MEDICAL POLICY I. POLICY PERCUTANEOUS VERTEBROPLASTY, KYPHOPLASTY AND SACROPLASTY POLICY NUMBER MP POLICY TITLE

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1 Original Issue Date (Created): August 9, 2002 Most Recent Review Date (Revised): November 26, 2013 Effective Date: February 1, 2014 I. POLICY Vertebroplasty and Kyphoplasty Percutaneous vertebroplasty or kyphoplasty may be considered medically necessary for the following indications: Osteoporotic vertebral compression fractures in the cervical, thoracic, or lumbar spine that are more than two weeks old, have not responded to conservative therapy and are causing severe pain; Painful metastasis, including multiple myeloma, with or without adjuvant radiation or surgical therapy Painful vertebral hemangiomas; Vertebral osteonecrosis; or Reinforcement of a pathological weak vertebral body prior to surgical stabilization. In addition, kyphoplasty may be considered medically necessary for the treatment of kyphosis. Percutaneous vertebroplasty and kyphoplasty for all other indications, including use in acute vertebral fractures (less than two weeks old) is considered investigational. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Percutaneous mechanical vertebral augmentation using any other device, including but not limited to Kiva, is considered investigational. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Sacroplasty Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Page 1

2 II. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] Capital Cares 4 Kids [N] PPO [N] HMO [N] SeniorBlue HMO [N] SeniorBlue PPO [N] Indemnity [N] SpecialCare [N] POS [Y] FEP PPO* * Refer to FEP Medical Policy Manual MP Percutaneous Kyphoplasty and Percutaneous Vertebroplasty and Sacroplasty.. The FEP Medical Policy manual can be found at: III. DESCRIPTION/BACKGROUND Vertebroplasty Percutaneous vertebroplasty (PVP) is an interventional radiologic technique involving a fluoroscopic guided injection of polymethylmethacrylate (PMMA) cement through a needle inserted into a weakened vertebral body. This technique has been investigated as an option to provide pain relief and increase bone strength in patients with vertebral compression fracture due to osteoporosis and in patients with osteolytic lesions of the spine,including myltiple myeloma or metastatic malignancies. Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, as a way to limit blood loss related to surgery. This technique has been used on all levels of the vertebrae, including cervical, thoracic, and lumbar spine. It has been proposed that PVP 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. Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval. 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 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, which is available online at: Page 2

3 and outlines the types of special controls required and describes the recommended labeling information. Thus, use of PMMA in vertebroplasty represented an off-label use of an FDA-regulated product prior to 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 pathological 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: cm htm. 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. Kyphoplasty 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.. Regulatory Status Kyphoplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval. Balloon 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 The Kiva VCF Treatment System (Benvenue Medical) is not available in the U.S. outside of a pivotal, FDA-regulated, investigational device exemption (IDE) trial. 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 Page 3

4 orthopedic companies have received approval of their bone cement products since 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 kyphoplasty represented an off-label use of an FDA-regulated product prior to July 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: 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 Sacroplasty 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 2001 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 excessive stress on weakened bone and are often the cause of low back pain among the elderly. Osteoporosis is the most common risk factor for SIF. 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 and Osteopal V) as the 510(k) marketing clearance was for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Sacroplasty was not included. 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 Page 4

5 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. Sacral Insufficiency Fractures 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 including bed rest, bracing and analgesics. Initial clinical improvements may occur quickly; however, the resolution of all symptoms may not occur for 9 to 12 months. Vertebral/Sacral Body Metastasis Metastatic malignant disease involving the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint. While radiation and chemotherapy are Page 5

6 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. IV. DEFINITIONS HEMANGIOMA is a benign tumor of dilated blood vessels. OSTEOLYTIC refers to osteolysis, which is the softening, and destruction of bone without osteoclastic activity. Osteolysis occurs within compact bone and results from a breakdown of the organic matrix and subsequent leaching out of the inorganic fracture. OSTEOPOROSIS refers to the loss of bone mass that occurs throughout the skeleton, predisposing patients to fractures. VERTEBRAE are any of the thirty-three (33) bony segments of the spinal column. V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. Page 6

