S.1717 - Ensuring Patient Access to Critical Breakthrough Products Act of 2025 (119th Congress)
Summary
S.1717, the "Ensuring Patient Access to Critical Breakthrough Products Act of 2025," aims to expedite Medicare coverage for breakthrough medical devices. It amends Title XVIII of the Social Security Act to ensure timely coverage of these devices. The bill establishes a transitional coverage period and mandates the Secretary to designate breakthrough devices based on specific criteria.
Expected Effects
The bill will likely lead to faster access to innovative medical technologies for Medicare beneficiaries. It also mandates a process for the Secretary to designate breakthrough devices and issue national coverage determinations within specified timeframes. The Act allocates $10 million annually from 2026-2031 to support the implementation of these changes.
Potential Benefits
- Expedited access to innovative medical devices for Medicare beneficiaries.
- Clearer regulatory pathways for breakthrough device coverage.
- Increased investment and innovation in the medical device industry.
- Improved patient outcomes through access to cutting-edge technology.
- Enhanced transparency and accountability in coverage decisions.
Potential Disadvantages
- Potential for increased healthcare costs due to rapid adoption of new technologies.
- Risk of covering devices before sufficient long-term data on safety and efficacy are available.
- Administrative burden on the Secretary to designate breakthrough devices and make coverage determinations.
- Possible inequities if certain populations do not have equal access to these devices.
- The transitional coverage period might not be sufficient for all devices, leading to coverage gaps.
Constitutional Alignment
The bill aligns with the Constitution's general welfare clause, as it seeks to improve healthcare access for seniors. Congress has the power to legislate on matters related to Medicare under the Social Security Act, which falls under its constitutional authority to provide for the general welfare. The specific designation and determination processes outlined in the bill do not appear to infringe on any specific constitutional rights or limitations.
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).