LEEDer Group Inc.
8508 North West 66th St.
Miami, Florida 33166 USA

Phone: 305.436.5030
Fax: 305.436.0086
E-mail Address: info {at] LEEDerGroup [dot] com

CIGNA AFO-KAFO COVERAGE POSITION FOR PROVIDERS

KYDEX-PRO

STRONGER

SAFER

LEEDerGroup.com

  • LEEDer Group comment: acupuncture, custom-molded foot orthoses, electron-generating devices, extracorporeal shock wave therapy, laser therapy, microwave diathermy, orthoses with magnetic foil, radiotherapy, stereotactic radiofrequency thermal lesioning are considered not medically necessary or considered of unproven benefit (this list may not be all-inclusive).
  • Whereas, Night Splints are recommended. Soft Ankle Support
LEEDerGroup.com: KYDEX Pro Multi Podus boot with ambulation pad Prevent Mitigate Heel UlcersKYDEX-PRO Ambulation OrthosisKYDEX PRO Multi PodusFlex-E-Core Techology
  • The Night Splint that Works! by LEEDer Group. It’s Guaranteed and Doctor Approved. L-4396 ICD-10 M24.576
  • KYDEX-PRO Multi Podus boots, PRO-RESTing Hand Splints, GRIP, DORSAL WHFO’S all with FLEX-E-CORE frames which allow near unlimited molding to the patient’s condition PLUS now with EASY 1 2 3 strap application numbering for Better Outcomes
CIGNA AFO-KAFO COVERAGE POSITION FOR PROVIDERS
  • CIGNA HEALTHCARE COVERAGE POSITION Subject: Foot Orthosis, Ankle Orthosis, Ankle-Foot Orthosis (AFO), Knee-Ankle-Foot Orthosis (KAFO) Coverage Position Number: 0150 Effective Date: 8/15/2004

Table of Contents: Related Coverage Positions: Plantar Fasciitis

  • Coverage Position………………………………………..1
  • General Background…………………………………….2
  • Coding/Billing Information……………………………..6
  • References………………………………………………..12
  • INSTRUCTIONS FOR USE
    Coverage Positions are intended to supplement certain standard CIGNA HealthCare benefit plans. Please note, the terms of a participant’s particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Positions are based. For example, a participant’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Position. In the event of a conflict, a participant’s benefit plan document always supercedes the information in the Coverage Positions. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of
  • 1) the terms of the applicable group benefit plan document in effect on the date of service;
  • 2) any applicable laws/regulations;
  • 3) any relevant collateral source materials including Coverage Positions and;
  • 4) the specific facts of the particular situation.

©2004 CIGNA Health Corporation Coverage Position

Some CIGNA HealthCare benefit plans may exclude coverage for orthotic devices. Please refer to specific plan language to determine benefit coverage. Coverage may be provided for custom foot orthoses and the following non-foot orthoses under the External Prosthetic Appliance benefit: .. rigid and semi-rigid custom fabricated orthoses .. semi-rigid pre-fabricated and flexible orthoses .. rigid pre-fabricated orthoses, including preparation, fitting and basic additions such as bars and joints.

CIGNA HealthCare covers custom foot orthotics when ANY ONE of the following medical necessity criteria is met:

  • for patients with conditions of impaired peripheral sensation and/or altered peripheral circulation (e.g., diabetic neuropathy and peripheral vascular disease)
  • when the foot orthosis is an integral part of a leg brace and is necessary for the proper functioning of the brace
  • when the foot orthosis is used for a replacement or substitute for missing parts of the foot (for example, amputation) and is necessary for the alleviation or correction of illness, injury or congenital defect
  • for patients with neurologic or neuromuscular conditions (e.g., cerebral palsy, hemiplegia, spina bifida) producing spasticity, malalignment or pathological positioning of the foot, and there is reasonable expectation of improvement

CIGNA HealthCare covers ankle orthotics when any of the following medical necessity criteria are met:

  • ankle fractures
  • ankle sprains Page 1 of 14 Coverage Position Number: 0150
  • ankle injuries requiring immobilization and/or stabilization

CIGNA HealthCare covers ankle-foot orthotics (AFO) and knee-ankle-foot orthotics (KAFO) (ankle contracture splint or foot drop splint) in NON-AMBULATORY patients who have ALL of the following medical necessity criteria:

  • The patient has a plantar flexion contracture of the ankle with dorsiflexion on passive range of motion testing of at least 10 degrees (i.e., a non-fixed contracture).
  • There is reasonable expectation of the ability to correct the contracture.
  • The contracture is interfering or expected to interfere significantly with the patient’s functional abilities.
  • The ankle contracture splint is used as a component of a therapy program that includes active stretching of the involved muscles and/or tendons.