7 VII. REFERENCES Percutaneous Kyphoplasty and Mechanical Vertebral Augmentation ACR ASNR ASSR SIR SNIS Practice guideline for the performance of vertebral augmentation [Website]: Accessed September 25, BCBSA 2000 TEC Assessment, Tab 21. BCBSA 2004 TEC Assessment. Percutaneous kyphoplasty for vertebral lesions from osteoporosis and malignancy, Tab 12. BCBSA 2005 TEC Assessment. Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis or malignancy, Tab 7. 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): Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for painful vertebral fractures caused by osteoporosis. TEC Assessments 2009; Tab 24 Boonen S, Van Meirhaeghe J, Bastian L et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res 2011; 26(7): 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): 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 2011; 26(7): Garfin SR, Buckley RA, Ledlie J, et al. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine 2006; 31(19): 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): Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009; 361(6): Khanna AJ, Reinhardt MK, Togawa D et al. Functional outcomes of kyphoplasty for the treatment of osteoporotic and osteolytic vertebral compression fractures. Osteoporos Int 2006; 17(6): Page 7

8 Korovessis P, Vardakastanis K, Repantis T et al. Balloon Kyphoplasty Versus KIVA Vertebral Augmentation-Comparison of 2 Techniques for Osteoporotic Vertebral Body Fractures: A Prospective Randomized Study. Spine (Phila Pa 1976) 2013; 38(4): Ledlie JT, Renfro MB. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine 2006; 31(1): National Institute for Health and Clinical Excellence (NICE), Guidence on balloon kyphoplasty for vertebral compression fractures. IP Guidance Number 166 : IPG; April 2006 [Website]: Accessed September 25, National Institute for Health and Clinical Excellence (NICE), Percutaneous cementoplasty for palliative treatment of bony malignancies. IP Guidance Number : IPG179;June Available online at: Accessed September 25, Robinson Y, Tschöke SK, Stahel PF et al. Complications and safety aspects of kyphoplasty for osteoporotic vertebral fractures: a prospective follow-up study in 102 consecutive patients. Patient Saf Surg 2008; 2:2. Saad WE, Funaki BS, Ray CE et al. ACR Appropriateness Criteria management of vertebral compression fractures [Website]: Accessed September 25, 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): Van Meirhaeghe J, Bastian L, Boonen S et al. A Randomized Trial of Balloon Kyphoplasty and Non-Surgical Management for Treating Acute Vertebral Compression Fractures: Vertebral Body Kyphosis Correction and Surgical Parameters. Spine (Phila Pa 1976) 2013 [Epub ahead of print]. Wardlaw D, Cummings SR, Meirhaeghe J et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fractures (FREE): a randomised controlled trial. Lancet 2009; 373(9668): Percutaneous Vertebroplasty and Sacroplasty ACR ASNR ASSR SIR SNIS Practice guideline for the performance of vertebral augmentation 2012.[Website]: Accessed September 25, Alvarez L, Alcaraz M, Perez-Higueras A, et al. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine 2006; 31(10): American College of Radiology. Practice guideline for the performance of percutaneous vertebroplasty [Website]: mentvertebralcompressionfractures.pdf Accessed September 25, Page 8

9 BCBSA 2000 TEC Assessment, Tab 21. BCBSA 2004 TEC Assessment; Percutaneous vertebroplasty for vertebral lesions from osteoporosis, malignancy, or hemangioma, Tab 13. BCBSA 2005 TEC Assessment; Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis or malignancy, Tab 6. Binaghi S, Guntern D, Schnyder P et al. A new, easy, fast, and safe method for CT-guided sacroplasty. Eur Radiol 2006; 16(12): Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for vertebral fractures caused by osteoporosis or malignancy. TEC Assessments 2008; 23(Tab 5): Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Special report: measuring and reporting pain outcomes in randomized controlled trials. TEC Assessments 2006; 21(Tab 11):1-35. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for painful vertebral fractures caused by osteoporosis. TEC Assessments 2009; Tab 24. 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): Chew C, Craig L, Edwards R et al. Safety and efficacy of percutaneous vertebroplasty in malignancy: a systematic review. Clin Radiol 2011; 66(1):63-72 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 2006; 184(3): 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): Dougherty RW, McDonald JS, Cho YW et al. Percutaneous sacroplasty using CT guidance for pain palliation in sacral insufficiency fractures. J Neurointerv Surg 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 2011; 26(7): 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 2011; 14(5): Frey ME, Depalma MJ, Cifu DX et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J 2008; 8(2): Furstenberg CH, Grieser T, Wiedenhofer B et al. The role of kyphoplasty in the management of osteogenesis imperfecta: risk or benefit? Eur Spine J 2010; 19 Suppl 2:S Gjertsen O, Schellhorn T, Nakstad PH. Fluoroscopy-guided sacroplasty: special focus on preoperative planning from three-dimensional computed tomography. Acta Radiol 2008; 49(9): Page 9

