This document addresses orthoses for the ankle-foot or the knee-ankle-foot. The purpose of an orthosis (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.

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
• CG-OR-PR-09 Microprocessor Controlled Knee-Ankle-Foot Orthosis
• SURG.00104 Extraosseous Subtalar Joint Implantation and Subtalar Arthroereisis

Clinical Indications

Medically Necessary:

An ankle-foot orthosis (AFO) is considered medically necessary for ambulatory (i.e., able to walk, independently or with assistance) 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 orthoses (KAFOs) are considered medically necessary for ambulatory individuals for whom an ankle-foot orthosis is appropriate and additional knee stability is required.

AFOs and KAFOs that are custom-fabricated are considered medically necessary for ambulatory individuals when medically necessary criteria are otherwise 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 orthosis 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.

A static AFO is considered medically necessary for non-ambulatory individuals 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 (that is, 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:

AFOs and KAFOs are considered not medically necessary if the above criteria are not met and for all other indications, including but not limited to the following:

1. Used solely for the treatment of edema; or
2. Used for the prevention or treatment of a heel pressure ulcer: or
3. Used for a fixed contracture; or
4. Used for foot drop but without an ankle flexion contracture.

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.

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.

Repairs and/or Replacement

Medically Necessary:

Repairs to medically necessary AFOs and KAFOs, due to wear or 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 damage is considered medically necessary if the device is still medically necessary.

* This may include significant growth in a child or adolescent, major weight loss or gain, or other body changes that result in poor prosthetic fit or function.

Not Medically Necessary:

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