Access to Pediatric Technologies Act of 2025
The Access to Pediatric Technologies Act of 2025 would amend Medicare’s payment rules to make it easier for new pediatric-focused medical technologies to be paid for under the physician fee schedule. Starting in 2026, if a manufacturer submits a request, the Secretary of Health and Human Services would establish national relative value units (RVUs) for qualifying pediatric technologies (QPTs) that lack existing RVUs. The new RVUs would be set using the standard payment methodology and available data (pricing, claims, time-and-motion studies, etc.) and would be determined through the annual physician fee schedule rulemaking. Importantly, the bill does not require coverage of these technologies; it only governs how they are reimbursed if covered, and it preserves existing coverage rules. Qualifying pediatric technologies are defined as devices covered by Medicare, cleared or approved by the FD&C Act, described by a temporary Level I HCPCS code for emerging tech, and used predominantly in pediatric procedures or designed specifically for pediatric use. The process requires manufacturer-supplied information to verify qualification and to aid RVU establishment, with a timeline that hinges on when the manufacturer submits the request (requests before May 1 are acted on in the same year’s rulemaking; later requests are acted on the following year). The bill also states that nothing in this provision should be read to require coverage or to alter existing coverage requirements.
Key Points
- 1Creates a new subsection (u) in Section 1848 of the Social Security Act to facilitate access to pediatric technologies through Medicare payment reform.
- 2Manufacturer-triggered RVU establishment: For each qualifying pediatric technology furnished after Jan 1, 2026, the Secretary shall establish national RVUs under the physician fee schedule upon a written request from the technology’s manufacturer.
- 3Data-driven payment methodology: RVUs for QPTs shall be developed using the standard payment framework and data such as contractor pricing, claims, time-and-motion studies, invoices, and other information used to set payment rates.
- 4Implementation timeline: If a manufacturer submits a request by May 1 in a given year, RVUs for that technology are established in that year’s rulemaking; if the request is after May 1, RVUs are established in the following year’s rulemaking.
- 5Qualifying pediatric technology definition and scope: A QPT must be a device covered by Medicare, approved/cleared/authorized under specific FD&C Act provisions, described by a temporary Level I HCPCS code for emerging technologies, and used predominantly in pediatric procedures or designed for safe and effective use in pediatric populations. The bill clarifies it does not require coverage or change existing coverage requirements.