Ensuring Patient Access to Critical Breakthrough Products Act of 2021

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).

Bill 117 HR 4043, also known as the Ensuring Patient Access to Critical Breakthrough Products Act of 2021, 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 process for Medicare coverage of breakthrough devices and drugs by requiring the Centers for Medicare and Medicaid Services (CMS) to establish a pathway for coverage within 30 days of FDA approval. This would help ensure that patients have timely access to these potentially life-saving treatments.

Additionally, the bill includes provisions to encourage the development of breakthrough products by providing incentives for manufacturers, such as extended market exclusivity and priority review by the FDA. These incentives are intended to spur innovation and accelerate the availability of breakthrough therapies for patients in need. Overall, the Ensuring Patient Access to Critical Breakthrough Products Act of 2021 aims to improve patient access to innovative medical products, while also incentivizing the development of breakthrough therapies. It is a bipartisan effort to support the advancement of medical innovation and improve patient outcomes.