Percutaneous Vertebroplasty and Kyphoplasty (for Tennessee Only)

Coverage Summary

Policy: CS330TN.E — Percutaneous Vertebroplasty and Kyphoplasty (Tennessee Medicaid/CoverKids). Effective date: February 1, 2025. Coverage stance: Covered with criteria. Scope: defines medical necessity criteria, exclusions, and applicable CPT references for PVP/PKP for Medicaid and CoverKids in Tennessee. Headline indications listed: 6 covered indications (osteoporotic VCF, steroid‑induced fracture, osteolytic metastatic disease, multiple myeloma, aggressive vertebral hemangioma, unstable osteonecrosis/Kümmell’s disease). Evidence summary (brief): numerous systematic reviews, meta‑analyses, randomized and observational studies support that vertebral augmentation is safe and effective in selected patients with symptomatic osteoporotic or neoplastic vertebral compression fractures, with common outcomes of pain reduction and improved function; cement leakage is common but usually asymptomatic and long‑term benefits vs sham remain uncertain in some trials.

Policy quick facts and thresholds

Pain onset windowWithin 4 months of pain onset

Listed Covered Indications (count)6

Covered indications (examples)Osteoporotic VCF; steroid-induced fracture; osteolytic metastatic disease; multiple myeloma; aggressive vertebral hemangioma; unstable osteonecrosis (Kümmell)

Evidence summary (brief)Systematic reviews, meta-analyses, and RCTs support benefit of vertebral augmentation in selected patients with symptomatic osteoporotic or neoplastic fractures

Policy status / effective dateEffective February 1, 2025

Medical-Necessity Criteria

Medically Necessary Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

Procedure is percutaneous vertebroplasty or kyphoplasty to treat pain causing Functional or Physical Impairment in cervical, thoracic, or lumbar vertebral bodies
Symptomatic VCF with functional/physical impairment
Onset of pain is within 4 monthswithin 4 months
Treatment must be within 4 months of pain onset
Pain has failed to respond to Optimal Medical Therapy
Optimal Medical Therapy defined in policy (first-line treatments prior to invasive procedures)
Indication is ONE of

Not Medically Necessary / Unproven Indications

Percutaneous vertebroplasty and kyphoplasty are unproven and not medically necessary for treating indications other than those listed in the medically necessary criteria due to insufficient evidence of efficacy.

Any indication not explicitly listed in the medically necessary indications (osteoporotic VCF, steroid-induced fracture, osteolytic metastatic disease, multiple myeloma, aggressive vertebral hemangioma, unstable osteonecrosis fractures)

Guidelines and Indications from Societies

Guideline concordance and conflicts: Professional guidance is mixed. AAOS (2010, updated 2023) recommends against vertebroplasty for neurologically intact osteoporotic compression fractures but considers kyphoplasty an option. AACE/ACE do not recommend vertebroplasty or kyphoplasty as first‑line treatments due to unclear benefit and possible increased adjacent‑fracture risk. ACR and allied radiology/interventional societies describe vertebral augmentation as usually appropriate for selected symptomatic VCFs refractory to conservative therapy and define failure of conservative therapy. ISASS and SNIS/SIR statements support vertebral augmentation as safe and effective in selected patients and endorse early treatment in appropriate cases. NICE recommends PVP and BKP only when severe ongoing pain persists despite optimal pain management and where pain is level‑specific on exam and imaging.

