Access to Pediatric Technologies Act of 2025
The Access to Pediatric Technologies Act of 2025 would add a new process under Medicare’s physician fee schedule to establish national relative value units (RVUs) for certain pediatric medical devices (qualifying pediatric technologies) when manufacturers request them. Starting in 2026, manufacturers could petition the Secretary of Health and Human Services to set RVUs for these devices, which would determine physician payments for services involving the devices through Medicare’s payment framework. The rulemaking would rely on data provided by manufacturers (pricing, claims data, time-and-motion studies, etc.) and follow an annual cycle. Importantly, the bill does not mandate coverage for these devices nor does it change the basic coverage standards; it only creates a mechanism to price physician services related to pediatric technologies if and when RVUs are established.
Key Points
- 1Establishes a new subsection (u) to Section 1848 of the Social Security Act to create national RVUs for qualifying pediatric technologies when requested.
- 2Qualifying pediatric technology criteria: the device must be covered by Medicare, FDA-approved/cleared/authorized under specified FDA authorities, described by a temporary Level I HCPCS code for emerging tech, and used predominantly in pediatric procedures or designed for safe and effective pediatric use.
- 3Implementation and timeline: manufacturers can submit a written request; the Secretary will set RVUs through the annual physician fee schedule rulemaking. If the request is received on or before May 1 in a given year, RVUs are established in that year’s rulemaking; if after May 1, RVUs are established in the following year’s rulemaking.
- 4Data requirements: manufacturers must provide information to verify eligibility and to help set RVUs, including pricing data, claims data, time/motion studies, invoices, and other relevant information.
- 5Nature of the change: this creates a pathway to price physician services for pediatric technologies under Medicare’s payment system but does not require Medicare coverage of the technology or alter existing coverage requirements.