CLINICAL GUIDELINES

BlueCross BlueShield of Kansas City Lumbar Spine Fusion

Effective July 1, 2013 (Reviewed January 1, 2019)

Clinical guidelines for medical necessity review of spine surgery. © 2019 eviCore healthcare. All rights reserved. Musculoskeletal Benefit Management Program: Lumbar Spine Fusion V1.0.2019 ______

2019 LUMBAR SPINE: FUSION GUIDELINES

LSF-1: INTRODUCTION AND GENERAL GUIDELINES 3 LSF-2: INSTABILITY 6 LSF-3: DEGENERATIVE DISORDERS OF THE SPINE 8 LSF-4: SPONDYLOLYSIS & SPONDYLOLISTHESIS 10 LSF-5: STENOSIS 12 LSF-6: PRIOR LUMBAR SPINE SURGERY 14 LSF-7: DEFORMITY 18 LSF-8: TRAUMA 20 LSF-9: NEOPLASTIC DISORDERS 22 LSF-10: INFECTION 23 LSF-11: APPENDIX - DEVICES 25 LSF-12: APPENDIX - ABBREVIATIONS 26 LSF-13: APPENDIX - GLOSSARY 27 LSF-14: APPENDIX – CPT® CODES 28 LSF-15: APPENDIX – SUPPORTING LITERATURE 29 LSF-16: APPENDIX – PROCEDURE DEFINTIONS 34

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LUMBAR SPINE: FUSION GUIDELINES

LSF-1: INTRODUCTION AND GENERAL GUIDELINES

LSF-1.1: Introduction

These guidelines address lumbar spine fusion (LSF) procedures and/or devices for the adult patient population 18 years of age and older. Both spinal conditions and procedural approaches and devices are described for their appropriateness and coverage.

Accepted indications for lumbar spinal fusion procedures and/or devices based primarily on appropriate supportive medical evidence will be addressed in condition specific sections outlined below. Those procedures and/or devices described as “not indicated” are based on a lack of a significant body of medical evidence supporting their efficacy.

The indications for lumbar spinal fusion will be further examined in the following condition-specific sections, which include:

 Degenerative Disorders

 Spondylolysis & Spondylolisthesis

 Stenosis

 Prior Lumbar Spine Surgery

 Deformity

 Trauma

 Neoplastic Disease

 Infection

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LSF -1.2: Tenets of Lumbar Spine Fusion Surgery: General Requirements The table below represents the essential documentation of conditions and evaluations that should be received prior to any considerations for all lumbar spine fusion procedures (exceptions as noted). All subsequent guidelines and indications in this document will reference these general requirements. Requirement Details Diagnosis and rational for fusion NA Lifestyle modifications, weight loss, nicotine cessation, medications, nonsteroidal anti-inflammatory medications, Non-operative care physical therapy, medical exercise, bracing, spinal manipulation, epidural steroid injections (when indicated), behavioral therapy, etc. Relative contraindications to spinal fusion include the following:  Osteoporosis Relative contraindications to  Smoking spine fusion, to be weighed  Malnutrition against the risks of not  Systemic infection performing surgery  Anemia  Chronic hypoxemia  Severe cardiopulmonary disease  Severe depression, psychosocial issues, and secondary gain issues Recent history & examination in  Detailed neurological exam relevant to fusion request  Bowel/bladder abnormalities the preceding 6 weeks  Motor deficits defined by location  0= No evidence of muscle function  1= Muscle contraction but no or very limited joint motion (“trace”) Grading of manual muscle  2=Complete range of motion with gravity eliminated testing in the preceding 6 weeks (“poor”)  3=Complete range of motion against gravity (“fair”)  4=Complete range of motion against gravity with some resistance (“good”)  5=Complete range of motion against gravity with full or normal resistance (“normal”) Continued next page . . .

