Health Affairs October 1, 2024
Last May, GRAIL—the company developing a blood-based screening test for more than 50 cancers—received approval for the Galleri-Medicare study from the Centers for Medicare and Medicaid Services (CMS). The CMS Category B approval provides for Medicare coverage of not only the subsequent testing required to evaluate “cancer signals,” but also the Galleri screening test itself (list price: $949 each). Because the study involves public funds and thousands of Medicare beneficiaries, CMS has an obligation to ensure a rigorous study design. CMS policy, in fact, requires that “the study design is methodologically appropriate and the anticipated number of enrolled subjects is adequate to confidently answer the research question.” Unfortunately, while there are plenty of subjects, the current design will produce a...
Today's Sponsors
Today's Sponsor