Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Ankle-Foot/Knee-Ankle-Foot Orthoses
Policy #:MA05.010d

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

ANKLE-FOOT ORTHOSES AND KNEE-ANKLE-FOOT ORTHOSES USED DURING AMBULATION
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 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.

ANKLE-FOOT ORTHOSES (AFOs) NOT USED DURING AMBULATION
Static or dynamic positioning ankle-foot orthosis, (including ankle contracture splints/static AFOs) (L4396 or L4397) is 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 are met:
  • The individual has plantar fasciitis; or
  • 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 pre-treatment 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 (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 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 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 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 MEDICALLY NECESSARY AFOs/KAFOs
  • A KAFO for a nonambulatory individual is considered not medically necessary and, therefore, not covered.
  • 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 is considered not medically necessary and, therefore, not covered 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).
  • 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 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 AFO and replacement interface are considered not medically necessary and, therefore, not covered for an individual who has foot drop and does not have a nonfixed ankle plantar flexion contracture.
  • Components of a static 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) 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

Femoral and tibial fracture socks (L2840, L2850) used in conjunction with orthoses 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.

Elastic support garments A4447 are not covered by the Company, because they are an item not covered by Medicare, because they are not rigid or semi-rigid devices. Therefore, they are not eligible for reimbursement consideration.

A foot pressure off-loading/supportive device (A9283) and associated replacement liners (L2999) are not covered by the Company, because they are items not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

An inverson /eversion correction device (A9285) is not covered by the Company, because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

Additions to a lower-extremity joint, knee, or ankle concentric adjustable torsion-style mechanism (L2861) for custom-fabricated orthotics 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.

REQUIRED DOCUMENTATION

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.
Policy Guidelines

Ankle Flexion Contracture is a condition in which there is shortening of the muscles and/or tendons that plantarflex the ankle with the resulting inability to bring the ankle to 0 degrees by passive range of motion. (0 degrees ankle position is when the foot is perpendicular to the lower leg.)

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. These features distinguish them from foot orthotics, which are shoe inserts that do not extend above the ankle.

CROW Orthosis, L4631, describes a Charcot's restraint orthotic walker (CROW) orthosis. Code L4631 is a custom-fabricated ankle-foot orthosis that has all of the following characteristics:
  • Designed to maintain the foot at a fixed position of ) 0 degrees (i.e., perpendicular to the lower leg); and,
  • Allows for varus or valgus deformity correction; and,
  • Contains a rocker bottom sole with a custom arch support; and,
  • Incorporates a rigid anterior tibial shell; and,
  • Is used by a individual who is ambulatory; and,
  • Has a soft interface.

Custom-Fabricated Orthoses are individually made for a specific individual starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. They involve substantial work such as cutting, bending, molding, sewing, etc. They may involve the incorporation of some prefabricated components. Custom-fabric orthoses involve more than trimming, bending, or making other modifications to a substantially prefabricated item.

Foot Drop is a condition in which there is weakness and/or lack of use of the muscles that dorsiflex the ankle, but there is the ability to bring the ankle to 0 degrees by passive range of motion.

Foot Drop Splint/Recumbent Positioning Device, L4398, is a prefabricated ankle-foot orthosis that has all of the following characteristics:
  • Designed to maintain the foot at a fixed position of 0 degrees (i.e., perpendicular to the lower leg); and
  • Not designed to accommodate an ankle with a plantar flexion contracture; and
  • Is used by a individual who is nonambulatory; and
  • Has a soft interface.

Foot Pressure Off-Loading/Supportive Device, A9283, is used for an item that is designed primarily to reduce pressure on the sole or heel of the foot but does not meet the definition of a therapeutic shoe for diabetes (A5500, A5501). It may be a shoe-like item, an item that is used inside a shoe and may or may not extend outside the shoe, or an item that is attached to a shoe. It may be prefabricated or custom fabricated.

Inversion/eversion correction device, such as the Agilium FreeStep, is an ankle foot orthosis, indicated for medial or lateral unicompartmental osteoarthritis of the knee.

Nonambulatory Ankle-Foot Orthosis may be an ankle contracture splint, night splint, or a foot drop splint.

Plantar Fasciitis is an inflammation of the heel of the foot typically resulting from trauma to the deep tissue of the foot (i.e., plantar fascia).

