The Centers for Medicare & Medicaid Services (CMS) published a final rule on May 18, 2021, delaying for a second time the rule on Medicare coverage of innovative technology (MCIT) and definition of "reasonable and necessary". The original rule, published on January 14, 2021, was delayed until March 17, 2021 by an interim final rule. It is now delayed until December 15, 2021.


The MCIT rule would require Medicare coverage for a medical device designated as a breakthrough device by the Food and Drug Administration (FDA). Breakthrough devices would be covered for four years starting on the date of FDA market authorization or a manufacturer-chosen date within two years thereafter. In its May 18 rule, CMS summarized numerous public comments on the MCIT rule. CMS noted that the FDA grants breakthrough designation early in the product lifecycle, and often based on clinical trials which had limited inclusion of Medicare beneficiaries. At this point in product development, there may be limited information available on whether the benefits and risks of the device differ for older or frailer patients with comorbidities, or whether clinician experience or facility requirements are needed to ensure good health outcomes. CMS expressed concern that the MCIT rule as written would take away tools that CMS otherwise has to limit coverage when a device can be harmful to the Medicare population. Also, there was uncertainty surrounding coding and payment for new MCIT devices.


CMS also noted that MCIT would be one of several coverage pathways for breakthrough devices. CMS reviewed claims data for several recent market-authorized breakthrough devices and found that breakthrough devices are receiving Medicare coverage when medically necessary through other coverage pathways such as claim-by-claim adjudication, National Coverage Determination or local coverage.


CMS also will use the additional time to consider whether the definition of reasonable and necessary should be a separate rule.

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