This policy is based primarily on Medicare DME MAC criteria for spinal orthoses and knee orthoses.

are devices (other than dental) that replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ. This does not require a determination that there is no possibility that the patient’s condition may improve sometime in the future. If the medical record, including the judgment of the attending practitioner, indicates that the condition is of long and indefinite duration, the test of permanence is considered met.

An

(brace) 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. It must provide support and counterforce (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. An orthosis can be classified as either prefabricated (off-the-shelf or custom fitted) or custom-fabricated.

A

item is one that is individually made for a specific patient. No other patient would be able to use this item. A custom fabricated item is a device which is fabricated based on clinically derived and rectified castings, tracings, measurements, and/or other images (such as X-rays) of the body part. The fabrication may involve using calculations, templates, and components. This process requires the use of basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of uncut or unshaped sheets, bars, or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, and finishing prior to fitting on the patient.

: A molded-to-patient-model is a negative impression taken of the patient’s body member and a positive model rectification is constructed. In positive models, a CAD-CAM system, by use of digitizers, transmits surface contour data to software that the practitioner uses to rectify or modify the model on the computer screen. The data depicting the modified shape is electronically transmitted to a commercial milling machine that carves the rectified model. Alternatively, a direct formed model is one in which the patient serves as the positive model. The device is constructed over the model of the patient and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made. There is no separate billing if CAD-CAM technology is used to fabricate an orthosis.

orthotics are defined as devices that are prefabricated. They may or may not be supplied as a kit that requires some assembly. They all require fitting and adjustment (for example, the item must be trimmed, bent, molded [with or without heat], or otherwise modified by an individual with expertise in customizing the fit in order for it to be used by a specific patient). Custom fitted requires modification of the item in order to provide an individualized fit. Modifications must result in alterations in the item beyond simple adjustments made by bending, trimming, and/or molding of the item, installation of add-on components or assembly of the item. Custom fitted orthotics are:

Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered as custom fitted if the final fitting upon delivery to the patient requires substantial modification requiring expertise as described in this section.

(OTS) orthotics are defined as those prefabricated items which require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual. Off-the-shelf (OTS) orthotics are:

Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS. There is no separate payment if CAD-CAM technology is used to fabricate an orthosis. Reimbursement is included in the allowance of the codes for custom fabricated orthoses.

is defined as changes made to achieve an individualized fit of the item that requires the expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthotics such as a physician, treating practitioner, an occupational therapist, or physical therapist in compliance with all applicable Federal and State licensure and regulatory requirements. A certified orthotist is defined as an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification.

is defined as an adjustment the member, caretaker for the member, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotics/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.

Individuals with specialized training necessary to provide custom fitting services for patients with a medical need for orthotics include: a physician, a treating practitioner (a physician assistant, nurse practitioner, or clinical nurse specialist), an occupational therapist, or physical therapist in compliance with all applicable Federal and State licensure and regulatory requirements.

are a collection of components, materials and parts that require further assembly before delivery of the final product. The elements of a kit may be packaged and complete from a single source or may be an assemblage of separate components from multiple sources by the supplier.

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

For prefabricated orthoses, there is no physical difference between orthoses coded as custom fitted versus those coded as off-the-shelf. The differentiating factor for proper coding is the need for "minimal self-adjustment" at the time of fitting by the member, caretaker for the member, or supplier. This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training. Items requiring minimal self-adjustment are coded as off-the-shelf orthoses. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS. Items requiring substantial modification by a qualified practitioner are coded as custom fitted. For custom fabricated orthoses, there must be detailed documentation in the supplier’s records to support the medical necessity of that type device rather than a prefabricated orthosis.

Knee orthoses

A

describes a prefabricated knee orthoses constructed of latex, neoprene, spandex or other elastic material. There are no condylar pads. There are hinges or joints.

A

describes a prefabricated knee orthosis with hinges or joints, constructed of latex, neoprene, spandex or other elastic material. There are medial and lateral condylar pads.

A

describes a prefabricated knee orthosis immobilizer, with rigid metal or plastic stays placed laterally and posteriorly. The interface material is constructed of canvas, closed cell foam or equal. The thigh and calf cuffs are one-piece construction held in place by velcro straps or equal. The orthosis immobilizes the knee joint and prevents flexion or extension. There are no hinges or joints.

A

describes a prefabricated knee orthoses with joint(s) which lock the knee into a particular position. A prefabricated knee orthosis, double upright with adjustable joint, with inflatable air support chambers also have joints which lock the knee into a particular position; in addition, they have an air bladder in the space behind the knee. These orthoses are designed for members who are nonambulatory. They are typically used to treat flexion/extension contractures of the knee.

An

is one which enables the practitioner to set limits on flexion and extension but allows the member free motion of the knee within those limits. The increments of adjustability must be, at a minimum, 15 degrees. The joint may be either unicentric or polycentric.

A

describes prefabricated knee orthoses that have double uprights and adjustable flexion and extension joints. Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. They may have condylar pads. These orthoses are designed for a member who can bear weight on the knee and is capable of ambulation. They are typically used for early rehabilitation following knee surgery.

are designed to prevent knee motion. These orthoses are designed for members who can bear weight on the knee, are capable of ambulating, and need additional support provided through immobilization of the knee joint. They may be custom fabricated or prefabricated.

A

describes a custom fabricated knee orthosis with knee joints designed to protect the ligaments of the knee through medial-lateral torsion, providing stability and preventing rotation.

A

, describes knee orthoses which are constructed of rigid thigh and calf cuffs and a single upright with an adjustable flexion and extension knee joint. It must have condylar pads. They may be prefabricated or custom-fabricated. It must have condylar pads. Through a series of straps/supports that cross over and around the knee joint, rotational control and varus or valgus force is exerted on the knee joint. These orthoses are designed to open the medial or lateral compartment of the knee to provide pain relief due to osteoarthritis. These orthoses are designed for persons who are fully ambulatory.

