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#SubHealth Votes to Advance 57 Bills to Combat the Opioid Crisis, Reauthorization of ADUFA and AGDUFA


48 Bills to Combat the Opioid Crisis Passed by Voice Vote

WASHINGTON, DC – The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today advanced 57 bills to the full Energy and Commerce Committee. Of the bills, 56 were focused on ways to help combat the opioid crisis. #SubHealth also considered the bipartisan, bicameral reauthorization of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA).

Speaking about the bills up for consideration to combat the opioid crisis, #SubHealth Chairman Burgess stated, “Many of these bills are a product of bipartisan effort and compromise. Taken together, the bills before us today will improve access to care for individuals suffering from substance use disorder, provide our health care system with tools and resources it needs to care for patients, and help prevent future misuse of opioids. … Some of these bills remain in discussion draft form intentionally, signaling our commitment to working with members and stakeholders to get technical details right so our agencies can implement these promising solutions in a timely manner.”

In total, #SubHealth advanced:

  • 57 bills to the #FullCmte
  • 35 passed by voice votes
  • 13 passed un bloc
  • 9 passed by individual roll call votes

#SubHealth advanced the following bills:

H.R. 3331, To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology, authored by Rep. Lynn Jenkins (R-KS). H.R. 3331 passed #SubHealth by voice vote.

H.R. __, Welcome to Medicare, will add a pain assessment as part of the Welcome to Medicare initial examination and provide intervention about non-opioid alternatives, as appropriate. H.R. __ passed #SubHealth by voice vote.

H.R. __, Post-Surgical Injections as an Opioid Alternative, will seek to incentivize post-surgical injections as a pain treatment alternative to opioids by reversing a reimbursement cut for these treatments. H.R. __ passed #SubHealth by a vote of 17-10.

H.R. __, Alternative Payment Model for Treating Substance Use Disorder, will create demonstration project for an Alternative Payment Model for treating substance use disorder.  This model includes the development of measures to evaluate the quality and outcomes of treatment. H.R. __ passed #SubHealth by voice vote.

H.R. __, Use of Telehealth to Treat Opioid Use Disorder, will instruct the Centers for Medicare and Medicaid Services (CMS) to evaluate the utilization of telehealth services in treating opioid use disorder. H.R. __ passed #SubHealth by voice vote.

H.R. __, Incentivizing Non-Opioid Drugs, will create a temporary pass through payment to encourage the development of non-opioid drugs for post-surgical pain management in Medicare. H.R. __ passed #SubHealth by a vote of 18-11.

H.R. 3528, Every Prescription Conveyed Securely Act, authored by Reps. Katherine Clark (D-MA) and Markwayne Mullin (R-OK), will require e-prescribing, with exceptions, for coverage of prescription drugs that are controlled substances under the Medicare Part D program. H.R. 3528 passed #SubHealth, as amended, by voice vote.

H.R. __, Mandatory Lock-In, will build off of work done in the Comprehensive Addiction Recovery Act (CARA), and require prescription drug plan sponsors under the Medicare program establish drug management programs for at-risk beneficiaries. H.R. __ passed #SubHealth by voice vote.

H.R. __, Beneficiary Education, will require prescription drug plans under Medicare Part D to include information on the adverse effects of opioid overutilization and of coverage of non-pharmacological therapies and non-opioid medications or devices used to treat pain. H.R. __ passed #SubHealth by voice vote.

H.R. 5582, the Abuse Deterrent Access Act of 2018, authored by Rep. Buddy Carter (R-GA), will direct CMS to evaluate the use of abuse-deterrent opioids in Medicare plans. H.R. 5582 passed #SubHealth by voice vote.

