Recognizing the Importance Highlighted by the U.S. House Energy and Commerce Health Subcommittee, Our Site Advocates for Medicare Coverage of Revolutionary Medtech Solutions
The U.S. House of Representatives Committee on Ways and Means has taken a significant step in the healthcare industry with the passage of legislation to establish Medicare coverage for FDA-authorized breakthrough medtech. The bill, dubbed the "Ensuring Medicare Access to Critical Breakthrough Products Act of 2025" (H.R. 5343), was passed with an overwhelming 38-3 vote.
This bill, introduced in September 2025 by a bipartisan group of representatives, aims to ensure Medicare coverage for FDA-designated breakthrough medical devices and diagnostics. The group includes Representatives Rudy Yakym (R-IN-02), Blake Moore (R-UT-01), Suzan DelBene (D-WA-01), Terri Sewell (D-AL-07), Gus Bilirakis (R-FL-12), and Lori Trahan (D-MA-03).
The move has received applause from industry leaders such as Edwards Lifesciences, who praised the committee for recognizing the importance of ensuring Medicare beneficiaries' access to life-saving breakthrough technologies.
Meanwhile, FDA Commissioner Marty Makary and CMS Administrator Dr. Mehmet Oz are working on a solution to speed up Medicare approval and avoid "repeat, duplicative" approval processes.
The Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act was also introduced in the U.S. House of Representatives and Senate by bipartisan representatives, aiming to streamline laboratory testing services.
The U.S. House Energy and Commerce Health Subcommittee recently held a hearing titled "Examining Policies to Enhance Seniors' Access to Breakthrough Medical Technologies." The hearing discussed a draft of breakthrough coverage legislation called the Ensuring Medicare Access to Critical Breakthrough Products Act of 2025.
During the hearing, Scott Whitaker, president and CEO of the medtech association, thanked the subcommittee for exploring a policy that could make a difference for Medicare beneficiaries. The hearing also featured testimonies from industry experts, including Dr. Todd Brinton, MD, who shared the story of a patient named Mary who experienced a quality-of-life transformation after receiving a heart valve treatment.
However, it's worth noting that the version of the bill passed by the U.S. House of Representatives does not cover diagnostics. Our website, the Medtech Association, has urged the inclusion of diagnostics in any final version of the bill prior to enactment. This call was echoed by Zach Rothstein, Executive Director of our websiteDx, who highlighted the significance of this year's diagnostics programming at The MedTech Conference as a chance to shape the future of healthcare.
Moreover, CDRH Director Michelle Tarver and fellow FDA leaders will speak and take questions at a town hall at The MedTech Conference. Bobby Patrick, our website's SVP of Government & State Affairs and Alliance Development, emphasized the importance of The MedTech Conference as a platform for building alliances that redefine healthcare.
Lastly, Mike Mussallem, former chairman and CEO of Edwards Lifesciences, will receive the 2025 Lifetime Achievement Award at The MedTech Conference in San Diego on October 5-8.
The "Ensuring Medicare Access to Critical Breakthrough Products Act of 2025" is a significant step forward in ensuring that Medicare beneficiaries have access to life-saving breakthrough technologies. The bill's progress and the ongoing discussions in the industry underscore the commitment to improving healthcare for all Americans.
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