Home / Top News / Renalytix Commends HHS/CMS on Finalization of MCIT Rule to Provide National Medicare Coverage for FDA Breakthrough Devices and Diagnostics
Renalytix Commends HHS/CMS on Finalization of MCIT Rule to Provide National Medicare Coverage for FDA Breakthrough Devices and Diagnostics
Creates Pathway for Beneficiary Access to KidneyIntelX for Medicare Beneficiary Kidney Disease Populations
NEW YORK, Jan. 13, 2021 (GLOBE NEWSWIRE) — The Centers for Medicaid & Medicare (CMS) announced the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway (
RIN: 0938-AT88), to provide a coverage pathway for Medicare beneficiaries nationwide to have faster access to new, innovative medical devices and diagnostic tests designated under the Breakthrough Device review program and with market authorization by the U.S. Food and Drug Administration (FDA). Under MCIT, national Medicare coverage can become effective on the date of FDA approval or clearance of a breakthrough designated device and will continue for a period of four years. After a four-year period, continued coverage for Medicare beneficiaries will be based on one of three methods, 1) case-by-case coverage, 2) a local coverage determination, or 3) a national coverage determination.