CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—MEDICARE PROGRAM (parts 405 to 426) > PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED > SUBPART B—Medical Services Coverage Decisions That Relate to Health Care Technology (§405.201 to §405.215) > 405.209—Payment for a non-experimental/investigational (Category B) device.

405.209—Payment for a non-experimental/investigational (Category B) device.

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.