More Flexible Methadone Access Should Continue Post-Pandemic

Methadone, an FDA-approved medication used to treat opioid use disorder (OUD), is the most tightly restricted treatment for this chronic disease. It can be dispensed to patients only at state and federally regulated opioid treatment programs (OTPs), often during daily monitored in-person clinic visits. This practice developed out of concern for potential diversion of these drugs and overdose but has perpetuated stigma against patients.

The federal government eased the requirements during the COVID-19 pandemic to allow people to continue needed treatment at a time of social distancing. And flexible take-home dosing—or allowing patients to consume their medication in an unsupervised setting—appears to be an effective way to ensure that those in treatment have easier access to methadone.

A new George Washington University (GWU) report, published April 22 and funded by The Pew Charitable Trusts, finds that the federal Substance Abuse and Mental Health Services Administration (SAMHSA) has the legal authority to extend methadone dispensing flexibilities post-pandemic.

As the country has dealt with the spread of COVID-19, the increased flexibility has helped people with OUD. By allowing some doses to be consumed at home, patients could avoid public transportation or unnecessary contact with health care providers that could increase exposure, but it also could help them stay on their treatment course. Before the pandemic, such flexible dosing was available to patients further along in their recovery who met certain criteria. Research also shows that take-home dosing increases treatment retention.

Maintaining flexibility is critical because under pre-pandemic rules, the more than 400,000 Americans a year who receive methadone for OUD had to travel and wait in line at OTPs, sometimes daily. In addition, state and local regulations affecting the location of treatment programs, patient monitoring, and dosing—including how often patients need to be present to receive their medication and level of dose they receive—can make it more difficult for individuals to access care.

These regulatory burdens also can perpetuate racial disparities in treatment. For example, racially segregated counties with Black and Hispanic/Latino residents have more capacity to provide methadone than buprenorphine—another OUD medication that is accessible by prescription in various settings, including primary care practices. This can result in a treatment landscape where patients from communities of color face more stringent requirements than others.

After the declaration of a COVID-19 public health emergency in early 2020, SAMHSA guidance made methadone more easily available to patients. It allowed state regulatory authorities to request blanket exceptions for patients to be able to take home more medication doses—up to 28 days for “stable” patients and up to 14 days for “less stable” patients.

The guidance does not define what it means to be “stable” or “less stable,” and local jurisdictions applied the flexibility differently, with some allowing smaller or larger supplies of take-home doses. Research done during the pandemic suggests that there has been minimal diversion of methadone associated with unsupervised use while these flexibilities have been in place. Practitioners and other experts are now concerned that, after the public health emergency ends, the flexibilities will end, reining in this newly expanded access to treatment.

What could change

To ensure that these flexibilities—and access to lifesaving care—continue after the pandemic is over, GWU researchers identified three legal approaches that SAMHSA, a branch of the U.S. Department of Health and Human Services, could take:

1. The agency could use its statutory authority to issue a rule that would make the flexibilities permanent after consulting with the Drug Enforcement Administration. If SAMHSA took this step, states would not need to request exemptions to continue to provide flexibility in their methadone prescribing.
2. It could release entirely new guidance implementing these changes. Federal law does not restrict SAMHSA to act only during a public health emergency. The agency could, for example, publish new requirements that go beyond pandemic-era flexibilities, such as allowing states to request blanket exemptions for all patients to be able to get up to 14 or 28 days of take-home medication based on the patient’s stability in treatment. SAMHSA could pair this approach with an effort to evaluate the effects of such changes to inform future decision-making.
3. SAMHSA could release new guidance implementing these changes but tie it to the separate opioid-specific public health emergency declaration. That declaration has been in place since October 2017 and must be regularly renewed for the guidance to stay in effect. The report authors note, however, that unsupervised-use flexibilities added during the pandemic fit neatly into the objectives of responding to the opioid crisis through expanded access to treatment.

The report says SAMHSA could follow any of these pathways to ensure that lifesaving OUD treatments such as methadone remain readily available. Making the take-home flexibilities permanent and ensuring that they are equitably applied can simplify access to methadone for patients who have historically faced burdens in accessing treatment. Even with the possibility of the COVID-19 pandemic slowing this year, the consequences of the opioid overdose crisis continue, as does the need for treatment policies to mitigate its toll.

Beth Connolly is a director and Alaina McBournie and Sheri Doyle are managers for Pew’s substance use prevention and treatment initiative.