SB249 amends the Social Security Act to create a pathway for valuing qualifying pediatric technologies through national relative value units (RVUs) under the Medicare physician fee schedule. The secretary would establish RVUs for these technologies if and when a manufacturer submits a timely request and the technology meets defined criteria.
Starting January 1, 2026, the secretary would set RVUs through annual rulemaking, using data such as pricing information, claims data, and time-and-motion studies where available. The law explicitly says this process does not by itself create coverage or alter existing coverage requirements under Medicare, preserving the current framework for what is and isn’t covered.
At a Glance
What It Does
For each qualifying pediatric technology furnished on or after Jan 1, 2026, the Secretary shall establish national RVUs under the physician fee schedule upon a manufacturer’s written request, if no RVUs have been established previously.
Who It Affects
Manufacturers of qualifying pediatric technologies; physicians and other providers billing under the MPFS; Medicare programs and contractors.
Why It Matters
Creates a formal valuation pathway for pediatric devices, potentially accelerating access for pediatric patients and bringing pricing transparency to commercialized technologies.
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What This Bill Actually Does
The bill adds a new mechanism to the Medicare payment framework for pediatric medical devices. It introduces a defined category—“qualifying pediatric technologies”—and grants the Secretary authority to establish national RVUs for these devices once triggered by a manufacturer’s request.
The process is designed to occur through the annual rulemaking cycle that governs the physician fee schedule. The bill specifies data sources the Secretary may use to set RVUs, including pricing, claims, and time-and-motion studies, to inform valuation.
Crucially, the act limits its effect to valuation and does not mandate coverage for the technologies or alter the existing coverage standards in section 1862. Even with new RVU values, coverage decisions remain governed by current Medicare rules.
The framework also includes a clear timing rule: requests received by the Secretary by May 1 of a given year are addressed in that year’s rulemaking, while requests received after May 1 are addressed in the following year’s process. The qualifying-pediatric-technology definition includes devices covered by Medicare, FDA-approval or clearance, a temporary HCPCS code, and pediatric-specific design or primary use in pediatric procedures.
The Five Things You Need to Know
The bill creates a new subsection (u) to Section 1848 of the Social Security Act for pediatric tech valuation.
Qualifying pediatric technologies must be covered, FDA-regulated, and pediatric-focused (or designed for safe pediatric use).
Manufacturers can trigger RVU establishment by submitting a written request with supporting information.
RVUs are set through annual Medicare rulemaking, using data such as pricing, claims, and time-and-motion studies.
The bill does not require Medicare coverage or alter existing coverage rules.
Section-by-Section Breakdown
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National RVUs for qualifying pediatric technologies
Section 2 adds a new subsection (u) to 1848 establishing a framework for creating national RVUs for qualifying pediatric technologies furnished on or after January 1, 2026. The secretary’s role is to determine whether an RVU should be created and, if so, how it should be calculated within the MPFS structure.
Payment methodology
The secretary must determine RVUs for qualifying pediatric technologies using the physician fee schedule methodology and may rely on contractor pricing data, claims data, time-and-motion analyses, invoice data, and other relevant information used in setting payment rates.
Implementation via manufacturer requests
A manufacturer may submit a written request detailing verification that the technology qualifies. The secretary will then establish RVUs through the annual rulemaking process in accordance with a defined timeline.
Qualifying pediatric technology defined
Qualifying pediatric technology is defined as a medical device covered under Medicare, FDA-approved/cleared/authorized, described by a temporary Level I HCPCS code, and primarily used for pediatric procedures or designed for safe pediatric use.
Rule of construction
This subsection does not require Medicare coverage of a qualifying pediatric technology or alter the standard coverage requirements in section 1862(a)(1)(A).
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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 benefit from an explicit valuation pathway that can lead to supported reimbursement for pediatric technologies via RVUs.
- Physicians and clinics that bill under the MPFS for pediatric procedures using qualifying technologies gain clearer payment signals and potential access to valuation for these devices.
- Pediatric hospitals and children’s health systems may see more predictable reimbursement for technologies central to pediatric care.
Who Bears the Cost
- Medicare program and taxpayers could incur higher short-term costs if RVUs increase reimbursement levels for popular pediatric technologies.
- CMS and contractors will bear administrative costs to collect data, process manufacturer requests, and run annual rulemaking cycles.
- Providers may incur transitional costs during the shift to RVU-based valuation for new pediatric technologies.
Key Issues
The Core Tension
The central dilemma is balancing an incentive to value and pay for innovative pediatric technologies against the risk of creating budgetary pressure or distorting incentives if RVUs are set without robust, pediatric-specific evidence.
The bill creates a new valuation pathway, but it does not guarantee coverage or imply that every qualifying pediatric technology will receive RVU support. The quality and completeness of manufacturer-submitted data may influence the secretary’s determinations, and the reliance on data such as time-and-motion studies and pricing can introduce uncertainty if data are limited or inconsistent.
In addition, adopting RVUs through annual rulemaking can lead to transitional variability as technologies mature and evidence evolves. Policymakers and implementers will need to monitor whether this valuation approach meaningfully improves access for pediatric patients without destabilizing Medicare spending or complicating provider workloads.
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