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

Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)

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Note: see later bulletin LCD L11527 and A19806
Policy Bulletin: Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)


Number: 0565 Last Review: 10/16/2009 Effective: 09/28/2001 Next Review: 07/08/2010

Policy
  • Aetna considers ankle orthoses, ankle-foot orthoses (AFOs), and knee-ankle-foot orthoses (KAFOs) medically necessary durable medical equipment (DME) according to the criteria set forth below. (See background section of this CPB for descriptions
    of the orthotics discussed in this policy).
  • Ankle Orthotics
    Aetna considers ankle orthoses medically necessary DME for members who meet the criteria set forth below. (See background section of CPB for descriptions of each of these orthotics).

1. Elastic ankle sleeves: Aetna considers reusable elastic ankle sleeves medically necessary DME for use to treat an ankle injury (acute and rehabilitative stages). Use of elastic ankle sleeves in a chronically unstable ankle or to prevent ankle re-injury is considered experimental and investigational because of a lack of adequate evidence of the effectiveness of elastic ankle sleeves for these indications.

2. Rigid ankle casts: Rigid ankle casts are considered medically necessary DME when used to treat ankle fractures. Rigid ankle casts are considered experimental and investigational when used after ankle sprains, for chronically unstable ankles, or when used to prevent re-injury because of a lack of adequate evidence of the effectiveness of rigid ankle casts for these indications.

3. Semi-rigid ankle casts: Semi-rigid ankle casts are considered medically necessary DME when used to treat ankle sprains. Semi-rigid ankle casts are considered experimental and investigational when used after ankle fractures, for use in chronically unstable ankles, or when used to prevent re-injury because of a lack of adequate evidence of effectiveness of semi-rigid ankle cases for these indications.

4. Unna boots: Unna boots are considered medically necessary DME when used after ankle sprains and other soft tissue injuries. Unna boots are considered experimental and investigational when used after ankle fractures, or when used in chronically unstable ankles or to prevent re- injury because of a lack of adequate evidence of the effectiveness of Unna boots for these indications. See CPB 009 – Orthopedic Casts, Braces, and Splints.

5. Ankle air-stirrups: Ankle air-stirrups (e.g., Air Cast) are considered medically necessary DME when used after an ankle injury (fractures or sprains). Air-stirrups are considered experimental and investigational for chronically unstable ankles or to prevent ankle re- injury because of a lack of adequate evidence of the effectiveness of ankle air-stirrups for these indications. See CPB 009 – Orthopedic Casts, Braces, and Splints.

6. Orthopedic ankle cast-braces: Orthopedic ankle cast-braces are considered medically necessary DME when used after an ankle injury (fractures or sprains). See CPB 009 – Orthopedic Casts, Braces, and Splints.

7. Lace-up ankle braces: Lace-up ankle braces are considered medically necessary DME when used in members with ankle injuries, when used in members with chronically unstable ankles, or when used to prevent ankle re-injury.

8. Orthoplast ankle stirrups: Orthoplast ankle stirrups are considered medically necessary DME for use after an acute injury. Use of orthoplast ankle stirrups in chronically unstable ankles or to prevent ankle re-injury is considered experimental and investigational because of a lack of adequate evidence of the effectiveness of orthoplast ankle stirrups for these indications.

9. Stabilizing shoes: Stabilizing shoes for ankle injuries (acute or chronic) are considered experimental and investigational. Note: In addition, most plans contractually exclude foot orthotics. Please check benefit plan descriptions. See CPB 451 – Foot Orthotics.

10. Post-operative rehabilitative ankle braces: Aetna considers postoperative rehabilitation ankle braces medically necessary when applied within six weeks of surgery. Such postoperative rehabilitative braces are considered an integral part of surgery. See also CPB 009 – Orthopedic Casts, Braces, and Splints.

Ankle Foot Orthoses (AFOs) and Knee Ankle Foot Orthoses (KAFOs)
AFOs and KAFOs used in Non-ambulatory Persons: Ankle Contracture Splints and Foot Drop Splints

1. Ankle contracture splints: Aetna considers ankle contracture splints medically necessary DME if all of the following criteria are met:

  1. The member 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), and
  2. There is a reasonable expectation of the ability to correct the contracture, and
  3. The contracture is interfering or expected to interfere significantly with the member’s functional abilities, and
  4. The ankle contracture splint is used as a component of aherapy program that includes active stretching of the involved muscles and/or tendons.
    If an ankle contracture splint is used for the treatment of a plantar flexion contracture, the pre-treatment passive range of motion must be measured with a goniometer and documented in the medical record. There must be documentation of an appropriate stretching program carried out by professional staff (in a nursing facility) or caregiver (at home). If an ankle contracture splint is considered medically necessary, a replacement interface is also considered medically necessary DME as long as the member continues to meet medical necessity criteria for the splint. Up to one replacement interface per six months is considered medically necessary.


  • An ankle contracture splint and replacement interface is not considered medically necessary for the following indications:
    1. Fixed contractures;
    2. Members with foot drop but without an ankle flexion contracture.
      Note: In addition, under HMO plans, an ankle contracture splint and replacement interface is not considered medically necessary when it is used solely for the prevention or treatment of a heel pressure ulcer because Medicare does not consider it medically necessary for these indications. A component of an ankle contracture splint that is used to address positioning of the knee or hip is considered experimental and investigational because the effectiveness of this type of component is not established.

2. Foot drop splint/ recumbent positioning device: Aetna’s HMO plans do not consider a foot drop splint/recumbent positioning device or replacement interface medically necessary. A foot drop splint/ recumbent positioning device and replacement interface is not considered medically necessary under HMO plans when it is used solely for the prevention or treatment of a heel pressure ulcer because Medicare does not consider it medicallynecessary for these indications. A foot drop splint/ recumbent positioning device and replacement interface is not considered medically necessary for members with foot drop who are non-ambulatory because there are other more appropriate treatment modalities.

