Access to Pediatric Technologies Act of 2025
- Bill Number
- S. 249
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-01-24: Read twice and referred to the Committee on Finance.
- Last Updated
- 2026-06-11T04:26:25Z
AI-Generated Summary
Purpose
The Access to Pediatric Technologies Act of 2025 aims to improve access to innovative medical devices designed for children by ensuring they receive appropriate payment codes under Medicare's physician fee schedule. This helps doctors get reimbursed for using these devices, making them more available to pediatric patients covered by Medicare.
Key Provisions
- Establishment of Payment Codes: Starting January 1, 2026, the Secretary of Health and Human Services (through the Centers for Medicare & Medicaid Services, or CMS) must create national relative value units (RVUs)—which are standardized values used to calculate Medicare payments for physician services—for qualifying pediatric technologies if none exist already. This happens upon a written request from the device's manufacturer.
- Payment Methodology: RVUs will be set using Medicare's standard processes and available data, such as pricing from contractors, insurance claims, time studies for procedures, invoices, or other relevant information.
- Request Process and Timeline:
- Manufacturers submit requests with verification that the device qualifies, including supporting data.
- If received by May 1 of a year, RVUs are established in that year's rulemaking cycle for the physician fee schedule.
- If received after May 1, it applies to the next year's cycle.
- Definition of Qualifying Pediatric Technology: A medical device that:
- Is covered under Medicare Part B (which pays for doctor services and certain devices).
- Has been approved, cleared, or authorized by the Food and Drug Administration (FDA) through specific pathways (e.g., 510(k) clearance for devices similar to existing ones, or full premarket approval).
- Is assigned a temporary Level I HCPCS code (a temporary billing code from the Healthcare Common Procedure Coding System for new or emerging technologies).
- Is either used mainly in procedures on children (under 18) or specifically designed for safe and effective use in children.
- Limitations: The law does not mandate Medicare coverage for these devices or change rules requiring that treatments be medically necessary.
Significant Changes to Existing Law
This bill amends Section 1848 of the Social Security Act (which governs Medicare payments to physicians) by adding a new subsection (u). It introduces a targeted, manufacturer-driven process to expedite RVU assignment for pediatric devices, which previously might lack codes and delay reimbursement. Unlike general procedures, this prioritizes emerging pediatric technologies through annual rulemaking, filling a gap where such devices could face payment barriers without dedicated pathways.
Potential Impacts
- Government Agencies: CMS will need to review manufacturer requests and integrate them into annual fee schedule updates, potentially increasing administrative workload but streamlining payments for pediatric care without new funding requirements.
- Citizens: Pediatric Medicare beneficiaries (e.g., children with disabilities or chronic conditions eligible for Medicare) and their families may gain better access to cutting-edge devices, as physicians are more likely to use and bill for them. This could improve treatment options and health outcomes for vulnerable children.
- International Relations: No direct impacts, as the bill focuses on domestic Medicare policy and FDA-regulated devices.
Main Stakeholders Affected
- Manufacturers of Pediatric Medical Devices: Benefit from a faster path to Medicare reimbursement codes, encouraging investment in child-specific innovations.
- Pediatric Patients and Families: Primarily children on Medicare, who may see expanded access to safe, effective technologies.
- Healthcare Providers: Pediatricians and specialists can more readily incorporate new devices into care without reimbursement delays.
- CMS and Medicare Program: Handles implementation, balancing efficiency with data verification.
Notable Legal, Constitutional, or Political Implications
- Legal: Reinforces Medicare's existing framework for device coverage and payment without overriding FDA approvals or medical necessity standards (e.g., under Section 1862(a)(1)(A) of the Social Security Act). The "rule of construction" clause prevents unintended expansions of coverage, reducing litigation risks.
- Constitutional: No apparent issues, as it involves congressional authority over federal spending programs like Medicare.
- Political: Supports bipartisan goals of enhancing pediatric healthcare access and innovation, potentially setting a precedent for similar expedited processes in other underserved areas, though it may raise concerns about administrative burdens on CMS or favoritism toward manufacturers.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Recent Actions
- 2025-01-24: Read twice and referred to the Committee on Finance.
- 2025-01-24: Introduced in Senate
Bill Versions
- Access to Pediatric Technologies Act of 2025 — issued 2025-01-24 — PDF (5 pages)