The Temporary Federal Rule on Telehealth Treatment, Explained

Interim regulations continue pandemic-era flexibilities, but remote access to opioid use disorder care is at risk

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The Temporary Federal Rule on Telehealth Treatment, Explained
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During the COVID-19 pandemic, the federal government relaxed regulations to allow patients with opioid use disorder (OUD) to start treatment with buprenorphine—an FDA-approved medication proved to reduce overdose deaths—remotely for the first time. That could be either via an audio-only (i.e., telephone) or audio-video appointment. These temporary regulations worked: Recent research shows that the pandemic-era telehealth rules helped a broader pool of patients start and stay in buprenorphine treatment without increasing overdose deaths.

When the Biden administration announced that the COVID-19 public health emergency would end in May, these telehealth flexibilities were set to expire at the same time unless the Drug Enforcement Administration (DEA) proposed new rules. The agency issued draft rules in March that would backtrack on many of the remote flexibilities allowed during the pandemic and require patients to see their providers in person. In response, the DEA received more than 38,000 comments, many of which criticized the rule as harmful to patients.

The DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) then issued in May a temporary rule that continues the pandemic-era telehealth regulations to give agency staff more time to consider the public comments before finalizing regulations and to “find a way forward to give Americans [telehealth] access with appropriate safeguards,” according to DEA administrator Anne Milgram. The DEA said that it wants to support a smooth transition for those who rely on telehealth for prescriptions and to give time for providers to comply with the regulations.

In this FAQ, The Pew Charitable Trusts examines what the temporary rule means for patients and health providers, what the priorities should be going forward, and what the future of telehealth treatment for OUD should look like.

What does the temporary rule do?

The rule now in place allows patients with OUD to initiate or continue receiving buprenorphine prescriptions via an audio-only or audio-video telehealth appointment with a DEA controlled substance-licensed health care provider through Nov. 11, 2023.

What happens after Nov. 11?

No new patients with OUD will be allowed to initiate buprenorphine treatment via telehealth unless they have an existing telehealth relationship with a provider. New patients will have to have an in-person visit with a licensed health care provider before they can receive a buprenorphine prescription via telehealth.

What will happen to patients already receiving buprenorphine remotely?

Any patient who receives a buprenorphine prescription remotely before Nov. 11, 2023, can continue to receive prescriptions via telehealth for one additional year—through Nov. 11, 2024.

What happens after Nov. 11, 2024?

The temporary rule will expire. All patients receiving buprenorphine treatment via telehealth will no longer be eligible to use audio-only or audio-video appointments without first having an in-person appointment unless the DEA and SAMHSA issue new guidance or Congress acts.

How should the federal government regulate telehealth treatment for buprenorphine moving forward?

The DEA and SAMHSA should make permanent the pandemic-era regulations allowing all patients with OUD to access buprenorphine treatment remotely. The agencies have the statutory authority to issue joint regulations that allow practitioners to prescribe this medication with proven effectiveness without first conducting an in-person medical evaluation.

More immediately, Congress should pass the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act. The legislation—which was recently introduced in the House with bipartisan support—would permanently allow patients to initiate buprenorphine treatment via an audio-only or audio-video telehealth appointment. Pew urges Congress to pass this legislation.

Why should telehealth access to buprenorphine continue?

Remote access during the pandemic allowed more patients to start and stay on this lifesaving medication without increasing overdose deaths. Health care providers have also found that remote treatment increased access and convenience for their patients, particularly people in rural or remote areas, as well as those using syringe services programs, leaving incarceration, or experiencing homelessness.

Requiring patients to schedule an in-person visit to receive treatment creates arbitrary barriers to care. Patients may not have child care or transportation, and providers may not have in-person appointments available for weeks in their schedules. Allowing health care providers to evaluate patients via telehealth solves these problems and allows patients who are ready for treatment to access it immediately.

A March 2023 comment letter from The Pew Charitable Trusts to the DEA outlines why remote access to buprenorphine is critical to addressing the overdose crisis. Now federal lawmakers should act to preserve these flexibilities.

Marcelo H. Fernández-Viña is an officer and Sheri Doyle is a senior manager with The Pew Charitable Trusts’ substance use prevention and treatment initiative.

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