Comparative Clinical Evidence

Evidence summary (selected high‑level findings): Multiple systematic reviews and meta‑analyses show vertebral augmentation (PVP/PKP) provides early and often meaningful pain relief and functional improvement compared with conservative care in selected symptomatic OVCFs, though double‑blind sham trials have produced mixed results. Meta‑analyses report PVP often yields greater early pain relief versus conservative treatment; KP/PKP and PVP generally have similar long‑term pain and function outcomes. Comparative reviews and NMAs indicate PKP tends to produce better radiographic correction (kyphosis/vertebral height) and lower cement leakage rates, while PVP may provide superior short‑term pain relief in some analyses; overall differences in VAS/ODI are frequently small or non‑significant. Cement leakage is common but most leaks are asymptomatic; some meta‑analyses report increased risk of new vertebral fractures after augmentation versus conservative care in certain pooled analyses. For malignant lesions and multiple myeloma, systematic reviews and cohort studies show clinically relevant pain and function improvements with generally low rates of symptomatic complications. For Kümmell’s disease, NMAs and meta‑analyses find no consistent difference in symptom improvement among PVP, PKP, and bone‑filling container techniques; PKP most likely provides better kyphosis correction and BFC may better limit cement leakage.

Coding

Applicable CPT codes (reference)CPT

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).

Procedures discussed (no explicit billing lists in this part)mixed

procedure	Percutaneous vertebroplasty (PVP) - procedure (no CPT/HCPCS listed in this document part)
procedure	Percutaneous kyphoplasty (PKP) - procedure (no CPT/HCPCS listed in this document part)
device	Bone-filling mesh container (BFC) - device/procedure variant (no specific codes listed)

FDA device product codes referencedmixed

NDN/LOD	PMMA bone cement product codes (informational website reference)
HRX/HXG	Bone tamps product codes (informational website reference)

Provider Actions

Prior Authorization

Prior authorization required (check plan)

As a medical policy governing coverage, prior authorization is typically required to confirm criteria are met before payment; providers should obtain authorization per payer procedures.

Documentation Required

Document imaging to exclude other pain generators

Obtain and document CT or MRI demonstrating exclusion of other spinal/bony pain generators and absence of spinal cord compression, significant vertebral collapse (<1/3 original height), or healed VCF.

Definitions

Definitions (policy terms):

Functional or Physical Impairment: deviation from normal tissue or organ function causing a significantly limited capacity to move, coordinate actions, or perform physical activities.

Optimal Medical Therapy: first‑line, noninvasive treatments employed before invasive procedures (examples: analgesics, bed rest, external bracing).

Osteonecrosis: bone disease from reduced blood flow (also called avascular necrosis or Kummel disease) that may lead to bone breakdown; causes include steroids, alcohol, injury.

Vertebral Hemangiomas: benign vascular spine tumors, usually asymptomatic; aggressive variants have extra‑osseous extension, bone expansion, disturbed blood flow, or compression fractures.

PVP/VP: percutaneous vertebroplasty — injection of bone cement into a vertebral body for stabilization and pain relief.

PKP/BKP/KP: percutaneous (balloon) kyphoplasty — balloon tamp used to restore vertebral height prior to cement injection.

BFMC/BFC: bone‑filling mesh container / bone‑filling container — adjunct device used with vertebroplasty to contain cement.

OVCF: osteoporotic vertebral compression fracture.

KD: Kümmell’s disease — post‑traumatic vertebral osteonecrosis leading to delayed vertebral collapse and instability.

VCF: vertebral compression fracture.

Evidence Summary

Key evidence highlights

Type of evidenceSystematic reviews, meta-analyses, randomized controlled trials, prospective and retrospective cohort studies

Safety/efficacy conclusionBroad consensus: safe and effective in selected patients with symptomatic osteoporotic and neoplastic fractures; insufficient evidence for other indications

Xie et al. 2017 (meta-analysis)12 RCTs, 1,231 patients; PVP associated with greater early pain relief vs conservative therapy; 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 daily function/HRQoL and lowest new-fracture risk

Wang et al. 2022 NMA (Kümmell's disease)4 RCTs + 16 CCTs, 1,114 patients; no difference in symptom improvement among PVP/PKP/BFC; PKP best for kyphosis correction; BFC best to reduce cement leakage

Uncertainty vs sham trials

Revision History

02/01/2025policy_changeLatest

Summary of Changes dated 02/01/2025; previous policy version CS330TN.D archived