CurrentUnitedHealthcarePolicy SURGERY 113.7

Vertebral Body Tethering for Scoliosis

This UnitedHealthcare / Oxford clinical policy section summarizes clinical evidence, guidelines, FDA HDE indications, and references regarding anterior vertebral body tethering (VBT) and similar fusionless devices (e.g., The Tether, REFLECT) for skeletally immature patients with adolescent idiopathic scoliosis (AIS). It informs interpretation of coverage decisions and documents revisions (code additions and supporting information updates).

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis

Policy CodePolicy N/A

Change TypeCodes added; supporting information updated

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionDocument radiographic assessment demonstrating skeletal immaturity and osseous adequacy for screw fixation and evidence of failed bracing or intolerance to brace wear as required by device indications.

POLICY UPDATE CHANGES

CPT codes 0790T and 22838 were added to the policy.

Supporting Information, Description of Services, Clinical Evidence, FDA, and References sections were updated to reflect current information.

26% vs 2%Pooled complication rate (VBT vs PSF)

14.1% vs 0.6%Pooled reoperation rate (VBT vs PSF)

24.7% vs 1.8%Reoperation rate ≥36 months (VBT vs PSF)

30-65°

FDA HDE Cobb angle range (The Tether)

Coverage Summary

This policy section summarizes clinical evidence, guidelines, and FDA HDE indications for anterior vertebral body tethering (VBT) and similar fusionless devices (e.g., The Tether, REFLECT) for skeletally immature patients with adolescent idiopathic scoliosis (AIS). Its purpose is to inform interpretation of coverage decisions and document recent policy revisions (including added CPT codes 0790T and 22838).

Coverage stance is mixed: VBT is reported to have potential motion-preserving benefits for some skeletally immature patients with progressive AIS but is also associated with higher complication and reoperation rates compared with posterior spinal fusion (PSF). As context, pooled complication and reoperation estimates reported in meta-analyses include pooled complication ~26% vs 2% (VBT vs PSF) and pooled reoperation up to ~14% overall (higher with longer follow-up).

Thresholds & Quick Facts

Major Cobb angle (HDE/device indication)30-65° (The Tether); 30-68° (REFLECT)

Target populationSkeletally immature patients with progressive adolescent idiopathic scoliosis (failed/intolerant to bracing)

Evidence stanceMixed — potential motion-preserving benefit but limited long-term data and higher complication/reoperation rates versus posterior spinal fusion

Mapped threshold (brief thresholds[0])Major Cobb angle HDE indication: 30-65° (Tether); 30-68° (REFLECT)

Mapped key stats (from brief)Pooled complication ~26% (VBT) vs 2% (PSF); pooled reoperation ~14.1% vs 0.6%

Medical‑Necessity Criteria and Device Indications

FDA HDE device indications (informational only)

FDA humanitarian device exemption (HDE) indications for The Tether and REFLECT devices (informational - not itself a coverage determination):

FDA HDE indications

Skeletal maturity: Skeletally immature patients
per device HDE
Indication for surgery: Require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis
Cobb angle range: Major Cobb angle 30 to 65 degrees (The Tether) or 30 to 68 degrees (REFLECT)30-65° (The Tether); 30-68° (REFLECT)

Provider Actions / Prior Authorization & Documentation

Documentation Required

Confirm skeletally immature status and prior bracing failure

Document radiographic evidence that the patient is skeletally immature and that their osseous anatomy is adequate for screw fixation. Also document prior conservative management failure: objective evidence that bracing was attempted and failed or that the patient was intolerant of brace wear. These items correspond to device indications and are required to support use of anterior VBT.

Radiographs or other imaging showing skeletal immaturity (e.g., Risser/Sanders staging)
Imaging demonstrating osseous dimensions adequate for screw fixation
Records showing failed bracing or documented intolerance to brace wear
Operative planning images that confirm screw purchase sites

Prior Authorization

Coding

Added/Supported CPT codesCPT

0790T	Revision (e.g., augmentation, division of tether), replacement, or removal of thoracolumbar or lumbar vertebral body tethering, including thoracoscopy, when performed.
22838	Revision (e.g., augmentation, division of tether), replacement, or removal of thoracic vertebral body tethering, including thoracoscopy, when performed.

Background & Clinical Evidence Summary

This section compiles evidence assessments (ECRI, Hayes), systematic reviews and meta-analyses, single-center cohort studies and registry analyses, and professional society position statements regarding anterior vertebral body tethering (VBT) as a fusionless surgical option for progressive adolescent idiopathic scoliosis in skeletally immature patients.

