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Interventions for Progressive Scoliosis

Policy Number: MP-464

​​​​​​​​​​​​​​

Latest Review Date: April 2021

Category: DME/Surgical                                                       

Policy Grade: C

POLICY

A cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis may be considered medically necessary for coverage 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)

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

Custom fabricated orthoses for the treatment of scoliosis created by 3-D or CAM-CAD technologies (i.e., Rigo-Cheneau) is considered investigational.

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

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.

The vertical expandable prosthetic titanium rib (VEPTR) is described in more detail in policy #299, Vertical Expandable Prosthetic Titanium Rib.

The COPES Scoliosis Treatment Recovery System is described in policy #019, COPES Scoliosis Treatment Recovery System. 

DESCRIPTION OF PROCEDURE OR SERVICE

Orthotic bracing attempts to slow spinal curve progression and reduce the need for fusion surgery in patients 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 review does not address patients who are not at high risk of progression or conventional fusion surgery for scoliosis such as patients with Cobb angles measuring 45° or more.

Scoliosis

Scoliosis is an abnormal lateral and rotational curvature of the vertebral column. Adolescent idiopathic scoliosis (AIS) 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 AIS 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  (e.g., 2-year), period.

Treatment

Treatment of scoliosis currently depends on 3 factors: the cause of the condition (idiopathic, congenital, 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. Because 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 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 (> 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 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.

Surgery

Fusionless surgical procedures, such as vertebral body stapling and vertebral body tethering, are being evaluated as alternatives to bracing. Both procedures use orthopedic devices off-label. 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.

Research Recommendations

The Scoliosis Research Society (SRS) provided evidence-based recommendations in 2005, which were updated in 2015, for bracing studies to standardize inclusion criteria, methodologies, and outcome measures to facilitate comparison of brace trials. Janicki et al (2007) reported the first study to use the SRS criteria concluded that a brace should prevent progression in 70% of patients to be considered effective. 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 indicated that skeletally immature patients and patients with larger curves (between 20° and 29°) are significantly more likely to have more than 5° curve progression. Brace treatment for idiopathic scoliosis is usually recommended for juveniles and adolescents with curves measuring between 25° and 40° who have not completed spinal growth, with maturity defined as Risser Grade 4, or at least 2 years after menarche for girls. Bracing may also be recommended for curves greater than 20° in a patient who has a rapidly progressing curve with more than 2 years of growth remaining.

Success from brace treatment is most frequently defined as progression of less than 5° before skeletal maturity, although alternative definitions may include progression of less than 10° before skeletal maturity or preventing the curve from reaching the threshold for surgical intervention. Surgery is usually recommended when the curve magnitude exceeds 45° to 50° (before or at skeletal maturity), although many patients will not undergo surgery at this point. Based on this information, SRS provided the following recommendations for brace studies on AIS:

  • “Optimal inclusion criteria for brace studies consist of: age is 10 years or older when the brace is prescribed, Risser [Grade] 0-2, curve 25°-40°, and no prior treatment.”
  • Outcomes of brace effectiveness should include all of the following:
    • The percentage of patients with 5° or less curve progression and the percentage of patients who have 6° or more progression at skeletal maturity.
      • The number of patients at the start and end of treatment exceeding 10°, 30°, and 50° Cobb angles, as these risk thresholds have potential health consequences in adulthood, such as back pain and curve progression.
      • A minimum of 2-year follow-up beyond skeletal maturity for each patient who was ‘successfully’ treated with a brace to determine the percentage who subsequently required or had surgery recommended. The surgical indications must be documented.
    • Clinically significant outcomes such as aesthetics, deformity progression, disability, pain, and quality of life.
  • Skeletal maturity should be considered achieved when 1 cm change in standing height has occurred on measurements made on 2 consecutive visits 6 months apart…. when Risser 4 is present and, in females, when the patient is 2 years after menarche.
  • All patients, regardless of subjective reports of compliance, should be included in the results. This process makes ‘intent to treat analysis possible.... An ‘efficacy analysis’ … should also be considered.”

