mp-004 - mp-004 - Medical Policies
Percutaneous Vertebroplasty and Sacroplasty
Policy Number: MP-004
Latest Review Date: April 2020
Policy Grade: B
Percutaneous vertebroplasty 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 six (6) weeks.
Percutaneous vertebroplasty 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 may be considered medically necessary for the treatment of vertebral hemangiomas with severe pain or nerve compression.
Percutaneous vertebroplasty is considered not medically necessary and investigational
for all other indications.
Percutaneous sacroplasty is considered not medically necessary and investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma.
DESCRIPTION OF PROCEDURE OR SERVICE:
Percutaneous vertebroplasty is an interventional technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. 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. Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, and as a technique to limit blood loss related to surgery.
Vertebral Compression Fracture
Osteoporotic compression fractures are common. 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. Nonetheless, some individuals with acute fractures will have severe pain and decreased function that interferes with ability to ambulate and is not responsive to usual medical management.
Chronic symptoms do not tend to respond to the management strategies for acute pain such as bedrest, immobilization or 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 does not improve with analgesics and may be better addressed through exercise. Improvements in pain and ability to function are the principal outcomes of interest for treatment of osteoporotic fractures.
Sacral Insufficiency Fractures
Sacral insufficiency fractures (SIFs) are the consequence of stress on weakened bone and often cause low back pain in the elderly population. Osteoporosis is the most common risk factor for SIF. Spontaneous fracture of the sacrum in patients with osteoporosis was described by Lourie in 1982 and presents as lower back and buttock pain with or without referred pain in the legs. Although common, SIFs can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention.
Similar interventions are used for sacral and vertebral fractures and include bedrest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, resolution of all symptoms may not occur for 9 to 12 months.
Vertebral/Sacral Body Metastasis
Metastatic malignant disease of the spine generally involves the vertebrae/sacrum, 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 strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty or sacroplasty.
Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (e.g., polymethylmethacrylate [PMMA], bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra. It has been suggested that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.
Percutaneous sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical, entails guided injection of PMMA through a needle inserted into the fracture zone. While first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive procedure employed as an alternative to conservative management for sacral insufficiency fractures (SIFs). SIFs are the consequence of stress on weakened bone and are often the cause of low back pain among the elderly population. Osteoporosis is the most common risk factor for SIF.
Pain and function are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may vary. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of vertebroplasty and sacroplasty over and above any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared with alternatives such as continued medical management.
In all clinical situations, adverse effects related to complications from vertebroplasty and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected PMMA or another injectate.
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 radiotherapy 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 vertebroplasty 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.
Kyphoplasty and mechanical vertebral augmentation are addressed separately in medical policy, #648- Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty and Mechanical Vertebral Augmentation.
The most recent literature update for this policy was performed through February 11, 2020.
Summary of Evidence
For individuals who have symptomatic osteoporotic vertebral fractures of between 6 weeks and 1 year old who receive vertebroplasty, the evidence includes 2 randomized sham-controlled trials, nonblinded randomized controlled trials (RCTs) comparing vertebroplasty with conservative management, and systematic reviews of these RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. Despite the completion of numerous RCTs, including 2 with sham controls, the efficacy of vertebroplasty for painful osteoporotic compression fractures remains uncertain. Two meta-analysis studies which included the 2 sham-controlled trials have demonstrated mixed results. The 2 studies had methodologic issues, including the choice of sham procedure and the potential effect of the sham procedure having a therapeutic effect by reducing pain. Questions have also been raised about the low percentage of patients screened who participated in the trial, the volume of polymethylmethacrylate injected, and the inclusion of patients with chronic pain. Overall, conclusions about the effect of vertebroplasty remain unclear. However, clinical input in 2008 provided uniform support for the use of vertebroplasty in painful osteoporotic fractures. After consideration of the available evidence and input, the consistent results of numerous case series, including large prospective reports, were sufficient to determine that vertebroplasty was a reasonable treatment option in patients with vertebral fractures who have failed to respond to conservative treatment (at least 6 weeks with analgesics, physical therapy, and rest). It is also clinically reasonable to consider the evidence supporting the clinical benefit of vertebroplasty in osteoporotic vertebral fracture to support its use in osteolytic lesions of the spine (e.g., multiple myeloma, metastatic malignancies).
