Medical Policy Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation

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1 Medical Policy Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History Endnotes Policy Number: 485 BCBSA Reference Number: Related Policies Percutaneous Vertebroplasty and Sacroplasty, #484 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Percutaneous balloon kyphoplasty may be MEDICALLY NECESSARY for the treatment of: Symptomatic osteoporotic vertebral s that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least 6 weeks Severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies. Percutaneous balloon kyphoplasty is INVESTIGATIONAL for all other indications, including use in acute vertebral s due to osteoporosis or trauma. Percutaneous mechanical vertebral augmentation using any other device, including but not limited to Kiva and vertebral body stenting, is INVESTIGATIONAL. Medicare HMO Blue SM and Medicare PPO Blue SM Members Indications: Radiographic studies to identify the, estimate the duration of the, define the anatomy, and assess for posterior vertebral body wall deficiency should be part of preoperative planning for vertebroplasty or vertebral augmentation surgery. Lateral radiographs are essential for planning the trajectory of any percutaneous procedure. MRI and bone scan have proven to be useful in determining the acuity of a vertebral compression. A pathologic is defined as "one due to weakening of the bone structure by pathologic processes, such as neoplasia, osteomalacia, osteomyelitis, and other disease." They are also called "secondary s and spontaneous s" (Dorland's Illustrated Medical Dictionary 2000; 29th edition). Vertebral compression s due to osteoporosis are considered pathologic s. A "recent" 1

2 compression is defined as one which demonstrates uptake on a bone scan or exhibits increased intensity on fluid-sensitive MRI sequences. The principal indications for percutaneous vertebroplasty include: An osteoporotic compression of the lumbar or thoracic vertebrae with persistent debilitating pain that has not responded to accepted standard medical treatment generally within six (6) weeks to three months; Osteolytic metastasis with severe back pain related to a destruction of the vertebral body; Multiple myeloma with severe back pain related to a destruction of the vertebral body; Painful and/or aggressive vertebral hemangiomas (or eosinophilic granulomas of the spine); Painful vertebral associated with osteonecrosis (Kummell Disease); and Reinforcement, or stabilization, of vertebral body prior to surgery. The principal indications for percutaneous vertebral augmentation include: A "recent" osteoporotic compression of the lumbar or thoracic vertebrae with persistent debilitating pain that has not responded to accepted standard medical treatment; and/or Osteolytic vertebral collapse secondary to multiple myeloma or osteolytic metastatic disease causing persisting or progressive pain. Limitations: Neither percutaneous vertebroplasty, nor percutaneous vertebral augmentation, are to be considered prophylactic procedures for osteoporosis of the spine. Neither percutaneous vertebroplasty, nor percutaneous vertebral augmentation should be used for chronic back pain of long-standing duration, even if associated with old compression s, unless pain is localized to a specific chronic and medical therapy has failed. The decision for treatment should be multidisciplinary and consider such factors as the extent of disease, the underlying etiology, the spinal level involved, the severity of the pain, the nature of any neurologic dysfunction, the outcome of any previous non-invasive treatment attempts, and the general state of the patient s health. Absolute contraindications to both percutaneous vertebroplasty and vertebral augmentation procedures include: Any existing uncorrected coagulopathy or anticoagulation therapy; A known allergy to any materials used in the procedure such as the contrast media or bone cement; Ongoing local or systemic infection; Retropulsed bone fragments resulting in spinal canal compromise and myopathy; and Spinal canal compromise secondary to tumor resulting in myelopathy. Relative contraindications to percutaneous vertebroplasty include: Significant vertebral collapse (i.e., vertebra reduced to less than one-third [l/3] of its original height); Neurologic symptoms related to the compression of the vertebrae; Radiculopathy in excess of vertebral pain caused by a compressive syndrome unrelated to vertebral collapse; Asymptomatic retropulsion of a fragment causing significant spinal canal compromise; Asymptomatic tumor extension into the epidural space; and/or Extensive vertebral destruction (extreme caution must be used in these patients during cement injection to prevent new or further neurologic compression that might result from leakage of the acrylic polymer into the epidural space). Relative contraindications to percutaneous vertebral augmentation include: Painful benign neoplasms; Fractures caused by high-velocity injury; or Other causes of disabling back pain not due to acute. 2

