Bill · H.R. 5343· House(119-HR-5343)

Ensuring Patient Access to Critical Breakthrough Products Act

Age: 46 years

Utah

Introduced: 9/15/2025
Last activity: 9/17/2025 — Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Sponsored by: Blake Moore
Cosponsors: - 33 - 32

Health

Introduced

What this bill would do

This bill, known as the "Ensuring Patient Access to Critical Breakthrough Products Act," aims to amend the Social Security Act to ensure Medicare covers breakthrough devices more promptly. It establishes a process where the Secretary can designate specific devices as "breakthrough devices" based on certain criteria, such as receiving priority review. Once designated, these devices would enter a "transitional coverage period" lasting four years. The bill also requires the Secretary to make final decisions on national coverage determinations before this transitional period ends. Finally, it provides specific annual funding to the Centers for Medicare & Medicaid Services to implement these changes.

Yes· 3 of 5

Would people over 65 be better off under this?+7
The bill ensures quicker Medicare coverage for breakthrough medical devices for those entitled to benefits.
Would retired people be better off under this?+7
The bill provides faster access to new medical technologies through the Medicare program.
Does this make health care easier to get in general?+7
The bill creates a four-year transitional coverage period to ensure faster access to breakthrough medical devices for Medicare beneficiaries.

The opposite

Does this reduce what the federal government spends?-1
The bill appropriates $10,000,000 annually for fiscal years 2025 through 2030 to implement these new Medicare coverage processes.