This bill expands Medicare coverage to include FDA-approved multi-cancer early detection screening tests, starting January 1, 2028, with specific age and frequency limitations, while preserving existing Medicare-covered cancer screenings.
Michael "Mike" Crapo
Senator
ID
The "Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act" expands Medicare coverage to include innovative multi-cancer early detection screening tests starting in 2028. These tests, which use genomic sequencing to detect multiple cancer types, will be covered for eligible beneficiaries with age and frequency limitations. The payment amount for these tests will initially align with that of multi-target stool screening DNA tests. This new coverage aims to improve early cancer detection without affecting existing Medicare-covered cancer screenings.
Medicare to Cover Multi-Cancer Blood Tests by 2028, But Age Limits Apply
The "Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act" is set to shake up cancer screening for Medicare beneficiaries—but with some catches that could affect who gets access and when.
What's Changing in Cancer Screening
Starting January 1, 2028, Medicare will cover new multi-cancer early detection (MCED) screening tests. These tests, typically using genomic sequencing of blood samples, are designed to spot multiple types of cancer from a single draw. Think of it like a broad-spectrum radar for cancer, potentially catching multiple types early on. To be covered, these tests need FDA approval and must be deemed "reasonable and necessary" by the Secretary of Health and Human Services (SEC. 2).
Real-World Rollout
Initially, the payment for these MCED tests will match that of a multi-target stool screening DNA test. Post-2031, it'll be the lesser of that initial amount or what's determined under Section 1834A. For example, if you're a lab tech running these tests, your reimbursement rate is locked in initially, but might change after a few years. For a small clinic, this could mean budgeting for potential shifts in revenue from these screenings.
But here's where it gets tricky: coverage is phased in by age. In 2028, it starts with those 68 and older, increasing by one year annually. So, if you're 65 in 2028, you're waiting a few more years unless the rules change. Plus, you can't get tested more than once every 11 months (SEC. 2). This could be a real headache for someone with a strong family history of cancer who wants more frequent checks.
The Task Force Twist
There's an important exception: if the United States Preventive Services Task Force (USPSTF) gives a test an "A" or "B" recommendation, those age and frequency limits don't apply (SEC. 2). This means that if a test is highly recommended, more people can access it, more often. It puts a lot of weight on the USPSTF's decisions—they become the gatekeepers for broader access.
Keeping It All Straight
Importantly, this new coverage doesn't mess with existing Medicare coverage for other cancer screenings (like mammograms or colonoscopies). If you're a retiree who gets regular screenings, those stay the same. This bill adds a new tool, it doesn't replace the old ones (SEC. 2). The bill also makes sure getting those other cancer screenings won't affect your ability to get an MCED or using the MCED as a diagnostic tool.
Potential Challenges
While early detection is generally a good thing, there are potential snags. The age limits could be a real barrier for younger people at high risk. Plus, there's always the risk of overutilization—more tests aren't always better, and they can lead to unnecessary follow-ups and anxiety. Companies might also push hard to get that "A" or "B" rating from the USPSTF to bypass the limitations, which could put pressure on the task force's independence.
Overall, this bill aims to bring cutting-edge cancer detection to Medicare, but the rollout and restrictions mean it's not a free-for-all. It's a step forward, but one that needs careful watching to see how it plays out in practice.