Ensuring Patient Access to Critical Breakthrough Products Act of 2024
- Last Action
- 12/24/2024
Actions
- 2024-12-24Placed on the Union Calendar, Calendar No. 801.
- 2024-12-24Committee on Energy and Commerce discharged.
- 2024-12-24Committee on Energy and Commerce discharged.
- 2024-12-24Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
- 2024-12-24Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
- 2024-06-27Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.
- 2024-06-27Committee Consideration and Mark-up Session Held
- 2023-11-15Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.
- 2023-11-15Subcommittee Consideration and Mark-up Session Held
- 2023-03-31Referred to the Subcommittee on Health.
- 2023-03-22Referred 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.
- 2023-03-22Referred 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.
- 2023-03-22Introduced in House
- 2023-03-22Introduced in House
CRS Summary
As of 2023-03-22 (00)
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).
Cosponsors (20)
- Suzan DelBene (D-WA)
- Gus Bilirakis (R-FL)
- Tony Cárdenas (D-CA)
- Blake Moore (R-UT)
- Terri Sewell (D-AL)
- Brett Guthrie (R-KY)
- ANNA ESHOO (D-CA)
- John Joyce (R-PA)
- Ann Kuster (D-NH)
- Dan Crenshaw (R-TX)
- Derek Kilmer (D-WA)
- Carol Miller (R-WV)
- Angie Craig (D-MN)
- Michelle Steel (R-CA)
- Madeleine Dean (D-PA)
- Don Bacon (R-NE)
- Scott Peters (D-CA)
- Troy Balderson (R-OH)
- Jake Auchincloss (D-MA)
- John Curtis (R-UT)
Subjects
- Congressional oversight
- Drug safety, medical device, and laboratory regulation
- Government studies and investigations
- Health care coverage and access
- Health information and medical records
- Health technology, devices, supplies
- Home and outpatient care
- Hospital care
- Medicare
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.