The changes aim to update the federal regulations for opioid use disorder (OUD) treatment standards, including making medication flexibilities implemented amid the COVID-19 public health emergency permanent.

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), has proposed to update federal rules to expand access to treatment for OUD. The proposal, a part of HHS’ Overdose Prevention Strategy, is the latest initiative from the agency to combat the growing opioid epidemic in which more than 107,000 Americans died due to overdose last year.

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The proposed rule would make medication flexibilities implemented amid the pandemic a permanent approach to OUD treatment, increasing access to take home doses of methadone as well as telehealth appointments to initiate buprenorphine administration at opioid treatment programs (OTP).

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

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SAMHSA has also proposed the first updates to the federal regulations, 42 CFR Part 8, in more than 20 years to remove stigmatizing or outdated language, support a patient-centered approach, and reduce barriers to care.

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The updated standards would include:

  • An updated definition of OTP treatment practitioners to include any appropriately licensed provider, such as nurses and physician assistants
  • The addition of evidence-based delivery models of care, including split dosing, telehealth, and harm reduction activities
  • The removal of outdated terms such as “detoxification”
  • Updated criteria for take-home doses of methadone
  • The promotion of shared and evidence-based decision-making between the patient and practitioner
  • Increased early access to take-home doses of methadone for all patients through mobile medication units
  • The review of OTP accreditation standards