The Access to Pediatric Technologies Act of 2025 directs the Secretary of Health and Human Services to establish Medicare physician fee schedule payment rates for qualifying pediatric medical devices upon manufacturer request.
Marsha Blackburn
Senator
TN
The Access to Pediatric Technologies Act of 2025 aims to improve patient care by streamlining the Medicare payment process for qualifying pediatric medical devices. The bill requires the Secretary of Health and Human Services to establish national physician fee schedule payment rates for these devices upon a manufacturer's request. This initiative seeks to ensure that innovative, pediatric-specific technologies are more accessible to the patients who need them.
New Pediatric Tech Act Streamlines Medicare Payments for Children's Medical Devices Starting 2026
Medical innovation often moves fast, but the bureaucracy that pays for it moves slow—especially when it comes to kids. The Access to Pediatric Technologies Act of 2025 aims to fix a specific bottleneck in the system. Starting January 1, 2026, the bill allows medical device manufacturers to bypass the usual waiting game by requesting that the Department of Health and Human Services (HHS) set national payment rates for new pediatric tools. To qualify, a device must be FDA-cleared, covered by Medicare, and specifically designed for or primarily used by children. If a company submits its data by May 1, the government has to set a price for that device in the same year’s rulemaking cycle, ensuring that new tech doesn't sit on a shelf simply because there isn't a payment code for it yet.
Breaking the Pricing Bottleneck
Currently, new medical devices often enter a 'limbo' period where they are approved for use but don't have a standardized price in the Medicare Physician Fee Schedule. For a pediatric surgeon wanting to use a specialized, high-tech heart valve designed specifically for a child's smaller anatomy, this lack of a clear payment rate can lead to billing nightmares or hospitals being hesitant to adopt the tool. Under Section 2 of this bill, manufacturers can hand over their internal data—including invoices, time and motion studies, and contractor pricing—to force a decision on what the reimbursement rate should be. By setting 'relative value units' (the math Medicare uses to determine pay), the bill creates a predictable financial path for hospitals and clinics to stock and use these specialized tools.
Guardrails and Reality Checks
While this bill speeds up the math, it doesn't automatically open the floodgates for every new gadget. The legislation includes a 'rule of construction' in Section 2 that explicitly states it does not force Medicare to cover a device. Every piece of tech must still meet the 'reasonable and necessary' standard for treating an illness or injury. For parents and healthcare providers, this means the bill is less about changing what is covered and more about ensuring that once a pediatric device is deemed necessary, the payment system doesn't stand in the way of a child actually getting it. It’s a move toward making the business side of pediatric care move at the same speed as the medical side.