10 Gray LA, Jarvik JG, Heagerty PJ et al. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty. BMC Musculoskelet Disord 2007; 8:126. Heron J, Connell DA, James SL. CT-guided sacroplasty for the treatment of sacral insufficiency fractures. Clin Radiol 2007; 62(11): ; discussion 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): Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009; 361(6): Kamel EM, Binaghi S, Guntern D et al. Outcome of long-axis percutaneous sacroplasty for the treatment of sacral insufficiency fractures. Eur Radiol 2009 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): Klazen C, Verhaar H, Lampmann L et al. VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial. Trials 2007; 8(1): 33. 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 Layton KF, Thielen KR, Wald JT. Percutaneous sacroplasty using CT fluoroscopy. AJNR Am J Neuroradiol 2006; 27(2): 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): Ma R, Chow R, Shen FH. Kummell's disease: delayed post-traumatic osteonecrosis of the vertebral body. Eur Spine J 2010; 19(7): Masala S, Massari F, Assako OP et al. Is 3T-MR spectroscopy a predictable selection tool in prophylactic vertebroplasty? Cardiovasc Intervent Radiol 2010; 33(6): National Institute for Health and Clinical Excellence (NICE). Percutaneous cementoplasty for palliative treatment of bony malignancies. IP Guidance Number: IPG179. Issue date: June [Website]: Accessed September 25, 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 2008; 33(1):90-4. Rousing R, Andersen MO, Jespersen SM et al. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral Page 10

11 fractures: three-months follow-up in a clinical randomized study. Spine (Phila Pa 1976) 2009; 34(13): 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): Sciubba DM, Wolinsky JP, Than KD et al. CT fluoroscopically guided percutaneous placement of transiliosacral rod for sacral insufficiency fracture: case report and technique. AJNR Am J Neuroradiol 2007; 28(8): Senn S. (2007). Statistical Issues in Drug Development. Wiley and Sons, NY. Smith DK, Dix JE. Percutaneous sacroplasty: long-axis injection technique. AJR Am J Roentgenol 2006; 186(5): Sonmez E, Yilmaz C, Caner H. Development of lumbar disc herniation following percutaneous vertebroplasty. Spine (Phila Pa 1976) 2010; 35(3):E93-5 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. Strub WM, Hoffmann M, Ernst RJ et al. Sacroplasty by CT and fluoroscopic guidance: is the procedure right for your patient? AJNR Am J Neuroradiol 2007; 28(1):38-41 Tjardes T, Paffrath T, Baethis H et al. Computer assisted percutaneous placement of augmented iliosacral screws: a reasonable alternative to sacroplasty. Spine (Phila Pa 1976) 2008; 33(13): 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 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 2007; 28(3): Wang LJ, Yang HL, Shi YX et al. Pulmonary cement embolism associated with percutaneous vertebroplasty or kyphoplasty: a systematic review. Orthop Surg 2012; 4(3): Whitlow CT, Mussat-Whitlow BJ, Mattern CW et al. Sacroplasty versus vertebroplasty: comparable clinical outcomes for the treatment of fracture-related pain. AJNR Am J Neuroradiol 2007; 28(7): Zaman FM, Frey M, Slipman CW. Sacral stress fractures. Curr Sports Med Rep 2006; 5(1): VIII. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. Page 11

