Clinical UM Guideline
|Subject:||Custom-made Knee Braces|
|Guideline #:||CG-OR-PR-03||Current Effective Date:||06/28/2016|
|Status:||Reviewed||Last Review Date:||05/05/2016|
This document addresses the intended use of custom-made (i.e. 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:
A. 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:
B. 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:
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.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|L1834||Knee orthosis; without knee joint, rigid, custom fabricated|
|L1840||Knee orthosis; derotation, medial-lateral, anterior cruciate ligament, custom fabricated|
|L1844||Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotation control, with or without varus/valgus adjustment; custom fabricated|
|L1846||Knee orthosis; double upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotation control, with or without varus/valgus adjustment, custom fabricated|
|L1860||Knee orthosis; modification of supracondylar prosthetic socket, custom fabricated (SK)|
|L2861||Addition to lower extremity joint, knee or ankle, concentric adjustable torsion style mechanism for custom fabricated orthotics only, each [when specified as knee]|
*Note: The code L1844 may be used either for a medically necessary custom-made unloader knee brace (only considered medically necessary in members with osteoarthritis) or it may be used to describe either a non-covered custom-made functional or rehabilitation (used in a postoperative setting) knee brace.
Knee braces can be subdivided into four categories based on their intended use. One category of braces, unloader knee braces, is specifically designed to "provide pain relief in arthritic knees." Unloader knee braces, also referred to as off-loader knee braces, are typically custom-made (custom fabricated, custom molded) and are considered for individuals who are unable to be fitted with a prefabricated (off-the-shelf) knee brace.
Individuals with osteoarthritis of the knee with varus or valgus deformity often develop increased pain in the affected compartment due to increased mechanical loading. Unloader knee braces are designed and constructed to reduce the asymmetric loading in such knees. In order to decrease the weight on a painful knee joint, an unloader knee brace is designed to provide stability during activities of daily living. There is biomechanical data demonstrating reduction in adduction movement in varus knees when the appropriate unloader brace is used. In a systematic review of the literature, Raja and Dewan (2011) identified the existence of a number of high-quality clinical studies that recommend the use of an unloader knee brace as conservative management in the relief of signs and symptoms associated with medial compartment knee osteoarthritis.
Functional knee braces are defined as braces designed to assist or provide stability for the anterior cruciate ligament (ACL) or other ligament deficient knees, and provide protection for the ACL or other ligaments after knee repairs or reconstructions. Derotation braces are typically used after injuries to ligaments and have medial and lateral bars with varying hinge and strap designs. These derotation braces are designed to permit significant motion and speed; in many instances, the braces are worn only during elective activities, such as sports. Braces made of graphite, titanium, or other lightweight materials are specifically designed for high-performance sports. Functional knee braces have also been used in individuals with osteoarthritis in order to decrease the weight on painful joints. Functional knee braces are worn throughout the day for unstable knees during activities of daily living or sports and may be either prefabricated (off-the-shelf) or custom-made. Custom-made functional knee braces may be prescribed as an alternative to a prefabricated, custom-fitted knee brace when an individual has a deformity of the knee or leg that interferes with fitting, such as a disproportionate thigh and calf; or minimal muscle mass upon which to suspend an orthosis. Height (exceptionally tall or short stature) or weight (obesity) alone are insufficient reasons for a custom-made functional knee brace. These individuals can be fitted with a prefabricated (custom-fitted) knee brace with the following adjustments: extensions for an unusually tall person, a pediatric model for a person of short stature, or extra-large straps for an obese person.
Custom-made (custom molded, custom fabricated) unloader knee braces are fabricated specifically for an individual. These braces generally use basic materials, including, but not limited to, plastic, metal, leather, or cloth in the form of sheets or bars. Fabrication involves substantial work such as cutting, bending, molding, or sewing and may involve the incorporation of some prefabricated components. Constructing a custom-made knee brace involves much more work than a predominantly prefabricated item. A molded-to-member-model orthosis is a particular type of custom-made orthosis in which an impression of the specific body part is made by means of a plaster cast or computer aided design/computer aided manufacturing (CAD-CAM) technology. This impression is then used to make a positive model of plaster or other material of the body part. The orthosis is then molded on this positive model.
Different radiographic grading systems have been used to classify the degree of osteoarthritis of the knee joint in symptomatic individuals. The Ahlbäck classification and Kellgren and Lawrence grading systems outlined in Table 1 are used to describe the severity of articular cartilage changes associated with osteoarthritis. These grading systems can be used to determine if an individual with osteoarthritis is a candidate for a knee brace.
