Medical Policy: 07.01.75 

Original Effective Date: April 2017 

Reviewed: April 2018 

Revised: April 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

These procedures involves the injection of a polymethylmethacrylate (PMMA), a cement, into a fractured or weakened vertebral body to provide stabilization as an alternative to spinal fusion.

 

Percutaneous vertebroplasty, vertebral balloon kyphoplasty, and mechanical augmentation have been proposed as options to provide mechanical support and symptomatic pain relief in patients with osteoporotic vertebral compression, insufficiency fractures, vertebral hemangioma, or osteolytic lesions of the spine (i.e., multiple myeloma or metastatic malignancies). These procedures, sometimes referred to as vertebral augmentation, have been used in all levels of the spinal column including the sacrum and coccyx. When vertebroplasty or kyphoplasty is used to treat insufficiency fractures of the sacrum or coccyx they may be referred to as sacroplasty or coccygeoplasty.

 

Percutaneous vertebroplasty is an interventional radiology technique involving the fluoroscopic- or CT-guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body.

 

Percutaneous kyphoplasty is a variant of vertebroplasty that is intended to restore the vertebral body height and alignment along with stabilizing the fracture, using one of the following techniques: Balloon kyphoplasty involves the use of a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body. PMMA is then injected into the created cavity to stabilize the vertebral body. Mechanical kyphoplasty describes techniques that do not involve a balloon device. In radiofrequency kyphoplasty, ultrahigh viscosity cement is injected into the fractured vertebral body. Radiofrequency energy is used to achieve the desired cement consistency. The ultrahigh viscosity cement is intended to restore height and alignment to the fractured vertebra, along with stabilizing the fracture. The Kiva® procedure uses shaped memory coil and a Kiva implant inserted into the vertebral body for structural support and to provide a reservoir for injection of bone cement. The proposed benefit of this technique is the adjustable height of the implant, which is made from a biocompatible polymer (e.g., PEEK-OPTIMA®), and a potential reduction in cement leakage. Vertebral body stenting utilizes an expandable scaffold instead of a balloon to restore vertebral height. The proposed advantages of vertebral body stenting are to reduce the risk of cement leakage by formation of a cavity for cement application and to prevent the loss of correction that is seen following removal of the balloon used for balloon kyphoplasty.

 

Practice Guidelines

The American Academy of Orthopaedic Surgeons (AAOS) published a clinical practice guideline and evidence report on the treatment of symptomatic osteoporotic spinal compression fractures in 2010:

  • We recommend against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.
  • Kyphoplasty is an option for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact. They also downgraded the recommendation supporting the use of kyphoplasty from “moderate” to “limited” based upon low quality and inconclusive evidence comparing this procedure with conservative care and vertebroplasty, respectively.

 

A practice guideline for the performance of vertebral augmentation (including vertebroplasty and kyphoplasty) developed in collaboration by the American College of Radiology (ACR), American Society of Neuroradiology (ASNR), Society of Neurointerventional Surgery (SNIS), American Society of Spine Radiology (ASSR), and the Society of Interventional Radiology (SIR), was amended in 2014 (ACR-ASNR-ASSR-SIR-SNIR, 2014).

 

The guideline states that the major indication for vertebroplasty is the treatment of symptomatic osteoporotic vertebral body compression fracture(s) refractory to medical therapy or vertebral bodies weakened due to neoplasia. Failure of medical therapy is defined as follows:

  • For a patient rendered nonambulatory due to pain from weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy.
  • For a patient with sufficient pain from weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy.
  • For any patient with weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation due to the analgesic therapy necessary to reduce pain to a tolerable level.

 

The guideline includes the following indications for vertebral augmentation:

  • Painful osteoporotic vertebral compression fracture(s) refractory to medical therapy
  • Vertebral bodies weakened by neoplasm
  • Symptomatic vertebral body microfracture (as documented by magnetic resonance imaging [MRI] or nuclear imaging, and/or lytic lesion seen on CT) without obvious loss of vertebral body height.

 

American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE)

In a clinical practice guideline for the diagnosis and treatment of postmenopausal osteoporosis, the AACE and ACE (2016) do not recommended vertebroplasty and kyphoplasty as first-line treatment of vertebral fractures given the unclear benefit on overall pain and the potential increased risk of vertebral fractures in adjacent vertebrae (Grade B, BEL 1; downgraded due to limitations of published studies).

