305 Form

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Medical Policy Vertical Expandable Prosthetic Titanium Rib Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 305

BCBSA Number: 7.01.110 (For Plan internal use only) NCD/LCD: N/A Related Policies
Orthotics for Progressive Scoliosis, #550 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Use of the vertical expandable prosthetic titanium rib may be considered MEDICALLY NECESSARY in the treatment of progressive thoracic insufficiency syndrome due to rib and/or chest wall defects in infants and children between 6 months of age and skeletal maturity (about age 14 for girls and age 16 for boys).

Notes:
• Implantation of this device should be performed in specialized centers, given the complexity of these procedures and individuals.
• Preoperative evaluation requires input from a pediatric orthopedist, pulmonologist, and thoracic surgeon. In addition, preoperative evaluation of nutritional, cardiac, and pulmonary function (when possible) is required.

Use of the vertical expandable prosthetic titanium rib for all other conditions, including but not limited to the treatment of scoliosis in individuals without thoracic insufficiency, is considered INVESTIGATIONAL.
Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient

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Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes There is no specific CPT code for this service.

Description Vertical Expandable Prosthetic Titanium Rib
While spinal fusion is an approach to treatment in individuals with thoracic insufficiency syndrome, or early-onset scoliosis without thoracic insufficiency syndrome, the procedure may not be successful and may limit growth (lengthening) of the spine.

The vertical expandable prosthetic titanium rib device is a curved rod placed vertically in the chest that helps to stabilize and shape the thoracic cavity. It is positioned either between ribs, or between the ribs and either the spine or pelvis. The vertical expandable prosthetic titanium rib may be described as “rib- based” growth-sparing instrumentation, which is compared with “spine-based” growing rods for Cobb angle correction. The vertical expandable prosthetic titanium rib device is designed to be expanded every 4 to 6 months as growth occurs and to be replaced if necessary. Some patients require multiple devices.

Summary Description The vertical expandable prosthetic titanium rib is a curved rod placed vertically in the chest to help shape the thoracic cavity. It is being evaluated in skeletally immature pediatric individuals with thoracic insufficiency syndrome to support thorax and lung development, and in pediatric individuals with scoliosis without thoracic insufficiency syndrome to slow or correct curve progression. Summary of Evidence For individuals who have progressive thoracic insufficiency syndrome due to rib and/or chest wall defects in childhood who receive vertical expandable prosthetic titanium rib thoracoplasty, the evidence includes case series. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related mortality and morbidity. Results from case series reported at different specialty centers have demonstrated improvement and/or stabilization in key measures with use of the vertical expandable prosthetic titanium rib in progressive thoracic insufficiency syndrome. This improvement has been noted in measures related to thoracic structure (eg, Cobb angle for those with scoliosis), growth of the thoracic spine and lung volumes, and stable or improved ventilatory status. While pulmonary function testing is difficult to track in patients suffering with thoracic insufficiency syndrome, a study has demonstrated an age-specific increase in forced vital capacity (FVC); further still, that same study reported a final FVC in the range of 50% to 70% of predicted value. Given the usual disease course of worsening thoracic volume and ventilatory status, the stabilization and/or improvement in the clinical measures outlined above would be highly unlikely if not for the intervention. Taken together, these outcomes demonstrate the positive impact of using the vertical expandable prosthetic titanium rib technology. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with early-onset scoliosis without thoracic insufficiency syndrome who receive vertical expandable prosthetic titanium rib thoracoplasty, the evidence includes a non-randomized controlled study,

