A Vast and Discretionary Regime

Federal Regulation of Methadone as a Treatment for Opioid Use Disorder
August 12, 2022

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Evaluating regulatory barriers to accessing methadone for treating opioid use disorder.

Illustration of the United States using pharmaceutical pills

Bridget C.E. Dooling (Research Professor) and Laura E. Stanley (Senior Policy Analyst) of the George Washington University Regulatory Studies Center authored this report with support provided by The Pew Charitable Trusts.

"As the opioid crisis continues to ravage the United States, policies that constrain access to methadone treatment should be examined to ensure that the restrictions adequately balance competing risks and are grounded in the best evidence."

Executive Summary

Methadone is an effective treatment for opioid use disorder, which makes it a key tool to address the opioid crisis. Paradoxically, regulations—particularly at the federal level, which is the focus of this report—greatly limit access to methadone when it is used to treat opioid use disorder. As policymakers consider what they can do to make it easier for people to begin and continue treatment, it is important to understand which changes regulators can make on their own by drawing upon existing statutory authority, and which changes would require an act of Congress.

This report analyzes four groups of regulations that are barriers to treatment for opioid use disorder with methadone. First, methadone-only patient care regulations limit who may provide treatment, who may receive it, how much medicine patients may take home, and more. Second, the prohibition on prescribing methadone—as opposed to dispensing it directly—requires patients to travel to their opioid treatment program to collect their medicine rather than collecting it from a pharmacy. Third, methadone’s categorization as a Schedule II controlled substance limits it further. Fourth, the cumulative effect of various entry barriers and operating costs depresses the available supply of treatment providers. 

Working through each group of regulations, this report explains the rules and how they function as barriers. Then, the report finds that in almost every instance, federal regulators have clear statutory authority to amend or remove these regulatory barriers to treatment. It also explains the legal steps that agencies can take to make changes. This report is limited to questions of legal authority, to clarify whether the agencies possess discretion to pursue policy changes. An important next step will be to determine which changes to make, a complex decision that should draw upon the best available evidence. What this report makes clear is that federal agencies have discretion to lower barriers and improve access to methadone treatment for opioid use disorder. The question is: how will they use it?

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