CurrentUnitedHealthcarePolicy 2025T0605K

Vertebral Body Tethering for Scoliosis

This policy governs coverage of vertebral body tethering (VBT) for treatment of scoliosis for UnitedHealthcare Commercial and Individual Exchange benefit plans, summarizing evidence, coding, and coverage stance.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis

Policy CodePolicy 2025T0605K

Change TypeNo material changes

Effective Date1,2025 May

Next Review DateN/A

Key ActionSubmit prior authorization with documentation supporting adolescent idiopathic scoliosis, skeletal immaturity, Cobb angle, prior bracing failure or intolerance, and device/registry enrollment when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

36%radiographic tether breakage (Cahill 2024)

50%estimated cumulative tether breakage by 36 mo

26%pooled complication rate (anterior VBT)

14.1%pooled reoperation rate (anterior VBT)

0.6%pooled reoperation rate (PSF comparator)

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Coverage determination and evidence summary

Overall coverage stance

Covered when ALL of the following are met

Not applicable: Policy states VBT is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

This is a not medically necessary stance rather than positive coverage criteria.

General evidence-based stance

Evidence synthesis and comparative outcomes

Evidence summary: Available studies are primarily small, retrospective, and single‑center cohorts, plus systematic reviews/meta‑analyses that report curve reduction but variable and often high complication and reoperation rates; long‑term durability to skeletal maturity and high‑quality randomized data are lacking.

See cited systematic reviews and evolving evidence reviews for pooled complication and reoperation rates and study limitations.

Coverage considerations tied to device indications and guideline recommendations

Coverage considerations and context from regulatory and professional guidance

Device-indication-based coverage: Patient is skeletally immature and requires surgical treatment for progressive idiopathic scoliosis with major Cobb angle 30 to 65 degrees, has failed or is intolerant to bracing, and has osseous anatomy adequate for screw fixation (per FDA HDE indications).Cobb 30-65°, failed/intolerant to bracing

Supports coverage when device HDE criteria are documented; FDA HDE indication does not by itself mandate coverage.

Research/center requirement: NICE recommends VBT only in the context of research and that procedures be performed in specialist centers by surgeons with specific anterior spinal surgery training; registry enrollment or RCT participation is encouraged.research or registry participation

May be required by payer policy or considered best practice.

Professional society stance: POSNA and SRS advise that FDA‑approved anterior fusionless devices may be considered under stated indications for skeletally immature patients (Risser <2 or Sanders <5; Cobb 30–65°) with counseling on higher reoperation risk, but they do not support use in skeletally mature individuals.

Vertebral body tethering (VBT) for the treatment of scoliosis is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy. Claims for VBT procedure codes (e.g., CPT/HCPCS codes listed in policy) may be denied on the basis that the service is not medically necessary.

Long-term outcomes through skeletal maturity and comparative effectiveness versus posterior spinal fusion (PSF) are inadequately characterized. Available systematic reviews and cohort studies report curve reduction at short-term follow-up but are limited by small sample sizes, retrospective or single-site designs, short follow-up, and lack of randomized comparisons; therefore durability of correction, functional outcomes at skeletal maturity, and the clinical impact of tether failure remain uncertain.

Professional society guidance from POSNA and SRS supports coverage of FDA-approved growth-modulating devices for skeletally immature patients who meet specified clinical indications (for example, Risser < 2 or Sanders < 5 and major Cobb angle within the device indication range), with counseling about higher reoperation risk. Both societies explicitly state they do not support use or reimbursement of anterior non-fusion instrumentation such as VBT in skeletally mature individuals.

Because the evidence base is low quality and inconclusive, VBT is designated as not medically necessary for routine use. Routine coverage is not supported absent robust comparative and long-term data demonstrating sustained safety and benefit over established fusion techniques.

Given the predominance of small, retrospective, and single-center studies with short follow-up, VBT should be considered investigational/experimental for many indications until higher-quality comparative trials and longer-term follow-up to skeletal maturity are available.

