Medicare to Cover Multi-Cancer Blood Tests Starting 2028: Age Limits and FDA Approval Required

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 significant caveats. Starting January 1, 2028, Medicare will cover blood tests designed to detect multiple types of cancer early, before symptoms even show up. That's the good news. The catch? It's not for everyone, at least not right away.

Rolling the Dice on Early Detection

The core of this bill (SEC. 2) is adding coverage for "multi-cancer early detection screening tests." Think of these as blood tests that look for tiny bits of DNA shed by cancer cells. To qualify, these tests need FDA approval and the Secretary of Health and Human Services has to deem them "reasonable and necessary." They also specifically need to analyze "cell-free nucleic acids" – basically, free-floating genetic material in your blood. This is important because it sets a clear standard for the technology these tests must use.

Show Me the Money (and the Limits)

Here's where it gets real for your wallet and your healthcare. Until 2031, Medicare will pay for these tests at the same rate as a "multi-target stool screening DNA test" (SEC. 2). After that, it's whichever is lower – that rate, or a new one calculated under section 1834A of the bill. In plain English, they're tying the initial cost to an existing test, likely to control spending. But, there's a built-in age limit: coverage starts at age 68 in 2028, increasing by one year, every year. So, if you're 65 in 2028, you're waiting a few more years. Plus, you can only get one test every 12 months.

Now, there's a potential escape hatch. If the U.S. Preventive Services Task Force (the folks who make recommendations on preventative care) gives a multi-cancer test an "A" or "B" grade, those age and frequency limits disappear (SEC. 2). This means if a test is proven highly effective, more people can access it, regardless of age.

For example, imagine a 70-year-old retired teacher in 2029. Under this bill, she could get a covered blood test to screen for multiple cancers. But, if she was only 60, she'd be out of luck unless a specific test got that top-tier recommendation. This creates a bit of a waiting game for some.

Keeping What You've Got

Importantly, the bill states that this new coverage doesn't mess with existing Medicare coverage for other cancer screenings (SEC. 2). Mammograms, colonoscopies, Pap smears – those are all still covered as they were before. This new test is an addition, not a replacement.

The Bottom Line

This bill introduces a potentially powerful tool for early cancer detection, but it's rolling out slowly and with restrictions. The age limits and cost controls are clear attempts to manage the program's budget, but they also raise questions about equal access. The reliance on FDA approval and the Task Force recommendations adds a layer of scientific rigor, but it also means the availability of these tests will depend on those approvals. While early detection is generally a good thing, the gradual rollout and reliance on external approvals mean the real-world impact will take time to fully materialize. It's a step forward, but a cautious one, with potential benefits balanced by practical limitations.