Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person visit with a patient, subject to certain conditions as outlined in our earlier blog post. Additionally, DEA waived the requirement for practitioners to obtain additional registrations with DEA in the states where the dispensing (including prescribing, and administering) occurs, for the duration of the public health emergency, if the practitioner registers with DEA in at least one state and has permission under state law to practice using controlled substances in the state where the dispensing occurs.
In anticipation of the expiration of the public health emergency on May 11, 2023, on March 1, 2023, DEA and the Department of Health and Human Services issued two notices of proposed rulemakings (NPRMs), reviewed in our earlier blog post, to authorize the prescription of controlled substances based on a telehealth consultation in certain limited circumstances. The NPRMs received over 38,000 comments from the public, all of which DEA will review to implement revisions to the NPRMs and develop a permanent rule.
Since the permanent rule is still in development, on May 10, 2023, just one day before the end of the public health emergency, DEA and the Substance Abuse and Mental Health Services Administration published a temporary rule that extends the public health emergency telemedicine flexibilities[1] for the prescription of controlled substance medications until November 11, 2023.
The temporary rule, which took effect on May 11, 2023, allows DEA-registered practitioners to prescribe controlled substance medications under the public health emergency telemedicine flexibilities to all patients through November 11, 2023. Additionally, until November 11, 2024, DEA-registered practitioners are further permitted to prescribe controlled substance medications under the public health emergency telemedicine flexibilities to patients if the practitioner established a telemedicine relationship with the patient on or before November 11, 2023. In other words, if a provider and patient established a telemedicine relationship on or before November 11, 2023, the same public health emergency telemedicine flexibilities that previously governed the relationship will apply until November 11, 2024.
In the text of the rule, DEA notes that it plans to issue one or more final rules, based on the two proposed rules, which will extend certain telemedicine flexibilities on a permanent basis and ensure a smooth transition for patients and practitioners that rely on the availability of telemedicine for controlled substance medications.
Follow our blog to receive additional updates and alerts on the DEA’s proposed rules regarding extension of the COVID-19 telemedicine flexibilities for the prescription of controlled substance medications.
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[1] In the temporary rule, the DEA references the DEA letter that authorized certain telemedicine flexibilities, including the waiver exceptions related to DEA registrations in individuals states and the in-person evaluation requirement.
The post DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances appeared first on Life Sciences Perspectives.