ModifiedUnitedHealthcarePolicy CS170NE.K

Vertebral Body Tethering for Scoliosis (for Nebraska Only)

Policy governing coverage of vertebral body tethering (VBT) surgery for adolescent idiopathic scoliosis for members in Nebraska; defines clinical criteria, facility and surgeon requirements, and indications for revision.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for Nebraska Only)

Policy CodePolicy CS170NE.K

Change TypeRevised coverage criteria and added revision indications

Effective Date05/01/2026

Next Review Date

Key ActionObtain prior authorization documenting failed conservative management, skeletal maturity (Sanders/Risser), Cobb angle and bending-film flexibility, facility and surgeon qualifications, and IRB study participation when applicable.

SourceLink

POLICY UPDATE CHANGES

Revised language to indicate VBT may be medically necessary for idiopathic scoliosis when specific clinical, facility, surgeon, and research-study criteria are met.

Revision surgery for VBT may be medically necessary for tether breakage, hardware failure, under- or over-correction, or removal for complications (e.g., impingement, infection, intractable pain).

Added documentation requirements clarifying that medical records must support medical necessity and may be requested for review.

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

45-65°Cobb Angle range for primary treated curve

Sanders 2-5Required skeletal maturity

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Instrumentation limits

20–55%Reported tether breakage rates

75%Two-year success rate (IDE)

20%Overall reoperation rate (mean 3.8 yr)

Coverage Criteria for Vertebral Body Tethering (VBT)

inv-01: Initial VBT — medical necessity criteria

Covered when ALL of the following are met:

Clinical eligibility: Physician documentation of failed conservative management with curvature progression to at least 45 degrees; major coronal Cobb angle 45–65° for the single curve planned and no spinal curve >65°; Sanders Maturity Score 2–5; Cobb angle decreases to ≤30° on bending films; osseous structure adequate for screw fixation; VBT instrumentation does not extend above T4 or below L4.see individual nodes

supported by chunks 3 and 4

Facility and surgeon requirements: Procedure performed at a facility with an established on-site pediatric scoliosis surgical program, inpatient pediatric physical therapy, intraoperative advanced imaging capability, pediatric anesthesiologist on staff, and a pediatric intensive care unit; surgery performed by a pediatric orthopedic spine surgeon experienced in VBT who is listed as an investigator on a prospective IRB-approved, actively recruiting study using The Tether™ VBT System; documented Shared Decision‑Making conversation with patient/family.program and investigator requirements

supported by chunk 4

inv-02: Revision VBT — indications

Revision VBT is 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).N/A

supported by chunk 5

inv-03: Study-derived favorable selection criteria

Study-derived patient selection and predictors of better outcomes (examples from IDE and cohort studies):

Typical favorable selection: Skeletally immature patients (commonly Sanders ≤4 or Risser ≤2) AND primary Cobb angle in study ranges (commonly ~40°–70°) AND flexible curve on preoperative bending/fulcrum radiographs (suggested <30–35°) AND ability to achieve adequate intraoperative correction (postoperative Cobb <35° associated with success).

Derived from FDA IDE and cohort analyses (Larson IDE and cohort series)

inv-04: Risk factors for revision or conversion to fusion

Factors associated with failure, revision, or conversion:

Predictors of poor outcome: Inadequate intraoperative correction (higher immediate postop Cobb), younger or very skeletally immature patients prone to overcorrection, radiographic tether breakage, and thoracolumbar curve progression — all associated with higher reoperation and conversion to PSF.

Associated with higher reoperation and fusion rates in mid-term follow-up

inv-05: Patient selection

Evidence summary related to patient selection and expected outcomes

Key considerations for candidate selection: Younger, skeletally immature patients with flexible thoracic curves have been primary VBT candidates; curve magnitude, skeletal maturity, and flexibility influence outcome and risk of overcorrection or tether failure.Risser 0-2 or Sanders 2-5 referenced in cohort studies

Immature patients may gain greater growth-modulated correction but face higher overcorrection risk; longer-term data limited.