A

describes a prefabricated orthosis with double uprights and thigh and calf pads. It may or may not have joints. These orthoses are used to prevent hyperextension of the knee joint in ambulatory members.

A

describes a custom fabricated orthosis without joints, constructed of plastic or other similar material. These orthoses are used to prevent hyperextension of the knee joint in ambulatory members.

An

describes an addition to a lower extremity orthosis composed of high strength and/or lightweight material such as kevlar, carbon fiber or other laminated or impregnated composite material.

Knee braces may be custom-fitted or

. A custom-fitted prefabricated brace is one which only measurements and a sizing chart are needed for fitting. A custom-made (custom-fabricated or made-to-order) knee brace is one that requires an initial impression of the knee for fitting. Knee orthoses that are custom-fitted require the assistance of an orthotist in adjusting the brace to the correct size, but do not require an initial impression of the knee for fitting. Custom-made functional knee braces have not been shown to be medically superior to custom-fitted prefabricated functional knee braces. Therefore, use of custom-made functional knee braces is reserved for those patients who are hard to fit because of a deformity of the knee or leg that interferes with fitting. Exceptionally tall persons can be fitted into an custom-fitted prefabricated brace with extensions, short persons can be fitted with a pediatric custom-fitted prefabricated brace, and obese persons can be fitted into an custom-fitted prefabricated knee brace with extra large straps.

A classification scheme devised by the American Academy of Orthopedic Surgeons (AAOS) divides knee braces into 3 categories:

Each of these types of braces will be discussed in turn below.

Prophylactic Knee Braces

Prophylactic knee braces and other protective gear (such as helmets, elbow pads, gloves, eye goggles, etc.) are considered safety items and are therefore not covered under terms of Aetna’s policies. Please check benefit plan descriptions.

The common occurrence of medial collateral sprains in football and other sports led to the fabrication of prophylactic hinge braces designed to prevent or attenuate this injury. These braces have lateral or sometimes medial and lateral hinges designed to absorb valgus impact to the knee. Prophylactic knee braces are available custom-fitted prefabricated (not custom-made) and without a prescription.

The effectiveness of prophylactic knee braces for collateral ligament injury to the knee is controversial. Prophylactic knee braces have not been shown to be effective. Indeed, some studies have shown that the risk of knee injury may be increased with use of prophylactic knee braces. Hald and Fandel (1996) explained that recent research has raised questions about the possibility of such braces "preloading" knee structures and predisposing the wearer to an increased risk of ligament injuries. These investigators concluded that "[w]e now feel that time and money might be better spent on preventive conditioning than for braces."

Functional Knee Braces

Functional knee braces are considered medically necessary if they are needed for activities of daily living, such as standing, walking, and climbing stairs, and thus are worn throughout the day. Functional knee braces are considered not medically necessary when used primarily for sports, because participation in sports is considered an elective activity.

Functional knee braces are designed to provide support to the knees made unstable by injury or to provide additional protection following surgery to correct such instabilities. They are usually recommended in the postoperative period and after completion of rehabilitation when full activity is resumed, or for the patient with a diagnosis of anterior cruciate ligament insufficiency in whom a nonoperative approach is used.

Some of these braces are ready-made in sizes to provide for immediate fit (so-called custom-fitted prefabricated braces). Others require custom construction based on some form of cast molding or measurement of the person’s leg (so called custom-made or custom-fabricated braces). Functional braces usually involve some form of hyperextension stop, as well as straps or fitted shells to control rotation. There is no clear-cut advantage of shell braces over strap braces.

Functional knee braces are fabricated from a variety of materials, including carbon composites, aluminum, and kevlar. Despite their relatively high cost, knee braces composed of carbon composites (also known as carbon fiber or graphite) are favored by competitive athletes because of their lightness. There are, however, no medical advantages of carbon fiber braces over braces composed of materials that are heavier, but equally as strong, such as steel or aluminum. A variety of suspension systems and knee joint designs are used in functional knee braces. There is, however, no evidence of medical benefits from one knee joint design over another. Therefore, custom-made braces is considered medically necessary only for persons who cannot be fit into off the shelf braces because deformity. Even persons who are very tall or markedly obese, however, can be fitted with custom-fitted prefabricated functional braces that have been modified with attachments, such as extensions and extra long straps.

Functional knee braces are most commonly used in persons with prior ligamentous knee injuries. The ligaments of the knee include the anterior cruciate ligament (ACL), the posterior cruciate ligament (PCL), the lateral collateral ligament (LCL), and the medial collateral ligament (MCL). The use of functional braces for injuries involving each of these ligaments is described below:

Up to 70 % of acute ACL injuries occur during sports. Episodes occur during sports requiring quick turns, sudden stopping, jumping, or lateral movements (such as football, volleyball, basketball, and racquetball). The diagnosis of an acutely torn anterior cruciate ligament (ACL) is based on the circumstance of the injury as reported by the patient and the stability assessment during the physical examination. Lachman’s test of assessing the anterior translation of the tibia on the femur with the knee in 20 to 30 degrees of flexion is the most accurate diagnostic examination. For patients treated conservatively, optional bracing has been used after rehabilitation to assist patients in returning to low-demand activity. However, neuromuscular rehabilitation and activity modification are far more important.

The use of the functional brace for the ACL-deficient knee remains controversial. Laboratory studies have shown that functional braces do not prevent abnormal tibial displacement, even at physiologic loads. However, persons with prior cruciate ligament injuries subjectively feel more secure in these devices.

Loss of the anterior cruciate ligament has been associated with a loss of ability to detect knee joint motion due to disruption of normal efferent pathways. Some have conjectured that knee braces can substitute for this lost pathway, and that subjective improvements while wearing the brace are due to heightened propioception (position sense), although the evidence supporting this hypothesis is inconclusive. Others feel that psychological support may be the greatest benefit of functional braces. Despite the subject’s subjective improvement, giving away episodes can occur in spite of wearing the functional brace. The AAOS concluded that the “scientific rationale for this ‘security’ is not clear, but perhaps related to the fact that the devices do provide warmth and increased knee awareness” (AAOS, 1991).

