TO BE CONTINUED (!?): DEA Announces It is Issuing a “Temporary Rule” to Address Telemedicine Flexibilities After the End of the COVID-19 Pandemic EmergencyMay 8, 2023
On May 3, 2023, DEA’s Administrator Anne Milgram issued a very brief and lightly publicized statement announcing that DEA intends to issue a “temporary rule” extending telemedicine flexibilities that existed during the COVID-19 Emergency Declaration, which Declaration is set to expire on May 11, 2023. Most notably for the millions of patients who, for over three years, have depended on telemedicine solutions to receive needed controlled substance medications, the Declaration’s expiration would also put an end to DEA’s flexibilities permitting certain exemptions to the Ryan Haight Online Privacy and Consumer Protection Act’s in-person examination requirements.
As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlled substances generally, and for buprenorphine use in opioid treatment. HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.” HPM’s Presentation Deck and Recording of the Presentation. slides are here, and here (passcode Bv3*o^i5).
Why is DEA now putting the brakes on its rulemakings, given the Emergency Declaration expires in just a week? DEA states that it received over 38,000 (yes, 38,000!) comments on the proposed rules. DEA is taking these comments “seriously” and is considering them “carefully,” which, by the way, it is generally required to do for rulemakings issued pursuant to the Administrative Procedure Act (5 U.S.C. §553). See Perez v. Mortg. Bankers Ass’n, 575 U.S. __, 135 S. Ct. 1199, 1203 (2015) (“An agency must consider and respond to significant comments received during the period for public comment.”).
DEA and HHS have submitted a draft Temporary Rule to the Office of Management and Budget titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” We eagerly await further details about the temporary rule. We will update our readers when the temporary rule is published – hopefully soon– in the Federal Register.