AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.
The House Ways and Means Committee has passed legislation that would provide Medicare coverage for US Food and Drug Administration (FDA)-designated breakthrough medical technologies, with industry advocates pushing for diagnostic tests to be added to the measure.
The Ensuring Patient Access to Critical Breakthrough Products Act, HR 5343, would provide four years of coverage for devices authorized by the FDA under the Breakthrough Devices Program. The bill also establishes a framework for additional evidence collection to help the Centers for Medicare and Medicaid Services make permanent coverage decisions after that period.
“Medicare beneficiaries shouldn’t have to wait years to benefit from medtech the FDA has already determined to be safe and effective for patients,” says Scott Whitaker, AdvaMed president and CEO, in a release. “This legislation ensures that delays in coverage and reimbursement decisions through Medicare no longer stand between patients and life-changing innovations.”
AdvaMed, the medtech association, welcomed the committee’s action while urging Congress to expand the legislation to include diagnostic tests before final passage.
Push for Diagnostic Test Inclusion
The association emphasized that diagnostic tests represent a critical component of modern medicine that should be covered under the breakthrough designation framework.
“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,” says Whitaker in a release. “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 legislation aims to address delays between FDA authorization of breakthrough technologies and Medicare coverage decisions that can leave beneficiaries without access to approved innovations.
Companion Legislation and Executive Support
A related Senate bill, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, S 1717, is pending in the US Senate. The legislative push has also received support from executive branch officials.
FDA Commissioner Marty Makary has indicated that he and CMS Administrator Dr Mehmet Oz are working on solutions to accelerate Medicare approval processes and eliminate duplicative approval requirements.
Cancer Screening Bill Also Advances
The Ways and Means Committee also passed the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Act, HR 842, during the same session. That measure would expand Medicare’s authority to determine coverage for multi-cancer early detection tests once they receive FDA approval and demonstrate clinical benefit.
Currently, CMS has limited authority to approve such screening technologies under existing coverage frameworks.
The legislative developments reflect ongoing industry efforts to streamline the path from FDA approval to Medicare coverage for breakthrough medical technologies, with particular focus on ensuring beneficiary access to innovative diagnostic tools.
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