Description:
A brace is an orthosis or orthopedic appliance that supports or holds in correct position any movable part of the body and that allows for motion of that part. It must be a rigid or semi-rigid device, used for the purpose of supporting a weak or deformed part or of restricting or eliminating motion in a diseased or injured part of the body. It must provide support and counterforce on the limb for which it is being used.

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 4 categories that are based on their intended use:

1. 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 injuries.
2. 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 off-the-shelf and are not custom-made.
3. Functional braces are designed to assist or provide stability for unstable knees during activities of daily living or sports and may be either off-the-shelf or custom-made. De-rotation braces are typically used after injuries to ligaments and have medial and lateral bars with varying hinge and strap designs. These de-rotation 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.
4. Unloader knee braces are specifically designed to reduce the pain and disability associated with osteoarthritis of the medial compartment of the knee by bracing the knee in the valgus position to unload the compressive forces on the medial compartment.

Knee braces may be off-the-shelf (prefabricated) or custom-made. 

Policy:
Knee braces are considered MEDICALLY NECESSARY when one of the following medical criteria is met:

• Recent (within 6 weeks prior to brace application) surgical intervention or injury to the ligaments of the knee, requiring range of motion limitations
• Member is ambulatory and has instability due to ligament insufficiency/deficiency or reconstruction

Prefabricated rigid knee orthosis without joints and knee orthosis with joints that lock a knee into a particular position are considered MEDICALLY NECESSARY for persons with non-fixed flexion contractures of the knee.

A prefabricated knee orthosis locking joints and inflatable air support chambers is considered NOT MEDICALLY NECESSARY because there is no proven clinical benefit to the inflatable air bladder incorporated into the design of this knee orthosis.

Examples of prefabricated knees braces include: knee immobilizer, knee orthosis with double uprights and adjustable flexion and extension joints, knee orthosis with double uprights, adjustable flexion and extension joint, and medial-lateral and rotational control and knee orthosis with double uprights and thigh and calf pads (Swedish-type knee orthosis).

Custom-made functional braces (also known as "custom-fabricated" or "molded" knee orthosis) are considered MEDICALLY NECESSARY if the member meets the criteria for a knee brace listed above but is unable to be fitted with a prefabricated (off-the-shelf) knee brace. Examples that may meet criteria for a custom-made knee brace include, but are not limited to:

• Deformity of the knee or leg that interferes with fitting.
• Disproportionate size of thigh or calf.
• Minimal muscle mass on which to suspend an orthosis.

Custom fabricated orthosis are NOT CONSIDERED MEDICALLY NECESSARY for treatment of knee contractures.

Knee orthoses with varus or valgus adjustment are considered MEDICALLY NECESSARY for ambulatory persons with at least one of the following:

• Moderate to severe unicompartmental osteoarthritis
• Meniscal cartilage derangement
• Knee ligamentous disruption
• Failed total knee arthroplasty
• Aseptic necrosis of the tibia/fibula
• Tibial plateau fracture

Prophylactic braces: Designed to reduce the likelihood or severity of knee ligament injuries in a relatively stable knee. These knee braces are generally indicated for the protection of the medial-collateral ligament against valgus knee stresses and ACL protection from rotational stress in similar situations. Examples of these braces are DonJoy Protective Knee Guard (dj Orthopedics, Inc.) and McDavid Protective Knee Guard (McDavid Sport Medical Products, Woodridge, Il). Both The American Academy of Orthopedic Surgeons (AAOA) and the American Academy of Pediatrics (AAP) indicate that there is insufficient evidence to provide strong conclusions that the use of prophylactic knee braces significantly decreases/reduces knee injuries. Prophylactic knee braces are NOT CONSIDERED MEDICALLY NECESSARY for the treatment of disease or injury.

Functional and Rehabilitation Braces: NOT MEDICALLY NECESSARY EXCEPT for those listed below — custom vs. prefabricated or off-the-shelf:

• Deformity of the knee or leg that interferes with fitting
• Disproportionate size of thigh or calf
• Minimal muscle mass on which to suspend an orthosis      

Exceptionally tall or short stature or obesity does not, by itself, establish MEDICAL NECESSITY for custom-made functional knee braces. Tall persons can typically be fitted with a prefabricated brace with extensions, short persons can be typically fitted with a pediatric prefabricated brace and obese persons can be typically fitted with a prefabricated knee brace with extra-large straps.

