To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes.
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).
Read twice and referred to the Committee on Finance.
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held
Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.
Committee Consideration and Mark-up Session Held
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.
Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
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Committee on Energy and Commerce discharged.
Committee on Energy and Commerce discharged.
Placed on the Union Calendar, Calendar No. 801.