MEDICAL POLICY

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Knee Braces

Number 1.03.501

Effective Date May 27, 2015

Revision Date(s) 11/10/14; 05/12/14; 10/14/13; 07/24/13; 06/10/13; 07/12/12; 07/12/11; 09/14/10; 08/11/09; 08/12/08; 08/14/07; 09/12/06; 09/13/05; 09/14/04; 07/13/04; 01/01/04; 12/11/03; 12/10/02; 10/08/02; 05/14/02; 10/09/01; 09/11/01; 11/05/99; 06/25/98

Replaces 1.03.02

Policy

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Custom-made (L1834, L1840, L1844, L1846, L1860)

Custom-made (custom fabricated, custom molded) unloader knee braces, may be considered medically necessary, as an alternative to a prefabricated brace, as a treatment for patients with painful osteoarthritis involving the medial (varus) or lateral (valgus) compartment of the knee.

Custom-made unloader knee braces for any condition other than what is listed above is considered a contract exclusion because it is considered a “Special or extra cost convenience feature” under the durable medical equipment/medical sup0plies benefit in most contracts. (See Benefit Application)

Custom-made (custom fabricated, custom molded) functional knee braces may be considered medically necessary, as an alternative to a prefabricated brace, when the following criteria are met:

  • Abnormal limb contour (disproportionate size of thigh and calf); or
  • Knee deformity that interferes with fitting (valgus=outward or lateral malalignment or varus limb=inward or medial malalignment); or
  • Minimal muscle mass upon which to suspend an orthosis.

Note: There should be documentation that effort was made to adjust a prefabricated brace. For example, use of pediatric knee orthoses in individuals with small limbs, use of straps with additional length for individuals with larger limbs or prefabricated brace with extensions for tall individuals. The request should also include documentation with reference to the manufacturer’s largest prefabricated brace and the size of thigh it is designed to fit. The patient’s thigh size should also be included.

Custom-made functional knee brace for any condition other than those listed directly above is considered a contract exclusion because it is considered a “Special or extra cost convenience feature” under the durable medical equipment/medical supplies benefit in most contracts. (See Benefit Application)

Prefabricated (L1810, L1820, L1830, L1831, L1832, L1836, L1843, L1845, L1847, L1850)

Prefabricated (off-the-shelf, ready-made, custom-fitted) knee braces may be considered medically necessary, for ambulatory patients with painful osteoarthritis of the medial compartment of the knee.

Prophylactic

Prophylactic (custom or prefabricated) knee braces are considered not medically necessary for all indications.

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Related Policies

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1.01.529

Durable Medical Equipment

7.01.15

Meniscal Allograft and Other Meniscus Implants

7.01.549

Knee Arthroscopy in Adults

Policy Guidelines

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Knee injury, knee surgery, or osteoarthritis may result in a knee that is unstable. A knee brace is used to provide support and motion control during functional activity.

There are different kinds of knee braces which may be used for different types of clinical situations. They are classified by the type of manufacturing process and categorized according to their intended use.

Manufacturing Classification

Prefabricated knee braces, (L1810, L1820, L1830, L1831, L1832, L1836, L1843, L1845, L1847, L1850 also known as off-the-shelf braces, are manufactured in standard sizes and require only minimal adjustments. These braces come in a selection of sizes (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. These minimal adjustments are custom fitted which should not be confused with custom fabricated (custom made).

Custom-made knee braces, (L1834, L1840, L1844, L1846, L1860) also known as custom molded or custom fabricated braces, are fabricated specifically for an individual. These braces generally use materials such as, 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 more than trimming, bending, or other modifications to a substantially 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.

Categories of knee braces

Prophylactic knee braces are designed to protect uninjured knees from valgus stresses that could damage the medial collateral ligaments. However, no conclusive evidence support their effectiveness and they are not recommended for regular use.

Rehabilitation knee braces are used to protect and control motion of an injured knee treated operatively or non-operatively. They are commonly used for 6 to 12 weeks after injury or surgery. They are usually prefabricated.

Functional knee braces are 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, are commonly used for a long period of time, and may be either off the shelf or custom made. Derotation braces are typically used after injury 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. Functional knee braces are also used in individuals with osteoarthritis in order to decrease the weight on painful joints.

Unloader knee braces are used to unload some of the weight from the medial or lateral compartment of a painful osteoarthritic knee to reduce pain and help increase mobility by bracing the knee in the valgus or varus position.

