Congress considers bills expanding Medicare coverage for transformative medical devices and early detection

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Medicare with a stethoscope

The Ohio State University College of Medicine Featured Expert:  

Vinay Rathi, MD, MBA, assistant professor in the Department of Otolaryngology - Head & Neck Surgery

After a lengthy, industry-backed push, the United States Congress is considering bills to speed up access for Medicare beneficiaries to two putative new advancements: medical devices that receive breakthrough designation from the Food and Drug Administration (FDA), and multicancer early detection (MCED) tests.  

Vinay Rathi, MD, MBA, worked with colleagues at Massachusetts General Hospital, the University of California, San Francisco and Yale University, to craft a “Perspective” article just published in the New England Journal of Medicine. The authors argued that the proposed legislation would: 

  1. Undermine the Centers for Medicare and Medicaid Services’ (CMS) authority to implement evidence-based coverage policies and would not serve the best interests of Medicare beneficiaries or the public.  
  2. Based on their recent analysis of the FDA Breakthrough Devices Program, the authors expressed concerns that automatic coverage would promote the adoption of potentially unsafe or ineffective devices. 
  3. Authors anticipated that widespread use of MCEDS – which have not yet demonstrated evidence of benefit – could lead to unnecessary testing cascades (due to false positives) or deter patients from guideline-based cancer screening (due to false negatives). 
  4. It may be difficult for CMS to repeal coverage, even if unfavorable evidence later becomes known.  
  5. They proposed that instead, Congress could provide CMS with the resources necessary to expand an existing, evidence-based pathway to expedite coverage for breakthrough-designated devices.  
  6. Finalized in 2024, the Transitional Coverage for Emerging Technologies pathway allows manufacturers to formulate evidence-development plans with CMS prior to FDA authorization and has demonstrated promise to shorten the period between FDA authorization and Medicare coverage. The proposed legislation would render this pathway obsolete. 

The authors acknowledged the fundamental and existing tension between regulatory speed and clinical certainty for new medical technologies. However, they believe that guaranteeing coverage for unproven technologies would not strike the right balance between unlocking the potential innovation and improving public health. 

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