its governing body; or
(B) an entity that is a quality improvement entity
with a contract under part B of title XI of the Social
Security Act (42 U.S.C. 1320c et seq.).
(2) Outlier prescriber of opioids.--The term ``outlier
prescriber of opioids'' means, with respect to a period, a
prescriber identified by the Secretary under subparagraph
(D)(ii) of section 1860D-4(c)(4) of the Social Security Act (42
U.S.C. 1395w-104(c)(4)), as added by section 6065 of this Act,
to be an outlier prescriber of opioids for such period.
(3) Prescribers.--The term ``prescriber'' means any health
care professional, including a nurse practitioner or physician
[[Page 132 STAT. 3986]]
assistant, who is licensed to prescribe opioids by the State or
territory in which such professional practices.
(f) Funding.--For purposes of implementing this section, $75,000,000
shall be available from the Federal Supplementary Medical Insurance
Trust Fund under section 1841 of the Social Security Act (42 U.S.C.
1395t), to remain available until expended.
Subtitle G <<NOTE: Preventing Addiction for Susceptible Seniors Act of
2018.>> --Preventing Addiction for Susceptible Seniors
SEC. 6061. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This subtitle may be cited as the ``Preventing Addiction for
Susceptible Seniors Act of 2018'' or the ``PASS Act of 2018''.
SEC. 6062. ELECTRONIC PRIOR AUTHORIZATION FOR COVERED PART D
DRUGS.
Section 1860D-4(e)(2) of the Social Security Act (42 U.S.C. 1395w-
104(e)(2)) is amended by adding at the end the following new
subparagraph:
``(E) Electronic prior authorization.--
``(i) In general.--Not later than January 1,
2021, the program shall provide for the secure
electronic transmission of--
``(I) a prior authorization request
from the prescribing health care
professional for coverage of a covered
part D drug for a part D eligible
individual enrolled in a part D plan (as
defined in section 1860D-23(a)(5)) to
the PDP sponsor or Medicare Advantage
organization offering such plan; and
``(II) a response, in accordance
with this subparagraph, from such PDP
sponsor or Medicare Advantage
organization, respectively, to such
professional.
``(ii) Electronic transmission.--
``(I) Exclusions.--For purposes of
this subparagraph, a facsimile, a
proprietary payer portal that does not
meet standards specified by the
Secretary, or an electronic form shall
not be treated as an electronic
transmission described in clause (i).
``(II) Standards.--In order to be
treated, for purposes of this
subparagraph, as an electronic
transmission described in clause (i),
such transmission shall comply with
technical standards adopted by the
Secretary in consultation with the
National Council for Prescription Drug
Programs, other standard setting
organizations determined appropriate by
the Secretary, and stakeholders
including PDP sponsors, Medicare
Advantage organizations, health care
professionals, and health information
technology software vendors.
``(III) Application.--
Notwithstanding any other provision of
law, for purposes of this subparagraph,
the Secretary may require the use of
such standards adopted under subclause
(II) in lieu of
[[Page 132 STAT. 3987]]
any other applicable standards for an
electronic transmission described in
clause (i) for a covered part D drug for
a part D eligible individual.''.
SEC. 6063. PROGRAM INTEGRITY TRANSPARENCY MEASURES UNDER MEDICARE
PARTS C AND D.
(a) In General.--Section 1859 of the Social Security Act (42 U.S.C.
1395w-28) is amended by adding at the end the following new subsection:
``(i) Program Integrity Transparency Measures.--
``(1) Program integrity portal.--
``(A) In general.--Not later than 2 years after the
date of the enactment of this subsection, the Secretary
shall, after consultation with stakeholders, establish a
secure internet website portal (or other successor
technology) that would allow a secure path for
communication between the Secretary, MA plans under this
part, prescription drug plans under part D, and an
eligible entity with a contract under section 1893 (such
as a Medicare drug integrity contractor or an entity
responsible for carrying out program integrity
activities under this part and part D) for the purpose
of enabling through such portal (or other successor
technology)--
``(i) the referral by such plans of
substantiated or suspicious activities, as defined
by the Secretary, of a provider of services
(including a prescriber) or supplier related to
fraud, waste, and abuse for initiating or
assisting investigations conducted by the eligible
entity; and
``(ii) data sharing among such MA plans,
prescription drug plans, and the Secretary.
``(B) Required uses of portal.--The Secretary shall
disseminate the following information to MA plans under
this part and prescription drug plans under part D
through the secure internet website portal (or other
successor technology) established under subparagraph
(A):
``(i) Providers of services and suppliers that
have been referred pursuant to subparagraph (A)(i)
during the previous 12-month period.
``(ii) Providers of services and suppliers who
are the subject of an active exclusion under
section 1128 or who are subject to a suspension of
payment under this title pursuant to section
1862(o) or otherwise.
``(iii) Providers of services and suppliers
who are the subject of an active revocation of
participation under this title, including for not
satisfying conditions of participation.
``(iv) In the case of such a plan that makes a
referral under subparagraph (A)(i) through the
portal (or other successor technology) with
respect to activities of substantiated or
suspicious activities of fraud, waste, or abuse of
a provider of services (including a prescriber) or
supplier, if such provider (including a
prescriber) or supplier has been the subject of an
administrative action under this title or title XI
with respect to similar activities, a notification
to such plan of such action so taken.
[[Page 132 STAT. 3988]]
``(C) Rulemaking.--For purposes of this paragraph,
the Secretary shall, through rulemaking, specify what
constitutes substantiated or suspicious activities of
fraud, waste, and abuse, using guidance such as what is
provided in the Medicare Program Integrity Manual 4.8.
In carrying out this subsection, a fraud hotline tip (as
defined by the Secretary) without further evidence shall
not be treated as sufficient evidence for substantiated
fraud, waste, or abuse.
``(D) HIPAA compliant information only.--For
purposes of this subsection, communications may only
occur if the communications are permitted under the
Federal regulations (concerning the privacy of
individually identifiable health information)
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996.
``(2) Quarterly reports.--Beginning not later than 2 years
after the date of the enactment of this subsection, the
Secretary shall make available to MA plans under this part and
prescription drug plans under part D in a timely manner (but no
less frequently than quarterly) and using information submitted
to an entity described in paragraph (1) through the portal (or
other successor technology) described in such paragraph or
pursuant to section 1893, information on fraud, waste, and abuse
schemes and trends in identifying suspicious activity.
Information included in each such report shall--
``(A) include administrative actions, pertinent
information related to opioid overprescribing, and other
data determined appropriate by the Secretary in
consultation with stakeholders; and
``(B) be anonymized information submitted by plans
without identifying the source of such information.
``(3) Clarification.--Nothing in this subsection shall
preclude or otherwise affect referrals to the Inspector General
of the Department of Health and Human Services or other law
enforcement entities.''.
(b) Contract Requirement to Communicate Plan Corrective Actions
Against Opioids Over-prescribers.--Section 1857(e) of the Social
Security Act (42 U.S.C. 1395w-27(e)) is amended by adding at the end the
following new paragraph:
``(5) Communicating plan corrective actions against opioids
over-prescribers.--
``(A) In general.--Beginning with plan years
beginning on or after January 1, 2021, a contract under
this section with an MA organization shall require the
organization to submit to the Secretary, through the
process established under subparagraph (B), information
on the investigations, credible evidence of suspicious
activities of a provider of services (including a
prescriber) or supplier related to fraud, and other
actions taken by such plans related to inappropriate
prescribing of opioids.
``(B) Process.--Not later than January 1, 2021, the
Secretary shall, in consultation with stakeholders,
establish a process under which MA plans and
prescription drug plans shall submit to the Secretary
information described in subparagraph (A).
[[Page 132 STAT. 3989]]
``(C) Regulations.--For purposes of this paragraph,
including as applied under section 1860D-12(b)(3)(D),
the Secretary shall, pursuant to rulemaking--
``(i) specify a definition for the term
`inappropriate prescribing' and a method for
determining if a provider of services prescribes
inappropriate prescribing; and
``(ii) establish the process described in
subparagraph (B) and the types of information that
shall be submitted through such process.''.
(c) Reference Under Part D to Program Integrity Transparency
Measures.--Section 1860D-4 of the Social Security Act (42 U.S.C. 1395w-
104) is amended by adding at the end the following new subsection:
``(m) Program Integrity Transparency Measures.--For program
integrity transparency measures applied with respect to prescription
drug plan and MA plans, see section 1859(i).''.
SEC. 6064. EXPANDING ELIGIBILITY FOR MEDICATION THERAPY MANAGEMENT
PROGRAMS UNDER PART D.
Section 1860D-4(c)(2)(A)(ii) of the Social Security Act (42 U.S.C.
1395w-104(c)(2)(A)(ii)) is amended--
(1) by redesignating subclauses (I) through (III) as items
(aa) through (cc), respectively, and adjusting the margins
accordingly;
(2) by striking ``are part D eligible individuals who--''
and inserting ``are the following:
``(I) Part D eligible individuals
who--''; and
(3) by adding at the end the following new subclause:
``(II) Beginning January 1, 2021,
at-risk beneficiaries for prescription
drug abuse (as defined in paragraph
(5)(C)).''.
SEC. 6065. COMMIT TO OPIOID MEDICAL PRESCRIBER ACCOUNTABILITY AND
SAFETY FOR SENIORS.
Section 1860D-4(c)(4) of the Social Security Act (42 U.S.C. 1395w-
104(c)(4)) is amended by adding at the end the following new
subparagraph:
``(D) Notification and additional requirements with
respect to outlier prescribers of opioids.--
``(i) Notification.--Not later than January 1,
2021, the Secretary shall, in the case of a
prescriber identified by the Secretary under
clause (ii) to be an outlier prescriber of
opioids, provide, subject to clause (iv), an
annual notification to such prescriber that such
prescriber has been so identified and that
includes resources on proper prescribing methods
and other information as specified in accordance
with clause (iii).
``(ii) Identification of outlier prescribers
of opioids.--
``(I) In general.--The Secretary
shall, subject to subclause (III), using
the valid prescriber National Provider
Identifiers included pursuant to
subparagraph (A) on claims for covered
part D drugs for part D eligible
individuals enrolled in prescription
drug plans under this part or MA-PD
plans under part C and based on the
thresholds
[[Page 132 STAT. 3990]]
established under subclause (II),
identify prescribers that are outlier
opioids prescribers for a period of time
specified by the Secretary.
``(II) Establishment of
thresholds.--For purposes of subclause
(I) and subject to subclause (III), the
Secretary shall, after consultation with
stakeholders, establish thresholds,
based on prescriber specialty and
geographic area, for identifying whether
a prescriber in a specialty and
geographic area is an outlier prescriber
of opioids as compared to other
prescribers of opioids within such
specialty and area.
``(III) Exclusions.--The following
shall not be included in the analysis
for identifying outlier prescribers of
opioids under this clause:
``(aa) Claims for covered
part D drugs for part D eligible
individuals who are receiving
hospice care under this title.
``(bb) Claims for covered
part D drugs for part D eligible
individuals who are receiving
oncology services under this
title.
``(cc) Prescribers who are
the subject of an investigation
by the Centers for Medicare &
Medicaid Services or the
Inspector General of the
Department of Health and Human
Services.
``(iii) Contents of notification.--The
Secretary shall include the following information
in the notifications provided under clause (i):
``(I) Information on how such
prescriber compares to other prescribers
within the same specialty and geographic
area.
``(II) Information on opioid
prescribing guidelines, based on input
from stakeholders, that may include the
Centers for Disease Control and
Prevention guidelines for prescribing
opioids for chronic pain and guidelines
developed by physician organizations.
``(III) Other information determined
appropriate by the Secretary.
``(iv) Modifications and expansions.--
``(I) Frequency.--Beginning 5 years
after the date of the enactment of this
subparagraph, the Secretary may change
the frequency of the notifications
described in clause (i) based on
stakeholder input and changes in opioid
prescribing utilization and trends.
``(II) Expansion to other
prescriptions.--The Secretary may expand
notifications under this subparagraph to
include identifications and
notifications with respect to concurrent
prescriptions of covered Part D drugs
used in combination with opioids that
are considered to have adverse side
effects when so used in such
combination, as determined by the
Secretary.
``(v) Additional requirements for persistent
outlier prescribers.--In the case of a prescriber
who
[[Page 132 STAT. 3991]]
the Secretary determines is persistently
identified under clause (ii) as an outlier
prescriber of opioids, the following shall apply:
``(I) Such prescriber may be
required to enroll in the program under
this title under section 1866(j) if such
prescriber is not otherwise required to
enroll, but only after other appropriate
remedies have been provided, such as the
provision of education funded through
section 6052 of the SUPPORT for Patients
and Communities Act, for a period
determined by the Secretary as
sufficient to correct the prescribing
patterns that lead to identification of
such prescriber as a persistent outlier
prescriber of opioids. The Secretary
shall determine the length of the period
for which such prescriber is required to
maintain such enrollment, which shall be
the minimum period necessary to correct
such prescribing patterns.
``(II) Not less frequently than
annually (and in a form and manner
determined appropriate by the
Secretary), the Secretary, consistent
with clause(iv)(I), shall communicate
information on such prescribers to
sponsors of a prescription drug plan and
Medicare Advantage organizations
offering an MA-PD plan.
``(vi) Public availability of information.--
The Secretary shall make aggregate information
under this subparagraph available on the internet
website of the Centers for Medicare & Medicaid
Services. Such information shall be in a form and
manner determined appropriate by the Secretary and
shall not identify any specific prescriber. In
carrying out this clause, the Secretary shall
consult with interested stakeholders.
``(vii) Opioids defined.--For purposes of this
subparagraph, the term `opioids' has such meaning
as specified by the Secretary.
``(viii) Other activities.--Nothing in this
subparagraph shall preclude the Secretary from
conducting activities that provide prescribers
with information as to how they compare to other
prescribers that are in addition to the activities
under this subparagraph, including activities that
were being conducted as of the date of the
enactment of this subparagraph.''.
SEC. 6066. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this subtitle and the amendments made by this
subtitle. Such requirements shall be carried out using amounts otherwise
authorized to be appropriated.
[[Page 132 STAT. 3992]]
Subtitle H <<NOTE: Expanding Oversight of Opioid Prescribing and Payment
Act of 2018.>> --Expanding Oversight of Opioid Prescribing and Payment
SEC. 6071. SHORT TITLE.
This subtitle may be cited as the ``Expanding Oversight of Opioid
Prescribing and Payment Act of 2018''.
SEC. 6072. MEDICARE PAYMENT ADVISORY COMMISSION REPORT ON OPIOID
PAYMENT, ADVERSE INCENTIVES, AND DATA
UNDER THE MEDICARE PROGRAM.
Not later than March 15, 2019, the Medicare Payment Advisory
Commission shall submit to Congress a report on, with respect to the
Medicare program under title XVIII of the Social Security Act, the
following:
(1) A description of how the Medicare program pays for pain
management treatments (both opioid and non-opioid pain
management alternatives) in both inpatient and outpatient
hospital settings.
(2) The identification of incentives under the hospital
inpatient prospective payment system under section 1886 of the
Social Security Act (42 U.S.C. 1395ww) and incentives under the
hospital outpatient prospective payment system under section
1833(t) of such Act (42 U.S.C. 1395l(t)) for prescribing opioids
and incentives under each such system for prescribing non-opioid
treatments, and recommendations as the Commission deems
appropriate for addressing any of such incentives that are
adverse incentives.
(3) A description of how opioid use is tracked and monitored
through Medicare claims data and other mechanisms and the
identification of any areas in which further data and methods
are needed for improving data and understanding of opioid use.
SEC. 6073. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this subtitle. Such requirements shall be carried
out using amounts otherwise authorized to be appropriated.
Subtitle I <<NOTE: Dr. Todd Graham Pain Management, Treatment, and
Recovery Act of 2018.>> --Dr. Todd Graham Pain Management, Treatment,
and Recovery
SEC. 6081. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This subtitle may be cited as the ``Dr. Todd Graham Pain Management,
Treatment, and Recovery Act of 2018''.
SEC. 6082. REVIEW AND ADJUSTMENT OF PAYMENTS UNDER THE MEDICARE
OUTPATIENT PROSPECTIVE PAYMENT SYSTEM TO
AVOID FINANCIAL INCENTIVES TO USE
OPIOIDS INSTEAD OF NON-OPIOID
ALTERNATIVE TREATMENTS.
(a) Outpatient Prospective Payment System.--Section 1833(t) of the
Social Security Act (42 U.S.C. 1395l(t)) is amended by adding at the end
the following new paragraph:
``(22) Review and revisions of payments for non-opioid
alternative treatments.--
[[Page 132 STAT. 3993]]
``(A) In general.--With respect to payments made
under this subsection for covered OPD services (or
groups of services), including covered OPD services
assigned to a comprehensive ambulatory payment
classification, the Secretary--
``(i) shall, as soon as practicable, conduct a
review (part of which may include a request for
information) of payments for opioids and evidence-
based non-opioid alternatives for pain management
(including drugs and devices, nerve blocks,
surgical injections, and neuromodulation) with a
goal of ensuring that there are not financial
incentives to use opioids instead of non-opioid
alternatives;
``(ii) may, as the Secretary determines
appropriate, conduct subsequent reviews of such
payments; and
``(iii) shall consider the extent to which
revisions under this subsection to such payments
(such as the creation of additional groups of
covered OPD services to classify separately those
procedures that utilize opioids and non-opioid
alternatives for pain management) would reduce
payment incentives to use opioids instead of non-
opioid alternatives for pain management.
``(B) Priority.--In conducting the review under
clause (i) of subparagraph (A) and considering revisions
under clause (iii) of such subparagraph, the Secretary
shall focus on covered OPD services (or groups of
services) assigned to a comprehensive ambulatory payment
classification, ambulatory payment classifications that
primarily include surgical services, and other services
determined by the Secretary which generally involve
treatment for pain management.
``(C) Revisions.--If the Secretary identifies
revisions to payments pursuant to subparagraph (A)(iii),
the Secretary shall, as determined appropriate, begin
making such revisions for services furnished on or after
January 1, 2020. Revisions under the previous sentence
shall be treated as adjustments for purposes of
application of paragraph (9)(B).
``(D) Rules of construction.--Nothing in this
paragraph shall be construed to preclude the Secretary--
``(i) from conducting a demonstration before
making the revisions described in subparagraph
(C); or
``(ii) prior to implementation of this
paragraph, from changing payments under this
subsection for covered OPD services (or groups of
services) which include opioids or non-opioid
alternatives for pain management.''.
(b) Ambulatory Surgical Centers.--Section 1833(i) of the Social
Security Act (42 U.S.C. 1395l(i)) is amended by adding at the end the
following new paragraph:
``(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including the second
sentence of subparagraph (C) of such paragraph, to payment for services
under this subsection, and make such revisions under
[[Page 132 STAT. 3994]]
this paragraph, in an appropriate manner (as determined by the
Secretary).''.
SEC. 6083. EXPANDING ACCESS UNDER THE MEDICARE PROGRAM TO
ADDICTION TREATMENT IN FEDERALLY
QUALIFIED HEALTH CENTERS AND RURAL
HEALTH CLINICS.
(a) Federally Qualified Health Centers.--Section 1834(o) of the
Social Security Act (42 U.S.C. 1395m(o)) is amended by adding at the end
the following new paragraph:
``(3) Additional payments for certain fqhcs with physicians
or other practitioners receiving data 2000 waivers.--
``(A) In general.--In the case of a Federally
qualified health center with respect to which, beginning
on or after January 1, 2019, Federally qualified health
center services (as defined in section 1861(aa)(3)) are
furnished for the treatment of opioid use disorder by a
physician or practitioner who meets the requirements
described in subparagraph (C), the Secretary shall,
subject to availability of funds under subparagraph (D),
make a payment (at such time and in such manner as
specified by the Secretary) to such Federally qualified
health center after receiving and approving an
application submitted by such Federally qualified health
center under subparagraph (B). Such a payment shall be
in an amount determined by the Secretary, based on an
estimate of the average costs of training for purposes
of receiving a waiver described in subparagraph (C)(ii).
Such a payment may be made only one time with respect to
each such physician or practitioner.
``(B) Application.--In order to receive a payment
described in subparagraph (A), a Federally qualified
health center shall submit to the Secretary an
application for such a payment at such time, in such
manner, and containing such information as specified by
the Secretary. A Federally qualified health center may
apply for such a payment for each physician or
practitioner described in subparagraph (A) furnishing
services described in such subparagraph at such center.
``(C) Requirements.--For purposes of subparagraph
(A), the requirements described in this subparagraph,
with respect to a physician or practitioner, are the
following:
``(i) The physician or practitioner is
employed by or working under contract with a
Federally qualified health center described in
subparagraph (A) that submits an application under
subparagraph (B).
``(ii) The physician or practitioner first
receives a waiver under section 303(g) of the
Controlled Substances Act on or after January 1,
2019.
``(D) Funding.--For purposes of making payments
under this paragraph, there are appropriated, out of
amounts in the Treasury not otherwise appropriated,
$6,000,000, which shall remain available until
expended.''.
(b) Rural Health Clinic.--Section 1833 of the Social Security Act
(42 U.S.C. 1395l) is amended--
(1) by redesignating the subsection (z) relating to medical
review of spinal subluxation services as subsection (aa); and
(2) by adding at the end the following new subsection:
[[Page 132 STAT. 3995]]
``(bb) Additional Payments for Certain Rural Health Clinics With
Physicians or Practitioners Receiving DATA 2000 Waivers.--
``(1) In general.--In the case of a rural health clinic with
respect to which, beginning on or after January 1, 2019, rural
health clinic services (as defined in section 1861(aa)(1)) are
furnished for the treatment of opioid use disorder by a
physician or practitioner who meets the requirements described
in paragraph (3), the Secretary shall, subject to availability
of funds under paragraph (4), make a payment (at such time and
in such manner as specified by the Secretary) to such rural
health clinic after receiving and approving an application
described in paragraph (2). Such payment shall be in an amount
determined by the Secretary, based on an estimate of the average
costs of training for purposes of receiving a waiver described
in paragraph (3)(B). Such payment may be made only one time with
respect to each such physician or practitioner.
``(2) Application.--In order to receive a payment described
in paragraph (1), a rural health clinic shall submit to the
Secretary an application for such a payment at such time, in
such manner, and containing such information as specified by the
Secretary. A rural health clinic may apply for such a payment
for each physician or practitioner described in paragraph (1)
furnishing services described in such paragraph at such clinic.
``(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect to a
physician or practitioner, are the following:
``(A) The physician or practitioner is employed by
or working under contract with a rural health clinic
described in paragraph (1) that submits an application
under paragraph (2).
``(B) The physician or practitioner first receives a
waiver under section 303(g) of the Controlled Substances
Act on or after January 1, 2019.
``(4) Funding.--For purposes of making payments under this
subsection, there are appropriated, out of amounts in the
Treasury not otherwise appropriated, $2,000,000, which shall
remain available until expended.''.
SEC. 6084. STUDYING THE AVAILABILITY OF SUPPLEMENTAL BENEFITS
DESIGNED TO TREAT OR PREVENT SUBSTANCE
USE DISORDERS UNDER MEDICARE ADVANTAGE
PLANS.
(a) In General.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall submit to Congress
a report on the availability of supplemental health care benefits (as
described in section 1852(a)(3)(A) of the Social Security Act (42 U.S.C.
1395w-22(a)(3)(A))) designed to treat or prevent substance use disorders
under Medicare Advantage plans offered under part C of title XVIII of
such Act. Such report shall include the analysis described in subsection
(c) and any differences in the availability of such benefits under
specialized MA plans for special needs individuals (as defined in
section 1859(b)(6) of such Act (42 U.S.C. 1395w-28(b)(6))) offered to
individuals entitled to medical assistance under title XIX of such Act
and other such Medicare Advantage plans.
[[Page 132 STAT. 3996]]
(b) Consultation.--The Secretary shall develop the report described
in subsection (a) in consultation with relevant stakeholders,
including--
(1) individuals entitled to benefits under part A or
enrolled under part B of title XVIII of the Social Security Act;
(2) entities who advocate on behalf of such individuals;
(3) Medicare Advantage organizations;
(4) pharmacy benefit managers; and
(5) providers of services and suppliers (as such terms are
defined in section 1861 of such Act (42 U.S.C. 1395x)).
(c) Contents.--The report described in subsection (a) shall include
an analysis on the following:
(1) The extent to which plans described in such subsection
offer supplemental health care benefits relating to coverage
of--
(A) medication-assisted treatments for opioid use,
substance use disorder counseling, peer recovery support
services, or other forms of substance use disorder
treatments (whether furnished in an inpatient or
outpatient setting); and
(B) non-opioid alternatives for the treatment of
pain.
(2) Challenges associated with such plans offering
supplemental health care benefits relating to coverage of items
and services described in subparagraph (A) or (B) of paragraph
(1).
(3) The impact, if any, of increasing the applicable rebate
percentage determined under section 1854(b)(1)(C) of the Social
Security Act (42 U.S.C. 1395w-24(b)(1)(C)) for plans offering
such benefits relating to such coverage would have on the
availability of such benefits relating to such coverage offered
under Medicare Advantage plans.
(4) Potential ways to improve upon such coverage or to
incentivize such plans to offer additional supplemental health
care benefits relating to such coverage.
SEC. 6085. CLINICAL PSYCHOLOGIST SERVICES MODELS UNDER THE CENTER
FOR MEDICARE AND MEDICAID INNOVATION;
GAO STUDY AND REPORT.
(a) CMI Models.--Section 1115A(b)(2)(B) of the Social Security Act
(42 U.S.C. 1315a(b)(2)(B)), as amended by section 6001, is further
amended by adding at the end the following new clauses:
``(xxvi) Supporting ways to familiarize
individuals with the availability of coverage
under part B of title XVIII for qualified
psychologist services (as defined in section
1861(ii)).
``(xxvii) Exploring ways to avoid unnecessary
hospitalizations or emergency department visits
for mental and behavioral health services (such as
for treating depression) through use of a 24-hour,
7-day a week help line that may inform individuals
about the availability of treatment options,
including the availability of qualified
psychologist services (as defined in section
1861(ii)).''.
(b) GAO Study and Report.--Not later than 18 months after the date
of the enactment of this Act, the Comptroller General of the United
States shall conduct a study, and submit to Congress
[[Page 132 STAT. 3997]]
a report, on mental and behavioral health services under the Medicare
program under title XVIII of the Social Security Act, including an
examination of the following:
(1) Information about services furnished by psychiatrists,
clinical psychologists, and other professionals.
(2) Information about ways that Medicare beneficiaries
familiarize themselves about the availability of Medicare
payment for qualified psychologist services (as defined in
section 1861(ii) of the Social Security Act (42 U.S.C.
1395x(ii)) and ways that the provision of such information could
be improved.
SEC. 6086. DR. TODD GRAHAM PAIN MANAGEMENT STUDY.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall conduct a study analyzing best
practices as well as payment and coverage for pain management services
under title XVIII of the Social Security Act and submit to the Committee
on Ways and Means and the Committee on Energy and Commerce of the House
of Representatives and the Committee on Finance of the Senate a report
containing options for revising payment to providers and suppliers of
services and coverage related to the use of multi-disciplinary,
evidence-based, non-opioid treatments for acute and chronic pain
management for individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act. The Secretary
shall make such report available on the public website of the Centers
for Medicare & Medicaid Services.
(b) Consultation.--In developing the report described in subsection
(a), the Secretary shall consult with--
(1) relevant agencies within the Department of Health and
Human Services;
(2) licensed and practicing osteopathic and allopathic
physicians, behavioral health practitioners, physician
assistants, nurse practitioners, dentists, pharmacists, and
other providers of health services;
(3) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(4) substance abuse and mental health professional
organizations;
(5) pain management professional organizations and advocacy
entities, including individuals who personally suffer chronic
pain;
(6) medical professional organizations and medical specialty
organizations;
(7) licensed health care providers who furnish alternative
pain management services;
(8) organizations with expertise in the development of
innovative medical technologies for pain management;
(9) beneficiary advocacy organizations; and
(10) other organizations with expertise in the assessment,
diagnosis, treatment, and management of pain, as determined
appropriate by the Secretary.
(c) Contents.--The report described in subsection (a) shall include
the following:
(1) An analysis of payment and coverage under title XVIII of
the Social Security Act with respect to the following:
[[Page 132 STAT. 3998]]
(A) Evidence-based treatments and technologies for
chronic or acute pain, including such treatments that
are covered, not covered, or have limited coverage under
such title.
(B) Evidence-based treatments and technologies that
monitor substance use withdrawal and prevent overdoses
of opioids.
(C) Evidence-based treatments and technologies that
treat substance use disorders.
(D) Items and services furnished by practitioners
through a multi-disciplinary treatment model for pain
management, including the patient-centered medical home.
(E) Items and services furnished to beneficiaries
with psychiatric disorders, substance use disorders, or
who are at risk of suicide, or have comorbidities and
require consultation or management of pain with one or
more specialists in pain management, mental health, or
addiction treatment.
(2) An evaluation of the following:
(A) Barriers inhibiting individuals entitled to
benefits under part A or enrolled under part B of such
title from accessing treatments and technologies
described in subparagraphs (A) through (E) of paragraph
(1).
(B) Costs and benefits associated with potential
expansion of coverage under such title to include items
and services not covered under such title that may be
used for the treatment of pain, such as acupuncture,
therapeutic massage, and items and services furnished by
integrated pain management programs.
(C) Pain management guidance published by the
Federal Government that may be relevant to coverage
determinations or other coverage requirements under
title XVIII of the Social Security Act.
(3) An assessment of all guidance published by the
Department of Health and Human Services on or after January 1,
2016, relating to the prescribing of opioids. Such assessment
shall consider incorporating into such guidance relevant
elements of the ``Va/DoD Clinical Practice Guideline for Opioid
Therapy for Chronic Pain'' published in February 2017 by the
Department of Veterans Affairs and Department of Defense,
including adoption of elements of the Department of Defense and
Department of Veterans Affairs pain rating scale.
(4) The options described in subsection (d).
(5) The impact analysis described in subsection (e).
(d) Options.--The options described in this subsection are, with
respect to individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act, legislative and
administrative options for accomplishing the following:
(1) Improving coverage of and payment for pain management
therapies without the use of opioids, including interventional
pain therapies, and options to augment opioid therapy with other
clinical and complementary, integrative health services to
minimize the risk of substance use disorder, including in a
hospital setting.
(2) Improving coverage of and payment for medical devices
and non-opioid based pharmacological and non-pharmacological
[[Page 132 STAT. 3999]]
therapies approved or cleared by the Food and Drug
Administration for the treatment of pain as an alternative or
augment to opioid therapy.
(3) Improving and disseminating treatment strategies for
beneficiaries with psychiatric disorders, substance use
disorders, or who are at risk of suicide, and treatment
strategies to address health disparities related to opioid use
and opioid abuse treatment.
(4) Improving and disseminating treatment strategies for
beneficiaries with comorbidities who require a consultation or
comanagement of pain with one or more specialists in pain
management, mental health, or addiction treatment, including in
a hospital setting.
(5) Educating providers on risks of coadministration of
opioids and other drugs, particularly benzodiazepines.
(6) Ensuring appropriate case management for beneficiaries
who transition between inpatient and outpatient hospital
settings, or between opioid therapy to non-opioid therapy, which
may include the use of care transition plans.
(7) Expanding outreach activities designed to educate
providers of services and suppliers under the Medicare program
and individuals entitled to benefits under part A or under part
B of such title on alternative, non-opioid therapies to manage
and treat acute and chronic pain.
(8) Creating a beneficiary education tool on alternatives to
opioids for chronic pain management.
(e) Impact Analysis.--The impact analysis described in this
subsection consists of an analysis of any potential effects implementing
the options described in subsection (d) would have--
(1) on expenditures under the Medicare program; and
(2) on preventing or reducing opioid addiction for
individuals receiving benefits under the Medicare program.
Subtitle <<NOTE: Combating Opioid Abuse for Care in Hospitals Act of
2018.>> J--Combating Opioid Abuse for Care in Hospitals
SEC. 6091. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This subtitle may be cited as the ``Combating Opioid Abuse for Care
in Hospitals Act of 2018'' or the ``COACH Act of 2018''.
SEC. 6092. <<NOTE: 42 USC 1395c note.>> DEVELOPING GUIDANCE ON
PAIN MANAGEMENT AND OPIOID USE DISORDER
PREVENTION FOR HOSPITALS RECEIVING
PAYMENT UNDER PART A OF THE MEDICARE
PROGRAM.
(a) In General.--Not later than July 1, 2019, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall develop and publish on the public website of the
Centers for Medicare & Medicaid Services guidance for hospitals
receiving payment under part A of title XVIII of the Social Security Act
(42 U.S.C. 1395c et seq.) on pain management strategies and opioid use
disorder prevention strategies with respect to individuals entitled to
benefits under such part.
(b) Consultation.--In developing the guidance described in
subsection (a), the Secretary shall consult with relevant stakeholders,
including--
(1) medical professional organizations;
[[Page 132 STAT. 4000]]
(2) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(3) health care consumers or groups representing such
consumers; and
(4) other entities determined appropriate by the Secretary.
(c) Contents.--The guidance described in subsection (a) shall
include, with respect to hospitals and individuals described in such
subsection, the following:
(1) Best practices regarding evidence-based screening and
practitioner education initiatives relating to screening and
treatment protocols for opioid use disorder, including--
(A) methods to identify such individuals at-risk of
opioid use disorder, including risk stratification;
(B) ways to prevent, recognize, and treat opioid
overdoses; and
(C) resources available to such individuals, such as
opioid treatment programs, peer support groups, and
other recovery programs.
(2) Best practices for such hospitals to educate
practitioners furnishing items and services at such hospital
with respect to pain management and substance use disorders,
including education on--
(A) the adverse effects of prolonged opioid use;
(B) non-opioid, evidence-based, non-pharmacological
pain management treatments;
(C) monitoring programs for individuals who have
been prescribed opioids; and
(D) the prescribing of naloxone along with an
initial opioid prescription.
(3) Best practices for such hospitals to make such
individuals aware of the risks associated with opioid use (which
may include use of the notification template described in
paragraph (4)).
(4) A notification template developed by the Secretary, for
use as appropriate, for such individuals who are prescribed an
opioid that--
(A) explains the risks and side effects associated
with opioid use (including the risks of addiction and
overdose) and the importance of adhering to the
prescribed treatment regimen, avoiding medications that
may have an adverse interaction with such opioid, and
storing such opioid safely and securely;
(B) highlights multimodal and evidence-based non-
opioid alternatives for pain management;
(C) encourages such individuals to talk to their
health care providers about such alternatives;
(D) provides for a method (through signature or
otherwise) for such an individual, or person acting on
such individual's behalf, to acknowledge receipt of such
notification template;
(E) is worded in an easily understandable manner and
made available in multiple languages determined
appropriate by the Secretary; and
(F) includes any other information determined
appropriate by the Secretary.
[[Page 132 STAT. 4001]]
(5) Best practices for such hospital to track opioid
prescribing trends by practitioners furnishing items and
services at such hospital, including--
(A) ways for such hospital to establish target
levels, taking into account the specialties of such
practitioners and the geographic area in which such
hospital is located, with respect to opioids prescribed
by such practitioners;
(B) guidance on checking the medical records of such
individuals against information included in prescription
drug monitoring programs;
(C) strategies to reduce long-term opioid
prescriptions; and
(D) methods to identify such practitioners who may
be over-prescribing opioids.
(6) Other information the Secretary determines appropriate,
including any such information from the Opioid Safety Initiative
established by the Department of Veterans Affairs or the Opioid
Overdose Prevention Toolkit published by the Substance Abuse and
Mental Health Services Administration.
SEC. 6093. REQUIRING THE REVIEW OF QUALITY MEASURES RELATING TO
OPIOIDS AND OPIOID USE DISORDER
TREATMENTS FURNISHED UNDER THE MEDICARE
PROGRAM AND OTHER FEDERAL HEALTH CARE
PROGRAMS.
Section 1890A of the Social Security Act (42 U.S.C. 1395aaa-1) is
amended by adding at the end the following new subsection:
``(g) Technical Expert Panel Review of Opioid and Opioid Use
Disorder Quality Measures.--
``(1) In general.--Not later than 180 days after the date of
the enactment of this subsection, the Secretary shall establish
a technical expert panel for purposes of reviewing quality
measures relating to opioids and opioid use disorders, including
care, prevention, diagnosis, health outcomes, and treatment
furnished to individuals with opioid use disorders. The
Secretary may use the entity with a contract under section
1890(a) and amend such contract as necessary to provide for the
establishment of such technical expert panel.
``(2) Review and assessment.--Not later than 1 year after
the date the technical expert panel described in paragraph (1)
is established (and periodically thereafter as the Secretary
determines appropriate), the technical expert panel shall--
``(A) review quality measures that relate to opioids
and opioid use disorders, including existing measures
and those under development;
``(B) identify gaps in areas of quality measurement
that relate to opioids and opioid use disorders, and
identify measure development priorities for such measure
gaps; and
``(C) make recommendations to the Secretary on
quality measures with respect to opioids and opioid use
disorders for purposes of improving care, prevention,
diagnosis, health outcomes, and treatment, including
recommendations for revisions of such measures, need for
development of new measures, and recommendations for
including such measures in the Merit-Based Incentive
Payment System under section 1848(q), the alternative
payment models under section 1833(z)(3)(C), the shared
savings program
[[Page 132 STAT. 4002]]
under section 1899, the quality reporting requirements
for inpatient hospitals under section
1886(b)(3)(B)(viii), and the hospital value-based
purchasing program under section 1886(o).
``(3) Consideration of measures by secretary.--The Secretary
shall consider--
``(A) using opioid and opioid use disorder measures
(including measures used under the Merit-Based Incentive
Payment System under section 1848(q), measures
recommended under paragraph (2)(C), and other such
measures identified by the Secretary) in alternative
payment models under section 1833(z)(3)(C) and in the
shared savings program under section 1899; and
``(B) using opioid measures described in
subparagraph (A), as applicable, in the quality
reporting requirements for inpatient hospitals under
section 1886(b)(3)(B)(viii), and in the hospital value-
based purchasing program under section 1886(o).
``(4) Prioritization of measure development.--The Secretary
shall prioritize for measure development the gaps in quality
measures identified under paragraph (2)(B).
``(5) Prioritization of measure endorsement.--The
Secretary--
``(A) during the period beginning on the date of the
enactment of this subsection and ending on December 31,
2023, shall prioritize the endorsement of measures
relating to opioids and opioid use disorders by the
entity with a contract under subsection (a) of section
1890 in connection with endorsement of measures
described in subsection (b)(2) of such section; and
``(B) on and after January 1, 2024, may prioritize
the endorsement of such measures by such entity.''.
SEC. 6094. TECHNICAL EXPERT PANEL ON REDUCING SURGICAL SETTING
OPIOID USE; DATA COLLECTION ON
PERIOPERATIVE OPIOID USE.
(a) Technical Expert Panel on Reducing Surgical Setting Opioid
Use.--
(1) In general.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall convene a technical expert panel, including
medical and surgical specialty societies and hospital
organizations, to provide recommendations on reducing opioid use
in the inpatient and outpatient surgical settings and on best
practices for pain management, including with respect to the
following:
(A) Approaches that limit patient exposure to
opioids during the perioperative period, including pre-
surgical and post-surgical injections, and that identify
such patients at risk of opioid use disorder pre-
operation.
(B) Shared decision making with patients and
families on pain management, including a review of
payment to ensure payment under the Medicare program
under title XVIII of the Social Security Act accounts
for time spent on shared decision making.
(C) Education on the safe use, storage, and disposal
of opioids.
[[Page 132 STAT. 4003]]
(D) Prevention of opioid misuse and abuse after
discharge.
(E) Development of a clinical algorithm to identify
and treat at-risk, opiate-tolerant patients and reduce
reliance on opioids for acute pain during the
perioperative period.
(2) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall submit to Congress
and make public a report containing the recommendations
developed under paragraph (1) and an action plan for broader
implementation of pain management protocols that limit the use
of opioids in the perioperative setting and upon discharge from
such setting.
(b) Data Collection on Perioperative Opioid Use.--Not later than 1
year after the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to Congress a report that
contains the following:
(1) The diagnosis-related group codes identified by the
Secretary as having the highest volume of surgeries.
(2) With respect to each of such diagnosis-related group
codes so identified, a determination by the Secretary of the
data that is both available and reported on opioid use following
such surgeries, such as with respect to--
(A) surgical volumes, practices, and opioid
prescribing patterns;
(B) opioid consumption, including--
(i) perioperative days of therapy;
(ii) average daily dose at the hospital,
including dosage greater than 90 milligram
morphine equivalent;
(iii) post-discharge prescriptions and other
combination drugs that are used before
intervention and after intervention;
(iv) quantity and duration of opioid
prescription at discharge; and
(v) quantity consumed and number of refills;
(C) regional anesthesia and analgesia practices,
including pre-surgical and post-surgical injections;
(D) naloxone reversal;
(E) post-operative respiratory failure;
(F) information about storage and disposal; and
(G) such other information as the Secretary may
specify.
(3) Recommendations for improving data collection on
perioperative opioid use, including an analysis to identify and
reduce barriers to collecting, reporting, and analyzing the data
described in paragraph (2), including barriers related to
technological availability.
SEC. 6095. <<NOTE: 42 USC 1395hh note.>> REQUIRING THE POSTING
AND PERIODIC UPDATE OF OPIOID
PRESCRIBING GUIDANCE FOR MEDICARE
BENEFICIARIES.
(a) In General.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall post on the public
website of the Centers for Medicare & Medicaid Services all guidance
published by the Department of Health and
[[Page 132 STAT. 4004]]
Human Services on or after January 1, 2016, relating to the prescribing
of opioids and applicable to opioid prescriptions for individuals
entitled to benefits under part A of title XVIII of the Social Security
Act (42 U.S.C. 1395c et seq.) or enrolled under part B of such title of
such Act (42 U.S.C. 1395j et seq.).
(b) Update of Guidance.--
(1) Periodic update.--The Secretary shall, in consultation
with the entities specified in paragraph (2), periodically (as
determined appropriate by the Secretary) update guidance
described in subsection (a) and revise the posting of such
guidance on the website described in such subsection.
(2) Consultation.--The entities specified in this paragraph
are the following:
(A) Medical professional organizations.
(B) Providers and suppliers of services (as such
terms are defined in section 1861 of the Social Security
Act (42 U.S.C. 1395x)).
(C) Health care consumers or groups representing
such consumers.
(D) Other entities determined appropriate by the
Secretary.
Subtitle <<NOTE: Providing Reliable Options for Patients and Educational
Resources Act of 2018. 42 USC 1305 note.>> K--Providing Reliable
Options for Patients and Educational Resources
SEC. 6101. SHORT TITLE.
This subtitle may be cited as the ``Providing Reliable Options for
Patients and Educational Resources Act of 2018'' or the ``PROPER Act of
2018''.
SEC. 6102. REQUIRING MEDICARE ADVANTAGE PLANS AND PART D
PRESCRIPTION DRUG PLANS TO INCLUDE
INFORMATION ON RISKS ASSOCIATED WITH
OPIOIDS AND COVERAGE OF
NONPHARMACOLOGICAL THERAPIES AND
NONOPIOID MEDICATIONS OR DEVICES USED TO
TREAT PAIN.
Section 1860D-4(a)(1) of the Social Security Act (42 U.S.C. 1395w-
104(a)(1)) is amended--
(1) in subparagraph (A), by inserting ``, subject to
subparagraph (C),'' before ``including'';
(2) in subparagraph (B), by adding at the end the following
new clause:
``(vi) For plan year 2021 and each subsequent
plan year, subject to subparagraph (C), with
respect to the treatment of pain--
``(I) the risks associated with
prolonged opioid use; and
``(II) coverage of
nonpharmacological therapies, devices,
and nonopioid medications--
``(aa) in the case of an MA-
PD plan under part C, under such
plan; and
``(bb) in the case of a
prescription drug plan, under
such plan and under parts A and
B.''; and
(3) by adding at the end the following new subparagraph:
``(C) Targeted provision of information.--A PDP
sponsor of a prescription drug plan may, in lieu of
disclosing
[[Page 132 STAT. 4005]]
the information described in subparagraph (B)(vi) to
each enrollee under the plan, disclose such information
through mail or electronic communications to a subset of
enrollees under the plan, such as enrollees who have
been prescribed an opioid in the previous 2-year
period.''.
