CurrentUnitedHealthcarePolicy CS330NE.E

Percutaneous Vertebroplasty and Kyphoplasty (for Nebraska Only)

State-specific medical policy for Nebraska governing coverage of percutaneous vertebroplasty and kyphoplasty for treatment of painful vertebral compression fractures and certain neoplastic or osteonecrotic indications; applies to providers and members in Nebraska.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Vertebroplasty and Kyphoplasty (for Nebraska Only)

Policy CodePolicy CS330NE.E

Change TypeState-specific version and documentation clarifications

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionDocument failure of Optimal Medical Therapy and provide required medical records showing symptom duration, pain scores, and correlating imaging to support prior authorization and coverage evaluation.

SourceLink

POLICY UPDATE CHANGES

Created state-specific policy version for the state of Nebraska (no change to coverage guidelines).

Updated reference link to the guidelines titled Medical Records Documentation Used for Reviews.

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to assess whether clinical criteria are met but does not guarantee coverage.

Updated Clinical Evidence and References sections to reflect the most current information.

4 monthsmaximum time from pain onset to be eligible

CS330NE.Epolicy identifier

Nebraskaapplicability

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22510-22515CPT codes listed

Level IIAAOS recommendation strength

Coverage Criteria for Vertebral Augmentation

inv-01: Medically Necessary Indications — Covered when ALL of the following are met

Covered when ALL of the following are met

Primary coverage criteria: 1) Pain causing Functional or Physical Impairment in cervical, thoracic, or lumbar vertebral bodies within 4 months of pain onset; 2) Failure to respond to Optimal Medical Therapy; 3) Indication is one of: osteoporotic vertebral compression fracture (VCF), steroid-induced vertebral fracture, osteolytic metastatic disease involving a vertebral body, multiple myeloma involving a vertebral body, vertebral hemangioma with aggressive features, or unstable fractures due to osteonecrosis (e.g., Kummel disease); 4) CT or MRI has ruled out other causes of spinal pain (e.g., foraminal stenosis, facet arthropathy, herniated intervertebral disk, other degenerative disease) and has ruled out clinical spinal cord compression, significant vertebral collapse or destruction (e.g., vertebra reduced to less than one-third of original height), healed VCF, lesions of the sacrum or coccyx, and the VCF is symptomatic and not responding to conservative therapy.within 4 months of pain onset

Per policy coverage rationale

inv-02: Evidence summary informing coverage — Evidence synthesis conclusions relevant to coverage decisions

Evidence synthesis conclusions relevant to coverage decisions:

Evidence supports selective use: Moderate-quality evidence suggests kyphoplasty may benefit some patients with osteoporotic VCFs not responsive to conservative treatment; vertebroplasty has mixed results versus sham and may show benefit versus conservative care in some analyses. Large database studies suggest possible mortality and complication differences between techniques but findings are limited by study design and heterogeneity.

Hayes HTA, meta-analyses, and Cochrane review summarized

inv-03: Patient selection — Patient selection considerations supported by the literature

Patient selection considerations supported by the literature:

Selection factors: Consider patient age, body mass index (BMI), bone mineral density, fracture severity (including high-degree collapse or vertebra plana), symptom duration, presence of intravertebral cleft or bone marrow edema, and correlation of pain to imaging and exam findings; lower BMI and occurrence of subsequent OVCF have been associated with poorer functional outcomes in some series.

Study-level predictors and observational findings

inv-04: Evidence and guideline-derived coverage-relevant conclusions — Evidence and guideline-derived positions and study outcomes

Evidence and guideline-derived positions and study outcomes present the following criteria-relevant points:

Symptomatic vertebral hemangioma: Case series report rapid and sustained pain relief and functional improvement after percutaneous vertebroplasty for symptomatic vertebral hemangiomas with low reported complication rates.based on small case series

Hao and Hu 2012; Boschi et al. 2012

Kümmell's disease treatment options: PVP and PKP are reported as safe and effective for neurologically intact Kümmell's disease; PKP tends to achieve superior radiographic correction and lower cement leakage but with greater resource use; network meta-analyses and comparative studies show similar clinical pain and function outcomes between techniques.multiple comparative studies and meta-analyses

Multiple retrospective and prospective studies and NMAs summarized

Conservative therapy prior to augmentation:

The policy excludes procedures when imaging (CT or MRI) or clinical evaluation demonstrates any of the following: lesions of the sacrum or coccyx, asymptomatic vertebral compression fractures (VCFs), healed VCFs, or significant vertebral collapse or destruction (for example, vertebra reduced to less than one-third of its original height). Procedures also are not indicated when the VCF is responding appropriately to conservative therapy or when there is clinical evidence of spinal cord compression.

