Final Rule To Establish Medicare Coverage Pathway For Medicare Beneficiary Access To Breakthrough-Designated Medical Devices

The final rule was released on January 14, 2021, by the Centers for Medicare & Medicaid Services (CMS). It establishes a pathway for a faster process for Medicare to cover new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer-chosen date within two years thereafter. The rule was slated to go into effect on March 15, 2021 . . .