The DEA Temporarily Extends COVID-19 Telemedicine Flexibilities for the Prescribing of Controlled Medications
On May 10, the Drug Enforcement Administration (“DEA”) in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”) issued a new temporary rule extending the telemedicine flexibilities that were instituted in March 2020 in response to the COVID-19 public health emergency (“PHE”). Since the COVID-19 PHE, providers have been able to prescribe a range of controlled substances, including medications used to treat opioid use disorder, via telehealth without performing a prior in-person encounter.
The DEA’s March 1, 2023 Notices of Proposed Rulemaking
The new temporary rule is in response to the March 1, 2023 Notices of Proposed Rulemaking (“NPRM”) issued by the DEA in conjunction with the Department of Health and Human Services (“HHS”), soliciting public comments on proposals to permit the prescribing of controlled medications via telemedicine encounters. One of the proposed rules would require individuals to have an in-person visit to secure a prescription for most controlled substances within a certain time period after the telemedicine encounter, with limited exceptions. The two NPRMs resulted in an unprecedented 38,369 comments, which are in the process of review by the DEA, HHS, and SAMHSA. Many of these comments assert that the DEA’s two proposed rules were “more restrictive than is warranted” and would hinder patient access to care.
The DEA’s Temporary Rule Extends the COVID-19 Telemedicine Flexibilities
The new temporary rule is effective as of May 11 and extends the full set of telemedicine flexibilities for an additional six months through Nov. 11, 2023. Additionally, the full set of telemedicine flexibilities is extended through Nov. 11, 2024, for any new practitioner-patient telemedicine relationships that are established during the six-month extension period of the telemedicine flexibilities in order to ensure continuity of patient care. Under the DEA’s temporary rule, a practitioner and patient establish a ‘‘telemedicine relationship via COVID–19 telemedicine prescribing flexibilities’’ if the practitioner has not conducted an in-person medical evaluation of the patient, and the practitioner issued the patient a prescription for controlled medications pursuant to the telemedicine flexibilities that were available during the COVID–19 PHE and extended through Nov. 11, 2023.
The Ryan Haight Act Is The Statutory Basis For the DEA’s Temporary Rule
The statutory basis of the DEA regulations arises from the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”), which amended the Controlled Substances Act to establish restrictions on practitioners prescribing controlled substances over the Internet (which is broadly defined to include telemedicine). The Ryan Haight Act requires that a prescribing practitioner perform at least one in-person medical evaluation of a patient prior to providing an online prescription for a controlled substance, with limited exceptions. While the Ryan Haight Act was targeted at “rogue Internet pharmacies” providing controlled substances without a legitimate practitioner-patient relationship, the language of the Ryan Haight Act was broadly drafted to include the prescription of controlled substances via telemedicine pursuant to a bona fide practitioner-patient relationship. In response to the COVID-19 PHE, the DEA granted temporary waivers to the Ryan Haight Act, thereby allowing practitioners to prescribe Schedule II to V controlled medications (including Schedule III to V narcotic controlled medications approved for the maintenance and withdrawal management treatment of opioid use disorder), even when the prescribing practitioner had not conducted a prior in-person medical evaluation of the patient. In order to prevent any lapse in treatment and to ensure continuity of patient care under the current telemedicine flexibilities while the DEA and SAMHSA are evaluating the extraordinary number of public comments, the DEA issued the temporary six-month extension of the telemedicine flexibilities on May 10, in anticipation of the scheduled end of the COVID-19 public health emergency on May 11.
The Purpose of The DEA’s Temporary Rule
The purpose of the DEA’s temporary extension of the COVID-19 PHE’s telemedicine flexibilities is multifold: (a) it promotes the continuity of patient care and prevents the inevitable backlog of in-person medical evaluations in the months shortly before and after the expiration of the COVID–19 PHE; (b) it ensures the availability of telemedicine for patients that have come to rely on it, such as those who live in rural areas lacking easy access to healthcare providers and needed medications; (c) it addresses the urgent public health need for continued access to buprenorphine to treat opioid use disorder during the continuing opioid public health crisis; (d) it allows patients, practitioners, pharmacists, service providers, and others sufficient time to prepare for the implementation of future regulations that apply to the prescribing of controlled medications via telemedicine; and (e) it enables the DEA, in collaboration with SAMHSA, to conduct a thorough evaluation of the extraordinary number of public comments and regulatory alternatives in order to promulgate a final regulation that most effectively expand access to telemedicine encounters in a manner that is consistent with public health and safety, while maintaining effective safeguards and controls against diversion of controlled substances.
The DEA’s Final Regulation On Telemedicine Prescribing Of Controlled Substances
The DEA and SAMHSA continue to review the unprecedented number of comments received during the NPRM period. We anticipate that the DEA’s final regulation will ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for the prescriptions of controlled medication without the requirement of at least one in-person examination. The final rule should afford adequate time for providers to comply with any new standards of care or patient safeguards required by the DEA final rule.
The views and opinions expressed in the article represent the view of the authors and not necessarily the official view of Clark Hill PLC. Nothing in this article constitutes professional legal advice nor is it intended to be a substitute for professional legal advice.
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