Clinical UM Guideline
|Subject:||Prefabricated and Prophylactic Knee Braces|
|Guideline #:||CG-OR-PR-02||Current Effective Date:||06/28/2016|
|Status:||Reviewed||Last Review Date:||05/05/2016|
This document addresses the intended use of prefabricated functional or rehabilitation knee braces and prophylactic knee braces.
Note: Please refer to the following document for additional information concerning knee braces:
Prefabricated functional or rehabilitation knee braces are considered medically necessary for individuals when any of the following criteria are met:
Not Medically Necessary:
Prefabricated functional or rehabilitation knee braces are considered not medically necessary for individuals who are status post knee surgery when the criteria are not met, including, but not limited to TKA (unless there is documented ligament insufficiency).
Prefabricated functional or rehabilitation knee braces are considered not medically necessary for non-surgical indications when the criteria are not met.
Prophylactic knee braces are considered not medically necessary for all indications.
Note: Individuals with height (tall or short stature) or weight (obesity) variations can be fitted with a prefabricated (custom-fitted) knee brace with any of the following adjustments:
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.
|K0901||Knee orthosis (KO), 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, prefabricated, off-the-shelf|
|K0902||Knee orthosis (KO), 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, prefabricated, off-the-shelf|
|L1810||Knee orthosis, elastic with joints, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise|
|L1812||Knee orthosis, elastic with joints, prefabricated, off-the-shelf|
|L1820||Knee orthosis, elastic with condylar pads and joints, with or without patellar control, prefabricated, includes fitting and adjustment|
|L1830||Knee orthosis, immobilizer, canvas longitudinal, prefabricated, off-the-shelf|
|L1831||Knee orthosis, locking knee joint(s), positional orthosis, prefabricated, includes fitting and adjustment|
|L1832||Knee orthosis, adjustable knee joints (unicentric or polycentric), positional orthosis, rigid support, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise|
|L1833||Knee orthosis, adjustable knee joints (unicentric or polycentric), positional orthosis, rigid support, prefabricated, off-the shelf|
|L1836||Knee orthosis, rigid, without joint(s), includes soft interface material, prefabricated, off-the-shelf|
|L1843||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; prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise|
|L1845||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; prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise|
|L1847||Knee orthosis, double upright with adjustable joint, with inflatable air support chamber(s), prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise|
|L1848||Knee orthosis, double upright with adjustable joint, with inflatable air support chamber(s), prefabricated, off-the-shelf|
|L1850||Knee orthosis, Swedish type, prefabricated, off-the-shelf|
Prefabricated knee braces, also known as off-the-shelf knee braces, are manufactured in standard sizes and require only minimal adjustments. These braces are custom-fitted to the extent that the individual is fitted to a limited selection of sizes (that is, small, medium, large, extra-large) and only require measurements and a sizing chart for fitting. A prefabricated knee brace may be modified by an individual with expertise with minimal adjustments that have been assembled, bent, trimmed, molded, or otherwise customized to fit the specific person. A custom-fitted, prefabricated knee brace should not be confused with a custom-made knee brace.
Knee braces can be subdivided into four categories based on their intended use: prophylactic braces, rehabilitation braces, functional braces, and unloader knee braces. With the exception of unloader (custom-made) knee braces (see CG-OR-PR-03 Custom-made Knee Braces); these categories are defined as follows:
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, 1968; Kellgren, 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. Prefabricated (Off-the-shelf, Custom-fitted) Knee Braces (Not intended to be a complete list of devices.)
