Senators Markey and Paul Introduce Bipartisan Legislation to Modernize, Improve Methadone Treatment Amid Skyrocketing Opioid Overdoses and Deaths

Bill would allow pharmacies to dispense methadone for opioid treatment for the first time, allow patients to access take-home doses earlier in treatment

Washington (February 10, 2022) -- Senators Edward J. Markey (D-Mass.) and Dr. Rand Paul (R-Ky.) today introduced the Opioid Treatment Access Act to improve access to life-saving methadone treatment for opioid-use disorder (OUD). The legislation would revise outdated regulations on methadone treatment for opioid-use disorder (OUD) by reducing the time in treatment required for patients to receive take-home doses of medication and allowing pharmacies to dispense methadone for OUD treatment for the first time. The bill also would codify a recent federal regulation allowing opioid treatment programs (OTPs) to add mobile treatment clinics and require the Substance Abuse and Mental Health Services Administration (SAMHSA) to study existing regulatory flexibilities on accessing treatment for OUD.

Prior to the COVID-19 pandemic, federal regulations required patients to make daily trips to opioid treatment clinics in order to receive doses of methadone. This process increased the stigma associated with methadone treatment and placed unnecessary burdens on patients. By expanding take-home doses and allowing pharmacy dispensing of methadone, the Opioid Treatment Access Act would make it easier for patients who work, have kids, or live far from opioid treatment programs to adhere to treatment regimens and stay in recovery.

Representative Donald Norcross (NJ-01) introduced the Opioid Treatment Access Act in the House of Representatives in December 2021.

"Opioid-related overdoses and deaths are the public health epidemic we aren't talking about. It's never been more important to modernize and expand how patients receive opioid treatment," said Senator Markey. "By decentralizing opioid treatment, making permanent expanded access to take home methadone, and allowing access to this life-saving treatment at pharmacies, we can expand access, create opportunity, and set more people on a pathway to recovery. This legislation will help break down barriers to treatment, reduce interruption of patients' work and family lives, destigmatize opioid-use disorder, and save lives."

"As a physician, I know the value of the doctor-patient relationship. This bipartisan legislation will return treatment decisions to health care providers, who know their patients best. Doing so will be another important step toward combating the opioid epidemic that has caused so much harm in Kentucky and our nation," said Dr. Paul.

A copy of the bill text can be found HERE.

The bipartisan Opioid Treatment Access Act would modernize and improve the process of obtaining methadone for opioid-use disorder (OUD) treatment by:

• Building on SAMHSA's COVID-19 exemptions that allow patients to receive longer take-home supplies of methadone;
• Allowing pharmacies to dispense methadone to OTP patients, rather than requiring patients to travel to clinics;
• Directing SAMHSA to conduct a full study on the impact of the COVID-19 methadone exemptions; and
• Codifying regulations that allow OTPs to operate mobile medication components without separate DEA registrations.

In March 2020, in response to the COVID-19 pandemic, SAMHSA eased restrictions on opioid treatment programs to allow providers to prescribe longer supplies of take-home methadone to patients in treatment. According to preliminary studies, and feedback from patients and providers, this change increased patient engagement in treatment with minimal incidents of misuse or diversion of methadone.

The Opioid Treatment Access Act is endorsed by: Addiction Professionals of North Carolina, AIDS United, Alcohol & Drug Abuse Certification Board of Georgia, American College of Academic Addiction Medicine (ACAAM), American College of Medical Toxicology (ACMT), American Counseling Association, American Hospital Association, American Medical Association, American Osteopathic Academy of Addiction Medicine, American Pharmacists Association, American Society of Addiction Medicine (ASAM), AmeriHealth Insurance, Behavioral Health Association of Providers, California Consortium of Addiction Programs & Professionals, CVS Health, Faces & Voices of Recovery, Grayken Center for Addiction at Boston Medical Center, Kennedy Forum, Kentucky Society of Addiction Medicine, Massachusetts Health & Hospital Association, Massachusetts Medical Society, Massachusetts Society of Addiction Medicine, NAMA Recovery, National Council for Mental Wellbeing, New Jersey Hospital Association, Opioid Task Force of Franklin County and the North Quabbin Region (MA), Partnership to End Addiction, Shatterproof, SMART Recovery, Talbot Legacy Centers, and Vizient and Young People in Recovery.

"The treatment of opioid use disorder with methadone has a long history and robust scientific evidence supporting its effectiveness, but U.S. federal law limits its availability to heavily regulated and commonly inaccessible opioid treatment programs - a structure that has implications for access to, and quality of, care. The Opioid Treatment Access Act represents a thoughtful expansion of access to a life-saving, effective medication for many Americans with opioid use disorder," said William F. Haning, MD, DLFAPA, DFASAM, president of the American Society of Addiction Medicine.

"NAMA Recovery's majority-patient Board of Directors acknowledges the critical and important role opioid treatment programs must play during the induction and stabilization of methadone treatment for opioid use disorder, but it is time access to treatment reflects the realities of patients' daily lives. The Opioid Treatment Access Act ensures access to comprehensive OTP services based on patient needs and pushes federal rulemaking beyond arbitrary time-in-treatment requirements to be more evidence-based. This legislation has the potential to save and restore many lives when opioid overdose deaths continue to spike to historically unprecedented levels," said Zachary Talbott, president of the National Alliance for Medication Assisted Recovery.

"As U.S. overdose deaths exceed 100,000 for the first time, and synthetic opioids like fentanyl dominate the drug supply, it is essential that we increase access to evidence-based treatments for opioid use disorder (OUD), such as methadone. Because of the stigma associated with addiction, patients are faced with multiple, unreasonable barriers when they try to access methadone. We would never ask anyone living with another life-threatening condition to tolerate this. We owe it to them to make addiction treatment as accessible as possible," said Miriam Komaromy, MD, FACP, DFASAM, Medical Director, Grayken Center for Addiction, Boston Medical Center.

"Massachusetts hospitals and health systems are proud to support this legislation as they continue to use every tool at their disposal to combat an intensifying opioid crisis. This proposal would enhance that set of tools by helping providers reach patients where they are, and by expanding access to treatment that has saved countless lives to date. MHA applauds Senator Markey and his co-sponsors for their leadership on this critical issue," said Leigh Simons Youmans, Senior Director, Healthcare Policy, Massachusetts Health and Hospital Association.

"Methadone is a lifesaving and critical component of treatment that can lead to recovery for many patients. The COVID-19 pandemic necessitated changes in treatment access and demonstrated that the availability of take-home methadone at the discretion of a physician serves to reduce daily patient visits to clinics and the stigma that all too often haunts those who seek lifesaving medical-assisted treatment. The Opioid Treatment Access Act will expand access to medication-assisted treatment for those living with opioid use disorder and peel away some of the restrictions and regulations that act as barriers to critical treatment," said Dr. Carole Allen, president of the Massachusetts Medical Society.

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