Code of Federal Regulations Title 42. Public Health § 42.405.603 Medical device eligibility

(a) That are FDA–designated breakthrough devices.

(b) That were FDA market authorized on [Enter date 2 years prior to effective date of final rule] and thereafter.

(c) That are used according to their FDA approved or cleared indication for use.

(d) That are within a Medicare benefit category.

(e) That are not the subject of a Medicare national coverage determination.

(f) That are not otherwise excluded from coverage through law or regulation.