Coverage Policy Manual
Policy #: 2010037
Category: Medicine
Initiated: August 2017
Last Review: August 2018
  Interventions for Progressive Scoliosis

Description:
Orthotic bracing attempts to slow curve progression and reduce the need for fusion surgery in patients with progressive scoliosis. Recently, fusionless surgical procedures (e.g., vertebral body stapling and implantation of vertical titanium growing rods) have been evaluated as alternatives to bracing to slow or correct curve progression in pediatric patients with scoliosis.
 
Scoliosis is an abnormal lateral and rotational curvature of the vertebral column. Treatment of scoliosis currently depends on 3 factors: the cause of the condition (idiopathic, congenital, or secondary), the severity of the condition (degrees of curve), and the growth of the patient remaining at the time of presentation. Children who have vertebral curves measuring between 25 and 40 degrees with at least 2 years of growth remaining are considered to be at high-risk of curve progression. Genetic markers to evaluate risk of progression are also being evaluated. Since severe deformity may lead to compromised respiratory function and is associated with back pain in adulthood, surgical intervention with spinal fusion is typically recommended for curves that progress to 45 degrees or more.
 
Bracing is used in an attempt to reduce the need for spinal fusion by slowing or preventing further progression of the curve during rapid growth. Commonly used brace designs include the Milwaukee, Wilmington, Boston, Charleston, and Providence orthoses. The longest clinical experience is with the Milwaukee cervical-thoracic-lumbar-sacral orthosis (CTLSO). Thoracic-lumbar-sacral orthoses (TLSO), such as the Wilmington and Boston braces, are intended to improve tolerability and compliance for extended (more than 18-hour) wear and are composed of lighter-weight plastics with a low-profile (underarm) design. The design of the nighttime Charleston and Providence braces is based on the theory that increased corrective forces will reduce the needed wear time (i.e., daytime), thereby lessening social anxiety and improving compliance. Braces that are more flexible than TLSOs or nighttime braces, such as the SpineCor, are also being evaluated. The SpineCor is composed of a thermoplastic pelvic base with stabilizing and corrective bands across the upper body.
 
Fusionless surgical procedures, such as vertebral body stapling, are being evaluated as an alternative to bracing. It is hoped that fusionless procedures improve the curve as well as prevent its progression, maintain spine mobility following correction, and provide an effective treatment option for patients who are non-compliant or refuse to wear a brace. In the current stapling procedure, nickel-titanium alloy staples with shape memory are applied to the convex (outer) side of the curve. The shape memory allows the prongs to be straight when cooled and clamp down into the bone when the staple returns to body temperature. The goal of vertebral stapling is to unilaterally reduce the rate of spine growth, thus allowing the other side to “catch up”. The memory shape staple was tested in a goat model of scoliosis for safety and efficacy prior to its use in humans. The vertical expandable prosthetic titanium rib (VEPTR), described in more detail in policy number 1998140, is also being explored for treatment of infantile and juvenile scoliosis that has advanced beyond 45 degrees. Use of the VEPTR requires expansion surgery every 4-6 months as growth occurs and may be replaced as needed.
 
Regulatory Status
Some of the braces used for the treatment of scoliosis are considered Class I devices by the U.S. Food and Drug Administration (FDA). Examples include the Boston scoliosis brace and the SpineCor Scoliosis System.
 
Staples, using a shape memory nickel-titanium alloy, have 510(k) clearance from the FDA for a variety of indications for bone fixation. For example, Nitinol staples (Sofamor Danek, Memphis Tenn.) are indicated for fixation with spinal systems. Other memory shape staples that have 510(k) clearance for bone fixation include the OSStaple™ and the reVERTO™. Vertebral body stapling in scoliosis is considered off-label use.
 
A VEPTR has received approval from the FDA under a humanitarian device exemption (HDE). The FDA review noted that the device is indicated for the treatment of thoracic insufficiency syndrome (TIS) in skeletally immature patients. This review also indicated that the device should not be used in patients younger than 6 months.
 
Coding
There is no specific CPT code for the the insertion of vertebral body staples.  The procedure would most likely be reported with the unlisted code 22899.
 

