DEA extends controlled substance prescribing flexibilities through 2024
by By Jarrod Fowler, MHA, FMA Director of Healthcare Policy and Innovation | Oct. 12, 2023
The FMA is pleased that the U.S. Drug Enforcement Administration (DEA) has issued a new temporary rule extending telehealth controlled substance prescribing flexibilities. While the DEA still expects to issue a final rule next year, the temporary rule will once again extend the telemedicine prescribing flexibilities that were in place for controlled substances under the COVID-19 PHE. This means that DEA-registered clinicians will be able to prescribe schedule II-V controlled substances via telehealth through Dec. 31, 2024, irrespective of whether they had established a telemedicine relationship with the patients on or before Nov. 11, 2023.

The following is a summary of the rule, as stated in the document:
 On March 1, 2023, the Drug Enforcement Administration (DEA), in concert with the Department of Health and Human Services (HHS), promulgated two notices of proposed rulemakings (NPRMs) soliciting comments on proposals to allow for prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. On May 10, 2023, following initial review of the comments received, DEA, jointly with HHS, issued a temporary rule (First Temporary Rule) extending certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID–19 Public Health Emergency (COVID–19 PHE). These exceptions were granted in order to avoid lapses in care for patients. In particular, with respect to practitioner-patient relationships formed after the May 11, 2023, expiration of the COVID– 19 PHE, the First Temporary Rule extended the temporary exceptions until November 11, 2023. In this second temporary rule, as DEA and HHS continue to consider revisions to the proposed rules set forth in the March 1, 2023, NPRMs and in light of Telemedicine Listening Sessions that DEA hosted on September 12 and 13, 2023, DEA and HHS are further extending such exceptions to existing DEA regulations for new practitioner-patient relationships through December 31, 2024.

The DEA states that the purpose of this rule is to:
 
  • Prevent a reduction in access to care for patients who do not yet have telemedicine relationships with their practitioners, pending promulgation of a final rule or rules addressing telemedicine more generally.

  • For relationships established both during the COVID–19 PHE and those established shortly after, prevent backlogs with respect to in-person medical evaluations in the months shortly before and after the expiration of the telemedicine flexibilities and ensure the availability of telemedicine for practitioners and patients who have come to rely on it.

  • Address the urgent public health need for continued access to the initiation of buprenorphine as medication for opioid use disorder in the context of the continuing opioid public health crisis.

  • Allow patients, practitioners, pharmacists, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine.

  • Enable the DEA and potentially HHS to thoroughly consider the presentations made at the Telemedicine Listening Sessions.

  •  Enable the DEA, jointly with HHS, to conduct a thorough evaluation of regulatory alternatives in order to promulgate regulations that most effectively expand access to telemedicine encounters in a manner that is consistent with public health and safety, while also effectively mitigating against the risk of possible diversion.

  • Avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices by limiting the second extension of flexibilities to a short, time-limited period.