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H.R. 6: Abuse Deterrent Access Act of 2018

Title: Abuse Deterrent Access Act of 2018

Introduced: Jun 13, 2018 (115th Congress)

Sponsor: (No First Name Found) (No Last Name Found) [-]

Status: Signed by the President - Became Public Law No: 115-271.

Summary: 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 management programs and drug-review and utilization requirements for at-risk beneficiaries. (Sec. 1007) 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. 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. 2003) The initial examination for new Medicare enrollees must include an opioid-use disorder screening and prescription history review. (Sec. 2004) The bill temporarily freezes Medicare payment at 2016 levels for specified spinal surgery outpatient procedures that are conducted in ambulatory surgical centers. (Sec. 2005) In general, prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs. (Sec. 2006) Medicare prescription drug plan sponsors must establish drug-management programs for at-risk beneficiaries. (Sec. 2007) The bill also requires coverage for services provided by certified opioid-treatment programs under Medicare. TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS (Sec. 3002) The bill establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids, including a new grant program for public health laboratories and a pilot program for point-of-use drug testing. (Sec. 3003) 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. 3007) The Department of Health and Human Services (HHS) must survey entities that receive federal funds for substance-use disorder treatment services; the scope of the survey must include the types of services provided, the populations served, and the adequacy of services. 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. 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 institutions for mental diseases (IMDs), including the number and type of IMDs in each sampled state, services offered, and funding sources. Subtitle C--CHIP Mental Health Parity CHIP Mental Health 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 prescription drug monitoring program (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. 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 Medicare Advantage (MA). Subtitle C--Medicare Opioid Safety Education Medicare Opioid Safety Education Act of 2018 (Sec. 6022) 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. Specifically, a federally qualified health center or rural health clinic may receive payment for each health care practitioner who becomes certified on or after January 1, 2019, to prescribe or dispense methadone, buprenorphine, or suboxone (medications used to treat opioid-use disorders). (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--Stop Excessive Narcotics in Our Retirement Communities Protection Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 or the SENIOR Communities Protection Act of 2018 (Sec. 6102) The bill authorizes the suspension of payments to a pharmacy under the Medicare prescription drug benefit and MA prescription drug plans pending the investigation of a credible allegation of fraud by the pharmacy. Subtitle L--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. 6112) 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. 6113) 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. 6114) 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. TITLE VII--OTHER HEALTH PROVISIONS Subtitle A--Synthetic Drug Awareness Synthetic Drug Awareness Act of 2018 (Sec. 7002) The bill requires the Surgeon General to report on the health effects of new psychoactive substances (also known as synthetic drugs). The report specifically relates to substances used by individuals aged 12 to 18 since January 2010. Examples of synthetic drugs include synthetic marijuana (also known as "spice") and synthetic amphetamines (also known as "bath salts"). Subtitle B--Empowering Pharmacists in the Fight against Opioid Abuse Empowering Pharmacists in the Fight Against Opioid Abuse Act (Sec. 7012) 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 indicative of abuse or diversion. Subtitle C-- Indexing Narcotics, Fentanyl, and Opioids Indexing Narcotics, Fentanyl, and Opioids Act of 2018 or the INFO Act (Sec. 7022) 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 recommends alternatives to controlled substances for pain management. Subtitle D--Ensuring Access to Quality Sober Living Ensuring Access to Quality Sober Living Act of 2018 (Sec. 7032) The bill amends the Public Health Service Act to require HHS 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 Advancing Cutting Edge Research Act or the ACE Research Act (Sec. 7042) 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 Jessie's Law (Sec. 7052) 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. 