ModifiedUnitedHealthcarePolicy CS170OH.D

Vertebral Body Tethering for Scoliosis (Ohio)

Defines UnitedHealthcare Ohio medical policy governing coverage and medical necessity criteria for vertebral body tethering (VBT) surgery for adolescent idiopathic scoliosis, and related revision indications; applies to providers and facilities in Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (Ohio)

Policy CodePolicy CS170OH.D

Change TypeRevised coverage criteria and added revision indications

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation demonstrating failed conservative management, Cobb 45–65°, Sanders 2–5, bending-film flexibility ≤30°, facility/surgeon qualifications, and IRB study participation when applicable.

SourceLink

POLICY UPDATE CHANGES

Revised language to indicate VBT may be medically necessary when multiple specified clinical, facility, surgeon, and research-study participation criteria are met.

Added that revision VBT surgery may be medically necessary for tether breakage, hardware failure, under-/over-correction, or removal for complications.

Added medical records documentation requirements and statement that documentation may be required to assess clinical criteria.

Added definitions for Cobb Angle, IRB, Lenke Classification, Sanders Skeletal Maturity Staging System, and Shared Decision-Making.

45-65°Cobb angle range

Sanders 2-5Skeletal maturity

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Coverage and Medical Necessity Criteria

Initial VBT coverage criteria

VBT may be medically necessary for idiopathic scoliosis when ALL of the following are met:

Clinical patient criteria: Physician documentation of failed conservative management (e.g., bracing, observation, or physical therapy) with curvature progression to at least 45 degrees; major coronal curve Cobb angle 45 to 65 degrees for the single curve planned for surgery and no spinal curve >65 degrees; skeletal immaturity defined by Sanders Maturity Score of 2 to 5; Cobb angle decreases to 30 degrees or less on bending films; osseous structure dimensionally adequate to accommodate screw fixation; VBT instrumentation does not extend above T4 or below L4.

Facility and provider criteria: Procedure performed at a facility with an established on-site surgical pediatric scoliosis program; inpatient pediatric physical therapy available; intraoperative advanced imaging capability; pediatric anesthesiologist on staff; and a pediatric intensive care unit. Surgery performed by a pediatric orthopedic spine surgeon experienced in scoliosis/VBT.

Research participation and patient engagement: Surgeon is listed as an investigator on a prospective IRB‑approved study actively recruiting participants for The Tether™ VBT System and the member is a study cohort candidate; the individual and family have engaged in Shared Decision‑Making with the pediatric orthopedic spine surgeon.

Initial VBT medical necessity criteria

Vertebral body tethering (VBT) may be medically necessary when ALL of the following are met:

Primary clinical criteria: There is physician documentation of failed conservative management (e.g., bracing, observation, or physical therapy) with curvature progression to at least 45 degrees; the major coronal curve Cobb angle is 45 to 65 degrees for the single curve planned for surgery and no spinal curve is >65 degrees; skeletal immaturity defined by Sanders score 2 to 5; Cobb angle decreases to 30 degrees or less on bending films; osseous structure adequate for screw fixation; VBT instrumentation does not extend above T4 or below L4.see thresholds

All items are required

Facility requirements: Facility must have an established on-site surgical pediatric scoliosis program, inpatient pediatric physical therapy, intraoperative advanced imaging capability, a pediatric anesthesiologist on staff, and a pediatric intensive care unit.

All items are required

Surgeon and research participation: Surgery must be performed by a pediatric orthopedic spine surgeon experienced in scoliosis and VBT who is listed as an investigator on a prospective IRB‑approved study at the pediatric spine center actively recruiting participants for The Tether™ HDE device, and the patient/family have engaged in shared decision‑making.

Revision VBT coverage criteria

Revision VBT surgery may be medically necessary when ANY of the following are present:

Revision indications: Tether breakage or other hardware failure; under‑ or over‑correction of curves; removal of tether and/or anchor screws for surgical complication (e.g., impingement on vital organs, infection, intractable pain).

Revision surgery — Revision VBT surgery may be medically necessary when ANY of the following are present

Revision VBT surgery may be medically necessary when ANY of the following are present:

Any one condition suffices

Coverage considerations (informational criteria set)

Evidence-based considerations and clinical findings relevant to coverage decisions for anterior VBT:

Patient selection and maturity: Most studies enrolled skeletally immature patients (mean ages ~11–15 years; Risser 0–2 common); benefits tied to remaining growth. Outcomes in patients with more advanced maturity are variable and tether breakage/overcorrection risks differ by maturity and curve type.examples: Risser 0–2 or Sanders 2–5 cited

Younger/less mature patients may achieve greater growth‑modulated correction but have higher overcorrection risk.

