CurrentUnitedHealthcarePolicy CSNCT0581.03

Percutaneous Vertebroplasty and Kyphoplasty (for North Carolina Only)

Policy governs medical necessity coverage for percutaneous vertebroplasty and kyphoplasty for members in North Carolina, specifying covered indications, required imaging exclusions, absolute exclusions, and that other indications are not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Vertebroplasty and Kyphoplasty (for North Carolina Only)

Policy CodePolicy CSNCT0581.03

Change TypeState-specific versioning; documentation and references updated

Effective DateJanuary 1, 2025

Next Review Date

Key ActionObtain and document CT or MRI that rules out other causes of spinal pain and document failure of Optimal Medical Therapy prior to performing vertebroplasty or kyphoplasty.

POLICY UPDATE CHANGES

Created state-specific policy version for the state of North Carolina

Updated Medical Records Documentation Used for Reviews reference link

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess coverage

Updated Clinical Evidence and References sections to reflect current information

Archived previous policy version CS330.D

6Covered Indications listed

1State-specific scope (NC only)

multipleEvidence summaries cited

multiple

Systematic reviews/meta-analyses

2010-2024Literature date range

Coverage Summary

Policy CSNCT0581.03 governs medical necessity coverage for percutaneous vertebroplasty and kyphoplasty for members located in North Carolina only. The policy is effective January 1, 2025 and takes the stance of covered with criteria, specifying required indications, imaging and absolute exclusions. Coverage is limited to the six listed indications. Refer to policy number CSNCT0581.03 for full criteria and documentation requirements.

Policy summary

Policy NumberCSNCT0581.03

Effective DateJanuary 1, 2025

StatusCURRENT

ScopePolicy applies only to members located in North Carolina and governs medical necessity coverage for percutaneous vertebroplasty and kyphoplasty, specifying covered indications, required imaging exclusions, and absolute exclusions.

Coverage stanceCovered with criteria (procedures covered when ALL specified criteria are met).

Pain onset thresholdPain onset within 4 months

Covered Indications listed (count)6

Medical-Necessity Criteria

Medically Necessary / Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Pain causing Functional or Physical Impairment in cervical, thoracic, or lumbar vertebral bodies
Functional or Physical Impairment: causes deviation from normal function resulting in significantly limited capacity to move or perform physical activities; see Definitions
Pain onset within 4 months<= 4 months
Failure to respond to Optimal Medical Therapy prior to consideration of vertebroplasty or kyphoplasty
Optimal Medical Therapy: first-line treatments (e.g., analgesics, rest, bracing, physical therapy)
ONE of the following diagnoses

Indications, Guidelines & Evidence Summaries

Indications and Appropriateness Summaries (guideline-derived)

Guideline summaries describing when vertebral augmentation is considered appropriate or not:

ANY of the following

ACR: Percutaneous vertebral augmentation is usually appropriate for symptomatic osteoporotic VCF with bone marrow edema or intravertebral cleft
ACR: Usually appropriate for new symptomatic VCF with history of prior vertebroplasty or surgery
ACR: Usually appropriate for benign VCF with worsening pain, deformity, or pulmonary dysfunction
ACR: Usually appropriate for pathological VCF with ongoing or increasing mechanical pain

Coding

Applicable CPTCPT

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).

Other / None Listedmixed

No codes listed

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization may be required per benefit

Medical records documentation may be required to determine whether the member meets the clinical criteria for coverage. Inclusion of codes or a procedure in the policy does not guarantee reimbursement; benefit coverage is determined by the member’s federal, state, or contractual benefit requirements. Refer to the protocol titled Medical Records Documentation Used for Reviews for details.

See Medical Records Documentation Used for Reviews.

Documentation Required

Imaging to exclude alternative pain generators

Obtain and document CT or MRI that rules out other causes of spinal pain and confirms the absence of imaging findings that would exclude vertebral augmentation.

CT or MRI excluding foraminal stenosis, facet arthropathy, herniated intervertebral disk, other spinal degenerative disease, or other significant coexistent spinal or bony pain generators.

Definitions

Term	Definition
Functional or Physical Impairment
Deviation from normal function causing significant limitation in physical/motor tasks, independent movement, or basic life functions.
Optimal Medical Therapy
First-line treatments employed before invasive procedures (e.g., analgesics, bed rest, external bracing).
Osteonecrosis
Bone disease caused by reduced blood flow; includes Kummel disease; nonsurgical treatments relieve pain short-term but do not cure.
Vertebral Hemangiomas
Benign vascular tumors of the spine; aggressive subset characterized by extra-osseous extension, bone expansion, disturbance of blood flow, and possible compression fractures.
PVP
Percutaneous vertebroplasty
PKP / BKP
Percutaneous kyphoplasty / balloon kyphoplasty
BFC / BFMC
Bone-filling mesh container(s)
VCF
Vertebral compression fracture
OVCF
Osteoporotic vertebral compression fracture
Vertebral augmentation
Procedures including percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PKP) intended to relieve pain and restore vertebral body height in vertebral compression fractures.
Kümmell's disease (KD)
Vertebral osteonecrosis leading to delayed collapse and intravertebral cleft associated with pain and instability.

