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Ankle-Foot/Knee-Ankle-Foot Orthoses
MA05.010j



Policy

MEDICALLY NECESSARY

ANKLE-FOOT ORTHOSES (AFOs) AND KNEE-ANKLE-FOOT ORTHOSES (KAFOs)​ USED FOR AMBULATORY INDIVIDUALS​​

Ankle-Foot Orthoses (AFOs)

AFOs (L1900, L1902-L1990, L2106-L2116, L4350, L4360, L4361, L4386, L4387 L4631) are considered medically necessary and, therefore, covered for ambulatory individuals with a weakness or deformity of the foot and ankle, who require stabilization for medical reasons and have the potential to benefit functionally from the orthosis.  

Knee-Ankle-Foot Orthoses (KAFOs)

KAFOs (L2000-L2038, L2126-L2136, and L4370) are considered medically necessary and, therefore, covered for ambulatory individuals who meet the criteria for an AFO and require additional knee stabilization.

Custom-Fabricated AFOs/KAFOs

Custom-fabricated and molded-to-individual-model AFOs/KAFOs (L1900, L1904, L1907, L1920, L1940, L1945, L1950, L1960, L1970, L1980, L1990, L2000, L2005, L2010, L2020, L2030, L2034, L2036, L2037, L2038, L2106, L2108, L2126, L2128, and L4631) are considered medically necessary and, th​erefore, covered for ambulatory individuals when the medical necessity criteria for AFOs/KAFOs listed above are met, and at least one of the following additional criteria is met:
  • The individual cannot be fitted with a prefabricated orthosis.
  • The condition necessitating the ​orthosis is expected to be permanent or of long-standing duration (more than 6 months).
  • There is a need to control the knee, ankle, or foot in more than one plane.
  • The individual has a documented neurologic, circulatory, or orthopedic status that requires custom fabricating over a model to prevent tissue injuries.
  • The individual has a healing fracture that lacks normal anatomic integrity or anthropometric proportions.
ANKLE-FOOT ORTHOSES (AFOs) NOT USED DURING AMBULATION (NON-AMBULATORY INDIVIDUALS) 
Static or dynamic positioning ankle-foot orthosis, (including ankle contracture splints/static AFOs) (L4396 or L4397) are considered medically necessary and, therefore, covered for nonambulatory individuals to support a weak or deformed body part or to restrict or eliminate motion in a diseased or injured body part when either of the following criteria is met:​​
  • The individual has plantar fasciitis
  • All of the following criteria are met:
    • The nonfixed ankle plantar flexion contracture exhibits dorsiflexion on passive range-of-motion testing of at least 10 degrees (the pretreatment passive range of motion is measured with a goniometer).
    • There is reasonable expectation that the device will correct the nonfixed contracture.
    • The nonfixed contracture is interfering or expected to interfere significantly with the individual's functional abilities.
    • The orthosis is a component of a therapy program that includes active stretching of the involved muscles and/or tendons.
CONCENTRIC ADJUSTABLE TORSION STYLE MECHANISMS
Concentric adjustable torsion style mechanisms (L2999) used to assist knee joint extension are considered medically necessary and, therefore, covered for individuals who require knee extension assist in the absence of any coexisting joint contracture.

Concentric adjustable torsion-style mechanisms (L2999) used to assist ankle joint plantarflexion or dorsiflexion are considered medically necessary and, therefore, covered for individuals who require ankle plantar or dorsiflexion assist in the absence of any co-existing joint contracture.

ADDITIONS
Additions to an AFO/KAFO are considered medically necessary and, therefore, covered when the AFO/KAFO is considered medically necessary according to the criteria listed in this policy. Refer to Attachment A for a list of corresponding codes.

EVALUATION AND FITTING
Evaluation of the individual, measurement and/or casting, and fitting of the orthosis are included in the allowance for the orthosis. There is no separate reimbursement for these services.

