On Monday, the Centers for Medicare and Medicaid Services announced a proposed rule that would provide four year coverage for FDA-designated breakthrough devices starting from the date they receive U.S. marketing authorization. The proposed rule has been under deliberation since March 2019 and according to CMS estimates, may cost the government US$ 291.5 million if finalized in its current form. The proposal comes on the heels of a concerted effort by the medical device industry to speed up Medicare reimbursements for emerging technologies. CMS invites comments on the proposal for the next two months. Read more here.
(Source: Maria Rachal, Health Care Dive, September 4, 2020)