#SubHealth passed the following 13 provisions en bloc:

  • H.R. __, CMS Action Plan, will call for the establishment of an Action Plan including studies, reports to Congress, and meetings with stakeholders for the purpose of addressing the opioid crisis.
  • H.R. __, Adding Resources on Non-Opioid Alternatives to the Medicare Handbook, will direct CMS to compile education resources for beneficiaries regarding opioid use, pain management, and alternative pain management treatments, and include these resources in the “Medicare and You” Handbook.
  • H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018, authored by Rep. David Schweikert (R-AZ), seeks to standardize electronic prior authorization under Medicare Part D.
  • H.R. __, Prescriber Notification, will require CMS to, in consultation with stakeholders, establish a threshold, based on specialty and geographic area, for which a prescriber would be considered an outlier opioid prescriber. CMS would then be responsible for notifying prescribers identified as outliers of their status.
  • H.R. __, Prescriber Education, will direct CMS to work with Quality Improvement Organizations to engage in outreach with prescribers identified as clinical outliers to share best practices.
  • H.R. __, Medication Therapy Management (MTM) Expansion, will add beneficiaries at-risk for prescription drug abuse to the list of targeted beneficiaries to be eligible for MTM under Part D.
  • H.R. __, CMS/Plan Sharing, will help facilitate communication between MA organizations, Part D plan sponsors, and CMS relating to substantiated fraud, waste, and abuse investigations.
  • H.R. 449, Synthetic Drug Awareness Act of 2017, authored by Rep. Hakeem Jeffries (D-NY), will require the U.S. Surgeon General to submit a comprehensive report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 in order to further educate parents and the medical community on the health effects of synthetics. An amendment to H.R. 449, offered by #SubHealth Ranking Member Gene Green (D-TX), also passed.
  • H.R. 5002, ACE Research Act, authored by Rep. Debbie Dingell (D-MI) and #SubEnergy Chairman Fred Upton (R-MI), will provide the National Institutes of Health (NIH) with new, flexible authorities to conduct innovative research and spur urgently needed research on new non-addictive pain medications.
  • H.R. 5009, Jessie’s Law, authored by Reps. Tim Walberg (R-MI) and Debbie Dingell (D-MI), will ensure medical professionals have access to a consenting patient’s complete health history when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and disseminate best practices regarding the prominent display of substance use disorder (SUD) history in patient records of patients who have previously provided this information to a health care provider.
  • H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act of 2018, authored by Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY), will create a loan repayment program for SUD treatment providers. Specifically, the bill will offer student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program will be available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals.
  • H.R. 5261, TEACH to Combat Addiction Act of 2018, authored by Rep. Bill Johnson (R-OH), will support Centers of Excellence, or institutions of learning that have championed SUD treatment and pain management education to improve how health professionals are taught about both SUD and pain. An amendment in the nature of a substitute (AINS) to H.R. 5261, offered by Chairman Burgess, also passed.
  • H.R. __, To improve fentanyl testing and surveillance, authored by Rep. Ann Kuster (D-NH), will provide grants to federal, state, and local agencies for the establishment or operation of public health laboratories to detect fentanyl, its analogs, and other synthetic opioids.

H.R. 1925, At-Risk Youth Medicaid Protection Act of 2017, authored by Rep. Tony Cardenas (D-CA), will prohibit state Medicaid programs from terminating a juvenile’s medical assistance eligibility because the juvenile is incarcerated. A state may suspend coverage while the juvenile is an inmate, but must restore coverage upon release without requiring a new application unless the individual no longer meets the eligibility requirements for medical assistance. A state must process an application submitted by, or on behalf of, an incarcerated juvenile, notwithstanding that the juvenile is an inmate. H.R. 1925 passed #SubHealth by voice vote, as amended.

H.R. 3192, CHIP Mental Health Parity Act, authored by Rep. Joseph Kennedy, III (D-MA). The Children’s Health Insurance Program (CHIP) provides health coverage to eligible children, through both Medicaid and separate CHIP programs. H.R. 3192 will require all CHIP plans to cover treatment of mental illness and substance use disorders. H.R. 3192 passed #SubHealth by voice vote.

H.R. __, Incentives to Create Medicaid Health Homes to Treat Substance Use Disorder, will amend Section 1945 of Title XIX to incentivize states to create health homes for Medicaid beneficiaries with substance use disorder. This bill extends the enhanced match from 8 quarters to 12 quarters so long as states meet quality, cost, and access targets. H.R. __ passed #SubHealth by voice vote.

