CMS Finishes New Medicare Coverage Path For Breakthrough Devices

In another 11th-hour move, the Trump CMS finalized Tuesday (Jan. 12) a rule, long-sought by the medical device industry, that provides instant Medicare coverage of FDA-designated breakthrough technology. The Advanced Medical Technology Association is urging the incoming Biden administration to continue the coverage policy that allows many devices approved through FDA’s breakthrough pathway to be covered by CMS for up to four years, which CMS thinks will encourage manufacturers to voluntarily gather clinical data that could support longer-term coverage. “It’s...