The purpose of an orthotic (rigid or semi-rigid brace) is to support a weak or deformed body part or to restrict or eliminate motion in a diseased or injured part of the body. This document addresses orthotics (e.g., braces) for the ankle-foot or the knee-ankle-foot.

Note: Please see the following related documents for additional information:

• CG-DME-19 Therapeutic Shoes, Inserts or Modifications for Individuals with Diabetes
• CG-DME-20 Orthopedic Footwear
• CG-OR-PR-02 Prefabricated and Prophylactic Knee Braces
• CG-OR-PR-03 Custom-made Knee Braces

Ankle-foot orthotics (AFOs) used in non-ambulatory individuals  

Medically Necessary: 

A static AFO is considered medically necessary if all of the following criteria are met:

1. Plantar flexion contracture of the ankle with dorsiflexion on passive range of motion testing of at least 10 degrees (i.e., a non-fixed contracture); and
2. Reasonable expectation of the ability to correct or prevent a fixed contracture in those who may become ambulatory; and
3. Contracture is interfering or expected to interfere significantly with the individual's functional abilities; and
4. Used as a component of a therapy program that includes passive stretching of the involved muscles or tendons.

If a static AFO is used for the treatment of a plantar flexion contracture, the pre-treatment passive range of motion must be measured with a goniometer and documented in the medical record. There must be documentation of an appropriate stretching program carried out by professional staff (in a nursing facility) or caregiver (at home).

Not Medically Necessary:

A static AFO, including replacement interface is considered not medically necessary when used solely for the prevention or treatment of a heel pressure ulcer. For these indications, it does not meet the definition of a brace (i.e., it is not used to support a weak or deformed body part or to restrict or eliminate motion in a diseased or injured part of the body).

A static AFO and replacement interface is considered not medically necessary if the contracture is fixed.

A static AFO and replacement interface is considered not medically necessary for a non-ambulatory individual with a foot drop but without an ankle flexion contracture.

A component of a static AFO that is used to address positioning of the knee or hip in a non-ambulatory individual is considered not medically necessary.

A foot drop splint/recumbent positioning device and replacement interface is considered not medically necessary when it is used solely for the prevention or treatment of a heel pressure ulcer because this does not meet the definition of a brace.

A foot drop splint/recumbent positioning device and replacement interface is considered not medically necessary in an individual with foot drop who is non-ambulatory.

Ankle-Foot Orthotics (AFOs) and Knee-Ankle-Foot Orthotics (KAFOs) used in ambulatory individuals

Medically Necessary: 

Ankle-foot orthotics (AFOs) are considered medically necessary for ambulatory individuals with weakness or deformity of the foot and ankle who require stabilization for medical reasons and have the potential to benefit functionally.

Knee-ankle-foot orthotics (KAFOs) are considered medically necessary for ambulatory individuals for whom an ankle-foot orthotic is appropriate and additional knee stability is required.

AFOs and KAFOs that are custom-fabricated are considered medically necessary for ambulatory individuals when the basic medically necessary criteria listed above are met and one or more of the following criteria are met:

1. The individual could not be fit with a prefabricated AFO; or
2. The condition necessitating the orthotic is expected to be permanent or of longstanding duration (more than 6 months); or
3. There is a need to control the knee, ankle, or foot in more than one plane; or
4. The individual has a documented neurological, circulatory, or orthopedic status that requires custom fabricating over a model to prevent tissue injury; or
5. The individual has a healing fracture which lacks normal anatomical integrity or anthropometric proportions.

Walking boots used to provide immobilization as treatment for an orthopedic condition or after orthopedic surgery are considered medically necessary.

Not Medically Necessary:

AFOs and KAFOs that do not meet the criteria above are considered not medically necessary.

An AFO or KAFO and any related addition, for an ambulatory individual, used solely for the treatment of edema or for the prevention or treatment of a heel pressure ulcer, is considered not medically necessary.

Walking boots used primarily to relieve pressure, especially on the sole of the foot, or used for individuals with foot ulcers, are considered not medically necessary.

Socks used in conjunction with AFOs and KAFOs are considered not medically necessary and do not meet the definition of durable medical equipment.