REPAIR AND REPLACEMENT
Repair and replacement for AFOs/KAFOs are considered medically necessary and, therefore, covered when the criteria listed in this policy are met for the specific orthosis. In addition, the requirements listed in the Repair and Replacement of Durable Medical Equipment (DME) policy must be met.

If the expense for repairs exceeds the estimated expense of providing another entire orthosis, no reimbursement will be made for the excess expense.

The allowance for the labor involved for the replacement for an orthotic component that is coded with a specific Healthcare Common Procedure Coding System (HCPCS) L-code, includes includes fitting and adjustment, is included in the reimbursement for that component.

The allowance for the labor involved in replacing an orthotic component that is coded with the miscellaneous HCPCS code L4210 is separately reimbursable in addition to the allowance for that component.

The reason for the repair or replacement must be documented in the supplier's record.

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

Orthotic training may include teaching the individual regarding a wearing schedule, placing and removing the orthosis, skin care and performing tasks while wearing the device. It is not appropriate to include the time spent assessing, measuring or fitting, fabricating or modifying, or making the orthotic in the time spent providing orthotic training. Only the time spent actually training the individual should be included in the orthotic training service.

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

NOT MEDICALLY NECESSARY

The following items are considered not medically necessary and, therefore, not covered:
  • A KAFO for a nonambulatory individual.
  • The use of an AFO/KAFO (and any related additions or components) for an ambulatory individual for the treatment of edema and/or the prevention or treatment of a heel pressure ulcer because it does not support a weak or deformed body part or restrict or eliminate motion in a diseased or injured part of the body (i.e., does not meet the definition of an orthosis).
  • An AFO/KAFO that does not meet medical necessity criteria.
  • Additions to the orthosis when an AFO/KAFO is considered not medically necessary.
  • A static or dynamic AFO and replacement interface for an individual who has a fixed ankle plantar flexion contracture.
  • A static or dynamic AFO and replacement interface for an individual who has foot drop without a nonfixed ankle flexion contracture.
  • Components of a static/dynamic AFO that are used to position the knee or hip because the effectiveness of these components has not been established.
  • Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out.
  • Replacement components (e.g. soft interfaces) in excess of one every 6 months.
  • Foot drop splints/recumbent positioning devices and related replacement interfaces for ambulatory and nonambulatory individuals with foot drop because there are other more appropriate treatment modalities.​
NOT COVERED

Elastic support garments (A4467) are not covered by the Company, because they are an item not covered by Medicare, because they are not rigid or semirigid devices. Therefore, they are not eligible for reimbursement consideration.

The following items are not covered by the Company, because they are an item or service not covered by Medicare. Therefore, they are not eligible for reimbursement consideration:
  • A foot pressure off-loading/supportive device (A9283) and associated replacement liners (L2999)
  • Additions to a lower-extremity joint, knee, or ankle concentric adjustable torsion-style mechanism (L2861) for custom-fabricated orthotics
  • Femoral and tibial fracture socks (L2840, L2850) used in conjunction with orthoses
  • Inverson/eversion correction device (A9285)
FACE-TO-FACE REQUIREMENTS 

As a condition for payment, a professional provider must have a face-to-face encounter with the individual for whom the item is ordered that meets all of the following requirements:
  • The treating professional provider must have an in-person encounter with the individual within the six (6) months prior to the date of the written order prior to delivery.
  • ​ This encounter must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of durable medical equipment (DME) ordered.
A new face-to-face encounter is required each time a new standard written order for one of the specified items is ordered. A new standard written order is required:
  • For all claims for purchases or initial rentals 
  • When there is a change in the standard written order for the accessory, supply, drug, etc. 
  • If periodic standard written order renewal required per medical policy
  • When an item is replaced 
  • When there is a change in the supplier 
In this policy the specified items are:
CodeNarrative
L1932
Ankle-foot​ orthosis (AFO), Rigid Anterior Tibial Section, Total Carbon Fiber Or Equal Material, Prefabricated, Includes Fitting And Adjustment
​  L1940
Ankle-Foot orthosis (AFO), plastic or other material, custom fabricated
​  L1951

