A prefabricated, off-the-shelf (OTS) knee orthosis. Code L1852 describes a prefabricated, OTS knee orthoses with: - Double uprights,
- Condylar pads,
- Adjustable flexion and extension joint,
- Both medial-lateral and rotation control.
- Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. - Rotation control is accomplished by the combination of solid metal (or similar material) in the anterior portion of the thigh and calf cuffs, and the condylar pads. These are designed for patients who are fully ambulatory. An orthosis (brace) is: - Rigid or semi-rigid device which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body
- Must provide support and counterforce (i.e., a force in a defined direction of a magnitude at least as great as a rigid or semi-rigid support) on the limb or body part being braced
Off-the-shelf (OTS) orthotics are: - Prefabricated Items.
- May or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
- OTS items requiring minimal self-adjustment for fitting at the time of delivery and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual.
- Do not require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthoses to fit the item to the individual beneficiary.
The term “minimal self-adjustment” is defined at 42 CFR §414.402 as an adjustment the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and does not require the services of a certified orthotist or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered OTS
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