 

American Society of Bone and Mineral Research (ASBMR)

In a review of pain, quality of life and safety outcomes of balloon kyphoplasty compared to other surgical techniques and non-surgical management for vertebral compression fractures (VCF), the ASBMR evaluated ten unique trials (1,837 participants). Balloon kyphoplasty in comparison to non-surgical management, was associated with greater reductions in pain, back-related disability, and better quality of life that appeared to lessen over time, but were less than minimally clinically important differences. Risk of new VCF at 3 and 12 months was not significantly different. Individuals with painful VCF experienced symptomatic improvement compared with baseline with all interventions.There were no significant differences between balloon kyphoplasty and percutaneous vertebroplasty in back pain, back disability, quality of life, risk of new VCF or any adverse events. Limitations of the studies included lack of a balloon kyphoplasty versus sham comparison, availability of only one randomized controlled trial of balloon kyphoplasty versus non-surgical management, and lack of study blinding.The authors noted that the clinical importance of the greater improvements with balloon kyphoplasty versus non-surgical management is unclear, may be due to placebo effect, and may not counterbalance short-term adverse event risks. Outcomes appeared similar between balloon kyphoplasty and other surgical interventions. The ASMBR recommends well-conducted randomized trials comparing balloon kyphoplasty with sham to help resolve remaining uncertainty about the relative benefits and harms of this procedure. (2017)

 

Prior Approval:

Not applicable

 

Policy:

Percutaneous vertebroplasty, percutaneous balloon kyphoplasty, or Kiva® may be considered medically necessary for treatment of no more than 3 symptomatic osteoporotic vertebral compression fractures of the T5-L5 spine, on any single date of service, or osteolytic metastatic disease involving a vertebral body of the T5-L5 spine, when all of the following criteria are met:

  1. Appropriate imaging (plain film x-ray, MRI, CT, or bone scan) has been performed preoperatively and the findings of such imaging correlate unequivocally with the patient’s pain; and
  2. It has been established in the clinical record that the patient’s pain is predominantly, if not solely, related to the demonstrated fracture(s); and
  3. Functional impairment attributed to vertebral fracture is documented in the clinical record as limiting performance of instrumental activities of daily living (ADLs). Instrumental ADLs are defined as feeding, bathing, dressing, grooming, meal preparation, household chores, and occupational tasks that are required as a daily part of job functioning and
  4. The patient has failed to respond to conservative treatment (e.g., analgesics, physical therapy, rest) for at least 6 weeks; and
  5. A pre-procedure assessment has documented the absence of the following contraindications:
    • Untreated symptomatic foraminal or canal stenosis, facet arthropathy, or other significant coexistent spinal or bony pain generators at the planned treatment level
    • Bone fragment retropulsion
    • Symptoms that cannot be related to a fracture or metastatic disease
    • Unstable fracture or requirement for stabilization procedure in same or adjacent spinal region
    • Active osteomyelitis whether fungal, bacterial or mycobacterial, or any other active infection, including urinary tract infection (UTI)
    • Presence of painful metastases to areas other than the spine, spinal cord compression, primary bone and osteoblastic tumors, solitary plasmacytomas
    • Uncorrected coagulation disorders
    • Known allergy to any of the materials used in these procedures
    • Chronic (>6 months) fracture at the same vertebral level

 

Clinical records must specifically document the following:

  • The specific instrumental ADL(s) that is impaired; and
  • A description of how performance of the instrumental ADL is limited.

 

Percutaneous vertebroplasty, percutaneous balloon kyphoplasty and Kiva® may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

 

Percutaneous vertebroplasty, percutaneous balloon kyphoplasty, or Kiva is considered investigational for all other indications, including but not limited to the following:

  • Vertebral hemangioma
  • Vertebrae of the cervical spine and thoracic levels T1-5
  • Stabilization of insufficiency fractures or lesions of the sacrum (sacroplasty) or coccyx (coccygeoplasty)
  • Prophylactic treatment for osteoporosis of the spine or for chronic back pain of long-standing duration, even if associated with old compression fracture(s).