Clinical studies that formed comparative evidence for percutaneous kyphoplasty (PKP) versus vertebroplasty (PVP) explicitly excluded patients with conditions that could confound outcomes. Exclusion criteria in these studies included neoplastic etiologies (metastasis or myeloma), infection, neural compression, traumatic fracture, neurologic deficit, spinal stenosis, severe degenerative spine disease, prior surgery at the involved vertebral body, or combined invasive/semi-invasive interventions.

More specifically, the PKP versus PVP meta-analysis and the individual comparative studies excluded patients with a neoplastic etiology (such as metastasis or multiple myeloma), active spinal infection, evidence of neural compression or existing neurologic deficit, traumatic fractures, or severe coexisting spinal disease (e.g., advanced degenerative disease or prior surgery at the index vertebral level). These exclusions limit generalizability of the comparative results to those populations.

Professional guidance and consensus statements note that vertebral augmentation is intended to treat symptomatic fractures and is not recommended as a preventive intervention. There is no indication for vertebral augmentation for prophylaxis against future fracture according to multi-society and consensus statements.

This document excerpt does not list every possible exclusion or contractual restriction. Users must reference the full UnitedHealthcare policy and applicable federal, state, or contractual benefit terms for complete exclusion criteria and coverage determinations.

The policy states that percutaneous vertebroplasty and kyphoplasty are unproven and not medically necessary when used for indications other than the specific covered conditions listed in the criteria, citing insufficient evidence of efficacy for other uses.

A Cochrane review (Buchbinder et al., 2018) concluded that, based on high- to moderate-quality evidence, vertebroplasty did not demonstrate clinically important benefits compared with placebo (sham) for acute or subacute osteoporotic vertebral fractures and highlighted the potential for serious adverse events; the reviewers recommended informing patients about the lack of demonstrated benefit and potential harms.

The American Academy of Orthopaedic Surgeons (AAOS) guidance (2010, updated 2023) recommends against vertebroplasty for patients with osteoporotic spinal compression fractures who are neurologically intact, based on Level II evidence showing no significant difference versus sham in pain and function. The AAOS considers kyphoplasty an option with limited evidence of short-term benefit.

This partial document does not include explicit 'not medically necessary' adjudications for every scenario. For determinations about noncoverage or 'not medically necessary' status, refer to the full policy text and the member's applicable benefit terms.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization / Documentation Required

Prior authorization may be required for percutaneous vertebroplasty and kyphoplasty (vertebral augmentation). Coverage applies when clinical criteria are met for specified indications (e.g., osteoporotic VCF, metastatic disease, multiple myeloma, aggressive hemangioma, steroid-induced fracture, unstable osteonecrosis) within 4 months of pain onset after failure of Optimal Medical Therapy. Medical records documentation may be requested to verify that conservative therapy failed and that imaging excludes alternative pain generators.

Confirm benefit terms and any prior authorization requirements per federal, state, or contractual plan provisions before requesting the procedure.
Document failure of Optimal Medical Therapy and correlate symptoms with imaging (CT or MRI) to localize pain to the treated vertebral level.
Medical records may be requested and submission does not guarantee coverage.

Note

Evidence Limitations for Vertebroplasty

Evidence limitations exist for vertebroplasty (PVP). High- to moderate-quality systematic reviews and randomized trials have not demonstrated clinically important benefit of vertebroplasty versus sham/placebo for acute or subacute osteoporotic VCFs, and potential harms have been reported. Kyphoplasty (KP/PKP) has more consistent evidence of benefit for selected patients who fail conservative therapy, but overall comparative evidence is mixed.

