BlueCross and BlueShield of Montana Medical Policy/Codes
Percutaneous Kyphoplasty
Chapter: Surgery: Procedures
Current Effective Date: May 03, 2012
Original Effective Date: June 25, 2002
Publish Date: May 03, 2012
Revised Dates: March 1, 2005, July 21, 2005, August 1, 2006, June 9, 2009, March 26, 2012; April 11, 2013
Description

Percutaneous kyphoplasty is an interventional radiology technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. Kyphoplasty is a variant of vertebroplasty, which uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of the PMMA. The technique has been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture, or in those with osteolytic lesions of the spine, i.e., multiple myeloma or metastatic malignancies.

It has been proposed that kyphoplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated including thermal damage to intraosseous nerve fibers, since PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.

Kyphoplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval. Kyphoplasty requires the use of an inflatable bone tamp. One such tamp, the KyphX® inflatable bone tamp, received 510(k) marketing clearance from the FDA in July 1998.

PMMA bone cement was available as a drug product prior to enactment of the FDA’s device regulation and was at first considered what the FDA terms a “transitional device.” It was transitioned to a class III device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In October 1999, PMMA was reclassified from class III to class II, which requires future 510(k) submissions to meet “special controls” instead of “general controls” to assure safety and effectiveness. The FDA issued a guidance document on July 17, 2002 (last accessed September 2002; available online at: http://www.fda.gov/cdrh/ode/guidance/668.pdf .), that outlines the types of special controls required and describes recommended labeling information.

Thus, use of PMMA in kyphoplasty represented an off-label use of an FDA-regulated product prior to July 2004. In July 2004, KyphX® HV-RTM bone cement was given 510(k) marketing clearance by the FDA for the treatment of pathologic fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Subsequently, other products such as Spine-Fix® Biomimetic Bone Cement and Osteopal ® V have been issued 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

The FDA also issued a “Public Health Web Notification: Complications related to the use of bone cement in vertebroplasty and kyphoplasty procedures,” which is available online at: www.fda.gov/cdrh/safety/bonecement.html. This notification is intended to inform the public about reports on safety and to encourage hospitals and other user facilities to report adverse events related to bone cement malfunctions either directly to manufacturers or to MedWatch, the FDA’s voluntary reporting program.

Osteoporotic Vertebral Compression Fracture

Osteoporotic compression fractures are a common problem, and it is estimated that up to one half of women and approximately one quarter of men will have a vertebral fracture at some point in their lives. However, only about one third of vertebral fractures actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month. However, a minority of patients will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management. Chronic symptoms do not tend to respond to the management strategies for acute pain such as bed rest, immobilization/bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently is not improved with analgesics and may be better addressed through exercise.

Vertebral Body Metastasis

Metastatic malignant disease involving the spine generally involves the vertebral bodies, with pain being the most frequent complaint. While radiation and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain vertebral body strength, which may necessitate supportive bracing to minimize the risk of vertebral body collapse during healing.

Vertebral Hemangiomas

Vertebral hemangiomas are relatively common lesions noted in up to 12% of the population based on autopsy series; however, only rarely do these lesions display aggressive features and produce neurologic compromise and/or pain. Treatment of aggressive vertebral hemangiomas has evolved from radiation therapy to surgical approaches using anterior spinal surgery for resection and decompression. There is the potential for large blood loss during surgical resection, and vascular embolization techniques have been used as adjuncts to treatment to reduce blood loss. Percutaneous cementoplasty has been proposed as a way to treat and stabilize some hemangioma to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.

*Note: Percutaneous Vertebroplasty and Sacroplasty is addressed in a separate policy

Policy

Prior authorization is recommended. Call Blue Cross and Blue Shield of Montana (BCBSMT) customer service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review will be performed if services are not prior authorized.

Medically Necessary

Percutaneous kyphoplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least 6 weeks.

Percutaneous kyphoplasty 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.

Investigational

Percutaneous kyphoplasty is considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.  

Federal Mandate

Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone. Call the BCBSMT FEP Customer Service Department at 1-800-634-3569 for benefit information.

