Medicare lets device makers set their own reimbursement rates for pediatric tech
H.R. 1931 — Access to Pediatric Technologies Act of 2025 · Filed by John Joyce (R-PA) · 16 cosponsors · Introduced Mar 6, 2025 · Referred to committee
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What it does
This bill directs Medicare to establish payment rates (called 'relative value units') for pediatric medical devices and technologies that lack them, upon manufacturer request. Manufacturers can submit requests by May 1 each year to have their pediatric device added to Medicare's payment schedule for implementation the same year; requests after May 1 are processed the following year. The bill does not require Medicare to cover any device—only to set a payment rate if the device is already covered, FDA-approved, and used primarily on children.
Why we flagged it
The bill's core function is to create an expedited, manufacturer-initiated process for establishing Medicare payment rates for pediatric medical devices. While framed as access facilitation, the operative mechanism is a reimbursement-rate-setting procedure that gives manufacturers significant control over timing and data submission.
What the text implies
- Manufacturers can strategically time requests (by May 1) to accelerate payment-rate establishment, creating a competitive advantage for well-resourced companies with sophisticated regulatory affairs teams.
- The bill permits manufacturers to submit their own pricing data, claims data, and 'other information' to support payment-rate requests, with no requirement for independent verification or competing data sources—creating asymmetric information advantage.
The full analysis lists 5 implications of this text.
Who stands to gain
pediatric medical device manufacturers; medical device companies with FDA-approved pediatric technologies