US HB5333 | 2019-2020 | 116th Congress

Status

Spectrum: Bipartisan Bill
Status: Introduced on December 6 2019 - 25% progression, died in committee
Action: 2019-12-09 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Summary

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).

Tracking Information

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Title

Ensuring Patient Access to Critical Breakthrough Products Act of 2019

Sponsors


History

DateChamberAction
2019-12-09HouseReferred to the Subcommittee on Health.
2019-12-06HouseReferred 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.
2019-12-06HouseReferred 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.
2019-12-06HouseIntroduced in House

Same As/Similar To

SB3914 (Related) 2020-06-08 - Read twice and referred to the Committee on Finance.

Subjects


US Congress State Sources


Bill Comments

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