What does ENSURING PROMPT COVERAGE OF BREAKTHROUGH DEVICES UNDER THE of Ensuring Patient Access to Critical Breakthrough Products Act of 2025 do?

This section amends the Social Security Act to establish a process for designating and providing transitional coverage for 'breakthrough devices' under the Medicare program. It defines 'breakthrough device' as a device designated by the Secretary under section 1899C and 'transitional coverage period' as a 4-year period following such designation. The Secretary is required to make a determination on applications for breakthrough device designation within 6 months of submission. If a device does not meet the criteria for designation, the Secretary must notify the manufacturer and explain why. The Secretary must submit annual reports to Congress detailing the number of applications received, devices designated, and applications denied. The Secretary is also required to ensure a final decision on requests for a national coverage determination for breakthrough devices prior to the end of the transitional coverage period. This section appropriates $10,000,000 annually from fiscal years 2026 through 2031 to the Centers for Medicare & Medicaid Services Program Management Account to carry out these amendments.

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Ensuring Patient Access to Critical Breakthrough Products Act of 2025

Q: What does Preamble of Ensuring Patient Access to Critical Breakthrough Products Act of 2025 do?

This bill, formally titled 'A bill to amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes,' aims to modify the Social Security Act. The bill intends to ensure prompt coverage of breakthrough devices within the Medicare program.

Q: What does SHORT TITLE. of Ensuring Patient Access to Critical Breakthrough Products Act of 2025 do?

This bill is formally titled the Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

Last updated: 5/12/2025 · Introduced: 5/12/2025

Author: Todd Young (R-IN)

TL;DR (AI)

This bill establishes a process for designating 'breakthrough devices' and providing up to four years of transitional Medicare coverage.
The bill requires the Secretary to make decisions on breakthrough device designation applications within six months and report annually on application status.
The bill allocates $10 million annually to the Centers for Medicare & Medicaid Services to manage the implementation of these changes.

119th Congressin committeeOfficial page

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