The DEA has issued a third extension of the telemedicine flexibilities for the prescribing of controlled medications. The extension will be in effect until the end of 2025 (21 C.F.R. §1307.41; 42 C.F.R. §12.1).

In a temporary rule released Nov. 18 and published in the Federal Register the following day (89 Fed. Reg. 91253), the DEA said that it was issuing a third temporary extension of the flexibilities “to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions.”

The DEA added that the extension “will allow DEA (and also [the Department of Health and Human Services (HHS)], for rules that must be issued jointly) to promulgate proposed and final regulations that are consistent with public health and safety, and that also effectively mitigate the risk of possible diversion.”

Moreover, the DEA said, the extension “will allow adequate time for providers to come into compliance with any new standards or safeguards eventually adapted in a final set of regulations.”

Background

The Controlled Substances Act was amended through the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 Act to generally require that the dispensing of controlled substances through the internet be predicated on a valid prescription involving at least one in-person medical evaluation (21 U.S.C. §829(e)).

However, the Ryan Haight Act established excepted categories of telemedicine under which a practitioner may prescribe controlled substance medications for a patient despite never having evaluated the patient in person, provided that (among other things) the prescribing accords with applicable federal and state laws.

One excepted category authorizes the attorney general and the HHS secretary to jointly promulgate rules allowing practitioners to prescribe controlled substances through telemedicine without an in-person evaluation when the telemedicine practice:

• complies with applicable federal and state laws;
• uses an approved telecommunications system; and
• is conducted under circumstances that have been “determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety” (21 U.S.C. §802(54)(G)).

COVID-19 PHE

During the COVID-19 public health emergency (PHE), the DEA allowed the prescribing of controlled medications via telemedicine encounters even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient.

The flexibilities allowed practitioners to prescribe Schedule II-V controlled medications via audio-video telemedicine encounters, including Schedule III-V narcotic controlled medications approved by the FDA for maintenance and withdrawal management treatment of opioid use disorder through audio-only telemedicine encounters, provided that the prescriptions otherwise comply with the requirements outlined in DEA guidance documents, DEA regulations, and applicable federal and state law.

Two NPRMs

In February 2023, the DEA promulgated two notices of proposed rulemaking (NPRMs) that proposed to expand patient access to prescriptions for controlled medications via telemedicine encounters “relative to the pre-COVID-19 PHE landscape.”

The two NPRMs were intended to make permanent some of the telemedicine flexibilities established during the COVID-19 PHE. The comment periods for the two NPRMs closed on March 31, 2023.

Previous Temporary Extensions

First temporary extension. On May 10, 2023, the DEA, together with the Substance Abuse and Mental Health Services Administration (SAMHSA) acting on behalf of HHS, issued the first temporary extension of the full set of COVID-19 PHE telemedicine flexibilities for the prescribing of controlled medications through Nov. 11, 2023. This extension also provided a one-year grace period (through Nov. 11, 2024) for any practitioner-patient telemedicine relationships established by Nov. 11, 2023.

Under the first temporary extension, if a patient and a practitioner had established a telemedicine relationship by Nov. 11, 2023, the same telemedicine flexibilities that had governed the relationship to that point would continue to apply through Nov. 11, 2024.

Second temporary extension. Following telemedicine listening session conducted by the DEA in September 2023, the agency on Oct. 10, 2023, issued a second temporary extension continuing the flexibilities through the end of 2024, whether or not the patient and practitioner had established a telemedicine relationship by Nov. 11, 2023.

This second temporary extension continued until the end of 2024 the flexibilities for all practitioner-patient relationships (not just for those established by Nov. 11, 2023).

In June 2024, the DEA transmitted a new draft telemedicine NPRM to the Office of Management and Budget (OMB) for review. In meetings coordinated by OMB, interested parties have had the opportunity “to provide further views to OMB,” the DEA said.