SEC. 6103. REQUIRING MEDICARE ADVANTAGE PLANS AND PRESCRIPTION
DRUG PLANS TO PROVIDE INFORMATION ON THE
SAFE DISPOSAL OF PRESCRIPTION DRUGS.
(a) Medicare Advantage.--Section 1852 of the Social Security Act (42
U.S.C. 1395w-22) is amended by adding at the end the following new
subsection:
``(n) Provision of Information Relating to the Safe Disposal of
Certain Prescription Drugs.--
``(1) In general.--In the case of an individual enrolled
under an MA or MA-PD plan who is furnished an in-home health
risk assessment on or after January 1, 2021, such plan shall
ensure that such assessment includes information on the safe
disposal of prescription drugs that are controlled substances
that meets the criteria established under paragraph (2). Such
information shall include information on drug takeback programs
that meet such requirements determined appropriate by the
Secretary and information on in-home disposal.
``(2) Criteria.--The Secretary shall, through rulemaking,
establish criteria the Secretary determines appropriate with
respect to information provided to an individual to ensure that
such information sufficiently educates such individual on the
safe disposal of prescription drugs that are controlled
substances.''.
(b) Prescription Drug Plans.--Section 1860D-4(c)(2)(B) of the Social
Security Act (42 U.S.C. 1395w-104(c)(2)(B)) is amended--
(1) by striking ``may include elements that promote'';
(2) by redesignating clauses (i) through (iii) as subclauses
(I) through (III) and adjusting the margins accordingly;
(3) by inserting before subclause (I), as so redesignated,
the following new clause:
``(i) may include elements that promote--'';
(4) in subclause (III), as so redesignated, by striking the
period at the end and inserting ``; and''; and
(5) by adding at the end the following new clause:
``(ii) with respect to plan years beginning on
or after January 1, 2021, shall provide for--
``(I) the provision of information
to the enrollee on the safe disposal of
prescription drugs that are controlled
substances that meets the criteria
established under section 1852(n)(2),
including information on drug takeback
programs that meet such requirements
determined appropriate by the Secretary
and information on in-home disposal; and
``(II) cost-effective means by which
an enrollee may so safely dispose of
such drugs.''.
[[Page 132 STAT. 4006]]
SEC. 6104. REVISING MEASURES USED UNDER THE HOSPITAL CONSUMER
ASSESSMENT OF HEALTHCARE PROVIDERS AND
SYSTEMS SURVEY RELATING TO PAIN
MANAGEMENT.
(a) Restriction on the Use of Pain Questions in HCAHPS.--Section
1886(b)(3)(B)(viii) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(viii)) is amended by adding at the end the following new
subclause:
``(XII)(aa) With respect to a Hospital Consumer Assessment of
Healthcare Providers and Systems survey (or a successor survey)
conducted on or after January 1, 2020, such survey may not include
questions about communication by hospital staff with an individual about
such individual's pain unless such questions take into account, as
applicable, whether an individual experiencing pain was informed about
risks associated with the use of opioids and about non-opioid
alternatives for the treatment of pain.
``(bb) The Secretary shall not include on the Hospital Compare
internet website any measures based on the questions appearing on the
Hospital Consumer Assessment of Healthcare Providers and Systems survey
in 2018 or 2019 about communication by hospital staff with an individual
about such individual's pain.''.
(b) Restriction on Use of 2018 and 2019 Pain Questions in the
Hospital Value-based Purchasing Program.--Section 1886(o)(2)(B) of the
Social Security Act (42 U.S.C. 1395ww(o)(2)(B)) is amended by adding at
the end the following new clause:
``(iii) HCAHPS pain questions.--The Secretary
may not include under subparagraph (A) a measure
that is based on the questions appearing on the
Hospital Consumer Assessment of Healthcare
Providers and Systems survey in 2018 or 2019 about
communication by hospital staff with an individual
about the individual's pain.''.
Subtitle L--Fighting the Opioid Epidemic With Sunshine
SEC. 6111. FIGHTING THE OPIOID EPIDEMIC WITH SUNSHINE.
(a) Inclusion of Information Regarding Payments to Additional
Practitioners.--
(1) In general.--Section 1128G(e)(6) of the Social Security
Act (42 U.S.C. 1320a-7h(e)(6)) is amended--
(A) in subparagraph (A), by adding at the end the
following new clauses:
``(iii) A physician assistant, nurse
practitioner, or clinical nurse specialist (as
such terms are defined in section 1861(aa)(5)).
``(iv) A certified registered nurse
anesthetist (as defined in section 1861(bb)(2)).
``(v) A certified nurse-midwife (as defined in
section 1861(gg)(2)).''; and
(B) in subparagraph (B), by inserting ``, physician
assistant, nurse practitioner, clinical nurse
specialist, certified nurse anesthetist, or certified
nurse-midwife'' after ``physician''.
(2) <<NOTE: 42 USC 1320a-7h note.>> Effective date.--The
amendments made by this subsection shall apply with respect to
information required to
[[Page 132 STAT. 4007]]
be submitted under section 1128G of the Social Security Act (42
U.S.C. 1320a-7h) on or after January 1, 2022.
(b) Sunset of Exclusion of National Provider Identifier of Covered
Recipient in Information Made Publicly Available.--Section
1128G(c)(1)(C)(viii) of the Social Security Act (42 U.S.C. 1320a-
7h(c)(1)(C)(viii)) is amended by striking ``does not contain'' and
inserting ``in the case of information made available under this
subparagraph prior to January 1, 2022, does not contain''.
(c) <<NOTE: 42 USC 1320a-7h note.>> Administration.--Chapter 35 of
title 44, United States Code, shall not apply to this section or the
amendments made by this section.
TITLE VII--PUBLIC HEALTH PROVISIONS
Subtitle A--Awareness and Training
SEC. 7001. REPORT ON EFFECTS ON PUBLIC HEALTH OF SYNTHETIC DRUG
USE.
(a) In General.--Not later than 3 years after the date of the
enactment of this Act, the Secretary of Health and Human Services, in
coordination with the Surgeon General of the Public Health Service,
shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the health effects of new
psychoactive substances, including synthetic drugs, used by adolescents
and young adults.
(b) New Psychoactive Substance Defined.--For purposes of subsection
(a), the term ``new psychoactive substance'' means a controlled
substance analogue (as defined in section 102(32) of the Controlled
Substances Act (21 U.S.C. 802(32)).
SEC. 7002. FIRST RESPONDER TRAINING.
Section 546 of the Public Health Service Act (42 U.S.C. 290ee-1) is
amended--
(1) in subsection (c)--
(A) in paragraph (2), by striking ``and'' at the
end;
(B) in paragraph (3), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(4) train and provide resources for first responders and
members of other key community sectors on safety around
fentanyl, carfentanil, and other dangerous licit and illicit
drugs to protect themselves from exposure to such drugs and
respond appropriately when exposure occurs.'';
(2) in subsection (d), by striking ``and mechanisms for
referral to appropriate treatment for an entity receiving a
grant under this section'' and inserting ``mechanisms for
referral to appropriate treatment, and safety around fentanyl,
carfentanil, and other dangerous licit and illicit drugs'';
(3) in subsection (f)--
(A) in paragraph (3), by striking ``and'' at the
end;
(B) in paragraph (4), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
[[Page 132 STAT. 4008]]
``(5) the number of first responders and members of other
key community sectors trained on safety around fentanyl,
carfentanil, and other dangerous licit and illicit drugs.'';
(4) by redesignating subsection (g) as subsection (h);
(5) by inserting after subsection (f) the following:
``(g) Other Key Community Sectors.--In this section, the term `other
key community sectors' includes substance use disorder treatment
providers, emergency medical services agencies, agencies and
organizations working with prison and jail populations and offender
reentry programs, health care providers, harm reduction groups,
pharmacies, community health centers, tribal health facilities, and
mental health providers.''; and
(6) in subsection (h), as so redesignated, by striking
``$12,000,000 for each of fiscal years 2017 through 2021'' and
inserting ``$36,000,000 for each of fiscal years 2019 through
2023''.
Subtitle B--Pilot Program for Public Health Laboratories To Detect
Fentanyl and Other Synthetic Opioids
SEC. 7011. <<NOTE: 42 USC 247d-10 note.>> PILOT PROGRAM FOR
PUBLIC HEALTH LABORATORIES TO DETECT
FENTANYL AND OTHER SYNTHETIC OPIOIDS.
(a) Grants.--The Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') shall award grants to, or enter
into cooperative agreements with, Federal, State, and local agencies to
improve coordination between public health laboratories and laboratories
operated by law enforcement agencies, such as Customs and Border
Protection and the Drug Enforcement Administration, to improve detection
of synthetic opioids, including fentanyl and its analogues, as described
in subsection (b).
(b) Detection Activities.--The Secretary, in consultation with the
Director of the National Institute of Standards and Technology, the
Director of the Centers for Disease Control and Prevention, the Attorney
General of the United States, and the Administrator of the Drug
Enforcement Administration, shall, for purposes of this section, develop
or identify--
(1) best practices for safely handling and testing synthetic
opioids, including fentanyl and its analogues, including with
respect to reference materials, instrument calibration, and
quality control protocols;
(2) reference materials and quality control standards
related to synthetic opioids, including fentanyl and its
analogues, to enhance--
(A) clinical diagnostics;
(B) postmortem data collection; and
(C) portable testing equipment utilized by law
enforcement and public health officials; and
(3) procedures for the identification of new and emerging
synthetic opioid formulations and procedures for reporting those
findings to appropriate law enforcement agencies and Federal,
State, and local public health laboratories and health
departments, as appropriate.
(c) Laboratories.--The Secretary shall require recipients of grants
or cooperative agreements under subsection (a) to--
[[Page 132 STAT. 4009]]
(1) follow the best practices established under subsection
(b) and have the appropriate capabilities to provide laboratory
testing of controlled substances, such as synthetic fentanyl,
and biospecimens for the purposes of aggregating and reporting
public health information to Federal, State, and local public
health officials, laboratories, and other entities the Secretary
deems appropriate;
(2) work with law enforcement agencies and public health
authorities, as practicable;
(3) provide early warning information to Federal, State, and
local law enforcement agencies and public health authorities
regarding trends or other data related to the supply of
synthetic opioids, including fentanyl and its analogues;
(4) provide biosurveillance capabilities with respect to
identifying trends in adverse health outcomes associated with
non-fatal exposures; and
(5) provide diagnostic testing, as appropriate and
practicable, for non-fatal exposures of emergency personnel,
first responders, and other individuals.
(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $15,000,000 for each of fiscal
years 2019 through 2023.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
SEC. 7021. ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION
DASHBOARD.
Title XVII of the Public Health Service Act (42 U.S.C. 300u et seq.)
is amended by adding at the end the following new section:
``SEC. 1711. <<NOTE: 42 USC 300u-16.>> ESTABLISHMENT OF SUBSTANCE
USE DISORDER INFORMATION DASHBOARD.
``(a) In General.--Not later than 6 months after the date of the
enactment of this section, the Secretary of Health and Human Services
shall, in consultation with the Director of National Drug Control
Policy, establish and periodically update, on the Internet website of
the Department of Health and Human Services, a public information
dashboard that--
``(1) provides links to information on programs within the
Department of Health and Human Services related to the reduction
of opioid and other substance use disorders;
``(2) provides access, to the extent practicable and
appropriate, to publicly available data, which may include data
from agencies within the Department of Health and Human Services
and--
``(A) other Federal agencies;
``(B) State, local, and Tribal governments;
``(C) nonprofit organizations;
``(D) law enforcement;
``(E) medical experts;
``(F) public health educators; and
``(G) research institutions regarding prevention,
treatment, recovery, and other services for opioid and
other substance use disorders;
[[Page 132 STAT. 4010]]
``(3) provides data on substance use disorder prevention and
treatment strategies in different regions of and populations in
the United States;
``(4) identifies information on alternatives to controlled
substances for pain management, such as approaches studied by
the National Institutes of Health Pain Consortium, the National
Center for Complimentary and Integrative Health, and other
institutes and centers at the National Institutes of Health, as
appropriate; and
``(5) identifies guidelines and best practices for health
care providers regarding treatment of substance use disorders.
``(b) Controlled Substance Defined.--In this section, the term
`controlled substance' has the meaning given that term in section 102 of
the Controlled Substances Act (21 U.S.C. 802).''.
SEC. 7022. <<NOTE: 42 USC 290aa note.>> INTERDEPARTMENTAL
SUBSTANCE USE DISORDERS COORDINATING
COMMITTEE.
(a) Establishment.--Not later than 3 months after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall, in coordination
with the Director of National Drug Control Policy, establish a
committee, to be known as the Interdepartmental Substance Use Disorders
Coordinating Committee (in this section referred to as the
``Committee''), to coordinate Federal activities related to substance
use disorders.
(b) Membership.--
(1) Federal members.--The Committee shall be composed of the
following Federal representatives, or the designees of such
representatives:
(A) The Secretary, who shall serve as the Chair of
the Committee.
(B) The Attorney General of the United States.
(C) The Secretary of Labor.
(D) The Secretary of Housing and Urban Development.
(E) The Secretary of Education.
(F) The Secretary of Veterans Affairs.
(G) The Commissioner of Social Security.
(H) The Assistant Secretary for Mental Health and
Substance Use.
(I) The Director of National Drug Control Policy.
(J) Representatives of other Federal agencies that
support or conduct activities or programs related to
substance use disorders, as determined appropriate by
the Secretary.
(2) Non-federal members.--The Committee shall include a
minimum of 15 non-Federal members appointed by the Secretary, of
which--
(A) at least two such members shall be an individual
who has received treatment for a diagnosis of a
substance use disorder;
(B) at least two such members shall be a director of
a State substance abuse agency;
(C) at least two such members shall be a
representative of a leading research, advocacy, or
service organization for adults with substance use
disorder;
(D) at least two such members shall--
[[Page 132 STAT. 4011]]
(i) be a physician, licensed mental health
professional, advance practice registered nurse,
or physician assistant; and
(ii) have experience in treating individuals
with substance use disorders;
(E) at least one such member shall be a substance
use disorder treatment professional who provides
treatment services at a certified opioid treatment
program;
(F) at least one such member shall be a substance
use disorder treatment professional who has research or
clinical experience in working with racial and ethnic
minority populations;
(G) at least one such member shall be a substance
use disorder treatment professional who has research or
clinical mental health experience in working with
medically underserved populations;
(H) at least one such member shall be a State-
certified substance use disorder peer support
specialist;
(I) at least one such member shall be a drug court
judge or a judge with experience in adjudicating cases
related to substance use disorder;
(J) at least one such member shall be a public
safety officer with extensive experience in interacting
with adults with a substance use disorder; and
(K) at least one such member shall be an individual
with experience providing services for homeless
individuals with a substance use disorder.
(c) Terms.--
(1) In general.--A member of the Committee appointed under
subsection (b)(2) shall be appointed for a term of 3 years and
may be reappointed for one or more 3-year terms.
(2) Vacancies.--A vacancy on the Committee shall be filled
in the same manner in which the original appointment was made.
Any individual appointed to fill a vacancy for an unexpired term
shall be appointed for the remainder of such term and may serve
after the expiration of such term until a successor has been
appointed.
(d) Meetings.--The Committee shall meet not fewer than two times
each year.
(e) Duties.--The Committee shall--
(1) identify areas for improved coordination of activities,
if any, related to substance use disorders, including research,
services, supports, and prevention activities across all
relevant Federal agencies;
(2) identify and provide to the Secretary recommendations
for improving Federal programs for the prevention and treatment
of, and recovery from, substance use disorders, including by
expanding access to prevention, treatment, and recovery
services;
(3) analyze substance use disorder prevention and treatment
strategies in different regions of and populations in the United
States and evaluate the extent to which Federal substance use
disorder prevention and treatment strategies are aligned with
State and local substance use disorder prevention and treatment
strategies;
[[Page 132 STAT. 4012]]
(4) make recommendations to the Secretary regarding any
appropriate changes with respect to the activities and
strategies described in paragraphs (1) through (3);
(5) make recommendations to the Secretary regarding public
participation in decisions relating to substance use disorders
and the process by which public feedback can be better
integrated into such decisions; and
(6) make recommendations to ensure that substance use
disorder research, services, supports, and prevention activities
of the Department of Health and Human Services and other Federal
agencies are not unnecessarily duplicative.
(f) Annual Report.--Not later than 1 year after the date of the
enactment of this Act, and annually thereafter for the life of the
Committee, the Committee shall publish on the Internet website of the
Department of Health and Human Services, which may include the public
information dashboard established under section 1711 of the Public
Health Service Act, as added by section 7021, a report summarizing the
activities carried out by the Committee pursuant to subsection (e),
including any findings resulting from such activities.
(g) Working Groups.--The Committee may establish working groups for
purposes of carrying out the duties described in subsection (e). Any
such working group shall be composed of members of the Committee (or the
designees of such members) and may hold such meetings as are necessary
to enable the working group to carry out the duties delegated to the
working group.
(h) Federal Advisory Committee Act.--The Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Committee only to the extent that
the provisions of such Act do not conflict with the requirements of this
section.
(i) Sunset.--The Committee shall terminate on the date that is 6
years after the date on which the Committee is established under
subsection (a).
SEC. 7023. <<NOTE: 42 USC 300u-16 note.>> NATIONAL MILESTONES TO
MEASURE SUCCESS IN CURTAILING THE OPIOID
CRISIS.
(a) In General.--Not later than 180 days after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary''), in coordination with the
Administrator of the Drug Enforcement Administration and the Director of
the Office of National Drug Control Policy, shall develop or identify
existing national indicators (referred to in this section as the
``national milestones'') to measure success in curtailing the opioid
crisis, with the goal of significantly reversing the incidence and
prevalence of opioid misuse and abuse, and opioid-related morbidity and
mortality in the United States within 5 years of such date of enactment.
(b) National Milestones to End the Opioid Crisis.--The national
milestones under subsection (a) shall include the following:
(1) Not fewer than 10 indicators or metrics to accurately
and expediently measure progress in meeting the goal described
in subsection (a), which shall, as appropriate, include,
indicators or metrics related to--
(A) the number of fatal and non-fatal opioid
overdoses;
(B) the number of emergency room visits related to
opioid misuse and abuse;
[[Page 132 STAT. 4013]]
(C) the number of individuals in sustained recovery
from opioid use disorder;
(D) the number of infections associated with illicit
drug use, such as HIV, viral hepatitis, and infective
endocarditis, and available capacity for treating such
infections;
(E) the number of providers prescribing medication-
assisted treatment for opioid use disorders, including
in primary care settings, community health centers,
jails, and prisons;
(F) the number of individuals receiving treatment
for opioid use disorder; and
(G) additional indicators or metrics, as
appropriate, such as metrics pertaining to specific
populations, including women and children, American
Indians and Alaskan Natives, individuals living in rural
and non-urban areas, and justice-involved populations,
that would further clarify the progress made in
addressing the opioid crisis.
(2) A reasonable goal, such as a percentage decrease or
other specified metric, that signifies progress in meeting the
goal described in subsection (a), and annual targets to help
achieve that goal.
(c) Consideration of Other Substance Use Disorders.--In developing
the national milestones under subsection (b), the Secretary shall, as
appropriate, consider other substance use disorders in addition to
opioid use disorder.
(d) Extension of Period.--If the Secretary determines that the goal
described in subsection (a) will not be achieved with respect to any
indicator or metric established under subsection (b)(2) within 5 years
of the date of enactment of this Act, the Secretary may extend the
timeline for meeting such goal with respect to that indicator or metric.
The Secretary shall include with any such extension a rationale for why
additional time is needed and information on whether significant changes
are needed in order to achieve such goal with respect to the indicator
or metric.
(e) Annual Status Update.--Not later than one year after the date of
enactment of this Act, the Secretary shall make available on the
Internet website of the Department of Health and Human Services, and
submit to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives, an update on the progress, including expected progress
in the subsequent year, in achieving the goals detailed in the national
milestones. Each such update shall include the progress made in the
first year or since the previous report, as applicable, in meeting each
indicator or metric in the national milestones.
SEC. 7024. STUDY ON PRESCRIBING LIMITS.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services, in consultation with the
Attorney General of the United States, shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report on the
impact of Federal and State laws and regulations that limit the length,
quantity, or dosage of opioid prescriptions. Such report shall address--
(1) the impact of such limits on--
[[Page 132 STAT. 4014]]
(A) the incidence and prevalence of overdose related
to prescription opioids;
(B) the incidence and prevalence of overdose related
to illicit opioids;
(C) the prevalence of opioid use disorders;
(D) medically appropriate use of, and access to,
opioids, including any impact on travel expenses and
pain management outcomes for patients, whether such
limits are associated with significantly higher rates of
negative health outcomes, including suicide, and whether
the impact of such limits differs based on the clinical
indication for which opioids are prescribed;
(2) whether such limits lead to a significant increase in
burden for prescribers of opioids or prescribers of treatments
for opioid use disorder, including any impact on patient access
to treatment, and whether any such burden is mitigated by any
factors such as electronic prescribing or telemedicine; and
(3) the impact of such limits on diversion or misuse of any
controlled substance in schedule II, III, or IV of section
202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
Subtitle D--Ensuring Access to Quality Sober Living
SEC. 7031. NATIONAL RECOVERY HOUSING BEST PRACTICES.
Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
et seq.) is amended by adding at the end the following new section:
``SEC. 550. <<NOTE: 42 USC 290ee-5.>> NATIONAL RECOVERY HOUSING
BEST PRACTICES.
``(a) Best Practices for Operating Recovery Housing.--
``(1) In general.--The Secretary, in consultation with the
individuals and entities specified in paragraph (2), shall
identify or facilitate the development of best practices, which
may include model laws for implementing suggested minimum
standards, for operating recovery housing.
``(2) Consultation.--In carrying out the activities
described in paragraph (1), the Secretary shall consult with, as
appropriate--
``(A) relevant divisions of the Department of Health
and Human Services, including the Substance Abuse and
Mental Health Services Administration, the Office of
Inspector General, the Indian Health Service, and the
Centers for Medicare & Medicaid Services;
``(B) the Secretary of Housing and Urban
Development;
``(C) directors or commissioners, as applicable, of
State health departments, tribal health departments,
State Medicaid programs, and State insurance agencies;
``(D) representatives of health insurance issuers;
``(E) national accrediting entities and reputable
providers of, and analysts of, recovery housing
services, including Indian tribes, tribal organizations,
and tribally designated housing entities that provide
recovery housing services, as applicable;
``(F) individuals with a history of substance use
disorder; and
[[Page 132 STAT. 4015]]
``(G) other stakeholders identified by the
Secretary.
``(b) Identification of Fraudulent Recovery Housing Operators.--
``(1) In general.--The Secretary, in consultation with the
individuals and entities described in paragraph (2), shall
identify or facilitate the development of common indicators that
could be used to identify potentially fraudulent recovery
housing operators.
``(2) Consultation.--In carrying out the activities
described in paragraph (1), the Secretary shall consult with, as
appropriate, the individuals and entities specified in
subsection (a)(2) and the Attorney General of the United States.
``(3) Requirements.--
``(A) Practices for identification and reporting.--
In carrying out the activities described in paragraph
(1), the Secretary shall consider how law enforcement,
public and private payers, and the public can best
identify and report fraudulent recovery housing
operators.
``(B) Factors to be considered.--In carrying out the
activities described in paragraph (1), the Secretary
shall identify or develop indicators, which may include
indicators related to--
``(i) unusual billing practices;
``(ii) average lengths of stays;
``(iii) excessive levels of drug testing (in
terms of cost or frequency); and
``(iv) unusually high levels of recidivism.
``(c) Dissemination.--The Secretary shall, as appropriate,
disseminate the best practices identified or developed under subsection
(a) and the common indicators identified or developed under subsection
(b) to--
``(1) State agencies, which may include the provision of
technical assistance to State agencies seeking to adopt or
implement such best practices;
``(2) Indian tribes, tribal organizations, and tribally
designated housing entities;
``(3) the Attorney General of the United States;
``(4) the Secretary of Labor;
``(5) the Secretary of Housing and Urban Development;
``(6) State and local law enforcement agencies;
``(7) health insurance issuers;
``(8) recovery housing entities; and
``(9) the public.
``(d) Requirements.--In carrying out the activities described in
subsections (a) and (b), the Secretary, in consultation with appropriate
individuals and entities described in subsections (a)(2) and (b)(2),
shall consider how recovery housing is able to support recovery and
prevent relapse, recidivism, or overdose (including overdose death),
including by improving access and adherence to treatment, including
medication-assisted treatment.
``(e) Rule of Construction.--Nothing in this section shall be
construed to provide the Secretary with the authority to require States
to adhere to minimum standards in the State oversight of recovery
housing.
``(f) Definitions.--In this section:
``(1) The term `recovery housing' means a shared living
environment free from alcohol and illicit drug use and centered
[[Page 132 STAT. 4016]]
on peer support and connection to services that promote
sustained recovery from substance use disorders.
``(2) The terms `Indian tribe' and `tribal organization'
have the meanings given those terms in section 4 of the Indian
Self-Determination and Education Assistance Act (25 U.S.C.
5304).
``(3) The term `tribally designated housing entity' has the
meaning given that term in section 4 of the Native American
Housing Assistance and Self-Determination Act of 1996 (25 U.S.C.
4103).
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $3,000,000 for the period of
fiscal years 2019 through 2021.''.
Subtitle E--Advancing Cutting Edge Research
SEC. 7041. UNIQUE RESEARCH INITIATIVES.
Section 402(n)(1) of the Public Health Service Act (42 U.S.C.
282(n)(1)) is amended--
(1) in subparagraph (A), by striking ``or'';
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(C) high impact cutting-edge research that fosters
scientific creativity and increases fundamental
biological understanding leading to the prevention,
diagnosis, or treatment of diseases and disorders, or
research urgently required to respond to a public health
threat.''.
SEC. 7042. PAIN RESEARCH.
Section 409J(b) of the Public Health Service Act (42 U.S.C. 284q(b))
is amended--
(1) in paragraph (5)--
(A) in subparagraph (A), by striking ``and treatment
of pain and diseases and disorders associated with
pain'' and inserting ``treatment, and management of pain
and diseases and disorders associated with pain,
including information on best practices for the
utilization of non-pharmacologic treatments, non-
addictive medical products, and other drugs or devices
approved or cleared by the Food and Drug
Administration'';
(B) in subparagraph (B), by striking ``on the
symptoms and causes of pain;'' and inserting the
following: ``on--
``(i) the symptoms and causes of pain,
including the identification of relevant
biomarkers and screening models and the
epidemiology of acute and chronic pain;
``(ii) the diagnosis, prevention, treatment,
and management of acute and chronic pain,
including with respect to non-pharmacologic
treatments, non-addictive medical products, and
other drugs or devices approved or cleared by the
Food and Drug Administration; and
``(iii) risk factors for, and early warning
signs of, substance use disorders in populations
with acute and chronic pain; and''; and
[[Page 132 STAT. 4017]]
(C) by striking subparagraphs (C) through (E) and
inserting the following:
``(C) make recommendations to the Director of NIH--
``(i) to ensure that the activities of the
National Institutes of Health and other Federal
agencies are free of unnecessary duplication of
effort;
``(ii) on how best to disseminate information
on pain care and epidemiological data related to
acute and chronic pain; and
``(iii) on how to expand partnerships between
public entities and private entities to expand
collaborative, cross-cutting research.'';
(2) by redesignating paragraph (6) as paragraph (7); and
(3) by inserting after paragraph (5) the following:
``(6) Report.--The Secretary shall ensure that
recommendations and actions taken by the Director with respect
to the topics discussed at the meetings described in paragraph
(4) are included in appropriate reports to Congress.''.
Subtitle F--Jessie's Law
SEC. 7051. <<NOTE: 42 USC 290dd-2 note.>> INCLUSION OF OPIOID
ADDICTION HISTORY IN PATIENT RECORDS.
(a) Best Practices.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary''), in
consultation with appropriate stakeholders, including a patient
with a history of opioid use disorder, an expert in electronic
health records, an expert in the confidentiality of patient
health information and records, and a health care provider,
shall identify or facilitate the development of best practices
regarding--
(A) the circumstances under which information that a
patient has provided to a health care provider regarding
such patient's history of opioid use disorder should,
only at the patient's request, be prominently displayed
in the medical records (including electronic health
records) of such patient;
(B) what constitutes the patient's request for the
purpose described in subparagraph (A); and
(C) the process and methods by which the information
should be so displayed.
(2) Dissemination.--The Secretary shall disseminate the best
practices developed under paragraph (1) to health care providers
and State agencies.
(b) Requirements.--In identifying or facilitating the development of
best practices under subsection (a), as applicable, the Secretary, in
consultation with appropriate stakeholders, shall consider the
following:
(1) The potential for addiction relapse or overdose,
including overdose death, when opioid medications are prescribed
to a patient recovering from opioid use disorder.
(2) The benefits of displaying information about a patient's
opioid use disorder history in a manner similar to other
potentially lethal medical concerns, including drug allergies
and contraindications.
[[Page 132 STAT. 4018]]
(3) The importance of prominently displaying information
about a patient's opioid use disorder when a physician or
medical professional is prescribing medication, including
methods for avoiding alert fatigue in providers.
(4) The importance of a variety of appropriate medical
professionals, including physicians, nurses, and pharmacists,
having access to information described in this section when
prescribing or dispensing opioid medication, consistent with
Federal and State laws and regulations.
(5) The importance of protecting patient privacy, including
the requirements related to consent for disclosure of substance
use disorder information under all applicable laws and
regulations.
(6) All applicable Federal and State laws and regulations.
SEC. 7052. <<NOTE: 42 USC 290dd-2 note.>> COMMUNICATION WITH
FAMILIES DURING EMERGENCIES.
(a) Promoting Awareness of Authorized Disclosures During
Emergencies.--The Secretary of Health and Human Services shall annually
notify health care providers regarding permitted disclosures under
Federal health care privacy law during emergencies, including overdoses,
of certain health information to families, caregivers, and health care
providers.
(b) Use of Material.--For the purposes of carrying out subsection
(a), the Secretary of Health and Human Services may use material
produced under section 7053 of this Act or section 11004 of the 21st
Century Cures Act (42 U.S.C. 1320d-2 note).
SEC. 7053. <<NOTE: 42 USC 290dd-2 note.>> DEVELOPMENT AND
DISSEMINATION OF MODEL TRAINING PROGRAMS
FOR SUBSTANCE USE DISORDER PATIENT
RECORDS.
(a) Initial Programs and Materials.--Not later than 1 year after the
date of the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary''), in
consultation with appropriate experts, shall identify the following
model programs and materials (or if no such programs or materials exist,
recognize private or public entities to develop and disseminate such
programs and materials):
(1) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, psychologists, counselors, therapists, nurse
practitioners, physician assistants, behavioral health
facilities and clinics, care managers, and hospitals, including
individuals such as general counsels or regulatory compliance
staff who are responsible for establishing provider privacy
policies) concerning the permitted uses and disclosures,
consistent with the standards and regulations governing the
privacy and security of substance use disorder patient records
promulgated by the Secretary under section 543 of the Public
Health Service Act (42 U.S.C. 290dd-2) for the confidentiality
of patient records.
(2) Model programs and materials for training patients and
their families regarding their rights to protect and obtain
information under the standards and regulations described in
paragraph (1).
(b) Requirements.--The model programs and materials described in
paragraphs (1) and (2) of subsection (a) shall address circumstances
under which disclosure of substance use disorder patient records is
needed to--
[[Page 132 STAT. 4019]]
(1) facilitate communication between substance use disorder
treatment providers and other health care providers to promote
and provide the best possible integrated care;
(2) avoid inappropriate prescribing that can lead to
dangerous drug interactions, overdose, or relapse; and
(3) notify and involve families and caregivers when
individuals experience an overdose.
(c) Periodic Updates.--The Secretary shall--
(1) periodically review and update the model program and
materials identified or developed under subsection (a); and
(2) disseminate such updated programs and materials to the
individuals described in subsection (a)(1).
(d) Input of Certain Entities.--In identifying, reviewing, or
updating the model programs and materials under this section, the
Secretary shall solicit the input of relevant stakeholders.
(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section--
(1) $4,000,000 for fiscal year 2019;
(2) $2,000,000 for each of fiscal years 2020 and 2021; and
(3) $1,000,000 for each of fiscal years 2022 and 2023.
Subtitle G--Protecting Pregnant Women and Infants
SEC. 7061. REPORT ON ADDRESSING MATERNAL AND INFANT HEALTH IN THE
OPIOID CRISIS.
(a) In General.--Not later than 18 months after the date of the
enactment of this Act, the Secretary of Health and Human Services, in
coordination with the Centers for Disease Control and Prevention, the
National Institutes of Health, the Indian Health Service, and the
Substance Abuse and Mental Health Services Administration, shall develop
and submit to the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives a report that includes--
(1) information on opioid, non-opioid, and non-pharmacologic
pain management practices during pregnancy and after pregnancy;
(2) recommendations for increasing public awareness and
education about substance use disorders, including opioid use
disorders, during and after pregnancy, including available
treatment resources in urban and rural areas;
(3) recommendations to prevent, identify, and reduce
substance use disorders, including opioid use disorders, during
pregnancy to improve care for pregnant women with substance use
disorders and their infants; and
(4) an identification of areas in need of further research
with respect to acute and chronic pain management during and
after pregnancy.
(b) No Additional Funds.--No additional funds are authorized to be
appropriated for purposes of carrying out subsection (a).
SEC. 7062. <<NOTE: 42 USC 290bb-1 note.>> PROTECTING MOMS AND
INFANTS.
(a) Report.--
(1) In general.--Not later than 60 days after the date of
enactment of this Act, the Secretary of Health and Human
[[Page 132 STAT. 4020]]
Services (referred to in this section as the ``Secretary'')
shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives, and make available to the
public on the Internet website of the Department of Health and
Human Services, a report regarding the implementation of the
recommendations in the strategy relating to prenatal opioid use,
including neonatal abstinence syndrome, developed pursuant to
section 2 of the Protecting Our Infants Act of 2015 (Public Law
114-91). Such report shall include--
(A) an update on the implementation of the
recommendations in the strategy, including information
regarding the agencies involved in the implementation;
and
(B) information on additional funding or authority
the Secretary requires, if any, to implement the
strategy, which may include authorities needed to
coordinate implementation of such strategy across the
Department of Health and Human Services.
(2) Periodic updates.--The Secretary shall periodically
update the report under paragraph (1).
(b) Residential Treatment Programs for Pregnant and Postpartum
Women.--Section 508(s) of the Public Health Service Act (42 U.S.C.
290bb-1(s)) is amended by striking ``$16,900,000 for each of fiscal
years 2017 through 2021'' and inserting ``$29,931,000 for each of fiscal
years 2019 through 2023''.
SEC. 7063. EARLY INTERVENTIONS FOR PREGNANT WOMEN AND INFANTS.
(a) Development of Educational Materials by Center for Substance
Abuse Prevention.--Section 515(b) of the Public Health Service Act (42
U.S.C. 290bb-21(b)) is amended--
(1) in paragraph (13), by striking ``and'' at the end;
(2) in paragraph (14), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(15) in consultation with relevant stakeholders and in
collaboration with the Director of the Centers for Disease
Control and Prevention, develop educational materials for
clinicians to use with pregnant women for shared decision making
regarding pain management and the prevention of substance use
disorders during pregnancy.''.
(b) Guidelines and Recommendations by Center for Substance Abuse
Treatment.--Section 507(b) of the Public Health Service Act (42 U.S.C.
290bb(b)) is amended--
(1) in paragraph (13), by striking ``and'' at the end;
(2) in paragraph (14), by striking the period at the end and
inserting a semicolon; and
(3) by adding at the end the following:
``(15) in cooperation with the Secretary, implement and
disseminate, as appropriate, the recommendations in the report
entitled `Protecting Our Infants Act: Final Strategy' issued by
the Department of Health and Human Services in 2017; and''.
(c) Support of Partnerships by Center for Substance Abuse
Treatment.--Section 507(b) of the Public Health Service
[[Page 132 STAT. 4021]]
Act (42 U.S.C. 290bb(b)), as amended by subsection (b), is further
amended by adding at the end the following:
``(16) in cooperation with relevant stakeholders, and
through public-private partnerships, encourage education about
substance use disorders for pregnant women and health care
providers who treat pregnant women and babies.''.
SEC. 7064. PRENATAL AND POSTNATAL HEALTH.
Section 317L of the Public Health Service Act (42 U.S.C. 247b-13) is
amended--
(1) in subsection (a)--
(A) by amending paragraph (1) to read as follows:
``(1) to collect, analyze, and make available data on
prenatal smoking and alcohol and other substance abuse and
misuse, including--
``(A) data on--
``(i) the incidence, prevalence, and
implications of such activities; and
``(ii) the incidence and prevalence of
implications and outcomes, including neonatal
abstinence syndrome and other maternal and child
health outcomes associated with such activities;
and
``(B) additional information or data, as
appropriate, on family health history, medication
exposures during pregnancy, demographic information,
such as race, ethnicity, geographic location, and family
history, and other relevant information, to inform such
analysis;'';
(B) in paragraph (2)--
(i) by striking ``prevention of'' and
inserting ``prevention and long-term outcomes
associated with''; and
(ii) by striking ``illegal drug use'' and
inserting ``other substance abuse and misuse'';
(C) in paragraph (3), by striking ``and cessation
programs; and'' and inserting ``, treatment, and
cessation programs;'';
(D) in paragraph (4), by striking ``illegal drug
use.'' and inserting ``other substance abuse and misuse;
and''; and
(E) by adding at the end the following:
``(5) to issue public reports on the analysis of data
described in paragraph (1), including analysis of--
``(A) long-term outcomes of children affected by
neonatal abstinence syndrome;
``(B) health outcomes associated with prenatal
smoking, alcohol, and substance abuse and misuse; and
``(C) relevant studies, evaluations, or information
the Secretary determines to be appropriate.'';
(2) in subsection (b), by inserting ``tribal entities,''
after ``local governments,'';
(3) by redesignating subsection (c) as subsection (d);
(4) by inserting after subsection (b) the following:
``(c) Coordinating Activities.--To carry out this section, the
Secretary may--
``(1) provide technical and consultative assistance to
entities receiving grants under subsection (b);
[[Page 132 STAT. 4022]]
``(2) ensure a pathway for data sharing between States,
tribal entities, and the Centers for Disease Control and
Prevention;
``(3) ensure data collection under this section is
consistent with applicable State, Federal, and Tribal privacy
laws; and
``(4) coordinate with the National Coordinator for Health
Information Technology, as appropriate, to assist States and
Tribes in implementing systems that use standards recognized by
such National Coordinator, as such recognized standards are
available, in order to facilitate interoperability between such
systems and health information technology systems, including
certified health information technology.''; and
(5) in subsection (d), as so redesignated, by striking
``2001 through 2005'' and inserting ``2019 through 2023''.
SEC. 7065. PLANS OF SAFE CARE.
(a) In General.--Section 105(a) of the Child Abuse Prevention and
Treatment Act (42 U.S.C. 5106(a)) is amended by adding at the end the
following:
``(7) Grants to states to improve and coordinate their
response to ensure the safety, permanency, and well-being of
infants affected by substance use.--
``(A) Program authorized.--The Secretary is
authorized to make grants to States for the purpose of
assisting child welfare agencies, social services
agencies, substance use disorder treatment agencies,
hospitals with labor and delivery units, medical staff,
public health and mental health agencies, and maternal
and child health agencies to facilitate collaboration in
developing, updating, implementing, and monitoring plans
of safe care described in section 106(b)(2)(B)(iii).
Section 112(a)(2) shall not apply to the program
authorized under this paragraph.
``(B) Distribution of funds.--
``(i) Reservations.--Of the amounts made
available to carry out subparagraph (A), the
Secretary shall reserve--
``(I) no more than 3 percent for the
purposes described in subparagraph (G);
and
``(II) up to 3 percent for grants to
Indian Tribes and tribal organizations
to address the needs of infants born
with, and identified as being affected
by, substance abuse or withdrawal
symptoms resulting from prenatal drug
exposure or a fetal alcohol spectrum
disorder and their families or
caregivers, which to the extent
practicable, shall be consistent with
the uses of funds described under
subparagraph (D).
``(ii) Allotments to states and territories.--
The Secretary shall allot the amount made
available to carry out subparagraph (A) that
remains after application of clause (i) to each
State that applies for such a grant, in an amount
equal to the sum of--
``(I) $500,000; and
``(II) an amount that bears the same
relationship to any funds made available
to carry out subparagraph (A) and
remaining after application
[[Page 132 STAT. 4023]]
of clause (i), as the number of live
births in the State in the previous
calendar year bears to the number of
live births in all States in such year.
``(iii) Ratable reduction.--If the amount made
available to carry out subparagraph (A) is
insufficient to satisfy the requirements of clause
(ii), the Secretary shall ratably reduce each
allotment to a State.
``(C) Application.--A State desiring a grant under
this paragraph shall submit an application to the
Secretary at such time and in such manner as the
Secretary may require. Such application shall include--
``(i) a description of--
``(I) the impact of substance use
disorder in such State, including with
respect to the substance or class of
substances with the highest incidence of
abuse in the previous year in such
State, including--
``(aa) the prevalence of
substance use disorder in such
State;
``(bb) the aggregate rate of
births in the State of infants
affected by substance abuse or
withdrawal symptoms or a fetal
alcohol spectrum disorder (as
determined by hospitals,
insurance claims, claims
submitted to the State Medicaid
program, or other records), if
available and to the extent
practicable; and
``(cc) the number of infants
identified, for whom a plan of
safe care was developed, and for
whom a referral was made for
appropriate services, as
reported under section
106(d)(18);
``(II) the challenges the State
faces in developing, implementing, and
monitoring plans of safe care in
accordance with section
106(b)(2)(B)(iii);
``(III) the State's lead agency for
the grant program and how that agency
will coordinate with relevant State
entities and programs, including the
child welfare agency, the substance use
disorder treatment agency, hospitals
with labor and delivery units, health
care providers, the public health and
mental health agencies, programs funded
by the Substance Abuse and Mental Health
Services Administration that provide
substance use disorder treatment for
women, the State Medicaid program, the
State agency administering the block
grant program under title V of the
Social Security Act (42 U.S.C. 701 et
seq.), the State agency administering
the programs funded under part C of the
Individuals with Disabilities Education
Act (20 U.S.C. 1431 et seq.), the
maternal, infant, and early childhood
home visiting program under section 511
of the Social Security Act (42 U.S.C.
711), the State judicial system, and
other agencies, as determined by the
Secretary, and Indian Tribes and tribal
organizations, as appropriate, to
implement the activities under this
paragraph;
[[Page 132 STAT. 4024]]
``(IV) how the State will monitor
local development and implementation of
plans of safe care, in accordance with
section 106(b)(2)(B)(iii)(II), including
how the State will monitor to ensure
plans of safe care address differences
between substance use disorder and
medically supervised substance use,
including for the treatment of a
substance use disorder;
``(V) if applicable, how the State
plans to utilize funding authorized
under part E of title IV of the Social
Security Act (42 U.S.C. 670 et seq.) to
assist in carrying out any plan of safe
care, including such funding authorized
under section 471(e) of such Act (as in
effect on October 1, 2018) for mental
health and substance abuse prevention
and treatment services and in-home
parent skill-based programs and funding
authorized under such section 472(j) (as
in effect on October 1, 2018) for
children with a parent in a licensed
residential family-based treatment
facility for substance abuse; and
``(VI) an assessment of the
treatment and other services and
programs available in the State to
effectively carry out any plan of safe
care developed, including identification
of needed treatment, and other services
and programs to ensure the well-being of
young children and their families
affected by substance use disorder, such
as programs carried out under part C of
the Individuals with Disabilities
Education Act (20 U.S.C. 1431 et seq.)
and comprehensive early childhood
development services and programs such
as Head Start programs;
``(ii) a description of how the State plans to
use funds for activities described in subparagraph
(D) for the purposes of ensuring State compliance
with requirements under clauses (ii) and (iii) of
section 106(b)(2)(B); and
``(iii) an assurance that the State will
comply with requirements to refer a child
identified as substance-exposed to early
intervention services as required pursuant to a
grant under part C of the Individuals with
Disabilities Education Act (20 U.S.C. 1431 et
seq.).
