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The U.S. Department of Health and Human Services (“HHS”) unveiled a set of significant new measures affecting clinics offering medication-assisted treatment for opioid use disorder. This marks the first substantial update to Opioid Treatment Program (“OTP”) regulations in over two decades.

The final rule was published in the Federal Register on February 2, 2024[1]. Following a 60-day period from the publication date, the new rules will take full effect within six months. This period will provide OTPs the opportunity to make all necessary preparations for implementation.  

The final rule seeks to expand access to life-saving medications for opioid use disorders and reduce stigma. Major provisions of the final rule include:[2]

1. Permanently extending COVID-19 era flexibilities for methadone take-home doses.
2. Allowing telehealth for initiation of treatment to alleviate transportation barriers (including methadone via audio-visual telehealth technology and buprenorphine via audio-only technology).
3. Expanding provider eligibility, allowing nurse practitioners and physician assistants to order medications in OTPs, where permitted by state law.
4. Removing stringent admission criteria, facilitating easier access to treatment (including the requirement that a patient have a history of addiction for a full year).
5. Expanding interim treatment access to initiate medication treatment while awaiting further services, reducing the barriers of treatment waitlists.
6. Promoting patient-centered models of care that are aligned with management approaches for other chronic conditions.

“This final rule represents a historic modernization of OTP regulations to help connect more Americans with effective treatment for opioid use disorders,” said Miriam E. Delphin-Rittmon, Ph.D., the HHS Assistant Secretary for Mental Health and Substance Use, and the leader of SAMHSA. “While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible. In short, this update will help those most in need.”

If you have questions regarding these new rules, implementing the changes at your clinic, or any other healthcare-related matter, you should consider contacting the experienced attorneys at Graff & McGovern, LPA at (614) 228-5800.

[1] https://www.federalregister.gov/documents/2024/02/02/2024-01693/medications-for-the-treatment-of-opioid-use-disorder

[2] https://www.hhs.gov/about/news/2024/02/01/biden-harris-administration-marks-two-years-advancements-hhs-overdose-prevention-strategy-new-actions-treat-addiction-save-lives-press-release.html