ARTICLE SUMMARY:
This week’s roundup: In Next Picks, we look to the likelihood of more delays or ambiguity for the Medicare Coverage of Innovative Technology program, and then report on CMS’ extension of joint replacement bundled payments, EU Medical Device Regulation updates with three weeks to lift-off, a tightening FDA commissioner race, and more to watch in medtech policy.
Next Picks
What we’re watching for:
Look for more MCIT delay. The next steps for the Medicare Coverage of Innovative Technology will be decided next week, before May 15, which CMS had set as the delayed start date for the hotly anticipated program by the device industry. There is a chance CMS will allow the program, which would grant four years of automatic national coverage of FDA-designated Breakthrough Devices to kick in upon FDA approval, to launch as planned, but Market Pathways expects further delay at best in the near-term.
CMS says it has finished reviewing the more than 200 comments submitted in response to the agency’s recent decision to delay the planned March 15 start date by two months and pose operational and substantive questions about the MCIT rule that was finalized in the closing days of the Trump administration. (See “MCIT Breakthrough Coverage Pathway In Doubt Following CMS Delay,” Market Pathways, March 16, 2021.) During an April 29 discussion at the Medical Device Manufacturers Association annual meeting, CMS officials were not able to directly comment on the fate of MCIT but their language did not exude confidence that the program would be getting off the ground in two weeks’ time.
