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Faster Access to Breakthrough Medical Devices in Medicare

This act aims to accelerate patient access to breakthrough medical devices under the Medicare program. This means new, innovative medical technologies will be available more quickly for individuals covered by Medicare, potentially improving their treatment and quality of life.
Key points
Establishes a 4-year transitional period for automatic Medicare coverage of breakthrough medical devices.
Implements a fast-track approval process for new medical devices by the Secretary, with a 6-month decision deadline.
Ensures national coverage decisions for innovative devices are made before the end of their transitional coverage period.
Allocates $10 million annually for fiscal years 2025-2030 for program management and implementation.
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Additional Information
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Print number: HR 1691
Sponsor: Rep. Wenstrup, Brad R. [R-OH-2]
Process start date: 2023-03-22