RetiredUnitedHealthcarePolicy CS170LA.G

Vertebral Body Tethering for Scoliosis (for Louisiana Only)

This Louisiana-specific medical policy governs coverage of vertebral body tethering (VBT) for treatment of adolescent idiopathic scoliosis and applies to providers and members in the state of Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for Louisiana Only)

Policy CodePolicy CS170LA.G

Change TypeRetirementcode additions and content updates

Effective DateJun 1, 2025

Next Review Date

Key ActionDo not authorize VBT for Louisiana members per this policy — VBT is considered not medically necessary; if prior authorization is submitted, ensure documentation supports FDA HDE indications and specialist care.

SourceLink

POLICY UPDATE CHANGES

Added CPT codes 0790T, 22836, 22837, and 22838.

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

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

36%tether breakage (registry)

8.3%revision surgery rate

10.1%overall reoperation rate

7.2%spinal fusion after VBT

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677patients in Roser et al.

Coverage Criteria for Vertebral Body Tethering

Not medically necessary — general

Policy determination

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

Policy applies to Louisiana only per Application section.

Evidence-derived candidate and outcome considerations

Study-derived characteristics associated with candidate selection and short-term success

Candidate profile: Adolescents with idiopathic scoliosis who retain residual growth potential (commonly defined in studies as Risser 0–2 or Sanders ≤4–5) and who have major curve magnitudes in ranges evaluated in the literatureExamples: Risser 0–2 or Sanders ≤4; Cobb often reported between ~40° and 70° in study cohorts

Multiple included studies used these inclusion ranges (see Treuheim, Roser, Zhu).

Outcomes reported: VBT can reduce Cobb angle and avoid spinal fusion in many patients but is associated with substantial rates of tether breakage, complications, and reoperation in systematic reviews and meta-analysesVaries by study (pooled complication rates reported ~23–37%; reoperation rates up to ~24.7% with longer follow-up)

See Roser et al., Zhu et al., Shin et al. for pooled estimates.

Factors affecting success: Greater remaining skeletal growth is associated with increased growth-modulated correction but also higher risk of overcorrection and tether breakage; posterior spinal fusion generally achieves greater immediate deformity correctionObservational findings from comparative and cohort studies

Treuheim and matched comparative series describe greater correction but different complication profiles; longer follow-up required for durability.

Eligibility Criteria (device-indication aligned)

Coverage considerations hinge on matching FDA HDE indications and meeting specialty guidance; evidence shows higher complications and reoperations compared to PSF.

Device HDE indication match: Patient is skeletally immature and has progressive idiopathic scoliosis with a major Cobb angle of 30 to 65 degreesCobb 30-65

Supported by FDA HDE indications for The Tether and REFLECT (HDE indications require skeletally immature patients who have failed or are intolerant to bracing).

Prior conservative therapy: Patient has failed bracing or is intolerant to brace wearfailed bracing or intolerance

FDA HDE indications specify prior bracing failure or intolerance; documentation of bracing attempt or intolerance is expected.

Specialist/systems requirement: Procedure performed in specialist centers by spinal surgeons with specific training in anterior spinal surgery or under IRB-approved protocols/registries

Informed Consent / Counseling

Shared decision-making and counseling requirements:

Risk counseling: Patient and family must be counseled that anterior VBT is associated with higher reported complication and reoperation rates compared with posterior spinal fusion, including risks of tether breakage, inadequate correction, overcorrection, pulmonary complications, and possible conversion to posterior spinal fusiondocumented counseling in medical record

Counseling should reference published meta-analyses and society position statements and document that long-term durability to skeletal maturity is not established.

Alternatives and uncertainties: Discussion should include alternatives (e.g., continued bracing, observation, posterior spinal fusion), the uncertain long-term outcomes through skeletal maturity, and potential need for future revision or fusion surgerydocumented discussion of alternatives and uncertainty

Position statements and systematic reviews emphasize the need for informed consent and introduction in controlled settings.

This Medical Policy applies only to the state of Louisiana.

Long-term durability and outcomes of vertebral body tethering (VBT) through skeletal maturity are not established. Multiple evidence reviews and device assessments note that available studies are small, often single-center, retrospective, and have short follow-up; none provide robust data on spine correction or function at skeletal maturity. Larger, multicenter studies with follow-up to skeletal maturity are needed to validate early results and determine long-term effectiveness.