Prefabricated Orthosis is manufactured in quantity without a specific individual in mind. A prefabricated orthosis may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific individual (i.e., custom fitted). An orthosis that is assembled from prefabricated components is considered prefabricated. Any orthosis that does not meet the definition of a custom-fabricated orthosis is considered prefabricated.

Static Ankle-Foot Orthosis, L4396, is a prefabricated ankle-foot orthosis has all of the following characteristics:
  • Designed to accommodate either plantar fasciitis or an ankle with a plantar flexion contracture up to 45 degrees; and
  • Applies a dorsiflexion force to the ankle; and
  • Is used by a individual who is minimally ambulatory or nonambulatory; and
  • Has a soft interface.

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

In accordance with Medicare, a brace (AFO, KAFO) is 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. The brace must provide support and counter-force (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.
References

Evidence of Coverage.

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.

Noridian. Noncovered items. [Noridian Web site]. Revised: April 26, 2017. Available at: https://med.noridianmedicare.com/web/jadme/topics/noncovered-items. 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)

L4392, L4396 and L4397 DEVICES ARE MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

M24.571 Contracture, right ankle

M24.572 Contracture, left ankle

M24.573 Contracture, unspecified ankle

M24.574 Contracture, right foot

M24.575 Contracture, left foot

M24.576 Contracture, unspecified foot

M72.2 Plantar fascial fibromatosis

L4631 DEVICE IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

A52.16 Charcot's arthropathy (tabetic)

M14.671 Charcot's joint, right ankle and foot

M14.672 Charcot's joint, left ankle and foot

M14.679 Charcot's joint, unspecified ankle and foot



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 FOR ANKLE-FOOT/ KNEE-ANKLE FOOT ORTHOSIS



Related Documents




Policy History

MA05.010d
09/25/2019This policy has been reissued in accordance with the Company's annual review process.
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.

In accordance with Medicare, the following policy limitations were added:

L4392, L4396 and L4397 DEVICES ARE MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

M24.571 Contracture, right ankle
M24.572 Contracture, left ankle
M24.573 Contracture, unspecified ankle
M24.574 Contracture, right foot
M24.575 Contracture, left foot
M24.576 Contracture, unspecified foot
M72.2 Plantar fascial fibromatosis

L4631 DEVICE IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

A52.16 Charcot's arthropathy (tabetic)
M14.671 Charcot's joint, right ankle and foot
M14.672 Charcot's joint, left ankle and foot
M14.679 Charcot's joint, unspecified ankle and foot

The following HCPCS code was added to this policy as eligible.
  • L4361, L4387

The following HCPCS code were added to this policy update as not covered.
  • A9285 Inversion/eversion correction device

MA05.010c
01/01/2017This policy has been identified for the HCPCS code update, effective 01/01/2017.

The following HCPCS code has been deleted from this policy:
  • A4466 Garment, belt, sleeve or other covering, elastic or similar stretchable material, any type, each


The following HCPCS code has been added to this policy:
  • A4467; Belt, strap, sleeve, garment, or covering, any type


The following HCPCS code has been revised in this policy:
    L1906:

    FROM: Ankle foot orthosis, multiligamentus ankle support, prefabricated, off-the-shelf

    TO: Ankle foot orthosis, multiligamentous ankle support, prefabricated, off-the-shelf

MA05.010b
11/18/2016This version of the policy will become effective 11/18/2016.
The following requirements have been revised:
  • A foot pressure off-loading/supportive device (A9283) and associated replacement liners (L2999) are not covered by the Company, because they are items not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.
  • The following Heading in Attachment A was revised:
    THE FOLLOWING CODE IS USED TO REPRESENT REPLACEMENT LINERS, WHEN BILLED WITH CODE A9283 (FOOT PRESSURE OFF-LOADINGF/SUPPORTIVE DEVICES)
      L2999 Lower extremity orthotic, not otherwise specified

MA05.010a
01/01/2016 This version of the policy will become effective 01/01/2016.

The following code narratives have been revised: L1902 and L1904.

MA05.010
01/01/2015This is a new policy.





Version Effective Date: 01/26/2018
Version Issued Date: 01/26/2018
Version Reissued Date: 09/25/2019