Rule Temporarily Extends Flexibilities in Prescribing Controlled Substances Via Telemedicine Created During Public Health Emergency

Just days before the COVID-19 Public Health Emergency (PHE) was about to expire on May 12, The Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule that extends flexibilities for prescribing controlled substances via telemedicine.

The rule was issued more than 38,000 public comments were made in response to a proposed rule issued on March 1 that no longer would allow telehealth providers to prescribe controlled substances if the patient never had an in-person examination, subject to limited exceptions. Another proposed rule would expand the instances in which doctors could prescribe buprenorphine, used in pain and withdrawal management.

Filed in the Federal Register, the temporary rule issued on May 11, gives practitioners another six months to prescribe controlled substances via telemedicine without having to evaluate the patient in person.

It also grants an additional one-year grace period through Nov. 11, 2024, to patients and practitioners who established a telemedicine relationship on or before Nov. 11, 2023. The one-year grace period only applies if a “telemedicine relationship†exists, which requires the practitioner to have issued a prescription for controlled substances to a patient pursuant to the telemedicine flexibilities that were available during the COVID-19 PHE and through November 11, 2023, as extended by the temporary rule.

Prior to the COVID-19 PHE, the Ryan Haight Act required an in-person visit before prescribing a controlled substance. During the PHE, the DEA allowed providers to prescribe controlled substances using telehealth without satisfying the in-person visit requirement

The DEA noted the “importance of telemedicine in providing Americans with access to needed medications†while working to “find a way forward to give Americans that access with appropriate safeguards.â€

The DEA said in the meantime, it will continue to evaluate the comments it received before determining a final set of regulations 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.â€

Opinions varied on whether to extend the flexibilities. One commentor in favor suggested: “In the absence of an extension, practitioners could be inundated with in-person evaluation requests and backlogs for in-person medical evaluations might result. Along similar lines, practitioner infrastructure might prove inadequate if practitioners were inundated with in-person evaluation requests over a short period of time.â€

While one against the extension worried: “The telemedicine flexibilities that existed during the COVID-19 PHE increased diversion and overprescribing of some controlled medications, particularly as a result of certain telemedicine companies that do not conduct or require bona fide medical evaluations of patients prior to issuance of controlled medication prescriptions.

DEA stated that it, along with SAMHSA will continue to review and respond to comments and conduct a thorough evaluation of regulatory alternatives. It plans to issue one or more final rules prior to Nov. 11, 2023.

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