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
A cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of scoliosis in juvenile and adolescent patients at high-risk of progression which meets the following criteria:
 
    • Idiopathic spinal curve angle between 25 and 40 degrees; AND
    • Spinal growth has not been completed (Risser grade 0-3; no more than 1 year post-menarche in females)
OR
    • Idiopathic spinal curve angle greater than 20 degrees; AND
    • There is documented increase in the curve angle; AND
    • At least 2 years growth remain (Risser grade 0 or 1; pre-menarche in females)
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Use of an orthosis for the treatment of scoliosis not meeting the above criteria does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, use of an orthosis for the treatment of scoliosis that does not meet the criteria above is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Vertebral body stapling and vertebral body tethering for the treatment of scoliosis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, vertebral body stapling and vertebral body tethering for the treatment of scoliosis is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 

Rationale:
The Scoliosis Research Society (SRS) Committee on Bracing and Nonoperative Management provided evidence-based recommendations in 2005 for bracing studies to facilitate comparison of brace trials (Richards, 2005). The first study to use the SRS criteria concluded that a brace should prevent progression in 70% of patients to be considered effective (Janicki, 2007). The SRS evidence review and recommendations may also aid in the evaluation of fusionless surgical treatments for scoliosis progression in children.
 
The SRS review of the natural history of scoliosis indicates that skeletally immature patients and patients with larger curves (between 20 and 29 degrees) are significantly more likely to have more than 5 degrees curve progression (Richards, 2005). Success from brace treatment is most frequently defined as progression of less than 5 degrees before skeletal maturity, although alternative definitions in the literature may include progression of less than 10 degrees before skeletal maturity or preventing the curve from reaching the threshold for surgical intervention. Surgery is usually recommended when the curve magnitude exceeds 45–50 degrees (before or at skeletal maturity), although many patients will not undergo surgery at this point. Based on this information, the SRS provided the following recommendations for brace studies on adolescent idiopathic scoliosis (AIS):
 
· Optimal inclusion criteria for AIS are patients 10 years or older, Risser sign 0 to 2, initial curve magnitude of 25 to 40 degrees, and no prior treatment at the initiation of brace treatment. (Risser sign is defined by the amount of calcification present in the iliac apophysis and measures remaining spinal growth by progressive anterolateral to posteromedial ossification. Immature patients will have 0% to 25% ossification [Risser grade 0 or 1], while 100% ossification [Risser grade 5] indicates maturity with no spinal growth remaining. Children may progress from a Risser grade 1 to grade 5 over a brief, e.g., 2-year, period.)
· Assessment of brace effectiveness should include the percentage of patients with less than 5 or greater than 6 degrees of progression at maturity, curves exceeding 45 degrees at maturity, and progression resulting in surgery or the recommendation for surgery.
· Intent-to-treat analysis should be performed, regardless of compliance. Efficacy analysis should also be considered, in which noncompliant patients are excluded in the analysis.
· A minimum of 2 years follow-up beyond skeletal maturity should be obtained for each patient who was “successfully” treated with a brace. Skeletal maturity is considered achieved when less than 1 cm change in standing height has occurred on measurements made on 2 consecutive visits 6 months apart, when Risser 4 is present, or in females, when the patient is 2 years post-menarche.
 
Bracing
 
Dolan and Weinstein published a systematic review of observation and bracing in AIS in 2007 (Dolan, 2007).  Selection criteria for inclusion were: study of patients with AIS (diagnosed at or after the age of 8 years), who met the following indications for brace initiation (primary angle between 20 and 45 degrees, age younger than 15 years, Risser 0 to 2) and had follow-up to at least skeletal maturity. Fifteen studies of bracing alone were included in the analysis, with a range for surgery of 1% to 43% and a pooled rate of 23%. Three studies were included for observation alone, with a pooled rate of 22% for surgery and a range of 13% to 38%. Both the study population (school screening program) and indications for surgery were unusual in the observational studies. This meta-analysis is limited by the heterogeneity of the study results and illustrates the difficulty in evaluating bracing efficacy when study populations include patients that would not progress without a brace. The authors considered their recommendation (no clear advantage of bracing) to have a grade of D, due to “troublingly inconsistent or inconclusive studies of any level.”
 