CPT Codes and Coding References

Applicable CPT CodesCPT

22510	Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic.
22511	Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral.
22512	Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure).
22513	Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g., kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic.
22514	Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g., kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar.
22515	Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g., kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (List separately in addition to code for primary procedure).

Definitions and Key Terms

Functional or Physical Impairment

DefinitionA deviation from normal tissue or organ function resulting in significantly limited capacity to move, coordinate actions, or perform physical activities (affecting physical/motor tasks, independent movement, or basic life functions).

Relevance to coveragePolicy requires pain causing a Functional or Physical Impairment as part of the primary coverage criteria for vertebral augmentation.

Clinical manifestation examplesMarked difficulty with mobility, activities of daily living, or sustained reduced physical function tied to the vertebral fracture level by exam and imaging.

Optimal Medical Therapy

DefinitionTreatments that are employed as first line before moving to more invasive, risky, or complex procedures.

Examples

Background and Clinical Context

Vertebroplasty and kyphoplasty are percutaneous procedures that stabilize painful vertebral compression fractures by injecting an acrylic polymer such as polymethylmethacrylate (PMMA) into the vertebral body. Kyphoplasty typically uses an inflatable bone tamp ('balloon') to create a cavity and may allow partial vertebral height restoration before cement injection; both procedures aim to relieve pain and improve function when conservative therapy has failed.

Policy Revision History

2025-11-01state_specific_versionLatest

Created state-specific policy version for Nebraska (no change to coverage guidelines).

2025-06-01reference_update

Updated reference link to the guidelines titled 'Medical Records Documentation Used for Reviews'.

2025-01-01policy_text_addition

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Vertebroplasty and Kyphoplasty (for Nebraska Only)

Policy CodePolicy CS330NE.E

Change TypeState-specific version and documentation clarifications

Effective DateJan 1, 2025

Next Review DateN/A

SourceLink

On This Page

Conservative management is first-line; vertebral augmentation is considered for symptomatic fractures refractory to medical therapy (failure defined as pain refractory to oral medications or requiring parenteral narcotics/hospitalization) and when pain localizes to the fracture level on imaging and exam.

ACR/consensus guidance applies

ACR and multi-society practice parameters emphasize failure of conservative care prior to augmentation

AAOS position on osteoporotic VCF: AAOS recommends against vertebroplasty for neurologically intact osteoporotic spinal compression fractures based on Level II evidence showing no benefit over sham; kyphoplasty is considered an option with limited short-term benefits in some trials.AAOS guidance (updated 2023)

AAOS guidance may influence consideration of vertebroplasty vs kyphoplasty

Inform patients about high- to moderate-quality evidence that vertebroplasty may show no important benefit compared with placebo and has potential risks.
Refer to systematic reviews and HTAs indicating kyphoplasty may benefit some patients after failed conservative care, while vertebroplasty evidence is less favorable.

Documentation Required

Excluded Clinical Situations in PKP vs PVP Studies

Clinical studies comparing percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) commonly exclude certain clinical situations. These exclusions should be recognized when assessing applicability of trial results to individual patients.

Common exclusions in PKP vs PVP studies: neoplastic etiology (metastasis or myeloma) when not under study, active infection, neural compression or spinal cord compression, traumatic fracture, neurological deficit, spinal stenosis, severe spinal deformity, previous surgery at the involved vertebral body, and concurrent invasive interventions.
When treating neoplastic fractures, cancer-specific evidence and guidance (e.g., multiple myeloma, metastatic disease) should be reviewed separately.

Step Therapy

Step Therapy / Sequencing Information Not Specified

No step-therapy or explicit sequencing (step therapy specifics) are specified in this policy excerpt. Conservative management (Optimal Medical Therapy) is required prior to vertebroplasty or kyphoplasty, but the policy does not define step therapy rules, timeframes beyond the 4-month pain-onset window, or mandated prior noninvasive modalities.

Confirm any plan-specific step therapy or utilization management programs separately; absence of step-therapy details here does not preclude payer-level requirements.
Conservative therapy and documented failure are prerequisites for coverage consideration, but specific step sequences are not provided in this policy portion.

