Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies

2025-09-18

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Summary

This meeting of the subcommittee focused on several legislative proposals aimed at enhancing Medicare beneficiaries' access to innovative medical technologies, particularly those related to cancer detection and treatment, while also addressing efficiency within federal health agencies.[ 00:23:15-00:23:22 ]

Discussions highlighted both the potential for life-saving advancements and significant concerns regarding policy implementation and the broader funding landscape for scientific research.[ 00:27:04-00:27:13 ] [ 00:51:17-00:51:20 ]

Themes

Delayed Access to Breakthrough Medical Technologies

Several speakers emphasized the "Valley of Death" period between FDA approval of medical devices and Medicare coverage, which can take several years and delay patient access to critical innovations.[ 00:26:16 ]

The Ensuring Patient Access to Critical Breakthrough Products Act was presented as a solution to provide four years of transitional Medicare coverage for breakthrough devices, accelerating their availability to seniors.[ 00:25:59 ] [ 00:26:43 ] Dr. Todd Brinton shared Edwards Life Sciences' positive experience with the TSET pilot program but advocated for a broader, more consistent approach beyond the current limit of five technologies per year, including a two-year look-back period and Medicare Advantage coverage.[ 01:16:54 ] Concerns were raised by Mr. David Lipschutz and Dr. Diana Zuckerman about waiving the "reasonable and necessary" standard for coverage, arguing it could compromise patient safety and lead to fraud if devices lack sufficient evidence for Medicare patients.[ 01:37:39 ]

Multi-Cancer Early Detection (MCED) Screening Coverage

The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act garnered significant support as a means to allow Medicare to cover emerging blood-based cancer screenings once FDA approved.[ 00:23:59 ]

Mr. Roger Royce provided compelling personal testimony, crediting an MCED test with detecting his pancreatic cancer early, enabling successful treatment, and contrasting it with the late-stage diagnosis and subsequent death of his brother who did not take the test. Mr. Stephen Ezell highlighted the potential of MCED tests to save lives and reduce healthcare costs by detecting cancers earlier, particularly for cancers without existing screening options and in rural communities.[ 01:09:18 ] However, Dr. Diana Zuckerman and Mr. David Lipschutz expressed reservations about the current accuracy of MCED tests, pointing to studies suggesting high false positive and false negative rates, which could lead to unnecessary anxiety, additional painful testing, or delayed treatment due to false reassurance. Mr. Lipschutz also criticized the bill's arbitrary age-based eligibility phase-in, arguing all beneficiaries should have equitable access based on medical needs, not birth year.[ 01:05:30 ]

Modernizing CMS Processes

There was a general consensus on the need to improve the transparency and efficiency of the National Coverage Determination (NCD) and Local Coverage Determination (LCD) processes at CMS. Dr. Todd Brinton specifically recommended streamlining the reconsideration process for existing therapies, suggesting a single comment period instead of dual periods to shorten delays for life-saving treatments like TAVR, which currently faces outdated coverage policies.[ 01:23:07 ]

Impact of Funding Cuts and Political Interference on Research

Several Democratic members voiced strong criticism regarding proposed cuts to federal health research agencies and alleged political interference in scientific bodies.[ 00:27:04-00:27:13 ]

Representatives Diana L. DeGette, Raul Ruiz, Greg John Landsman, Lizzie Fletcher, Marc A. Veasey, and Troy Anthony Carter cited concerns about the Trump administration's actions affecting NIH, FDA, and CDC, including halting pediatric brain tumor research, vaccine program cuts, and political appointees influencing scientific decisions.[ 00:34:57 ] [ 02:00:25 ] [ 02:00:49 ] They argued these cuts undermine U.S. leadership in biomedical innovation, cause a "brain drain" of scientists, and ultimately lead to slower progress and higher costs in fighting diseases like cancer.[ 02:42:23 ] Mr. Stephen Ezell affirmed the direct link between federal R&D funding and innovation, stating that proposed cuts would negatively impact America's global competitiveness in biotechnology.[ 02:42:23 ]

Expanding Access to Diabetes Self-Management Training

The Expanding Access to Diabetes Self-Management Training Act received bipartisan support as a valuable initiative to help Medicare beneficiaries with diabetes manage their disease, improve wellness, and potentially lower costs.[ 01:48:36 ]

Tone of the Meeting

The meeting exhibited a dual tone, marked by both bipartisan cooperation and shared purpose on specific legislative initiatives, and intense partisan contention regarding broader health policy, especially federal science funding and administrative actions.[ 00:23:15-00:23:22 ]

[ 00:27:03 ] [ 00:27:04 ] [ 00:34:44 ] There was widespread agreement among members and witnesses on the critical need for innovation and timely patient access to medical advancements, particularly in cancer detection.[ 00:41:15 ] Mr. Roger Royce's personal testimony was a particularly poignant and unifying moment, underscoring the human impact of early detection.[ 00:51:17-00:51:20 ] However, this positive collaboration was frequently overshadowed by sharp criticism from Democratic members directed at the current administration's alleged dismantling of federal health agencies and cuts to research, which they argued threatened the very foundation of medical innovation.[ 00:27:04-00:27:13 ] [ 00:34:57 ] [ 02:00:16 ] This led to a juxtaposition of legislative optimism with profound concern over national health policy direction.