ModifiedUnitedHealthcarePolicy CS170NJ.G

Vertebral Body Tethering for Scoliosis (for New Jersey Only)

This medical policy governs coverage of vertebral body tethering (VBT) for treatment of scoliosis for members in New Jersey; it defines the payer stance that VBT is unproven and not medically necessary based on current evidence.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for New Jersey Only)

Policy CodePolicy CS170NJ.G

Change TypeAdded CPT codescontent updates

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of skeletal immaturity (Risser ≤2 or Sanders ≤5), failed or intolerant bracing, and Cobb angle when requesting coverage for VBT.

SourceLink

POLICY UPDATE CHANGES

Added CPT codes 0790T and 22838.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information.

36%tether breakage (registry)

50%expected breakage by 36 mo

8.3%revision surgery rate

10.1%reoperation rate

677

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patients in meta-analysis

7.2%fusion after VBT

Coverage Determinations and Rationale

Coverage stance

Policy determination

Policy decision: Vertebral body tethering for the treatment of scoliosis is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Applies to New Jersey only as stated in application.

Evidence summaries to inform coverage

Summary of clinical findings relevant to coverage decisions

VBT evidence summary: Randomized controlled trials are lacking; most evidence derives from retrospective and single-surgeon cohort studies and systematic reviews/meta-analyses reporting variable outcomes.

See supporting chunks for complication and success rates

Outcomes and risks: Studies report meaningful curve reduction in many patients but higher rates of tether breakage, complications (pulmonary and surgical), and revision/unplanned reoperation compared with fusion in some series.

Complication rates reported between ~6.5% (single-surgeon 90-day) and up to ~36.8% in pooled analyses; fusion conversion rates vary (approx 7% meta-analysis to 11% in some reviews)

Patient selection considerations: Skeletal maturity, curve magnitude, curve flexibility, and Lenke classification influence outcomes; immature patients may achieve greater growth-modulated correction but risk overcorrection.

Specific cutoffs not consistently reported in this excerpt; many studies used Risser and Sanders staging

Covered Indications (society and FDA-aligned)

Covered when ALL of the following are met (per specialty society and device HDE indications):

Setting and oversight: Device use and procedures should be performed in specialist centers with experience in anterior spinal surgery and, where guidance applies (NICE), within research protocols or registries to monitor outcomes and complications.

Reflects NICE and British Scoliosis Society recommendations for controlled introduction and registry monitoring.

Device-specific approvals: Use of FDA HDE-approved devices (e.g., The Tether, REFLECT) may be covered when used within their labeled indications; coverage may be contingent on meeting the HDE criteria and payer-specific requirements.

FDA HDE indications cited for The Tether (2019) and REFLECT (2023).

Counseling and Evidence Limitations

Coverage conditional on counseling and shared decision-making when the following increased risks are acknowledged:

Evidence limitations: Acknowledge that much evidence is single-center, retrospective, or case series with limited long-term outcomes; consider enrollment in registries or trials.

Reflects limitations noted in Pehlivanoglu et al. and systematic review commentary.

This medical policy applies only to the state of New Jersey.

No specific exclusion list for vertebral body tethering (VBT) is provided in this excerpt; however, the evidence base is limited by small, predominantly retrospective studies and systematic reviews that report substantial rates of complications, tether breakage, revision, and conversion to posterior spinal fusion, which constrain broader coverage for generalized indications.

The Pediatric Orthopaedic Society of North America (POSNA) and the Scoliosis Research Society (SRS) state that VBT may be considered only for skeletally immature patients (clinical descriptors: Risser ≤ 2 or Sanders ≤ 5) and explicitly do not support use or reimbursement of anterior non-fusion instrumentation in skeletally mature individuals.

Vertebral body tethering for the treatment of scoliosis is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

The evidence supporting VBT is low quality and limited: randomized controlled trials are lacking and much of the literature comprises single-center, retrospective cohorts and pre-post studies. Systematic reviews and meta-analyses report meaningful short-term curve reduction but also relatively high rates of tether breakage, complications (including pulmonary events), and unplanned revision or conversion to fusion; importantly, long-term follow-up to skeletal maturity and comparative durability versus posterior spinal fusion are generally absent or inadequate.

