Custom Fabricated And Fitted Devices

(1) “Custom fabricated and fitted device” means an orthosis, prosthesis, or pedorthic device which is fabricated to original measurements or a mold for use by a patient in accordance with a prescription from a health care practitioner authorized by law to write such prescriptions and which requires substantial clinical and technical judgment in its design and fitting. (2) “Custom fitted device” means a prefabricated orthosis, prosthesis, or pedorthic device sized or modified for use by the patient in accordance with a prescription from a health care practitioner authorized by law to write such prescriptions and which requires substantial clinical judgment and substantive alteration for appropriate use. (3) Custom fabricated devices and custom fabricated and fitted devices must be dispensed by a licensed health care practitioner or by a person licensed under these rules in accordance with a prescription from a licensed health care practitioner.