Other
Ensuring Patient Access to Critical Breakthrough Products Act
This bill requires Medicare to provide four years of temporary insurance coverage for new, cutting-edge medical devices that earn breakthrough status from the Food and Drug Administration. To qualify, device makers must provide clinical data showing the technology is safe and effective for Medicare patients. The measure also allows health officials to audit and review healthcare providers who show suspicious or unusually high billing patterns for these new treatments.
People affected—not determinable from the text provided; impacts Medicare beneficiaries eligible for breakthrough medical devices and device manufacturers, but no specific counts are stated.
Fiscal magnitude$60.0Mprovisional · pending reviewSec. 2(c) explicitly appropriates $10,000,000 for each of fiscal years 2025 through 2030 ($60,000,000 total) to the CMS Program Management Account; broader changes in Medicare benefit spending are not determinable from the text.
Reach52provisional · pending reviewrigor: heuristic llm
What this bill touches.
Spending vs. restraint+20Government role in coverage+30
Who it helps · who it burdens.
Who it helps
- Medical device manufacturersCan apply for and receive a four-year transitional Medicare coverage period for qualifying FDA-cleared or approved breakthrough devices, with decisions required within six months.
- Medicare beneficiariesGain up to four years of Medicare coverage for qualifying FDA breakthrough medical devices used according to approved labeling and indications.
- Centers for Medicare & Medicaid ServicesReceives $10 million in direct appropriations for each fiscal year from 2025 through 2030 to administer the transitional breakthrough device coverage program.
Who it burdens
- Department of Health and Human ServicesMust establish an application and designation process for breakthrough devices, evaluate clinical criteria, issue rulings within six months (with written explanations for denials), and submit annual reports to Congress.
- Healthcare providers and suppliers with outlier billing patternsSubject to medical necessity and reasonableness reviews by HHS if they exhibit aberrant or outlier billing patterns for breakthrough devices.