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Testimony to the House Energy and Commerce Subcommittee on Health Regarding Seniors’ Access to Breakthrough Medical Technologies

Testimony to the House Energy and Commerce Subcommittee on Health Regarding Seniors’ Access to Breakthrough Medical Technologies

Key Takeaways

  • Cancer’s Impact on Seniors: Cancer is the second leading cause of death in the U.S. and disproportionately affects older citizens, culminating in an urgent need for effective screening.

  • Innovative Technologies: Multi-cancer early detection (MCED) tests, utilizing modern technologies such as AI and genomic sequencing, can potentially identify multiple cancers through a simple blood test.

  • Economic Benefits: Early detection via MCED could significantly reduce healthcare costs, given that late-stage cancer treatment is exponentially more expensive.

  • Legislative Support: Bipartisan legislative efforts are required to ensure that CMS covers MCED tests for Medicare beneficiaries.

Introduction and Summary

Cancer remains one of the most pressing health issues, particularly for seniors, as they represent a significant percentage of diagnoses and deaths. The House Energy and Commerce Subcommittee on Health recently examined policies to enhance access to innovative medical technologies, specifically spotlighting Multi-cancer early detection (MCED) tests. These emerging technologies signal a transformative shift in cancer screening protocols, potentially saving lives and reducing healthcare expenditures.

The Scourge of Cancer

Cancer claims over 600,000 lives annually in the U.S., making it the second leading cause of death. These grim statistics highlight that nearly 40% of Americans will develop cancer during their lifetime, with older adults being particularly vulnerable. People aged 65 and older account for 60% of new cancer cases and a staggering 70% of all cancer-related deaths.

America’s Cancer Fight

While the number of deaths from cancer has declined over the past few decades—thanks in part to advances in both screening and treatment—much work remains. Approximately 1,200 Medicare beneficiaries are diagnosed with late-stage cancer daily, a statistic that underscores failures in early detection.

Currently, only five types of cancer have guideline-recommended screening methods. The majority of cancers—comprising about 70% of cancer deaths—lack such screening options.

Transformative New Technologies Revolutionizing Cancer Screening

Enter Multi-cancer Early Detection (MCED) tests, which can identify multiple types of cancer through a simple blood draw. Using advanced technologies like artificial intelligence and genomic sequencing, MCED tests analyze circulating tumor DNA (ctDNA) shed into the bloodstream. This revolutionary capability permits the simultaneous screening of many cancers, providing early detection of malignancies that currently remain undetectable until advanced symptoms arise.

The Importance of Early Cancer Detection

Early detection is crucial in the fight against cancer. Diagnosing cancer at an earlier stage significantly enhances the chances of survival. For instance, patients diagnosed with localized cancers have five-year survival rates exceeding 80%, while those diagnosed at later stages see this rate drop to around 21%.

Health Benefits

The potential life-saving capabilities of MCED screening extend beyond survival rates. Early detection can optimize treatment strategies, making them more effective and less costly. For the Medicare population, costs could be up to seven times higher for those diagnosed at later stages.

Economic Benefits

The economic advantages of earlier cancer detection through MCED tests are profound. Research suggests that improving early detection could save the U.S. healthcare system billions. For example, earlier diagnosis could lead to estimated annual savings of $26 billion in treatment costs. Furthermore, cancer screenings have previously saved the U.S. approximately $6.5 trillion by averting cancer deaths.

Specific Benefits of MCED Screening Technologies

MCED technologies bring unique advantages:

  1. Broad Screening Capabilities: They allow for simultaneous testing for multiple cancers, streamlining the screening process.
  2. Less Invasive Testing: The blood draw method is easier and less invasive than many traditional screening modalities.
  3. Increasing Accessibility: More accessible MCED tests can help reach individuals in rural areas, improving equity in cancer detection.
  4. Addressing Inequities: These tests could potentially alleviate existing disparities in cancer-related deaths among racial and ethnic minorities.

Addressing Potential Misgivings About MCED Approaches

Despite their promise, concerns around MCED technologies include potential overdiagnosis and false positives. However, research suggests that MCED tests are likely to tail characterized "indolent" cancers, primarily identifying more aggressive, life-threatening cancers.

An Emerging and Intensely Competitive Global Industry

The competitive landscape for MCED technologies is rapidly evolving, particularly with countries like China heavily investing in this area. China’s emphasis on biotechnology puts American firms at risk of losing their leading edge unless proactive policies are enacted to enhance support for innovation domestically.

Getting the Regulatory and Coverage Environment Right for MCED in the United States

The regulatory framework that governs Medicare coverage needs to adapt to emerging technologies. The bipartisan “Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act” seeks to grant CMS the authority to implement MCED tests under Medicare, making it crucial for Congress to support such initiatives.

Multi-Cancer Early Detection Policy Recommendations

To facilitate MCED technologies, Congress should consider:

  1. Expanding Medicare Coverage: Enable coverage for these diagnostic tests through transparent and evidence-based guidelines.
  2. Supporting Innovation: Encourage medical technology firms by fostering a regulatory environment conducive to innovation.
  3. Public Awareness: Increase awareness of MCED technologies among healthcare providers and patients to facilitate early adoption and utilization.

Supporting Innovation in Breakthrough Medical Products

Legislative measures like the "Ensuring Patient Access to Critical Breakthrough Products Act of 2025" would streamline the process for Medicare reimbursement of innovative medical technologies, reducing barriers and accelerating access for patients.

Conclusion

The imperative for early cancer detection has never been clearer, especially for our nation’s seniors. MCED technologies pose a transformative opportunity, enabling earlier, more efficient detection of multiple cancers from a simple blood draw. Legislative support and timely action are essential to leverage this potential, promising significant health improvements and cost savings in the battle against cancer. As the landscape evolves, America must embrace innovation, ensuring that necessary interventions reach those who can benefit the most. Now is the time for Congress to act decisively in support of these groundbreaking medical technologies.

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