This document addresses the intended use of custom-made (that is, custom fabricated, custom molded) functional and unloader knee braces. This document does not address custom-fitted, prefabricated knee braces.

Note: Please refer to the following document for additional information concerning knee braces:

• CG-OR-PR-02 Prefabricated and Prophylactic Knee Braces

Clinical Indications

Medically Necessary:

1. Custom-made (custom fabricated, custom molded) unloader knee braces are considered medically necessary as an alternative to a prefabricated (custom-fitted) knee brace for the treatment of unicompartmental osteoarthritis with or without valgus/varus deformity, when any of the following criteria are met:
   1. Individual is a candidate for high tibial osteotomy or total knee arthroplasty (replacement) and may elect non-surgical treatment; or
   2. To predict the success of high tibial osteotomy versus total knee arthroplasty; or
   3. Individual has severe patellofemoral arthrosis in conjunction with medial or lateral compartment arthrosis.
2. Custom-made (custom fabricated, custom molded) functional knee braces may be medically necessary as an alternative to a prefabricated (custom-fitted) knee brace when the individual meets any of the following criteria, including but not limited to:
   1. Abnormal limb contour (disproportionate size of thigh and calf); or
   2. Knee deformity that interferes with fitting (valgus or varus limb); or
   3. Minimal muscle mass upon which to suspend an orthosis.

Not Medically Necessary:

Custom-made (custom molded, custom fabricated) knee braces, functional or unloader, are considered not medically necessary when the above criteria are not met.