No study has demonstrated medically significant advantages of custom-made functional knee braces over custom-fitted prefabricated functional knee braces in patients with knee ligament injuries. Because the benefits of functional knee braces are due to their ability to effect heightened propioception and to the sense of security the impart, the precise fitting of the brace, as through custom-fabrication or custom-molding, is not essential to its effectiveness.

More than 50 functional braces are on the market, with no clear-cut advantage for any brand. “[B]eing aware of the growing number of ‘off the shelf’ functional braces on the market, physicians and clinicians must decide whether the custom-made brace is worth the extra cost to the athlete or patient if the protection offered is propioceptive in nature” (Harrelson, 1991). Reider explained that “[w]e currently favor the new generation of custom-fitted prefabricated braces for economic reasons, saving the more expensive custom-molded types for the harder-to-fit athlete” (Reider et al, 1996).

In proving that one brace is superior to another, the manufacturer must demonstrate brace efficacy in studies designed to approximate the in vivo situation. Current studies do not provide adequate evidence to conclude that custom-made functional knee braces result in medical benefits beyond those provided by custom-fitted prefabricated braces. The manufacturer claiming superiority of their brace must be asked to verify claims and to provide documentation of efficacy.

The medial collateral ligament is the most commonly injured knee ligament in sports. Persons with a

MCL sprain need only wear a knee immobilizer for a few days, and no functional brace is necessary.

A first-degree sprain is, by definition, an injury to the ligament in which there is no increased laxity of that ligament. If there is laxity present, then there is either a second- or third-degree sprain. A second-degree sprain is differentiated clinically from a third degree sprain by the feel of the "end-point" on examination and the amount of laxity. A second-degree sprain has a "firm" end point on stressing, as the ligament fibers that were not torn in the injury become taut. A third-degree sprain has a "soft" end point, as translation is gradually stopped when other ligaments and tendon fibers (secondary restraints) become taut.

For the patient with a

MCL sprain (partial tear), it is appropriate to prescribe an custom-fitted prefabricated functional knee brace after the rehabilitative knee brace is removed, and have the patient use this brace for up to 8 weeks after injury.

Isolated third-degree MCL injuries (complete tear) may be treated with a hinged rehabilitative brace, rather than a knee immobilizer, for the first 6 weeks after injury. (An isolated MCL sprain is one where the ACL and PCL (posterior cruciate ligament) have been proven intact by MRI and instrumented laxity testing.) It is recommended that following the acute injury, a functional brace be worn for 4 to 6 months.

The posterior cruciate ligament is infrequently injured. Functional bracing has little role in PCL injuries because there is no clinical benefit or biomechanical evidence for the use of a functional brace in the PCL-injured knee.

The lateral collateral ligament is the least frequently injured of all the knee ligaments in sports because the knee is usually protected from a blow to the medial side by the person's other leg. Treatment for first- and second-degree sprains follows the same program and a very similar time frame that was used for MCL injuries. A custom-fitted prefabricated functional brace is appropriate for the patient that desires early return to activity. Operative referral is necessary for patients with third-degree sprains.

Evidence is insufficient to support the use of knee braces as a treatment for patellofemoral pain syndrome. In a Cochrane review on orthotic devices for treating patello-femoral pain syndrome, D'hondt et al (2002) concluded that the evidence from randomized controlled trials is currently too limited to draw definitive conclusions about the use of knee and foot orthotics for the treatment of patellofemoral pain. The authors stated that future high quality trials in this field are warranted. An earlier systematic evidence review of treatments for patellofemoral pain similarly concluded that, "[d]ue to the low quality and quantity of the current evidence, the use of patellofemoral orthoses ... cannot be supported or refuted" (Crossley et al, 2001). In a review on the management of patients with patello-femoral pain syndrome, Dixit and colleagues (2007) stated that there is little evidence to support the routine use of knee braces or non-steroidal anti-inflammatory drugs.

Rehabilitative (or Rehabilitation) Knee Braces

Rehabilitative (or rehabilitation) braces are used as alternatives to knee immobilizers used immediately after surgery or injury to both control knee motion and protect the knee during rehabilitation. Rehabilitative knee orthoses offer the patient early limited mobility to improve recovery time and decrease the effects of disuse on the graft or reconstructed ligament.

Rehabilitative knee orthoses are custom-fitted prefabricated, and can be ordered either as small, medium, or large, or by a size chart. Most of them can be adjusted within each size to allow for edema or atrophy, and thus can be conveniently stocked in a hospital or clinic for quick fittings.

In collateral ligament injuries that do not involve a complete tear (second degree injuries), the torn fibers are internally splinted from excessive stress by the intact ligament fibers, and the use of the knee immobilizer or rehabilitative brace is only for comfort.

There are few objective studies offering objective data about the stabilizing effects of various types, and no guidelines for choosing any particular rehabilitative knee brace over another. Choice of rehabilitation brace is usually based on availability, ancillary features, and ease of use.

Rehabilitative knee braces do not require precise fitting (and, hence, are never custom-made) because their size must be repeatedly readjusted throughout the course of rehabilitation to accommodate changes in swelling that occur following injury or surgery to the knee.

The Ottobock E-Mag Electronically Locking Knee Brace

The Ottobock E-Mag electronically locking knee brace supposedly offers wearers increased stability when standing and helps patients achieve a more active lifestyle. It features an electronically controlled lock that is activated by a small remote control to provide absolute stability in the stance phase. The lock is activated with the touch of a button, allowing the wearer to support themselves with both arms and stand safely at all times. The Ottobock E-Mag's special feedback system also informs the wearer when the joint is opening.

