Vertebral Body Tethering for Scoliosis (for Kentucky Only)

Coverage Summary

Policy Number: CS170KY.08. Effective Date: March 1, 2025. This UnitedHealthcare (Kentucky only) policy defines coverage for vertebral body tethering (VBT) for scoliosis: VBT is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy. The intent of the policy is to summarize applicable procedure codes for reference, describe the clinical evidence base and FDA HDE indications, and provide documentation and prior authorization considerations to support payer determinations under member-specific plan rules.

Key thresholds & quick facts

Cobb angle for device indication30-65°

Coverage stanceNot medically necessary

State-specific policyKentucky only

Policy numberCS170KY.08

Medical Necessity and Indications

Medical Necessity Determination

Policy statement determining medical necessity for vertebral body tethering:

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

FDA Indications for HDE Devices (informational)

Devices with HDE approvals are indicated for the following patient characteristics (informational):

FDA Indications for HDE Devices (informational): Skeletally immature patients; Progressive idiopathic scoliosis; Major Cobb angle of 30 to 65°; Osseous structure dimensionally adequate to accommodate screw fixation as determined by radiographic imaging; Failed bracing and/or intolerant to brace wear.Cobb 30-65°

Informational — FDA HDE device indications

Evidence-based considerations impacting medical necessity

Professional Society & Position Statements

Professional Society / Position Statements (coverage context)

Statements from professional societies and position statements to inform payer interpretation and expectations:

POSNA/SRS statement: Payors should provide coverage for any FDA approved devices under stated clinical indications and requirements (limited to surgeons with active IRB approval) at the same level as traditional spinal instrumentation/fusion and growing rod procedures for skeletally immature patients (Risser ≤ 2 or Sanders ≤ 5) with idiopathic scoliosis (30 to 65° Cobb angle).

Coverage recommendation context from POSNA/SRS

NICE statement: Evidence limited and raises concerns for serious complications; VBT should only be used in the context of research and performed in specialist centers by trained spinal surgeons.

NICE interventional procedures guidance

BSS statement: VBT should be introduced in a controlled manner at limited centers with patient selection, informed consent, and registry monitoring prior to wider adoption.

Applicable Codes

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

Added/Applicable CPT codesCPT

0790T	Unspecified - added to policy (exact descriptor not provided in this part)
22838	Spinal instrumentation device (specific descriptor not provided in this part)

Device / FDA product codemixed

QHP	FDA product code referenced for HDE devices (The Tether™, REFLECT™)

Provider Actions & Billing Guidance

Prior Authorization

Prior authorization may be required per plan

UnitedHealthcare uses InterQual for primary medical/surgical criteria; coverage decisions must also follow federal, state, and contractual benefit requirements and may require prior authorization consistent with InterQual and plan rules. Plans and laws govern benefit determinations and prior authorization requirements; confirm with the member-specific benefit plan.

Related procedure codes (reference only): 0656T, 0657T, 0790T, 22836, 22837, 22838, 22899

Documentation Required

Document skeletally immature status and prior brace failure/intolerance

Document that the patient is skeletally immature and has failed or is intolerant to bracing; record radiographic suitability for screw fixation and the major Cobb angle (30–65°) to align with FDA HDE device indications.

Background & Evidence Summary

Background: Vertebral body tethering (VBT) is an anterior, fusionless surgical technique that places vertebral body screws and a tensioned flexible cord on the convex side of the spine to modulate growth and correct adolescent idiopathic scoliosis (AIS). It is intended for skeletally immature patients with progressive AIS—typically with major Cobb angles 30° to 65°—who have failed or are intolerant of bracing. Existing studies report radiographic curve correction and some functional benefits but are limited by small sample sizes, retrospective designs, and short follow-up. Reported concerns include substantial rates of complications (including pulmonary events), tether breakage, overcorrection, and higher reoperation and conversion-to-fusion rates compared with posterior spinal fusion; long-term comparative data to skeletal maturity are lacking.

Source	Key findings
Systematic reviews / meta-analyses	Multiple reviews report significant curve correction at ≥2 years but high overall complication rates (reported 18–36%), tether breakage up to ~21–37%, and reoperation rates from ~7–10% to >20% in various series
Registry / cohort findings	Registry and cohort studies report tether breakage incidence up to 36% with estimated cumulative breakage ~50% by 36 months; conversion to posterior spinal fusion reported 2–12% in different series; reoperation after breakage common
Hayes assessment	Hayes concluded minimal support for use of The Tether™ due to high complication rates, limited long-term data, low-quality studies, and inconsistent position statements; annual review found no change
Efficacy vs PSF	Comparative studies/meta-analysis show PSF often achieves greater curve correction (e.g., 66% vs 46% correction; higher % reaching <35°), while VBT may preserve motion and show some functional benefits in select studies
Complications	VBT associated with higher complication and reoperation rates vs PSF (pooled complication rates 26% vs 2%; reoperation 14.1% vs 0.6%; tether breakage frequent; pulmonary and mechanical complications reported)
Quality of evidence	Evidence predominantly small, retrospective, single-center studies and case series with short to medium follow-up; overall low quality and lack of long-term comparative RCTs to skeletal maturity

Evidence highlights

Pooled complication rates (VBT vs PSF)26% vs 2%

Pooled reoperation rates (VBT vs PSF)14.1% vs 0.6%

Registry tether breakage incidence36% (radiographic); estimated 50% by 36 months

Registry conversion-to-fusion after breakage

Definitions

Definitions:

AIS (Adolescent idiopathic scoliosis): Lateral curvature of the spine of unknown cause with a Cobb angle of at least 10° occurring in children/adolescents aged 10–18 years (definition and context of AIS and Cobb angle).

Cobb angle: Radiographic measure of spinal curvature used to quantify scoliosis severity; FDA HDE device indications specify a major Cobb angle of 30 to 65°.

VBT (Vertebral body tethering): An anterior, fusionless surgical technique using vertebral body screws and a tensioned flexible cord to modulate growth and correct progressive AIS while attempting to preserve spinal motion.

HDE (Humanitarian Device Exemption): FDA regulatory pathway permitting marketing of devices for small populations with specified indications; examples include The Tether™ and REFLECT™ with HDE product code QHP and specified indications.

PSF (Posterior spinal fusion): Standard posterior fusion surgery for scoliosis correction, used as the primary comparator in many studies.

Risser / Sanders: Staging systems used to assess skeletal maturity (policy and professional statements reference Risser ≤ 2 or Sanders ≤ 5 when describing eligible skeletally immature patients).

Revision History

2025-03-01material_changeLatest

Added CPT codes 0790T and 22838 to Applicable Codes.