The proposed Medicare Coverage of Innovative Technologies (MCIT) Pathway would make breakthrough devices eligible for Medicare coverage as soon as they received FDA approval, which could help promote product innovation, reports the National Law Review.
The Centers for Medicare and Medicaid Services recently issued a proposed rule that would grant Medicare coverage to breakthrough medical devices immediately upon FDA approval. The rule also proposes to codify a new definition of “reasonable and necessary” for Medicare national coverage determinations that takes into account commercial insurance coverage of items and services. It is unclear how broadly this new “reasonable and necessary” definition will apply if the proposed rule is finalized.
Read more in the National Law Review.