The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.

When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.

Site neutral payments under the U.S. Medicare program have been contentious for some time, and Congress seems poised to act on the issue in 2025. The Medicare Payment Advisory Commission is wary of making any recommendations as yet — a position that MedPAC may hold pending the collection of additional data.

Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.