MCIT has Died and Requires a Successor
This afternoon, CMS retracted the Medicare Coverage of Innovative Technologies (MCIT) rule. See here: https://public-inspection.federalregister.gov/2021-20016.pdf.
The spirit of MCIT was excellent - provide Medicare beneficiaries access to innovative technologies as early as possible. However, CMS has now rejected MCIT because its design attempted to do that poorly - MCIT didn't address efficacy standards adequately and didn't address other considerations at all. Exclusively relying on FDA clearance to establish efficacy for broad coverage decisions is, as CMS argues, inadequate.
Certainly, while we agree that MCIT was drafted terribly and did not address critical considerations that needed to be addressed to have a chance at being implemented, we hope that the desirable spirit of giving Medicare beneficiaries access to innovative medical technologies can be worked into a future policy draft that CMS could justify implementing.
With some thoughtful and well-designed policy work, we believe this is possible, so readers should not consider the spirit of MCIT dead just yet; it does, however, appear to be firmly triaged in the waiting room until at least 2023.