CMS, FDA team up to fast-track reimbursement for breakthrough devices
The FDA and CMS announced a new Medicare coverage pathway, RAPID, to fast-track reimbursement for breakthrough medical devices. The program aims to synchronize the FDA's premarket review process with Medicare's coverage determination to speed up patient access to innovative technology.
The FDA and CMS have launched a new Medicare coverage pathway called RAPID to expedite reimbursement for breakthrough medical devices. The program seeks to align the FDA's premarket review process with Medicare's coverage determination. This alignment aims to ensure that enough data is collected before authorization, enabling Medicare to cover products soon after they hit the market. Medicare Deputy Administrator John Brooks stated that the initiative will provide device manufacturers with clear targets for Medicare coverage. The goal is to speed up patient access to life-saving treatments. The new pathway addresses industry complaints about the lengthy time it takes for Medicare to pay for innovative technology.
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