42 C.F.R. § 405.209 Payment for a non-experimental/investigational (Category B) device.
Title 42 - Public Health
Payment under Medicare for a non-experimental/investigational (Category B) 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.
Title 42: Public Health
PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology
§ 405.209 Payment for a non-experimental/investigational (Category B) device.