CIGNA HealthCare covers ankle-foot orthotics (AFO) in AMBULATORY patients when the patient has weakness or deformity of the foot and ankle, which requires stabilization for medical reasons, and when the patient has the potential to benefit functionally from the device.
CIGNA HealthCare covers knee-ankle-foot orthoses (KAFO) in AMBULATORY patients who meet criteria for ankle-foot orthoses and who require additional knee stability.
CIGNA HealthCare covers molded-to-patient model AFOs and KAFOs in AMBULATORY patients when the BASIC coverage criteria and ANY ONE of the following additional criteria are met:

  1. The patient could not be fitted with a prefabricated (off-the-shelf) AFO.
  2. The condition necessitating the orthosis is expected to be permanent or of long-standing duration (>6 months).
  3. There is a need to control the knee, ankle or foot in more than one plane.
  4. The patient has a documented neurological, circulatory or orthopedic status that necessitates custom fabricating to prevent tissue injury.
  5. The patient has a healing fracture that lacks normal anatomical integrity or anthropometric proportions.

Most CIGNA HealthCare benefit plans do not cover the following orthoses and orthotic devices in most benefit plans:

  1. pre-fabricated foot orthoses
  2. orthotic shoes, shoe additions, procedures for foot orthopedic shoes, shoe modifications and transfers
  3. orthoses primarily used for cosmetic reasons
  4. orthoses primarily for improved athletic performance or sports participation

Note: Unmodified, pre-fabricated orthoses are generally used in treating conditions prior to a custom-fitted orthosis (pre-fabricated orthoses that are modified by bending or molding for a specific patient). Custom-fitted orthoses are generally attempted prior to the use of custom-fabricated orthoses (individually constructed from materials).

General Background
Orthoses are devices added to the body to stabilize or immobilize a body part, prevent deformity, protect against injury or to assist with function. They can be divided into different types based on their intended function: protective, accommodative and functional. Protective devices do not typically provide structural or functional support. Accommodative devices of the foot are designed to protect fixed or long-term malalignment, to cushion bones exposed by tissue atrophy or to protect skin at risk from neuropathic anesthesia (e.g., diabetic neuropathy). Functional devices realign or assist the neuromusculoskeletal system by providing dynamic or static support. Static orthoses are rigid and are used to support weakened or paralyzed body parts in a particular position. Dynamic orthoses are used to facilitate body motion to allow optimal function. Page 2 of 14 Coverage Position Number: 0150 Orthoses can also be classified by anatomic location (e.g., foot orthoses, ankle orthoses, ankle-foot orthoses [AFO], knee-ankle-foot orthoses [KAFO]).The term foot orthoses typically refers to devices that are placed into shoes. Ankle orthoses are supportive devices used to provide immobilization to the ankle. AFOs have a shoe insert component as well as an ankle component. KAFOs contain a knee component, ankle component and shoe insert.

A splint is defined as an appliance for preventing movement of joints or for the fixation of a displaced or movable part.

A brace is defined as an orthosis or orthopedic appliance that supports or holds in correct position any movable part of the body and that allows for motion of that part. It must be a rigid or semi-rigid device 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 on the limb on which it is being used. Items that do not meet the definition of a brace are not covered.

A pre-fabricated orthosis is one that is manufactured in quantity without a specific patient in mind. A pre-fabricated orthosis can be modified (e.g., trimmed, bent or molded) for use by a specific patient and is then considered a custom-fitted orthosis.

[ INSERT by LEEDer Group: the Multi USE Boot / Night Splint with Flex-E-Core Technology can be bent and molded. Mulit Use Boot / Night Splint by LEEDer Group.]