3. Additions to AFOs and KAFOs: Additions to AFOs or KAFOs are not considered medically necessary if either the base orthosis is not medically necessary or the specific addition is not medically necessary.

  • AFOs and KAFOs used in Ambulatory Persons

1. AFOs in ambulatory members: Ankle-foot orthoses (AFO) are considered medically necessary DME for ambulatory members with weakness or deformity of the foot and ankle, which require stabilization for medical reasons, and have the potential to benefit functionally. Members prescribed custom-made “molded-to- patient-model? AFOs must also meet the criteria set forth in section II.B.3, below. AFOs are not considered medically necessary for ambulatory members who do not meet these medical necessity criteria.

Aetna’s HMO plans do not consider AFOs and any related addition medically necessary when used solely for the treatment of edema and/or for the prevention or treatment of a heel pressure ulcer in ambulatory patients, as Medicare does not consider AFO’s medically necessary for these indications.

Additions to AFOs or KAFOs are not considered medically necessary if either the base orthosis is not medically necessary or the specific addition is not medically necessary.

2. KAFOs in ambulatory members: Knee-ankle-foot orthoses (KAFO) are considered medically necessary DME for ambulatory members for whom an ankle-foot orthosis is covered and for whom additional knee stability is required. Members prescribed custom-made “molded-to-patient model? KAFOs must also meet the criteria set forth in section II.B.3, below. KAFOs are not medically necessary and are not covered for ambulatory members who do not meet these coverage criteria.

Aetna’s HMO plans do not consider KAFOs and any related addition medically necessary when used solely for the treatment of edema and/or for the prevention or treatment of a heel pressure ulcer in ambulatory members, as Medicare does not consider KAFO’s medically necessary for these indications.

3. Molded-to-patient model AFO’s and KAFO’s in ambulatory members: Custom-made AFOs and KAFOs that are “molded-to-patient-model? are considered medically necessary DME for ambulatory members when the basic medical necessity criteria listed in sections II.B.1 and II.B.2 above are met and one of the following criteria is met:

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

4. Additions to AFOs and KAFOs: Additions to AFOs and KAFOs are not considered medically necessary if either the base orthosis is not medically necessary and/or the specific addition is not medically necessary.

3. General Notes:

  • Shoes: Please see CPB 451 – Foot Orthotics for medical necessity criteria for shoes and related items that are an integral part of a leg brace.
  • Socks: Socks used in conjunction with ankle orthoses, AFOs, or KAFOs are not covered because socks do not meet the contractual definition of durability for covered durable medical equipment (DME).
  • Prophylactic orthotics: Aetna does not consider ankle orthotics, AFOs, and KAFOs medically necessary treatment of disease when used to prevent injury in a previously uninjured ankle or knee. Such use is solely preventive, and therefore is considered not medically necessary treatment of disease or injury. In addition, many Aetna plans exclude coverage of safety items. See CPB 623 – Safety Items.
  • Sports orthotics: Aetna does not consider ankle orthotics, AFOs, and KAFOs medically necessary if they are to be used only during participation in sports. Such use is considered not medically necessary, as participation in sports is considered an elective activity.
  • Repairs and replacements: Repairs to a medically necessary ankle orthosis, AFO, or KAFO due to wear and tear are considered medically necessary DME when they are needed to make the orthosis functional. Replacement of a complete ankle orthosis, AFO, or KAFO or component of these orthoses due to a significant change in the member’s condition or irreparable wear is considered medically necessary DME if the device is still medically necessary.
  • Spare orthotics: Identical spare orthotics purchased for the member’s convenience is not considered medically necessary. More than one set of different orthotics, however, may be medically necessary.

See also CPB 696 – Suit Therapy.

  • Background

This CPB is based primarily on Medicare Durable Medical Equipment Carrier (DMERC) coverage policy on ankle foot orthoses and a review of ankle orthoses fromBuschbacher (1991).

An orthosis (brace) is a rigid or semi-rigid device that 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. An orthosis can be either prefabricated or custom fabricated.

Custom-made versus prefabricated (off-the-shelf) orthoses:

A prefabricated (off-the-shelf) orthosis is one that is manufactured in quantity without a specific patient in mind. A prefabricated orthosis may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific patient (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 (custom-made) orthosis is considered prefabricated.

A custom fabricated (custom-made) orthosis is one that is individually made for a specific patient starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. It involves
substantial work such as cutting, bending, molding, sewing, etc. It may involve the incorporation of some prefabricated components. It involves more than trimming, bending, or making other modifications to a substantially prefabricated item. A molded-to-patient-model orthosis is a particular type of custom fabricated orthosis in which an impression of the specific body part is made (by means of a plaster cast, CAD-CAM technology, etc.) and this impression is then used to make a positive model (of plaster or other material) of the body part. The orthosis is then molded on this positive model.

  • Ankle orthotics:

Ankle orthotics may potentially be useful after an acute ankle injury (acute ankle sprain (ligament injury) or fracture), for rehabilitation, to prevent ankle re-injury, and for chronically unstable ankles. Whether a specific ankle orthotic is
effective depends on the particular indication for its use.

There are four potential uses for ankle supports: 1) treatment of acute injury (i.e., beginning within 3 days following injury); 2) rehabilitation (for the first few weeks following injury until full function is obtained); 3) prophylaxis (used
primarily in patients with a history of ankle injury); and 4) treatment of chronic instability. The length of time that ankle supports need to be used following injury varies depending largely on the type and severity of the injury

Treatment after acute injury: The ankle begins to swell after injury, and swelling continues to increase for about three days following injury. Significant swelling persists for about two weeks following injury.

