DEA Issues Third Extension of Telemedicine Prescribing Flexibilities

The Drug Enforcement Administration (DEA) has issued the “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” (Third Extension), which extends the flexibilities allowing qualified practitioners to prescribe controlled substances via telemedicine that were introduced during the COVID-19 public health emergency (PHE).

Main Takeaways From the Third Extension

• The Third Extension allows providers to continue prescribing controlled substances without a prior in-person examination through December 31, 2025, at which time a permanent update is expected.
• State laws that may prohibit prescribing controlled substances without a prior in-person examination are not affected by the extension, so providers must ensure their current practices are compliant.
• Healthtech companies whose operations involve prescribing controlled substances should continue to explore potential alternatives, as it remains highly uncertain where the DEA will land when a final, permanent standard is established.

History of the Flexibilities and DEA Rulemaking

• Prior to the PHE, the Controlled Substances Act (as amended by the Ryan Haight Act of 2008) required providers to perform an in-person medical examination of each patient and obtain a DEA registration in each state where their patients were located before issuing a prescription for a controlled substance unless a few, narrow exceptions were satisfied.
• During the PHE, the DEA relaxed these requirements, allowing providers to prescribe controlled substances without an in-person examination and waiving the requirement that practitioners hold a DEA-controlled substances registration in every state where a patient who is prescribed controlled substances is located (though certain states, independent of the federal requirement, impose their own controlled substance registration requirements).
• In February 2023, the DEA issued a Notice of Proposed Rulemaking (NPRM) focused on establishing a permanent approach to telemedicine prescribing. The NPRM only provided modest flexibilities going forward, such as limiting the allowable supply of certain controlled substances to 30 days without a prior in-person examination.
• The DEA received over 38,000 comments on the NPRM, including significant criticism of the impact of the proposed limitations, and held two days of public listening sessions. Given the unprecedented volume of comments, the DEA ultimately withdrew the NPRM and extended the temporary PHE-era flexibilities, first in May 2023, and again in October 2023, through the end of 2024.

How PHE Flexibilities Have Impacted the Industry

Technological advances, together with flexibilities around prescribing and cross-border care more broadly, led to an explosion in the use of telemedicine during the PHE. In clinical specialties reliant upon controlled substance medication regimens, such as behavioral health and gender-affirming care, the need for virtual care solutions and temporary flexibilities fueled new care delivery models on which thousands of patients now rely to access healthcare services.

Orrick will continue to track these developments and provide updates as further guidance emerges from the DEA. If you have any questions, please contact the authors (Anna Booth, Melania Jankowski, Amy Joseph, and Jeremy Sherer) or another Orrick team member.