LUGPA Policy Brief: The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

April 2025 

The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act seeks to enhance access to innovative cancer screening technologies for Medicare beneficiaries. By establishing a clear pathway for Medicare coverage of MCED screenings upon approval by the Food and Drug Administration (FDA), this legislation aims to improve early detection and treatment of cancer, ultimately leading to better health outcomes for seniors.

Currently, routine cancer screenings are limited to a small subset of cancers, and only 14% of cancers are detected through screening. Traditional screening methods focus on five common cancers, leaving many undetected until they have progressed to more advanced stages. Multi-cancer early detection tests represent a significant advancement in screening technology, using blood-based diagnostics to identify potential malignancies earlier and more comprehensively. Given that about 7 in 10 cancer deaths occur in the Medicare population, timely access to these innovative screening tools is critical.

Key Provisions of the Legislation

The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act would:

• Establish CMS authority to provide Medicare coverage for blood-based MCED tests and future test methods upon FDA approval and demonstration of clinical benefit.
• Ensure that CMS retains the ability to use an evidence-based process to determine appropriate coverage parameters for MCED screenings.
• Clarify that MCED tests will complement, rather than replace, existing screening methods and that cost-sharing structures for beneficiaries will remain unchanged.

Importance of Early Detection in Urological Care

Advancements in diagnostic tools have significantly improved early detection and personalized treatment strategies for urological cancers, such as prostate, kidney, and bladder cancer.

LUGPA advocates for greater access to these diagnostic tools, recognizing their role in facilitating precision medicine and minimizing unnecessary treatments. Legislative efforts to enhance insurance coverage and reduce financial barriers are essential in ensuring that patients receive timely and appropriate testing based on clinical guidelines.

Policy Considerations

• Coverage Expansion: Modifying Medicare statutes to include comprehensive coverage for screening would align policy with contemporary clinical practices.
• Patient Access: Addressing cost-sharing requirements is essential to reducing financial barriers that may deter high-risk individuals from seeking preventive care.
• Equitable Implementation: Ensuring that access to MCED tests is widely available across diverse patient populations is critical for maximizing the benefits of early cancer detection.

LUGPA supports policies that enhance access to innovative diagnostic technologies and ensure that Medicare beneficiaries can benefit from the latest advancements in cancer screening. By advocating for expanded Medicare coverage of cancer testing, LUGPA aims to improve early cancer detection, facilitate informed decision-making between physicians and patients, and promote equitable access to precision medicine.

As legislative discussions progress, LUGPA remains committed to working with policymakers, healthcare providers, and stakeholders to ensure that the integration of new screening technologies aligns with clinical best practices and supports optimal patient outcomes.