H.R. __, Medicaid IMD ADDITIONAL INFO Act, will direct the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on IMDs. The study will report on the requirements, standards, and oversight that state Medicaid programs have for IMDs. MACPAC, considering input from stakeholders, will summarize the findings and make recommendations on improvements and best practices by January 2020. H.R. __ passed #SubHealth by voice vote.

H.R. __, Require Medicaid Programs to Report on All Core Behavioral Health Measures. A more complete view of behavioral health quality of care will inform Congress, CMS, and stakeholders on how to target improvement moving forward. H.R. __ passed #SubHealth by voice vote.

H.R. __, HUMAN CAPITAL in Medicaid Act, will provide enhanced federal medical assistance percentage to use toward hiring and retaining senior leadership for Medicaid programs who meet certain quantifiable professional standards. This policy change improves the ability of state Medicaid programs to recruit and retain high caliber private sector talent to manage state Medicaid programs, and will help reduce the short duration of most Medicaid directors (which averages about 18 months). The enhanced funding will sunset in 2026. H.R. __ passed #SubHealth by a vote of 18-12.

H.R. __, Medicaid Pharmaceutical Home Act, will require all states to have a lock-in program that identifies at-risk Medicaid beneficiaries and assigns them to a pharmacy home program that sets reasonable limits on the number of prescribers and dispensers they may utilize, whether under a fee-for-service or managed care arrangement. H.R. __ passed #SubHealth by a vote of 18-14.

H.R. __, Limited repeal of the IMD Exclusion for adult Medicaid beneficiaries with substance use disorder, will allow states to receive federal Medicaid matching dollars for up to a total of 90 days per year for services in an IMD for Medicaid beneficiaries with a substance use disorder. Beneficiaries would need to be assessed after the first 30 days to determine if continued care (up to 60 more days) is medically necessary. H.R. __ passed #SubHealth by a vote of 16-10.

H.R. __, Medicaid DRUG Improvement Act, will require all state Medicaid programs to use common sense drug utilization review activities to help combat the opioid crisis. States will be required to have state-determined limitations in place for opioid refills, monitor concurrent prescribing of opioids and other drugs (such as benzodiazepines and antipsychotics), monitor antipsychotic prescribing for children, and have at least one buprenorphine/naloxone combination drug on the Medicaid drug formulary. H.R. __ passed #SubHealth by a vote of 18-9.

H.R. __, Medicaid PARTNERSHIP Act, will require the Medicaid program in each state to integrate prescription drug monitoring program (PDMP) usage into Medicaid providers’ and pharmacists’ clinical workflow. This bill also establishes basic standard criteria (based on industry best practices) that a PDMP must meet to be counted as a qualified PDMP. The bill would require states to report to the CMS on how their PDMPs are working and the number of covered providers who are using the PDMPs, as well statewide trends in controlled substance utilization. H.R. __ passed #SubHealth by a vote of 18-9.

H.R. __, Medicaid Graduate Medical Education Transparency Act, will improve transparency in the Graduate Medical Education (GME) program by requiring state Medicaid programs to periodically report to CMS data and information on how GME funds are being used to support physician training. Additionally, the state Medicaid program is required to report specific information on how physicians are trained in specialties that are essential in the opioid crisis (i.e., psychiatry, addiction medicine, etc.) and how GME recipients are using Medicaid funds to train physicians on substance use disorder. H.R. __ passed #SubHealth by a vote of 18-10.

H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, authored by Reps. Mark DeSaulnier (D-CA) and Buddy Carter (R-GA), will help pharmacists detect fraudulent prescriptions. H.R. 4275 will help develop and disseminate materials, giving pharmacists greater understanding and ability to decline to fill controlled substances when they suspect the prescriptions are fraudulent, forged, or appear to be for abuse or diversion. H.R. 4275 passed #SubHealth, as amended, by voice vote.

H.R. 5041, Safe Disposal of Unused Medication Act, authored by Reps. Tim Walberg and Debbie Dingell, will help reduce the number of unused controlled substances at risk of diversion or misuse by allowing hospice workers to safely dispose of these medications in patients’ homes. H.R. 5041 passed #SubHealth, as amended, by voice vote.