The WorkSafeBC Evidence-Based Practice Group’s report on the “E-MAG Active” (Edeer and Martin, 2010) stated that “E-MAG Active has recently been introduced by Otto Bock as a SCKAFO [Stance Control Knee Ankle Foot Orthoses] that utilizes an electromagnetic technique (hence, the name E-MAG which refers to this Electronic Magnet). It became available in the market in North America in December 2008 …. To use E-MAG Active the patient is required to have both functional extensors and flexors of the hip with a strength of 3 to 5 (based on the Kendall and Kendall scale). The patient must also have the capacity for full extension of the knee, both prior to the initial contact and at the terminal stance (to lock and unlock the knee) …. Otto Bock recommends E-MAG Active for “patients that present with flaccid paralysis/paresis of the knee extensors coupled with limited ankle ROM” …. Currently, there are no review articles, or any other study papers (case reports, comparative studies, or cost effectiveness studies) specifically about E-MAG Active …. There is no specific coverage policy regarding E-MAG Active at WorkSafeBC …. The policy manual of the US Department of Veterans Affairs contains a section on “orthotics” but does not include a specific policy regarding E-MAG Active or SCKAFOs in general …. We did not come across any specific coverage policy on E-MAG Active from any of the searched workers compensation organizations or health insurance companies”.

Cymedica QB1 Knee Brace

The CyMedica QB1 Knee Brace is used for the treatment of quadriceps muscle atrophy. It employs neuromuscular electrical stimulation (NMES) technology for the treatment of quadriceps muscle atrophy and combines 3 products: a post-operative knee brace, a form-fitting conductive garment, and a NMES control interface. The device simplifies the delivery of "at home" NMES treatment and encourages patient compliance. However, there is a lack of published evidence on the safety and effectiveness of the CyMedica QB1 Knee Brace.

Spinal Orthoses

Spinal orthoses have the following characteristics:

In addition, the body jacket type spinal orthoses are characterized by a rigid plastic shell that encircles the trunk with overlapping edges and stabilizing closures and provides a high degree of immobility. The entire circumference of the plastic shell must be the same rigid material.

A rigid or semi rigid spinal orthotic device eliminates or restricts motion in the planes being controlled by an orthosis.

A spinal orthosis is designed to control gross movement of the trunk and intersegmental motion of the vertebrae in one or more planes of motion:

Lumbar Sacral Orthoses (LSO) and Thoracic Lumbar Sacral Orthoses (TLSO) are considered braces. Elastic support garments (e.g. made of material such as neoprene or spandex [elastane, Lycra]) are not considered braces because they are not rigid or semi-rigid devices. Flexible spinal orthoses that are made primarily of nonelastic material (e.g., canvas, cotton or nylon) or that have a rigid posterior panel are considered braces.

The purpose of a rigid or semi-rigid LSO and TLSO spinal orthosis is to restrict the effect of the forces within a three point pressure system. The posterior panel must encompass the paraspinal muscle bodies from one lateral border to another in order to provide sufficient surface area to enhance the three point pressure system. The posterior panel must provide coverage to meet the minimum height requirements as described in the individual HCPCS codes.

For an item to be classified as a TLSO the posterior portion of the brace must extend from the sacrococcygeal junction to just inferior to the scapular spine. This excludes elastic or equal shoulder straps or other strapping methods. The anterior portion of the orthosis must at a minimum extend from the symphysis pubis to the xiphoid. Some TLSOs may require the anterior portion of the orthosis to extend up to the sternal notch.

A

is one which is individually made for a specific member (no other member would be able to use this orthosis) 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 vacuum forming, cutting, bending, molding, sewing, etc. It requires more than trimming, bending, or making other modifications to a substantially prefabricated item.

A

is a particular type of custom fabricated orthosis in which either:

The spinal orthosis is then individually fabricated and molded over the positive model of the member.

Scapular Bracing

Posture was measured using lateral-view photography with retro-reflective markers. Electromyography (EMG) of the upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) in the dominant upper extremity was measured during 4 exercises (scapular punches, W's, Y's, T's) and 2 gleno-humeral motions (forward flexion, shoulder extension). Posture and exercise EMG measurements were taken with and without the brace applied. Head and shoulder angles were measured from lateral-view digital photographs. Normalized surface EMG was used to assess mean muscle activation of the UT, MT, LT, and SA. Application of the brace decreased forward shoulder angle in the S + T condition. Brace application also caused a small increase in LT EMG during forward flexion and Y's and a small decrease in UT and MT EMG during shoulder extension. Brace application in the S + T group decreased UT EMG during W's, whereas UT EMG increased during W's in the S group. The authors concluded that application of the scapular brace improved shoulder posture and scapular muscle activity, but EMG changes were highly variable. They stated that the use of a scapular brace might improve shoulder posture and muscle activity in overhead athletes with poor posture. One important drawback of this study was the variable fit of the scapular brace on each participant. Braces were provided in 6 sizes to fit the participants, and the investigators involved in the application of the braces were trained by a representative from the manufacturer on how to fit each brace for each participant. However, the material of the compression top often gathered during movement, and the participants with short torsos had more difficulty with fit than did other participants. Other drawbacks included: (a) 1 type of brace application was used – different brace applications might affect posture and EMG differently, and using a different method might be more beneficial; and (b) although every effort was made to blind the participants and the primary investigators to ensure the validity of the results, it cannot be ruled out that the subjects might have altered their posture and muscle activity simply because of research participation.

Spine and Scapula Stabilizing Brace (S3 Brace)

According to the manufacturer, the vest-type Spine and Scapula Stabilizing brace (the S3 brace) (AlignMed, Inc., Santa Ana, CA) is designed to help restore normal shoulder kinematics. It consists of a Velcro strapping system with "propioceptive padding" and mesh vest "to allow biofeedback to patients". According to the manufacturer, "this neural feedback, along with the vest's innate postural support, could potentially emphasize proper shoulder muscular mechanics". Evidence for the S3 brace consists of unpublished abstracts examining the effect on shoulder kinematics in normal subjects as well as subjects with "scapular dyskinesis". There are no published clinical outcome studies of the S3 brace.

