A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

Bill Number: S. 339
Origin Chamber: Senate
Congress: 119th Congress, Session 1
Policy Area: Health
Status: Introduced
Latest Action: 2025-01-30: Read twice and referred to the Committee on Finance.
Last Updated: 2026-03-03T11:56:30Z

AI-Generated Summary

Purpose

The legislation aims to expand Medicare coverage to include multi-cancer early detection (MCED) screening tests, which are advanced diagnostic tools designed to identify multiple types of cancer early across various organs. This is intended to improve early cancer detection and prevention for Medicare beneficiaries, potentially leading to better health outcomes.

Key Provisions

Definition of MCED Tests: An MCED test is defined as a screening tool that detects multiple cancer types simultaneously in different organ sites, starting from January 1, 2028. It must be approved, cleared, or classified by the Food and Drug Administration (FDA—a federal agency that regulates medical devices and drugs) and involve genomic sequencing of blood or comparable biological samples. The Secretary of Health and Human Services must determine it is "reasonable and necessary" for preventing or detecting illness in Medicare-eligible individuals.
Coverage Process: Coverage decisions will follow the National Coverage Determination (NCD) process, a formal review by the Centers for Medicare & Medicaid Services (CMS) to evaluate medical necessity and appropriateness.
Payment Structure:
Before January 1, 2031: Payment equals the current rate for a multi-target stool DNA test (an existing colorectal cancer screening).
On or after January 1, 2031: Payment is the lower of the prior rate or a rate set under Medicare's clinical diagnostic laboratory fee schedule (a standardized payment system for lab tests).
Frequency and Eligibility Limits:
Tests are limited to once every 11 months per person.
Initial eligibility starts at age 68 in 2028, increasing by one year annually (e.g., age 69 in 2029), to phase in coverage gradually.
Future Adjustments: If the U.S. Preventive Services Task Force (USPSTF—an independent panel that reviews preventive services) gives the test an "A" or "B" recommendation (indicating high certainty of substantial or moderate net benefit), coverage will shift to the standard USPSTF process, overriding the bill's specific payment and limits.
Non-Interference with Other Screenings: The bill explicitly states it does not affect Medicare coverage for other cancer screenings (e.g., mammograms for breast cancer, colonoscopies for colorectal cancer) or allow MCED tests to replace them.

Significant Changes to Existing Law

Amends Section 1861 of the Social Security Act (which defines Medicare-covered services) by adding MCED tests as a new covered benefit under Medicare Part B (outpatient services).
Introduces a new subsection in Section 1834 for dedicated payment rules and standards for MCED tests, separate from existing lab test payments.
Updates Section 1862 to exclude payment for MCED tests that are not deemed reasonable and necessary for multi-cancer detection.
Makes conforming changes to payment calculation sections (e.g., Section 1833) to integrate MCED tests without disrupting other services.

Potential Impacts

On Citizens: Medicare beneficiaries, particularly older adults (starting at age 68+), gain access to innovative screening for multiple cancers, which could enable earlier treatment, reduce mortality, and improve quality of life. However, phased age limits may delay access for some.
On Government Agencies: CMS will need to develop NCD processes, evaluate tests, and manage payments, potentially increasing administrative workload and short-term costs to the Medicare program (funded by taxpayers). Long-term, early detection might lower overall treatment expenses.
On International Relations: No direct impacts, as the bill focuses on domestic U.S. healthcare policy.
Broader Effects: Could encourage development of MCED technologies, benefiting public health by addressing rising cancer rates, but may strain Medicare's budget if adoption is widespread before cost savings materialize.

Main Stakeholders Affected

Medicare Beneficiaries: Primary users, especially those at higher cancer risk due to age.
Healthcare Providers: Doctors and clinics that order or administer tests, gaining new preventive tools.
Test Manufacturers and Labs: Companies developing FDA-approved MCED tests (e.g., those using blood-based genomic analysis), who benefit from guaranteed Medicare reimbursement.
Government Entities: CMS and the Department of Health and Human Services for implementation; Congress and taxpayers for funding.
Advocacy Groups: Cancer research organizations and patient advocates, who may support expanded screening access.

Notable Legal, Constitutional, or Political Implications

Legal: Relies on FDA approvals and CMS discretion for "reasonable and necessary" determinations, which could lead to future litigation if coverage decisions are challenged (e.g., under administrative law). The bill preserves flexibility by deferring to USPSTF recommendations, aligning with evidence-based policymaking.
Constitutional: No apparent issues, as it involves spending under Congress's enumerated powers (taxing and spending for general welfare) and does not infringe on individual rights.
Political: Bipartisan sponsorship (from Senators Crapo, Bennet, Scott, and Wyden) signals broad support for preventive health measures. It could set a precedent for covering emerging technologies in Medicare, influencing future debates on healthcare innovation versus fiscal responsibility. The naming after Nancy Gardner Sewell highlights personal advocacy for cancer screening.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Crapo, Mike [R-ID]

Cosponsors (68)

Sen. Bennet, Michael F. [D-CO], Sen. Scott, Tim [R-SC], Sen. Wyden, Ron [D-OR], Sen. Lankford, James [R-OK], Sen. Rounds, Mike [R-SD], Sen. Tillis, Thomas [R-NC], Sen. Budd, Ted [R-NC], Sen. Klobuchar, Amy [D-MN], Sen. Marshall, Roger [R-KS], Sen. Ossoff, Jon [D-GA], Sen. Risch, James E. [R-ID], Sen. Merkley, Jeff [D-OR], Sen. Barrasso, John [R-WY], Sen. Kelly, Mark [D-AZ], Sen. Capito, Shelley Moore [R-WV], Sen. Rosen, Jacky [D-NV], Sen. Coons, Christopher A. [D-DE], Sen. Fetterman, John [D-PA], Sen. Blumenthal, Richard [D-CT], Sen. Reed, Jack [D-RI], Sen. Hickenlooper, John W. [D-CO], Sen. Shaheen, Jeanne [D-NH], Sen. Whitehouse, Sheldon [D-RI], Sen. Grassley, Chuck [R-IA], Sen. Cantwell, Maria [D-WA], Sen. Cramer, Kevin [R-ND], Sen. Boozman, John [R-AR], Sen. Gallego, Ruben [D-AZ], Sen. Graham, Lindsey [R-SC], Sen. Cassidy, Bill [R-LA], Sen. Mullin, Markwayne [R-OK], Sen. Collins, Susan M. [R-ME], Sen. Gillibrand, Kirsten E. [D-NY], Sen. Scott, Rick [R-FL], Sen. Cortez Masto, Catherine [D-NV], Sen. Slotkin, Elissa [D-MI], Sen. Daines, Steve [R-MT], Sen. Cornyn, John [R-TX], Sen. Justice, James C. [R-WV], Sen. Moreno, Bernie [R-OH], Sen. Heinrich, Martin [D-NM], Sen. McConnell, Mitch [R-KY], Sen. Warner, Mark R. [D-VA], Sen. Baldwin, Tammy [D-WI], Sen. Booker, Cory A. [D-NJ], Sen. Murray, Patty [D-WA], Sen. Hyde-Smith, Cindy [R-MS], Sen. King, Angus S., Jr. [I-ME], Sen. Welch, Peter [D-VT], Sen. Padilla, Alex [D-CA] and 18 more

Recent Actions

2025-01-30: Read twice and referred to the Committee on Finance.
2025-01-30: Introduced in Senate

Bill Versions

Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act — issued 2025-01-30 — PDF (7 pages)