HR842-119

What This Bill Does

The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act amends the Social Security Act to add multi-cancer early detection screening tests to Medicare-covered medical and other health services. A covered test must be furnished on or after January 1, 2028, be cleared under FDA section 510(k), classified under section 513(f)(2), or approved under section 515, and either be a genomic sequencing blood or blood-product test analyzing cell-free nucleic acids or a comparable biological-material test as determined by the HHS Secretary. The Secretary must determine that the test is reasonable and necessary for prevention or early detection and appropriate for people entitled to Medicare Part A or enrolled in Part B. New-test coverage determinations must use the Medicare national coverage determination process. For tests furnished before January 1, 2031, payment equals the then-current payment amount for a covered multi-target stool screening DNA test. For tests furnished on or after January 1, 2031, payment is the lesser of that amount or the amount determined under the clinical laboratory payment rules in section 1834A. The bill also bars payment for a test furnished during a year if the beneficiary has reached a specified age for that year or had such a test in the previous 11 months.

Who Benefits and How

Medicare beneficiaries eligible for cancer screening benefit from a pathway to covered blood-based or comparable multi-cancer early detection tests. Cancer patients at risk of late diagnosis benefit if covered screening detects multiple cancer types earlier. Diagnostic test manufacturers benefit from a Medicare coverage category and defined payment pathway for qualifying FDA-reviewed tests. Clinical laboratories benefit from potential Medicare payment for qualifying tests. Oncologists and primary care clinicians benefit from a new covered screening tool once tests meet FDA and Medicare standards. Medicare Advantage plans benefit from clearer fee-for-service coverage rules they can mirror for enrollee benefits.

Who Bears the Burden and How

The HHS Secretary and CMS coverage staff must evaluate whether tests are reasonable, necessary, and appropriate, use national coverage determinations for new tests, apply age and frequency limits, and set payment amounts. FDA-regulated test developers must obtain clearance, classification, or approval before Medicare coverage. Medicare Administrative Contractors must process coverage and payment rules. Federal budget managers may face higher Medicare spending if covered screening use grows. Beneficiaries may face noncoverage if they exceed age or 11-month frequency limits. Clinical laboratories must meet billing, documentation, and applicable laboratory payment requirements.

Key Provisions

• Adds multi-cancer early detection screening tests to Medicare-covered services beginning January 1, 2028.
• Requires FDA clearance, classification, or approval and genomic blood or comparable biological-material test design.
• Requires the HHS Secretary to find each test reasonable and necessary for prevention or early detection and appropriate for Medicare beneficiaries.
• Requires use of the Medicare national coverage determination process for new tests.
• Sets pre-2031 payment at the multi-target stool screening DNA test payment amount.
• Sets post-2030 payment at the lesser of that amount or the clinical laboratory fee schedule amount.
• Bars payment when age or prior-11-month testing limits apply.