Clinical UM Guideline


Subject:  Prefabricated and Prophylactic Knee Braces
Guideline #:  CG-OR-PR-02Current Effective Date:  07/15/2014
Status:ReviewedLast Review Date:  05/15/2014

Description

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:

Clinical Indications

Medically Necessary:

Prefabricated functional or rehabilitation knee braces are considered medically necessary for individuals when any of the following criteria are met:

  1. Documented anterior or posterior cruciate ligament (ACL or PCL) tears or functional instability episodes due to cruciate ligament insufficiency when non-surgical treatment is elected; or
  2. Grade II or III medial collateral or lateral collateral ligament sprain to support ambulation when the use of a hinged brace allows for controlled joint motion; or
  3. Posterior cruciate or posterior lateral reconstruction, including reconstruction after knee dislocation; or
  4. Recent surgery for ACL repair in the post-operative recovery phase; or
  5. Recent surgery for meniscal cartilage repair in the post-operative recovery phase; or
  6. Major ligament and bony reconstruction above the knee such as patella or quadriceps tendon repair, medial and lateral collateral ligament repair; or
  7. Major fractures requiring early post-injury or post-operative motion such as patella fractures or tibial plateau fractures; or
  8. Osteoarthritis of the knee (unicompartmental) who meet any of the following:
    • High tibial osteotomy or total knee arthroplasty (TKA) (replacement) candidate that may elect non-surgical treatment; or
    • To predict the success of high tibial osteotomy versus TKA; or
    • Severe patellofemoral arthrosis in conjunction with medial or lateral compartment arthrosis. 

Not Medically Necessary:

Prefabricated functional or rehabilitation knee braces are considered not medically necessary for individuals who are status post knee surgery when the above 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 above 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 the following adjustments:

Coding

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.

HCPCS 
L1810Knee 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
L1812Knee orthosis, elastic with joints, prefabricated, off-the-shelf
L1820Knee orthosis, elastic with condylar pads and joints, with or without patellar control, prefabricated, includes fitting and adjustment
L1830Knee orthosis, immobilizer, canvas longitudinal, prefabricated, off-the-shelf
L1831Knee orthosis, locking knee joint(s), positional orthosis, prefabricated, includes fitting and adjustment
L1832Knee 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
L1833Knee orthosis, adjustable knee joints (unicentric or polycentric), positional orthosis, rigid support, prefabricated, off-the shelf
L1836Knee orthosis, rigid, without joint(s), includes soft interface material, prefabricated, off-the-shelf
L1843Knee 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
L1845Knee 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
L1847Knee 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
L1848Knee orthosis, double upright with adjustable joint, with inflatable air support chamber(s), prefabricated, off-the-shelf
L1850Knee orthosis, Swedish type, prefabricated, off-the-shelf
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
 All diagnoses
  
Discussion/General Information

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:  

  1. Prophylactic knee braces: Braces designed to prevent or reduce the severity of ligament injuries in a relatively normal (stable) knee. These injuries, primarily to the medial collateral ligament, are among the most common athletic knee injuries. 
  2. Rehabilitation knee braces: Braces designed to allow protected and controlled motion of the injured knee treated operatively or non-operatively. These braces allow for controlled joint motion and typically consist of hinges that can be locked into place to limit range of motion. Rehabilitation braces are commonly used for 6 to 12 weeks after injury. Rehabilitation braces are usually purchased prefabricated (off-the-shelf) and can be ordered either as small, medium, or large, or by a size chart. Most rehabilitation knee braces can be adjusted within each size to allow for edema or atrophy, and are not custom-made.
  3. Functional knee braces: Braces designed to assist or provide stability for the ACL or other ligament deficient knees, and provide protection for the ACL or other ligaments after knee repairs or reconstructions. 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. 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.

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 GradeAhlbäck DefinitionKellgren & Lawrence GradeKellgren & Lawrence Definition
  Grade 1 DoubtfulMinute osteophyte, doubtful significance
  Grade 2 MinimalDefinite osteophyte, unimpaired joint space
Grade IJoint space narrowing (joint space < 3 mm)Grade 3 ModerateModerate dimunition of joint space
Grade IIJoint space obliterationGrade 4 SevereJoint space greatly impaired with sclerosis of subchondral bone
Grade IIIMinor bone attrition (0-5 mm)Grade 4 SevereJoint space greatly impaired with sclerosis of subchondral bone
Grade IVModerate bone attrition (5-10 mm)Grade 4 SevereJoint space greatly impaired with sclerosis of subchondral bone
Grade VSevere bone attrition (>10 mm)Grade 4 SevereJoint space greatly impaired with sclerosis of subchondral bone

 

