42 CFR § 405.209
Payment for a Category B (Nonexperimental/investigational) device
June 11, 2020
Payment under Medicare for a Category B (Nonexperimental/investigational) device is based on, and may not exceed, the amount that would have been paid for a currently used device serving the same medical purpose that has been approved or cleared for marketing by the FDA.
[78 FR 74809, Dec. 10, 2013]
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