NICE recommends that VBT be used only in the context of research because current evidence is limited and raises concerns about serious complications; similarly, SRS highlights the lack of demonstrated clinically relevant advantage over PSF and the expectation of increased revision risk, supporting a research-focused approach or performance in specialist centers with registry participation.

Procedure, product, and indication codes

VBT-related procedure codes listedCPT | HCPCS | mixed

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

Device product codes (FDA)mixed

QHP	FDA product code referenced for The Tether and REFLECT HDE devices

Major Cobb angle (device indication)

Major Cobb angle (device indication)30 to 65 degrees

Device indication contextSkeletally immature patients with progressive idiopathic scoliosis who have failed or are intolerant to bracing

Anatomic requirementOsseous structure dimensionally adequate to accommodate screw fixation as determined by radiographic imaging

Prior authorization, documentation, and denial considerations

Prior Authorization

Prior authorization required

Prior authorization is required and should include documentation of individualized risk/benefit justification for vertebral body tethering (VBT). The request should clearly state why alternative, more established options (including continued conservative care or spinal fusion when indicated) are not appropriate for this patient.

Affected codes: 0656T, 0657T, 0790T, 22836, 22837, 22838

Prior Authorization

Specialist, registry, research, and HDE documentation

Prior authorization submissions for VBT should document that the procedure will be performed by a spine surgeon with appropriate anterior spinal surgery training and/or at a specialist center. If the device is being used under an FDA Humanitarian Device Exemption (HDE) or within a research protocol or registry, include the HDE indication details or registry/research protocol identifier and supporting documentation.

If device is HDE-approved (e.g., The Tether, REFLECT), submit HDE indication documentation and patient-specific justification (major Cobb angle, skeletal immaturity, failed/intolerant to bracing).
If performed as part of research or registry, include protocol/registry name, IRB approval when applicable, and enrollment documentation.

Clinical context

Adolescent idiopathic scoliosis (AIS) is a progressive lateral and rotational spinal deformity typically identified by a Cobb angle ≥10° in an adolescent. VBT is a fusionless, growth‑modulating technique that places vertebral body screws and a tensioned flexible cord along the convexity to partially correct the curve and preserve motion. It is intended primarily for skeletally immature patients with progressive idiopathic scoliosis who have failed or are intolerant of bracing; reported risks include pulmonary complications, tether breakage, inadequate correction or overcorrection, and potential need for revision or conversion to posterior spinal fusion.

Terms and device definitions

AIS definition

Definition (AIS)Adolescent idiopathic scoliosis (AIS): lateral curvature of the spine of unknown cause with a Cobb angle of at least 10 degrees occurring in adolescents and often progressive before skeletal maturity.

Clinical relevanceProgression commonly occurs during adolescence; curves >40° at skeletal maturity often progress into adulthood and may cause long-term morbidity.

Typical management contextBracing is a conservative treatment; surgical options considered for progressive curves or bracing failure/intolerance.

VBT definition

Definition (VBT)Vertebral body tethering (VBT): a fusionless procedure using vertebral body screws and a tensioned flexible cord across the convexity to modulate growth and correct spinal curvature while preserving motion.

Surgical approach

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis

Policy CodePolicy 2025T0605K

Change TypeNo material changes

Effective Date1,2025 May

Next Review DateN/A

SourceLink

On This Page

skeletally immature per Risser/Sanders

Document counseling about higher complication and reoperation rates compared with posterior spinal fusion.

Documentation Required

Documentation required for prior authorization

Providers must include detailed clinical documentation to support medical necessity and prior authorization decisions. This includes history and physical, imaging (Cobb angle measurements and Risser score or other skeletal maturity indicators), prior treatment history, and documented counseling regarding risks, benefits, and alternatives.

