Legis Daily

Ensuring Patient Access to Critical Breakthrough Products Act of 2024

USA118th CongressHR-1691| House 
| Updated: 12/24/2024
Brad R. Wenstrup

Brad R. Wenstrup

Republican Representative

Ohio

Cosponsors (89)
Kim Schrier (Democratic)Michael C. Burgess (Republican)Adrian Smith (Republican)Wiley Nickel (Democratic)Celeste Maloy (Republican)Chris Pappas (Democratic)Brett Guthrie (Republican)Chrissy Houlahan (Democratic)Darren Soto (Democratic)Derek Kilmer (Democratic)Neal P. Dunn (Republican)Darin LaHood (Republican)Glenn Thompson (Republican)Mike Carey (Republican)Claudia Tenney (Republican)Mariannette Miller-Meeks (Republican)Beth Van Duyne (Republican)Terri A. Sewell (Democratic)Young Kim (Republican)Jimmy Panetta (Democratic)J. Luis Correa (Democratic)Eric Swalwell (Democratic)John R. Curtis (Republican)Madeleine Dean (Democratic)Steve Cohen (Democratic)Tony Cárdenas (Democratic)Suzan K. DelBene (Democratic)Scott H. Peters (Democratic)Angie Craig (Democratic)John James (Republican)Donald G. Davis (Democratic)Earl L. "Buddy" Carter (Republican)Haley M. Stevens (Democratic)Danny K. Davis (Democratic)Jake Auchincloss (Democratic)Ted Lieu (Democratic)Rudy Yakym (Republican)Lloyd Smucker (Republican)Thomas H. Kean (Republican)Ann M. Kuster (Democratic)Gus M. Bilirakis (Republican)A. Drew Ferguson (Republican)Don Bacon (Republican)Brendan F. Boyle (Democratic)Andy Barr (Republican)Carol D. Miller (Republican)Mike Kelly (Republican)Marilyn Strickland (Democratic)Dean Phillips (Democratic)John Joyce (Republican)Brad Finstad (Republican)Kelly Armstrong (Republican)Brittany Pettersen (Democratic)Anna G. Eshoo (Democratic)Brian J. Mast (Republican)Ami Bera (Democratic)Nicholas A. Langworthy (Republican)Blake D. Moore (Republican)Bruce Westerman (Republican)John H. Rutherford (Republican)Laurel M. Lee (Republican)Mary Gay Scanlon (Democratic)Larry Bucshon (Republican)Joe Neguse (Democratic)Diana DeGette (Democratic)Michael K. Simpson (Republican)James P. McGovern (Democratic)Michelle Steel (Republican)Dan Crenshaw (Republican)Brian K. Fitzpatrick (Republican)Jay Obernolte (Republican)Deborah K. Ross (Democratic)Juan Ciscomani (Republican)Lori Trahan (Democratic)Elissa Slotkin (Democratic)Burgess Owens (Republican)Yadira Caraveo (Democratic)Greg Pence (Republican)Josh Gottheimer (Democratic)Zoe Lofgren (Democratic)Nanette Diaz Barragán (Democratic)Kevin Mullin (Democratic)Jason Crow (Democratic)Bradley Scott Schneider (Democratic)Bill Johnson (Republican)Michelle Fischbach (Republican)Troy Balderson (Republican)Katie Porter (Democratic)Susan Wild (Democratic)

Ways and Means Committee, Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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).

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-5333
Ensuring Patient Access to Critical Breakthrough Products Act of 2019

Bill from Previous Congress

HR 117-4043
Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Mar 22, 2023
Introduced in House
Mar 22, 2023
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.
Mar 31, 2023
Referred to the Subcommittee on Health.
Nov 15, 2023
Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.
Nov 15, 2023
Subcommittee Consideration and Mark-up Session Held
Jun 27, 2024
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.
Jun 27, 2024
Committee Consideration and Mark-up Session Held
Nov 20, 2024

Latest Companion Bill Action

S 118-5349
Introduced in Senate
Dec 24, 2024
Placed on the Union Calendar, Calendar No. 801.
Dec 24, 2024
Committee on Energy and Commerce discharged.
Dec 24, 2024
Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
  • Bill from Previous Congress

    HR 116-5333
    Ensuring Patient Access to Critical Breakthrough Products Act of 2019


  • Bill from Previous Congress

    HR 117-4043
    Ensuring Patient Access to Critical Breakthrough Products Act of 2021


  • March 22, 2023
    Introduced in House


  • March 22, 2023
    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.


  • March 31, 2023
    Referred to the Subcommittee on Health.


  • November 15, 2023
    Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.


  • November 15, 2023
    Subcommittee Consideration and Mark-up Session Held


  • June 27, 2024
    Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.


  • June 27, 2024
    Committee Consideration and Mark-up Session Held


  • November 20, 2024

    Latest Companion Bill Action

    S 118-5349
    Introduced in Senate


  • December 24, 2024
    Placed on the Union Calendar, Calendar No. 801.


  • December 24, 2024
    Committee on Energy and Commerce discharged.


  • December 24, 2024
    Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.

