In an effort to increase Medicare beneficiary access to new and innovative medical devices, CMS this week issued a proposed rule that would create a new coverage pathway: Medicare Coverage of Innovative Technology (MCIT). The MCIT program would provide four years of Medicare coverage for new devices approved through the FDA’s breakthrough device program. Coverage would only extend to devices used within their FDA-approved labeling. Breakthrough devices that were approved within two years prior to the effective date of the final rule would also be eligible for the MCIT program. CMS proposes that the four-year time frame allows manufacturers enough time to demonstrate clinical effectiveness and outcomes associated with the device, which CMS would use to make an eventual long-term coverage determination. 

In addition to the MCIT pathway, the proposed rule includes a proposed definition of “reasonable and necessary” in regard to how CMS makes coverage determinations for drugs and devices. Current statute requires that Medicare only cover treatments considered “reasonable or necessary” but gives CMS broad authority to determine what meets those criteria. In response to stakeholder feedback that CMS’ determinations are not consistent and the process is not transparent, CMS proposes to set a standard by codifying the current definition of reasonable and necessary in the Medicare Program Integrity Manual. This definition requires that the item or service be: safe and effective; not experimental or investigational; and appropriate for Medicare patients. CMS is also proposing to consider whether the item or service is covered in the commercial market. Any device covered under the MCIT program discussed above would be considered to have met the standard since it was approved through the FDA breakthrough device program. 

CMS also released a factsheet on this proposed rule. 

(Published 9.2.20)