DEA Proposes Permanent Telehealth Prescribing Rules for Controlled Substances Post-PHE

Introduction

The Drug Enforcement Administration (DEA) has issued proposed rules outlining the permanent framework for prescribing controlled substances via telehealth after the expiration of the COVID-19 Public Health Emergency (PHE) flexibilities. These proposals, initially released in March 2023 and subsequently subject to extensions and further consideration, aim to establish a balance between ensuring patient access to necessary care and preventing the diversion of controlled medications. The rules represent a significant shift from the temporary waivers that allowed for broader telehealth prescribing during the pandemic.

Background: The Evolution of Telehealth Prescribing

Prior to the COVID-19 PHE, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally required an in-person medical evaluation before a practitioner could prescribe controlled substances to a patient via the internet. The Act included several exceptions, such as when a patient was being examined by, and located in, a DEA-registered hospital or clinic, or when a referring practitioner had conducted an in-person medical evaluation. However, the onset of the COVID-19 pandemic led to temporary waivers of these in-person requirements, allowing practitioners to prescribe controlled substances to patients via telehealth without a prior in-person medical evaluation, provided certain conditions were met. This dramatically expanded access to care, particularly for mental health and pain management services.

As the PHE drew to a close, the DEA, in coordination with the Substance Abuse and Mental Health Services Administration (SAMHSA), recognized the need for a permanent regulatory framework. The initial proposed rules published in March 2023 generated significant public comment, leading the DEA to extend the PHE flexibilities and issue a second notice of proposed rulemaking in October 2023 to gather additional feedback and refine its approach.

Key Provisions of the Proposed Rules

The DEA's proposed rules, as outlined in their notices of proposed rulemaking (NPRMs), establish the following key requirements for prescribing controlled substances via telehealth:

1. General In-Person Examination Requirement

For Schedule II-V controlled substances, a telehealth practitioner generally must conduct an in-person medical evaluation of a patient before prescribing controlled medications. This re-establishes the core principle of the Ryan Haight Act.

2. Telehealth Exception for Initial Prescriptions (30-Day Supply)

An exception is proposed for an initial 30-day supply of a Schedule III-V non-narcotic controlled medication and an initial 30-day supply of buprenorphine for the treatment of opioid use disorder (OUD). Under this exception, a practitioner may prescribe these medications via telehealth without a prior in-person medical evaluation, provided:

• The prescription is issued pursuant to a legitimate medical purpose in the usual course of professional practice.
• The practitioner is acting in accordance with applicable Federal and State laws.
• The prescription is for a 30-day supply or less.
• The practitioner refers the patient for an in-person medical evaluation within 30 days of the initial telehealth prescription.
• If the patient does not receive an in-person medical evaluation within 30 days, the practitioner cannot issue any further prescriptions for controlled substances to that patient until an in-person evaluation occurs.

3. Schedule II Medications

Schedule II controlled substances cannot be prescribed via telehealth without a prior in-person medical evaluation, except in very limited circumstances such as during another declared public health emergency or for patients in specific institutional settings where an in-person visit might be impractical or impossible.

4. Referring Practitioner Exception

The proposed rules maintain the existing Ryan Haight Act exception where a telehealth practitioner may prescribe controlled substances without a prior in-person evaluation if a referring practitioner has conducted an in-person medical evaluation. This requires a formal referral and communication between the practitioners.

5. Telemedicine for Patients in Specific Settings

The rules also address prescribing for patients located in a DEA-registered hospital or clinic, or under the direct supervision of a DEA-registered practitioner, allowing for telehealth prescribing in these controlled environments without a separate in-person visit by the prescribing practitioner.

6. Public Health Emergency Exceptions

The rules include provisions for future public health emergencies, allowing the DEA Administrator to issue a PHE telemedicine exception that would temporarily waive the in-person examination requirement during such crises, similar to the COVID-19 flexibilities.

7. State Law Precedence

It is crucial to note that these federal rules establish a baseline. State laws and regulations regarding telehealth and controlled substance prescribing remain applicable, and practitioners must comply with both federal and state requirements. If a state law is more restrictive than the federal rule, the state law generally takes precedence.

Rationale Behind the Proposed Rules

The DEA's primary objective is to prevent the diversion of controlled substances while ensuring legitimate patient access. The agency acknowledges the benefits of telehealth, particularly in expanding access to care for underserved populations and those with mobility issues. However, it also highlights concerns about potential risks associated with prescribing controlled substances without an initial in-person evaluation, including:

• Patient safety: An in-person exam allows for a comprehensive physical assessment, vital sign checks, and diagnostic testing that may not be fully replicable via telehealth, which can be critical for accurate diagnosis and safe prescribing.
• Diversion risk: The absence of an in-person visit can increase the risk of