3 Local Coverage Determination (LCD): Vertebroplasty and Vertebral Augmentation (Percutaneous) (L26439) vanced&bc=kaaaaagaiaaaaa%3d%3d& Prior Authorization Information Pre-service approval is required for all inpatient services for all products. See below for situations where prior authorization may be required or may not be required for outpatient services. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Commercial Managed Care (HMO and POS) Commercial PPO and Indemnity Medicare HMO Blue SM Medicare PPO Blue SM Outpatient Yes Yes Yes Yes CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes CPT codes: Code Description Percutaneous vertebral augmentation, including cavity creation ( reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); thoracic Percutaneous vertebral augmentation, including cavity creation ( reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); lumbar Percutaneous vertebral augmentation, including cavity creation ( reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); each additional thoracic or lumbar vertebral body (list separately in addition to code for primary procedure) Radiological supervision and interpretation, percutaneous vertebroplasty or vertebral augmentation including cavity creation, per vertebral body; under fluoroscopic guidance Radiological supervision and interpretation, percutaneous vertebroplasty or vertebral augmentation including cavity creation, per vertebral body; under CT guidance ICD-9 Diagnosis Codes ICD-9-CM diagnosis codes: Code Description Malignant neoplasm of vertebral column, excluding sacrum and coccyx Secondary malignant neoplasm of bone and bone marrow Multiple myeloma, without mention of having achieved remission Multiple myeloma, in remission 3

4 Multiple myeloma, in relapse Neoplasm related pain (acute) (chronic) Pathologic of vertebrae ICD-9 Procedure Codes ICD-9-CM procedure codes: Code Description Percutaneous vertebral augmentation ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description C41.2 Malignant neoplasm of vertebral column 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 G89.3 Neoplasm related pain (acute) (chronic) M48.50xA M48.50xD M48.50xG M48.50xS M48.51xA M48.51xD M48.51xG M48.51xS M48.52xA M48.52xD M48.52xG M48.52xS M48.53xA M48.53xD M48.53xG M48.53xS M48.54xA M48.54xD Collapsed vertebra, not elsewhere classified, site unspecified, initial encounter for Collapsed vertebra, not elsewhere classified, site unspecified, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, site unspecified, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, site unspecified, sequela of Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, initial encounter for Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, sequela of Collapsed vertebra, not elsewhere classified, cervical region, initial encounter for Collapsed vertebra, not elsewhere classified, cervical region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, cervical region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, cervical region, sequela of Collapsed vertebra, not elsewhere classified, cervicothoracic region, initial encounter for Collapsed vertebra, not elsewhere classified, cervicothoracic region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, cervicothoracic region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, cervicothoracic region, sequela of Collapsed vertebra, not elsewhere classified, thoracic region, initial encounter for Collapsed vertebra, not elsewhere classified, thoracic region, subsequent encounter for 4

5 M48.54xG M48.54xS M48.55xA M48.55xD M48.55xG M48.55xS M48.56xA M48.56xD M48.56xG M48.56xS M48.57xA M48.57xD M48.57xG M48.57xS M48.58xA M48.58xD M48.58xG M48.58xS M80.08xA M80.08xD M80.08xG M80.08xK M80.08xP M80.08xS M80.88xA M80.88xD M80.88xG M80.88xK M80.88xP with routine healing Collapsed vertebra, not elsewhere classified, thoracic region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, thoracic region, sequela of Collapsed vertebra, not elsewhere classified, thoracolumbar region, initial encounter for Collapsed vertebra, not elsewhere classified, thoracolumbar region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, thoracolumbar region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, thoracolumbar region, sequela of Collapsed vertebra, not elsewhere classified, lumbar region, initial encounter for Collapsed vertebra, not elsewhere classified, lumbar region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, lumbar region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, lumbar region, sequela of Collapsed vertebra, not elsewhere classified, lumbosacral region, initial encounter for Collapsed vertebra, not elsewhere classified, lumbosacral region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, lumbosacral region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, lumbosacral region, sequela of Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, initial encounter for Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, subsequent encounter for with routine healing Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, subsequent encounter for with delayed healing Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, sequela of Age-related osteoporosis with current pathological, vertebra(e), initial encounter for Age-related osteoporosis with current pathological, vertebra(e), subsequent encounter for with routine healing Age-related osteoporosis with current pathological, vertebra(e), subsequent encounter for with delayed healing Age-related osteoporosis with current pathological, vertebra(e), subsequent encounter for with nonunion Age-related osteoporosis with current pathological, vertebra(e), subsequent encounter for with malunion Age-related osteoporosis with current pathological, vertebra(e), sequela Other osteoporosis with current pathological, vertebra(e), initial encounter for Other osteoporosis with current pathological, vertebra(e), subsequent encounter for with routine healing Other osteoporosis with current pathological, vertebra(e), subsequent encounter for with delayed healing Other osteoporosis with current pathological, vertebra(e), subsequent encounter for with nonunion Other osteoporosis with current pathological, vertebra(e), subsequent encounter for with malunion 5

