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Ensuring Patient Access to Critical Breakthrough Products Act of 2019

USA116th CongressHR-5333| House 
| Updated: 12/9/2019
Suzan K. DelBene

Suzan K. DelBene

Democratic Representative

Washington

Cosponsors (8)
Roger Marshall (Republican)Jefferson Van Drew (Republican)Terri A. Sewell (Democratic)Jackie Walorski (Republican)Tony Cárdenas (Democratic)Scott Perry (Republican)Gus M. Bilirakis (Republican)Andy Kim (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 2019 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 three-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
Dec 6, 2019
Introduced in House
Dec 6, 2019
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.
Dec 9, 2019
Referred to the Subcommittee on Health.
Jun 8, 2020

Latest Companion Bill Action

S 116-3914
Introduced in Senate
  • December 6, 2019
    Introduced in House


  • December 6, 2019
    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.


  • December 9, 2019
    Referred to the Subcommittee on Health.


  • June 8, 2020

    Latest Companion Bill Action

    S 116-3914
    Introduced in Senate

Health

Related Bills

  • S 116-3914: Ensuring Patient Access to Critical Breakthrough Products Act of 2020
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 careMedicarePublic contracts and procurement

Ensuring Patient Access to Critical Breakthrough Products Act of 2019

USA116th CongressHR-5333| House 
| Updated: 12/9/2019
Ensuring Patient Access to Critical Breakthrough Products Act of 2019 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 three-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
Dec 6, 2019
Introduced in House
Dec 6, 2019
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.
Dec 9, 2019
Referred to the Subcommittee on Health.
Jun 8, 2020

Latest Companion Bill Action

S 116-3914
Introduced in Senate
  • December 6, 2019
    Introduced in House


  • December 6, 2019
    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.


  • December 9, 2019
    Referred to the Subcommittee on Health.


  • June 8, 2020

    Latest Companion Bill Action

    S 116-3914
    Introduced in Senate
Suzan K. DelBene

Suzan K. DelBene

Democratic Representative

Washington

Cosponsors (8)
Roger Marshall (Republican)Jefferson Van Drew (Republican)Terri A. Sewell (Democratic)Jackie Walorski (Republican)Tony Cárdenas (Democratic)Scott Perry (Republican)Gus M. Bilirakis (Republican)Andy Kim (Democratic)

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

Health

Related Bills

  • S 116-3914: Ensuring Patient Access to Critical Breakthrough Products Act of 2020
  • 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 careMedicarePublic contracts and procurement