The Access to Pediatric Technologies Act of 2025 adds a new subsection to section 1848 of the Social Security Act that directs the Secretary of HHS to establish national relative value units (RVUs) under the Medicare physician fee schedule for qualifying pediatric medical devices when a manufacturer submits a written request. The provision applies to qualifying devices furnished on or after January 1, 2026, and requires CMS to use available pricing, claims, and operational data to set RVUs via the annual physician fee-schedule rulemaking.
This is a targeted statutory fix to a familiar practical problem: pediatric-specific devices can lack clear billing codes and payment valuations, which delays adoption and creates uncertainty for suppliers and clinicians. The bill creates an expedited, manufacturer-triggered pathway for valuation under the physician fee schedule while preserving Medicare's existing coverage standards—so an RVU does not automatically create coverage or payment outside the fee schedule framework.
At a Glance
What It Does
The bill amends §1848 to require CMS to establish national RVUs for a 'qualifying pediatric technology' if a manufacturer requests it and no RVUs exist. CMS must follow its standard payment methodology and may rely on contractor pricing, claims, time-and-motion studies, invoice data, or similar information.
Who It Affects
Manufacturers of pediatric-focused devices that are covered by Medicare and cleared/approved under FDA pathways identified in the bill, clinicians billing Medicare under the physician fee schedule, and CMS/Medicare administrative contractors responsible for fee-schedule rulemaking and valuation.
Why It Matters
It creates an administrative pathway to produce physician-fee valuations for child-specific technologies that can eliminate a major billing obstacle and change payment signals that influence adoption and product investment—without altering Medicare coverage law.
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What This Bill Actually Does
The bill inserts a new subsection (u) into the physician fee-schedule statute creating a manufacturer-initiated process for generating national RVUs for pediatric medical devices. If a device meets the statute's definition of a "qualifying pediatric technology" and no national RVUs exist for it, the manufacturer can request that CMS set RVUs under the physician fee schedule for devices furnished beginning January 1, 2026.
CMS must carry out requests through the physician fee-schedule rulemaking cycle. The statute sets a practical timing rule: written requests received by May 1 of a given year go into that year’s rulemaking; requests after May 1 go into the next year’s rulemaking.
That timeline creates an administrative rhythm for manufacturers to target but does not guarantee a particular outcome—the Secretary retains authority to apply the standard valuation methodology.To support valuation, the bill directs CMS to use “available data” including contractor pricing information, claims records, time-and-motion studies, invoice data, and other information CMS ordinarily uses when setting payment rates. The manufacturer’s written request must include available evidence to show the device fits the qualifying definition and to permit valuation.
The definition ties eligibility to four elements: Medicare coverage under Title XVIII, FDA clearance/approval under specified pathways (510(k), 513(f)(2), or PMA/515), assignment of a temporary Level I HCPCS code intended for emerging technologies, and either predominant use in pediatric patients or design specifically for pediatric populations.Importantly, the bill does not change Medicare coverage law. Section 1848(u)’s last paragraph explicitly says nothing in it requires Medicare to cover a qualifying technology or changes the statutory coverage test in 1862(a)(1)(A).
Practically, that means an RVU under the physician fee schedule is a pricing/valuation instrument for services billed to Medicare, not a substitute for a separate coverage or medical-necessity determination.Operationally, this measure mainly affects the physician fee schedule. Devices billed to Medicare through other payment systems (for example, the Hospital Outpatient Prospective Payment System or durable medical equipment channels) may be unaffected unless and until corresponding coding and payment changes are pursued in those systems.
Manufacturers will need to assemble credible data packages to persuade CMS to act through rulemaking; CMS will need to reconcile potentially limited manufacturer data with its valuation methodologies and broader Medicare payment policies.
The Five Things You Need to Know
The statute applies to qualifying pediatric technologies furnished on or after January 1, 2026 and triggers CMS action only after a manufacturer submits a written request.
CMS must establish national relative value units under the physician fee schedule only when no national RVUs already exist for the device.
Requests received by May 1 are processed in that year’s physician fee-schedule rulemaking; requests after May 1 are processed in the following year’s rulemaking.
A device qualifies only if it is covered under Medicare, has FDA clearance/authorization under 510(k), 513(f)(2), or 515, and is associated with a temporary Level I HCPCS code and pediatric use or pediatric-specific design.
The bill expressly does not require Medicare coverage of a qualifying technology and does not alter the medical-necessity coverage standard in 1862(a)(1)(A).