7053) 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--Safe Disposal of Unused Medication Safe Disposal of Unused Medication Act (Sec. 7062) The bill amends the Controlled Substances Act to allow a hospice employee to handle lawfully dispensed controlled substances of a deceased hospice patient to assist with disposal of the controlled substances, so long as such disposal occurs onsite in accordance with applicable law. Subtitle H--Substance Use Disorder Workforce Loan Repayment Substance Use Disorder Workforce Loan Repayment Act of 2018 (Sec. 7072) 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. Subtitle I--Preventing Overdoses While in Emergency Rooms Preventing Overdoses While in Emergency Rooms Act of 2018 (Sec. 7082) HHS must establish a grant program to develop protocols for discharging patients who are treated for a drug overdose and to enhance the integration and coordination of postdischarge care for individuals with a substance-use disorder. Subtitle J--Alternatives to Opioids in the Emergency Department Alternatives to Opioids in the Emergency Department Act or the ALTO Act (Sec. 7092) HHS must also establish a demonstration program through which hospitals and emergency departments receive grants to support alternative pain-management protocols and treatments that limit the use and prescription of opioids in emergency departments. Subtitle K--Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act (Sec. 7102) The bill amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Food and Drug Administration (FDA) to destroy illegally imported or hazardous drugs. (Sec. 7103) The bill requires the FDA to halt the distribution of a drug that is found to be a public hazard and, if appropriate, order the drug to be recalled. (Sec. 7104) 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. 7105) The bill establishes a fund to support efforts by the FDA to address the opioid epidemic, including educational campaigns and inspections of imported drugs. (Sec. 7106) The FDA must deny an application for a new drug that contains a controlled substance and that is found to be unsafe due to a potential for misuse or abuse. Subtitle L--Treatment, Education, and Community Help to Combat Addiction Treatment, Education, and Community Help to Combat Addiction Act of 2018 or the TEACH to Combat Addiction Act of 2018 (Sec. 7112) The bill requires the Substance Abuse and Mental Health Services Administration (SAMHSA) to designate Regional Centers of Excellence in Substance Use Disorder Education. Such centers must improve pain-management and substance-use disorder education through the distribution of evidence-based curricula for health care professional schools. Subtitle M--Guidance from National Mental Health and Substance Use Policy Laboratory (Sec. 7121) 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 N--Comprehensive Opioid Recovery Centers Comprehensive Opioid Recovery Centers Act of 2018 (Sec. 7132) 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 O--Poison Center Network Enhancement Poison Center Network Enhancement Act of 2018 (Sec. 7142) The bill reauthorizes through FY2023 and revises the national toll-free phone number, public-awareness campaign, and grant program relating to poison-control centers, including provisions that specifically address the role of poison-control centers in combating opioid misuse. Subtitle P--Eliminating Opioid Related Infectious Diseases Eliminating Opioid Related Infectious Diseases Act of 2018 (Sec. 7152) HHS must expand its 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 Q--Better Pain Management through Better Data Better Pain Management Through Better Data Act of 2018 (Sec. 7162) The FDA must develop guidance regarding alternative methods for collecting data on opioid sparing (i.e., the use of drugs that reduce pain while also allowing reduced use or avoidance of oral opioids) and using such information in product labels. Subtitle R--Special Registration for Telemedicine Clarification Special Registration for Telemedicine Clarification Act of 2018 (Sec. 7172) The bill establishes a deadline for the Drug Enforcement Administration (DEA) to promulgate regulations for the special registration of practitioners to practice telemedicine. Subtitle S--Peer Support Communities of Recovery Peer Support Communities of Recovery Act (Sec. 7182) SAMHSA may award grants to nonprofits that focus on substance-use disorder in order to establish regional technical-assistance centers. Such centers must implement peer-delivered addiction-recovery support services and establish recovery community organizations and centers. Subtitle T--Stop Illicit Drug Importation Stop Illicit Drug Importation Act of 2018 (Sec. 7192) The bill prohibits the importation of drugs containing substances that have been requested, or are under review, to be scheduled as controlled substances. (Sec. 7194) 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. Subtitle U--Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigation Strategies Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 or the CONNECTIONS Act (Sec. 7202) The Centers for Disease Control and Prevention 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. 