1. Aetna considers surface electrical muscle stimulators (direct or alternating current, not high-voltage galvanic current) medically necessary durable medical equipment (DME) for the management of idiopathic scoliosis when all of the following criteria are met:
   
   
   1. Member has juvenile or adolescent idiopathic scoliosis that has not been surgically treated and the scoliosis is not currently being treated with bracing, and
   2. Spinal curvature is between 20 and 45 degrees (Cobb measurement based on radiographic studies), and
   3. Spinal curvature is highly progressive, with documented progression of curvature of 5 degrees or more within the past 12 months for curves between 20 and 30 degrees. (With skeletally immature members, curves of 30 degrees or more are presumed to be highly progressive.), and
   4. There is a minimum of 50% correction on forced lateral bending, and
   5. Member has a minimum of 1 year of bone growth remaining, as judged by the treating physician.

   Note: Since treatment may last from 6 to 18 months, purchase of the equipment in some cases may be more cost effective than rental of the equipment.

   Aetna considers electrical muscle stimulators experimental and investigational for idiopathic scoliosis when medical necessity criteria are not met.

2. Aetna considers surgery for the treatment of idiopathic scoliosis medically necessary for any of the following conditions:
   
   
   1. An increasing curve (greater than 40 degrees) in a growing child; or
   2. Severe deformity (curve greater than 50 degrees) with trunk asymmetry in children and adolescents; or
   3. Scoliosis related pain that is refractory to conservative treatments; or

   4. Thoracic lordosis that can't be treated conservatively.

   Aetna considers idiopathic scoliosis surgery experimental and investigational when these criteria are not met.

3. Scoliosis braces
   
   
   1. Aetna considers the following types of braces medically necessary durable medical equipment (DME) for the treatment of scoliosis:
      
      
      1. Standard thoracolumbrosacral orthosis (TLSO) brace
      2. Boston scoliosis brace
      3. Charleston scoliosis brace
      4. Milwaukee scoliosis brace.
         
         
   2. Aetna considers the following types of scoliosis braces experimental and investigational:
      
      
      1. SpineCor Dynamic Corrective Brace
      2. Providence Scoliosis System
      3. Copes scoliosis brace
      4. The Rosenberger brace.
         
         
4. Aetna considers spinal unloading devices (e.g., LTX 3000, Orthotrac) experimental and investigational for treatment of scoliosis. See also CPB 569 - Lumbar Traction Devices.

5. Aetna considers vertebral body stapling experimental and investigational for the treatment of scoliosis because its effectiveness has not been established.

Note: Some plans exclude coverage of durable medical equipment (DME). Please check benefit plan descriptions for details.

Scoliosis may be classified as functional or structural. Functional scoliosis may be transient or fairly persistent, but is not associated with any structural alterations. Structural scoliosis involves a fixed lateral curve with rotation, and is associated with many conditions including neuropathic diseases/disorders such as cerebral palsy, poliomyelitis, and muscular dystrophy; congenital causes such as failure of formation or segmentation, and myelomeningocele; traumatic causes such as fracture or dislocation (non-paralytic) and post-radiation; soft tissue contractures such as post-empyema and burns; osteochondrodystrophies such as achondroplasia and spondyloepiphyseal dysplasia; tumor; and rheumatoid disease. However, the most common type of structural scoliosis is idiopathic scoliosis. Although idiopathic scoliosis is thought to have a genetic predisposition, its exact cause is still unknown.

Idiopathic scoliosis can be further divided into 3 categories: (i) infantile (0 to 3 years of age), (ii) juvenile (3 to 10 years of age), and (iii) adolescent (over 10 years of age but before maturity). Idiopathic scoliosis most frequently affects young girls. The spinal curvature that persists after skeletal maturity is termed adult scoliosis.