Section-by-Section Breakdown
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Creates a manufacturer-triggered RVU pathway for pediatric devices
This provision is the statutory vehicle: it tells the Secretary to set national RVUs under the physician fee schedule for qualifying pediatric technologies when a manufacturer asks and no RVUs exist. The practical effect is to convert an item that lacks a physician-fee valuation into one that has an RVU, subject to standard valuation rules and CMS discretion.
When CMS must act
Paragraph (1) establishes the triggering condition: an RVU must be set only after a manufacturer request and only to the extent no national RVUs already exist. That limits the statute’s reach to uncoded or unvalued items and prevents it from displacing existing valuations.
Valuation methodology and data sources
Paragraph (2) requires CMS to use its existing payment methodology and allows CMS to rely on available data—including contractor pricing, claims, time-and-motion studies, or invoice information—when assigning RVUs. This directs CMS to adapt its normal analytic toolkit to potentially sparse pediatric-device datasets, but it leaves the agency discretion to weigh and validate the information.
Request content and rulemaking timeline
Paragraph (3) sets a process: manufacturers must submit a written request that includes supporting data; requests submitted by May 1 go into that year’s physician fee-schedule rulemaking, later requests roll into the following year. The rulemaking requirement subjects valuations to notice-and-comment but also imposes a practical deadline that manufacturers must meet to accelerate consideration.
Definition of qualifying pediatric technology and coverage limit
Paragraph (4) defines eligible technologies by combining Medicare coverage, specific FDA pathways, assignment of a temporary Level I HCPCS code, and pediatric use/design. Paragraph (5) clarifies that establishing an RVU doesn’t create or require Medicare coverage. Together these clauses limit the pathway to devices that have regulatory clearance and some coding footprint while preserving separate coverage rules.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Pediatric device manufacturers — Gain a clear administrative pathway to obtain a national RVU under the physician fee schedule, which reduces billing uncertainty and can improve reimbursement visibility for child-specific products.
- Pediatric clinicians and specialty practices — Receive a standardized valuation that can simplify billing for procedures involving pediatric devices and reduce disputes over payment amounts for physician services tied to those devices.
- Investors and developers focused on pediatric technologies — Get a stronger market signal that Medicare will support physician-fee valuation for pediatric devices, which can lower commercialization risk and encourage R&D investment.
- Medicare beneficiaries (pediatric patients) — Indirect benefit from reduced adoption friction for pediatric-specific devices that might otherwise be hard to bill, potentially improving access to age-appropriate technologies.
Who Bears the Cost
- Manufacturers — Must assemble, submit, and potentially defend data packages (pricing, claims, time-and-motion studies, invoices) to CMS, creating upfront analytic and administrative costs.
- CMS and Medicare administrative contractors — Bear additional workload for reviewing manufacturer submissions, conducting valuation analyses, and completing rulemaking steps within the physician fee-schedule cycle.
- Medicare Trust Funds — May face higher spending if new RVUs increase physician fee payments or incentivize greater utilization, depending on how valuations are set and how frequently devices are used.
- Clinics and billing offices — Must update billing practices and systems to use new HCPCS/RVU combinations and may incur training and systems-integration costs during transition.
Key Issues
The Core Tension
The central dilemma is speed versus rigor: the bill speeds the creation of payment valuations to improve access and reduce billing uncertainty for pediatric technologies, but doing so on a manufacturer-triggered, data-limited basis risks producing premature or inflated payment rates and shifting Medicare spending without the full evidence and cross-program alignment that rigorous coverage and payment decisions normally require.
The bill accelerates valuation work but relies heavily on manufacturer-supplied or otherwise limited datasets. When devices are novel or used in small pediatric populations, available claims and pricing data may be thin, forcing CMS to make valuation choices with higher uncertainty.
That raises the risk of over- or under-valuing services based on sparse evidence and could create misaligned incentives for utilization.
Another implementation challenge is cross-program consistency. The statute targets the physician fee schedule; many pediatric devices are furnished in hospital outpatient settings, through durable medical equipment channels, or billed as device-only items under different payment systems.
Without coordination, establishing an RVU for the physician fee schedule may not resolve reimbursement or access problems in those other payment streams. Finally, the May 1 rulemaking deadline creates a hard administrative cadence but also a window where manufacturers that miss the cutoff must wait another year—producing an access cliff for technologies deployed shortly after the date.
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