Using the new SRS criteria, Janicki and colleagues reported outcomes from a database of patients with AIS who had used a TLSO or a nighttime orthosis (Janicki, 2007).  Retrospective analysis identified 160 patients treated orthotically for idiopathic scoliosis between 1992 and 2004. Patients with incomplete follow-up were phoned and asked to return if needed. From the cohort of 160 patients, 83 met the SRS inclusion criteria and had complete data. Due to poor outcomes with the TLSO, which the investigators suspected were predominantly due to a lack of compliance, practice had been changed from using a TLSO to recommending a nighttime orthosis. Thus, the 48 patients treated with a TLSO and 35 treated with a nighttime orthosis were not concurrent. For patients with an initial curve between 25-40 degrees and treated with a TLSO, 85% progressed to greater than 5 degrees, 56% progressed to greater than 45 degrees, and 79% progressed to surgery. With the nighttime orthosis, 69% progressed to greater than 5 degrees, 45% progressed to greater than 45 degrees, and 60% progressed to surgery. Thus, only 21% in the TLSO group and 40% in the nighttime orthosis group were considered to have had successful orthotic management. Subgroup analysis showed little benefit of either brace type in patients with an initial curve between 36 and 40 degrees, with 86% of the TLSO group and 91% of the nighttime orthosis group progressing to surgery.
 
Higher quality evidence on bracing is expected from a NIH-sponsored multicenter randomized trial of bracing in patients with adolescent idiopathic scoliosis (BrAIST) versus watchful waiting (ClinicalTrials.gov; NCT00448448). Enrollment criteria include: skeletally immature (Risser grade 0 – 2); pre-menarchal or post-menarchal by no more than 1 year; primary angle between 20 and 40 degrees; curve apex caudal to T7; and no previous surgical or orthotic treatment for AIS. Participation in the study will last until a participant reaches skeletal maturity or his or her spinal curve progresses to 50 degrees, after which usual care will continue. The trial began in 2007 with an estimated enrollment of 500 patients; completion of the trial is expected in 2010.
 
Vertebral Body Stapling
 
A search of the MEDLINE database in 2010 identified a total of 3 publications on vertebral stapling; all from Betz and colleagues (Betz, 2003) (Betz, 2005) (Betz, 2010).  The most recent (2010) publication reported on 29 patients with juvenile or adolescent idiopathic scoliosis who met the study inclusion criteria (out of a database of 93 patients). The reasons for excluding 69% of the patients from the database were not specifically described but included a change in the type of staple in 2002. Included in the report were patients with idiopathic scoliosis, a coronal curve magnitude of 20 to 45 degrees, Risser 0 or 1, staples with tines proportional to staple size (beginning in 2002), and a minimum 2-year follow-up. One patient from the series was lost to follow-up after 1 year, leaving 28 patients (96%) in the analysis. The average age at the time of stapling was 9.4 years (range, 4 to 13 years), with an average follow-up of 3.2 years (range 2 - 5.3 years). Only the thoracic curve was stapled in 13 patients, both thoracic and lumbar curves were stapled in 13 patients, and only the lumbar curve was stapled in 2 patients. For thoracic curves greater than 35 degrees at baseline, 75% progressed to greater than 50 degrees (threshold for recommending spinal fusion). The authors now use additional treatments such as growing rods or nighttime braces for curves that are greater than 35 degrees at baseline or that cannot be corrected to less than 20 degrees on first standing radiograph. For thoracic curves less than 35 degrees at baseline, 6% of patients progressed to greater than 50 degrees (threshold for surgery), 22% progressed between 5 and 50 degrees, and 78% had no change. Notably, 8 curves in 7 patients improved from baseline, and one curve in a 6-year-old (25 degrees) reversed direction, leading the authors to recommend waiting until the child is 8 years old or until the curve has exceeded 30 degrees in a younger child. Betz et al. concluded that the results should be considered preliminary, as follow-up to skeletal maturity will be needed for definitive results. Additional studies from other centers are also needed.
 