For individuals with symptomatic osteoporotic vertebral fractures less than 6 weeks old who receive vertebroplasty, the evidence includes a randomized sham-controlled trial and other nonblinded RCTs comparing vertebroplasty with conservative management. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. For acute fractures, conservative therapy consisting of rest, analgesics, and physical therapy is an option, and symptoms will resolve in a large percentage of patients with conservative treatment only. However, a sham-controlled randomized trial in patients who had severe pain of less than 6 weeks in duration found a significant benefit of vertebroplasty for the treatment of osteoporotic vertebral fracture at the thoracolumbar junction. Other RCTs without sham controls have reported that vertebroplasty is associated with significant improvements in pain and reductions in the duration of bedrest. Given the high morbidity associated with extended bedrest in older adults, this procedure is considered to have a significant health benefit. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals with sacral insufficiency fractures who receive sacroplasty, the evidence includes two prospective cohort studies, several retrospective reviews, and a case series. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. No RCTs have been reported. The available evidence includes a prospective cohort study and a retrospective series with 243 patients. These studies have reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional literature has mostly reported immediate improvements following the procedure. However, due to the small size of the evidence base, the harms associated with sacroplasty have not been adequately studied. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
American College of Radiology et al
The American College of Radiology and 4 other medical specialty associations updated a 2012 joint position statement on percutaneous vertebral augmentation in 2014. The statement indicated that percutaneous vertebral augmentation with the use of vertebroplasty or kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures, when performed in accordance with public standards. The document also stated that these procedures are offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering patients’ quality of life.
American College of Radiology
The American College of Radiology (2018) revised its ACR Appropriateness Criteria for the use of percutaneous vertebral augmentation in the management of vertebral compression fractures. Table 1 shows the appropriateness categories for each variant.
ACR Appropriateness Criteria for the use of Percutaneous Vertebral Augmentation for the Management of Vertebral Compression Fractures
"New symptomatic compression fracture identified on radiographs or CT. No known malignancy."
May Be Appropriate
"Osteoporotic compression fracture, with or without edema on MRI and no ‘red flags.' With or without spinal deformity, worsening symptoms, or pulmonary dysfunction."
"Asymptomatic pathologic spinal fracture with or without edema on MRI."
May Be Appropriate
"Pathologic spinal fracture with severe and worsening pain."
"Pathologic spinal fracture with spinal deformity or pulmonary dysfunction."
CT: computed tomography; MRI: magnetic resonance imaging; ACR: American College of Radiology.
Society for Interventional Radiology
The Society of Interventional Radiology (2014) issued a joint position statement with 7 other societies on percutaneous vertebral augmention noting that "percutaneous vertebral augmentation (PVA) with the use of 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." The society states that percutaneous vertebral augmentation should be "offered only when nonoperative medical therapy has not provided adequate pain relief or pain is significantly altering the patient's quality of life." Finally, the society notes that "the benefits of PVA outweigh its risk and the risks of non-operative medical therapy, and the success rate in appropriately selected patients is consistently high."
In a 2014 quality improvement guideline from SIR, failure of medical therapy is defined as follows:
- A patient rendered nonambulatory as a result of pain from a weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy;
- A patient with sufficient pain from a weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy; or
- Any patient with a weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.
American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons (AAOS) approved practice guidelines (2010) on the treatment of osteoporotic spinal compression fractures. AAOS approved a strong recommendation against the use of vertebroplasty for patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.” With this recommendation, AAOS expressed its confidence that future evidence is unlikely to overturn the existing evidence. These recommendations were based on a literature review through September 2009; therefore, the 2010 Klazen trial was not considered.
National Institute for Health and Care Excellence
The U.K.’s National Institute for Health and Care Excellence (NICE) concluded in its 2003 guidance on percutaneous vertebroplasty that the current evidence on the safety and efficacy of vertebroplasty for vertebral compression fractures appeared “adequate to support the use of this procedure” to “provide pain relief for people with severe painful osteoporosis with loss of height and/or compression fractures of the vertebral body….”The guidance also recommended that the procedure be limited to patients whose pain is refractory to more conservative treatment. A 2013 NICE guidance indicated that percutaneous vertebroplasty and percutaneous balloon kyphoplasty “are recommended as options for treating osteoporotic vertebral compression fractures” in persons having “severe, ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management” and whose “pain has been confirmed o be at the level of the fracture by physical examination and imaging.”
