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Ensuring Patient Access to Critical Breakthrough Products Act of 2020

USA116th CongressS-3914| Senate 
| Updated: 6/8/2020
Martha McSally

Martha McSally

Republican Senator

Arizona

Finance Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Ensuring Patient Access to Critical Breakthrough Products Act of 2020 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 9, 2019

Latest Companion Bill Action

HR 116-5333
Referred to the Subcommittee on Health.
Jun 8, 2020
Introduced in Senate
Jun 8, 2020
Read twice and referred to the Committee on Finance.
  • December 9, 2019

    Latest Companion Bill Action

    HR 116-5333
    Referred to the Subcommittee on Health.


  • June 8, 2020
    Introduced in Senate


  • June 8, 2020
    Read twice and referred to the Committee on Finance.

Health

Related Bills

  • HR 116-5333: Ensuring Patient Access to Critical Breakthrough Products Act of 2019
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 2020

USA116th CongressS-3914| Senate 
| Updated: 6/8/2020
Ensuring Patient Access to Critical Breakthrough Products Act of 2020 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 9, 2019

Latest Companion Bill Action

HR 116-5333
Referred to the Subcommittee on Health.
Jun 8, 2020
Introduced in Senate
Jun 8, 2020
Read twice and referred to the Committee on Finance.
  • December 9, 2019

    Latest Companion Bill Action

    HR 116-5333
    Referred to the Subcommittee on Health.


  • June 8, 2020
    Introduced in Senate


  • June 8, 2020
    Read twice and referred to the Committee on Finance.
Martha McSally

Martha McSally

Republican Senator

Arizona

Finance Committee

Health

Related Bills

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