# 119-s-1717: Ensuring Patient Access to Critical Breakthrough Products Act of 2025

119-s-1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025, is a 119th Congress bill sponsored by Sen. Young, Todd [R-IN] (R-IN); status introduced; PRIA reads it as touching household money (as of 2026-06-12).

- Canonical: https://policyrisk.com/legislation/119-s-1717
- As of: 2026-06-12
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-1717
- Congress: 119
- Title: Ensuring Patient Access to Critical Breakthrough Products Act of 2025
- Status: introduced
- Introduced: 2025-05-12
- Sponsor: Sen. Young, Todd [R-IN] (R-IN)
- Cosponsors: 5
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-06-12

## Summary

**This bill would speed Medicare access to FDA-priority medical devices by creating a formal "breakthrough device" designation and a four-year transitional coverage window.** It ties temporary coverage to FDA labeling and safety reviews so Medicare only covers devices that meet labeling rules and do not pose undue risk during that window.

## Cosponsors (5)

- Sen. Padilla, Alex [D-CA] (D-CA), 2025-05-12T00:00:00.000Z
- Sen. Schiff, Adam B. [D-CA] (D-CA), 2025-11-10T00:00:00.000Z
- Sen. Barrasso, John [R-WY] (R-WY), 2025-11-10T00:00:00.000Z
- Sen. Shaheen, Jeanne [D-NH] (D-NH), 2026-06-10T00:00:00.000Z
- Sen. Marshall, Roger [R-KS] (R-KS), 2026-06-10T00:00:00.000Z

## Provisions PRIA read

- Medicare agency funding for implementation: benefit, low. If enacted, the bill would give CMS $10 million per year for each fiscal year 2026 through 2031 to carry out these changes. The money would be in addition to other funds and would remain available until spent. CMS would use the funds to implement the breakthrough device designation and coverage rul…
- New Medicare rules for breakthrough devices: mixed, medium. If enacted, the bill would create a new "breakthrough device" designation and give such devices a 4-year transitional coverage period. Definitions take effect on enactment and manufacturers could apply starting 18 months after enactment. The Secretary must decide designation applications within 6 m…

## Related bills

- 119-s-5066: Health Equity and Accountability Act of 2026
- 119-s-4429: Connected Vehicle Security Act of 2026
- 119-s-1261: CONNECT for Health Act of 2025
- 119-s-1289: 25th Anniversary of 9/11 Commemorative Coin Act
- 119-s-1032: Major Richard Star Act
- 119-s-339: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

## Sources
- [119-s-1717 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/1717)

## Related
- [119-s-5066: Health Equity and Accountability Act of 2026](https://policyrisk.com/legislation/119-s-5066)
- [119-s-4429: Connected Vehicle Security Act of 2026](https://policyrisk.com/legislation/119-s-4429)
- [119-s-1261: CONNECT for Health Act of 2025](https://policyrisk.com/legislation/119-s-1261)
- [119-s-1289: 25th Anniversary of 9/11 Commemorative Coin Act](https://policyrisk.com/legislation/119-s-1289)
- [119-s-1032: Major Richard Star Act](https://policyrisk.com/legislation/119-s-1032)
- [119-s-339: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-s-339)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-1717 (as of 2026-06-12).