# 119-hr-5343: Ensuring Patient Access to Critical Breakthrough Products Act

119-hr-5343, Ensuring Patient Access to Critical Breakthrough Products Act, is a 119th Congress bill sponsored by Rep. Moore, Blake D. [R-UT-1] (R-UT); status in_committee; PRIA reads it as touching household money (as of 2026-10-24).

- Canonical: https://policyrisk.com/legislation/119-hr-5343
- As of: 2026-10-24
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-5343
- Congress: 119
- Title: Ensuring Patient Access to Critical Breakthrough Products Act
- Status: in_committee
- Introduced: 2025-09-15
- Sponsor: Rep. Moore, Blake D. [R-UT-1] (R-UT)
- Cosponsors: 68
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-10-24

## Summary

**This bill would create a structured, four-year pathway that gives Medicare special, time-limited coverage for FDA-designated **breakthrough medical devices**.** Coverage during that transition is tied to following FDA-approved labeling or to a Secretary review that the device's benefits outweigh its risks. - Medicare beneficiaries: Seniors and other people on Parts A and B would have a defined four-year window of transitional coverage for devices the FDA designates as breakthrough. Coverage depends on using the device as labeled or on a Secretary risk-benefit finding. - Device manufacturers: Manufacturers can seek a breakthrough designation starting 18 months after enactment and would get a decision within six months of application. A designation triggers the four-year transitional coverage period and faster coverage review timelines. - CMS and providers: CMS must report annually on applications and designations and may review providers with unusual billing for these devices to protect program integrity. The Secretary must issue final national coverage decisions within set deadlines so decisions finish during the transition when requests meet timing rules. *This bill would increase federal spending by $10 million per year from fiscal 2025 through 2030, about $60 million total, to fund CMS implementation and oversight.*

