Industry Notes: CMS Proposes Reversal of MCIT Final Rule

Article Overview

This industry note summarizes CMS’s proposed reversal of the Medicare Coverage of Innovative Technology (MCIT) final rule and the agency’s stated reasons for reconsidering how Medicare coverage is extended to breakthrough devices. It is relevant to professionals tracking Medicare coverage policy, FDA breakthrough device pathways, and CMS rulemaking on the definition of reasonable and necessary. The article covers the earlier final rule, the later proposal to repeal it, stakeholder concerns cited by CMS, and the proposed effective date of the new rule.