​Ankle-Foot Orthosis (AFO), Spiral, (Institute Of Rehabilitative Medicine Type), Plastic Or Other Material, Prefabricated, Includes Fitting And Adjustment
​  L1960​Ankle-Foot Orthosis (AFO), Posterior Solid Ankle, Plastic, Custom-Fabricated
​  L1970
​Ankle-Foot Orthosis (AFO)​, Plastic With Ankle Joint, Custom-Fabricated
  L2005
​Knee-Ankle-Foot Orthosis (KAFO), Any Material, Single Or Double Upright, Stance Control, Automatic Lock And Swing Phase Release, Any Type Activation, Includes Ankle Joint, Any Type, Custom Fabricated

​ L2036
Knee-Ankle-Foot Orthosis (KAFO)​, Full Plastic, Double Upright, With Or Without Free Motion Knee, With Or Without Free Motion Ankle, Custom Fabricated​

REQUIRED DOCUMENTATION


When providing off-the-shelf (OTS) or custom-fitted orthotics, suppliers must:

  • Provide the product that is specified by the ordering professional provider, i.e., type of orthosis and method of fitting (OTS or custom fitted).
  • Be sure that the medical record justifies the need for the type of product and method of fitting.
  • Be sure only to use the code that accurately reflects both the type of orthosis and the appropriate level of fitting.
  • Have detailed documentation that justifies the code selected for custom fitted versus OTS.

 When providing custom-fabricated orthotics, there must be documentation in the supplier's records to support the medical necessity of that type device rather than a prefabricated orthosis.

If an ankle contracture splint/static or dynamic AFO is used for the treatment of a nonfixed ankle plantar flexion contracture, the pretreatment passive range of motion should be measured with a goniometer and documented in the medical record. There should also be documentation that an appropriate stretching program is being overseen by professional staff (in a nursing facility) or a caregiver (at home).


The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

For specified DME items, documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.​

BILLING REQUIREMENTS

It is not appropriate to report L2999 for devices incorporating concentric adjustable torsion style mechanisms used for the treatment of any joint contracture.

Replacement components that do not have a unique HCPCS code must be billed with a “not otherwise specified" code (L2999). The claim must include a description of the component provided, the reason for replacement, and the HCPCS code or narrative description of the base orthosis.

HCPCS code L4205 may only be billed for time involved with the actual repair of an orthotic, or for medically necessary adjustments.

HCPCS code L4205 must not be used to bill for time involved with other professional services including those listed below. Reimbursement for these services is included in the allowance for the HCPCS codes that describe the orthosis.

  • Evaluating the individual
  • Taking measurements, making a cast, making a model, use of computer-aided design/computer-aided manufacturing (CAD/CAM)
  • Making modifications to a prefabricated item to fit it to the individual
  • Follow-up visits
  • Making adjustments at the time of or within 90 days after delivery

HCPCS code L4210 must not be used for casting supplies or other materials used in the fitting or fabrication of an orthosis.

Addition codes L4002-L4130, and L4392 are for billing of replacement components and are not payable at initial issue of a base orthosis.


Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, ankle-foot and knee-ankle-foot orthoses are covered under the medical benefits of the Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary or not covered are not eligible for coverage or reimbursement by the Company.

Description

An orthosis (orthotic), which may also be called a brace or splint, is a rigid or semirigid device that supports a weak or deformed body part or restricts or eliminates motion in a diseased or injured part of the body. An orthosis can also be used to treat plantar fasciitis, which is an inflammation of the broad band of fibrous tissue that runs along the bottom surface of the foot. Caused by excessive stretching, plantar fasciitis often leads to heel pain, heel spurs, and/or arch pain if left untreated.

