POLICY NUMBER

A.2.01.83

DESCRIPTION

Orthotic bracing attempts to slow spinal curve progression and reduce the need for fusion surgery in individuals with juvenile or adolescent idiopathic scoliosis who are at high-risk of progression. Vertebral body stapling and vertebral body tethering, both fusionless surgical procedures, have been evaluated to determine whether the procedures could be used as alternatives to traditional orthotic bracing. This policy does not address individuals who are not at high-risk of progression or conventional fusion surgery for scoliosis, such as individuals with Cobb angles measuring 45° or more.

Scoliosis

Scoliosis is an abnormal lateral and rotational curvature of the vertebral column. Adolescent idiopathic scoliosis is the most common form of idiopathic scoliosis, defined by the U.S. Preventive Services Task Force as “a lateral curvature of the spine with onset at ≥10 years of age, no underlying etiology, and risk for progression during puberty.” Progression of the curvature during periods of rapid growth can result in deformity, accompanied by cardiopulmonary complications. Diagnosis is made clinically and radiographically. The curve is measured by the Cobb angle, which is the angle formed between intersecting lines drawn perpendicular to the top of the vertebrae of the curve and the bottom vertebrae of the curve. Patients with adolescent idiopathic scoliosis are also assessed for skeletal maturity, using the Risser sign, which describes the level of ossification of the iliac apophysis.

The Risser sign measures remaining spinal growth by progressive anterolateral to posteromedial ossification. Risser sign ranges from 0 (no ossification) to 5 (full bony fusion of the apophysis). 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 (eg, 2-year) period.

Males and females are equally affected by scoliosis, but curve progression is up to 10 times more common in females than males. Patients who are overweight or obese have a greater risk of presenting with larger Cobb angles and more advanced skeletal maturity, possibly due to delayed detection. A retrospective review of 341 patients with adolescent idiopathic scoliosis who underwent surgery at a single tertiary pediatric hospital between 2013 and 2018 found that the major curve magnitude at presentation was significantly higher in patients with public compared to private insurance (50.0° versus 45.1°; p=.0040 and in Black compared to White patients (51.8° versus 47.0°; p=.042). Additionally, the odds of having an initial major curve magnitude <40° within the range of nonoperative treatment were 67% lower among Black patients with public insurance compared to Black patients with private insurance (odds ratio [OR], 0.33; 95% CI, 0.13 to 0.83; p=.019).

Treatment

Treatment of scoliosis currently depends on 3 factors: the cause of the condition (idiopathic, congenital, or secondary), the severity of the condition (degrees of the curve), and the growth of the patient remaining at the time of presentation. Children who have vertebral curves measuring between 25° and 40° with at least 2 years of growth remaining are considered to be at high risk of curve progression. Genetic markers to evaluate the 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° or more.

Bracing

Bracing is used 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. Thoracic-lumbar-sacral orthoses, such as the Wilmington and Boston braces, are intended to improve tolerability and compliance for extended (over 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. The smart brace consists of a standard rigid brace with a microcomputer system, a force transducer, and an air-bladder control system to control the interface pressure. Braces that are more flexible than thoracic-lumbar-sacral orthoses or nighttime braces, such as the SpineCor® Scoliosis System, are also being evaluated. The SpineCor is composed of a thermoplastic pelvic base with stabilizing and corrective bands across the upper body.

Surgery

Fusionless surgical procedures, such as vertebral body stapling and vertebral body tethering, are being evaluated as alternatives to bracing. The goal of these procedures is to reduce the rate of spine growth unilaterally, thus allowing the other side of the spine to “catch up.” The mechanism of action is believed to be down-regulation of the growth plate on the convex (outer) side by compression and stimulation of growth on the endplate of the concave side by distraction. In the current stapling procedure, nickel-titanium alloy staples with shape memory are applied to the convex 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.

Anterolateral tethering uses polyethylene ligaments that are attached to the convex side of the vertebral bodies by pedicle screws or staples. The ligament can be tightened to provide greater tension than the staple. The optimum degree of tension is not known. The polyethylene ligaments are more flexible than staples and are predicted to allow more spinal mobility. The goal of a fusionless growth modulating procedure is to reduce the curve and prevent progression, maintain spine mobility following correction, and provide an effective treatment option for patients who are noncompliant or who have a large curve but substantial growth is remaining. Observational data suggest that overweight patients may be at higher risk for scoliosis progression after surgery.

