On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Second Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2024. The Second Temporary Rule is scheduled for publication in the Federal Register today (October 10, 2023) and scheduled to take effect on November 11, 2023.
In the Second Temporary Rule filing, DEA cites the need for more time to further evaluate the information and perspectives presented at the September 2023 listening sessions, and the comments received in response to the proposed permanent rules, to determine the best course of action. The Second Temporary Rule filing also indicates that DEA is working to promulgate new permanent standards or safeguards by the Fall of 2024.
Background – NPRMs, the First Temporary Rule, and DEA Listening Sessions
As covered in one of our previous posts, DEA promulgated two notices of proposed rulemaking in the Federal Register in March of 2023 (“NPRMs”), related to prescribing controlled substances via telemedicine. DEA received more than 38,000 comments in response to the NPRMs, with a significant majority of the comments expressing concerns that the proposed rules were more restrictive than necessary.
In order to further evaluate the best course of permanent action given the record-breaking number of comments received, DEA issued a temporary rule, published May 10, 2023 (“First Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the PHE through November 11, 2023, and providing a one-year grace period, through November 11, 2024, to any practitioner-patient telemedicine relationships established on or before November 11, 2023.
Also as covered in one of our previous posts, DEA held two public listening sessions in September 2023, to collect additional input regarding the practice of telemedicine and specifically the remote prescribing of controlled substances without conducting an in-person evaluation of patients before prescribing.
Current Telemedicine Prescribing Flexibilities
The Second Temporary Rule, as filed, provides that through December 31, 2024, DEA-registered practitioners (“Practitioners”) may prescribe schedule II-V controlled substances without having previously examined a patient in-person where: (1) the prescription is issued for a legitimate medical purpose by a Practitioner acting in the usual course of that Practitioner’s professional practice; (2) the prescription is issued pursuant to a communication between the Practitioner and patient using an interactive audio-visual telecommunication system; and (3) such prescription complies with other requirements included in applicable Federal and State law, and DEA regulations and guidance.
The new Second Temporary Rule does not include any requirements around establishing a telemedicine relationship before a certain date.
Epstein Becker Green will be closely following all related news and developments. For additional information about the issues discussed above, or if you have any other telemedicine or digital health concerns, please contact the Epstein Becker Green attorney who regularly handles your legal matters, or one of the authors of this blog post. Read more about our expansive capabilities and offerings here and more generally on EBG’s website at www.ebglaw.com.
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