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 four 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

1. Custom-fit, prefabricated (Off-the-shelf) functional knee braces are considered MEDICALLY NECESSARY in members with knee instability due to injury, including patients who have had surgery for the injury. (HCPCS L1810, L1812, L1820, L1830, L1832, L1833, L1836)
2. Custom-fit, prefabricated rigid knee orthoses without joints and knee orthosis with joints that lock the knee into a particular position are considered MEDICALLY NECESSARY for persons with non-fixed flexion contractures of the knee. (HCPCS L1831)
3. Custom-fit, prefabricated orthoses with locking joints and inflatable air support chambers are considered NOT MEDICALLY NECESSARY because there is no proven clinical benefit to the inflatable air bladder incorporated into the design of this knee orthosis (HCPCS L1847 and L1848).
4. Custom-fabricated unloader knee braces are considered MEDICALLY NECESSARY as a treatment of members with painful moderate (Grade III) or severe (Grade IV) osteoarthritis involving the medial compartment of the knee, or in the immediate post-operative period (6 weeks) after osteochondral grafting, chondrocyte implantation, or microfracture surgery to allow for healing (HCPCS L1843, L1845, L1847, L1851, L1852).
5. Custom-fabricated braces (also known as "custom-made" or "molded" knee orthoses) are considered MEDICALLY NECESSARY if the member meets criteria for a prefabricated knee brace above but is unable to be fitted with a prefabricated knee brace. Examples of situations in which a person may meet criteria for a custom-made knee brace include, but are not limited to: (HCPCS L1834, L1840, L1844, L1846, L1860)
   1. A deformity of the knee or leg that interferes with fitting;
   2. Disproportionate size of thigh and calf;
   3. Minimal muscle mass upon which to suspend an orthosis.
6. Prophylactic knee braces (prefabricated or custom-fabricated) worn to prevent injury or re-injury are considered NOT MEDICALLY NECESSARY for all indications.
7. MEDICALLY NECESSARY additions to knee braces (e.g., L2397, L2820, and L2830) are separately reimbursable. (NOTE Heavy duty knee joint codes (L2385, L2395) are covered only for members who weigh more than 300 pounds.)
8. Approval for the replacement of a previously covered knee brace is limited to the following conditions:
   1. irreparable damage;
   2. wear causing the orthosis to be ill-fitting;
   3. a change in the member’s condition or
   4. when necessitated due to growth.

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 immobilizers:
Dynamic splinting devices
Includes but is 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 used 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 noncovered, 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