7203) 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 V--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. 7212) The FDA may require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs. Subtitle W--Postapproval study requirements (Sec. 7221) The FDA may also require a post-approval study for certain drugs that contain controlled substances in order to assess potential reduced effectiveness. 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--Recognizing Early Childhood Trauma Related to Substance Abuse Recognizing Early Childhood Trauma Related to Substance Abuse Act of 2018 (Sec. 8012) 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 C--Assisting States' Implementation of Plans of Safe Care Assisting States' Implementation of Plans of Safe Care Act (Sec. 8022) HHS must also provide states with guidance and technical assistance regarding their plans under the Child Abuse Prevention and Treatment Act for assuring the safe care of infants affected by prenatal substance use. Subtitle D--Improving the Federal Response to Families Impacted by Substance Use Disorder Improving the Federal Response to Families Impacted by Substance Use Disorder Act (Sec. 8032) The bill establishes the Interagency Task Force to Improve the Federal Response to Families Impacted by Substance Use Disorders to recommend ways to better coordinate the responses of federal agencies to substance-use disorders and the opioid crisis. Subtitle E--Establishment of an Advisory Committee on Opioids and the Workplace (Sec. 8041) The Department of Labor must establish an Advisory Committee on Opioids and the Workplace to recommend ways to address the impact of opioid abuse on the workplace and to support workers who abuse opioids. Subtitle F--Veterans Treatment Court Improvement Veterans Treatment Court Improvement Act of 2018 (Sec. 8052) The Department of Veterans Affairs (VA) must hire at least 50 Veterans Justice Outreach Specialists under the Veterans Justice Outreach Program. Each of these specialists must serve as part of a justice team in a veterans treatment court or other veteran-focused court. Subtitle G--Peer Support Counseling Program for Women Veterans (Sec. 8061) The 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 H--Treating Barriers to Prosperity Treating Barriers to Prosperity Act of 2018 (Sec. 8072) The bill allows the Appalachian Regional Commission to support projects and activities addressing drug abuse, such as infrastructure development for telemedicine. Subtitle I--Supporting Grandparents Raising Grandchildren Supporting Grandparents Raising Grandchildren Act (Sec. 8083) The bill establishes an Advisory Council to Support Grandparents Raising Grandchildren. The council must develop resources to help older relatives meet the needs of the children in their care and maintain their own health and emotional well-being. Subtitle J--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 the Department of Justice. TITLE IX--SITSA ACT Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 or the SITSA Act (Sec. 9002) The bill establishes a new, sixth schedule of controlled substances--schedule A. A drug or substance in schedule A has a chemical structure that is similar to a controlled substance in schedule I, II, III, IV, or V, and has a similar or greater depressive, stimulant, or hallucinogenic effect than a controlled substance in one of those schedules. The bill also authorizes, and establishes procedures for, the DEA to place a drug or substance in schedule A. The bill also establishes registration and labeling requirements, as well as criminal penalties, relating to schedule A substances. (Sec. 9012) 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. TITLE X--THRIVE ACT Transitional Housing for Recovery in Viable Environments Demonstration Program Act or the THRIVE Act (Sec. 10002) The bill amends the United States Housing Act of 1937 to require the Department of Housing and Urban Development to establish a five-year demonstration program for nonprofit organizations and tribally designated housing entities to provide low-income rental-assistance vouchers to individuals recovering from an opioid- or other substance-use disorder. TITLE XI--IMD CARE ACT Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act (Sec. 11002) The bill temporarily allows states to apply to receive federal Medicaid payment for services provided in IMDs and for other medically necessary services for enrollees (aged 21 to 64) with opioid-use or cocaine-use disorders. Services may be covered for a total of up to 30 days in a 12-month period for an eligible enrollee. States must include specified information in their applications, including plans to improve access to outpatient care. 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).


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