ModifiedUnitedHealthcarePolicy CS170PA.H

Vertebral Body Tethering for Scoliosis (for Pennsylvania Only)

This policy governs coverage for vertebral body tethering (VBT) for treatment of scoliosis in Pennsylvania; it states the payer's coverage stance and applies to Pennsylvania members and providers requesting this service.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for Pennsylvania Only)

Policy CodePolicy CS170PA.H

Change TypeAdded CPT codescontent updates

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of skeletal maturity, Cobb angle, prior bracing failure/intolerance, and operative details; include applicable codes (now including 0790T and 22838) when requesting VBT.

SourceLink

POLICY UPDATE CHANGES

Added CPT codes 0790T and 22838 to the list of applicable codes.

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

unprovencoverage stance

1,366systematic review patients

20.8%tether breakage (mean)

8.3%revision surgery (agg)

7.2%

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fusion after VBT (meta)

Coverage determination and evidence summary

Overall coverage stance

Covered when ALL of the following are met

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

policy-level determination

patient_population: Patient is skeletally immature (e.g., Risser 0–2 or Sanders stage consistent with device labeling) with a diagnosis of progressive adolescent idiopathic scoliosis (AIS).

Intended population per policy and device labeling

device_labeling_and_indication: Patient meets FDA HDE device labeling criteria for an approved VBT system: major Cobb angle approximately 30–65°, osseous anatomy adequate for screw fixation, and failed or intolerant to bracing.Cobb 30-65°, failed bracing

Informational: FDA HDE indications

documentation_required: Clinical documentation provided with request demonstrates skeletal maturity staging, Cobb angle, prior bracing failure or intolerance, planned instrumented levels, and counseling about risks including tether breakage, pulmonary complications, and potential need for revision or eventual fusion.

Per prior-authorization/documentation guidance

Evidence synthesis and implications

Summary of clinical evidence and comparative outcomes reported in the document (by study):

O'Donnell et al. (2023): Prospective single‑surgeon cohort (VBT n=9 vs PSIF n=22) reported less early postoperative pain, improved PROMIS mobility and faster return to functional milestones with anterior VBT in the early recovery period; limited by single‑surgeon design and small sample.

Treuheim et al. (2023): Retrospective review comparing skeletally immature versus more mature patients after single thoracic anterior VBT (n=16 vs n=19) found greater growth‑modulated correction in immature patients but higher risk of overcorrection; no conversions to fusion at 2 years; limited follow‑up and single‑surgeon design.

Welborn et al. (2023): Multi‑center registry retrospective review (Lenke 1A/1C) showed similar thoracic curve outcomes between groups at ≥2 years; high apparent tether rupture rate (~50% in registry subset) with average loss of correction ~5°; small sample and incomplete registry data.

Roser et al. (2023) — systematic review/meta‑analysis:

Coverage evidence and selection criteria

Summary of evidence and guidance relevant to coverage decisions

Patient selection per device labeling: Patient is skeletally immature and meets device labeling criteria (e.g., major Cobb angle 30–65°, failed or intolerant to bracing, osseous anatomy adequate for screw fixation).Cobb 30-65°, failed bracing

Based on FDA HDE indications

Comparative outcomes and risks: Comparative studies and meta‑analyses report similar mid‑term deformity correction and patient‑reported outcomes between anterior VBT and PSF but consistently report higher pooled complication and reoperation rates for anterior VBT (examples: pooled complication ~26% and reoperation 14.1% overall; 24.7% with ≥36 months follow‑up) versus low complication/reoperation rates for PSF.

Clinicians should counsel patients on higher reoperation and complication risk

Evidence quality and research recommendations: Evidence is low quality (predominantly small, single‑center, retrospective cohorts and case series); major guidance (NICE) recommends use only in research contexts, and professional societies (POSNA/SRS) recommend coverage limited to FDA‑approved devices under stated clinical indications with surgeon/center oversight and registry participation where applicable.

Vertebral body tethering (VBT) for the treatment of scoliosis is considered unproven and not medically necessary by this policy. The available evidence is insufficient to demonstrate the safety and/or effectiveness of VBT to support routine coverage; requests for VBT that do not meet investigational or research exceptions may be denied.

Long-term durability of VBT into skeletal maturity is uncertain and the clinical consequences of tether breakage are not well quantified. Systematic reviews report meaningful short‑term Cobb angle reductions but note substantial complication rates and incomplete data on outcomes at skeletal maturity; additional long-term studies are needed to determine how tether failure affects final curve magnitude and functional outcomes.

Professional society guidance does not support VBT for skeletally mature patients. POSNA and SRS explicitly state they do not support use or reimbursement of anterior non‑fusion instrumentation in skeletally mature individuals, and available literature provides no scientific reports supporting VBT in this population.

Given the current evidence base, VBT is judged not medically necessary for treatment of scoliosis. The policy determination is based on insufficient high‑quality data demonstrating sustained safety and efficacy compared with established alternatives.

