Latest Review Date: May 2024

Category: DME/Surgical                                                       

 

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 individuals 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 tethering for the treatment of scoliosis is considered investigational.

Vertebral body stapling for the treatment of scoliosis is considered investigational.

Use of the vertical expandable titanium prosthetic rib (with or without expansion thoracoplasty) for the treatment of scoliosis in individuals 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. 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.

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. 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.

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), 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 7, 2024.

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 systematic review, a high-quality randomized controlled trial, and 3 retrospective studies. 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. Two retrospective studies with long-term follow-up (mean, 13 to 15 years) has also shown that curvature corrections with bracing were maintained. Another retrospective study demonstrated that nighttime bracing was more effective than a 24-hour brace for avoiding surgery and preventing curve progression, but investigators attributed this finding to likely noncompliance with the 24-hour brace. A systematic review and meta-analysis reported higher success with full-time and nighttime rigid braces compared to soft bracing or observation only. 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. 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 (N=12)ultimately limited the interpretation of these results. The evidence is insufficient 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 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 observational studies and a systematic review and meta-analysis of these studies. 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 observational studies with the REFLECT device, The Tether and on off-label use of the Dynesys system. Available evidence for The Tether™ is limited to a small, single-center, uncontrolled, unpublished retrospective cohort study of 57 pediatric patients. A meta-analysis of vertebral body tethering studies with morethan 36 months follow-up reported a 74% clinical success rate, a 52% complication rate, and a 16% unplanned reoperation rate. Most commonly reported complications were tether breakages, pulmonary complications, and overcorrections. Although reported Cobb angle corrections are promising, serious adverse events occurred, data are 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

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, July 2023). 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.

 

National Institute for Health and Care Excellence

In 2022, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance onvertebral body tethering for idiopathic scoliosis in children and young people. Recommendations stated that "evidence on thesafety of vertebral body tethering for idiopathic scoliosis in children and young people is limited but raises concerns of seriouscomplications. Evidence on its efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in thecontext of research."

 

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 recommended for patients whose curves are less than 25° or 30° who are still growing, or people who have stopped growing and have curves that aren't changing or causing problems.
• Bracing is recommended for curves larger than 25°, but smaller than and 45° to 50° in someone who is still growing.  
• Surgical treatment is recommended for people with curves usually greater than 45º or 50º and/or who are at high risk of continued worsening even after they are finished growing.
• Statements on VBS and tethers include, "This technique can be used in children who are still growing, have a progressive curvature that measures less than 35º, and who are able to tolerate open or endoscopic exposure of the spine. By placing special vertebral body staples or tethers on the convex side of the curve, growth is inhibited on that side. The idea is that the scoliosis may then correct through more growth on the concave side of the curve.

 

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."

 

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.

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, REFLECT Scoliosis Correction System

APPROVED BY GOVERNING BODIES

Some  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. ). This classification does not require submission of clinical data regarding efficacy but only notification of FDA prior to marketing.

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 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." The REFLECTTM 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 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.  

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	Anterior lumbar or thoracolumbar vertebral body tethering (Revised 1/1/2024)
0657T	Anterior lumbar or thoracolumbar vertebral body tethering (Revised 1/1/2024)
0790T	Revision (eg, augmentation, division of tether), replacement, or removal of thoracolumbar or lumbar vertebral body tethering, including thoracoscopy, when performed (Effective 1/1/2024)
22836	Anterior thoracic vertebral body tethering, including thoracoscopy, when performed; up to 7 vertebral segments (Effective 1/1/2024)
22837	Anterior thoracic vertebral body tethering, including thoracoscopy, when performed; 8 or more vertebral segments (Effective 1/1/2024)
22838	Revision (eg, augmentation, division of tether), replacement, or removal of thoracic vertebral body tethering, including thoracoscopy, when performed (Effective 1/1/2024)

 

