S.249 - Access to Pediatric Technologies Act of 2025 (119th Congress)
Summary
S.249, the Access to Pediatric Technologies Act of 2025, aims to amend Title XVIII of the Social Security Act to improve patient access to specific pediatric medical technologies. The bill directs the Secretary of Health and Human Services to establish national relative value units under the physician fee schedule for qualifying pediatric technologies. This would apply if such values haven't already been established.
The bill outlines a process for manufacturers to request the establishment of these values. It also defines 'qualifying pediatric technology' as a covered medical device approved under specific sections of the Federal Food, Drug, and Cosmetic Act, described by a temporary HCPCS code, and used predominantly in pediatric procedures or specifically designed for pediatric use.
Ultimately, the goal is to facilitate and expedite the process by which new pediatric medical devices are reimbursed under Medicare, thereby increasing access for children.
Expected Effects
The primary effect of this bill would be to streamline the payment process for new pediatric medical devices under Medicare. This could lead to quicker adoption of innovative technologies in pediatric care.
It would also create a more predictable reimbursement environment for manufacturers, potentially incentivizing further development and innovation in this area. The changes would be implemented through the existing physician fee schedule rulemaking process.
However, the bill explicitly states that it does not require coverage of any specific technology, leaving coverage decisions to existing guidelines.
Potential Benefits
- Increased access to advanced medical technologies for pediatric patients.
- Incentivizes innovation and development of new pediatric medical devices by clarifying the reimbursement process.
- Streamlines the payment process for qualifying pediatric technologies under Medicare.
- Provides a clear pathway for manufacturers to request national relative value units for their products.
- Potentially improves the quality of care and health outcomes for children.
Potential Disadvantages
- Potential increase in Medicare costs due to the adoption of new technologies.
- The definition of 'qualifying pediatric technology' may be subject to interpretation, potentially leading to disputes.
- The rulemaking process could be slow, delaying the implementation of the bill's provisions.
- Manufacturers may face administrative burdens in submitting requests and providing necessary information.
- The bill does not guarantee coverage of any specific technology, which could limit its impact.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution (Preamble), as it aims to improve healthcare access for children. Congress has the power to legislate on matters related to Medicare under its enumerated powers (Article I, Section 8).
There are no apparent conflicts with individual rights or freedoms protected by the Bill of Rights. The bill focuses on the payment mechanism for medical devices and does not infringe upon any fundamental rights.
However, the implementation of the bill would rely on the Secretary of Health and Human Services, raising questions about the delegation of legislative authority. It is important that the guidelines are clear and specific to avoid arbitrary decision-making.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).