LEEDer Group Inc.
8508 North West 66th St.
Miami, Florida 33166 USA

Phone Toll-free: 866.814.0192 or 305.436.5030
Fax Toll-free: 866.818.0373 or 305.436.0086
E-mail Address: orders {at] LEEDerGroup [dot] com

Knee Braces Functional

Durable Medical Equipment Section – Functional Knee Braces
Topic: Functional Knee Braces Splints Blue Cross Blue Shield

Date of Origin: 04/1998
Section: DME Policy No: 46
Approved Date: 09/07/2004 Effective Date: 09/07/2004
Next Review Date: 09/2005

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

LEEDer Knee Contracture Management

JUMP to LEEDer Knee Page L1832

Description
Knee braces typically consist of three components: a superstructure (usually a rigid shell), a hinge, and a strap system. The superstructure extends proximally and distally to a hinge centered around the knee axis of motion. The strapping system secures the brace to the limb. Knee braces can be subdivided into three categories that are based on their intended use:

Prophylactic braces are those that attempt to prevent or reduce the severity of knee ligament injuries. These braces are primarily designed to prevent injuries to the medial collateral ligament, which is among the most common athletic knee injury.

Rehabilitation braces are designed to allow protected motion of injured knees that have been 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 not custom-fabricated.

Functional braces are designed to assist or provide stability for unstable knees during activities of daily living or sports and may be either prefabricated off-the-shelf or custom-fabricated. Derotation braces or stabilizing knee 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 patients with osteoarthritis to decrease the weight on painful joints.

Unloader braces are designed specifically to reduce the pain and disability associated with osteoarthritis of the medial compartment of the knee by bracing the knee in the valgus position in order to unload the compressive forces on the medial compartment.

The Kellgren-Lawrence scale is used to assess the severity of articular cartilage changes of osteoarthritis. The scale emphasizes patellofemoral joint space narrowing and presence of osteophytes as determined by radiographs:
Kellgren-Lawrence Scale
0-No osteophytes
1-Doubtful osteophytes
2-Minimal osteophytes, possible narrowing, cysts, and sclerosis
3-Moderate or definite osteophytes with moderate joint space narrowing
4-Severe with large osteophytes and definite joint space narrowing

According to the HCPCS codes, “custom fabricated” describes a brace that is individually custom-made according to precise measurements or molds/casts of an individual patient. A custom fabricated brace may be used only by the individual patient. Off-the-shelf knee braces are described as “prefabricated” in HCPCS coding. These braces are fitted only to the extent that the patient is fitted to a limited selection of sizes, e.g., small, medium, large, etc. A prefabricated brace may be initially fitted by an orthotist, but this involves simple adjustments.

Policy/Criteria
Prefabricated knee braces may be considered medically necessary in patients with one of the following conditions:

  • Knee instability
  • Ligament insufficiency/deficiency
  • Reconstructed ligament
  • Articular defect repair
  • Avascular necrosis
  • Meniscal cartilage repair
  • Painful failed total knee arthroplasty
  • Painful high tibial osteotomy
  • Painful unicompartmental osteoarthritis
  • Tibial plateau fracture

Custom-fabricated knee braces may be considered medically necessary for patients with the following conditions which may preclude the use of a prefabricated model:

  • Abnormal limb contour, such as:
    1. Valgus [bow-legged] limb
    2. Varus [knock-kneed] limb
    3. Tibial varum
    4. Disproportionate thigh and calf (example: large thigh and small calf)
    5. Minimal muscle mass on which to suspend a brace
  • Skin changes, such as:
    1. Excessive redundant soft skin
    2. Thin skin with risk of breakdown (example: chronic steroid medication)
  • Severe osteoarthritis (grade III or IV)
  • Maximal off-loading of painful or repaired knee compartment (example: heavy patient; significant pain)
  • Severe instability as noted on physical examination of knee

Many functional knee braces are designed specifically for participation in elective sports and thus would be considered not medically necessary.

Prophylactic knee braces are considered not medically necessary.