When needed; clinical information, including a radiology report, may be requested to document the medical condition that requires the use of a knee brace.

Source: https://www.djoglobal.com/products/donjoy/armor

Terminology and Coding information

The HCPCS terminology regarding custom-made and off-the-shelf knee braces may be unclear. In general, the term “custom-made” describes a brace that is made for one patient according to precise measurements or molds/casts of the individual patient. Thus, a custom-made brace is only used by one specific patient. According to the HCPCS codes, the following terms describe “custom-made” braces:

  • Custom fabricated; or
  • Molded-to-patient model.

According to the HCPCS codes, off-the-shelf knee brace models are described as “custom fitted”. These braces are prefabricated or mass-produced and come pre-sized, i.e., small, medium, large, etc. The brace can be modified easily to meet the patient’s rehabilitation need without the wait for a custom-made brace that requires special molds/casts and detailed fitting. The orthotist may provide the initial functional assessment and fit, as well as make simple adjustments to the off-the-shelf brace(s) to enable same day use, in many cases.

Unloader knee braces include, but may not be limited to, Generation II Unloader, Donjoy Monarch, and the Orthotech Montana. These knee braces may be coded as HCPCS code L-1844.

Table 1. Examples of Custom-made Functional Knee Braces (not all inclusive)

Manufacturer

Brand Name

DonJoy

CE 200, Defiance, Monarch

Generation II

GII Sports Brace

Innovation Sports

CTI Classic, CTII Superlight, CTI Standard, CTI Pro Sport

Lennox Hill

Regular, Light, Spectralite

MedTechna

Can Am

Mueller Sports Medicine

Magnum Competition

Omni Scientific

Elite, TS-7

Orthotech

Oti Performer

Spademan

Custom

Sutter

Talon

Townsend Design

Air Custom, Original

Vixie Enterprise

MKS2 Custom, MKS2PCL

Zimmer

Sports Caster I, Sports Caster II

Table 2. Examples of Off-The-Shelf Functional or Rehabilitation Knee Braces (not all inclusive)

Manufacturer

Brand Name

Bauerfeind

Moss Gen U Short

Bledsoe

Force 1, Force 2, Force 3, Proshifter ACL, Proshifter Contact

Comfy Splints

Comfy Standard Knee, Comfy Goniometer Knee, Spring-loaded Goniometer Knee, Comfy Lite Knee, Torq Knee

Deroval

Three-D

DonJoy

Gold Point, Legend, Point Supersport, Playmaker, Monarch

Innovation

MVP

Medical Designs

Lorus

Mueller Sports

Magna-Lite Prefit

Omni Scientific

Spectrum, OS-5

Orthomedics

Ecko

Orthotech

Contender, Controller

Spademan

ACL Sport

Townsend

Off-shelf

Vixie Enterprise

MKS2 OTS

Zinco

Lehrman Multilig, MSO

Coding

HCPCS

The following codes describe custom-made (custom fabricated, custom molded) functional knee braces:

L1834

Knee orthotic (KO), without knee joint, rigid, custom fabricated

L1840

Knee orthotic (KO), derotation, medial-lateral, anterior cruciate ligament, custom fabricated

L1846

Knee orthotic, 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

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

L1860

Knee orthotic (KO), modification of supracondylar prosthetic socket, custom fabricated (SK)

The following codes describe custom-made (custom fabricated, custom molded) unloader braces:

L1840

Knee orthotic (KO), derotation, medial-lateral, anterior cruciate ligament, custom fabricated

L1844

Knee orthotic (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, custom fabricated

The following codes describe off-the-shelf functional knee braces:

L1800

Knee orthotic (KO), elastic with stays, prefabricated, includes fitting and adjustment

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

L1815

Knee orthotic (KO), elastic or other elastic type material with condylar pad(s), prefabricated, includes fitting and adjustment

L1820

Knee orthotic, elastic with condylar pads and joints, with or without patellar control, prefabricated, includes fitting and adjustment

L1825

Knee orthotic (KO), elastic knee cap, prefabricated, includes fitting and adjustment

L1830

Knee orthosis, immobilizer, canvas longitudinal, prefabricated, off-the-shelf

L1831

Knee orthotic, locking knee joint(s), positional orthotic, 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

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

L1850

Knee orthosis, swedish type, prefabricated, off-the-shelf

Note: Skin protectors like brace sleeves are considered medically necessary supplies when used in conjunction with knee braces/knee orthoses.