H.R. 5202, Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, authored by Reps. Ryan Costello (R-PA) and Rick Nolan (D-MN) will make long overdue updates federal law to improve dispensing of implantable and injectable therapies – developed to make abuse, misuse, and diversion more difficult. H.R. 5202 passed #SubHealth by voice vote.

H.R. 5483, Special Registration for Telemedicine Clarification Act of 2018, a discussion draft written by Reps. Buddy Carter and Rep. Cheri Bustos (D-IL) will clarify telemedicine waivers. Federal law permits the Attorney General to issue a special registration to health care providers to prescribe controlled substances via telemedicine in legitimate emergency situations, such as a lack of access to an in-person specialist. Unfortunately, the waiver process has never been implemented through regulation, and some patients do not have the emergency access they need to treatment. This bipartisan draft directs the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 30 days of passage of the law. H.R. 5483 passed #SubHealth, as amended, by voice vote.

H.R. __, Improving Access to Remote Behavioral Health Treatment Act of 2018, authored by Reps. Gregg Harper (R-MS) and Rep. Doris Matsui (D-CA) will expand access for patients in rural and underserved communities who may live near community mental health or addiction treatment centers, but not a hospital or state-licensed clinic. Without a DEA registration these health facilities do not qualify for the Ryan Haight Act’s telemedicine exception, and are unable to provide care to patients in need. This proposal would direct the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 120 days of passage of the law for these treatment facilities to register with the DEA to engage in the practice of telemedicine. H.R. __ passed #SubHealth by voice vote.

H.R. __, To amend title XIX of the Social Security Act to provide for Medicaid coverage protections for pregnant and postpartum women while receiving inpatient treatment for a substance use disorder. H.R. __ passed #SubHealth by voice vote.

H.R. __, 21st Century Tools for Pain and Addiction Treatments, will spur innovation in the development of nonaddictive treatments for pain and addiction by clarifying how such products can qualify for FDA pathways like breakthrough therapy designation and the accelerated approval program. H.R. __ passed #SubHealth by a vote of 19-10.

H.R. __, FDA and International Mail, authored by #SubCommTech Chairman Marsha Blackburn (R-TN), will streamline and enhance tools the Food and Drug Administration (FDA) has available to effectively intercept illegal products. In doing so, this bill will create efficiencies for government resources and better protect American citizens from dangerous imported substances. H.R. __ passed #SubHealth, as amended, by voice vote.

H.R. 5228, Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, authored by Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), will strengthen FDA’s authority to detain, refuse, and destroy substances identified through international mail facilities, improve their enforcement mechanisms, and provide funding to combat the influx of illegally manufactured opioids into the country. H.R. 5228 passed #SubHealth, as amended, by voice vote.

H.R. __, FDA Opioid Sparing, authored by Reps. Barbara Comstock (R-VA) and Ben Ray Lujan (D-NM), will direct FDA to articulate clear data collection methods that could be used to inform opioid-sparing labeling claims for products that may replace, delay, or reduce or the use of opioid analgesics. H.R. __ passed #SubHealth by voice vote.

H.R. __, FDA Misuse/Abuse, authored by #SubHealth Ranking Member Gene Green (D-TX), will clarify FDA’s authority to consider misuse and abuse as part of the drug approval and assessment process for opioids. It would also augment FDA’s capacity to take necessary action to minimize the public health consequences of opioid misuse and abuse. H.R. __ passed #SubHealth by voice vote.

H.R. __, FDA Packaging and Disposal, authored by Rep. Richard Hudson (R-NC), will direct FDA to work with manufacturers to establish programs for efficient return or destruction of unused Schedule II drugs, with an emphasis on opioids. These methods could include mail-back pouches to secure facilities for incineration, or methods to immediately inactivate/render unattractive unused drugs. In addition, this bill will facilitate utilization of packaging that may reduce overprescribing of opioids. Finally, this bill will require the Government Accountability Office (GAO) to study new and innovative technologies that claim to be able to safely dispose of opioids and other unused medications. GAO would review and detail the effectiveness of these disposal methods. H.R. __ passed #SubHealth by voice vote.

