In Comments to CMS, AdvaMed Urges Agency to Finalize Breakthrough Coverage Pathway, Offers Recommendations to Fully Leverage TCET

Whitaker: “Without expedited access to FDA-approved, breakthrough technologies, millions of patients are at risk.”

WASHINGTON – This week, AdvaMed, the Medtech Association, submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the Transitional Coverage for Emerging Technologies (TCET) notice. The comments, which acknowledge CMS’ efforts to recognize the importance of new innovations and the role they play in improving the lives of patients, offer recommendations to better leverage the TCET program for FDA-approved breakthrough technologies.

AdvaMed has long supported the TCET program and its predecessor, Medicare Coverage for Innovative Technologies (MCIT), and have urged the Administration to implement a predictable pathway to national Medicare coverage for these medical technologies.

“For more than two years, AdvaMed and our members have urged the Administration to develop a predictable coverage pathway for breakthrough technologies, and they have finally, after much delay, provided us with that proposal. Without expedited access to FDA-approved devices and tests, millions of patients are risk,” said AdvaMed President and CEO Scott Whitaker. “We share a common goal with CMS – establishing a clear and expeditious coverage process for these life-saving diagnostics, treatments, and therapies – however, as it is written, the current proposed TCET notice does not allow for expedited, national coverage for breakthrough in vitro diagnostics. Our recommendations to CMS address these concerns and serve to achieve our shared goal with maximal impact on improving patient health outcomes. We continue to work in tandem with lawmakers on both sides of the aisle to find a bipartisan legislative solution to this issue, and we look forward to engaging with CMS as they move forward with a final policy.”

The comments, which can be found here, include details about:

• CMS Resource and Prioritizing Requests
• Appropriate TCET Candidates
• Procedures for the TCET Pathway
• Coverage under the TCET Pathway
• Transition to Post-Coverage

A recent study published in JAMA Health Forum measured time from FDA authorization to Medicare coverage for technologies requiring a new reimbursement pathway and found that of the 64 novel technologies with no current reimbursement pathway, only 44 percent successfully achieved explicit or implicit coverage following FDA authorization, with a median time to coverage of 5.7 years.

From the comments:“AdvaMed recommends that CMS move quickly to finalize the TCET notice incorporating the clarifications and refinements… We encourage CMS to commit to routine evaluation and on-going refinement. Beyond TCET, we see additional opportunities to continue to work with CMS, using its existing authority, to continue to expand and accelerate access to innovative technologies after they are proven safe and effective by the FDA, and we look forward to continuing our work with the Agency.”