SAMHSA Proposes Update to Federal Rules to Expand Access to Opioid Use Disorder Treatment and Help Close Gap in Care

December 13, 2022

Our friends at COMPA are the first to briefly summarize some of the proposed updates to federal rules pertaining to access to Opioid Use Disorder Treatment.

See below. Thanks to COMPA for sharing news regarding the proposed rule.


Dear Colleagues,

The U.S. Department of Health & Human Services has issued a notice of Proposed Rulemaking to update 42 CFR Part 8. The proposed rule change would allow Americans to access the treatment by allowing greater flexibility for take-home doses of methadone and the use of telehealth for buprenorphine.

Click here for the announcement from SAMHSA

Click here for the NPRM in the Federal Register

Click here for the statement from Dr. Rahul Gupta, ONDCP Director

Among other items, the proposal includes:

  • expanding the definition of an OTP treatment practitioner to include any provider who is appropriately 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).” During the COVID-19 public health emergency, this has been formally expanded to align with broader definitions of a practitioner (nurse practitioners, physician assistants, etc.), and OTPs reported that this change was essential in supporting workflow and access;
  • adding evidence-based delivery models of care such as split dosing,  telehealth, and harm reduction activities;
  • removing such outdated terms as “detoxification”;
  • updating criteria for provision of take-home doses of methadone;
    strengthening the patient-practitioner relationship through the promotion of shared and evidence-based decision-making;
  • allowing for early access to take-home doses of methadone for all patients, to promote flexibility in the creation of plans of care that facilitate such everyday needs as employment, while also affording people with unstable access to reliable transportation the opportunity to also receive treatment;
  • likewise, promoting mobile medication units to expand an OTP’s geographic reach; and
  • reviewing OTP accreditation standards.

Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register which is scheduled for December 16.


Allegra Schorr