Summary
 
Bracing has been considered the only available option to prevent curve progression in juvenile or adolescent idiopathic scoliosis, although efficacy has not been consistently demonstrated when compared with watchful waiting. The inconclusive evidence may be due, in part, to lack of compliance in this population as well as variability in inclusion criteria and definitions of success in case series. The quality of evidence on bracing is expected to be improved with a new randomized controlled trial on bracing versus watchful waiting. Based on the currently available evidence of efficacy in some patients, lack of alternative treatment options, professional society recommendations, and potential to prevent the need for a more invasive procedure, bracing may be considered medically necessary for the treatment of scoliosis in patients with high-risk of curve progression. Curves have a high-risk of progression when they measure 25 degrees or more and spinal growth has not been completed, or when a 20-degree- curve is progressively worsening and at least 2 years of growth remain.
 
Over the past decade, investigators have been evaluating use of memory shape staples for preventing curve progression in juvenile and adolescent scoliosis. The most recent paper on vertebral stapling suggests that for many patients with curves between 20 and 35 degrees, vertebral stapling may maintain or even improve the curve, thus reducing the rate of subsequent spinal fusion and providing a potential option for the treatment of idiopathic scoliosis. The evidence to date, which consists of only 3 publications with limited follow-up from a single center that developed the technique, is insufficient to permit conclusions concerning the effect of this procedure on health outcomes. Additional studies from other centers, with a larger number of total subjects and longer follow-up, are needed to evaluate the safety and efficacy of this surgical procedure.
 
Technology Assessments, Guidelines, and Position Statements
The Scoliosis Research Society (SRS) stated in 2010 that the treatment of adolescent idiopathic scoliosis falls into three main categories (observation, bracing, and surgery) and is based on the risk of curve progression.  In general, AIS curves progress in two ways: first, during the rapid growth period of the patient, and second, into adulthood if the curves are relatively large. Since scoliosis gets larger during rapid growth, the potential for growth is evaluated taking into consideration the patient's age, the status of whether females have had their first menstrual period, as well as radiographic parameters. The Risser grading system rates a child's' skeletal maturity on a scale of 0 to 5. Patients who are Risser 0 and 1 are growing rapidly, while patients who are 4 and 5 have stopped growing.
 
· Observation is generally for patients whose curves are less than 25 degrees who are still growing, or for curves less than 50 degrees in patients who have completed their growth.
· Bracing is for patients with curves that measure between 25 and 40 degrees during their growth phase. The goal of the brace is to prevent the curve from getting bigger.
· Surgical treatment is used for patients whose curves are greater than 45 degrees while still growing or greater than 50 degrees when growth has stopped. The goal of surgical treatment is two-fold: First, to prevent curve progression and, secondly, to obtain some curve correction. Implants are used to correct the spine and hold the spine in the corrected position until the spine segments which have been operated on are fused as one bone.
· Alternative treatments to prevent curve progression or prevent further curve progression, such as chiropractic medicine, physical therapy, yoga, etc., have not demonstrated any scientific value in the treatment of scoliosis.
Information updated in 2010 from the American Academy of Orthopaedic Surgeons (AAOS) indicates that the type of treatment required for idiopathic scoliosis in children and adolescents depends on the kind and degree of the curve, the child's age, and the number of remaining growth years until the child reaches skeletal maturity.
· Observation is appropriate when the curve is mild (less than 20 degrees) or if the child is near skeletal maturity.
· The goal of bracing is to prevent scoliotic curves from worsening. Bracing can be effective if the child is still growing and has a spinal curvature between 25 and 45 degrees. There are several types of braces, most being the underarm type.
· Surgery may be recommended if the curve is more than 45 degrees and the child are still growing. If the patient has reached skeletal maturity, surgery may still be recommended for scoliotic curves that exceed 50 to 55 degrees. An implant made up of rods, hooks, screws, and/or wires is used to straighten the spine. Bone graft from the bone bank, or from the patient's hip region, is also used to help the operated portion of the spine heal solid.
· At present, the main research focus in idiopathic scoliosis is investigation into genetic factors as a cause of scoliosis.
 