Repairs and/or Replacement

Medically Necessary:

Repairs to medically necessary AFOs and KAFOs, due to wear or to accidental damage, are considered medically necessary when they are necessary to make the AFO or KAFO functional.

Replacement of an AFO or KAFO or component of an AFO or KAFO due to loss, significant change in the individual's condition, or irreparable accidental damage is considered medically necessary if the device is still medically necessary.

Not Medically Necessary:

Replacement components (e.g., soft interfaces) that are provided on a routine basis without regard to whether the original item is worn out are considered not medically necessary.

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.

A non-ambulatory ankle-foot orthotic may be either an ankle contracture splint or a foot drop splint.

A static AFO is a prefabricated ankle-foot orthotic that has all of the following characteristics:

1. Designed to accommodate an ankle with a plantar flexion contracture up to 45^○_;and
2. Applies a dorsiflexion force to the ankle; and
3. Allows pressure reduction; and
4. Has a soft interface.

A foot drop splint/recumbent positioning device is a prefabricated ankle-foot orthotic that has all of the following characteristics:

1. Designed to maintain the foot at a fixed position of zero degrees (i.e., perpendicular to the lower leg); and
2. Not designed to accommodate an ankle with a plantar flexion contracture; and
3. Used by an individual who is non-ambulatory; and
4. Has a soft interface.

Medicare criteria was utilized in the development of this document.

Ankle flexion contracture: A condition in which there is shortening of the muscles or tendons that plantar-flex the ankle with the resulting inability to bring the ankle to zero degrees by passive range of motion (zero degrees ankle position is when the foot is perpendicular to the lower leg).

Ankle-foot orthotics (AFOs): These extend well above the ankle (usually to near the top of the calf) and are fastened around the lower leg above the ankle. These features distinguish them from foot orthotics which are shoe inserts that do not extend above the ankle.

Custom-fabricated orthotic: An orthotic that is individually made for a specific individual starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. The process involves substantial work such as cutting, bending, molding, sewing, etc. It may involve the incorporation of some prefabricated components and it involves more than trimming, bending, or making other modifications to a substantially prefabricated item.

Foot drop: A condition in which there is weakness or lack of use of the muscles that dorsiflex the ankle, but there is the ability to bring the ankle to zero degrees by passive range of motion.

Knee-ankle-foot-orthotics (KAFOs): An orthotic designed to control knee and ankle motion that extends from the upper portion of the thigh, crossing the knee and ankle and ending at the toes.

Orthotic (brace) (orthosis): A rigid or semi-rigid device that is used for the purpose of supporting a weak or deformed body part, or for restricting or eliminating motion in a diseased or injured part of the body. An orthotic can be either prefabricated or custom-fabricated.

Prefabricated orthotic: An orthotic that is manufactured in quantity without a specific individual in mind. A prefabricated orthotic may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific individual (i.e., custom fitted). An orthotic that is assembled from prefabricated components is considered prefabricated. Any orthotic that does not meet the definition of a custom-fabricated orthotic is considered prefabricated.

Government Agency, Medical Society, and Other Authoritative Publications:

1. CIGNA Government Services. Local Coverage Determination for Ankle-Foot/Knee-Ankle-Foot Orthosis (L11517). Revised 02/04/2011. Available at: http://www.cms.gov/mcd/index_local_alpha.asp?from=alphalmrp&letter=A. Accessed on July 26, 2011.
2. NHIC, Corp. Local Coverage Determination for Ankle-Foot/Knee-Ankle-Foot Orthosis (L11527). Revised 02/04/2011. Available at: http://www.cms.gov/mcd/index_local_alpha.asp?from=alphalmrp&letter=A. Accessed on July 26, 2011.
3. Noridian Administrative Services. Local Coverage Determination for Ankle-Foot/Knee-Ankle-Foot Orthosis (L142). Revised 02/04/2011. Available at: http://www.cms.gov/mcd/index_local_alpha.asp?from=alphalmrp&letter=A. Accessed on July 26, 2011.

Ankle-Foot Orthotics
Knee-Ankle-Foot Orthotics