Table 1.The Ahlbäck classification of radiographic knee OA of the tibiofemoral joint and the Kellgren and Lawrence grading system (Ahlbäck S, 1968; Kellgren JH, 1963)
|Ahlbäck Grade||Ahlbäck Definition||Kellgren & Lawrence Grade||Kellgren & Lawrence Definition|
|Grade 1 Doubtful||Minute osteophyte, doubtful significance|
|Grade 2 Minimal||Definite osteophyte, unimpaired joint space|
|Grade I||Joint space narrowing (joint space < 3 mm)||Grade 3 Moderate||Moderate dimunition of joint space|
|Grade II||Joint space obliteration||Grade 4 Severe||Joint space greatly impaired with sclerosis of subchondral bone|
|Grade III||Minor bone attrition (0-5 mm)||Grade 4 Severe||Joint space greatly impaired with sclerosis of subchondral bone|
|Grade IV||Moderate bone attrition (5-10 mm)||Grade 4 Severe||Joint space greatly impaired with sclerosis of subchondral bone|
|Grade V||Severe bone attrition (>10 mm)||Grade 4 Severe||Joint space greatly impaired with sclerosis of subchondral bone|
Table 2. Custom-made Knee Braces (Not intended to be a complete list of devices.)
|Bledsoe Brace Systems (Grand Prairie, TX)||Axion OA-Custom (Axion series), OA AIR-Custom, Thruster RLF, Z-12 OA|
|DeRoyal® Industries (Powell, TN)||Custom Knee Braces, OA Knee Brace|
|DonJoy/dj Orthopedics (Vista, CA)||OA Defiance®|
|Össur Americas (Foothill Ranch, CA)||CTi® OA models (Pro Sport, Standard, Vapor®), Custom OA Unloader® models (ADJ®, LP®, One®, Select®, XT®)|
|Townsend Design (Bakersfield, CA)||Polio & Trigger series, Premier & Reliever series (Custom-fabricated models for severe osteoarthritis)|
Cartilage: A cellular tissue in adults that is specific to joints. A tough, fibrous material with high collagen content, such as found in the meniscus of the knee.
Instability: Looseness, unsteadiness, or an inability to withstand normal physiologic loading without mechanical deformation.
Knee brace: A limb orthosis or device intended for medical purposes that is worn on the lower extremity to support, to correct, or to prevent deformities, or to align body structures for functional improvement.
Ligament: A collagenous tissue that connects two bones to stabilize a joint.
Meniscus: A soft-tissue structure that lines some joints and provides load distribution, shock absorption, and lubrication.
Osteoarthritis (OA): A deterioration of the weight bearing surface distinguished by destruction of the hyaline cartilage and narrowing at the joint space.
Osteotomy: A surgical procedure in which bone is cut and realigned.
Unicompartmental osteoarthritis of the knee: A condition characterized by degenerative articular cartilage in the medial or lateral aspect of the tibiofemoral joint; may be associated with meniscal disruption, ligamentous instability, and malalignment.
Valgus deformity: Angulation of a distal bone away from the midline in relation to its proximal partner; also referred to as "bow-legged."
Varus deformity: Angulation of a distal bone toward the midline in relation to its proximal partner; also referred to as "knock-kneed."
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Custom Fabricated Knee Brace
Custom-made Functional Knee Brace
Custom-molded Knee Brace
Offloader Knee Brace
Unloader Knee Brace
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||05/05/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Description, Table 2 and Reference section. Removed ICD-9 codes from Coding section.|
|Reviewed||05/07/2015||MPTAC review. Updated Discussion/General Information, Reference and Websites sections.|
|Reviewed||05/15/2014||MPTAC review. Updated References and History sections.|
|Reviewed||05/09/2013||MPTAC review. Updated Table 2, References and Index.|
|Reviewed||05/10/2012||MPTAC review. Updated Discussion, Product Table and References.|
|Reviewed||05/19/2011||MPTAC review. Updated Product Table, Definitions, Coding and References.|
|Reviewed||05/13/2010||MPTAC review. Updated Discussion and References.|
|01/01/2010||Updated Coding section with 01/01/2010 HCPCS changes.|
|Reviewed||08/27/2009||MPTAC review. Updated Product Table and References.|
|Revised||08/28/2008||MPTAC review. Revised medically necessary Clinical Indications to address custom-made functional knee braces as an alternative to prefabricated knee braces when specific criteria are met. Clarified not medically necessary statement to include "functional or unloader" to describe the custom-made knee braces that are not medically necessary when criteria are not met. Updated Discussion, Coding and References.|
|New||05/15/2008||MPTAC review. Archived CG-DME-02, addressing custom-made knees braces as a separate and new clinical UM guideline. Clarified Clinical Indications. Revised the Discussion, Definitions (AAOS), and Index. References and Product Table updated.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|Anthem, Inc.||04/28/2005||DME.021||Knee Braces|
|WellPoint Health Networks, Inc.||09/23/2004||9.07.02||Knee Braces|