The DEA is extending the flexibilities given to practitioners to prescribe controlled substances via telemedicine — flexibilities originally allowed during the COVID-19 public health emergency (PHE).

Under a new temporary rule, the DEA together with the Department of Health and Human Services (HHS) is extending the telemedicine exceptions for new practitioner-patient relationships through Dec. 31, 2024.

The temporary rule was released Oct. 6 and was published in the Oct. 10 issue of the Federal Register (88 Fed. Reg. 69879).

Background

Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, a prescribing practitioner may prescribe controlled medications to a patient only after conducting an in-person evaluation of the patient, with certain statutory exceptions (21 U.S.C. §829(e)).

During the COVID-19 PHE, the DEA granted temporary exceptions to the in-person evaluation requirement, allowing practitioners to prescribe Schedule II-V controlled medications, including Schedule III-V narcotic controlled medications approved by the FDA for maintenance and withdrawal management treatment of opioid use disorder, via audio-video telemedicine encounters, if the prescriptions otherwise complied with the agency’s guidance documents, DEA regulations, and federal and state law.

In two notices of proposed rulemaking (NPRMs) published in the Federal Register on March 1, 2023 — a general telemedicine NPRM covering Schedule III-V nonnarcotic controlled medications (88 Fed. Reg. 12875), and an NPRM covering buprenorphine prescribed as a treatment for opioid use disorder (88 Fed. Reg. 12890) — the DEA said that it would set safeguards for “a narrow subset” of controlled medication prescriptions written during telemedicine consultations.

Under the proposals, the DEA would establish safeguards for situations in which a telemedicine consultation is conducted by a medical practitioner who has never conducted an in-person evaluation of the patient and the consultation results in the prescribing of controlled medication.

For these consultations, the medical practitioner would be able to prescribe:

• a 30-day supply of a Schedule III-V nonnarcotic controlled medication; and/or
• a 30-day supply of buprenorphine for the treatment of opioid use disorder

without an in-person evaluation or a referral from a medical practitioner who has conducted an in-person evaluation.

May 10 Temporary Rule

A temporary rule published on May 10 (88 Fed. Reg. 30037), the DEA and HHS’ Substance Abuse and Mental Health Services Administration (SAMHSA) provided the following:

• All the telemedicine flexibilities regarding the prescription of controlled substances as were in place during the COVID-19 PHE would remain in place through Nov. 11, 2023.
• For any practitioner-patient telemedicine relationships that had been or would be established on or before Nov. 11, 2023, the full set of COVID-19 PHE telemedicine flexibilities regarding the prescription of controlled medicines would continue during a one-year grace period, through Nov. 11, 2024. “In other words,” the DEA said at the time, “if a patient and practitioner have established a telemedicine relationship on or before Nov. 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until Nov. 11, 2024.”

DEA Public Listening Sessions

On Sept. 12 and 13, the DEA held public listening sessions to receive more input about the practice of telemedicine with respect to controlled substances. In an Aug. 7 Federal Register notice announcing the listening sessions (88 Fed. Reg. 52210), the agency said that during the two-day event stakeholders would be invited to discuss:

• “the advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all;
• “the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine that are either already reported or could be reported; and
• “specific additional safeguards that could be placed around the prescribing of Schedule II controlled substances via telemedicine.”

No November 2013 Deadline for Establishing Relationships

In the preamble to the Oct. 10 temporary rule, the DEA said, “This extension authorizes all DEA-registered practitioners to prescribe Schedule II–V controlled medications via telemedicine through Dec. 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before Nov. 11, 2023.”

“In other words,” the DEA said, “the grace period provided in the [May 10] temporary rule is effectively subsumed by this second temporary tule, which continues the extension of the current flexibilities for all practitioner-patient relationships — not just those established on or before Nov. 11, 2023 — until the end of 2024.”

Revisions to Proposed Rules Under Consideration

The agency said that the additional extension would give it more time to continue to consider revisions to the proposed rules set forth in the two March 1 NPRMs based on information presented during the listening sessions and on comments received in response to the NPRMs.

The new temporary rule, the DEA said, is intended “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.”

The agency added that it “is working to promulgate new standards or safeguards by the fall of 2024.”

The Oct. 10 temporary rule will take effect on Nov. 11, the end of the effective period of the May 10 temporary rule.