DEA and SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications until November 2023 while Considering Public Comments

The Drug Enforcement Administration (DEA) jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA) published a temporary rule, effective May 11, 2023, extending flexibilities for the prescribing of controlled substances through telemedicine that have been in effect since the beginning of the COVID-19 public health emergency (PHE). These flexibilities will remain in place through November 11, 2023.

If a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted to continue until November 11, 2024. It should be noted that the Consolidated Appropriations Act has promulgated additional provisions for Rural Health Clinics and Federally Qualified Health Centers.[1]

The temporary extension of COVID-19 flexibilities for prescribing controlled substances was issued in response to over 38,000 comments DEA received on the proposed rule. “We take those comments seriously and are considering them carefully,” said DEA Administrator Milgram. “We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for six months while we work to find a way forward to give Americans that access with appropriate safeguards.”[2]

Under the current flexibilities, a practitioner may prescribe Schedule II-V medications by telemedicine where there is a legitimate medical purpose and if such prescribing falls within the usual course of his or her professional practice. The prescription must be issued pursuant to communication between a practitioner and a patient using an interactive telecommunications system as set forth in 42 CFR 410.78(a)(3). The practitioner is authorized to prescribe the basic class of controlled substance specified on the prescription.

A continuation of the current rule will allow patients, practitioners, pharmacists, and service providers sufficient time to prepare for the implementation of any future regulations governing the prescribing of controlled medications via telemedicine. It will also provide the DEA time to conduct a thorough evaluation of regulatory alternatives to create a final regulation that most effectively expands access to telemedicine while providing sufficient safeguards against diversion.

The full text of the temporary rule may be found here. Should you, your practice, or your business have any questions about the implications of the DEA and SAMHSA extension of telemedicine flexibilities, please contact Peter Mellette, Harrison Gibbs, Elizabeth Dahl Coleman, or Trace Hall at Mellette PC.

This client advisory is for general educational purposes only. It is not intended to provide legal advice specific to any situation you may have. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.

[1] Section 4113 of the Consolidated Appropriations Act, 2023 delayed the in-person visit requirements under Medicare for mental health visits provided by Rural Health Clinics and Federally Qualified Health Centers via telecommunications technology and will not require in-person visits until January 1, 2025.