SAMHSA's final rule makes COVID-era flexibilities permanent for opioid treatment programs

Several COVID-era flexibilities relied upon by opioid treatment programs and their hundreds of thousands of patients will become permanent later this year, the Substance Abuse and Mental Health Services Administration (SAMHSA) said last week.

SAMHSA's new final rule allows some opioid treatment program (OTP) providers to prescribe medication for opioid use disorder (MOUD) like buprenorphine via telehealth without an initial in-person exam. It also allows them to dispense unsupervised, take-home doses of methadone to relatively stable patients.

This marks the first time OTP regulations have been substantially updated in two decades. The rule is effective April 2, and the compliance date is October 2, 2024. SAMHSA developed the final rule in consultation with the Drug Enforcement Administration (DEA).

“This final rule represents a historic modernization of OTP regulations to help connect more Americans with effective treatment for opioid use disorders,” Miriam E. Delphin-Rittmon, the Health and Human Services (HHS) Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA, said in a press release. “While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible. In short, this update will help those most in need.”

As of June 2023, there were more than 2,000 OTPs providing care to more than 650,000 patients. These are the only settings where methadone can legally be provided to patients with OUD outside the context of hospital admission or certain other special cases. 

The stress and isolation precipitated by the pandemic exacerbated substance misuse and overdose deaths. These changes led to the proposed rule to promote engagement in OTP services and expand access to care.

In 2020, SAMHSA issued historic exemptions that allowed states to let patients take home more doses of methadone, with 43 states and D.C. deciding to do so, the final rule document said. The goal was to reduce the risk of COVID infection and expand access to care. It was well received, with patients reporting that increased take-home doses of methadone left them feeling more respected as responsible individuals. 

Also that year, the DEA granted temporary exceptions to the Ryan Haight Act, allowing for the prescribing of controlled substances via telehealth. In its final rule, SAMHSA noted there are no significant differences between starting buprenorphine treatment via telehealth or in-person.

“In the face of an escalating overdose crisis and an increasing need to reach remote and underserved communities, making the buprenorphine telehealth flexibility permanent is of paramount importance,” the final rule said.

Some virtual providers of OUD treatment see the rule as an important first step, but hope that removal of such restrictions doesn't stop there. 

"We encourage our regulators to support more patient-centered and evidence-based rulemaking," Brian Clear, M.D., Chief Medical Officer at Bicycle Health, told Fierce Healthcare in an emailed comment. "The next necessary step is for the DEA to remove arbitrary in-person requirements for addiction medicine specialty programs and primary care programs in their broader rulemaking since opioid treatment programs are just a small part of our national treatment infrastructure.”

In a statement sent to Fierce Healthcare, the Coalition of Medication-Assisted Treatment Providers and Advocates of New York State applauded the rule. 

“They promise to normalize treatment for people in our programs and reduce both stigma and barriers,” Allegra Schorr, president of COMPA, said. “SAMHSA is transforming the way essential treatment can be delivered, which will, in turn, advance health equity and save lives. These updates make permanent some of the changes brought about during COVID-19 and will help our providers continue to battle the opioid epidemic and overdose death rates that soared during COVID and continue to rise in New York State.”  

The American Medical Association similarly praised the rule. Bobby Mukkamala, M.D., chair of the AMA Substance Use and Pain Care Task Force, said in a statement that “cementing these policies is a step in the right direction in the fight against the worsening overdose epidemic to increase equitable access to care, reduce stigma of seeking treatment for OUD, and embrace technology in medicine.”