Levitation 2 Bionic Knee Brace

Budarick et al (2020) noted that knee osteoarthritis (OA) is a significant problem in the aging population, causing pain, impaired mobility, and decreased quality of life (QOL). Conservative treatment methods are necessary to reduce rapidly increasing rates of knee joint surgery. Recommended strategies include weight loss and knee bracing to unload knee joint forces. Although weight loss can be beneficial for joint unloading, knee OA patients often find it difficult to lose weight or exercise due to knee pain, and not all patients are over-weight. Uni-compartment off-loader braces can re-distribute joint forces away from 1 tibio-femoral (TF) compartment, however, less than 5 % of patients have uni-compartmental TFOA, while isolated patella-femoral (PF) or multi-compartmental OA are much more common. By absorbing body weight and aiding the knee extension moment using a spring-loaded hinge, sufficiently powerful knee-extension-assist (KEA) braces could be useful for unloading the whole knee. These researchers described the design of a spring-loaded tri-compartment unloader (TCU) knee brace intended to provide unloading in all 3 knee compartments while weight-bearing, measured and compared the force output of the TCU against the only published and commercially available KEA brace, and calculated the static unloading capacity of each device. The TCU and KEA braces delivered maximum assistive moments equivalent to reducing body weight by 45 and 6 lbs, respectively. The authors concluded that sufficiently powerful spring-loaded knee braces showed promise in a new class of multi-compartment unloader knee orthoses, capable of providing a clinically meaningful unloading effect across all 3 knee compartments.

Bracing for Patella-Femoral Osteoarthritis

In a prospective, randomized study, Merino and colleagues (2021) compared the long-term effects of a brace designed to stabilize the patella-femoral (PF) joint in comparison to a standard neoprene sleeve for the knee with patellar hole in patients with patella-femoral osteoarthritis (PFOA). A total of 38 patients with PFOA and co-morbidities received either a functional PF brace (Study Group, SG) or a neoprene sleeve for the knee (Control Group, CG). Both groups received clinical treatment to OA and co-morbidities according to a program from the institution. Patients were examined with Western Ontario and MacMaster (WOMAC) and Lequesne questionnaires, 30-second chair stand test (30CST), Timed Up and Go (TUG), anthropometric measures and self-reported physical activity in minutes/week at inclusion, 1, 3 and 12 months after placing the brace. X-Rays were taken to measure the angles. At 1year there was more abandonment in the CG without differences in weight and body mass index (BMI) between groups during the study. The SG maintained improvements in Lequesne and WOMAC total and subsets during the year, whereas the CG returned to baseline values for pain, function and total (p < 0.01). TUG and 30CST results were always better in the study group without any clinically important improvement in both groups. The authors concluded that long-term use of functional brace added to self-management program improved pain and function in patients with PFOA. Level of Evidence = II.

In a prospective, randomized trial, Yamamoto and associates (2021) compared the effect of a brace designed to stabilize the PF joint to that of a patella-shaped neoprene sleeve with patella cut out in patients with PFOA. A total of 57 patients with PFOA were allocated to 2 groups -- patients with PF functional brace and those with a neoprene knee with a patellar orifice. Both groups underwent clinical treatment of OA and used medications daily 1 month before and up to 3 months after brace placement. They were evaluated with the WOMAC and Lequesne questionnaires and performed 5 times sit to stand test, TUG test, and six-minute walk test (6MWT) immediately before and 1 and 3 months after brace placement. Both groups had improved pain, stiffness, and function with no difference between groups. Drug use decreased in both groups in the 1st month but increased in the 3rd month; naproxen use was progressively higher in the control group. The authors concluded that both knee orthoses improved pain and function and altered drug use only in the 1st month. They stated that functional knee brace provided analgesia without increased use of naproxen. Level of Evidence IB.

Furthermore, an UpToDate review on “Patellofemoral pain” (O'Connor and Mulvaney, 2021) states that “Although the foundation of treatment for PFP remains exercise and strengthening, if a patient cannot participate fully in rehabilitation exercises due to pain or does not make progress, it is reasonable to perform taping or patellofemoral bracing if this improves symptoms”.

Hip Brace for Individuals with Acetabular Labral Tears / Femoro-Acetabular Impingement Syndrome

In a parallel, 2-arm, exploratory randomized trial, Eyles and colleagues (2022) examined if a hip brace could improve hip health QOL and is well-tolerated in individuals with symptomatic labral tears or femoro-acetabular impingement syndrome (FAIS) after 6 weeks of wear. Subjects were individuals aged 18 years with FAIS or labral tears. Patient-reported outcomes were assessed with the International Hip Outcome Tool (iHOT-33), and Copenhagen Hip and Groin Outcome Scores (HAGOS). Brace acceptability was measured using the Quebec User Evaluation of Satisfaction with Assistive Technology survey. Independent t-tests assessed between-group differences. A total of 38 subjects were recruited, 19 each group, 60 % women, mean age of 39.3 ± 11.8 years, body mass index (BMI) of 25.3 ± 4.4 kg/m2, iHOT-33 36.6 ± 24.8; 3 subjects dropped out (1 usual care, 2 braced). The mean between-group difference for iHOT-33 was 19.4 (95 % confidence interval [CI]: 1.68 to 37.06, p = 0.03) favoring the brace. There were improvements in most HAGOS subscale scores favoring the brace. Issues with brace tolerability for some subjects were perceived comfort and effectiveness; 3 brace-related adverse events (AEs) were reported. The authors concluded that between-group differences favored the braced group for hip health QOL, pain, symptoms, and function. Moreover, these researchers stated that although these findings were promising, the CIs for the estimates were wide, the small sample size (n = 35) likely a contributing factor. They stated that these findings suggested that further investigation of the brace is needed; these researchers calculated sample sizes and made recommendations for the design of a future trial.

