New cancer Screening test faces coverage hurdles for older Americans

An FDA advisory panel favorably reviewed Galleri on September 23, 2026, voting in favor of its effectiveness and safety. Grail anticipates a decision from the FDA in early Q1 2027.

Galleri analyzes DNA shed by tumors in the blood, identifying cancer-specific patterns and predicting the affected organ. It’s intended to supplement existing screening procedures, not replace them. Grail currently markets Galleri as a laboratory-developed test requiring a prescription, and it is not yet FDA-approved.

In February 2026, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act was enacted, establishing a framework for potential Medicare coverage beginning January 1, 2029. This requires both FDA approval and a CMS determination of reasonableness and necessity.

A significant barrier is the age phase-in provision. Medicare will initially cover the test for individuals under 65 as of January 1, 2029, with the eligible age increasing annually. This means individuals aged 70 or older today will likely remain ineligible for several years.

One potential exception exists: if the U.S. Preventive Services Task Force assigns the test a rating of A or B, the age restriction would be lifted. Otherwise, even eligible individuals would be limited to one test every 11 months.

Patients seeking the test now must pay out-of-pocket, though Grail often offers promotional pricing, potentially reducing the cost to $799 or less. Alternative coverage options include TRICARE for eligible military retirees, employer-sponsored plans, or participation in Grail’s REACH study, which includes Medicare beneficiaries.

A positive result can trigger further diagnostic testing, potentially incurring additional costs beyond the initial test price. The test has a reported false-positive rate of 0.4%. Diagnostic follow-up is subject to the Part B deductible of $283 in 2026, plus coinsurance.

While FDA approval is a step towards Medicare coverage, it doesn’t guarantee it. CMS approval is still required, and the benefit cannot begin before 2029. For those 70 or older, Galleri should be considered an out-of-pocket expense until the age restriction is lifted or a Task Force rating changes the landscape.