Available studies are generally low quality, often single‑center and retrospective, and report relatively high rates of complications, tether breakage, and revision surgery. Because of these evidence limitations and a lack of long‑term comparative data to posterior spinal fusion through skeletal maturity, routine use of VBT outside controlled investigational programs or registries is not supported.

NICE concludes the evidence on VBT is inadequate in quality and quantity and raises concerns about serious complications. Therefore, NICE recommends VBT only in the context of research, performed in specialist centers with appropriate oversight and data collection.

Procedure codes, indications, and follow-up thresholds

Applicable procedure CPT/HCPCS 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.

Applicable CPT codes addedCPT

0790T	CPT code added to policy (description provided in policy Applicable Codes section).
22838	CPT code added to policy (description provided in policy Applicable Codes section).

Cobb angle — indication range

Indication Cobb angle rangeMajor Cobb angle 30 to 65° (per FDA HDE device labeling)

PopulationSkeletally immature patients requiring surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis

Anatomic requirementOsseous structure dimensionally adequate to accommodate screw fixation (radiographically determined)

Follow-up duration thresholds reported

Average follow-up — anterior VBT studiesPooled anterior VBT studies average follow-up ≈33.7 months

Average follow-up — PSF studiesPSF studies average follow-up ≈46.9 months

Prior authorization, documentation, and clinical selection

Prior Authorization

Prior authorization required

Prior authorization is required for vertebral body tethering (VBT) procedures. Requests will be reviewed against this policy and medical necessity criteria; inclusion of procedure codes in the policy does not guarantee coverage.

Prior authorization must reference the applicable CPT codes for VBT and revision/removal procedures (0656T, 0657T, 0790T, 22836, 22837, 22838).
Added CPT codes 0790T and 22838 were included in the 04/01/2025 policy update; prior authorization workflows should be updated to accept these codes.

Documentation Required

Documentation required for prior authorization

Provide clear, contemporaneous documentation demonstrating that the patient meets clinical selection criteria and that shared decision-making counseling occurred. Documentation should be submitted with the prior authorization request.

Required documentation should include: operative indication, radiographic documentation of Cobb angle(s) with dates, skeletal maturity staging (Risser and/or Sanders), curve location and magnitude, curve flexibility (bending films), prior nonoperative management (dates and outcomes), and the specific levels intended for tethering.

Clinical background and context

Adolescent idiopathic scoliosis (AIS) is a lateral and rotational curvature of the spine occurring in children and adolescents, defined as a Cobb angle of ≥ 10° and typically presenting between ages 10 and 18. AIS often progresses during growth, and more severe curves at skeletal maturity can lead to long‑term functional impairment and reduced quality of life. VBT is a fusionless, growth‑modulating anterior procedure intended primarily for skeletally immature patients to limit progression while preserving spinal motion.

Definitions and key terms

Adolescent idiopathic scoliosis (AIS)

DefinitionAdolescent idiopathic scoliosis (AIS) — lateral curvature of the spine of unknown cause with Cobb angle ≥10° occurring in children/adolescents aged 10–18 years

Clinical courseProgressive condition that usually worsens during adolescence and before skeletal maturity

Potential long-term consequencesSevere curvature (>40° at skeletal maturity) may progress into adulthood and be associated with pulmonary disorders, disability, pain, and reduced quality of life

Vertebral body tethering (VBT)

DefinitionVertebral body tethering (VBT) — fusionless surgical technique using vertebral body screws and a tensioned flexible cord on the convex side of the spine to modulate growth and correct progressive AIS

Approach and technique

Policy changes and history

2025-04-01code_additionLatest

Policy history indicates CPT codes 0790T and 22838 were added to the list of applicable codes.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for Pennsylvania Only)

Policy CodePolicy CS170PA.H

Change TypeAdded CPT codescontent updates

Effective DateApr 1, 2025

Next Review DateN/A

SourceLink

On This Page

Included 19 studies (677 patients); mean Cobb reduced from 47.8° to 22.2° at ≥2 years; overall complication rate 23% and tether breakage ~21.9%; spinal fusion conversion 7.2%; authors note predominance of retrospective, nonrandomized studies and need for longer follow‑up.

Siu et al. (2023): Retrospective cohort (VBT n=23 vs PSF n=24) reported VBT advantages of lower blood loss, shorter procedure and length of stay, and lower opioid use, but PSF achieved greater curve correction at follow‑up; higher revision rate observed after VBT (39% vs 17%, p=0.09).

Zhu et al. (2022) — single‑arm meta‑analysis: 26 studies (1,045 patients): overall clinical success ~73%, pooled unplanned reoperation ~8.7%, overall complications ~36.8%; subgroup analyses suggested higher reoperation and complication rates with longer follow‑up (>36 months).

Shin et al. (2021) — comparative meta‑analysis: Pooled anterior VBT studies (avg follow‑up ~33.7 months) versus PSF (avg ~46.9 months) found higher pooled complication rates for anterior VBT (26% vs 2%) and higher reoperation rates (14.1% vs 0.6% overall; 24.7% vs 1.8% for ≥36 months), while deformity correction and mid‑term patient‑reported outcomes were similar.

