- Home
- Advocacy
- Latest News and Practice Data
- CMS Repeals Controversial Device Coverage, Asks For Further Input
The CAP is pleased that the CMS will repeal its coverage of medical technology regulation and seek further procedural and implementation clarifications. The CAP and other stakeholders raised questions regarding whether blanket coverage without specific guidance would be beneficial or harmful to Medicare beneficiaries and expressed concerns that the regulation could undermine or circumvent current coverage pathways.
In January 2021, the CMS released The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ (MCIT/R&N) final regulation, which would expedite Food and Drug Administration (FDA)-designated breakthrough device once the device received or cleared market authorization. The CAP commented on the initial proposed rule and will submit feedback to the CMS on a new MCIT/R&N regulation to ensure that Medicare coverage includes robust transparency in any process including coding and reimbursement aspects of the MCIT, as well as how the process interacts with current coverage pathways