In response to 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”) allowing healthcare providers to prescribe controlled medications via telemedicine without requiring in-person medical examinations. As discussed in our May 2023 blog post “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescriptions of Controlled Medications,” the DEA, together with the Department of Health and Human Services (“HHS”), issued a temporary rule titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” (“First Temporary Rule”), which not only extended the full set of Public Health Emergency (“PHE”) telemedicine flexibilities and allowed controlled substances to be prescribed for new patients without an initial in-person examination through Nov. 11, 2023, but also created a 1 year grace period extending these flexibilities through Nov. 11, 2024, for any practitioner-patient telemedicine relationship established on or before Nov. 11, 2023.

As discussed in our October 2023 blog post , the DEA and HHS issued a further extension, pursuant to 21 U.S.C. § 802(54)(G), titled “Further Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescriptions of Controlled Medications” (“Second Temporary Rule”). The Second Temporary Rule, effective Nov. 11, 2023, extended the PHE prescribing flexibilities through Dec. 31, 2024, and eliminated the grace period established in the First Temporary Rule. By eliminating the grace period, the Second Temporary Rule removed the distinction between new and established patients and extended telemedicine prescribing flexibilities to all practitioner-patient relationships, regardless of when the relationship was established. The Second Temporary Rule is set to expire on Dec. 31, 2024.

On October 11, 2024, the DEA submitted a proposed rule titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” (“Proposed Third Temporary Rule”), which is not yet available for public review. It is anticipated that the Proposed Third Temporary Rule will be released for public review before the year ends and the Second Temporary Rule expires. It is anticipated that a further extension will be implemented to allow sufficient time for the DEA to draft a new proposed rule.

If a further extension is not issued, thousands of patients will lose access to critical medications in approximately two months. For the last 4 years, the prescribing flexibilities under the First Temporary Rule and the Second Temporary Rule have increased access to health care for thousands of patients, including those in rural areas. A further extension is essential to maintain these patients’ access to their critical medications.

A full discussion of the Ryan Haight Act, as well as the First and Second Temporary Rules, can be found in our May 2023 and October 2023 blog posts.