## Cosponsors (68)

- Rep. DelBene, Suzan K. [D-WA-1] (D-WA), 2025-09-15T00:00:00.000Z
- Rep. Yakym, Rudy [R-IN-2] (R-IN), 2025-09-15T00:00:00.000Z
- Rep. Sewell, Terri A. [D-AL-7] (D-AL), 2025-09-15T00:00:00.000Z
- Rep. Bilirakis, Gus M. [R-FL-12] (R-FL), 2025-09-15T00:00:00.000Z
- Rep. Trahan, Lori [D-MA-3] (D-MA), 2025-09-15T00:00:00.000Z
- Rep. Tenney, Claudia [R-NY-24] (R-NY), 2025-09-16T00:00:00.000Z
- Rep. Fischbach, Michelle [R-MN-7] (R-MN), 2025-09-16T00:00:00.000Z
- Rep. Schneider, Bradley Scott [D-IL-10] (D-IL), 2025-09-17T00:00:00.000Z
- Rep. Correa, J. Luis [D-CA-46] (D-CA), 2025-09-19T00:00:00.000Z
- Rep. Smith, Adrian [R-NE-3] (R-NE), 2026-10-22T00:00:00.000Z
- Rep. Thanedar, Shri [D-MI-13] (D-MI), 2026-10-22T00:00:00.000Z
- Rep. Bergman, Jack [R-MI-1] (R-MI), 2026-10-22T00:00:00.000Z
- Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA), 2025-10-31T00:00:00.000Z
- Rep. Auchincloss, Jake [D-MA-4] (D-MA), 2025-10-31T00:00:00.000Z
- Rep. Miller, Carol D. [R-WV-1] (R-WV), 2025-11-07T00:00:00.000Z
- Rep. Lieu, Ted [D-CA-36] (D-CA), 2025-11-07T00:00:00.000Z
- Rep. Owens, Burgess [R-UT-4] (R-UT), 2025-11-18T00:00:00.000Z
- Rep. Bera, Ami [D-CA-6] (D-CA), 2025-11-18T00:00:00.000Z
- Rep. Weber, Randy K. Sr. [R-TX-14] (R-TX), 2025-12-02T00:00:00.000Z
- Rep. Soto, Darren [D-FL-9] (D-FL), 2025-12-02T00:00:00.000Z
- Rep. Kiggans, Jennifer A. [R-VA-2] (R-VA), 2025-12-09T00:00:00.000Z
- Rep. Pappas, Chris [D-NH-1] (D-NH), 2025-12-09T00:00:00.000Z
- Rep. Bean, Aaron [R-FL-4] (R-FL), 2025-12-17T00:00:00.000Z
- Rep. Panetta, Jimmy [D-CA-19] (D-CA), 2026-01-06T00:00:00.000Z
- Rep. Bentz, Cliff [R-OR-2] (R-OR), 2026-01-14T00:00:00.000Z
- Rep. Ross, Deborah K. [D-NC-2] (D-NC), 2026-01-14T00:00:00.000Z
- Rep. Lawler, Michael [R-NY-17] (R-NY), 2026-02-03T00:00:00.000Z
- Rep. Strickland, Marilyn [D-WA-10] (D-WA), 2026-02-03T00:00:00.000Z
- Rep. Carey, Mike [R-OH-15] (R-OH), 2026-02-03T00:00:00.000Z
- Rep. Gottheimer, Josh [D-NJ-5] (D-NJ), 2026-02-03T00:00:00.000Z
- Rep. Malliotakis, Nicole [R-NY-11] (R-NY), 2026-02-03T00:00:00.000Z
- Rep. Pettersen, Brittany [D-CO-7] (D-CO), 2026-02-03T00:00:00.000Z
- Rep. Fitzpatrick, Brian K. [R-PA-1] (R-PA), 2026-02-10T00:00:00.000Z
- Rep. Lofgren, Zoe [D-CA-18] (D-CA), 2026-02-10T00:00:00.000Z
- Rep. Joyce, John [R-PA-13] (R-PA), 2026-02-11T00:00:00.000Z
- Rep. Cohen, Steve [D-TN-9] (D-TN), 2026-02-11T00:00:00.000Z
- Rep. Maloy, Celeste [R-UT-2] (R-UT), 2026-02-11T00:00:00.000Z
- Rep. Houlahan, Chrissy [D-PA-6] (D-PA), 2026-02-11T00:00:00.000Z
- Rep. Meuser, Daniel [R-PA-9] (R-PA), 2026-03-16T00:00:00.000Z
- Rep. Craig, Angie [D-MN-2] (D-MN), 2026-03-16T00:00:00.000Z
- Rep. Valadao, David G. [R-CA-22] (R-CA), 2026-04-02T00:00:00.000Z
- Rep. Whitesides, George [D-CA-27] (D-CA), 2026-04-02T00:00:00.000Z
- Rep. Obernolte, Jay [R-CA-23] (R-CA), 2026-04-09T00:00:00.000Z
- Rep. Boyle, Brendan F. [D-PA-2] (D-PA), 2026-04-09T00:00:00.000Z
- Rep. Ciscomani, Juan [R-AZ-6] (R-AZ), 2026-04-09T00:00:00.000Z
- Rep. Crow, Jason [D-CO-6] (D-CO), 2026-04-09T00:00:00.000Z
- Rep. Kennedy, Mike [R-UT-3] (R-UT), 2026-04-16T00:00:00.000Z
- Rep. Goodlander, Maggie [D-NH-2] (D-NH), 2026-04-16T00:00:00.000Z
- Rep. Murphy, Gregory F. [R-NC-3] (R-NC), 2026-05-14T00:00:00.000Z
- Rep. Mullin, Kevin [D-CA-15] (D-CA), 2026-05-14T00:00:00.000Z
- Rep. Kustoff, David [R-TN-8] (R-TN), 2026-05-19T00:00:00.000Z
- Rep. Davids, Sharice [D-KS-3] (D-KS), 2026-05-19T00:00:00.000Z
- Rep. Rutherford, John H. [R-FL-5] (R-FL), 2026-05-20T00:00:00.000Z
- Rep. Liccardo, Sam T. [D-CA-16] (D-CA), 2026-05-20T00:00:00.000Z
- Rep. Salazar, Maria Elvira [R-FL-27] (R-FL), 2026-06-29T00:00:00.000Z
- Rep. Barragán, Nanette Diaz [D-CA-44] (D-CA), 2026-06-29T00:00:00.000Z
- Rep. Hern, Kevin [R-OK-1] (R-OK), 2026-06-30T00:00:00.000Z
- Rep. Kelly, Mike [R-PA-16] (R-PA), 2026-06-30T00:00:00.000Z
- Rep. Mrvan, Frank J. [D-IN-1] (D-IN), 2026-06-30T00:00:00.000Z
- Rep. McCormick, Richard [R-GA-7] (R-GA), 2026-07-13T00:00:00.000Z
- Rep. Scanlon, Mary Gay [D-PA-5] (D-PA), 2026-07-13T00:00:00.000Z
- Rep. Kim, Young [R-CA-40] (R-CA), 2026-07-13T00:00:00.000Z
- Rep. Peters, Scott H. [D-CA-50] (D-CA), 2026-07-13T00:00:00.000Z
- Rep. Dunn, Neal P. [R-FL-2] (R-FL), 2026-07-20T00:00:00.000Z
- Rep. Stevens, Haley M. [D-MI-11] (D-MI), 2026-07-20T00:00:00.000Z
- Rep. Kean, Thomas H. [R-NJ-7] (R-NJ), 2026-08-03T00:00:00.000Z
- Rep. Dean, Madeleine [D-PA-4] (D-PA), 2026-08-03T00:00:00.000Z
- Rep. Langworthy, Nicholas A. [R-NY-23] (R-NY), 2026-08-31T00:00:00.000Z

## Provisions PRIA read

- Faster Medicare decisions on new devices: benefit, medium. If enacted, Medicare would need to finish a national coverage decision for a breakthrough device before its 4-year transition ends. This would apply when a request is filed at least 9 months before the end of the transition. In some cases, the filing would need to be 12 months ahead. This aims to g…
- Checks on unusual Medicare device billing: benefit, low. If enacted, the Secretary could review providers who bill unusually for a breakthrough device. Reviews would check if using the device was medically necessary and reasonable. This tool would target outliers and protect Medicare from improper payments.
- Funds to run Medicare device program: benefit, low. This bill would give CMS $10 million each year from 2025 through 2030. The money would stay available until spent. CMS would use it to carry out the bill’s Medicare device coverage changes.
- Temporary Medicare coverage for breakthrough devices: mixed, medium. This bill would create a new path for some FDA-designated "breakthrough" devices to get Medicare coverage. Starting 18 months after enactment, makers could apply for a breakthrough label, and the Secretary would decide within 6 months. If designated, a 4-year transition period would start on the de…

## Related bills

- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025
- 119-hr-909: Crime Victims Fund Stabilization Act of 2025
- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act
- 119-hr-9250: Great American Outdoors Act 250

## Sources
- [119-hr-5343 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/5343)

## Related
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [119-hr-909: Crime Victims Fund Stabilization Act of 2025](https://policyrisk.com/legislation/119-hr-909)
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act](https://policyrisk.com/legislation/119-hr-4382)
- [119-hr-9250: Great American Outdoors Act 250](https://policyrisk.com/legislation/119-hr-9250)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-5343 (as of 2026-10-24).