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NEW YORK (360Dx) – The Centers for Medicare & Medicaid Services has proposed changes to its payment policy for medical devices that are part of the US Food and Drug Administration's 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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