May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. Today is indeed the official “end” of the COVID-19 pandemic Public Health Emergency (PHE) Declaration, and DEA, jointly with the Substance Abuse Mental Health Services Administration (SAMHSA), have announced the issuance of a temporary rule extending the PHE telemedicine exemptions, as described below.  DEA states the temporary rule will take effect today, and “extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency for six months – through November 11, 2023.”  In addition, concerning any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, all telemedicine flexibilities concerning prescribing of controlled substances established during the COVID-19 PHE will also be extended for one year – through November 11, 2024.  

This much welcomed — and needed — extension of the telemedicine flexibilities is a result of DEA’s receipt of over 38,000 comments on its set of proposed telemedicine rules for controlled substances and for buprenorphine treatment. We applaud DEA’s and SAMHA’s recognition that:

[T]he goal of this 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 that DEA and/or SAMHSA promulgate in one or more final rules.

88 Fed. Reg. 30,038 (May 10, 2023).

This time around, DEA is acting jointly with SAMHSA, which agency “concurs” with the temporary rule, and has advised DEA that no additional rulemaking is necessary at this time other than the temporary rule, nor are amendments required to 21 U.S.C. § 802(54)(G) (which references CMS’s statutory definition of “practice of telemedicine”). DEA’s preamble sets forth the temporary rule’s purpose:

• Facilitates continuity of care;
• Prevents backlogs concerning in-person medical evaluations in the months before and after the expiration of the COVID–19 PHE declaration;
• Ensures the availability of telemedicine for practitioners and patients that have come to rely on it;
• Addresses the urgent public health need for continued access to the initiation of buprenorphine for opioid use disorder in the context of the continuing opioid crisis;
• Allows patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for future regulations;
• Enables DEA and SAMHSA to review the 38,369 comments in response to the proposed rules; and
• Permits time to consider regulatory alternatives that may effectively expand access to telemedicine, which “alternatives may be consistent with public health and safety, while maintaining effective controls against diversion.”

More specifically, the temporary rule adds new regulatory sections 21 C.F.R. §1307.41and 42 C.F.R. 12.1, effective May 12, 2023 through November 11, 2024,  Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023.  It is extremely important to keep in mind that telemedicine relationships that are in effect or that are established for the prescribing of controlled substances including buprenorphine must include all of the following:

• First, the prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

• Second, the prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in CMS requirements for telemedicine services set forth at 42 C.F.R. § 410.78(a)(3). More specifically, it must be issued using audio and video  equipment permitting “two-way, real-time interactive communication or, for prescriptions to treat a mental health disorder—which include, but are not limited to, prescriptions for buprenorphine for opioid use disorder—a two-way, real-time audio-only communication if the distant site physician or practitioner is technically capable of using an interactive audio-video telecommunications system, but the patient is not capable of, or does not consent to, the use of video technology.”

• Third, the practitioner must be authorized by DEA to prescribe the basic class of controlled medications specified on the prescription or otherwise exempt

• Fourth, the prescription must be consistent with all other requirements of 21 C.F.R. part 1306 (which include DEA’s general requirements for prescribing controlled substances);

88 Fed. Reg. at 30,039 (emphasis added).

By any measure, prescribers that handle controlled substances and  have engaged actively in a telemedicine practice since the onset of the pandemic, and patients that have come to rely on needed telemedicine relations and resulting controlled substance prescriptions, have been granted a reprieve from an imminent retraction in services and the potential for DEA enforcement activity. The plain message here is that citizens and industry commented — loudly, and both DEA and SAMHSA are listening.  We hope that prudent use of the practice of telemedicine continues during this longer transition period while both DEA and SAMHSA meaningfully evaluate the more than 38,000 comments received.