Policy Guidelines

Effective in 2006, there are CPT codes specific to this procedure:

  • 22523
  • 22524
  • 22525
  • 72291-72292

ICD Procedure Code

In October 2004, a specific ICD-9 procedure code was added for kyphoplasty –

81.66 – Kyphoplasty (descriptor changed 10/1/08 to Percutaneous vertebral augmentation)

Prior to that, 78.49 might have been used to describe kyphoplasty.

Rationale

This policy was originally based on a 2000 TEC Assessment (1) and updated with TEC Assessments in 2004, (2) 2005, (3) 2008, (4) 2009, (5) and 2010. (6) Originally the available data were observational. Evidence from observational studies were generally consistent in showing significant decreases in pain from an initial preoperative level of 7 to 9 on a visual analogue scale ([VAS] or similar score proportionate to the highest possible score]) to 2 to 4, typically within 1 day of receiving the procedure. Such pain relief appears to be lasting in the 4 studies that reported long-term outcomes, although most of the studies had large losses to follow-up. (7-10) Only 1 study of 24 patients by Berlemann et al. retained most of the patients at the end of long-term follow-up. (8) This study showed continued pain relief out to 1 year after the procedure. In terms of other outcomes, results generally showed improvement after kyphoplasty. Coumans et al. (7) reported statistically significant improvements in several subscores of the short form-36 (SF-36), including physical function, mental health, pain, vitality, and social function. Ledlie et al. (11) showed that the proportion of patients fully ambulatory increased after the procedure, but the study had progressive losses to follow-up over time. Crandall et al. (9) showed decreases in the amount of medication use over time. In terms of adverse outcomes, leakage of the cement outside of the vertebral body is common, occurring between 6% and 38% in 6 studies that reported its occurrence. Two nonrandomized studies that compared kyphoplasty to conservative management for treatment of osteoporotic fractures, Kasperk et al. and Komp and colleagues, showed that patients receiving kyphoplasty had greater improvements in pain and function. (12,13) In these 2 studies, the control groups showed minimal improvement in pain and function over the period of observation, which contrasts with the comparative study of percutaneous vertebroplasty, in which the control group improved over time. Differences in patient presentation and selection for treatment could be responsible for the differences observed. These studies point out the uncertainty of the natural history of vertebral fractures and that controlled studies would help determine the efficacy of kyphoplasty. The early literature review also identified a publication on treatment of pathologic compression fractures in which kyphoplasty and spinal radiosurgery were combined. (14)

Beginning in 2009, data from randomized clinical trials (RCTs) began appearing in the literature. This policy is now focused on RCTs data. Additionally, while originally a part of the TEC assessment, the indication of osteolytic destruction due to metastasis was removed in 2009 and now is only reviewed in this policy and follows in its own section.

Outcomes of Treatment

For treatment of osteoporosis and malignancy with percutaneous kyphoplasty, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Kyphoplasty may also result in restoration of lost vertebral body height with associated reduction in kyphotic deformity. Potential health outcomes related to kyphotic deformity include pulmonary or gastrointestinal compression and associated symptoms, and vertebral compression fractures may be associated with lower health-related quality of life. Ex vivo cadaver studies reporting bone strength as a surrogate outcome measure have been reported but are not included in this evaluation of health outcomes.

Pain and functional ability are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may be variable. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of kyphoplasty over and above any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared to an alternative such as continued medical management.

In all clinical situations, adverse effects related to complications from kyphoplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethylmethacrylate (PMMA).

In 2009, Wardlaw et al. reported on the findings of a multisite, RCT in which 300 adult participants with 1 to 3 painful osteoporotic vertebral fractures of less than 3 months’ duration were assigned to undergo kyphoplasty or conservative care. (15) This study was designed to examine short-term efficacy and safety of kyphoplasty for the treatment of acute vertebral compression fractures. There was no blinding in this trial. Participants were recruited from 21 sites in 8 countries. Participants needed to have back pain of no more than 3 months’ duration and the presence of at least one but no more than 3 acute vertebral fractures. Participants were evaluated at baseline, then at 1 and 12 months after the procedure. The primary outcome was the difference in change from baseline to 1 month in the SF-36 physical component summary (PCS) between the kyphoplasty and control groups.