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LSF -1.2: Tenets of Lumbar Spine Fusion Surgery: General Requirements Table continued . . . Requirement Details

 Plain lumbar x-rays (as indicated)  Lumbar flexion/extension x-rays (as indicated)  Lumbar bending films (as indicated)  Advanced imaging (as indicated) All relevant imaging studies o Lumbar MRI o Lumbar CT o Lu mbar CT/Myelography o Lumbar CT/Discography  Other imaging studies (as indicated) Psych evaluations, including The “Waddell Test” is a screening tool for to assess for “Waddell’s Test” psychological factors (nonorganic findings) when evaluating for back pain. Nicotine cessation 4 to 8 weeks Patient attempts nicotine cessation prior to fusion, and until prior fusion has consolidated

LSF-1.3: Exceptions: Exceptions considered on a case by case basis.

LSF-1.4: References 1. Brox JI et al. (2003). Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine, 28: p. 1913-1921. 2. Mirza SK, Deyo RA. Systematic review of randomized trials comparing lumbar fusion surgery to nonoperative care for treatment of chronic back pain. Spine 2007;32:816-823. 3. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

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LUMBAR SPINE: FUSION GUIDELINES

LSF-2: INSTABILITY

LSF-2.1: Background The stable spine is recognized as having normal sagittal and coronal plane alignment without evidence of imbalance. For the stable spine, there is no evidence on imaging of abnormal segmental alignment such as intersegmental translation, angulation, or subluxation, either at rest or with motion. By contrast, there is no agreed upon definition for spine instability. Generally, instability refers to a loss of spinal integrity to withstand physiologic loads or stresses resulting in increased or abnormal motion between vertebral motion segments that result in pain, deformity and/or neurologic compromise, and/or significant angular and/or rotational and/or translational changes in the spine. Diagnostic checklists are often used to diagnose spinal instability including, White and Panjabi's classification, Holdsworth's two- column theory, and Denis’ three-column theory; however, documentation of these checklists is not required for consideration of fusion surgery.

Ultimately, instability may be the result of a variety of spine conditions and can result in pain, deformity and/or neurologic compromise. Despite lack of an agreed upon clinical definition, instability is generally accepted as the underlying primary indication for a lumbar spinal fusion procedure.

LSF-2.2: Indicated  Instability from angular and translational changes in the spine

 Instability from spondylolisthesis as defined below under LSF-4

 Instability from deformity as defined below under LSF-7

 Instability from trauma as defined below under LSF-8

 Instability from neoplastic disorders as defined below under LSF-9

 Instability from infection as defined below under LSF-10

 Instability resulting in neuroforaminal stenosis with neurologic compression

 Instability created surgically:

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o Unilateral facetectomy

o Bilateral partial facetectomy of 50% or greater

o Pars resection or fracture

o Corpectomy and vertebrectomy

o Any other decompressive procedures known to cause instability

o Adjacent Segment Disease (ASD) associated with clinically symptomatic spinal stenosis

LSF-2.3: Not Indicated  Initial routine laminectomy without instability  Initial routine hemilaminectomy, partial laminectomy, laminotomy or foraminotomy without instability  Initial routine discectomy without instability, single or multiple levels

LSF-2.4: References 1. Posner I, White AA 3rd, Edwards WT, Hayes WC. A biomechanical analysis of the clinical stability of the lumbar and lumbosacral spine. Spine 1982; 7:374–389.

2. Leone A, Guglielmi G, et al. (2007). Lumbar Intervertebral Instability: A Review. Radiology, 245:62-77.

3. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

4. Hu SS, Tribus CB, Tay BK, Bhatia NN. Chapter 5. Disorders, Diseases, & Injuries of the Spine. In: Skinner HB, ed. CURRENT Diagnosis & Treatment in Orthopedics. 4th Ed. New York: McGraw-Hill; 2006. http://www.accessmedicine.com/content.aspx?aID=2319334. Accessed June 14, 2013.

5. Dixit RK. Chapter 10. Approach to the Patient with Low Back Pain. In: Imboden JB, Hellmann DB, Stone JH, eds. CURRENT Rheumatology Diagnosis & Treatment. 2nd Ed. New York: McGraw-Hill; 2007. http://www.accessmedicine.com/content.aspx?aID=2724130. Accessed June 14, 2013.