Scientific Background
There are no data in the published peer-reviewed literature that shows that custom-fabricated functional knee braces offer any benefit over prefabricated, off-the-shelf braces in terms of activities of daily living. In addition, many of the custom-fabricated functional knee braces are designed specifically for participation in elective sports and thus would be considered not medically necessary. (2,3)

Research on the unloader knee braces for osteoarthritis has focused on the custom-made knee braces. There are minimal data on prefabricated unloader knee braces. Several case series suggest that unloader knee braces appear to be associated with a reduction in pain in patients with painful osteoarthritis of the medial compartment. (4, 5) Kirkley and colleagues published the results of a controlled trial that randomized 119 patients with medial compartment osteoarthritis to receive either standard medical management, medical management plus a Neoprene sleeve, or medical management plus an unloader knee brace. (6) The patients were evaluated at multiple points during the 6-month follow-up study period for the following outcomes: disease-specific quality of life, 6-minute walk, 30-second stair climb, and varus deformity as assessed by x-ray. The unloader knee brace group reported statistically significant improvements in pain, stiffness, and physical function. Pollo and colleagues reported outcomes of valgus bracing in eleven patients with pain and restricted mobility due to knee osteoarthritis. (7) During gait analysis, valgus bracing reduced varus movement by 13% and medial compartment load by an average 11% the result being improvement in pain and activity levels in all patients.

A search of the MEDLINE database through August 2004 did not identify any new published studies that would alter the above conclusions. Specifically, there were no controlled trials that compared the performance of custom-fabricated and prefabricated, custom-fitted functional knee braces for use after reconstructive knee surgery.

  • References 1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 1.03.02 2. Liu SH, Mirzayan R. Functional knee bracing. Clin Ortho Rel Research 1995;317:273-81 3. Beynonn 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 1992;74A:1298-1312 4. Horlick SG, Loomer RL. Valgus knee bracing for medial gonarthrosis. Clin J Sport Med 1993;3:251-55 5. Matsuno H, Kadowaki KM, Tsuji H. Generation II knee bracing for severe medial compartment osteoarthritis of the knee. Arch Phys Med Rehabil 1997;78:745-49 6. Kirkley A, Webster-Bogaert S, Litchfiled R, et al. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am 1999; 81(4):539-48 7. Pollo FE, Otis JC, Backus SI, et al. Reduction of Medial Compartment Loads with Valgus Bracing of the Osteoarthritic Knee. Am J Sports Med 2002, 30(3):414-421
  • Cross References Codes Number Description
    HCPCS L1800 Knee orthosis (KO); elastic with stays, prefabricated, includes fitting and adjustment L1810 KO; elastic with joints, prefabricated, includes fitting and adjustment L1815 KO; elastic or other elastic type material with condylar pad(s), prefabricated, includes fitting and adjustment L1820 KO; elastic with condylar pads and joints, prefabricated, includes fitting and adjustment L1825 KO; elastic knee cap, prefabricated, includes fitting and adjustment L1830 KO; immobilizer, canvas longitudinal, prefabricated, includes fitting and adjustment L1831 KO; locking knee joint(s), positional orthosis, prefabricated, includes fitting and adjustment L1832 KO; adjustable knee joints, positional orthosis, rigid support, prefabricated, includes fitting and adjustment L1834 KO; without knee joint, rigid, custom fabricated L1836 Knee orthosis, rigid, without joint(s), includes soft interface material, prefabricated, includes fitting and adjustment L1840 Knee orthosis, derotation, medial-lateral, anterior cruciate ligament, custom fabricated L1843 Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, includes varus/valgus adjustment; prefabricated, includes fitting and adjustment L1844 Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, includes varus/valgus adjustment; custom fabricated L1845 Knee orthosis, double upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, prefabricated, includes fitting and adjustment L1846 Knee orthosis, double upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, custom fabricated L1847 Knee orthosis, double upright with adjustable joint, with inflatable air support chamber(s), prefabricated, includes fitting and adjustment L1850 Knee orthosis, Swedish type, prefabricated, includes fitting and adjustment L1855 Knee orthosis, molded plastic, thigh and calf sections, with double upright knee joints, custom fabricated L1858 Knee orthosis, molded plastic, polycentric knee joints, pneumatic knee pads (CTI), custom fabricated L1860 Knee orthosis, modification of supracondylar prosthetic socket, custom fabricated (SK) L1870 Knee orthosis, double upright, thigh and calf lacers, with knee joint, custom fabricated L1880 Knee orthosis, double upright, non-molded thigh and calf cuffs/lacers with knee joints, custom fabricated