Center for Medicare and Medicaid Services(CMS) recently announced the introduction of a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (MCIT). This unprecedented Pathway is aimed specifically at medical devices that have been recognized with the FDA breakthrough designation. Under this new proposal, eligible devices will gain national Medicare coverage for four years, starting the day of their FDA market authorization.
CMS expects that this four-year coverage provided through the MCIT will encourage innovative medical device companies to gather more clinical data for a wider impact. The process to apply for MCIT has been made quick and efficient where a simple notification of interest will lead to the medical device being included in the process.
This proposal has been introduced as part of an executive order, EO 13890, issued last year with the objective of improving Medicare for nation’s seniors. Although the FDA has taken several steps to expediate the market authorization of advanced and innovative medical devices, the CMS has experienced delays in getting these devices to Medicare patients at the same pace in the past.
Niche Biomedical as a recipient of the FDA breakthrough designation commends this new measure taken by the CMS. A senior member of the Niche Bio team added, “Receiving CMS coverage is challenging and a daunting process, and potentially the determining factor to the wide adoption of the innovative device. This four-year window will allow the patients to have access to promising breakthrough technologies when receiving approval, and thus enable the device manufacturer to generate clinical evidence on health outcomes.”
A detailed summary of the MCIT can be found in the CMS press release: https://www.cms.gov/newsroom/fact-sheets/proposed-medicare-coverage-innovative-technology-cms-3372-p