Use or reimbursement of anterior non-fusion instrumentation (VBT) is not supported for skeletally mature individuals. Position statements from POSNA/SRS and SRS explicitly state there are no published scientific reports supporting VBT in skeletally mature patients and do not support its use or reimbursement in that population.

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 base for VBT is limited by small sample sizes, nonrandomized designs, and generally low-quality observational studies with inconsistent comparative findings. Systematic reviews and evidence assessments highlight retrospective, single-center series and a lack of randomized controlled trials, limiting confidence in comparative efficacy and safety estimates.

The National Institute for Health and Care Excellence (NICE) recommends that VBT for idiopathic scoliosis in children and young people should only be used in the context of research because the evidence is limited and raises concerns about serious complications; routine use outside research settings is not recommended.

Applicable Codes and Clinical Parameters

Applicable procedure 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

Applicable CPT Codes (added)CPT

0790T	CPT code added (document notes)
22836	CPT code added (document notes)
22837	CPT code added (document notes)
22838	CPT code added (document notes)

FDA product codemixed

QHP	FDA product code for The Tether and REFLECT HDE entries

Cobb angle (clinical parameter)

Cobb angle rangeMajor Cobb angle 30 to 65° (FDA HDE indication)

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

Implication at skeletal maturityCurvatures >40° at skeletal maturity likely progress into adulthood

Skeletal maturity (clinical parameter)

Skeletally immature (policy/device indication)Patient must be skeletally immature per device HDE (example threshold used in indications)

Example Risser stagingRisser index 0–2 commonly used in studies to indicate remaining growth potential

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required / Coverage Implication

Prior authorization is required. Vertebral body tethering (VBT) is considered investigational / not medically necessary by this policy; authorization requests should include complete clinical documentation to support medical necessity per the member’s contract. Inclusion of CPT/HCPCS codes in the policy does not guarantee coverage; benefit determination is subject to federal, state, and contractual requirements.

Applicable codes: 0656T, 0657T, 0790T, 22836, 22837, 22838, 22899
Note: Codes marked with an asterisk (*) are not on the State of Louisiana Medicaid Fee Schedule and may not be covered for Louisiana Medicaid (0790T noted in policy history)

Denial Risk

Evidence Quality Risk

Available evidence is limited, of low quality, and at risk of bias (small, single-center, retrospective studies, short follow-up). High rates of complications (including tether breakage), unplanned reoperation, and uncertainty about long-term outcomes raise a risk that clinical benefit is not well established.

Background and Clinical Context

Adolescent idiopathic scoliosis (AIS) is a three-dimensional lateral and rotational curvature of the spine of unknown cause that occurs in individuals aged approximately 10–18 years and is defined radiographically by a Cobb angle ≥ 10°. Curves commonly progress during growth, and management depends on curve magnitude and remaining growth potential.

Definitions and Key Terms

AIS definition

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

Natural historyAIS is progressive during adolescence and before skeletal maturity; severe curvature can lead to pulmonary and other long‑term consequences.

Typical surgical candidacyMajor Cobb angle commonly between 30° and 65° for VBT candidates per procedure description.

VBT definition

DefinitionVertebral body tethering (VBT): anterior surgical procedure using vertebral body screws and a tensioned flexible cord across the convex side of the spine to induce asymmetric growth modulation and preserve motion.

Approaches and hardwarePerformed via anterior thoracotomy, thoracoscopic, or mini‑open approach; single or dual cords may be used; surgical revision may be required to replace, remove, or add hardware.

Policy Revision History

2026-04-01retirementLatest

Policy retired for Louisiana; Louisiana plan membership disenrolled effective April 1, 2026.

2025-06-01codes_added

Operational update added CPT codes 0790T, 22836, 22837, and 22838 to the Applicable Codes section; noted 0790T is not on the Louisiana Medicaid Fee Schedule.

