Life Sciences Horizons Brochure 2025 - Flipbook - Page 20
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2025 Horizons Life Sciences and Health Care
Drug Enforcement Administration proposes new framework for telemedicine prescribing
In the waning days of the Biden Administration, the
Drug Enforcement Administration (DEA) released
long-awaited final and proposed rules permitting
DEA-registered practitioners to prescribe Schedule
II-V controlled substances via telemedicine under
certain circumstances.
During the COVID-19 public health emergency, DEA had allowed
practitioners to prescribe controlled substances via telemedicine
without first conducting an in-person medical evaluation. Since
then, DEA has made unsuccessful attempts to develop a
permanent framework for telehealth prescribing. In March 2023,
DEA proposed a stringent rule on telemedicine prescribing that
was poorly received by stakeholders. DEA eventually withdrew
the proposed rule and extended the COVID-era flexibilities in
May and again in October 2023.
Then, in June 2024, DEA submitted a new proposed rule to OMB
that was never published, but widely thought to be as restrictive as
the March 2023 proposal. In November 2024, DEA extended the
flexibilities for a third time through 31 December 2025.
DEA would also require the special registrant to maintain a
state telemedicine registration for every state where the special
registrant treats patients. DEA is accepting comments on the
rule until March 18.
The final and proposed rules represent DEA’s latest attempt
to develop a framework that balances the legitimate need for
telemedicine services with diversion concerns. The recently
published final rule focuses solely on buprenorphine, allowing
practitioners to prescribe an initial six-month supply of
buprenorphine for opioid use disorder treatment via
telemedicine without first conducting an in-person evaluation.
Given the public and stakeholder interest DEA received each time
it has attempted to develop a telemedicine rule, we anticipate the
proposed rule will trigger a significant number of comments, and
is unlikely to be finalized as-is. If the proposed rule is not finalized
before 31 December 2025, DEA may need to extend its COVID-era
flexibilities again as it reworks the telemedicine framework.
The new proposed rule would establish three Special Registration
pathways for practitioners to prescribe certain controlled
substances via telemedicine without first conducting an inperson evaluation:
Telemedicine Prescribing Registration, applicable to qualified
practitioners prescribing Schedule III-V controlled substances;
Lynn Mehler
Partner
Washington, D.C.
Advanced Telemedicine Prescribing Registration, applicable to
qualified specialized physicians and board-certified mid-level
practitioners (e.g., psychiatrists, hospice care physicians)
prescribing Schedule II-V controlled substances; and
Stephanie Agu
Senior Associate
Miami
the Telemedicine Platform Registration, which authorizes
covered telemedicine platforms to dispense Schedule II-V
controlled substances.
