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; Medicare coverage would have lasted for a period of four years after which a breakthrough device would either be covered through a National Coverage Determination or at the local-level by Medicare Administrative Contractor discretion.  The MCIT/RN Rule was intended to address concerns that delay or uncertainty around Medicare coverage hampered beneficiary access to innovative technologies.  Digital health technologies that are eligible for breakthrough designation and fall within a Medicare benefit category would have been eligible for the MCIT pathway.

In deciding to repeal the MCIT/RN Rule, CMS identified that FDA and CMS are guided by different statutory standards: FDA must determine whether a device is safe and effective, and CMS must determine whether a device is reasonable and necessary for the diagnosis or treatment of illness or injury.  CMS explained that accelerated coverage for breakthrough devices would result in inadequate evidence that the device is reasonable and necessary.  In particular, CMS noted its concern that FDA regulations do not require clinical studies to include Medicare beneficiaries and as a result, MCIT might result in coverage of devices that do not have data demonstrating reasonableness and necessity for Medicare patients.

More information about the proposed repeal can be found here: LINK