  • Rehabilitation: Ankle supports have been used for the first few weeks following injury to prevent re-injury during early return to activity. After the pain has subsided and the patient can walk without a limp, use of the ankle support is only appropriate during high-risk activities (i.e., especially racquetball, football, and basketball). Leaving the ankle support on all the time only serves to restrict functional range of motion and encourage psychological dependence.
  • Prophylaxis: Ankle supports have been used to prevent injury in uninjured individuals and persons with a history of ankle sprain. There is generally no reason for prophylactic bracing in low-risk activities, such as standing, walking, or
    climbing stairs. And it is not clear that prophylactic bracing should be advocated for use during high-risk sports as well, because of prophylactic bracing’s cost, inconvenience, and possible detraction from athletic performance.
  • Chronic instability: Ankle supports are used to stabilize the ankle in patients with chronic instability. In most instances, they are to be used only during high-risk sports and activities. It is unusual for ankle supports to be prescribed for use during normal daily activities.

Many types of ankle supports exist as an alternative to ankle taping. In addition, shoes for some sports (particularly basketball) are available with high tops and built in straps for additional ankle protection.

Recent studies have shown that use of ankle supports during early rehabilitation of acute grade I or grade II ankle sprains (partial ligament rupture) produced results as good as cast immobilization, with more rapid return to activity.

The following is a description of various types of ankle supports, and a summary of the evidence of their effectiveness. Numerous difficulties arise in interpreting the studies of the various treatments for ankle sprains.

First, most ankle sprains heal well regardless of the form of treatment; thus, almost all treatments produce good results. It is difficult to measure marginal differences among them.

Second, difficulties arise in comparing different treatment protocols and brands of products. Research is needed to standardize forms of treatment and to compare the many products on the market.

Third, research has focused on which provide the best mechanical support of the ankle in laboratory stress testing, but it has not been demonstrated that this is the most important factor in predicting clinical outcomes. It may be that the quality of the proprioceptive (position-sense) feedback from the device is the most important predictor of clinical outcomes.

  • Taping:

A number of studies have supported the use of tape in helping stabilize the ankle and reducing sprains in persons with previous sprains.

The goal of taping is to prevent the ankle ligaments from being stressed to the point of injury. Taping should limit ankle inversion and eversion but allow functional dorsiflexion and plantarflexion. There is evidence that ankle taping also helps prevent injury by stimulating proprioceptive (position-sense) nerve fibers, causing the peroneus brevis muscle to be activated just before heel strike.

For treatment of acute injury (beginning within about 3 days following injury), taping may be used to provide support and to help reduce edema (swelling). Felt or foam pads may be applied under the tape to help reduce edema.

Taping may be used for rehabilitation (i.e., to prevent re-injury during early return to activity). About three days after the injury, swelling subsides, and tape is reapplied to decrease the risk of re-injury. Using tape to prevent injury,
however, is a time-consuming procedure, so it is recommended for early stages of
rehabilitation only. Tape may be applied for the first few weeks after return to
activity for rehabilitation of ankle injuries.

Taping may be used prophylactically in persons with or without a prior ankle sprain,
although it is not recommended for routine use for this indication. Although taping
probably reduces the rate of ankle injuries, it loses support rapidly with movement
and sweating. This is not as much as a factor in acute sprains, because in which
tape is not stressed so much. For use prophylactically, however, it is not a time-
and cost-effective option compared to the alternatives described below.

Taping has also been recommended as a possible treatment for chronic instability,
although it is not recommended for routine use in this situation. With movement and
sweating, tape rapidly loses support. Also, if used permanently, tape becomes
expensive. This approach is probably not as cost- and time-effective as other
options described below.

One-inch wide standard tape is used for the foot, and 1½-inch tape for the ankle.
Areas sensitive to blistering must be protected with lubricated gauze sponges.
Special adherent spray may be applied under the tape. If tape is to be reapplied
often, an underwrap is used to prevent chronic skin irritation.

Tape should only be wrapped by a person well trained in its application, such as a
trainer, physician, nurse, or physician assistant. Improperly applied tape may cause
further injury.

Elastic tape has also been studied, and although it provides more compression than
non-elastic tape, it loses its restriction of range of motion even more than
standard tape.

Tape and wrapping does not meet the durability requirement for covered durable
medical equipment, in that it is not reusable and is not “made to withstand
prolonged use.? Although Aetna will cover taping or wrapping provided by a
healthcare provider in their office, take-home tape and wrapping are not covered.

  • Elastic wrapping and sleeves:

Wrapping with elastic bandages is useful in the early stages (about the first three
days) of ankle sprain to provide compression that reduces swelling. It is used as an
adjunct to ice and elevation. It needs to be changed often to monitor the skin.
Wrapping has not been proven to be useful for other indications: prevention of re-
injury, prophylactic use, and use for chronic ankle instability. This is because
wrapping provides little or no support during activity.

Elastic ankle sleeves that are pulled over the foot like open-ended socks offer no
value as supports. They may, however, enhance proprioception. They may also provide even compression to reduce ankle edema. Thus, they have been shown to be useful only in treating an acute ankle sprain (i.e., within about three days after injury). Like elastic wrapping, elastic ankle sleeves have not been proven to be useful for rehabilitation, prophylaxis, or use in chronically unstable ankles.

Certain manufacturers, e.g., Stromgen, combine the comfort of even compression by using Spandex, elastic, and Velcro strap combinations to restrict eversion, and
inversion. They have been used primarily for prophylaxis.

  • Bracing:

Like taping, bracing can be used in an acute injury, during rehabilitation to
prevent re-injury, prophylactically, and in chronically unstable ankles. Braces come
in three main types: casts, lace-up wraps, and plastic orthoses. Casts can be either
semi-rigid or rigid; lace-up braces and plastic orthoses are considered semi-rigid.

Braces have been shown to have several advantages over taping. They can be used by persons who do not have access to a person skilled in taping techniques. In some cases, they can be more cost-effective than taping. But some braces may migrate during vigorous movement because of the lack of adhesion to skin. This movement may cause the brace to fail to provide support. But tape adhesion or straps to reduce migration may help. During wear-and-tear, Velcro fasteners tend to fail and release, straps or buckles break, and elastic stretches out. Off-the-shelf braces may not fit persons who are too tall, are obese, or deformed. Custom-made braces are available, but are generally more expensive.