An orthosis that is made from pre-fabricated components is considered a pre-fabricated orthosis. Any orthosis that does not meet the standard definition of custom-fabricated is considered to be a pre-fabricated device. HCPCs codes representing pre-fabricated orthoses are L1901, L1902, L1906, L1910, L1930, L1951, L1971, L2035, L2112-L2116, L2036-L2108 and L2126-L2128.

A custom-fabricated orthosis is one that is specifically made for an individual patient starting with the most basic materials that may include plastic, metals, leather or various cloths. The construction of these devices requires substantial labor such as cutting, bending, molding and sewing, and may even involve the use of some pre-fabricated components. A molded-to-patient model orthosis is a type of custom-fabricated device for which an impression of the specific body part is made (e.g., by means of a plaster cast, or CAD-CAM technology). The impression is then used to make a specific patient model. The actual orthosis is molded from the patient-specific model. HCPCs codes representing custom fabricated orthoses are L1900, L1904, L1907, L1940-L1950, L1960-L1970, L1980-L2030, L2036-L2108 and L2126-L2128.

An unmodified, pre-fabricated orthosis is generally used in treating a condition prior to a custom-fitted orthosis (pre-fabricated orthosis that is modified by bending or molding for a specific patient). A custom-fitted orthosis is generally attempted prior to the use of custom-fabricated orthosis (individually constructed from materials).

Conditions with impaired peripheral circulation and sensation: The major foot-related conditions that increase the risk of ulcers and amputations in those with diabetes and other conditions that impair peripheral circulation, are peripheral neuropathy, altered biomechanics (caused by increased plantar pressure, bony deformities, limited joint mobility), peripheral vascular disease, skin pathology and a history of prior ulcers. When properly fitted, footwear can reduce abnormal pressures, reduce formation of calluses and ulcers and protect the foot from external trauma. Most patients with these conditions can safely wear properly-fitted commercial shoes. Pre-fabricated shoe inserts may also be used. The use of custom-fitted or custom-molded orthotic inserts are typically reserved for those patients with neuropathy and/or altered circulation who also have severe foot deformities such as Charcot arthropathy, severe arthritis, large bunions or prior amputation.

Neurologic and neuromuscular conditions: Certain neurologic and muscle control conditions such as stroke, neoplasms, hemiplegia, cerebral palsy, myelomeningocele and atrophic or dystrophic conditions may produce lower extremity spasticity or hyperactivity of muscles, hypotonicity of certain muscles and neuromuscular imbalances. Gait functioning, balance and foot/ankle positioning may be impacted. Custom-fitted and custom-molded foot orthoses and ankle-foot orthoses (AFOs) are used in ambulatory patients to control or correct foot joints, counteract internal deforming forces, compensate for weakness, correct or eliminate pathologic positioning, improve balance, improve gait functioning and reduce excessive plantar flexion.

Page 3 of 14 Coverage Position Number:
0150 Plantar fasciitis (Heel Pain Syndrome):
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). Conditions involving heel pain are referred to by many names, including heel spurs, heel spur syndrome, plantar fasciitis, heel pain syndrome, painful-heel syndrome, calcaneodynia, subcalcaneal bursitis and stone bruise. Pre-fabricated orthoses have been shown to be adequate for the majority of patients with plantar fasciitis or other heel pain syndromes. Custom-molded foot orthoses are used when more conservative measures fail. The intended goals of strapping and orthosis use are to minimize pathologic forces of the gait cycle, attempt to restore the desired biomechanical function of the foot and support the medial and lateral longitudinal arch. Pre-made orthotic devices used for the treatment of heel-pain syndrome include heel lifts, heel protectors, heel cushions and dynamic insoles. Pre-made, posterior night splints are also used for plantar fasciitis and Achilles tendonitis.

Foot deformities:
Some foot deformities cause malalignment of feet and/or ankles and pathologic foot positioning, thereby causing impaired gait, balance and pain. Deformities that are significant may require modification of footwear in order to maintain normal alignment, gait patterns and balance. Commercially available, properly fitted footwear is adequate for most of these patients. Pre-fabricated orthoses may also be used. Adult flatfoot or pes planus is a condition that may be acquired or congenital in nature. Pre-fabricated arch supports with properly fitted, commercially available footwear provide adequate support for most patients with flat feet. There is not sufficient evidence in the published, peer-reviewed, scientific literature to demonstrate that custom foot orthoses are equal or superior to standard, properly fitted, commercially available footwear or over the counter pre-fabricated supports for patients with congenital or acquired foot deformities, such as bunions or pes planus.