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LUMBAR SPINE: FUSION GUIDELINES

LSF-3: DEGENERATIVE DISORDERS OF THE SPINE

LSF-3.1: Background Disc degeneration is a term used to describe the natural changes that occur in the spinal discs as a result of the aging process. These changes involve disc desiccation as well as loss of disc height among other changes. Disc degeneration is most commonly asymptomatic. In some cases degeneration of the spinal elements can cause pain and be clinically relevant. These changes can cause disorders of the disc and facet joints, as well as the spinal motion segments. Painful degenerative clinical syndromes include lumbar spondylosis, facet syndrome and Degenerative disc disease (also called internal disc derangement in discographic positive patients). Degenerative disc disease is believed to occur in patients who have variable degrees of degeneration of the disc in association with intervertebral disc mediated pain. A concordantly painful discogram is believed by some surgeons and clinicians to be the gold standard method of diagnosis.

LSF-3.2: Indicated

 Lumbar spinal fusion surgery is indicated in the setting of Degenerative Disc Disease (DDD) at a maximum of two identifiable motion segments or facet syndrome joints levels, when all of the following conditions are met:

o LSF-1.2: General Requirements

o Significant degeneration is confined to two or less identifiable levels and is reasonably expected to be the source of pain based on clinical evaluation and advanced imaging (MRI or CT or discography)

o Has failed six consecutive months of physician guided non-operative care, including exercise based/spine stabilization physical therapy and cognitive behavioral therapy (if available in the community)

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LSF -3.3: Not Indicated  3 or greater levels of spinal degeneration with diffuse, non-radicular pain

 Chronic low back pain without a clear cause demonstrated by imaging or other studies

LSF-3.4: References 1. Fairbank J, Frost H (2005). Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ. 2005;330:1233.

2. Brox JI et al. (2003). Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration, Spine, 28: p. 1913-1921.

3. Nguyen TH, Randolph DC, Talmage J, Succop P, Travis R (2011). Long-term Outcomes of Lumbar Fusion Among Workers’ Compensation Subjects: A Historical Cohort Study. Spine, 36(4) 320-31.

4. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

5. Whang W, Erens G, Jarrett CD, Hoffler CE. Chapter 65. Common Orthopedic Surgical Procedures. In: Lawry GV, McKean SC, Matloff J, Ross JJ, Dressler DD, Brotman DJ, Ginsberg JS, eds. Principles and Practice of Hospital Medicine. New York: McGraw-Hill; 2012. http://www.accessmedicine.com/content.aspx?aID=56195770. Accessed June 14, 2013.

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LUMBAR SPINE: FUSION GUIDELINES

LSF-4: SPONDYLOLYSIS & SPONDYLOLISTHESIS

LSF-4.1: Background Spondylolysis is a defect or fracture of part of the vertebral bones called the pars interarticularis. It usually occurs in the fifth and, less often, in the fourth lumbar vertebra. It is the most common cause of spondylisthesis in which one vertebral body is slipped forward over another.

There are also several subtypes of spondylolisthesis (isthmic, dysplastic, degenerative, traumatic, pathologic and iatrogenic) but in general the most common subtypes for which lumbar fusion is performed in adults are isthmic and degenerative.

LSF-4.2: Indicated  Single-level or multi-level spondylolysis and spondylolisthesis may be eligible for lumbar fusion when all of the following are met:

o LSF-1.2: General Requirements

o For adult patients, 6 months of non-operative care without improvement

 Two level fusions may be covered, following the above criteria, for certain cases of high grade slips and/or sacral inclination where a one level fusion would not reasonably be expected to achieve a successful outcome

 Degenerative spondylolisthesis with significant stenosis requiring a laminectomy is covered for lumbar fusion if all of the following criteria are met:

o LSF-1.2: General Requirements o 3 months of non-operative care without improvement

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LSF -4.3: References

1. Weinstein JN et al., (2007). Surgical versus Nonsurgical Treatment for Lumbar Degenerative Spondylolisthesis. New England Journal of Medicine, 356:2257–70. 2. Weinstein JN, Lurie JD, Tosteson TD, et al (2009). Surgical versus non-operative treatment for lumbar degenerative spondylolisthesis: four-year results of the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am, 91:1295–304. 3. NASS Clinical Practice Guidelines, Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis http://www.spine.org/Documents/Spondylolisthesis_Clinical_Guideline.pdf. Accessed June 2011 4. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. 5. Herman MJ, Pizzutillo PD, Cavalier R. Spondylolysis and spondylolisthesis in the child and adolescent athlete. Orthop Clin North Am 2003, 34, 461-467.