  • Rigid plaster casts:

Rigid plaster casting, once a common treatment for acute ankle sprains, has now been generally abandoned for this use. Plaster casting continues to be used in foot and ankle fractures.

Compared with taping, rigid plaster casting has been shown to increase the time to
return to activity and has not been shown to produce a better outcome, even in
patients with grade III ankle sprains (complete rupture of a ligament).

Still, rigid casting is an option to consider for the early postoperative phase or
in cases of gross ankle instability. When acute swelling subsides, the cast should
be replaced with a better fitting one. It should be replaced with semi-rigid bracing
as soon as possible, usually within 1 to 2 weeks.

Rigid casting is not used to prevent re-injury during rehabilitation, for
prophylaxis, or for chronic instability.

  • Soft (semi-rigid) casts:

Semi-rigid casting is done with a wrap that hardens somewhat after application but
does not become completely rigid. The Una (Unna’s) boot (Graham Field, Inc.,
Hauppage, NY) is a semi-rigid cast that consists of a gauze bandage that contains
glycerin and gelatin and is applied over a felt bone around the anklebone (the
medial malleolus). In an acute sprain, it provides some support and compression. Ice is commonly applied around the boot, but no studies have demonstrated adequate tissue cooling with this technique. In the treatment of acute ankle injuries, semi-rigid casts have not been shown to be more effective than tape. Semi-rigid casting does not offer enough support to be used to prevent injury during rehabilitation, for prophylaxis, or for chronic instability.

  • Lace-up braces:

Lace-up braces have been proven to be as effective as tape at restricting ankle
range of motion, and unlike tape, lace-ups do not tend to lose their supportive
ability during activity. Lace-up braces are a cost-effective alternative to taping.
They are safe, easy to apply, and reusable. They are not of much value in the acute stage of injury because they do not provide good uniform compression. They are probably of some value in preventing re-injury during rehabilitation, for
prophylactic use, and for use in patients with chronic ankle instability.

There are a number of brands of lace-ups available; no controlled comparisons have been performed to determine if one brand offers advantages over others. Examples of variants of standard lace-ups include: 1) braces that use Velcro closures in place of laces; 2) the Cramer brace (Cramer Products, Gardner, KS), which incorporates a lace-up design with outside straps to provide a heel lock; 3) the McDavid ankle lace-up brace (McDavid Knee Guard, Chicago, IL) and the Swede-O ankle lace-up brace (Swede-O Universal, North Branch, MN), which can accommodate steel or plastic stays for extra support.

  • Air-stirrups:

The air-stirrup is a prefabricated semi-rigid orthosis. The largest-selling brand is
the Aircast air-stirrup ankle brace (Aircast, Summit, NJ), which is composed of a
rigid outer plastic shell that fits up both sides of the leg and is connected under
the heel. It is lined with inner air bags and is attached to the leg with Velcro. As
with lace-up ankle supports, some clinicians combine use of the air-stirrup with
taping. The air-stirrup is an off-the-shelf device that does not require custom
fitting. It can be worn under regular shoes.

The air-stirrup decreases inversion and eversion, and protects the already injured
ligament and soft tissues from re-injury, thereby decreasing rehabilitation time.
The pressure in the air-stirrup increases when weight-bearing, which is thought to
provide intermittent compression during walking that aids in the milking out of
edematous fluid. The air-stirrup can also be readjusted to allow total contact
fitting while swelling is fluctuating.

The air-stirrup can be used after acute ankle sprains and in the early stages of
rehabilitation to prevent recurrent sprain. It can also be used after rigid casting
and for treatment of some fractures. There is currently insufficient evidence for
their use for prophylaxis or in chronic instability, although some newer variations
of the splint have been designed for this purpose.

  • Other semi-rigid orthoses:

Other semi-rigid orthoses have not been studied adequately to make accurate
comparisons with taping or with air-stirrups. These include the following:

  1. DonJoy Ankle Ligament Protector (DonJoy, Carlsbad, CA) is a plastic brace that seems to restrict range of motion as well as the air-stirrup and possibly better than tape, although no head-to-head comparisons have been published.
  2. The Active Ankle (Active Ankle Systems, Louisville, KY) has a stirrup and air cell liner with a hinged ankle may also be useful.
  3. The Malleoloc (Bauerfiend USA, Kennesaw, GA) is a stabilizing ankle orthosis that uses a wrap-around ankle brace in conjunction with Velcro strapping. Although it shows promise, definitive proof if its effectiveness is not yet available.
  • Other ankle-stabilizing orthoses:
  1. Non-elastic Cloth Wrapping: Non-elastic cloth wrap (also known as the Louisiana heel lock) has been applied over socks to prevent ankle injury. The advantage of this system is that the wrap can be washed or reused, thus reducing cost. Cloth wrapping may improve position-sense, but it appears to offer less benefit than taping. Its use in ankle injuries has not been adequately studied.
  2. Nylon and Nylon/Elastic Wrapping: Nylon or Nylon/Elastic heel wraps to be placed over socks may also improve position sense, but like non-elastic cloth wrapping, their use in ankle injuries has not been adequately studied.
  3. Orthoplast Stirrup: The orthoplast stirrup is a strip of thermoplastic material custom-fitted to run under the heel and up both sidesof the leg. The ankle bones (malleoli) and other bony prominences are covered with foam padding, and the stirrup is fitted with an elastic bandage.

Orthoplast is a low-temperature thermoplastic that becomes pliable when submerged in hot water. It is applied directly to the patient and molded evenly around the ankle. The fabrication is simple enough to be carried out in the office or clinic.

The orthoplast stirrup has been successfully used to treat ankle sprains, but
because it is relatively hard, it does not adapt to reduction in swelling. It has
not been shown to decrease inversion range of motion more than tape, and is most
commonly used in the acute or early rehabilitative stages. Orthoplast deteriorates
with long-term use, limiting its usefulness in prophylaxis and for chronic ankle
sprains.

  • Stabilizing shoes:

Several shoe designs have been used for prevention and treatment of ankle sprains.

