The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final buprenorphine rule) to December 31, 2025. In its final rule postponing the effective date, the DEA notes that it received 32 comments. Of those, 13 commenters requested the effective date be finalized as soon as possible, while three urged an additional delay. Eleven commenters raised concerns about the final buprenorphine rule itself. The DEA states that, because of these comments, it will further delay the effective date to further review any questions of fact, law, and policy the rules may raise.
简史
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 prior blog “DEA Tightens Buprenorphine Telemedicine Prescribing Rules” which discusses the requirements of the final buprenorphine rule.) On January 20, 2025, the Trump administration issued the Regulatory Freeze Pending Review Presidential Memorandum authorizing HHS and the DEA to delay the effective date of the final buprenorphine rule until March 21, 2025. The delay was intended to allow time to review any questions of fact, law, and policy the rule may raise, as well as to open a comment period to gather input from interested parties. On February 14, 2025, in accordance with the Presidential Memorandum, HHS and the DEA announced this delay and review of the final buprenorphine rule. (See our prior blog “DEA Delays Final Buprenorphine Rule” about the first delayed effective date of the final buprenorphine rule.)
让人们听到你的声音
HHS and the DEA are not accepting formal comments with this final rule. However, stakeholders with concerns about the final buprenorphine rule and its effective date are encouraged to share their feedback by contacting their local Congressperson or the White House.
接下来会发生什么
With the delay of the final buprenorphine rule, stakeholders can continue relying on the current set of telemedicine prescribing flexibilities through the end of 2025 without uncertainty about whether the obligations of the final buprenorphine final rule will apply and potentially supersede the flexibilities now that the dates are aligned. As a potential permanent solution for prescribing OUD treatment via telemedicine, two U.S. Senators reintroduced the Telehealth Response for E-Prescribing Addiction Therapy Services (TREATS) Act in March 2025, as bipartisan legislation. The TREATS Act amends the Controlled Substances Act to make the buprenorphine-related telemedicine prescribing flexibilities permanent. It was previously introduced in June 2020, February 2021, and November 2023, but in each instance, it did not progress out of Committee.
Although the TREATS Act is more favorable to stakeholders than the final buprenorphine rule because it does not include the additional obligations of the final buprenorphine rule, its history suggests it is unlikely to be signed into law. However, because the current DEA stance on the issue is still unclear, there remains a possibility that the TREATS Act could be finalized in place of the final buprenorphine rule. We will continue to monitor developments regarding the final buprenorphine rule and the TREATS Act.
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