Interventions for Progressive Scoliosis Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 12|01|2024 POLICY LAST REVIEWED: 05|07|2025

OVERVIEW 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 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.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION Not applicable

POLICY STATEMENT Medicare Advantage Plans Vertebral body stapling and vertebral body tethering for the treatment of scoliosis are not covered for Medicare Advantage Plans as the evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Commercial Products Vertebral body stapling and vertebral body tethering for the treatment of scoliosis are not medically necessary for Commercial Products as the evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate section of the Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage.

BACKGROUND 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.

Medical Coverage Policy | Interventions for Progressive Scoliosis

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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, 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.

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.

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, a case-control study, and case series. 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 studies with larger sample sizes and longer follow-up are 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 outcome.

For individuals who have juvenile or adolescent idiopathic scoliosis at high-risk of progression who receive vertebral body tethering, the evidence includes case series and a systematic review and meta-analysis of case series. 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 Tether and on off-label use of the Dynesys system. Available evidence for The Tether includes a small, single-center, uncontrolled, unpublished retrospective cohort study of 57 pediatric patients and a prospective observational

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM study with 40 pediatric patients. A meta-analysis of vertebral body tethering studies with more than 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 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 outcome. CODING Medicare Advantage Plans and Commercial Products The following code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:
22836 Anterior thoracic vertebral body tethering, including thoracoscopy, when performed; up to 7 vertebral segments
22837 Anterior thoracic vertebral body tethering, including thoracoscopy, when performed; 8 or more vertebral segments
22838 Revision (eg, augmentation, division of tether), replacement, or removal of thoracic vertebral body tethering, including thoracoscopy, when performed
0790T Revision (eg, augmentation, division of tether), replacement, or removal of thoracolumbar or lumbar vertebral body tethering, including thoracoscopy, when performed
0656T Anterior lumbar or thoracolumbar vertebral body tethering; up to 7 vertebral segments
0657T Anterior lumbar or thoracolumbar vertebral body tethering; 8 or more vertebral segments RELATED POLICIES Not applicable PUBLISHED Provider Update, July 2025 Provider Update, January/October 2024 REFERENCES 1. U.S. Preventive Services Task Force (USPSTF). Final Recommendation Statement: Adolescent Idiopathic Scoliosis: Screening. 2018; https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/ado lescent-idiopathic-scoliosis-screening. Accessed March 4, 2025. 2. American Academy of Orthopaedic Surgeons (AAOS). Idiopathic Scoliosis in Children and Adolescents. April 2021; https://orthoinfo.aaos.org/en/diseases--conditions/idiopathic-scoliosis-in-children-and- adolescents. Accessed March 4, 2025. 3. 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. PMID 27861214 4. 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. PMID 35856501 5. Mishreky A, Parent S, Miyanji F, et al. Body mass index affects outcomes after vertebral body tethering surgery. Spine Deform. May 2022; 10(3): 563-571. PMID 35013996 6. 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): 2068-75; discussion 2076-7. PMID 16166897 7. 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. PMID 25780381 8. 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

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inclusion and assessment criteria for bracing studies. J Pediatr Orthop. Jun 2007; 27(4): 369-74. PMID 17513954

9. Fayssoux RS, Cho RH, Herman MJ. A history of bracing for idiopathic scoliosis in North America. Clin Orthop Relat Res. Mar 2010; 468(3): 654-64. PMID 19462214
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11. 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): 1512-21. PMID 24047455
12. 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. PMID 32990686
13. 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. 2017; 12: 36. PMID 29094108
14. 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). PMID 34063540
15. Charalampidis A, Diarbakerli E, Dufvenberg M, et al. Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. Jan 02 2024; 7(1): e2352492. PMID 38285447
16. 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: 338-41. PMID 22744524
17. 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): 1360-5. PMID 18496349
18. 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): 2650-7. PMID 24378629
19. Plewka B, Sibiński 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. Mar 26 2013; 78: 85-9. PMID 23535882
20. Plewka B, Sibiński 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): 227-34. PMID 23897999
21. 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. PMID 26618169
22. 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. PMID 32026438
23. Bumpass DB, Fuhrhop SK, Schootman M, et al. Vertebral Body Stapling for Moderate Juvenile and Early Adolescent Idiopathic Scoliosis: Cautions and Patient Selection Criteria. Spine (Phila Pa 1976). Dec 2015; 40(24): E1305-14. PMID 26655807
24. 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° to 39°. Spine (Phila Pa 1976). Dec 01 2013; 38(25): E1583-8. PMID 23963018
25. Laituri CA, Schwend RM, Holcomb GW. Thoracoscopic vertebral body stapling for treatment of scoliosis in young children. J Laparoendosc Adv Surg Tech A. Oct 2012; 22(8): 830-3. PMID 23039706
26. O'leary PT, Sturm PF, Hammerberg KW, et al. Convex hemiepiphysiodesis: the limits of vertebral stapling. Spine (Phila Pa 1976). Sep 01 2011; 36(19): 1579-83. PMID 21681138
27. 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): 169-76. PMID 20081512

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28. Zhu F, Qiu X, Liu S, et al. Minimum 3-year experience with vertebral body tethering for treating scoliosis: A systematic review and single-arm meta-analysis. J Orthop Surg (Hong Kong). 2022; 30(3):
29. PMID 36420934
30. U.S. Food and Drug Administration (FDA). 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 March 4, 2025.
31. Larson AN, Todderud JE, Mathew SE, et al. Vertebral Body Tethering in Skeletally Immature Patients: Results of a Prospective U.S. FDA Investigational Device Exemption Study. J Bone Joint Surg Am. Dec 24 2024. PMID 39719007
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): 1688-93. PMID 24921854
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): 1533-9. PMID 25510515
34. 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. PMID 33611658
35. Meyers J, Eaker L, Zhang J, et al. Vertebral Body Tethering in 49 Adolescent Patients after Peak Height Velocity for the Treatment of Idiopathic Scoliosis: 2-5 Year Follow-Up. J Clin Med. Jun 02 2022; 11(11). PMID 35683548
36. 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. PMID 34910244
37. 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. PMID 37211667
38. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and Answers about Scoliosis in Children and Adolescents. December 2023; https://www.niams.nih.gov/health- topics/scoliosis. Accessed March 4, 2025.
39. National Institute for Health and Care Excellence (NICE). Interventional procedures guidance: Vertebral body tethering for idiopathic scoliosis in children and young people [IPG728]. June 29, 2022; https://www.nice.org.uk/guidance/ipg728. Accessed March 4, 2025.
40. Scoliosis Research Society (SRS). Adolescent Idiopathic Scoliosis. n.d.; http://www.srs.org/professionals/online-education-and-resources/conditions-and- treatments/adolescent-idiopathic-scoliosis. Accessed March 4, 2025.
41. 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/POSNA/media/Documents/Position%20Statements/Why-Should-Insurance-Cover- AVBT-April-2020.pdf. Accessed March 4, 2025.
42. Negrini S, Donzelli S, Aulisa AG, et al. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018; 13: 3. PMID 29435499

43. 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. PMID 29318284i

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