Prophylaxis: High topped shoes have been shown to increase ankle stiffness in sports. However, the advantage of high-topped shoes over low-topped shoes in prophylaxis has been shown to be relatively small. The prophylactic benefits of various shoe types in sports have not been adequately investigated. * Acute injury, rehabilitation, and chronic instability: The use of ankle-stabilizing shoes, such as the Künzli line of shoes (Swiss Balance, Santa Monica, CA), to treat ankle sprain and to prevent re-injury have not been studied adequately to date.

  • Cast-braces:

A number of hinged polypropylene cast braces have been used in the treatment of
ankle sprains. These involve have a foot section with heel stabilizer, a lateral
ankle extension, and an articulating ankle joint joining the two. An example is the
Sarmiento cast brace, which is removable and fits in the patient’s shoe. They were
designed primarily for long-term use in athletes who suffer from recurrent ankle
sprains (i.e., prophylaxis and chronic instability).

Cast-braces require custom fitting by an orthotist for proper impression,
fabrication, and fitting. Fitting of a fresh ankle sprain with a cast-brace is
usually not recommended because changes in swelling of the ankle during the initial
recovery phase will compromise the cast-brace’s fit.

Although these cast-braces have reportedly given good results in the treatment of
ankle sprains, they are cumbersome, expensive, and have not been shown to offer any benefits over other forms of treatment.

  • The Boston ankle system:

The Boston Ankle System (Physical Support Systems, Boston, MA) is a custom-fitted ankle stabilizer. The Boston Ankle System is made of polypropylene and requires an exact impression. The services of an orthotist are often required for fine adjustment and accurate fitting.

  • Ice pack with air-stirrup:

The Cryo/Strap (Aircast, Summit, NJ) ice pack with air-stirrup uses a U-pad for
compression of the soft tissue around the ankle. The pad contains a liquid that can
be frozen and is held in place by an elastic strap. A modified air-stirrup is worn
over this device. This system has been shown to provide uniform compression and to decrease skin temperature for up to 90 minutes. It has not been shown, however, to improve long-term outcomes.

  • Ankle-foot orthoses (AFOs) and knee-ankle-foot orthoses (KAFOs):

Ankle-foot orthoses (AFOs) 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.

Below the knee, the components of a KAFO are the same as those of an AFO. However, the KAFO extends to the knee joint and thigh.

A non-ambulatory ankle-foot orthosis may be either an ankle contracture splint or a
foot drop splint.

Figueiredo et al (2008) performed a literature review evaluating the quality of
current research on the influence of AFO on gait in children with cerebral palsy
(CP). Two between-group and 18 within-group studies met the inclusion criteria
indicating a low level of evidence. Between-group studies each scored “4? on the
PEDro Scale, and seventeen within-group studies scored “3? and one scored “2?,
indicating low quality. Standard terminology for AFO was not used and only six
studies described functional status using appropriate instruments. The authors
concluded that studies using high quality methods are still needed to support
evidence-based decisions regarding the use of AFO for this population.

In a pilot study, Sheffler et al (2008) examined if an AFO would improve gait
velocity and tasks of functional ambulation in patients with multiple sclerosis
(MS). This cross-sectional study enrolled 15 participants with diagnosis of MS,
dorsiflexion and eversion weakness, and more than 3 months of using a physician-
prescribed AFO. Subjects’ ambulation was evaluated (i) without an AFO and (ii) with
an AFO. Outcome measures were the Timed 25-Foot (T25-FW) walk portion of the
Multiple Sclerosis Functional Composite and the 5 trials (Floor, Carpet, Up and Go,
Obstacles, Stairs) of the Modified Emory Functional Ambulation Profile (mEFAP). The
mean timed differences on the T25-FW and the 5 components of the mEFAP between the AFO versus no device trials were not statistically significant. The authors concluded that in MS subjects with dorsiflexion and eversion weakness, no
statistically significant improvement was found performing timed tasks of functional
ambulation with an AFO.

  • Ankle contraction splint:

According to Medicare Durable Medical Equipment Carrier Guidelines, an ankle
contracture splint is a prefabricated ankle-foot orthosis that has all of the
following characteristics:

  1. Designed to accommodate an ankle with a plantar flexion contracture up to 45°, and
  2. Applies a dorsiflexion force to the ankle, and
  3. Used by a patient who is non-ambulatory, and
  4. Has a soft interface.

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.)

  • Foot drop splint:

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

  1. Designed to maintain the foot at a fixed position of 0° (i.e., perpendicular to the lower leg), and
  2. Not designed to accommodate an ankle with a plantar flexion contracture, and
  3. Used by a patient who is non-ambulatory, and
  4. Has a soft interface.

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.