The traditional treatment for adolescent idiopathic scoliosis is the use of a supportive brace, (e.g., the Milwaukee brace, the Boston brace). Torso exercises to increase muscle strength should be used in conjunction with braces. Since bracing is restrictive and must be worn 23 hours a day for up to several years, non-compliance has been estimated to be 20 to 50 % (Moe and Kettelson, 1970). Additionally, this method is associated with side effects such as anxiety, depression, and sleep disturbance. Another non-invasive method to straighten abnormal lateral curvature is surface electrical muscle stimulation. In this approach, muscles on one side of the spine are stimulated electrically (direct or alternating current, not high-voltage galvanic current) to contract and pull the vertebrae into a more normal position. Surface electrical muscle stimulation is usually applied for 8 to 10 hours during sleep. Treatment is terminated when patients reach skeletal maturity and structural stability. It is postulated that electro-muscular stimulation in the scoliotics may produce changes in muscle structure resulting in more fatigue-resistant muscles which increase the ability for postural stabilizing muscle activity in the spine (Grimby et al, 1985). Advantages of surface electrical muscle stimulation include freedom from bracing, the need for only part-time therapy, and an improvement of self-image in the affected adolescents. In severe cases, spinal fusion with instrumentation is effective in halting progression of the curve(s).

Surface electrical muscle stimulation has been shown to be effective in reversing or arresting progression of spinal curvatures in adolescents with idiopathic scoliosis. Brown et al (1984) reported the findings of a multicenter study on the use of night-time lateral electrical surface stimulation (LESS) for the treatment of juvenile or adolescent idiopathic scoliotics (484 girls and 64 boys, mean ages of 12.8 and 13.9 years, respectively). Only individuals with rapidly progressing scoliosis and at least 1 year of growth remaining were selected for this trial. The mean treatment time was 12 months, and the longest follow-up was 51 months. During the initial 6 months of therapy, a pre-treatment curvature progression rate of 1 degree/month was reversed to a reduction rate of 0.5 degree/month. Overall, 395 (72 %) patients had either reduced or stabilized their scoliosis. Seventy-one (13 %) patients had experienced temporary progression with subsequent stabilization and treatment continuation, while 82 (15 %) patients dropped out because of progression of their conditions. The major problem with LESS was skin irritation. The authors concluded that LESS treatment is a viable alternative to bracing for patients with idiopathic scoliosis.

Dutro and Keene (1985) performed a literature review on surface electrical muscle stimulation in the treatment of progressive adolescent idiopathic scoliosis. Patient selection criteria for studies reviewed were as follows: (i) Cobb angle of 25 to 45 degrees as indicated by radiographic studies, (ii) documented history of progression, (iii) minimum of 50 % correction on forced lateral bending, and (iv) minimum of 1 year of bone growth remaining. The authors concluded that electro-muscular stimulation is equally effective as bracing in treating progressive adolescent idiopathic scoliosis -- progression was arrested in 60 to 84 % of treated curves. For juvenile scoliosis, if treatment begins early enough and progression is not too severe, a curve cannot only be arrested, but reversed. Surface electro-muscular stimulation can also be employed to halt progression while patients await surgery.

The peer reviewed medical literature suggest that surgery is indicated for growing children whose curve has exceeded 40 degrees; for individuals of any age whose curve is greater than 50 degrees; individuals with scoliosis-related pain that is refractory to conservative treatments; and patients with thoracic lordosis that can't be treated conservatively.

Braces are a primary treatment for idiopathic scoliosis. Standard scoliosis braces include the Milwaukee brace and the Boston brace.

Unlike other commonly used scoliosis braces, such as the Boston brace and the Milwaukee brace, the Charleston brace is worn only at night. Clinical studies have been published that have shown that the Charleston brace compares favorably to the traditional Boston and Milwaukee TLSO braces (Trivedi, et al., 2001; Gepstein, et al., 2002; Howard, et al., 1998). The Charleston brace is especially useful for children with scoliosis who are not compliant with a traditional Boston or Milwaukee TLSO brace or who do not respond well to TLSO braces (Roach, 2002).

The Copes Scoliosis Brace is a custom-fitted polypropene support structure that utilizes air to attain spinal curvature correction. This is achieved through the use of strategically placed pneumatic force vector pads that are adjusted every 4 to 6 weeks during treatment. The brace is generally used for 12 to 36 months in conjunction with hydrotherapy, regular muscle strengthening exercises, as well as chiropractic treatments such as osseous manipulation and muscle stimulation therapy. There is no scientific evidence that the Copes Scoliosis Brace is effective in treating scoliosis. Additionally, there are no published data concerning the long-term effectiveness of this device, the rate of recurrence of scoliosis after patients stop wearing the brace or the number of patients who eventually have to undergo surgical intervention. Furthermore, the Copes Scoliosis Brace is used in conjunction with hydrotherapy, regular muscle strengthening exercises and chiropractic treatments. Thus, it is unclear what role the brace actually plays in the improvement, if any, of the condition.