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) in 2008 indicates that many children who are sent to the doctor by a school scoliosis screening program have very mild spinal curves that do not need treatment. When treatment is needed, an orthopedic spine specialist will suggest the best treatment for each patient based on the patient's age, how much more he or she is likely to grow, the degree and pattern of the curve, and the type of scoliosis.
 
· Observation may be advised for idiopathic curve of less than 25 degrees; with follow-up every 4 to 6 months when the patient is still growing (is skeletally immature).
· Bracing is advised to stop a curve from worsening when the patient:
· is still growing and has an idiopathic curve that is more than 25 to 30 degrees
· has at least 2 years of growth remaining, has an idiopathic curve that is between 20 and 29 degrees, and, if a girl, has not had her first menstrual period
· is still growing and has an idiopathic curve between 20 and 29 degrees that is getting worse.
· Surgery may be advised to correct a curve or stop it from worsening when the patient is still growing, has a curve that is more than 45 degrees, and has a curve that is worsening.
 
NIAMS also stated that studies of the following treatments have not demonstrated prevention of curve progression or worsening:
 
· Chiropractic manipulation
· Electrical stimulation
· Nutritional supplementation
· Exercise
 
2012 Update
A search of the MEDLINE database through September 2012 did not reveal any new literature that would prompt a change in the coverage statement. One ongoing trial was identified on the clinicaltrials.gov website. NCT00448448 is a National Institutes of Health (NIH)-sponsored multicenter randomized trial of bracing in patients with adolescent idiopathic scoliosis (BrAIST) versus watchful waiting. Enrollment criteria include: skeletally immature (Risser grade 0 to 2); pre-menarchal or post-menarchal by no more than 1 year; primary angle between 20 and 40 degrees; curve apex caudal to T7; and no previous surgical or orthotic treatment for AIS. Participation in the study will last until a participant reaches skeletal maturity or his or her spinal curve progresses to 50 degrees, after which usual care will continue. The trial began in 2007 with an estimated enrollment of 500 patients; completion of the trial is expected in 2012.
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
Lou et al. published a pilot study that compared the smart brace with a standard rigid brace in 12 patients with scoliosis (Lou, 2912). Compliance with the microcomputer-controlled brace in the first year of bracing (2 years of total bracing) was similar in the 2 groups. The smart brace was associated with greater pad pressure and improved outcomes. None of the patients in the smart brace group had a significant change in their curves (a Cobb angle change of less than 5 degrees), whereas 2 of 6 patients in the standard TLSO group had a significant change in Cobb angle (7 and 20 degrees) over the 3 years of the study.
 
Plewka et al. reported the efficacy of the SpineCor brace (n=45) compared with physiotherapy and observation (n=45) in children with scoliosis (Plewka, 2013). The control group comprised children who qualified for brace treatment but whose parents did not agree to treatment or in whom the treatment was not possible due to social reasons. Baseline measures of the 2 groups were similar. After 2 years of treatment, the patients treated with the SpineCor brace showed significant improvements in clinical parameters. There was no significant difference in measurements between baseline and follow-up in control patients. Changes in Cobb angle over the course of the study were not reported.
 
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) in 2012 indicates that many children who are sent to the doctor by a school scoliosis screening program have very mild spinal curves that do not need treatment (NIAMS, 2012). When treatment is needed, an orthopedic spine specialist will suggest the best treatment for each patient based on the patient's age, how much more he or she is likely to grow, the degree and pattern of the curve, and the type of scoliosis.
 
  • Observation may be advised if the patient is still growing (is skeletally immature) and the curve is mild.
  • Doctors may advise patients to wear a brace to stop a curve from getting any worse in patients who are still growing with moderate spinal curvature. As a child nears the end of growth, the indications for bracing will depend on how the curve affects the child’s appearance, whether the curve is getting worse, and the size of the curve.
  • Surgery may be advised to correct a curve or stop it from worsening when the patient is still growing, has a curve that is more than 45 degrees, and has a curve that is worsening.
 
