WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices.
Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not. Right now, most people pay for it out of pocket. It runs about $950.
In general, Medicare covers FDA-approved medicines and medical devices that help diagnose or treat disease or injury. But there’s a catch for Grail: Medicare doesn’t cover tests that simply screen healthy people, as Galleri does.