Ensuring Patient Access to Critical Breakthrough Products Act of 2025
Sens. Young and Padilla Introduce Bipartisan Bill to Speed Up Medicare Coverage for Breakthrough Medical Devices
This bill was recently introduced in the Senate and is currently being reviewed by the Committee on Finance. It is in the early stages of the legislative process and is considered active. There are no upcoming votes scheduled at this time.
Legislative Progress
This bill has strong support from both parties and the medical industry, but concerns about the cost of new technology could slow it down.
Key Points
Impact Analysis
Personal Impact
Life & Work
Small medical device companies that develop breakthrough products would benefit from a clearer and faster pathway to Medicare reimbursement. Under the current system, uncertainty about whether Medicare will cover a new device can discourage investment. This bill gives manufacturers more predictability, potentially helping smaller innovators compete with large device companies.
“upon application of a manufacturer of a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) that is cleared, classified, or approved under section 510(k), 513(f)(2), or 515 of such Act”
Programs
Disabilities
Milestones
Read twice and referred to the Committee on Finance.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
Votes
No votes have been recorded for this legislation yet.
Related News
3 articles
House committee advances Medicare coverage bill for breakthrough devices
Legislation to formalize a Medicare coverage pathway for breakthrough medical devices cleared a key House committee. Sponsors noted the bill creates a streamlined pathway for FDA-designated products to receive transitional coverage, addressing the 'valley of death' between approval and payment.
House Ways & Means Committee has approved H.R. 5343
The House Ways & Means Committee voted 38 to 3 to approve the Ensuring Patient Access to Critical Breakthrough Products Act. The bill amends the Social Security Act to provide four years of transitional Medicare coverage for devices designated as breakthroughs by the FDA.
Bipartisan Legislation Reintroduced to Expand Access to Breakthrough Medical Innovations
Senators Todd Young and Alex Padilla reintroduced the Ensuring Patient Access to Critical Breakthrough Products Act. The bill aims to streamline the process for breakthrough devices to receive immediate Medicare coverage, reducing financial risks for innovators and speeding up patient care.
Source Information
Document Type
Congressional Bill
Official Title
Ensuring Patient Access to Critical Breakthrough Products Act of 2025
Data Sources
Sponsor
Cosponsors
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