Abduction Splint (e.g., the Pavlik Harness and the Tubingen Splint) for the Treatment of Stable and Unstable Developmental Dysplasia of the Hip

In a retrospective study, Lyu et al (2021) examined the clinical and radiological outcomes of patients younger than 6 months of age with DDH managed by either a Pavlik harness or Tubingen hip flexion splint. Records of 251 consecutive infants with a mean age of 89 days (SD 47), diagnosed with DDH between January 2015 and December 2018, were reviewed. Inclusion criteria for patients with DDH were entailed younger than 180 days at the time of diagnosis; ultrasound (US) Graf classification of IIc or greater; treatment by Pavlik harness or Tubingen splint; and no prior treatment history. All patients underwent hip US every 7 days during the first 3 weeks of treatment and subsequently every 3 to 4 weeks until completion of treatment . If no signs of improvement were found after 3 weeks, the Pavlik harness or Tubingen splint was discontinued. Statistical analysis was carried out. The study included 251 patients with Graf grades IIc to IV in 18 males and 233 females with DDH. Mean follow-up time was 22 months (SD 10). A total of 116 hips were graded as Graf IIc (39.1 %), 9 as grade D (3.0 %), 100 as grade III (33.7 %), and 72 as grade IV (24.2 %). There were 109 patients (128 hips) in the Pavlik group and 142 patients (169 hips) in the Tubingen group (p = 0.227). The Tubingen group showed a 69.8 % success rate in Graf III and Graf IV hips while the success rate was significantly lower in the Pavlik group, 53.9 % (p = 0.033). For infants older than 3 months of age, the Tubingen group showed a 71.4 % success rate, and the Pavlik group a 54.4 % success rate (p = 0.047). The authors concluded that the Tubingen splint should be the preferred therapeutic option for children older than 3 months, and for those with severe forms of DDH such as Graf grade III and IV, who are younger than 6 months at time of diagnosis. The Tubingen hip flexion splint is a valid alternative to the Pavlik harness for older infants and those with more severe DDH.

Merchant et al (2021) stated that bracing is considered a gold standard in treating DDH in infants under 6 months of age with reducible hips. A variety of braces are available that work on similar principles of limiting hip adduction and extension. These investigators examined the current evidence regarding bracing in DDH. Most of the literature pertains to the Pavlik harness and there were few studies for other brace types. Bracing eliminates dislocating forces from the hamstrings, the block to reduction of the psoas and improves the muscle line of pull to stabilize the hip joint. Recent studies have shown no benefit in bracing for stable dysplasia. The rates of Pavlik harness treatment failure in Ortolani-positive hips have been reported to be high. Barlow positive hips have lower Graf grades and are more amenable to Pavlik harness treatment. There is consensus that the earlier the diagnosis of DDH and initiation of Pavlik harness treatment, the better the outcome. Failure rates due to unsuccessful reduction and AVN were higher with treatment initiated after age of 4 to 6 months. Studies have shown no benefits of staged weaning of braces. The authors stated that while there is no maximum time in brace, current consensus suggested a minimum of 6 weeks.

Chaibi et al (2022) stated that the Tubingen splint was initially developed for the treatment of stable DDH. Later on, some investigators expanded its use to treat unstable DDH; however, there remain some controversies regarding its effectiveness for this indication. In a retrospective study, these researchers compared the outcome between stable and unstable DDH treated with a Tubingen splint. Epidemiological data and US data of all infants diagnosed with DDH and initially treated with a Tubingen splint at the authors’ institution between May 2017 and February 2020 were assessed. These investigators divided the population into stable and unstable hips using the Graf classification. Age at treatment initiation, duration of treatment, complications, and radiological outcome between 12 and 24 months were examined. This study included a total of 45 patients (57 hips) affected by DDH treated with the Tubingen splint. Treatment has been successful in 93 % of stable hips and only 40 % of unstable hips. Radiological outcome at 1-year follow-up significantly correlated with initial Graf classification (p < 0.001). The authors concluded that the findings of this study confirmed that the Tubingen splint is a safe and effective treatment for stable hips. For unstable hips in which treatment with a Tubingen splint is initiated, very close monitoring is mandatory in order to adapt the treatment in the event of poor evolution. The treatment of choice will then be closed reduction and spica cast.

Furthermore, an UpToDate review on “Developmental dysplasia of the hip: Treatment and outcome” (Rosenfeld, 2022) states that “We recommend treatment with an abduction splint for infants younger than six months with hip dislocation or persistently dislocatable or subluxatable hips (Grade 1B). The Pavlik harness is the most thoroughly studied and most commonly used abduction splint”.

Prefabricated Volar Wrist Brace (Cock Up Non-Molded) for Carpal Tunnel Syndrome

The American Academy of Orthopedic Surgeons’ evidence-based clinical practice guideline on “Management of carpal tunnel syndrome” (AAOs, 2016) noted that “Strong evidence supports that the use of immobilization (brace/splint/orthosis) should improve patient reported outcomes. (Evidence from 2 or more “high” strength studies with consistent findings for recommending for the intervention).

Appendix

The following chart reflects the reasonable useful lifetime of prefabricated knee orthoses:

The reasonable useful lifetime of custom fabricated orthoses is 3 years.

Noridian (2015).

The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified prefabricated base orthosis. Addition codes may be separately payable if both the base orthosis and the addition are medically necessary:

: Noridian, 2019.

The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified custom fabricated base orthosis. Addition codes may be separately payable if both the base orthosis and the addition are medically necessary:

: Noridian, 2019.

Medically Necessary Quantity of Orthotics

The Coverage Table in the following link provides the medically necessary numbers of orthotics (Washington State Health Care Authority, 2016):

The table limits durable orthotics to 1 per limb per year.

Scope of Policy

This Clinical Policy Bulletin addresses orthopedic casts, braces, and splints.

