H.R. 1931: Access to Pediatric Technologies Act of 2025

The Access to Pediatric Technologies Act of 2025 aims to improve the availability and reimbursement for medical devices specifically designed for children. The bill proposes amendments to the Social Security Act to facilitate the use of qualifying pediatric technologies by establishing a clearer payment structure for these devices under Medicare.

Key Provisions

• Establishment of Payment Rates: The bill mandates that the Secretary of Health and Human Services create national relative value units for qualifying pediatric technologies that do not already have established payment rates. This aims to ensure that pediatric technologies are properly valued and reimbursed.
• Manufacturer Requests: Manufacturers of these pediatric devices can request the establishment of national relative value units for their technologies. The Secretary must then consider these requests during the annual rulemaking process for the physician fee schedule.
• Timeline for Requests: If a manufacturer submits a request by May 1 of a given year, the payment rates will be established in that year. If submitted after this date, the rates will be set the following year.
• Definition of Qualifying Pediatric Technologies: Qualifying pediatric technologies are defined as medical devices that meet several criteria, including being covered under Medicare and having specific regulatory approvals, as well as being intended for use primarily in pediatric patients.
• Information Requirements: Manufacturers must provide data to support their requests, which may include pricing information and usage studies, to help the Secretary establish appropriate payment rates.
• Coverage Limitations: The bill clarifies that it does not require coverage for any qualifying pediatric technology under Medicare, nor does it alter existing coverage requirements.

The Act is designed to enhance the access to and use of important medical technologies for children, thereby aiming to improve pediatric healthcare outcomes by ensuring that medical devices specifically for young patients are adequately recognized and reimbursed by Medicare.

Relevant Companies

• ISRG - Intuitive Surgical, known for its robotic surgical systems including technologies used in pediatric surgery.
• ABMD - Abiomed, which manufactures heart pumps used in pediatric cardiology.
• VAR - Varian Medical Systems, involved in technologies that may include pediatric oncology treatments.