6 M80.88xS M84.48xA M84.48xD M84.48xG M84.48xK M84.48xP M84.48xS M84.58xA M84.58xD M84.58xG M84.58xK M84.58xP M84.58xS M84.68xA M84.68xD M84.68xG M84.68xK M84.68xP M84.68xS Other osteoporosis with current pathological, vertebra(e), sequela Pathological, other site, initial encounter for Pathological, other site, subsequent encounter for with routine healing Pathological, other site, subsequent encounter for with delayed healing Pathological, other site, subsequent encounter for with nonunion Pathological, other site, subsequent encounter for with malunion Pathological, other site, sequela Pathological in neoplastic disease, other specified site, initial encounter for Pathological in neoplastic disease, other specified site, subsequent encounter for with routine healing Pathological in neoplastic disease, other specified site, subsequent encounter for with delayed healing Pathological in neoplastic disease, other specified site, subsequent encounter for with nonunion Pathological in neoplastic disease, other specified site, subsequent encounter for with malunion Pathological in neoplastic disease, other specified site, sequela Pathological in other disease, other site, initial encounter for Pathological in other disease, other site, subsequent encounter for with routine healing Pathological in other disease, other site, subsequent encounter for with delayed healing Pathological in other disease, other site, subsequent encounter for with nonunion Pathological in other disease, other site, subsequent encounter for with malunion Pathological in other disease, other site, sequela ICD-10 Procedure Codes ICD-10-PCS procedure codes: 0PU33JZ 0PU34JZ 0PU43JZ 0PU44JZ 0QU03JZ 0QU04JZ 0QU13JZ Code Description Supplement Cervical Vertebra with Synthetic Substitute, Percutaneous Approach Supplement Cervical Vertebra with Synthetic Substitute, Percutaneous Endoscopic Approach Supplement Thoracic Vertebra with Synthetic Substitute, Percutaneous Approach Supplement Thoracic Vertebra with Synthetic Substitute, Percutaneous Endoscopic Approach Supplement Lumbar Vertebra with Synthetic Substitute, Percutaneous Approach Supplement Lumbar Vertebra with Synthetic Substitute, Percutaneous Endoscopic Approach Supplement Sacrum with Synthetic Substitute, Percutaneous Approach Description Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression, or in those with osteolytic lesions of the spine, ie, multiple myeloma or metastatic malignancies. 6

7 Balloon kyphoplasty is a variant of vertebroplasty and 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. Radiofrequency kyphoplasty is a modification of balloon kyphoplasty. In this procedure, an ultra-high viscosity cement is injected into the d vertebral body, and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the d vertebra, along with stabilizing the. It has been proposed that kyphoplasty may provide an analgesic effect through mechanical stabilization of a d or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, one of which is thermal damage to intraosseous nerve fibers given that PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process. Kiva is another mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body and to provide a reservoir for bone cement. The Kiva VCF system consists of a flexible polymer implant which is filled with bone cement. The implant is made from PEEK-OPTIMA, a biocompatible polymer, and is inserted into the vertebral body over a removable spiral shaped guide wire. The implant can be customized by changing the number of loops of the coil, with a maximum height of 12 mm. PMMA is injected through the lumen of the implant, which fixes the implant to the vertebral body and contains the PMMA in a cylindrical column. The proposed advantage of the Kiva system is a reduction in cement leakage. Another variant of kyphoplasty is vertebral body stenting, which utilizes an expandable scaffold instead of a balloon to restore vertebral height. The proposed advantages of vertebral body stenting are to reduce the risk of cement leakage by formation of a cavity for cement application and to prevent the loss of correction that is seen following removal of the balloon used for balloon kyphoplasty. Summary After consideration of the available evidence and uniform clinical input, it was concluded that although the scientific evidence does not permit conclusions about the impact on health outcomes and that comparativestudies with long-term outcomes are lacking; numerous case series, including large prospectivereports,consistently showedthat vertebroplasty or kyphoplasty may alleviate painand improve functionin patients with vertebral s who fail to respond to conservative treatment (at least 6 weeks) with analgesics, physical therapy, and rest. More recent randomized trials that compare kyphoplasty with medical management have also reported benefit, so have not changed these conclusions. Given the absence of alternative treatment options and the morbidity associated with extended bedrest,kyphoplastymay be considered a reasonable treatment option in patients with vertebral s who failto improve after 6 weeks of conservative therapy and therefore may be considered medically necessary both for this patient population, as well as for patients who have severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies. There is insufficient evidence to permit conclusions on the use of kyphoplasty for an acute (<6 weeks) vertebral. The scientific evidence does not permit conclusions about the impact on net health outcome; sham-controlled comparativestudies are needed. There are no additional data to alter these conclusions. There is a single published randomized trial on mechanical vertebral augmentation using the Kiva VCF System. Results from the pivotal FDA-regulated investigational device exemption trial have been reported as an abstract from a scientific meeting. In both trials, the Kiva system is compared with kyphoplasty. It is considered investigational pending publication and review of the IDE trial. Early evidence suggests that vertebral body stenting may have worse outcomes compared with balloon kyphoplasty and is considered investigational. 7

