On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to the OTP regulations in over 20 years, and significantly increases access to lifesaving medication while easing operational restrictions.

The agency eased admission requirements and cemented some of the telehealth and take-home dose flexibilities put in place during the COVID-19 pandemic. Other changes streamline OTP operations, reduce restrictions on providers, and revise language to reduce the stigma of opioid use disorder (OUD) treatment.

Reduced Admissions Barriers

The final rule replaces stringent admission criteria with an individualized determination made by a health care professional. Previously, patients were required to have an active opioid addiction for one year before receiving treatment at an OTP. Patients under 18 were required to have two documented instances of unsuccessful short-term drug-free treatment in a year before being admitted to an OTP. The final rule revises admission to a determination by a health care professional that the patient either meets criteria for moderate to severe OUD, is in remission from OUD, or is at high risk for recurrence or overdose. Access to medication is also no longer contingent on receiving counseling services. The change removes unnecessary barriers to medication access and focuses on individual patient needs.

Telehealth Flexibilities and Take-Home Dosages

In response to the global COVID-19 pandemic, SAMHSA softened requirements that patients be physically examined in-person before beginning treatment and permitted OTPs to evaluate patients via telehealth before beginning buprenorphine treatment. The flexibilities did not extend to methadone treatment.

The final rule cements and expands the flexibilities to allow patients to start critical treatment right away. OTPs may now evaluate patients for buprenorphine treatment via audio-only or audio-visual technology, but also evaluate patients for methadone treatment using audio-visual technology (no audio-only technology). The relaxed telehealth rules only apply to the initial screening; an in-person examination must still be completed within two weeks of a patient’s admission to an OTP.

The final rule also adopts limited take-home dosages which SAMHSA permitted during the COVID-19 pandemic. Generally, patients were required to make daily in-person visits to OTPs for medication dispensing and administration. To limit in-person interactions, in March 2020, SAMHSA issued exemptions which allowed OTPs to dispense up to 28 days of dosages for “stable patients” and 14 doses for “less stable” patients.

Although initially scheduled to sunset with the end of the COVID-19 Public Health Emergency, the final rule adopts and expands the take-home option. SAMHSA removed the ambiguous and stigmatizing “stable”/“less stable” determination and correlated the amount of take-home doses to the number of days a patient has been in treatment:

Within the first two weeks, the take-home supply is limited to seven days’ worth of medication.

From 15 to 30 days of treatment, the take-home supply is limited to 14 days’ worth of medication.

After 31 days, the patient may have a take-home supply of up to 28 days of medication.

The take-home dosages were widely supported and celebrated by OTPs and patients alike as a way of reducing the impact of OUD treatment on those most in need, for whom consistent, reliable transportation may be a challenge and ultimately prevent a patient’s successful treatment.

Reducing Provider and Operational Restrictions

Several revisions are targeted at easing nationwide staffing shortages and the development of new OTPs.

Historically, the term “practitioner” has limited which providers may render care in OTPs. Previously, only licensed physicians could be practitioners, but the final rule now includes any health care professional licensed by the state to prescribe and dispense medications for OUD. Subject to state laws, this may include nurse practitioners, physician assistants, nurse-midwives, or even pharmacists. The final rule also eliminated the requirement that providers obtain a Drug Addiction Treatment Act waiver to prescribe buprenorphine and the accompanying patient caps that limited the number of patients a provider could treat.

As it relates to certification standards for OTPs, OTPs may now use both online and electronic forms during the accreditation process. The final rule also incorporates a corrective action procedure which allows OTPs 180 days to implement corrective action following notice of a compliance issue.

Other revisions incorporate harm reduction principles over abstinence-only practices, and remove outdated “detoxification” terminology.

The final rule takes effect April 2, 2024 with compliance required by October 2, 2024. A table of the changes can be found here.