1. CMS Proposes Changes to Payments Tied to FDA Breakthrough Device Program

    CMS Proposes Changes to Payments Tied to FDA Breakthrough Device Program

    The proposed policy would waive for two years a requirement that a device maker show that their product demonstrates 'substantial clinical improvement.' It also would increase the add-on payment to device makers of such breakthrough devices to a maximum of 65 percent of the cost of the technology from the current 50 percent.

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