The National Institute for Health and Care Excellence (NICE) concluded that current evidence for VBT is limited and raises concerns about serious complications; NICE recommends that VBT be used only in the context of research (for example, randomized controlled trials or registry analyses) and performed in specialist centers by surgeons with specific training in anterior spinal surgery.

Billing Codes and Clinical Thresholds

Referenced procedure CPT codesCPT

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	Revision (e.g., augmentation, division of tether), replacement, or removal of thoracic vertebral body tethering, including thoracoscopy, when performed.
22899	Unlisted procedure, spine.

Added CPT CodesCPT

0790T	Newly added CPT code (document notes added).
22838	Newly added CPT code (document notes added).

Cobb angle (clinical threshold)

Cobb angle inclusion range30–65° (major Cobb angle) per POSNA/SRS and FDA HDE device indications

AIS diagnostic thresholdCobb angle ≥10° defines adolescent idiopathic scoliosis (AIS) in ages 10–18 years

Clinical success target used in studiesCobb angle <35° at follow-up commonly used to define clinical success after VBT

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for vertebral body tethering (VBT)–related CPT codes. Requests should be submitted before scheduling the procedure to allow review of clinical indication and supporting documentation.

Prior authorization required for VBT-related CPT codes.
Include device-specific CPTs and unlisted spine procedure codes when applicable.

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for new or evolving VBT–related CPT codes to ensure coverage determination is made with current clinical and regulatory context. This is an evidence-driven recommendation to align review with evolving literature and device approvals.

Recommend authorization for new CPT codes and for procedures using recently approved devices (e.g., The Tether™, REFLECT™).

Background and Clinical Context

Adolescent idiopathic scoliosis (AIS) is an abnormal lateral and rotational curvature of the spine, typically defined by a Cobb angle ≥ 10°, occurring in children and adolescents (commonly ages 10–18). AIS often progresses before skeletal maturity; severe curves at maturity (>40°) can progress into adulthood and lead to functional and psychosocial consequences. Vertebral body tethering (VBT) is a fusionless, anterior growth-modulating surgical technique that uses vertebral body screws and a tensioned cord across the convex side of the curve to modulate asymmetric growth and preserve motion. VBT is intended for skeletally immature patients with progressive curves (commonly cited major Cobb angle range 30–65°) who have failed or are intolerant of bracing.

Key Definitions and Terms

Adolescent idiopathic scoliosis (AIS)

DefinitionAdolescent idiopathic scoliosis (AIS) — lateral curvature of the spine of unknown cause in children/adolescents aged 10–18 years

Radiographic criterionCobb angle ≥10° defines scoliosis; AIS commonly managed when major Cobb angle between 30–65° for surgical consideration

Clinical relevanceAIS is progressive during adolescence and may worsen before skeletal maturity; curves >40° at maturity commonly progress into adulthood

Vertebral body tethering (VBT)

Procedure descriptionVertebral body tethering (VBT) — fusionless anterior procedure using vertebral body screws and a tensioned flexible cord along the convex side of the spine to modulate growth and preserve motion

Indicated patient population (per devices/societies)

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for New Jersey Only)

Policy CodePolicy CS170NJ.G

Change TypeAdded CPT codescontent updates

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of skeletal immaturity (Risser ≤2 or Sanders ≤5), failed or intolerant bracing, and Cobb angle when requesting coverage for VBT.

SourceLink

On This Page

Prior Authorization

New CPT Codes Require Authorization

New and recently added CPT codes for VBT (including 0790T and 22838 added 03/01/2025) require authorization. Verify code list and submit prior authorization reflecting the specific code(s) billed.

CPT 0790T and 22838 added to code list effective 03/01/2025.
Ensure authorization request references the exact CPT(s) to be billed.

Denial Risk

Insufficient High-Quality Evidence (Coverage Risk)

Available clinical evidence is insufficient in quality (many small, single-center, retrospective studies and short follow-up) to establish VBT as standard of care for AIS. Coverage decisions may be denied when supporting evidence does not meet medical necessity thresholds.

