The Centers for Medicare & Medicaid Services (CMS) is committed to ensuring people on Medicare have quicker access to innovative medical technologies for life-threatening or irreversibly debilitating diseases – like cancer and heart disease.

In January 2021, we published a final rule called The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ (MCIT/R&N). The rule would have granted expedited Medicare coverage for up to four years for any U.S. Food & Drug Administration (FDA)-designated breakthrough device once the device received or cleared market authorization. This is assuming the device was not excluded from coverage by the Medicare statute.

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