inv-06: Expected outcomes and risks

Outcomes and comparative performance

Expected radiographic outcomes: Most series report significant mean Cobb angle reduction at ≥2 years; pooled analyses show mean pre-op ~48° reduced to ~20–27° with overall clinical success ≈73%; PSF achieves greater immediate correction and a higher proportion of residual curves <35°.Residual curve <35° achieved in ~76% of VBT patients vs ~97% in PSF (reported studies)

Derived from comparative and single-arm meta-analyses

Complications and reoperation rates: Complication rates vary (approximately 18–37%); tether breakage reported between ~6% and 36% in cohorts and meta-analyses; reoperation/conversion to PSF ranges ~7–24% depending on series and follow-up, with higher rates at longer follow-up.Tether breakage cumulative up to 50% by 36 months in some series

Not all tether breaks require revision, but breakage is a leading reason for reoperation.

inv-07: Durability considerations

Durability and timing considerations

Effect of skeletal maturity on durability: Tether breakage after skeletal maturity may have limited clinical impact if sufficient growth modulation occurred, whereas tether failure before maturity can permit substantial curve progression; follow-up to skeletal maturity is often lacking and longer-term data are needed.Follow-up to skeletal maturity often lacking; inflection in complications often noted beyond 24–36 months

Supported by cohort analyses and systematic reviews

inv-08: VBT candidate coverage criteria

Covered when ALL of the following are met (as supported by position statements and device indication):

Patient selection: Patient is skeletally immature (Risser ≤ 2 or Sanders ≤ 5).Risser ≤ 2 or Sanders ≤ 5

POSNA/SRS position statement and cohort/device guidance

Curve magnitude: Major Cobb angle between 30° and 65°.30–65°

Consistent with FDA HDE indication for The Tether

Conservative therapy failure: Failed bracing and/or intolerance to brace wear documented.failed/intolerant bracing

FDA HDE requirement

inv-10: Facility and surgeon requirements

AND the facility and surgeon must meet ALL of the following:

Facility criteria: On-site pediatric scoliosis surgical program; inpatient pediatric physical therapy available; intraoperative advanced imaging capability; pediatric anesthesiologist on staff; pediatric intensive care unit available.

Supported by policy language

Surgeon and research criteria: Procedure performed by a pediatric orthopedic spine surgeon experienced in VBT and listed as an investigator on a prospective IRB‑approved research study using The Tether™ VBT System (HDE/FDA) that is actively recruiting and for which the member is a study cohort candidate; documented Shared Decision‑Making conversation.

Supported by policy language

inv-11: Revision VBT criteria

Revision surgery for VBT 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 such as impingement on vital organs, infection, or intractable pain.

Supported by policy revision text

inv-12: Not medically necessary

Not medically necessary: VBT surgery (initial or revision) is not medically necessary when the specified clinical, facility, surgeon, research‑study, or required documentation criteria are not met.

Supported by chunks 5 and 75

VBT is not medically necessary when the stated coverage criteria are not met. Requests for initial VBT that do not satisfy the policy’s clinical thresholds (including documented failed conservative management with progression to ≥45° Cobb, Cobb angle and bending film flexibility thresholds, and Sanders skeletal maturity requirements), the facility program and pediatric support requirements, the surgeon experience/IRB study participation requirements, or the required medical record documentation will be denied as not medically necessary.

Available evidence includes retrospective series, systematic reviews, and limited comparative studies with short- to mid-term follow-up; reviewers have noted a lack of long-term (>3–4 year) clinical and safety data. Comparative evidence versus posterior spinal fusion (PSF) is limited, and several reviews report higher complication and revision rates after VBT, leading to uncertainty about long-term benefit.

Existing published studies of The Tether are small, often single-center, and generally lack follow-up through skeletal maturity. Available series do not provide definitive comparative evidence against spinal fusion through skeletal maturity, and reviewers have emphasized that larger, multicenter studies following patients to skeletal maturity are needed to validate outcomes.

Professional society statements do not support use of anterior non-fusion instrumentation in skeletally mature individuals. POSNA and SRS explicitly state that reimbursement and use of anterior non-fusion instrumentation (including VBT) is not supported for skeletally mature patients, and there are no published reports demonstrating benefit in mature individuals.

