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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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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.