12 Covered when medically necessary: CPT Codes Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. HCPCS Code S2360 S2361 VERT PERCUTANEOUS VERTEBROPLASTY, ONE VERTEBRAL BODY, UNILATERAL OR BILATERAL INJECTION; CERVICAL EACH ADDITIONAL CERVICAL VERTEBRAL BODY (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) ICD-9-CM Diagnosis Description Code* MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW MULTIPLE MYELOMA AND IMMUNOPROLIFERATIVE NEOPLASMS HEMANGIOMA OF OTHER SITES MAJOR OSSEOUS DEFECTS OSTEOPOROSIS PATHOLOGIC FRACTURE OF VERTEBRAE KYPHOSIS (ACQUIRED) KYPHOSIS ASSOCIATED WITH OTHER CONDITION CLOSED FRACTURE OF CERVICAL VERTEBRA WITHOUT MENTION OF SPINAL CORD INJURY CLOSED FRACTURE OF DORSAL (THORACIC) VERTEBRA WITHOUT MENTION OF SPINAL CORD INJURY CLOSED FRACTURE OF LUMBAR VERTEBRA WITHOUT MENTION OF SPINAL CORD INJURY CLOSED FRACTURE OF SACRUM AND COCCYX WITHOUT MENTION OF SPINAL CORD INJURY CLOSED FRACTURE OF UNSPECIFIED PART OF VERTEBRAL COLUMN WITHOUT MENTION OF SPINAL CORD INJURY *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. Investigational; therefore not covered: CPT Codes 0200T 0201T Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. Page 12

13 The following ICD-10 diagnosis codes will be effective October 1, 2014: ICD-10-CM Diagnosis Description Code* C41.0 Malignant neoplasm of bones of skull and face C41.1 Malignant neoplasm of mandible C41.2 Malignant neoplasm of vertebral column C41.3 Malignant neoplasm of ribs, sternum and clavicle C40.00 Malignant neoplasm of scapula and long bones of unspecified upper limb C40.01 Malignant neoplasm of scapula and long bones of right upper limb C40.02 Malignant neoplasm of scapula and long bones of left upper limb C40.10 Malignant neoplasm of short bones of unspecified upper limb C40.11 Malignant neoplasm of short bones of right upper limb C40.12 Malignant neoplasm of short bones of left upper limb C41.4 Malignant neoplasm of pelvic bones, sacrum and coccyx C40.20 Malignant neoplasm of long bones of unspecified lower limb C40.21 Malignant neoplasm of long bones of right lower limb C40.22 Malignant neoplasm of long bones of left lower limb C40.30 Malignant neoplasm of short bones of unspecified lower limb C40.31 Malignant neoplasm of short bones of right lower limb C40.32 Malignant neoplasm of short bones of left lower limb C40.80 Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb C40.81 Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb C40.82 Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb C40.90 Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb C40.91 Malignant neoplasm of unspecified bones and articular cartilage of right limb C40.92 Malignant neoplasm of unspecified bones and articular cartilage of left limb C41.9 Malignant neoplasm of bone and articular cartilage, unspecified C79.51 Secondary malignant neoplasm of bone C79.52 Secondary malignant neoplasm of bone marrow C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in remission C90.02 Multiple myeloma in relapse C90.10 Plasma cell leukemia not having achieved remission C90.11 Plasma cell leukemia in remission C90.12 Plasma cell leukemia in relapse C88.2 Heavy chain disease C88.3 Immunoproliferative small intestinal disease C88.8 Other malignant immunoproliferative diseases Page 13

14 ICD-10-CM Diagnosis Description Code* C88.9 Malignant immunoproliferative disease, unspecified C90.20 Extramedullary plasmacytoma not having achieved remission C90.30 Solitary plasmacytoma not having achieved remission D18.09 Hemangioma of other sites M89.70 Major osseous defect, unspecified site M Major osseous defect, right shoulder region M Major osseous defect, left shoulder region M Major osseous defect, unspecified shoulder region M Major osseous defect, right humerus M Major osseous defect, left humerus M Major osseous defect, unspecified humerus M Major osseous defect, right forearm M Major osseous defect, left forearm M Major osseous defect, unspecified forearm M Major osseous defect, right hand M Major osseous defect, left hand M Major osseous defect, unspecified hand M Major osseous defect, right pelvic region and thigh M Major osseous defect, left pelvic region and thigh M Major osseous defect, unspecified pelvic region and thigh M Major osseous defect, right lower leg M Major osseous defect, left lower leg M Major osseous defect, unspecified lower leg M Major osseous defect, right ankle and foot M Major osseous defect, left ankle and foot M Major osseous defect, unspecified ankle and foot M89.78 Major osseous defect, other site M89.79 Major osseous defect, multiple sites M81.0 Age-related osteoporosis without current pathological fracture M81.6 Localized osteoporosis [Lequesne] M81.8 Other osteoporosis without current pathological fracture M48.50xa M48.51xa M48.52xa M48.53xa Collapsed vertebra, not elsewhere classified, site unspecified, initial encounter for fracture Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, initial encounter for fracture Collapsed vertebra, not elsewhere classified, cervical region, initial encounter for fracture Collapsed vertebra, not elsewhere classified, cervicothoracic region, initial encounter for fracture Page 14