Medical Necessity

Aetna considers the following orthopedic casts, braces and splints medically necessary (unless otherwise stated) for the listed indications when they are used to treat disease or injury:

Orthosis (Orthopedic Brace) and/or Prosthesis

Aetna considers an orthosis (orthopedic brace) and/or prosthesis medically necessary when:

Back Braces

Lumbar orthosis, lumbar-sacral orthosis, and thoracic-lumbar-sacral orthosis

Aetna considers a lumbar orthosis, lumbar-sacral orthosis, and thoracic-lumbar-sacral orthosis medically necessary for

of the following indications:

Supportive lumbar orthosis, lumbar-sacral orthosis, and thoracic-lumbar-sacral orthosis are considered experimental and investigational for other indications because their effectiveness for indications other than the ones listed above has not been established. Following a strain/sprain, supportive lumbar orthosis, lumbar-sacral orthosis, and thoracic-lumbar-sacral orthosis (back supports, lumbo-sacral supports, support vests) are used to render support to an injured site of the back. The main effect is to support the injured muscle and reduce discomfort. The following additional criteria apply to custom-fitted and custom-fabricated back braces:

: Back braces are considered DME, except when used as a post-operative brace (see

below).

Post-operative back braces

Aetna considers post-operative back braces medically necessary to facilitate healing when applied within 6 weeks following a surgical procedure on the spine or related soft tissue.

A post-operative back brace is used to immobilize the spine following laminectomy with or without fusion and metal screw fixation is considered medically necessary. This brace promotes healing of the operative site by maintaining proper alignment and immobilization of the spine. Post-operative back braces are considered experimental and investigational for other indications because their effectiveness or indications other than the one listed above has not been estalbished.

: Post-operative back braces are considered part of the surgical protocol for certain back operations.

Knee Braces

A prefabricated knee orthosis with joints or knee orthosis with condylar pads and joints with or without patellar control is considered medically necessary for ambulatory members who have weakness or deformity of the knee and require stabilization.

A prefabricated knee orthosis with a locking knee joint (i.e., joints that lock a knee into a particular position) or a rigid knee orthosis (knee immobilizer) is considered medically necessary for members with flexion or extension contractures of the knee with movement on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture).

A prefabricated knee immobilizer without joints, or a knee orthosis with adjustable knee joints, or a knee orthosis with an adjustable flexion and extension joint that provides both medial-lateral and rotation control, are considered medically necessary if the member has had recent injury to or a surgical procedure on the knees (within 6 weeks prior to brace application) requiring range of motion limitations. These braces are considered experimental and investigational for other indications because their effectiveness for indications other than the one listed above has not been established.

When used for this indication, the knee brace is considered a rehabilitation brace (also known as a post-operative or post-injury brace) and is considered an integral part of the orthopedic surgical or fracture care protocol. Examples include: Bledsoe Postop Brace, DonJoy IROM Brace.

A prefabricated knee orthosis with double uprights and adjustable knee joints or adjustable flexion and extension joints that provides both medial-lateral and rotation control, are also considered medically necessary for members who are ambulatory and have knee instability due to

of the following:

Knee instability must be documented by examination of the member and objective description of joint laxity (e.g., varus/valgus instability, anterior/posterior Drawer test). For persons with these indications, valgus or varus bracing alleviates pressure on the medial or lateral compartment of the knee.

A prefabricated knee orthosis, Swedish type (i.e., knee orthoses with double uprights and thigh and calf pads) is considered medically necessary for a member who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee. Knee instability must be documented by examination of the member and objective description of joint laxity (e.g., varus/valgus instability, anterior/posterior Drawer test).

Knee braces may be custom-fitted prefabricated or custom-made. Custom-made functional braces (also known as "custom-fabricated" or "molded" knee orthoses) are considered medically necessary if the member meets criteria for a prefabricated knee brace above but is unable to be fitted with a custom-fitted prefabricated knee brace. Examples of situations in which a person may meet criteria for a custom-made knee brace include, but are not limited to:

Exceptionally tall or short stature or obesity does not, by itself, establish the medical necessity for custom-made functional knee braces. Exceptionally tall persons can usually be fitted with a prefabricated brace with extensions, short persons can usually be fitted with a pediatric prefabricated brace, and obese persons can usually be fitted with a prefabricated knee brace with extra large straps. Custom-fabricated orthoses are not considered medically necessary for treatment of knee contractures in cases where the member is nonambulatory. Custom-fabricated orthoses are considered experimental and investigational when criteria are not met.

A custom fabricated knee immobilizer without joints is considered medically necessary if criteria a and b are met:

A custom fabricated derotation knee orthosis is considered medically necessary for instability due to internal ligamentous disruption of the knee (such as due to ligament deficiency/insufficiency or reconstruction).

When used for this indication, the knee brace is considered a functional (derotational) knee brace and is considered DME. Examples include: Lenox Hill Brace, Boston Knee Brace, DonJoy CI Brace.

A custom fabricated knee orthosis with an adjustable flexion and extension joint is considered medically necessary if both criteria are met: (a) The medical necessity criteria for the knee orthosis, with an adjustable flexion and extension joint that provides both medial-lateral and rotation control are met; and (b) The general criterion defined above for a custom fabricated orthosis is met.

A custom fabricated knee orthosis with a modified supracondylar prosthetic socket is considered medically necessary for a member who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee.

Heavy duty knee joints are considered medically necessary for persons who weigh more than 300 pounds.

Up to two removable soft interfaces are considered medically necessary per year beginning one year after the date of service for initial issuance of the orthosis.

Concentric adjustable torsion style mechanisms used to assist knee joint extension are considered medically necessary for members who require knee extension assist in the absence of any co-existing joint contracture. For the use of concentric adjustable torsion style mechanisms used for joint contracture, see

.

Knee braces composed of high-strength, lightweight material are considered medically necessary for persons who meet criteria for a knee orthosis and whose weight is greater than 250 lbs. Knee braces composed of high-strength, lightweight material are considered experimental and investigational for other indications.

