Rx-tension: Temporary Rule Extends Telemedicine Flexibilities for Controlled Substance Prescribing

Providers now have until November 11, 2023, to continue prescribing controlled substances through telemedicine without an in-person examination.

In anticipation of the expiration of the COVID-19 Public Health Emergency (PHE), the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced on May 10, 2023, a temporary extension of PHE telemedicine flexibilities for prescribing controlled substances, lasting from May 11, 2023, through November 11, 2023. The extension maintains the full set of telemedicine flexibilities established during the PHE. Additionally, telemedicine flexibilities for those practitioner-patient telemedicine relationships that are established through November 11, 2023, will extend even further, lasting through November 11, 2024.

With more than 38,000 public comments received in response to DEA’s March 2023 proposed rules to replace the expiring telehealth flexibilities, the DEA is reviewing input to strike a balance between patient access to necessary medications and appropriate safeguards. Ultimately, the comment review will help develop a permanent rule that aligns with public health, safety, and effective measures against diversion.

Despite the temporary extension, providers are still subject to following requirements for prescribing controlled substances via telemedicine:

1. The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
2. The prescription must be issued through a communication between a practitioner and a patient using an interactive telecommunications system;
3. The practitioner must be authorized under their registration to prescribe the specific class of controlled medications mentioned in the prescription or be exempt from obtaining a registration to dispense controlled medications; and
4. The prescription must comply with all other requirements outlined in 21 CFR Part 1306.

If you have any questions about the information in this alert, please contact, Kathleen Reed (kreed@dykema.com or 734-214-7661), David Padalino (dpadalino@dykema.com or 734-214-7616), or your Dykema relationship attorney.