Table 2. Prefabricated (Off-the-shelf, Custom-fitted) Knee Braces

Manufacturer Brand Name
Bauerfeind USA, Inc. (Marietta, GA)SecuTec® Genu, SofTec® Genu, SofTec® OA
Bledsoe Brace Systems (Grand Prairie, TX)AlignAir Z-13, Aligner ESE, Axiom, Axiom-D, Axiom-OA, Axiom OTS, Axiom-D OTS, Axiom Sport, Bledsoe Z-12 OA, Bledsoe 20.50 Patellofemoral, Crossover, Crossover ROM, Extender Plus, Lever Lock, Merit OR, OA Air, Original Knee Brace, Primas-D PCL, Revolution 3, Thruster RLF, Ultimate Cl, Ultimate Dynamic, Ultimate Sport 
Comfy Splints (Lenjoy Medical Engineering, Inc, Gardena, CA)Comfy Standard Knee, Comfy Goniometer Knee, Spring-Loaded Goniometer Knee
DeRoyal® Industries (Powell, TN)Flexgard™, Hypercontrol®, Slimline, Slimline II, Transition, Warrior®, Warrior® II Deluxe Hinged, M.4® S Functional Knee Brace, M.3® OA Knee Brace, M.4® OA Knee Brace
DonJoy/dj Orthopedics DJO, LLC (Vista, CA)4TITUDE™, ACL Everyday, Armor, Armor FourcePoint, Competitor, Defiance, Defiance III, Drytex™ Hinged Knee models, Female Fource, Fource Point™, FULLFORCE, IROM Playmaker, Lateral J, Legend, OA Adjuster, OA Assist, OA Everyday, OA FullForce, OA Nano™, Playmaker models, TROM models (cool, ELS, 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; PRO-LEVEL™ Hinged Knee Brace Deluxe, MuellerHinge™ 2100
Össur Americas (Foothill Ranch, CA)Aspire®, C180 (various models), CTi® (various models), Edge/Edge Lite, Flex® OTS, Flex Sport™, GII Unloader Express®, Innovator DLX®/DLX®+, Morph, OAsys® Carticare, MVP® Contour OTS, OAJ®, Paradigm® OTS, PCL Opposition, Rebound® Cartilage, Rehab, Sentry™, Trainer OA, Trainer OTS, Unloader® ADJ, Unloader Express®, Unloader One®Plus, Unloader® Select, Unloader Spirit®
Townsend Design (Bakersfield, CA)Air Lite, Air Townsend, Premier Series, Rebel Series, ROM Post Operative Knee Braces, Sport Series
  
Definitions

Anterior cruciate ligament 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 two bones to stabilize a joint.

Medial collateral ligament 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.

References

Peer Reviewed Publications:

