AdvaMed Welcomes Key U.S. House Committee Passage of Breakthrough Medtech Coverage Bill, Urges Addition of Diagnostic Tests
WASHINGTON—AdvaMed, the medtech association, today welcomed U.S. House of Representatives Committee on Ways and Means passage of legislation providing Medicare coverage of FDA-designated and authorized breakthrough medtech. AdvaMed also urged legislators to add diagnostic tests to the measure, the Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 5343.
“Medicare beneficiaries shouldn’t have to wait years to benefit from medtech the FDA has already determined to be safe and effective for patients,” said Scott Whitaker, AdvaMed president and CEO. “This legislation ensures that delays in coverage and reimbursement decisions through Medicare no longer stand between patients and life-changing innovations. We thank the committee leaders and bill sponsors for their leadership and urge Congress to pass this bipartisan legislation so patients can access the most advanced medical technologies available to help alleviate their suffering and restore their health.”
“We also look forward to working with Congress to ensure diagnostic tests are added to the legislation before enactment. Diagnostics are a critical part of medicine, and innovative diagnostics, such as those for early cancer detection, Alzheimer’s disease, or traumatic brain injury, are transforming patient care. By providing precise diagnoses, the tests lead to appropriate treatment and early intervention, promoting good patient outcomes and preventing hospitalization and other costly care.”
The bill would provide four years of coverage for designated devices authorized by the FDA under the Breakthrough Devices Program. It would also create a roadmap for additional evidence collection for the Centers for Medicare and Medicaid Services (CMS) to make a permanent coverage decision after that period. This would ensure beneficiaries have quicker access to these safe and effective technologies, while providing the necessary autonomy for CMS to evaluate the technologies.
AdvaMed has long pressed for Medicare coverage of FDA-authorized breakthrough medtech and appreciates the strong momentum toward a solution this year. A related bill, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, S. 1717, is pending in the U.S. Senate. In the executive branch, FDA Commissioner Marty Makary said he and CMS Administrator Dr. Mehmet Oz have been working on a solution to speed up Medicare approval and avoid “repeat, duplicative” approval processes.
AdvaMed also praised Ways and Means Committee passage today of the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Act (H.R. 842), which aims to improve access to new, innovative cancer screenings among Medicare beneficiaries to increase early detection of more cancers for more individuals. The bill would allow Medicare to determine coverage for MCED tests, once FDA approved and showing clinical benefit. Currently, CMS has limited authority to approve such tests.