 

An ankle-foot orthosis (AFO) extends well above the ankle (usually near the top of the calf) and is fastened around the lower leg above the ankle. AFOs differ from therapeutic shoes and supportive devices for the foot (e.g., shoe inserts, arch supports), which are placed within the shoe and do not extend above the ankle.

 

A knee-ankle-foot or​thosis (KAFO) supports the knee as well as the ankle and foot.

 

TYPES OF ORTHOSES

 

An orthosis can be classified as prefabricated (off-the-shelf [OTS] or custom fitted) or custom fabricated.

 

PREFABRICATED (OFF-THE-SHELF) (OTS) ORTHOTICS 

  • Are prefabricated (i.e., manufactured in quantity without a specific individual in mind).
  • May or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
  • Require minimal self-adjustment (i.e., an adjustment the individual, caretaker for the beneficiary, or supplier of the device can perform) for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual.
  • Do not require the expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthoses to fit the item to the individual.
​Fabrication of an orthosis using computer-aided design/computer-aided manufacturing (CAD/CAM) or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered OTS.

CUSTOM-FITTED ORTHOTICS
  • Are devices that are prefabricated.
  • They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
  • Require substantial modification (i.e., changes made to achieve an individualized fit) for fitting at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.
  • Require the expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of the orthosis to fit the item to the individual beneficiary.
Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered custom fitted if the final fitting upon delivery to the individual requires substantial modification requiring expertise.

CUSTOM-FABRICATED ORTHOTICS
  • Are devices that are made for a specific individual.
  • Are made with basic materials including, but not limited to: plastic, metal, leather, or cloth in the form of sheets, bars, etc.
  • Involve substantial work such as cutting, bending, molding, and sewing.
  • Require more work than merely modifying a prefabricated item, although some prefabricated components may be used in the construction of the device.
​A molded-to-patient-model orthosis is a type of custom-fabricated orthosis in which an impression of a specific body part is made (by means of a plaster cast, CAD-CAM technology, or other techniques) and used to make a positive model of the body part. The orthosis is then molded on this model.

The Charcot's restraint orthotic walker (CROW) orthosis is a custom fabricated ankle-foot orthosis used by an ambulatory individual and has all of the following characteristics:

  • Is designed to maintain the foot at a fixed position of 0 degrees (i.e., perpendicular to the lower leg).
  • Allows for varus or vulgus deformity correction.
  • Contains a rocker bottom sole with a custom arch support.
  • Incorporates a rigid anterior tibial shell.
  • Has a soft interface
  • Totally encapsulated  
ORTHOSES FOR AMBULATORY AND NONAMBULATORY INDIVIDUALS

DYNAMIC ORTHOSIS
A dynamic orthosis is appropriate for an ambulatory individual because it gives support to a moving body part (e.g., ankle) to optimize its function. Ambulatory individuals include those who are able to walk a distance, as well as those who are able only to stand and/or transfer. AFOs and KAFOs may be used by ambulatory individuals.

STATIC ORTHOSIS
A static orthosis is a rigid brace that supports a body part in a fixed position; it may be used for individuals who are minimally ambulatory or nonambulatory. Nonambulatory individuals may use either an ankle contracture splint, night splint or a foot drop splint.

Ankle Contracture Splint

Ankle contracture splints are prefabricated static AFOs that are commonly used to treat ankle plantar flexion contractures. An ankle plantar flexion contracture occurs when the muscles and/or tendons that plantarflex the ankle are shortened, which results in an inability to bring the ankle to 0 degrees by passive range of motion. Zero degrees ankle position is when the foot is perpendicular to the lower leg. Ankle contracture splints are used by individuals who are minimally ambulatory or nonambulatory.

An ankle contracture splint has all of the following characteristics:

  • Accommodates either plantar fasciitis or an ankle plantar flexion contracture up to 45 degrees
  • Applies a dorsiflexion force to the ankle
  • Allows pressure reduction
  • Has a soft interface
Ankle-Foot Orthoses (AFOs)/Knee-Ankle-Foot Orthoses (KAFOs) Used for Night Splinting

Ankle-foot orthoses (AFOs) and knee-ankle-foot orthoses (KAFOs) are used in the treatment of muscle contractures in children with neuromuscular disorders (e.g., cerebral palsy [CP]).  The term "orthotic management in rest" may also be used instead of "night splinting" to describe the use of splints during rest.

