Procedures performed at more than two (2) levels of the T5-L5 spine on the same date of service are outside the stated covered indication. The policy limits vertebral augmentation to no more than two (2) levels between T5 and L5 on the same date of service, and treatments that exceed this anatomic/level threshold are not within the covered criteria and risk denial or non-coverage.

Prior authorization and documentation must reflect the treated levels; procedural claims or prior authorization requests listing more than two treated levels between T5-L5 on the same date of service will not meet the policy’s anatomic limit.

Percutaneous vertebroplasty/kyphoplasty is considered not medically necessary when any of the following contraindications are present: allergy to materials used in the procedure, uncorrected coagulation disorder or ongoing anticoagulation therapy, myelopathy from a bone fragment or cord compression from tumor, extensive vertebral destruction, burst fracture with widened pedicles and/or retropulsed fragments, potential space‑occupying lesions causing cord compression, collapse to vertebra plana, or radiculopathy from a herniated intervertebral disc.

These contraindications should be documented and reconciled in the medical record and prior authorization submission; the presence of any of these conditions makes vertebral augmentation not medically appropriate per policy language and may result in denial.

Collapse to vertebra plana (collapse of the vertebral body to less than the level of the vertebra) and unstable fractures requiring stabilization are explicit exclusions from vertebral augmentation. When vertebral collapse meets vertebra plana criteria or when a fracture is unstable and requires an operative stabilization procedure, vertebral augmentation is not appropriate under this policy.

Providers must document vertebral body morphology and stability on imaging; cases demonstrating vertebra plana or instability should be referred for appropriate stabilization and are not eligible for vertebroplasty/augmentation per this policy.

Percutaneous vertebroplasty and mechanical vertebral augmentation will NOT be separately reimbursed when combined with any open spine procedure. If augmentation is performed in conjunction with an open spinal procedure, documentation and billing should reflect the combined operative approach and reimbursement will be managed accordingly.

Operationally, providers should not expect separate payment for vertebroplasty/mechanical augmentation when performed as part of an open spine surgery; coding and prior authorization submissions should account for this reimbursement policy.

There is insufficient evidence to conclude efficacy of vertebral augmentation for indications beyond osteoporotic vertebral collapse or osteolytic vertebral metastasis / multiple myeloma. The supportive literature includes single‑arm IDE studies and randomized trials for specific devices and indications, but evidence for many other indications is limited or mixed.

For sacroplasty specifically, the literature is heterogeneous and often lacks controlled, long‑term outcome data; therefore sacroplasty and other off‑label or less‑studied indications do not meet the standard evidence threshold for routine coverage.

Services not covered by a specific product contract are excluded from application of this medical policy. Coverage is contract dependent; if a member’s product does not cover a service, the medical policy criteria do not apply and the service may be denied per product benefit design.

Before proceeding, confirm product‑level benefits and prior authorization requirements because medical necessity criteria in this policy only govern services that are covered by the member’s specific product.

Treatment that exceeds two (2) levels of the T5‑L5 spine on the same date of service or that does not meet the policy’s required imaging and symptom criteria should be considered not medically necessary. The policy explicitly limits covered vertebral augmentation to procedures performed at no more than two levels between T5 and L5 on the same date of service.

Prior authorization reviewers and billers should confirm that submitted imaging, symptom documentation, and coding reflect the ≤2 level limit and that all other listed coverage criteria are met; failure to meet these requirements places the request at risk for denial.

Vertebral augmentation (percutaneous vertebroplasty/kyphoplasty) is considered not medically necessary when any listed contraindications are present. The policy lists specific contraindications (e.g., allergy to procedure materials, uncorrected coagulopathy, myelopathy, extensive vertebral destruction, burst fracture with retropulsion) that preclude the procedure.

If any contraindication exists, document the condition clearly in the medical record and prior authorization materials; presence of a contraindication will render the procedure not medically necessary under this policy.

Vertebral augmentation is considered not medically necessary for alternative causes of axial back pain. Specifically excluded indications include lumbar/thoracic radiculopathy or facet disease, lumbar/thoracic/sacral trigger points, and insufficiency fractures or lesions of the sacrum or coccyx.

Providers must document that axial pain is concordant with vertebral imaging and not primarily due to other spinal pain generators; cases in which the primary pain driver is an excluded alternative cause should not proceed to vertebral augmentation under this policy.

Percutaneous sacroplasty is considered investigational for all indications and therefore is not covered as standard therapy under this policy.

The investigational stance for sacroplasty reflects the policy’s assessment that available studies are heterogeneous, often uncontrolled, and insufficient to establish consistent long‑term clinical benefit; sacroplasty requests should be managed per investigational coverage rules.

The American Academy of Orthopaedic Surgeons (AAOS) issued a practice guideline recommending a strong recommendation against the use of vertebroplasty for patients with acute osteoporotic spinal compression fracture who are neurologically intact. This guideline informs the policy’s cautious approach to vertebroplasty in acute, neurologically intact patients.

While some other bodies (e.g., NICE) allow vertebroplasty or kyphoplasty in selected patients with persistent severe pain despite optimal management, the AAOS strong recommendation against vertebroplasty for acute, neurologically intact fractures is a key guideline referenced in the policy.

Vertebral augmentation involves injection of polymethylmethacrylate (PMMA) cement under imaging guidance to stabilize fractured or diseased vertebral bodies and reduce pain. The policy covers augmentation for specific indications, including prophylactic augmentation at the time of fusion and treatment of painful osteoporotic or osteolytic neoplastic compression fractures when criteria are met.

Supportive literature cited in the policy includes IDE and randomized controlled trials (for example, the Crosstrees PVA Pod IDE study and the Kiva vs kyphoplasty randomized trial), which demonstrated reduced pain and procedural outcomes in selected patient populations; however, evidence limitations for other indications are noted.

Evidence is insufficient for many indications beyond osteoporotic collapse and osteolytic metastases/myeloma. The policy references an IDE single‑arm study for the Crosstrees PVA Pod and the KAST randomized trial comparing Kiva with balloon kyphoplasty; while these show efficacy for specified indications, the document states that there is not sufficient data to support broader indications.

Randomized trials and IDE data cited in the policy support selected device clearances and non‑inferiority results, but the policy emphasizes that evidence gaps remain for other indications and for long‑term outcomes in some procedures.

Sacroplasty evidence is limited, heterogeneous, and often lacks control groups and long‑term outcome data. Systematic reviews and the majority of published studies include small, nonrandomized cohorts with variable techniques and follow‑up; although many report substantial VAS reductions, the overall evidence is conflicting and inadequate to support routine coverage.

Given these limitations, the policy classifies sacroplasty as investigational for all indications and advises against routine reimbursement outside of research or explicitly approved product coverage.

Several randomized controlled trials and IDE studies are cited in support of vertebral augmentation for narrowly defined indications. The Crosstrees PVA Pod IDE trial enrolled 135 patients and met primary endpoints for pain reduction and reduced cement extravasation; the KAST randomized trial (Kiva vs kyphoplasty) enrolled 300 patients and met non‑inferiority endpoints with similar pain and function outcomes and lower cement volume and extravasation for Kiva.

These device‑level studies inform the policy’s coverage decisions for specific clinical contexts (e.g., osteoporotic or neoplastic painful compression fractures) while the policy continues to restrict coverage for indications or devices lacking sufficient controlled evidence.