AdvaMed - Advanced Medical Technology Association
09/18/2025 | Press release | Distributed by Public on 09/18/2025 16:40
AdvaMed Thanks U.S. House Energy and Commerce Health Subcommittee for Highlighting the Need for Medicare Coverage of Breakthrough Medtech
Press Releases
AdvaMed Thanks U.S. House Energy and Commerce Health Subcommittee for Highlighting the Need for Medicare Coverage of Breakthrough Medtech
- Coverage & Payment
- Diagnostics
- Government & Legislative Affairs
- Health Access
- September 18, 2025
WASHINGTON-AdvaMed, the medtech association, today thanked the U.S. House Energy and Commerce Health Subcommittee for highlighting the need for Medicare coverage of FDA-authorized breakthrough medtech and releasing a discussion draft of breakthrough coverage legislation at a hearing, "Examining Policies to Enhance Seniors' Access to Breakthrough Medical Technologies."
"Thank you to committee Chairman Guthrie, subcommittee Chairman Griffith, Ranking Member DeGette, and subcommittee members for exploring a policy that would make a huge difference for Medicare beneficiaries," said Scott Whitaker, president and CEO of AdvaMed. "When the FDA has deemed medtech safe, effective, and ready for patients, Medicare should make that medtech available as an option for patients and their doctors. It was encouraging to hear so much agreement among the subcommittee members in favor of this common-sense idea."
Hearing witnesses included Dr. Todd Brinton, MD, corporate vice president, Advanced Technology, and chief scientific officer, Edwards Lifesciences, who shared the story of a patient named Mary who experienced a "complete quality-of-life transformation" after receiving a heart valve treatment developed for patients with no other treatment options. Congress created the FDA breakthrough designation precisely for such innovations.
"On behalf of Edwards, we applaud the committee for recognizing the importance of ensuring Medicare beneficiaries' access to life-saving breakthrough technologies," Brinton said. "Mary's story highlights how timely access to breakthrough technologies radically transforms patients' lives."
The hearing and release of the discussion draft legislation, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, mark the second instance of congressional action on the breakthrough issue this week. On Wednesday, the U.S. House of Representatives Committee on Ways and Means passed legislation to establish Medicare coverage of FDA-authorized breakthrough medtech on an overwhelming 38-3 vote. That version of the bill doesn't cover diagnostics, though related bills, including a Senate bill, do so. AdvaMed urges the inclusion of diagnostics in any final version prior to enactment.
Leaders in the executive branch also support the breakthrough coverage concept. 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.
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