AdvaMed Welcomes Bipartisan Senate Bill to Expedite Medicare Coverage of Breakthrough Medical Technologies, Diagnostic Tests

Washington, D.C. - AdvaMed, the Medtech Association, today welcomed introduction in the U.S. Senate of bipartisan legislation to expedite Medicare coverage of FDA-"breakthrough"-designated medical technologies and diagnostic tests. The legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Sen. Todd Young (R-IN) and Sen. Alex Padilla (D-CA), is similar to H.R. 1691, which the U.S. House of Representatives Ways and Means Committee passed on a bipartisan basis in June.

"The message is clear: With bipartisan legislation now introduced in both houses of Congress, it is time for Medicare to cover the breakthrough technologies to which so many patients are in need of access," said AdvaMed President and CEO Scott Whitaker. "These medical technologies and diagnostic tests, by definition, are approved by FDA for patients who literally have no other options available to them currently. We can all agree that these patients deserve the best medical technology has to offer, so we urge Congress to pass this bipartisan legislation before the end of the year."

The FDA's Breakthrough Devices Program is intended to provide patients and health care providers with timely access to emerging medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA invites medtech innovators to seek the designation if their device meets the criteria. The accepted devices will receive prioritized FDA review. As of Sept. 30, 2024, 1,029 devices have received the designation, and 124 devices have received marketing authorization.

However, the Centers for Medicare and Medicaid Services (CMS) was slow to finalize an option for Medicare coverage of the procedures enabled through breakthrough devices. When CMS finally offered an option, the proposal was lacking, excluding diagnostics and providing for only a handful of devices to receive approval each year. In a recent op-ed for RealClear Health, Whitaker urged congressional approval of comprehensive legislation as the best solution for Medicare beneficiaries and suggested Congress provide CMS more resources if the agency lacks the capacity to consider more than only a few of the many devices that could help Medicare beneficiaries.