Changes in the Provision of Take-Home Methadone for People with Opioid Use Disorder During the COVID-19 Pandemic: Implications for Future Policymaking

Abstract

The COVID-19 pandemic has created a natural experiment for the treatment of opioid use disorder (OUD) that decades of advocacy could not achieve. Evidence-based treatment for OUD currently exists in the form of medications for opioid use disorder (MOUD), including buprenorphine, naltrexone, and methadone. Methadone, an FDA-approved, long-acting, synthetic opioid used to treat OUD, is the oldest MOUD and has a significant body of evidence to demonstrate its safety and efficacy. Despite this, access to methadone is significantly limited in the United States due to federal regulations that place unique restrictions on the use of methadone to treat OUD. Unlike any other medication in the United States, patients must initially report to an opioid treatment programs (OTP) daily to receive their methadone dose. It takes at least one year for a patient to receive a fourteen-day supply of take-home doses (THDs) and two years for a twenty-eight-day supply. The justifications for these stringent regulations have included fears of diversion of the medication for recreational use; however, as we demonstrate below, much of the motivation for such strict regulation was also racist sentiments by regulators.

Since the federal regulations of methadone were introduced in 1972, advocates of methadone treatment for OUD have suggested that THD policies should be relaxed to increase access to methadone treatment. Until the COVID-19 pandemic, however, methadone continued to be more strenuously regulated due to the lack of political power among those prescribed methadone (a higher proportion of Black, Indigenous, and Persons of Color (BIPOC)); competing financial incentives of OTPs, where THD can minimize financial return; and the lack of pharmaceutical lobbying efforts to support the deregulation of this generic medication.

During the pandemic, the Substance (Ab)use and Mental Health Services Administration (SAMHSA) relaxed regulations surrounding THDs, along with the Drug Enforcement Agency (DEA), which authorized OTP employees, law enforcement, and the National Guard to allow for methadone doorstep delivery to limit viral spread. Prior to the pandemic, people were required to attend OTPs in person to obtain their medication up to six times a day, taking one to two years to be deemed eligible for fourteen- or twenty-eight-day THDs, respectively—widely viewed as a major barrier to methadone access. We focus on the relaxed federal SAMHSA waiver, released in March 2020, which allowed “clinically stable” patients enrolled in OTPs to immediately receive either fourteen or twenty-eight days of THDs, regardless of time enrolled in treatment.

This chapter tells a larger story about methadone regulations in the United States and how COVID-19 prompted a historic change in the way methadone is dispensed for the first time in fifty years. We begin with a history of the 1972 federal methadone regulations and the socio-political context that informed this legislation, paying specific attention to what motivated initial restrictions on THDs. We next describe SAMHSA’s March 2020 waiver and pertinent results from research studies conducted in the United States and internationally on how increases in THDs during COVID-19 affected overdose rates, diversion, and patient preferences. We then conclude with our preliminary survey data, contextualized within this growing body of scholarship, which assess patient experiences with increased THDs due to COVID-19 at a for-profit OTP located in Nashville, Tennessee.

Note:
Funding Information: None to declare.

Conflict of Interests: None to declare.

Keywords: drug policy, opioid, policy, drugs, addiction, drug use, legislation, public health, COVID-19