ARTICLE SUMMARY:
In this week’s roundup: The medtech-championed Medicare Coverage of Innovative Technologies program is on track for near-term finalization; WHO issues device postmarket guidance; FDA rolls out home-based COVID-19 EUAs, and more.
CMS has made quick work toward realizing its proposal to nationally cover Breakthrough Devices automatically upon FDA approval for four years. A final version of the agency’s Medicare Coverage of Innovative Technologies (MCIT) rule was sent to the White House Office of Information and Regulatory Affairs December 14, according to OIRA’s online dashboard, meaning CMS and HHS overseers have completed work on it, just three-and-a-half months after the proposed rule was released and one-and-a half months after public comments were due. That and much more in the latest Pathways’ Picks.