``(D) Uses of funds.--Funds awarded to a State under
this paragraph may be used for the following activities,
which may be carried out by the State directly, or
through grants or subgrants, contracts, or cooperative
agreements:
``(i) Improving State and local systems with
respect to the development and implementation of
plans of safe care, which--
``(I) shall include parent and
caregiver engagement, as required under
section 106(b)(2)(B)(iii)(I), regarding
available treatment and service options,
which may include resources available
for pregnant, perinatal, and postnatal
women; and
``(II) may include activities such
as--
[[Page 132 STAT. 4025]]
``(aa) developing policies,
procedures, or protocols for the
administration or development of
evidence-based and validated
screening tools for infants who
may be affected by substance use
withdrawal symptoms or a fetal
alcohol spectrum disorder and
pregnant, perinatal, and
postnatal women whose infants
may be affected by substance use
withdrawal symptoms or a fetal
alcohol spectrum disorder;
``(bb) improving assessments
used to determine the needs of
the infant and family;
``(cc) improving ongoing
case management services;
``(dd) improving access to
treatment services, which may be
prior to the pregnant woman's
delivery date; and
``(ee) keeping families
safely together when it is in
the best interest of the child.
``(ii) Developing policies, procedures, or
protocols in consultation and coordination with
health professionals, public and private health
facilities, and substance use disorder treatment
agencies to ensure that--
``(I) appropriate notification to
child protective services is made in a
timely manner, as required under section
106(b)(2)(B)(ii);
``(II) a plan of safe care is in
place, in accordance with section
106(b)(2)(B)(iii), before the infant is
discharged from the birth or health care
facility; and
``(III) such health and related
agency professionals are trained on how
to follow such protocols and are aware
of the supports that may be provided
under a plan of safe care.
``(iii) Training health professionals and
health system leaders, child welfare workers,
substance use disorder treatment agencies, and
other related professionals such as home visiting
agency staff and law enforcement in relevant
topics including--
``(I) State mandatory reporting laws
established under section
106(b)(2)(B)(i) and the referral and
process requirements for notification to
child protective services when child
abuse or neglect reporting is not
mandated;
``(II) the co-occurrence of
pregnancy and substance use disorder,
and implications of prenatal exposure;
``(III) the clinical guidance about
treating substance use disorder in
pregnant and postpartum women;
``(IV) appropriate screening and
interventions for infants affected by
substance use disorder, withdrawal
symptoms, or a fetal alcohol spectrum
disorder and the requirements under
section 106(b)(2)(B)(iii); and
[[Page 132 STAT. 4026]]
``(V) appropriate multigenerational
strategies to address the mental health
needs of the parent and child together.
``(iv) Establishing partnerships, agreements,
or memoranda of understanding between the lead
agency and other entities (including health
professionals, health facilities, child welfare
professionals, juvenile and family court judges,
substance use and mental disorder treatment
programs, early childhood education programs,
maternal and child health and early intervention
professionals (including home visiting providers),
peer-to-peer recovery programs such as parent
mentoring programs, and housing agencies) to
facilitate the implementation of, and compliance
with, section 106(b)(2) and clause (ii) of this
subparagraph, in areas which may include--
``(I) developing a comprehensive,
multi-disciplinary assessment and
intervention process for infants,
pregnant women, and their families who
are affected by substance use disorder,
withdrawal symptoms, or a fetal alcohol
spectrum disorder, that includes
meaningful engagement with and takes
into account the unique needs of each
family and addresses differences between
medically supervised substance use,
including for the treatment of substance
use disorder, and substance use
disorder;
``(II) ensuring that treatment
approaches for serving infants, pregnant
women, and perinatal and postnatal women
whose infants may be affected by
substance use, withdrawal symptoms, or a
fetal alcohol spectrum disorder, are
designed to, where appropriate, keep
infants with their mothers during both
inpatient and outpatient treatment; and
``(III) increasing access to all
evidence-based medication-assisted
treatment approved by the Food and Drug
Administration, behavioral therapy, and
counseling services for the treatment of
substance use disorders, as appropriate.
``(v) Developing and updating systems of
technology for improved data collection and
monitoring under section 106(b)(2)(B)(iii),
including existing electronic medical records, to
measure the outcomes achieved through the plans of
safe care, including monitoring systems to meet
the requirements of this Act and submission of
performance measures.
``(E) Reporting.--Each State that receives funds
under this paragraph, for each year such funds are
received, shall submit a report to the Secretary,
disaggregated by geographic location, economic status,
and major racial and ethnic groups, except that such
disaggregation shall not be required if the results
would reveal personally identifiable information on,
with respect to infants identified under section
106(b)(2)(B)(ii)--
``(i) the number who experienced removal
associated with parental substance use;
[[Page 132 STAT. 4027]]
``(ii) the number who experienced removal and
subsequently are reunified with parents, and the
length of time between such removal and
reunification;
``(iii) the number who are referred to
community providers without a child protection
case;
``(iv) the number who receive services while
in the care of their birth parents;
``(v) the number who receive post-
reunification services within 1 year after a
reunification has occurred; and
``(vi) the number who experienced a return to
out-of-home care within 1 year after
reunification.
``(F) Secretary's report to congress.--The Secretary
shall submit an annual report to the Committee on
Health, Education, Labor, and Pensions and the Committee
on Appropriations of the Senate and the Committee on
Education and the Workforce and the Committee on
Appropriations of the House of Representatives that
includes the information described in subparagraph (E)
and recommendations or observations on the challenges,
successes, and lessons derived from implementation of
the grant program.
``(G) Assisting states' implementation.--The
Secretary shall use the amount reserved under
subparagraph (B)(i)(I) to provide written guidance and
technical assistance to support States in complying with
and implementing this paragraph, which shall include--
``(i) technical assistance, including programs
of in-depth technical assistance, to additional
States, territories, and Indian Tribes and tribal
organizations in accordance with the substance-
exposed infant initiative developed by the
National Center on Substance Abuse and Child
Welfare;
``(ii) guidance on the requirements of this
Act with respect to infants born with and
identified as being affected by substance use or
withdrawal symptoms or fetal alcohol spectrum
disorder, as described in clauses (ii) and (iii)
of section 106(b)(2)(B), including by--
``(I) enhancing States'
understanding of requirements and
flexibilities under the law, including
by clarifying key terms;
``(II) addressing state-identified
challenges with developing,
implementing, and monitoring plans of
safe care, including those reported
under subparagraph (C)(i)(II);
``(III) disseminating best practices
on implementation of plans of safe care,
on such topics as differential response,
collaboration and coordination, and
identification and delivery of services
for different populations, while
recognizing needs of different
populations and varying community
approaches across States; and
``(IV) helping States improve the
long-term safety and well-being of young
children and their families;
[[Page 132 STAT. 4028]]
``(iii) supporting State efforts to develop
information technology systems to manage plans of
safe care; and
``(iv) preparing the Secretary's report to
Congress described in subparagraph (F).
``(H) Sunset.--The authority under this paragraph
shall sunset on September 30, 2023.''.
(b) Repeal.--The Abandoned Infants Assistance Act of 1988 (42 U.S.C.
5117aa et seq.) <<NOTE: 42 USC 5101 note, 5117aa, 5117aa-11, 5117aa-12,
5117aa-21, 5117aa-22.>> is repealed.
Subtitle H--Substance Use Disorder Treatment Workforce
SEC. 7071. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER
TREATMENT WORKFORCE.
Title VII of the Public Health Service Act is amended--
(1) by redesignating part F as part G; and
(2) by inserting after part E (42 U.S.C. 294n et seq.) the
following:
``PART F--SUBSTANCE USE DISORDER TREATMENT WORKFORCE
``SEC. 781. <<NOTE: 42 USC 295h.>> LOAN REPAYMENT PROGRAM FOR
SUBSTANCE USE DISORDER TREATMENT
WORKFORCE.
``(a) In General.--The Secretary, acting through the Administrator
of the Health Resources and Services Administration, shall carry out a
program under which--
``(1) the Secretary enters into agreements with individuals
to make payments in accordance with subsection (b) on the
principal of and interest on any eligible loan; and
``(2) the individuals each agree to the requirements of
service in substance use disorder treatment employment, as
described in subsection (d).
``(b) Payments.--For each year of obligated service by an individual
pursuant to an agreement under subsection (a), the Secretary shall make
a payment to such individual as follows:
``(1) Service in a shortage area.--The Secretary shall pay--
``(A) for each year of obligated service by an
individual pursuant to an agreement under subsection
(a), \1/6\ of the principal of and interest on each
eligible loan of the individual which is outstanding on
the date the individual began service pursuant to the
agreement; and
``(B) for completion of the sixth and final year of
such service, the remainder of such principal and
interest.
``(2) Maximum amount.--The total amount of payments under
this section to any individual shall not exceed $250,000.
``(c) Eligible Loans.--The loans eligible for repayment under this
section are each of the following:
``(1) Any loan for education or training for a substance use
disorder treatment employment.
``(2) Any loan under part E of title VIII (relating to
nursing student loans).
[[Page 132 STAT. 4029]]
``(3) Any Federal Direct Stafford Loan, Federal Direct PLUS
Loan, Federal Direct Unsubsidized Stafford Loan, or Federal
Direct Consolidation Loan (as such terms are used in section 455
of the Higher Education Act of 1965).
``(4) Any Federal Perkins Loan under part E of title I of
the Higher Education Act of 1965.
``(5) Any other Federal loan as determined appropriate by
the Secretary.
``(d) Requirements of Service.--Any individual receiving payments
under this program as required by an agreement under subsection (a)
shall agree to an annual commitment to full-time employment, with no
more than 1 year passing between any 2 years of covered employment, in
substance use disorder treatment employment in the United States in--
``(1) a Mental Health Professional Shortage Area, as
designated under section 332; or
``(2) a county (or a municipality, if not contained within
any county) where the mean drug overdose death rate per 100,000
people over the past 3 years for which official data is
available from the State, is higher than the most recent
available national average overdose death rate per 100,000
people, as reported by the Centers for Disease Control and
Prevention.
``(e) Ineligibility for Double Benefits.--No borrower may, for the
same service, receive a reduction of loan obligations or a loan
repayment under both--
``(1) this section; and
``(2) any Federally supported loan forgiveness program,
including under section 338B, 338I, or 846 of this Act, or
section 428J, 428L, 455(m), or 460 of the Higher Education Act
of 1965.
``(f) Breach.--
``(1) Liquidated damages formula.--The Secretary may
establish a liquidated damages formula to be used in the event
of a breach of an agreement entered into under subsection (a).
``(2) Limitation.--The failure by an individual to complete
the full period of service obligated pursuant to such an
agreement, taken alone, shall not constitute a breach of the
agreement, so long as the individual completed in good faith the
years of service for which payments were made to the individual
under this section.
``(g) Additional Criteria.--The Secretary--
``(1) may establish such criteria and rules to carry out
this section as the Secretary determines are needed and in
addition to the criteria and rules specified in this section;
and
``(2) shall give notice to the committees specified in
subsection (h) of any criteria and rules so established.
``(h) Report to Congress.--Not later than 5 years after the date of
enactment of this section, and every other year thereafter, the
Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on--
``(1) the number and location of borrowers who have
qualified for loan repayments under this section; and
[[Page 132 STAT. 4030]]
``(2) the impact of this section on the availability of
substance use disorder treatment employees nationally and in
shortage areas and counties described in subsection (d).
``(i) Definition.--In this section:
``(1) The terms `Indian tribe' and `tribal organization'
have the meanings given those terms in section 4 of the Indian
Self-Determination and Education Assistance Act.
``(2) The term `municipality' means a city, town, or other
public body created by or pursuant to State law, or an Indian
tribe.
``(3) The term `substance use disorder treatment employment'
means full-time employment (including a fellowship)--
``(A) where the primary intent and function of the
position is the direct treatment or recovery support of
patients with or in recovery from a substance use
disorder, including master's level social workers,
psychologists, counselors, marriage and family
therapists, psychiatric mental health practitioners,
occupational therapists, psychology doctoral interns,
and behavioral health paraprofessionals and physicians,
physician assistants, and nurses, who are licensed or
certified in accordance with applicable State and
Federal laws; and
``(B) which is located at a substance use disorder
treatment program, private physician practice, hospital
or health system-affiliated inpatient treatment center
or outpatient clinic (including an academic medical
center-affiliated treatment program), correctional
facility or program, youth detention center or program,
inpatient psychiatric facility, crisis stabilization
unit, community health center, community mental health
or other specialty community behavioral health center,
recovery center, school, community-based organization,
telehealth platform, migrant health center, health
program or facility operated by an Indian tribe or
tribal organization, Federal medical facility, or any
other facility as determined appropriate for purposes of
this section by the Secretary.
``(j) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $25,000,000 for each of fiscal
years 2019 through 2023.''.
SEC. 7072. CLARIFICATION REGARDING SERVICE IN SCHOOLS AND OTHER
COMMUNITY-BASED SETTINGS.
Subpart III of part D of title III of the Public Health Service Act
(42 U.S.C. 254l et seq.) is amended by adding at the end the following:
``SEC. 338N. <<NOTE: 42 USC 254v.>> CLARIFICATION REGARDING
SERVICE IN SCHOOLS AND OTHER COMMUNITY-
BASED SETTINGS.
``(a) Schools and Community-based Settings.--An entity to which a
participant in the Scholarship Program or the Loan Repayment Program
(referred to in this section as a `participant') is assigned under
section 333 may direct such participant to provide service as a
behavioral or mental health professional at a school or other community-
based setting located in a health professional shortage area.
``(b) Obligated Service.--
[[Page 132 STAT. 4031]]
``(1) In general.--Any service described in subsection (a)
that a participant provides may count towards such participant's
completion of any obligated service requirements under the
Scholarship Program or the Loan Repayment Program, subject to
any limitation imposed under paragraph (2).
``(2) Limitation.--The Secretary may impose a limitation on
the number of hours of service described in subsection (a) that
a participant may credit towards completing obligated service
requirements, provided that the limitation allows a member to
credit service described in subsection (a) for not less than 50
percent of the total hours required to complete such obligated
service requirements.
``(c) Rule of Construction.--The authorization under subsection (a)
shall be notwithstanding any other provision of this subpart or subpart
II.''.
SEC. 7073. PROGRAMS FOR HEALTH CARE WORKFORCE.
(a) Program for Education and Training in Pain Care.--Section 759 of
the Public Health Service Act (42 U.S.C. 294i) is amended--
(1) in subsection (a), by striking ``hospices, and other
public and private entities'' and inserting ``hospices, tribal
health programs (as defined in section 4 of the Indian Health
Care Improvement Act), and other public and nonprofit private
entities'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``award may be made under subsection (a) only
if the applicant for the award agrees that the program
carried out with the award will include'' and inserting
``entity receiving an award under this section shall
develop a comprehensive education and training plan that
includes'';
(B) in paragraph (1)--
(i) by inserting ``preventing,'' after
``diagnosing,''; and
(ii) by inserting ``non-addictive medical
products and non-pharmacologic treatments and''
after ``including'';
(C) in paragraph (2)--
(i) by inserting ``Federal, State, and local''
after ``applicable''; and
(ii) by striking ``the degree to which'' and
all that follows through ``effective pain care''
and inserting ``opioids'';
(D) in paragraph (3), by inserting ``, integrated,
evidence-based pain management, and, as appropriate,
non-pharmacotherapy'' before the semicolon;
(E) in paragraph (4), by striking ``; and'' and
inserting ``;''; and
(F) by striking paragraph (5) and inserting the
following:
``(5) recent findings, developments, and advancements in
pain care research and the provision of pain care, which may
include non-addictive medical products and non-pharmacologic
treatments intended to treat pain; and
``(6) the dangers of opioid abuse and misuse, detection of
early warning signs of opioid use disorders (which may
[[Page 132 STAT. 4032]]
include best practices related to screening for opioid use
disorders, training on screening, brief intervention, and
referral to treatment), and safe disposal options for
prescription medications (including such options provided by law
enforcement or other innovative deactivation mechanisms).'';
(3) in subsection (d), by inserting ``prevention,'' after
``diagnosis,''; and
(4) in subsection (e), by striking ``2010 through 2012'' and
inserting ``2019 through 2023''.
(b) Mental and Behavioral Health Education and Training Program.--
Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
amended--
(1) in subsection (a)--
(A) in paragraph (1), by inserting ``, trauma,''
after ``focus on child and adolescent mental health'';
and
(B) in paragraphs (2) and (3), by inserting
``trauma-informed care and'' before ``substance use
disorder prevention and treatment services''; and
(2) in subsection (f), by striking ``2018 through 2022'' and
inserting ``2019 through 2023''.
Subtitle I--Preventing Overdoses While in Emergency Rooms
SEC. 7081. <<NOTE: 42 USC 290dd-4.>> PROGRAM TO SUPPORT
COORDINATION AND CONTINUATION OF CARE
FOR DRUG OVERDOSE PATIENTS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall identify or
facilitate the development of best practices for--
(1) emergency treatment of known or suspected drug overdose;
(2) the use of recovery coaches, as appropriate, to
encourage individuals who experience a non-fatal overdose to
seek treatment for substance use disorder and to support
coordination and continuation of care;
(3) coordination and continuation of care and treatment,
including, as appropriate, through referrals, of individuals
after a drug overdose; and
(4) the provision or prescribing of overdose reversal
medication, as appropriate.
(b) Grant Establishment and Participation.--
(1) In general.--The Secretary shall award grants on a
competitive basis to eligible entities to support implementation
of voluntary programs for care and treatment of individuals
after a drug overdose, as appropriate, which may include
implementation of the best practices described in subsection
(a).
(2) Eligible entity.--In this section, the term ``eligible
entity'' means--
(A) a State substance abuse agency;
(B) an Indian Tribe or tribal organization; or
(C) an entity that offers treatment or other
services for individuals in response to, or following,
drug overdoses or a drug overdose, such as an emergency
department, in consultation with a State substance abuse
agency.
[[Page 132 STAT. 4033]]
(3) Application.--An eligible entity desiring a grant under
this section shall submit an application to the Secretary, at
such time and in such manner as the Secretary may require, that
includes--
(A) evidence that such eligible entity carries out,
or is capable of contracting and coordinating with other
community entities to carry out, the activities
described in paragraph (4);
(B) evidence that such eligible entity will work
with a recovery community organization to recruit,
train, hire, mentor, and supervise recovery coaches and
fulfill the requirements described in paragraph (4)(A);
and
(C) such additional information as the Secretary may
require.
(4) Use of grant funds.--An eligible entity awarded a grant
under this section shall use such grant funds to--
(A) hire or utilize recovery coaches to help support
recovery, including by--
(i) connecting patients to a continuum of care
services, such as--
(I) treatment and recovery support
programs;
(II) programs that provide non-
clinical recovery support services;
(III) peer support networks;
(IV) recovery community
organizations;
(V) health care providers, including
physicians and other providers of
behavioral health and primary care;
(VI) education and training
providers;
(VII) employers;
(VIII) housing services; and
(IX) child welfare agencies;
(ii) providing education on overdose
prevention and overdose reversal to patients and
families, as appropriate;
(iii) providing follow-up services for
patients after an overdose to ensure continued
recovery and connection to support services;
(iv) collecting and evaluating outcome data
for patients receiving recovery coaching services;
and
(v) providing other services the Secretary
determines necessary to help ensure continued
connection with recovery support services,
including culturally appropriate services, as
applicable;
(B) establish policies and procedures, pursuant to
Federal and State law, that address the provision of
overdose reversal medication, the administration of all
drugs or devices approved or cleared under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and
all biological products licensed under section 351 of
the Public Health Service Act (42 U.S.C. 262) to treat
substance use disorder, and subsequent continuation of,
or referral to, evidence-based treatment for patients
with a substance use disorder who have experienced a
non-fatal drug overdose, in order to support long-term
treatment, prevent relapse, and reduce recidivism and
future overdose; and
[[Page 132 STAT. 4034]]
(C) establish integrated models of care for
individuals who have experienced a non-fatal drug
overdose which may include patient assessment, follow
up, and transportation to and from treatment facilities.
(5) Additional permissible uses.--In addition to the uses
described in paragraph (4), a grant awarded under this section
may be used, directly or through contractual arrangements, to
provide--
(A) all drugs or devices approved or cleared under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.) and all biological products licensed under
section 351 of the Public Health Service Act (42 U.S.C.
262) to treat substance use disorders or reverse
overdose, pursuant to Federal and State law;
(B) withdrawal and detoxification services that
include patient evaluation, stabilization, and
preparation for treatment of substance use disorder,
including treatment described in subparagraph (A), as
appropriate; or
(C) mental health services provided by a certified
professional who is licensed and qualified by education,
training, or experience to assess the psychosocial
background of patients, to contribute to the appropriate
treatment plan for patients with substance use disorder,
and to monitor patient progress.
(6) Preference.--In awarding grants under this section, the
Secretary shall give preference to eligible entities that meet
any or all of the following criteria:
(A) The eligible entity is a critical access
hospital (as defined in section 1861(mm)(1) of the
Social Security Act (42 U.S.C. 1395x(mm)(1))), a low
volume hospital (as defined in section 1886(d)(12)(C)(i)
of such Act (42 U.S.C. 1395ww(d)(12)(C)(i))), a sole
community hospital (as defined in section
1886(d)(5)(D)(iii) of such Act (42 U.S.C.
1395ww(d)(5)(D)(iii))), or a hospital that receives
disproportionate share hospital payments under section
1886(d)(5)(F) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(F)).
(B) The eligible entity is located in a State with
an age-adjusted rate of drug overdose deaths that is
above the national overdose mortality rate, as
determined by the Director of the Centers for Disease
Control and Prevention, or under the jurisdiction of an
Indian Tribe with an age-adjusted rate of drug overdose
deaths that is above the national overdose mortality
rate, as determined through appropriate mechanisms as
determined by the Secretary in consultation with Indian
Tribes.
(C) The eligible entity demonstrates that recovery
coaches will be placed in both health care settings and
community settings.
(7) Period of grant.--A grant awarded to an eligible entity
under this section shall be for a period of not more than 5
years.
(c) Definitions.--In this section:
(1) Indian tribe; tribal organization.--The terms ``Indian
Tribe'' and ``tribal organization'' have the meanings given the
terms ``Indian tribe'' and ``tribal organization'' in section 4
of the Indian Self-Determination and Education Assistance Act
(25 U.S.C. 5304).
[[Page 132 STAT. 4035]]
(2) Recovery coach.--the term ``recovery coach'' means an
individual--
(A) with knowledge of, or experience with, recovery
from a substance use disorder; and
(B) who has completed training from, and is
determined to be in good standing by, a recovery
services organization capable of conducting such
training and making such determination.
(3) Recovery community organization.--The term ``recovery
community organization'' has the meaning given such term in
section 547(a) of the Public Health Service Act (42 U.S.C.
290ee-2(a)).
(d) Reporting Requirements.--
(1) Reports by grantees.--Each eligible entity awarded a
grant under this section shall submit to the Secretary an annual
report for each year for which the entity has received such
grant that includes information on--
(A) the number of individuals treated by the entity
for non-fatal overdoses, including the number of non-
fatal overdoses where overdose reversal medication was
administered;
(B) the number of individuals administered
medication-assisted treatment by the entity;
(C) the number of individuals referred by the entity
to other treatment facilities after a non-fatal
overdose, the types of such other facilities, and the
number of such individuals admitted to such other
facilities pursuant to such referrals; and
(D) the frequency and number of patients with
reoccurrences, including readmissions for non-fatal
overdoses and evidence of relapse related to substance
use disorder.
(2) Report by secretary.--Not later than 5 years after the
date of enactment of this Act, the Secretary shall submit to
Congress a report that includes an evaluation of the
effectiveness of the grant program carried out under this
section with respect to long term health outcomes of the
population of individuals who have experienced a drug overdose,
the percentage of patients treated or referred to treatment by
grantees, and the frequency and number of patients who
experienced relapse, were readmitted for treatment, or
experienced another overdose.
(e) Privacy.--The requirements of this section, including with
respect to data reporting and program oversight, shall be subject to all
applicable Federal and State privacy laws.
(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $10,000,000 for each of fiscal
years 2019 through 2023.
Subtitle J--Alternatives to Opioids in the Emergency Department
SEC. 7091. <<NOTE: 42 USC 294i note.>> EMERGENCY DEPARTMENT
ALTERNATIVES TO OPIOIDS DEMONSTRATION
PROGRAM.
(a) Demonstration Program Grants.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall
[[Page 132 STAT. 4036]]
carry out a demonstration program for purposes of awarding
grants to hospitals and emergency departments, including
freestanding emergency departments, to develop, implement,
enhance, or study alternatives to opioids for pain management in
such settings.
(2) Eligibility.--To be eligible to receive a grant under
paragraph (1), a hospital or emergency department shall submit
an application to the Secretary at such time, in such manner,
and containing such information as the Secretary may require.
(3) Geographic distribution.--In awarding grants under this
section, the Secretary shall seek to ensure geographical
distribution among grant recipients.
(4) Use of funds.--Grants under paragraph (1) shall be used
to--
(A) target treatment approaches for painful
conditions frequently treated in such settings;
(B) train providers and other hospital personnel on
protocols or best practices related to the use and
prescription of opioids and alternatives to opioids for
pain management in the emergency department; and
(C) develop or continue strategies to provide
alternatives to opioids, as appropriate.
(b) Additional Demonstration Program.--The Secretary may carry out a
demonstration program similar to the program under subsection (a) for
other acute care settings.
(c) Consultation.--The Secretary shall implement a process for
recipients of grants under subsection (a) or (b) to share evidence-based
and best practices and promote consultation with persons having robust
knowledge, including emergency departments and physicians that have
successfully implemented programs that use alternatives to opioids for
pain management, as appropriate, such as approaches studied through the
National Center for Complimentary and Integrative Health or other
institutes and centers at the National Institutes of Health, as
appropriate. The Secretary shall offer to each recipient of a grant
under subsection (a) or (b) technical assistance as necessary.
(d) Technical Assistance.--The Secretary shall identify or
facilitate the development of best practices on alternatives to opioids
for pain management and provide technical assistance to hospitals and
other acute care settings on alternatives to opioids for pain
management. The technical assistance provided shall be for the purpose
of--
(1) utilizing information from recipients of a grant under
subsection (a) or (b) that have successfully implemented
alternatives to opioids programs;
(2) identifying or facilitating the development of best
practices on the use of alternatives to opioids, which may
include pain-management strategies that involve non-addictive
medical products, non-pharmacologic treatments, and technologies
or techniques to identify patients at risk for opioid use
disorder;
(3) identifying or facilitating the development of best
practices on the use of alternatives to opioids that target
common painful conditions and include certain patient
populations, such as geriatric patients, pregnant women, and
children; and
(4) disseminating information on the use of alternatives to
opioids to providers in acute care settings, which may include
[[Page 132 STAT. 4037]]
emergency departments, outpatient clinics, critical access
hospitals, Federally qualified health centers, Indian Health
Service health facilities, and tribal hospitals.
(e) Report to the Secretary.--Each recipient of a grant under this
section shall submit to the Secretary (during the period of such grant)
annual reports on the progress of the program funded through the grant.
These reports shall include, in accordance with all applicable State and
Federal privacy laws--
(1) a description of and specific information about the
opioid alternative pain management programs, including the
demographic characteristics of patients who were treated with an
alternative pain management protocol, implemented in hospitals,
emergency departments, and other acute care settings;
(2) data on the opioid alternative pain management
strategies used, including the number of opioid prescriptions
written--
(A) during a baseline period before the program
began; or
(B) at various stages of the program; and
(3) data on patients who were eventually prescribed opioids
after alternative pain management protocols and treatments were
utilized; and
(4) any other information the Secretary determines
appropriate.
(f) Report to Congress.--Not later than 1 year after completion of
the demonstration program under this section, the Secretary shall submit
a report to the Congress on the results of the demonstration program and
include in the report--
(1) the number of applications received and the number
funded;
(2) a summary of the reports described in subsection (e),
including data that allows for comparison of programs; and
(3) recommendations for broader implementation of pain
management strategies that encourage the use of alternatives to
opioids in hospitals, emergency departments, or other acute care
settings.
(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2019 through 2021.
Subtitle K--Treatment, Education, and Community Help To Combat Addiction
SEC. 7101. ESTABLISHMENT OF REGIONAL CENTERS OF EXCELLENCE IN
SUBSTANCE USE DISORDER EDUCATION.
Part D of title V of the Public Health Service Act, as amended by
section 7031, is further amended by adding at the end the following new
section:
``SEC. 551. <<NOTE: 42 USC 290ee-6.>> REGIONAL CENTERS OF
EXCELLENCE IN SUBSTANCE USE DISORDER
EDUCATION.
``(a) In General.--The Secretary, in consultation with appropriate
agencies, shall award cooperative agreements to eligible entities for
the designation of such entities as Regional Centers of Excellence in
Substance Use Disorder Education for purposes of
[[Page 132 STAT. 4038]]
improving health professional training resources with respect to
substance use disorder prevention, treatment, and recovery.
``(b) Eligibility.--To be eligible to receive a cooperative
agreement under subsection (a), an entity shall--
``(1) be an accredited entity that offers education to
students in various health professions, which may include--
``(A) a teaching hospital;
``(B) a medical school;
``(C) a certified behavioral health clinic; or
``(D) any other health professions school, school of
public health, or Cooperative Extension Program at
institutions of higher education, as defined in section
101 of the Higher Education Act of 1965, engaged in the
prevention, treatment, or recovery of substance use
disorders;
``(2) demonstrate community engagement and partnerships with
community stakeholders, including entities that train health
professionals, mental health counselors, social workers, peer
recovery specialists, substance use treatment programs,
community health centers, physician offices, certified
behavioral health clinics, research institutions, and law
enforcement; and
``(3) submit to the Secretary an application containing such
information, at such time, and in such manner, as the Secretary
may require.
``(c) Activities.--An entity receiving an award under this section
shall develop, evaluate, and distribute evidence-based resources
regarding the prevention and treatment of, and recovery from, substance
use disorders. Such resources may include information on--
``(1) the neurology and pathology of substance use
disorders;
``(2) advancements in the treatment of substance use
disorders;
``(3) techniques and best practices to support recovery from
substance use disorders;
``(4) strategies for the prevention and treatment of, and
recovery from substance use disorders across patient
populations; and
``(5) other topic areas that are relevant to the objectives
described in subsection (a).
``(d) Geographic Distribution.--In awarding cooperative agreements
under subsection (a), the Secretary shall take into account regional
differences among eligible entities and shall make an effort to ensure
geographic distribution.
``(e) Evaluation.--The Secretary shall evaluate each project carried
out by an entity receiving an award under this section and shall
disseminate the findings with respect to each such evaluation to
appropriate public and private entities.
``(f) Funding.--There is authorized to be appropriated to carry out
this section, $4,000,000 for each of fiscal years 2019 through 2023.''.
SEC. 7102. <<NOTE: 42 USC 290bb-7a.>> YOUTH PREVENTION AND
RECOVERY.
(a) Substance Abuse Treatment Services for Children, Adolescents,
and Young Adults.--Section 514 of the Public Health Service Act (42
U.S.C. 290bb-7) is amended--
(1) in the section heading, by striking ``children and
adolescents'' and inserting ``children, adolescents, and young
adults'';
[[Page 132 STAT. 4039]]
(2) in subsection (a)(2), by striking ``children,
including'' and inserting ``children, adolescents, and young
adults, including''; and
(3) by striking ``children and adolescents'' each place it
appears and inserting ``children, adolescents, and young
adults''.
(b) Resource Center.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'', except as otherwise
provided), in consultation with the Secretary of Education and other
heads of agencies, including the Assistant Secretary for Mental Health
and Substance Use and the Administrator of the Health Resources and
Services Administration, as appropriate, shall establish a resource
center to provide technical support to recipients of grants under
subsection (c).
(c) Youth Prevention and Recovery Initiative.--
(1) In general.--The Secretary, in consultation with the
Secretary of Education, shall administer a program to provide
support for communities to support the prevention of, treatment
of, and recovery from, substance use disorders for children,
adolescents, and young adults.
(2) Definitions.--In this subsection:
(A) Eligible entity.--The term ``eligible entity''
means--
(i) a local educational agency that is seeking
to establish or expand substance use prevention or
recovery support services at one or more high
schools;
(ii) a State educational agency;
(iii) an institution of higher education (or
consortia of such institutions), which may include
a recovery program at an institution of higher
education;
(iv) a local board or one-stop operator;
(v) a nonprofit organization with appropriate
expertise in providing services or programs for
children, adolescents, or young adults, excluding
a school;
(vi) a State, political subdivision of a
State, Indian tribe, or tribal organization; or
(vii) a high school or dormitory serving high
school students that receives funding from the
Bureau of Indian Education.
(B) Foster care.--The term ``foster care'' has the
meaning given such term in section 1355.20(a) of title
45, Code of Federal Regulations (or any successor
regulations).
(C) High school.--The term ``high school'' has the
meaning given such term in section 8101 of the
Elementary and Secondary Education Act of 1965 (20
U.S.C. 7801).
(D) Homeless youth.--The term ``homeless youth'' has
the meaning given the term ``homeless children or
youths'' in section 725 of the McKinney-Vento Homeless
Assistance Act (42 U.S.C. 11434a).
(E) Indian tribe; tribal organization.--The terms
``Indian tribe'' and ``tribal organization'' have the
meanings given such terms in section 4 of the Indian
Self-Determination and Education Assistance Act (25
U.S.C. 5304).
(F) Institution of higher education.--The term
``institution of higher education'' has the meaning
given such term in section 101 of the Higher Education
Act of 1965 (20 U.S.C. 1001) and includes a
``postsecondary
[[Page 132 STAT. 4040]]
vocational institution'' as defined in section 102(c) of
such Act (20 U.S.C. 1002(c)).
(G) Local educational agency.--The term ``local
educational agency'' has the meaning given such term in
section 8101 of the Elementary and Secondary Education
Act of 1965 (20 U.S.C. 7801).
(H) Local board; one-stop operator.--The terms
``local board'' and ``one-stop operator'' have the
meanings given such terms in section 3 of the Workforce
Innovation and Opportunity Act (29 U.S.C. 3102).
(I) Out-of-school youth.--The term ``out-of-school
youth'' has the meaning given such term in section
129(a)(1)(B) of the Workforce Innovation and Opportunity
Act (29 U.S.C. 3164(a)(1)(B)).
(J) Recovery program.--The term ``recovery program''
means a program--
(i) to help children, adolescents, or young
adults who are recovering from substance use
disorders to initiate, stabilize, and maintain
healthy and productive lives in the community; and
(ii) that includes peer-to-peer support
delivered by individuals with lived experience in
recovery, and communal activities to build
recovery skills and supportive social networks.
(K) State educational agency.--The term ``State
educational agency'' has the meaning given such term in
section 8101 of the Elementary and Secondary Education
Act (20 U.S.C. 7801).
(3) Best practices.--The Secretary, in consultation with the
Secretary of Education, shall--
(A) identify or facilitate the development of
evidence-based best practices for prevention of
substance misuse and abuse by children, adolescents, and
young adults, including for specific populations such as
youth in foster care, homeless youth, out-of-school
youth, and youth who are at risk of or have experienced
trafficking that address--
(i) primary prevention;
(ii) appropriate recovery support services;
(iii) appropriate use of medication-assisted
treatment for such individuals, if applicable, and
ways of overcoming barriers to the use of
medication-assisted treatment in such population;
and
(iv) efficient and effective communication,
which may include the use of social media, to
maximize outreach efforts;
(B) disseminate such best practices to State
educational agencies, local educational agencies,
schools and dormitories funded by the Bureau of Indian
Education, institutions of higher education, recovery
programs at institutions of higher education, local
boards, one-stop operators, family and youth homeless
providers, and nonprofit organizations, as appropriate;
(C) conduct a rigorous evaluation of each grant
funded under this subsection, particularly its impact on
the indicators described in paragraph (7)(B); and
(D) provide technical assistance for grantees under
this subsection.
[[Page 132 STAT. 4041]]
(4) Grants authorized.--The Secretary, in consultation with
the Secretary of Education, shall award 3-year grants, on a
competitive basis, to eligible entities to enable such entities,
in coordination with Indian tribes, if applicable, and State
agencies responsible for carrying out substance use disorder
prevention and treatment programs, to carry out evidence-based
programs for--
(A) prevention of substance misuse and abuse by
children, adolescents, and young adults, which may
include primary prevention;
(B) recovery support services for children,
adolescents, and young adults, which may include
counseling, job training, linkages to community-based
services, family support groups, peer mentoring, and
recovery coaching; or
(C) treatment or referrals for treatment of
substance use disorders, which may include the use of
medication-assisted treatment, as appropriate.
(5) Special consideration.--In awarding grants under this
subsection, the Secretary shall give special consideration to
the unique needs of tribal, urban, suburban, and rural
populations.
(6) Application.--To be eligible for a grant under this
subsection, an entity shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require. Such application shall
include--
(A) a description of--
(i) the impact of substance use disorders in
the population that will be served by the grant
program;
(ii) how the eligible entity has solicited
input from relevant stakeholders, which may
include faculty, teachers, staff, families,
students, and experts in substance use disorder
prevention, treatment, and recovery in developing
such application;
(iii) the goals of the proposed project,
including the intended outcomes;
(iv) how the eligible entity plans to use
grant funds for evidence-based activities, in
accordance with this subsection to prevent,
provide recovery support for, or treat substance
use disorders amongst such individuals, or a
combination of such activities; and
(v) how the eligible entity will collaborate
with relevant partners, which may include State
educational agencies, local educational agencies,
institutions of higher education, juvenile justice
agencies, prevention and recovery support
providers, local service providers, including
substance use disorder treatment programs,
providers of mental health services, youth serving
organizations, family and youth homeless
providers, child welfare agencies, and primary
care providers, in carrying out the grant program;
and
(B) an assurance that the eligible entity will
participate in the evaluation described in paragraph
(3)(C).
(7) Reports to the secretary.--Each eligible entity awarded
a grant under this subsection shall submit to the Secretary a
report at such time and in such manner as the Secretary may
require. Such report shall include--
[[Page 132 STAT. 4042]]
(A) a description of how the eligible entity used
grant funds, in accordance with this subsection,
including the number of children, adolescents, and young
adults reached through programming; and
(B) a description, including relevant data, of how
the grant program has made an impact on the intended
outcomes described in paragraph (6)(A)(iii), including--
(i) indicators of student success, which, if
the eligible entity is an educational institution,
shall include student well-being and academic
achievement;
(ii) substance use disorders amongst children,
adolescents, and young adults, including the
number of overdoses and deaths amongst children,
adolescents, and young adults served by the grant
during the grant period; and
(iii) other indicators, as the Secretary
determines appropriate.
(8) Report to congress.--The Secretary shall, not later than
October 1, 2022, submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce and the Committee on Education and the
Workforce of the House of Representatives a report summarizing
the effectiveness of the grant program under this subsection,
based on the information submitted in reports required under
paragraph (7).
(9) Authorization of appropriations.--There is authorized to
be appropriated $10,000,000 to carry out this subsection for
each of fiscal years 2019 through 2023.
Subtitle L--Information From National Mental Health and Substance Use
Policy Laboratory
SEC. 7111. INFORMATION FROM NATIONAL MENTAL HEALTH AND SUBSTANCE
USE POLICY LABORATORY.
Section 501A(b) of the Public Health Service Act (42 U.S.C. 290aa-
0(b)) is amended--
(1) in paragraph (5)(C), by striking ``; and'' at the end
and inserting a semicolon;
(2) by redesignating paragraph (6) as paragraph (7); and
(3) by inserting after paragraph (5) the following:
``(6) issue and periodically update information for entities
applying for grants or cooperative agreements from the Substance
Abuse and Mental Health Services Administration in order to--
``(A) encourage the implementation and replication
of evidence-based practices; and
``(B) provide technical assistance to applicants for
funding, including with respect to justifications for
such programs and activities; and''.
[[Page 132 STAT. 4043]]
Subtitle M--Comprehensive Opioid Recovery Centers
SEC. 7121. COMPREHENSIVE OPIOID RECOVERY CENTERS.
(a) In General.--Part D of title V of the Public Health Service Act
(42 U.S.C. 290dd et seq.), as amended by sections 7031 and 7101, is
further amended by adding at the end the following new section:
``SEC. 552. <<NOTE: 42 USC 290ee-7.>> COMPREHENSIVE OPIOID
RECOVERY CENTERS.
``(a) In General.--The Secretary shall award grants on a competitive
basis to eligible entities to establish or operate a comprehensive
opioid recovery center (referred to in this section as a `Center'). A
Center may be a single entity or an integrated delivery network.
``(b) Grant Period.--
``(1) In general.--A grant awarded under subsection (a)
shall be for a period of not less than 3 years and not more than
5 years.
``(2) Renewal.--A grant awarded under subsection (a) may be
renewed, on a competitive basis, for additional periods of time,
as determined by the Secretary. In determining whether to renew
a grant under this paragraph, the Secretary shall consider the
data submitted under subsection (h).
``(c) Minimum Number of Centers.--The Secretary shall allocate the
amounts made available under subsection (j) such that not fewer than 10
grants may be awarded. Not more than one grant shall be made to entities
in a single State for any one period.
``(d) Application.--
``(1) Eligible entity.--An entity is eligible for a grant
under this section if the entity offers treatment and other
services for individuals with a substance use disorder.
``(2) Submission of application.--In order to be eligible
for a grant under subsection (a), an entity shall submit an
application to the Secretary at such time and in such manner as
the Secretary may require. Such application shall include--
``(A) evidence that such entity carries out, or is
capable of coordinating with other entities to carry
out, the activities described in subsection (g); and
``(B) such other information as the Secretary may
require.
``(e) Priority.--In awarding grants under subsection (a), the
Secretary shall give priority to eligible entities--
``(1) located in a State with an age-adjusted rate of drug
overdose deaths that is above the national overdose mortality
rate, as determined by the Director of the Centers for Disease
Control and Prevention; or
``(2) serving an Indian Tribe (as defined in section 4 of
the Indian Self-Determination and Education Assistance Act) with
an age-adjusted rate of drug overdose deaths that is above the
national overdose mortality rate, as determined through
appropriate mechanisms determined by the Secretary in
consultation with Indian Tribes.
[[Page 132 STAT. 4044]]
``(f) Preference.--In awarding grants under subsection (a), the
Secretary may give preference to eligible entities utilizing technology-
enabled collaborative learning and capacity building models, including
such models as defined in section 2 of the Expanding Capacity for Health
Outcomes Act (Public Law 114-270; 130 Stat. 1395), to conduct the
activities described in this section.
``(g) Center Activities.--Each Center shall, at a minimum, carry out
the following activities directly, through referral, or through
contractual arrangements, which may include carrying out such activities
through technology-enabled collaborative learning and capacity building
models described in subsection (f):
``(1) Treatment and recovery services.--Each Center shall--
``(A) Ensure that intake, evaluations, and periodic
patient assessments meet the individualized clinical
needs of patients, including by reviewing patient
placement in treatment settings to support meaningful
recovery.
``(B) Provide the full continuum of treatment
services, including--
``(i) all drugs and devices approved or
cleared under the Federal Food, Drug, and Cosmetic
Act and all biological products licensed under
section 351 of this Act to treat substance use
disorders or reverse overdoses, pursuant to
Federal and State law;
``(ii) medically supervised withdrawal
management, that includes patient evaluation,
stabilization, and readiness for and entry into
treatment;
``(iii) counseling provided by a program
counselor or other certified professional who is
licensed and qualified by education, training, or
experience to assess the psychological and
sociological background of patients, to contribute
to the appropriate treatment plan for the patient,
and to monitor patient progress;
``(iv) treatment, as appropriate, for patients
with co-occurring substance use and mental
disorders;
``(v) testing, as appropriate, for infections
commonly associated with illicit drug use;
``(vi) residential rehabilitation, and
outpatient and intensive outpatient programs;
``(vii) recovery housing;
``(viii) community-based and peer recovery
support services;
``(ix) job training, job placement assistance,
and continuing education assistance to support
reintegration into the workforce; and
``(x) other best practices to provide the full
continuum of treatment and services, as determined
by the Secretary.
``(C) Ensure that all programs covered by the Center
include medication-assisted treatment, as appropriate,
and do not exclude individuals receiving medication-
assisted treatment from any service.
``(D) Periodically conduct patient assessments to
support sustained and clinically significant recovery,
as defined by the Assistant Secretary for Mental Health
and Substance Use.
