(a) When payment is not made. Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered because CMS determines the device is not ``reasonable'' and ``necessary'' under section 1862(a)(1)(A) of the Act or because it is excluded from coverage for other reasons. These services include all services furnished in preparation for the use of a noncovered device, services furnished contemporaneously with and necessary to the use of a noncovered device, and services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related noncovered services.
(b) When payment is made. Medicare payment may be made for--
(1) Covered services to treat a condition or complication that arises due to the use of a noncovered device or a noncovered device-related service; or
(2) Routine care items and services related to Category A (Experimental) devices as defined in Sec. 405.201(b), and furnished in conjunction with FDA-approved clinical studies that meet the coverage requirements in Sec. 405.211.
(3) Routine care items and services related to Category B (Nonexperimental/investigational) devices as defined in Sec. 405.201(b), and furnished in conjunction with FDA-approved clinical studies that meet the coverage requirements in Sec. 405.211. [60 FR 48423, Sept. 19, 1995, as amended at 69 FR 66420, Nov. 15, 2004; 78 FR 74809, Dec. 10, 2013]