Medicare does not cover the Galleri test as a screening tool for the general population

The Galleri test is a blood test designed to detect multiple types of cancer early by looking for circulating tumor DNA. Medicare does not pay for it as a routine cancer screening for people without symptoms or a known cancer diagnosis. This is because the test has not yet met the criteria Medicare uses to decide whether to cover new screening tools.

Medicare's coverage decisions for cancer screening are based on evidence from large clinical trials showing the test reduces deaths from cancer in specific populations. The Galleri test is still relatively new, and the evidence supporting its use in screening healthy people is still being gathered. Until that evidence is strong enough, Medicare treats it as an investigational test rather than a covered benefit.

Key Takeaways

  • Medicare does not cover the Galleri test for screening people without cancer symptoms or a prior diagnosis.
  • The test may be covered in limited cases if you are enrolled in a Medicare-approved clinical trial studying its effectiveness.
  • If your doctor orders the Galleri test outside of a clinical trial, you will likely receive a bill for the full cost, which typically ranges from several hundred to over a thousand dollars depending on the provider.
  • Some private insurance plans have begun covering the Galleri test, but coverage varies widely by plan and employer.
  • You can ask your doctor whether any clinical trials in your area are enrolling participants for Galleri test studies.

When Medicare might cover the Galleri test

The main exception is if you are enrolled in a Medicare-approved clinical trial that is studying the Galleri test as a cancer screening tool. Clinical trials test new medical approaches to see whether they work and are safe. If Medicare has approved a trial, it will cover the costs of the test for participants in that trial, even though the test is not yet a standard covered benefit.

To find out whether a clinical trial near you is enrolling, you can search ClinicalTrials.gov, which is the national registry of clinical studies. You can also ask your primary care doctor whether they know of any trials recruiting in your area. Your doctor may be able to refer you directly to a trial site.

What happens if you get the Galleri test without Medicare coverage

If your doctor orders the Galleri test and you are not in a clinical trial, Medicare will not pay for it. You will receive a bill from the laboratory or provider that performed the test. The cost varies depending on which company runs the test and which provider ordered it, but it is typically several hundred dollars or more.

Before your doctor orders the test, ask whether it is covered by your Medicare plan. If it is not, ask your doctor to explain why they are recommending it and whether there are other screening options that Medicare does cover. This conversation can help you decide whether to pay out of pocket or explore alternatives.

How Medicare decides to cover new cancer screening tests

Medicare uses a formal process to review evidence about new screening tests before deciding whether to cover them. The process typically involves a review by the Centers for Medicare & Medicaid Services (CMS), which may request input from an independent panel of medical experts. CMS looks for evidence that the test reduces the number of deaths from cancer in a specific group of people, that the benefits outweigh the harms, and that the test is accurate and reliable.

For the Galleri test, this review is ongoing. The test's developer, GRAIL (a subsidiary of Illumina), has published early results from a large study called PATHFINDER, which showed the test can detect cancer in people without symptoms. However, CMS has not yet determined that the evidence is strong enough to cover the test for routine screening in Medicare beneficiaries. This does not mean the test will never be covered — it means the evidence is still being evaluated.

Other cancer screening tests Medicare does cover

Medicare covers several cancer screening tests that have strong evidence behind them. These include mammograms for breast cancer, colonoscopies and other tests for colorectal cancer, Pap tests for cervical cancer, and low-dose CT scans for lung cancer in people with a significant smoking history. Your doctor can help you understand which screening tests are right for you based on your age, health history, and risk factors.

If you are interested in early cancer detection but the Galleri test is not covered, talking with your doctor about these established screening options is a good starting point. They can explain which tests are recommended for you and how often you should have them.

What to do if your doctor recommends the Galleri test

If your doctor recommends the Galleri test, ask them directly whether Medicare will cover it. If the answer is no, ask why they believe the test is right for you despite the lack of coverage. Some doctors may recommend it because they believe it offers value even if you have to pay for it yourself; others may not realize it is not covered.

You can also contact Medicare directly to confirm coverage. Call 1-800-MEDICARE (1-800-633-4227) and ask whether the Galleri test is covered under your specific Medicare plan. If it is not covered and you decide to have the test anyway, ask the provider for an estimate of the cost before you proceed.

Frequently Asked Questions

Will Medicare cover the Galleri test in the future?

It is possible, but there is no set timeline. CMS will continue to review evidence as more research is published. If the evidence eventually shows the test reduces cancer deaths in Medicare beneficiaries, CMS may decide to cover it. You can check the CMS website periodically or ask your doctor to let you know if coverage status changes.

Does Medigap or Medicare Advantage cover the Galleri test?

Coverage varies by plan. Some Medicare Advantage plans and Medigap policies may cover the Galleri test, while others do not. Contact your specific plan to ask about coverage before your doctor orders the test. Your plan's member services number is on your insurance card.

Can I get the Galleri test through a clinical trial even if I do not have cancer symptoms?

Yes. Clinical trials studying the Galleri test are specifically designed to test it in people without cancer symptoms. If you enroll in a Medicare-approved trial, Medicare will cover the test. Search ClinicalTrials.gov or ask your doctor for information about trials in your area.

What is the difference between the Galleri test and other cancer blood tests?

The Galleri test looks for DNA from multiple types of cancer in a single blood sample. Other blood tests may look for specific cancer markers or proteins related to one type of cancer. The Galleri test is newer and designed to cast a wider net, but it is not yet proven to reduce cancer deaths in the general population the way colonoscopies or mammograms are.

If I pay for the Galleri test myself, will Medicare reimburse me later?

No. If Medicare does not cover the test at the time you have it, paying out of pocket does not make you may be able to access for reimbursement later. However, if you are later enrolled in a clinical trial, Medicare may cover future Galleri tests as part of that trial.