Health

Congressional oversightDrug safety, medical device, and laboratory regulationGovernment studies and investigationsHealth care coverage and accessHealth information and medical recordsHealth technology, devices, suppliesHome and outpatient careHospital careMedicare

Ensuring Patient Access to Critical Breakthrough Products Act of 2024

USA118th CongressHR-1691| House 
| Updated: 12/24/2024
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).

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-5333
Ensuring Patient Access to Critical Breakthrough Products Act of 2019

Bill from Previous Congress

HR 117-4043
Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Mar 22, 2023
Introduced in House
Mar 22, 2023
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.
Mar 31, 2023
Referred to the Subcommittee on Health.
Nov 15, 2023
Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.
Nov 15, 2023
Subcommittee Consideration and Mark-up Session Held
Jun 27, 2024
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.
Jun 27, 2024
Committee Consideration and Mark-up Session Held
Nov 20, 2024

Latest Companion Bill Action

S 118-5349
Introduced in Senate
Dec 24, 2024
Placed on the Union Calendar, Calendar No. 801.
Dec 24, 2024
Committee on Energy and Commerce discharged.
Dec 24, 2024
Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
  • Bill from Previous Congress

    HR 116-5333
    Ensuring Patient Access to Critical Breakthrough Products Act of 2019


  • Bill from Previous Congress

    HR 117-4043
    Ensuring Patient Access to Critical Breakthrough Products Act of 2021


  • March 22, 2023
    Introduced in House


  • March 22, 2023
    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.


  • March 31, 2023
    Referred to the Subcommittee on Health.


  • November 15, 2023
    Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.


  • November 15, 2023
    Subcommittee Consideration and Mark-up Session Held


  • June 27, 2024
    Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.


  • June 27, 2024
    Committee Consideration and Mark-up Session Held


  • November 20, 2024

    Latest Companion Bill Action

    S 118-5349
    Introduced in Senate


  • December 24, 2024
    Placed on the Union Calendar, Calendar No. 801.


  • December 24, 2024
    Committee on Energy and Commerce discharged.


  • December 24, 2024
    Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
Brad R. Wenstrup

Brad R. Wenstrup

Republican Representative

Ohio

Cosponsors (89)
Kim Schrier (Democratic)Michael C. Burgess (Republican)Adrian Smith (Republican)Wiley Nickel (Democratic)Celeste Maloy (Republican)Chris Pappas (Democratic)Brett Guthrie (Republican)Chrissy Houlahan (Democratic)Darren Soto (Democratic)Derek Kilmer (Democratic)Neal P. Dunn (Republican)Darin LaHood (Republican)Glenn Thompson (Republican)Mike Carey (Republican)Claudia Tenney (Republican)Mariannette Miller-Meeks (Republican)Beth Van Duyne (Republican)Terri A. Sewell (Democratic)Young Kim (Republican)Jimmy Panetta (Democratic)J. Luis Correa (Democratic)Eric Swalwell (Democratic)John R. Curtis (Republican)Madeleine Dean (Democratic)Steve Cohen (Democratic)Tony Cárdenas (Democratic)Suzan K. DelBene (Democratic)Scott H. Peters (Democratic)Angie Craig (Democratic)John James (Republican)Donald G. Davis (Democratic)Earl L. "Buddy" Carter (Republican)Haley M. Stevens (Democratic)Danny K. Davis (Democratic)Jake Auchincloss (Democratic)Ted Lieu (Democratic)Rudy Yakym (Republican)Lloyd Smucker (Republican)Thomas H. Kean (Republican)Ann M. Kuster (Democratic)Gus M. Bilirakis (Republican)A. Drew Ferguson (Republican)Don Bacon (Republican)Brendan F. Boyle (Democratic)Andy Barr (Republican)Carol D. Miller (Republican)Mike Kelly (Republican)Marilyn Strickland (Democratic)Dean Phillips (Democratic)John Joyce (Republican)Brad Finstad (Republican)Kelly Armstrong (Republican)Brittany Pettersen (Democratic)Anna G. Eshoo (Democratic)Brian J. Mast (Republican)Ami Bera (Democratic)Nicholas A. Langworthy (Republican)Blake D. Moore (Republican)Bruce Westerman (Republican)John H. Rutherford (Republican)Laurel M. Lee (Republican)Mary Gay Scanlon (Democratic)Larry Bucshon (Republican)Joe Neguse (Democratic)Diana DeGette (Democratic)Michael K. Simpson (Republican)James P. McGovern (Democratic)Michelle Steel (Republican)Dan Crenshaw (Republican)Brian K. Fitzpatrick (Republican)Jay Obernolte (Republican)Deborah K. Ross (Democratic)Juan Ciscomani (Republican)Lori Trahan (Democratic)Elissa Slotkin (Democratic)Burgess Owens (Republican)Yadira Caraveo (Democratic)Greg Pence (Republican)Josh Gottheimer (Democratic)Zoe Lofgren (Democratic)Nanette Diaz Barragán (Democratic)Kevin Mullin (Democratic)Jason Crow (Democratic)Bradley Scott Schneider (Democratic)Bill Johnson (Republican)Michelle Fischbach (Republican)Troy Balderson (Republican)Katie Porter (Democratic)Susan Wild (Democratic)

Ways and Means Committee, Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationGovernment studies and investigationsHealth care coverage and accessHealth information and medical recordsHealth technology, devices, suppliesHome and outpatient careHospital careMedicare