Ensuring Patient Access to Critical Breakthrough Products Act of 2024

Summary

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).

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Timeline

1. 22 March 2023

   Introduced

   Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

2. 22 March 2023

   Introduced

   Introduced in House

   Source: IntroReferral

3. 22 March 2023

   Introduced

   Introduced in House

   Source: IntroReferral

4. 31 March 2023

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 15 November 2023

   Vote

   Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.

   Source: Committee

6. 15 November 2023

   Committee

   Subcommittee Consideration and Mark-up Session Held

   Source: Committee

7. 27 June 2024

   Vote

   Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.

   Source: Committee

8. 27 June 2024

   Committee

   Committee Consideration and Mark-up Session Held

   Source: Committee

9. 24 December 2024

   Calendars

   Placed on the Union Calendar, Calendar No. 801.

   Source: Calendars

10. 24 December 2024

    Discharge

    Committee on Energy and Commerce discharged.

    Source: Discharge

11. 24 December 2024

    Committee

    Committee on Energy and Commerce discharged.

    Source: Committee

12. 24 December 2024

    Reported

    Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.

    Source: Committee

13. 24 December 2024

    Reported

    Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.

    Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported in House · 24 December 2024 · Official file
• Introduced in House · 22 March 2023 · Official file

Documents

5 official files

• Reported in House (text)

  Reported in House · EN · 24 December 2024

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 24 December 2024

  ViewDownloadOpen at official source

• Introduced in House (text)

  Introduced in House · EN · 22 March 2023

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 22 March 2023

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 22 March 2023

  Open at official source

Sponsors

• Brad Wenstrup · R · Sponsor
• Rep. DelBene, Suzan K. [D-WA-1] · D · Sponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Sponsor
• Tony Cárdenas · D · Sponsor
• Blake Moore · R · Sponsor
• Rep. Sewell, Terri A. [D-AL-7] · D · Sponsor
• Brett Guthrie · R · Sponsor
• Anna Eshoo · D · Sponsor
• John Joyce · R · Cosponsor
• Ann Kuster · D · Cosponsor
• Dan Crenshaw · R · Cosponsor
• Derek Kilmer · D · Cosponsor
• Rep. Miller, Carol D. [R-WV-1] · R · Cosponsor
• Rep. Craig, Angie [D-MN-2] · D · Cosponsor
• Michelle Steel · R · Cosponsor
• Rep. Dean, Madeleine [D-PA-4] · D · Cosponsor
• Rep. Bacon, Don [R-NE-2] · R · Cosponsor
• Rep. Peters, Scott H. [D-CA-50] · D · Cosponsor
• Troy Balderson · R · Cosponsor
• Rep. Auchincloss, Jake [D-MA-4] · D · Cosponsor
• Sen. Curtis, John R. [R-UT] · R · Cosponsor
• Rep. Houlahan, Chrissy [D-PA-6] · D · Cosponsor
• Larry Bucshon · R · Cosponsor
• Rep. Fitzpatrick, Brian K. [R-PA-1] · R · Cosponsor
• Rep. Yakym, Rudy [R-IN-2] · R · Cosponsor
• Rep. Lofgren, Zoe [D-CA-18] · D · Cosponsor
• Kim Schrier · D · Cosponsor
• Rep. Trahan, Lori [D-MA-3] · D · Cosponsor
• Rep. Lieu, Ted [D-CA-36] · D · Cosponsor
• Rep. McGovern, James P. [D-MA-2] · D · Cosponsor
• Rep. Boyle, Brendan F. [D-PA-2] · D · Cosponsor
• Susan Wild · D · Cosponsor
• Rep. Bera, Ami [D-CA-6] · D · Cosponsor
• Rep. Correa, J. Luis [D-CA-46] · D · Cosponsor
• Katie Porter · D · Cosponsor
• Eric Swalwell · D · Cosponsor
• Rep. Ciscomani, Juan [R-AZ-6] · R · Cosponsor
• A. Ferguson · R · Cosponsor
• Rep. Carey, Mike [R-OH-15] · R · Cosponsor
• Michael Simpson · R · Cosponsor
• Young Kim · R · Cosponsor
• Chris Pappas · D · Cosponsor
• Michael Burgess · R · Cosponsor
• Rep. Miller-Meeks, Mariannette [R-IA-1] · R · Cosponsor
• Rep. Scanlon, Mary Gay [D-PA-5] · D · Cosponsor
• Rep. Panetta, Jimmy [D-CA-19] · D · Cosponsor
• Neal Dunn · R · Cosponsor
• Rep. Mullin, Kevin [D-CA-15] · D · Cosponsor

Showing 48 of 92 sponsors and actors.

Related records

• related to ← Ensuring Patient Access to Critical Breakthrough Products Act of 2024