In 2008, NICE issued guidance on the diagnosis and management of adults with metastatic spinal cord compression. This guidance indicated that vertebroplasty or kyphoplasty should be considered for “patients who have vertebral metastases and no evidence of MSCC [metastatic spinal cord compression] or spinal instability if they have: mechanical pain resistant to conventional pain management, or vertebral body collapse.”
U.S Preventive Services Task Force Recommendations
Percutaneous vertebroplasty, vertebroplasty, polymethylmethacrylate, PMMA, osteoporosis, vertebral body compression fracture, vertebral fracture, vertebral compression fracture, PV, VCF, optiplasty, OptiMesh, Arcuate XP device, Arcuplasty, ARCUATE™ Vertebral Augmentation System, sacroplasty, Cortoss Bone Augmentation Material, Osteopal, SpineFix, Parallax Contour Vertebral Augmentation device
APPROVED BY GOVERNING BODIES:
Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval.
Polymethylmethacrylate (PMMA) bone cement was available as a drug product before enactment of FDA’s device regulation and was at first considered what 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. Thus, use of PMMA in vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, PMMA bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were issued 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.
The use of PMMA in sacroplasty represents an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement [Teknimed] and Osteopal® V [Heraeus]), as the 510(k) marketing clearance was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included.
In May 2009, Cortoss® (Stryker) Bone Augmentation Material was cleared for marketing by FDA through the 510(k) process. Cortoss® is a nonresorbable synthetic material that is a composite resin-based, bis-glycidal dimethacrylate. FDA classifies this product as a PMMA bone cement.
In February 2010, the Parallax® Contour® Vertebral Augmentation Device (ArthroCare) was cleared for marketing by FDA through the 510(k) process. The device creates a void in cancellous bone that can then be filled with bone cement.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Anesthesia for percutaneous image guided procedures on the spine and spinal cord; therapeutic
Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, one or more needles, includes imaging guidance and bone biopsy, when performed
; two or more needles includes imaging guidance and bone biopsy, when performed
Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic
Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral
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)
Unlisted procedure, nervous system
- Aebli, Nikolaus, et al. Cardiovascular changes during multiple vertebroplasty with and without vent-hole, SPINE, Vol. 28, No. 14, pp. 1504-1512.
- Aebli, Nikolaus, et al. Pressurization of vertebral bodies during vertebroplasty causes cardiovascular complications, SPINE, Vol. 28, No. 14, pp. 1513-1520.
- Alvarez, L., et al. Vertebroplasty in the treatment of vertebral tumors: Post-procedural outcome and quality of life, European Spine Journal, Springer-Verlag 2003.
- American Academy of Orthopaedic Surgeons (AAOS). Clinical practice guideline, Treatment of osteoporotic spinal compression fractures. 2010; http://www.aaos.org/research/guidelines/SCFguideline.pdf.
- American College of Radiology. Standard for the performance of percutaneous vertebroplasty, 2000 (Res. 14).
- American College of Radiology. ACR Appropriateness Criteria management of vertebral compression fractures. 2013. http://www.acr.org/~/media/ACR/Documents/AppCriteria/Interventional/RadiologicManagementVertebralCompressionFractures.pdf.
- Aretxabala I, Fraiz E, Perez-Ruiz F et al. Sacral insufficiency fractures. High association with pubic rami fractures. Clin Rheumatol 2000; 19(5):399-401.
- 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.
- Baerlocher MO, Saad WE, Dariushnia S et al. Quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. Feb 2014; 25(2):165-170.
- 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.
- Belkoff, Stephen M. and Molloy, Sean. Temperature measurement during polymerization of polymethylmethacrylate cement used for vertebroplasty, SPINE, Vol. 28, No. 14, pp. 1555-1559.
- Betts A. Sacral vertebral augmentation; confirmation of fluoroscopic landmarks by open dissection. Pain Physician 2008;11(1):57-65.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty. TEC Assessments 2000; Volume 15, Tab 21.
- Blue Cross and Blue Shield Technology Evaluation Center (TEC). Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis, malignancy, or hemangioma. TEC Assessments 2004; Volume 19, Tab 13.
- Blue Cross and Blue Shield Technology Evaluation Center (TEC). Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis or malignancy. TEC Assessments 2005; Volume 20, Tab 6.