  • CPT Codes / HCPCS Codes / ICD-9 Codes CPT codes covered if selection criteria are
    met: 29405 – 29425 29515 29580 HCPCS codes covered if selection criteria are met:
    L1900 Ankle-foot orthosis (AFO), spring wire, dorsiflexion assist calf band,
    custom fabricated L1901 Ankle orthosis, elastic, prefabricated, includes
    fitting and adjustment (e.g., neoprene, Lycra) [for ankle injury only, not
    chronically unstable ankle or to prevent ankle re-injury] L1902 AFO, ankle
    gauntlet, prefabricated, includes fitting and adjustment [lace-up ankle brace] L1904
    AFO, molded ankle gauntlet, custom fabricated L1906 AFO, multiligamentus ankle
    support, prefabricated, includes fitting and adjustment L1907 AFO, supramalleolar,
    with straps, with or without interface/pads, custom fabricated L1910 AFO,
    posterior, single bar, clasp attachment to shoe counter, prefabricated, includes
    fitting and adjustment L1920 AFO, single upright with static or adjustable stop
    (Phelps or Perlstein type), custom fabricated L1930 AFO, plastic or other
    material, prefabricated, includes fitting and adjustment L1932 AFO, rigid anterior
    tibial section, total carbon fiber or equal material, prefabricated, includes
    fitting and adjustment L1940 AFO, plastic or other material, custom-fabricated
    L1945 AFO, molded to patient model, plastic, rigid anterior tibial section (floor
    reaction), custom-fabricated L1950 Ankle foot orthosis, spiral, (Institute of
    Rehabilitative Medicine type), plastic, custom-fabricated L1951 Ankle foot
    orthosis, spiral (Institute of Rehabilitative Medicine type), plastic or other
    material, prefabricated, includes fitting and adjustment L1960 AFO, posterior solid
    ankle, plastic, custom-fabricated L1970 AFO, plastic, with ankle joint,
    custom-fabricated L1971 Ankle foot orthosis, plastic or other material with
    ankle joint, prefabricated, includes fitting and adjustment L1980 AFO, single
    upright free plantar dorsiflexion, solid stirrup, calf band/cuff (single bar “BK?
    orthosis), custom-fabricated L1990 AFO, double upright free plantar
    dorsiflexion, solid stirrup, calf band/cuff (double bar “BK? orthosis), custom-
    fabricated L2000 Knee-ankle-foot orthosis (KAFO), single upright, free knee,
    free ankle, solid stirrup, thigh and calf bands/cuffs (single bar “AK? orthosis),
    custom-fabricated L2005 Knee-ankle-foot orthosis, any material, single or
    double upright, stance control, automatic lock and swing phase release, mechanical
    activation, includes ankle joint, any type, custom-fabricated L2010 KAFO, single
    upright, free ankle, solid stirrup, thigh and calf bands/cuffs (single bar “AK?
    orthosis), without knee joint, custom-fabricated L2020 KAFO, double upright, free
    knee, free ankle, solid stirrup, thigh and calf bands/cuffs (double bar “AK?
    orthosis), custom-fabricated L2030 KAFO, double upright, free ankle, solid
    stirrup, thigh and calf bands/cuffs, (double bar “AK? orthosis), without knee joint,
    custom-fabricated L2034 Knee-ankle-foot orthosis, full plastic, single
    upright, with or without free motion knee, medial lateral rotation control, with or
    without free motion ankle, custom-fabricated L2035 KAFO, full plastic, static,
    (pediatric size), without free motion ankle, prefabricated, includes fitting and
    adjustment L2036 Knee-ankle-foot orthosis, full plastic, double upright, with
    or without free motion knee, with or without free motion ankle, custom-fabricated
    L2037 Knee-ankle-foot orthosis, full plastic, single upright, with or without free
    motion knee, with or without free motion ankle, custom-fabricated L2038
    Knee-ankle-foot orthosis, full plastic, with or without free motion knee, multi-axis
    ankle, custom-fabricated L2106 AFO, fracture orthosis, tibial fracture cast
    orthosis, thermoplastic type casting material, custom-fabricated L2108 AFO,
    fracture orthosis, tibial fracture cast orthosis, custom-fabricated L2112 AFO,
    fracture orthosis, tibial fracture orthosis, soft, prefabricated, includes fitting
    and adjustment L2114 AFO, fracture orthosis, tibial fracture orthosis, semi-
    rigid, prefabricated, includes fitting and adjustment [for ankle sprains only] L2116
    AFO, fracture orthosis, tibial fracture orthosis, rigid, prefabricated, includes
    fitting and adjustment [for ankle fractures only] L2126 KAFO, fracture
    orthosis, femoral fracture cast orthosis, thermoplastic type casting material,
    custom-fabricated L2128 KAFO, fracture orthosis, femoral fracture cast
    orthosis, custom-fabricated L2132 KAFO, fracture orthosis, femoral fracture
    cast orthosis, soft, prefabricated, includes fitting and adjustment L2134
    KAFO, fracture orthosis, femoral fracture cast orthosis, semi-rigid, prefabricated,
    includes fitting and adjustment [for ankle sprains only] L2136 KAFO, fracture
    orthosis, femoral fracture cast orthosis, rigid, prefabricated, includes fitting and
    adjustment [for ankle fractures only] L2180 Addition to lower extremity fracture
    orthosis, plastic shoe insert with ankle joints L2182 Addition to lower extremity
    fracture orthosis, drop lock knee joint L2184 Addition to lower extremity fracture
    orthosis, limited motion knee joint L2186 Addition to lower extremity fracture
    orthosis, adjustable motion knee joint, Lerman type L2188 Addition to lower
    extremity fracture orthosis, quadrilateral brim L2190 Addition to lower extremity
    fracture orthosis, waist belt L2192 Addition to lower extremity fracture
    orthosis, hip joint, pelvic band, thigh flange, and pelvic belt L2200 Addition to
    lower extremity, limited ankle motion, each joint L2210 Addition to lower
    extremity, dorsiflexion assist (plantar flexion resist), each joint L2220
    Addition to lower extremity, dorsiflexion and plantar flexion assist/resist, each
    joint L2230 Addition to lower extremity, split flat caliper stirrups and plate
    attachment L2232 Addition to lower extremity orthosis, rocker bottom for
    total contact ankle foot orthosis, for custom fabricated orthosis only L2240
    Addition to lower extremity, round caliper and plate attachment L2250 Addition to
    lower extremity, foot plate, molded to patient model, stirrup attachment L2260
    Addition to lower extremity, reinforced solid stirrup (Scott-Craig type) L2265
    Addition to lower extremity, long tongue stirrup L2270 Addition to lower extremity,
    varus/valgus correction (“T?) strap, padded/lined or malleolus pad L2275
    Addition to lower extremity, varus/valgus correction, plastic modification,
    padded/lined L2280 Addition to lower extremity, molded inner boot L2300
    Addition to lower extremity, abduction bar (bilateral hip involvement), jointed,
    adjustable L2310 Addition to lower extremity, abduction bar, straight L2320
    Addition to lower extremity, non-molded lacer, for custom fabrictaed orthosis only
    [lace-up ankle brace] L2330 Addition to lower extremity, lacer molded to patient
    model, for custom fabricated orthosis only [lace-up ankle brace] L2335 Addition to
