FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS).
The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and certain diagnostic tests. The coverage would last for four years, during which CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.
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