Bill Summary:

This bill aims to ensure that breakthrough medical devices are promptly covered under the Medicare program. Breakthrough devices are new technologies that have the potential to significantly improve patient outcomes. The bill establishes a transitional coverage period for these devices and outlines criteria for designating a device as breakthrough. It also requires a timely national coverage determination for breakthrough devices.

Bill Details:

Short Title: Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Section 2: Ensures prompt coverage of breakthrough devices under the Medicare program through a transitional coverage period and sets criteria for designating a device as breakthrough.
Designation Process: Manufacturers can apply for breakthrough status for their devices, with the Secretary making determinations within 6 months.
National Coverage Determination: Requires a final decision on coverage for breakthrough devices before the end of the transitional period.

Funding:

An additional $10 million per year for fiscal years 2025 to 2030 is appropriated to the Centers for Medicare & Medicaid Services Program Management Account to support the implementation of the bill.

Sen. John Curtis

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