[[Page 132 STAT. 4045]]
``(E) Provide onsite access to medication, as
appropriate, and toxicology services; for purposes of
carrying out this section.
``(F) Operate a secure, confidential, and
interoperable electronic health information system.
``(G) Offer family support services such as child
care, family counseling, and parenting interventions to
help stabilize families impacted by substance use
disorder, as appropriate.
``(2) Outreach.--Each Center shall carry out outreach
activities regarding the services offered through the Centers,
which may include--
``(A) training and supervising outreach staff, as
appropriate, to work with State and local health
departments, health care providers, the Indian Health
Service, State and local educational agencies, schools
funded by the Indian Bureau of Education, institutions
of higher education, State and local workforce
development boards, State and local community action
agencies, public safety officials, first responders,
Indian Tribes, child welfare agencies, as appropriate,
and other community partners and the public, including
patients, to identify and respond to community needs;
``(B) ensuring that the entities described in
subparagraph (A) are aware of the services of the
Center; and
``(C) disseminating and making publicly available,
including through the internet, evidence-based resources
that educate professionals and the public on opioid use
disorder and other substance use disorders, including
co-occurring substance use and mental disorders.
``(h) Data Reporting and Program Oversight.--With respect to a grant
awarded under subsection (a), not later than 90 days after the end of
the first year of the grant period, and annually thereafter for the
duration of the grant period (including the duration of any renewal
period for such grant), the entity shall submit data, as appropriate, to
the Secretary regarding--
``(1) the programs and activities funded by the grant;
``(2) health outcomes of the population of individuals with
a substance use disorder who received services from the Center,
evaluated by an independent program evaluator through the use of
outcomes measures, as determined by the Secretary;
``(3) the retention rate of program participants; and
``(4) any other information that the Secretary may require
for the purpose of--ensuring that the Center is complying with
all the requirements of the grant, including providing the full
continuum of services described in subsection (g)(1)(B).
``(i) Privacy.--The provisions of this section, including with
respect to data reporting and program oversight, shall be subject to all
applicable Federal and State privacy laws.
``(j) Authorization of Appropriations.--There is authorized to be
appropriated $10,000,000 for each of fiscal years 2019 through 2023 for
purposes of carrying out this section.''.
(b) Reports to Congress.--
(1) Preliminary report.--Not later than 3 years after the
date of the enactment of this Act, the Secretary of Health and
Human Services shall submit to Congress a preliminary
[[Page 132 STAT. 4046]]
report that analyzes data submitted under section 552(h) of the
Public Health Service Act, as added by subsection (a).
(2) Final report.--Not later than 2 years after submitting
the preliminary report required under paragraph (1), the
Secretary of Health and Human Services shall submit to Congress
a final report that includes--
(A) an evaluation of the effectiveness of the
comprehensive services provided by the Centers
established or operated pursuant to section 552 of the
Public Health Service Act, as added by subsection (a),
with respect to health outcomes of the population of
individuals with substance use disorder who receive
services from the Center, which shall include an
evaluation of the effectiveness of services for
treatment and recovery support and to reduce relapse,
recidivism, and overdose; and
(B) recommendations, as appropriate, regarding ways
to improve Federal programs related to substance use
disorders, which may include dissemination of best
practices for the treatment of substance use disorders
to health care professionals.
Subtitle N--Trauma-Informed Care
SEC. 7131. <<NOTE: 42 USC 242t.>> CDC SURVEILLANCE AND DATA
COLLECTION FOR CHILD, YOUTH, AND ADULT
TRAUMA.
(a) Data Collection.--The Director of the Centers for Disease
Control and Prevention (referred to in this section as the ``Director'')
may, in cooperation with the States, collect and report data on adverse
childhood experiences through the Behavioral Risk Factor Surveillance
System, the Youth Risk Behavior Surveillance System, and other relevant
public health surveys or questionnaires.
(b) Timing.--The collection of data under subsection (a) may occur
biennially.
(c) Data From Rural Areas.--The Director shall encourage each State
that participates in collecting and reporting data under subsection (a)
to collect and report data from rural areas within such State, in order
to generate a statistically reliable representation of such areas.
(d) Data From Tribal Areas.--The Director may, in cooperation with
Indian Tribes (as defined in section 4 of the Indian Self-Determination
and Education Assistance Act) and pursuant to a written request from an
Indian Tribe, provide technical assistance to such Indian Tribe to
collect and report data on adverse childhood experiences through the
Behavioral Risk Factor Surveillance System, the Youth Risk Behavior
Surveillance System, or another relevant public health survey or
questionnaire.
(e) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $2,000,000 for each of fiscal
years 2019 through 2023.
SEC. 7132. TASK FORCE TO DEVELOP BEST PRACTICES FOR TRAUMA-
INFORMED IDENTIFICATION, REFERRAL, AND
SUPPORT.
(a) Establishment.--There is established a task force, to be known
as the Interagency Task Force on Trauma-Informed Care (in this section
referred to as the ``task force'') that shall identify, evaluate, and
make recommendations regarding--
[[Page 132 STAT. 4047]]
(1) best practices with respect to children and youth, and
their families as appropriate, who have experienced or are at
risk of experiencing trauma; and
(2) ways in which Federal agencies can better coordinate to
improve the Federal response to families impacted by substance
use disorders and other forms of trauma.
(b) Membership.--
(1) Composition.--The task force shall be composed of the
heads of the following Federal departments and agencies, or
their designees:
(A) The Centers for Medicare & Medicaid Services.
(B) The Substance Abuse and Mental Health Services
Administration.
(C) The Agency for Healthcare Research and Quality.
(D) The Centers for Disease Control and Prevention.
(E) The Indian Health Service.
(F) The Department of Veterans Affairs.
(G) The National Institutes of Health.
(H) The Food and Drug Administration.
(I) The Health Resources and Services
Administration.
(J) The Department of Defense.
(K) The Office of Minority Health of the Department
of Health and Human Services.
(L) The Administration for Children and Families.
(M) The Office of the Assistant Secretary for
Planning and Evaluation of the Department of Health and
Human Services.
(N) The Office for Civil Rights of the Department of
Health and Human Services.
(O) The Office of Juvenile Justice and Delinquency
Prevention of the Department of Justice.
(P) The Office of Community Oriented Policing
Services of the Department of Justice.
(Q) The Office on Violence Against Women of the
Department of Justice.
(R) The National Center for Education Evaluation and
Regional Assistance of the Department of Education.
(S) The National Center for Special Education
Research of the Institute of Education Science.
(T) The Office of Elementary and Secondary Education
of the Department of Education.
(U) The Office for Civil Rights of the Department of
Education.
(V) The Office of Special Education and
Rehabilitative Services of the Department of Education.
(W) The Bureau of Indian Affairs of the Department
of the Interior.
(X) The Veterans Health Administration of the
Department of Veterans Affairs.
(Y) The Office of Special Needs Assistance Programs
of the Department of Housing and Urban Development.
(Z) The Office of Head Start of the Administration
for Children and Families.
(AA) The Children's Bureau of the Administration for
Children and Families.
(BB) The Bureau of Indian Education of the
Department of the Interior.
[[Page 132 STAT. 4048]]
(CC) Such other Federal agencies as the Secretaries
determine to be appropriate.
(2) Date of appointments.--The heads of Federal departments
and agencies shall appoint the corresponding members of the task
force not later than 60 days after the date of enactment of this
Act.
(3) Chairperson.--The task force shall be chaired by the
Assistant Secretary for Mental Health and Substance Use, or the
Assistant Secretary's designee.
(c) Task Force Duties.--The task force shall--
(1) solicit input from stakeholders, including frontline
service providers, educators, mental health professionals,
researchers, experts in infant, child, and youth trauma, child
welfare professionals, and the public, in order to inform the
activities under paragraph (2); and
(2) identify, evaluate, make recommendations, and update
such recommendations not less than annually, to the general
public, the Secretary of Education, the Secretary of Health and
Human Services, the Secretary of Labor, the Secretary of the
Interior, the Attorney General, and other relevant cabinet
Secretaries, and Congress regarding--
(A) a set of evidence-based, evidence-informed, and
promising best practices with respect to--
(i) prevention strategies for individuals at
risk of experiencing or being exposed to trauma,
including trauma as a result of exposure to
substance use;
(ii) the identification of infants, children
and youth, and their families as appropriate, who
have experienced or are at risk of experiencing
trauma;
(iii) the expeditious referral to and
implementation of trauma-informed practices and
supports that prevent and mitigate the effects of
trauma, which may include whole-family and multi-
generational approaches; and
(iv) community based or multi-generational
practices that support children and their
families;
(B) a national strategy on how the task force and
member agencies will collaborate, prioritize options
for, and implement a coordinated approach, which may
include--
(i) data sharing;
(ii) providing support to infants, children,
and youth, and their families as appropriate, who
have experienced or are at risk of experiencing
trauma;
(iii) identifying options for coordinating
existing grants that support infants, children,
and youth, and their families as appropriate, who
have experienced, or are at risk of experiencing,
exposure to substance use or other trauma,
including trauma related to substance use; and
(iv) other ways to improve coordination,
planning, and communication within and across
Federal agencies, offices, and programs, to better
serve children and families impacted by substance
use disorders; and
(C) existing Federal authorities at the Department
of Education, Department of Health and Human Services,
Department of Justice, Department of Labor, Department
[[Page 132 STAT. 4049]]
of the Interior, and other relevant agencies, and
specific Federal grant programs to disseminate best
practices on, provide training in, or deliver services
through, trauma-informed practices, and disseminate such
information--
(i) in writing to relevant program offices at
such agencies to encourage grant applicants in
writing to use such funds, where appropriate, for
trauma-informed practices; and
(ii) to the general public through the
internet website of the task force.
(d) Best Practices.--In identifying, evaluating, and recommending
the set of best practices under subsection (c), the task force shall--
(1) include guidelines for providing professional
development and education for front-line services providers,
including school personnel, early childhood education program
providers, providers from child- or youth-serving organizations,
housing and homeless providers, primary and behavioral health
care providers, child welfare and social services providers,
juvenile and family court personnel, health care providers,
individuals who are mandatory reporters of child abuse or
neglect, trained nonclinical providers (including peer mentors
and clergy), and first responders, in--
(A) understanding and identifying early signs and
risk factors of trauma in infants, children, and youth,
and their families as appropriate, including through
screening processes and services;
(B) providing practices to prevent and mitigate the
impact of trauma, including by fostering safe and stable
environments and relationships; and
(C) developing and implementing policies,
procedures, or systems that--
(i) are designed to quickly refer infants,
children, youth, and their families as
appropriate, who have experienced or are at risk
of experiencing trauma to the appropriate trauma-
informed screening and support and age-appropriate
treatment, and to ensure such infants, children,
youth, and family members receive such support;
(ii) utilize and develop partnerships with
early childhood education programs, local social
services organizations, such as organizations
serving youth, and clinical mental health or other
health care providers with expertise in providing
support services and age-appropriate trauma-
informed and evidence-based treatment aimed at
preventing or mitigating the effects of trauma;
(iii) educate children and youth to--
(I) understand and identify the
signs, effects, or symptoms of trauma;
and
(II) build the resilience and coping
skills to mitigate the effects of
experiencing trauma;
(iv) promote and support multi-generational
practices that assist parents, foster parents, and
kinship and other caregivers in accessing
resources related to, and developing environments
conducive to, the prevention and mitigation of
trauma; and
[[Page 132 STAT. 4050]]
(v) collect and utilize data from screenings,
referrals, or the provision of services and
supports to evaluate outcomes and improve
processes for trauma-informed services and
supports that are culturally sensitive,
linguistically appropriate, and specific to age
ranges and sex, as applicable;
(2) recommend best practices that are designed to avoid
unwarranted custody loss or criminal penalties for parents or
guardians in connection with infants, children, and youth who
have experienced or are at risk of experiencing trauma; and
(3) recommend opportunities for local- and State-level
partnerships that--
(A) are designed to quickly identify and refer
children and families, as appropriate, who have
experienced or are at risk of experiencing exposure to
trauma, including related to substance use;
(B) utilize and develop partnerships with early
childhood education programs, local social services
organizations, and health care services aimed at
preventing or mitigating the effects of exposure to
trauma, including related to substance use;
(C) offer community-based prevention activities,
including educating families and children on the effects
of exposure to trauma, such as trauma related to
substance use, and how to build resilience and coping
skills to mitigate those effects;
(D) in accordance with Federal privacy protections,
utilize non-personally-identifiable data from
screenings, referrals, or the provision of services and
supports to evaluate and improve processes addressing
exposure to trauma, including related to substance use;
and
(E) are designed to prevent separation and support
reunification of families if in the best interest of the
child.
(e) Operating Plan.--Not later than 120 days after the date of
enactment of this Act, the task force shall hold the first meeting. Not
later than 2 years after such date of enactment, the task force shall
submit to the Secretary of Education, Secretary of Health and Human
Services, Secretary of Labor, Secretary of the Interior, the Attorney
General, and Congress an operating plan for carrying out the activities
of the task force described in subsection (c)(2). Such operating plan
shall include--
(1) a list of specific activities that the task force plans
to carry out for purposes of carrying out duties described in
subsection (c)(2), which may include public engagement;
(2) a plan for carrying out the activities under subsection
(c)(2);
(3) a list of members of the task force and other
individuals who are not members of the task force that may be
consulted to carry out such activities;
(4) an explanation of Federal agency involvement and
coordination needed to carry out such activities, including any
statutory or regulatory barriers to such coordination;
(5) a budget for carrying out such activities;
(6) a proposed timeline for implementing recommendations and
efforts identified under subsection (c); and
[[Page 132 STAT. 4051]]
(7) other information that the task force determines
appropriate as related to its duties.
(f) Final Report.--Not later than 3 years after the date of the
first meeting of the task force, the task force shall submit to the
general public, Secretary of Education, Secretary of Health and Human
Services, Secretary of Labor, Secretary of the Interior, the Attorney
General, other relevant cabinet Secretaries, the Committee on Energy and
Commerce and the Committee on Education and the Workforce of the House
of Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate, and Congress, a final report containing all of
the findings and recommendations required under this section, and shall
make such report available online in an accessible format.
(g) Additional Reports.--In addition to the final report under
subsection (f). the task force shall submit--
(1) a report to Congress identifying any recommendations
identified under subsection (c) that require additional
legislative authority to implement; and
(2) a report to the Governors describing the opportunities
for local- and State-level partnerships, professional
development, or best practices recommended under subsection
(d)(3).
(h) Definitions.--In this section--
(1) the term ``early childhood education program'' has the
meaning given such term in section 103 of the Higher Education
Act of 1965 (20 U.S.C. 1003);
(2) The term ``Governor'' means the chief executive officer
of a State; and
(3) the term ``State'' means each of the several States, the
District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa, and the Commonwealth of
the Northern Mariana Islands.
(i) Sunset.--The task force shall sunset on the date that is 60 days
after the submission of the final report under subsection (f), but not
later than September 30, 2023.
SEC. 7133. NATIONAL CHILD TRAUMATIC STRESS INITIATIVE.
Section 582(j) of the Public Health Service Act (42 U.S.C. 290hh-
1(j)) (relating to grants to address the problems of persons who
experience violence-related stress) is amended by striking ``$46,887,000
for each of fiscal years 2018 through 2022'' and inserting ``$63,887,000
for each of fiscal years 2019 through 2023''.
SEC. 7134. <<NOTE: 42 USC 280h-7.>> GRANTS TO IMPROVE TRAUMA
SUPPORT SERVICES AND MENTAL HEALTH CARE
FOR CHILDREN AND YOUTH IN EDUCATIONAL
SETTINGS.
(a) Grants, Contracts, and Cooperative Agreements Authorized.--The
Secretary, in coordination with the Assistant Secretary for Mental
Health and Substance Use, is authorized to award grants to, or enter
into contracts or cooperative agreements with, State educational
agencies, local educational agencies, Indian Tribes (as defined in
section 4 of the Indian Self-Determination and Education Assistance Act)
or their tribal educational agencies, a school operated by the Bureau of
Indian Education, a Regional Corporation, or a Native Hawaiian
educational organization, for the purpose of increasing student access
to evidence-based trauma support services and mental health care by
developing innovative initiatives, activities, or programs to link local
school systems with
[[Page 132 STAT. 4052]]
local trauma-informed support and mental health systems, including those
under the Indian Health Service.
(b) Duration.--With respect to a grant, contract, or cooperative
agreement awarded or entered into under this section, the period during
which payments under such grant, contract or agreement are made to the
recipient may not exceed 4 years.
(c) Use of Funds.--An entity that receives a grant, contract, or
cooperative agreement under this section shall use amounts made
available through such grant, contract, or cooperative agreement for
evidence-based activities, which shall include any of the following:
(1) Collaborative efforts between school-based service
systems and trauma-informed support and mental health service
systems to provide, develop, or improve prevention, screening,
referral, and treatment and support services to students, such
as providing trauma screenings to identify students in need of
specialized support.
(2) To implement schoolwide positive behavioral
interventions and supports, or other trauma-informed models of
support.
(3) To provide professional development to teachers, teacher
assistants, school leaders, specialized instructional support
personnel, and mental health professionals that--
(A) fosters safe and stable learning environments
that prevent and mitigate the effects of trauma,
including through social and emotional learning;
(B) improves school capacity to identify, refer, and
provide services to students in need of trauma support
or behavioral health services; or
(C) reflects the best practices for trauma-informed
identification, referral, and support developed by the
Task Force under section 7132.
(4) Services at a full-service community school that focuses
on trauma-informed supports, which may include a full-time site
coordinator, or other activities consistent with section 4625 of
the Elementary and Secondary Education Act of 1965 (20 U.S.C.
7275).
(5) Engaging families and communities in efforts to increase
awareness of child and youth trauma, which may include sharing
best practices with law enforcement regarding trauma-informed
care and working with mental health professionals to provide
interventions, as well as longer term coordinated care within
the community for children and youth who have experienced trauma
and their families.
(6) To provide technical assistance to school systems and
mental health agencies.
(7) To evaluate the effectiveness of the program carried out
under this section in increasing student access to evidence-
based trauma support services and mental health care.
(8) To establish partnerships with or provide subgrants to
Head Start agencies (including Early Head Start agencies),
public and private preschool programs, child care programs
(including home-based providers), or other entities described in
subsection (a), to include such entities described in this
paragraph in the evidence-based trauma initiatives, activities,
support services, and mental health systems established under
this section in order to provide, develop, or improve
prevention,
[[Page 132 STAT. 4053]]
screening, referral, and treatment and support services to young
children and their families.
(d) Applications.--To be eligible to receive a grant, contract, or
cooperative agreement under this section, an entity described in
subsection (a) shall submit an application to the Secretary at such
time, in such manner, and containing such information as the Secretary
may reasonably require, which shall include the following:
(1) A description of the innovative initiatives, activities,
or programs to be funded under the grant, contract, or
cooperative agreement, including how such program will increase
access to evidence-based trauma support services and mental
health care for students, and, as applicable, the families of
such students.
(2) A description of how the program will provide
linguistically appropriate and culturally competent services.
(3) A description of how the program will support students
and the school in improving the school climate in order to
support an environment conducive to learning.
(4) An assurance that--
(A) persons providing services under the grant,
contract, or cooperative agreement are adequately
trained to provide such services; and
(B) teachers, school leaders, administrators,
specialized instructional support personnel,
representatives of local Indian Tribes or tribal
organizations as appropriate, other school personnel,
and parents or guardians of students participating in
services under this section will be engaged and involved
in the design and implementation of the services.
(5) A description of how the applicant will support and
integrate existing school-based services with the program in
order to provide mental health services for students, as
appropriate.
(6) A description of the entities in the community with
which the applicant will partner or to which the applicant will
provide subgrants in accordance with subsection (c)(8).
(e) Interagency Agreements.--
(1) Local interagency agreements.--To ensure the provision
of the services described in subsection (c), a recipient of a
grant, contract, or cooperative agreement under this section, or
their designee, shall establish a local interagency agreement
among local educational agencies, agencies responsible for early
childhood education programs, Head Start agencies (including
Early Head Start agencies), juvenile justice authorities, mental
health agencies, child welfare agencies, and other relevant
agencies, authorities, or entities in the community that will be
involved in the provision of such services.
(2) Contents.--In ensuring the provision of the services
described in subsection (c), the local interagency agreement
shall specify with respect to each agency, authority, or entity
that is a party to such agreement--
(A) the financial responsibility for the services;
(B) the conditions and terms of responsibility for
the services, including quality, accountability, and
coordination of the services; and
[[Page 132 STAT. 4054]]
(C) the conditions and terms of reimbursement among
such agencies, authorities, or entities, including
procedures for dispute resolution.
(f) Evaluation.--The Secretary shall reserve not more than 3 percent
of the funds made available under subsection (l) for each fiscal year
to--
(1) conduct a rigorous, independent evaluation of the
activities funded under this section; and
(2) disseminate and promote the utilization of evidence-
based practices regarding trauma support services and mental
health care.
(g) Distribution of Awards.--The Secretary shall ensure that grants,
contracts, and cooperative agreements awarded or entered into under this
section are equitably distributed among the geographical regions of the
United States and among tribal, urban, suburban, and rural populations.
(h) Rule of Construction.--Nothing in this section shall be
construed--
(1) to prohibit an entity involved with a program carried
out under this section from reporting a crime that is committed
by a student to appropriate authorities; or
(2) to prevent Federal, State, and tribal law enforcement
and judicial authorities from exercising their responsibilities
with regard to the application of Federal, tribal, and State law
to crimes committed by a student.
(i) Supplement, Not Supplant.--Any services provided through
programs carried out under this section shall supplement, and not
supplant, existing mental health services, including any special
education and related services provided under the Individuals with
Disabilities Education Act (20 U.S.C. 1400 et seq.).
(j) Consultation With Indian Tribes.--In carrying out subsection
(a), the Secretary shall, in a timely manner, meaningfully consult with
Indian Tribes and their representatives to ensure notice of eligibility.
(k) Definitions.--In this section:
(1) Elementary school.--The term ``elementary school'' has
the meaning given such term in section 8101 of the Elementary
and Secondary Education Act of 1965 (20 U.S.C. 7801).
(2) Evidence-based.--The term ``evidence-based'' has the
meaning given such term in section 8101(21)(A)(i) of the
Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801(21)(A)(i)).
(3) Native hawaiian educational organization.--The term
``Native Hawaiian educational organization'' has the meaning
given such term in section 6207 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 7517).
(4) Local educational agency.--The term ``local educational
agency'' has the meaning given such term in section 8101 of the
Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).
(5) Regional corporation.--The term ``Regional Corporation''
has the meaning given the term in section 3 of the Alaska Native
Claims Settlement Act (43 U.S.C. 1602)).
(6) School.--The term ``school'' means a public elementary
school or public secondary school.
[[Page 132 STAT. 4055]]
(7) School leader.--The term ``school leader'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(8) Secondary school.--The term ``secondary school'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(9) Secretary.--The term ``Secretary'' means the Secretary
of Education.
(10) Specialized instructional support personnel.--The term
``specialized instructional support personnel'' has the meaning
given such term in section 8101 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 7801).
(11) State educational agency.--The term ``State educational
agency'' has the meaning given such term in section 8101 of the
Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).
(l) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $50,000,000 for each of fiscal
years 2019 through 2023.
SEC. 7135. <<NOTE: 42 USC 280h-8.>> RECOGNIZING EARLY CHILDHOOD
TRAUMA RELATED TO SUBSTANCE ABUSE.
(a) Dissemination of Information.--The Secretary of Health and Human
Services shall disseminate information, resources, and, if requested,
technical assistance to early childhood care and education providers and
professionals working with young children on--
(1) ways to properly recognize children who may be impacted
by trauma, including trauma related to substance use by a family
member or other adult; and
(2) how to respond appropriately in order to provide for the
safety and well-being of young children and their families.
(b) Goals.--The information, resources, and technical assistance
provided under subsection (a) shall--
(1) educate early childhood care and education providers and
professionals working with young children on understanding and
identifying the early signs and risk factors of children who
might be impacted by trauma, including trauma due to exposure to
substance use;
(2) suggest age-appropriate communication tools, procedures,
and practices for trauma-informed care, including ways to
prevent or mitigate the effects of trauma;
(3) provide options for responding to children impacted by
trauma, including due to exposure to substance use, that
consider the needs of the child and family, including
recommending resources and referrals for evidence-based services
to support such family; and
(4) promote whole-family and multi-generational approaches
to keep families safely together when it is in the best interest
of the child.
(c) Coordination.--The Secretary of Health and Human Services shall
coordinate with the task force to develop best practices for trauma-
informed identification, referral, and support authorized under section
7132 in disseminating the information, resources, and technical
assistance described under subsection (b).
[[Page 132 STAT. 4056]]
(d) Rule of Construction.--Such information, resources, and if
applicable, technical assistance, shall not be construed to amend the
requirements under--
(1) the Child Care and Development Block Grant Act of 1990
(42 U.S.C. 9858 et seq.);
(2) the Head Start Act (42 U.S.C. 9831 et seq.); or
(3) the Individuals with Disabilities Education Act (20
U.S.C. 1400 et seq.).
Subtitle O--Eliminating Opioid Related Infectious Diseases
SEC. 7141. REAUTHORIZATION AND EXPANSION OF PROGRAM OF
SURVEILLANCE AND EDUCATION REGARDING
INFECTIONS ASSOCIATED WITH ILLICIT DRUG
USE AND OTHER RISK FACTORS.
Section 317N of the Public Health Service Act (42 U.S.C. 247b-15) is
amended to read as follows:
``SEC. 317N. SURVEILLANCE AND EDUCATION REGARDING INFECTIONS
ASSOCIATED WITH ILLICIT DRUG USE AND
OTHER RISK FACTORS.
``(a) In General.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, may (directly or through
grants to public and nonprofit private entities) provide for programs
for the following:
``(1) To cooperate with States and Indian tribes in
implementing or maintaining a national system to determine the
incidence of infections commonly associated with illicit drug
use, such as viral hepatitis, human immunodeficiency virus, and
infective endocarditis, and to assist the States in determining
the prevalence of such infections, which may include the
reporting of cases of such infections.
``(2) To identify, counsel, and offer testing to individuals
who are at risk of infections described in paragraph (1)
resulting from illicit drug use, receiving blood transfusions
prior to July 1992, or other risk factors.
``(3) To provide appropriate referrals for counseling,
testing, and medical treatment of individuals identified under
paragraph (2) and to ensure, to the extent practicable, the
provision of appropriate follow-up services.
``(4) To develop and disseminate public information and
education programs for the detection and control of infections
described in paragraph (1), with priority given to high-risk
populations as determined by the Secretary.
``(5) To improve the education, training, and skills of
health professionals in the detection and control of infections
described in paragraph (1), including to improve coordination of
treatment of substance use disorders and infectious diseases,
with priority given to substance use disorder treatment
providers, pediatricians and other primary care providers,
obstetrician-gynecologists, and infectious disease clinicians,
including HIV clinicians.
``(b) Laboratory Procedures.--The Secretary may (directly or through
grants to public and nonprofit private entities) carry out programs to
provide for improvements in the quality of clinical-
[[Page 132 STAT. 4057]]
laboratory procedures regarding infections described in subsection
(a)(1).
``(c) Definition.--In this section, the term `Indian tribe' has the
meaning given that term in section 4 of the Indian Self-Determination
and Education Assistance Act.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $40,000,000
for each of the fiscal years 2019 through 2023.''.
Subtitle P--Peer Support Communities of Recovery
SEC. 7151. BUILDING COMMUNITIES OF RECOVERY.
Section 547 of the Public Health Service Act (42 U.S.C. 290ee-2) is
amended to read as follows:
``SEC. 547. BUILDING COMMUNITIES OF RECOVERY.
``(a) Definition.--In this section, the term `recovery community
organization' means an independent nonprofit organization that--
``(1) mobilizes resources within and outside of the recovery
community, which may include through a peer support network, to
increase the prevalence and quality of long-term recovery from
substance use disorders; and
``(2) is wholly or principally governed by people in
recovery for substance use disorders who reflect the community
served.
``(b) Grants Authorized.--The Secretary shall award grants to
recovery community organizations to enable such organizations to
develop, expand, and enhance recovery services.
``(c) Federal Share.--The Federal share of the costs of a program
funded by a grant under this section may not exceed 85 percent.
``(d) Use of Funds.--Grants awarded under subsection (b)--
``(1) shall be used to develop, expand, and enhance
community and statewide recovery support services; and
``(2) may be used to--
``(A) build connections between recovery networks,
including between recovery community organizations and
peer support networks, and with other recovery support
services, including--
``(i) behavioral health providers;
``(ii) primary care providers and physicians;
``(iii) educational and vocational schools;
``(iv) employers;
``(v) housing services;
``(vi) child welfare agencies; and
``(vii) other recovery support services that
facilitate recovery from substance use disorders,
including non-clinical community services;
``(B) reduce stigma associated with substance use
disorders; and
``(C) conduct outreach on issues relating to
substance use disorders and recovery, including--
``(i) identifying the signs of substance use
disorder;
``(ii) the resources available to individuals
with substance use disorder and to families of an
individual
[[Page 132 STAT. 4058]]
with a substance use disorder, including programs
that mentor and provide support services to
children;
``(iii) the resources available to help
support individuals in recovery; and
``(iv) related medical outcomes of substance
use disorders, the potential of acquiring an
infection commonly associated with illicit drug
use, and neonatal abstinence syndrome among
infants exposed to opioids during pregnancy.
``(e) Special Consideration.--In carrying out this section, the
Secretary shall give special consideration to the unique needs of rural
areas, including areas with an age-adjusted rate of drug overdose deaths
that is above the national average and areas with a shortage of
prevention and treatment services.
``(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2019 through 2023.''.
SEC. 7152. PEER SUPPORT TECHNICAL ASSISTANCE CENTER.
Title V of the Public Health Service Act (42 U.S.C. 290dd et seq.)
is amended by inserting after section 547 the following:
``SEC. 547A. <<NOTE: 42 USC 290ee-2a.>> PEER SUPPORT TECHNICAL
ASSISTANCE CENTER.
``(a) Establishment.--The Secretary, acting through the Assistant
Secretary, shall establish or operate a National Peer-Run Training and
Technical Assistance Center for Addiction Recovery Support (referred to
in this section as the `Center').
``(b) Functions.--The Center established under subsection (a) shall
provide technical assistance and support to recovery community
organizations and peer support networks, including such assistance and
support related to--
``(1) training on identifying--
``(A) signs of substance use disorder;
``(B) resources to assist individuals with a
substance use disorder, or resources for families of an
individual with a substance use disorder; and
``(C) best practices for the delivery of recovery
support services;
``(2) the provision of translation services, interpretation,
or other such services for clients with limited English speaking
proficiency;
``(3) data collection to support research, including for
translational research;
``(4) capacity building; and
``(5) evaluation and improvement, as necessary, of the
effectiveness of such services provided by recovery community
organizations.
``(c) Best Practices.--The Center established under subsection (a)
shall periodically issue best practices for use by recovery community
organizations and peer support networks.
``(d) Recovery Community Organization.--In this section, the term
`recovery community organization' has the meaning given such term in
section 547.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $1,000,000 for each of fiscal
years 2019 through 2023.''.
[[Page 132 STAT. 4059]]
Subtitle Q--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
SEC. 7161. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
(a) In General.--Part J of title III of the Public Health Service
Act (42 U.S.C. 280b et seq.) is amended by inserting after section 392
(42 U.S.C. 280b-1) the following:
``SEC. 392A. <<NOTE: 42 USC 280b-1.>> PREVENTING OVERDOSES OF
CONTROLLED SUBSTANCES.
``(a) Evidence-Based Prevention Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out and
expand any evidence-based prevention activities
described in paragraph (2);
``(B) provide training and technical assistance to
States, localities, and Indian tribes for purposes of
carrying out such activity; and
``(C) award grants to States, localities, and Indian
tribes for purposes of carrying out such activity.
``(2) Evidence-based prevention activities.--An evidence-
based prevention activity described in this paragraph is any of
the following activities:
``(A) Improving the efficiency and use of a new or
currently operating prescription drug monitoring
program, including by--
``(i) encouraging all authorized users (as
specified by the State or other entity) to
register with and use the program;
``(ii) enabling such users to access any
updates to information collected by the program in
as close to real-time as possible;
``(iii) improving the ease of use of such
program;
``(iv) providing for a mechanism for the
program to notify authorized users of any
potential misuse or abuse of controlled substances
and any detection of inappropriate prescribing or
dispensing practices relating to such substances;
``(v) encouraging the analysis of prescription
drug monitoring data for purposes of providing de-
identified, aggregate reports based on such
analysis to State public health agencies, State
substance abuse agencies, State licensing boards,
and other appropriate State agencies, as permitted
under applicable Federal and State law and the
policies of the prescription drug monitoring
program and not containing any protected health
information, to prevent inappropriate prescribing,
drug diversion, or abuse and misuse of controlled
substances, and to facilitate better coordination
among agencies;
``(vi) enhancing interoperability between the
program and any health information technology
(including
[[Page 132 STAT. 4060]]
certified health information technology),
including by integrating program data into such
technology;
``(vii) updating program capabilities to
respond to technological innovation for purposes
of appropriately addressing the occurrence and
evolution of controlled substance overdoses;
``(viii) facilitating and encouraging data
exchange between the program and the prescription
drug monitoring programs of other States;
``(ix) enhancing data collection and quality,
including improving patient matching and
proactively monitoring data quality;
``(x) providing prescriber and dispenser
practice tools, including prescriber practice
insight reports for practitioners to review their
prescribing patterns in comparison to such
patterns of other practitioners in the specialty;
and
``(xi) meeting the purpose of the program
established under section 399O, as described in
section 399O(a).
``(B) Promoting community or health system
interventions.
``(C) Evaluating interventions to prevent controlled
substance overdoses.
``(D) Implementing projects to advance an innovative
prevention approach with respect to new and emerging
public health crises and opportunities to address such
crises, such as enhancing public education and awareness
on the risks associated with opioids.
``(3) Additional grants.--The Director may award grants to
States, localities, and Indian Tribes--
``(A) to carry out innovative projects for grantees
to rapidly respond to controlled substance misuse,
abuse, and overdoses, including changes in patterns of
controlled substance use; and
``(B) for any other evidence-based activity for
preventing controlled substance misuse, abuse, and
overdoses as the Director determines appropriate.
``(4) Research.--The Director, in coordination with the
Assistant Secretary for Mental Health and Substance Use and the
National Mental Health and Substance Use Policy Laboratory
established under section 501A, as appropriate and applicable,
may conduct studies and evaluations to address substance use
disorders, including preventing substance use disorders or other
related topics the Director determines appropriate.
``(b) Enhanced Controlled Substance Overdose Data Collection,
Analysis, and Dissemination Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out any
controlled substance overdose data collection activities
described in paragraph (2);
``(B) provide training and technical assistance to
States, localities, and Indian tribes for purposes of
carrying out such activity;
[[Page 132 STAT. 4061]]
``(C) award grants to States, localities, and Indian
tribes for purposes of carrying out such activity; and
``(D) coordinate with the Assistant Secretary for
Mental Health and Substance Use to collect data pursuant
to section 505(d)(1)(A) (relating to the number of
individuals admitted to emergency departments as a
result of the abuse of alcohol or other drugs).
``(2) Controlled substance overdose data collection and
analysis activities.--A controlled substance overdose data
collection, analysis, and dissemination activity described in
this paragraph is any of the following activities:
``(A) Improving the timeliness of reporting data to
the public, including data on fatal and nonfatal
overdoses of controlled substances.
``(B) Enhancing the comprehensiveness of controlled
substance overdose data by collecting information on
such overdoses from appropriate sources such as
toxicology reports, autopsy reports, death scene
investigations, and emergency departments.
``(C) Modernizing the system for coding causes of
death related to controlled substance overdoses to use
an electronic-based system.
``(D) Using data to help identify risk factors
associated with controlled substance overdoses.
``(E) Supporting entities involved in providing
information on controlled substance overdoses, such as
coroners, medical examiners, and public health
laboratories to improve accurate testing and
standardized reporting of causes and contributing
factors to controlled substances overdoses and analysis
of various opioid analogues to controlled substance
overdoses.
``(F) Working to enable and encourage the access,
exchange, and use of information regarding controlled
substance overdoses among data sources and entities.
``(c) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled substance'
has the meaning given that term in section 102 of the Controlled
Substances Act.
``(2) Indian tribe.--The term `Indian tribe' has the meaning
given that term in section 4 of the Indian Self-Determination
and Education Assistance Act.
``(d) Authorization of Appropriations.--For purposes of carrying out
this section, section 399O of this Act, and section 102 of the
Comprehensive Addiction and Recovery Act of 2016 (Public Law 114-198),
there is authorized to be appropriated $496,000,000 for each of fiscal
years 2019 through 2023.''.
(b) Education and Awareness.--Section 102 of the Comprehensive
Addiction and Recovery Act of 2016 (Public Law 114-198) is amended--
(1) by amending subsection (a) to read as follows:
``(a) In General.--The Secretary of Health and Human Services,
acting through the Director of the Centers for Disease Control and
Prevention and in coordination with the heads of other departments and
agencies, shall advance education and awareness regarding the risks
related to misuse and abuse of opioids, as appropriate, which may
include developing or improving existing
[[Page 132 STAT. 4062]]
programs, conducting activities, and awarding grants that advance the
education and awareness of--
``(1) the public, including patients and consumers--
``(A) generally; and
``(B) regarding such risks related to unused opioids
and the dispensing options under section 309(f) of the
Controlled Substances Act, as applicable; and
``(2) providers, which may include--
``(A) providing for continuing education on
appropriate prescribing practices;
``(B) education related to applicable State or local
prescriber limit laws, information on the use of non-
addictive alternatives for pain management, and the use
of overdose reversal drugs, as appropriate;
``(C) disseminating and improving the use of
evidence-based opioid prescribing guidelines across
relevant health care settings, as appropriate, and
updating guidelines as necessary;
``(D) implementing strategies, such as best
practices, to encourage and facilitate the use of
prescriber guidelines, in accordance with State and
local law;
``(E) disseminating information to providers about
prescribing options for controlled substances, including
such options under section 309(f) of the Controlled
Substances Act, as applicable; and
``(F) disseminating information, as appropriate, on
the National Pain Strategy developed by or in
consultation with the Assistant Secretary for Health;
and
``(3) other appropriate entities.''; and
(2) in subsection (b)--
(A) by striking ``opioid abuse'' each place such
term appears and inserting ``opioid misuse and abuse'';
and
(B) in paragraph (2), by striking ``safe disposal of
prescription medications and other'' and inserting
``non-addictive treatment options, safe disposal options
for prescription medications, and other applicable''.
SEC. 7162. PRESCRIPTION DRUG MONITORING PROGRAM.
Section 399O of the Public Health Service Act (42 U.S.C. 280g-3) is
amended to read as follows:
``SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM.
``(a) Program.--
``(1) In general.--Each fiscal year, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, in coordination with the heads of other departments
and agencies as appropriate, shall support States or localities
for the purpose of improving the efficiency and use of PDMPs,
including--
``(A) establishment and implementation of a PDMP;
``(B) maintenance of a PDMP;
``(C) improvements to a PDMP by--
``(i) enhancing functional components to work
toward--
``(I) universal use of PDMPs among
providers and their delegates, to the
extent that State laws allow;
[[Page 132 STAT. 4063]]
``(II) more timely inclusion of data
within a PDMP;
``(III) active management of the
PDMP, in part by sending proactive or
unsolicited reports to providers to
inform prescribing; and
``(IV) ensuring the highest level of
ease in use of and access to PDMPs by
providers and their delegates, to the
extent that State laws allow;
``(ii) in consultation with the Office of the
National Coordinator for Health Information
Technology, improving the intrastate
interoperability of PDMPs by--
``(I) making PDMPs more actionable
by integrating PDMPs within electronic
health records and health information
technology infrastructure; and
``(II) linking PDMP data to other
data systems within the State,
including--
``(aa) the data of pharmacy
benefit managers, medical
examiners and coroners, and the
State's Medicaid program;
``(bb) worker's compensation
data; and
``(cc) prescribing data of
providers of the Department of
Veterans Affairs and the Indian
Health Service within the State;
``(iii) in consultation with the Office of the
National Coordinator for Health Information
Technology, improving the interstate
interoperability of PDMPs through--
``(I) sharing of dispensing data in
near-real time across State lines; and
``(II) integration of automated
queries for multistate PDMP data and
analytics into clinical workflow to
improve the use of such data and
analytics by practitioners and
dispensers; or
``(iv) improving the ability to include
treatment availability resources and referral
capabilities within the PDMP.
``(2) Legislation.--As a condition on the receipt of support
under this section, the Secretary shall require a State or
locality to demonstrate that it has enacted legislation or
regulations--
``(A) to provide for the implementation of the PDMP;
and
``(B) to permit the imposition of appropriate
penalties for the unauthorized use and disclosure of
information maintained by the PDMP.
``(b) PDMP Strategies.--The Secretary shall encourage a State or
locality, in establishing, improving, or maintaining a PDMP, to
implement strategies that improve--
``(1) the reporting of dispensing in the State or locality
of a controlled substance to an ultimate user so the reporting
occurs not later than 24 hours after the dispensing event;
``(2) the consultation of the PDMP by each prescribing
practitioner, or their designee, in the State or locality before
initiating treatment with a controlled substance, or any
substance as required by the State to be reported to the PDMP,
[[Page 132 STAT. 4064]]
and over the course of ongoing treatment for each prescribing
event;
``(3) the consultation of the PDMP before dispensing a
controlled substance, or any substance as required by the State
to be reported to the PDMP;
``(4) the proactive notification to a practitioner when
patterns indicative of controlled substance misuse by a patient,
including opioid misuse, are detected;
``(5) the availability of data in the PDMP to other States,
as allowable under State law; and
``(6) the availability of nonidentifiable information to the
Centers for Disease Control and Prevention for surveillance,
epidemiology, statistical research, or educational purposes.
``(c) Drug Misuse and Abuse.--In consultation with practitioners,
dispensers, and other relevant and interested stakeholders, a State
receiving support under this section--
``(1) shall establish a program to notify practitioners and
dispensers of information that will help to identify and prevent
the unlawful diversion or misuse of controlled substances;
``(2) may, to the extent permitted under State law, notify
the appropriate authorities responsible for carrying out drug
diversion investigations if the State determines that
information in the PDMP maintained by the State indicates an
unlawful diversion or abuse of a controlled substance;
``(3) may conduct analyses of controlled substance program
data for purposes of providing appropriate State agencies with
aggregate reports based on such analyses in as close to real-
time as practicable, regarding prescription patterns flagged as
potentially presenting a risk of misuse, abuse, addiction,
overdose, and other aggregate information, as appropriate and in
compliance with applicable Federal and State laws and provided
that such reports shall not include protected health
information; and
``(4) may access information about prescriptions, such as
claims data, to ensure that such prescribing and dispensing
history is updated in as close to real-time as practicable, in
compliance with applicable Federal and State laws and provided
that such information shall not include protected health
information.
``(d) Evaluation and Reporting.--As a condition on receipt of
support under this section, the State shall report on interoperability
with PDMPs of other States and Federal agencies, where appropriate,
intrastate interoperability with health information technology systems
such as electronic health records, health information exchanges, and e-
prescribing, where appropriate, and whether or not the State provides
automatic, up-to-date, or daily information about a patient when a
practitioner (or the designee of a practitioner, where permitted)
requests information about such patient.
``(e) Evaluation and Reporting.--A State receiving support under
this section shall provide the Secretary with aggregate nonidentifiable
information, as permitted by State law, to enable the Secretary--
``(1) to evaluate the success of the State's program in
achieving the purpose described in subsection (a); or
``(2) to prepare and submit to the Congress the report
required by subsection (i)(2).
[[Page 132 STAT. 4065]]
``(f) Education and Access to the Monitoring System.--A State
receiving support under this section shall take steps to--
``(1) facilitate prescribers and dispensers, and their
delegates, as permitted by State law, to use the PDMP, to the
extent practicable; and
``(2) educate prescribers and dispensers, and their
delegates on the benefits of the use of PDMPs.
``(g) Electronic Format.--The Secretary may issue guidelines
specifying a uniform electronic format for the reporting, sharing, and
disclosure of information pursuant to PDMPs. To the extent possible,
such guidelines shall be consistent with standards recognized by the
Office of the National Coordinator for Health Information Technology.