Unloader Braces (Osteoarthritis braces): MEDICALLY NECESSARY as an alternative to surgery for those members with severe (Grade 4) symptomatic osteoarthritis of the knee who have pain that has failed to respond to medical therapy who have progressive limitations in their ADLs and who do NOT have ANY of the following:

• Arthritis other than Grade 4 osteoarthritis
• A recent knee operation (within the previous 6 weeks)
• Symptomatic disease of the hip, ankle or foot
• Diseases that would preclude the use of a brace (e.g., skin disease, peripheral vascular disease, varicose veins, etc.)
• Severe cardiovascular deficit
• Paresis or other diseases that would preclude ambulation
• Inability to apply the brace (e.g., physical limitations such as arthritis in the hands or ability or inability to bend)

Cast braces (fracture braces):
Non-therapeutic cast braces are CONSIDERED MEDICALLY NECESSARY after a fracture or surgery. Typically utilized after the patient has been in a walking cast. Usually removable, allowing patient the ability to bathe the affected extremity. May also be used when a fracture is slow to heal or non-healing. Usage of a removable cast replaces monthly cast changes.

Functional cast braces are CONSIDERED MEDICALLY NECESSARY after a fracture or surgery. It is typically used following a short period of standard fracture treatment using a non-weight bearing or partial weight-bearing cast or immediately following surgery. These casts have become the standard brace for certain fractures, including tibial-femoral fractures.

Cervical (Neck) Braces:
MEDICALLY NECESSARY for neck injury or other appropriate indications. Cervical foam neck collars are not considered DME as they are not durable and not made to withstand prolonged use.

Childhood Hip Braces:
MEDICALLY NECESSARY for children with hip disorders to stabilize the hip and/or to correct and maintain hip abduction. Typically, these are specialized and are considered integral to the management of the hip disorder.

Braces for Congenital Defects:
Orthopedic braces are considered MEDICALLY NECESSARY in the treatment of congenital defects. Replacement braces are also considered MEDICALLY NECESSARY when the member has outgrown the previous brace or because his/her condition has changed such that the previous brace is not usable.

Wheaton Brace:
MEDICALLY NECESSARY to treat metatarsus adductus in infants, replacing the need for serial casting.

Splints and Immobiliziers:
Dynamic Splinting devices
Includes, but not limited to: Dynasplint Systems, LMB Proglide, EMPI Advance, Ultraflex and Advance Bio Mechanics. Dynamic splinting is considered MEDICALLY NECESSARY for the use of the knee, elbow and wrist in ANY of the following clinical settings:
 

• In the sub-acute injury or postoperative period ( ≥ 3 weeks but < 4 months after injury or operation) in patients with signs/symptoms of persistent joint stiffness despite maximum physical therapy efforts
• In the acute postoperative period for patient who is undergoing additional surgery to improve the range of motion of a previously affected joint
• For patients who are unable to benefit from standard physical therapy modalities due to an inability to exercise
  
  **No significant change after 4 months is prophylactic use in contractures and is NOT MEDICALLY NECESSARY.**
  
  Dynamic splinting is considered NOT MEDICALLY NECESSARY/INVESTIGATIONAL, as there is lack of scientific evidence demonstrating effectiveness, for the following:

• Use in the management of chronic joint stiffness and/or chronic or fixed contractures
• Use in shoulders, fingers, toes or any other condition not listed above
• Bi-directional static progressive stretch splinting (including, but not limited to, Joint Active Systems [JAS splints] and Air Cast)

Certain orthopedic problems are routinely treated with splint and splint-like devices. The following are considered to be MEDICALLY NECESSARY:

• Clavicle splint (figure 8 splint)
• Acromio-clavicular splint

Unna Boots:
MEDICALLY NECESSARY only for non-fracture care. They can be utilized to treat the following:

• Treat sprains and torn ligaments
• Provide protection for other soft tissue injuries
• May be used after certain surgical procedures as a protective cover to promote healing

Unna boots are NOT CONSIDERED MEDICALLY NECESSARY when used in conjunction with fracture treatment.

Air Casts:
MEDICALLY NECESSARY for treatment of fractures or other injuries (i.e., sprains, torn ligaments). They may be used as an alternative to plaster casts to immobilize an elbow, ankle or knee.

Each benefit plan defines which services are covered or non-covered, which are subject to monetary dollar caps or other limitations. Please see specific benefit contract guidelines for determination of exclusion, limitations, etc.

References:

1. van Rhijn LW, Plasmans CM, Veraart BE. Changes in curve pattern after brace treatment for idiopathic scoliosis. Acta Orthop Scand. 2002;73(3):277-281.
2. Gepstein R, Leitner Y, Zohar E, et al. Effectiveness of the Charleston bending brace in the treatment of single-curve idiopathic scoliosis. J Pediatr Orthop. 2002;22(1):84-87.
3. South Carolina Medicare; CMS: Centers for Medicare & Medicaid Services. DMERC. Local Coverage Determination. Accessed December 2005.
4. OrthoRehab. Protonics for patellofemoral pain. Accessed December 2005.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved." 

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