|Footnotes for this article are available at the end of this page.
The U.S. Department of Health and Human Services (“HHS”), through its Substance Abuse and Mental Health Services Administration (“SAMHSA”), announced on December 13, 2022, that they were proposing to update 42 CFR Part 8, Opioid Treatment Programs (“OTPs”).1
The Proposal would update the federal regulations that oversee opioid use disorder treatment standards. Specifically, the rule change would improve access to treatment by permitting individuals to take home doses of methadone and enable the use of telehealth in initiating buprenorphine at opioid treatment programs.
Current OTP regulations have not been updated in more than 20 years. A large criticism of the current regulations is that they perpetuate stigma in seeking treatment as they create additional barriers to access, such as frequent visits to a practitioner and required in-person dosing. These updates reflect flexibilities that were implemented during the COVID-19 pandemic to meet patients where they are in a more patient-centric approach. They also expand on the groundwork laid by the CARES Act in updating regulations governing substance use disorder (“SUD”) treatment programs and build on the momentum for medication assisted treatment (“MAT”) and tackling mental health and substance use disorders (SUD) seen in the legislative and executive branches recently, such as through the Restoring Hope for Mental Health and Well-Being Act (“HR 7666”), which passed in the House in mid-2022, and millions of dollars in expanded grant funding offered to certified community behavioral health clinics.2
Evidence gathered in 2020 showed that patients who received increased take-home doses after federal flexibilities were enacted during COVID-19 saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids.
Proposed changes include:
- Expanding the definition of an OTP practitioner
- Adding evidence-based delivery models of care
- Removing outdated terms such as “detoxification”
- Updating criteria for provision of take-home doses of methadone
- Strengthening the patient-practitioner relationship through promotion of shared and evidence-based decision making
- Allowing early access to take-home doses of methadone for all patients to promote flexibility in treatment plans and support everyday needs like employment or support individuals with transportation limitations
- Reviewing OTP accreditation standards
- Updating admission criteria and removing requirement that an OTP only admit people with a year of an opioid addiction
OTPs remain a heavily regulated area of SUD treatment and provider organizations may have concerns that the regulations still do not go far enough in expanding prescribing privileges and access to methadone and other forms of MAT.
Public comments in response to the rule may be submitted to SAMHSA by February 14, 2023.
 Press Release, SAMHSA, Update Federal Rules Expand Access Opioid Use Disorder Treatment (Dec. 13, 2022), https://www.samhsa.gov/newsroom/press-announcements/20221213/update-federal-rules-expand-access-opioid-use-disorder-treatment.
 Press Release, HHS, Biden-Harris Administration Announces Millions of Dollars in New Funds for States to Tackle Mental Health Crisis (Oct. 18, 2022), https://www.hhs.gov/about/news/2022/10/18/biden-harris-administration-announces-millions-dollars-new-funds-states-tackle-mental-health-crisis.html.