Scott Whitaker Op-Ed: Medicare must keep pace with FDA-authorized breakthrough medical technologies 

Medicare must keep pace with FDA-authorized breakthrough medical technologies 

In this op-ed published in the Washington Times,AdvaMed® President and CEO Scott Whitaker highlights the gap between FDA authorization of breakthrough medical technologies and Medicare coverage decisions, which can leave Medicare beneficiaries waiting years to access life-saving innovations. Whitaker explains that devices cleared through FDA’s rigorous Breakthrough Devices Program meet the same high standards for safety and effectiveness as other technologies, yet Medicare beneficiaries often face delays of nearly six years before coverage is available. 

These delays limit treatment options for older Americans with serious conditions and create significant challenges for the small companies and startups that drive much of the nation’s medtech innovation. Whitaker points to bipartisan legislation, the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343/S. 1717), as a solution that would provide temporary Medicare coverage for FDA-cleared breakthrough technologies while CMS conducts a structured evaluation for permanent coverage. 

This op-ed offers important insight into AdvaMed’s advocacy priorities to modernize Medicare policy, strengthen America’s leadership in medical technology, and ensure patients can access breakthrough innovations without unnecessary delay.