AdvaMed Welcomes the Re-Introduction of the Ensuring Patient Access to Critical Breakthrough Products Act
Washington, D.C.–AdvaMed President and CEO Scott Whitaker released the following statement upon re-introduction of bipartisan legislation aimed at accelerating Medicare coverage for breakthrough medtech and diagnostics. The Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Senators Todd Young (R-Ind.) and Alex Padilla (D-Calif.), allows Medicare beneficiaries with life-threatening or debilitating diseases or conditions access to groundbreaking medical innovations, designated as breakthrough devices to treat unmet needs and already authorized by the FDA.
“Patients shouldn’t have to wait years to benefit from medtech the FDA has already determined to be safe and effective for patients,” Whitaker said. “This legislation ensures that delays in coverage and reimbursement decisions through Medicare no longer stand between patients and life-changing innovations. We thank Senators Young and Padilla 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.”
The bill would provide temporary Medicare coverage for qualifying breakthrough devices, giving manufacturers time to work with the Centers for Medicare and Medicaid Services (CMS) to establish a pathway for permanent coverage. This transitional coverage would accelerate patient access to critical technologies with no existing treatment alternatives while CMS completes its review process. To learn more about this important policy, you can read Whitaker’s op-ed in RealClearHealth.
Improving Medicare reimbursement and coverage pathways for medical innovation is a key pillar of AdvaMed’s Medical Innovation Agenda for the 119th Congress.
As the leading medtech association, AdvaMed has worked with lawmakers, CMS, and the broader medtech industry for years to advance legislation or agency policies that ensure timely patient access to safe and effective innovations while maintaining rigorous review standards. A key part of that effort was the Medicare Coverage of Innovative Technology (MCIT) rule, issued by CMS in 2021, which aimed to provide expedited coverage for FDA-designated breakthrough technologies. The rule was later repealed. Its successor, the Transitional Coverage of Emerging Technologies (TCET) rule implemented by CMS in 2024, was a step in the right direction but limited in scope.
The legislation, if enacted into law, would be a welcome, permanent solution.
Momentum for breakthrough coverage also is growing in the executive branch. FDA Commissioner Marty Makary recently 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.
####