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CMS releases MCIT final rule

CMS releases MCIT final rule


On January 12, CMS released the final rule for the Medicare Coverage of Innovative Technology (MCIT) pathway. This is a significant victory for the medical device industry and a policy that Biocom had been advocating for many years. The rule provides four years of automatic national Medicare coverage for medical devices that have been designated as breakthrough by the Food and Drug Administration (FDA), starting on the date of FDA market authorization. Biocom submitted a comment letter on the draft regulation, expressing our support for the policy, with recommended changes. The final guidance clarified CMS’s ruling on the exclusion of diagnostics beyond clinical laboratory tests, outlined deadlines for length of coverage under the pathway, and noted that some breakthrough devices will not be covered by Medicare if they do not have a benefit category.

The rule added flexibility in the start date of MCIT. Manufacturers are eligible for MCIT coverage only during the four-year period beginning on the date of FDA market authorization. Waiting after approval to apply will only reduce the period length. Retroactively, the MCIT program would apply to breakthrough technologies that received FDA authorization within the last two calendar years. For these technologies, coverage also lasts from the date of FDA market authorization. After the pathway sunsets, all of the conventional coverage pathways will be available for MCIT devices and reasonable and necessary coverage standards will apply.

Also note-worthy is that CMS codified the definition of “reasonable and necessary.”  The definition applies more broadly than MCIT and will be used for NCDs and other coverage decisions.  The definition has three main elements: an item or service must be (1) safe and effective, (2) not experimental or investigational, and (3) appropriate for the Medicare patients. This will be very influential for regulation moving forward and will continue to be an area of advocacy interest.


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