The temporary rule will take effect immediately upon the expiration of the PHE on May 11, 2023, and contains two specific provisions:
- Extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency for six months – through November 11, 2023.
- For any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications established during the COVID-19 PHE will be extended for one year – through November 11, 2024.
The DEA/SAMHSA announcement can be found here.
Background
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), a prescribing practitioner – subject to certain exceptions – may prescribe controlled medications to a patient only after conducting an in-person evaluation of that patient. In response to the COVID-19 PHE, the DEA granted temporary exceptions to the Ryan Haight Act regulations, thereby allowing the prescribing of controlled medications via telemedicine encounters – even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient – to prevent lapses in care.
These telemedicine flexibilities authorize practitioners to prescribe schedule II-V controlled medications via audio-video telemedicine encounters, including schedule III-V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters, without requiring an in-person medical evaluation, provided that such prescriptions otherwise comply with the requirements outlined in DEA guidance documents, DEA regulations, and applicable Federal and State law.
On March 1, 2023, the 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. Those NPRMs resulted in 38,369 public comments, which require extensive review before finalization later this year.
In the meantime, the DEA and SAMHSA are issuing this
temporary rule to extend, for a limited period, the telemedicine flexibilities that existed during the COVID-19 PHE to:
- Facilitate continuity of care for telemedicine relationships established via telemedicine during the COVID-19 PHE.
- 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 COVID-19 PHE and ensure the availability of telemedicine for practitioners and patients that 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, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine.
- Enable DEA, jointly with SAMHSA, to thoroughly review and respond to the 38,369 comments they received in response to the two NPRMs.
- Enable DEA, jointly with SAMHSA, to conduct a thorough evaluation of regulatory alternatives to promulgate regulations that most effectively expand access to telemedicine encounters in a manner that is consistent with public health and safety, while maintaining effective controls against diversion.