On March 1, 2023, the Drug Enforcement Administration (DEA), in concert with the Department of Health and Human Services (HHS), issued two proposed rules for prescribing certain controlled substances via telemedicine: “Expansion of Induction of Buprenorphine via Telemedicine Encounter” and “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation.” DEA issued these proposed rules in response to the Biden-Harris Administration announcing its intent to end the COVID-19 Public Health Emergency (PHE) on May 11, 2023. During the PHE, DEA temporarily relaxed certain requirements related to prescribing controlled substances via telemedicine without first conducting an in-person medical evaluation. The proposed rules seek to make permanent many of these flexibilities with appropriate safeguards.
“Expansion of Induction of Buprenorphine via Telemedicine Encounter” proposes to allow DEA-registered practitioners to prescribe buprenorphine for opioid use disorder via telemedicine, including an audio-only telemedicine encounter, to a new patient without first conducting an in-person evaluation or receiving a referral from a practitioner who has conducted an in-person evaluation.
“Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” proposes a similar regulatory framework, but would apply to telemedicine prescriptions for Schedule III-V non-narcotic controlled substances. Schedule II prescriptions would be permitted only if (1) the prescriber receives a qualifying telemedicine referral from a DEA-registered practitioner (unless exempt from registration) who has conducted an in-person evaluation; or (2) the prescriber established a “telemedicine relationship” with the patient during the PHE, with such authority expiring 180 days after the effective date of the final rule or the end of the PHE, whichever is later.
Proposed safeguards set forth in both rules include limiting the prescription to a 30-day supply until an in-person medical evaluation can be conducted; requiring practitioners to review and consider controlled prescription data contained in prescription drug monitoring program databases; requiring practitioners to keep certain records; and requiring practitioners to be technically capable of conducting a telemedicine encounter using audio and video equipment permitting two-way, real-time interactive communication with the patient. Furthermore, the rule reiterates that all prescriptions must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and that all other applicable state and federal laws must be followed.
The proposed rules are open for public comment until 11:59 PM on March 31, 2023. As of March 7, 2023, DEA has received over 1,000 comments between the two rules. Most of the comments have expressed disapproval of various aspects of the rules, arguing that they re-establish barriers to care. DEA will review and consider public comments before finalizing the rules. Final rules generally are effective no less than 30 days after the date of publication in the Federal Register.
Research has shown that regulatory actions during the PHE to expand the use of telehealth and provide flexibilities for prescribing medications for opioid use disorder were associated with improved retention in care and lower odds of medically treated drug poisonings. However, unlike the proposed rules, the PHE flexibilities did not limit prescriptions to a 30-day supply before an in-person medical evaluation could be conducted. This could reduce the effectiveness of the PHE flexibilities. In finalizing the rules, the Center for U.S. Policy urges DEA to fully consider comments regarding how its proposed safeguards could impact treatment for patients with substance use disorders.
Read the DEA’s statement here.
Read the proposed rule on the induction of buprenorphine here.
Read the proposed rule on prescribing of other controlled substances here.
 Jones, C. M., Shoff, C., Hodges, K., Blanco, C., Losby, J. L., Ling, S. M., & Compton, W. M. (2022). Receipt of Telehealth Services, Receipt and Retention of Medications for Opioid Use Disorder, and Medically Treated Overdose Among Medicare Beneficiaries Before and During the COVID-19 Pandemic. JAMA Psychiatry, 79(10), 981–992. https://doi.org/10.1001/jamapsychiatry.2022.2284