CMS Proposes Repeal of MCIT

On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule ("MCIT/RN Rule"), which was published on January 14, 2021 and was set to take effect on December 15, 2021. The MCIT/RN Rule would have created a pathway to provide nationwide Medicare coverage for medical devices simultaneous to a device's receipt of market authorization under FDA’s Breakthrough Devices Program.