Just before PHE expires, DEA and SAMHSA issue temporary rule extending telemedicine flexibilities for certain controlled substances
On May 9, 2023, the US Drug Enforcement Administration (DEA) and the US Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a temporary rule (the Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications Temporary Rule) (Temporary Rule), which extends telemedicine flexibilities issued during the public health emergency (PHE) to permit patients to receive prescriptions for controlled substances via telemedicine and without a prior in-person examination.
The DEA and SAMHSA had previously slated these flexibilities to end as of the end of the PHE on May 11, 2023. Accordingly, while the Temporary Rule extends the full set of telemedicine flexibilities for the prescription of controlled substances for 6 months, the Temporary Rule also allows practitioners who establish a relationship with a patient prior to November 11, 2023 (the end of the 6-month extension period) to utilize the full set of PHE flexibilities for the prescription of controlled substances until November 11, 2024, which amounts to an 18-month extension from the end of the PHE.
We note that the Temporary Rule comes on the heels of the DEA, in concert with the US Department of Health and Human Services (HHS), promulgating proposed rules in March 2023 in anticipation of the end of the PHE (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule, collectively the Proposed Rules). The Proposed Rules aimed to establish a pathway for practitioners to prescribe certain controlled substances via telemedicine without an initial in-person examination.
In their simplest form, the Proposed Rules would permit, subject to certain requirements, a medical practitioner to prescribe, via telemedicine, up to a 30-day supply of non-narcotic Schedule III-V controlled substances (or buprenorphine for the treatment of opioid use disorder if issued for maintenance or detoxification treatment). The Proposed Rules would not permit renewals of such prescriptions beyond the initial 30 days unless the practitioner examined the patient in person, performed a synchronous audio-video telemedicine encounter with the patient while the patient was located in the physical presence of another DEA-registered practitioner, or received a qualifying telemedicine referral from a DEA-registered practitioner who had conducted an in-person examination of the patient. For more information on the DEA’s Proposed Rules, please see our prior alert.
With the Temporary Rule, there is a degree of uncertainty to the final form of the DEA and SAMHSA’s regulations related to the prescribing of controlled substances via telemedicine. The DEA and HHS are in the midst of reviewing over 38,000 public comments made in response to the Proposed Rules. Thus, practically, the Temporary Rule is a stop-gap measure intended to “extend the current flexibilities while [the DEA works] to find a way forward to give Americans” access to needed medications while preventing an interruption in patient care following the PHE.1
While the Temporary Rule may signal the DEA’s intent to revise the Proposed Rules in a manner that would promote a continuation of telemedicine prescribing flexibilities in the future, there is no guarantee that the DEA will take this approach in the final regulations, and the DEA remains focused on promoting effective controls against diversion. Further, the timing of any final rule on this topic from the DEA could impact the existing timeline for the extension of flexibilities set forth in the Temporary Rule. We further note that the Temporary Rule does not supersede more restrictive state laws addressing telehealth prescribing and therefore, prescribers must also be cognizant of telehealth prescribing limitations under applicable state law.
As a result, given the complex nature of the regulatory landscape, we encourage healthcare entities and providers to work with healthcare counsel to carefully evaluate their telehealth prescribing practices and the shifting regulatory landscape. Again, while the Temporary Rule may be a promising sign of telemedicine flexibilities post-PHE, we encourage providers to re-evaluate their business strategies and prepare to conform current treatment models to comply with the Proposed Rules’ or any future requirements under the final rules, as applicable.
If you have any questions about the Temporary Rule, Proposed Rules, or related matters, please contact your DLA Piper relationship partner, the authors of this alert, or any member of our healthcare industry group.
1 Statement from DEA Administrator Anne Milgram (May 3, 2023).
