- Potential benefitCreates clearer Medicare payment values for pediatric devices, aiding provider billing and adoption.
- ManufacturersProvides manufacturers predictable payment pathways, potentially encouraging pediatric device development.
- Potential benefitEstablishes a defined timeline for valuation, which may speed patient access to new pediatric technologies.
Access to Pediatric Technologies Act of 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for c…
The bill amends Medicare physician fee schedule law to require the HHS Secretary to establish national relative value units (RVUs) for certain "qualifying pediatric technologies" when a manufacturer requests it. Qualifying technologies must be Medicare-covered devices with FDA 510(k)/513(f)(2)/515 authorization, assigned a temporary Level I HCPCS code for emerging technologies, and predominantly used or designed for pediatric patients.
Liberal emphasizes affordability and broader pediatric coverage gaps
Relative to its intended legislative type, this bill establishes a targeted substantive change with clear procedural mechanisms but leaves gaps in fiscal acknowledgement, remediation, and oversight.
The bill amends Medicare physician fee schedule law to require the HHS Secretary to establish national relative value units (RVUs) for certain "qualifying pediatric technologies" when a manufacturer requests it.
Qualifying technologies must be Medicare-covered devices with FDA 510(k)/513(f)(2)/515 authorization, assigned a temporary Level I HCPCS code for emerging technologies, and predominantly used or designed for pediatric patients.
The Secretary must use available data (claims, contractor pricing, time-and-motion studies, invoices) and follow a rulemaking timeline tied to May 1 manufacturer requests.
Narrow, technical Medicare tweak with modest fiscal impact increases plausibility, but final passage depends on legislative priorities and scoring.
Relative to its intended legislative type, this bill establishes a targeted substantive change with clear procedural mechanisms but leaves gaps in fiscal acknowledgement, remediation, and oversight.
Liberal emphasizes affordability and broader pediatric coverage gaps
Who stands to gain, and who may push back.
These are examples from the analysis, not a ranked list of the most-affected groups.
- Potential burdenCould increase Medicare spending if use of newly valued pediatric technologies grows.
- ManufacturersImposes additional administrative and rulemaking burdens on CMS to review manufacturer requests.
- ManufacturersMay enable manufacturers to seek RVUs for devices with limited clinical benefit or insufficient evidence.
Why the argument around this bill splits.
Liberal emphasizes affordability and broader pediatric coverage gaps
Likely generally supportive because the bill aims to reduce payment barriers for pediatric-specific medical devices and improve access for children.
However, there will be concerns about ensuring affordability, limiting manufacturer-driven price-setting, and the bill's limited reach for most children covered by Medicaid/CHIP.
They will want stronger consumer protections and transparency in pricing and implementation.
Likely supportive as a targeted, procedural fix that clarifies payment rules and reduces administrative uncertainty for pediatric technologies.
Will highlight the bill's narrow scope and praise using existing rulemaking processes.
Concerns will focus on budget impact, adequacy of data, and ensuring the rulemaking is timely and evidence-based.
Mixed but cautiously favorable: the bill reduces regulatory uncertainty for device manufacturers and can promote innovation in pediatric devices.
However, objections will focus on creating a new federal obligation to set payments on manufacturer request and potential expansion of Medicare spending.
They will seek strict limits on administrative burden and fiscal impact.
The path through Congress.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Narrow, technical Medicare tweak with modest fiscal impact increases plausibility, but final passage depends on legislative priorities and scoring.
- No official cost estimate or fiscal score included
- CMS capacity to implement coding and RVU rulemaking timelines
Recent votes on the bill.
No vote history yet
The bill has not accumulated any surfaced votes yet.
Go deeper than the headline read.
Liberal emphasizes affordability and broader pediatric coverage gaps
Narrow, technical Medicare tweak with modest fiscal impact increases plausibility, but final passage depends on legislative priorities and…
Relative to its intended legislative type, this bill establishes a targeted substantive change with clear procedural mechanisms but leaves gaps in fiscal acknowledgement, remediation, and oversight.
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.