A total of 138 participants who underwent kyphoplasty and 128 control patients completed 1 month of follow-up. Scores for the primary outcome, 1-month change in SF-36 PCS score, were significantly higher for those in the kyphoplasty group. The difference between the 2 groups was 5.2 points (95% confidence interval [CI]: 2.9–7.4; p <0.0001). Participants in the kyphoplasty group also reported greater improvements in quality of life and Roland Morris disability score. While not a study outcome, the authors also noted that patients who received kyphoplasty had approximately 60 fewer days of restricted activity during the year than controls. Differences between the groups were no longer apparent at 12 months; possibly due to natural healing of fractures.

The major limitation of the study was the lack of a sham procedure. Nonspecific or placebo effects can be quite large for an invasive procedure such as kyphoplasty. (16,17) In addition, there was no blinding in this trial. The analyses were appropriate; however, it would have been preferable to have the number of participants reporting a clinically meaningful change as the primary outcome. In cases of chronic pain, continuous measures can miss responders. The authors acknowledge that their participants at baseline had substantially reduced quality of life compared with other patients with chronic disease, which may have affected their results.

Due to the sham effect observed in the recent trials of vertebroplasty, results from a non-sham-controlled trial, as published by Wardlaw et al., (15) are questionable as the placebo effect may be substantial, on the order of 6 to 7 mm on a 100-mm scale, for invasive procedures. (16-19) Even larger effects (10%) were observed in the vertebroplasty trials reported by Buchbinder et al. and Kallmes et al. (20,21)

Berenson and colleagues reported the results of an international randomized multicenter clinical trial. (22) They enrolled 134 patients with cancer who were at least 21 years of age. Participant had at least one and not more than 3 painful vertebral compression fractures (VCF). (These appear to be due to osteoporosis, rather than from a metastatic lesion.) The primary outcome was change in functional status from baseline at 1 month as measured by the Roland Morris Disability Questionnaire (RMDQ). Treatment allocation was not blinded, and the primary outcome at 1 month was analyzed using all participants with data both at baseline and at 1 month. Participants needed to have a pain score of at least 4 on a 0-10 scale. Crossover to the balloon kyphoplasty arm was allowed after 1 month. The authors report scores in the kyphoplasty and nonsurgical groups of 17.6 and 18.2, respectively and 9.10 and 18.0 at 1-month follow-up. P-value for the between group difference in scores p=0.0001.

Due to the lack of comparative trials of sufficient size and rigor, it is difficult to come to conclusions regarding the efficacy of kyphoplasty. Despite most case series showing consistent improvements in pain after the procedure, and the same conclusion being reached in the 2 RCTs, it is difficult to separate out placebo and natural history effects from actual efficacy. Although not including the Berenson et al. study, the 2010 TEC Assessment concluded that the scientific evidence did not permit conclusions concerning the effects of kyphoplasty on net health outcome for osteoporotic vertebral fractures.(23)

Vertebral Body Metastasis

In the early literature reviews, 3 case series were reviewed evaluating a total of 52 patients. (24-26) Outcome measures varied among these 3 studies, but all showed improvements either in VAS pain score, several aspects of physical functioning as measured by SF-36, or improvement in a disability score. There are no RCTs of kyphoplasty for vertebral body metastasis. Because the results of the comparative studies of vertebroplasty suggest possible placebo or natural history effects, case series are insufficient to make conclusions about the effect of kyphoplasty on health outcomes.

Vertebral Hemangiomas

For symptomatic vertebral body hemangioma with aggressive features, no studies reported pre- and post-procedure pain evaluations. Therefore, the findings of all studies that reported more than a single case (6 studies, totaling 64 patients) were evaluated. The studies using percutaneous cementoplasty as an adjunct to surgical treatment suggest that the use of percutaneous cementoplasty to treat the vertebral body component of the vascular lesion may contribute to avoiding the substantial blood loss that has been historically described with primary surgical resection (curettage). However, the additional use of other procedures in these studies may make it difficult to attribute the lower blood loss to this procedure. These studies do not provide controlled comparisons of the morbidity of treating hemangiomas with percutaneous cementoplasty as an adjunct to surgery and the morbidity of surgical treatment without cementoplasty.

