The U.S. Department of Health and Human Services (HHS) is still looking for stakeholders to comment on what regulations should be modified. The HHS deregulation request for information (RFI), issued on May 14, has a public comment period that closes on July 14 at midnight.
At the American Health Law Association Annual Meeting on Wednesday, Elizabeth Kelley, the acting deputy general counsel at the HHS Office of General Counsel indicated that the overarching theme of the Trump Administration is to take a market-based approach to a number of issues, deregulation among them. Kelley said that with the RFI, HHS is seeking information about regulations that are either an extreme burden or may not be consistent with the enabling statute.
Additionally, Kelley indicated that HHS was interested in potentially addressing regulations that would have been approved by a court under the deference standard of the defunct Chevron doctrine. That doctrine required a court to defer to an agency’s interpretation of its enabling statute when crafting a regulation if that interpretation was reasonable and the statute was sufficiently ambiguous as to require interpretation.
Executive Orders Driving Deregulation
The RFI was instigated by a pair of executive orders by President Trump issued in February of this year.
The first one, Executive Order 14192, entitled “Unleashing Prosperity Through Deregulation” included requirements for agency heads to find a way to limit new regulations in 2025 and beyond. To accomplish this the E.O. created a regulatory cost cap of “significantly less than zero” for new regulations in Fiscal Year 2025. That would mean reductions in regulations to offset new costs created by regulations going forward. Additionally, it instructed agencies to identify 10 existing regulations that should be rescinded for every new regulation that is proposed in future years.
The second one, Executive Order 14219, entitled “Ensuring Lawful Regulation and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Agenda” included a requirement for agency heads to identify certain classes of regulations that coule be eliminated because they do not comply with clear statutory authority or impose undue burdens and costs on the public.
Format for Responses
In its RFI, HHS indicates that it would prefer to have responses that it could publish directly to the Federal Register with minimal revisions seeking to withdraw or rescind the offending regulation. Barring that, HHS has indicated that stakeholders should identify a specific regulation that they would like to see rescinded and describe how the recommendation would lead to cost savings, how much savings are anticipated, and the statutory authority that would permit HHS to act on the recommendation.
HHS has said that responses to the RFI can be made anonymously and that any regulations presented as a potential target for recission will be accepted and may be acted upon at a later date if need to comply with the 10-1 deregulation requirement of E.O. 14192.
Reed Smith will continue to follow developments with regard to the HHS deregulation efforts. If you have any questions about this, or would like to submit a response to the HHS RFI, please do not hesitate to reach out to the authors of this post or to the health care lawyers at Reed Smith.
The Chevron doctrine was abandoned by the Supreme Court in the Loper Bright decision in 2024, which created a new standard for a court to evaluate statutory ambiguities without deference to agency interpretation. But the Supreme Court in Loper Bright specifically refused to apply the new standard to regulations that were already approved under Chevron. As a result, there are a number of regulations on the books that may not have survived a Loper Bright analysis and it is these regulations that Kelley says HHS is targeting.