The Providence Scoliosis System is designed to be worn only at night. It includes pressure sensors to ascertain if sufficient pressure is being administered. There is a lack of scientific evidence to support the effectiveness of the Providence Scoliosis System in treating idiopathic scoliosis, including a lack of direct comparative studies with other bracing systems. The only published peer-reviewed study of the Providence Scoliosis System is the report by d'Amato, et al. (2001) of their experience with the first consecutive 102 patients with adolescent idiopathic scoliosis who were followed for two years after completing treatment. This study reported on the experience of a single investigator group, limiting the generalizability of the findings. Other limitations of this study are the lack of an internal comparison group and limited duration of follow-up.

Yrjonen et al (2006) evaluated the results of treatment of adolescent idiopathic scoliosis (AIS) with the Providence night-time brace at 1.8 years after discontinuation of bracing. A total of 36 female patients with an average Cobb angle of 28.4 degrees and an apex below T-10 were studied prospectively. For comparisons, 36 matched patients treated with the Boston full-time brace were studied retrospectively. With the Providence night brace an average of 92 % for brace correction of the primary curve was achieved and during follow-up progression of the curve greater than 5 degrees occurred in 27 % of the patients. In the control group of the Boston full-time brace patients, brace correction was 50 % and the progression of the major curve occurred in 22 % of the patients. The authors concluded that the Providence night brace may be recommended for the treatment of AIS with curves less than 35 degrees in lumbar and thoracolumbar cases. The major drawbacks of this study were its small sample size and its limited duration of follow-up. Its findings need to be validated by randomized controlled trials with large sample size and long-term follow-up.

There is a lack of scientific evidence in the peer-reviewed published medical literature to support the effectiveness of the SpineCor Scoliosis System in treating idiopathic scoliosis, including insufficient data on its long-term effectiveness and a lack of studies directly comparing the dynamic corrective brace with rigid bracing systems.

In a prospective, observational study, Couillard and colleages (2007) assessed the effectiveness of the Dynamic SpineCor brace for adolescent idiopathic scoliosis in accordance with the standardized criteria proposed by the Scoliosis Research Society Committee on bracing and non-operative management. From 1993 to 2006, 493 patients were treated using the SpineCor brace. A total of 249 patients met the criteria for inclusion, and 79 patients were still actively being treated. Overall, 170 patients have a definitive outcome. All girls were pre-menarchal or less than 1 year post-menarchal. Assessment of brace effectiveness included (i) % of patients who have 5 degrees or less curve progression, and % of patients who have 6 degrees or more progression; (ii) % of patients who have been recommended/undergone surgery before skeletal maturity; (iii) % of patients with curves exceeding 45 degrees at maturity (end of treatment); and (iv) 2-year follow-up beyond maturity to determine the % of patients who subsequently underwent surgery. Successful treatment (correction, greater than 5 degrees, or stabilization, +/- 5 degrees) was achieved in 101 (59.4 %) of the 170 patients from the time of the fitting of the SpineCor brace to the point in which it was discontinued. Thirty-nine immature patients (22.9 %) required surgical fusion while receiving treatment. Two (1.2 %) of 170 patients had curves exceeding 45 degrees at maturity. One mature patient (2.1 %) needed surgery within 2 years of follow-up beyond skeletal maturity. The authors concluded that the SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 45 (95.7 %) of 47 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing. The results of this observational study are promising; however the findings need to be validated by future well-designed studies.

