To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.
Sponsors
Legislative Progress
IntroducedMr. Crapo (for himself, Mr. Bennet, Mr. Scott of South …
Summary
What This Bill Does
This bill amends Medicare to cover a new category of preventive health tests called multi-cancer early detection (MCED) screening tests starting January 1, 2028. These are advanced blood tests that can detect multiple types of cancer simultaneously by analyzing cell-free DNA in the bloodstream. The bill creates a framework for Medicare reimbursement, sets initial payment rates tied to existing stool-based cancer screening tests (like Cologuard), and establishes age-based eligibility that starts at 68 and increases by one year annually.
Who Benefits and How
The primary beneficiaries are MCED test manufacturers like Grail, Exact Sciences, Guardant Health, and Freenome, who gain access to the lucrative Medicare market with guaranteed payment rates of approximately $500-550 per test. Clinical laboratories performing these tests also benefit from the new revenue stream. Medicare beneficiaries aged 68 and older gain access to cutting-edge cancer screening technology that could detect cancers earlier when treatment is more effective.
Who Bears the Burden and How
The Medicare Trust Fund and federal taxpayers bear the cost, with potential annual spending ranging from $1.5 billion (at 10% uptake) to $7.5 billion (at 50% uptake) once fully implemented. The Department of Health and Human Services faces new administrative responsibilities for implementing coverage determinations and payment calculations. Traditional cancer screening providers (colonoscopies, mammograms) may face reduced demand if MCED tests displace some existing screenings.
Key Provisions
- Requires MCED tests to have FDA clearance or approval and be deemed "reasonable and necessary" by HHS
- Sets payment at the multi-target stool DNA test rate (approximately $500-550) until 2031, then transitions to the Clinical Lab Fee Schedule
- Limits coverage to once every 12 months per beneficiary
- Starts eligibility at age 68 in 2028, increasing by one year annually (69 in 2029, 70 in 2030, etc.)
- Removes age and frequency limitations if the U.S. Preventive Services Task Force gives the test an A or B rating
- Preserves Medicare coverage for traditional cancer screenings; MCED tests are additive, not replacements
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Amends Medicare to provide coverage for FDA-approved multi-cancer early detection screening tests that can detect multiple cancer types simultaneously through blood or biological samples
Policy Domains
Legislative Strategy
"Create a new Medicare preventive benefit for multi-cancer early detection tests with generous initial payment rates (tied to Cologuard, which has high reimbursement) to incentivize adoption while phasing in market-based pricing after 3 years. The rising age threshold creates a gradual rollout that limits initial costs"
Likely Beneficiaries
- Multi-cancer early detection (MCED) test manufacturers (Grail, Exact Sciences, Guardant Health, Freenome, etc.)
- Clinical laboratories performing MCED tests
- Medicare beneficiaries aged 68+ who gain access to new cancer screening technology
- Oncology centers that may receive referrals from positive MCED test results
Likely Burden Bearers
- Medicare Trust Fund / Federal taxpayers (new spending on MCED test coverage)
- HHS/CMS (administrative burden of implementing new benefit, national coverage determinations, payment calculations)
- Potentially existing cancer screening providers if MCED tests displace some traditional screening (colonoscopy, mammography, etc.)
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
Note: None identified - the bill has a simple structure with a single actor (Secretary of HHS) and clear definitions
Key Definitions
Terms defined in this bill
A test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2028, that: (A) is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act; (B) is either (i) a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids, or (ii) a test based on samples of biological material that provides results comparable to those obtained with a test described in clause (i); and (C) the Secretary determines is reasonable and necessary for the prevention or early detection of an illness or disability and appropriate for individuals entitled to benefits under part A or enrolled under part B
Before January 1, 2031: equal to the payment amount for a multi-target stool screening DNA test (e.g., Cologuard). On or after January 1, 2031: the lesser of the stool test amount or the payment amount determined under section 1834A (Clinical Laboratory Fee Schedule)
For 2028: age 68 years. For each succeeding year: the age specified for the preceding year, increased by 1 year (so 69 in 2029, 70 in 2030, etc.). Frequency: once per 12 months. These limitations do not apply if USPSTF recommends the test with grade A or B
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology