ARTICLE SUMMARY:
In this week’s Pathways Picks: A Government Accountability Office report on national coverage determinations; CMS staffing woes; FDA real-world evidence guide coming; MAHA report; more input sought on EU device regulation reforms; Canadian agencies issue report on reducing bureaucracy; Australia AI list; and more from the US, Europe, and the UK.
US Picks
CMS coverage scrutiny, staffing woes, and FDA reg updates:
Coverage process scrutiny. CMS should take more steps to identify the causes of any delays in national coverage determination (NCD) analyses. The agency should also make public the criteria it employs for prioritizing which national coverage policies for items and services it agrees to review. Those are the recommendations of a September 9 US Government Accountability Office (GAO) report assessing the Medicare NCD program. GAO, the investigative arm of Congress, analyzed NCD review requests and decisions made between October 2012 and February 2025 and interviewed government officials and stakeholder groups about experiences with the program. It found that CMS finalized 44 of 53 (83%) NCD analyses it initiated during the twelve-and-a-half-year period within regulatory deadlines (nine to 12 months). GAO also identified approximately 98 requests for NCD analyses received by CMS during this period, but the agency either declined to review or couldn’t get to 45 of them. Agency officials and stakeholders alike blamed chronic understaffing at CMS’ Coverage and Analysis Group as a reason why NCD requests tend to languish at the agency. (See below, “CAG staffing woes.”) But stakeholders interviewed said they wanted clearer guidelines from CMS about how it prioritized what they chose to review for coverage. The GAO report was requested by the Republican chairs of the House Energy and Commerce and Ways and Means Committees. “The GAO report makes clear that CMS must do more to provide transparency and accountability in its coverage decisions,” Reps. Brett Guthrie (R-KY) and Jason Smith (R-MO) said. Notably, of the 53 NCDs finalized during the study period, 42 addressed medical devices, diagnostics, or combination products.
