42 C.F.R. § 414.224 Customized items.
Title 42 - Public Health
(a) Criteria for a customized item. To be considered a customized item for payment purposes under paragraph (b) of this section, a covered item (including a wheelchair) must be uniquely constructed or substantially modified for a specific beneficiary according to the description and orders of a physician and be so different from another item used for the same purpose that the two items cannot be grouped together for pricing purposes. (b) Payment rule. Payment is made on a lump sum basis for the purchase of a customized item based on the carrier's individual consideration and judgment of a reasonable payment amount for each customized item. The carrier's individual consideration takes into account written documentation on the costs of the item including at least the cost of labor and materials used in customizing an item. [56 FR 65998, Dec. 20, 1991, as amended at 58 FR 34919, June 30, 1993]
Title 42: Public Health
PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
Subpart D—Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices
§ 414.224 Customized items.