Wong and colleagues (2007) stated that the conventional rigid spinal orthosis and the flexible spinal orthosis, SpineCor, have different treatment principles in the management of adolescent idiopathic scoliosis (AIS). These may influence the patients' gait pattern and clinical outcome. In this study, gait analysis on patients with AIS undergoing these two orthotic interventions were conducted. The patients' lower limb kinematic and kinetic data during level walking were collected using a motion analysis system and 2 force platforms in 4-test conditions: pre-intervention, having used the orthosis for 1 month and 1 year (in and out of the orthosis). A total of 21 subjects were randomly assigned to the rigid spinal orthosis group (10 subjects) and the SpineCor group (11 subjects). Neither group showed gait asymmetry when comparing the convex and concave sides in the 4-test conditions. However, significant reduction in the range of motion of the pelvis and hip joints in the coronal plane were found. Although patients with AIS undergoing these two orthotic interventions showed significant changes in walking pattern within the study period, their long-term effect on gait and function requires further investigation through long-term prospective studies.

The Rosenberger brace is a low-profile, custom-molded thoracolumbosacral orthosis (TLSO) that includes design changes from other TLSOs that are intended to improve compliance and, therefore, outcomes. The Rosenberger low profile orthoses is intended to offer better appearance than the Milwaukee orthosis with its neck ring (Gavin, et al., 1986). While the Rosenberger brace was developed in the 1980's, the effectiveness of the brace had never been evaluated in the literature prior to 2004 (Gavin, et al., 1986; Grabowski & Gelb, 2005). At that time, Spoonamore et al (2004) assessed the effectiveness of the Rosenberger brace in preventing curve progression in adolescent idiopathic scoliosis (n = 71). The investigators found the brace to have an overall failure rate similar to that of untreated cases from published natural history studies, although subgroups of patients had lower failure rates. These findings suggested the need for further refinement of the indications for the Rosenberger brace.

Negrini, et al. (2003) performed a systematic review of the literature to verify the effectiveness of physical exercises in the treatment of adolescent idiopathic scoliosis. These investigators carried out a search of different databases, and a hand-search of the non-indexed pertinent literature, and found 11 papers: none of the studies was randomized, 6 were prospective, 7 were controlled, and 2 compared their results to historical controls; 1 paper had both a prospective design and a concurrent control group. The methodological quality of the retrieved studies was reviewed and found to be very poor. With one exception, the published studies demonstrated the effectiveness of physical exercises in reducing both the rate of progression and the magnitude of the Cobb angle at the end of treatment. However, being of poor quality, the literature failed to provide solid evidence for or against the efficacy of physical exercises in the treatment of adolescent idiopathic scoliosis.

Spinal Unloading Devices:

In a pilot study, Chromy and colleagues (2006) evaluated potential benefits of axial spinal unloading (LTX 3000 Lumbar Rehabilitation System) over a 3-month period. A total of 5 adolescent girls with scoliosis were enrolled in the study. Three laboratory sessions: (i) initial baseline, (ii) immediately after 3-month treatment period (axial unloading by using LTX 3000 for two 10-minute treatments daily), and (iii) 1-month post-treatment.  Initial baseline postural data were obtained from 2 sets of radiographs (standing antero-posterior [AP] and lateral, sitting AP and lateral), back range of motion (ROM) measurements, and numeric pain scales. The following were assessed: static postural changes; potential functional benefits; and therapeutic compliance. All subjects elicited reductions in lumbar Cobb angles immediately after 3 months of treatment; initial average scoliotic curves of 13.7 degrees were reduced 42 % to 8 degrees (alpha = 0.05, p = 0.004). Additionally, such reductions were evident 1 month post-treatment; average original curves were reduced by 27 %. Subjects' ROM and lumbar lengthening were not significantly altered by this therapeutic protocol. Reported subject compliance was high (95 %). The authors concluded that the LTX 3000 is a potential adjunct therapy for the treatment of adolescent scoliosis. The findings of the present study need to be validated by randomized controlled trials with large sample size and long-term follow-up.

Vertebral Body Stapling:

Vertebral body stapling (VBS) is an alternative to bracing or spinal fusion for the treatment of progressive scoliosis. It is believed that for patients with progressive moderate scoliosis who are still growing, intervertebral body stapling of the outer (convex) side of the anterior spine (the side of the spine facing the chest) may keep the curve from progressing. With the convex growth plates held in check, continued development of the inner (concave) growth plates should stabilize the progression and may allow correction of deformity as the subject grows. This approach employs a special metal device that is clamp-shaped at body temperature, but can be straightened when subjected to cold temperatures and inserted into the spine. When warmed up, the staple returns to its clamp shape and supports the spine.