Physician Specialty Society and Academic Medical Center Input

In response to requests, input was received from 6 physician specialty societies (1 unsolicited) and 2 academic medical centers while this policy was under review in 2008. Unsolicited input was received from another physician specialty society. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. All reviewers disagreed with the proposed policy, referring to a body of evidence from uncontrolled studies that support use of kyphoplasty.

Summary

After consideration of the uniform clinical input, it was concluded that although the scientific evidence does not permit conclusions about the impact on health outcomes and that comparative studies with long-term outcomes are lacking; numerous case series, including large prospective reports, consistently show that vertebroplasty or kyphoplasty may alleviate pain and improve function in patients with vertebral fractures who fail to respond to conservative treatment (at least 6 weeks) with analgesics, physical therapy, and rest. Given the absence of alternative treatment options and the morbidity associated with extended bed rest, kyphoplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy.

After reviewing the literature, there is insufficient evidence to permit conclusions on the use of kyphoplasty for an acute vertebral fracture. The scientific evidence does not permit conclusions about the impact on net health outcome; comparative studies are needed. There are no additional data to alter these conclusions.

Practice Guidelines and Position Statements

In 2010 the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures, which is available online at: http://www.aaos.org/Research/guidelines/SCFguideline.asp. The Board approved a weak recommendation for offering the option of kyphoplasty for patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact”. In coming out with a weak recommendation the committee expressed that future evidence could overturn the existing evidence and that the quality of the current literature is poor. As a note, these recommendations were based on a literature review through September 2009.

A 2008 TEC Assessment found that although many case series had been published, there was a lack of rigorous comparative trials of vertebroplasty and kyphoplasty. (4) Since case series studies are subject to many sources of bias and are generally not reliable evidence of efficacy, it was concluded that the evidence for kyphoplasty did not meet TEC criteria.

The updated 2009 and 2010 TEC Assessments (5,6) concluded; due to the lack of comparative trials of sufficient size and rigor, it is difficult to come to conclusions regarding the efficacy of kyphoplasty. Despite most case series showing consistent improvements in pain after the procedure, and the same conclusion being reached in the 1 randomized controlled trial, it is difficult to separate out placebo and natural history effects from actual efficacy. It was concluded that the evidence for kyphoplasty did not meet TEC criteria, because the scientific evidence did not permit conclusions concerning the effects of kyphoplasty on net health outcome for osteoporotic vertebral fractures

2006 Guidance from United Kingdom’s National Institute for Health and Clinical Excellence (NICE) concluded that the current evidence on the safety and efficacy of balloon kyphoplasty for vertebral compression fractures appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit, and clinical governance. (27) NICE also concluded that current evidence on the safety and efficacy of percutaneous cementoplasty for the palliative treatment of bony malignancies is limited but appears adequate to support the use of this procedure in patients for whom other treatments have failed, provided that the normal arrangements are in place for consent, audit, and clinical governance. The aim of the procedure is to reduce pain and stabilize bones. (28)

A position statement from the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology (“the Societies”) from 2007 states that “percutaneous vertebral augmentation with vertebroplasty and kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures when performed in a manner in accordance with published standards. These procedures are offered only when traditional medical therapy has not provided pain relief or pain is substantially altering the patient’s lifestyle.” (29) The societies determined that the clinical response rate in individuals treated with kyphoplasty is equivalent to that seen in patients treated with vertebroplasty and that there is no proven advantage of kyphoplasty relative to vertebroplasty with regard to pain relief, vertebral height restoration, or complication rate. 

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered please note that member contract language will take precedence over medical policy when there is a conflict.

ICD-9 Codes
170.2, 198.5, 203.00-203.01, 238.6, 733.13, 81.66
ICD-10 Codes

C41.2, C79.51 – C75.52, C90.00 – C90.02, D18.09, D47.Z9, M48.50- – M48.58, M80.08, M84.48, M84.58, M84.68, 0PU33JZ, 0PU34JZ, 0PU43JZ, 0PU44JZ, 0QU03JZ, 0QU04JZ, 0QU13JZ, 0QU14JZ