- 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.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for painful vertebral fractures caused by osteoporosis. TEC Assessments 2009; Volume 24, Tab 7.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for vertebral fractures caused by osteoporosis. TEC Assessments 2010; Volume 25, Tab 9.
- Blue Cross 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.
- Buchbinder R, Golmohammadi K, Johnston RV, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. Apr 30 2015(4):CD006349.
- 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.
- Butler CL, Given CA, Michel SJ, et al. Percutaneous sacroplasty for the treatment of sacral insufficiency fractures. AJR Am J Roentgenol 2005;184:1956.
- Canale: Campbell’s Operative Orthopaedic, 10th ed. Mosby, Inc. 2003.
- Chang X, Lv YF, Chen B, et al. Vertebroplasty versus kyphoplasty in osteoporotic vertebral compression fracture: a meta-analysis of prospective comparative studies. Int Orthop. Mar 2015;39(3):491-500.
- 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.
- Chew C, Craig L, Edwards R et al. Safety and efficacy of percutaneous vertebroplasty in malignancy: a systematic review. Clin Radiol. Jan 2011; 66(1):63-72.
- Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. Oct 01 2016;388(10052):1408-1416.
- Comstock BA, Sitlani CM, Jarvik JG et al. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. Oct 2013; 269(1):224-231.
- Cornell CN, Lane JM, Poynton AR. Orthopedic management of vertebral and long bone fractures in patients with osteoporosis. Clinics in Geriatric Medicine 19(2): 2003.
- Cortet B., Cotton A., Boutry N., and et al. Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: an open prospective study, J Rheumatology; 1999; 2222-2228.
- 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.
- Cranney A, Jamal SA, Tsang JF, et al. Low bone mineral density and fracture burden in postmenopausal women. CMAJ 2007;177(6)575-580.
- Dehdashti AR, Martin JB, Jean B, et al. PMMA cementoplasty in symptomatic metastatic lesions of the S1 vertebral body. Cardiovasc Intervent Radiol. May-Jun 2000;23:235-237.
- Denis F, Davis S, Comfort T. Sacral fractures: an important problem. Retrospective analysis of 236 cases. Clin Orthop Relat Res. Feb 1988;227:67-81.
- Diamond TH, Bryant C, Browne L et al. Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy. Med J Aust. Feb 6 2006; 184(3):113-117.
- Diamond, Terrence H., et al. Management of acute osteoporotic vertebral fractures: A non-randomized trial comparing percutaneous vertebroplasty with conservative therapy, American Journal of Medicine, March 1, 2003, Vol. 114, No. 4.
- Dohm M, Black CM, Dacre A, et al. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. Dec 2014;35(12):2227-2236.
- Doody O, Czarnecki C, Given MF et al. Vertebroplasty in the management of traumatic burst fractures: a case series. J Med Imaging Radiat Oncol 2009;53(5):489-492.
- Dougherty RW, McDonald JS, Cho YW et al. Percutaneous sacroplasty using CT guidance for pain palliation in sacral insufficiency fractures. J Neurointerv Surg. Jan 2014; 6(1):57-60.
- Edidin AA, Ong KL, Lau E, et al. Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population. J Bone Miner Res. Jul 2011;26(7):1617-1626.
- Edidin AA, Ong KL, Lau E, et al. Mobidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population. Spine (Phila Pa 1976). Aug 01 2015;40(15):1228-1241.
- Evans, Avery J., et al. Vertebral compression fractures: Pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty-Retrospective report of 245 cases, Radiology, February 2003, Vol. 226, No. 2, pp. 366-372.
- Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. May 2011; 14(5):561-569.
- Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551.
- Fournery DR, et al. Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J of Neurosurg. Jan 2003: 98 (1 Suppl): 21-30.
- Frey ME, DePalma MJ, Cifu DX et al. Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures: a prospective, multicenter trial. Spine 2007;32(15):1635-1640.
- Frey ME, DePalma MJ, Cifu DX et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures; a prospective, multicenter, observational pilot study. Spine. Mar-Apr 2008 8(2):367-373.
- Frey ME, Warner C, Thomas SM, et al. Sacroplasty: a ten-year analysis of prospective patients treated with percutaneous sacroplasty: literature review and technical considerations. Pain Physician. Nov 2017;20(7):E1063-E1072.
