C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES › Subpart D—Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices

42 C.F.R. § 414.224

Customized items

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(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]
Notes of Decisions
Cited in 2 cases, 1998–2005 · leading case: Warder v. Shalala, 149 F.3d 73 (1st Cir. 1998).
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Warder v. Shalala, 149 F.3d 73 (1st Cir. 1998). · cites it 2× “” 42 C.F.R. § 414.224 . In effect, Congress, and subsequently HCFA, treated as DME any wheelchair modified in light of an individual patient’s disability, per a physician’s instructions.”
Power Mobility Coalition v. Leavitt, 404 F. Supp. 2d 190 (D.D.C. 2005). “(quoting 42 C.F.R. § 414.224 (a)). All Medicare coverage is limited to services that are medically “reasonable and necessary” for the diagnosis or treatment of illness.”
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