The literature indicates VBT can reduce spinal curvature and may preserve spinal motion in some patients, but most studies are small, single-center, observational, and at risk of bias (retrospective design, short follow-up, and limited or absent control groups). Evidence assessments (ECRI, Hayes) found the evidence inconclusive or only minimally supportive, noting lack of data through skeletal maturity.

Meta-analyses and systematic reviews report higher pooled complication and reoperation rates for anterior VBT versus posterior spinal fusion (e.g., pooled complications ~26% vs 2%; pooled reoperation ~14% overall and higher with longer follow-up), and registry and cohort studies document substantial rates of tether breakage and revisions.

Professional society guidance (BSS, NICE, POSNA/SRS, SRS) urges cautious or research‑context introduction, recommends use in specialist centers and registry or IRB oversight, and supports coverage aligned with FDA HDE device indications when applicable.

Source	Conclusion
ECRI conclusion (2021)	Evidence for The Tether was inconclusive: appeared safe and reduced curvature up to 3 years, but no data through skeletal maturity and studies at risk of bias.
Hayes conclusion (2021/2024)	Minimal support; low-quality evidence with high rates of tether breakage and revision; additional evidence needed; 2024 review found new studies unlikely to change minimal level of support.
Shin et al. meta-analysis (2021)	Pooled complication rates higher with VBT (26%) vs PSF (2%); pooled reoperation 14.1% vs 0.6%; with >=36 months reoperation 24.7% vs 1.8%; deformity correction and mid-term outcomes similar.

Key Statistics (complications & reoperations)

Pooled complication rate (VBT vs PSF)26% vs 2%

Definitions

VBT: Vertebral body tethering is an anterior, fusionless surgical technique that uses vertebral body screws and a tensioned flexible cord across the convex side of the spine to modulate growth in skeletally immature patients with idiopathic scoliosis, aiming to obtain and maintain correction while preserving spinal motion.

HDE: Humanitarian Device Exemption (HDE) is a U.S. FDA regulatory pathway for devices intended to benefit patients with conditions affecting a limited number of individuals per year; The Tether and REFLECT devices have HDE indications specifying skeletally immature patients with progressive idiopathic scoliosis (major Cobb angle ranges noted in device labeling).

Revision History

02/01/2025material_changeLatest

Summary of Changes dated 02/01/2025 notes applicable codes added; CPT codes 0790T and 22838 were added to the policy.

02/01/2025supporting_information_updateLatest

Supporting Information, Description of Services, Clinical Evidence, FDA, and References sections were updated to reflect current information (non-material).

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis

Policy CodePolicy N/A

Change TypeCodes added; supporting information updated

Effective DateFebruary 1, 2025

Next Review DateN/A

On This Page

Osseous adequacy: Osseous structure dimensionally adequate to accommodate screw fixation as determined by radiographic imaging

Prior bracing: Patients should have failed bracing and/or be intolerant to brace wear

Caveats: Notes: consider failed bracing, confirm osseous adequacy on imaging, and restrict to skeletally immature patients per HDE indications (informational only)

Coverage review / use in research context per guidelines

Be prepared to show that use of anterior VBT follows current guideline and research-context recommendations. National guidance (NICE, BSS) advises VBT only in specialist centers and within research/registry settings; POSNA/SRS support payer coverage for FDA‑approved devices when used per the stated clinical indications and recommend surgeon IRB/registry involvement and documented informed consent. Payers may require adherence to the FDA HDE device indications (skeletally immature patients with major Cobb angle ~30–65° [The Tether] or up to ~68° [REFLECT], osseous adequacy for screw fixation, and failed/intolerant bracing) and may expect enrollment in registries or IRB‑approved protocols.

Expect payer review of alignment with FDA HDE indications (Cobb angle thresholds, skeletal immaturity, osseous adequacy, prior bracing failure)
Anticipate requests for evidence of informed consent describing experimental/limited evidence and higher reoperation rates
Consider registry participation or IRB approval per guideline/position‑statement recommendations

Denial Risk

Risk of denial for skeletally mature patients

Claims for anterior non‑fusion instrumentation in skeletally mature individuals lack supporting evidence and are specifically not endorsed by POSNA/SRS and related position statements; such claims are at risk of denial. To avoid denial, clearly document skeletal maturity status (e.g., Risser/Sanders stage or other imaging) and that the patient meets device indications for skeletally immature patients.

Do not submit claims for anterior non‑fusion instrumentation for skeletally mature patients without strong supporting evidence
Include explicit documentation of skeletal maturity (Risser/Sanders) in the medical record to justify patient eligibility
Reference FDA HDE indication language in supporting documentation when applicable

Pooled reoperation rate (VBT vs PSF, overall)

Reoperation rate at ≥36 months (VBT vs PSF)24.7% vs 1.8%