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. This report clarifies
that federal agencies have discretion to lower barriers and improve access to methadone
treatment for opioid use disorder. How will they use it?