KEY POINTS

This policy has been updated regularly with searches of the MEDLINE database. The most recent review was performed through February 19, 2021.

Summary of Evidence

For individuals who have juvenile or adolescent idiopathic scoliosis at high-risk of progression who receive a conventional rigid brace, the evidence includes a high-quality randomized controlled trial. The relevant outcomes are change in disease status, morbid events, quality of life, and treatment-related morbidity. Bracing has been considered the only option to prevent curve progression in juvenile or adolescent idiopathic scoliosis. The highest quality study on bracing is a sizable 2013 National Institutes of Health-sponsored trial that, using both randomized and observational arms, compared bracing with watchful waiting. This trial was stopped after interim analysis because of a significant benefit of bracing for the prevention of spinal fusion. Based on several factors (evidence of efficacy, lack of alternative treatment options, professional society recommendations, potential to prevent the need for a more invasive procedure), bracing with a conventional rigid brace is considered an option for the treatment of scoliosis in patients with a high-risk of curve progression. Curves have a high-risk of progression when they measure 25° or more, and spinal growth has not been completed, or when a 20° curve is progressively worsening and at least 2 years of growth remain. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have juvenile or adolescent idiopathic scoliosis at high-risk of progression who receive a microcomputer-controlled brace, the evidence includes a pilot RCT. The relevant outcomes are change in disease status, morbid events, quality of life, and treatment-related morbidity. A pilot randomized trial using a microcomputer-controlled brace reported improved outcomes compared with the use of a standard rigid brace; however, the low number of individuals included in the trial ultimately limited the interpretation of these results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have juvenile or adolescent idiopathic scoliosis at high-risk of progression who receive a flexible brace, the evidence includes a randomized and a nonrandomized comparative study. The relevant outcomes are change in disease status, morbid events, quality of life, and treatment-related morbidity. One RCT evaluating a flexible brace did not show equivalent outcomes compared with conventional brace designs. Another study has suggested the flexible brace might improve outcomes compared with no treatment but this study had design flaws, which interfered with drawing significant conclusions from the study. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have juvenile or adolescent idiopathic scoliosis at high-risk of progression who receive vertebral body stapling, the evidence includes a comparative cohort study and case series. The relevant outcomes are change in disease status, morbid events, quality of life, and treatment-related morbidity. There is a small body of published evidence on surgical interventions for preventing curve progression in juvenile and adolescent idiopathic scoliosis. Vertebral body stapling with memory shape staples may control some thoracic curves between 20° and 35° but it is less effective than bracing for larger curves. The evidence is composed primarily from a center that developed the technique, along with a few case series from other institutions. Additional study with larger sample sizes and longer follow-up is needed to evaluate the safety and efficacy of this procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have juvenile or adolescent idiopathic scoliosis at high-risk of progression who receive vertebral body tethering, the evidence includes case series. The relevant outcomes are change in disease status, morbid events, quality of life, and treatment related morbidity. Vertebral body tethering has been evaluated for thoracic curves at high-risk of progression. Currently, there is very limited evidence on this technique, with published case series on the Dynesys system reporting 1-year follow-up in 32 patients and 2-year follow-up in 11 patients. Available evidence for The Tether™ is limited to a small, single-center, uncontrolled, unpublished retrospective cohort study of 57 pediatric patients. Although reported Cobb angle corrections are promising, serious adverse events occurred, data is lacking on other important health outcomes, and there are important study design limitations including lack of a control group. Additional studies, with a larger number of total subjects and longer follow-up, are needed to evaluate the safety and efficacy of this surgical procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

Society on Scoliosis Orthopaedic and Rehabilitation Treatment

The guidelines from the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (2016) included recommendations on the following conservative treatments for idiopathic scoliosis: assessment, bracing, physiotherapy, physiotherapeutic scoliosis-specific exercises  and other conservative treatments for idiopathic scoliosis exercises, special inpatient rehabilitation, and bracing (nighttime rigid bracing, soft bracing, part-time rigid bracing, full-time bracing). The guidelines did not address vertebral body stapling (VBS) or vertebral body tethering (VBT). Treatment decisions should be individualized based on the probability of progression, curve magnitude, skeletal maturity, patient age, and sexual maturity. The following is a summary of the 20 recommendations in the guidelines specific to bracing:

