The Access to Pediatric Technologies Act of 2025 would amend the Medicare physician fee schedule provisions in title XVIII of the Social Security Act to make it easier for certain pediatric medical devices to receive national relative value units (RVUs). For qualifying pediatric technologies furnished on or after January 1, 2026, the Secretary of Health and Human Services would be required, upon a manufacturer’s request, to establish national RVUs if none already exist for that technology. The bill sets out a process for manufacturers to submit supporting information and directs the Secretary to use available data such as contractor pricing, claims data, time-and-motion studies, and invoice information when setting payment values.
The bill defines a “qualifying pediatric technology” as a covered medical device that has been approved, cleared, or authorized under specified FDA pathways, is described by a temporary Level I HCPCS code for emerging technologies, and is either used in procedures predominantly performed on pediatric patients or specifically designed for safe and effective use in children. Requests submitted by May 1 would be addressed in that year’s physician fee schedule rulemaking; later requests would be handled in the following year’s cycle. The bill also states that it does not require Medicare coverage of any device or change the existing medical necessity standard in section 1862(a)(1)(A).
Its main legal effect would be to add a new subsection to section 1848 of the Social Security Act governing Medicare payment methodology, creating a more explicit pathway for pediatric device manufacturers to seek payment valuation. The measure would affect the Centers for Medicare & Medicaid Services’ annual rulemaking process and could influence reimbursement for pediatric devices under Medicare, but it would not itself mandate coverage or alter coverage criteria.
Overall, the bill appears to have a supportive, bipartisan framing, as it was introduced by Representatives Joyce and Trahan and is presented as a patient-access measure. Because there are no recorded committee transcripts or votes in the provided context, there is no documented opposition or formal debate to gauge broader sentiment. The bill’s structure suggests the most likely area of contention would be whether the new manufacturer-request process could increase administrative burden or affect Medicare payment-setting discretion, but the text attempts to limit that concern by preserving existing coverage rules.
Impact
The bill would amend section 1848 of the Social Security Act to require CMS to establish national relative value units for qualifying pediatric technologies under the Medicare physician fee schedule when requested by a manufacturer, using specified data sources and annual rulemaking timelines. It would create a new payment-valuation pathway for certain pediatric medical devices, but it would not require Medicare coverage or change the medical necessity standard in section 1862(a)(1)(A).
Sentiment
The available context suggests generally favorable sentiment. The bill was introduced by members of both parties and is framed as improving access to pediatric technologies, with no recorded votes or committee testimony indicating opposition. Because there is no hearing or vote history provided, broader support or criticism cannot be measured from the record here.
Contention
No specific contention is documented in the provided materials. Potential concerns, if raised, would likely center on the Secretary’s obligation to establish RVUs upon manufacturer request, the reliance on manufacturer-submitted data, and whether the process could affect Medicare payment-setting discretion or create administrative complexity. The bill explicitly addresses one likely objection by stating that it does not require coverage or alter existing Medicare coverage standards.
Access to Pediatric Technologies Act of 2025This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish, upon request, specific payment methodologies for qualifying pediatric technologies under the Medicare physician fee schedule. Qualifying pediatric technologies are medical devices that are (1) covered under Medicare, (2) approved by the Food and Drug Administration, (3) currently billed using a specified temporary billing code for emerging technologies, and (4) predominantly used or specifically designated for pediatric patients.The CMS must develop a payment methodology for a qualifying pediatric technology upon request from the manufacturer and based on available data, including pricing information and claims data. Manufacturers must include relevant information in their requests to enable the CMS to develop the corresponding methodologies.
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Access to Pediatric Technologies Act of 2025This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish, upon request, specific payment methodologies for qualifying pediatric technologies under the Medicare physician fee schedule. Qualifying pediatric technologies are medical devices that are (1) covered under Medicare, (2) approved by the Food and Drug Administration, (3) currently billed using a specified temporary billing code for emerging technologies, and (4) predominantly used or specifically designated for pediatric patients.The CMS must develop a payment methodology for a qualifying pediatric technology upon request from the manufacturer and based on available data, including pricing information and claims data. Manufacturers must include relevant information in their requests to enable the CMS to develop the corresponding methodologies.