VBT surgery is not medically necessary when the specified clinical, facility, surgeon, research-study, or documentation criteria are not met. This includes failure to meet the multi-part clinical thresholds (e.g., Cobb angle, Sanders score, bending film flexibility), lack of required facility pediatric program elements, surgeon experience or investigator listing on an IRB‑approved VBT study, or absence of supporting medical record documentation.

Any initial VBT cases that do not meet the listed clinical eligibility, facility and pediatric program, surgeon experience/IRB study participation, or required documentation elements are considered not medically necessary and are not covered under this policy.

Because high-quality comparative evidence is limited and several analyses report relatively high complication and revision rates (including tether breakage and conversion to fusion), VBT may be considered investigational or appropriate only in defined research settings for many patients. Guidance such as NICE recommends use of VBT in the context of research due to concerns about serious complications and insufficient long-term data.

For patients in whom established posterior spinal fusion (PSF) is indicated and preferred (for example, older adolescents near skeletal maturity seeking maximal durable correction), PSF should be considered the established therapy. Comparative data show PSF achieves higher immediate radiographic correction and lower reoperation rates than VBT in many series.

Procedures in patients outside the evidence-supported indications — where studies do not show improved outcomes compared with PSF and where VBT carries higher complication or reoperation risk — are not supported by current evidence. This includes mature patients or those with curve characteristics outside device or policy thresholds.

Initial or revision VBT procedures that do not meet the policy’s clinical thresholds, facility capabilities, surgeon experience/IRB study participation, or required documentation are considered not covered. Revision surgery is covered only when specified indications (e.g., tether breakage, hardware failure, under/over-correction, or removal for complication) are present.

Coding and Codes Related to VBT

Applicable procedure CPT/HCPCS codesmixed

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

Devices discussedmixed

Device: The Tether

Proprietary growth modulation device assessed in evidence reviews

Device/Product codes (informational)mixed

QHP	FDA product code referenced for The Tether (informational)

inv-26: Minimum preoperative major curve

Minimum preoperative major curve>= 45 degrees

ContextDocumentation must show failed conservative management with progression to at least 45° prior to initial VBT

Policy referenceInitial VBT clinical criteria specify major coronal curve 45–65° for planned single curve

inv-27: Allowed major curve for surgery

Allowed major curve for surgery45 to 65 degrees

RestrictionNone of the spinal curves present may be greater than 65°

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required — Clinical & Documentation Prerequisites

Prior authorization is required to demonstrate that all listed clinical criteria, facility capabilities, and surgeon/IRB study participation are met. Requests should include documentation showing failed conservative management with documented progression to at least 45° prior to VBT, patient age and skeletal maturity (Sanders score), primary curve magnitude (Cobb angle), fulcrum- or bending-film flexibility, and osseous dimensions adequate for screw fixation. Absent or incomplete documentation of these elements may lead to denial.

Prior authorization required for initial VBT and revisions
Document failed conservative management (e.g., bracing, observation, physical therapy) with progression to ≥45°
Provide Cobb angle(s) for major and other curves; major curve 45–65° for planned single-curve VBT and no curve >65°
Provide skeletal maturity: Sanders score 2–5 (or Risser when documented)
Include bending- or fulcrum-film showing major curve decreases to ≤30° (flexible curve)
Document osseous dimensions adequate for screw fixation and that instrumentation will not extend above T4 or below L4
Facility must have pediatric scoliosis program, inpatient pediatric PT, intraoperative advanced imaging, pediatric anesthesiologist, and pediatric ICU

Background and Evidence Summary

Adolescent idiopathic scoliosis (AIS) is a progressive lateral and rotational spinal curvature typically occurring between ages 10 and 18 and quantified radiographically by the Cobb Angle. VBT is an anterior, growth‑modulating, non‑fusion technique intended to correct progressive curves in skeletally immature patients while preserving spinal motion; it has been evaluated primarily in research and selective clinical series.

