CMS Departure, Apple 510(k) Questions, PCCPs on the Rise, and More

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ARTICLE SUMMARY:

In this week’s Pathways Picks: Long-time CMS coverage director Tamara Syrek Jensen leaves the agency; medtech reimbursement professional society formed; CPT code, NCD analysis updates; medtech reimbursement bills on Capitol Hill; Apple hypertension clearance; predetermined change plans; France’s evaluation principles for digital health; Africa advances continent-wide review; Europe updates borderline manual; and more global medtech policy updates.

Reimbursement Picks

Jensen departs, professionals unite, CPT agenda, and more:

Veteran coverage official leaves CMS. Long-time CMS coverage director Tamara Syrek Jensen left the agency this month, taking a post as principal and VP of federal programs at the consultancy Rubrum Advising. Jensen served at CMS for more than 25 years, including about 10 years as director of CMS’ Coverage and Analysis Group and, before that, deputy director of CAG, which performs all national coverage analyses and oversees the Medicare Administrative Contractors that manage local coverage determinations. She was a key player in developing the agency’s coverage-with-evidence development (CED) program, forging collaborations with FDA, and establishing the Transitional Coverage for Emerging Technologies (TCET) program. Jensen is one of many who have left CAG this year amid significant federal workforce reductions during the Trump administration. The coverage office has lost at least 22% of its staff since December 2024, according to a September 9 report from the Government Accountability Office. Rubrum Advising is led by Jensen’s former boss at CMS, Lee Fleisher, MD, who was previously director of CMS’ Center for Clinical Standards and Quality.

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