Clinical Guideline - Prefabricated and Prophylactic Knee Braces PDF Print E-mail

1. Description

This document addresses the intended use of prefabricated functional or rehabilitation knee braces and prophylactic knee braces.

2. Clinical Indications

2.1. 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.

2.2. 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:

  • extra large straps for an obese person
  • a pediatric model for a person of short stature
  • extensions for an unusually tall person

3. Discussion/General Information

Prefabricated knee braces, also known as off-the-shelf knee braces, are manufactured in standard sizes. According to the HCPCS codes, off-the-shelf models are described as custom-fitted. These braces are custom-fitted only to the extent that the individual is fitted to a limited selection of sizes, i.e., small, medium, large, and only require measurements and a sizing chart for fitting. A prefabricated knee brace may be initially fitted by an orthotist and involve simple adjustments. A prefabricated knee brace may be trimmed, bent, molded (with or without heat), or otherwise modified for use by the individual. 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. The AAOS and the American Academy of Pediatrics (AAP) both indicate that there is insufficient evidence to provide strong conclusions that use of prophylactic knee braces significantly reduces knee injuries (AAOS, 2008; AAP, 2001).
  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.

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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 Grade Ahlbäck
Definition
Kellgren & Lawrence Grade Kellgren & Lawrence
Definition
Grade 1 Doubtful Minute osteophyte, doubtful significance
Grade 2 Minimal Definite osteophyte, unimpaired joint space
Grade I Joint space narrowing (joint space < 3 mm) Grade 3 Moderate Moderate dimunition of joint space
Grade II Joint space obliteration Grade 4 Severe Joint space greatly impaired with sclerosis of subchondral bone
Grade III Minor bone attrition (0-5 mm) Grade 4 Severe Joint space greatly impaired with sclerosis of subchondral bone
Grade IV Moderate bone attrition (5-10 mm) Grade 4 Severe Joint space greatly impaired with sclerosis of subchondral bone
Grade V Severe bone attrition (>10 mm) Grade 4 Severe Joint space greatly impaired with sclerosis of subchondral bone

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

Manufacturer Brand Name
Bauerfeind USA, Inc. (Marietta, GA) MOS Genu®,SecuTec®, SofTec® Genu, SofTec® OA
Bledsoe Brace Systems (Grand Prairie, TX) Axiom-OA, Axiom OTS, Axiom-D OTS, Axiom Sport, Bledsoe Z-12 OA, Bledsoe 20.50, Sport & Sport Max, Ultimate Cl, Ultimate Dynamic; Extender, Lever Lock, Merit OR, OA AIR, Original; Aligner ESE, Thruster RLF
Comfy Splints (Lenjoy Medical Engineering, Inc, Gardena, CA) Comfy Standard Knee, Comfy Goniometer Knee, Spring-Loaded Goniometer Knee
DeRoyal® Industries (Powell, TN) Flexgard™ Off-The-Shelf ACL, Hypercontrol™, Slimline, Slimline II, Transition, Warrior™, M.4® ACL Functional Knee Brace, M.4® OA Knee Brace

DonJoy/dj Orthopedics

DJO, LLC (Vista, CA)

4titude™, Armour, Drytex™ Hinged, Fource Point™, FULLFORCE, Lateral J, Legend, OA Adjuster, OA Everyday, Playmaker, TROM (6 models)
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 (Aliso Viejo, CA) Aspire®, C180 (various models), C.Ti® (various models), Edge/Edge Lite, Flex®, Flex Sport™, GII Extreme®, GII Paradigm®, GII UnloaderExpress®, Innovator DLX™, Morph, MVP, Oasys® Carticare, OAJ®, Paradigm®, PCL Opposition, Sentry™, Trainer®, Unloader Express®, Unloader® One, Unloader Spirit®
Townsend Bracing Solutions (Bakersfield, CA) Rebel Series, ROM Post Operative Knee Braces, Sport Series

 

4. 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: describes a surgical procedure in which bone is cut and realigned

Sprain: partial or complete tear of a ligament

5. 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, includes fitting and adjustment
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, includes fitting and adjustment
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, includes fitting and adjustment
L1836 Knee orthosis, rigid, without joint(s), includes soft interface material, prefabricated, includes fitting and adjustment
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, includes fitting and adjustment
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, includes fitting and adjustment
L1847 Knee orthosis, double upright with adjustable joint, with inflatable air support chambers, prefabricated, includes fitting and adjustment
L1850 Knee orthosis, Swedish type, prefabricated, includes fitting and adjustment
ICD-9 Diagnosis
715.00-715.96 Osteoarthrosis and allied disorders
717.0-717.9 Internal derangement of knee
718.26 Pathological dislocation lower leg
718.36 Recurrent dislocation of joint lower leg
718.76 Developmental dislocation of joint lower leg
718.86 Other joint derangement, knee instability; not otherwise classified
727.65-727.66 Rupture of tendon, nontraumatic quadriceps tendon, patellar tendon
822.0-822.1 Fracture of patella
823.00-823.12 Fracture of tibia and fibula
836.0-836.69 Dislocation of knee
844.0-844.9 Sprains and strains of knee and leg
905.4-905.8 Late effect of fracture, dislocation, other injuries
959.7 Injury, other/unspecified; knee, leg, ankle and foot

article reference: http://www.empireblue.com/medicalpolicies/guidelines/gl_pw_a047994.htm

 

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