8 Policy History Date Action 9/2014 BCBSA National medical policy review. New investigational indications described. Effective 9/1/ /2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/ /2014 Local Coverage Determination (LCD) for Percutaneous Vertebroplasty/Percutaneous Augmentation (L11417) retired and replaced by LCD L26439 Vertebroplasty and Vertebral Augmentation (Percutaneous). Effective October 25, /2013 BCBSA National medical policy review. New investigational indications described. Effective 10/1/ /2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 12/2011 BCBSA National medical policy review. Changes to policy statements. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 7/2010 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. 6/2010 BCBSA National medical policy review. Changes to policy statements. 1/2010 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 7/2009 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. 6/2009 New policy, effective 6/1/2009, describing covered and non-covered indications. 11/2008 BCBSA National medical policy review. 7/2008 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. 1/2008 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 1/2007 Reviewed - Medical Policy Group - Neurology and Neurosurgery. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References 1. U.S. Food and Drug Administration. FDA Public Health web notification Available online at: =Bone+Cement&spell=1&proxystylesheet=FDAgov&output=xml_no_dtd&site=FDAgov- PubHealthNotifications-Devices&client=FDAgov&ie=UTF- 8&access=p&ulang=en&ip= , &sort=date:D:L:d1&entqr=3&entqrm=0&oe= UTF-8&ud=1. Last accessed February,

9 2. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty. TEC Assessments 2000; Volume 15, Tab Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous kyphoplasty for vertebral s caused by osteoporosis and malignancy. TEC Assessments 2004; Volume 19, Tab Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous kyphoplasty for vertebral s caused by osteoporosis or malignancy. TEC Assessments 2005; Volume 20, Tab Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for vertebral s caused by osteoporosis or malignancy. TEC Assessments 2008; Volume 23, Tab Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for vertebral s caused by osteoporosis. TEC Assessments 2009; Volume 24, Tab Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for vertebral s caused by osteoporosis. TEC Assessments 2010; Volume 25, Tab Coumans JV, Reinhardt MK, Lieberman IH. Kyphoplasty for vertebral compression s: 1-year clinical outcomes from a prospective study. J Neurosurg 2003; 99(1 Suppl): Berlemann U, Franz T, Orler R et al. Kyphoplasty for treatment of osteoporotic vertebral s: a prospective non-randomized study. Eur Spine J 2004; 13(6): Crandall D, Slaughter D, Hankins PJ et al. Acute versus chronic vertebral compression s treated with kyphoplasty: early results. Spine J 2004; 4(4): Gaitanis IN, Hadjipavlou AG, Katonis PG et al. Balloon kyphoplasty for the treatment of pathological vertebral compressive s. Eur Spine J 2005; 14(3): Ledlie JT, Renfro M. Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg 2003; 98(1 Suppl): Kasperk C, Hillmeier J, Noldge G et al. Treatment of painful vertebral s by kyphoplasty in patients with primary osteoporosis: a prospective nonrandomized controlled study. J Bone Miner Res 2005; 20(4): Komp M RS, Godolias G. Minimally invasive therapy for functional unstable osteoporotic vertebral by means of kyphoplasty: a prospective comparative study of 18 surgically and 17 conservatively treatment patients. J Miner Stoffwechs 2004; 11 (suppl 1):13-15 (in German; translated). 15. Gerszten PC, Germanwala A, Burton SA et al. Combination kyphoplasty and spinal radiosurgery: a new treatment paradigm for pathological s. J Neurosurg Spine 2005; 3(4): Wardlaw D, Cummings SR, Van Meirhaeghe J et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression (FREE): a randomised controlled trial. Lancet 2009; 373(9668): Boonen S, Van Meirhaeghe J, Bastian L et al. Balloon kyphoplasty for the treatment of acute vertebral compression s: 2-year results from a randomized trial. J Bone Miner Res 2011; 26(7): 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) Berenson J, Pflugmacher R, Jarzem P et al. Balloon kyphoplasty versus non-surgical management for treatment of painful vertebral body compression s in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol 2011; 12(3): Edidin AA, Ong KL, Lau E et al. Mortality risk for operated and nonoperated vertebral patients in the medicare population. J Bone Miner Res 2011; 26(7): Jarvik JG, Deyo RA. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol 2000; 21(8): Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med 2002; 136(6): 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):

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