Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Latest action · Jun 23, 2021 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJun 22, 2021
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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).
Cosponsors 33
Members who signed on, in the order they did. Signatures ran from Jun 22, 2021 to Oct 7, 2022, with 5 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-MI | Fred Upton | Original | Jun 22, 2021 |
| R-FL | Gus M. Bilirakis | Original | Jun 22, 2021 |
| R-IN | Jackie Walorski | Original | Jun 22, 2021 |
| D-AL | Terri A. Sewell | Original | Jun 22, 2021 |
| D-CA | Tony Cárdenas | Original | Jun 22, 2021 |
| D-NY | Thomas R. Suozzi | Jul 30, 2021 | |
| D-PA | Chrissy Houlahan | Aug 31, 2021 | |
| R-FL | Neal P. Dunn | Aug 31, 2021 | |
| D-CA | Ami Bera | Sep 21, 2021 | |
| D-PA | Brendan F. Boyle | Sep 21, 2021 | |
| D-MA | James P. McGovern | Sep 21, 2021 | |
| R-OH | Brad R. Wenstrup | Sep 30, 2021 | |
| R-TX | Dan Crenshaw | Sep 30, 2021 | |
| D-CA | J. Luis Correa | Sep 30, 2021 | |
| D-WA | Kim Schrier | Oct 15, 2021 | |
| D-NH | Chris Pappas | Oct 22, 2021 | |
| D-PA | Susan Wild | Oct 22, 2021 | |
| D-CA | Scott H. Peters | Nov 5, 2021 | |
| D-MN | Angie Craig | Nov 16, 2021 | |
| R-WV | David B. McKinley | Nov 16, 2021 | |
| R-PA | Mike Kelly | Nov 16, 2021 | |
| D-CA | Ted Lieu | Nov 16, 2021 | |
| R-WV | Carol D. Miller | Jan 21, 2022 | |
| R-WY | Liz Cheney | Jan 21, 2022 | |
| R-PA | Lloyd Smucker | Jan 21, 2022 | |
| D-PA | Madeleine Dean | Jan 21, 2022 | |
| R-CA | Michelle Steel | Jan 21, 2022 | |
| D-CA | Pete Aguilar | Jan 21, 2022 | |
| R-MN | Tom Emmer | Jan 21, 2022 | |
| R-PA | John Joyce | Mar 15, 2022 | |
| R-MO | Jason Smith | Mar 17, 2022 | |
| D-PA | Conor Lamb | Apr 6, 2022 | |
| D-MA | Jake Auchincloss | Oct 7, 2022 |
Actions 4
Everything that happened, newest first.
- Jun 23, 2021Referred to the Subcommittee on Health.
- Jun 22, 2021Introduced in House
- Jun 22, 2021Referred 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 22, 2021Referred to the Subcommittee on Health.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 6000 | Cures 2.0 Act | Related bill | Jan 4, 2022 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Jun 22, 2021Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.