  • Bracing is recommended to treat adolescent, juvenile, and infantile idiopathic scoliosis “as the first step in an attempt to avoid or at least postpone surgery to a more appropriate age.”
  • “It is recommended not to apply bracing to treat patients with curves below 15º ± 5º 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 that each treating team provide the brace that they know best, which means the brace they are more experienced and with perceived outcomes. This is due to the actual knowledge; there is no brace that can be recommended over the others.”
  • Braces should be “worn full time or no less than 18 hours per day at the beginning of treatment …” and “in proportion with the severity of deformity, the age of the patient, the stage, aim and overall results of treatment, and the achievable compliance.”
  • “[B]racing is applied by a well-trained therapeutic team, including a physician, an orthoptist and a therapist, according to … (prescription, construction, … correction, follow-up)….”
  • Braces should be “specifically designed for the type of the curve to be treated”: to treat frontal, horizontal, and sagittal planes; not to restrict respiratory function; to be least invasive; to ensure patient compliance.

The Scoliosis Research Society

The Scoliosis Research Society has indicated that the treatment of adolescent idiopathic scoliosis falls into three main categories (observation, bracing, surgery) and is based on the risk of curve progression. In general, adolescent idiopathic scoliosis curves progress in two ways: first, during the rapid growth period of the patient and, second, into adulthood if the curves are relatively large. Because 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 Grade 0 and 1 are growing rapidly, while patients who are 4 and 5 have stopped growing. The Society made the following recommendations:

  • Observation is generally for patients whose curves are <25° who are still growing, or for curves less than 50° in patients who have completed their growth.
  • Bracing is for patients with curves that measure between 25° and 40° 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° while still growing or greater than 50° 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.

Vertebral body stapling and vertebral body tethering are not addressed on the Society’s website.

Scoliosis Research Society/Pediatric Orthopaedic Society of North America

A joint Scoliosis Research Society/Pediatric Orthopaedic Society of North America position statement (2020) on payor coverage for anterior fusionless scoliosis technologies for immature patients with idiopathic scoliosis drew the following conclusions after a review of scientific evidence on anterior vertebral growth modulation:

  • "...payors should provide coverage for any FDA approved devices under FDA stated clinical indications and requirements (limited to surgeons with active IRB approval) at the same level as traditional spinal instrumentation/fusion and growing rod procedures for management of skeletally immature patients (Risser ≤ 2 or Sanders ≤ 5) with idiopathic scoliosis (as defined above, 30 to 65 degrees Cobb angle)."
  • "For those patients who meet criteria for use of The Tether™ or other similarly FDA approved growth modulation systems, the decision for fusion versus growth modulation is best made between the patient, guardians, and treating physician - accounting for individual needs, values, and perspectives."
  • "The SRS and POSNA do not support the use or reimbursement for anterior nonfusion instrumentation in skeletally mature individuals for the management of scoliosis or other spinal deformities."

American Academy of Orthopaedic Surgeons

Information updated on the American Academy of Orthopaedic Surgeons’ OrthoInfo website indicates that the type of treatment required for idiopathic scoliosis in children and adolescents depends on the kind and degree

of the curve, child's age and the number of remaining growth years until the child reaches skeletal maturity

  • Observation is appropriate when the curve is mild (<25°) 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 curve between 25° and 45°”.
  • Surgery may be recommended if the curve is “greater than 45°-50°” or if bracing did not stop the curve from reaching this point. An implant made up of rods, hooks, screws, and/or wires is used to straighten the spine.
  • VBS and VBT are not addressed on the Society’s website.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has an educational website page on scoliosis in children and adolescents (last reviewed, December 2015). 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 curve is mild” and “the child is still growing.”
  • Doctors may advise "If the curve is moderate" and the "child or teen is still growing...using a brace to keep the curve from getting any worse."
  • Surgery may be advised ”if the "child or teen is still growing and the scoliosis continues to progress."