Betz and colleagues (2003) reported the feasibility, safety, and utility of VBS without fusion as an alternative treatment for adolescent idiopathic scoliosis. These researchers retrospectively reviewed 21 patients (27 curves) with adolescent idiopathic scoliosis treated with VBS. Patients were immature as defined by Risser sign less than or equal to 2. The procedure was safe, with no major complications and three minor complications. One patient had an intra-operative segmental vein bleed resulting in an increased estimated blood loss of 1500 ml as compared to the average estimated blood loss of 247 ml for all patients. One patient had a chylothorax and one pancreatitis. No patient has had a staple dislodge or move during the follow-up period (mean 11 months, range of 3 to 36 months), and no adverse effects specifically from the staples have been identified. Utility (defined as curve stability) was evaluated in 10 patients with stapling with greater than 1-year follow-up (mean of 22.6 months) and pre-operative curve less than 50 degrees. Progression of greater than or equal to 6 degrees or beyond 50 degrees was considered a failure of treatment. Of these 10 patients, 6 (60 %) remained stable or improved and 4 (40 %) progressed. One of 10 (10 %) in the stapling group had progressed beyond 50 degrees and went on to fusion. Six patients required stapling of a second curve, three as part of the primary surgery, and three as a second stage, because a second untreated curve progressed. The results need to be considered with caution, as the follow-up was short. The authors concluded that the data showed that VBS for the treatment of scoliosis in the adolescent was feasible and safe in this group of 21 patients. In the short-term, stapling appears to have utility in stabilizing curves of progressive adolescent idiopathic scoliosis.

Betz et al (2005) reported the findings of 39 consecutive patients who have had VBS of 52 curves (26 patients with one curve stapled and 13 patients with two curves). For patients who were 8 years or older with less than 50 degrees pre-operative curve and a minimum 1-year follow-up, coronal curve stability was 87 % when defined by progression less than or equal to 10 degrees. Fusion was necessary in 2 patients. No curves less than 30 degrees at the time of stapling progressed greater than or equal to 10 degrees. Major complications occurred in 1 patient (2.6 %, diaphragmatic hernia) and minor complications occurred in 5 patients (13 %). The authors concluded that further follow-up of treated patients and more research into effectiveness and indications are needed.

Cunningham et al (2005) noted that standard interventions for adolescents and adults, including spinal deformity correction and fusion, may not be appropriate for young patients with considerable growth remaining. Alternative surgical options that provide deformity correction and protect the growth remaining in the spine are needed to treat this population of patients. Several groups have reported advances in the field of deformity spine surgery. Updated findings concerning the successful implementation of growing rods have revived this technique as a viable option for preserving near normal growth of the spine. New techniques have also been recently described, including vertebral stapling that produces asymmetric and corrective growth of the concavity of a deformity, and vertical expandable prosthetic titanium rib instrumentation that indirectly corrects spine deformity and protects spine growth remaining to treat an associated thoracic insufficiency syndrome. The authors concluded that new techniques and instrumentation allow the treatment of this challenging patient population to approach the goals of deformity correction and maintenance with preservation of potential growth. Preliminary outcomes from the different techniques are promising, but further investigation, including long-term follow-up, is needed.

In an assessment of VBS for the treatment of idiopathic scoliosis, the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (2005) concluded that limited evidence exists on the safety and effectiveness of VBS. Current evidence of this procedure is limited to small patient numbers and short-term follow-up. Furthermore, long-term safety and effectiveness data from prospective, randomized controlled studies will be needed before VBS can be widely accepted.

Guille et al (2007) stated that the recent investigations of convex anterior VBS have offered promising early results with use of improved implants and techniques. The use of a shape memory alloy staple tailored to the size of the vertebral body, the application of several staples per level, the instrumentation of the Cobb levels of all curves, and the employment of minimally invasive thoracoscopic approaches all offer substantial improvements over previous fusionless techniques. Patient selection may also play a role in the current success of these fusionless treatments, with perhaps the ideal candidates for this intervention possessing smaller and more flexible curves. However, the authors stated that long-term results of the effects on the instrumented motion segments and adjacent spine are not yet available.