Verterbral Body Tethering Procedure Summary

Vertebral Body Tethering (VBT) is a technique for scoliosis correction in selected adolescent idiopathic scoliosis patients.

Vertebral body tethering is performed under general anesthesia with an operating time of 4-6 hours. Double‑lumen intubation confirmed by bronchoscopy establishes single‑lung insufflation and the patient is positioned lateral decubitus with the curve convexity upward. A 12‑mm thoracoscopic portal is placed, carbon dioxide insufflation facilitates lung deflation, and the spinal pleura is opened to expose the lateral vertebral bodies while preserving disc spaces. A total of 3-5 portals may be used to introduce instrumentation.

Using biplanar fluoroscopy, bicortical tether anchors are placed sequentially from caudal to cephalad levels on the convex side, with motor evoked potentials obtained at each level. The tether is introduced through the caudal portal, secured proximally, and sequentially tensioned across anchors, with maximal tension at the curve apex and decreasing tension toward the ends. Radiographs confirm correction. A chest tube is typically placed to re-inflate the lung and may be retained depending on patient status.

Post operative hospitalization is anticipated to be 3-5 days with resumption of baseline activity by 12 weeks. Serial radiographic follow‑up continues until skeletal maturity or identification of a clinical concern.

Anterior vertebral tethering is associated with complications that may arise from both the surgical approach and the implanted device. Approach-related complications include pulmonary events such as pneumonia, pneumothorax, and hemothorax. In addition, the anterior approach places adjacent anatomical structures at risk, including major vascular structures, visceral organs including the heart, lungs, liver, kidneys, spleen, and bowel; and neurologic structures such as the spinal cord and spinal nerve roots.

Implant-related complications primarily involve mechanical and fixation issues. These include rupture of the tether as well as malposition or loosening of the anchoring components, which may compromise device stability and intended biomechanical correction including producing treatment limiting overcorrection.

While VBT had originally been developed for adolescent idiopathic scoliosis, some studies have explored its use in selected patients with non‑idiopathic scoliosis and early‑onset scoliosis. Non‑idiopathic patients may also carry higher infection and pulmonary complication risks, making the less invasive nature of VBT particularly appealing due to reduced pain and earlier mobilization. The VBT procedure has also demonstrated improved curve correction, fewer implant‑related complications, and fewer unplanned surgeries compared to other procedures, while preserving spinal mobility and soft tissues until definitive fusion.

Some braces used to treat scoliosis are considered class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements. Examples include the Boston scoliosis brace [Boston Orthotics & Prosthetics] and the SpineCor Scoliosis System. This classification does not require submission of clinical data regarding efficacy but only notification prior to marketing.

Staples, using a shape memory nickel-titanium alloy, have been cleared for marketing by the FDA through the 510(k) process for various bone fixation indications. For example, nitinol staples (Sofamor Danek) are indicated for fixation with spinal systems. Other memory shape staples cleared for marketing for bone fixation include the OSStaple™ (BioMedical Enterprises) and the reVERTO™ Dynamic Compression Device. Vertebral body stapling in scoliosis is considered off-label use. FDA product code: JDR

A vertebral body tethering device (The Tether™; Zimmer Biomet Spine) received an FDA Humanitarian Device Exemption (HDE) (H190005, product code QHP) on 6/4/2019. The FDA HDE allows marketing of the device as indicated for "skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear."

The REFLECT™ Scoliosis Correction System (Globus Medical), another vertebral tethering system, was granted HDE by the FDA on 5/15/2023 and intended for use in the same population as The Tether.

Scoliosis Bracing and Stapling Devices Cleared by the U.S. Food and Drug Administration

Related policies -

• Vertical Expandable Prosthetic Titanium Rib

POLICY

A rigid cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis (brace) may be considered medically necessary for the treatment of scoliosis in juvenile and adolescent individuals at high risk of progression that meets the following criteria:

• Idiopathic spinal curve angle between 25° and 40°; 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°; AND

• There is a documented increase in the curve angle; AND

• At least 2 years of growth remain (Risser grade 0 or 1; pre-menarche in females).