Description

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Knee braces may be custom made or available off-the-shelf in a variety of sizes. Knee braces may be intended for rehabilitation, to reduce pain, or to prevent injury in either stable or unstable knees.

Knee braces typically consist of 3 components:

  1. A superstructure (usually a rigid shell),
  2. A hinge,
  3. A strap system.

The superstructure extends proximally and distally to a hinge centered on the knee axis of motion. The strapping system secures the brace to the limb.

Scope

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Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

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Knee braces are considered durable medical equipment. Some member contracts exclude medical equipment and supplies that are “Special or extra cost convenience features.” Please check the member contract for benefit exclusions.

There are a variety of HCPCS codes describing knee braces. Some describe knee braces according to their specific function, while others describe knee braces according to their composition/construction, leading to overlapping HCPCS codes. (See Policy Guidelines).

Rationale

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This policy was originally created in 1998 and has been updated periodically with searches of the MEDLINE database. The most recent review was performed through April 2014.

At the time this policy was created in 1998 no data in the published peer-reviewed literature showed that custom-made functional knee braces offered any benefit over off-the-shelf braces in terms of activities of daily living. Many of the custom-made functional knee braces were designed specifically for participation in elective sports and thus would be considered not medically necessary. (1, 2) Research on unloader knee braces for osteoarthritis had focused on the custom-made knee braces and there were minimal data on off-the-shelf unloader knee braces, although several case series suggested that unloader knee braces were associated with a reduction in pain in patients with painful osteoarthritis of the medial compartment. (3)

Osteoarthritis

In 1999, Kirkley and colleagues reported on a controlled trial that randomized 119 patients with medial compartment osteoarthritis to receive standard medical management, medical management plus a polychloroprene (Neoprene) sleeve, or medical management plus an unloader knee brace. (4) Compared to the control group, the unloader knee brace was associated with a significant improvement in quality of life and function. In comparing the unloader knee brace with the neoprene sleeve, there was a significant difference in functional outcomes favoring the unloader knee, but no significant difference in terms of quality of life measures.

In a 2005 Cochrane review of braces and orthoses for treating osteoarthritis of the knee, Brouwer et al. concluded that there was limited evidence in favor of an unloader knee brace. (5) In 2006, Brouwer and colleagues reported a randomized multicenter trial of 117 patients that compared off-the-shelf unloading braces and conservative therapy with conservative therapy alone for unicompartmental (valgus or varus) osteoarthritis of the knee. (6) The addition of a brace resulted in a slight increase in reported walking distances at three, six, and 12 months (effect size of 0.4), with trends for improvement in subjective pain (-0.63 on a 10-point visual analogue scale) and knee function (3 points on a 100-point Hospital for Special Surgery score). Quality of life did not differ between the two groups. The authors noted that adherence to the brace was low, with 16 of 60 patients (27%) discontinuing by three months and another nine (15%) stopping treatment by 12 months. Patient-reported reasons for discontinuing use of the unloading brace were lack of benefit and adverse effects (i.e., skin irritation, bad fit).

Another study from 2006 compared custom and off-the-shelf bracing for varus gonarthrosis. (7) Ten patients wore each type of braces for four-to-five weeks (about nine hours per day) in a randomized order. Pain scores were reduced from 197 mm (500 mm maximum) to 71 mm with the custom brace and 120 mm with the off-the-shelf brace. Stiffness was reduced from 91 mm (200 mm maximum) to 36 mm with the custom brace and 63 mm with the off-the-shelf brace. Function was improved from 664 mm (1700 mm maximum) to 248 mm with the custom brace, whereas the off-the-shelf brace did not significantly affect function. Kinematic analysis showed a reduction in peak knee adduction moments during gait and stair-stepping and reduced varus angulation by 1.5° compared with baseline with the custom brace. The off-the-shelf brace did not reduce the varus angle.

A French clinical practice guideline committee evaluated evidence on the use of braces in knee osteoarthritis in 2009. (8) The review found mainly low quality evidence in support of valgus knee braces for symptomatic medial femoro-tibial osteoarthritis with short- and mid-term reduction of pain and disability. Side effects included venous thromboembolic events. No additional controlled trials were identified in a 2010 review of bracing in the management of knee osteoarthritis. (9)

A 2010 study compared use of insoles or off-the-shelf braces for medial knee osteoarthritis in a randomized trial of 91 patients with medial compartmental knee osteoarthritis. (10) Pain severity, measured by a 10 point visual analog scale (VAS), improved by 0.9 in the insole group and 1.0 for the brace group in intent-to-treat analysis. Function on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) improved by 4.2 and 4.0 points out of 100, respectively. There was no significant effect on the hip-knee-ankle angle for either device. Compliance was 45% for the brace group, with a mean wearing time of 39 hours (SD 32 hours). After six months of use, neither insoles nor off-the-shelf braces resulted in clinically significant changes in varus angle, pain, or function.