Foot Orthotics:
A foot orthotic is a type of shoe insert that does not extend beyond the ankle, and may include heel wedges and arch supports. The goal of treating conditions with foot orthotics is to decrease pain and increase function. They may also correct some foot deformities and provide shock absorption to the foot. Codes representing foot orthotics provided to patients without diabetes are L3000-L3090. Prosthetic shoes are used when all or a portion of the foot is missing. A brace may or may not be attached to the prosthetic shoe. The absence of all or a portion of the foot may be the result of a congenital deformity, illness (amputation secondary to diabetic foot ulcer) or injury (traumatic amputation). Patients with minor distal amputations typically do not require special shoes. When all digits have been amputated, a forefoot filler orthosis may be used with a commercial shoe. For more extensive partial-foot amputations (e.g., mid-level Tran metatarsal, Chopart’s amputation), a prosthetic may be needed consisting of a conventional shoe with an ankle-foot orthosis (AFO), brace and a forefoot filler. A custom-fitted or custom-molded foot orthosis may be used as a replacement or substitute for missing parts of the foot (e.g., due to amputation) and when it is necessary for the alleviation or correction of illness, injury or congenital defect.

Ankle Orthotics:
An ankle orthotic is a type of orthotic used in treating acute ankle injuries such as a sprain, for rehabilitation after the initial injury and to prevent re-injury of the ankle. They are also used to treat chronically unstable ankles. Ankle orthotic options include lightweight sports plastics/Velcro models, hinged devices, lace-up devices, neoprene sleeves, ankle wraps and taping, braces, various types of casts, stabilizing shoes and air stirrups.
Page 4 of 14 Coverage Position Number: 0150

Ankle-foot Orthotics:
An AFO extends well above the ankle to the top of the calf. It requires fastening at the lower leg, just above the ankle. This device may be covered for ambulatory patients with weakness or deformity of the foot and ankle, which also require stabilization for medical reasons and when the patient has the potential to benefit functionally from use of the device.

Commonly, AFOs are used to treat disorders including but not limited to ankle dorsiflexion, plantar flexion, inversion and eversion, spastic displegia due to cerebral palsy, lower motor neuron weakness due to poliomyelitis and spastic hemiplegia in cerebral infarction. HCPCs codes representing AFO devices are L1900-L1990, L2106-L2116, L4350, L4360, and L4386.

Knee-ankle-foot orthotics:
A KAFOs is an AFO with metal uprights, a mechanical knee joint and two thigh bands. KAFOs are covered for ambulatory patients who meet criteria for an ankle-foot orthosis, and who also require additional support to the knee for stability. HCPCs codes representing KAFOs are L2000-L2039, L2126-L2136, and L4370.

Stance control orthotics:
A stance control orthosis is an orthotic knee joint or custom-fabricated KAFO that allows swing-phase knee flexion. The knee joint locks when weightbearing to provide stance phase stability, and when unweighted it unlocks to allow a swinging motion of the knee. It is proposed that the stance control components allow the patients to swing their impaired limb with sufficient ground clearance to provide a more normal gait. While there are no specific patient criteria, it is intended for use in patients with lower extremity weakness and who demonstrate some control of hip muscles. Candidates who may benefit from this type of device typically have conditions such as polio, post-polio syndrome, spinal cord injuries, multiple sclerosis, stroke or trauma. These devices may be mechanical or electronic.

