An orthosis is an orthopedic appliance or apparatus used to support, align, prevent, or correct deformities or to improve function of movable parts of the body. Ankle-Foot Orthosis (AFO) and Knee-Ankle-Foot Orthosis (KAFO) are designed to control knee and ankle motion.

The purpose of a brace is to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body.

For an item to be considered for coverage under the brace benefit category, it must be a rigid or semi-rigid device which is used for the purpose of supporting a weak or deformed body extremity 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. 

Elastic support garments do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices and are non-covered.

An orthosis can be classified as either prefabricated (off-the-shelf or custom fitted) or custom-fabricated. Items that do not meet the definition of a brace are non-covered.

(AFO) not used during ambulation

A static or dynamic positioning ankle-foot orthosis may be considered medically necessary for the treatment of plantar fasciitis OR when ALL of the following are met.

• Plantar flexion contracture of the ankle with dorsiflexion on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture); and
• Reasonable expectation of the ability to correct the contracture; and
• Contracture is interfering or expected to interfere significantly with the individual’s functional abilities; and
• Used as a component of a therapy program; this includes active stretching of the involved muscles and/or tendons.

If a static or dynamic positioning 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).

If a static or dynamic positioning AFO is considered medically necessary, a replacement interface is considered medically necessary as long as the individual continues to meet indications and other coverage rules for the splint.  Coverage of a replacement interface is limited to a maximum of one (1) per six (6) months.  Additional interfaces will be denied as not medically necessary.

AFO and KAFO used during ambulation

 An AFO may be considered medically necessary for ambulatory individuals with weakness or deformity of the foot and ankle, who require stabilization for medical reasons (including required support for  standing transfers), and have the potential to benefit functionally.

 A KAFO may be considered medically necessary for ambulatory individuals for whom an ankle-foot orthosis is considered medically necessary and additional knee stability is required.

An AFO or KAFO that is custom-fabricated may be considered medically necessary for ambulatory individuals when the basic coverage criteria listed above and ANY ONE of the following criteria are met:

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

If a custom fabricated orthosis is provided but ALL of the coverage criteria above including the additional criteria for a custom fabricated orthosis are not met, the custom fabricated orthosis will be denied as not medically necessary.

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 used to assist ankle joint plantarflexion or dorsiflexion may be considered medically necessary for individuals who require ankle plantar or dorsiflexion assist in the absence of any co-existing joint contracture.

Concentric adjustable torsion style mechanisms may be considered medically necessary when used for the treatment of contractures, regardless of any co-existing condition(s).

Replacement of a complete orthosis or component of an orthosis due to loss, significant change in the individual’s condition, or irreparable accidental damage may be considered medically necessary if the device is still medically necessary.  The reason for the replacement must be documented in the supplier’s record. Replacements not meeting criteria will be considered not medically necessary.

If the specific AFO or KAFO criteria are not met, the orthosis will be considered not medically necessary.

A static AFO and replacement interface will be denied as not medically necessary if the contracture is fixed. A static AFO and replacement interface will be denied as not medically necessary for an 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 will be denied as not medically necessary because the effectiveness of this type of component is not established.

A static AFO and replacement interface is non-covered when it is used solely for the prevention or treatment of a heel pressure ulcer because for these indications it is 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).

A foot drop splint/recumbent positioning device or replacement interface is considered not medically necessary.  A foot drop splint/recumbent positioning device and replacement interface will be denied as not medically necessary in an individual with foot drop who is nonambulatory because there are other more appropriate treatment modalities.

A foot drop splint/recumbent positioning device and replacement interface will be considered not medically necessary when used solely for the prevention or treatment of a pressure ulcer because for these indications it is 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).

Additions to AFOs and KAFOs will be considered not medically necessary if either the base orthosis is not medically necessary or the specific addition is not medically necessary.

A foot pressure off-loading/supportive device is denied as non-covered because it does not support a weak or deformed body member or restrict or eliminate motion in a diseased or injured part of the body.

Socks used in conjunction with orthoses are non-covered.

Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out, are non-covered.