H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017, authored by #SubDCCP Chairman Bob Latta (R-OH), will direct HHS to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts and strategies to combat the opioid crisis. H.R. 4284 passed #SubHealth, as amended, by voice vote.

H.R. 4684, Ensuring Access to Quality Sober Living Act of 2017, authored by Reps. Judy Chu (D-CA), Mimi Walters (R-CA), Raul Ruiz (D-CA), and Gus Bilirakis (R-FL) will authorize SAMHSA to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment for sustained recovery from SUD. H.R. 4684, passed #SubHealth, as amended, by voice vote.

H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act of 2018, authored by #SubEnvironment Vice Chairman David McKinley (R-WV) and Michael Doyle (D-PA), will provide resources for hospitals to develop protocols on discharging patients who have presented with an opioid overdose. These protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patient’s needs. H.R. 5176 passed #SubHealth, as amended, by voice vote.

H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act, authored by Reps. Bill Pascrell, Jr. (D-NJ) and David McKinley, will establish a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. H.R. 5197 passed #SubHealth, as amended, by voice vote.

H.R. 5272, Reinforcing Evidence-based Standards Under Law in Treating Substance abuse (RESULTS) Act of 2018, authored by Reps. Steve Stivers (R-OH) and Eliot Engel (D-NY), will require entities applying for funding that would be used to support programs or activities that address mental health or SUD, to submit materials to HHS demonstrating that the programs or activities are evidence-based. H.R. 5272 passed #SubHealth, as amended, by voice vote.

H.R. 5327, Comprehensive Opioid Recovery Centers Act 2018, authored by #SubHealth Vice Chairman Brett Guthrie (R-KY) and #SubHealth Ranking Member Green, will establish Comprehensive Opioid Recovery Centers (CORCs) that will serve as models for comprehensive treatment and recovery. CORCs would utilize the full range of FDA-approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery as productive members of society. H.R. 5327 passed #SubHealth, as amended, by voice vote.

H.R. 5329, Poison Center Network Enhancement Act of 2018, authored by Reps. Susan Brooks (R-IN) and Eliot Engel, will reauthorize the important network of centers within the National Poison Data System that offer free, confidential, expert medical advice 24 hours a day, seven days a week.  Oftentimes these programs serve as the primary resource for poisoning information and help reduce Emergency Room visits through in-home treatment. H.R. 5329 passed #SubHealth by voice vote.

H.R. 5353, Eliminating Opioid-Related Infectious Diseases Act of 2018, authored by #SubCommTech Vice Chairman Leonard Lance (R-NJ) and Rep. Joe Kennedy (D-MA), will authorize the CDC to undertake an injection drug use-associated infection elimination initiative and work with states to improve education, surveillance and treatment of injection drug-use associated infections, like human immunodeficiency virus (HIV) and hepatitis. H.R. 5353 passed #SubHealth, as amended, by voice vote.

H.R. __, To enhance and improve state-run prescription drug monitoring programs, authored by #SubOversight Vice Chairman Morgan Griffith (R-VA), will improve current federal support for Prescription Drug Monitoring Programs (PDMPs) by requiring a coordinated effort amongst the Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Office of the National Coordinator for Health Information Technology to improve surveillance, data collection, and integration into physician clinical workflow so that timely, complete and accurate information will get into the hands of providers and dispensers, allowing them to make the best clinical decisions for their patients. H.R. __ passed #SubHealth by voice vote.

H.R. __, To support the peer support specialist workforce, authored by Reps. Ben Ray Lujan, and Johnson would increase the funding for the Comprehensive Addiction and Recovery Act’s Building Communities of Recovery Program and authorize HHS to award grants to peer support specialist organizations for the development and expansion of recovery services. H.R. __ passed #SubHealth by voice vote.

H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, authored by Rep. Markwayne Mullin (R-OK), will amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs. H.R. 5554 passed #SubHealth, as amended, by voice vote.

A background memo, electronic copies of the legislation, and live stream of the markup can be found online here. Amendment text and votes will be available at the same link as they are posted.


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