Evidence Metrics

Select quantitative evidence metrics

Wang et al. (2022) NMA - patients1,114 patients

Zhang et al. (2022) systematic review - studies and patients8 studies, 438 patients

Dai et al. (2021) prospective study - follow-up24 months

Wang et al. (2022) NMA - study composition4 RCTs + 16 retrospective case-control studies (total 20 studies)

Zhang et al. (2022) KD analysis - PKP vs PVP findingsPKP associated with greater Cobb angle and some vertebral height improvements and lower cement leakage but greater resource use

Revision History

2025-11-01added

Created state-specific policy version for the state of North Carolina (No change to coverage guidelines).

2025-06-01revised

Updated Medical Records Documentation Used for Reviews reference link.

2025-01-01added

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess coverage; refer to the protocol titled Medical Records Documentation Used for Reviews.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Vertebroplasty and Kyphoplasty (for North Carolina Only)

Policy CodePolicy CSNCT0581.03

Change TypeState-specific versioning; documentation and references updated

Effective DateJanuary 1, 2025

Next Review Date

Key ActionObtain and document CT or MRI that rules out other causes of spinal pain and document failure of Optimal Medical Therapy prior to performing vertebroplasty or kyphoplasty.

On This Page

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
Unstable fractures due to Osteonecrosis (e.g., Kümmell disease)

Computed tomography (CT) or magnetic resonance imaging (MRI) has ruled out other causes of spinal pain (foraminal stenosis, facet arthropathy, herniated intervertebral disk, other spinal degenerative disease, or other significant coexistent spinal or bony pain generators)

Imaging must exclude other pain generators

The following ABSENT findings

Clinical evidence of spinal cord compression as confirmed by CT or MRI
Significant vertebral collapse or destruction (e.g., vertebra reduced to less than one-third of its original height) as confirmed by CT or MRI
Healed vertebral compression fracture as confirmed by CT or MRI
Lesions of the sacrum or coccyx (see related Minimally Invasive Spine Surgery Procedures policy for sacral augmentation)
Asymptomatic vertebral compression fractures
Vertebral compression fractures responding appropriately to conservative therapy

Not Medically Necessary / Unproven

The following indications are considered not medically necessary or unproven:

ANY of the following

Percutaneous vertebroplasty or kyphoplasty for indications other than the diagnoses listed in the Medically Necessary criteria (insufficient evidence of efficacy)
Treatment of asymptomatic vertebral compression fractures
Vertebral augmentation for lesions of the sacrum or coccyx (see Minimally Invasive Spine Surgery Procedures policy)
Use of vertebroplasty or kyphoplasty in the presence of clinical spinal cord compression or active infection at the procedure site

Comparative Evidence for Kümmell's Disease and Other Conditions: Evidence supports vertebral augmentation for unstable fractures due to osteonecrosis (e.g., Kümmell disease) when criteria above are met; comparative studies are limited and decision should be individualized based on imaging-confirmed instability, symptom duration, and failure of conservative care.

FDA / Device Information (Informational): Cement materials (e.g., polymethylmethacrylate) and vertebral augmentation devices have device-specific FDA clearances/registrations. Device selection and use should follow manufacturer instructions for use and institutional privileging. Inclusion of device information here is informational and does not alone establish medical necessity.

ACR: Percutaneous vertebral augmentation is usually not appropriate for asymptomatic osteoporotic VCF

AAOS (2023 update): Recommends against vertebroplasty for neurologically intact patients with osteoporotic spinal compression fracture

Based on Level II trials vs sham showing no difference in pain/function

AAOS (2023 update): Kyphoplasty is considered an option for neurologically intact osteoporotic spinal compression fracture (limited evidence showing short-term benefits)

NICE (2013, confirmed 2016): Recommends vertebroplasty and balloon kyphoplasty as options only in people with severe ongoing pain after a recent unhealed vertebral fracture despite optimal pain management and pain confirmed at the fracture level by exam and imaging

SIR/AANS/CNS/ACR/ASNR/ASSR/CIRA/SNIS (2014/2017): Vertebral augmentation is safe, efficacious, and durable in appropriate patients with symptomatic osteoporotic and neoplastic fractures when non-operative therapy has not provided adequate pain relief

SNIS (2014): Kyphoplasty in selected patients superior to conservative therapy for cancer-related disabling back pain; vertebroplasty/kyphoplasty reasonable for selected patients with severe back pain refractory to conservative therapy (AHA Class IIA, Level B)

ISASS (2019): Endorses early treatment of painful VCFs with vertebral augmentation (kyphoplasty preferred) and cites level 1 evidence favoring augmentation over conservative management

Comparative evidence for Kümmell's disease and related indications includes randomized trials, prospective cohorts, retrospective series, and network/meta-analyses comparing PVP, PKP, and bone-filling mesh containers (BFC).

