CONTINUED AGAIN: DEA Announces A Second Extension of its “Temporary Rule” Addressing Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency.  As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) 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 are here, and here (passcode Bv3*o^i5).  DEA received a whopping 38,000 (!) comments on the two proposed rules.

Next, on May 9, 2023 DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued the First Temporary Rule, which extended the full set of telemedicine flexibilities regarding the prescribing of controlled medications through November 11, 2023. That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. Thus, under the First Temporary Rule, if a patient and a practitioner established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that governed the relationship to that point would continue to apply through November 11, 2024. DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present. DEA noted that industry will have another opportunity for comment once new proposed rules are promulgated.

Based on industry input, DEA and HHS announced in its Second Temporary Rule a further extension of existing telemedicine flexibilities for new practitioner-patient relationships through December 31, 2024. Unlike the first extension back in May 2023, this time around DEA will not require the practitioner-patient relationship to be one that exists prior to on or before November 11, 2023.  Instead, DEA states:

This extension authorizes all DEA-registered practitioners to prescribe schedule II–V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023. In other words, the grace period provided in the First Temporary Rule is effectively subsumed by this Second Temporary Rule, which continues the extension of the current flexibilities for all practitioner-patient relationships— not just those established on or before November 11, 2023—until the end of 2024.

Temporary Rule: Second Temporary Extension of COVID–19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 Fed. Reg. 69,879, 69,880 (Oct. 10, 2023) (emphasis added).

DEA stated its reasons behind the second extension include the need to spend more time considering industry comments and the input it received during its Listening Sessions.  DEA also stated it intends to “ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards.”  Id.  DEA also announced that it is working to promulgate these new telemedicine standards or safeguards by the fall of 2024.  This blogger appreciates DEA’s continued deliberative consideration of these new rules as it works through the unprecedented number of comments and extensive Listening Session input received to date.