    lower extremity, anterior swing band L2340 Addition to lower extremity, pre-
    tibial shell, molded to patient model L2350 Addition to lower extremity,
    prosthetic type, (BK) socket, molded to patient model, (used for “PTB?, “AFO?
    orthoses) L2360 Addition to lower extremity, extended steel shank L2370
    Addition to lower extremity, Patten bottom L2375 Addition to lower extremity,
    torsion control, ankle joint and half solid stirrup L2380 Addition to lower
    extremity, torsion control, straight knee joint, each joint L2385 Addition to
    lower extremity, straight knee joint, heavy duty, each joint L2387 Addition to
    lower extremity, polycentric knee joint, for custom fabricated knee ankle foot
    orthosis, each joint L2390 Addition to lower extremity, offset knee joint, each
    joint L2395 Addition to lower extremity, offset knee joint, heavy duty, each
    joint L2397 Addition to lower extremity, orthosis, suspension sleeve L2405
    Addition to knee joint, drop lock, each L2415 Addition to knee lock with
    integrated release mechanism (ball, cable, or equal), any material, each joint L2425
    Addition to knee joint, disc or dial lock for adjustable knee flexion, each joint
    L2430 Addition to knee joint, ratchet lock for active and progressive knee
    extension, each joint L2492 Addition to knee joint, lift loop for drop lock ring
    L2750 Addition to lower extremity orthosis, plating chrome or nickel, per bar
    L2755 Addition to lower extremity orthosis, high strength, lightweight material,
    all hybrid lamination/prepreg composite, per segment, for custom fabricated orthosis
    only L2760 Addition to lower extremity orthosis, extension, per extension, per
    bar (for lineal adjustment for growth) L2768 Orthotic side bar disconnect device,
    per bar L2770 Addition to lower extremity orthosis, any material, per bar or joint
    L2780 Addition to lower extremity orthosis, non-corrosive finish, per bar L2785
    Addition to lower extremity orthosis, drop lock retainer, each L2795 Addition to
    lower extremity orthosis, knee control, full kneecap L2800 Addition to lower
    extremity orthosis, knee control, kneecap, medial or lateral pull, for use with
    custom fabricated orthosis only L2810 Addition to lower extremity orthosis, knee
    control, condylar pad L2820 Addition to lower extremity orthosis, soft interface
    for molded plastic, below knee section L2830 Addition to lower extremity
    orthosis, soft interface for molded plastic, above knee section L2840 Addition to
    lower extremity orthosis, tibial length sock, fracture or equal, each L2850
    Addition to lower extremity orthosis, femoral length sock, fracture or equal, each
    L2860 Addition to lower extremity joint, knee or ankle, concentric adjustable
    torsion style mechanism, each L2999 Lower extremity orthosis, not otherwise
    specified L3208 Surgical boot, each, infant L3209 Surgical boot, each,
    child L3211 Surgical boot, each, junior L3212 Benesch boot, pair, infant
    L3213 Benesch boot, pair, child L3214 Benesch boot, pair, junior L3260
    Surgical boot/shoe, each L3500 – L3595 Miscellaneous shoe additions [covered only
    if base orthosis is covered] L3620 Transfer of an orthosis from one shoe to
    another, solid stirrup, existing L3630 Transfer of an orthosis from one shoe to
    another, solid stirrup, new L4002 Replacement strap, any orthosis, includes
    all components, any length, any type L4010 Replace trilateral socket brim L4020
    Replace quadrilateral socket brim, molded to patient model L4030 Replace
    quadrilateral socket brim, custom fitted L4040 Replace molded thigh lacer, for
    custom fabricated orthosis only L4045 Replace non-molded thigh lacer, for custom
    fabricated orthosis only L4050 Replace molded calf lacer, for custom fabricated
    orthosis only L4055 Replace non-molded calf lacer, for custom fabricated
    orthosis only L4060 Replace high roll cuff L4070 Replace proximal and distal
    upright for KAFO L4080 Replace metal bands KAFO, proximal thigh L4090 Replace
    metal bands KAFO-AFO, calf or distal thigh L4100 Replace leather cuff KAFO,
    proximal thigh L4110 Replace leather cuff KAFO-AFO, calf or distal thigh L4130
    Replace pretibial shell L4205 Repair of orthotic device, labor component, per 15
    minutes L4210 Repair of orthotic device, repair or replace minor parts L4350
    Ankle control orthosis, stirrup style, rigid, includes any type interface (e.g.,
    pneumatic gel), prefabricated, includes fitting and adjustment [ankle air-
    stirrups/Air Cast] L4360 Walking boot, pneumatic, with or without joints,
    with or without interface material, prefabricated, includes fitting and adjustment
    L4386 Walking boot, nonpneumatic, with or without joints, with or without
    interface material, prefabricated, includes fitting and adjustment L4392
    Replacement soft interface material, static AFO [covered only if orthosis is
    covered] L4394 Replace soft interface material, foot drop splint [covered only if
    foot drop splint is covered] L4396 Static ankle foot orthosis, including soft
    interface material, adjustable for fit, for positioning, pressure reduction, may be
    used for minimal ambulation, prefabricated, includes fitting and adjustment L4398
    Foot drop splint, recumbent positioning device, prefabricated, includes fitting and
    adjustment [not covered for HMO plans] Q4037 – Q4040 Cast supplies, short leg
    cast [rigid for ankle fractures only] [semi-rigid for ankle sprains only] Q4045 -
    Q4048 Cast supplies, short leg splint [for plantar flexion non-fixed contractures
    without foot drop, with reasonable expectation of correction, that interfere with
    functional abilities, and are a component of a therapy program] S8451 Splint,
    prefabricated, wrist or ankle [for plantar flexion non-fixed contractures without
    foot drop, with reasonable expectation of correction, that interfere with functional
    abilities, and are a component of a therapy program] ICD-9 codes covered if
    selection criteria are met (not all-inclusive): 718.47 Contracture of joint, ankle
    and foot 718.87 Other joint derangement, not elsewhere classified, ankle and
    foot 727.81 Contracture of tendon (sheath) 728.71 Plantar fascial fibromatosis
    733.16 Pathologic fracture of tibia or fibula 824.0 – 824.8 Fracture of ankle
    837.0 – 837.1 Dislocation of ankle 845.00 – 845.09 Sprains and strains of ankle
    959.7 Injury, other and unspecified, knee, leg, ankle, and foot Other ICD-9 codes
    related to the CPB: 728.85 Spasm of muscle 728.89 Other disorders of muscle,
    ligament, and fascia 736.79 Other acquired deformities of ankle and foot V15.5
    Personal history of injury V54.16 Aftercare of healing traumatic fracture of
    lower leg V54.26 Aftercare of healing pathologic fracture of lower leg V54.89
    Other orthopedic aftercare V58.43 Aftercare following surgery for injury or
    trauma V58.78 Aftercare following surgery of the musculoskeletal system, NEC
    V67.09 Follow up examination, following other surgery V67.4 Follow up
    examination, following treatment of healed fracture

