S. 249 — Access to Pediatric Technologies Act of 2025

This section directs the Secretary of Health and Human Services to establish national relative value units under the Medicare physician fee schedule for qualifying pediatric technologies (as defined below) furnished on or after January 1, 2026, upon manufacturer request, if no such units have previously been established. The Secretary must use the standard physician fee schedule payment methodology and available data (e.g., contractor pricing, claims data, time and motion studies, or invoices) and implement via annual rulemaking: if the request is received by May 1, in that year's rulemaking; if after May 1, in the following year. A qualifying pediatric technology is a Medicare-covered medical device that is FDA-approved, cleared, or authorized under specified pathways (i.e., 510(k), breakthrough device designation, or premarket approval); has a temporary Level I HCPCS code for emerging technologies; and is used predominantly in pediatric procedures or specifically designed for pediatric use. (Thus, the provision facilitates Medicare payment for such devices while not mandating coverage or altering medical necessity requirements.)