SAMHSA Finally Makes Permanent Its Eased Rules on Access to Buprenorphine and Take‐​Home Methadone

By Jeffrey A. Singer of Cato.

"In March 2020, as the COVID-19 pandemic made it more difficult for people with opioid use disorder (OUD) to access daily methadone treatment at federally‐​approved opioid treatment programs (OTPs), the Substance Abuse and Mental Health Services Administration (SAMHSA) temporarily liberalized methadone take‐​home rules for OTPs, and allowed “stable” patients to take home up to a 28‐​day supply. SAMHSA also allowed patients to visit clinicians via telehealth, rather than in‐​person, to obtain buprenorphine treatment for OUD. The program was a success. Follow‐​up studies found the policy improved patient compliance and did not cause buprenorphine or methadone diversion into the black market.

In November 2021, SAMHSA announced it was extending the policy. Then, in December 2022, SAMHSA issued a Notice of Proposed Rulemaking, announcing its intention to make the policy permanent and asking interested parties to comment. I submitted this comment.

Yesterday, the Department of Health and Human Services announced SAMHSA’s eased rules are finally permanent.

Anything that makes it easier to get access to medications to treat opioid use disorder is a welcome change. Unfortunately, in another example of cops practicing medicine, the Drug Enforcement Administration is working against that goal by requiring people who want to use telehealth to access buprenorphine to see a clinician in person within 30 days to renew their buprenorphine prescriptions. This means if the patient can’t get an office appointment with the provider within 30 days, the buprenorphine treatment abruptly ends. It takes an average of 26 days to get a new appointment with a primary care provider, so there is no guarantee a new buprenorphine patient can get an appointment within the 30‐​day window. It might be even more difficult in rural or other areas with primary care provider shortages.

Even without the DEA’s interference, this new rule change is “small ball.” As Sofia Hamilton and I wrote in a recent Cato briefing paper, a more effective way to improve access to methadone treatment is by enabling primary care clinicians to prescribe it to treat patients with opioid use disorder in their offices. Clinicians in the US were doing so before 1972. Clinicians in the UK, Canada, and Australia have continued to treat their office‐​based patients with methadone for over 50 years.

The Modernizing Opioid Treatment Access Act (MOTAA), introduced in the US Senate by Senator Edward Markey (D‑MA) and co‐​sponsored by Senators Rand Paul (R‑KY), Bernie Sanders (I‑VT), Mike Braun (R‑IN), Cory Booker (D‑NJ), and Maggie Hassan (D‑NH), would expand access to methadone treatment for people with opioid use disorder (OUD) by allowing board‐​certified addiction specialists to prescribe methadone to patients in their offices or clinics.

As I wrote here, the MOTAA doesn’t go far enough. Even assuming they were all accepting new patients, there are not nearly enough board‐​certified addiction specialists to meet the needs of people with OUD. However, MOTAA takes a much bigger step to improve access to methadone treatment than SAMHSA does in its revised policy. MOTAA is the first serious attempt in many years to remove unnecessary government barriers to methadone treatment. The bill also helps to destigmatize people with OUD by treating them as suffering from a medical condition.

Reacting to the new permanently liberalized SAMHSA policy in a press release, Senator Markey stated:

“Ultimately, tethering methadone exclusively to opioid treatment programs is less about access, or health and safety, but about control, and for many investors in those programs, it is about profit. The longer we leave this antiquated system in place, the more lives we lose. We must put people first, unwind outdated laws, and treat methadone like the life‐​saving medication it is…”

I couldn’t agree more."