2014 Update
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2013, Weinstein et al reported results from the National Institutes of Health (NIH) -sponsored multicenter Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST, NCT00448448) that compared bracing versus watchful waiting (Weinstein, 2013). Patients were enrolled who met current criteria for bracing: skeletally immature (Risser grade 0 to 2); pre-menarchal or post-menarchal by no more than 1 year; primary angle between 20 and 40 degrees; curve apex caudal to T7, as well as no previous surgical or orthotic treatment for AIS. Due to difficulty recruiting into the randomized trial, the final study included both a randomized (n=116) and a preference cohort (n=126). The primary outcomes were curve progression to 50 degrees or more (treatment failure) or skeletal maturity without this degree of progression (treatment success). The trial began in 2007 with an estimated 500 patients but was stopped early by the data safety and monitoring board due to the efficacy of bracing found in interim analysis. The rate of treatment success was 72% after bracing compared with 48% after observation, with a propensity-score-adjusted odds ratio for treatment success of 1.93. Intent-to-treat analysis of the randomized cohort showed that the number needed to treat in order to prevent one case of curve progression warranting surgery was 3.0. Hours of brace wear, measured with a temperature sensor embedded in the brace, was significantly correlated with the rate of treatment success. The effectiveness of brace wear of less than 6 hours per day was similar to observation (41%), while success rates of 90 to 93% were found in patients who wore a brace for at least 12.9 hours per day.
 
Wong and colleagues reported a prospective study of clinical efficacy and acceptance of rigid or flexible spinal bracing in 43 patients with moderate adolescent scoliosis in 2008. Follow-up to a mean of 45.1 months after skeletal maturity was reported in 2013 (Guo, 2013). Follow-up for a mean of 45 months (range, 24 to 77 months) after the brace was worn showed a rate of progression of 1.5 degrees per year post-maturity, with no additional patients proceeding to surgery.
 
Plewka et al. reported the efficacy of the SpineCor brace (n=45) compared with physiotherapy and observation (n=45) in children and adolescents with scoliosis (Plewka, 2013). Stabilization or improvement of the angle was observed in 78% of the SpineCor treated patients (45% stabilized and 33% improved) compared with 53% of the control group (53% stabilized, none improved). Compliance with brace wear was good, with 95% of the patients reporting regular brace wear.
 
A 2013 report from this group described vertebral body stapling in 12 children younger than 10 years old (range, 6.3 to 9.7 years) who were considered extremely likely to require fusion (ie, curves of 30 to 39 degrees in a young child) (Theologis, 2013). At an average 3.4 year follow-up (range, 2.2 to 5.4 years) curves had decreased by a mean of 10 degrees (range, -3 to 20 degrees). All of the curves in this high risk population were successfully treated with either no change (within 10 degrees) or improvement in the curve (greater than 10 degrees). Complications can include broken staples, staple dislodgement, curve overcorrection, congenital diaphragmatic hernia rupture, contralateral pleural effusion, pneumothoraces, and superior mesenteric artery syndrome.
 
In 2012, a separate group of investigators reported a retrospective review of 7 children aged 8 to 11 years who had undergone vertebral body stapling and had at least 2 years of follow-up (Laituri, 2012). All of the children had either curve progression despite bracing or were unable to wear a brace. Prior to stapling the mean angle was 34.1 degrees (range, 25 to 41 degrees). At an average follow-up of 34 months (range, 29 to 44 months) the mean angle was 24.7 degrees (range, 15 to 38 degrees). The curves of 5 children improved more than 10 degrees and 2 children had no change in the postoperative angle (less than 10 degrees). The mean percentage correction was 36% (range, 16.2% to 56% correction). None of the children had curve progression or required postoperative bracing or spinal fusion.
 
NCT01661959 – The Adolescent Idiopathic Scoliosis Outcomes Database Registry will assess the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. The study will also assess the long-term outcomes of non-operative idiopathic scoliosis. The study began in 2005 and has an estimated enrollment of over 4,000 patients. Patients will be followed for 25 years. The registry is sponsored by the Setting Scoliosis Straight Foundation.
 