|Advanced Orthopaedics (Philadelphia, PA)||ACL Knee Brace, Advanced Hinged Range of Motion, Airprene Hinged, Cobra Unloaded Knee, Deluxe Hinged, F.M. Hinged, Min-Knee Hinged Knee Brace, TM Wrap-Around Hinged Knee Brace, Wrap-Around Hinged Knee Brace|
|Bauerfeind USA, Inc. (Marietta, GA)||MOS Genu®, SecuTec® Genu, SofTec® series,|
|Bledsoe Brace Systems (Grand Prairie, TX)||Aligner, Axiom series, Crossover series, Extender Plus, G3, Jet, Lever Lock, Merit, Merit OR, OA Impulse, Original Knee Brace, Primas, Revolution 3, Thruster, Z-12, Z-13, 20.50|
|Comfy Splints (Lenjoy Medical Engineering, Inc, Gardena, CA)||Comfy™ and Comfyprene™ series|
|DeRoyal® Industries (Powell, TN)||Deluxe Hinged, Flexgard™, Functional ACL, Hypercontrol®, M.3 or M.4® S Functional Knee Brace, OA Upright series, Slimline series, Transition series, Warrior® series|
DJO, LLC (Vista, CA)
|4TITUDE™, A22 Custom, ACL Everyday, Armor series, Competitor, Defiance series, Drytex™ Hinged Knee models, ELS, Female Fource, Fource Point™, OA FullForce, Hinged Lateral J, IROM Playmaker, Legend, OA Adjuster, OA Assist, OA Everyday, OA FullForce, OA Nano™, Playmaker models, TROM models (cool, Rehab, telescoping, with or without shells), TROM models, X-Act ROM|
|Mueller Sports Medicine, Inc. (Prairie du Sac, WI)||Hg80® Hinged Knee Brace, Hg80® Knee Stabilizer, Mueller® Green Adjustable Hinged Knee, MuellerHinge™ 2100, PRO LEVEL™ Hinged Knee Brace Deluxe|
|Össur Americas (Foothill Ranch, CA)||Aspire®, C180 (various models), CTi® Series, Edge/Edge Lite, Extreme®, Flex® OTS, Flex Sport™, GII Unloader Express®, Innovator DLX®/DLX®+, Morph, OAsys® Carticare, MVP® Contour OTS, OAJ®, OASYS ® OTS, Paradigm® OTS, PCL Opposition, Rebound® Cartilage series, Rehab, Sentry™, Trainer OA, Trainer OTS, Unloader® ADJ, Unloader Express®, Unloader One®Plus, Unloader® Select, Unloader Spirit®|
|Townsend Design (Bakersfield, CA)||Active Reliever, Air Lite, Air Townsend, BOLD, Full Shell, Premier Series, Rebel Series, Reliever Series ROM Post Operative Knee Braces, SoftForce, Sport Series|
Anterior cruciate ligament (ACL) tear: An acute knee injury that occurs when the foot is planted, the knee is flexed, and a valgus force is applied to the knee with the lower leg in external rotation; commonly occurs in sports that require twisting, jumping, and pivoting.
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 2 bones to stabilize a joint.
Medial collateral ligament (MCL) injury: An acute knee injury that is the result of a blow to the lateral side of the knee when the foot is planted; a commonly occurring sports-related injury.
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.
Sprain: A partial or complete tear of a ligament.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Functional Knee Braces
Prophylactic Knee Braces
Rehabilitation Knee Braces
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 Table 2, Discussion and Reference sections. Removed ICD-9 codes from Coding section.|
|Revised||05/07/2015||MPTAC review. Updated Clinical Indications with format changes and minor revisions to the not medically necessary statements and the Note. Updated References section.|
|10/01/2014||Updated Coding section with 10/01/2014 HCPCS changes.|
|Reviewed||05/15/2014||MPTAC review. Updated Description, Discussion, Table 2, and Reference sections.|
|01/01/2014||Updated Coding section with 01/01/2014 HCPCS changes.|
|Reviewed||05/09/2013||MPTAC review. Updated Table 2, References, and Index.|
|Reviewed||05/10/2012||MPTAC review. Updated Discussion and References.|
|Reviewed||05/19/2011||MPTAC review. Updated Product Table, Definitions, Coding and References.|
|Revised||05/13/2010||MPTAC review. Clarified and reformatted Clinical Indications. Revised medically necessary indication for a prefabricated functional or rehabilitation knee brace for patellar fractures, expanding criteria to include patellar fractures that do not require surgical intervention. Updated Discussion, Product Tables and References.|
|01/01/2010||Updated Coding section with 01/01/2010 HCPCS changes; removed HCPCS L1800, L1815, L1825 deleted 12/31/2009.|
|Reviewed||05/21/2009||MPTAC review. Updated References and Product Tables.|
|Revised||05/15/2008||MPTAC review. Archived document CG-DME-02, split and renamed into two separate orthotic documents: Prefabricated and Prophylactic Knee Braces (CG-OR-PR-02) and Custom-made Knee Braces (CG-OR-PR-03). Updated Tables, Coding, Discussion, and Reference sections. Revised and added AAOS definitions.|
|01/01/2008||Updated Coding section with 01/01/2008 HCPCS changes; removed HCPCS codes L1855, L1858, L1870, L1880 deleted 12/31/2007. Removed Coding discussion from Definitions section.|
|Revised||05/17/2007||MPTAC review. Clinical indications clarified. References updated.|
|Reviewed||03/08/2007||MPTAC review. Clinical indications clarified. Discussion, Definitions, Coding and References updated.|
|Revised||03/23/2006||MPTAC review. The wording of the criteria under 1-d was changed to eliminate the time frame of 6 weeks. References and Coding updated.|
|11/17/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||04/28/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|Anthem, Inc.||04/28/05||DME 021||Knee Braces|
|WellPoint Health Networks, Inc.||09/23/04||9.07.02||Knee Braces|