This bill directs the Centers for Medicare and Medicaid Services to establish payment rates for certain new pediatric medical devices under Medicare's physician fee schedule. Specifically, it applies to FDA-approved devices designed for or primarily used in children that don't yet have established payment codes. When a device manufacturer requests payment rate establishment, the bill requires CMS to process the request through its annual rulemaking process, with requests submitted by May 1st being addressed that same year and later requests handled the following year. The law takes effect January 1, 2026, and manufacturers must provide CMS with relevant data such as pricing information, claims data, and time studies to support the payment rate determination. The bill does not mandate that Medicare must actually cover these technologies, nor does it create new funding mechanisms, but rather streamlines the administrative process for getting pediatric medical devices into the Medicare payment system.
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