DEA Controlled Substance Prescribing via Telehealth: Navigating the Post-PHE Landscape and Proposed Rules

Introduction to the Ryan Haight Act and Telehealth Flexibilities

The ability of healthcare providers to prescribe controlled substances via telehealth has been a complex and evolving area of federal regulation, primarily governed by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act). This act generally requires an in-person medical evaluation before a practitioner can prescribe controlled substances to a patient. The purpose of this requirement is to prevent the illicit online distribution of controlled medications and ensure patient safety.

However, the onset of the COVID-19 Public Health Emergency (PHE) in early 2020 introduced significant flexibilities. The Drug Enforcement Administration (DEA), in conjunction with the Department of Health and Human Services (HHS), issued waivers that allowed practitioners to prescribe controlled substances via telehealth without an initial in-person medical evaluation, provided certain conditions were met. These flexibilities were critical in ensuring continued access to care, particularly for mental health and addiction treatment services, during a period of unprecedented public health crisis.

The Expiration of the Public Health Emergency and DEA's Response

The federal Public Health Emergency officially ended on May 11, 2023. This expiration triggered a need for the DEA to address the future of telehealth prescribing for controlled substances, as the PHE-related flexibilities were set to expire. Recognizing the importance of maintaining access to care while developing a permanent framework, the DEA issued several extensions and proposed rules.

Initially, the DEA and HHS announced that the full PHE telehealth flexibilities would remain in effect until November 11, 2023. This six-month grace period was intended to allow patients to find in-person care if necessary and for practitioners to adjust their practices. Following this, for patient-prescriber relationships established on or before November 11, 2023, the full flexibilities were further extended for an additional year, until November 11, 2024. This means that for existing patients, practitioners can continue to prescribe controlled substances via telehealth without an in-person exam until that date, provided the patient-prescriber relationship was established during the PHE or the initial six-month grace period.

For new patient-prescriber relationships established after November 11, 2023, the original Ryan Haight Act requirements generally apply, meaning an in-person examination is required before prescribing controlled substances, unless another exception applies.

DEA's Proposed Rules for Telehealth Prescribing

In March 2023, prior to the PHE's expiration, the DEA published two Notices of Proposed Rulemaking (NPRMs) to establish a permanent framework for prescribing controlled substances via telehealth after the PHE. These proposed rules aimed to strike a balance between expanding access to care and preventing diversion and misuse.

Proposed Rule 1: General Telehealth Prescribing of Controlled Substances

This proposed rule, titled