HHS, through SAMHSA, published a final rule to comprehensively update regulations governing Opioid Treatment Programs (OTPs), the only programs where people can access methadone treatment for opioid use disorder. The final rule seeks to dramatically expand access to life-saving medications for opioid use disorder (MOUD) and to reduce stigma. Today’s updates are the first substantial changes to these regulations in more than two decades.
“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.”
The final rule incorporates critical feedback submitted by treatment providers, advocates, and patients. Major provisions of the final rule that will expand access to medications for opioid use disorder while ensuring high-quality care include:
In addition to reducing barriers to medication, the updated rule also removes stigmatizing and outdated language, and updates definitions to reflect current medical usage. While finalizing more flexible regulations for OTPs, SAMHSA will continue to maintain robust quality standards through accreditation requirements for all programs. The final OTP regulations will be published in the Federal Register on February 2, 2024. Following a 60-day period from the publication date, the new rules will take full effect within six months, providing OTPs with the opportunity to prepare for implementation.