ARTICLE SUMMARY:
In this week’s roundup: New CMS coverage office leader; a reimbursement milestone in France; the UK extends regulatory transition timelines; Mexico, Colombia, and Cuba forge a cross-border regulatory agency; FDA issues decentralized clinical trial guide; Commissioner Califf worries about EPA, and more from the US, Europe, and China.
Reimbursement Picks
CMS appointment and French milestone:
New Medicare coverage chief. Joseph Chin, MD, has been promoted from deputy to director of CMS’ Coverage and Analysis Group (CAG). Chin, a primary care physician who has served as chief medical officer for CAG, is stepping up, as veteran CAG chief Tamara Syrek Jensen has been promoted to the role of acting deputy director of the Center of Clinical Standards and Quality (CCSQ, which houses CAG). The transition occurred just as CAG finished work on a Transitional Coverage for Emerging Technologies (TCET) proposal. The TCET proposed rule is now undergoing review by the White House Office of Information and Regulatory Affairs and is expected to be released in the coming weeks. Read more about this and other CMS updates from agency officials who appeared at last week’s Medical Device Manufacturers Association annual meeting: Medicare Chief Change as TCET Looms, and More From CMS.
French reimbursement milestone. A diagnostic test for a genetic neurologic disorder is on track to be the first medical technology to transition from France’s “Forfait” early-development innovation program to traditional reimbursement in the country. The French National Authority for Health (HAS) delivered a positive reimbursement recommendation May 2 for the METAglut1 test for Glut1 Deficiency Syndrome (Metafora), and a reimbursement rate will be set by the national insurance system within six months. The METAglut1 assay is one of 15 items that have been selected into the Forfait program, which provides temporary reimbursement for promising technologies while evidence is being collected. HAS says it is currently reviewing the long-term reimbursement case for another Forfait device that delivers high-intensity focused ultrasound (HIFU) for prostate cancer. (Links in French.)
