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(a) The Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) is used as a universal coding database for orthotic, prosthetic and pedorthic devices. To determine the appropriate level of supervision the following categorization are used:
(1) "Custom fabricated device" means an orthosis, prosthesis or pedorthic device fabricated to comprehensive measurements and/or a mold or patient model, for use by a patient in accordance with a prescription and which requires clinical and technical judgment in its design, fabrication and fitting. Only licensees whose scope of practice allows for provision of custom fabricated devices should provide care in the fitting of custom fabricated devices.
(2) "Custom fitted device" means a prefabricated orthosis or pedorthic device which is manufactured in quantity without a specific patient in mind. The device may be supplied as separate prefabricated components that require some assembly and/or fitting and adjustment. These orthoses or pedorthic devices must be trimmed, bent, molded (with or without heat) or otherwise modified for use by a specific patient.
(3) “Off-the-shelf device” means a prefabricated orthosis sized and/or modified for interim, evaluative or short-term use by the patient themselves, in accordance with a prescription and which does not require clinical judgment and alteration for appropriate use. There is no supervision requirement for the dispensing of this type of device.
(4) "Over-the-counter device" means a prefabricated, mass-produced device that is prepackaged and requires no professional advice or judgment in either size selection or use. There is no supervision requirement for the dispensing of this type of device.