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AdvaMed Commends House Progress on Breakthroughs Legislation


AdvaMed, the Medtech Association, released this statement from President and CEO Scott Whitaker following the House Energy & Commerce Committee’s Subcommittee on Health markup of H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act of 2023:

“I want to thank Chair McMorris Rodgers, Chair Guthrie, and Ranking Member Eshoo for their focus on ensuring seniors on Medicare have access life-saving, FDA-approved breakthrough medical technologies. Because there currently is no pathway for Medicare coverage of these breakthrough treatments, millions of patients are missing out on the latest innovations that could extend, improve, and even save their lives. It is critical that Congress and the Administration move these policies forward, and the broad, bipartisan support this bill has received shows that it can and should be passed and signed into law. We look forward to continuing our work together to make it happen.”

The bipartisan legislation, which was introduced earlier this year by Representatives Brad Wenstrup (OH-02), Suzan DelBene (WA-01), Gus Bilirakis (FL-12), Tony Cárdenas (CA-29), Blake Moore (UT-01), Terri Sewell (AL-07), Brett Guthrie (KY-02), and Anna Eshoo (CA-16), would ensure FDA-designated breakthrough technologies are covered for four years by Medicare, and during this period CMS would be required to make permanent coverage determinations for the devices. This ensures safe and effective care is made available to millions of patients. In addition, the bill addresses temporary coverage for breakthrough devices that did not exist when Medicare was created.

Earlier this year, AdvaMed Board Member and CEO of PAVmed and Lucid Diagnostics, Dr. Lishan Aklog, testified before the Subcommittee on the importance of ensuring equitable access to life-saving innovations by developing a predictable pathway to Medicare coverage for emerging technologies.

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