Insufficient high‑quality evidence: small sample sizes, lack of randomized controlled trials, limited long‑term outcomes to skeletal maturity.
High rates of tether breakage, revision, and complication rates reported in multiple reviews.

Note

Research-Only Recommendation (NICE)

NICE advises that VBT should only be used in the context of research (RCTs or registry analysis) due to limited evidence and concerns about serious complications. Consideration of this guidance may influence coverage decisions and expectations for documentation of research enrollment.

NICE recommends VBT only in research settings; include trial/registry identifiers if applicable.

Documentation Required

Coverage Linked to Device Approval and IRB/Surgeon Requirements

Coverage for VBT is linked to device regulatory status and institutional oversight. When device-specific FDA HDE approval exists (e.g., The Tether™, REFLECT™), coverage considerations may be contingent on use within the approved indications and on surgeon/center requirements such as IRB approval and surgeon training.

Coverage considerations tied to FDA HDE indications: skeletally immature patients, Cobb angle 30–65°, failed/intolerant to bracing.
POSNA/SRS position: payors should provide coverage for FDA‑approved devices under stated indications and requirements (surgeons with active IRB approval).

Billing Rule

Billing/Code Documentation Note

Document billing and coding thoroughly. When using unlisted procedure codes (e.g., 22899) or newer Category III codes (e.g., 0656T, 0657T, 0790T), include operative reports, device identifiers, FDA approval status, and rationale for code selection to support medical necessity and payment.

Include operative report, device name and model, FDA HDE/approval documentation if applicable, and clinical justification.
If billing unlisted codes, append detailed documentation explaining procedure components and why existing codes are not appropriate.

Documentation Required

Bracing Failure Requirement

Before authorization, confirm that the patient met a trial of and failed or was intolerant to bracing when indicated. Many approvals and device indications require prior bracing failure or documented intolerance as part of eligibility.

Document prior brace trial, duration, and evidence of failure or intolerance.
Confirm skeletal immaturity criteria (e.g., Risser, Sanders staging) and major Cobb angle within indicated range.

Intended for skeletally immature patients with progressive AIS and major Cobb angle 30–65° who have failed or are intolerant to bracing

Approach and hardwarePerformed via anterior thoracotomy, thoracoscopic, or mini-open approach; single or dual cords may be used; revision may require removal/replacement of hardware

Tether breakage

DefinitionTether breakage — fracture or failure of the tether construct reported after VBT, often associated with loss of correction or need for reoperation

Observed frequencyReported tether breakage rates vary across studies (e.g., ~21.9% in a 19-study meta-analysis; single-study reports up to 50% in lumbar tethers)

Clinical consequenceBreakage may be associated with loss of correction and is a common reason for revision or additional procedures; clinical effect of broken tethers not fully quantified

Skeletally immature vs mature

Skeletal maturity descriptorsSkeletally immature commonly defined as Risser ≤2 or Sanders ≤5 (POSNA/SRS) — used to select VBT candidates

Outcome differencesSkeletally immature patients may achieve greater growth-modulated correction but have increased risk of overcorrection compared with more mature patients

Study findingsIn comparative studies, immature patients showed lower residual curve at 2 years but had reports of overcorrection and similar rates of suspected cord breakage

Humanitarian Device Exemption (HDE)

Regulatory definitionHumanitarian Device Exemption (HDE) — FDA pathway permitting marketing of devices for rare conditions with limited evidence; used for The Tether (2019) and REFLECT (2023)

Implication for coverageHDE status indicates limited evidence base and FDA labeling specific to skeletally immature patients with 30–65° Cobb angle who failed bracing

Device examplesThe Tether (Zimmer Biomet Spine) received HDE August 16, 2019; REFLECT (Globus Medical) received HDE May 15, 2023

Skeletally immature (POSNA/SRS descriptors)

POSNA/SRS clinical descriptorSkeletally immature: Risser ≤ 2 or Sanders ≤ 5 (used by POSNA and SRS for VBT candidate selection)

RationaleThese staging cutoffs identify patients with remaining growth capacity for growth-modulation by VBT

Risks in immature patientsImmature patients may have increased risk of overcorrection and tether-related complications despite greater potential for curve modulation