  1. Ahlbäck S. Osteoarthrosis of the knee: a radiographic investigation. Acta Radiol Stockholm 1968; (suppl 277):7-72.
  2. Andersson D, Samuelsson K, Karlsson J. Treatment of anterior cruciate ligament injuries with special reference to surgical technique and rehabilitation: an assessment of randomized controlled trials. Arthroscopy. 2009; 25(6):653-685.
  3. Beaudreuil J, Bendaya S, Faucher M, et al. Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee  braces in knee osteoarthritis. Joint Bone Spine. 2009; 76(6):629-636.
  4. Beynnon BD, Fleming BC, Churchill DL, Brown D. The effect of anterior cruciate ligament deficiency and functional bracing on translation of the tibia relative to the femur during non-weight bearing and weight bearing. Am J Sports Med. 2003; 31(1):99-105.
  5. Birmingham TB, Bryant DM, Giffin JR, et al. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve use after anterior cruciate ligament reconstruction. Am J Sports Med. 2008; 36(4):648-655.
  6. Brouwer RW, van Raaij TM, Verharr JA, et al. Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial. Osteoarthritis Cartilage. 2006; 14(8):777-783.
  7. Chew KT, Lew HL, Date E, Fredericson M. Current evidence and clinical applications of therapeutic knee braces. Am J Phys Med Rehabil. 2007; 86(8):678-686.
  8. DeVita P, Lassiter T, Hortobagyi T, Torry M. Functional knee brace effects during walking in patients with anterior cruciate ligament reconstruction. Am J Sports Med 1998; 26(6):778-784.
  9. Feller J, Bartlett J, Chapman S, Delahunt M. Use of an extension-assisting brace following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1997; 5(1):6-9.
  10. Fitzgerald GK, Axe MJ, Snyder-Mackler L. Proposed practice guidelines for nonoperative anterior cruciate ligament rehabilitation of physically active individuals. J Orthop & Sports Phys Ther. 2000; 30(4):194-203.
  11. Giotis D, Zampeli F, Pappas E, et al. The effect of knee braces on tibial rotation in anterior cruciate ligament-deficient  knees during high-demand athletic activities. Clin J Sport Med. 2013 Jan 23. [Epub ahead of print].
  12. Harilainen A, Sandelin J. Post-operative use of knee brace in reconstruction: 5-year follow-up results of a randomized prospective study. Scand J Med Sci Sports. 2006; 16(1):14-18.
  13. Harilainen A, Sandelin J, Vanhanen I, et al. Knee brace after bone-tendon-bone anterior cruciate ligament reconstruction. Randomized, prospective study with 2-year follow-up. Knee Surg Sports Traumatol Arthrosc. 1997; 5(1):10-13.
  14. Kartus J, Stener S, Kohler K, et al. Is bracing after anterior cruciate ligament reconstruction necessary? A 2-year follow-up of 78 consecutive patients rehabilitated with or without a brace. Knee Surg Sports Traumatol Arthrosc. 1997; 5(3):157-161.
  15. Kellgren JH, Jeffrey M, Ball J. Atlas of standard radiographs. Oxford: Blackwell Scientific. 1963; 2.
  16. Kirkley A, Webster-Bogaert S, Litchfield R, et al. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999; 81(4):539-548.
  17. Jacobi M, Reischl N, Wahl P, et al. Acute isolated injury of the posterior cruciate ligament treated by a dynamic anterior drawer brace: a preliminary report. J Bone Joint Surg Br. 2010; 92(10):1381-1384.
  18. Maak TG, Marx RG, Wickiewicz TL. Management of chronic tibial subluxation in the multiple-ligament injured knee. Sports Med Arthrosc. 2011; 19(2):147-152.
  19. Matsuno H, Kadowaki KM, Tsuji H. Generation II knee bracing for severe medial compartment osteoarthritis of the knee. Arch Phys Med Rehabil. 1997; 78(7):745-749.
  20. McDevitt ER, Taylor DC, Miller MD, et al. Functional bracing after anterior cruciate ligament reconstruction: a prospective, randomized, multicenter study. Am J Sports Med. 2004; 32(8):1887-1892.
  21. Muellner T, Alacamlioglu Y, Nikolic A, Schabus R. No benefit of bracing on the early outcome after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1998; 6(2):88-92.
  22. Paluska S., McKeag D. Knee braces: current evidence and clinical recommendations for their use. American Family Medicine. 2000; 61(2):411-418, 423-424.
  23. Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil. 2011; 90(3):247-262.
  24. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol. 2010; 22(2):218-222.
  25. Risberg MA, Beynnon BD, Peura GD, Uh BS. Proprioception after anterior cruciate ligament reconstruction with and without bracing. Knee Surg Sports Traumatol Arthrosc. 1999; 7(5):303-309.
  26. Risberg MA, Holm I, Steen H, et al. The effect of knee bracing after anterior cruciate ligament reconstruction. A prospective, randomized study with two years' follow-up. Am J Sports Med. 1999; 27(1):76-83.
  27. Vadalá A, Iorio R, DeCarli A, et al. The effect of accelerated, brace free, rehabilitation on bone tunnel enlargement after ACL reconstruction using hamstring tendons: a CT study. Knee Surg Sports Traumatol Arthrosc. 2007; 15(4):365-371.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Brouwer RW, Jakma TS, Verhagen AP, et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2005; (1):CD004020.
  2. Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011; (7):CD001256.
Index

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.

History

Status

Date

Action

Reviewed05/15/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Description, Discussion, Table 2, and Reference sections.
 01/01/2014Updated Coding section with 01/01/2014 HCPCS changes.
Reviewed05/09/2013MPTAC review. Updated Table 2, References, and Index.
Reviewed05/10/2012MPTAC review. Updated Discussion and References.
Reviewed05/19/2011MPTAC review. Updated Product Table, Definitions, Coding and References.
Revised05/13/2010MPTAC 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.
 01/01/2010Updated Coding section with 01/01/2010 HCPCS changes; removed HCPCS L1800, L1815, L1825 deleted 12/31/2009.
Reviewed05/21/2009MPTAC review. Updated References and Product Tables.
Revised05/15/2008MPTAC 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.  
 01/01/2008Updated 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.
Revised05/17/2007MPTAC review. Clinical indications clarified. References updated.
Reviewed03/08/2007MPTAC review. Clinical indications clarified. Discussion, Definitions, Coding and References updated.
Revised03/23/2006MPTAC review.  The wording of the criteria under 1-d was changed to eliminate the time frame of 6 weeks. References and Coding updated.

 

11/17/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised04/28/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.04/28/05DME 021Knee Braces
WellPoint Health Networks, Inc.09/23/049.07.02Knee Braces