Ensuring Patient Access to Critical Breakthrough Products Act of 2021
- Last Action
- 6/23/2021
Actions
- 2021-06-23Referred to the Subcommittee on Health.
- 2021-06-22Referred to the Subcommittee on Health.
- 2021-06-22Referred 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.
- 2021-06-22Referred 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.
- 2021-06-22Introduced in House
- 2021-06-22Introduced in House
CRS Summary
As of 2021-06-22 (00)
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 (20)
- Jackie Walorski (R-IN)
- Tony Cárdenas (D-CA)
- Gus Bilirakis (R-FL)
- Terri Sewell (D-AL)
- FRED UPTON (R-MI)
- Thomas Suozzi (D-NY)
- Chrissy Houlahan (D-PA)
- Neal Dunn (R-FL)
- Ami Bera (D-CA)
- JAMES MCGOVERN (D-MA)
- Brendan Boyle (D-PA)
- J. Correa (D-CA)
- Brad Wenstrup (R-OH)
- Dan Crenshaw (R-TX)
- Kim Schrier (D-WA)
- Susan Wild (D-PA)
- Chris Pappas (D-NH)
- Scott Peters (D-CA)
- Angie Craig (D-MN)
- David McKinley (R-WV)
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.