A night splint has the following characteristics:

  • Used during sleep or rest periods
  • Used to minimize the impact or limit the degree of a contracture
  • Used to improve range of motion and reduce spasticity of the surrounding muscles
Foot Drop Splint/Recumbent Positioning Device

Foot drop is a condition in which there is weakness and/or lack of use of the muscles that dorsiflex the ankle, but the ankle can be brought to 0 degrees by passive range of motion. Foot drop splints/recumbent positioning devices are used by individuals who are nonambulatory. A foot drop splint/recumbent positioning device is a prefabricated AFO that has all of the following characteristics:

  • Maintains the foot at a fixed position of 0 degrees (i.e., perpendicular to the lower leg)
  • Is not designed to accommodate an ankle plantar flexion contracture
  • Has a soft interface
Inversion/Eversion Correction Device

The Agilium Freestep, an ankle foot orthosis, is indicated for medial or lateral unicompartmental osteoarthritis. The device is proposed to control the subtalar joint in combination with a lever arm to counter the varus moment acting on the knee.

References

Centers for Medicare & Medicaid Services (CMS). Department of Health and Human Services. Required Face-to-Face Encounter and Written Order Prior to Delivery List. DMEPOS Items (Non-Power Mobility Device Codes) Added to the Required Face-to-Face Encounter and Written Order Prior to Delivery List. Published 01/17/2023.  Effective 04/13/2023. Available at: https://www.cms.gov/files/document/required-face-face-encounter-and-written-order-prior-delivery-list.pdfAccessed February 07, 2024.

Evidence of Coverage.

Noridian. Joint DME MAC Publication. Definitions Used for Off-the-Shelf versus Custom Fitted Prefabricated Orthotics (Braces) - Correct Coding – 02/01/2024. Available at: https://med.noridianmedicare.com/web/jadme/policies/dmd-articles/2024/definitions-used-for-off-the-shelf-versus-custom-fitted-prefabricated-orthotics-braces-correct-coding-revised. Accessed February 07, 2024.

Noridian. Local Coverage Determination (LCD): Ankle-foot/knee-ankle-foot Orthosis (L33686). Original 10/01/2015. Effective 01/01/2020. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33686. Accessed February 07, 2024.

Noridian. Local Coverage Article for Ankle-foot/knee-ankle-foot Orthoses. Local Coverage Article (LCA) (A52457). Original 10/01/2015. Effective 02/01/2021. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52457. Accessed February 07, 2024.

Noridian. Noncovered items. [Noridian Web site]. Revised: 09/27/2022. Available at: https://med.noridianmedicare.com/web/jadme/topics/noncovered-items. Accessed February 07, 2024.


Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)

PROCEDURE CODES L4392, L4396, and L4397 ARE MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:
M24.571 Contracture, right ankle
M24.572
Contracture, left ankle
M24.574
Contracture, right foot
M24.575
Contracture, left foot
M72.2
Plantar fascial fibromatosis


PROCEDURE CODE L4631 IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES​:
A52.16 Charcot's arthropathy (tabetic)
E08.610
Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy
E09.610
Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathy
E10.610
Type 1 diabetes mellitus with diabetic neuropathic arthropathy
E11.610
Type 2 diabetes mellitus with diabetic neuropathic arthropathy
M14.671
Charcot's joint, right ankle and foot
M14.672
Charcot's joint, left ankle and foot​


HCPCS Level II Code Number(s)
See Attachment A.

Revenue Code Number(s)
N/A




Coding and Billing Requirements


Policy History

4/8/2024
4/8/2024
MA05.010
Medical Policy Bulletin
Medicare Advantage
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No