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SAMHSA Proposes Federal Rule Changes to Expand Access to OUD Treatment

Tom Valentino, Digital Managing Editor

The Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced on Tuesday that it is proposing to expand access to treatment for opioid use disorder (OUD) by updating federal regulations overseeing OUD treatment standards.

Specifically, the proposed rule change would update 42 CFR Part 8 to allow individuals to take home doses of methadone and use telehealth-based services to initiate buprenorphine at opioid treatment programs (OTPs).

In a news release announcing the proposal, SAMHSA officials said the changes “reflect the widespread desire by many stakeholders for SAMHSA to provide greater autonomy to OTP practitioners.”

“These proposed updates would address longstanding barriers [to] treatment in regulations—most of which have not been revised in more than 20 years,” Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA, said in the release. “I am committed to moving these forward as quickly as possible because we have heard from both providers and patients how urgent the need is for treatment.”  

In March and April 2020—the first months of the COVID-19 pandemic—SAMHSA enacted flexibilities allowing the provision of take-home methadone doses and the use of telehealth to initiate buprenorphine treatment for OUD. Patients deemed stable by physicians have been able to take home up to 28 days’ worth of methadone doses, while other patients received up to a 14-day supply. A recent study showed that patients receiving increased take-home doses saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids.

SAMHSA's proposed changes include the following updates:

  • Expanding the definition of an OTP provider to include any provider who is licensed to dispense and/or prescribe approved medications. (The current Part 8 rule defines a practitioner as being “a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C.823(g)(2).”);
  • Adding care delivery models such as split dosing, telehealth, and harm reduction activities;
  • Removing terms deemed outdated by SAMHSA, including “detoxification”;
  • Updating criteria for the provision of methadone take-home doses;
  • Strengthening patient-practitioner relationships by promoting shared and evidence-based decision-making; and
  • Allowing for early access to take-home methadone doses for all patients—a move that would promote flexibility in the creation of care plans.

SAMHSA is also proposing an update to Part 8’s OTP admission criteria, including the removal of the 1-year requirement for opioid addiction before admission to an OTP. Additionally, the proposal would eliminate the requirement that practitioners who have a waiver to prescribe buprenorphine for up to 275 patients to provide annual reports to SAMHSA.

The proposal can be viewed on the Federal Register website. Public comments are being received until February 14, 2023.

 

Reference

SAMHSA proposes update to federal rules to expand access to opioid use disorder treatment and help close gap in care. News release. US Department of Health and Human Services. December 13, 2022. Accessed December 14, 2022.

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