DEA Proposes New Telehealth Prescribing Rules for Buprenorphine and Other Controlled Substances

Introduction to the Regulatory Landscape

The landscape of telehealth prescribing for controlled substances has been a dynamic area of regulation, particularly since the onset of the COVID-19 Public Health Emergency (PHE). Prior to the PHE, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally required an in-person medical evaluation before a controlled substance could be prescribed via telemedicine. The PHE introduced temporary waivers, allowing practitioners to prescribe controlled substances, including buprenorphine for opioid use disorder (OUD), without an initial in-person examination, provided certain conditions were met.

As the PHE officially ended on May 11, 2023, the U.S. Drug Enforcement Administration (DEA), in conjunction with the Substance Abuse and Mental Health Services Administration (SAMHSA), has been working to establish permanent rules for telehealth prescribing of controlled substances. This article details the DEA's proposed rules and their implications, particularly for buprenorphine prescribing.

Understanding the DEA's Proposed Rules

On March 1, 2023, the DEA published two proposed rules regarding the prescribing of controlled substances via telemedicine. These proposals aimed to create a framework that balances patient access to care, especially for OUD, with the need to prevent diversion and ensure patient safety. Following significant public comment, the DEA issued a Supplemental Notice of Proposed Rulemaking (SNPRM) on May 10, 2023, which extended certain PHE flexibilities.

Key Provisions of the Proposed Rules (as amended by SNPRM):

1. General Requirement for In-Person Evaluation: For most Schedule II controlled substances and non-buprenorphine Schedule III-V controlled substances, an in-person medical evaluation would generally be required before a practitioner could issue an initial prescription via telemedicine. This aligns with the original intent of the Ryan Haight Act.

2. Buprenorphine for OUD Exception: The proposed rules recognize the unique importance of buprenorphine in treating OUD. While an in-person evaluation is generally preferred, the rules propose specific flexibilities for buprenorphine:

   • Initial 30-day supply: A practitioner may prescribe an initial 30-day supply of buprenorphine for OUD via telemedicine without a prior in-person medical evaluation, provided the practitioner conducts a real-time, two-way audio-visual communication with the patient. This allows for immediate initiation of treatment.
   • Subsequent Prescriptions: For prescriptions beyond the initial 30-day supply, an in-person medical evaluation would be required. If an in-person evaluation is not feasible, the practitioner could refer the patient to another practitioner who can conduct an in-person evaluation. The referring practitioner could continue to prescribe buprenorphine for up to another 30-day supply while the patient awaits the in-person evaluation, provided certain conditions are met.

3. Telemedicine Relationship Established During PHE: A critical aspect of the SNPRM is the extension of PHE flexibilities. For patient-prescriber relationships established on or before November 11, 2023, where a controlled substance was prescribed via telemedicine without an in-person medical evaluation, the full set of telemedicine flexibilities will continue to be permitted until November 11, 2024. This provides a one-year grace period for these existing relationships.

4. Referral to an In-Person Practitioner: The proposed rules allow for a practitioner to prescribe controlled substances via telemedicine if the patient has been referred to them by another practitioner who has conducted an in-person medical evaluation. This facilitates collaborative care models.

5. Emergency Situations: The rules acknowledge the need for exceptions in emergency situations, where an immediate prescription is necessary to avoid patient suffering or harm.

Rationale Behind the DEA's Stance

The DEA's approach reflects a careful consideration of several factors:

• Public Health Crisis: The ongoing opioid crisis necessitates expanded access to OUD treatment, and buprenorphine is a critical tool in this effort. The flexibilities for buprenorphine aim to reduce barriers to care.
• Patient Safety and Diversion Prevention: The Ryan Haight Act was enacted to combat the proliferation of