What are the Rules for Prescribing Medications for OUD Via Telehealth?

There are three sets of rules for prescribing medications for opioid use disorder (MOUD) via telehealth because there are three different FDA-approved medications that are considered MOUD: methadone, buprenorphine, and naltrexone.

Rules for Prescribing Naltrexone via Telehealth

Intramuscular naltrexone (Vivitrol) is an opioid receptor antagonist that is used to treat both opioid and alcohol use disorders. Since this must be administered via injection in-person, prescribing it over telehealth is generally not available. However, there may be exceptions or special cases depending on the state.

Rules for Prescribing Methadone and Buprenorphine via Telehealth

Methadone and buprenorphine have a more strict set of rules around prescribing via telehealth because they are considered controlled substances by the U.S. Drug Enforcement Administration (DEA).

Methadone is a Schedule II drug and buprenorphine is a Schedule III controlled substance. Historically, both medications could only be prescribed by physicians in-person at federally certified opioid treatment programs (OTPs). This means that people with OUD could not access methadone or buprenorphine without getting evaluated in-person by a medical doctor at an OTP. This restriction made it difficult to get MOUD, especially given the fact that about 80% of US counties don’t have a single OTP.

Creation of & Elimination of the X Waiver for Buprenorphine

In 2000, the DEA allowed doctors to get a special “waiver” (known as the X waiver) that allowed them to prescribe buprenorphine in an office-based setting, outside of OTPs for up to 100 patients. The purpose of this was to increase access to medication for opioid use disorder.

In 2016, President Obama passed a new law allowing nurse practitioners (NPs) and physician assistants (PAs) to get the DEA waiver to prescribe buprenorphine after special training, and the patient limit was increased to 275.

Finally, in 2022, President Biden eliminated the waiver so that any prescriber registered with the DEA could prescribe buprenorphine with no patient limits.

Telehealth Prescribing Rules and In-Person Requirements

In 2020, after the start of the COVID-19 pandemic, the COVID Public Health Emergency temporarily allowed providers to write buprenorphine prescriptions for new patients without conducting in-person examinations. 

However, that was not the case for starting methadone, which still required an in-person evaluation at an OTP because the Substance Abuse and Mental Health Services Administration (SAMHSA) felt methadone was riskier than buprenorphine. However, OTPs were allowed to conduct their counseling over telehealth instead of in-person.

As of February 1, 2024, SAMHSA and the Department of Health and Human Services (HSS) announced changes to OTP regulations: now, an OTP practitioner can initiate treatment of methadone or buprenorphine via telehealth without an in-person exam. 

It’s important to note that this final rule does not authorize the prescription of methadone via telehealth outside the OTP context. Methadone must still be prescribed and dispensed by licensed OTP practitioners. 

As for buprenorphine, the temporary exception lifting the in-person exam requirement has been extended to December 31, 2024. So until the end of 2024, telehealth prescriptions of buprenorphine can continue without an in-person physical exam.

Is DEA Regulatory Uncertainty a Risk for OUD TelehealtH?

Yes, it absolutely is. If the DEA decides to reinstate an in-person requirement for telehealth buprenorphine prescribing, it will reduce access to buprenorphine, which will likely lead to more overdoses and deaths.

The evidence is clear: telehealth MOUD access saves lives. Studies looking at the COVID telehealth flexibilities showed that OUD-related emergency room visits and overdoses dropped when it became more accessible over telehealth.

But there are glimmers of hope:

1. The DEA has repeatedly extended these flexibilities in response to the advocacy from patients, family and community members, policymakers and healthcare professionals. It seems that the DEA is considering improving the regulations around MOUD prescribing.
2. The final rule updating regulations for OTPs to increase flexibility around methadone medication take-home doses should greatly increase access to MOUD and reduce barriers to care.

Although DEA regulatory uncertainty can be nerve-racking, we at Bicycle Health will continue to advocate for more compassionate and just policies affecting people with addiction. And whether or not you’ve been standing on the sidelines, please join us in the fight to stop stigmatizing and punishing people with addiction and increase access to addiction treatment.