The Institute also stated that regular exercise helps children remain physically fit and helps strengthen muscles.

The educational page does not address VBS or vertebral body tethering.

U.S. Preventive 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). 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.”

KEY WORDS

Adolescent idiopathic scoliosis (AIS), Vertebral stapling, Vertebral body stapling, Scoliosis bracing, Scoliosis stapling, Milwaukee Brace, Wilmington Brace, Boston Brace, Charleston Brace, Providence Brace, SpineCor Brace, Vertebral body tethering, fusionless surgery, Rigo-Cheneau, custom thermoplastic TLSO, El corse de RSC, 3-D scoliosis braces, Tether Vertebral Body Tethering System

APPROVED BY GOVERNING BODIES

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 cleared for marketing by the FDA through the 510(k) process for bone fixation include the OSStaple™ (BioMedical Enterprises) and the reVERTO™ Dynamic Compression Device. FDA product code: JDR. Vertebral body stapling in scoliosis is considered off-label use.

A new titanium clip-screw system (HemiBridge™ System; SpineForm) has been tested on 6 patients with AIS, and investigational approval has now been granted by FDA for the next cohort of 30 patients.

A new vetebral 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 states that this device is 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."

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

Device

Manufacturer

Date Cleared

510(k) No.

Indication

Coronet Soft Tissue Fixation System

CoNextions Medical

3/4/2020

K200028

Off Label Use for Scoliosis support

Superelastic Staple

Neosteo

2/28/2020

K192447

Off Label Use for Scoliosis support

Mactafix CI Fixation Button with Continuous Loop

Medacta International SA

2/10/2020

K193165

Off Label Use for Scoliosis support

Motoband Cp Implant System

CrossRoads Extemity Systems, LLC

1/10/2020

K193452

Off Label Use for Scoliosis support

Trimax Implant System

CrossRoads Extemity Systems, LLC

8/16/2019

K190772

Off Label Use for Scoliosis support

Colink Plating System, Fracture and Correction System, Rts Implant System, Neospan Compression Staple System

In2Bones USA, LLC

8/8/2019

K190385

Off Label Use for Scoliosis support

Trimed Nitinol Staple System

TriMed, Inc.

7/1/2019

K190166

Off Label Use for Scoliosis support

Vertex Nitinol Staple System

Nvision Biomedical Technologies,

LLC

4/4/2019

K182943

Off Label Use for Scoliosis support

Geo Staple System

Gramercy Extremity Orthopedics LLC

1/11/2019

K182212

Off Label Use for Scoliosis support

DynaClipTM Bone Staple

MedShape Inc.

11/5/2018

K181781

Off Label Use for Scoliosis support

DynaBridge

Fusion Orthopedics LLC

10/15/2018

K181815

Off Label Use for Scoliosis support

MotoCLIP/HiMAX Step Staple Implant System

CrossRoads Extremity Systems LLC

8/9/2018

K181866

Off Label Use for Scoliosis support

DePuy Synthes Static Staples

Synthes (USA) Products LLC

7/24/2018

K180544

Off Label Use for Scoliosis support

MotoCLIP/HiMAX Implant System

CrossRoads Extremity Systems LLC

6/29/2018

K181410

Off Label Use for Scoliosis support

Clench Compression Staple

F & A Foundation LLC d.b.a. Reign Medical

4/6/2018

K173775

Off Label Use for Scoliosis support

Orbitum Bone Staple Implant X and VI

Orthovestments LLC

2/23/2018

K173693

Off Label Use for Scoliosis support

ExoToe Staple

ExoToe LLC

1/11/2018

K172205

Off Label Use for Scoliosis support

ToggleLoc System

Biomet Inc.