2025-06-01supporting_content_updated

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for Louisiana Only)

Policy CodePolicy CS170LA.G

Change TypeRetirementcode additions and content updates

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

specialist/IRB/registry

NICE, BSS, and joint POSNA/SRS statements recommend use in specialist centers and/or research contexts; POSNA/SRS link coverage to surgeon/center requirements and IRB/registry participation.

Skeletally mature exclusion: Use or reimbursement of anterior non-fusion instrumentation (VBT) is not supported for skeletally mature individualsskeletally mature

POSNA/SRS and SRS statements do not support use in skeletally mature patients; HDE indications are limited to skeletally immature individuals.

Example Sanders stagingSanders stage ≤4–5 used across studies as an indicator of remaining growth potential

Reported overall complication rates range roughly 23–52% across reviews/meta-analyses
Reported unplanned reoperation and fusion rates vary (eg, pooled unplanned reoperation ~8–16%; fusion conversion up to ~7%)

Note

Research-only Recommendation (NICE)

NICE recommends that VBT should only be used in the context of research because evidence is limited and raises concerns about serious complications. If performed, procedures should occur in specialist centers and ideally within RCTs or registry studies.

Research-only recommendation: National Institute for Health and Care Excellence (NICE) interventional procedures guidance (2022)

Documentation Required

FDA HDE Indication Documentation

For devices cleared under an FDA Humanitarian Device Exemption (HDE), submit documentation that the patient meets the HDE indication: skeletally immature, major Cobb angle 30–65°, osseous anatomy adequate for screw fixation on imaging, and failed or intolerant of bracing. Provide device name and HDE reference in the request (eg, The Tether™ [Zimmer Biomet], REFLECT™ [Globus Medical]).

Include imaging reports demonstrating skeletal immaturity and Cobb angle
Document prior bracing attempt and intolerance or failure
Specify device and HDE product code when applicable (eg, QHP for The Tether)

Prior Authorization

Bracing Failure Prerequisite

Authorization requests should document that the patient is skeletally immature and that a documented trial of bracing has failed or was not tolerated. Bracing failure or intolerance is a required prerequisite per the HDE indications and the policy description of intended patient selection.

Documented bracing trial with duration, adherence, and objective failure criteria or clear intolerance
Clinical notes confirming skeletal maturity status and Cobb angle measurements

Intended patient populationIntended for skeletally immature individuals with major Cobb 30–65° who have failed or are intolerant to bracing (per device HDE).

Clinical success (as used in studies)

Common study definitionClinical success frequently defined as avoidance of spinal fusion and achievement of major curve ≤35° at follow‑up (example used in Zhu, Mathew, and other studies).

Timing for assessmentSuccess is typically assessed at minimum 2‑year follow‑up or earlier radiographs (eg, 3‑month imaging associated with later success in some series).

Related practical markerAchievement of Cobb <35° on early post‑op imaging (eg, 3 months) correlated with 2‑year success in some cohorts.

Skeletal maturity indicators

Common indicatorsRisser index and Sanders staging are used to stratify remaining growth potential and predict outcomes after VBT.

Risser examplesRisser 0–2 often indicates substantial remaining growth and is used for candidate selection in studies.

Sanders examplesSanders stage ≤4 (or ≤5 in related statements) used across studies as an indicator of skeletal immaturity likely to benefit from growth modulation.

HDE

AcronymHDE = Humanitarian Device Exemption (FDA)

Devices referencedThe Tether™ and REFLECT™ systems are FDA‑cleared under HDEs for skeletally immature patients with Cobb 30–65° who have failed or are intolerant to bracing.

Regulatory implicationHDE indications specify skeletally immature status and curve magnitude and are used to align candidate eligibility and documentation requirements.

Clinical outcome risks

Higher complication and reoperation ratesAnterior VBT associated with higher pooled complication rates (eg, 26% pooled in meta‑analysis) and higher reoperation rates (14.1% overall; 24.7% among studies with ≥36 months follow‑up) compared with PSF.

Common specific risksTether breakage (reported ~21.9% in Roser et al.) and pulmonary complications (eg, chylothorax, hemothorax) are notable risks in several series.

Clinical consequence uncertaintyLong‑term durability and consequences of complications (including broken tethers) remain uncertain; studies often lack follow‑up to skeletal maturity.

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

archival

Previous policy version CS170LA.F was archived.