Senate bill would set Medicare pay rates for FDA-approved pediatric devices

What does this do?

S 249 would require Medicare to establish official payment rates for FDA-approved pediatric medical devices when a manufacturer formally requests one, beginning January 1, 2026. The process would follow Medicare's standard annual rulemaking schedule, with a May 1 deadline each year determining whether a device's rate is set that year or the next. To qualify, a device must be FDA-approved, covered by Medicare, currently carrying a temporary billing code for new technologies, and either used mostly in procedures on children or specifically designed for pediatric patients.

Who does it affect?

Children who qualify for Medicare and the doctors who treat them with specialized pediatric devices are most directly affected. Medical device manufacturers with FDA-approved pediatric products also gain a formal process to request Medicare reimbursement rates.

Why does it matter?

Without set payment codes, doctors using FDA-approved pediatric devices may not be reimbursed properly, which could affect how widely those devices are adopted. Clearer payment rates could influence whether physicians choose to use pediatric-specific devices, though the bill does not guarantee coverage of any particular device.

Where does it stand?