What's Happening?
AdvaMed, along with 66 other groups, has urged the Centers for Medicare and Medicaid Services (CMS) to establish a streamlined pathway for covering breakthrough medical devices. In a letter to CMS Administrator Dr. Mehmet Oz, AdvaMed highlighted the delay between FDA authorization and Medicare coverage, advocating for a program similar to the withdrawn Medicare Coverage of Innovative Technology (MCIT) framework. The MCIT would have provided immediate national coverage for four years for new breakthrough devices approved by the FDA.
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Why It's Important?
Accelerating Medicare coverage for breakthrough devices is crucial for ensuring timely access to innovative medical technologies for patients. The current delays in coverage can hinder the adoption of life-saving devices and impact patient outcomes. AdvaMed's proposal aims to create a predictable and efficient pathway for Medicare coverage, potentially benefiting patients and the medtech industry by facilitating quicker access to new technologies.
What's Next?
CMS's response to AdvaMed's proposal will be pivotal in shaping the future of Medicare coverage for breakthrough devices. Legislative efforts to incorporate aspects of the MCIT framework into U.S. law are ongoing, but progress has been slow. The medtech industry and patient advocacy groups may continue to push for reforms to ensure consistent and timely access to innovative medical devices.
