Access to Pediatric Technologies Act of 2025
Sponsored By: Senator Marsha Blackburn
Introduced
Summary
Payment rules for pediatric medical devices. This bill would require the Centers for Medicare & Medicaid Services to create specific payment rates under the Medicare physician fee schedule for FDA‑approved medical devices that are designed for or mainly used on children when a manufacturer requests one.
Show full summary
- Manufacturers: Device makers could request national relative value units for a qualifying pediatric technology to get a clear Medicare payment rate. If a request arrives by May 1 it would be included in that year's physician fee schedule rulemaking, otherwise it would be considered the next year.
- Patients and clinicians: Pediatric patients and the doctors who treat them could see more predictable Medicare payment for child‑specific devices, which may help hospitals and clinics adopt those technologies.
- CMS and payment methodology: CMS would develop payment methods using available data such as contractor pricing, claims, time‑and‑motion studies, and invoice information to set rates.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Medicare payments for pediatric devices
This bill would let HHS set national Medicare payment values (called RVUs) for certain pediatric medical devices starting January 1, 2026, when a manufacturer asks in writing. If a manufacturer asks by May 1, the RVUs would be set in that year’s physician fee schedule rule; later requests would be set the next year. The manufacturer must show the device meets the bill’s definition and supply available data like contractor pricing, claims, time-and-motion studies, or invoices to help set rates. The bill defines which devices qualify by Medicare coverage, FDA authorization, a temporary Level I HCPCS code, and pediatric use or design. The bill would also say that setting RVUs does not require Medicare to cover the device or change the existing “reasonable and necessary” coverage rule.
Sponsors & CoSponsors
Sponsor
Marsha Blackburn
TN • R
Cosponsors
James Lankford
OK • R
Sponsored 1/24/2025
Roll Call Votes
No roll call votes available for this bill.
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