History of present illness and progression of curve documented with dates.
Radiology: preoperative Cobb angles, side(s) of curve, and radiographic evidence of skeletal immaturity (e.g., Risser score).
Documentation of prior brace treatment, duration, adherence, and reason for failure or intolerance.
Patient counseling notes: discussion of alternative treatments (including bracing and posterior spinal fusion), expected outcomes, risks (including tether breakage, overcorrection, complications), and shared decision-making.
If HDE/device use: document that patient meets the device-specific labeling criteria (e.g., Cobb angle 30–65°, skeletally immature).

Prior Authorization

Conservative therapy precedence and bracing

Conservative therapies (such as appropriately prescribed and performed bracing) should be attempted and documented prior to consideration of VBT when consistent with device indications and clinical judgment. Prior authorization should show that conservative management was tried or was not appropriate/tolerated.

Documented bracing trial: type of brace, start/end dates, adherence, and objective response.
If bracing not attempted, provide rationale (e.g., intolerance, noncompliance, rapid progression despite bracing).

Denial Risk

Denial risk due to inconclusive evidence

There is inconclusive and evolving evidence for VBT; requests lacking adequate supporting documentation or that do not meet patient-selection and device-indication criteria may be denied as not medically necessary.

High rates of complications, tether breakage, and reoperation have been reported in comparative reviews and meta-analyses; provide long-term follow-up data when available.
Comparative evidence to standard posterior spinal fusion (PSF) is limited—include any study data relevant to the individual patient when available.

Denial Risk

Research-only recommendations may trigger denial

If VBT is being recommended only in the context of research or per guidance that supports research-only use (for example, NICE guidance), and the submission does not document appropriate research oversight or registry participation, the request may be denied.

Include study protocol, IRB approval, registry enrollment, or other documentation of prospective data collection when the indication is research-only.
If facility/surgeon is not a designated specialist center as required by guidance, provide justification and training credentials.

Performed via anterior thoracotomy, thoracoscopic, or mini-open approaches under general anesthesia.

Indicated populationIntended for skeletally immature individuals with progressive curves who have failed or are intolerant to bracing.

VBT — anterior, growth-modulating technique

Technique descriptionAnterior VBT is a growth-modulating, fusionless surgical technique applying an anterior tether (tensioned cord) to the convex side of the spine to slow growth on the concave side and allow asymmetric growth for curve correction.

Expected effectAims to obtain and maintain correction through growth modulation rather than fusion, preserving segmental motion.

Reported risksAssociated risks include inadequate correction, overcorrection, tether breakage, higher complication and reoperation rates compared with PSF.

PSF definition (posterior spinal fusion comparator)

Definition (PSF)Posterior spinal fusion (PSF): instrumented spinal fusion surgery used as the comparative standard for deformity correction in AIS.

Comparative outcomesPSF demonstrates lower pooled complication and reoperation rates compared with anterior VBT (pooled complication ~2% and reoperation ~0.6% for PSF vs 26% and 14.1% for anterior VBT).

Clinical roleConsidered the established surgical option for durable deformity correction; used as the comparator in existing VBT studies and meta-analyses.

HDE definition

Definition (HDE)Humanitarian Device Exemption (HDE): FDA designation allowing marketing of devices intended for conditions affecting a small population; cited for The Tether and REFLECT VBT systems.

Device examplesThe Tether Vertebral Body Tethering System (Zimmer Biomet) and REFLECT Scoliosis Correction System (Globus Medical) are HDE-designated VBT devices.

Implication for coverageHDE status is informational and not by itself a basis for coverage; HDE indications specify skeletally immature patients, Cobb 30–65°, and failed/intolerant to bracing.

Cobb angle (device indication)

Cobb angle range (device indication)Major Cobb angle: 30 to 65 degrees

Associated device indication criteriaSkeletally immature patients requiring surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis who have failed or are intolerant to bracing.

Source of rangeSpecified in FDA HDE indications for The Tether and REFLECT VBT systems.