Effectiveness outcomes: VBT generally reduces major Cobb angle (examples: mean pre-op ~48° to ~20–27° at follow-up in multiple reviews). Reported clinical success rates ~73% in single‑arm meta‑analysis; PSF typically achieves greater immediate correction and lower residual curves in comparative series.Cobb angle examples reported

Comparative evidence limited by nonrandomized designs and differing baseline characteristics.

Coverage considerations and evidence context

Coverage considerations and context summarized from device indication and professional guidance:

FDA HDE indication (informational): The Tether™ VBT System HDE indication: skeletally immature patients with progressive idiopathic scoliosis, major Cobb angle 30–65°, failed bracing and/or intolerant to brace wear, and osseous structure adequate for screw fixation.Cobb 30–65°; Risser/Sanders criteria per clinician

Informational — FDA HDE labeling alone is not a coverage decision

Professional society guidance: POSNA/SRS recommend coverage for FDA‑approved devices under stated indications when used by surgeons with active IRB approval; SRS and NICE caution about limited evidence and higher revision rates and recommend use in research settings or specialist centers.Risser ≤2 or Sanders ≤5 per POSNA/SRS context

Emphasizes shared decision‑making and counseling about higher reoperation risk

Evidence stance:

VBT surgery is not medically necessary when the stated clinical, facility, surgeon, or research‑study participation criteria are not met. Examples include failure to document prior conservative management with progression to at least 45°, a major coronal Cobb angle outside the policy range, skeletal maturity outside the required range, inadequate bending‑film flexibility, insufficient osseous anatomy for screw fixation, instrumentation that would extend above T4 or below L4, lack of required pediatric specialty services at the treating facility, or absence of the surgeon’s participation as an investigator on an IRB‑approved prospective study for The Tether™ device.

VBT surgery is not medically necessary when the policy’s initial or revision coverage criteria are not satisfied. Coverage requires documentation that the patient meets all clinical criteria (including failed conservative management with progression to at least 45°, major coronal Cobb angle 45–65°, Sanders skeletal maturity score 2–5, bending‑film Cobb ≤ 30°, and adequate osseous anatomy), that the facility meets specified pediatric program requirements, and that the surgeon participates in an IRB‑approved prospective study for The Tether™ under HDE; absence of these elements supports a not‑medically‑necessary determination.

Initial VBT is considered not medically necessary if the required clinical, facility, or provider/research study participation criteria are not satisfied. The policy requires prior failed conservative management with documented progression, specific Cobb angle and skeletal maturity thresholds, facility pediatric scoliosis program capabilities, and that the operating surgeon be an investigator on an IRB‑approved prospective study of The Tether™ (FDA HDE device); failure to meet and document these elements precludes coverage.

Revision VBT (including removal, augmentation, division, replacement, or conversion procedures) is not medically necessary when the policy’s revision‑procedure criteria and documentation requirements are not met. Revision indications that would support medical necessity include tether breakage or other hardware failure, clinically significant under‑ or over‑correction, or removal for complications (e.g., infection, impingement, intractable pain); absent documentation of these indications, requests for revision VBT may be denied.

Coverage is limited by uncertainty in the comparative evidence base: randomized controlled trials comparing VBT with posterior spinal fusion (PSF) are largely lacking, many published series are retrospective or single‑center, and systematic reviews report relatively high complication and reoperation rates. Because long‑term safety and effectiveness beyond medium‑term follow‑up remain insufficiently characterized, routine coverage is constrained and VBT is managed under defined selection, facility, and research participation conditions.

VBT remains an evolving and, in many respects, experimental technique with unresolved issues in optimal patient selection and surgical technique. Systematic reviews and evidence assessments note limitations including retrospective designs, small single‑center cohorts, variable follow‑up, and technical heterogeneity; these factors contribute to uncertainty about which patients derive durable benefit and to higher observed rates of tether failure, overcorrection, and reoperation compared with selective fusion.

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

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required and requests will be evaluated against the medical necessity criteria in the Coverage Rationale and the facility/surgeon/research participation requirements. Medical records may be requested to confirm eligibility and that all preoperative elements (e.g., Cobb angle, skeletal maturity, failed conservative management) are documented.