``(h) Rules of Construction.--
``(1) Functions otherwise authorized by law.--Nothing in
this section shall be construed to restrict the ability of any
authority, including any local, State, or Federal law
enforcement, narcotics control, licensure, disciplinary, or
program authority, to perform functions otherwise authorized by
law.
``(2) Additional privacy protections.--Nothing in this
section shall be construed as preempting any State from imposing
any additional privacy protections.
``(3) Federal privacy requirements.--Nothing in this section
shall be construed to supersede any Federal privacy or
confidentiality requirement, including the regulations
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law 104-191;
110 Stat. 2033) and section 543 of this Act.
``(4) No federal private cause of action.--Nothing in this
section shall be construed to create a Federal private cause of
action.
``(i) Progress Report.--Not later than 3 years after the date of
enactment of this section, the Secretary shall--
``(1) complete a study that--
``(A) determines the progress of grantees in
establishing and implementing PDMPs consistent with this
section;
``(B) provides an analysis of the extent to which
the operation of PDMPs has--
``(i) reduced inappropriate use, abuse,
diversion of, and overdose with, controlled
substances;
``(ii) established or strengthened initiatives
to ensure linkages to substance use disorder
treatment services; or
``(iii) affected patient access to appropriate
care in States operating PDMPs;
``(C) determine the progress of grantees in
achieving interstate interoperability and intrastate
interoperability of PDMPs, including an assessment of
technical, legal, and financial barriers to such
progress and recommendations for addressing these
barriers;
``(D) determines the progress of grantees in
implementing near real-time electronic PDMPs;
``(E) provides an analysis of the privacy
protections in place for the information reported to the
PDMP in each State or locality receiving support under
this section and
[[Page 132 STAT. 4066]]
any recommendations of the Secretary for additional
Federal or State requirements for protection of this
information;
``(F) determines the progress of States or
localities in implementing technological alternatives to
centralized data storage, such as peer-to-peer file
sharing or data pointer systems, in PDMPs and the
potential for such alternatives to enhance the privacy
and security of individually identifiable data; and
``(G) evaluates the penalties that States or
localities have enacted for the unauthorized use and
disclosure of information maintained in PDMPs, and the
criteria used by the Secretary to determine whether such
penalties qualify as appropriate for purposes of
subsection (a)(2); and
``(2) submit a report to the Congress on the results of the
study.
``(j) Advisory Council.--
``(1) Establishment.--A State or locality may establish an
advisory council to assist in the establishment, improvement, or
maintenance of a PDMP consistent with this section.
``(2) Limitation.--A State or locality may not use Federal
funds for the operations of an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP.
``(3) Sense of congress.--It is the sense of the Congress
that, in establishing an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP, a State or
locality should consult with appropriate professional boards and
other interested parties.
``(k) Definitions.--For purposes of this section:
``(1) The term `controlled substance' means a controlled
substance (as defined in section 102 of the Controlled
Substances Act) in schedule II, III, or IV of section 202 of
such Act.
``(2) The term `dispense' means to deliver a controlled
substance to an ultimate user by, or pursuant to the lawful
order of, a practitioner, irrespective of whether the dispenser
uses the Internet or other means to effect such delivery.
``(3) The term `dispenser' means a physician, pharmacist, or
other person that dispenses a controlled substance to an
ultimate user.
``(4) The term `interstate interoperability' with respect to
a PDMP means the ability of the PDMP to electronically share
reported information with another State if the information
concerns either the dispensing of a controlled substance to an
ultimate user who resides in such other State, or the dispensing
of a controlled substance prescribed by a practitioner whose
principal place of business is located in such other State.
``(5) The term `intrastate interoperability' with respect to
a PDMP means the integration of PDMP data within electronic
health records and health information technology infrastructure
or linking of a PDMP to other data systems within the State,
including the State's Medicaid program, workers' compensation
programs, and medical examiners or coroners.
``(6) The term `nonidentifiable information' means
information that does not identify a practitioner, dispenser, or
an ultimate user and with respect to which there is no
reasonable
[[Page 132 STAT. 4067]]
basis to believe that the information can be used to identify a
practitioner, dispenser, or an ultimate user.
``(7) The term `PDMP' means a prescription drug monitoring
program that is State-controlled.
``(8) The term `practitioner' means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or
other person licensed, registered, or otherwise permitted, by
the United States or the jurisdiction in which the individual
practices or does research, to distribute, dispense, conduct
research with respect to, administer, or use in teaching or
chemical analysis, a controlled substance in the course of
professional practice or research.
``(9) The term `State' means each of the 50 States, the
District of Columbia, and any commonwealth or territory of the
United States.
``(10) The term `ultimate user' means a person who has
obtained from a dispenser, and who possesses, a controlled
substance for the person's own use, for the use of a member of
the person's household, or for the use of an animal owned by the
person or by a member of the person's household.
``(11) The term `clinical workflow' means the integration of
automated queries for prescription drug monitoring programs data
and analytics into health information technologies such as
electronic health record systems, health information exchanges,
and/or pharmacy dispensing software systems, thus streamlining
provider access through automated queries.''.
Subtitle R--Review of Substance Use Disorder Treatment Providers
Receiving Federal Funding
SEC. 7171. REVIEW OF SUBSTANCE USE DISORDER TREATMENT PROVIDERS
RECEIVING FEDERAL FUNDING.
(a) In General.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') shall conduct a review of
entities that receive Federal funding for the provision of substance use
disorder treatment services. The review shall include:
(1) The length of time the entity has provided substance use
disorder treatment services and the geographic area served by
the entity.
(2) A detailed analysis of the patient population served by
the entity, including but not limited to the number of patients,
types of diagnosed substance use disorders and the demographic
information of such patients, including sex, race, ethnicity,
and socioeconomic status.
(3) Detailed information on the types of substance use
disorders for which the entity has the experience, capability,
and capacity to provide such services.
(4) An analysis of how the entity handles patients requiring
treatment for a substance use disorder that the organization is
not able to treat.
(5) An analysis of what is needed in order to improve the
entity's ability to meet the addiction treatment needs of the
communities served by that entity.
[[Page 132 STAT. 4068]]
(6) Based on the identified needs of the communities served,
a description of unmet needs and inadequate services and how
such needs and services could be better addressed to treat
individuals with methamphetamine, cocaine, including crack
cocaine, heroin, opioid, and other substance use disorders.
(b) Report.--Not later than 2 years after the date of the enactment
of this Act, the Secretary shall develop and submit to Congress a plan
to direct appropriate resources to entities that provide substance use
disorder treatment services in order to address inadequacies in services
or funding identified through the survey described in subsection (a).
Subtitle S--Other Health Provisions
SEC. 7181. STATE RESPONSE TO THE OPIOID ABUSE CRISIS.
(a) In General.--Section 1003 of the 21st Century Cures Act (Public
Law 114-255) <<NOTE: 42 USC 290ee-3 note.>> is amended--
(1) in subsection (a)--
(A) by striking ``the authorization of
appropriations under subsection (b) to carry out the
grant program described in subsection (c)'' and
inserting ``subsection (h) to carry out the grant
program described in subsection (b)''; and
(B) by inserting ``and Indian Tribes'' after
``States'';
(2) by striking subsection (b);
(3) by redesignating subsections (c) through (e) as
subsections (b) through (d), respectively;
(4) by redesignating subsection (f) as subsection (j);
(5) in subsection (b), as so redesignated--
(A) in paragraph (1)--
(i) in the paragraph heading, by inserting
``and tribal'' after ``State'';
(ii) by striking ``States for the purpose of
addressing the opioid abuse crisis within such
States'' and inserting ``States and Indian Tribes
for the purpose of addressing the opioid abuse
crisis within such States and Indian Tribes'';
(iii) by inserting ``or Indian Tribes'' after
``preference to States''; and
(iv) by inserting before the period of the
second sentence ``or other Indian Tribes, as
applicable''; and
(B) in paragraph (2)--
(i) in the matter preceding subparagraph (A),
by striking ``to a State'';
(ii) in subparagraph (A), by striking
``Improving State'' and inserting ``Establishing
or improving'';
(iii) in subparagraph (C), by inserting
``preventing diversion of controlled substances,''
after ``treatment programs,''; and
(iv) in subparagraph (E), by striking ``as the
State determines appropriate, related to
addressing the opioid abuse crisis within the
State'' and inserting ``as the State or Indian
Tribe determines appropriate, related to
addressing the opioid abuse crisis within the
State or Indian Tribe, including directing
resources
[[Page 132 STAT. 4069]]
in accordance with local needs related to
substance use disorders'';
(6) in subsection (c), as so redesignated, by striking
``subsection (c)'' and inserting ``subsection (b)'';
(7) in subsection (d), as so redesignated--
(A) in the matter preceding paragraph (1), by
striking ``the authorization of appropriations under
subsection (b)'' and inserting ``subsection (h)''; and
(B) in paragraph (1), by striking ``subsection (c)''
and inserting ``subsection (b)''; and
(8) by inserting after subsection (d), as so redesignated,
the following:
``(e) Indian Tribes.--
``(1) Definition.--For purposes of this section, the term
`Indian Tribe' has the meaning given the term `Indian tribe' in
section 4 of the Indian Self-Determination and Education
Assistance Act (25 U.S.C. 5304).
``(2) Appropriate mechanisms.--The Secretary, in
consultation with Indian Tribes, shall identify and establish
appropriate mechanisms for Tribes to demonstrate or report the
information as required under subsections (b), (c), and (d).
``(f) Report to Congress.--Not later than 1 year after the date on
which amounts are first awarded after the date of enactment of this
subsection, pursuant to subsection (b), and annually thereafter, the
Secretary shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives a report summarizing the information provided
to the Secretary in reports made pursuant to subsection (c), including
the purposes for which grant funds are awarded under this section and
the activities of such grant recipients.
``(g) Technical Assistance.--The Secretary, including through the
Tribal Training and Technical Assistance Center of the Substance Abuse
and Mental Health Services Administration, shall provide State agencies
and Indian Tribes, as applicable, with technical assistance concerning
grant application and submission procedures under this section, award
management activities, and enhancing outreach and direct support to
rural and underserved communities and providers in addressing the opioid
crisis.
``(h) Authorization of Appropriations.--For purposes of carrying out
the grant program under subsection (b), there is authorized to be
appropriated $500,000,000 for each of fiscal years 2019 through 2021, to
remain available until expended.
``(i) Set Aside.--Of the amounts made available for each fiscal year
to award grants under subsection (b) for a fiscal year, 5 percent of
such amount for such fiscal year shall be made available to Indian
Tribes, and up to 15 percent of such amount for such fiscal year may be
set aside for States with the highest age-adjusted rate of drug overdose
death based on the ordinal ranking of States according to the Director
of the Centers for Disease Control and Prevention.''.
(b) Conforming Amendment.--Section 1004(c) of the 21st Century Cures
Act (Public Law 114-255) is amended by striking ``, the FDA Innovation
Account, or the Account For the State Response to the Opioid Abuse
Crisis'' and inserting ``or the FDA Innovation Account''.
[[Page 132 STAT. 4070]]
SEC. 7182. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL
HEALTH AND SUBSTANCE USE DISORDER
BENEFITS.
(a) In General.--Section 13003 of the 21st Century Cures Act (Public
Law 114-255) is amended--
(1) in subsection (a)--
(A) by striking ``with findings of any serious
violation regarding'' and inserting ``concerning''; and
(B) by inserting ``and the Committee on Education
and the Workforce'' after ``Energy and Commerce''; and
(2) in subsection (b)(1)--
(A) by inserting ``complaints received and number
of'' before ``closed''; and
(B) by inserting before the period ``, and, for each
such investigation closed, which agency conducted the
investigation, whether the health plan that is the
subject of the investigation is fully insured or not
fully insured and a summary of any coordination between
the applicable State regulators and the Department of
Labor, the Department of Health and Human Services, or
the Department of the Treasury, and references to any
guidance provided by the agencies addressing the
category of violation committed''.
(b) Applicability.--The amendments made by subsection (a) shall
apply with respect to the second annual report required under such
section 13003 and each such annual report thereafter.
SEC. 7183. <<NOTE: 42 USC 290ee-8.>> CAREER ACT.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in consultation with
the Secretary of Labor, shall continue or establish a program to support
individuals in substance use disorder treatment and recovery to live
independently and participate in the workforce.
(b) Grants Authorized.--In carrying out the activities under this
section, the Secretary shall, on a competitive basis, award grants for a
period of not more than 5 years to entities to enable such entities to
carry out evidence-based programs to help individuals in substance use
disorder treatment and recovery to live independently and participate in
the workforce. Such entities shall coordinate, as applicable, with
Indian tribes or tribal organizations (as applicable), State boards and
local boards (as defined in section 3 of the Workforce Innovation and
Opportunity Act (29 U.S.C. 3102), lead State agencies with
responsibility for a workforce investment activity (as defined in such
section 3), and State agencies responsible for carrying out substance
use disorder prevention and treatment programs.
(c) Priority.--
(1) In general.--In awarding grants under this section, the
Secretary shall give priority based on the State in which the
entity is located. Priority shall be given among States
according to a formula based on the rates described in paragraph
(2) and weighted as described in paragraph (3).
(2) Rates.--The rates described in this paragraph are the
following:
(A) The amount by which the rate of drug overdose
deaths in the State, adjusted for age, is above the
national
[[Page 132 STAT. 4071]]
overdose mortality rate, as determined by the Director
of the Centers for Disease Control and Prevention.
(B) The amount by which the rate of unemployment for
the State, based on data provided by the Bureau of Labor
Statistics for the preceding 5 calendar years for which
there is available data, is above the national average.
(C) The amount by which rate of labor force
participation in the State, based on data provided by
the Bureau of Labor Statistics for the preceding 5
calendar years for which there is available data, is
below the national average.
(3) Weighting.--The rates described in paragraph (2) shall
be weighted as follows:
(A) The rate described in paragraph (2)(A) shall be
weighted 70 percent.
(B) The rate described in paragraph (2)(B) shall be
weighted 15 percent.
(C) The rate described in paragraph (2)(C) shall be
weighted 15 percent.
(d) Preference.--In awarding grants under this section, the
Secretary shall give preference to entities located in areas within
States with the greatest need, with such need based on the highest
mortality rate related to substance use disorder.
(e) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means an
entity that offers treatment or recovery services for
individuals with substance use disorders, and partners with one
or more local or State stakeholders, which may include local
employers, community organizations, the local workforce
development board, local and State governments, and Indian
Tribes or tribal organizations, to support recovery, independent
living, and participation in the workforce.
(2) Indian tribes; tribal organization.--The terms ``Indian
Tribe'' and ``tribal organization'' have the meanings given the
terms ``Indian tribe'' and ``tribal organization'' in section 4
of the Indian Self-Determination and Education Assistance Act
(25 U.S.C. 5304).
(3) State.--The term ``State'' includes only the several
States and the District of Columbia.
(f) Applications.--An eligible entity shall submit an application at
such time and in such manner as the Secretary may require. In submitting
an application, the entity shall demonstrate the ability to partner with
local stakeholders, which may include local employers, community
stakeholders, the local workforce development board, local and State
governments, and Indian Tribes or tribal organizations, as applicable,
to--
(1) identify gaps in the workforce due to the prevalence of
substance use disorders;
(2) in coordination with statewide employment and training
activities, including coordination and alignment of activities
carried out by entities provided grant funds under section 8041,
help individuals in recovery from a substance use disorder
transition into the workforce, including by providing career
services, training services as described in paragraph (2) of
section 134(c) of the Workforce Innovation and Opportunity Act
(29 U.S.C. 3174(c)), and related services described in section
134(a)(3) of such Act (42 U.S.C. 3174(a)); and
[[Page 132 STAT. 4072]]
(3) assist employers with informing their employees of the
resources, such as resources related to substance use disorders
that are available to their employees.
(g) Use of Funds.--An entity receiving a grant under this section
shall use the funds to conduct one or more of the following activities:
(1) Hire case managers, care coordinators, providers of peer
recovery support services, as described in section 547(a) of the
Public Health Service Act (42 U.S.C. 290ee-2(a)), or other
professionals, as appropriate, to provide services that support
treatment, recovery, and rehabilitation, and prevent relapse,
recidivism, and overdose, including by encouraging--
(A) the development and strengthening of daily
living skills; and
(B) the use of counseling, care coordination, and
other services, as appropriate, to support recovery from
substance use disorders.
(2) Implement or utilize innovative technologies, which may
include the use of telemedicine.
(3) In coordination with the lead State agency with
responsibility for a workforce investment activity or local
board described in subsection (b), provide--
(A) short-term prevocational training services; and
(B) training services that are directly linked to
the employment opportunities in the local area or the
planning region.
(h) Support for State Strategy.--An eligible entity shall include in
its application under subsection (f) information describing how the
services and activities proposed in such application are aligned with
the State, outlying area, or Tribal strategy, as applicable, for
addressing issues described in such application and how such entity will
coordinate with existing systems to deliver services as described in
such application.
(i) Data Reporting and Program Oversight.--Each eligible entity
awarded a grant under this section shall submit to the Secretary a
report at such time and in such manner as the Secretary may require.
Such report shall include a description of--
(1) the programs and activities funded by the grant;
(2) outcomes of the population of individuals with a
substance use disorder the grantee served through activities
described in subsection (g); and
(3) any other information that the Secretary may require for
the purpose of ensuring that the grantee is complying with all
of the requirements of the grant.
(j) Reports to Congress.--
(1) Preliminary report.--Not later than 2 years after the
end of the first year of the grant period under this section,
the Secretary shall submit to Congress a preliminary report that
analyzes reports submitted under subsection (i).
(2) Final report.--Not later than 2 years after submitting
the preliminary report required under paragraph (1), the
Secretary shall submit to Congress a final report that
includes--
(A) a description of how the grant funding was used,
including the number of individuals who received
services under subsection (g)(3) and an evaluation of
the effectiveness of the activities conducted by the
grantee with respect
[[Page 132 STAT. 4073]]
to outcomes of the population of individuals with
substance use disorder who receive services from the
grantee; and
(B) recommendations related to best practices for
health care professionals to support individuals in
substance use disorder treatment or recovery to live
independently and participate in the workforce.
(k) Authorization of Appropriations.--There is authorized to be
appropriated $5,000,000 for each of fiscal years 2019 through 2023 for
purposes of carrying out this section.
TITLE VIII--MISCELLANEOUS
Subtitle <<NOTE: Synthetics Trafficking and Overdose Prevention Act of
2018. 19 USC 1 note.>> A--Synthetics Trafficking and Overdose
Prevention
SEC. 8001. SHORT TITLE.
This subtitle may be cited as the ``Synthetics Trafficking and
Overdose Prevention Act of 2018'' or ``STOP Act of 2018''.
SEC. 8002. CUSTOMS FEES.
(a) In General.--Section 13031(b)(9) of the Consolidated Omnibus
Budget Reconciliation Act of 1985 (19 U.S.C. 58c(b)(9)) is amended by
adding at the end the following:
``(D)(i) With respect to the processing of items that are
sent to the United States through the international postal
network by `Inbound Express Mail service' or `Inbound EMS' (as
that service is described in the mail classification schedule
referred to in section 3631 of title 39, United States Code),
the following payments are required:
``(I) $1 per Inbound EMS item.
``(II) If an Inbound EMS item is formally entered,
the fee provided for under subsection (a)(9), if
applicable.
``(ii) Notwithstanding section 451 of the Tariff Act of 1930
(19 U.S.C. 1451), the payments required by clause (i), as
allocated pursuant to clause (iii)(I), shall be the only
payments required for reimbursement of U.S. Customs and Border
Protection for customs services provided in connection with the
processing of an Inbound EMS item.
``(iii)(I) The payments required by clause (i)(I) shall be
allocated as follows:
``(aa) 50 percent of the amount of the payments
shall be paid on a quarterly basis by the United States
Postal Service to the Commissioner of U.S. Customs and
Border Protection in accordance with regulations
prescribed by the Secretary of the Treasury to reimburse
U.S. Customs and Border Protection for customs services
provided in connection with the processing of Inbound
EMS items.
``(bb) 50 percent of the amount of the payments
shall be retained by the Postal Service to reimburse the
Postal Service for services provided in connection with
the customs processing of Inbound EMS items.
``(II) Payments received by U.S. Customs and Border
Protection under subclause (I)(aa) shall, in accordance with
section 524 of the Tariff Act of 1930 (19 U.S.C. 1524), be
deposited in the Customs User Fee Account and used to directly
[[Page 132 STAT. 4074]]
reimburse each appropriation for the amount paid out of that
appropriation for the costs incurred in providing services to
international mail facilities. Amounts deposited in accordance
with the preceding sentence shall be available until expended
for the provision of such services.
``(III) Payments retained by the Postal Service under
subclause (I)(bb) shall be used to directly reimburse the Postal
Service for the costs incurred in providing services in
connection with the customs processing of Inbound EMS items.
``(iv) Beginning in fiscal year 2021, the Secretary, in
consultation with the Postmaster General, may adjust, not more
frequently than once each fiscal year, the amount described in
clause (i)(I) to an amount commensurate with the costs of
services provided in connection with the customs processing of
Inbound EMS items, consistent with the obligations of the United
States under international agreements.''.
(b) Conforming Amendments.--Section 13031(a) of the Consolidated
Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(a)) is
amended--
(1) in paragraph (6), by inserting ``(other than an item
subject to a fee under subsection (b)(9)(D))'' after ``customs
officer''; and
(2) in paragraph (10)--
(A) in subparagraph (C), in the matter preceding
clause (i), by inserting ``(other than Inbound EMS items
described in subsection (b)(9)(D))'' after ``release'';
and
(B) in the flush at the end, by inserting ``or of
Inbound EMS items described in subsection (b)(9)(D),''
after ``(C),''.
(c) <<NOTE: 19 USC 58c note.>> Effective Date.--The amendments made
by this section shall take effect on January 1, 2020.
SEC. 8003. MANDATORY ADVANCE ELECTRONIC INFORMATION FOR POSTAL
SHIPMENTS.
(a) Mandatory Advance Electronic Information.--
(1) In general.--Section 343(a)(3)(K) of the Trade Act of
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended to
read as follows:
``(K)(i) The Secretary shall prescribe regulations
requiring the United States Postal Service to transmit
the information described in paragraphs (1) and (2) to
the Commissioner of U.S. Customs and Border Protection
for international mail shipments by the Postal Service
(including shipments to the Postal Service from foreign
postal operators that are transported by private
carrier) consistent with the requirements of this
subparagraph.
``(ii) In prescribing regulations under clause (i),
the Secretary shall impose requirements for the
transmission to the Commissioner of information
described in paragraphs (1) and (2) for mail shipments
described in clause (i) that are comparable to the
requirements for the transmission of such information
imposed on similar non-mail shipments of cargo, taking
into account the parameters set forth in subparagraphs
(A) through (J).
``(iii) The regulations prescribed under clause (i)
shall require the transmission of the information
described in paragraphs (1) and (2) with respect to a
shipment as soon
[[Page 132 STAT. 4075]]
as practicable in relation to the transportation of the
shipment, consistent with subparagraph (H).
``(iv) Regulations prescribed under clause (i) shall
allow for the requirements for the transmission to the
Commissioner of information described in paragraphs (1)
and (2) for mail shipments described in clause (i) to be
implemented in phases, as appropriate, by--
``(I) setting incremental targets for
increasing the percentage of such shipments for
which information is required to be transmitted to
the Commissioner; and
``(II) taking into consideration--
``(aa) the risk posed by such
shipments;
``(bb) the volume of mail shipped to
the United States by or through a
particular country; and
``(cc) the capacities of foreign
postal operators to provide that
information to the Postal Service.
``(v)(I) Notwithstanding clause (iv), the Postal
Service shall, not later than December 31, 2018, arrange
for the transmission to the Commissioner of the
information described in paragraphs (1) and (2) for not
less than 70 percent of the aggregate number of mail
shipments, including 100 percent of mail shipments from
the People's Republic of China, described in clause (i).
``(II) If the requirements of subclause (I) are not
met, the Comptroller General of the United States shall
submit to the appropriate congressional committees, not
later than June 30, 2019, a report--
``(aa) assessing the reasons for the failure
to meet those requirements; and
``(bb) identifying recommendations to improve
the collection by the Postal Service of the
information described in paragraphs (1) and (2).
``(vi)(I) Notwithstanding clause (iv), the Postal
Service shall, not later than December 31, 2020, arrange
for the transmission to the Commissioner of the
information described in paragraphs (1) and (2) for 100
percent of the aggregate number of mail shipments
described in clause (i).
``(II) The Commissioner, in consultation with the
Postmaster General, may determine to exclude a country
from the requirement described in subclause (I) to
transmit information for mail shipments described in
clause (i) from the country if the Commissioner
determines that the country--
``(aa) does not have the capacity to collect
and transmit such information;
``(bb) represents a low risk for mail
shipments that violate relevant United States laws
and regulations; and
``(cc) accounts for low volumes of mail
shipments that can be effectively screened for
compliance with relevant United States laws and
regulations through an alternate means.
``(III) The Commissioner shall, at a minimum on an
annual basis, re-evaluate any determination made under
subclause (II) to exclude a country from the requirement
[[Page 132 STAT. 4076]]
described in subclause (I). If, at any time, the
Commissioner determines that a country no longer meets
the requirements under subclause (II), the Commissioner
may not further exclude the country from the requirement
described in subclause (I).
``(IV) The Commissioner shall, on an annual basis,
submit to the appropriate congressional committees--
``(aa) a list of countries with respect to
which the Commissioner has made a determination
under subclause (II) to exclude the countries from
the requirement described in subclause (I); and
``(bb) information used to support such
determination with respect to such countries.
``(vii)(I) The Postmaster General shall, in
consultation with the Commissioner, refuse any shipments
received after December 31, 2020, for which the
information described in paragraphs (1) and (2) is not
transmitted as required under this subparagraph, except
as provided in subclause (II).
``(II) If remedial action is warranted in lieu of
refusal of shipments pursuant to subclause (I), the
Postmaster General and the Commissioner shall take
remedial action with respect to the shipments, including
destruction, seizure, controlled delivery or other law
enforcement initiatives, or correction of the failure to
provide the information described in paragraphs (1) and
(2) with respect to the shipments.
``(viii) Nothing in this subparagraph shall be
construed to limit the authority of the Secretary to
obtain information relating to international mail
shipments from private carriers or other appropriate
parties.
``(ix) In this subparagraph, the term `appropriate
congressional committees' means--
``(I) the Committee on Finance and the
Committee on Homeland Security and Governmental
Affairs of the Senate; and
``(II) the Committee on Ways and Means, the
Committee on Oversight and Government Reform, and
the Committee on Homeland Security of the House of
Representatives.''.
(2) Joint strategic plan on mandatory advance information.--
Not later than 60 days after the date of the enactment of this
Act, the Secretary of Homeland Security and the Postmaster
General shall develop and submit to the appropriate
congressional committees a joint strategic plan detailing
specific performance measures for achieving--
(A) the transmission of information as required by
section 343(a)(3)(K) of the Trade Act of 2002, as
amended by paragraph (1); and
(B) the presentation by the Postal Service to U.S.
Customs and Border Protection of all mail targeted by
U.S. Customs and Border Protection for inspection.
(b) Capacity Building.--
(1) In general.--Section 343(a) of the Trade Act of 2002
(Public Law 107-210; 19 U.S.C. 2071 note) is amended by adding
at the end the following:
``(5) Capacity building.--
[[Page 132 STAT. 4077]]
``(A) In general.--The Secretary, with the
concurrence of the Secretary of State, and in
coordination with the Postmaster General and the heads
of other Federal agencies, as appropriate, may provide
technical assistance, equipment, technology, and
training to enhance the capacity of foreign postal
operators--
``(i) to gather and provide the information
required by paragraph (3)(K); and
``(ii) to otherwise gather and provide postal
shipment information related to--
``(I) terrorism;
``(II) items the importation or
introduction of which into the United
States is prohibited or restricted,
including controlled substances; and
``(III) such other concerns as the
Secretary determines appropriate.
``(B) Provision of equipment and technology.--With
respect to the provision of equipment and technology
under subparagraph (A), the Secretary may lease, loan,
provide, or otherwise assist in the deployment of such
equipment and technology under such terms and conditions
as the Secretary may prescribe, including
nonreimbursable loans or the transfer of ownership of
equipment and technology.''.
(2) Joint strategic plan on capacity building.--Not later
than 1 year after the date of the enactment of this Act, the
Secretary of Homeland Security and the Postmaster General shall,
in consultation with the Secretary of State, jointly develop and
submit to the appropriate congressional committees a joint
strategic plan--
(A) detailing the extent to which U.S. Customs and
Border Protection and the United States Postal Service
are engaged in capacity building efforts under section
343(a)(5) of the Trade Act of 2002, as added by
paragraph (1);
(B) describing plans for future capacity building
efforts; and
(C) assessing how capacity building has increased
the ability of U.S. Customs and Border Protection and
the Postal Service to advance the goals of this subtitle
and the amendments made by this subtitle.
(c) Report and Consultations by Secretary of Homeland Security and
Postmaster General.--
(1) Report.--Not later than 180 days after the date of the
enactment of this Act, and annually thereafter until 3 years
after the Postmaster General has met the requirement under
clause (vi) of subparagraph (K) of section 343(a)(3) of the
Trade Act of 2002, as amended by subsection (a)(1), the
Secretary of Homeland Security and the Postmaster General shall,
in consultation with the Secretary of State, jointly submit to
the appropriate congressional committees a report on compliance
with that subparagraph that includes the following:
(A) An assessment of the status of the regulations
required to be promulgated under that subparagraph.
(B) An update regarding new and existing agreements
reached with foreign postal operators for the
transmission of the information required by that
subparagraph.
[[Page 132 STAT. 4078]]
(C) A summary of deliberations between the United
States Postal Service and foreign postal operators with
respect to issues relating to the transmission of that
information.
(D) A summary of the progress made in achieving the
transmission of that information for the percentage of
shipments required by that subparagraph.
(E) An assessment of the quality of that information
being received by foreign postal operators, as
determined by the Secretary of Homeland Security, and
actions taken to improve the quality of that
information.
(F) A summary of policies established by the
Universal Postal Union that may affect the ability of
the Postmaster General to obtain the transmission of
that information.
(G) A summary of the use of technology to detect
illicit synthetic opioids and other illegal substances
in international mail parcels and planned acquisitions
and advancements in such technology.
(H) Such other information as the Secretary of
Homeland Security and the Postmaster General consider
appropriate with respect to obtaining the transmission
of information required by that subparagraph.
(2) Consultations.--Not later than 180 days after the date
of the enactment of this Act, and every 180 days thereafter
until the Postmaster General has met the requirement under
clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as
amended by subsection (a)(1), to arrange for the transmission of
information with respect to 100 percent of the aggregate number
of mail shipments described in clause (i) of that section, the
Secretary of Homeland Security and the Postmaster General shall
provide briefings to the appropriate congressional committees on
the progress made in achieving the transmission of that
information for that percentage of shipments.
(d) Government Accountability Office Report.--Not later than June
30, 2019, the Comptroller General of the United States shall submit to
the appropriate congressional committees a report--
(1) assessing the progress of the United States Postal
Service in achieving the transmission of the information
required by subparagraph (K) of section 343(a)(3) of the Trade
Act of 2002, as amended by subsection (a)(1), for the percentage
of shipments required by that subparagraph;
(2) assessing the quality of the information received from
foreign postal operators for targeting purposes;
(3) assessing the specific percentage of targeted mail
presented by the Postal Service to U.S. Customs and Border
Protection for inspection;
(4) describing the costs of collecting the information
required by such subparagraph (K) from foreign postal operators
and the costs of implementing the use of that information;
(5) assessing the benefits of receiving that information
with respect to international mail shipments;
(6) assessing the feasibility of assessing a customs fee
under section 13031(b)(9) of the Consolidated Omnibus Budget
Reconciliation Act of 1985, as amended by section 8002, on
international mail shipments other than Inbound Express Mail
service in a manner consistent with the obligations of the
United States under international agreements; and
[[Page 132 STAT. 4079]]
(7) identifying recommendations, including recommendations
for legislation, to improve the compliance of the Postal Service
with such subparagraph (K), including an assessment of whether
the detection of illicit synthetic opioids in the international
mail would be improved by--
(A) requiring the Postal Service to serve as the
consignee for international mail shipments containing
goods; or
(B) designating a customs broker to act as an
importer of record for international mail shipments
containing goods.
(e) Technical Correction.--Section 343 of the Trade Act of 2002
(Public Law 107-210; 19 U.S.C. 2071 note) is amended in the section
heading by striking ``advanced'' and inserting ``advance''.
(f) Appropriate Congressional Committees Defined.--In this section,
the term ``appropriate congressional committees'' means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on Homeland
Security of the House of Representatives.
SEC. 8004. <<NOTE: 19 USC 1415 note.>> INTERNATIONAL POSTAL
AGREEMENTS.
(a) Existing Agreements.--
(1) In general.--In the event that any provision of this
subtitle, or any amendment made by this subtitle, is determined
to be in violation of obligations of the United States under any
postal treaty, convention, or other international agreement
related to international postal services, or any amendment to
such an agreement, the Secretary of State should negotiate to
amend the relevant provisions of the agreement so that the
United States is no longer in violation of the agreement.
(2) Rule of construction.--Nothing in this subsection shall
be construed to permit delay in the implementation of this
subtitle or any amendment made by this subtitle.
(b) Future Agreements.--
(1) Consultations.--Before entering into, on or after the
date of the enactment of this Act, any postal treaty,
convention, or other international agreement related to
international postal services, or any amendment to such an
agreement, that is related to the ability of the United States
to secure the provision of advance electronic information by
foreign postal operators, the Secretary of State should consult
with the appropriate congressional committees (as defined in
section 8003(f)).
(2) Expedited negotiation of new agreement.--To the extent
that any new postal treaty, convention, or other international
agreement related to international postal services would improve
the ability of the United States to secure the provision of
advance electronic information by foreign postal operators as
required by regulations prescribed under section 343(a)(3)(K) of
the Trade Act of 2002, as amended by section 8003(a)(1), the
Secretary of State should expeditiously conclude such an
agreement.
SEC. 8005. <<NOTE: 19 USC 1415 note.>> COST RECOUPMENT.
(a) In General.--The United States Postal Service shall, to the
extent practicable and otherwise recoverable by law, ensure
[[Page 132 STAT. 4080]]
that all costs associated with complying with this subtitle and
amendments made by this subtitle are charged directly to foreign
shippers or foreign postal operators.
(b) Costs Not Considered Revenue.--The recovery of costs under
subsection (a) shall not be deemed revenue for purposes of subchapter I
and II of chapter 36 of title 39, United States Code, or regulations
prescribed under that chapter.
SEC. 8006. <<NOTE: 19 USC 1583a.>> DEVELOPMENT OF TECHNOLOGY TO
DETECT ILLICIT NARCOTICS.
(a) In General.--The Postmaster General and the Commissioner of U.S.
Customs and Border Protection, in coordination with the heads of other
agencies as appropriate, shall collaborate to identify and develop
technology for the detection of illicit fentanyl, other synthetic
opioids, and other narcotics and psychoactive substances entering the
United States by mail.
(b) Outreach to Private Sector.--The Postmaster General and the
Commissioner shall conduct outreach to private sector entities to gather
information regarding the current state of technology to identify areas
for innovation relating to the detection of illicit fentanyl, other
synthetic opioids, and other narcotics and psychoactive substances
entering the United States.
SEC. 8007. CIVIL PENALTIES FOR POSTAL SHIPMENTS.
Section 436 of the Tariff Act of 1930 (19 U.S.C. 1436) is amended by
adding at the end the following new subsection:
``(e) Civil Penalties for Postal Shipments.--
``(1) Civil penalty.--A civil penalty shall be imposed
against the United States Postal Service if the Postal Service
accepts a shipment in violation of section 343(a)(3)(K)(vii)(I)
of the Trade Act of 2002.
``(2) Modification of civil penalty.--
``(A) In general.--U.S. Customs and Border
Protection shall reduce or dismiss a civil penalty
imposed pursuant to paragraph (1) if U.S. Customs and
Border Protection determines that the United States
Postal Service--
``(i) has a low error rate in compliance with
section 343(a)(3)(K) of the Trade Act of 2002;
``(ii) is cooperating with U.S. Customs and
Border Protection with respect to the violation of
section 343(a)(3)(K)(vii)(I) of the Trade Act of
2002; or
``(iii) has taken remedial action to prevent
future violations of section 343(a)(3)(K)(vii)(I)
of the Trade Act of 2002.
``(B) Written notification.--U.S. Customs and Border
Protection shall issue a written notification to the
Postal Service with respect to each exercise of the
authority of subparagraph (A) to reduce or dismiss a
civil penalty imposed pursuant to paragraph (1).
``(3) Ongoing lack of compliance.--If U.S. Customs and
Border Protection determines that the United States Postal
Service--
``(A) has repeatedly committed violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002,
``(B) has failed to cooperate with U.S. Customs and
Border Protection with respect to violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and
[[Page 132 STAT. 4081]]
``(C) has an increasing error rate in compliance
with section 343(a)(3)(K) of the Trade Act of 2002,
civil penalties may be imposed against the United States Postal
Service until corrective action, satisfactory to U.S. Customs
and Border Protection, is taken.''.
SEC. 8008. <<NOTE: 19 USC 1436a.>> REPORT ON VIOLATIONS OF
ARRIVAL, REPORTING, ENTRY, AND CLEARANCE
REQUIREMENTS AND FALSITY OR LACK OF
MANIFEST.
(a) In General.--The Commissioner of U.S. Customs and Border
Protection shall submit to the appropriate congressional committees an
annual report that contains the information described in subsection (b)
with respect to each violation of section 436 of the Tariff Act of 1930
(19 U.S.C. 1436), as amended by section 8007, and section 584 of such
Act (19 U.S.C. 1584) that occurred during the previous year.
(b) Information Described.--The information described in this
subsection is the following:
(1) The name and address of the violator.
(2) The specific violation that was committed.
(3) The location or port of entry through which the items
were transported.
(4) An inventory of the items seized, including a
description of the items and the quantity seized.
(5) The location from which the items originated.
(6) The entity responsible for the apprehension or seizure,
organized by location or port of entry.
(7) The amount of penalties assessed by U.S. Customs and
Border Protection, organized by name of the violator and
location or port of entry.
(8) The amount of penalties that U.S. Customs and Border
Protection could have levied, organized by name of the violator
and location or port of entry.
(9) The rationale for negotiating lower penalties, organized
by name of the violator and location or port of entry.
(c) Appropriate Congressional Committees Defined.--In this section,
the term ``appropriate congressional committees'' means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on Homeland
Security of the House of Representatives.
SEC. 8009. EFFECTIVE DATE; REGULATIONS.
(a) <<NOTE: 19 USC 1436 note.>> Effective Date.--This subtitle and
the amendments made by this subtitle (other than the amendments made by
section 8002) shall take effect on the date of the enactment of this
Act.
(b) <<NOTE: 19 USC 58c note.>> Regulations.--Not later than 1 year
after the date of the enactment of this Act, such regulations as are
necessary to carry out this subtitle and the amendments made by this
subtitle shall be prescribed.
[[Page 132 STAT. 4082]]
Subtitle <<NOTE: Opioid Addiction Recovery Fraud Prevention Act of
2018.>> B--Opioid Addiction Recovery Fraud Prevention
SEC. 8021. <<NOTE: 15 USC 58 note.>> SHORT TITLE.
This subtitle may be cited as the ``Opioid Addiction Recovery Fraud
Prevention Act of 2018''.
SEC. 8022. <<NOTE: 15 USC 45d note.>> DEFINITIONS.
For purposes of this subtitle only, and not be construed or applied
as to challenge or affect the characterization, definition, or treatment
under any other statute, regulation, or rule:
(1) Substance use disorder treatment product.--The term
``substance use disorder treatment product'' means a product for
use or marketed for use in the treatment, cure, or prevention of
a substance use disorder, including an opioid use disorder.
(2) Substance use disorder treatment service.--The term
``substance use disorder treatment service'' means a service
that purports to provide referrals to treatment, treatment, or
recovery housing for people diagnosed with, having, or
purporting to have a substance use disorder, including an opioid
use disorder.
SEC. 8023. <<NOTE: 15 USC 45d.>> UNFAIR OR DECEPTIVE ACTS OR
PRACTICES WITH RESPECT TO SUBSTANCE USE
DISORDER TREATMENT SERVICE AND PRODUCTS.
(a) Unlawful Activity.--It is unlawful to engage in an unfair or
deceptive act or practice with respect to any substance use disorder
treatment service or substance use disorder treatment product.
(b) Enforcement by the Federal Trade Commission.--
(1) Unfair or deceptive acts or practices.--A violation of
subsection (a) shall be treated as a violation of a rule under
section 18 of the Federal Trade Commission Act (15 U.S.C. 57a)
regarding unfair or deceptive acts or practices.
(2) Powers of the federal trade commission.--
(A) In general.--The Federal Trade Commission shall
enforce this section in the same manner, by the same
means, and with the same jurisdiction, powers, and
duties as though all applicable terms and provisions of
the Federal Trade Commission Act (15 U.S.C. 41 et seq.)
were incorporated into and made a part of this section.
(B) Privileges and immunities.--Any person who
violates subsection (a) shall be subject to the
penalties and entitled to the privileges and immunities
provided in the Federal Trade Commission Act as though
all applicable terms and provisions of the Federal Trade
Commission Act (15 U.S.C. 41 et seq.) were incorporated
and made part of this section.
(c) Authority Preserved.--Nothing in this subtitle shall be
construed to limit the authority of the Federal Trade Commission or the
Food and Drug Administration under any other provision of law.
[[Page 132 STAT. 4083]]
Subtitle C--Addressing Economic and Workforce Impacts of the Opioid
Crisis
SEC. 8041. <<NOTE: 29 USC 3225a.>> ADDRESSING ECONOMIC AND
WORKFORCE IMPACTS OF THE OPIOID CRISIS.
(a) Definitions.--Except as otherwise expressly provided, in this
section:
(1) WIOA definitions.--The terms ``core program'',
``individual with a barrier to employment'', ``local area'',
``local board'', ``one-stop operator'', ``outlying area'',
``State'', ``State board'', and ``supportive services'' have the
meanings given the terms in section 3 of the Workforce
Innovation and Opportunity Act (29 U.S.C. 3102).
(2) Education provider.--The term ``education provider''
means--
(A) an institution of higher education, as defined
in section 101 of the Higher Education Act of 1965 (20
U.S.C. 1001); or
(B) a postsecondary vocational institution, as
defined in section 102(c) of such Act (20 U.S.C.
1002(c)).
(3) Eligible entity.--The term ``eligible entity'' means--
(A) a State workforce agency;
(B) an outlying area; or
(C) a Tribal entity.
(4) Participating partnership.--The term ``participating
partnership'' means a partnership--
(A) evidenced by a written contract or agreement;
and
(B) including, as members of the partnership, a
local board receiving a subgrant under subsection (d)
and 1 or more of the following:
(i) The eligible entity.
(ii) A treatment provider.
(iii) An employer or industry organization.
(iv) An education provider.
(v) A legal service or law enforcement
organization.
(vi) A faith-based or community-based
organization.
(vii) Other State or local agencies, including
counties or local governments.
(viii) Other organizations, as determined to
be necessary by the local board.
(ix) Indian Tribes or tribal organizations.
(5) Program participant.--The term ``program participant''
means an individual who--
(A) is a member of a population of workers described
in subsection (e)(2) that is served by a participating
partnership through the pilot program under this
section; and
(B) enrolls with the applicable participating
partnership to receive any of the services described in
subsection (e)(3).
(6) Provider of peer recovery support services.--The term
``provider of peer recovery support services'' means a provider
that delivers peer recovery support services through an
organization described in section 547(a) of the Public Health
Service Act (42 U.S.C. 290ee-2(a)).
[[Page 132 STAT. 4084]]
(7) Secretary.--The term ``Secretary'' means the Secretary
of Labor.
(8) State workforce agency.--The term ``State workforce
agency'' means the lead State agency with responsibility for the
administration of a program under chapter 2 or 3 of subtitle B
of title I of the Workforce Innovation and Opportunity Act (29
U.S.C. 3161 et seq., 3171 et seq.).
(9) Substance use disorder.--The term ``substance use
disorder'' has the meaning given such term by the Assistant
Secretary for Mental Health and Substance Use.
