A Change to Federal Methadone Regulations

For the first time in more than 20 years, the Substance Abuse and Mental Health Services Administration has relaxed federal requirements for how methadone is dispensed at opioid treatment programs (OTPs), the only settings allowed to provide this lifesaving medication. 

Methadone is a critical medication for treating opioid use disorder (OUD), but long-standing rules at the federal and state level had made it difficult for many people to access it. The new federal regulations dramatically improve access to care and flexibility for patients, and many of the changes are a permanent extension of flexible rules enacted during the COVID-19 pandemic designed to encourage social distancing and keep patients safe. Patients now can receive up to 28 days of take-home medication after a month in treatment—prior to the COVID-19 health emergency, they could have such access only after two years of in-person treatment. 

In addition, counseling is no longer required as a prerequisite for treatment, more types of providers in OTPs—such as physician assistants and nurse practitioners—are able to dispense methadone, and people can start treatment more quickly, without first demonstrating a one-year history of OUD. The Pew Charitable Trusts’ substance use prevention and treatment initiative has long advocated for increased access to this critical medication. But in order to maximize the benefits these federal changes can have for patients, state policymakers now must also review state rules and align them with these new evidence-based standards.

“These new federal regulations align with decades of evidence on the safety and efficacy of methadone and have the potential to transform OTP care,” said Frances McGaffey, who works on Pew’s substance use prevention and treatment initiative. “But states also need to follow suit and install changes that will make methadone more easily accessible to patients.”