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Ensuring Patient Access to Critical Breakthrough Products Act of 2024
12/27/2024, 10:53 AM
Summary of Bill HR 1691
The bill seeks to streamline the regulatory process for these breakthrough products, making it easier for patients to access them in a timely manner. It also includes provisions to ensure that insurance coverage is provided for these products, so that cost is not a barrier to patients who need them.
Additionally, the bill includes measures to enhance communication between the FDA, healthcare providers, and patients about the availability and benefits of breakthrough products. This will help ensure that patients are informed about their treatment options and can make informed decisions about their healthcare. Overall, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 is aimed at improving patient access to innovative medical products and ensuring that patients have timely access to breakthrough treatments that can improve their health outcomes.
Congressional Summary of HR 1691
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 the Full Bill
Current Status of Bill HR 1691
Bipartisan Support of Bill HR 1691
Total Number of Sponsors
3Democrat Sponsors
0Republican Sponsors
3Unaffiliated Sponsors
0Total Number of Cosponsors
263Democrat Cosponsors
128Republican Cosponsors
135Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 1691
Primary Policy Focus
HealthPotential Impact Areas
Alternate Title(s) of Bill HR 1691
Comments
Abdiel Melton
11 months ago
This bill bad for us. It affects everyone negatively.
Katelyn McDowell
11 months ago
I think this bill is good for us, right? How will it help people like me get the medicine we need?
