S. 249: Access to Pediatric Technologies Act of 2025

This bill, known as the Access to Pediatric Technologies Act of 2025, aims to improve access to certain pediatric medical technologies. Here are the key points of what the bill proposes:

1. Establishment of National Relative Value Units

The bill directs the Secretary of Health and Human Services to create national relative value units for qualifying pediatric technologies that are furnished starting January 1, 2026. This is specifically applied to technologies that have not yet been assigned national relative value units under the existing physician fee schedule.

2. Payment Methodology

When establishing these national relative value units, the Secretary must adhere to a payment methodology which includes:

• Using available data related to the pediatric technologies, such as contractor pricing information or claims data.
• Considering various analytical tools like time and motion studies and invoice information.

3. Manufacturer Requests

Manufacturers of qualifying pediatric technologies can submit written requests for the establishment of relative value units. The process will follow an annual rulemaking schedule. The timing for the Secretary to establish these units depends on when the request is received:

• If a request is submitted on or before May 1 of a given year, the units will be established within that year.
• If submitted after May 1, the units will be established in the following year.

4. Requirements for Requests

Manufacturers submitting requests must provide sufficient information to verify their technology qualifies as a pediatric technology, which includes relevant data that assists the Secretary in establishing relative value units.

5. Definition of Qualifying Pediatric Technology

The bill defines "qualifying pediatric technology" as a medical device that meets specific criteria:

• It must be covered under the Social Security Act.
• It has to be approved, cleared, or authorized by the FDA.
• It should be associated with a temporary Level I HCPCS Code meant for emerging technologies.
• It must be used for procedures predominantly performed on pediatric patients or specifically designed for pediatric populations.

6. Coverage Clarification

Finally, the bill clarifies that it does not require the coverage of a qualifying pediatric technology under the Social Security Act nor does it change existing coverage requirements.

Relevant Companies

• MDT - Medtronic, a manufacturer of medical devices, could be impacted as they produce various pediatric medical devices that may qualify under this new framework.
• ISRG - Intuitive Surgical develops robotic surgical systems that may include technologies for pediatric patients, potentially benefiting from this legislation.
• CMI - Caterpillar Inc. provides equipment for healthcare settings, but they may see indirect effects based on technology adoption across the industry.