15 ICD-10-CM Diagnosis Code* M48.54xa M48.55xa M48.56xa M48.57xa M48.58xa M80.08xa M80.88xa M84.48xa M84.58xa M84.68xa Description Collapsed vertebra, not elsewhere classified, thoracic region, initial encounter for fracture Collapsed vertebra, not elsewhere classified, thoracolumbar region, initial encounter for fracture Collapsed vertebra, not elsewhere classified, lumbar region, initial encounter for fracture Collapsed vertebra, not elsewhere classified, lumbosacral region, initial encounter for fracture Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, initial encounter for fracture Age-related osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture Other osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture Pathological fracture, other site, initial encounter for fracture Pathological fracture in neoplastic disease, vertebrae, initial encounter for fracture Pathological fracture in other disease, other site, initial encounter for fracture M40.00 Postural kyphosis, site unspecified M40.03 Postural kyphosis, cervicothoracic region M40.04 Postural kyphosis, thoracic region M40.05 Postural kyphosis, thoracolumbar region M Unspecified kyphosis, cervical region M Unspecified kyphosis, cervicothoracic region M Unspecified kyphosis, thoracic region M Unspecified kyphosis, thoracolumbar region M Unspecified kyphosis, site unspecified M96.2 Postradiation kyphosis M96.3 Postlaminectomy kyphosis M Other kyphosis, cervical region M Other kyphosis, cervicothoracic region M Other kyphosis, thoracic region M Other kyphosis, thoracolumbar region M Other kyphosis, site unspecified M40.30 Flatback syndrome, site unspecified M40.35 Flatback syndrome, thoracolumbar region M40.36 Flatback syndrome, lumbar region M40.37 Flatback syndrome, lumbosacral region M40.10 Other secondary kyphosis, site unspecified M40.12 Other secondary kyphosis, cervical region M40.13 Other secondary kyphosis, cervicothoracic region M40.14 Other secondary kyphosis, thoracic region M40.15 Other secondary kyphosis, thoracolumbar region Page 15

