Ensuring Patient Access to Critical Breakthrough Products Act aims to expedite Medicare coverage for breakthrough medical devices.
The Ensuring Patient Access to Critical Breakthrough Products Act amends title XVIII of the Social Security Act to facilitate prompt coverage of breakthrough devices under the Medicare program. The bill defines a breakthrough device as one designated by the Secretary based on specific criteria, including priority review by the FDA and clinical data involving Medicare beneficiaries. It establishes a four-year transitional coverage period for these devices, during which Medicare must ensure coverage.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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