Analgesics, activity modification, physical therapy, bracing, and other non-surgical management used prior to considering vertebral augmentation.

Policy roleFailure of Optimal Medical Therapy is required prior to authorization of vertebroplasty or kyphoplasty per the coverage criteria.

Osteonecrosis (including Kümmell disease)

DefinitionA bone disease caused by reduced blood flow to bone leading to bone breakdown; also referred to as avascular necrosis, aseptic necrosis, pseudarthrosis, or Kummell disease in the context of unstable vertebral fractures.

Common causes/risk factorsSteroid medications, alcohol use, injury; risk factors include radiation, chemotherapy, and organ transplantation.

Policy relevance (Kümmell disease)Unstable fractures due to osteonecrosis (e.g., Kummell disease) are listed as a potential covered indication for vertebral augmentation when criteria are met.

Vertebral Hemangiomas

DefinitionBenign vascular tumors of the bony spine, usually asymptomatic; a subset (aggressive hemangiomas) can have extra‑osseous extension, bone expansion, disturbed blood flow, and may cause compression fractures.

Typical locationMost often occur between T3 and T9 vertebral segments.

Policy relevanceSymptomatic vertebral hemangiomas with aggressive features are included among indications where vertebral augmentation (e.g., PVP) has case-series evidence of rapid and sustained pain relief.

High-degree fracture (HDF) / Vertebra plana (VP)

ClassificationHigh-degree fracture (HDF): vertebral body collapse > 50% of original height; Vertebra plana (VP): > 70% collapse.

UseThese categories are used in surgical series to stratify fracture severity and guide treatment selection (e.g., percutaneous augmentation).

Clinical implicationMore severe collapse (VP) may have greater pain reduction after surgical cement augmentation compared with conservative care, per retrospective series.

SpineJack®

Device descriptionSpineJack® is an expandable titanium implant used with cement augmentation to restore vertebral body height and correct kyphosis.

Comparative contextEvaluated in a pilot randomized prospective study comparing SpineJack® versus balloon kyphoplasty, showing improved vertebral height restoration and kyphosis correction with SpineJack® while both techniques improved pain and function over follow-up.

Typical outcomes reportedAnalgesic use, VAS pain scores, ODI, and quality-of-life measures were improved with both SpineJack® and BKP; SpineJack® showed superior height restoration in preliminary results.

OPM / OPLA (trial control definitions)

OPM definitionOptimized medical management (OPM): non-surgical, best-practice conservative care used as a comparator in trials (e.g., analgesics, activity modification, physical therapy, bracing).

OPLA definitionOpen-label placebo/local anesthetic (OPLA): placebo or local anesthetic control arms used in double-blind trials to assess procedure-specific effects of vertebroplasty/kyphoplasty.

Trial relevanceDouble-blind trials using OPLA showed PVP no better than local anesthetic, highlighting the importance of these control arms in interpreting efficacy versus shams.

Failure of conservative therapy

ACR-based definitionFailure of conservative therapy: pain refractory to oral medications or requiring parenteral narcotics or hospital admission (per ACR guidance).

Clinical documentationDocumentation should show non-operative therapy was tried and ineffective and that pain localizes to the fracture level by exam and imaging.

Policy implicationProfessional society consensus and practice parameters indicate vertebral augmentation is offered only when non-operative medical therapy has not provided adequate pain relief or pain significantly alters quality of life.

Vertebral augmentation (PVP and PKP)

Procedures includedVertebral augmentation comprises minimally invasive percutaneous vertebroplasty (PVP) and balloon kyphoplasty (BKP/PKP), which stabilize VCFs by injection of bone cement; kyphoplasty involves cavity creation (balloon) prior to cement to restore height.

Key technical pointsPVP involves cement injection into the vertebral body; PKP/BKP includes cavity creation (fracture reduction) and may reduce kyphotic deformity before cement placement.

Policy roleThese procedures are the interventions referenced throughout the policy for treating symptomatic osteoporotic, neoplastic, hemangioma-related, or osteonecrotic VCFs when criteria are met.

2025-01-01supporting_information_update

Updated Clinical Evidence and References sections to reflect the most current information and archived previous policy version CS330.D.