The Medical Imaging & Technology Alliance (MITA) in a comment letter to Centers for Medicare & Medicaid Services (CMS), expressed disappointment with the agency’s proposal to withdraw the previously finalized Medicare Coverage of Innovative Technology (MCIT) rule and urged CMS to work with industry, health care providers, patients and others to improve and expedite the path from U.S. Food & Drug Administration (FDA) marketing authorization to CMS coverage.
“Medical technology developers need to have access to expedient, transparent, and predictable pathways to bring innovative products to Medicare beneficiaries,” the letter noted. It continued by highlighting MITA comments requesting that the MCIT program be expanded beyond just “Breakthrough” technologies, given that not all innovative products earn this designation.
In January 2021, CMS published a final rule called The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ (MCIT/R&N). The MCIT program would have granted expedited Medicare coverage for up to four years for any FDA-designated “Breakthrough” device once the device received marketing authorization.
The full MITA comments are available here.