(10) Treatment provider.--The term ``treatment provider''--
(A) means a health care provider that--
(i) offers services for treating substance use
disorders and is licensed in accordance with
applicable State law to provide such services; and
(ii) accepts health insurance for such
services, including coverage under title XIX of
the Social Security Act (42 U.S.C. 1396 et seq.);
and
(B) may include--
(i) a nonprofit provider of peer recovery
support services;
(ii) a community health care provider;
(iii) a Federally qualified health center (as
defined in section 1861(aa) of the Social Security
Act (42 U.S.C. 1395x));
(iv) an Indian health program (as defined in
section 3 of the Indian Health Care Improvement
Act (25 U.S.C. 1603)), including an Indian health
program that serves an urban center (as defined in
such section); and
(v) a Native Hawaiian health center (as
defined in section 12 of the Native Hawaiian
Health Care Improvement Act (42 U.S.C. 11711)).
(11) Tribal entity.--The term ``Tribal entity'' includes any
Indian Tribe, tribal organization, Indian-controlled
organization serving Indians, Native Hawaiian organization, or
Alaska Native entity, as such terms are defined or used in
section 166 of the Workforce Innovation and Opportunity Act (29
U.S.C. 3221).
(b) Pilot Program and Grants Authorized.--
(1) In general.--The Secretary, in consultation with the
Secretary of Health and Human Services, shall carry out a pilot
program to address economic and workforce impacts associated
with a high rate of a substance use disorder. In carrying out
the pilot program, the Secretary shall make grants, on a
competitive basis, to eligible entities to enable such entities
to make subgrants to local boards to address the economic and
workforce impacts associated with a high rate of a substance use
disorder.
(2) Grant amounts.--The Secretary shall make each such grant
in an amount that is not less than $500,000, and not more than
$5,000,000, for a fiscal year.
(c) Grant Applications.--
(1) In general.--An eligible entity applying for a grant
under this section shall submit an application to the Secretary
at such time and in such form and manner as the Secretary
[[Page 132 STAT. 4085]]
may reasonably require, including the information described in
this subsection.
(2) Significant impact on community by opioid and substance
use disorder-related problems.--
(A) Demonstration.--An eligible entity shall include
in the application--
(i) information that demonstrates significant
impact on the community by problems related to
opioid abuse or another substance use disorder,
by--
(I) identifying the counties,
communities, regions, or local areas
that have been significantly impacted
and will be served through the grant
(each referred to in this section as a
``service area''); and
(II) demonstrating for each such
service area, an increase equal to or
greater than the national increase in
such problems, between--
(aa) 1999; and
(bb) 2016 or the latest year
for which data are available;
and
(ii) a description of how the eligible entity
will prioritize support for significantly impacted
service areas described in clause (i)(I).
(B) Information.--To meet the requirements described
in subparagraph (A)(i)(II), the eligible entity may use
information including data on--
(i) the incidence or prevalence of opioid
abuse and other substance use disorders;
(ii) the age-adjusted rate of drug overdose
deaths, as determined by the Director of the
Centers for Disease Control and Prevention;
(iii) the rate of non-fatal hospitalizations
related to opioid abuse or other substance use
disorders;
(iv) the number of arrests or convictions, or
a relevant law enforcement statistic, that
reasonably shows an increase in opioid abuse or
another substance use disorder; or
(v) in the case of an eligible entity
described in subsection (a)(3)(C), other
alternative relevant data as determined
appropriate by the Secretary.
(C) Support for state strategy.--The eligible entity
may include in the application information describing
how the proposed services and activities are aligned
with the State, outlying area, or Tribal strategy, as
applicable, for addressing problems described in
subparagraph (A) in specific service areas or across the
State, outlying area, or Tribal land.
(3) Economic and employment conditions demonstrate
additional federal support needed.--
(A) Demonstration.--An eligible entity shall include
in the application information that demonstrates that a
high rate of a substance use disorder has caused, or is
coincident to--
(i) an economic or employment downturn in the
service area; or
(ii) persistent economically depressed
conditions in such service area.
[[Page 132 STAT. 4086]]
(B) Information.--To meet the requirements of
subparagraph (A), an eligible entity may use information
including--
(i) documentation of any layoff, announced
future layoff, legacy industry decline, decrease
in an employment or labor market participation
rate, or economic impact, whether or not the
result described in this clause is overtly related
to a high rate of a substance use disorder;
(ii) documentation showing decreased economic
activity related to, caused by, or contributing to
a high rate of a substance use disorder, including
a description of how the service area has been
impacted, or will be impacted, by such a decrease;
(iii) information on economic indicators,
labor market analyses, information from public
announcements, and demographic and industry data;
(iv) information on rapid response activities
(as defined in section 3 of the Workforce
Innovation and Opportunity Act (29 U.S.C. 3102))
that have been or will be conducted, including
demographic data gathered by employer or worker
surveys or through other methods;
(v) data or documentation, beyond anecdotal
evidence, showing that employers face challenges
filling job vacancies due to a lack of skilled
workers able to pass a drug test; or
(vi) any additional relevant data or
information on the economy, workforce, or another
aspect of the service area to support the
application.
(d) Subgrant Authorization and Application Process.--
(1) Subgrants authorized.--
(A) In general.--An eligible entity receiving a
grant under subsection (b)--
(i) may use not more than 5 percent of the
grant funds for the administrative costs of
carrying out the grant;
(ii) in the case of an eligible entity
described in subparagraph (A) or (B) of subsection
(a)(3), shall use the remaining grant funds to
make subgrants to local entities in the service
area to carry out the services and activities
described in subsection (e); and
(iii) in the case of an eligible entity
described in subsection (a)(3)(C), shall use the
remaining grant funds to carry out the services
and activities described in subsection (e).
(B) Equitable distribution.--In making subgrants
under this subsection, an eligible entity shall ensure,
to the extent practicable, the equitable distribution of
subgrants, based on--
(i) geography (such as urban and rural
distribution); and
(ii) significantly impacted service areas as
described in subsection (c)(2).
(C) Timing of subgrant funds distribution.--An
eligible entity making subgrants under this subsection
shall
[[Page 132 STAT. 4087]]
disburse subgrant funds to a local board receiving a
subgrant from the eligible entity by the later of--
(i) the date that is 90 days after the date on
which the Secretary makes the funds available to
the eligible entity; or
(ii) the date that is 15 days after the date
that the eligible entity makes the subgrant under
subparagraph (A)(ii).
(2) Subgrant application.--
(A) In general.--A local board desiring to receive a
subgrant under this subsection from an eligible entity
shall submit an application at such time and in such
manner as the eligible entity may reasonably require,
including the information described in this paragraph.
(B) Contents.--Each application described in
subparagraph (A) shall include--
(i) an analysis of the estimated performance
of the local board in carrying out the proposed
services and activities under the subgrant--
(I) based on--
(aa) primary indicators of
performance described in section
116(c)(1)(A)(i) of the Workforce
Innovation and Opportunity Act
(29 U.S.C. 3141(c)(1)(A)(i), to
assess estimated effectiveness
of the proposed services and
activities, including the
estimated number of individuals
with a substance use disorder
who may be served by the
proposed services and
activities;
(bb) the record of the local
board in serving individuals
with a barrier to employment;
and
(cc) the ability of the
local board to establish a
participating partnership; and
(II) which may include or utilize--
(aa) data from the National
Center for Health Statistics of
the Centers for Disease Control
and Prevention;
(bb) data from the Center
for Behavioral Health Statistics
and Quality of the Substance
Abuse and Mental Health Services
Administration;
(cc) State vital statistics;
(dd) municipal police
department records;
(ee) reports from local
coroners; or
(ff) other relevant data;
and
(ii) in the case of a local board proposing to
serve a population described in subsection
(e)(2)(B), a demonstration of the workforce
shortage in the professional area to be addressed
under the subgrant (which may include substance
use disorder treatment and related services, non-
addictive pain therapy and pain management
services, mental health care treatment services,
emergency response services, or mental health
care), which shall include information that can
demonstrate such a shortage, such as--
(I) the distance between--
[[Page 132 STAT. 4088]]
(aa) communities affected by
opioid abuse or another
substance use disorder; and
(bb) facilities or
professionals offering services
in the professional area; or
(II) the maximum capacity of
facilities or professionals to serve
individuals in an affected community, or
increases in arrests related to opioid
or another substance use disorder,
overdose deaths, or nonfatal overdose
emergencies in the community.
(e) Subgrant Services and Activities.--
(1) In general.--Each local board that receives a subgrant
under subsection (d) shall carry out the services and activities
described in this subsection through a participating
partnership.
(2) Selection of population to be served.--A participating
partnership shall elect to provide services and activities under
the subgrant to one or both of the following populations of
workers:
(A) Workers, including dislocated workers,
individuals with barriers to employment, new entrants in
the workforce, or incumbent workers (employed or
underemployed), each of whom--
(i) is directly or indirectly affected by a
high rate of a substance use disorder; and
(ii) voluntarily confirms that the worker, or
a friend or family member of the worker, has a
history of opioid abuse or another substance use
disorder.
(B) Workers, including dislocated workers,
individuals with barriers to employment, new entrants in
the workforce, or incumbent workers (employed or
underemployed), who--
(i) seek to transition to professions that
support individuals with a substance use disorder
or at risk for developing such disorder, such as
professions that provide--
(I) substance use disorder treatment
and related services;
(II) services offered through
providers of peer recovery support
services;
(III) non-addictive pain therapy and
pain management services;
(IV) emergency response services; or
(V) mental health care; and
(ii) need new or upgraded skills to better
serve such a population of struggling or at-risk
individuals.
(3) Services and activities.--Each participating partnership
shall use funds available through a subgrant under this
subsection to carry out 1 or more of the following:
(A) Engaging employers.--Engaging with employers
to--
(i) learn about the skill and hiring
requirements of employers;
(ii) learn about the support needed by
employers to hire and retain program participants,
and other individuals with a substance use
disorder, and the support needed by such employers
to obtain their
[[Page 132 STAT. 4089]]
commitment to testing creative solutions to
employing program participants and such
individuals;
(iii) connect employers and workers to on-the-
job or customized training programs before or
after layoff to help facilitate reemployment;
(iv) connect employers with an education
provider to develop classroom instruction to
complement on-the-job learning for program
participants and such individuals;
(v) help employers develop the curriculum
design of a work-based learning program for
program participants and such individuals;
(vi) help employers employ program
participants or such individuals engaging in a
work-based learning program for a transitional
period before hiring such a program participant or
individual for full-time employment of not less
than 30 hours a week; or
(vii) connect employers to program
participants receiving concurrent outpatient
treatment and job training services.
(B) Screening services.--Providing screening
services, which may include--
(i) using an evidence-based screening method
to screen each individual seeking participation in
the pilot program to determine whether the
individual has a substance use disorder;
(ii) conducting an assessment of each such
individual to determine the services needed for
such individual to obtain or retain employment,
including an assessment of strengths and general
work readiness; or
(iii) accepting walk-ins or referrals from
employers, labor organizations, or other entities
recommending individuals to participate in such
program.
(C) Individual treatment and employment plan.--
Developing an individual treatment and employment plan
for each program participant--
(i) in coordination, as appropriate, with
other programs serving the participant such as the
core programs within the workforce development
system under the Workforce Innovation and
Opportunity Act (29 U.S.C. 3101 et seq.); and
(ii) which shall include providing a case
manager to work with each participant to develop
the plan, which may include--
(I) identifying employment and
career goals;
(II) exploring career pathways that
lead to in-demand industries and
sectors, as determined by the State
board and the head of the State
workforce agency or, as applicable, the
Tribal entity;
(III) setting appropriate
achievement objectives to attain the
employment and career goals identified
under subclause (I); or
(IV) developing the appropriate
combination of services to enable the
participant to achieve
[[Page 132 STAT. 4090]]
the employment and career goals
identified under subclause (I).
(D) Outpatient treatment and recovery care.--In the
case of a participating partnership serving program
participants described in paragraph (2)(A) with a
substance use disorder, providing individualized and
group outpatient treatment and recovery services for
such program participants that are offered during the
day and evening, and on weekends. Such treatment and
recovery services--
(i) shall be based on a model that utilizes
combined behavioral interventions and other
evidence-based or evidence-informed interventions;
and
(ii) may include additional services such as--
(I) health, mental health,
addiction, or other forms of outpatient
treatment that may impact a substance
use disorder and co-occurring
conditions;
(II) drug testing for a current
substance use disorder prior to
enrollment in career or training
services or prior to employment;
(III) linkages to community
services, including services offered by
partner organizations designed to
support program participants; or
(IV) referrals to health care,
including referrals to substance use
disorder treatment and mental health
services.
(E) Supportive services.--Providing supportive
services, which shall include services such as--
(i) coordinated wraparound services to provide
maximum support for program participants to assist
the program participants in maintaining employment
and recovery for not less than 12 months, as
appropriate;
(ii) assistance in establishing eligibility
for assistance under Federal, State, Tribal, and
local programs providing health services, mental
health services, vocational services, housing
services, transportation services, social
services, or services through early childhood
education programs (as defined in section 103 of
the Higher Education Act of 1965 (20 U.S.C.
1003));
(iii) services offered through providers of
peer recovery support services;
(iv) networking and mentorship opportunities;
or
(v) any supportive services determined
necessary by the local board.
(F) Career and job training services.--Offering
career services and training services, and related
services, concurrently or sequentially with the services
provided under subparagraphs (B) through (E). Such
services shall include the following:
(i) Services provided to program participants
who are in a pre-employment stage of the program,
which may include--
(I) initial education and skills
assessments;
(II) traditional classroom training
funded through individual training
accounts under chapter 3 of subtitle B
of title I of the Workforce
[[Page 132 STAT. 4091]]
Innovation and Opportunity Act (29
U.S.C. 3171 et seq.);
(III) services to promote
employability skills such as
punctuality, personal maintenance
skills, and professional conduct;
(IV) in-depth interviewing and
evaluation to identify employment
barriers and to develop individual
employment plans;
(V) career planning that includes--
(aa) career pathways leading
to in-demand, high-wage jobs;
and
(bb) job coaching, job
matching, and job placement
services;
(VI) provision of payments and fees
for employment and training-related
applications, tests, and certifications;
or
(VII) any other appropriate career
service or training service described in
section 134(c) of the Workforce
Innovation and Opportunity Act (29
U.S.C. 3174(c)).
(ii) Services provided to program participants
during their first 6 months of employment to
ensure job retention, which may include--
(I) case management and support
services, including a continuation of
the services described in clause (i);
(II) a continuation of skills
training, and career and technical
education, described in clause (i) that
is conducted in collaboration with the
employers of such participants;
(III) mentorship services and job
retention support for such participants;
or
(IV) targeted training for managers
and workers working with such
participants (such as mentors), and
human resource representatives in the
business in which such participants are
employed.
(iii) Services to assist program participants
in maintaining employment for not less than 12
months, as appropriate.
(G) Proven and promising practices.--Leading efforts
in the service area to identify and promote proven and
promising strategies and initiatives for meeting the
needs of employers and program participants.
(4) Limitations.--A participating partnership may not use--
(A) more than 10 percent of the funds received under
a subgrant under subsection (d) for the administrative
costs of the partnership;
(B) more than 10 percent of the funds received under
such subgrant for the provision of treatment and
recovery services, as described in paragraph (3)(D); and
(C) more than 10 percent of the funds received under
such subgrant for the provision of supportive services
described in paragraph (3)(E) to program participants.
(f) Performance Accountability.--
[[Page 132 STAT. 4092]]
(1) Reports.--The Secretary shall establish quarterly
reporting requirements for recipients of grants and subgrants
under this section that, to the extent practicable, are based on
the performance accountability system under section 116 of the
Workforce Innovation and Opportunity Act (29 U.S.C. 3141) and,
in the case of a grant awarded to an eligible entity described
in subsection (a)(3)(C), section 166(h) of such Act (29 U.S.C.
3221(h)), including the indicators described in subsection
(c)(1)(A)(i) of such section 116 and the requirements for local
area performance reports under subsection (d) of such section
116.
(2) Evaluations.--
(A) Authority to enter into agreements.--The
Secretary shall ensure that an independent evaluation is
conducted on the pilot program carried out under this
section to determine the impact of the program on
employment of individuals with substance use disorders.
The Secretary shall enter into an agreement with
eligible entities receiving grants under this section to
pay for all or part of such evaluation.
(B) Methodologies to be used.--The independent
evaluation required under this paragraph shall use
experimental designs using random assignment or, when
random assignment is not feasible, other reliable,
evidence-based research methodologies that allow for the
strongest possible causal inferences.
(g) Funding.--
(1) Covered fiscal year.--In this subsection, the term
``covered fiscal year'' means any of fiscal years 2019 through
2023.
(2) Using funding for national dislocated worker grants.--
Subject to paragraph (4) and notwithstanding section
132(a)(2)(A) and subtitle D of the Workforce Innovation and
Opportunity Act (29 U.S.C. 3172(a)(2)(A), 3221 et seq.), the
Secretary may use, to carry out the pilot program under this
section for a covered fiscal year--
(A) funds made available to carry out section 170 of
such Act (29 U.S.C. 3225) for that fiscal year;
(B) funds made available to carry out section 170 of
such Act that remain available for that fiscal year; and
(C) funds that remain available under section 172(f)
of such Act (29 U.S.C. 3227(f)).
(3) Availability of funds.--Funds appropriated under section
136(c) of such Act (29 U.S.C. 3181(c)) and made available to
carry out section 170 of such Act for a fiscal year shall remain
available for use under paragraph (2) for a subsequent fiscal
year until expended.
(4) Limitation.--The Secretary may not use more than
$100,000,000 of the funds described in paragraph (2) for any
covered fiscal year under this section.
[[Page 132 STAT. 4093]]
Subtitle D--Peer Support Counseling Program for Women Veterans
SEC. 8051. PEER SUPPORT COUNSELING PROGRAM FOR WOMEN VETERANS.
(a) In General.--Section 1720F(j) of title 38, United States Code,
is amended by adding at the end the following new paragraph:
``(4)(A) As part of the counseling program under this subsection,
the Secretary shall emphasize appointing peer support counselors for
women veterans. To the degree practicable, the Secretary shall seek to
recruit women peer support counselors with expertise in--
``(i) female gender-specific issues and services;
``(ii) the provision of information about services and
benefits provided under laws administered by the Secretary; or
``(iii) employment mentoring.
``(B) To the degree practicable, the Secretary shall emphasize
facilitating peer support counseling for women veterans who are eligible
for counseling and services under section 1720D of this title, have
post-traumatic stress disorder or suffer from another mental health
condition, are homeless or at risk of becoming homeless, or are
otherwise at increased risk of suicide, as determined by the Secretary.
``(C) The Secretary shall conduct outreach to inform women veterans
about the program and the assistance available under this paragraph.
``(D) In carrying out this paragraph, the Secretary shall coordinate
with such community organizations, State and local governments,
institutions of higher education, chambers of commerce, local business
organizations, organizations that provide legal assistance, and other
organizations as the Secretary considers appropriate.
``(E) In carrying out this paragraph, the Secretary shall provide
adequate training for peer support counselors, including training
carried out under the national program of training required by section
304(c) of the Caregivers and Veterans Omnibus Health Services Act of
2010 (38 U.S.C. 1712A note).''.
(b) <<NOTE: 38 USC 1720F note.>> Funding.--The Secretary of
Veterans Affairs shall carry out paragraph (4) of section 1720F(j) of
title 38, United States Code, as added by subsection (a), using funds
otherwise made available to the Secretary. No additional funds are
authorized to be appropriated by reason of such paragraph.
(c) Report to Congress.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Veterans Affairs shall
submit to the Committees on Veterans' Affairs of the Senate and House of
Representatives a report on the peer support counseling program under
section 1720F(j) of title 38, United States Code, as amended by this
section. Such report shall include--
(1) the number of peer support counselors in the program;
(2) an assessment of the effectiveness of the program; and
(3) a description of the oversight of the program.
[[Page 132 STAT. 4094]]
Subtitle <<NOTE: Treating Barriers to Prosperity Act of 2018.>> E--
Treating Barriers to Prosperity
SEC. 8061. <<NOTE: 40 USC 101 note.>> SHORT TITLE.
This subtitle may be cited as the ``Treating Barriers to Prosperity
Act of 2018''.
SEC. 8062. DRUG ABUSE MITIGATION INITIATIVE.
(a) In General.--Chapter 145 of title 40, United States Code, is
amended by inserting after section 14509 the following:
``Sec. 14510. <<NOTE: 40 USC 14510.>> Drug abuse mitigation
initiative
``(a) In General.--The Appalachian Regional Commission may provide
technical assistance to, make grants to, enter into contracts with, or
otherwise provide amounts to individuals or entities in the Appalachian
region for projects and activities to address drug abuse, including
opioid abuse, in the region, including projects and activities--
``(1) to facilitate the sharing of best practices among
States, counties, and other experts in the region with respect
to reducing such abuse;
``(2) to initiate or expand programs designed to eliminate
or reduce the harm to the workforce and economic growth of the
region that results from such abuse;
``(3) to attract and retain relevant health care services,
businesses, and workers; and
``(4) to develop relevant infrastructure, including
broadband infrastructure that supports the use of telemedicine.
``(b) Limitation on Available Amounts.--Of the cost of any activity
eligible for a grant under this section--
``(1) not more than 50 percent may be provided from amounts
appropriated to carry out this section; and
``(2) notwithstanding paragraph (1)--
``(A) in the case of a project to be carried out in
a county for which a distressed county designation is in
effect under section 14526, not more than 80 percent may
be provided from amounts appropriated to carry out this
section; and
``(B) in the case of a project to be carried out in
a county for which an at-risk designation is in effect
under section 14526, not more than 70 percent may be
provided from amounts appropriated to carry out this
section.
``(c) Sources of Assistance.--Subject to subsection (b), a grant
provided under this section may be provided from amounts made available
to carry out this section in combination with amounts made available--
``(1) under any other Federal program (subject to the
availability of subsequent appropriations); or
``(2) from any other source.
``(d) Federal Share.--Notwithstanding any provision of law limiting
the Federal share under any other Federal program, amounts made
available to carry out this section may be used to increase that Federal
share, as the Appalachian Regional Commission determines to be
appropriate.''.
[[Page 132 STAT. 4095]]
(b) Clerical Amendment.--The analysis for chapter 145 of title 40,
United States Code, <<NOTE: 40 USC 14501 prec.>> is amended by
inserting after the item relating to section 14509 the following:
``14510. Drug abuse mitigation initiative.''.
Subtitle F--Pilot Program to Help Individuals in Recovery From a
Substance Use Disorder Become Stably Housed
SEC. 8071. <<NOTE: 42 USC 5301 note.>> PILOT PROGRAM TO HELP
INDIVIDUALS IN RECOVERY FROM A SUBSTANCE
USE DISORDER BECOME STABLY HOUSED.
(a) Authorization of Appropriations.--There is authorized to be
appropriated under this section such sums as may be necessary for each
of fiscal years 2019 through 2023 for assistance to States to provide
individuals in recovery from a substance use disorder stable, temporary
housing for a period of not more than 2 years or until the individual
secures permanent housing, whichever is earlier.
(b) Allocation of Appropriated Amounts.--
(1) In general.--The amounts appropriated or otherwise made
available to States under this section shall be allocated based
on a funding formula established by the Secretary of Housing and
Urban Development (referred to in this section as the
``Secretary'') not later than 60 days after the date of
enactment of this Act.
(2) Criteria.--
(A) In general.--The funding formula required under
paragraph (1) shall ensure that any amounts appropriated
or otherwise made available under this section are
allocated to States with an age-adjusted rate of drug
overdose deaths that is above the national overdose
mortality rate, according to the Centers for Disease
Control and Prevention.
(B) Priority.--
(i) In general.--Among such States, priority
shall be given to States with the greatest need,
as such need is determined by the Secretary based
on the following factors, and weighting such
factors as described in clause (ii):
(I) The highest average rates of
unemployment based on data provided by
the Bureau of Labor Statistics for
calendar years 2013 through 2017.
(II) The lowest average labor force
participation rates based on data
provided by the Bureau of Labor
Statistics for calendar years 2013
through 2017.
(III) The highest age-adjusted rates
of drug overdose deaths based on data
from the Centers for Disease Control and
Prevention.
(ii) Weighting.--The factors described in
clause (i) shall be weighted as follows:
(I) The rate described in clause
(i)(I) shall be weighted at 15 percent.
[[Page 132 STAT. 4096]]
(II) The rate described in clause
(i)(II) shall be weighted at 15 percent.
(III) The rate described in clause
(i)(III) shall be weighted at 70
percent.
(3) Distribution.--Amounts appropriated or otherwise made
available under this section shall be distributed according to
the funding formula established by the Secretary under paragraph
(1) not later than 30 days after the establishment of such
formula.
(c) Use of Funds.--
(1) In general.--Any State that receives amounts pursuant to
this section shall expend at least 30 percent of such funds
within one year of the date funds become available to the
grantee for obligation.
(2) Priority.--Any State that receives amounts pursuant to
this section shall distribute such amounts giving priority to
entities with the greatest need and ability to deliver effective
assistance in a timely manner.
(3) Administrative costs.--Any State that receives amounts
pursuant to this section may use up to 5 percent of any grant
for administrative costs.
(d) Rules of Construction.--
(1) In general.--Except as otherwise provided by this
section, amounts appropriated, or amounts otherwise made
available to States under this section shall be treated as
though such funds were community development block grant funds
under title I of the Housing and Community Development Act of
1974 (42 U.S.C. 5301 et seq.).
(2) No match.--No matching funds shall be required in order
for a State to receive any amounts under this section.
(e) Authority to Waive or Specify Alternative Requirements.--
(1) In general.--In administering any amounts appropriated
or otherwise made available under this section, the Secretary
may waive or specify alternative requirements to any provision
under title I of the Housing and Community Development Act of
1974 (42 U.S.C. 5301 et seq.) except for requirements related to
fair housing, nondiscrimination, labor standards, the
environment, and requirements that activities benefit persons of
low- and moderate-income, upon a finding that such a waiver is
necessary to expedite or facilitate the use of such funds.
(2) Notice of intent.--The Secretary shall provide written
notice of its intent to exercise the authority to specify
alternative requirements under paragraph (1) to the Committee on
Banking, Housing, and Urban Affairs of the Senate and the
Committee on Financial Services of the House of Representatives
not later than 15 business days before such exercise of
authority occurs.
(3) Notice to the public.--The Secretary shall provide
written notice of its intent to exercise the authority to
specify alternative requirements under paragraph (1) to the
public via notice, on the internet website of the Department of
Housing and Urban Development, and by other appropriate means,
not later than 15 business days before such exercise of
authority occurs.
[[Page 132 STAT. 4097]]
(f) Technical Assistance.--For the 2-year period following the date
of enactment of this Act, the Secretary may use not more than 2 percent
of the funds made available under this section for technical assistance
to grantees.
(g) State.--For purposes of this section the term ``State'' includes
any State as defined in section 102 of the Housing and Community
Development Act of 1974 (42 U.S.C. 5302) and the District of Columbia.
Subtitle G--Human Services
SEC. 8081. <<NOTE: 42 USC 290bb-11 note.>> SUPPORTING FAMILY-
FOCUSED RESIDENTIAL TREATMENT.
(a) Definitions.--In this section:
(1) Family-focused residential treatment program.--The term
``family-focused residential treatment program'' means a trauma-
informed residential program primarily for substance use
disorder treatment for pregnant and postpartum women and parents
and guardians that allows children to reside with such women or
their parents or guardians during treatment to the extent
appropriate and applicable.
(2) Medicaid program.--The term ``Medicaid program'' means
the program established under title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(4) Title iv-e program.--The term ``title IV-E program''
means the program for foster care, prevention, and permanency
established under part E of title IV of the Social Security Act
(42 U.S.C. 670 et seq.).
(b) Guidance on Family-focused Residential Treatment Programs.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary, in consultation with
divisions of the Department of Health and Human Services
administering substance use disorder or child welfare programs,
shall develop and issue guidance to States identifying
opportunities to support family-focused residential treatment
programs for the provision of substance use disorder treatment.
Before issuing such guidance, the Secretary shall solicit input
from representatives of States, health care providers with
expertise in addiction medicine, obstetrics and gynecology,
neonatology, child trauma, and child development, health plans,
recipients of family-focused treatment services, and other
relevant stakeholders.
(2) Additional requirements.--The guidance required under
paragraph (1) shall include descriptions of the following:
(A) Existing opportunities and flexibilities under
the Medicaid program, including under waivers authorized
under section 1115 or 1915 of the Social Security Act
(42 U.S.C. 1315, 1396n), for States to receive Federal
Medicaid funding for the provision of substance use
disorder treatment for pregnant and postpartum women and
parents and guardians and, to the extent applicable,
their children, in family-focused residential treatment
programs.
[[Page 132 STAT. 4098]]
(B) How States can employ and coordinate funding
provided under the Medicaid program, the title IV-E
program, and other programs administered by the
Secretary to support the provision of treatment and
services provided by a family-focused residential
treatment facility such as substance use disorder
treatment and services, including medication-assisted
treatment, family, group, and individual counseling,
case management, parenting education and skills
development, the provision, assessment, or coordination
of care and services for children, including necessary
assessments and appropriate interventions, non-emergency
transportation for necessary care provided at or away
from a program site, transitional services and supports
for families leaving treatment, and other services.
(C) How States can employ and coordinate funding
provided under the Medicaid program and the title IV-E
program (including as amended by the Family First
Prevention Services Act enacted under title VII of
division E of Public Law 115-123, and particularly with
respect to the authority under subsections (a)(2)(C) and
(j) of section 472 and section 474(a)(1) of the Social
Security Act (42 U.S.C. 672, 674(a)(1)) (as amended by
section 50712 of Public Law 115-123) to provide foster
care maintenance payments for a child placed with a
parent who is receiving treatment in a licensed
residential family-based treatment facility for a
substance use disorder) to support placing children with
their parents in family-focused residential treatment
programs.
SEC. 8082. IMPROVING RECOVERY AND REUNIFYING FAMILIES.
(a) Family Recovery and Reunification Program Replication Project.--
Section 435 of the Social Security Act (42 U.S.C. 629e) is amended by
adding at the end the following:
``(e) Family Recovery and Reunification Program Replication
Project.--
``(1) Purpose.--The purpose of this subsection is to provide
resources to the Secretary to support the conduct and evaluation
of a family recovery and reunification program replication
project (referred to in this subsection as the `project') and to
determine the extent to which such programs may be appropriate
for use at different intervention points (such as when a child
is at risk of entering foster care or when a child is living
with a guardian while a parent is in treatment). The family
recovery and reunification program conducted under the project
shall use a recovery coach model that is designed to help
reunify families and protect children by working with parents or
guardians with a substance use disorder who have temporarily
lost custody of their children.
``(2) Program components.--The family recovery and
reunification program conducted under the project shall adhere
closely to the elements and protocol determined to be most
effective in other recovery coaching programs that have been
rigorously evaluated and shown to increase family reunification
and protect children and, consistent with such elements and
protocol, shall provide such items and services as--
``(A) assessments to evaluate the needs of the
parent or guardian;
[[Page 132 STAT. 4099]]
``(B) assistance in receiving the appropriate
benefits to aid the parent or guardian in recovery;
``(C) services to assist the parent or guardian in
prioritizing issues identified in assessments,
establishing goals for resolving such issues that are
consistent with the goals of the treatment provider,
child welfare agency, courts, and other agencies
involved with the parent or guardian or their children,
and making a coordinated plan for achieving such goals;
``(D) home visiting services coordinated with the
child welfare agency and treatment provider involved
with the parent or guardian or their children;
``(E) case management services to remove barriers
for the parent or guardian to participate and continue
in treatment, as well as to re-engage a parent or
guardian who is not participating or progressing in
treatment;
``(F) access to services needed to monitor the
parent's or guardian's compliance with program
requirements;
``(G) frequent reporting between the treatment
provider, child welfare agency, courts, and other
agencies involved with the parent or guardian or their
children to ensure appropriate information on the
parent's or guardian's status is available to inform
decision-making; and
``(H) assessments and recommendations provided by a
recovery coach to the child welfare caseworker
responsible for documenting the parent's or guardian's
progress in treatment and recovery as well as the status
of other areas identified in the treatment plan for the
parent or guardian, including a recommendation regarding
the expected safety of the child if the child is
returned to the custody of the parent or guardian that
can be used by the caseworker and a court to make
permanency decisions regarding the child.
``(3) Responsibilities of the secretary.--
``(A) In general.--The Secretary shall, through a
grant or contract with 1 or more entities, conduct and
evaluate the family recovery and reunification program
under the project.
``(B) Requirements.--In identifying 1 or more
entities to conduct the evaluation of the family
recovery and reunification program, the Secretary
shall--
``(i) determine that the area or areas in
which the program will be conducted have
sufficient substance use disorder treatment
providers and other resources (other than those
provided with funds made available to carry out
the project) to successfully conduct the program;
``(ii) determine that the area or areas in
which the program will be conducted have enough
potential program participants, and will serve a
sufficient number of parents or guardians and
their children, so as to allow for the formation
of a control group, evaluation results to be
adequately powered, and preliminary results of the
evaluation to be available within 4 years of the
program's implementation;
``(iii) provide the entity or entities with
technical assistance for the program design,
including by
[[Page 132 STAT. 4100]]
working with 1 or more entities that are or have
been involved in recovery coaching programs that
have been rigorously evaluated and shown to
increase family reunification and protect children
so as to make sure the program conducted under the
project adheres closely to the elements and
protocol determined to be most effective in such
other recovery coaching programs;
``(iv) assist the entity or entities in
securing adequate coaching, treatment, child
welfare, court, and other resources needed to
successfully conduct the family recovery and
reunification program under the project; and
``(v) ensure the entity or entities will be
able to monitor the impacts of the program in the
area or areas in which it is conducted for at
least 5 years after parents or guardians and their
children are randomly assigned to participate in
the program or to be part of the program's control
group.
``(4) Evaluation requirements.--
``(A) In general.--The Secretary, in consultation
with the entity or entities conducting the family
recovery and reunification program under the project,
shall conduct an evaluation to determine whether the
program has been implemented effectively and resulted in
improvements for children and families. The evaluation
shall have 3 components: a pilot phase, an impact study,
and an implementation study.
``(B) Pilot phase.--The pilot phase component of the
evaluation shall consist of the Secretary providing
technical assistance to the entity or entities
conducting the family recovery and reunification program
under the project to ensure--
``(i) the program's implementation adheres
closely to the elements and protocol determined to
be most effective in other recovery coaching
programs that have been rigorously evaluated and
shown to increase family reunification and protect
children; and
``(ii) random assignment of parents or
guardians and their children to be participants in
the program or to be part of the program's control
group is being carried out.
``(C) Impact study.--The impact study component of
the evaluation shall determine the impacts of the family
recovery and reunification program conducted under the
project on the parents and guardians and their children
participating in the program. The impact study component
shall--
``(i) be conducted using an experimental
design that uses a random assignment research
methodology;
``(ii) consistent with previous studies of
other recovery coaching programs that have been
rigorously evaluated and shown to increase family
reunification and protect children, measure
outcomes for parents and guardians and their
children over multiple time periods, including for
a period of 5 years; and
[[Page 132 STAT. 4101]]
``(iii) include measurements of family
stability and parent, guardian, and child safety
for program participants and the program control
group that are consistent with measurements of
such factors for participants and control groups
from previous studies of other recovery coaching
programs so as to allow results of the impact
study to be compared with the results of such
prior studies, including with respect to
comparisons between program participants and the
program control group regarding--
``(I) safe family reunification;
``(II) time to reunification;
``(III) permanency (such as through
measures of reunification, adoption, or
placement with guardians);
``(IV) safety (such as through
measures of subsequent maltreatment);
``(V) parental or guardian treatment
persistence and engagement;
``(VI) parental or guardian
substance use;
``(VII) juvenile delinquency;
``(VIII) cost; and
``(IX) other measurements agreed
upon by the Secretary and the entity or
entities operating the family recovery
and reunification program under the
project.
``(D) Implementation study.--The implementation
study component of the evaluation shall be conducted
concurrently with the conduct of the impact study
component and shall include, in addition to such other
information as the Secretary may determine, descriptions
and analyses of--
``(i) the adherence of the family recovery and
reunification program conducted under the project
to other recovery coaching programs that have been
rigorously evaluated and shown to increase family
reunification and protect children; and
``(ii) the difference in services received or
proposed to be received by the program
participants and the program control group.
``(E) Report.--The Secretary shall publish on an
internet website maintained by the Secretary the
following information:
``(i) A report on the pilot phase component of
the evaluation.
``(ii) A report on the impact study component
of the evaluation.
``(iii) A report on the implementation study
component of the evaluation.
``(iv) A report that includes--
``(I) analyses of the extent to
which the program has resulted in
increased reunifications, increased
permanency, case closures, net savings
to the State or States involved (taking
into account both costs borne by States
and the Federal government), or other
outcomes, or if the program did not
produce such outcomes, an analysis of
why
[[Page 132 STAT. 4102]]
the replication of the program did not
yield such results;
``(II) if, based on such analyses,
the Secretary determines the program
should be replicated, a replication
plan; and
``(III) such recommendations for
legislation and administrative action as
the Secretary determines appropriate.
``(5) Appropriation.--In addition to any amounts otherwise
made available to carry out this subpart, out of any money in
the Treasury of the United States not otherwise appropriated,
there are appropriated $15,000,000 for fiscal year 2019 to carry
out the project, which shall remain available through fiscal
year 2026.''.
(b) Clarification of Payer of Last Resort Application to Child
Welfare Prevention and Family Services.--Section 471(e)(10) of the
Social Security Act (42 U.S.C. 671(e)(10)), as added by section
50711(a)(2) of division E of Public Law 115-123, is amended--
(1) in subparagraph (A), by inserting ``, nor shall the
provision of such services or programs be construed to permit
the State to reduce medical or other assistance available to a
recipient of such services or programs'' after ``under this
Act''; and
(2) by adding at the end the following:
``(C) Payer of last resort.--In carrying out its
responsibilities to ensure access to services or
programs under this subsection, the State agency shall
not be considered to be a legally liable third party for
purposes of satisfying a financial commitment for the
cost of providing such services or programs with respect
to any individual for whom such cost would have been
paid for from another public or private source but for
the enactment of this subsection (except that whenever
considered necessary to prevent a delay in the receipt
of appropriate early intervention services by a child or
family in a timely fashion, funds provided under section
474(a)(6) may be used to pay the provider of services or
programs pending reimbursement from the public or
private source that has ultimate responsibility for the
payment).''.
(c) <<NOTE: 42 USC 671 note.>> Effective Date.--The amendments made
by subsection (b) shall take effect as if included in section 50711 of
division E of Public Law 115-123.
SEC. 8083. <<NOTE: 42 USC 290bb-11.>> BUILDING CAPACITY FOR
FAMILY-FOCUSED RESIDENTIAL TREATMENT.
(a) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means a
State, county, local, or tribal health or child welfare agency,
a private nonprofit organization, a research organization, a
treatment service provider, an institution of higher education
(as defined under section 101 of the Higher Education Act of
1965 (20 U.S.C. 1001)), or another entity specified by the
Secretary.
(2) Family-focused residential treatment program.--The term
``family-focused residential treatment program'' means a trauma-
informed residential program primarily for substance
[[Page 132 STAT. 4103]]
use disorder treatment for pregnant and postpartum women and
parents and guardians that allows children to reside with such
women or their parents or guardians during treatment to the
extent appropriate and applicable.
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(b) Support for the Development of Evidence-based Family-focused
Residential Treatment Programs.--
(1) Authority to award grants.--The Secretary shall award
grants to eligible entities for purposes of developing,
enhancing, or evaluating family-focused residential treatment
programs to increase the availability of such programs that meet
the requirements for promising, supported, or well-supported
practices specified in section 471(e)(4)(C) of the Social
Security Act (42 U.S.C. 671(e)(4)(C))) (as added by the Family
First Prevention Services Act enacted under title VII of
division E of Public Law 115-123).
(2) Evaluation requirement.--The Secretary shall require any
evaluation of a family-focused residential treatment program by
an eligible entity that uses funds awarded under this section
for all or part of the costs of the evaluation be designed to
assist in the determination of whether the program may qualify
as a promising, supported, or well-supported practice in
accordance with the requirements of such section 471(e)(4)(C).
(c) Authorization of Appropriations.--There is authorized to be
appropriated to the Secretary to carry out this section, $20,000,000 for
fiscal year 2019, which shall remain available through fiscal year 2023.
Subtitle <<NOTE: Reauthorizing and Extending Grants for Recovery from
Opioid Use Programs Act of 2018.>> H--Reauthorizing and Extending
Grants for Recovery From Opioid Use Programs
SEC. 8091. <<NOTE: 34 USC 10101 note.>> SHORT TITLE.
This subtitle may be cited as the ``Reauthorizing and Extending
Grants for Recovery from Opioid Use Programs Act of 2018'' or the
``REGROUP Act of 2018''.
SEC. 8092. REAUTHORIZATION OF THE COMPREHENSIVE OPIOID ABUSE GRANT
PROGRAM.
Section 1001(a)(27) of the Omnibus Crime Control and Safe Streets
Act of 1968 (34 U.S.C. 10261(a)(27)) is amended by striking ``through
2021'' and inserting ``and 2018, and $330,000,000 for each of fiscal
years 2019 through 2023''.
Subtitle <<NOTE: Fighting Opioid Abuse in Transportation Act.>> I--
Fighting Opioid Abuse in Transportation
SEC. 8101. <<NOTE: 49 USC 101 note.>> SHORT TITLE.
This subtitle may be cited as the ``Fighting Opioid Abuse in
Transportation Act''.
[[Page 132 STAT. 4104]]
SEC. 8102. <<NOTE: 49 USC 20140 note.>> ALCOHOL AND CONTROLLED
SUBSTANCE TESTING OF MECHANICAL
EMPLOYEES.
(a) In General.--Not later than 2 years after the date of enactment
of this Act, the Secretary of Transportation shall publish a rule in the
Federal Register revising the regulations promulgated under section
20140 of title 49, United States Code, to cover all employees of
railroad carriers who perform mechanical activities.
(b) Definition of Mechanical Activities.--For the purposes of the
rule under subsection (a), the Secretary shall define the term
``mechanical activities'' by regulation.
SEC. 8103. <<NOTE: 49 USC 329 note.>> DEPARTMENT OF
TRANSPORTATION PUBLIC DRUG AND ALCOHOL
TESTING DATABASE.
(a) In General.--Subject to subsection (c), the Secretary of
Transportation shall--
(1) not later than March 31, 2019, establish and make
publicly available on its website a database of the drug and
alcohol testing data reported by employers for each mode of
transportation; and
(2) update the database annually.
(b) Contents.--The database under subsection (a) shall include, for
each mode of transportation--
(1) the total number of drug and alcohol tests by type of
substance tested;
(2) the drug and alcohol test results by type of substance
tested;
(3) the reason for the drug or alcohol test, such as pre-
employment, random, post-accident, reasonable suspicion or
cause, return-to-duty, or follow-up, by type of substance
tested; and
(4) the number of individuals who refused testing.
(c) Commercially Sensitive Data.--The Department of Transportation
shall not release any commercially sensitive data or personally
identifiable data furnished by an employer under this section unless the
data is aggregated or otherwise in a form that does not identify the
employer providing the data.
(d) Savings Clause.--Nothing in this section may be construed as
limiting or otherwise affecting the requirements of the Secretary of
Transportation to adhere to requirements applicable to confidential
business information and sensitive security information, consistent with
applicable law.
SEC. 8104. GAO REPORT ON DEPARTMENT OF TRANSPORTATION'S COLLECTION
AND USE OF DRUG AND ALCOHOL TESTING
DATA.
(a) In General.--Not later than 2 years after the date the
Department of Transportation public drug and alcohol testing database is
established under section 8103, the Comptroller General of the United
States shall--
(1) review the Department of Transportation Drug and Alcohol
Testing Management Information System; and
(2) submit to the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on Transportation
and Infrastructure of the House of Representatives a report on
the review, including recommendations under subsection (c).