Use of an orthosis for the treatment of scoliosis that does not meet the criteria above is considered investigational.

Vertebral body stapling and vertebral body tethering for the treatment of scoliosis are considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

This policy does not address conventional posterior spinal fusion surgery for scoliosis in individuals with curve angles measuring 45° or more. Brace treatment for idiopathic scoliosis is usually recommended for juveniles and adolescents with curves above 20° ± 5° Cobb, still growing (Risser 0 to 3), and with demonstrated progression of deformity or elevated risk of worsening, unless otherwise justified in the opinion of a clinician specialized in conservative treatment of spinal deformities. It is recommended not to apply bracing to treat patients with curves below 15° ± 5° Cobb, unless otherwise justified in the opinion of a clinician specialized in conservative treatment of spinal deformities.

Assessments related to decision-making for interventions in adolescent idiopathic scoliosis.

Cobb Angle in Scoliosis

The Cobb angle is the standard radiographic measure (in degrees) used to quantify the magnitude of a spinal curvature in scoliosis in the coronal (frontal) plane. The standard method for measurement uses a full-length, upright (standing) posteroanterior (PA) or anteroposterior (AP) spine radiograph so the curve is assessed under physiologic load. The upper and lower end vertebrae (e.g., T5–T12) used to calculate each Cobb angle are recorded.

A coronal spinal curve is considered scoliosis when the Cobb angle is ≥ 10° on an appropriate radiograph. Curves < 10° are commonly described as spinal asymmetry rather than scoliosis. Because scoliosis is a three-dimensional deformity, other abnormalities may be assessed alongside the Cobb angle, including vertebral rotation, trunk/rib prominence, and coexisting sagittal-plane abnormalities (e.g., kyphosis or lordosis measured using Cobb-type techniques on lateral radiographs).

The classification of abnormalities by Cobb angle magnitude is summarized as:

• < 10°: Spinal asymmetry (not diagnostic of scoliosis)

• 10–24°: Mild scoliosis

• 25–40°: Moderate scoliosis

• > 40°: Severe scoliosis

Risser Grading System (Risser Sign).

The Risser grading system (also called the Risser sign) is a radiographic method used to estimate skeletal maturity by assessing the degree of ossification and fusion of the iliac crest apophysis. It is most commonly used in the evaluation and management of adolescent idiopathic scoliosis (AIS) because remaining spinal growth strongly influences the risk of curve progression. This evaluation informs how closely to monitor a curve and whether nonoperative or operative treatment is likely to be beneficial.

A standing AP pelvis radiograph or a full-length standing spine radiograph that includes both iliac crests is used for assessment.

The stage/grade (0–5) that serves as a proxy for remaining growth is summarized as follows:

• Risser 0–1: Substantial growth remaining; considered the highest-risk window for AIS progression.

• Risser 2–3: Ongoing but decelerating growth; moderate progression risk (risk varies with curve magnitude, age, menarche status, and other maturity markers).

• Risser 4: Near maturity (depending on which grading variant is used); typically, lower progression risk than earlier grades, but not necessarily “zero growth remaining.”

• Risser 5: Skeletal maturity with fusion of the iliac apophysis; generally low risk of growth-driven progression (large curves may still progress slowly in adulthood).

Sanders Skeletal Maturity Score (SMS).

SMS stages skeletal maturity using a posteroanterior (PA) radiograph of the hand and wrist (commonly the left). The score is assigned by evaluating the appearance and fusion status of epiphyses/physes in the phalanges and metacarpals and the distal radius. SMS is a categorical staging system designed to align with clinically meaningful growth phases, particularly the curve-acceleration period in AIS.

Summary of 8 stages of SMS:

• Stages 1–2 (prepubertal / early adolescence): substantial growth remaining; scoliosis progression risk depends heavily on curve size but can increase as the patient approaches Peak Height Velocity (PHV).

• Stages 3–4 (early puberty and around PHV): highest-risk window for rapid curve progression (curve-acceleration phase); management decisions aim to ensure appropriate treatment is in place before or during this period.

