DEA Telehealth Prescribing of Controlled Substances: Navigating the Ryan Haight Act and Post-PHE Waivers

The landscape for prescribing controlled substances via telehealth has undergone significant shifts, particularly with the expiration of the COVID-19 Public Health Emergency (PHE) declaration. Healthcare providers and organizations leveraging telehealth must possess a clear understanding of the Drug Enforcement Administration (DEA) regulations, primarily the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, and the current status of waivers and proposed rules.

The Ryan Haight Act: The Foundational Rule

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 829(e)) was enacted to combat the proliferation of rogue internet pharmacies prescribing controlled substances without a legitimate medical purpose. At its core, the Act mandates that a controlled substance prescription issued by a practitioner via the internet is not valid unless the practitioner has conducted at least one in-person medical evaluation of the patient. This evaluation must occur prior to the issuance of the prescription.

Statutory Exceptions to the In-Person Requirement

The Ryan Haight Act does provide specific, limited exceptions to the in-person medical evaluation requirement. These include:

• Telemedicine Practice: When the practitioner is engaged in the practice of telemedicine in accordance with applicable federal and state laws, and the practitioner has conducted an in-person medical evaluation or has a qualifying telemedicine relationship with the patient. A qualifying telemedicine relationship typically means the practitioner has previously conducted an in-person medical evaluation or the patient has been referred by another practitioner who has conducted such an evaluation.
• Emergency Situations: In certain emergency situations, where delay would cause harm to the patient, a controlled substance may be prescribed without a prior in-person evaluation, subject to specific reporting and follow-up requirements.
• Federal Facilities: Practitioners acting within the scope of their employment in a federal facility (e.g., VA hospitals).
• Indian Health Service/Tribal Organizations: Practitioners acting within the scope of their employment with the Indian Health Service or a tribal organization.
• Public Health Emergencies: During a declared public health emergency, the Secretary of Health and Human Services (HHS), in conjunction with the DEA, may waive the in-person requirement, as was done during the COVID-19 PHE. This is the exception that has been most impactful recently.

The Impact of the COVID-19 Public Health Emergency (PHE) Waivers

Beginning in March 2020, in response to the COVID-19 PHE, the DEA, in coordination with HHS, issued temporary waivers to the Ryan Haight Act's in-person examination requirement. These waivers allowed DEA-registered practitioners to prescribe Schedule II-V controlled substances via telehealth without an initial in-person medical evaluation, provided certain conditions were met, such as the prescription being issued for a legitimate medical purpose in the usual course of professional practice and the telehealth communication being conducted using an audio-visual, real-time, two-way interactive communication system.

This temporary flexibility significantly expanded access to care, particularly for mental health conditions requiring medications like buprenorphine for opioid use disorder, stimulants for ADHD, and benzodiazepines for anxiety. Many telehealth platforms built their models around these waivers.

Expiration of the PHE and the Return to Pre-PHE Rules

The COVID-19 PHE officially ended on May 11, 2023. This triggered a complex transition period for telehealth prescribing of controlled substances. The DEA initially announced that the full Ryan Haight Act requirements would return, meaning the in-person examination would once again be mandatory for most telehealth-initiated controlled substance prescriptions.

However, recognizing the potential for significant disruption to patient care, the DEA issued a temporary rule on May 10, 2023, and subsequently extended it on October 10, 2023. This temporary rule provides a grace period and specific conditions under which practitioners can continue to prescribe controlled substances via telehealth without an in-person exam, even after the PHE's expiration. The most recent extension allows for this flexibility until December 31, 2024.

Current Temporary Rule Provisions (as of October 2023 Extension):

• Established Patient Relationships: For patients for whom the practitioner has already established a telemedicine relationship on or before November 11, 2023, the practitioner may continue to prescribe controlled medications via telehealth without an in-person medical evaluation until November 11, 2024.
• New Patient Relationships: For patients for whom a telemedicine relationship is established on or after November 12, 2023, the practitioner may prescribe a 30-day supply of Schedule III-V non-narcotic controlled medications via telehealth without an in-person medical evaluation. However, for any subsequent prescriptions of controlled medications (including refills or Schedule II substances), an in-person medical evaluation or a qualifying telemedicine referral is required.

It is crucial to note that this is a temporary measure designed to prevent an abrupt cutoff of care while the DEA finalizes its permanent rules.

DEA's Proposed Permanent Rules

In February 2023, the DEA issued two proposed rules outlining potential permanent frameworks for telehealth prescribing of controlled substances post-PHE:

1. Proposed Rule: Telemedicine Prescribing of Controlled Substances: This rule proposed that, generally, an in-person medical evaluation would be required for the prescription of Schedule II controlled substances and narcotic Schedule III-V controlled substances (e.g., buprenorphine for OUD). For non-narcotic Schedule III-V controlled substances, a 30-day supply could be prescribed via telehealth without an initial in-person exam, but subsequent prescriptions would require an in-person evaluation or a referral from a practitioner who has conducted one.
2. Proposed Rule: Expansion of Induction of Buprenorphine via Telemedicine: This rule sought to expand the ability to prescribe buprenorphine for opioid use disorder (OUD) via telehealth without an initial in-person exam, recognizing the public health crisis of OUD.

These proposed rules generated significant public comment, with many stakeholders advocating for greater flexibility to ensure continued access to care. The DEA is currently reviewing these comments and is expected to issue a final rule in the future. The temporary rule extensions are intended to bridge the gap until those final rules are promulgated.

State Law Considerations

It is vital to remember that federal DEA regulations represent a baseline. State laws and medical board rules often impose additional, stricter requirements for telehealth practice and controlled substance prescribing. Practitioners must comply with both federal and state regulations. For example, some states may have specific definitions of a