[author: Beatrice Edler]
On October 10, 2024, the Drug Enforcement Administration (the DEA) submitted a new rule to the White House Office of Management and Budget titled, “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications" (the New Rule). The New Rule is expected to extend the current flexibilities for telemedicine providers to prescribe controlled substances without an initial in-person consultation. The details of the New Rule and the expected extension period are not yet available but are expected to be made available for public review before the end of the year.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 amended the Controlled Substances Act to restrict practitioners’ prescribing of controlled substances unless the practitioner makes an in-person examination of the patient. 21 U.S.C. 829(e). The new law included several exemptions to the in-person consultation requirement, including: (i) authorizing the DEA to waive the law’s requirements during public health emergencies; and (ii) allowing prescriptions pursuant to a special registration process, to be created by the DEA.
In 2020, during the COVID-19 pandemic, the DEA promulgated a waiver of the requirement for an in-person visit prior to the prescription of controlled substances. After promulgating the waiver in 2020, the DEA extended the waiver twice, with the last extension, issued in October 2023, extending the waiver through December 31, 2024.
It was reported in August 2024 that the DEA intended to let the waiver expire and propose a special registration exception with substantial limits on telemedicine providers’ abilities to prescribe controlled substances. After these reports, the DEA received criticism from the industry and Congress over the allegedly proposed limits in its rule. U.S. House Representatives Doris Matsui and Earl L. “Buddy” Carter of Sacramento, California with eighteen other House colleagues, urged the DEA on October 11, 2024, in a letter that there were several concerns as to the DEA’s proposed rule for telemedicine prescriptions. The letter stated that even though there is a need for a special registration rule for the prescription of substances through telemedicine as previously mandated by Congress, the letter suggests that DEA’s draft proposal would categorically exclude entire classes of medications and providers which would be burdensome to patients and providers. Hence, the letter urges the DEA to extend the waiver to ensure that patients do not lose access to care until a new registration rule is implemented.
Leading up to October 11, 2024, the DEA submitted a new temporary rule that is believed to be a third extension of the COVID-19 flexibility, maintaining the waiver of in-person examination and special registration in each state where patients are located for what is expected to be at least another year.