The USPSTF The U.S. Preventive Services Task Force (USPSTF) published recommendations for idiopathic scoliosis screening in 2004 (USPSTF, 2004). The USPSTF recommends against the routine screening of asymptomatic adolescents for idiopathic scoliosis. Grade: D Recommendation.
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
O’Leary and colleagues reported results of vertebral stapling in 11 children (O’Leary, 2011). Diagnoses included myelodysplasia, congenital scoliosis, juvenile and infantile idiopathic scoliosis, Marfan syndrome, paralytic scoliosis, and neuromuscular scoliosis. Patients with idiopathic adolescent scoliosis were not included in this report. The average age at surgery was 6 years, and pre-operative curves averaged 68º. At an average 22 month follow-up, curves averaged 69º, and 8 of 11 patients had undergone or were scheduled to undergo further spinal surgery for curve progression. It is unknown if the young age at surgery, the severe pre-operative curve, or the nature of the underlying scoliosis contributed to the high failure rate.
 
Vertebral Body Tethering
In 2014, Samdani and colleagues published 2 retrospective reviews on the off-label use of the Zimmer Dynesys for anterior vertebral body tethering for idiopathic scoliosis (Samdani, 2014a; Samdani, 2014b). The authors reported that they pursued vertebral body tethering at their institution due to lack of success with vertebral body stapling for thoracic curves greater than 35􀁱. At the time of these reports, 32 patients had a minimum of 1-year follow-up (Samdani, 2014a) and 11 consecutive patients had 2-year follow-up (Samdani, 2014b). The mean age at surgery was 12 years, and all patients were skeletally immature. Three patients also had vertebral body stapling of their lumbar curves. For the 11 patients with 2-year follow-up, an average of 7.8 levels (range, 7 to 9) were tethered. Thoracic Cobb angle averaged 44.3􀁱 pre-operatively, was corrected to 20.3º degrees after surgery, and improved to 13.5º at 2 years. The lumbar curve improved from 25.1º pre-operatively to 7.2􀁱 at 2 years. Two patients required that tension be reduced after 2 years due to over-correction.
 
Ongoing and Unpublished Clinical Trials
Ongoing
 
NCT01610908 - A Multicenter Randomized Cntrolled Trial to Compare the Effect of Schroth Exercises to Standard Care on Curve Characteristics, Posture, and quality of Lift in Adolescents with Idiopathic Scoliosis; planned enrollment of 258; projected completion date January 2017.
 
NCT01465295 an industry sponsored or co-sponsored trial; Prospective Trial to Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis; planned enrollment 6; projected completion date December 2017.
 
There is a small body of published evidence on surgical interventions for preventing curve progression in juvenile and adolescent scoliosis. Vertebral stapling with memory shape staples has been investigated for patients with curves between 20º and 35º. The evidence to date, which consists of 6 publications with limited follow-up from a single center that developed the technique, and 2 small case series from other institutions, is insufficient to conclude that vertebral stapling maintains or improves the curve, or that stapling reduces the rate of subsequent spinal fusion. Vertebral body tethering, which was developed by the same investigators as the vertebral stapling technique, has been evaluated for thoracic curves greater than 35º. There is very limited evidence to date on this technique, with case series reporting 1-year follow-up in 32 patients and 2-year follow-up in 11 patients. Additional studies from other centers, with a larger number of total subjects and longer follow-up, are needed to evaluate the safety and efficacy of these surgical procedures.
 
The Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) and Scoliosis
Research Society (SRS) In 2015, the Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) and the SRS non-operative management committee (SRS-NOC) published consensus-based recommendations for non-operative research studies on treatment of idiopathic scoliosis (Negrini, 2015).  Eighteen recommendations were developed using the Delphi method. These recommendations addressed research needs, clinically significant outcomes, radiographic outcomes, other key outcomes (quality of life, adherence to treatment), and standardization of methods of non-operative research.
 
