ARTICLE SUMMARY:
In this week’s Pathways Picks: Key medtech considerations from Donald Trump’s election victory and Republicans’ retake of the US Senate; positive outcomes from Medicare 2025 payment rules; CardioMEMS coverage conditions; EU health commissioner hearings; FDA delves into AI; and more global medtech policy updates.
Top Pick
Trump wins presidency, uncertainty ahead:
Donald Trump’s definitive US election victory and the Republican takeover of the Senate signals a sharp shift in policy direction from Washington DC. However, the specific implications for medtech are, at the moment, unpredictable. Here are some key factors and questions to consider in the months ahead:
Uncertainty at the agencies. The most significant near-term shift for medtech could come from the impending change in leadership at HHS, FDA, and other federal agencies. Specific policies and practices that will result in the medtech realm are unclear, but a period of instability for career staff and routine practices at federal agencies including FDA is likely in the near term. Trump has vowed to empower Robert F. Kennedy Jr. to lead health policy in his administration, a move that could prioritize specific issues like anti-vaccination policies but also a broader skepticism that Kennedy espouses about the role of FDA and other public health agencies. Kennedy says FDA is financially beholden to the drug industry, implicitly criticizing the user fee program in which companies provide significant funding to support premarket review programs. He recently warned FDA employees who are part of the agency’s “war on public health” to “1. Preserve your records, and 2. Pack your bags.” Trump surrogates have signaled Kennedy is less likely to be nominated as head of HHS and more likely to serve as a health care “czar” from the White House. From that post, he could help decide who Trump nominates for key public health posts, and the newly Republican-controlled Senate is also more likely to confirm Trump’s nominees.
