Posted by Michael Wonder on 15 Mar 2021
Update on finalisation of MCIT rule to provide national Medicare coverage for FDA breakthrough devices and diagnostics
15 March 2021 - Renalytix AI provides an update on the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway to provide a coverage pathway for Medicare beneficiaries nationwide for innovative medical devices and diagnostic tests designated under the Breakthrough Device review program and with market authorisation by the U.S. FDA.
Centers for Medicare & Medicaid Services will delay the implementation date of the MCIT rule by 60 days, beginning a 30 day comment period to solicit additional public feedback on the rule.
RenalytixAI expects the MCIT rule, as is or amended, will become effective within the expected 2021 FDA review and clearance period for KidneyIntelX and will have no material effect on the RenalytixAI business plan.