Definitions

inv-58: Cobb Angle

Cobb Angle — definitionAn objective radiographic method to measure spinal curvature; preferred standard for quantifying scoliosis

UsageAdopted by the Scoliosis Research Society as the standard measurement method

ReproducibilityPreferred for better reproducibility and applicability to severe curvature

inv-59: Lenke Classification System

Lenke Classification System — definitionCurve classification system for adolescent idiopathic scoliosis used to categorize curve type and modifiers for surgical planning

ComponentsIncludes curve type (1–6), sagittal thoracic modifier, and lumbar modifier to guide levels for arthrodesis

Policy Revision History

2026-05-01policy_revisionLatest

Revised coverage rationale to specify multi-part clinical criteria for VBT (including Cobb angle 45–65°, Sanders score 2–5, bending film flexibility ≤30°, osseous adequacy, and instrumentation limits T4–L4), facility and surgeon requirements, shared decision‑making, and that revision VBT may be medically necessary for tether breakage, hardware failure, under‑ or over‑correction, or removal for complications.

Policy Summary

PayerUnitedHealthcare

PolicyVertebral Body Tethering for Scoliosis (for Nebraska Only)

Policy CodePolicy CS170NE.K

Change TypeRevised coverage criteria and added revision indications

Effective Date05/01/2026

Next Review Date

SourceLink

On This Page

Surgeon/center requirements: Procedure performed by surgeons with specific training in anterior spinal surgery at specialized centers; IRB approval or participation in research registry when required.specialist center and surgeon training

POSNA/SRS recommends IRB‑approved use; NICE recommends research context

Shared decision-making: Patient/family counseled on higher complication and reoperation rates compared with PSF and alternatives discussed; documentation of Shared Decision‑Making.documented shared decision-making

SRS and systematic review conclusions

Related requirementOsseous structure must be adequate for screw fixation

inv-28: Bending film reduction requirement

Bending film reduction requirementCobb angle decreases to 30 degrees or less on bending films

PurposeDemonstrates sufficient curve flexibility for VBT candidacy

Policy citationListed as a required clinical criterion for initial VBT

inv-29: Skeletal maturity (Sanders)

Skeletal maturity (Sanders)Sanders Maturity Score 2 to 5

Definition sourceSanders Skeletal Maturity Staging System (hand/wrist x‑ray staging)

RoleDefines skeletal immaturity required for initial VBT candidacy

inv-30: Follow-up time

Follow-up time — clinical inflectionMany complications and tether failures increase beyond 24 months; notable inflection at 24–36 months

EvidenceCahill et al. reported most initial breaks at/after 24 months with cumulative breakage rising from 19% at 24 months to 50% at 36 months

ImplicationLonger follow-up (≥36 months) shows higher complication and reoperation rates; durability assessment requires follow-up to skeletal maturity

inv-31: Cobb angle (device HDE)

Cobb angle (device HDE indication)30–65°

DeviceThe Tether™ HDE indication specifies major Cobb angle 30–65° and osseous structure adequate for screw fixation

Prior therapyPatients should have failed bracing and/or be intolerant to brace wear per HDE

inv-32: Skeletal maturity

Skeletal maturity — policy limitsRisser ≤ 2 or Sanders ≤ 5

Policy contextPOSNA/SRS and device guidance reference Risser ≤2 or Sanders ≤5 for candidate selection

Relation to outcomesImmature patients achieve more growth-modulated correction but have higher overcorrection risk

inv-33: Cobb Angle (policy)

Cobb Angle (policy) — major coronal curveMajor coronal curve 45 to 65 degrees

Upper limitNo spinal curves present may be greater than 65 degrees

Related criterionCurve must decrease to ≤30° on bending films to demonstrate flexibility

inv-34: Skeletal maturity (Sanders score)

Sanders Maturity Score requirementSanders Maturity Score 2 to 5

Assessment methodDetermined by hand/wrist x‑ray per Sanders Skeletal Maturity Staging System

PurposeUsed to define skeletal immaturity for initial VBT candidacy

inv-35: Flexibility on bending films

Flexibility on bending filmsCobb angle decreases to 30 degrees or less on bending films

Policy useRequired clinical criterion for initial VBT to document curve flexibility

Clinical implicationSupports selection of patients likely to achieve growth‑modulated correction

