Medical Policy: 07.01.75
Original Effective Date: April 2017
Reviewed: April 2019
Revised: April 2019
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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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. This stabilization of the structure provides immediate pain relief in many cases.
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, kyphoplasty is 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/vertebral augmentation is a variant of vertebroplasty that is intended to restore the vertebral body height and alignment along with stabilizing the fracture. 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 and Position Statements
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.
Joint Guideline (AANS, CNS, ACR, ASNR, ASSR, CIRA and the SNIS)
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 (AANS, CNS, ACR, ASNR, ASSR, CIRA, and the SNIS, 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)
Percutaneous vertebroplasty, percutaneous balloon or mechanical kyphoplasty, may be considered medically necessary for treatment of no more than 3 symptomatic fractures of the T5-L5 spine, on any single date of service. When the fractures are due to the following conditions:
- Multiple myeloma or
- Osteoporotic/osteolytic compression fractures or
- Malignant neoplasm of the bone or bone marrow
Additionally all of the following criteria must be met:
- 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
- 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
- The fracture is recent (less than 3 months)
- 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
- The patient has failed to respond to conservative treatment (e.g., analgesics, physical therapy, rest) for at least 6 weeks; and
- 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
- Symptoms that cannot be related to the 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)
- Uncorrected coagulation disorders
- Known allergy to any of the materials used in these procedures
- Chronic (>6 months) fracture at the same vertebral level
- When the vertebral body fracture is associated with widened pedicles or retropulsion of bone as in a burst fracture.
- Significant vertebral collapse (i.e., vertebra reduced to less than one-third [l/3] of its original height)
Percutaneous vertebroplasty or kyphoplasty are considered investigational for all other indications, including but not limited to the following:
- Acute vertebral fractures due to trauma
- Vertebral hemangioma
- Vertebrae of the cervical spine and thoracic levels T1-4
- 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 (>6 months), even if associated with old compression fracture(s).
Radiofrequency Kyphoplasty/Radiofrequency-Assisted Vertebral Augmentation
Radiofrequency-assisted vertebral augmentation with ultrahigh viscosity cement, including but not limited to Radiofrequency-Targeted Vertebral Augmentation™ (RF-TVA™) with the StabiliT® System is considered investigational.
Vertebral Body Stenting
Vertebral body stenting is considerd investigational.
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
- 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
- Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol 2017;40:331–42
- Chandra RV, Meyers PM, Hirsch JA, et al; Society of NeuroInterventional Surgery. Vertebral Augmentation: report of the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery. J Neurointerv Surg 2014;6:7–15
- 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 euroInterventional Surgery (SNIS). J Vasc Interv Radiol 2014;25: 171– 81
- Beall D, Coe J, McIlduff M, et al. Serious adverse events associated with readmission through one year after vertebral augmentation with either a polyetheretherketone implant or balloon kyphoplasty. Follow-up analysis of the KAST randomized controlled trial comparing the Kiva Vertebral Compression Fracture Treatment System. Pain Physician. 2017;20:521-528.
- UpToDate, Inc. Evaluation and management of complete and impending pathologic fractures in patients with metastatic bone disease, multiple myeloma and lymphoma. Updated June 2018.
- April 2019 - Annual review, Policy Revised
- April 2018 - Annual review, Policy Revised
- April 2017 - New Policy
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