The Stance Control Orthotic Knee Joint (Horton SCOKJ) and the Free Walk Stance Control Knee Ankle System (Otto Bock) are currently available in the United States and function as mechanical devices. The Horton SCOTJ is a knee joint that is fabricated into a custom KAFO. This device has a switch allowing the patient to select an automatic mode for stance control, an unlocked position for motion associated with free-swinging KAFO, and a locked extension for use with climbing. The Free Walk (Otto Bock) is an entire KAFO system, a single-upright KAFO with a foot-plate design. This device has an automatic lock initiated by knee extension. An electronic device, the Becker 9001 E-Knee is one that can be programmed to lock at any degree of flexion and unlock in response to various conditions. It is a computer-controlled, foot-force activated, electromechanical orthotic knee joint. Based on review of the published, peer-reviewed, scientific literature it has not been shown that stance control orthotic devices are superior to standard knee-ankle-foot orthoses. There are no studies evaluating the degenerative changes in the contralateral limb and lower back with use of a standard device compared to use of a stance control orthotic to support long-term outcomes. L-code additions to AFOs or KAFOs (L2180-L2550, L2750-L2830) are not covered if either the base orthosis is not medically necessary or the specific addition is not medically necessary. AFOs and KAFOs used for ambulatory patients for the treatment of edema and/or for the prevention or treatment of pressure ulcers are not covered. Walking boots (L4360 and L4386) are AFOs that may be used to relieve pressure on the sole of the foot or used for patients with foot ulcers and are noncovered for those conditions. Walking boots may be covered when used to treat orthopedic conditions or postoperatively for orthopedic surgery. Ankle flexion contracture is a condition where the muscles and/or tendons that plantarflex the ankle are shortened resulting in an inability to bring the ankle to 0° by passive range of motion. At 0° flexion, the ankle is perpendicular to the lower leg. Foot drop is a condition where there is a weakness and/or lack of use of the muscles that dorsiflex the ankle but there is the ability to bring the ankle to 0° by passive range of motion. An ankle-foot orthosis used in non-ambulatory patients may be either an ankle contracture splint, night splint or a foot drop splint. Ankle contracture splints (L4396) are not covered when they are used solely for the prevention or treatment of a heel pressure ulcer. Foot drop splints (L4398) and/or replacement interface (L4393) are recumbent positioning devices and are not covered in a non-ambulatory patient or when used solely for the prevention or treatment of heel pressure ulcers. These types of devices are 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., they do not meet the definition of a brace). HCPCs codes representing ankle-foot orthoses worn when the patient is ambulatory are L1900-L1990, L2106-L2116, L4350, L4360 and L4386.

An ankle-contraction splint is a prefabricated ankle-foot orthosis that has all of the following characteristics:

  • designed to accommodate an ankle with a plantar flexion contracture of up to 45°
  • applies dorsiflexion force up to the ankle
  • for use by a patient who is non-ambulatory
  • has a soft interface.

A foot drop splint/recumbent positioning device is a prefabricated ankle-foot orthosis which has all of the following characteristics:

  • designed to maintain the foot at a fixed position of 0° (i.e., perpendicular to the lower leg)
  • not designed to accommodate an ankle with a plantar flexion contracture
  • used by a patient who is non-ambulatory
  • has a soft interface

If an AFO is to be used for a non-ambulatory patient for the treatment of 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 the professional staff (in a nursing facility) or caregiver (at home). An ankle-contracture splint is not considered medically necessary for the treatment of a fixed contracture and/or in patients who demonstrate foot drop without an ankle-flexion contracture. The effectiveness of components of the ankle-contracture splint used to correct positioning of the knee or hip is not well established in the peer-reviewed literature.

University of California Berkeley Laboratory (UCBL) Orthosis:
This orthosis is a variant of the traditional pre-fabricated arch support and was originally designed to maintain a flexible, paralytic valgus, foot deformity in the corrected position. It is used to treat flatfoot, plantar fasciitis, calcaneal spurs, posterior tibial tendon dysfunction and rheumatoid arthritis. This orthosis is cast in a semi-weight-bearing position. The efficacy of the UCBL for the treatment of any of these conditions has not been demonstrated through well-designed, randomized, controlled clinical trials. Socks (L2840, L2850) used in conjunction with orthoses are not covered items.

Orthotics that are used to prevent injury in an otherwise uninjured body part is solely preventive and is therefore considered not medically necessary for the treatment of disease or injury.

Orthotics that are used only for participation in sports are considered not medically necessary. Participation in sports is considered an elective activity.

Identical, spare orthotics purchased only for the patient’s convenience are considered not medically necessary and are not covered.

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