16 ICD-10-CM Diagnosis Code* S12.9xxa S12.000a S12.001a S12.01xa S12.02xa S12.030a S12.031a S12.040a S12.041a S12.090a S12.091a S12.100a S12.101a S12.110a S12.111a S12.112a S12.120a S12.121a S12.130a S12.131a S12.14xa S12.150a S12.151a S12.190a S12.191a S12.200a S12.201a S12.230a S12.231a S12.24xa S12.250a Description Fracture of neck, unspecified, initial encounter Unspecified displaced fracture of first cervical vertebra, initial encounter for Unspecified nondisplaced fracture of first cervical vertebra, initial encounter for Stable burst fracture of first cervical vertebra, initial encounter for Unstable burst fracture of first cervical vertebra, initial encounter for Displaced posterior arch fracture of first cervical vertebra, initial encounter for Nondisplaced posterior arch fracture of first cervical vertebra, initial encounter for Displaced lateral mass fracture of first cervical vertebra, initial encounter for Nondisplaced lateral mass fracture of first cervical vertebra, initial encounter for Other displaced fracture of first cervical vertebra, initial encounter for Other nondisplaced fracture of first cervical vertebra, initial encounter for Unspecified displaced fracture of second cervical vertebra, initial encounter for Unspecified nondisplaced fracture of second cervical vertebra, initial encounter for Anterior displaced Type II dens fracture, initial encounter for Posterior displaced Type II dens fracture, initial encounter for Nondisplaced Type II dens fracture, initial encounter for Other displaced dens fracture, initial encounter for Other nondisplaced dens fracture, initial encounter for Unspecified traumatic displaced spondylolisthesis of second cervical vertebra, initial encounter for Unspecified traumatic nondisplaced spondylolisthesis of second cervical vertebra, initial encounter for Type III traumatic spondylolisthesis of second cervical vertebra, initial encounter for closed fracture Other traumatic displaced spondylolisthesis of second cervical vertebra, initial encounter for Other traumatic nondisplaced spondylolisthesis of second cervical vertebra, initial encounter for Other displaced fracture of second cervical vertebra, initial encounter for Other nondisplaced fracture of second cervical vertebra, initial encounter for Unspecified displaced fracture of third cervical vertebra, initial encounter for Unspecified nondisplaced fracture of third cervical vertebra, initial encounter for Unspecified traumatic displaced spondylolisthesis of third cervical vertebra, initial encounter for Unspecified traumatic nondisplaced spondylolisthesis of third cervical vertebra, initial encounter for Type III traumatic spondylolisthesis of third cervical vertebra, initial encounter for Other traumatic displaced spondylolisthesis of third cervical vertebra, initial encounter for closed fracture Page 16

17 ICD-10-CM Diagnosis Code* S12.251a S12.290a S12.291a S12.300a S12.301a S12.330a S12.331a S12.34xa S12.350a S12.351a S12.390a S12.391a S12.400a S12.401a S12.430a S12.431a S12.44xa S12.450a S12.451a S12.490a S12.491a S12.500a S12.501a S12.530a S12.531a S12.54xa S12.550a S12.551a Description Other traumatic nondisplaced spondylolisthesis of third cervical vertebra, initial encounter for Other displaced fracture of third cervical vertebra, initial encounter for Other nondisplaced fracture of third cervical vertebra, initial encounter for Unspecified displaced fracture of fourth cervical vertebra, initial encounter for Unspecified nondisplaced fracture of fourth cervical vertebra, initial encounter for Unspecified traumatic displaced spondylolisthesis of fourth cervical vertebra, initial encounter for Unspecified traumatic nondisplaced spondylolisthesis of fourth cervical vertebra, initial encounter for Type III traumatic spondylolisthesis of fourth cervical vertebra, initial encounter for closed fracture Other traumatic displaced spondylolisthesis of fourth cervical vertebra, initial encounter for closed fracture Other traumatic nondisplaced spondylolisthesis of fourth cervical vertebra, initial encounter for Other displaced fracture of fourth cervical vertebra, initial encounter for Other nondisplaced fracture of fourth cervical vertebra, initial encounter for Unspecified displaced fracture of fifth cervical vertebra, initial encounter for Unspecified nondisplaced fracture of fifth cervical vertebra, initial encounter for Unspecified traumatic displaced spondylolisthesis of fifth cervical vertebra, initial encounter for Unspecified traumatic nondisplaced spondylolisthesis of fifth cervical vertebra, initial encounter for Type III traumatic spondylolisthesis of fifth cervical vertebra, initial encounter for Other traumatic displaced spondylolisthesis of fifth cervical vertebra, initial encounter for closed fracture Other traumatic nondisplaced spondylolisthesis of fifth cervical vertebra, initial encounter for Other displaced fracture of fifth cervical vertebra, initial encounter for Other nondisplaced fracture of fifth cervical vertebra, initial encounter for Unspecified displaced fracture of sixth cervical vertebra, initial encounter for Unspecified nondisplaced fracture of sixth cervical vertebra, initial encounter for Unspecified traumatic displaced spondylolisthesis of sixth cervical vertebra, initial encounter for Unspecified traumatic nondisplaced spondylolisthesis of sixth cervical vertebra, initial encounter for Type III traumatic spondylolisthesis of sixth cervical vertebra, initial encounter for Other traumatic displaced spondylolisthesis of sixth cervical vertebra, initial encounter for closed fracture Other traumatic nondisplaced spondylolisthesis of sixth cervical vertebra, initial encounter for Page 17

