Health & Human Services Releases Final Rule for Opioid Treatment Programs

The U.S. Department of Health and Human Services (“HHS”) and the Substance Abuse and Mental Health Service Administration (“SAMHSA”) published a final rule on Feb. 2, 2024, that cemented significant Pandemic-era flexibilities for individuals receiving treatment for Opioid Use Disorder (“OUD”) from Opioid Treatment Programs (“OTPs”). The rule aims to reduce barriers to care for OUD by permanently adopting telehealth and take-home treatment options that were initially permitted in response to the COVID-19 Pandemic. Additionally, the rule expands the types of practitioners covered under the rule, and subsequently enables them to provide more accessible OUD care to patients. The rule also made updates to OTP accreditation and certification standards to reflect a modern treatment environment and clarify various administrative issues.

Notably, the final rule:

• Significantly revised the criteria for take-home doses of OUD medication to permit clinical judgement of the treating practitioner to allow take-home doses upon entry into treatment;
• Makes permanent the ability of OTPs to initiate buprenorphine via telehealth (including both audio-only and audio-visual telehealth modalities);
• Permits the initiation of methadone treatment via audio-visual telehealth, although the first dose, at a minimum, must still be taken under supervision at the OTP;
• Updated admission criteria for patients to reduce barriers to entering care; and
• Expands the definition of qualifying practitioner under the rule to include a practitioner who is appropriately licensed by the state to prescribe (including dispense) covered medications. Where state law allows, this includes nurse practitioners and physician assistants.

It is important to note that the rule, and the increased flexibility and access to care it promotes, are limited to accredited OTPs and practitioners within them. Non-OTP practitioners are not covered by the rule and must still wait for final action from HHS and the Drug Enforcement Agency to see if Pandemic-era telehealth and OUD treatment flexibilities will become permanent outside of OTP settings.

The final rule can be viewed on the Federal Register at 89 FR 7528.

Please reach out to Benesch’s Healthcare+ Practice Group for more information.

Dana J. Molt at dmolt@beneschlaw.com or 312.212.4935.

Frank Carsonie at fcarsonie@beneschlaw.com or 614.223.9361.

W. Clifford Mull at cmull@beneschlaw.com or 216.363.4198.