Ensuring Patient Access to Critical Breakthrough Products Act
Summary
What This Bill Does
This bill adds a Medicare coverage pathway for breakthrough medical devices. A device manufacturer can apply for HHS breakthrough-device designation beginning 18 months after enactment if the device has been cleared, classified, or approved by FDA under 510(k), de novo, or premarket approval pathways, received FDA priority review, has clinical data that includes Medicare beneficiaries when cleared through 510(k), would otherwise be coverable under Medicare Part A or Part B, and does not present undue risk that outweighs clinical benefits.
Once designated, the device receives a four-year transitional coverage period under Medicare when furnished according to FDA-approved labeling and the indication for which the device received priority review. HHS must make designation decisions within six months. The bill also requires monitoring for aberrant billing patterns and appropriates $10 million per year from fiscal years 2025 through 2030 for CMS implementation.
Who Benefits and How
Medical device manufacturers benefit from faster Medicare market access for FDA breakthrough devices. Medicare beneficiaries benefit from earlier access to innovative devices when the safety and labeling criteria are met. Hospitals and clinics benefit from clearer coverage rules during the four-year transitional period. CMS coverage staff benefit from a defined designation process and implementation funding. Investors in breakthrough-device companies benefit if coverage uncertainty falls.
Who Bears the Burden and How
CMS must process applications, make designation decisions within six months, administer the transitional coverage period, monitor aberrant billing, and use the annual implementation funding. The Medicare Trust Fund bears coverage costs for devices that might otherwise wait for a slower coverage determination. HHS clinical reviewers must assess risk and clinical benefit. Device manufacturers applying for designation must submit clinical data and show FDA priority-review status. Providers with aberrant billing patterns face monitoring and potential scrutiny.
Key Provisions
- Adds Medicare coverage for breakthrough devices during a four-year transitional coverage period.
- Requires HHS to decide breakthrough-device designation applications within six months.
- Requires qualifying devices to have FDA priority review and relevant clinical data.
- Bars coverage when the device is outside FDA-approved labeling or presents undue risk.
- Requires monitoring for aberrant billing patterns related to breakthrough devices.
- Appropriates $10 million per fiscal year from 2025 through 2030 for CMS implementation.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Creates a Medicare transitional coverage pathway for FDA breakthrough devices, requiring HHS to designate qualifying cleared or approved devices within six months of application, cover them for a four-year period when used according to FDA labeling and priority-review indications, monitor aberrant billing, and fund CMS implementation from fiscal years 2025 through 2030.
Key Policy Areas
Medicare, Health Care, Medical Devices, FDA
Primary Purpose
Creates a Medicare transitional coverage pathway for FDA breakthrough devices, requiring HHS to designate qualifying cleared or approved devices within six months of application, cover them for a four-year period when used according to FDA labeling and priority-review indications, monitor aberrant billing, and fund CMS implementation from fiscal years 2025 through 2030.
Policy Domains
House resolution provisions
Identified Gains
- Medical device manufacturers
- Medicare beneficiaries
- Hospitals
- Clinics
- CMS coverage staff
- Investors in breakthrough-device companies
Identified Costs
- Centers for Medicare and Medicaid Services
- Medicare Trust Fund
- HHS clinical reviewers
- Device manufacturers applying for designation
- Providers with aberrant billing patterns
Sponsors
Legislative Progress
ReportedOrdered to be Reported in the Nature of a Substitute …
Committee Consideration and Mark-up Session Held
Mr. Moore of Utah (for himself, Ms. DelBene, Mr. Yakym, …
Referred to the Committee on Ways and Means, and in …
Introduced in House
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Healthcare providers (hospitals, clinics), Healthcare providers with aberrant billing patterns, Medical device manufacturers applying for breakthrough designation
Positive-direction: Healthcare providers (hospitals, clinics), Medical device manufacturers with FDA breakthrough-designated products
Negative-direction: Healthcare providers with aberrant billing patterns
Centers for Medicare & Medicaid Services, HHS Secretary (Centers for Medicare & Medicaid Services), Medicare Trust Fund
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "cms"
- → Centers for Medicare and Medicaid Services
- "fda"
- → Food and Drug Administration
- "hhs"
- → Department of Health and Human Services
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology