An orthosis (brace) is a rigid or semi-rigid device which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. It must provide support and counterforce (i.e., a force in a defined direction of a magnitude at least as great as a rigid or semi-rigid support) on the limb or body part that it is being used to brace. An orthosis can be either prefabricated or custom-fabricated.

Prefabricated Knee Orthoses

A knee orthosis, elastic with joints, or knee orthosis with condylar pads and joints, with or without patellar control may be considered medically necessary for ambulatory individuals who have weakness or deformity of the knee and require stabilization.

If the knee orthosis, elastic with joints, or knee orthosis elastic with condylar pads and joints, with or without patellar control, is provided but the criteria above are not met, the orthosis is considered not medically necessary.

A knee orthosis, with a locking knee joint, or a rigid knee orthosis may be considered medically necessary for individuals with flexion or extension contractures of the knee with movement on passive range of motion testing of at least 10 degrees (i.e., a non-fixed contracture). 

If the knee orthosis, with locking knee joint, or rigid knee orthosis is provided but the criteria above is not met, the orthosis is considered not medically necessary. 

A knee orthosis, double upright with adjustable joint, with inflatable air support chambers(s), also known as bladders, customized or off the shelf is considered not medically necessary. There is no proven clinical benefit to the bladder incorporated into the design.

A knee immobilizer without joints, a knee orthosis with adjustable knee joints, or a knee orthosis with adjustable flexion and extension joints that provides both medial, lateral and rotation control may be considered medically necessary if the individual has a recent injury or surgical procedure on the knee(s) and has ANY ONE of the following diagnosis:

·         Rheumatoid arthritis; or

·         Osteoarthritis; or

·         Meniscal cartilage derangement; or

·         Chondromalacia of patella; or

·         Knee ligamentous disruption; or

·         Rupture of tendon, non-traumatic - quadriceps tendon; or

·         Pathologic fracture of femur; or

·         Pathologic fracture of tibia or fibula; or

·         Aseptic necrosis of tibia or fibula; or

·         Stress fracture of tibia or fibula; or

·         Congenital deformity of knee; or

·         Fracture of femur- lower end; or

·         Fracture of patella; or

·         Fracture of tibia and/or fibula - upper end; or

·         Dislocation of knee; or

·         Sprains and strains of knee; or

·         Failed total knee arthroplasty; or

·         Infection or other complications due to internal joint prosthesis; or

·         Knee joint replacement.

Knee orthosis with adjustable knee joints or a knee orthosis with adjustable flexion and extension joints may be considered medically necessary for an individual who is ambulatory and has knee instability due to a condition specified in ANY ONE of the diagnoses listed above or ANY ONE of the following diagnoses:

·         Multiple sclerosis; or

·         Hemiplegia, unspecified; or

·         Infantile cerebral palsy, unspecified; or

·         Paraplegia of both lower limbs; or

·         Mononeuritis of lower limb, unspecified.

Knee immobilizer without joints, knee orthosis with adjustable knee joints, or a knee orthosis with adjustable flexion and extension joints that provides both medial, lateral and rotation control for any other condition not stated above is considered not medically necessary. 

A knee orthosis, Swedish type, prefabricated may be considered medically necessary for an individual who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee.

A knee orthosis, Swedish type, prefabricated for any other condition is considered not medically necessary. 

Knee orthosis with adjustable knee joint(s), knee orthosis with adjustable flexion and extension joints and knee orthosis, Swedish type require the knee instability be documented by examination and objective description of joint laxity (e.g., Varus/valgus instability, anterior/posterior Drawer test).

Knee orthosis with adjustable knee joint(s), knee orthosis with adjustable flexion and extension joints, and knee orthosis, Swedish type are considered not medically necessary when the individual does not meet the above criteria.

Prefabricated addition codes

Addition codes are grouped into four (4) categories in relation to knee orthosis base codes.

·         Eligible for separate payment; and

·         Not medically necessary; and

·         Not separately payable; and

·         Incompatible.

The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified prefabricated base orthosis. Addition codes may be separately payable if:

·         They are provided with the related base code orthosis; and

·         The base orthosis is considered medically necessary; and

·         The addition is considered medically necessary.

Addition codes are considered not medically necessary if the base orthosis is considered not medically necessary or the addition is considered not medically necessary.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified prefabricated base orthosis but are considered not medically necessary.

These addition codes, if they are billed with the related base code, are considered not medically necessary. 

Addition codes in the first two (2) categories are addressed in the tables above. Addition codes that are not separately payable are addressed in the tables below.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified prefabricated base orthosis but are considered to be included in the allowance for the orthosis. The addition codes are considered not separately payable if they are billed with the related base code.

Custom Fabricated Knee Orthoses

General Criteria for Custom Fabricated Knee Orthoses:

·         A custom fabricated orthosis may be considered medically necessary when there is a documented physical characteristic which requires the use of a custom fabricated orthosis instead of a prefabricated orthosis. Examples of situations which meet the criterion for a custom fabricated orthosis include, but are not limited to:

o   Deformity of the leg or knee; or

o    Size of thigh and calf; or

o    Minimal muscle mass upon which to suspend an orthosis.

·         Although these are examples of potential situations where a custom fabricated orthosis may be appropriate, suppliers must consider prefabricated alternatives such as pediatric knee orthoses in individuals with small limbs, straps with additional length for large limbs, etc.

·         If a custom fabricated orthosis is provided but the medical record does not document why that item is medically necessary instead of a prefabricated orthosis, the custom fabricated orthosis is considered not medically necessary.

·         Custom fabricated orthoses are considered not medically necessary in the treatment of knee contractures in cases where the individual is not ambulatory.

A custom fabricated knee immobilizer without joints may be considered medically necessary when BOTH of the following criteria are met: 

·         The coverage criteria for the prefabricated orthosis, knee immobilizer without joints as mentioned above are met; and

·         The general criteria for a custom fabricated orthosis is met.

Custom fabricated knee orthosis may be considered medically necessary in non-ambulatory individuals with severe spastic conditions such as, but not limited to cerebral palsy.

Custom fabricated knee orthosis in non-ambulatory individuals for indications other than severe spastic conditions is considered not medically necessary.

If a custom fabricated knee immobilizer without joints is provided and both criteria above are not met, the orthosis is considered not medically necessary.

A custom fabricated derotation knee orthosis may be considered medically necessary for instability due to internal ligamentous disruption of the knee.

A custom fabricated knee orthosis with an adjustable flexion and extension joint may be considered medically necessary if ALL the following are met:

• The coverage criteria for the prefabricated orthosis, and knee orthosis with an adjustable flexion and extension joint are met; and
• The general criteria for a custom fabricated orthosis are met.

If a custom fabricated knee orthosis with an adjustable flexion and extension joint is provided and both criteria above are not met, the orthosis is considered not medically necessary.

A custom fabricated knee orthosis with a modified supracondylar prosthetic socket may be considered medically necessary for an individual who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee. 

A custom fabricated orthosis for any other condition not stated above is considered not medically necessary.

Custom fabricated addition codes

The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified custom fabricated base orthosis. Addition codes may be separately payable if:

·         They are provided with the related base code orthosis; and

·         The base orthosis is considered medically necessary; and

·         The addition is considered medically necessary.

Addition codes are considered not medically necessary if the base orthosis is not medically necessary or the addition is not medically necessary.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified custom fabricated base orthosis but are considered not medically necessary.

These addition codes, if they are billed with the related base code, are considered not medically necessary.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified custom fabricated base orthosis but that are considered to be included in the allowance for the orthosis.  The addition codes are considered not separately payable if they are billed with the related base code.

 All addition codes that are not listed as either separately payable or not medically necessary in the tables in the policy or as not separately payable in the tables above describe components or features that either cannot be physically incorporated in the specified base orthosis or whose narrative description is incompatible with base orthosis code (e.g., billing a prefabricated base code with an addition code which specifies that is it only used with custom fabricated orthoses). 

Miscellaneous

Heavy duty knee joints, addition to lower extremity, straight knee joint and offset knee joint may be considered medically necessary for individuals who weigh more than 300 pounds. They may also be considered medically necessary for individuals whose activity level requires extra support. This would extend but not be limited to professional athletes. Physician documentation would be required.

Coverage of a removable soft interface is limited to a maximum of two (2) per year beginning one (1) year after the date of service for initial issuance of the orthosis. Additional replacement interfaces are considered not medically necessary.

Heavy duty knee joints, addition to lower extremity, straight knee joint and offset knee joint for any other condition not stated above are considered not medically necessary.

Concentric Adjustable Torsion Style Mechanisms

Concentric adjustable torsion style mechanisms used to assist knee joint extension may be considered medically necessary:

For individuals who require knee extension assist in the absence of any co-existing joint contracture.

Concentric adjustable torsion style mechanisms for any other condition not stated above is considered not medically necessary.

Claims for devices incorporating concentric adjustable torsion style mechanisms used for the treatment of any joint contracture are considered non-covered.

Reasons for Non-coverage

Items that do not meet the definition of a brace are considered non-covered.

Elastic support garments (e.g. made of material such as neoprene or spandex [elastane, Lycra®]) do not meet the definition of a brace because they are not rigid or semi-rigid devices and therefore are considered non-covered.

Correct coding of prefabricated knee orthoses is dependent upon whether or not there is a need for minimal self-adjustment at the time of fitting by the individual, caretaker for the individual, or supplier that does not require the services of a qualified practitioner.

Quantity Level Limits (QLL) for custom fabricated knee orthosis

One (1) knee orthosis, i.e., one (1) RT modifier and/or one (1) LT modifier, per every three (3) years may be considered medically necessary as the reasonable useful lifetime of custom fabricated knee orthosis.

QLL or quantity of supplies that exceed the frequency guidelines listed on the policy are considered not medically necessary. 

Quantity Level Limits (QLL) for prefabricated knee orthosis

One (1) knee orthosis, i.e., one (1) RT modifier and/or one (1) LT modifier, per every one (1) year may be considered medically necessary as the reasonable useful lifetime of prefabricated knee orthosis.

QLL or quantity of supplies that exceed the frequency guidelines listed on the policy are considered not medically necessary.

Quantity Level Limits (QLL) for prefabricated knee orthosis

One (1) knee orthosis, i.e., one (1) RT modifier and/or one (1) LT modifier, per every two (2) years may be considered medically necessary as the reasonable useful lifetime of prefabricated knee orthosis.

QLL or quantity of supplies that exceed the frequency guidelines listed on the policy are considered not medically necessary.

Quantity Level Limits (QLL) for prefabricated knee orthosis

One (1) knee orthosis, i.e., one (1) RT modifier and/or one (1) LT modifier, per every three (3) years may be considered medically necessary as the reasonable useful lifetime of prefabricated knee orthosis.

QLL or quantity of supplies that exceed the frequency guidelines listed on the policy are considered not medically necessary.

Brace sleeves used in conjunction with orthoses are non-covered because they are not used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body (i.e., it does not meet the definition of a brace).

Replacement

Replacement during the reasonable useful lifetime may be considered medically necessary if the item is lost or irreparably damaged. Replacement may be considered medically necessary when the individual has a progressive disease which renders the initial brace to be non-supportive before the reasonable useful lifetime of the brace. Documentation by a qualified physician is required. Replacement for other reasons, including but not limited to irreparable wear, during the period of reasonable useful lifetime is denied as non-covered. L-coded additions to knee orthoses will be denied as non-covered when the base orthosis is non-covered. Repairs to a covered orthosis are covered when they are necessary to make the orthosis functional. The reason for the repair must be documented in the supplier’s record. If the expense for repairs exceeds the estimated expense of providing another entire orthosis, no payment will be made for the amount in excess.

Replacement items not meeting the criteria above are considered not medically necessary.