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an uncontrolled cohort study, and a case series. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related mortality and morbidity. The vertical expandable prosthetic titanium rib is being evaluated for curves greater than 45° in infants and juveniles without thoracic insufficiency. Similar to thoracic insufficiency syndrome, limited data are available on the use of the vertical expandable prosthetic titanium rib for early-onset scoliosis without thoracic insufficiency. Additionally, little is known about the disease progression of early-onset scoliosis, and therefore little is known regarding the risk-benefit trade-off of the vertical expandable prosthetic titanium rib surgery. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 6/2025 Annual policy review. References updated. Policy statements unchanged. 6/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2023 Annual policy review. Minor editorial refinements to policy statements; intent unchanged. 6/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 12/2016 Annual policy review. New references added. 7/2015 Annual policy review. New references added. 1/2014 Removed ICD-9 procedure code 78.51 as it does not meet the intent of the policy. 6/2013 Annual policy review. New references added. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
6/1/2011 New policy effective 6/1/2011 describing covered and non-covered indications. 6/2011 Reviewed - Medical Policy Group – Orthopedics, Rehabilitation and Rheumatology.
No changes to policy statement. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Food and Drug Administration. Vertical Expandable Prosthetic Titanium Rib (VEPTR). 2004; https://www.accessdata.fda.gov/cdrh_docs/pdf14/k142587.pdf. Accessed February 21, 2025.
2. Food and Drug Administration. RESPONSE Rib and Pelvic System. 2024; https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233105.pdf. Accessed February 20, 2025.
3. Campbell RM, Smith MD, Mayes TC, et al. The characteristics of thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis. J Bone Joint Surg Am. Mar 2003; 85(3): 399-408. PMID 12637423
4. Campbell RM. VEPTR: past experience and the future of VEPTR principles. Eur Spine J. Mar 2013; 22 Suppl 2(Suppl 2): S106-17. PMID 23354777

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5. Campbell RM, Smith MD, Mayes TC, et al. The effect of opening wedge thoracostomy on thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis. J Bone Joint Surg Am. Aug 2004; 86(8): 1659-74. PMID 15292413
6. Flynn JM, Emans JB, Smith JT, et al. VEPTR to treat nonsyndromic congenital scoliosis: a multicenter, mid-term follow-up study. J Pediatr Orthop. 2013; 33(7): 679-84. PMID 23812154
7. Gadepalli SK, Hirschl RB, Tsai WC, et al. Vertical expandable prosthetic titanium rib device insertion: does it improve pulmonary function?. J Pediatr Surg. Jan 2011; 46(1): 77-80. PMID 21238644
8. Emans JB, Caubet JF, Ordonez CL, et al. The treatment of spine and chest wall deformities with fused ribs by expansion thoracostomy and insertion of vertical expandable prosthetic titanium rib: growth of thoracic spine and improvement of lung volumes. Spine (Phila Pa 1976). Sep 01 2005; 30(17 Suppl): S58-68. PMID 16138067
9. Motoyama EK, Deeney VF, Fine GF, et al. Effects on lung function of multiple expansion thoracoplasty in children with thoracic insufficiency syndrome: a longitudinal study. Spine (Phila Pa 1976). Feb 01 2006; 31(3): 284-90. PMID 16449900
10. Waldhausen JH, Redding GJ, Song KM. Vertical expandable prosthetic titanium rib for thoracic insufficiency syndrome: a new method to treat an old problem. J Pediatr Surg. Jan 2007; 42(1): 76-
11. PMID 17208544
12. Skaggs DL, Sankar WN, Albrektson J, et al. Weight gain following vertical expandable prosthetic titanium ribs surgery in children with thoracic insufficiency syndrome. Spine (Phila Pa 1976). Nov 01 2009; 34(23): 2530-3. PMID 19927103
13. Mayer OH, Redding G. Early changes in pulmonary function after vertical expandable prosthetic titanium rib insertion in children with thoracic insufficiency syndrome. J Pediatr Orthop. 2009; 29(1): 35-8. PMID 19098643
14. Farley FA, Li Y, Jong N, et al. Congenital scoliosis SRS-22 outcomes in children treated with observation, surgery, and VEPTR. Spine (Phila Pa 1976). Oct 15 2014; 39(22): 1868-74. PMID 25099323
15. El-Hawary R, Kadhim M, Vitale M, et al. VEPTR Implantation to Treat Children With Early-Onset Scoliosis Without Rib Abnormalities: Early Results From a Prospective Multicenter Study. J Pediatr Orthop. Dec 2017; 37(8): e599-e605. PMID 28141685
16. El-Hawary R, Morash K, Kadhim M, et al. VEPTR Treatment of Early Onset Scoliosis in Children Without Rib Abnormalities: Long-term Results of a Prospective, Multicenter Study. J Pediatr Orthop. Jul 2020; 40(6): e406-e412. PMID 32501900
17. White KK, Song KM, Frost N, et al. VEPTR™ growing rods for early-onset neuromuscular scoliosis: feasible and effective. Clin Orthop Relat Res. May 2011; 469(5): 1335-41. PMID 21213088
18. Waldhausen JH, Redding G, White K, et al. Complications in using the vertical expandable prosthetic titanium rib (VEPTR) in children. J Pediatr Surg. Nov 2016; 51(11): 1747-1750. PMID 27397045