- Gangi, Afshin, et al. Percutaneous vertebroplasty: Indications, technique, and results, Radiographics, Online, November 20, 2002.
- Gardos F., Depriester C., Cayrolle G., and et al. Long-term observations of vertebral osteoporotic fractures treated by percutaneous vertebroplasty, Rheumatology 2000:39; 1410-1414.
- Garfin S.R., Yuan H.A., and Reiley M.A. Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures, Spine: 26(14); 1511-1515.
- Garfin S.R., Yuan H.A., and Reiley M.A. Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures, Spine: 26(14); 1511-1515.
- Gotis-Graham I, McGuigan L, Diamond T, et al. Sacral insufficiency fractures in the elderly. J Bone Joint Surg Br. Nov 1994;76(6):882-886.
- Grant M. Sacroplasty: a new treatment for sacral insufficiency fracture. J Vasc Interv Radiol 2002;13:1265.
- Grotle M, Brox JI, Vollestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine. Nov 1 2004; 29(21):E492-501.
- Heini PF, Walcli B, and Berlemann U. Percutaneous transpedicular vertebroplasty with PMMA: operative technique and early results, Eur Spine J (2000) 9: 445-450.
- Heran MKS, Legiehn GM, Munk PL. Current concepts and techniques in percutaneous vertebroplasty. Orthop Clin N Am 2006; 37:409-434.
- Hodler, Juerg, et al. Midterm outcome after vertebroplasty: Predictive value of technical and patient-related factors, Radiology 2003. Published online before print, April 17, 2003. ww.fda.gov/cdrh/pdf/k014200.pdf.
- 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):1594-1602. www.aaos.org/aaos/archives/bulletin/apr05/acdnws15.asp.
- Jang, Jee-Soo, et al. Efficacy of percutaneous vertebroplasty in the treatment of intravertebral pseudarthrosis associated with noninfected avascular necrosis of the vertebral body, SPINE, Vol. 28, No. 14, pp. 1588-1592.
- Jarvik, Jeffrey G., et al. Vertebroplasty. Learning more, but not enough, SPINE, Vol. 28, No. 14, pp. 1487-1489.
- Jarvik JG, Deyo RA. Cementing the evidence; time for a randomized trial of vertebroplasty. Am J Neuroradiol. Sep 2000; 21(8):1373-1374.
- Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty of osteoporotic spinal fractures. N Engl J Med. Aug 6 2009; 361(6):569-579.
- Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-252.
- Kaufmann, Timothy J., et al. Age of fracture and clinical outcomes of percutaneous vertebroplasty, American Journal of Neuroradiology, Nov-Dec 2001, Vol. 22, pp. 1860-1863.
- Kelekis, Alexis D. Radicular pain after vertebroplasty, SPINE, Vol. 28, No. 14, pp. E265-E269.
- Klazen CA, Lohle PN, de Vries J et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010; 376(9746):1085-1092.
- Kortman K, Ortiz O, Miller T et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. Sep 2013; 5(5):461-466.
- Kroon F, Staples M, Ebeling PR, et al. Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures. J Bone Miner Res. Jun 2014;29(6):1346-1355.
- Kruger, Randell and Faciszewski, Thomas. Radiation dose reduction to medical staff during vertebroplasty, SPINE, Vol. 28, No. 14, pp. 1608-1613.
- Lane JM, Johnson CE, et al. Advances in spine surgery: minimally invasive options for the treatment of osteoporotic vertebral compression factors. Orthopedic Clinics of North America 33(2):2002.
- Lavelle WF, Lavell ED, Smith HS. Interventional techniques for back pain. Clin Geriatr Med 2008;24(2):345-368, viii.
- Layton KF, Thielen KR, Koch CA et al. Vertebroplasty, first 1000 levels of a single center: evaluation of the outcomes and complications. AJNR Am J Neuroradiol 2007; 28(4):683-689.
- 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.
- Leroux JL, Denat B, Thomas E et al. Sacral insufficiency fractures presenting as acute low-back pain. Biomechanical aspects. Spine (Phila Pa 1976) 1993; 18(16):2502-2506.
- Lewis CA, Barr JD, Cardella JF, et al. ACR practice guideline. Practice guideline for the performance of percutaneous vertebroplasty. American College of Radiology Standards 2000-2001. Amended 2006;135-144.
