405.211—Procedures for Medicare contractors in making coverage decisions for a non-experimental/investigational (Category B) device.

(a) General rule. In their review of claims for payment, Medicare contractors are bound by the statute, regulations, and all CMS administrative issuances, including all national coverage decisions.

(b) Potentially covered non-experimental/investigational (Category B) devices. Medicare contractors may approve coverage for any device with an FDA-approved IDE categorized as a non-experimental/investigational (Category B) device if all other coverage requirements are met.

(c) Other considerations. Medicare contractors must consider whether any restrictions concerning site of service, indications for use, or any other list of conditions for coverage have been placed on the device's use.

CFR

405.211—Procedures for Medicare contractors in making coverage decisions for a non-experimental/investigational (Category B) device.