Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
Beginning in 2028, Medicare will cover FDA-approved multi-cancer early detection blood tests that screen for several cancers at once. Beneficiaries will be eligible for one covered test per year under a phased-in age schedule, with standard Medicare cancer screenings like mammograms and colonoscopies remaining fully covered. Medicare will initially cap test reimbursement rates at the price of existing stool-based DNA tests, but payment and age restrictions will be removed if the tests receive high recommendations from national preventive health guidelines.
What this bill touches.
Who it helps · who it burdens.
Who it helps
- Medicare beneficiaries under applicable age thresholdsGain Medicare coverage starting January 1, 2028, for FDA-approved or cleared multi-cancer early detection screening tests (subject to age and frequency limits), while maintaining full coverage for other cancer screenings like breast, colorectal, and prostate tests.
- Laboratories and medical device manufacturers producing multi-cancer screening testsReceive established Medicare payments and reimbursement for furnishing FDA-approved or cleared multi-cancer early detection tests to eligible Medicare beneficiaries starting in 2028.
Who it burdens
- Department of Health and Human ServicesRequired to evaluate multi-cancer early detection screening tests using the national coverage determination process to determine if they are reasonable, necessary, and appropriate for Medicare beneficiaries.
Who backs it
- Medicare program (Department of Health and Human Services)Finances Medicare Part B payment amounts for covered multi-cancer early detection screening tests provided to eligible beneficiaries starting in 2028.
The provisions, in plain language.
Authorizes Medicare coverage starting January 1, 2028, for FDA-approved or cleared multi-cancer early detection blood or biological screening tests determined by the Department of Health and Human Services to be reasonable and appropriate for beneficiaries.
Sets Medicare payment amounts for multi-cancer screening tests equal to the rate for multi-target stool DNA tests through 2030, and starting in 2031 sets payments at the lesser of that rate or the clinical laboratory fee schedule amount.
Limits Medicare payment for multi-cancer screening tests to individuals below a specified age (under 68 in 2028, increasing by one year each subsequent year) and prohibits payment if a beneficiary received a test within the previous 11 months.
Exempts a multi-cancer screening test from the bill's specific payment, age, and frequency limits if the U.S. Preventive Services Task Force recommends the test with an A or B rating.
Specifies that receiving a multi-cancer screening test does not reduce or affect Medicare coverage for other individual cancer screenings, such as breast, cervical, colorectal, lung, or prostate cancer tests.