Surgeon must have VBT experience and be an investigator on an IRB‑approved, actively recruiting prospective study (when device is used under HDE)

Include shared decision‑making documentation with patient/family

Documentation Required

Required Clinical Prerequisites for Review

Prior authorization should document detailed clinical prerequisites commonly required in clinical studies and device labeling. Provide the patient’s chronological age at surgery, skeletal maturity (Sanders score and/or Risser), preoperative Cobb angle(s) with curve classification, results of bending/fulcrum radiographs (showing flexibility to ≤30°), prior bracing history including evidence of failure or intolerance, and imaging measurements demonstrating adequate vertebral osseous dimensions for pedicle/anchor screw placement.

Patient age at surgery and growth potential indicators (Sanders score, Risser)
Preoperative coronal Cobb angles for all curves and planned instrumented levels
Fulcrum‑ or bending‑film flexibility demonstrating reducible curve (≤30°)
Documentation of prior bracing: duration, adherence, and evidence of continued progression or intolerance
Radiographic measurements of vertebral body size and pedicle/anchor screw feasibility
Intraoperative plan details (levels instrumented, intended tensioning), when available for review

Prior Authorization

Prior Authorization Recommended — Candidate Selection and Alternative Therapies

Given variable outcomes and substantial reported rates of tether breakage, revisions, and conversions to posterior spinal fusion (PSF), prior authorization is recommended to ensure appropriate candidate selection and that alternative established therapies (e.g., PSF) have been considered. Denial may result if the multi-part clinical, facility, surgeon, or study criteria are not met or if required documentation is missing.

Consideration of PSF: comparative studies show higher rates of residual curve <35° and lower reoperation rates with PSF
High reported tether breakage and subsequent reoperation/conversion rates should be discussed with patient/family in shared decision‑making
Prior authorization recommended to verify all clinical, facility, and surgeon/study criteria are satisfied before approval

Documentation Required

Medical Record Documentation Requirements for Review

The patient’s medical record must contain documentation that fully supports medical necessity for the requested service. Required elements include relevant history, physical examination findings, diagnostic test results, imaging (standing, bending/fulcrum radiographs), documentation of prior conservative therapy and its failure or intolerance, Sanders/Risser maturity scores, and measurements showing adequate osseous structure for fixation. Lack of these records may be a basis for denial.

History and physical exam supporting indication for VBT
Standing coronal and sagittal radiographs with measured Cobb angles
Bending/fulcrum radiographs documenting curve flexibility
Documentation of prior conservative management and progression to ≥45°, or brace intolerance
Sanders maturity score (2–5) and/or Risser score documentation
Radiographic measurements confirming vertebral osseous dimensions adequate for anchor/screw fixation

Note

FDA HDE / Research Study Documentation

When The Tether™ or other growth‑modulation systems are used under FDA Humanitarian Device Exemption (HDE) labeling or within research protocols, authorization requests must include evidence of FDA indication conformity (failed bracing/intolerance, Cobb 30–65° when applicable), and documentation of IRB‑approved prospective study enrollment or investigator status when required by payer policy.

Document HDE indication elements (failed bracing/intolerance; osseous adequacy; Cobb angle per labeling)
If coverage requires participation in an IRB‑approved prospective study, include study title, IRB approval identifier, and surgeon listed as investigator
Include links or references to relevant FDA HDE information when available

Clinical roleReferenced in operative planning and selecting instrumented levels

inv-60: Institutional Review Board (IRB)

Institutional Review Board (IRB)An independent ethics committee that reviews, approves, and monitors clinical research involving human participants

Policy roleIRB‑approved prospective research study participation is required for surgeon investigator listing per policy

ProtectionEnsures ethical conduct and participant safety in clinical research

inv-61: Sanders Skeletal Maturity Staging System

Sanders Skeletal Maturity Staging System — definitionA hand/wrist x‑ray staging system (levels 1–8) used to assess skeletal maturity

Policy useSanders score 2–5 defines skeletal immaturity required for initial VBT per policy

