CLSA Applauds The Release The Medicare Coverage Of Innovative Technology (MCIT) Final Rule


Earlier this month, the Centers for Medicare and Medicaid Services (CMS) released the final “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary” rule (42 CFR Part 405).  The rule, if implemented as planned in March of this year, creates a pathway for automatic CMS coverage – for 4 years – of medical devices that receive Food and Drug Administration (FDA) breakthrough technologies program designation and subsequent market authorization through their Expedited Review Approval Process.

This is a tremendous benefit for patients who would otherwise have severely delayed access to these lifesaving and life-altering devices.

This final rule is a welcome relief for medical device manufacturers who experience a gap, often years long, between FDA approval and CMS coverage for Medicare beneficiaries.  CLSA has long advocated – both via legislation and regulation – for efficient regulatory processes at the FDA for breakthrough medical technologies to be coupled with timely and appropriate coverage and payment determinations at CMS.  Such efficiency avoids the “valley of death” between approval and coverage for innovative products and speeds up their availability for patients in need.

In response to the MCIT proposed rule, CLSA submitted public comments to the Federal Register supporting the rule and asking that the final version expand coverage to breakthrough diagnostic tests, in addition to breakthrough medical devices.  While we are disappointed that diagnostics were not included in the final version, we recognize that additional work, either legislative or regulatory, is needed to close the persisting coverage gap for breakthrough diagnostics.  CLSA applauds the finalization of the MCIT pathway for medical devices and hopes the Biden Administration will examine this rule on its merit and allow it to be implemented given the tremendous benefit to patients and their families.

For more information about the MCIT pathway, please contact Oliver Rocroi ([email protected]), CLSA’s Manager of Federal Government Relations and Programs.