The DEA along with the Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) May 9 issued a temporary rule extending telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE).

The temporary rule was published in the Federal Register the following day (88 Fed. Reg. 30037).

The agencies’ action responded to more than 38,000 public comments on two Feb. 24 notices of proposed rulemaking (NPRMs), under which in some circumstances the DEA would allow the prescribing of controlled substances where the prescribing practitioner had not conducted an in-person medical evaluation of the patient.

In the NPRMs, published in the Federal Register March 1 — 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.

“The purpose of the two proposed rules,” the DEA said in the preamble to the May 9 temporary rule, “was to make permanent some of the telemedicine flexibilities established during the COVID-19 PHE in order to facilitate patient access to controlled medicines via telemedicine when consistent with public health and safety, while maintaining effective controls against diversion.”

During the comment period for the two NPRMs, which closed March 31, the DEA received a record 38,369 public comments — 35,454 comments on the general telemedicine NPRM and 2,915 comments on the buprenorphine NPRM.

Extended Flexibilities

On the basis of the comments, the DEA and SAMHSA issued the temporary rule, under which:

• All the telemedicine flexibilities regarding the prescription of controlled substances that were in place during the COVID-19 PHE will remain in place through Nov. 11, 2023.
• For any practitioner-patient telemedicine relationships that have been or will be established on or before Nov. 11, 2023, the full set of COVID-19 PHE telemedicine flexibilities regarding the prescription of controlled medicines will continue during a one-year grace period, through Nov. 11, 2024. “In other words,” the DEA said, “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.”

The temporary rule will “ensure a smooth translation for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions,” the two agencies said. Moreover, they noted, the temporary rule will give providers time to come into compliance with any new telemedicine prescribing standards or safeguards promulgated by the agencies in any upcoming final rules.

Responses to Comments

The DEA reported that “several thousand” comments on the NPRMs supported extending an extension of the COVID-19 PHE telemedicine flexibilities for all practitioner-patient telemedicine relationships, not just telemedicine relationships that had been established during the COVID-19 PHE. Among other things, the commenters argued that absent a broad extension, practitioners might be inundated with requests for in-person evaluations.

On the other hand, several commenters opposed extending any of the telemedicine flexibilities, arguing that they had resulted in overprescribing of some controlled medications during the PHE, particularly because some telemedicine companies allegedly do not conduct or require bona fide medical evaluations of patients before issuing controlled substance prescriptions.

Responding to the comments, the DEA and SAMHSA said that they “largely” agreed with those urging a broadening of the telemarketing flexibilities, citing the decision to extend the flexibilities beyond those who established practitioner-patient relationships during the COVID-19 PHE. The agencies also signaled that they “anticipate the issuance of final rules extending certain telemedicine flexibilities on a permanent basis.”

On the other hand, the agencies rejected extending for more than six months the period for creating practitioner-patient relationships to which the telemarketing flexibilities would apply, saying that doing so would not be “consistent with effective controls against diversion.”

The DEA added that the agency “is actively investigating certain telemedicine companies that it believes may have engaged in problematic practices.”

In addition, the DEA said that the limited extension of the telemedicine flexibilities through Nov. 11, 2024, “would be unlikely to incentivize the investment necessary to further develop telemedicine companies that have already encouraged and enabled … problematic prescribing practices during the COIVD-19 PHE.” The one-year grace period for the establishment of practitioner-patient relationships “is consistent with effective controls against diversion,” the agency said.

The temporary rule, which is effective May 11, 2023, through Nov. 11, 2024, added a new 21 C.F.R. §1307.41, “Temporary Extension of Certain COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” and a new 42 C.F.R. Part 12, “Special Exceptions Related to Telemedicine.”