In response to the need for remote medical consultations and treatments caused by the COVID-19 pandemic, the United States Drug Enforcement Administration (“DEA”) granted temporary exceptions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“the Ryan Haight Act”). These exceptions allowed healthcare providers to prescribe controlled medications via telemedicine without the need for an in-person medical examination. Since then, the DEA, in concert with the Department of Health and Human Services (“HHS”), has issued two temporary rules extending COVID-19 flexibilities for telemedicine prescriptions of controlled medications. The Second Temporary Rule extended the full set of public health emergency (“PHE”) telemedicine flexibilities through Dec. 31, 2024, and eliminated the grace period established in the First Temporary Rule, thereby extending prescribing flexibilities to all practitioner-patient relationships regardless of when the relationship was established (see our May 2023 and October 2023 blog posts). The Second Temporary Rule was set to expire on Dec. 31, 2024

On Nov. 15, 2024, the DEA and HHS jointly issued the Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, , set to go into effect on Jan. 1, 2025, and extending the current COVID-era prescribing flexibilities for an additional year, through Dec. 31, 2025. Under the Third Temporary Rule, prescribers may continue to prescribe Schedule II-V controlled substances via telemedicine without having conducted an in-person evaluation of the patient if the following conditions are met:

1. The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
2. The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system as defined in 42 CFR 410.78(a)(3);
3. The practitioner is:
   
   1301. Authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled substance specified on the prescription; or
   1302. Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d); and
4. The prescription is consistent with all other requirements of 21 CFR part 1306.

In the Third Temporary Rule, the DEA acknowledges that allowing the existing telemedicine flexibilities to end on Dec. 31, 2024, would result in a reduction in access to care that would be contrary to the public interest, as it could lead to potential patient harm—due to an inability to access appropriate care in some instances. Prior to issuing the First Temporary Rule, the DEA published two proposed rules to address prescribing of controlled substances via telemedicine. In response, the DEA received over 38,000 public comments to the proposed rules. As a result of the number of comments received, the DEA and HHS issued the First Temporary Rule. The DEA has stated that that it considered the comments in publishing the First Temporary Rule and the Second Temporary Rule. The further extension of the COVID-era prescribing flexibilities under the Third Temporary Rule will provide the DEA and HHS additional time to review the comments received in March 2023.

The Third Temporary Rule extends existing telemedicine flexibilities through Dec. 31, 2025. Thereafter, the future for the prescription of controlled substances via telemedicine is uncertain. While the DEA has explicitly acknowledged in the temporary rules that ending the existing flexibilities could lead to potential patient harm, it is likely the future rule(s) will be more restrictive than the COVID-era flexibilities. We will continue to monitor and report on developments.

A full discussion of the Ryan Haight Act, as well as the First and Second Temporary Rules, can be found in:

• May 2023: “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescriptions of Controlled Medications”
• October 2023: “Further Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescriptions of Controlled Medications”
• November 2024: “Expected Further Extension of COVID-19 Telemedicine Flexibilities for Prescriptions of Controlled Medications”