In a comment letter to the Centers for Medicare & Medicaid Services (CMS), the Medical Imaging & Technology Alliance (MITA) expressed disappointment with the agency’s proposal to withdraw the previously finalized Medicare Coverage of Innovative Technology (MCIT) rule. MITA urged CMS to work with the medical device industry, healthcare providers, and patients to improve and expedite the path from U.S. 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. The communication also highlighted 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.” 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.