Prior authorization required for VBT procedures
Requests evaluated against clinical criteria, facility requirements, and surgeon/research participation criteria

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for VBT even when not strictly required by contract to ensure documentation includes indication, preoperative Cobb angles, skeletal maturity (Sanders score), curve flexibility (bending films), prior conservative management attempts, and detailed operative planning.

Include preoperative Cobb angles and bending-film flexibility results

Billing Codes and Key Numeric Criteria

Applicable CPT/HCPCS codes referencedmixed

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

inv-18: Cobb Angle (major coronal curve) — 45 to 65 degrees

Cobb angle for eligibilityMajor coronal curve Cobb angle 45 to 65 degrees for the single curve planned for surgery (no spinal curve >65°)

Conservative management prerequisiteDocumentation of failed conservative management with progression to at least 45 degrees

Instrumented level limitsInstrumentation must not extend above T4 or below L4

inv-19: Bending film Cobb Angle (flexibility) — 30 degrees or less

Bending film flexibility thresholdCobb angle decreases to 30 degrees or less on bending films

Purpose of bending filmDemonstrates curve flexibility to support candidacy for growth-modulating VBT

Clinical Background and Evidence Summary

Adolescent idiopathic scoliosis (AIS) is a progressive lateral and rotational spinal deformity that typically progresses until skeletal maturity. Surgical approaches aim to correct deformity and prevent progression; posterior spinal fusion (PSF) is the established standard that provides durable deformity correction, while vertebral body tethering (VBT) is a fusionless, anterior growth‑modulating technique using screws and a tensioned cord to preserve motion and harness remaining growth. VBT is being evaluated as an alternative for select skeletally immature patients but has shown higher pooled complication and reoperation rates in systematic reviews, and long‑term outcomes to skeletal maturity and randomized comparative data versus PSF are limited.

Long‑term benefit and appropriate indications for VBT remain unclear. Systematic reviews and evidence appraisals consistently report relatively high complication and reoperation rates, frequent tether breakage, and limited high‑quality comparative data versus PSF. These evidence gaps increase the risk of subsequent procedures and contribute to cautious coverage policies that require stringent patient selection, specialized centers, and research participation.

Key evidence gaps include a lack of outcomes reported to skeletal maturity, few randomized controlled trials or high‑quality comparative studies versus posterior spinal fusion, and a preponderance of single‑center, retrospective case series with small sample sizes and variable follow‑up. Major device‑specific registries and multicenter prospective trials with long‑term follow‑up are needed to define comparative effectiveness, durability of correction, and the clinical consequences of tether breakage and overcorrection.

Definitions and Terminology

inv-42: Cobb Angle — Radiographic method to quantify spinal curvature.

DefinitionAn objective radiographic method to quantify spinal curvature based on measurements from radiographs; preferred for reproducibility and severity assessment.

Clinical useStandard method adopted by the Scoliosis Research Society for measuring and tracking curve magnitude

Measurement contextUsed in preoperative, immediate postoperative, and follow-up radiographs to assess correction and progression

inv-43: Institutional Review Board (IRB) — Independent ethics committee that reviews clinical research.

DefinitionAn independent ethics committee responsible for reviewing, approving, and monitoring clinical research involving human participants, ensuring ethical conduct and participant protection.

Role in policy

Policy Changes and Versioning

2026-05-01policy_revisionLatest

Revised coverage rationale to specify numeric clinical criteria (Cobb angle 45–65°, Sanders score 2–5, bending-film flexibility ≤30°), facility requirements, and requirement that surgeon be an investigator on an IRB‑approved prospective study using The Tether™ HDE device; added explicit revision surgery indications (tether breakage, hardware failure, under/over‑correction, removal for complications).

2026-05-01documentation_update

Added explicit medical records documentation requirements stating that records may be required to assess whether the member meets clinical criteria and must fully support medical necessity (history, exam, pertinent tests).

2026-05-01

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (Ohio)

Policy CodePolicy CS170OH.D

Change TypeRevised coverage criteria and added revision indications

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

Denial Risk

Denial Risk — Limited/Low-Quality Evidence

Evidence for VBT is limited, with many studies being retrospective case series or short-term cohorts; comparative evidence versus posterior spinal fusion (PSF) is sparse. Because of these limitations, requests for VBT may be denied when clinical criteria, documentation, or facility/surgeon/research participation requirements are not met.

Denial risk increases when documentation of failed conservative therapy, Cobb angles, or skeletal maturity is missing
Limited/low-quality evidence and lack of long-term comparative outcomes may support denial

Note

Use Limited to Research per NICE Guidance

NICE recommends VBT only be used in the context of research because evidence is limited and there are concerns about serious complications. Consideration of VBT should follow participation in randomized controlled trials or registry-based research and be performed in specialist centers.

