Medicare Policy at the Crossroads: Addressing Artificial Intelligence and Software

AdvaMed® collaborated with CapView Strategies to develop this new report on improving coverage and payment for AI/software in Medicare. This work builds on the analysis and recommendations from an earlier collaboration. As described in the first report, CMS has the regulatory flexibility to incorporate digital health technologies—including AI/software innovations—into its payment pathways as the statutory parameters for Medicare’s benefit categories accommodate evidence-based, digital health solutions. This second report updates the previous analysis with a specific focus on AI/software.
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AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.
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WASHINGTON—AdvaMed, the MedTech Association®, today announced Melissa Torres is the new Executive Vice President of Technology and Regulatory Affairs. Torres succeeds Janet Trunzo, who retired after 30 distinguished, productive years withAdvaMed®.
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Why the Health Tech Investment Act Matters: Peter Weems Breaks Down What This Means for Patients
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In a new video developed in partnership with Patients Rising, AdvaMed’s Peter Weems, Vice President of Imaging Government Affairs and Policy Strategy, explains why the Health Tech Investment Act is critical to expanding patient access to FDA-authorized AI-enabled medical devices.
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AdvaMed® Names Brian J. Blaser, QuidelOrtho President and CEO, Chair of AdvaMedDx Board of Directors
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WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Rich Fabian, president and CEO of FUJIFILM Sonosite, will serve as the chair of the Medical Imaging division’s board of directors. He will succeed David Pacitti, CEO of Avanos Medical and former president and head of the Americas at Siemens Healthineers, the inaugural division board chair.
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Robert Cohen of Stryker Named Chair of AdvaMed’s Digital Health Tech Division Board of Directors
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WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Robert Cohen, vice president, innovation and technology, orthopaedic group at Stryker, will be the next chair of theAdvaMed® Digital Health Tech Board of Directors. He succeeds Dr. Taha Kass-Hout, global chief science and technology officer at GE HealthCare, who served as the inaugural chair of the board overseeing the then-newly created division.
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Mick Farrell, Chairman and CEO of Resmed, Named Chair ofAdvaMed® Board of Directors
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WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced Michael “Mick” Farrell, chairman and CEO of Resmed Inc. (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing, and care delivered in the home, will be the next chair of theAdvaMed® Board of Directors. Farrell will serve a two-year term beginning in January 2026.