 

Percutaneous vertebroplasty, percutaneous balloon kyphoplasty, or Kiva is considered investigational for acute fractures due to trauma

 

Use of any device other than a balloon device is considered investigational, including but not limited to the following:

  • Radiofrequency-assisted vertebral augmentation with ultrahigh viscosity cement, including but not limited to Radiofrequency-Targeted Vertebral Augmentation™ (RF-TVA™) with the StabiliT® System
  • Vertebral body stenting

 

For treatment of vertebral body fractures related to osteoporosis or malignancy with percutaneous vertebroplasty, balloon kyphoplasty, or Kiva, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Both of these outcomes can be influenced by nonspecific effects, placebo response, and natural history of the disease. Therefore, data from large, blinded, randomized controlled trials (RCTs) of sufficient long-term follow-up are required to control for the placebo effect, determine its magnitude, and determine whether any treatment effect from vertebroplasty or kyphoplasty provides a significant advantage over sham or nonsurgical treatment. Further, adverse effects related to complications from percutaneous vertebroplasty or kyphoplasty, such as risk of additional fractures or cement leakage, must be considered in evaluating the net health impact of these technologies.

 

The current evidence for mechanical vertebral augmentation using techniques other than balloon kyphoplasty (e.g., radiofrequency-assisted vertebral augmentation, vertebral body stenting) is limited to preliminary randomized trials. Two widely discussed recent studies comparing vertebroplasty to sham procedures demonstrated no significant improvement with vertebroplasty. This mixed evidence has sparked considerable debate as to the appropriate role of this procedure. Vertebral body stents have not received approval/clearance by the FDA at this time. In addition, there are no clinical practice guidelines from U.S. professional societies that recommend these techniques.

 

Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and sacral lesions due to metastatic malignancies or multiple myeloma.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 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 (eg, 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 (eg, 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 (eg, 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)
  • 0200T Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles, includes imaging guidance and bone biopsy, when performed
  • 0201T Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles, includes imaging guidance and bone biopsy, when performed

 

Selected References:

  • Blue Cross and Blue Shield Technology Evaluation Center (TEC). Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis. TEC Assessments. 2010;Volume 25, Tab 9.
  • Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. Aug 6 2009;361(6):557-568. PMID 19657121
  • Staples MP, Kallmes DF, Comstock BA, et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ. 2011;343:d3952. PMID 21750078
  • Chen D, An ZQ, Song S, et al. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. Mar 2014;21(3):473-477. PMID 24315046
  • Wang LJ, Yang HL, Shi YX, et al. Pulmonary cement embolism associated with percutaneous vertebroplasty or kyphoplasty: a systematic review. Orthop Surg. Aug 2012;4(3):182-189. PMID 22927153
  • ACR-ASNR-ASSR=SIR-SNIS. Practice guideline for the performance of vertebral augmentation 2012.
  • Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. Feb 2014;25(2):171-181. PMID 24325929
  • American College of Radiology. Management of Compression Fractures. 2013.
  • American Academy of Orthopaedic Surgeons (AAOS). Clinical Practice Guideline Treatment of osteoporotic spinal compression fractures. 2010.
  • National Institute for Health and Care Excellence (NICE). IPG 12: Percutaneous Vertebroplasty. 2003.
  • National Institute for Health and Care Excellence (NICE). TA 279 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. 2013.
  • ECRI Institute, Health Technology Assessment, StabiliT vertebral augmentation system (Dfine, Inc.) for treating vertebral fractures. June 2016.
  • ECRI Institute, Health Technology Assessment, Overview of four selected balloon kyphoplasty and vertebral augmentation systems. November 2015.
  • Rodriguez AJ, Fink HA, Mirigian L, et al. Pain, quality of life and safety outcomes of kyphoplasty for vertebral compression fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2017 May 17. [Epub ahead of print]
  • Bae H, Hatten HP, Jr., Linovitz R, et al. A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up. Spine (Phila Pa 1976). Apr 01 2012;37(7):544-550. PMID
  • Yang EZ, Xu JG, Huang GZ, et al. Percutaneous Vertebroplasty versus conservative treatment in aged patients with acute osteoporotic vertebral compression fractures: a prospective randomized controlled clinical study. Spine (Phila Pa 1976). Apr 2016;41(8):653-660. PMID 26630417
  • Leali PT, Solla F, Maestretti G, et al. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study. Clin Cases Miner Bone Metab. Sep-Dec 2016;13(3):234-236. PMID 28228788

 

Policy History:

April 2018 - Annual review, Policy revised

April 2017 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.