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Telehealth Update: DEA Issues Temporary Rule on Prescribing Controlled Substances via Telehealth as the Public Health Emergency Comes to an End

As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur once the COVID-19 Public Health Emergency (PHE) ends on May 11, 2023. The proposed rule provided some flexibility, but required a much more restrictive framework for prescribing controlled substances via telehealth compared to the flexibilities available during the PHE. During the 30-day comment period following the announcement of the proposed rule, the DEA received over 38,000 comments, which the agency says it is closely reviewing. Many commentators across the health care industry criticized the proposed rule because the in-person examination requirement would limit access to care. The DEA, working with the U.S. Department of Health and Human Services, is also considering revisions to the proposed rule. 

In order to avoid any lapse in care while the DEA reviews the comments received and finalizes the proposed rule, the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have issued a temporary rule extending some of the PHE flexibilities that have been in place since 2020. Those flexibilities have allowed providers to prescribe schedule III-V controlled substances via audio-video telehealth encounters without having conducted an in-person evaluation of the patient. 

In its press release announcing the temporary rule, the DEA acknowledged the importance of this change, stating:

“We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for six months while we work to find a way forward to give Americans that access with appropriate safeguards.”

The temporary rule, which will go into effect the day after the PHE ends (expected to be May 12, 2023) provides the following: 

  • The full set of telehealth waivers regarding the prescription of controlled substances, which have been in place during the PHE, will remain in place through November 11, 2023. This means that providers will be able to continue prescribing controlled substances to patients with whom they have previously established a relationship via audio-visual telehealth interaction AND prescribe to new patients based on an audio-visual telehealth interaction through November 11, 2023. 
  • Additionally, the telehealth flexibilities related to the prescription of controlled substances will continue to apply for one year, through November 11, 2024, for any patients with whom a practitioner has established a prescribing relationship prior to November 11, 2023. 

The temporary rule also provides a summary of the requirements for prescribing via telehealth, which have been in place for the duration of the PHE: 

  • The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
  • The prescription must be issued pursuant to a telehealth interaction using two-way, real-time audio-visual technology, or for prescriptions to treat a mental health disorder, a two-way, real-time audio-only communication if the patient is not capable of, or does not consent to, the use of video technology. 
  • The practitioner must be authorized under their DEA registration to prescribe the basic class of controlled medication specified on the prescription or be exempt from obtaining a registration to dispense controlled substances. 
  • The prescription must meet all other requirements of the DEA regulations.

The temporary rule provides a much hoped-for reprieve for telehealth-only providers and their patients. We will continue to track the status of the DEA’s proposed rule and will provide additional updates on this important issue. 

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Ellen provides strategic advice to health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states.
Cassandra L. Paolillo is Of Counsel at Mintz whose practice involves advising health care clients on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance, and general contracting. Cassie primarily works with providers and payors.