Medicare To Cover Breakthrough Devices Under Proposed Rule

Medicare will provide four years of coverage for FDA-designated breakthrough medical devices starting the same day the FDA approves them, the Centers for Medicare & Medicaid Services (CMS) said Sept. 1 in a proposed rule.

The proposed rule sets out a definition of “reasonable and necessary” for items that may be covered under Medicare Parts A and B as CMS implements an Oct. 3, 2019, executive order by President Trump aimed at improving Medicare.

Public comments on the proposed rule are due by Nov. 2.