The federal Drug Enforcement Agency (DEA) and the U.S. Department of Health and Human Services (HHS) have extended COVID-19 telemedicine flexibilities for prescribing controlled substances. Until December 31, 2025, a DEA-registered practitioner can prescribe schedule II-V controlled substances via telemedicine without having conducted an in-person medical evaluation of the patient if specific requirements are met. This will likely be the DEA’s last extension of such flexibilities, as a final rule regarding prescribing controlled substances via telemedicine is expected sometime in 2025.
Background
Subject to certain exceptions, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act) requires that a prescribing practitioner conduct an in-person evaluation of a patient before prescribing controlled medications to that patient. To ensure care continuity during the COVID-19 pandemic, the DEA granted a temporary exception to the in-person medical evaluation requirement and allowed DEA-registered practitioners to prescribe controlled medications via telemedicine encounters even when the practitioner had not conducted an in-person medical evaluation of the patient. This exception was previously extended twice: once in May 2023 and again in October 2023. Now, the DEA has extended the exception once more.
Summary of the Extended Flexibilities
Pursuant to the extension, a DEA-registered practitioner is authorized to prescribe schedule II-V controlled substances via telemedicine to a patient without having conducted an in-person medical evaluation of the patient if:
- Legitimate Medical Purpose. The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
- Synchronous Telemedicine Communication. The prescription is issued pursuant to a communication between a practitioner and a patient using audio and video equipment permitting two-way, real-time interactive communication between the patient and practitioner (under certain circumstances, audio-only communications are permitted for mental health patients);
- DEA-Registered Practitioner. The practitioner is either:
- authorized under their DEA registration to prescribe the basic class of controlled substance specified on the prescription; or
- exempt from obtaining a DEA registration.
- Compliance. The prescription is consistent with all other requirements of 21 CFR part 1306 (relating to prescriptions).
Another Extension Unlikely
The DEA and HHS have extended these flexibilities three times, but the DEA has indicated that another extension is unlikely. In its announcement of the extension, the DEA suggests that the extension was granted to give the DEA time to promulgate proposed and final regulations regarding prescribing controlled substances via telemedicine and to give providers time to comply with any new standards or safeguards eventually adopted in a final set of regulations.
In 2023 and 2024, the DEA issued three notices of proposed rulemaking (NPRMs), which proposed permanent rules for prescribing controlled substances via telemedicine; however, none have been finalized. Most recently, the DEA’s plans for a new NPRM were leaked, which revealed a proposed requirement that prescribers do at least 50 percent of their prescribing in person. The proposal faced significant backlash from patients, providers, industry, and Congress, casting doubt on its inclusion in any future proposed or final rule.
Contact Us
Wilson Sonsini will continue to closely monitor DEA and HHS developments regarding telemedicine prescribing.
For more information, please contact Wilson Sonsini attorneys Andrea Linna, Eva Yin, Shawn Lichaa, Dan Orr, Nawa Lodin, Jonathan Trinh, Seamus Taylor, or any member of Wilson Sonsini’s digital health practice.