Clinicians should counsel patients on increased complication/reoperation risk

Meyers et al. (2021, 2022, 2021 series) and other cohort studies: Single‑surgeon series report variable tether breakage rates (up to ~41% in some cohorts), pulmonary complications (chylothorax, pneumothorax), and low rates of immediate major complications overall but notable pulmonary morbidity associated with anterior approaches; rib resection associated with higher major complication rate.

Systematic review conclusions and evidence quality: Multiple systematic reviews and evidence reviews conclude that current evidence is low quality (mostly small, retrospective case series), with uncertainty about long‑term durability to skeletal maturity and the clinical impact of tether breakage; longer‑term, multicenter, controlled studies are needed.

Emphasizes need for registry/RCT data and specialist center experience

Implications for coverage decisions: Given the uncertain long‑term durability to skeletal maturity, frequent reports of tether breakage and revision surgery, and low‑quality evidence, routine coverage outside defined investigational programs, registries, or strict device‑label indications is not supported by the current evidence base and may be denied per policy.

Policy‑level implication based on evidence and guidance

Longer-term findingsStudies with ≥36 months follow-up report increased reoperation rates for anterior VBT (pooled reoperation 24.7% with ≥36 months) and higher complication rates versus PSF

Document clinical counseling and informed consent discussions addressing the experimental/unproven nature of VBT, risks (including tether breakage, overcorrection, inadequate correction, and risk of revision surgery), and alternative options (including bracing and posterior spinal fusion).

If revision/removal is requested, include prior operative reports and rationale for revision and relevant imaging.

Denial Risk

Coverage rationale / denial risk

Coverage rationale: VBT is considered unproven and not medically necessary due to insufficient evidence of long-term safety and efficacy compared with standard surgical fusion.

The available evidence is limited, low quality, and inconsistent; high rates of tether breakage and revision surgeries have been reported in several series.
Requests that do not sufficiently demonstrate the patient is an appropriate candidate per the policy’s clinical selection criteria or lack supporting documentation are at increased risk of denial as not medically necessary.

Denial Risk

Evidence limitations may prompt denial

Evidence limitations that may prompt denial include small sample sizes, single-center or retrospective study designs, short-term follow-up, inconsistent comparative outcomes versus posterior spinal fusion (PSF), and high reported revision/tether failure rates.

High rates of tether breakage and revision surgery reported in the literature.
Lack of long‑term outcomes to skeletal maturity and limited data on functional outcomes and durability.
Absence of robust randomized trials or large multicenter registry data; NICE recommends use in research settings only.

Note

Specialist center and operator requirement (informational)

NICE guidance recommends limiting VBT to specialist centers and surgeons with specific training in anterior spinal approaches; consider operator experience when reviewing authorizations.

VBT should ideally be performed in specialist centers with appropriate multidisciplinary support and registry participation or research oversight.
Document surgeon credentials and center experience with anterior spinal surgery and VBT when submitting prior authorization.

Documentation Required

Clinical selection and counseling documentation required

Clinical selection: VBT is intended for skeletally immature patients with progressive idiopathic scoliosis. Prior authorization must document failed or intolerant bracing per FDA HDE indications and other selection metrics.

Skeletal maturity staging: provide Risser and/or Sanders stage.
Major Cobb angle: typically 30° to 65° per device HDE labeling; include measurements and date-stamped radiographs.
Curve location and magnitude, and flexibility assessment (bending films) to support candidacy.
Document that bracing was attempted and failed, or that the patient is intolerant to brace wear, consistent with FDA HDE device labeling.
Intended instrumented/operated levels and surgical approach (thoracoscopic, mini-open, anterior thoracotomy).

Performed via anterior thoracotomy, thoracoscopic, or mini-open approach; single or dual cords may be used; intended to preserve spinal motion

Intended patient criteria (per labeling)Generally intended for skeletally immature patients who have failed or are intolerant to bracing with major Cobb 30–65°

Clinical success

Common study definitionClinical success often defined as avoidance of fusion and a major curve Cobb angle ≤35° at follow-up

Reported pooled clinical successSingle-arm meta-analyses report pooled clinical success ≈73% (example: Zhu et al. overall clinical success 73.02%)

Time-dependencyClinical success rates vary with follow-up duration; some analyses report increased success but also increased reoperations with longer (>36 months) follow-up

Tether breakage

DefinitionTether breakage — mechanical failure of the implanted tether reported across studies

Reported ratesMeta-analyses report tether breakage around 21.9% (Roser et al.) and series-level reports ranging higher (registry reports up to ~36–50% by 24–36 months noted elsewhere)

Clinical impact uncertainConsequences of tether breakage on final curve and function have not been fully quantified and require longer-term study

Humanitarian Device Exemption (HDE)

Definition and purposeHumanitarian Device Exemption (HDE) — FDA pathway allowing marketing of devices for limited populations; examples include The Tether and REFLECT systems approved under HDEs

Labeling implicationsHDE-labeled devices specify patient selection criteria (e.g., skeletally immature, Cobb 30–65°, failed/intolerant to bracing, adequate osseous anatomy)

Coverage noteFDA HDE approval is informational only and not itself a basis for coverage decisions