In 2011, Hunter et al. reported a randomized trial of patellofemoral bracing for the treatment of patellofemoral osteoarthritis. (11) Eighty subjects completed 6 weeks with a BioSkin Q Brace with the patellar realigning strap applied, and 6 weeks with the realigning strap removed. There was a 6-week interval between the 2 conditions and the order of treatment was randomized. They found no effect of treatment on VAS knee pain and no significant difference between the groups for WOMAC pain, function, or stiffness outcomes.

Ligamentous Instability of the Knee

Soma and colleagues compared the performance of custom-made and off-the-shelf functional knee braces from four manufacturers in 2004. (11) As a group, the custom-made knees braces restrained anterior displacement better than the off-the-shelf models by a mean difference of 0.84 mm. The clinical significance of this minimal, but statistically significant, difference is questionable.

A 2007 systematic review of 12 randomized controlled trials of bracing for rehabilitation following anterior cruciate ligament (ACL) reconstruction “found no evidence supporting the routine use of functional or rehabilitative bracing in a patient with a reconstructed ACL. In particular no study demonstrated a clinically important finding of improved range of motion, decreased pain, improved graft stability or decreased complications and reinjuries.” (12)

In 2008, Birmingham and colleagues reported a randomized controlled trial comparing use of an off-the-shelf functional knee brace or neoprene sleeve beginning six-weeks after ACL reconstruction. (13) Out of 150 patients randomized to a brace or sleeve after surgery, 127 (85%) completed 24-month follow-up. Compliance was similar for the two groups and three patients from each group had graft failures and revision surgeries. Confidence in the knee was rated higher for the brace (70 versus 55 out of 100), as was the rating of help in returning to sport (66 versus 53). No other outcome measures differed between the groups, including the ACL-quality of life questionnaire, highest activity level, satisfaction with the brace/sleeve, side-to-side laxity, or functional tests. As this report described evaluators as blinded to the patient’s group allocation, it does not appear that the patients were wearing the brace or sleeve at the time of functional testing.

Section Summary

There is insufficient and conflicting research on the net benefit of bracing for anterior cruciate ligament repair (pre, post, and prophylaxis). More research is needed.

Patellofemoral Pain Syndrome

In 2008, Warden et al reported a meta-analysis of 16 randomized or quasi-randomized studies assessing patellar taping or bracing effects on chronic knee pain. (14) Thirteen trials investigated taping or bracing for anterior knee pain and three investigated taping for osteoarthritis. The authors concluded there was limited evidence to demonstrate the efficacy of patellar bracing. They reported high heterogeneity between study outcomes and significant publication bias in the studies.

Section Summary

Evidence of efficacy of off-the-shelf bracing is limited for osteoarthritis of the medial compartment, ligamentous instability, or patellofemoral pain.

Technology Assessments, Guidelines and Position Statements

The American Academy of Orthopaedic Surgeons (AAOS) provided a 2009 clinical practice guideline on the nonarthroplasty treatment of osteoarthritis of the knee. (15) The AAOS was unable to make a recommendation for or against the use of a brace with a varus- or valgus- directing force for patients with medial or lateral unicompartmental osteoarthritis of the knee, based on limited evidence for the effectiveness of knee braces. (4, 6)

The Osteoarthritis Research Society International (OARSI) 2008 treatment guidelines recommend the following: “In patients with knee OA and mild/moderate varus or valgus instability, a knee brace can reduce pain, improve stability and diminish the risk of falling.” This guideline is based in part on the Brower study previous referenced in which there was a small but significant effect with unloading knee braces for patients with mild or moderate varus or valgus instability. (6) In this study, the patients had medial or lateral osteoarthritis and the unloading knee brace was adapted to each kind of compartment. A slightly better effect was shown for the varus group.

