Ensuring Patient Access to Critical Breakthrough Products Act of 2024

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).

Bill 118 HR 1691, also known as the Ensuring Patient Access to Critical Breakthrough Products Act of 2023, aims to improve patient access to innovative medical products that have received breakthrough designation from the Food and Drug Administration (FDA).

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.