Wang et al. (2022) NMA (4 RCTs + 16 CCTs, n = 1,114) found no statistical difference among PVP, PKP, and BFC for clinical symptom improvement; PKP most likely best for kyphosis correction; BFC likely best for minimizing cement leakage; and no difference in adjacent-segment new fractures.

Multiple comparative studies and systematic reviews (Zhang 2022; Dai 2021; Chang 2020; Li 2022; Liu 2022) show broadly that PVP and PKP both relieve pain and improve function but: PKP often achieves better radiographic kyphosis correction and vertebral height restoration and is associated with lower cement leakage, while PVP may have shorter operative time, less radiation, and lower resource consumption. Some prospective studies report no significant difference in VAS/ODI between PVP and PKP over follow-up, despite PKP's radiographic advantages.

Regulatory context is informational: percutaneous vertebroplasty and kyphoplasty are procedures not regulated by the FDA. The FDA has cleared multiple PMMA bone cement products (Class II, product codes NDN, LOD) and has cleared/approved bone tamps for creating a void in cancellous bone including use in balloon kyphoplasty (product codes HRX, HXG).

Evidence Source	Summary
Hayes Health Technology Assessment (updated 2021)
Moderate-quality evidence that kyphoplasty may be beneficial for some patients not responding to conservative treatment; KP and VP provide similar improvements.
Cochrane review (Buchbinder et al., 2018)
High- to moderate-quality evidence does not support vertebroplasty vs sham for routine practice; no demonstrable clinically important benefits and potential for harm.
Xie et al. (2017) meta-analysis
12 RCTs, 1,231 patients; PVP associated with higher early pain relief vs conservative treatment; no increase in adjacent fracture rate.
Zhao et al. (2017) network meta-analysis
16 RCTs, 2,046 participants; VP best for pain relief, KP best for function/quality of life and lowest risk of new fractures; comparable new fracture risk overall.
Mattie et al. (2016) meta-analysis
PVP effect exceeded conservative therapy up to 1 year for pain relief; effect size near MCID.
Wang et al. (2015) PKP vs PVP meta-analysis
8 studies, 845 patients; PKP superior for short-term VAS, kyphosis angle improvement, and lower cement leakage; similar long-term VAS and adjacent fracture rates.
Stevenson et al. (2014) systematic review
9 RCTs; unblinded trials favor PVP and BKP vs OPM, but double-blind trials show PVP no better than local anesthetic; uncertainty remains.
Wang et al. (2022) NMA (Kümmell's disease)
4 RCTs + 16 CCTs, 1,114 patients: no statistical difference among PVP, PKP, and BFC for symptom improvement; PKP most effective for kyphosis correction; BFC likely best to minimize cement leakage.

No clinical evidence of spinal cord compression on CT or MRI.

No significant vertebral collapse or destruction (e.g., vertebra reduced to less than one‑third of its original height).

No healed vertebral compression fracture (VCF) as confirmed by CT or MRI.

Documentation Required

Document failure of Optimal Medical Therapy

Document that the pain causing Functional or Physical Impairment has failed to respond to Optimal Medical Therapy before performing vertebroplasty or kyphoplasty. Optimal Medical Therapy is defined as first‑line, noninvasive treatments employed prior to invasive procedures.

Examples of Optimal Medical Therapy include analgesics (e.g., NSAIDs, opioids as appropriate), bed rest, and external bracing.

Documentation Required

Medical records documentation may be required

Medical records documentation may be requested to assess whether the member meets clinical criteria for coverage. Providers should follow the protocol titled Medical Records Documentation Used for Reviews when submitting records. Submission of documentation does not guarantee that the service will be covered.

Refer to the protocol: Medical Records Documentation Used for Reviews.
Provision of records and inclusion of relevant codes does not guarantee coverage or payment.

Prior Authorization

State/contract-specific coverage governance

Benefit coverage is governed by federal, state, and contractual requirements and applicable laws; check these requirements prior to proceeding as they may mandate coverage for specific services or affect prior authorization and coverage decisions. This policy applies only to members located in North Carolina.

Verify federal, state, and contractual benefit requirements that apply to the member.
Note: This policy version applies to North Carolina only.

2025-01-01revised

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

archived

Archived previous policy version CS330.D.