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.

Ankle-Foot Orthoses Not Used During Ambulation

A static ankle-foot orthosis (L4396) is covered if either all of criteria 1-4 or criterion 5 is met:

1. 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
2. Reasonable expectation of the ability to correct the contracture; and
3. Contracture is interfering or expected to interfere significantly with the patient’s functional abilities; and
4. Used as a component of a therapy program which includes active stretching of the involved muscles and/or tendons.
5. The patient has plantar fasciitis.

If a static ankle-foot orthosis 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 code L4396 is covered, a replacement interface (L4392) is covered as long as the patient 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 months.  Additional interfaces will be denied as not medically necessary.

Ankle-Foot Orthoses and Knee-Ankle-Foot Orthoses Used During Ambulation

Ankle-foot orthoses described by codes L1900, L1902-L1990, L2106-L2116, L4350, L4360, L4386, and L4631 are covered for ambulatory patients 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 described by codes L2000-L2038, L2126-L2136, and L4370 are covered for ambulatory patients for whom an ankle-foot orthosis is covered and for whom additional knee stability is required.

Ankle-foot orthoses and knee-ankle-foot orthoses that are molded-to-patient-model, or custom-fabricated, are covered for ambulatory patients when the basic coverage criteria listed above and one of the following criteria are met:

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

If the specific criteria for a molded-to-patient-model or custom-fabricated orthosis are not met, but the criteria for a prefabricated, custom fitted orthosis are met, payment will be based on the allowance for the least costly medically appropriate alternative.

Replacement of a complete orthosis or component of an orthosis due to loss, significant change in the patient’s condition, or irreparable accidental damage is covered if the device is still medically necessary.  The reason for the replacement must be documented in the supplier’s record.  Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out, are denied as not medically necessary.

Please reference Medical Policy Bulletin E-15 for diabetic orthosis.

Reasons for Noncoverage

A static ankle-foot orthosis and replacement interface will be denied as not medically necessary if the contracture is fixed. A static ankle-foot orthosis and replacement interface will be denied as not medically necessary for a patient with a foot drop but without an ankle flexion contracture.  A component of a static ankle-foot orthotic 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 ankle-foot orthosis and replacement interface (L4392) 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 participating, preferred, or network provider can bill the member for the non-covered service.

A foot drop splint/recumbent positioning device (L4398) or replacement interface (L4394) is not reimbursable.  A foot drop splint/recumbent positioning device and replacement interface will be denied as not medically necessary in a patient with foot drop who is nonambulatory because there are other more appropriate treatment modalities.

A foot drop splint/recumbent positioning device (L4398) and replacement interface (L4394) is also non-covered when it is 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).  A participating, preferred, or network provider can bill the member for the non-covered device.

If the basic coverage criteria for an ankle-foot orthosis or knee-ankle-foot orthosis are not met, the orthosis will be denied as not medically necessary.

L- coded additions to ankle-foot orthoses and knee-ankle-foot orthoses (L2180-L2550, L2750-L2768, L2780-L2830) will be denied as not medically necessary if either the base orthosis is not medically necessary or the specific addition is not medically necessary.

Quantities of supplies greater than those described in the policy as the usual maximum amounts, in the absence of documentation clearly explaining the medical necessity of the excess quantities, will be denied as not medically necessary.

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 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.  Items that do not meet the definition of a brace are non-covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Certain products may have both covered and non-covered uses, and must be coded based on the patient’s condition.  For example, when used as a brace for the treatment of an orthopedic condition, walking boots are coded L4360 and L4386.  However, walking boots must be coded A9283 when used solely for the prevention or treatment of a lower extremity ulcer or pressure reduction.

When using code A9283, there is no separate billing using addition codes.  Replacement liners for devices billed with A9283 must be billed with code A9270 (non-covered item or service).  A participating, preferred or network provider can bill the member for the non-covered device.

