StacksVerified U.S. regulatory reference

42 CFR §405.209

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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.