• Stage 5 (late PHV / early deceleration): growth continues but begins slowing; risk of progression persists, especially for larger curves.

• Stages 6–7 (decelerating growth / approaching maturity): less remaining growth; progression risk typically declines but does not become zero, particularly for larger curves.

• Stage 8 (skeletal maturity): minimal remaining growth; in AIS, progression risk decreases, although larger curves (especially ≥~50°) may still progress after maturity.

Traditional pelvic maturity measures such as the Risser sign can be less granular during the early-to-mid pubertal period when AIS progression risk is greatest. SMS provides multiple stages during the time when some patients would still be classified as “Risser 0,” which can improve risk stratification and support more tailored follow-up and treatment timing.

Scoliosis Research Society-22 (SRS-22 / SRS-22r) Score.

The Scoliosis Research Society-22 (SRS-22) is a disease-specific patient-reported outcome measure (PROM) designed to assess health-related quality of life (HRQoL) in scoliosis and spinal deformity populations. The current recommended version is the SRS-22r (refined) which has been validated for ages ≥ 10 years.

The SRS-22 score measures 5 domains—pain, function/activity, self-image/appearance, mental health each with 5 items in the domain, and satisfaction with management with 2 items. Items are scored on a 1 (worst) –5 (best) Likert scale; domain scores are typically the mean of items in that domain. Higher scores indicate better HRQoL (less pain, better function, better self-image/mental health, greater satisfaction).

The score is commonly used to quantify baseline burden, compare interventions (e.g., bracing vs surgery; different surgical techniques), and evaluate change over time in clinical studies and registries.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/22/2010: Approved by Medical Policy Advisory Committee.

07/29/2011: Policy reviewed; no changes.

07/12/2012: Removed the following policy statement as it is addressed in the Vertical Expandable Prosthetic Titanium Rib policy: Use of the vertical expandable titanium prosthetic rib (with or without expansion thoracoplasty) for the treatment of scoliosis in patients without thoracic insufficiency is considered investigational. Other policy statements unchanged.

08/09/2013: Policy reviewed; no changes.

07/09/2014: Policy reviewed; description updated. Policy statement unchanged.

08/28/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 diagnosis code 737.32 from the Covered Codes table in the Code Reference section.

09/17/2015: Policy description updated to include vertebral body tethering as a fusionless surgical procedure. Policy statement revised to add vertebral body tethering as investigational for the treatment of scoliosis. Policy Guidelines section updated to add medically necessary and investigative definitions. Investigational Codes table updated to revise the code description for CPT code 22899 to include vertebral body tethering.

06/01/2016: Policy number A.2.01.83 added.

12/02/2016: Policy description updated regarding fusionless surgical procedures. Policy statements unchanged.

08/30/2017: Policy description updated. Policy statements unchanged.

04/27/2018: Policy description updated regarding adolescent idiopathic scoliosis and research recommendations. Policy statement updated to state that a "rigid" cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis may be considered medically necessary for the treatment of scoliosis in juvenile and adolescent patients at high risk of progression that meets certain criteria.

05/07/2019: Policy description updated regarding devices. Policy statements unchanged.

05/15/2020: Policy description updated regarding devices. Policy statements unchanged.

06/11/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/26/2021: Code Reference section updated to add new CPT codes 0656T and 0657T, effective 07/01/2021.

05/24/2022: Policy description updated regarding scoliosis and devices. Policy statements unchanged.

05/08/2023: Policy description updated regarding scoliosis. Policy statement updated to change "patients" to "individuals."

12/21/2023: Code Reference section updated to add new 2024 CPT codes 22836, 22837, 22838, and 0790T. Revised the code description for CPT codes 0656T and 0657T, effective 01/01/2024.

05/07/2024: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

05/06/2025: Policy description and Policy Guidelines updated with minor changes. Policy statements unchanged.

10/14/2026: Policy description updated regarding vertebral body tethering. First medically necessary policy statement updated for clarity. Policy Guidelines updated regarding Cobb Angle in scoliosis, the Risser grading system, the Sanders skeletal maturity score, and the scoliosis research society-22 score.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.83

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.