Elastic support garments do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices.  Devices that are not rigid or semi-rigid must be coded A4466.  Code A4466 will be denied as non-covered.  A participating, preferred, or network provider can bill the member for the non-covered service.

A foot pressure off-loading/supportive device (A9283) 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. A participating, preferred, or network provider can bill the member for the non-covered service.

Socks (L2840, L2850) used in conjunction with orthoses are non-covered. The provider can bill the member for the non-covered service.

Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out, are not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Services that do not meet the medical necessity criteria documented in this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Documentation Requirements

An order for each new or full replacement item must be signed and dated by the treating physician, kept on file by the supplier and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

The order must list the unique features of the base code that is billed plus every addition that will be billed on a separate claim line.  The medical record must contain information which supports the medical necessity of the item and all additions that are ordered.  An order is not necessary for the repair of an orthosis.

Suppliers must add a KX modifier to the AFO/KAFO base and addition codes only if all of the coverage criteria in the "Indications and Limitations of Coverage" section of this policy have been met and evidence of such is retained in the supplier's files and available upon request.

If all of the criteria in the medical policy have not been met, the GA or GZ modifier must be added to the code.  When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have given advanced written notice to the member or the GZ modifier if they have not given advanced written notice to the member.  The provider can bill the member if the GA modifier is entered on the claim.  The provider cannot bill the member if the GZ modifier is billed on the claim.

Claims lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.

The supplier must include on the claim for a static or dynamic positioning ankle-foot orthosis (L4396) or replacement interface material (L4392) the diagnosis code for the underlying condition.

For custom-fabricated orthoses, there must be documentation in the supplier’s records to support the medical necessity of that type device rather than a prefabricated orthosis.  This information does not have to be routinely sent in with the claim, but must be available upon request.

When code L2999 is billed, the claim must include a narrative description of the item (for custom fabricated items) or the manufacturer name and model name/number (for prefabricated items). For replacement components billed with miscellaneous code L2999, there must also be a procedure code or the manufacturer name and model name/number of the base orthosis. This information should be entered in the narrative field of the claim.

A claim for code L4205 must include an explanation of what is being repaired.  A claim for code L4210 must include a description of each item that is billed.   This information should be entered in the narrative field of an electronic claim or attached to a hard copy claim.

All codes for orthoses or repairs of orthoses billed with the same date of service must be submitted on the same claim.

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, there must be documentation in the patient’s medical record supporting the medical necessity for the higher utilization.  This information must be available upon request.

Coding Guidelines 

Codes L1900, L1904, L1907, L1920, L1940-L1950, L1960, L1970, L1980-L2030, L2034, L2036- L2108, L2126, L2128 and L4631 describe custom-fabricated orthoses.  These codes must not be used for prefabricated (i.e., non-custom-fabricated) orthoses.

Codes L1902, L1906, L1910, L1930, L1951, L1971, L2035, L2112-L2116 and L2132-L2136 describe prefabricated orthoses.  These codes must not be used for custom-fabricated orthoses.

Codes L1900, L1902-L1990, L2106-L2116, L4350, L4360, L4386 and A4631 are used for ankle-foot orthoses which are worn when a patient is ambulatory.  Code L4396 is used for an ankle-foot orthosis which is worn when a patient is nonambulatory or minimally ambulatory.  Code L4398 is used for an ankle-foot orthosis which is worn when a patient is nonambulatory.

Code L4631 includes all additions including straps and closures.  No additional codes may be billed with L4631.

Some replacement items have unique procedure codes.  For example, replacement soft interfaces used with ankle contracture orthoses or foot drop splints are billed with codes L4392 and L4394, respectively.  Replacement components that do not have a unique procedure code must be billed with a “not otherwise specified” code – L2999.  Procedure codes L4050-L4055 do not describe replacement soft interfaces used with contracture orthoses.

