Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Ankle-Foot/Knee-Ankle-Foot Orthoses

Policy #:05.00.39o

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

MEDICALLY NECESSARY

Ankle-foot orthoses (AFOs) and knee-ankle-foot orthoses (KAFOs) and associated additions are considered medically necessary and, therefore, covered when the specific medical necessity criteria listed below for each type of orthosis are met, with the following clarification:
  • In accordance with the State of New Jersey's orthotic and prosthetic appliances mandate, members who are enrolled in New Jersey commercial products may obtain an AFO/KAFO from any licensed orthotist or prosthetist or certified pedorthotist. The individual's physician must establish that the AFO/KAFO is medically necessary for the individual.

The coverage position described in this policy does not supersede a Company policy on a specific device, or benefit limitations or exclusions of an individual's group product for a specific device. Individual benefits must be verified, as coverage may vary between products and/or groups.

AFOs AND KAFOs USED FOR AMBULATORY INDIVIDUALS
Ankle-Foot Orthoses (AFOs)

AFOs (L1900, L1902-L1990, L2106-L2116, L4350, L4360, L4361, L4386, L4387 and L4631) are considered medically necessary and, therefore, covered 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 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-patient-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, therefore, 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 six 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 injury.
  • The individual has a healing fracture that lacks normal anatomic integrity or anthropometric proportions.

Shoes

Shoes (L3224, L3225, and L3649) are considered medically necessary and, therefore, covered if they are an integral part of a covered AFO or KAFO used during ambulation (L1900, L1920, L1980-L2030, L2050, L2060, L2080, or L2090) and are medically necessary for the proper functioning of the brace.

AFOs NOT USED DURING AMBULATION (NON-AMBULATORY INDIVIDUALS)
Static or dynamic positioning AFOs (including ankle contracture splints,(L4396 or L4397) are considered medically necessary and, therefore, covered for individuals when non-ambulatory 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 are 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 (pre-treatment passive range of motion should be 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.

AFOS/ KAFOs USED FOR NIGHT SPLINTING IN CHILDREN WITH NEUROMUSCULAR DISORDERS/ ORTHOTIC MANAGEMENT AT REST SPLINTING

AFOs/KAFOs used for night/orthotic management at rest splinting is considered medically necessary and, therefore, covered when used in the treatment of muscle contractures in children with neuromuscular disorders (e.g., cerebral palsy [CP]).

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 co-existing joint contracture.

Concentric adjustable torsion style mechanisms (L2999) used to assist ankle joint plantar flexion 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 Table I in 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 to the requirements listed in the policy on the repair and replacement of durable medical equipment (DME).

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 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 MEDICALLY NECESSARY
  • A KAFO for a nonambulatory individual is considered not medically necessary and, therefore, not covered.
  • If the medical necessity criteria for an AFO/KAFO are not met, the orthosis is considered not medically necessary and, therefore, not covered.
  • If an AFO/KAFO is considered not medically necessary, additions to the orthosis are also considered not medically necessary and, therefore, not covered.
  • A static or dynamic AFO and replacement interface are considered not medically necessary and, therefore, not covered for an individual who has a fixed ankle plantar flexion contracture.
  • A static or dynamic AFO and replacement interface are considered not medically necessary and, therefore, not covered for an individual who has foot drop but does not have a nonfixed ankle plantar flexion contracture.
  • Components of a static/dynamic AFO that are used to position the knee or hip are considered not medically necessary and, therefore, not covered 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, are considered not medically necessary and, therefore, not covered.
  • Replacement interfaces in excess of one every six months are considered not medically necessary and, therefore, not covered.
  • Foot drop splints/recumbent positioning devices, and related replacement interfaces are considered not medically necessary and, therefore, not covered for ambulatory and nonambulatory individuals with foot drop because there are other more appropriate treatment modalities.

NOT COVERED

Items that are not primarily medical in nature (e.g., femoral and tibial fracture socks) are not covered by the Company because they are a benefit contract exclusion. Therefore, they are not eligible for reimbursement consideration.

Elastic support garments are not covered by the Company because 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 (i.e., it does not meet the definition of a brace). Therefore it is not eligible for reimbursement consideration..

An inversion/eversion correction device (A9285) is not covered by the Company because 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 (i.e., it does not meet the definition of a brace). Therefore it is not eligible for reimbursement consideration.

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. This policy is consistent with Medicare's documentation requirements, including the following required documentation.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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
The durable medical equipment (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 seven 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 five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (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 which describe the orthosis.
  • Evaluating the individual
  • Taking measurements, making a cast, making a model, use of 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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, ankle-foot orthoses (AFOs) and knee-ankle-foot orthoses (KAFOs) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage:
  • The State of New Jersey mandates coverage of orthotics for individuals enrolled in New Jersey commercial products when such items are determined to be medically necessary by the individual's physician. This mandate is effective for all newly issued contracts and contracts renewed on or after April 11, 2008.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The US Food and Drug Administration (FDA) considers AFOs and KAFOs to be class I devices and, as such, are exempt from premarket notification requirements.

Description

An orthosis (orthotic), which may also be called a brace or splint, is a rigid or semi-rigid 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 orthosis (KAFO) supports the knee as well as the ankle and foot.

TYPES OF ORTHOSES

An orthosis can be classified as prefabricated (off-the-shelf 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.

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, 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


Company Benefit Contracts.

MedlinePlus. US National Library of Medicine. Plantar fasciitis. [MedlinePlus Web site]. 03/08/2014. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007021.htm. Accessed August 31, 2017.

New Jersey (NJ) Department of Banking and Insurance (DOBI). Bulletin No. 08-10. P.L. 2007, c. 345: Health benefits coverage for orthotic and prosthetic appliances. [NJ DOBI Web site]. 04/11/08. Available at: http://www.state.nj.us/dobi/bulletins/blt08_10.pdf. Accessed August 31, 2017.

New Jersey (NJ) Legislature. 17:48-6ff: Hospital service corporation to provide benefits for orthotic and prosthetic appliances. [NJ State Legislature Web site]. 01/13/08. Available at: http://www.njleg.state.nj.us/2006/Bills/PL07/345_.PDF. Accessed August 31, 2017.

Noridian. Local Coverage Determination (LCD): Ankle-foot/knee-ankle-foot Orthosis (L33686). Original effective date 10/01/2015. Effective 1/1/2017. Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Ankle-Foot+Knee-Ankle-Foot+Orthosis+LCD/7af687cc-36e4-4b06-bf1c-f657797576ef. Accessed August 31, 2017.

Noridian. Local Coverage Article for Ankle-foot/knee-ankle-foot Orthoses - Policy Article – Effective January 2017(A52457). Effective 1/1/2017. Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Ankle-Foot+Knee-Ankle-Foot+Orthosis+LCD/7af687cc-36e4-4b06-bf1c-f657797576ef. Accessed August 31, 2017.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

See Attachment A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Ankle-Foot/Knee-Ankle-Foot Orthoses
Description: HCPCS Codes




Policy History

Revision from 05.00.39o
12/19/2018This policy has been reissued in accordance with the Company's annual review process.
01/26/2018This version of the policy will become effective 01/26/2018.

The following HCPCS code was added to this policy update as not covered: A9285 Inversion/eversion correction device

The following NOC code and narrative was removed from Attachment A:THE FOLLOWING CODE IS USED TO REPRESENT REPLACEMENT LINERS: L2999 Lower extremity orthotic, not otherwise specified

Version Effective Date: 01/26/2018
Version Issued Date: 01/26/2018
Version Reissued Date: 12/19/2018

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