- Lieberman I.H., Dudeney S., Reinhard M.K., and Bell G. Initial outcome of efficacy of “kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures, Spine: 26(14); 1631-1638.
- Lin JH, Chien LN, Tsai WL, et al. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. Sep 2017;17(9):1310-1318.
- Lin J, Lachmann E, Nagler W. Sacral insufficiency fractures: a report of two cases and a review of the literature. J Womens Health Gend Based Med 2001; 10(7):699-705.
- Lourie H. Spontaneous osteoporotic fracture of the sacrum: an unrecognized syndrome of the elderly. JAMA 1982;248(6):715-717.
- Marcy PY, Palussiere J, Descamps B, et al. Percutaneous cementoplasty for pelvic bone metastasis. Support Care Cancer 2000;8(6):500-503.
- Masala S, Massari F, Assako OP et al. Is 3T-MR spectroscopy a predictable selection tool in prophylactic vertebroplasty? Cardiovasc Intervent Radiol. Dec 2010; 33(6):1243-1252.
- Mathis, John M., et al. Percutaneous vertebroplasty: A developing standard of care for vertebral compression fractures, AJNR, February 2001, Vol. 22, pp. 373-381.
- McGraw JK, Cardella J, Barr JD, et al. Standards of practice. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol 2003;14:827-831.
- McGuire R. AAOS Clinical Practice Guideline: the Treatment of Symptomatic Osteoporotic Spinal Compression Fractures. J Am Acad
- Orthop Surg. 2011 Mar;19(3).
- McGuire RAJ. AAOS Now: Treating spinal compression fractures. 2010; https://www.aaos.org/AAOSNow/2010/Oct/cover/cover1/?ssopc=1.
- Medical Policy Reference Manual. Percutaneous vertebroplasty and kyphoplasty, Blue Cross and Blue Shield Association. 6.01.25. May 2001.
- Molloy, Sean, Mathis, John M., and Belkoff, Stephen M. The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty, SPINE, Vol. 28, Vol. 14, pp. 1549-1554.
- Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning of response. Ann Intern Med. Mar 19 2002; 136(6):471-476.
- National Institutes of Health. Consensus statement. Bethesda, MD: National Institutes of Health; 2000:17:1.
- National Institute for Health and Clinical Excellence (NICE). CG 75 Metastatic spinal cord compression, diagnosis and management of adults 2008. https://publications.nice.org.uk/metastatic-spinal-cord-compression-cg75.
- National Institute for Health and Clinical Excellence (NICE), Guidance on balloon kyphoplasty for vertebral compression fractures. IP Guidance Number: IPG166; April 2006. http://www.nice.org.uk/nicemedia/pdf/IPG166A4Updated.pdf.
- National Institute for Health and Clinical Excellence (NICE). Percutaneous cementoplasty for palliative treatment of bony malignancies. IP Guidance Number: IPG179. Issue date: June 2006. https://www.nice.org.uk/nicemedia/pdf/ip/IPG179guidance.pdf.
- National Institute for Health and Care Excellence (NICE). IPG 12: Percutaneous vertebroplasty. 2003. https://publications.nice.org.uk/percutaneous-vertebroplasty-ipg12.
- National Institute for Health and Clinical Excellence (NICE). TA 279 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. 2013. https://publications.nice.org.uk/percutaneous-vertebroplasty-and-percutaneous-balloon-kyphoplasty-for-treating-osteoporotic-vertebral-ta279.
- Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. Dec 1992; 74(10):1472-1477.
- Ostelo RW, Deyo RA, Stratford P et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. Jan 1 2008;33(1):90-94.
- Peh, W.C.G., and Gilna, C.A. Percutaneous vertebroplasty: Indications, contraindications, and technique, British Journal of Radiology, January 2003, Vol. 76, pp. 69-75.
- Peh, Wilfred C.G., et al. Percutaneous vertebroplasty: Treatment of painful vertebral compression fractures with intraosseous vacuum phenomena, AJR, May 2003, Vol. 180, 1411-1417.
- Perez-Higueras, A., et al. Percutaneous vertebroplasty: Long-term clinical and radiological outcome, Neuroradiology, 2002, Vol. 44, pp. 950-954.