SOSRT
2011 SOSORT guidelines include the following interventions for scoliosis (Negrini, 2012).  Observation,
Physiotherapeutic Specific Exercises (PDE), Special Inpatient Rehabilitation (SIR), Bracing: (Night Time
Rigid Bracing, Soft Bracing, Part Time Rigid Bracing, Full Time Bracing). SOSORT states that the likelihood that a curve will progress depends on a number of factors, including age at diagnosis, type and severity of curve, sex and skeletal maturity. Approximately 25% to 75% of curves found at screening may remain unchanged, and 3% to 12% of curves may improve. Treatment decisions should be individualized based on the probability of progression, curve magnitude, skeletal maturity, and patient age and sexual maturity.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
CONVENTIONAL RIGID BRACES
Aulisa et al investigated whether scoliotic curve correction was maintained long-term in patients with AIS who were treated with the rigid brace (Aulisa, 2017). From a database of patients treated with a rigid brace, 93 patients who had completed treatment at least 10 years prior agreed to participate and underwent a follow-up examination. Participants had a mean age of 32.6 years and had been treated with the brace for a mean 5.3 years. Mean follow-up was 15 years posttreatment. The mean pre-brace Cobb angle was 32°, which was reduced to 19° following brace removal. At short-term follow-up (5 years), the mean Cobb angle was 21°; at long-term follow-up, the angle had increased to 22°. The change in Cobb angle from brace removal to long-term follow-up was not statistically significant. Subgroup analyses on patients with pre-brace Cobb angles of 30° or less compared with pre-brace Cobb angles greater than 30°, showed no significant difference in angle increase at long-term follow-up.
 
PRACTICE GUIDELINES AND POSITION STATEMENTS
 
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
The U.S. Preventive Services Task Force (USPSTF) has published recommendations for idiopathic scoliosis screening. In 2004, USPSTF recommended against the routine screening of asymptomatic adolescents for idiopathic scoliosis (grade D recommendation). In 2018, USPSTF updated their recommendation to state that there is insufficient evidence to assess screening of adolescents for idiopathic scoliosis (grade I recommendation) (USPSTF, 2018). Review conclusions for scoliosis treatments are listed below:
 
“The USPSTF found inadequate evidence on treatment with exercise and surgery. It found adequate evidence that treatment with bracing may slow curvature progression in adolescents with mild or moderate curvature severity (Cobb angle <40° to 50°); however, evidence on the association between reduction in spinal curvature in adolescence and long-term health outcomes in adulthood is inadequate. The USPSTF found inadequate evidence on the harms of treatment.”

CPT/HCPCS:
22899Unlisted procedure, spine
L1000Cervical-thoracic-lumbar-sacral orthotic (CTLSO) (Milwaukee), inclusive of furnishing initial orthotic, including model
L1001Cervical-thoracic-lumbar-sacral orthotic (CTLSO), immobilizer, infant size, prefabricated, includes fitting and adjustment
L1005Tension based scoliosis orthotic and accessory pads, includes fitting and adjustment
L1010Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, axilla sling
L1020Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, kyphosis pad
L1025Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, kyphosis pad, floating
L1030Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, lumbar bolster pad
L1040Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, lumbar or lumbar rib pad
L1050Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, sternal pad
L1060Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, thoracic pad
L1070Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, trapezius sling
L1080Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, outrigger
L1085Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, outrigger, bilateral with vertical extensions
L1090Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, lumbar sling
L1100Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, ring flange, plastic or leather
L1110Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO) or scoliosis orthotic, ring flange, plastic or leather, molded to patient model
L1120Addition to cervical-thoracic-lumbar-sacral orthotic (CTLSO), scoliosis orthotic, cover for upright, each
L1200Thoracic-lumbar-sacral orthotic (TLSO), inclusive of furnishing initial orthotic only
L1210Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), lateral thoracic extension
L1220Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), anterior thoracic extension
L1230Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), Milwaukee type superstructure
L1240Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), lumbar derotation pad
L1250Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), anterior ASIS pad
L1260Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), anterior thoracic derotation pad
L1270Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), abdominal pad
L1280Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), rib gusset (elastic), each
L1290Addition to thoracic-lumbar-sacral orthotic (TLSO), (low profile), lateral trochanteric pad
L1300Other scoliosis procedure, body jacket molded to patient model
L1310Other scoliosis procedure, postoperative body jacket
L1499Spinal orthotic, not otherwise specified

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