On February 24, 2023, the United States Drug Enforcement Administration (“DEA”) announced proposed permanent rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule — collectively, the “Proposed Rules”) for the prescription of controlled substances in limited quantities via telemedicine without an in-person medical examination. Following the Biden administration’s decision to end the COVID-19 Public Health Emergency (“PHE”) effective May 11, 2023, the Proposed Rules are ostensibly intended to bridge the flexibilities enjoyed by telemedicine prescribers of controlled substances during the PHE to the post-PHE regulatory environment.
During the PHE, DEA-registered prescribers were allowed to issue prescriptions for controlled substances via telemedicine without a prior in-person evaluation, so long as the telemedicine provider acted in accordance with state law and the prescription was for a legitimate medical purpose. With the PHE ending in May, the Proposed Rules aim to curtail the prescription of controlled substances via telemedicine without a prior in-person examination. More specifically, telemedicine providers will be prohibited from prescribing Schedule II controlled substances or narcotics without an initial in-person examination. Schedule III-V controlled substances or buprenorphine (for opioid use disorder treatment) may be prescribed via telemedicine, up to an initial 30-day supply, but any refills of these prescriptions will require an in-person examination.
The Proposed Rules also set forth several exceptions to these limitations. For example, if the telemedicine relationship was established during the PHE, the Proposed Rules extend the in-person examination waiver for an additional 180 days. This 180-day extension is only available to patients who previously received a controlled substance prescription via telemedicine during the PHE. It does not apply to patients seeking controlled substance prescriptions after the PHE has ended. Moreover, the Proposed Rules do not affect:
- telemedicine consultations that do not involve the prescribing of controlled medications;
- telemedicine consultations by a medical practitioner that has previously conducted an in-person medical examination of a patient; or
- telemedicine consultations and prescriptions by a medical practitioner to whom a patient has been referred, so long as the referring medical practitioner has previously conducted an in-person medical examination of the patient.
While providing safeguards to prevent the over-prescription of controlled substances, the Proposed Rules aim to expand the use of telemedicine for prescribing controlled substances beyond what was allowed prior to the PHE. However, by placing regulatory burdens on both patients and providers, the Proposes Ruled are more restrictive than the tele-prescribing permitted during the PHE. Some have questioned whether the in-person examination requirement will adversely impact access to healthcare for many Americans. In addition, for those providers that do not maintain a physical practice location, the Proposed Rules create the need for the establishment of a physical presence or reliance on other providers to meet the in-person examination requirements.
Given the uncertainty created by the Proposed Rules, we encourage healthcare providers to begin carefully evaluating their practices in light of the shifting, post-PHE regulatory landscape. To the extent necessary, healthcare providers should conform their current treatment models to comply with the requirements of the Proposed Rules.
Comments will be accepted through 11:59 p.m. Eastern Time on March 31, 2023, after which the DEA will issue final regulations. Physical copies of any comments may be submitted by mail to:
Drug Enforcement Administration
Attn: DEA Federal Register Representative/DPW
8701 Morrissette Drive
Springfield, VA 22152
Electronic comments to the proposed rule can be submitted here.
All submissions materials should reference Docket No. DEA-407.
If you need assistance with your submission, please contact a member of the AGG Healthcare team.