Congress is introducing bipartisan bills to expedite Medicare coverage for breakthrough medical technologies, addressing delays in patient access caused by the current complex process. The 21st Century Cures Act aimed to prioritize FDA review of new medical devices, but FDA approval does not ensure Medicare coverage. Critics express concerns about potential cost increases, yet data shows only a small percentage of devices would qualify for coverage, with minimal cost impact on the CMS budget. Proponents highlight the clinical benefits and cost savings from improved patient outcomes. The legislative efforts seek to maintain U.S. leadership in medical technology innovation by reducing barriers to adopting breakthrough devices.
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