Code L4205 is used for the labor component of repair of a previously provided orthosis except for any labor involved in the replacement of an orthotic component that has a specific L code.  It may only be billed for the actual time involved in the repair of an orthosis.  It must not be used for any labor involved in the evaluation, fabrication, or fitting of a new or full replacement orthosis.  Labor involved in the replacement of an orthotic component that has a specific L code is not separately billable.

Ankle-foot orthoses extend well above the ankle (usually to near the top of the calf) and are fastened around the lower leg above the ankle.  Foot orthotics are shoe inserts that do not extend above the ankle.  The correct codes for foot orthotics provided for patients without diabetes are L3000-L3090.  Multiple density foot orthotics used in the management of diabetic foot problems are coded A5512 and A5513.

Claims for prefabricated or custom-fabricated devices that contain a concentric adjustable torsion style mechanism in the knee or ankle joint should be coded as E1810 (dynamic adjustable knee extension/flexion device, includes soft interface material) or E1815 (dynamic adjustable ankle extension/flexion device, includes soft interface material), respectively.  All claims billed with L-codes for devices incorporating a concentric adjustable torsion style mechanism in the knee or ankle joint will be rejected as incorrect coding.

The right (RT) and left (LT) modifiers must be used with orthosis base codes, additions and replacement parts.  When the same code for bilateral items (left and right) is billed on the same date of service, bill both items on the same claim line using the LTRT modifiers and two units of service.  Claims billed without modifiers RT and/or LT will be rejected as incorrect coding.

Evaluation of the patient, measurement and/or casting, and fitting of the orthosis are included in the allowance for the orthosis.  There is no separate payment for these services.

Repairs to a covered orthosis due to wear or to accidental damage 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.

The allowance for the labor involved in replacing an orthotic component that is coded with a specific L code is included in the allowance for that component.  The allowance for the labor involved in replacing an orthotic component that is coded with the miscellaneous code L4210 is separately payable in addition to the allowance for that component.

Addition codes L4002-L4130, L4392 are for billing of replacement components and are not payable at initial issue of a base orthosis.  When claims for code(s) L4002-L4130, L4392 are billed at the time of initial issue of a base orthosis, the addition code(s) will be rejected as incorrect coding.

Coverage for prosthetics is determined according to individual or group customer benefits.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits, or a contract.  Benefits are determined by the Federal Employee Program.

06/2010, New Ankle-Foot or Knee-Ankle-Foot Orthosis policy effective October 11, 2010
02/2011, Ankle-foot/knee-ankle-foot orthosis coverage guidelines to change

Sheffler LR, Hennessey MT, Knutson JS, et al.  Functional effect of an ankle foot orthosis on gait in multiple sclerosis:  a pilot study.  AM J Phys Med Rehabil.  2008;87(1):26-32.

Figueiredo EM, Ferreira GB, Maia Moreira RC, et al.  Efficacy of ankle-foot orthoses on gait of children with cerebral palsy:  systematic review of literature.  Pediatr Phys Ther.  2008;20(3):207-223.

Rjichie DH Jr.  Effects of foot orthoses on patients with chronic ankle instability.  J AM Podiatr Med Assoc.  2007;97(1):19-30.

Hijmans JM, Geertzen JH, Dijkstra PU, Postema K.  A systematic review of the effects of shoes and other ankle or foot appliances on balance in older people and people with peripheral nervous system disorders.  Gait Posture.  2007;25(2):316-323.

De Pisi F.  Aids and orthoses in patients with stroke consequences.  Clin Exp Hypertens.  2006;28(3-4):383-385.

Gok H, Kucukdeveci A, Altinkaynak H, et al.  Effects of ankle-foot orthoses on hemiparetic gait.  Clin Rehabil. 2003;17(2):137-139.

Rome K, Brown CL.  Randomized clinical trial into the impact of rigid foot orthoses on balance parameters in excessively pronated feet.  Clin Rehabil. 2004;18(6):624-630.