U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

Searching within: All TitlesTitle 42Chapter IVPart 405Subpart B - Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology
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§ 405.209 - Payment for a Category B (Nonexperimental/investigational) device.

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]