The above policy is based on the following references:

1. National Heritage Insurance Company (NHIC). Ankle-Foot/Knee-Ankle-Foot Orthosis. Local Coverage Determination No. L11527. Durable Medical Equipment Medicare Administrative Carrier Jurisdiction A. Chico, CA: NHIC; revised March 1, 2008. 2. Buschbacher RM. Ankle sprain evaluation and bracing. In Physical Rehabilitation of the Injured Athlete. JR Andrews, GL Harrelson, eds. Philadelphia, PA: WB Saunders Co.; 1991:221-239. 3. Barringer WJ. Principles of orthotic management of athletic injury. In Clinical Sports Medicine. WA Grana, A Kalenak, eds. Philadelphia, PA: WB Saunders Co.; 1991:315-331. 4. Reider B, Belniak R, Miller DW. Football. In Sports Medicine: The School-Age Athlete. 2nd ed. B Reider, ed. Philadelphia, PA: WB Saunders Co.; 1996:613-645. 5. American Academy of Orthopedic Surgeons. Athletic Training and Sports Medicine. 2nd ed. Rosemont, IL: American Academy of Orthopedic Surgeons; 1991:705-715. 6. Hald RD, Fandel DM. Taping and bracing. In Sports Medicine and Rehabilitation: A Sports-Specific Approach. RM Buschbacher, RL Braddom, eds. Philadelphia, PA: Hanley & Belfus, Inc; 1994:337-354. 7. Handoll HH, Rowe BH, Quinn KM, et al. Interventions for preventing ankle ligament injuries. Cochrane Database Syst Rev. 2001;(3):CD000018. 8. Bono CM, Berberian WS. Orthotic devices. Degenerative disorders of the foot and ankle. Foot Ankle Clin. 2001;6(2):329-340. 9. Buonomo LJ, Klein JS, Keiper TL. Orthotic devices. Custom-made, prefabricated, and material selection. Foot Ankle Clin. 2001;6(2):249-252. 10. Grissom SP, Blanton S. Treatment of upper motoneuron plantarflexion contractures by using an adjustable ankle-foot orthosis. Arch Phys Med Rehabil. 2001;82(2):270-273. 11. Mauritz KH. Gait training in hemiplegia. Eur J Neurol. 2002;9 Suppl 1:23-29; discussion 53-61. 12. Gok H, Kucukdeveci A, Altinkaynak H, et al. Effects of ankle-foot orthoses on hemiparetic gait. Clin Rehabil. 2003;17(2):137-139. 13. Kerkhoffs GMMJ, Struijs PAA, Marti RK, et al. Different functional treatment strategies for acute lateral ankle ligament injuries in adults. Cochrane Database Syst Rev. 2002;(3):CD002938. 14. Sackley C, Disler PB, Turner-Stokes L, Wade DT. Rehabilitation interventions for foot drop in neuromuscular disease. Cochrane Database Syst Rev. 2007;(2):CD003908. 15. Rome K, Brown CL. Randomized clinical trial into the impact of rigid foot orthoses on balance parameters in excessively pronated feet. Clin Rehabil. 2004;18(6):624-630. 16. Pinzur MS, Slovenkai MP, Trepman E, et al. Guidelines for diabetic foot care: Recommendations endorsed by the Diabetes Committee of the American Orthopaedic Foot and Ankle Society. Foot Ankle Int. 2005;26(1):113-119. 17. Struijs P, Kerkhoffs G. Ankle sprain. In: BMJ Clinical Evidence. London, UK: BMJ Publication Group; March 2007. 18. De Pisi F. Aids and orthoses in patients with stroke consequences. Clin Exp Hypertens. 2006;28(3-4):383-385. 19. Hijmans JM, Geertzen JH, Dijkstra PU, Postema K. A systematic review of the effects of shoes and other ankle or foot appliances on balance in older people and people with peripheral nervous system disorders. Gait Posture. 2007;25(2):316-323. 20. Richie DH Jr. Effects of foot orthoses on patients with chronic ankle instability. J Am Podiatr Med Assoc. 2007;97(1):19-30. 21. Lin CWC, Moseley AM, Refshauge KM. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2008;(3):CD005595. 22. Figueiredo EM, Ferreira GB, Maia Moreira RC, et al. Efficacy of ankle-foot orthoses on gait of children with cerebral palsy: Systematic review of literature. Pediatr Phys Ther. 2008;20(3):207-223. 23. Sheffler LR, Hennessey MT, Knutson JS, et al. Functional effect of an ankle foot orthosis on gait in multiple sclerosis: A pilot study. Am J Phys Med Rehabil. 2008;87(1):26-32. 24. Cooke MW, Marsh JL, Clark M, et al. Treatment of severe ankle sprain: A pragmatic randomised controlled trial comparing the clinical effecitveness and cost-effectiveness of three types of mechanical ankle support with tubular bandage. The CAST trial. Health Technol Assess. 2009;13(13):1-144.