References

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  1. Liu SH, Mirzayan R. Functional knee bracing. Clin Ortho Rel Research 1995; 317:273-281.
  2. Beynnon BD, Pope MH, Wertheimer CM et al. The effect of functional knee-braces on strain on the anterior cruciate ligament in vivo. J Bone Joint Surg Am 1992; 74(9):1298-312.
  3. 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):745-9.
  4. Kirkley A, Webster-Bogaert S, Litchfield R et al. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am 1999; 81(4):539-48.
  5. Brouwer RW, Jakma TS, Verhagen AP et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev 2005; (1):CD004020.
  6. Brouwer RW, van Raaij TM, Verhaar JA et al. Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial. Osteoarthritis Cartilage 2006; 14(8):777-83.
  7. Draganich L, Reider B, Rimington T et al. The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis. J Bone Joint Surg Am 2006; 88(12):2645-52.
  8. 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):629-36.
  9. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol 2010; 22(2):218-22.
  10. van Raaij TM, Reijman M, Brouwer RW et al. Medial Knee Osteoarthritis Treated by Insoles or Braces: A Randomized Trial. Clin Orthop Relat Res 2010.
  11. Soma CA, Cawley PW, Liu S et al. Custom-fit versus premanufactured braces. Orthopedics 2004; 27(3):307-10.
  12. Wright RW, Fetzer GB. Bracing after ACL reconstruction: a systematic review. Clin Orthop Relat Res 2007; 455:162-8.
  13. 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):648-55.
  14. Warden SJ, Hinman RS, Watson MA, Jr. et al. Patellar taping and bracing for the treatment of chronic knee pain: a systematic review and meta-analysis. Arthritis Rheum 2008; 59(1):73-83.
  15. Richmond J, Hunter D, Irrgang J et al. Treatment of osteoarthritis of the knee (nonarthroplasty). J Am Acad Orthop Surg 2009; 17(9):591-600.
  16. Zhang, W, Moskowitz RW, Nuki G et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008; 16:137-162.
  17. Hunter DJ, Harvey W, Gross KD et al. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis. Osteoarthritis Cartilage 2011; 19(7) 792-800.
  18. Pietrosimone BG, Grindstaff TL, Linens SW, Uczekaj E, Hertel J. A systematic review of prophylactic braces in the prevention of knee ligament injuries in collegiate football players. Journal of Athletic Training 2008 Jul-Aug;43(4):409-15.
  19. Wright RW, et al. Asystematic review of anterior cruciate ligament reconstruction rehabilitation: part I: continuous passive motion, early weight bearing, postoperative bracing, and home-based rehabilitation. Journal of Knee Surgery 2008;21(3):217-24.
  20. Smith TO, Davies L. A systematic review of bracing following reconstruction of the anterior cruciate ligament. Physiotherapy 2008;94(1):1-10.
  21. 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):653-85.
  22. Ahn JH, Chang MH, Lee YS, Koh KH, Park YS, Eun SS. Non-operative treatment of ACL rupture with mild instability. Archives of Orthopaedic and Trauma Surgeyr 2010; 130(8):1001-6.
  23. Birmingham TB, et al. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve use after anterior cruciate ligament reconstruction. American Journal of Sports Medicine 2008;36(4):648-55.
  24. Kruse LM, Gray BL, Wright RW. Anterior cruciate ligament reconstruction rehabilitation in the pediatric population. Clinics in Sports Medicine 2011;30(4):817-24.
  25. Rishiraj N, Taunton JE, Lloyd-Smith R, Woollard R, Regan W, Clement DB. The potential role of prophylactic/functional knee bracing in preventing knee ligament injury. Sports Medicine 2009;39(11):937-60.
  26. Stanley CJ, Creighton RA, Gross MT, Garrett WE, Yu B. Effects of a knee extension constraint brace on lower extremity movements after ACL reconstruction. Clinical Orthopaedics and Related Research 2011;469(6):1774-80.
  27. Albright JC, Crepeau AE. Functional bracing and return to play after anterior cruciate ligament reconstruction in the pediatric and adolescent patient. Clinics in Sports Medicine 2011;30(4):811-5.
  28. Noridian Healthcare Solutions. Local Coverage Determination for Knee Orthoses (L27058), 2014. Available at: https://www.noridianmedicare.com/dme/coverage/docs/lcds/current/knee_orthoses.htm Last accessed October 29, 2014.
  29. Paluska S., McKeag D. Knee braces: current evidence and clinical recommendations for their use. American Family Medicine. 2000; 61(2):411-418, 423-424.

