The CAP is advocating for the Medicare program to include a new pathway to cover innovative tests and add transparency measures on how coverage decisions are made. On August 28, the CAP sent a letter for the Center for Medicare and Medicaid Services (CMS) with recommendations to improve a proposed procedural notice outlining a new Medicare coverage pathway that will achieve "more timely and predictable access to new medical technologies for people with Medicare,” the CAP said.

According to the CMS, the new transitional coverage for emerging technologies pathway for breakthrough devices would support improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population. Under this new pathway, the Food and Drug Administration (FDA)-designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for three to five years, pending the development of evidence.

The CMS acknowledged that diagnostic tests, as devices, would be eligible for the new pathway. The CMS stated, however, that coverage determinations for most diagnostic laboratory tests granted breakthrough designation should continue to be made by the Medicare Administrative Contractors (MAC) through existing pathways instead of leveraging the new pathway.

In the letter to CMS, the CAP stated its concerns with the following:

• Inclusion of diagnostic tests in TCET pathway – The CAP is urging the CMS to remove the language suggesting that coverage for diagnostic tests qualifying for breakthrough designation should continue to be determined by the MACs through existing pathways. The CAP further encourages the CMS to evaluate future ways to broaden the pathway to include innovative medical technologies beyond FDA-designated breakthrough devices and existing Medicare benefit categories.
• Transparency - The CAP has concerns about the unspecified criteria the CMS may use to prioritize innovative technologies the agency believes have “the potential to benefit the greatest number of individuals with Medicare.” The CAP is alarmed about coverage pathways that have the potential to arbitrarily decide which technologies receive a head start or other advantage in the traditional coverage process.
• Timelines and stakeholder involvement - While the CMS is attempting to improve both predictability and transparency, there are gaps in the pathway timeline. The CMS acknowledges some timeframes may take longer, such as with the evidence preview and FDA market authorization. Given these gaps, it is unclear if the proposed timeline for the pathway is realistic.
• Sharing evidence with MACs - The CAP supports an opt-in approach where a manufacturer would voluntarily notify the CMS of its interest in pursuing the pathway and can withdraw from the process at any point. If a manufacturer withdraws from the process during the premarket stage, the CAP believes that the CMS should make every effort to ensure the protection of a developer or manufacturer’s proprietary information about a device that it has developed.

The CAP has applauded the CMS’ continuing commitment to ensuring Medicare beneficiaries have more timely and predictable access to new and innovative medical technologies and will continue to work with the agency to move this new Medicare coverage pathway forward.