DEA verschiebt endgültige Buprenorphin-Regelung
The Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have delayed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final buprenorphine rule) to March 21, 2025, and have requested public comments on the rule. In its final rule delaying the effective date, the DEA reiterates that the delay in effective date will not delay or limit the ability of practitioners covered by the final buprenorphine rule to prescribe via telemedicine due to the current telemedicine prescribing flexibilities in place through December 31, 2025.
Eine kurze Geschichte
On January 17, 2025, in anticipation of the change of administration, the DEA and HHS finalized and published the final buprenorphine rule, which establishes a permanent pathway for the telemedicine prescribing of buprenorphine for opioid use disorder (OUD). The final buprenorphine rule was set to take effect February 18, 2025. (See our discussion on the requirements of the final buprenorphine rule here.) On January 20, 2025, the Trump administration issued the Regulatory Freeze Pending Review Presidential Memorandum authorizing HHS and the DEA to delay until March 21, 2025, the effective date of the final buprenorphine rule for the purpose of reviewing any questions of fact, law, and policy the rule may raise and to open a comment period to gather input from interested parties.
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Stakeholders are encouraged to participate in the comment process and share their insights on the final buprenorphine rule. The DEA is soliciting comments on the extension of the effective date of the final buprenorphine rule and whether the effective date should be further extended to address issues of fact, law, and policy raised by the rule. Comments may be submitted until 11:59 p.m. ET February 28, 2025. Stakeholders may submit comments electronically here or via regular or express mail to the following address:
Drug Enforcement Administration
Attn: DEA Federal Register Representative/DPW
8701 Morrissette Drive, Springfield, VA 22152
All correspondence, including attachments, must include a reference to “Docket No. DEA-948”.
Additionally, those with concerns about the final buprenorphine rule can share their feedback by contacting their local Congressperson or the White House.
Opportunity for Clarity
Because so much time had passed since the proposed buprenorphine rule was introduced in March 2023, its finalization in January caught many stakeholders by surprise. This additional comment period is a welcome opportunity for the telemedicine industry to seek clarity on several key issues regarding the final buprenorphine rule.
One concern is whether practitioners may continue to rely on the existing telemedicine flexibilities through the end of year if the final buprenorphine rule takes effect before the flexibilities expire, or if they will need to comply with the additional requirements of the rule once it takes effect. Additionally, stakeholders have raised concerns about the DEA’s shift from the originally proposed 30-day supply to a six-month initial supply. Although a step in the right direction to increase the supply, six months seems like an arbitrary choice to OUD telehealth providers who foresee a potential disruption in patient care depending on the available pathways for telemedicine prescribing after the initial supply.
To help initiate discussions, ATA Action has submitted a letter to the DEA seeking further clarification on several aspects of the final buprenorphine rule. We will continue to monitor developments regarding the final buprenorphine rule, including any further extensions of its effective date.
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