Knowledge Base Article

Background

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act) enforced that a prescribing practitioner, subject to certain exceptions, may prescribe controlled medications to a patient only after conducting an in-person evaluation of the patient.

In response to the COVID-19 public health emergency (PHE), on January 31, 2020, the Drug Enforcement Agency (DEA) granted temporary exceptions to the Ryan Haight Act. To prevent lapses in care, the exceptions allowed a practitioner to prescribe controlled medication via telemedicine encounters, even when the practitioner had not conducted an in-person medical evaluation of the patient.

The telemedicine flexibilities authorized practitioners to prescribe schedule II-V controlled medications via audio-video telemedicine encounters, including schedule III-V narcotic-controlled medications approved by the FDA for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters.

March 1, 2023: First Temporary Rule Proposed

On March 1, 2023, The Drug Enforcement Agency (DEA) worked with the Department of Health and Human Services (HHS) to release two notices of proposed rulemakings (NPRMs):

• The General Telemedicine Rule where the practitioner can prescribe controlled substances via telemedicine without the patient having a prior in-person medical evaluation, and
• The Buprenorphine Rule which proposed to expand patient access to prescriptions for controlled medications by telemedicine encounters relative to the pre-COVID-19 PHE landscape.

“The purpose of the two proposals was to make permanent some of the telemedicine flexibilities established during the COVID-19 PHE in order to facilitate patient access to controlled medications via telemedicine when consistent with public health and safety, while maintaining effective controls against diversion.”

May 10, 2023: First Temporary Rule Issued

This rule extended the full set of telemedicine flexibilities regarding the prescribing of controlled medications, as had been in place under the COVID-19 PHE, through November 11, 2023. The rule also provided a one-year grace period, through November 11, 2024, to any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023.

October 6, 2023: Second Temporary Rule Issued

The DEA and HHS issued a Second Temporary Rule extending the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE, through December 31, 2024.

“This extension authorizes all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023.”

The stated purpose of the Second Temporary Rule “is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards.”

Note, the DEA is working to develop new standards or safeguards by the fall of 2024.

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