NICE guidance: use VBT only in context of research (RCTs or registry data)
Perform VBT in specialist centers with surgeons trained in anterior spinal surgery

Documentation Required

Records Supporting Medical Necessity

The patient's medical record must fully support medical necessity. Documentation should include relevant history, physical exam, diagnostic test results, preoperative Cobb angles, Sanders score (skeletal maturity), curve flexibility on bending films, prior conservative management details, and the informed/shared decision-making discussion.

Legible medical record with history, exam, and diagnostic tests
Preoperative Cobb angles and bending-film results
Sanders maturity score and documentation of failed bracing or intolerance
Records of shared decision-making and counseling about higher reoperation risk

Prior Authorization

Conservative Management Requirement

Conservative management (e.g., bracing, observation, physical therapy) must have been attempted and documented prior to VBT, with documented progression despite therapy. FDA HDE and the policy require failed bracing or intolerance to brace wear before considering The Tether; documentation should show progression to the policy-specified threshold.

Documented attempt and failure/intolerance of bracing
Progression of curvature documented (policy requires progression to at least ~45° for eligibility)
Duration and type of conservative therapy tried

Note

Consideration of Posterior Spinal Fusion (PSF) as Standard Option

Posterior spinal fusion (PSF) should be discussed with the patient and family as the standard, well-established option. Comparative studies generally show PSF achieves greater and more durable curve correction and lower revision rates; VBT’s potential benefits and higher revision risks must be weighed against PSF.

Discuss PSF as standard of care and comparative outcomes (greater correction, lower revision rates)
Document that PSF was considered during shared decision-making

Prior Authorization

Conservative Therapy Prerequisite (FDA HDE)

Per FDA HDE labeling and the policy, patients considered for The Tether should have failed bracing and/or be intolerant to brace wear; prior conservative therapy is a prerequisite and should be clearly documented in authorization requests and medical records.

FDA HDE: indication includes failure of bracing and/or intolerance to brace wear
Ensure documentation of brace trial and intolerance or failure before device use

inv-48: Tether breakage — Mechanical failure of the tether cord identified radiographically or intraoperatively.

DefinitionMechanical failure of the tether cord identified radiographically or intraoperatively, often associated with loss of correction or need for revision/conversion to fusion.

Reported ratesReported tether breakage rates vary widely across studies (examples include 20.8% in Alasadi review; 21.9% in Roser meta‑analysis; rates up to 55% in long‑term cohorts).

ImplicationsTether breakage is a common cause for revision surgery or conversion to posterior spinal fusion in some series

inv-50: Tether breakage (summary) — Reported in multiple series and meta-analyses with variable rates.

SummaryTether breakage has been reported across multiple series and meta‑analyses with variable rates (examples: 0–36% in Alasadi; 21.9% pooled in Roser; variable in other reviews).

Range and variabilityRates differ by study design, follow‑up duration, curve location (lumbar single tether higher breakage), and single vs double‑cord constructs

Clinical noteNot all radiographic breakages result in clinical failure; some patients remain clinically successful despite suspected tether breakage

inv-51: The Tether (Vertebral Body Tethering System) — FDA HDE device indication summary.

Device and indicationThe Tether™ Vertebral Body Tethering System is an FDA Humanitarian Device Exemption (HDE) device indicated for skeletally immature patients with progressive idiopathic scoliosis and major Cobb angle 30–65° who have failed bracing and whose osseous structure can accommodate screw fixation.

Policy linkageThe policy requires surgeon participation in an IRB‑approved prospective study using The Tether™ for coverage under specified criteria

Informational noteFDA HDE information is informational and not itself a coverage decision, but device indication informs selection criteria

inv-52: Complication / Reoperation rates — Pooled and single-series complication and reoperation rates for VBT vs PSF.

Pooled complication comparisonMeta-analyses report higher pooled complication rates for anterior VBT (~26%) versus PSF (~2%).

Reoperation/conversion ratesPooled reoperation rates for anterior VBT reported ~14.1% overall and up to ~24.7% in studies with ≥36 months follow‑up versus much lower rates for PSF (0.6–1.8% in analyses).

Single‑series findingsSingle‑surgeon and cohort series report variable major complication rates (example: Meyers et al. major complication 3.3%, all‑complication 6.5%) and higher pulmonary complications than PSF.