It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025

In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. The federal telemedicine flexibilities (i.e., temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. All DEA-registered practitioners may continue to prescribe via audio-visual telemedicine encounters schedule II-V controlled substances, and schedule III-narcotic controlled substances that are FDA-approved for opioid use disorder management and treatment.  DEA notes in the Federal Register notice that it received over 38,000 comments to its 2023 proposed rules (35,454 for the general telemedicine flexibilities proposed rule and 2,915 for the buprenorphine telemedicine flexibilities proposed rule), and held two days of public listening sessions addressing industry comments.  It cited that feedback as the impetus to once again give DEA time to consider “a new path forward for telemedicine” and to allow for a “smooth transition” for both patients and practitioners that have relied on the availability of telemedicine for prescription of needed controlled substance medications.  While not stated in the Temporary Rule, telemedicine prescribers and pharmacies should ensure that state laws permit telemedicine prescribing, and should ensure they hold necessary licenses in accordance with state law, especially if prescribing or dispensing across state lines.

As a reminder (and as blogged about here), on March 1, 2023, DEA, together HHS, promulgated two notices of proposed rulemaking (NPRMs), one for general telemedicine prescribing of controlled substances and another for telemedicine prescribing of Buprenorphine (“Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation,” here, and “Expansion of Induction of Buprenorphine via Telemedicine Encounter,” here).  The proposed rules, while expanding pre-COVID-19 patient access to telemedicine prescriptions for controlled substances, fell well short of the telemedicine flexibilities that existed during the COVID-19 pandemic. More specifically, the proposed rules leave somewhat limited telemedicine options for both medication assisted treatment (i.e., use of buprenorphine) for opioid use disorder, and for Schedule III-V non-narcotic controlled substances unless the patient receives an in-person examination. In addition, the proposed rules leaves no telemedicine options for Schedule II or Schedule III-V narcotic medications, which would require an initial in-person visit before issuing a prescription. The sole exception to this limitation is for a prescription of buprenorphine for treatment of opioid use disorder, where a patient may receive an initial 30-day telemedicine prescription; but the “refill” (or second prescription) still requires an in-person exam.  For schedule III-V non-narcotic prescriptions, patients similarly would be eligible to receive an initial 30-day telemedicine prescription prior to an in-person exam. Any refill, however, would require an in-person exam either by a “referring” provider or dispensing provider.

Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations.  Notably, the draft telemedicine regulatory framework comes 16 years after passage of the Ryan Haight Act of 2008, in which Congress specifically tasked DEA with crafting a framework that included a DEA registration category for telemedicine providers; and some in Congress have voiced concerns with not only telemedicine’s current nebulous status, but also with this lengthy delay.  We cannot predict with any certainty what effect President Trump’s election will have on HHS’s and DEA’s proposed telemedicine framework, especially when one considers the anticipated DOGE (Department of Government Efficiency) activities commencing with President Trump’s January 2025 inauguration. One undertaking of the DOGE, led by Elon Musk and Vivek Ramaswamy, intends to chop away at the broad-sweeping breadth of existing federal regulations. This blogger questions whether any revised proposed telemedicine regulations will successfully dodge DOGE.  Thankfully, we have until December 31, 2025 to ruminate about it.