Procedural Codes: 22523, 22524, 22525, 72291, 72292
References
  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty. TEC Assessments 2000; Volume 15, Tab 21.
  2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Kyphoplasty for Vertebral Fractures Caused by Osteoporosis and Malignancy. TEC Assessments 2004; Volume 19, Tab 12.
  3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Kyphoplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2005; Volume 20, Tab 7.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty or Kyphoplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2008; Volume 23, Tab 5.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty or Kyphoplasty for Vertebral Fractures Caused by Osteoporosis. TEC Assessments 2009; Volume 24, Tab 7.
  6. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty or Kyphoplasty for Vertebral Fractures Caused by Osteoporosis. TEC Assessments 2010; Volume 25, Tab TBA.
  7. Coumans JV, Reinhardt MK, Lieberman IH. Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg 2003; 99(1 Suppl):44-50.
  8. Berlemann U, Franz T, Orler R et al. Kyphoplasty for treatment of osteoporotic vertebral fractures: a prospective non-randomized study. Eur Spine J 2004; 13(6):496-501.
  9. Crandall D, Slaughter D, Hankins PJ et al. Acute versus chronic vertebral compression fractures treated with kyphoplasty: early results. Spine J 2004; 4(4):418-24.
  10. Gaitanis IN, Hadjipavlou AG, Katonis PG et al. Balloon kyphoplasty for the treatment of pathological vertebral compressive fractures. Eur Spine J 2005; 14(3):250-60.
  11. Ledlie JT, Renfro M. Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg 2003; 98(1 Suppl):36-42.
  12. Kasperk C, Hillmeier J, Noldge G et al. Treatment of painful vertebral fractures by kyphoplasty in patients with primary osteoporosis: a prospective nonrandomized controlled study. J Bone Miner Res 2005; 20(4):604-12.
  13. Komp M RS, Godolias G. Minimally invasive therapy for functional unstable osteoporotic vertebral fracture by means of kyphoplasty: a prospective comparative study of 18 surgically and 17 conservatively treatment patients. J Miner Stoffwechs 2004; 11 (suppl 1):13-15 (in German; translated).
  14. Gerszten PC, Germanwala A, Burton SA et al. Combination kyphoplasty and spinal radiosurgery: a new treatment paradigm for pathological fractures. J Neurosurg Spine 2005; 3(4):296-301.
  15. Wardlaw D, Cummings SR, Van Meirhaeghe J et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 2009; 373(9668):1016-24.
  16. Jarvik JG, Deyo RA. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol 2000; 21(8):1373-4.
  17. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med 2002; 136(6):471-6.
  18. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001; 344(21):1594-602.
  19. Vase L, Riley JL, 3rd, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain 2002; 99(3):443-52.
  20. Buchbinder R, Osborne RH, Ebeling PR et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009; 361(6):557-68.
  21. Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009; 361(6):569-79.
  22. Berenson J, Pflugmacher R, Jarzem P et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol 2011; 12(3):225-35.
  23. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Special Report: measuring and reporting pain outcomes in randomized controlled trials. TEC Assessments 2006; Volume 21, Tab 11.
  24. Dudeney S, Lieberman IH, Reinhardt MK et al. Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol 2002; 20(9):2382-7.
  25. Fourney DR, Schomer DF, Nader R et al. Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg 2003; 98(1 Suppl):21-30.
  26. Lane JM, Hong R, Koob J et al. Kyphoplasty enhances function and structural alignment in multiple myeloma. Clin Orthop Relat Res 2004; (426):49-53.
  27. National Institute for Health and Clinical Excellence (NICE), Guidence on balloon kyphoplasty for vertebral compression fractures. IP Guidance Number 166 : IPG;April 2006 Available online at: http://www.nice.org.uk/nicemedia/pdf/IPG166A4Updated.pdf Last Accessed March 2011.
  28. National Institute for Health and Clinical Excellence (NICE), Percutaneous cementoplasty for palliative treatment of bony malignancies. IP Guidance Number : IPG179;June 2006. Available online at: http://www.nice.org.uk/nicemedia/pdf/ip/IPG179guidence.pdf  Last accessed May 2011.
  29. Jensen ME, McGraw JK, Cardella JF et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2007; 18(3):325-30.
History
March 2012  Policy Vertebroplasty and Kyphoplasty divided into each their own policy. Medically Necessary statement policy guidelines, rationale, and references updated; No coding changes
April 2013 Policy statements added to Vertebroplasty policy.  Policy retired.
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Percutaneous Kyphoplasty