DEA Is Expected to Extend Telemedicine Prescribing Flexibilities Through 2025

Following significant pressure from both Congress and the White House, the DEA submitted a proposed rule on October 11, 2024, aimed at maintaining telemedicine prescribing flexibilities for controlled substances. Although the details of this rule have not been disclosed, it is anticipated that the existing telemedicine allowances will be extended for at least another year, possibly two. The proposed rule, expected for public review by year-end, should continue to waive the requirements for in-person exams and state-specific DEA registrations.

In late August 2024, POLITICO reported on the DEA’s internal draft of a regulation that would make telemedicine prescribing of controlled substances nearly impractical. Though the draft was not publicly available, journalists revealed that the U.S. Department of Health and Human Services had opposed the draft, formally objecting on at least three occasions and raising approximately 400 specific concerns. This revelation led to widespread frustration among stakeholders, sparking responses from patients, clinicians, and advocacy groups such as the American Telemedicine Association, ATA Action, and the Alliance for Connected Care. A surge of online petitions and critical letters from members of Congress then urged the DEA to fulfill its promise to implement telemedicine regulations by the end of 2024.

With limited time remaining in the year, the only feasible solution to prevent a sudden cutoff in telehealth access—the so-called "Telehealth Cliff"—is to extend current flexibilities. Such an extension would provide the DEA additional time to develop a revised rule in collaboration with clinicians and industry representatives. Without this extension, the telemedicine options that have expanded access to healthcare for rural and underserved communities over recent years would end after December 31, 2024, leaving thousands of patients at risk of losing access to essential medications.

A Brief Recap

The Ryan Haight Act introduced amendments to the Controlled Substances Act, which limited clinicians' ability to prescribe controlled substances without first conducting an in-person exam. Additionally, the Controlled Substances Act requires clinicians to obtain a DEA registration in each state where their patients reside. When the Ryan Haight Act was passed in 2008, Congress expected the DEA to establish a special registration rule for telemedicine clinics soon after. However, years passed without action, leading Congress and the White House to enact the SUPPORT Act of 2018, which required the DEA to issue the rule by October 2019. Five years later, and seventeen years after the initial mandate from Congress, the DEA has still not released it.

During the COVID-19 Public Health Emergency (PHE), the DEA introduced temporary measures allowing clinicians to prescribe controlled substances without requiring in-person exams and only needing a single-state DEA registration. In February 2023, two months before the PHE’s end, the DEA proposed a new rule regarding telemedicine prescribing, but it faced widespread criticism. The proposal attracted a record 38,000 public comments, nearly all critical, with objections focusing on its lack of alignment with how healthcare services are actually delivered. In response to this backlash, the DEA withdrew the proposal and extended the COVID-era flexibilities twice—first in May 2023, then in October 2023. These extensions were intended to give the DEA additional time to create a feasible rule for telemedicine prescribing of controlled substances.

What happens if the flexibilities expire on December 31, 2024?

If the current flexibilities expire, clinicians who wish to prescribe controlled substances through telemedicine must:

1. Fulfill one of the limited exceptions under the Ryan Haight Act or conduct an in-person exam of the patient; and
2. Secure a separate DEA registration in each state where their patients reside.

These requirements apply even if a clinician has treated a patient continuously since 2020 under the COVID-era flexibilities, as the DEA has clarified that no “grandfathering” provision exists to allow continued prescribing under these conditions. Compliance is critical, as failure to meet these rules is considered an automatic violation of the Controlled Substances Act, potentially leading to criminal or civil penalties, along with the revocation or suspension of the clinician’s DEA registration. Any actions against a clinician’s DEA registration could prompt mandatory disclosures to state licensing boards, Medicare, Medicaid, and potentially the clinician’s employer.

Conclusion

We will continue to monitor the rule development and provide updates. Be sure to subscribe to Functional Lawyer on social media and email to stay within these changing rules.