As detailed in The Wall Street Journal, Chairman Walden and #SubHealth Chairman Burgess announced three legislative hearings, each focused on different aspects of the crisis: helping communities balance enforcement and public safety; public health and prevention efforts; and insurance coverage and payment issues, all intended to promote treatment and recovery.
Energy and Commerce has been developing bipartisan ideas to combat the crisis for months. As part of that effort, more than 50 members testified before #SubHealth on Wednesday, October 11, 2017, for Member Day, an opportunity for members both on and off the committee to share personal and local stories, statistics, and potential solutions to combat the opioid crisis. For a recap of the day’s 12 panels or to watch archived testimony, click here. As part of our collaborative, bipartisan effort, many of the solutions proposed at Member Day will inform our legislative effort going forward.
February 28, 2018: “Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety.”
- Hearing Recap: “#SubHealth Reviews Legislation to Improve Patient Safety and Bolster Enforcement Tools in Midst of Opioid Crisis“
- This is the first of three legislative hearings and will review several bills pertaining to the Controlled Substances Act.
- In the following weeks, the committee will hold two additional legislative hearings, which will focus on legislation related to public health and prevention legislation as well as insurance coverage-related bills, all intended to promote treatment and recovery.
March 21 & 22, 2018: “Combating the Opioid Crisis: Prevention and Public Health Solutions.”
- This two-day hearing is the second of three legislative hearings and will focus on legislation related to public health and prevention.
The legislative ideas that were considered in the February 28 hearing are listed below:
H.R. 2851, the Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act, authored by Rep. John Katko (R-NY), will give law enforcement the tools they need to help get illicit synthetic drugs, like fentanyl, off our streets without compromising important public health and research protections. H.R. 2851 will also modernize scheduling guidelines to keep pace with the fast-changing nature of synthetic drugs.
H.R. 5041, the Safe Disposal of Unused Medication Act, authored by Reps. Tim Walberg (R-MI) and Debbie Dingell (D-MI), 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. __, the Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, a discussion draft written 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. __, the Special Registration for Telemedicine Clarification Act of 2018, a discussion draft written by Reps. Buddy Carter (R-GA) 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. __, the Improving Access to Remote Behavioral Health Treatment Act of 2018, a discussion draft written 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. __, the Tableting and Encapsulating Machine Regulation Act of 2018, authored by Rep. David Kustoff (R-TN), will make it tougher to traffick synthetic drugs. This bill will give the DEA the authority to regulate the use of tableting and encapsulating machines with requirements for the maintenance of records, inspections for verifying location and stated use, and security provisions.
H.R. 2063, the Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017, authored by Rep. Brad Schneider (D-IL), aims to improve provider understanding of pain management treatment guidelines and best practices, early detection of opioid addiction, and the treatment and management of opioid-dependent patients by requiring 12 hours of continuing medical education on the topic every three years.
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.
The legislative ideas to be considered in the March 21 & 22 hearing are listed below:
NOTE: Some bills have not received formal titles and instead are denoted by working descriptions.
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. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act (AINS), 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. __, 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. 5176, the Preventing Overdoses While in Emergency Rooms (POWER) Act, 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. 3545, the Overdose Prevention and Patient Safety Act (AINS), authored by Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR), will permit SUD records to be shared without patient consent, in accordance with Health Insurance Portability and Accountability Act (HIPAA), and only for very specific purposes. The bill would also increase the penalties in the event of disclosure, add breach notification requirements, and provide discrimination prohibitions to protect people seeking and receiving SUD treatment. *AINS
H.R. __, the Eliminating Opioid-Related Infectious Diseases Act, 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. 5261, the Treatment, Education, And Community Help (TEACH) to Combat Addiction Act, 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.
H.R. __, the Comprehensive Opioid Recovery Centers Act of 2018, authored by #SubHealth Vice Chairman Brett Guthrie (R-KY), 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. 5272, the Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) Act, 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.
Discussion Draft, PDMPs, 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. __, the 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. 5140, Tribal Addiction and Recovery Act of 2018 (TARA), authored by Rep. Mullin would make Indian tribes eligible to be direct grantees of State Targeted Response to the Opioid Crisis Grants to fight the opioid epidemic in Indian Country, reflecting the government-to-government relationship between Indian tribes and the United States. Tribes would receive their own $25 million allocation that they could apply directly to the federal government, instead of having to go through their states.
H.R. __, FDA Accelerated Approval & Breakthrough Therapy Status, will take steps to make FDA pathways like the accelerated approval program available to take on the opioid crisis, leading to expedited development and review of drugs which may demonstrate substantial improvement over available therapies.
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. __, FDA Opioid Sparing, authored by Rep. Barbara Comstock (R-VA), 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. 4684, the Ensuring Access to Quality Sober Living Act, 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. 5002, the Advancing Cutting Edge (ACE) Research Act, authored by Rep. Debbie Dingell 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. 5197, the 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. 5102, the 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. 449, the Synthetic Drug Awareness Act, 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.
H.R. 3692, the Addiction Treatment Access Improvement Act, authored by Rep. Paul Tonko (D-NY), will expand access to medication-assisted treatment (MAT) by allowing clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists to prescribe buprenorphine and permanently authorize non-physician providers to prescribe buprenorphine. The bill would also codify regulations that increased the cap on the number of patients a physician can treat with buprenorphine to 275 patients.
H.R. __, Fentanyl Testing, 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. __, Peer Support Specialists Workforce Grants, authored by Reps. Ben Ray Lujan (D-NM), 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. __, FDA Long-term Efficacy, authored by Rep. Jerry McNerney (D-CA), will enhance FDA’s authorities and enforcement tools to ensure timely post-marketing studies for chronically administered opioids.
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.
Last Congress, E&C led two major initiatives being signed into law that provide critical resources for combating the crisis: The Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act
- CARA includes 11 committee bills which ranged from additional resources to combat the epidemic to establishing an inter-agency task force to review, modify, and update best practices for pain management and how it is prescribed. In September 2017, HHS released $144.1 million, largely through CARA to help prevent and treat opioid addiction.
- The 21st Century Cures Act – Provides $1 billion in state grants to be applied to the fight on the front lines. The first half of these grants were issued in April 2017 and totaled $485 million. The second half will be issued in 2018.
October 2017 Full Committee Hearing Reviewing Previous Legislation and Federal Response to the Opioid Crisis
“The primary purpose of this hearing is to hear from the federal agencies charged with implementing the provisions of the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act,” said Chairman Walden during his opening remarks. “But it also allows this committee to have an important conversation with the Drug Enforcement Administration (DEA).”
During the full committee hearing on federal efforts to combat the opioid crisis, Chairman Walden grilled the DEA on their lack of cooperation or responsiveness to the committee’s ongoing investigation.
Chairman Walden detailed the committee’s ongoing bipartisan investigation into alleged pill dumping in the state of West Virginia, adding, “It is time for DEA to get this committee the information we need, and to do it quickly. No more dodges. No more delays.”