Coding

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Codes

Number

Description

HCPCS

L1840

Knee orthosis (KO); Derotation, medial-lateral, anterior cruciate ligament, custom-fabricated

 

L1843

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, includes fitting and adjustment

 

L1844

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, custom fabricated

 

L1845

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, includes fitting and adjustment

 

L1846

Knee orthosis (KO); 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, custom fabricated

 

L1847

Knee orthosis (KO); Double upright with adjustable joint, with inflatable air support chamber(s), prefabricated, includes fitting and adjustment

 

L1850

Knee orthosis (KO); Swedish type, includes fitting and adjustment

 

L1860

Knee orthosis (KO); modification of supracondylar prosthetic socket, custom fabricated (SK)

Type of Service

Orthopedics

 

Place of Service

Outpatient

 

Appendix

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N/A

History

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Date

Reason

06/25/98

Add to Durable Medical Equipment Section - New Policy

11/05/99

Replace Policy - Description revised.

09/11/01

Replace Policy - Scheduled update

10/09/01

Replace Policy - HCPCS codes added; reviewed by Care Management staff.

05/14/02

Replace Policy - Benefits Application Section updated.

10/08/02

Replace Policy - Policy reviewed; policy statement unchanged. Additional references added.

12/10/02

Replace Policy - Policy reviewed; reimbursement for custom brace language updated.

12/09/03

Replace Policy - Policy reviewed; policy statement added concerning elective sports braces. Additional references and HCPC codes added.

01/01/04

Replace Policy - HCPC code update only.

07/13/04

Replace Policy - Policy reviewed; policy statement unchanged. Tables, Rationale and References updated.

09/01/04

Replace Policy - Policy renumbered from PR.1.03.100. No date changes.

09/14/04

Replace Policy - Policy reviewed; policy statement unchanged. Benefit Application and Rationale updated.

09/13/05

Replace Policy - Policy statement revised to indicate that custom knee braces not meeting criteria are considered an extra cost convenience feature excluded under most contract provisions. Rationale and References updated.

02/06/06

Codes updated - No other changes.

06/23/06

Update Scope and Disclaimer - No other changes.

09/12/06

Replace Policy - Policy reviewed with literature search; references added; no change in policy statement.

08/14/07

Replace Policy - Policy updated with literature review; references added. No change in policy statement.

08/12/08

Replace Policy - Policy updated with literature search; no change to the policy statement.

08/11/09

New BC - Policy updated with literature search and converted to BC version. Replaces PR.1.03.500. Policy statement reworded but essentially unchanged.

09/14/10

New PR Policy - Policy updated with literature search; references added and reordered. Policy statements changed to allow unloader bracing for “lateral” compartment of knee, in addition to medial. A new PR policy has been developed to replace BC.1.03.02

07/12/11

Replace Policy - Policy updated with literature review; reference added. 2011 update added to osteoarthritis section. No change to the policy statement.

07/20/12

Replace policy. No change in policy statement.

07/24/13

Replace policy. Policy reviewed. Minor edits for readability. A review of the literature through April 2013 did not prompt any additions to the references. Policy statement unchanged.

10/14/13

Replace policy. Removed Policy guideline stating “When the patient’s clinical condition meets the requirement for an off-the-shelf (prefabricated) knee brace but the patient prefers a custom knee brace, payment for the most common type of off-the-shelf knee brace (L1845) may be allowed toward that purchase”. Moved codes from benefit application to Policy Guidelines following the descriptions of the types of knee braces. A review of the literature through August 2013 did not prompt any additions to the references. Policy statement unchanged.

05/12/14

Annual Review. Policy statements extensively revised. Functional knee braces for knee instability due to injury or surgery, previously considered medically necessary is now considered not medically necessary. Added references 18-27. Coding update: ICD diagnosis codes removed; HCPCS codes L1810-L1812 (these apply to a separate medical policy) and L1820-32, 34-36 removed as they do not apply to this policy.

07/24/14

Update Related Policies. Change title to 7.01.549.

08/18/14

Coding update. HCPCS codes L1844 and L1846 reversed in coding table within Policy Guidelines section. In the previous version; they have been corrected.

11/10/14

Interim review. Clarifications to policy statements: Custom made contract exclusion policy statement split into two. Prophylactic policy statement reworded. HCPC codes added to policy statements. Manufacturing and classification of knee braces definitions added to policy guidelines section. HCPCS code E1810 removed; it relates to another policy (1.01.514).

03/11/15

Update Related Policies. Add 1.01.529.

03/24/15

Update Related Policies. Change title to 7.01.549.

05/27/15

Annual review. Added an off the shelf knee brace sizing chart to the Policy Guidelines section.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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