(b) Contents.--The report under subsection (a) shall include--
[[Page 132 STAT. 4105]]
(1) a description of the process the Department of
Transportation uses to collect and record drug and alcohol
testing data submitted by employers for each mode of
transportation;
(2) an assessment of whether and, if so, how the Department
of Transportation uses the data described in paragraph (1) in
carrying out its responsibilities; and
(3) an assessment of the Department of Transportation public
drug and alcohol testing database under section 8103.
(c) Recommendations.--The report under subsection (a) may include
recommendations regarding--
(1) how the Department of Transportation can best use the
data described in subsection (b)(1);
(2) any improvements that could be made to the process
described in subsection (b)(1);
(3) whether and, if so, how the Department of Transportation
public drug and alcohol testing database under section 8103
could be made more effective; and
(4) such other recommendations as the Comptroller General
considers appropriate.
SEC. 8105. <<NOTE: 5 USC 7301 note.>> TRANSPORTATION WORKPLACE
DRUG AND ALCOHOL TESTING PROGRAM;
ADDITION OF FENTANYL AND OTHER
SUBSTANCES.
(a) Mandatory Guidelines for Federal Workplace Drug Testing
Programs.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall--
(A) determine whether a revision of the Mandatory
Guidelines for Federal Workplace Drug Testing Programs
to expand the opiate category on the list of authorized
substance testing to include fentanyl is justified,
based on the reliability and cost-effectiveness of
available testing; and
(B) consider whether to include with the
determination under subparagraph (A) a separate
determination on whether a revision of the Mandatory
Guidelines for Federal Workplace Drug Testing Programs
to expand the list of substances authorized for testing
to include any other drugs or other substances listed in
schedule I and II of section 202 of the Controlled
Substances Act (21 U.S.C. 812) is justified based on the
criteria described in subparagraph (A).
(2) Revision of guidelines.--If an expansion of the
substance list is determined to be justified under paragraph
(1), the Secretary of Health and Human Services shall--
(A) notify the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on
Transportation and Infrastructure of the House of
Representatives of the determination; and
(B) publish in the Federal Register, not later than
18 months after the date of the determination under that
paragraph, a final notice of the revision of the
Mandatory Guidelines for Federal Workplace Drug Testing
Programs to expand the list of substances authorized to
be tested to include the substance or substances
determined to be justified for inclusion.
[[Page 132 STAT. 4106]]
(3) Report.--If an expansion of the substance list is
determined not to be justified under paragraph (1), the
Secretary of Health and Human Services shall submit to the
Committee on Commerce, Science, and Transportation of the Senate
and the Committee on Transportation and Infrastructure of the
House of Representatives a report explaining, in detail, the
reasons the expansion of the list of authorized substances is
not justified.
(b) Department of Transportation Drug-testing Panel.--If an
expansion is determined to be justified under subsection (a)(1), the
Secretary of Transportation shall publish in the Federal Register, not
later than 18 months after the date the final notice is published under
subsection (a)(2), a final rule revising part 40 of title 49, Code of
Federal Regulations, to include such substances in the Department of
Transportation's drug-testing panel, consistent with the Mandatory
Guidelines for Federal Workplace Drug Testing Programs as revised by the
Secretary of Health and Human Services under subsection (a).
(c) Savings Provision.--Nothing in this section may be construed
as--
(1) delaying the publication of the notices described in
sections 8106 and 8107 of this Act until the Secretary of Health
and Human Services makes a determination or publishes a notice
under this section; or
(2) limiting or otherwise affecting any authority of the
Secretary of Health and Human Services or the Secretary of
Transportation to expand the list of authorized substance
testing to include an additional substance.
SEC. 8106. <<NOTE: 49 USC 31306 note.>> STATUS REPORTS ON HAIR
TESTING GUIDELINES.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, and annually thereafter until the date that the Secretary
of Health and Human Services publishes in the Federal Register a final
notice of scientific and technical guidelines for hair testing in
accordance with section 5402(b) of the Fixing America's Surface
Transportation Act (Public Law 114-94; 129 Stat. 1312), the Secretary of
Health and Human Services shall submit to the Committee on Commerce,
Science, and Transportation of the Senate and the Committee on
Transportation and Infrastructure of the House of Representatives a
report on--
(1) the status of the hair testing guidelines;
(2) an explanation for why the hair testing guidelines have
not been issued; and
(3) an estimated date of completion of the hair testing
guidelines.
(b) Requirement.--To the extent practicable and consistent with the
objective of the hair testing described in subsection (a) to detect
illegal or unauthorized use of substances by the individual being
tested, the final notice of scientific and technical guidelines under
that subsection, as determined by the Secretary of Health and Human
Services, shall eliminate the risk of positive test results, of the
individual being tested, caused solely by the drug use of others and not
caused by the drug use of the individual being tested.
[[Page 132 STAT. 4107]]
SEC. 8107. <<NOTE: 5 USC 7301 note.>> MANDATORY GUIDELINES FOR
FEDERAL WORKPLACE DRUG TESTING PROGRAMS
USING ORAL FLUID.
(a) Deadline.--Not later than December 31, 2018, the Secretary of
Health and Human Services shall publish in the Federal Register a final
notice of the Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Oral Fluid, based on the notice of proposed mandatory
guidelines published in the Federal Register on May 15, 2015 (94 FR
28054).
(b) Requirement.--To the extent practicable and consistent with the
objective of the testing described in subsection (a) to detect illegal
or unauthorized use of substances by the individual being tested, the
final notice of scientific and technical guidelines under that
subsection, as determined by the Secretary of Health and Human Services,
shall eliminate the risk of positive test results, of the individual
being tested, caused solely by the drug use of others and not caused by
the drug use of the individual being tested.
(c) Rule of Construction.--Nothing in this section may be construed
as requiring the Secretary of Health and Human Services to reissue a
notice of proposed mandatory guidelines to carry out subsection (a).
SEC. 8108. <<NOTE: 5 USC 7301 note.>> ELECTRONIC RECORDKEEPING.
(a) Deadline.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall--
(1) ensure that each certified laboratory that requests
approval for the use of completely paperless electronic Federal
Drug Testing Custody and Control Forms from the National
Laboratory Certification Program's Electronic Custody and
Control Form systems receives approval for those completely
paperless electronic forms instead of forms that include any
combination of electronic traditional handwritten signatures
executed on paper forms; and
(2) establish a deadline for a certified laboratory to
request approval under paragraph (1).
(b) Savings Clause.--Nothing in this section may be construed as
limiting or otherwise affecting any authority of the Secretary of Health
and Human Services to grant approval to a certified laboratory for use
of completely paperless electronic Federal Drug Testing Custody and
Control Forms, including to grant approval outside of the process under
subsection (a).
(c) <<NOTE: 49 USC 322 note.>> Electronic Signatures.--Not later
than 18 months after the date of the deadline under subsection (a)(2),
the Secretary of Transportation shall issue a final rule revising part
40 of title 49, Code of Federal Regulations, to authorize, to the extent
practicable, the use of electronic signatures or digital signatures
executed to electronic forms instead of traditional handwritten
signatures executed on paper forms.
SEC. 8109. STATUS REPORTS ON COMMERCIAL DRIVER'S LICENSE DRUG AND
ALCOHOL CLEARINGHOUSE.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, and annually thereafter until the compliance date, the
Administrator of the Federal Motor Carrier Safety Administration shall
submit to the Committee on Commerce, Science, and Transportation of the
Senate and the Committee on
[[Page 132 STAT. 4108]]
Transportation and Infrastructure of the House of Representatives a
status report on implementation of the final rule for the Commercial
Driver's License Drug and Alcohol Clearinghouse (81 FR 87686),
including--
(1) an updated schedule, including benchmarks, for
implementing the final rule as soon as practicable, but not
later than the compliance date; and
(2) a description of each action the Federal Motor Carrier
Safety Administration is taking to implement the final rule
before the compliance date.
(b) Definition of Compliance Date.--In this section, the term
``compliance date'' means the earlier of--
(1) January 6, 2020; or
(2) the date that the national clearinghouse required under
section 31306a of title 49, United States Code, is operational.
Subtitle <<NOTE: Eliminating Kickbacks in Recovery Act of 2018.>> J--
Eliminating Kickbacks in Recovery
SEC. 8121. <<NOTE: 18 USC 1 note.>> SHORT TITLE.
This subtitle may be cited as the ``Eliminating Kickbacks in
Recovery Act of 2018''.
SEC. 8122. CRIMINAL PENALTIES.
(a) In General.--Chapter 11 of title 18, United States Code, is
amended by inserting after section 219 the following:
``Sec. 220. <<NOTE: 18 USC 220.>> Illegal remunerations for
referrals to recovery homes, clinical treatment
facilities, and laboratories
``(a) Offense.--Except as provided in subsection (b), whoever, with
respect to services covered by a health care benefit program, in or
affecting interstate or foreign commerce, knowingly and willfully--
``(1) solicits or receives any remuneration (including any
kickback, bribe, or rebate) directly or indirectly, overtly or
covertly, in cash or in kind, in return for referring a patient
or patronage to a recovery home, clinical treatment facility, or
laboratory; or
``(2) pays or offers any remuneration (including any
kickback, bribe, or rebate) directly or indirectly, overtly or
covertly, in cash or in kind--
``(A) to induce a referral of an individual to a
recovery home, clinical treatment facility, or
laboratory; or
``(B) in exchange for an individual using the
services of that recovery home, clinical treatment
facility, or laboratory,
shall be fined not more than $200,000, imprisoned not more than 10
years, or both, for each occurrence.
``(b) Applicability.--Subsection (a) shall not apply to--
``(1) a discount or other reduction in price obtained by a
provider of services or other entity under a health care benefit
program if the reduction in price is properly disclosed and
appropriately reflected in the costs claimed or charges made by
the provider or entity;
``(2) a payment made by an employer to an employee or
independent contractor (who has a bona fide employment or
[[Page 132 STAT. 4109]]
contractual relationship with such employer) for employment, if
the employee's payment is not determined by or does not vary
by--
``(A) the number of individuals referred to a
particular recovery home, clinical treatment facility,
or laboratory;
``(B) the number of tests or procedures performed;
or
``(C) the amount billed to or received from, in part
or in whole, the health care benefit program from the
individuals referred to a particular recovery home,
clinical treatment facility, or laboratory;
``(3) a discount in the price of an applicable drug of a
manufacturer that is furnished to an applicable beneficiary
under the Medicare coverage gap discount program under section
1860D-14A(g) of the Social Security Act (42 U.S.C. 1395w-
114a(g));
``(4) a payment made by a principal to an agent as
compensation for the services of the agent under a personal
services and management contract that meets the requirements of
section 1001.952(d) of title 42, Code of Federal Regulations, as
in effect on the date of enactment of this section;
``(5) a waiver or discount (as defined in section
1001.952(h)(5) of title 42, Code of Federal Regulations, or any
successor regulation) of any coinsurance or copayment by a
health care benefit program if--
``(A) the waiver or discount is not routinely
provided; and
``(B) the waiver or discount is provided in good
faith;
``(6) a remuneration described in section 1128B(b)(3)(I) of
the Social Security Act (42 U.S.C. 1320a-7b(b)(3)(I));
``(7) a remuneration made pursuant to an alternative payment
model (as defined in section 1833(z)(3)(C) of the Social
Security Act) or pursuant to a payment arrangement used by a
State, health insurance issuer, or group health plan if the
Secretary of Health and Human Services has determined that such
arrangement is necessary for care coordination or value-based
care; or
``(8) any other payment, remuneration, discount, or
reduction as determined by the Attorney General, in consultation
with the Secretary of Health and Human Services, by regulation.
``(c) Regulations.--The Attorney General, in consultation with the
Secretary of Health and Human Services, may promulgate regulations to
clarify the exceptions described in subsection (b).
``(d) Preemption.--
``(1) Federal law.--This section shall not apply to conduct
that is prohibited under section 1128B of the Social Security
Act (42 U.S.C. 1320a-7b).
``(2) State law.--Nothing in this section shall be construed
to occupy the field in which any provisions of this section
operate to the exclusion of State laws on the same subject
matter.
``(e) Definitions.--In this section--
``(1) the terms `applicable beneficiary' and `applicable
drug' have the meanings given those terms in section 1860D-
14A(g) of the Social Security Act (42 U.S.C. 1395w-114a(g));
``(2) the term `clinical treatment facility' means a medical
setting , other than a hospital, that provides detoxification,
[[Page 132 STAT. 4110]]
risk reduction, outpatient treatment and care, residential
treatment, or rehabilitation for substance use, pursuant to
licensure or certification under State law;
``(3) the term `health care benefit program' has the meaning
given the term in section 24(b);
``(4) the term `laboratory' has the meaning given the term
in section 353 of the Public Health Service Act (42 U.S.C.
263a); and
``(5) the term `recovery home' means a shared living
environment that is, or purports to be, free from alcohol and
illicit drug use and centered on peer support and connection to
services that promote sustained recovery from substance use
disorders.''.
(b) Clerical Amendment.--The table of sections for chapter 11 of
title 18, United States Code, <<NOTE: 18 USC 201 prec.>> is amended by
inserting after the item related to section 219 the following:
``220. Illegal remunerations for referrals to recovery homes, clinical
treatment facilities, and laboratories.''.
Subtitle <<NOTE: Substance Abuse Prevention Act of 2018. 21 USC 1701
note.>> K--Substance Abuse Prevention
SEC. 8201. SHORT TITLE.
This subtitle may be cited as the ``Substance Abuse Prevention Act
of 2018''.
SEC. 8202. REAUTHORIZATION OF THE OFFICE OF NATIONAL DRUG CONTROL
POLICY.
(a) Office of National Drug Control Policy Reauthorization Act of
1998.--
(1) In general.--The Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.), as in
effect on September 29, 2003, and as amended by the laws
described in paragraph (2), <<NOTE: 21 USC 1701 and note, 1702-
1708, 1710-1712, 1714.>> is revived and restored.
(2) Laws described.--The laws described in this paragraph
are:
(A) The Office of National Drug Control Policy
Reauthorization Act of 2006 (Public Law 109-469; 120
Stat. 3502).
(B) The Presidential Appointment Efficiency and
Streamlining Act of 2011 (Public Law 112-166; 126 Stat.
1283).
(b) Reauthorization.--
(1) In general.--Section 714 of the Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1711) is
amended by striking ``such sums as may be necessary for each of
fiscal years 2006 through 2010'' and inserting ``$18,400,000 for
each of fiscal years 2018 through 2023''.
(2) Repeal of termination.--The Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et
seq.) is amended by striking section 715 (21 U.S.C. 1712).
SEC. 8203. REAUTHORIZATION OF THE DRUG-FREE COMMUNITIES PROGRAM.
(a) Revival of National Narcotics Leadership Act of 1988.--
[[Page 132 STAT. 4111]]
(1) In general.--Chapter 2 of the National Narcotics
Leadership Act of 1988 (21 U.S.C. 1521 et seq.), except for
subchapter II (21 U.S.C. 1541 et seq.), as in effect on
September 29, 1997, and as amended by the laws described in
paragraph (2), is revived <<NOTE: 21 USC 1521 note. 21 USC 1521
note.>> and restored.
(2) Laws described.--The laws described in this paragraph
are:
(A) Public Law 107-82 (115 Stat. 814).
(B) The Office of National Drug Control Policy
Reauthorization Act of 2006 (Public Law 109-469: 120
Stat. 3502), as amended by paragraph (4).
(3) Amendment to termination provision.--Section 1009 of the
National Narcotics Leadership Act of 1988 (21 U.S.C. 1056) is
amended <<NOTE: 21 USC 1506.>> by inserting ``and sections 1021
through 1035'' after ``section 1007''.
(4) Technical correction.--
(A) In general.--Title VIII of the Office of
National Drug Control Policy Reauthorization Act of 2006
(Public Law 109-469; 120 Stat. 3535) <<NOTE: 21 USC
1524, 1532 and note.>> is amended by striking ``Drug-
Free Communities Act of 1997'' each place it appears and
inserting ``National Narcotics Leadership Act of 1988''.
(B) <<NOTE: 21 USC 1524 note.>> Effective date.--
The amendments made by subparagraph (A) shall take
effect as though enacted as part of the Office of
National Drug Control Policy Reauthorization Act of 2006
(Public Law 109-469; 120 Stat. 3502).
(b) Amendment to National Narcotics Leadership Act of 1988.--Chapter
2 of subtitle A of title I of the National Narcotics Leadership Act of
1988 (21 U.S.C. 1521 et seq.) is amended--
(1) in section 1022 (21 U.S.C. 1522), by striking
``substance abuse'' each place it appears and inserting
``substance use and misuse'';
(2) in section 1023 (21 U.S.C. 1523), by striking paragraph
(9) and inserting the following:
``(9) Substance use and misuse.--The term `substance use and
misuse' means--
``(A) the illegal use or misuse of drugs, including
substances for which a listing is effect under any of
schedules I through V under section 202 of the
Controlled Substances Act (21 U.S.C. 812);
``(B) the misuse of inhalants or over-the-counter
drugs; or
``(C) the use of alcohol, tobacco, or other related
product as such use is prohibited by State or local
law.'';
(3) in section 1024 (21 U.S.C. 1524), by striking
subsections (a) and (b) and inserting the following:
``(a) In General.--There is authorized to be appropriated to the
Office of National Drug Control Policy to carry out this chapter
$99,000,000 for each of fiscal years 2018 through 2023.
``(b) Administrative Costs.--Not more than 8 percent of the funds
appropriated to carry out this chapter may be used by the Office of
National Drug Control Policy to pay administrative costs associated with
the responsibilities of the Office under this chapter.'';
(4) in subchapter I (21 U.S.C. 1531 et seq.)--
(A) <<NOTE: 21 USC 1531-1533, 1535.>> by striking
``substance abuse'' each place it appears and inserting
``substance use and misuse''; and
[[Page 132 STAT. 4112]]
(B) in section 1032(b)(1)(A) (21 U.S.C.
1532(b)(1)(A)), by striking clause (iii) and inserting
the following:
``(iii) Renewal grants.--Subject to clause
(iv), the Administrator may award a renewal grant
to a grant recipient under this subparagraph for
each fiscal year of the 4-fiscal-year period
following the first fiscal year for which the
initial additional grant is awarded in an amount
not to exceed the following:
``(I) For the first and second
fiscal years of the 4-fiscal-year
period, the amount of the non-Federal
funds, including in-kind contributions,
raised by the coalition for the
applicable fiscal year is not less than
125 percent of the amount awarded.
``(II) For the third and fourth
fiscal tears of the 4-fiscal-year
period, the amount of the non-Federal
funds, including in-kind contributions,
raised by the coalition for the
applicable fiscal year is not less than
150 percent of the amount awarded.'';
and
(5) <<NOTE: 21 USC 1541-1548.>> by striking subchapter II
(21 U.S.C. 1541 et seq.).
SEC. 8204. REAUTHORIZATION OF THE NATIONAL COMMUNITY ANTI-DRUG
COALITION INSTITUTE.
Section 4 of Public Law 107-82 (21 U.S.C. 1521 note) is amended to
read as follows:
``SEC. 4. AUTHORIZATION FOR NATIONAL COMMUNITY ANTIDRUG COALITION
INSTITUTE.
``(a) In General.--The Director shall, using amounts authorized to
be appropriated by subsection (d), make a competitive grant to provide
for the continuation of the National Community Anti-drug Coalition
Institute.
``(b) Eligible Organizations.--An organization eligible for the
grant under subsection (a) is any national nonprofit organization that
represents, provides technical assistance and training to, and has
special expertise and broad, national-level experience in community
antidrug coalitions under this subchapter.
``(c) Use of Grant Amount.--The organization that receives the grant
under subsection (a) shall continue a National Community Anti-Drug
Coalition Institute to--
``(1) provide education, training, and technical assistance
for coalition leaders and community teams, with emphasis on the
development of coalitions serving economically disadvantaged
areas;
``(2) develop and disseminate evaluation tools, mechanisms,
and measures to better assess and document coalition performance
measures and outcomes; and
``(3) bridge the gap between research and practice by
translating knowledge from research into practical information.
``(d) Authorization of Appropriations.--The Director shall, using
amounts authorized to be appropriated by section 1032 of the National
Narcotics Leadership Act of 1988 (15 U.S.C. 1532), make a grant of $2
million under subsection (a), for each of the fiscal years 2018 through
2023.''.
[[Page 132 STAT. 4113]]
SEC. 8205. REAUTHORIZATION OF THE HIGH-INTENSITY DRUG TRAFFICKING
AREA PROGRAM.
Section 707 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1706) is amended--
(1) in subsection (f), by striking ``no Federal'' and all
that follows through ``programs.'' and inserting the following:
``not more than a total of 5 percent of Federal funds
appropriated for the Program are expended for substance use
disorder treatment programs and drug prevention programs.'';
(2) in subsection (p)--
(A) in paragraph (4), by striking ``and'' at the
end;
(B) in paragraph (5), by striking the period at the
end and inserting ``; and''; and
(C) by adding at the end the following:
``(6) $280,000,000 for each of fiscal years 2018 through
2023.''; and
(3) in subsection (q)--
(A) by striking paragraph (2) and inserting the
following:
``(2) Required uses.--The funds used under paragraph (1)
shall be used to ensure the safety of neighborhoods and the
protection of communities, including the prevention of the
intimidation of witnesses of illegal drug distribution and
related activities and the establishment of, or support for,
programs that provide protection or assistance to witnesses in
court proceedings.''; and
(B) by adding at the end the following:
``(3) Best practice models.--The Director shall work with
HIDTAs to develop and maintain best practice models to assist
State, local, and Tribal governments in addressing witness
safety, relocation, financial and housing assistance, or any
other services related to witness protection or assistance in
cases of illegal drug distribution and related activities. The
Director shall ensure dissemination of the best practice models
to each HIDTA.''.
SEC. 8206. REAUTHORIZATION OF DRUG COURT PROGRAM.
Section 1001(a)(25)(A) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (34 U.S.C. 10261(a)(25)(A)) is amended by
striking ``Except as provided'' and all that follows and inserting the
following: ``Except as provided in subparagraph (C), there is authorized
to be appropriated to carry out part EE $75,000,000 for each of fiscal
years 2018 through 2023.''.
SEC. 8207. DRUG COURT TRAINING AND TECHNICAL ASSISTANCE.
Section 705 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1704) is amended by adding at the
end the following:
``(e) Drug Court Training and Technical Assistance Program.--
``(1) Grants authorized.--The Director may make a grant to a
nonprofit organization for the purpose of providing training and
technical assistance to drug courts.
``(2) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $2,000,000 for
each of fiscal years 2018 through 2023.''.
[[Page 132 STAT. 4114]]
SEC. 8208. DRUG OVERDOSE RESPONSE STRATEGY.
Section 707 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1706) is amended by adding at the
end the following:
``(r) Drug Overdose Response Strategy Implementation.--The Director
may use funds appropriated to carry out this section to implement a drug
overdose response strategy in high intensity drug trafficking areas on a
nationwide basis by--
``(1) coordinating multi-disciplinary efforts to prevent,
reduce, and respond to drug overdoses, including the uniform
reporting of fatal and non-fatal overdoses to public health and
safety officials;
``(2) increasing data sharing among public safety and public
health officials concerning drug-related abuse trends, including
new psychoactive substances, and related crime; and
``(3) enabling collaborative deployment of prevention,
intervention, and enforcement resources to address substance use
addiction and narcotics trafficking.''.
SEC. 8209. PROTECTING LAW ENFORCEMENT OFFICERS FROM ACCIDENTAL
EXPOSURE.
Section 707 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1706), as amended by section
8208, is amended by adding at the end the following:
``(s) Supplemental Grants.--The Director is authorized to use not
more than $10,000,000 of the amounts otherwise appropriated to carry out
this section to provide supplemental competitive grants to high
intensity drug trafficking areas that have experienced high seizures of
fentanyl and new psychoactive substances for the purposes of--
``(1) purchasing portable equipment to test for fentanyl and
other substances;
``(2) training law enforcement officers and other first
responders on best practices for handling fentanyl and other
substances; and
``(3) purchasing protective equipment, including overdose
reversal drugs.''.
SEC. 8210. COPS ANTI-METH PROGRAM.
Section 1701 of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (34 U.S.C. 10381) is amended--
(1) by redesignating subsection (k) as subsection (l); and
(2) by inserting after subsection (j) the following:
``(k) COPS Anti-Meth Program.--The Attorney General shall use
amounts otherwise appropriated to carry out this section for a fiscal
year (beginning with fiscal year 2019) to make competitive grants, in
amounts of not less than $1,000,000 for such fiscal year, to State law
enforcement agencies with high seizures of precursor chemicals, finished
methamphetamine, laboratories, and laboratory dump seizures for the
purpose of locating or investigating illicit activities, such as
precursor diversion, laboratories, or methamphetamine traffickers.''.
SEC. 8211. COPS ANTI-HEROIN TASK FORCE PROGRAM.
Section 1701 of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (34 U.S.C. 10381) is amended--
(1) by redesignating subsection (l), as so redesignated by
section 8210, as subsection (m); and
[[Page 132 STAT. 4115]]
(2) by inserting after subsection (k), as added by section
8210, the following:
``(l) Cops Anti-heroin Task Force Program.--The Attorney General
shall use amounts otherwise appropriated to carry out this section, or
other amounts as appropriated, for a fiscal year (beginning with fiscal
year 2019) to make competitive grants to State law enforcement agencies
in States with high per capita rates of primary treatment admissions,
for the purpose of locating or investigating illicit activities, through
Statewide collaboration, relating to the distribution of heroin,
fentanyl, or carfentanil or relating to the unlawful distribution of
prescription opioids.''.
SEC. 8212. COMPREHENSIVE ADDICTION AND RECOVERY ACT EDUCATION AND
AWARENESS.
Title VII of the Comprehensive Addiction and Recovery Act of 2016
(Public Law 114-198; 130 Stat. 735) is amended by adding at the end the
following:
``SEC. 709. <<NOTE: 42 USC 290ee-9.>> SERVICES FOR FAMILIES AND
PATIENTS IN CRISIS.
``(a) In General.--The Secretary of Health and Human Services may
make grants to entities that focus on addiction and substance use
disorders and specialize in family and patient services, advocacy for
patients and families, and educational information.
``(b) Allowable Uses.--A grant awarded under this section may be
used for nonprofit national, State, or local organizations that engage
in the following activities:
``(1) Expansion of resource center services with
professional, clinical staff that provide, for families and
individuals impacted by a substance use disorder, support,
access to treatment resources, brief assessments, medication and
overdose prevention education, compassionate listening services,
recovery support or peer specialists, bereavement and grief
support, and case management.
``(2) Continued development of health information technology
systems that leverage new and upcoming technology and techniques
for prevention, intervention, and filling resource gaps in
communities that are underserved.
``(3) Enhancement and operation of treatment and recovery
resources, easy-to-read scientific and evidence-based education
on addiction and substance use disorders, and other
informational tools for families and individuals impacted by a
substance use disorder and community stakeholders, such as law
enforcement agencies.
``(4) Provision of training and technical assistance to
State and local governments, law enforcement agencies, health
care systems, research institutions, and other stakeholders.
``(5) Expanding upon and implementing educational
information using evidence-based information on substance use
disorders.
``(6) Expansion of training of community stakeholders, law
enforcement officers, and families across a broad-range of
addiction, health, and related topics on substance use
disorders, local issues and community-specific issues related to
the drug epidemic.
``(7) Program evaluation.''.
[[Page 132 STAT. 4116]]
SEC. 8213. REIMBURSEMENT OF SUBSTANCE USE DISORDER TREATMENT
PROFESSIONALS.
Not later than January 1, 2020, the Comptroller General of the
United States shall submit to Congress a report examining how substance
use disorder services are reimbursed.
SEC. 8214. SOBRIETY TREATMENT AND RECOVERY TEAMS (START).
Title V of the Public Health Service Act (42 U.S.C. 290dd et seq.)
is amended by adding at the end the following:
``SEC. 550. <<NOTE: 42 USC 290ee-10.>> SOBRIETY TREATMENT AND
RECOVERY TEAMS.
``(a) In General.--The Secretary may make grants to States, units of
local government, or tribal governments to establish or expand Sobriety
Treatment And Recovery Team (referred to in this section as `START') or
other similar programs to determine the effectiveness of pairing social
workers or mentors with families that are struggling with a substance
use disorder and child abuse or neglect in order to help provide peer
support, intensive treatment, and child welfare services to such
families.
``(b) Allowable Uses.--A grant awarded under this section may be
used for one or more of the following activities:
``(1) Training eligible staff, including social workers,
social services coordinators, child welfare specialists,
substance use disorder treatment professionals, and mentors.
``(2) Expanding access to substance use disorder treatment
services and drug testing.
``(3) Enhancing data sharing with law enforcement agencies,
child welfare agencies, substance use disorder treatment
providers, judges, and court personnel.
``(4) Program evaluation and technical assistance.
``(c) Program Requirements.--A State, unit of local government, or
tribal government receiving a grant under this section shall--
``(1) serve only families for which--
``(A) there is an open record with the child welfare
agency; and
``(B) substance use disorder was a reason for the
record or finding described in paragraph (1); and
``(2) coordinate any grants awarded under this section with
any grant awarded under section 437(f) of the Social Security
Act focused on improving outcomes for children affected by
substance abuse.
``(d) Technical Assistance.--The Secretary may reserve not more than
5 percent of funds provided under this section to provide technical
assistance on the establishment or expansion of programs funded under
this section from the National Center on Substance Abuse and Child
Welfare.''.
SEC. 8215. PROVIDER EDUCATION.
Not later than 60 days after the date of enactment of this Act, the
Attorney General, in consultation with the Secretary of Health and Human
Services, shall complete the plan related to medical registration
coordination required by Senate Report 114-239, which accompanied the
Veterans Care Financial Protection Act of 2017 (Public Law 115-131; 132
Stat. 334).
[[Page 132 STAT. 4117]]
SEC. 8216. DEFINITIONS.
Section 702 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1701) is amended--
(1) by striking paragraphs (5), (12), and (13);
(2) by redesignating paragraph (11) as paragraph (17);
(3) by redesignating paragraphs (9) and (10) as paragraphs
(14) and (15), respectively;
(4) by redesignating paragraphs (6), (7), and (8) as
paragraphs (10), (11), and (12), respectively;
(5) by redesignating paragraphs (1), (2), (3), and (4) as
paragraphs (3), (4), (5), and (6), respectively;
(6) by inserting before paragraph (3), as so redesignated,
the following:
``(1) Agency.--The term `agency' has the meaning given the
term `executive agency' in section 102 of title 31, United
States Code.
``(2) Appropriate congressional committees.--
``(A) In general.--The term `appropriate
congressional committees' means--
``(i) the Committee on the Judiciary, the
Committee on Appropriations, and the Committee on
Health, Education, Labor, and Pensions of the
Senate; and
``(ii) the Committee on Oversight and
Government Reform, the Committee on the Judiciary,
the Committee on Energy and Commerce, and the
Committee on Appropriations of the House of
Representatives.
``(B) Submission to congress.--Any submission to
Congress shall mean submission to the appropriate
congressional committees.'';
(7) by amending paragraph (3), as so redesignated, to read
as follows:
``(3) Demand reduction.--The term `demand reduction' means
any activity conducted by a National Drug Control Program
Agency, other than an enforcement activity, that is intended to
reduce or prevent the use of drugs or support, expand, or
provide treatment and recovery efforts, including--
``(A) education about the dangers of illicit drug
use;
``(B) services, programs, or strategies to prevent
substance use disorder, including evidence-based
education campaigns, community-based prevention
programs, collection and disposal of unused prescription
drugs, and services to at-risk populations to prevent or
delay initial use of an illicit drug;
``(C) substance use disorder treatment;
``(D) support for long-term recovery from substance
use disorders;
``(E) drug-free workplace programs;
``(F) drug testing, including the testing of
employees;
``(G) interventions for illicit drug use and
dependence;
``(H) expanding availability of access to health
care services for the treatment of substance use
disorders;
``(I) international drug control coordination and
cooperation with respect to activities described in this
paragraph;
``(J) pre- and post-arrest criminal justice
interventions such as diversion programs, drug courts,
and the provision of evidence-based treatment to
individuals with substance
[[Page 132 STAT. 4118]]
use disorders who are arrested or under some form of
criminal justice supervision, including medication
assisted treatment;
``(K) other coordinated and joint initiatives among
Federal, State, local, and Tribal agencies to promote
comprehensive drug control strategies designed to reduce
the demand for, and the availability of, illegal drugs;
``(L) international illicit drug use education,
prevention, treatment, recovery, research,
rehabilitation activities, and interventions for illicit
drug use and dependence; and
``(M) research related to illicit drug use and any
of the activities described in this paragraph.'';
(8) by inserting after paragraph (6), as so redesignated,
the following:
``(7) Emerging drug threat.--The term `emerging drug threat'
means the occurrence of a new and growing trend in the use of an
illicit drug or class of drugs, including rapid expansion in the
supply of or demand for such drug.
``(8) Illicit drug use; illicit drugs; illegal drugs.--The
terms `illicit drug use', `illicit drugs', and `illegal drugs'
include the illegal or illicit use of prescription drugs.
``(9) Law enforcement.--The term `law enforcement' or `drug
law enforcement' means all efforts by a Federal, State, local,
or Tribal government agency to enforce the drug laws of the
United States or any State, including investigation, arrest,
prosecution, and incarceration or other punishments or
penalties.'';
(9) by amending paragraph (11), as so redesignated, to read
as follows:
``(11) National drug control program agency.--The term
`National Drug Control Program Agency' means any agency (or
bureau, office, independent agency, board, division, commission,
subdivision, unit, or other component thereof) that is
responsible for implementing any aspect of the National Drug
Control Strategy, including any agency that receives Federal
funds to implement any aspect of the National Drug Control
Strategy, but does not include any agency that receives funds
for drug control activity solely under the National Intelligence
Program or the Joint Military Intelligence Program.'';
(10) in paragraph (12), as so redesignated--
(A) by inserting ``or `Strategy' '' before
``means''; and
(B) by inserting ``, including any report, plan, or
strategy required to be incorporated into or issued
concurrently with such strategy'' before the period at
the end;
(11) by inserting after paragraph (12), as so redesignated,
the following:
``(13) Nonprofit organization.--The term `nonprofit
organization' means an organization that is described in section
501(c)(3) of the Internal Revenue Code of 1986 and exempt from
tax under section 501(a) of such Code.'';
(12) in paragraph (14), as so redesignated, by striking
``Unless the context clearly indicates otherwise, the'' and
inserting ``The'';
(13) by inserting after paragraph (15), as so redesignated,
the following:
``(16) Substance use disorder treatment.--The term
`substance use disorder treatment' means an evidence-based,
[[Page 132 STAT. 4119]]
professionally directed, deliberate, and planned regimen
including evaluation, observation, medical monitoring, and
rehabilitative services and interventions such as
pharmacotherapy, behavioral therapy, and individual and group
counseling, on an inpatient or outpatient basis, to help
patients with substance use disorder reach recovery.''; and
(14) in paragraph (17), as so redesignated--
(A) by redesignating subparagraphs (B), (C), (D),
and (E), as subparagraphs (C), (D), (E), and (F),
respectively;
(B) by inserting after subparagraph (A) the
following:
``(B) domestic law enforcement;'';
(C) in subparagraph (E), as so redesignated, by
striking ``and'' at the end;
(D) in subparagraph (F), as so redesignated, by
striking the period at the end and inserting a
semicolon; and
(E) by adding at the end the following:
``(G) activities to prevent the diversion of drugs
for their illicit use; and
``(H) research related to any of the activities
described in this paragraph.''.
SEC. 8217. AMENDMENTS TO ADMINISTRATION OF THE OFFICE.
(a) Responsibilities of Office.--Section 703(a) of the Office of
National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C.
1702(a)) is amended--
(1) by striking paragraph (1) and inserting the following:
``(1) lead the national drug control effort, including
coordinating with the National Drug Control Program Agencies;'';
(2) in paragraph (2), by inserting before the semicolon the
following: ``, including the National Drug Control Strategy'';
(3) in paragraph (3), by striking ``and'' at the end; and
(4) by striking paragraph (4) and all that follows through
``the National Academy of Sciences.'' and inserting the
following:
``(4) evaluate the effectiveness of national drug control
policy efforts, including the National Drug Control Program
Agencies' program, by developing and applying specific goals and
performance measurements and monitoring the agencies' program-
level spending;
``(5) identify and respond to emerging drug threats related
to illicit drug use;
``(6) administer the Drug-Free Communities Program, the
High-Intensity Drug Trafficking Areas Program, and other grant
programs directly authorized to be administered by the Office in
furtherance of the National Drug Control Strategy; and
``(7) facilitate broad-scale information sharing and data
standardization among Federal, State, and local entities to
support the national drug control efforts.''.
(b) Ethics Guidelines.--Section 703(d) of the Office of National
Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1702(d)) is
amended by adding at the end the following:
``(4) Ethics guidelines.--The Director shall establish
written guidelines setting forth the criteria to be used in
determining whether a gift or donation should be declined under
this subsection because the acceptance of the gift or donation
would--
[[Page 132 STAT. 4120]]
``(A) reflect unfavorably upon the ability of the
Director or the Office, or any employee of the Office,
to carry out responsibilities or official duties under
this chapter in a fair and objective manner; or
``(B) compromise the integrity or the appearance of
integrity of programs or services provided under this
chapter or of any official involved in those programs or
services.
``(5) Registry of gifts.--The Director shall maintain a list
of--
``(A) the source and amount of each gift or donation
accepted by the Office; and
``(B) the source and amount of each gift or donation
accepted by a contractor to be used in its performance
of a contract for the Office.
``(6) Report to congress.--The Director shall include in the
annual assessment under section 706(g) a copy of the registry
maintained under paragraph (5).''.
(c) Appointment of Director and Deputy Director.--Section 704(a) of
the Office of National Drug Control Policy Reauthorization Act of 1998
(21 U.S.C. 1703(a)) is amended--
(1) in paragraph (1), by striking subparagraphs (A), (B),
and (C), and inserting the following:
``(A) Director.--
``(i) In general.--There shall be at the head
of the Office a Director who shall hold the same
rank and status as the head of an executive
department listed in section 101 of title 5,
United States Code.
``(ii) Appointment.--The Director shall be
appointed by the President, by and with the advice
and consent of the Senate, and shall serve at the
pleasure of the President.
``(B) Deputy director.--There shall be a Deputy
Director who shall report directly to the Director, and
who shall be appointed by the President, and shall serve
at the pleasure of the President.
``(C) Coordinators.--The following coordinators
shall be appointed by the Director:
``(i) Performance Budget Coordinator, as
described in section 704(c)(4).
``(ii) Interdiction Coordinator, as described
in section 711.
``(iii) Emerging and Continuing Threats
Coordinator, as described in section 709.
``(iv) State, Local, and Tribal Affairs
Coordinator, to carry out the activities described
in section 704(j).
``(v) Demand Reduction Coordinator, as
described in subparagraph (D).
``(D) Demand reduction coordinator.--The Director
shall designate or appoint a United States Demand
Reduction Coordinator to be responsible for the
activities described in section 702(3). The Director
shall determine whether the coordinator position is a
noncareer appointee in the Senior Executive Service or a
career appointee in a position at level 15 of the
General Schedule (or equivalent).'';
[[Page 132 STAT. 4121]]
(2) in paragraph (5), by striking ``such official'' and
inserting ``such officer or employee''; and
(3) by adding at the end the following:
``(6) Prohibition on the use of funds for ballot
initiatives.--No funds authorized under this title may be
obligated for the purpose of expressly advocating the passage or
defeat of a State or local ballot initiative.''.
(d) Consultation.--Section 704(b) of the Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1703(b)) is
amended--
(1) in paragraph (19), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (20), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(21) in order to formulate the national drug control
policies, goals, objectives, and priorities--
``(A) shall consult with and assist--
``(i) State and local governments;
``(ii) National Drug Control Program Agencies;
``(iii) each committee, working group,
council, or other entity established under this
chapter, as appropriate;
``(iv) the public;
``(v) appropriate congressional committees;
and
``(vi) any other person in the discretion of
the Director; and
``(B) may--
``(i) establish advisory councils;
``(ii) acquire data from agencies; and
``(iii) request data from any other entity.''.
(e) National Drug Control Program Budget.--Section 704(c) of the
Office of National Drug Control Policy Reauthorization Act of 1998 (21
U.S.C. 1703(c)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A), by striking ``paragraph
(1)(C);'' and inserting the following: ``paragraph
(1)(C) and include--
``(i) the funding level for each National Drug
Control Program agency; and
``(ii) alternative funding structures that
could improve progress on achieving the goals fo
the National Drug Control Strategy; and'';
(B) in subparagraph (B), strike ``the President;
and'' and inserting ``the President and Congress.''; and
(C) by striking subparagraph (C);
(2) in paragraph (3)(E), by striking clause (ii) and
inserting the following:
``(ii) Certification.--The Director shall--
``(I) review each budget submission
submitted under subparagraph (A);
``(II) based on the review under
clause (i), make a determination as to
whether the budget submission of a
National Drug Control Program agency
includes the funding levels and
initiatives described in subparagraph
(B); and
[[Page 132 STAT. 4122]]
``(III) submit to the appropriate
congressional committees--
``(aa) a written statement
that either--
``(AA) certifies that
the budget submission
includes sufficient funding;
or
``(BB) decertifies the
budget submission as not
including sufficient
funding;
``(bb) a copy of the
description made under
subparagraph (B); and
``(cc) the budget
recommendations made under
subsection (b)(8).''; and
(3) by adding at the end the following:
``(5) Performance-budget coordinator.--
``(A) Designation.--The Director shall designate or
appoint a United States Performance-Budget Coordinator
to--
``(i) ensure the Director has sufficient
information necessary to analyze the performance
of each National Drug Control Program Agency, the
impact Federal funding has had on the goals in the
Strategy, and the likely contributions to the
goals of the Strategy based on funding levels of
each National Drug Control Program Agency, to make
an independent assessment of the budget request of
each agency under this subsection;
``(ii) advise the Director on agency budgets,
performance measures and targets, and additional
data and research needed to make informed policy
decisions under this section and section 706; and
``(iii) other duties as may be determined by
the Director with respect to measuring or
assessing performance or agency budgets.
``(B) Determination of position.--The Director shall
determine whether the coordinator position is a
noncareer appointee in the Senior Executive Service or a
career appointee in a position at level 15 of the
General Schedule (or equivalent).
``(6) Budget estimate or request submission to congress.--
Whenever the Director submits any budget estimate or request to
the President or the Office of Management and Budget, the
Director shall concurrently transmit to the appropriate
congressional committees a detailed statement of the budgetary
needs of the Office to execute its mission based on the good-
faith assessment of the Director.''.
(f) Powers and Responsibilities of the Director.--Section 704 of the
Office of National Drug Control Policy Reauthorization Act of 1998 (21
U.S.C. 1703) is amended--
(1) in subsection (d)(8)--
(A) in subparagraph (D), by striking ``and'' at the
end;
(B) in subparagraph (E)--
(i) in clause (i)--
(I) by striking ``Congress,
including to the Committees on
Appropriations of the Senate and the
House of Representatives, the
authorizing committees for the Office,''
and inserting ``the appropriate
congressional committees''; and
(II) by striking ``or agencies'';
[[Page 132 STAT. 4123]]
(ii) in clause (ii)--
(I) by striking ``Congress'' and
inserting ``the appropriate
congressional committees''; and
(II) by adding ``and'' at the end;
and
(iii) by adding at the end the following:
``(iii) funds may only be used for--
``(I) expansion of demand reduction
activities;
``(II) interdiction of illicit drugs
on the high seas, in United States
territorial waters, and at United States
ports of entry by officers and employees
of National Drug Control Program
Agencies and domestic and foreign law
enforcement officers;
``(III) accurate assessment and
monitoring of international drug
production and interdiction programs and
policies;
``(IV) activities to facilitate and
enhance the sharing of domestic and
foreign intelligence information among
National Drug Control Program Agencies
related to the production and
trafficking of drugs in the United
States and foreign countries; and
``(V) research related to any of
these activities.'';
(2) in subsection (e)(2)(A), by striking ``Notwithstanding
any other provision of law'' and inserting ``Subject to the
availability of appropriations''; and
(3) by adding at the end the following:
``(i) Model Acts Program.--
``(1) In general.--The Director shall provide for or shall
enter into an agreement with a nonprofit organization to--
``(A) advise States on establishing laws and
policies to address illicit drug use issues; and
``(B) revise such model State drug laws and draft
supplementary model State laws to take into
consideration changes in illicit drug use issues in the
State involved.
