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Ensuring Patient Access to Critical Breakthrough Products Act of 2021

USA117th CongressHR-4043| House 
| Updated: 6/23/2021
Suzan K. DelBene

Suzan K. DelBene

Democratic Representative

Washington

Cosponsors (33)
Kim Schrier (Democratic)Chris Pappas (Democratic)Chrissy Houlahan (Democratic)Neal P. Dunn (Republican)Pete Aguilar (Democratic)Brad R. Wenstrup (Republican)Terri A. Sewell (Democratic)Jackie Walorski (Republican)J. Luis Correa (Democratic)Madeleine Dean (Democratic)Tony Cárdenas (Democratic)Scott H. Peters (Democratic)Angie Craig (Democratic)Thomas R. Suozzi (Democratic)Jake Auchincloss (Democratic)Ted Lieu (Democratic)David B. McKinley (Republican)Jason Smith (Republican)Lloyd Smucker (Republican)Gus M. Bilirakis (Republican)Brendan F. Boyle (Democratic)Fred Upton (Republican)Carol D. Miller (Republican)Liz Cheney (Republican)Mike Kelly (Republican)John Joyce (Republican)Ami Bera (Democratic)Conor Lamb (Democratic)James P. McGovern (Democratic)Michelle Steel (Republican)Tom Emmer (Republican)Dan Crenshaw (Republican)Susan Wild (Democratic)

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

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Ensuring Patient Access to Critical Breakthrough Products Act of 2021 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

Bill from Previous Congress

HR 116-5333
Ensuring Patient Access to Critical Breakthrough Products Act of 2019
Jun 22, 2021
Introduced in House
Jun 22, 2021
Referred to the Subcommittee on Health.
Jun 22, 2021
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.
Jun 23, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

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


  • June 22, 2021
    Introduced in House


  • June 22, 2021
    Referred to the Subcommittee on Health.


  • June 22, 2021
    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.


  • June 23, 2021
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 117-6000: Cures 2.0 Act
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 2021

USA117th CongressHR-4043| House 
| Updated: 6/23/2021
Ensuring Patient Access to Critical Breakthrough Products Act of 2021 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).
View Full Text

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
Jun 22, 2021
Introduced in House
Jun 22, 2021
Referred to the Subcommittee on Health.
Jun 22, 2021
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.
Jun 23, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

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


  • June 22, 2021
    Introduced in House


  • June 22, 2021
    Referred to the Subcommittee on Health.


  • June 22, 2021
    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.


  • June 23, 2021
    Referred to the Subcommittee on Health.
Suzan K. DelBene

Suzan K. DelBene

Democratic Representative

Washington

Cosponsors (33)
Kim Schrier (Democratic)Chris Pappas (Democratic)Chrissy Houlahan (Democratic)Neal P. Dunn (Republican)Pete Aguilar (Democratic)Brad R. Wenstrup (Republican)Terri A. Sewell (Democratic)Jackie Walorski (Republican)J. Luis Correa (Democratic)Madeleine Dean (Democratic)Tony Cárdenas (Democratic)Scott H. Peters (Democratic)Angie Craig (Democratic)Thomas R. Suozzi (Democratic)Jake Auchincloss (Democratic)Ted Lieu (Democratic)David B. McKinley (Republican)Jason Smith (Republican)Lloyd Smucker (Republican)Gus M. Bilirakis (Republican)Brendan F. Boyle (Democratic)Fred Upton (Republican)Carol D. Miller (Republican)Liz Cheney (Republican)Mike Kelly (Republican)John Joyce (Republican)Ami Bera (Democratic)Conor Lamb (Democratic)James P. McGovern (Democratic)Michelle Steel (Republican)Tom Emmer (Republican)Dan Crenshaw (Republican)Susan Wild (Democratic)

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

Health

Related Bills

  • HR 117-6000: Cures 2.0 Act
  • 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