18 ICD-10-CM Diagnosis Code* S12.590a S12.591a S12.600a S12.601a S12.630a S12.631a S12.64xa S12.650a S12.651a S12.690a S12.691a S12.9xxa S22.000a S22.001a S22.002a S22.008a S22.009a S22.010a S22.011a S22.012a S22.018a S22.019a S22.020a S22.021a S22.022a S22.028a S22.029a S22.030a S22.031a S22.032a S22.038a S22.039a Description Other displaced fracture of sixth cervical vertebra, initial encounter for Other nondisplaced fracture of sixth cervical vertebra, initial encounter for Unspecified displaced fracture of seventh cervical vertebra, initial encounter for Unspecified nondisplaced fracture of seventh cervical vertebra, initial encounter for closed fracture Unspecified traumatic displaced spondylolisthesis of seventh cervical vertebra, initial encounter for Unspecified traumatic nondisplaced spondylolisthesis of seventh cervical vertebra, initial encounter for Type III traumatic spondylolisthesis of seventh cervical vertebra, initial encounter for closed fracture Other traumatic displaced spondylolisthesis of seventh cervical vertebra, initial encounter for Other traumatic nondisplaced spondylolisthesis of seventh cervical vertebra, initial encounter for Other displaced fracture of seventh cervical vertebra, initial encounter for Other nondisplaced fracture of seventh cervical vertebra, initial encounter for Fracture of neck, unspecified, initial encounter Wedge compression fracture of unspecified thoracic vertebra, initial encounter for Stable burst fracture of unspecified thoracic vertebra, initial encounter for Unstable burst fracture of unspecified thoracic vertebra, initial encounter for Other fracture of unspecified thoracic vertebra, initial encounter for Unspecified fracture of unspecified thoracic vertebra, initial encounter for Wedge compression fracture of first thoracic vertebra, initial encounter for Stable burst fracture of first thoracic vertebra, initial encounter for Unstable burst fracture of first thoracic vertebra, initial encounter for Other fracture of first thoracic vertebra, initial encounter for thoracic vertebra, initial encounter for Wedge compression fracture of second thoracic vertebra, initial encounter for Stable burst fracture of second thoracic vertebra, initial encounter for Unstable burst fracture of second thoracic vertebra, initial encounter for Other fracture of second thoracic vertebra, initial encounter for Unspecified fracture of second thoracic vertebra, initial encounter for Wedge compression fracture of third thoracic vertebra, initial encounter for Stable burst fracture of third thoracic vertebra, initial encounter for Unstable burst fracture of third thoracic vertebra, initial encounter for Other fracture of third thoracic vertebra, initial encounter for Unspecified fracture of third thoracic vertebra, initial encounter for Page 18

19 ICD-10-CM Diagnosis Code* S22.040a S22.041a S22.042a S22.048a S22.049a S22.050a S22.051a S22.052a S22.058a S22.059a S22.060a S22.061a S22.062a S22.068a S22.069a S22.070a S22.071a S22.072a S22.078a S22.079a S22.080a S22.081a S22.082a S22.088a S22.089a S32.000a S32.001a S32.002a S32.008a S32.009a S32.010a S32.011a S32.012a S32.018a S32.019a S32.020a Description Wedge compression fracture of fourth thoracic vertebra, initial encounter for Stable burst fracture of fourth thoracic vertebra, initial encounter for Unstable burst fracture of fourth thoracic vertebra, initial encounter for Other fracture of fourth thoracic vertebra, initial encounter for Unspecified fracture of fourth thoracic vertebra, initial encounter for Wedge compression fracture of T5-T6 vertebra, initial encounter for Stable burst fracture of T5-T6 vertebra, initial encounter for Unstable burst fracture of T5-T6 vertebra, initial encounter for Other fracture of T5-T6 vertebra, initial encounter for Unspecified fracture of T5-T6 vertebra, initial encounter for Wedge compression fracture of T7-T8 vertebra, initial encounter for Stable burst fracture of T7-T8 vertebra, initial encounter for Unstable burst fracture of T7-T8 vertebra, initial encounter for Other fracture of T7-T8 thoracic vertebra, initial encounter for Unspecified fracture of T7-T8 vertebra, initial encounter for Wedge compression fracture of T9-T10 vertebra, initial encounter for Stable burst fracture of T9-T10 vertebra, initial encounter for Unstable burst fracture of T9-T10 vertebra, initial encounter for Other fracture of T9-T10 vertebra, initial encounter for Unspecified fracture of T9-T10 vertebra, initial encounter for Wedge compression fracture of T11-T12 vertebra, initial encounter for Stable burst fracture of T11-T12 vertebra, initial encounter for Unstable burst fracture of T11-T12 vertebra, initial encounter for Other fracture of T11-T12 vertebra, initial encounter for Unspecified fracture of T11-T12 vertebra, initial encounter for Wedge compression fracture of unspecified lumbar vertebra, initial encounter for Stable burst fracture of unspecified lumbar vertebra, initial encounter for Unstable burst fracture of unspecified lumbar vertebra, initial encounter for Other fracture of unspecified lumbar vertebra, initial encounter for Unspecified fracture of unspecified lumbar vertebra, initial encounter for Wedge compression fracture of first lumbar vertebra, initial encounter for Stable burst fracture of first lumbar vertebra, initial encounter for Unstable burst fracture of first lumbar vertebra, initial encounter for Other fracture of first lumbar vertebra, initial encounter for Unspecified fracture of first lumbar vertebra, initial encounter for Wedge compression fracture of second lumbar vertebra, initial encounter for Page 19