``(2) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $1,250,000 for
each of fiscal years 2018 through 2023.
``(j) State, Local, and Tribal Affairs Coordinator.--The Director
shall designate or appoint a United States State, Local, and Tribal
Affairs Coordinator to perform the duties of the Office outlined in this
section and 706 and such other duties as may be determined by the
Director with respect to coordination of drug control efforts between
agencies and State, local, and Tribal governments. The Director shall
determine whether the coordinator position is a noncareer appointee in
the Senior Executive Service or a career appointee in a position at
level 15 of the General Schedule (or equivalent).
``(k) Harm Reduction Programs.--When developing the national drug
control policy, any policy of the Director, including policies relating
to syringe exchange programs for intravenous drug users, shall be based
on the best available medical and scientific evidence regarding the
effectiveness of such policy in promoting individual health and
preventing the spread of infectious disease and the impact of such
policy on drug addiction and use. In making any policy relating to harm
reduction programs, the Director shall
[[Page 132 STAT. 4124]]
consult with the National Institutes of Health and the National Academy
of Sciences.''.
(g) Accounting of Funds Expended.--Section 705 of the Office of
National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C.
1704(d)), as amended by section 8207 is further amended--
(1) by amending subsection (d) to read as follows:
``(d) Accounting of Funds Expended.--
``(1) In general.--Not later than February 1 of each year,
in accordance with guidance issued by the Director, the head of
each National Drug Control Program Agency shall submit to the
Director a detailed accounting of all funds expended by the
agency for National Drug Control Program activities during the
previous fiscal year and shall ensure such detailed accounting
is authenticated for the previous fiscal year by the Inspector
General for such agency prior to the submission to the Director
as frequently as determined by the Inspector General but not
less frequently that every 3 years.
``(2) Submission to congress.--The Director shall submit to
Congress not later than April 1 of each year the information
submitted to the Director under paragraph (1).''; and
(2) by adding at the end the following:
``(f) Tracking System for Federally Funded Grant Programs.--
``(1) Establishment.--The Director, or the head of an agency
designated by the Director, in coordination with the Secretary
of Health and Human Services, shall track federally-funded grant
programs to--
``(A) ensure the public has electronic access to
information identifying:
``(i) all drug control grants and pertinent
identifying information for each grant;
``(ii) any available performance metrics,
evaluations, or other information indicating the
effectiveness of such programs;
``(B) facilitate efforts to identify duplication,
overlap, or gaps in funding to provide increased
accountability of Federally-funded grants for substance
use disorder treatment, prevention, and enforcement; and
``(C) identify barriers in the grant application
process impediments that applicants currently have in
the grant application process with applicable agencies.
``(2) National drug control agencies.--The head of each
National Drug Control Program Agency shall provide to the
Director a complete list of all drug control program grant
programs and any other relevant information for inclusion in the
system developed under paragraph (1) and annually update such
list.
``(3) Updating existing systems.--The Director may meet the
requirements of this subsection by utilizing, updating, or
improving existing Federal information systems to ensure they
meet the requirements of this subsection.
``(4) Report.--Not later than 3 years after the date of
enactment of this subsection, the Comptroller General of the
United States shall submit to Congress a report examining
implementation of this subsection.''.
[[Page 132 STAT. 4125]]
(h) Technical and Conforming Amendment.--Section 1105 of the Office
of National Drug Control Policy Reauthorization Act of 2006 (21 U.S.C.
1701 note) is repealed.
SEC. 8218. EMERGING THREATS COMMITTEE, PLAN, AND MEDIA CAMPAIGN.
(a) In General.--Section 709 of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1708) is amended to read
as follows:
``SEC. 709. EMERGING THREATS COMMITTEE, PLAN, AND MEDIA CAMPAIGN.
``(a) Emerging Threats Coordinator.--The Director shall designate or
appoint a United States Emerging and Continuing Threats Coordinator to
perform the duties of that position described in this section and such
other duties as may be determined by the Director. The Director shall
determine whether the coordinator position is a noncareer appointee in
the Senior Executive Service or a career appointee in a position at
level 15 of the General Schedule (or equivalent).
``(b) Emerging Threats Committee.--
``(1) In general.--The Emerging Threats Committee shall--
``(A) monitor evolving and emerging drug threats in
the United States;
``(B) identify and discuss evolving and emerging
drug trends in the United States using the criteria
required to be established under paragraph (6);
``(C) assist in the formulation of and oversee
implementation of any plan described in subsection (d);
``(D) provide such other advice to the Coordinator
and Director concerning strategy and policies for
emerging drug threats and trends as the Committee
determines to be appropriate; and
``(E) disseminate and facilitate the sharing with
Federal, State, local, and Tribal officials and other
entities as determined by the Director of pertinent
information and data relating to--
``(i) recent trends in drug supply and demand;
``(ii) fatal and nonfatal overdoses;
``(iii) demand for and availability of
evidence-based substance use disorder treatment,
including the extent of the unmet treatment need,
and treatment admission trends;
``(iv) recent trends in drug interdiction,
supply, and demand from State, local, and Tribal
law enforcement agencies; and
``(v) other subject matter as determined
necessary by the Director.
``(2) Chairperson.--The Director shall designate one of the
members of the Emerging Threats Committee to serve as
Chairperson.
``(3) Members.--The Director shall appoint other members of
the Committee, which shall include--
``(A) representatives from National Drug Control
Program Agencies or other agencies;
``(B) representatives from State, local, and Tribal
governments; and
[[Page 132 STAT. 4126]]
``(C) representatives from other entities as
designated by the Director.
``(4) Meetings.--The members of the Emerging Threats
Committee shall meet, in person and not through any delegate or
representative, not less frequently than once per calendar year,
before June 1. At the call of the Director or the Chairperson,
the Emerging Threats Committee may hold additional meetings as
the members may choose.
``(5) Contract, agreement, and other authority.--The
Director may award contracts, enter into interagency agreements,
manage individual projects, and conduct other activities in
support of the identification of emerging drug threats and in
support of the development, implementation, and assessment of
any Emerging Threat Response Plan.
``(6) Criteria to identify emerging drug threats.--Not later
than 180 days after the date on which the Committee first meets,
the Committee shall develop and recommend to the Director
criteria to be used to identify an emerging drug threat or the
termination of an emerging drug threat designation based on
information gathered by the Committee, statistical data, and
other evidence.
``(c) Designation.--
``(1) In general.--The Director, in consultation with the
Coordinator, the Committee, and the head of each National Drug
Control Program Agency, may designate an emerging drug threat in
the United States.
``(2) Standards for designation.--The Director, in
consultation with the Coordinator, shall promulgate and make
publicly available standards by which a designation under
paragraph (1) and the termination of such designation may be
made. In developing such standards, the Director shall consider
the recommendations of the committee and other criteria the
Director considers to be appropriate.
``(3) Public statement required.--The Director shall publish
a public written statement on the portal of the Office
explaining the designation of an emerging drug threat or the
termination of such designation and shall notify the appropriate
congressional committees of the availability of such statement
when a designation or termination of such designation has been
made.
``(d) Plan.--
``(1) Public availability of plan.--Not later than 90 days
after making a designation under subsection (c), the Director
shall publish and make publicly available an Emerging Threat
Response Plan and notify the President and the appropriate
congressional committees of such plan's availability.
``(2) Timing.--Concurrently with the annual submissions
under section 706(g), the Director shall update the plan and
report on implementation of the plan, until the Director issues
the public statement required under subsection (c)(3) to
terminate the emerging drug threat designation.
``(3) Contents of an emerging threat response plan.--The
Director shall include in the plan required under this
subsection--
``(A) a comprehensive strategic assessment of the
emerging drug threat, including the current availability
[[Page 132 STAT. 4127]]
of, demand for, and effectiveness of evidence-based
prevention, treatment, and enforcement programs and
efforts to respond to the emerging drug threat;
``(B) comprehensive, research-based, short- and
long-term, quantifiable goals for addressing the
emerging drug threat, including for reducing the supply
of the drug designated as the emerging drug threat and
for expanding the availability and effectiveness of
evidence-based substance use disorder treatment and
prevention programs to reduce the demand for the
emerging drug threat;
``(C) performance measures pertaining to the plan's
goals, including quantifiable and measurable objectives
and specific targets;
``(D) the level of funding needed to implement the
plan, including whether funding is available to be
reprogrammed or transferred to support implementation of
the plan or whether additional appropriations are
necessary to implement the plan;
``(E) an implementation strategy for the media
campaign under subsection (f), including goals as
described under subparagraph (B) of this paragraph and
performance measures, objectives, and targets, as
described under subparagraph (C) of this paragraph; and
``(F) any other information necessary to inform the
public of the status, progress, or response of an
emerging drug threat.
``(4) Implementation.--
``(A) In general.--Not later than 120 days after the
date on which a designation is made under subsection
(c), the Director, in consultation with the President,
the appropriate congressional committees, and the head
of each National Drug Control Program Agency, shall
issue guidance on implementation of the plan described
in this subsection to the National Drug Control Program
Agencies and any other relevant agency determined to be
necessary by the Director.
``(B) Coordinator's responsibilities.--The
Coordinator shall--
``(i) direct the implementation of the plan
among the agencies identified in the plan, State,
local, and Tribal governments, and other relevant
entities;
``(ii) facilitate information-sharing between
agencies identified in the plan, State, local, and
Tribal governments, and other relevant entities;
and
``(iii) monitor implementation of the plan by
coordinating the development and implementation of
collection and reporting systems to support
performance measurement and adherence to the plan
by agencies identified in plan, where appropriate.
``(C) Reporting.--Not later than 180 days after the
date on which a designation is made under subsection (c)
and in accordance with subparagraph (A), the head of
each agency identified in the plan shall submit to the
Coordinator a report on implementation of the plan.
``(e) Evaluation of Media Campaign.--Upon designation of an emerging
drug threat, the Director shall evaluate whether a media campaign would
be appropriate to address that threat.
[[Page 132 STAT. 4128]]
``(f) National Anti-drug Media Campaign.--
``(1) In general.--The Director shall, to the extent
feasible and appropriate, conduct a national anti-drug media
campaign (referred to in this subtitle as the `national media
campaign') in accordance with this subsection for the purposes
of--
``(A) preventing substance abuse among people in the
United States;
``(B) educating the public about the dangers and
negative consequences of substance use and abuse,
including patient and family education about the
characteristics and hazards of substance abuse and
methods to safeguard against substance use, to include
the safe disposal of prescription medications;
``(C) supporting evidence-based prevention programs
targeting the attitudes, perception, and beliefs of
persons concerning substance use and intentions to
initiate or continue such use;
``(D) encouraging individuals affected by substance
use disorders to seek treatment and providing such
individuals with information on--
``(i) how to recognize addiction issues;
``(ii) what forms of evidence-based treatment
options are available; and
``(iii) how to access such treatment;
``(E) combating the stigma of addiction and
substance use disorders, including the stigma of
treating such disorders with medication-assisted
treatment therapies; and
``(F) informing the public about the dangers of any
drug identified by the Director as an emerging drug
threat as appropriate.
``(2) Use of funds.--
``(A) In general.--Amounts made available to carry
out this subsection for the national media campaign may
only be used for the following:
``(i) The purchase of media time and space,
including the strategic planning for, tracking,
and accounting of, such purchases.
``(ii) Creative and talent costs, consistent
with subparagraph (B)(i).
``(iii) Advertising production costs, which
may include television, radio, internet, social
media, and other commercial marketing venues.
``(iv) Testing and evaluation of advertising.
``(v) Evaluation of the effectiveness of the
national media campaign.
``(vi) Costs of contracts to carry out
activities authorized by this subsection.
``(vii) Partnerships with professional and
civic groups, community-based organizations,
including faith-based organizations, and
government organizations related to the national
media campaign.
``(viii) Entertainment industry outreach,
interactive outreach, media projects and
activities, public information, news media
outreach, and corporate sponsorship and
participation.
``(ix) Operational and management expenses.
``(B) Specific requirements.--
[[Page 132 STAT. 4129]]
``(i) Creative services.--In using amounts for
creative and talent costs under subparagraph
(A)(ii), the Director shall use creative services
donated at no cost to the Government wherever
feasible and may only procure creative services
for advertising--
``(I) responding to high-priority or
emergent campaign needs that cannot
timely be obtained at no cost; or
``(II) intended to reach a minority,
ethnic, or other special audience that
cannot reasonably be obtained at no
cost.
``(ii) Testing and evaluation of
advertising.--In using amounts for testing and
evaluation of advertising under subparagraph
(A)(iv), the Director shall test all
advertisements prior to use in the national media
campaign to ensure that the advertisements are
effective with the target audience and meet
industry-accepted standards. The Director may
waive this requirement for advertisements using no
more than 10 percent of the purchase of
advertising time purchased under this subsection
in a fiscal year and no more than 10 percent of
the advertising space purchased under this
subsection in a fiscal year, if the advertisements
respond to emergent and time-sensitive campaign
needs or the advertisements will not be widely
utilized in the national media campaign.
``(iii) Consultation.--For the planning of the
campaign under paragraph (1), the Director may
consult with--
``(I) the head of any appropriate
National Drug Control Program Agency;
``(II) experts on the designated
drug;
``(III) State, local, and Tribal
government officials and relevant
agencies;
``(IV) communications professionals;
``(V) the public; and
``(VI) appropriate congressional
committees.
``(iv) Evaluation of effectiveness of national
media campaign.--In using amounts for the
evaluation of the effectiveness of the national
media campaign under subparagraph (A)(v), the
Director shall--
``(I) designate an independent
entity to evaluate by April 20 of each
year the effectiveness of the national
media campaign based on data from--
``(aa) the Monitoring the
Future Study published by the
Department of Health and Human
Services;
``(bb) the National Survey
on Drug Use and Health; and
``(cc) other relevant
studies or publications, as
determined by the Director,
including tracking and
evaluation data collected
according to marketing and
advertising industry standards;
and
``(II) ensure that the effectiveness
of the national media campaign is
evaluated in a manner
[[Page 132 STAT. 4130]]
that enables consideration of whether
the national media campaign has
contributed to changes in attitude or
behaviors among the target audience with
respect to substance use and such other
measures of evaluation as the Director
determines are appropriate.
``(3) Advertising.--In carrying out this subsection, the
Director shall ensure that sufficient funds are allocated to
meet the stated goals of the national media campaign.
``(4) Responsibilities and functions under the program.--
``(A) In general.--The Director shall determine the
overall purposes and strategy of the national media
campaign.
``(B) Director.--
``(i) In general.--The Director shall
approve--
``(I) the strategy of the national
media campaign;
``(II) all advertising and
promotional material used in the
national media campaign; and
``(III) the plan for the purchase of
advertising time and space for the
national media campaign.
``(ii) Implementation.--The Director shall be
responsible for implementing a focused national
media campaign to meet the purposes set forth in
paragraph (1) and shall ensure--
``(I) information disseminated
through the campaign is accurate and
scientifically valid; and
``(II) the campaign is designed
using strategies demonstrated to be the
most effective at achieving the goals
and requirements of paragraph (1), which
may include--
``(aa) a media campaign, as
described in paragraph (2);
``(bb) local, regional, or
population specific messaging;
``(cc) the development of
websites to publicize and
disseminate information;
``(dd) conducting outreach
and providing educational
resources for parents;
``(ee) collaborating with
law enforcement agencies; and
``(ff) providing support for
school-based public health
education classes to improve
teen knowledge about the effects
of substance use.
``(5) Prohibitions.--None of the amounts made available
under paragraph (2) may be obligated or expended for any of the
following:
``(A) To supplant current anti-drug community-based
coalitions.
``(B) To supplant pro bono public service time
donated by national and local broadcasting networks for
other public service campaigns.
``(C) For partisan political purposes, or to express
advocacy in support of or to defeat any clearly
identified candidate, clearly identified ballot
initiative, or clearly identified legislative or
regulatory proposal.
[[Page 132 STAT. 4131]]
``(D) To fund advertising that features any elected
officials, persons seeking elected office, cabinet level
officials, or other Federal officials employed pursuant
to section 213 of Schedule C of title 5, Code of Federal
Regulations.
``(E) To fund advertising that does not contain a
primary message intended to reduce or prevent substance
use.
``(F) To fund advertising containing a primary
message intended to promote support for the national
media campaign or private sector contributions to the
national media campaign.
``(6) Matching requirement.--
``(A) In general.--Amounts made available under
paragraph (2) for media time and space shall be matched
by an equal amount of non-Federal funds for the national
media campaign, or be matched with in-kind contributions
of the same value.
``(B) No-cost match advertising direct relationship
requirement.--The Director shall ensure that not less
than 85 percent of no-cost match advertising directly
relates to substance abuse prevention consistent with
the specific purposes of the national media campaign.
``(C) No-cost match advertising not directly
related.--The Director shall ensure that no-cost match
advertising that does not directly relate to substance
abuse prevention consistent with the purposes of the
national media campaign includes a clear anti-drug
message. Such message is not required to be the primary
message of the match advertising.
``(7) Financial and performance accountability.--The
Director shall cause to be performed--
``(A) audits and reviews of costs of the national
media campaign pursuant to section 4706 of title 41,
United States Code; and
``(B) an audit to determine whether the costs of the
national media campaign are allowable under chapter 43
of title 41, United States Code.
``(8) Report to congress.--The Director shall submit on an
annual basis a report to Congress that describes--
``(A) the strategy of the national media campaign
and whether specific objectives of the national media
campaign were accomplished;
``(B) steps taken to ensure that the national media
campaign operates in an effective and efficient manner
consistent with the overall strategy and focus of the
national media campaign;
``(C) plans to purchase advertising time and space;
``(D) policies and practices implemented to ensure
that Federal funds are used responsibly to purchase
advertising time and space and eliminate the potential
for waste, fraud, and abuse;
``(E) all contracts entered into with a corporation,
partnership, or individual working on behalf of the
national media campaign;
``(F) the results of any financial audit of the
national media campaign;
[[Page 132 STAT. 4132]]
``(G) a description of any evidence used to develop
the national media campaign;
``(H) specific policies and steps implemented to
ensure compliance with this section;
``(I) a detailed accounting of the amount of funds
obligated during the previous fiscal year for carrying
out the national media campaign, including each
recipient of funds, the purpose of each expenditure, the
amount of each expenditure, any available outcome
information, and any other information necessary to
provide a complete accounting of the funds expended; and
``(J) a review and evaluation of the effectiveness
of the national media campaign strategy for the past
year.
``(9) Required notice for communication from the office.--
Any communication, including an advertisement, paid for or
otherwise disseminated by the Office directly or through a
contract awarded by the Office shall include a prominent notice
informing the audience that the communication was paid for by
the Office.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to the Office to carry out this section, $25,000,000 for
each of fiscal years 2018 through 2023.''.
(b) Technical and Conforming Amendment.--Subsection (a) of section
203 of the Office of National Drug Control Policy Reauthorization Act of
2006 (21 U.S.C. 1708a) is repealed.
SEC. 8219. DRUG INTERDICTION.
(a) Repeal.--This first section 711 of the Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1710) is repealed.
(b) Amendments.--Section 711 of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1710), as added by Public
Law 109-469 (120 Stat. 3507), is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``The United'' and inserting
``The Director shall designate or appoint an
appointee in the Senior Executive Service or an
appointee in a position at level 15 of the General
Schedule (or equivalent) as the United''; and
(ii) by striking ``shall'' and inserting
``to'';
(B) in paragraph (2)(B)--
(i) by striking ``March 1'' and inserting
``September 1''; and
(ii) by striking ``paragraph (3)'' and
inserting ``paragraph (4)'';
(C) in paragraph (3)--
(i) by striking ``also, at his discretion,'';
and
(ii) by striking ``the Office of Supply
Reduction for that purpose'' and inserting
``assist in carrying out such responsibilities'';
and
(D) in paragraph (4)--
(i) in subparagraph (B), by striking ``The
United'' and inserting ``Before submission of the
National Drug Control Strategy or annual
assessment required under section 706, as
applicable, the United'';
(ii) by striking subparagraphs (C) and (E);
[[Page 132 STAT. 4133]]
(iii) by redesignating subparagraph (D) as
subparagraph (C);
(iv) in subparagraph (C), as so redesignated--
(I) in the matter preceding clause
(i)--
(aa) by striking ``March 1''
and inserting ``September 1'';
(bb) by inserting ``the
Director, acting through''
before ``the United States'';
(cc) by inserting a comma
after ``Coordinator'';
(dd) by striking ``a report
on behalf of the Director''; and
(ee) by striking ``, which
shall include'' and inserting
``a report that'';
(II) by redesignating clauses (i),
(ii), and (iii) as subclauses (I), (II),
and (III), and adjusting the margins
accordingly;
(III) by inserting before subclause
(I), as so redesignated, the following:
``(i) includes--'';
(IV) in clause (i), as so
redesignated--
(aa) in subclause (I), as so
redesignated, by inserting ``,
including information about how
each National Drug Control
Program agency conducting drug
interdiction activities is
engaging with relevant
international partners'' after
``Plan'';
(bb) in subclause (II), as
so redesignated, by striking ``,
as well as'' and inserting
``and'';
(cc) in subclause III, as so
redesignated--
(AA) by striking ``, as
well as'' and inserting
``and''; and
(BB) by striking the
period at the end and
inserting ``; and''; and
(V) by adding at the end the
following:
``(ii) may include recommendations for changes
to existing agency authorities or laws governing
interagency relationships.''; and
(v) by adding at the end the following:
``(D) Classified annex.--Each report required to be
submitted under subparagraph (C) shall be in
unclassified form, but may include a classified
annex.'';
(2) in subsection (b)--
(A) in paragraph (1)(B), by inserting ``and how to
strengthen international partnerships to better achieve
the goals of that plan'' after ``that plan'';
(B) in paragraph (2)--
(i) in the paragraph heading, by striking
``Chairman'' and inserting ``Chairperson''; and
(ii) by striking ``chairman'' and inserting
``Chairperson'';
(C) in paragraph (3)--
(i) by striking ``prior to March 1'' and
inserting ``before June 1'';
(ii) by striking ``either'' each place it
appears;
(iii) by striking ``current chairman'' and
inserting ``Chairperson''; and
[[Page 132 STAT. 4134]]
(iv) by striking ``they'' and inserting ``the
members''; and
(D) in paragraph (4)--
(i) by striking ``chairman'' each place it
appears and inserting ``Chairperson'';
(ii) in the first sentence, by striking ``a
report'';
(iii) by inserting ``a report'' after
``committees''; and
(iv) by striking the second sentence and
inserting the following: ``The report required
under this paragraph shall be in unclassified
form, but may include a classified annex.''; and
(3) by adding at the end the following:
``(c) International Coordination.--The Director may facilitate
international drug control coordination efforts.''.
SEC. 8220. <<NOTE: 21 USC 1715.>> GAO AUDIT.
Not later than 4 years after the date of enactment of this Act, and
every 4 years thereafter, the Comptroller General of the United States
shall--
(1) conduct an audit relating to the programs and operations
of--
(A) the Office; and
(B) certain programs within the Office, including--
(i) the High Intensity Drug Trafficking Areas
Program;
(ii) the Drug-Free Communities Program; and
(iii) the campaign under section 709(f) of the
Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1708(f));
and
(2) submit to the Director and the appropriate congressional
committees a report containing an evaluation of and
recommendations on the--
(A) policies and activities of the programs and
operations subject to the audit;
(B) economy, efficiency, and effectiveness in the
administration of the reviewed programs and operations;
and
(C) policy or management changes needed to prevent
and detect fraud and abuse in such programs and
operations.
SEC. 8221. NATIONAL DRUG CONTROL STRATEGY.
(a) In General.--Section 706 of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1705) is amended to read
as follows:
``SEC. 706. NATIONAL DRUG CONTROL STRATEGY.
``(a) In General.--
``(1) Statement of drug policy priorities.--The Director
shall release a statement of drug control policy priorities in
the calendar year of a Presidential inauguration following the
inauguration, but not later than April 1.
``(2) National drug control strategy submitted by the
president.--Not later than the first Monday in February
following the year in which the term of the President commences,
and every 2 years thereafter, the President shall submit to
Congress a National Drug Control Strategy.
[[Page 132 STAT. 4135]]
``(b) Development of the National Drug Control Strategy.--
``(1) Promulgation.--The Director shall promulgate the
National Drug Control Strategy, which shall set forth a
comprehensive plan to reduce illicit drug use and the
consequences of such illicit drug use in the United States by
limiting the availability of and reducing the demand for illegal
drugs and promoting prevention, early intervention, treatment,
and recovery support for individuals with substance use
disorders.
``(2) State and local commitment.--The Director shall seek
the support and commitment of State, local, and Tribal officials
in the formulation and implementation of the National Drug
Control Strategy.
``(3) Strategy based on evidence.--The Director shall ensure
the National Drug Control Strategy is based on the best
available evidence regarding the policies that are most
effective in reducing the demand for and supply of illegal
drugs.
``(4) Process for development and submission of national
drug control strategy.--In developing and effectively
implementing the National Drug Control Strategy, the Director--
``(A) shall consult with--
``(i) the heads of the National Drug Control
Program Agencies;
``(ii) each Coordinator listed in section 704;
``(iii) the Interdiction Committee and the
Emerging Threats Committee;
``(iv) the appropriate congressional
committees and any other committee of
jurisdiction;
``(v) State, local, and Tribal officials;
``(vi) private citizens and organizations,
including community and faith-based organizations,
with experience and expertise in demand reduction;
``(vii) private citizens and organizations
with experience and expertise in supply reduction;
and
``(viii) appropriate representatives of
foreign governments; and
``(B) in satisfying the requirements of subparagraph
(A), shall ensure, to the maximum extent possible, that
State, local, and Tribal officials and relevant private
organizations commit to support and take steps to
achieve the goals and objectives of the National Drug
Control Strategy.
``(c) Contents of the National Drug Control Strategy.--
``(1) In general.--The National Drug Control Strategy
submitted under subsection (a)(2) shall include the following:
``(A) A mission statement detailing the major
functions of the National Drug Control Program.
``(B) Comprehensive, research-based, long-range,
quantifiable goals for reducing illicit drug use, and
the consequences of illicit drug use in the United
States.
``(C) Annual quantifiable and measurable objectives
and specific targets to accomplish long-term
quantifiable goals that the Director determines may be
achieved during each year beginning on the date on which
the National Drug Control Strategy is submitted.
[[Page 132 STAT. 4136]]
``(D) A 5-year projection for the National Drug
Control Program and budget priorities.
``(E) A review of international, State, local, and
private sector drug control activities to ensure that
the United States pursues coordinated and effective drug
control at all levels of government.
``(F) A description of how each goal established
under subparagraph (B) will be achieved, including for
each goal--
``(i) a list of each relevant National Drug
Control Program Agency and each such agency's
related programs, activities, and available assets
and the role of each such program, activity, and
asset in achieving such goal;
``(ii) a list of relevant stakeholders and
each such stakeholder's role in achieving such
goal;
``(iii) an estimate of Federal funding and
other resources needed to achieve such goal;
``(iv) a list of each existing or new
coordinating mechanism needed to achieve such
goal; and
``(v) a description of the Office's role in
facilitating the achievement of such goal.
``(G) For each year covered by the Strategy, a
performance evaluation plan for each goal established
under subparagraph (B) for each National Drug Control
Program Agency, including--
``(i) specific performance measures for each
National Drug Control Program Agency;
``(ii) annual and, to the extent practicable,
quarterly objectives and targets for each
performance measure; and
``(iii) an estimate of Federal funding and
other resources needed to achieve each performance
objective and target.
``(H) A list identifying existing data sources or a
description of data collection needed to evaluate
performance, including a description of how the Director
will obtain such data.
``(I) A list of any anticipated challenges to
achieving the National Drug Control Strategy goals and
planned actions to address such challenges.
``(J) A description of how each goal established
under subparagraph (B) was determined, including--
``(i) a description of each required
consultation and a description of how such
consultation was incorporated; and
``(ii) data, research, or other information
used to inform the determination to establish the
goal.
``(K) A description of the current prevalence of
illicit drug use in the United States, including both
the availability of illicit drugs and the prevalence of
substance use disorders.
``(L) Such other statistical data and information as
the Director considers appropriate to demonstrate and
assess trends relating to illicit drug use, the effects
and consequences of illicit drug use (including the
effects on children), supply reduction, demand
reduction, drug-related
[[Page 132 STAT. 4137]]
law enforcement, and the implementation of the National
Drug Control Strategy.
``(M) A systematic plan for increasing data
collection to enable real time surveillance of drug
control threats, developing analysis and monitoring
capabilities, and identifying and addressing policy
questions related to the National Drug Control Strategy
and Program, which shall include--
``(i) a list of policy-relevant questions for
which the Director and each National Drug Control
Program Agency intends to develop evidence to
support the National Drug Control Program and
Strategy;
``(ii) a list of data the Director and each
National Drug Control Program Agency intends to
collect, use, or acquire to facilitate the use of
evidence in drug control policymaking and
monitoring;
``(iii) a list of methods and analytical
approaches that may be used to develop evidence to
support the National Drug Control Program and
Strategy and related policy;
``(iv) a list of any challenges to developing
evidence to support policymaking, including any
barriers to accessing, collecting, or using
relevant data;
``(v) a description of the steps the Director
and the head of each National Drug Control Program
Agency will take to effectuate the plan; and
``(vi) any other relevant information as
determined by the Director.
``(N) A plan to expand treatment of substance use
disorders, which shall--
``(i) identify unmet needs for treatment for
substance use disorders and a strategy for closing
the gap between available and needed treatment;
``(ii) describe the specific roles and
responsibilities of the relevant National Drug
Control Programs for implementing the plan;
``(iii) identify the specific resources
required to enable the relevant National Drug
Control Agencies to implement that strategy; and
``(iv) identify the resources, including
private sources, required to eliminate the unmet
need for evidence-based substance use disorder
treatment.
``(2) Consultation.--In developing the plan required under
paragraph (1), the Director shall consult with the following:
``(A) The public.
``(B) Any evaluation or analysis units and personnel
of the Office.
``(C) Office officials responsible for implementing
privacy policy.
``(D) Office officials responsible for data
governance.
``(E) The appropriate congressional committees.
``(F) Any other individual or entity as determined
by the Director.
``(3) Additional strategies.--
``(A) In general.--The Director shall include in the
National Drug Control Strategy the additional strategies
[[Page 132 STAT. 4138]]
described under this paragraph and shall comply with the
following:
``(i) Provide a copy of the additional
strategies to the appropriate congressional
committees and to the Committee on Armed Services
and the Committee on Homeland Security of the
House of Representatives, and the Committee on
Homeland Security and Governmental Affairs and the
Committee on Armed Services of the Senate.
``(ii) Issue the additional strategies in
consultation with the head of each relevant
National Drug Control Program Agency, any relevant
official of a State, local, or Tribal government,
and the government of other relevant countries.
``(iii) Not change any existing agency
authority or construe any strategy described under
this paragraph to amend or modify any law
governing interagency relationship but may include
recommendations about changes to such authority or
law.
``(iv) Present separately from the rest of any
strategy described under this paragraph any
information classified under criteria established
by an Executive order, or whose public disclosure,
as determined by the Director or the head of any
relevant National Drug Control Program Agency,
would be detrimental to the law enforcement or
national security activities of any Federal,
State, local, or Tribal agency.
``(B) Requirement for southwest border
counternarcotics strategy.--
``(i) Purposes.--The Southwest Border
Counternarcotics Strategy shall--
``(I) set forth the Government's
strategy for preventing the illegal
trafficking of drugs across the
international border between the United
States and Mexico, including through
ports of entry and between ports of
entry on that border;
``(II) state the specific roles and
responsibilities of the relevant
National Drug Control Program Agencies
for implementing that strategy; and
``(III) identify the specific
resources required to enable the
relevant National Drug Control Program
Agencies to implement that strategy.
``(ii) Specific content related to drug
tunnels between the united states and mexico.--The
Southwest Border Counternarcotics Strategy shall
include--
``(I) a strategy to end the
construction and use of tunnels and
subterranean passages that cross the
international border between the United
States and Mexico for the purpose of
illegal trafficking of drugs across such
border; and
``(II) recommendations for criminal
penalties for persons who construct or
use such a tunnel or subterranean
passage for such a purpose.
``(C) Requirement for northern border
counternarcotics strategy.--
``(i) Purposes.--The Northern Border
Counternarcotics Strategy shall--
[[Page 132 STAT. 4139]]
``(I) set forth the strategy of the
Federal Government for preventing the
illegal trafficking of drugs across the
international border between the United
States and Canada, including through
ports of entry and between ports of
entry on the border;
``(II) state the specific roles and
responsibilities of each relevant
National Drug Control Program Agency for
implementing the strategy;
``(III) identify the specific
resources required to enable the
relevant National Drug Control Program
Agencies to implement the strategy;
``(IV) be designed to promote, and
not hinder, legitimate trade and travel;
and
``(V) reflect the unique nature of
small communities along the
international border between the United
States and Canada, ongoing cooperation
and coordination with Canadian law,
enforcement authorities, and variations
in the volumes of vehicles and
pedestrians crossing through ports of
entry along the international border
between the United States and Canada.
``(ii) Specific content related to cross-
border indian reservations.--The Northern Border
Counternarcotics Strategy shall include--
``(I) a strategy to end the illegal
trafficking of drugs to or through
Indian reservations on or near the
international border between the United
States and Canada; and
``(II) recommendations for
additional assistance, if any, needed by
Tribal law enforcement agencies relating
to the strategy, including an evaluation
of Federal technical and financial
assistance, infrastructure capacity
building, and interoperability
deficiencies.
``(4) Classified information.--Any contents of the National
Drug Control Strategy that involve information properly
classified under criteria established by an Executive order
shall be presented to Congress separately from the rest of the
National Drug Control Strategy.
``(5) Selection of data and information.--In selecting data
and information for inclusion in the Strategy, the Director
shall ensure--
``(A) the inclusion of data and information that
will permit analysis of current trends against
previously compiled data and information where the
Director believes such analysis enhances long-term
assessment of the National Drug Control Strategy; and
``(B) the inclusion of data and information to
permit a standardized and uniform assessment of the
effectiveness of drug treatment programs in the United
States.
``(d) Submission of Revised Strategy.--The President may submit to
Congress a revised National Drug Control Strategy that meets the
requirements of this section--
``(1) at any time, upon a determination of the President, in
consultation with the Director, that the National Drug Control
Strategy in effect is not sufficiently effective; or
[[Page 132 STAT. 4140]]
``(2) if a new President or Director takes office.
``(e) Failure of Director to Submit National Drug Control
Strategy.--If the Director does not submit a National Drug Control
Strategy to Congress in accordance with subsection (a)(2), not later
than five days after the first Monday in February following the year in
which the term of the President commences, the Director shall send a
notification to the appropriate congressional committees--
``(1) explaining why the Strategy was not submitted; and
``(2) specifying the date by which the Strategy will be
submitted.
``(f) Drug Control Data Dashboard.--
``(1) In general.--The Director shall collect and
disseminate, as appropriate, such information as the Director
determines is appropriate, but not less than the information
described in this subsection. The data shall be publicly
available in a machine-readable format on the online portal of
the Office, and to the extent practicable on the Drug Control
Data Dashboard.
``(2) Establishment.--The Director shall publish to the
online portal of the office in a machine-readable, sortable, and
searchable format, or to the extent practicable, establish and
maintain a data dashboard on the online portal of the Office to
be known as the `Drug Control Data Dashboard'. To the extent
practicable, when establishing the Drug Control Dashboard, the
Director shall ensure the user interface of the dashboard is
constructed with modern design standards. To the extent
practicable, the data made available on the dashboard shall be
publicly available in a machine-readable format and searchable
by year, agency, drug, and location.
``(3) Data.--The data included in the Drug Control Data
Dashboard shall be updated quarterly to the extent practicable,
but not less frequently than annually and shall include, at a
minimum, the following:
``(A) For each substance identified by the Director
as having a significant impact on the prevalence of
illicit drug use--
``(i) data sufficient to show the quantities
of such substance available in the United States,
including--
``(I) the total amount seized and
disrupted in the calendar year and each
of the previous 3 calendar years,
including to the extent practicable the
amount seized by State, local, and
Tribal governments;
``(II) the known and estimated flows
into the United States from all sources
in the calendar year and each of the
previous 3 calendar years;
``(III) the total amount of known
flows that could not be interdicted or
disrupted in the calendar year and each
of the previous 3 calendar years;
``(IV) the known and estimated
levels of domestic production in the
calendar year and each of the previous
three calendar years, including the
levels of domestic production if the
drug is a prescription drug, as
determined under the Federal Food, Drug,
and Cosmetic Act, for which a listing
[[Page 132 STAT. 4141]]
is in effect under section 202 of the
Controlled Substances Act (21 U.S.C.
812);
``(V) the average street price for
the calendar year and the highest known
street price during the preceding 10-
year period; and
``(VI) to the extent practicable,
related prosecutions by State, local,
and Tribal governments;
``(ii) data sufficient to show the frequency
of use of such substance, including--
``(I) use of such substance in the
workplace and productivity lost by such
use;
``(II) use of such substance by
arrestees, probationers, and parolees;
``(III) crime and criminal activity
related to such substance;
``(IV) to the extent practicable,
related prosecutions by State, local,
and Tribal governments;
``(B) For the calendar year and each of the previous
three years data sufficient to show, disaggregated by
State and, to the extent feasible, by region within a
State, county, or city, the following:
``(i) The number of fatal and non-fatal
overdoses caused by each drug identified under
subparagraph (A)(i).
``(ii) The prevalence of substance use
disorders.
``(iii) The number of individuals who have
received substance use disorder treatment,
including medication assisted treatment, for a
substance use disorder, including treatment
provided through publicly-financed health care
programs.
``(iv) The extent of the unmet need for
substance use disorder treatment, including the
unmet need for medication-assisted treatment.
``(C) Data sufficient to show the extent of
prescription drug diversion, trafficking, and misuse in
the calendar year and each of the previous 3 calendar
years.
``(D) Any quantifiable measures the Director
determines to be appropriate to detail progress toward
the achievement of the goals of the National Drug
Control Strategy.
``(g) Development of an Annual National Drug Control Assessment.--
``(1) Timing.--Not later than the first Monday in February
of each year, the Director shall submit to the President,
Congress, and the appropriate congressional committees, a report
assessing the progress of each National Drug Control Program
Agency toward achieving each goal, objective, and target
contained in the National Drug Control Strategy applicable to
the prior fiscal year.
``(2) Process for development of the annual assessment.--Not
later than November 1 of each year, the head of each National
Drug Control Program Agency shall submit, in accordance with
guidance issued by the Director, to the Director an evaluation
of progress by the agency with respect to the National Drug
Control Strategy goals using the performance measures for the
agency developed under this title, including progress with
respect to--
[[Page 132 STAT. 4142]]
``(A) success in achieving the goals of the National
Drug Control Strategy;
``(B) success in reducing domestic and foreign
sources of illegal drugs;
``(C) success in expanding access to and increasing
the effectiveness of substance use disorder treatment;
``(D) success in protecting the borders of the
United States (and in particular the Southwestern border
of the United States) from penetration by illegal
narcotics;
``(E) success in reducing crime associated with drug
use in the United States;
``(F) success in reducing the negative health and
social consequences of drug use in the United States;
``(G) implementation of evidence-based substance use
disorder treatment and prevention programs in the United
States and improvements in the adequacy and
effectiveness of such programs; and
``(H) success in increasing the prevention of
illicit drug use.
``(3) Contents of the annual assessment.--The Director shall
include in the annual assessment required under paragraph (1)--
``(A) a summary of each evaluation received by the
Director under paragraph (2);
``(B) a summary of the progress of each National
Drug Control Program Agency toward the National Drug
Control Strategy goals of the agency using the
performance measures for the agency developed under this
chapter;
``(C) an assessment of the effectiveness of each
National Drug Control Program Agency and program in
achieving the National Drug Control Strategy for the
previous year, including a specific evaluation of
whether the applicable goals, measures, objectives, and
targets for the previous year were met; and
``(D) the assessments required under this subsection
shall be based on the Performance Measurement System.''.
(b) Technical and Conforming Amendments.--
(1) Section 704(b) of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1703(b)) is
amended--
(A) by striking paragraphs (13) and (17); and
(B) in paragraph (14)(A), by striking ``paragraph
(13)'' and inserting ``section 706(g)(2)''.
(2) The Office of National Drug Control Policy
Reauthorization Act of 2006 (Public Law 109-469; 120 Stat.
3502) <<NOTE: 21 USC 1705 notes.>> is amended by striking
sections 1110 and 1110A.
SEC. 8222. TECHNICAL AND CONFORMING AMENDMENTS TO THE OFFICE OF
NATIONAL DRUG CONTROL POLICY
REAUTHORIZATION ACT OF 1998.
The Office of National Drug Control Policy Reauthorization Act of
1998 (21 U.S.C. 1701 et seq.) is amended--
(1) by striking section 703(b) (21 U.S.C. 1702(b));
(2) in section 704 (21 U.S.C. 1703)--
(A) in subsection (c)--
(i) in paragraph (3)(C)--
[[Page 132 STAT. 4143]]
(I) in the matter before clause (i),
by inserting ``requests a level of
funding that will not enable achievement
of the goals of the National Drug
Control Strategy, including'' after
``request that'';
(II) in clause (iii)--
(aa) by striking ``drug
treatment'' and inserting
``substance use disorder
prevention and treatment''; and
(bb) by striking the
semicolon at the end and
inserting ``; and'';
(III) by striking clauses (iv),
(vi), and (vii);
(IV) by redesignating clause (v) as
clause (iv); and
(V) in clause (iv), as so
redesignated, by striking the semicolon
and inserting a period;
(ii) in paragraph (4)(A), by striking
``$1,000,000'' and inserting ``$5,000,000 or 10
percent of a specific program or account''; and
(B) in subsection (f)--
(i) by striking the first paragraph (5); and
(ii) by striking the second paragraph (4); and
(3) by striking section 708 (21 U.S.C. 1707).
Subtitle L--Budgetary Effects
SEC. 8231. BUDGETARY EFFECT.
(a) In General.--The budgetary effects of this Act shall not be
entered on either PAYGO scorecard maintained pursuant to section 4(d) of
the Statutory Pay-As-You-Go Act of 2010 (2 U.S.C. 933(d)).
(b) Senate PAYGO Scorecards.--The budgetary effects of this Act
shall not be entered on any PAYGO scorecard maintained for purposes of
section 4106 of H. Con. Res. 71 (115th Congress).
Approved October 24, 2018.
LEGISLATIVE HISTORY--H.R. 6:
---------------------------------------------------------------------------
CONGRESSIONAL RECORD, Vol. 164 (2018):
June 22, considered and passed House.
Sept. 17, considered and passed Senate, amended.
Sept. 28, House concurred in Senate amendment with an
amendment pursuant to H. Res. 1099.
Oct. 3, Senate concurred in House amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2018):
Oct. 24, Presidential remarks and statement.
<all>
Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 485.
Measure laid before Senate by unanimous consent. (consideration: CR S6159-6180)
Passed/agreed to in Senate: Passed Senate with an amendment by Yea-Nay Vote. 99 - 1. Record Vote Number: 210.
Roll Call #210 (Senate)Passed Senate with an amendment by Yea-Nay Vote. 99 - 1. Record Vote Number: 210.
Roll Call #210 (Senate)Message on Senate action sent to the House.
Resolving differences -- House actions: House agreed to Senate amendment with an amendment pursuant to H. Res. 1099.
House agreed to Senate amendment with an amendment pursuant to H. Res. 1099.
Message on House action received in Senate and at desk: House amendment to Senate amendment.
Measure laid before Senate by unanimous consent. (consideration: CR S6467-6483)
Enacted as Public Law 115-271
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Motion by Senator Thune to concur in the House amendment to the Senate amendment to H.R. 6 made in Senate.
Resolving differences -- Senate actions: Senate agreed to the House amendment to the Senate amendment to H.R. 6. by Yea-Nay Vote. 98 - 1. Record Vote Number: 221.
Roll Call #221 (Senate)Senate agreed to the House amendment to the Senate amendment to H.R. 6. by Yea-Nay Vote. 98 - 1. Record Vote Number: 221.
Roll Call #221 (Senate)Message on Senate action sent to the House.
Presented to President.
Presented to President.
Signed by President.
Signed by President.
Became Public Law No: 115-271.
Became Public Law No: 115-271.