Medicare Coverage Processes: An Analysis of Procedural and Resource Concerns

This report focuses on coverage for devices and issues related to procedural delays, the lack of transparency in Medicare’s National Coverage Determination (NCD) process, the use of Coverage with Evidence Development, harmonizing with the Food and Drug Administration (FDA), and ensuring patient safety. CMS has conducted its NCD review process for medical devices for many years but in recent years the process has slowed and become less predictable. The operational flaws that exist within the NCD process ultimately could prevent Medicare beneficiaries from accessing innovative technologies, especially at a time when CMS considers assuming new responsibilities for evaluating new technologies.
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Resource / Artificial Intelligence (AI) / Coverage & Payment / Digital Health / Regulatory Affairs
AdvaMed® Comment Letter to ASTP/ONC: Accelerating AI Adoption in Clinical Care
February 24, 2026
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 As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.
Blog / Coverage & Payment
The Pulse of Medtech Payment: Join Us at the 2026 Payment Policy Forum
February 13, 2026
The 2026AdvaMed® Payment Policy Forum takes place May 28–29 in Washington, D.C. at Hogan Lovells Office. Registration is now open, and as always,AdvaMed® members receive preferred pricing.
News / Coverage & Payment / Diagnostics / Regulatory Affairs
AdvaMed® Announces Melissa Torres as New Executive Vice President of Technology and Regulatory Affairs
February 10, 2026
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®.
Blog / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Health Access / Medical Imaging
Why the Health Tech Investment Act Matters: Peter Weems Breaks Down What This Means for Patients
January 26, 2026
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.
News / Coverage & Payment / Diagnostics / Regulatory Affairs
AdvaMed® Names Brian J. Blaser, QuidelOrtho President and CEO, Chair of AdvaMedDx Board of Directors
January 21, 2026
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Brian Blaser, president and CEO of QuidelOrtho, will serve as the next chair of the AdvaMedDx Division Board of Directors, succeeding Thierry Bernard, CEO of QIAGEN. AdvaMedDx represents more than 70 manufacturers of the innovative in vitro diagnostic (IVD) tests critical to patient care.
News / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Medical Imaging / Regulatory Affairs
Medical Imaging Division Announces Rich Fabian as New Board Chair
January 16, 2026
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.
News / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Orthopedic / Regulatory Affairs
Robert Cohen of Stryker Named Chair of AdvaMed’s Digital Health Tech Division Board of Directors
January 5, 2026
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.
News / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Medical Imaging / Orthopedic / Regulatory Affairs / Small Business
Mick Farrell, Chairman and CEO of Resmed, Named Chair ofAdvaMed® Board of Directors
December 11, 2025
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.