Osteoarthritis Braces (Unloader Braces)

Aetna considers prefabricated unloader braces medically necessary DME as an alternative to surgery for members with severe symptomatic osteoarthritis of the knee or patellofemoral osteoarthritis who have pain that has failed to respond to medical therapy and knee bracing with a neoprene sleeve, who have progressive limitation in activities of daily living, and who do not have

of the following:

A custom-fabricated unloader brace is considered medically necessary for members who meet criteria for a prefabricated unloader brace and meet medical necessity criteria for a custom-made brace noted in the section on functional and rehabilitation knee braces above. Unloader braces are considered experimental and investigational when criteria are not met.

Socks and braces sleeves are considered medically necessary supplies when used in conjunction with knee orthoses.

Please see

for guidelines on the reasonable usable lifetime of knee orthoses. These guidelines also provide the medically necessary frequency of replacement interfaces.

Cast-Braces (also called Fracture Braces)

Comfort, non-therapeutic

Comfort, non-therapeutic cast-braces are considered medically necessary DME after a fracture or surgery. Comfort, non-therapeutic cast-braces are considered experimental and investigational for other indications because their effectiveness for indications other than the ones listed above has not been established. These braces are often used after the patient has been in a walking cast. They are usually removable. Molded casts, which allow the user to remove the cast to bathe the affected extremity, can also be used when a fracture is slow to heal or non-healing. The use of these removable casts replaces monthly cast changes. A removable cast of this type offers no therapeutic advantages over a non-removable cast.

Example: Cam Walker

Functional cast-brace

Functional cast-braces are considered medically necessary after a fracture or surgery. These have become the standard brace for certain fractures, including tibial-femoral fractures. The functional cast-brace is used following a short period of standard fracture treatment using a non-weight bearing or partial weight-bearing cast, or immediately following surgery. It allows protected weight bearing, and motion of the joints above and below the fracture. The joints are moved earlier, contractures are prevented, and early healing is effected due to the weight bearing. Functional cast-braces are considered experimental and investigational for other indications because their effectiveness for indications other than the one listed above has not been established.

Examples: Patellar tendon bearing (PTB) cast brace, PTB fracture brace, MAFO (molded ankle-foot orthosis) fracture brace with pelvic band, Achilles tendon hinged brace

: Functional cast-braces are considered integral to the treatment of the fracture.

Cervical (Neck) braces

Cervical (neck) braces are considered medically necessary DME for members with neck injury and other appropriate indications (e.g., torticollis).

Example: Philadelphia Cervical Collar

: Cervical foam neck collars do not meet Aetna's definition of covered DME because they are not durable, and not made to withstand prolonged use.

Childhood Hip Braces

Specialized hip braces are considered medically necessary for children with hip disorders to stabilize the hip and/or to correct and maintain hip abduction. These hip braces are considered experimental and investigational for other indications because their effectiveness for indications other than the one listed above has not been established.

Example: Pavlik Harness, Frejka Pillow Splint, Friedman Strap

Abduction splint (e.g., the Pavlik harness and the Tubingen splint) is considered medically necessary for the treatment of infants with hip dislocation or persistently dislocatable or subluxatable hips.

: Childhood hip braces are considered integral to the management of hip disorders in children.

Braces for Congenital Defects

Aetna considers orthopedic braces medically necessary in the treatment of congenital defects. Aetna also considers replacement braces medically necessary when the member has outgrown the previous brace or because his/her condition has changed such as to make the previous brace unusable. This includes scoliosis braces.

Plastic braces (MAFOs)

Increasing use is made of plastic braces. These devices have various names and are often called molded ankle-foot orthoses (AFOs) or molded ankle-foot orthoses (MAFOs). They may also be called orthotics. For information on ankle-foot orthotics, see

. Orthotics of this type should not be confused with simple, removable orthotic arch supports or shoe inserts. For information on foot orthotics, see

.

Wheaton brace

A Wheaton Brace is considered medically necessary DME to treat metatarsus adductus in infants replacing the need for serial casting. A Wheaton Brace is considered experimental and investigational for other indications because its effectiveness for indications other than the one listed above has not been established.

Scoliosis braces

For Aetna's policy on scoliosis braces, see

.

Prefabricated Volar Wrist Brace

Aetna considers prefabricated volar wrist brace (cock up non-molded) medically necessary for the treatment of carpal tunnel syndrome.

Splints and Immobilizers

Certain orthopedic problems are routinely treated with splints or splint-like devices. The following are considered medically necessary:

Unna Boots

Unna boots are considered medically necessary only for non-fracture care. Unna boots have no proven value when used in conjunction with fracture treatment. They can be used to treat sprains and torn ligaments, provide protection for other soft tissue injuries and may be used after certain surgical procedures as a protective cover to promote healing. Occasionally they are used in the first days after a fracture before a cast is put on. Their use in this regard is controversial.

Air Casts

Miscellaneous Covered Services

Fiberglass versus Plaster Casts

Experimental and Investigational

The following DME and supplies are considered experimental and investigational because the effectiveness for the specified indication(s) has not been established (not an all-inclusive list):

Prophylactic Lumbar Supports

Prophylactic lumbar supports (Tech Belts, air belts, tool belts, elastic or inflatable lumbar supports, back rest supports) are considered experimental and investigational supplies because they have not been proven to be effective treatments for back injuries.

: Prophylactic inflatable or elastic lumbar supports do not meet Aetna's definition of covered DME because they are not durable (not made to withstand prolonged use) and because they are not mainly used in the treatment of disease or injury or to improve body function lost as the result of a disease or injury.

Knee Braces

Policy Limitations and Exclusions

: Most Aetna traditional plans cover durable medical equipment (DME) as a standard benefit. Standard Aetna HMO plans do not cover DME without a policy rider. Please check benefit plan descriptions for details. Certain orthopedic casts, braces and splints are covered under HMO plans without the DME rider because their use is integral to the treatment of certain orthopedic fractures and recovery after certain orthopedic procedures.

Note on Code Verification Review

Consistent with CMS policy, the only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the appropriate Product Classification List:

Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A Product Classification List with products which have received a coding verification can be found on the

.

Product information such as manufacturer, part number or part name must be recorded in the medical records.