20 ICD-10-CM Diagnosis Code* S32.021a S32.022a S32.028a S32.029a S32.030a S32.031a S32.032a S32.038a S32.039a S32.040a S32.041a S32.042a S32.048a S32.049a S32.050a S32.051a S32.052a S32.058a S32.059a S32.10xa S32.110a S32.111a S32.112a S32.119a S32.120a S32.121a S32.122a S32.129a S32.130a S32.131a S32.132a S32.139a S32.14xa S32.15xa S32.16xa S32.17xa Description Stable burst fracture of second lumbar vertebra, initial encounter for Unstable burst fracture of second lumbar vertebra, initial encounter for Other fracture of second lumbar vertebra, initial encounter for Unspecified fracture of second lumbar vertebra, initial encounter for Wedge compression fracture of third lumbar vertebra, initial encounter for Stable burst fracture of third lumbar vertebra, initial encounter for Unstable burst fracture of third lumbar vertebra, initial encounter for Other fracture of third lumbar vertebra, initial encounter for Unspecified fracture of third lumbar vertebra, initial encounter for Wedge compression fracture of fourth lumbar vertebra, initial encounter for Stable burst fracture of fourth lumbar vertebra, initial encounter for Unstable burst fracture of fourth lumbar vertebra, initial encounter for Other fracture of fourth lumbar vertebra, initial encounter for Unspecified fracture of fourth lumbar vertebra, initial encounter for Wedge compression fracture of fifth lumbar vertebra, initial encounter for Stable burst fracture of fifth lumbar vertebra, initial encounter for Unstable burst fracture of fifth lumbar vertebra, initial encounter for Other fracture of fifth lumbar vertebra, initial encounter for Unspecified fracture of fifth lumbar vertebra, initial encounter for Unspecified fracture of sacrum, initial encounter for Nondisplaced Zone I fracture of sacrum, initial encounter for Minimally displaced Zone I fracture of sacrum, initial encounter for Severely displaced Zone I fracture of sacrum, initial encounter for Unspecified Zone I fracture of sacrum, initial encounter for Nondisplaced Zone II fracture of sacrum, initial encounter for Minimally displaced Zone II fracture of sacrum, initial encounter for Severely displaced Zone II fracture of sacrum, initial encounter for Unspecified Zone II fracture of sacrum, initial encounter for Nondisplaced Zone III fracture of sacrum, initial encounter for Minimally displaced Zone III fracture of sacrum, initial encounter for Severely displaced Zone III fracture of sacrum, initial encounter for Unspecified Zone III fracture of sacrum, initial encounter for Type 1 fracture of sacrum, initial encounter for Type 2 fracture of sacrum, initial encounter for Type 3 fracture of sacrum, initial encounter for Type 4 fracture of sacrum, initial encounter for Page 20