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.
2. Aulisa AG, Guzzanti V, Falciglia F, et al. Curve progression after long-term brace treatment in adolescent idiopathic scoliosis: comparative results between over and under 30 Cobb degrees - SOSORT 2017 award winner. Scoliosis Spinal Disord. Oct 30 2017; 12:36.
3. Aulisa AG, Toniolo RM, Falciglia F, et al. Long-term results after brace treatment with Progressive Action Short Brace in adolescent idiopathic scoliosis. Eur J Phys Rehabil Med. Jun 2021; 57(3): 406-413.
4. Baroncini A, Courvoisier A, Berjano P, et al. The effects of vertebral body tethering on sagittal parameters: evaluations from a 2-years follow-up. Eur Spine J. Apr 2022; 31(4): 1060-1066.
5. Betz RR, Ranade A, Samdani AF et al. Vertebral body stapling: a fusionless treatment option for a growing child with moderate idiopathic scoliosis. Spine (Phila Pa 1976). Jan 15 2010; 35(2):169-176.
6. Bumpass DB, Fuhrhop SK, Schootman M, Smith JC, Luhmann SJ. Vertebral body stapling for moderate juvenile and early adolescent idiopathic scoliosis: cautions and patient selection criteria. Spine (Phila Pa 1976). Dec 2015; 40(24):E1305-1314.
7. Costa L, Schlosser TPC, Jimale H, et al. The Effectiveness of Different Concepts of Bracing in Adolescent Idiopathic Scoliosis (AIS): A Systematic Review and Meta-Analysis. J Clin Med. May 15 2021; 10(10).
8. Cuddihy L, Danielsson AJ, Cahill PJ, et al. Vertebral Body Stapling versus Bracing for Patients with High-Risk Moderate Idiopathic Scoliosis. Biomed Res Int. 2015; 2015:438452.
9. Fayssoux RS, Cho RH, Herman MJ. A history of bracing for idiopathic scoliosis in North America. Clin Orthop Relat Res 2010; 468(3):654-664.
10. Grossman DC, Curry SJ, Owens DK, et al. Screening for Adolescent Idiopathic Scoliosis: US Preventive Services Task Force Recommendation Statement. JAMA. Jan 09 2018; 319(2): 165-172.
11. 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.
12. Hegde S, Badikillaya V, Kanade U, et al. Are We Looking at a Paradigm Shift in the Management of Adolescent Idiopathic Scoliosis? Comprehensive Retrospective Analysis of 75 Patients of Nonfusion Anterior Scoliosis Correction with 2-5-Year Follow-up: A Single Center Experience. Asian Spine J. Jun 2023; 17(3): 529-537
13. Heffernan MJ, Younis M, Song B, et al. Disparities in Pediatric Scoliosis: The Impact of Race and Insurance Type on Access to Nonoperative Treatment for Adolescent Idiopathic Scoliosis. J Pediatr Orthop. Sep 01 2022; 42(8): 427-431.
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. Janicki JA, Poe-Kochert C, Armstrong DG et al. A comparison of the thoracolumbosacral orthoses and providence orthosis in the treatment of adolescent idiopathic scoliosis: results using the new SRS inclusion and assessment criteria for bracing studies. J Pediatr Orthop. Jun 2007; 27(4):369-374.
16. Laituri CA, Schwend RM, Holcomb GW, 3rd. Thoracoscopic vertebral body stapling for treatment of scoliosis in young children. J Laparoendosc Adv Surg Tech A. Oct 2012; 22(8):830-833.
17. Lou E, Hill D, Raso J et al. Smart brace versus standard rigid brace for the treatment of scoliosis: a pilot study. Stud Health Technol Inform. 2012; 176:338-341.
18. Margalit A, McKean G, Constantine A, et al. Body Mass Hides the Curve: Thoracic Scoliometer Readings Vary by Body Mass Index Value. J Pediatr Orthop. Jun 2017; 37(4): e255-e260. 
19. Meyers J, Eaker L, Zhang J, et al. Vertebral Body Tethering in 49 Adolescent Patients after Peak Height Velocity for the Treatment ofIdiopathic Scoliosis: 2-5 Year Follow-Up. J Clin Med. Jun 02 2022; 11(11).
20. Mishreky A, Parent S, Miyanji F, et al. Body mass index affects outcomes after vertebral body tethering surgery. Spine Deform. Jan 11 2022.
21. Murray E, Tung R, Sherman A, et al. Continued vertebral body growth in patients with juvenile idiopathic scoliosis following vertebral body stapling. Spine Deform. Apr 2020; 8(2): 221-226.
22. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and Answers about Scoliosis in Children and Adolescents. December 2023; www.niams.nih.gov/health-topics/scoliosis.
23. National Institute for Health and Care Excellence (NICE). Interventional procedures guidance: Vertebral body tethering for idiopathicscoliosis in children and young people [IPG728]. June 29, 2022; www.nice.org.uk/guidance/ipg728.
24. Negrini S, Donzelli S, Aulisa AG, et al. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3.
25. 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.
26. 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.
27. Pehlivanoglu T, Oltulu I, Erdag Y, et al. Double-sided vertebral body tethering of double adolescent idiopathic scoliosis curves: radiographic outcomes of the first 13 patients with 2 years of follow-up. Eur Spine J. Jul 2021; 30(7): 1896-1904. 
28. 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.
29. 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.
30. 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.
31. 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.
32. 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.
33. Schiller JR, Thakur NA, Eberson CP. Brace management in adolescent idiopathic scoliosis. Clin Orthop Relat Res 2010; 468(3):670-678.
34. Scoliosis Research Society (SRS). Adolescent Idiopathic Scoliosis. n.d.; http://www.srs.org/professionals/onlineeducation-and-resources/conditions-and-treatments/adolescent-idiopathic-scoliosis.
35. Scoliosis Research Society (SRS)/Pediatric Orthopaedic Society of North America (POSNA). Joint SRS/POSNA Position Statement on Payor Coverage for Anterior Fusionless Scoliosis Technologies for Immature Patients with Idiopathic Scoliosis. April 2020. https://posna.org/getattachment/Physician-Education/Postion-Statements/Why-Should-Insurance-Cover-AVBT-April-2020.pdf?lang=en-US. 
36. 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.
37. 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.
38. U.S. Preventive Services Task Force. Final Recommendation Statement: Adolescent Idiopathic Scoliosis: Screening. 2018; https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/adolescent- idiopathicscoliosis-screening1.
39. 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.
40. 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.
41. Zhu F, Qiu X, Liu S, et al. Minimum 3-year experience with vertebral body tethering for treating scoliosis: A systematic review andsingle-arm meta-analysis. J Orthop Surg (Hong Kong). 2022; 30(3): 10225536221137753.

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."

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Group, August 2022 (7): Clarification to Policy Statement- created separate investigational statements for vertebral body stapling and vertebral body tethering. No change in policy intent.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (7): Updates to Description, Key Points, Benefit Application, and References. Replaced the word “patients” with the word “individuals” in Policy Statement. No change to policy intent.

Medical Policy Group, November 2023 (7): 2024 Coding Update- Added new codes 22836, 22837, 22838, 0790T to Current Coding. Revised codes 0656T and 0657T.

Medical Policy Panel, April 2024

Medical Policy Group, May 2024 (7): Updates to Description, Key Points, Approved by Governing Bodies, and References. Added Key Words: “REFLECT Scoliosis Correction System.” No change to Policy Statement.

 

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.