Clinical UM Guideline

 

Subject: Prefabricated and Prophylactic Knee Braces
Guideline #:  CG-OR-PR-02 Publish Date:    04/25/2018
Status: Reviewed Last Review Date:    03/22/2018

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 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 anterior cruciate ligament 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:
    1. High tibial osteotomy or total knee arthroplasty (replacement) candidate that may elect non-surgical treatment; or
    2. To predict the success of high tibial osteotomy versus total knee arthroplasty; or
    3. 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 criteria are not met, including, but not limited to total knee arthroplasty (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:

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

 

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

L1851

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

L1852

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

 

 

ICD-10 Diagnosis

 

 

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.

The U.S. Food and Drug Administration (FDA) defines a brace as “device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.” Knee braces are classified as a Class 1 device by the FDA and are exempt from a premarket notification application (PMA) requirement prior to marketing any device.

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:

Prophylactic knee braces

Prophylactic braces are designed to prevent or reduce the severity of ligament injuries in a relatively normal (stable) knee. These injuries, primarily to the medial collateral ligament (MCL), are among the most common athletic knee injuries. There is a lack of evidence to support that the use of prophylactic braces reduce the incidence or severity of injuries of ligaments of the knee.

Rehabilitation knee braces

Rehabilitation braces are 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 following an 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.

Functional knee braces

Functional braces are 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. 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.

The American Academy of Orthopaedic Surgeons (AAOS) 2014 guidelines on the management of ACL injuries do not support the routine use of functional knee bracing following isolated ACL reconstruction noting there is no demonstrated efficacy (moderate recommendation). A recently published systematic review (Lowe, 2017) evaluating the efficacy of functional knee braces following ACL reconstruction notes that there is limited evidence supporting the use of functional bracing. No specific functional brace has been validated as a means of effectively reducing the risk of re-injury following ACL reconstruction. The authors note that further studies are needed to clarify the role of functional knee braces following ACL reconstruction.

Table 1. Prefabricated (Off-the-shelf, Custom-fitted) Knee Braces (Not intended to be a complete list of devices.)

Manufacturer

Brand Name

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

DonJoy/dj Orthopedics
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

Fillauer LLC (Chattanooga, TN)

OAK™ series Comfil® TFC, Kydex®, ABS

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

Definitions

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.

References

Peer Reviewed Publications:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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; 23(4):287-292.
  11. 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.
  12. 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.
  13. 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.
  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. Lowe WR, Warth RJ, Davis EP, Bailey L. Functional Bracing After Anterior Cruciate Ligament Reconstruction: A Systematic Review. J Am Acad Orthop Surg. 2017; 25(3):239-249.
  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. Moyer RF, Birmingham TB, Bryant DM, et al. Biomechanical effects of valgus knee bracing: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015; 23(2):178-188.
  22. 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.
  23. Paluska S., McKeag D. Knee braces: current evidence and clinical recommendations for their use. Am Fam Physician. 2000; 61(2):411-418, 423-424.
  24. 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.
  25. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol. 2010; 22(2):218-222.
  26. 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.
  27. 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.
  28. 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. American Academy of Orthopaedic Surgeons (AAOS). Management of Anterior Cruciate Ligament Injuries. September 5, 2014. Available at: https://www.aaos.org/research/guidelines/ACLGuidelineFINAL.pdf. Accessed on March 1, 2018.
  2. Duivenvoorden T, Brouwer RW, van Raaij TM, et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2015;(3):CD004020.
  3. Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011;(7):CD001256.
  4. U.S. Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21. Current as of April 1, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3475. Accessed on March 1, 2018.
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

Reviewed

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date”. Updated Discussion and References sections.

Revised

05/04/2017

MPTAC review. Made minor typographical edits to Clinical Indications section. Updated Table 2.

 

01/01/2017

Updated Coding section with 01/01/2017 HCPCS changes; removed codes K0901, K0902 deleted 12/31/2016.

Reviewed

05/05/2016

MPTAC review. Updated Table 2, Discussion and References 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