Item means a product included in a competitive bidding program that is identified by a HCPCS code, which may be specified for competitive bidding (for example, a product when it is furnished through mail order), or a combination of codes and/or modifiers, and includes the services directly related to the furnishing of that product to the beneficiary. Items that may be included in a competitive bidding program are:
(1) Durable medical equipment (DME) other than class III devices under the Federal Food, Drug and Cosmetic Act, as defined in § 414.202, group 3 complex rehabilitative power wheelchairs, complex rehabilitative manual wheelchairs, manual wheelchairs described by HCPCS codes E1235, E1236, E1237, E1238, and K0008, and related accessories when furnished in connection with such wheelchairs, and further classified into the following categories:
(i) Inexpensive or routinely purchased items, as specified in § 414.220(a).
(ii) Items requiring frequent and substantial servicing, as specified in § 414.222(a).
(iii) Oxygen and oxygen equipment, as specified in § 414.226(c)(1).
(iv) Other DME (capped rental items), as specified in § 414.229.
(2) Supplies necessary for the effective use of DME other than inhalation and infusion drugs.
(3) Enteral nutrients, equipment, and supplies.
(4) Off-the-shelf orthotics, which are orthotics described in section 1861(s)(9) of the Act that require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling or customizing to fit a beneficiary.


42 CFR § 414.402

Scoping language

For purposes of this subpart, the following definitions apply:

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