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US Health Regulators to Speed up Medicare Device Coverage
The program could cut Medicare coverage decisions to about 2 months after FDA authorization, officials said.
- On Thursday, the CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device pathway, designed to accelerate Medicare coverage for breakthrough medical devices to as little as two months.
- Previously, it took approximately one year or more to secure national Medicare coverage after FDA market authorization, leaving patients waiting for life-changing health technology despite regulatory approval.
- Regulators expect about 40 devices to be initially eligible for the accelerated pathway, with agencies collaborating earlier in development to align clinical trials with Medicare requirements.
- The Transitional Coverage for Emerging Technologies program will be paused for new candidates as the CMS focuses on successful RAPID implementation.
- AdvaMed called the program a "positive step," though CEO Scott Whitaker cautioned that meaningful timelines and effective management remain critical for patients to realize full benefits.
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FDA, CMS to Launch Speedy Coverage Pathway for Breakthrough Medical Devices
(MedPage Today) -- Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage at the same time under a new coverage pathway announced Thursday by the FDA and the Centers for Medicare...
·New York, United States
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Coverage Details
Total News Sources11
Leaning Left1Leaning Right0Center8Last UpdatedBias Distribution89% Center
Bias Distribution
- 89% of the sources are Center
89% Center
11%
C 89%
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