The Centers for Medicaid and Medicare (CMS) announced the establishment of the MCIT (Medicare Coverage of Innovative Technology) pathway, which is designed to provide coverage and access to new, innovative medical devices and diagnostics which have received FDA Breakthrough Device Designation to Medicare beneficiaries nationwide. Through this pathway, Breakthrough devices will automatically be eligible for national Medicare coverage for a period of four years upon FDA clearance or approval. After this four-year period, coverage may be continued through a case-by-case basis, a national coverage determination, or a local coverage determination.
This gives a clear path to Medicare coverage for innovative products like ImCare Biotech’s Seravue, which received FDA Breakthrough Device designation in June, 2020. By accelerating patient access to technologies like Seravue, MCIT will help improve the health outcomes for those at risk of developing liver cancer and ultimately save lives. This pathway will further encourage the research and development need to advance the field of cancer diagnostics, and ImCare Biotech appreciates the opportunity to work the FDA and CMS in order to advance the standard of care for liver diseases.
ImCare plans to opt-in for the automatic four-year national Medicare coverage period upon FDA clearance.
