ARTICLE SUMMARY:
In this week’s Pathways Picks: Agency appointments, congressional hearings, executive orders, and other actions in the first days of Donald Trump’s presidency; a draft guidance from CMS on employing real-world data for coverage with evidence development; a Medicare genetic testing reprieve; the latest HCPCS codes; an IVD guidance from India, a new EU data law; and more global picks.
Trump Week One
Medtech-relevant updates from the new administration:
RFK Jr. hearings scheduled. Two Senate committees with shared jurisdiction over the Department of Health and Human Services have schedule hearings to consider President Trump’s nomination of Robert F. Kennedy Jr. as the next HHS secretary. The Finance Committee, chaired by Sen. Mike Crapo (R-ID), will question Kennedy on January 29 and the Health, Education, Labor, and Pensions Committee, chaired by Sen. Bill Cassidy (R-LA), will do so on the following day. In conjunction with the upcoming hearings, the Office of Government Ethics released RFK Jr.’s financial disclosure document and ethics agreement.
No FDA commissioner yet, but CDRH Dx official may take temporary reins. Sara Brenner, MD, the current chief medical officer within CDRH’s IVD review office, is reportedly expected to be named acting commissioner of the entire FDA while President Trump’s agency pick Marty Makary, MD, undergoes the confirmation process in the Senate. The anticipated appointment was first reported by Politico January 20. Brenner has served as CMO and associate director of medical affairs for CDRH’s Office of Health Technology 7: In Vitro Diagnostics since 2019. She has played a leadership role in FDA’s Diagnostic Data Program to improve and standardize diagnostic output from laboratories and she concurrently served as diagnostics data lead on HHS’s National COVID-19 Response Operations from 2020 to 2022, according to her LinkedIn profile. During the first Trump administration, she served as a senior policy advisor to the White House Office of Science and Technology Policy in 2018 and 2019.
According to reporting, Brenner may be in line to take a senior FDA role under Makary, possibly principal deputy commissioner. Robert Califf, MD, who served as FDA commissioner under President Biden and President Obama, officially relinquished the post when Trump was inaugurated on January 20. Notably, as of January 22, no acting commissioner or principal deputy commissioner is listed on FDA’s website.