- Pommersheim W, Huang-Hellinger F, Baker M, et al. Sacroplasty: a treatment for sacral insufficiency fractures: case report. AJNR Am J Neuroradiol 2003;24:1003.
- Reidy, Declan, Ahn, Henry, et al. A biomechanical analysis of intravertebral pressures during vertebroplasty of cadaveric spines with and without simulated metastases, SPINE, Vol. 28, No. 14, pp. 1534-1539.
- Rousing R, Andersen MO, Jespersen SM et al. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-month follow-up in a clinical randomized study. Spin (Phila Pa 976). Jun 1 2009; 34(13):1349-1354.
- Schofer MD, Efe T, Timmesfeld N et al. Comparison of kyphoplasty and vertebroplasty in the treatment of fresh vertebral compression fractures. Arch Orthop Trauma Surg 2009;129(10):1391-1399.
- Senn S. (2007). Statistical Issues in Drug Development. NY: Wiley and Sons; 2007.
- Shah, LM, Jennings JW, Kirsch CFE et al. ACR appropriateness Criteria management of vertebral compression fractures. J Am Coll Radiol. 2018 Nov; 15(11S).
- 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.
- Stratford PW, Binkley J, Solomon P, et al. Defining the minimum level of 3
- Suparna HC, Vadhiraja BM, Apsani RC, et al. Symptomatic vertebral hemangiomas—results of treatment with radiotherapy. Indian J Radiol Imaging 2006;16:37-40.
- Tanner SB. Back pain, vertebroplasty, and kyphoplasty: treatment of osteoporotic vertebral compression fractures. Bulletin on the Rheumatic Diseases 52(2).
- U.S. Food and Drug Administration. FDA Public Health web notification. 2009. http://google2.fda.gov/search?as_sitesearch=www.fda.gov/medicaldevices/safety/alertsandnotice s&q=Bone+Cement&spell=1&proxystylesheet=FDAgov&output=xml_no_dtd&site=FDAgov- PubHealthNotifications-Devices&client=FDAgov&ie=UTF-8&access=p&ulang=en&ip=10.100.50.81,220.127.116.11&sort=date:D:L:d1&entqr=3&entqrm=0&o e=UTF-8&ud=1.
- Vase L, Riley JL 3rd, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain. Oct 2002; 99(3):443-452.
- Venmans A, Klazen CA, Lohle PN et al. Natural History of Pain in Patients with Conservatively Treated Osteoporotic Vertebral Compression Fractures: Results from VERTOS II. AJNR Am J Neuroradiol. Nov 24 2011.
- Voormolen MH, Mali WP, Lohle PN et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol. Mar 2007; 28(3):555-560.
- 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.
- Watts, Nelson B. Is percutaneous vertebral augmentation (vertebroplasty) effective treatment for painful vertebral fractures? American Journal of Medicine, March 2003, Vol. 114, No. 4.
- Watts, N.B., Harris, S.T., and Genant, H.K. Treatment of painful osteoporotic vertebral fractures with percutaneous vertebroplasty or kyphoplasty. Osteoporosis International, 2001, Vol. 12, pp. 429-437.
- Werner CM, Osterhoff G, Schlickeiser J et al. Vertebral body stenting versus kyphoplasty for the treatment of osteoporotic vertebral compression fractures: a randomized trial. J Bone Joint Surg Am 2013; 95(7):577-584.
- WHO Scientific Group on the Prevention and Management of Osteoporosis. Prevention and management of osteoporosis: report of a WHO scientific group 2003. www.who.org.
- Xie L, Zhao ZG, Zhang SJ, et al. Percutaneous vertebroplasty versus conservative treatment for osteoporotic vertebral compression fractures: An updated meta-analysis of prospective randomized controlled trials. Int J Surg. Nov 2017;47:25-32.
- 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.
- Yi X, Lu H, Tian F et al. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. Jan 2014; 134(1):21- 30.
- Zaman FM, Frey M, Slipman CW. Sacral stress fractures. Curr Sports Med Rep. Feb 2006; 5(1):37-43.