InterpretationLower Sanders levels indicate more remaining growth; higher risk of overcorrection in very immature patients

inv-62: Shared Decision-Making

Shared Decision-Making — definitionA collaborative process where provider, patient, and family discuss options, risks, and preferences to make a healthcare decision together

Policy requirementDocumented shared decision‑making with patient/family is required per facility and surgeon criteria

ComponentsShould include discussion of higher complication and reoperation rates compared with PSF and alternatives

inv-63: Success (as defined in IDE study)

Success (IDE study definition)Two‑year outcome defined as major Cobb angle < 35° and no reoperation

Study evidenceLarson IDE reported 75% success at two years using this definition

UseUsed as a study endpoint to evaluate effectiveness of VBT

inv-64: Radiographic tether breakage

Radiographic tether breakage — definitionRadiographic sign defined as an increase in adjacent screw angle >5° from minimum over follow-up

Study applicationCahill et al. used this definition to identify tether breaks in registry data

Clinical consequenceAssociated with larger final curve and higher rates of reoperation including conversion to PSF

inv-65: Tether breakage

Tether breakage — characterizationRadiographically identified increase in adjacent screw angle >5° from minimum; commonly reported complication

FrequencyCahill et al. reported 36% radiographic breakage in 208 patients with many initial breaks at/after 24 months

Outcome associationBreakage linked to higher reoperation and conversion to PSF rates

inv-66: Skeletal maturity indicators

Skeletal maturity indicatorsRisser stage and Sanders staging are used to stratify remaining growth

Policy thresholdsPolicy references Sanders 2–5 and Risser ≤2 as indicators of skeletal immaturity for candidacy

Clinical relevanceMaturity affects growth‑modulated correction and risk of overcorrection or loss of correction

inv-67: The Tether (VBT system, FDA HDE)

The Tether (VBT system)The Tether™ — vertebral body tethering system granted FDA Humanitarian Device Exemption (HDE) for skeletally immature patients

Indication summaryIndicated for patients with progressive idiopathic scoliosis, major Cobb angle 30–65°, failed/intolerant bracing, and adequate osseous structure

Policy linkagePolicy references The Tether HDE and requires IRB‑approved study investigator listing for surgeon per facility criteria

inv-68: Skeletal immaturity

Skeletal immaturity — policy definitionRisser ≤ 2 or Sanders ≤ 5

Policy useReferenced as common candidate selection limits by POSNA/SRS and in policy coverage criteria

Relation to device HDEHDE and position statements limit use to skeletally immature patients

inv-69: Cobb Angle (def)

Cobb Angle (def)Measure of coronal plane spinal curvature using radiographs; standard method for quantifying scoliosis

Clinical adoptionPreferred for reproducibility and use in severity assessment and study endpoints

Policy roleUsed as the primary radiographic threshold for VBT candidacy and outcomes

inv-70: Lenke Classification System (def)

Lenke Classification System (def)Scoliosis curve classification system used to guide surgical planning and determination of instrumented levels

ComponentsIncludes curve types, sagittal thoracic modifier, and lumbar modifier

Use in policyReferenced among definitions added in policy revision to clarify surgical planning terminology

inv-71: Sanders Skeletal Maturity Staging System (def)

Sanders Skeletal Maturity Staging System (def)Radiographic staging system using hand/wrist x‑rays to assess remaining skeletal growth (levels 1–8)

Policy linkageSanders score used as a key eligibility criterion (2–5) for initial VBT

InterpretationLower scores indicate more remaining growth; informs risk of overcorrection

inv-72: Institutional Review Board (IRB) (def)

Institutional Review Board (IRB) (def)Committee approving human subjects research; required for referenced study participation criteria

Policy roleSurgeon must be listed as investigator on IRB‑approved prospective VBT study for policy coverage in specified scenario

PurposeProtects participant safety and ensures ethical conduct of research

inv-73: Shared Decision-Making (def)

Shared Decision-Making (def)Documented discussion between surgeon, patient, and family regarding risks, benefits, and alternatives

Policy requirementDocumentation of shared decision‑making is required per facility and surgeon criteria for initial VBT

Content suggestionsShould include discussion of higher complication and reoperation rates compared with PSF