Medical Policy: 07.01.75
Original Effective Date: April 2017
Reviewed: April 2018
Revised: April 2018
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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.
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.
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:
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:
The guideline includes the following indications for vertebral augmentation:
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).
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)
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 disese involving a vertebral body of the T5-L5 sping, when all of the following criteria are met:
Clinical records must specifically document the following:
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:
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:
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.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
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.
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