Medical Policy Group, November 1999
Medical Review Committee, January 2000
TEC Review, April 2000
Medical Policy Group, January 2001
Medical Review Committee, March 2001
TEC Review, May 2001
Medical Policy Group, February 2002 (2)
Medical Review Committee, March 2002
Available for Comment April 15-May 29, 2002
Medical Policy Group, June 2003 (2)
Medical Review Committee, June 2003
Medical Review Committee, July 2003
Medical Policy Administration Committee, July 2003
Available for comment July 28-September 10, 2003
Medical Policy Group, August 2003 (2)
Medical Review Committee, September 2003
Medical Policy Administration Committee, October 2003
Available for comment October 7-November 20, 2003
Medical Policy Group, October 2005 (2)
Medical Policy Administration Committee, November 2005
Available for comment November 30, 2005-January 13, 2006
Medical Policy Group, July 2006 (1)
Medical Policy Administration Committee, July 2006
Available for comment July 18-August 31, 2006
Medical Policy Group, January 2007 (2)
Medical Policy Group, June 2007 (2)
Medical Policy Group, July 2007 (2)
Medical Policy Administration Committee, July 2007
Available for comments July 16-September 3, 2007
Medical Policy Group, March 2008 (2)
Medical Policy Administration Committee, April 2008
Available for comment April 4-May 18, 2008
Medical Policy Group, May 2008 (2)
Medical Policy Administration Committee, June 2008
Available for comment June 11-July 26, 2008
Medical Policy Group, June 2009 (2)
Medical Policy Administration Committee, July 2009
Available for comment July 1-August 14, 2009
Medical Policy Panel, February 2010
Medical Policy Group, March 2010 (2)
Medical Policy Administration Committee, April 2010
Available for comment April 12-May 26, 2010
Medical Policy Panel, February 2011
Medical Policy Group, June 2011 (2): Key Points and Reference Updated
Medical Policy Group, December 2011 (3): Updated verbiage on CPT 22520 & 22521 for 2012 code update.
Medical Policy Panel, April 2013
Medical Policy Group, August 2013 (2): Title change to include Mechanical Vertebral Augmentation. Policy statement added that all other percutaneous mechanical vertebral augmentation devices, including but not limited to Kiva are investigational. Description, Key Points, Approved by Governing Bodies, Key Words, and Reference updated to support new policy statement and literature search.
Medical Policy Administration Committee, September 2013
Available for comment September 19 through November 2, 2013
Medical Policy Group, March 2014 (2): Corrected policy statement with addition of coverage for vertebral hemangiomas with severe pain or nerve compression.
Medical Policy Group, March 2014 (5): Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.
Medical Policy Panel, July 2014
Medical Policy Group, July 2014 (3): 2014 Updates to Key Points, Governing Bodies & References; no change in policy statements; removed policy statements for 2010 & prior years
Medical Policy Group, November 2014 (3): 2015 Annual Coding update; added CPT codes 22510-22515 and moved previous codes 22520-22525 and 72291-72292; changed verbiage on 0200T & 0201T by adding ‘includes imaging guidance and bone biopsy, when performed.
Medical Policy Panel, April 2015
Medical Policy Group, May 2015 (2): 2015 Updates to Description, Key Points, Current Coding, and References; no change to policy statement.
Medical Policy Group, November 2015: 2016 Annual Coding Update; Moved HCPCS codes S2360 and S2361 from current coding to previous coding.
Medical Policy Panel, November 2016
Medical Policy Group, November 2016 (7): 2016 Updates to Key Points, Coding- Removed previous codes deleted in 2006 and ICD-9 and ICD-10-CM diagnosis under Coding Section. No change to policy statement.
Medical Policy Panel, April 2018
Medical Policy Group, April 2018 (7): 2018 Updates to Title, Description, Key Points, Key Words, Approved by Governing Bodies and References; removed all aspects of kyphoplasty and mechanical augmentation, now in separate policy, #648. Policy Statement clarified- removed “including use in acute vertebral fractures due to osteoporosis or trauma”. No change in intent.
Medical Policy Panel, April 2019
Medical Policy Group, May 2019 (7): Updates to Key Points and References. No change in Policy Statement.
Medical Policy Panel, April 2020
Medical Policy Group, May 2020 (7): Updates to Key Points and References. No change in Policy Statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
- The technology must have final approval from the appropriate government regulatory bodies;
- The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
- The technology must improve the net health outcome;
- The technology must be as beneficial as any established alternatives;
- The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
- In accordance with generally accepted standards of medical practice; and
- Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
- Not primarily for the convenience of the patient, physician or other health care provider; and
- Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.