Summary

Requires the Secretary of Health and Human Services to create national relative value units (RVUs) and payment rates under Medicare’s Physician Fee Schedule for qualifying pediatric medical devices when a manufacturer requests it. This applies to items furnished on or after January 1, 2026. It sets a clear, annual process and timetable (including a May 1 request cutoff), outlines the data manufacturers must submit, defines which pediatric devices qualify, and makes clear it does not require coverage or change existing coverage rules. The goal is more predictable, transparent Medicare payment for pediatric devices, which many other payers often reference.

Key Points

• Creates a process to assign national RVUs for qualifying pediatric medical devices upon manufacturer request.
• Payment based on the Medicare Physician Fee Schedule once RVUs are set.
• Effective for items furnished on or after January 1, 2026.
• Annual May 1 deadline for manufacturer submissions to be considered for the next rulemaking cycle.
• Manufacturers must submit specified information to support RVU and rate-setting.
• Only defines payment mechanics; it does not require or change Medicare coverage policies.
• Qualifying pediatric devices are defined in the new subsection.
• Provides a predictable, transparent path for pediatric device payment under Medicare.

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