Ensures prompt Medicare coverage for breakthrough medical devices.
The Ensuring Patient Access to Critical Breakthrough Products Act amends title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program. The Secretary of Health and Human Services must designate a device as a breakthrough device if it meets specified criteria, including being provided with priority review and not presenting an undue risk of harm. Medicare coverage is ensured during a four-year transitional period.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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