1/5/2018

K173278

Off Label Use for Scoliosis support

 

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING

There is no specific CPT code for the insertion of vertebral body staples, vertebral body tethering, or vertical expandable titanium prosthetic ribs.

CPT Codes:

22899

Unlisted procedure, spine

0656T

Vertebral body tethering, anterior; up to 7 vertebral segments (Effective 7/1/21)

0657T

; 8 or more vertebral segments (Effective 7/1/21)

 

HCPCS Codes:

L0999

Addition to spinal orthotic, not otherwise specified

L1000-L1499

Code range for orthotic devices (CTLSO and TLSO) for use in scoliosis

REFERENCES

  1. American Academy of Orthopaedic Surgeons (AAOS). Idiopathic Scoliosis in Children and Adolescents. OrthoInfo 2019; https://orthoinfo.aaos.org/en/diseases--conditions/idiopathic-scoliosis-in-children-and-adolescents. Accessed February 19, 2021.
  2. American Academy of Orthopaedic Surgeons (AAOS). Idiopathic Scoliosis in Children and Adolescents. OrthoInfo 2015; https://orthoinfo.aaos.org/en/diseases--conditions/idiopathic-scoliosis-in-children-and-adolescents. Accessed March 9, 2020.
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  16. Guo J. Lam TP, Wong MS et al. A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria. Eur Spine J. Dec 2014; 23(12):2650-2657.
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  20. Lavelle WF, Samdani AF, Cahill PJ et al. Clinical outcomes of nitinol staples for preventing curve progression in idiopathic scoliosis. J Pediatr Orthop 2011; 31(1 Suppl):S107-113.
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  26. Negrini S, Hresko TM, O'Brien JP, et al. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015; 10:8.
  27. O'Leary P T, Sturm PF, Hammerberg KW, et al. Convex hemiepiphysiodesis: the limits of vertebral stapling. Spine (Phila Pa 1976). Sep 1 2011; 36(19):1579-1583.
  28. Pehlivanoglu T, Oltulu I, Ofluoglu E, et al. Thoracoscopic Vertebral Body Tethering for Adolescent Idiopathic Scoliosis: A Minimum of 2 Years' Results of 21 Patients. J Pediatr Orthop. Nov/Dec 2020; 40(10): 575-580.
  29. Plewka B, Sibinski M, Synder M et al. Clinical assessment of the efficacy of SpineCor brace in the correction of postural deformities in the course of idiopathic scoliosis. Pol Orthop Traumatol 2013; 78:85-89.
  30. Plewka B, Sibinski M, Synder M et al. Radiological evaluation of treatment with SpineCor brace in children with idiopathic spinal scoliosis. Ortop Traumatol Rehabil. Jun 28 2013; 15(3):227-234.
  31. Richards BS, Bernstein RM, D'Amato CR et al. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). Sep 15 2005; 30(18):2068-2075; discussion 2076-2077.
  32. Rigo M, Quera-Salvá G, Puigdevall N, Martínez M. Retrospective results in immature idiopathic scoliotic patients treated with a Chêneau brace. Stud Health Technol Inform. 2002; 88:241-245.
  33. Samdani AF, Ames RJ, Kimball JS, et al. Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: one-year results on the first 32 patients. Eur Spine J. Jul 2015; 24(7):1533-1539.
  34. Samdani AF, Ames RJ, Kimball JS, et al. Anterior vertebral body tethering for idiopathic scoliosis: two-year results. Spine (Phila Pa 1976). Sep 15 2014; 39(20):1688-1693.
  35. Schiller JR, Thakur NA, Eberson CP. Brace management in adolescent idiopathic scoliosis. Clin Orthop Relat Res 2010; 468(3):670-678.
  36. Scoliosis Research Society. Adolescent idiopathic scoliosis 2010. www.srs.org/professionals/education/adolescent/idiopathic/treatment.php. Accessed February 18, 2021.
  37. Theologis AA, Cahill P, Auriemma M et al. Vertebral body stapling in children younger than 10 years with idiopathic scoliosis with curve magnitude of 30 degrees to 39 degrees. Spine (Phila Pa 1976). Dec 1 2013: 38(25); E1583-1588.
  38. Trobisch PD, Samdani A, Cahill P et al. Vertebral body stapling as an alternative in the treatment of idiopathic scoliosis. Oper Orthop Traumatol 2011; 23(3): 227-231.
  39. U.S. Food and Drug Administration. SUMMARY OF SAFETY AND PROBABLE BENEFIT (SSPB): The Tether Vertebral Body Tethering System. 2019; https://www.accessdata.fda.gov/cdrh_docs/pdf19/H190005b.pdf. Accessed February 19, 2021.
  40. U.S. Preventive Services Task Force (USPSTF). Final Research Plan for Adolescent Idiopathic Scoliosis: Screening. www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan/adolescent-idiopathic-scoliosis-screening1.
  41. U.S. Preventive Services Task Force. Screening for idiopathic scoliosis in adolescents 2004. www.uspreventiveservicestaskforce.org/3rduspstf/scoliosis/scoliors.htm.
  42. U.S. Preventive Services Task Force. Final Recommendation Statement: Adolescent Idiopathic Scoliosis: Screening. 2018; https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/adolescent- idiopathicscoliosis-screening1. Accessed February 19, 2021.
  43. Wall EJ, Reynolds JE, Jain VV, et al. Spine growth modulation in early adolescent idiopathic scoliosis: two-year results of prospective US FDA IDE pilot clinical safety study of titanium clip-screw implant. Spine Deform. Sep 2017;5(5):314-324.
  44. Weinstein SL, Dolan LA, Wright JG et al. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. Oct 17 2013; 369(16): 1512-1521.
  45. Weiss HR, Dallmayer R, Gallo D. Sagittal counter forces (SCF) in the treatment of idiopathic scoliosis: A preliminary report. Pediatr Rehabil. 2006; 9(1):24-30.
  46. Wong MS, Cheng JC, Lam TP et al. The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis. Spine (Phila Pa 1976). May 20 2008; 33(12):1360-1365.

