State Considerations for the 42 CFR Part 8 Rule

On Thursday, April 18, 2024, the National Governors Association (NGA) health team hosted individuals representing 20 states at a virtual meeting of the Opioid State Action Network (OSAN). This month’s topic was the final rule revising federal regulations surrounding Opioid Treatment Programs (OTPs) and Medications for Opioid Use Disorder (MOUD). NGA welcomed Bridget Dooling, Assistant Professor of Law at Ohio State University, and Elizabeth Platt, Director of Research and Operations at the Center for Public Health Law Research at Temple University, to discuss the implications of this new rule.

During the COVID-19 pandemic, the federal government enacted a series of temporary rule changes for patients receiving MOUD, including those prescribed methadone and buprenorphine. As social distancing measures and telehealth became necessary during the National Public Health Emergency, Opioid Treatment Programs (OTPs) extended increased flexibility to their patients not previously allowed under federal regulation. For example, healthcare providers could begin a patient on treatment with buprenorphine through telehealth consultations, and more patients at OTPs were eligible for take-home doses of methadone to limit potential exposure to COVID-19 for patients and staff. These flexibilities were aligned with rule changes advocates had historically requested but were never previously implemented.

On February 2, 2024, final revisions to regulations on Opioid Treatment Programs and MOUD (42 CFR Part 8) were published, updating the federal regulations to make the MOUD flexibilities permanent beyond the temporary emergency time period. SAMHSA cites a significant body of research supporting this final rule, including studies of the temporary flexibilities during the COVID-19 pandemic and publications authored by Professor Dooling. Research showed the potential downsides and risks of the new regulations,–such as medication diversion or misuse–were vastly outweighed by the operational benefits felt by doctors and patients. For example, patients receiving increased take-home doses were more likely to remain in treatment. While patient and practitioner outcomes were positive due to these new policy reforms, questions remain about how federal policy translates to individual states and healthcare providers.

A full table detailing the changes and rationale can be found on the SAMHSA website. The changes generally aim to increase practitioner autonomy, remove stigmatizing language, align with a patient-centered approach, and reduce barriers to care.

Platt talked through those changes in the final rule that have state law implications, including the elimination of 1-year opioid addiction history requirement before MOUD is prescribed, the expansion of criteria that qualify someone to be able to take home doses of methadone, the allowance for initiating treatment with buprenorphine via telehealth (and methadone in certain circumstances), the scope of practice expansion allowing Nurse Practitioners and Physician Assistants to order MOUD, and finally accreditation measures in the federal ruling work to improve monitoring and allow continuity of operations if compliance issues arise.  

With these changes at the federal level, there may be misalignments across state lines or between the state and federal rules, which may prevent the full implementation of the new ruling. Current state policy areas that pose potential barriers to aligning with the new federal ruling include:  

  • Zoning restrictions
  • Business hours
  • Medication unit authorization
  • Government identification requirements
  • Set counseling schedules,
  • X-waivers
  • Increased frequency of drug screenings

The proposed rule provides an opportunity for states to meaningfully expand access to evidence-based treatment for people with opioid use disorders. For more information, please contact Alex Entner at