Expansion of Buprenorphine Treatment via Telemedicine Encounter

Document 2025-01049 is a Final Rule published by the Department of Justice in the Federal Register on January 17, 2025, with an effective date of February 18, 2025. The Drug Enforcement Administration and the Department of Health and Human Services are amending their regulations to expand the circumstances under which practitioners registered by the Drug Enforcement Administration are authorized to prescribe schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient's prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in- person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the Ryan Haight Act. Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder. View the original at https://www.federalregister.gov/documents/2025/01/17/2025-01049/expansion-of-buprenorphine-treatment-via-telemedicine-encounter.

No. Document 2025-01049 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.