POLICY HISTORY

Medical Policy Panel, May 2010

Medical Policy Group, January 2011 (2)

Medical Policy Administration Committee, February 2011

Available for comment February 9 – March 25, 2011

Medical Policy Group January 2012 (2): 2012 Update- Description, Key Points and References

Medical Policy Group, October 2012 (2): Updates to Key Points and References

Medical Policy Group, June 2013 (4): Updates to Description, Key Points and References, no changes were made to the policy statement.

Medical Policy Group, February 2014 (4): Updates to References.  No change to policy statement.

Medical Policy Group, July 2014 (4): Update to References only.

Medical Policy Panel, May 2015

Medical Policy Group, June 2015 (2): 2015 Updates to Description, Key Points, Key Words, Coding, and References; policy statement updated to include “vertebral body tethering” for the treatment of scoliosis is considered not medically necessary and investigational; no change to intent.

Available for comment June 9 through July 23, 2015

Medical Policy Group, January 2016 (2): updated reference information to policy 299 for information on (VEPTR).

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (7): 2016 Updates to Description, Key Points, and References. No change in Policy Statement.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (7): 2017 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Group, November 2017 (7): Policy statement updated- Investigational statement added re: “Custom fabricated orthoses for the treatment of scoliosis created by 3-D or CAM-CAD technologies (i.e., Rigo-Cheneau).” Updates to Description, Key Points, Key Words, and References. Added L0999 to Coding Section.

Medical Policy Administration Committee, November 2017

Available for comment November 14 through December 29, 2017

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (7):  Updates to Description, Key Points, Approved by Governing Bodies and References. No change in Policy Statement.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points, Practice Guidelines, Approved by Governing Bodies and References. No change to Policy Statement.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (7): Updates to Key Points, Approved by Governing Bodies and References. No change to Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Key Points, Practice Guidelines and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, June 2021: Quarterly Coding Update.  Added codes 0656T and 0657T to current coding section.  Key Words added Tether Vertebral Body Tethering System

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.