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LUMBAR SPINE: FUSION GUIDELINES

LSF-5: STENOSIS LSF-5.1: Background Spinal stenosis refers to the narrowing of the spinal canal and/or the neuroforamina. It can be asymptomatic or can impair nerve function resulting in radicular pain, neurogenic claudication, loss of sensation, altered reflexes, loss of motor control and rarely cauda equine syndrome. Lumbar fusion is not generally necessary as an adjunct to decompressive procedures carried out for most cases of routine spinal stenosis with exceptions as outlined below. LSF-5.2: Indicated  Established instability: see required criteria under LSF-2.2

 Spondylolisthesis: see required criteria under LSF-4.2

 Surgically created instability:

o Unilateral facetectomy

o Bilateral partial facetectomy of 50% or greater

o Pars resection or fracture

o Corpectomy and vertebrectomy

o Any other decompressive procedures known to cause instability LSF-5.3: Not Indicated  Routine lumbar decompressive procedures that do not have pre-existing instability or do not cause expectation of iatrogenic instability as a result of the procedure itself.

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LSF -5.4: References 1. Amundsen T, et al. (2000). Lumbar spinal stenosis: conservative or surgical management? A prospective 10-year study. Spine; 25(11):1424-1435. 2. Radcliff K, et al. (2011). Does the duration of symptoms in patients with spinal stenosis and degenerative spondylolisthesis affect outcomes? Analysis of the Spine Outcomes Research Trial. Spine, 36(25), 2197–2210. 3. Hurri H et al., (1998). Lumbar Spinal Stenosis: Assessment of Long-Term Outcome 12 Years After Operative and Conservative Treatment. Journal of Spinal Disorders, 11(2):110- 115. 4. Chou et al., (2007). Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medicine, 147 (7), 478-491. 5. NASS guidelines, 2011, http://www.spine.org/Documents/NASSCG_Stenosis.pdf. 6. Resnick DK, et al., (2005). Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: fusion following decompression in patients with stenosis without spondylolisthesis J Neurosurg Spine, 2(6):686-91. 7. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. 8. Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H (2010). Surgical Versus Nonoperative Treatment for Lumbar Spinal Stenosis Four-Year Results of the Spine Patient Outcomes Research Trial. Spine, 35(14)1329–1338. 9. Yone K, Sakou T (1999). Usefulness of Posner's definition of spinal instability for selection of surgical treatment for lumbar spinal stenosis. J Spinal Disord, 12:40–44.

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LSF-6: PRIOR LUMBAR SPINE SURGERY

LSF-6.1: Background Prior lumbar spine surgery includes such procedures as discectomy, laminectomy, partial laminectomy, laminotomy, foraminotomy, percutaneous or minimally invasive procedures and various types of spinal fusion procedures (anterior, posterior, lateral combined 360 degree fusions, etc.) with or without internal fixation and/or interbody devices. Under certain circumstances, revision or additional surgery may be indicated and a lumbar spinal fusion procedure may be considered as outlined below. LSF-6.2: Indicated LSF-6.21: Instrumentation Removal  Instrumentation (internal fixation device) removal may be considered for the following indications: o Painful instrumentation e.g. insufficient soft tissue coverage o This does not occur often. Diagnostic intervention should be used to determine if instrumentation is the cause of pain. o Instrumentation that poses a risk to a patient, e.g. loose or malpositioned devices that pose a threat to the anterior great vessels or neurological structures o Instrumentation removal or reimplantation as part of a subsequent surgery LSF-6.22: Pseudarthrosis  Pseudarthrosis is the failure of bone graft to consolidate or fuse solidly to the spine, i.e. non-union. Revision fusion of the same level may be considered if all of the following criteria are met: o LSF-1.2: General Requirements o It has been at least 12 months from the prior fusion procedure OR identified failure of implant instrumentation has occurred at any time (e.g. broken rod ) o 3 months of non-operative care without improvement

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o If 3 months of non-operative care occur less than 12 months after the first procedure, the patient must still wait the full 12 months before being considered for follow-up surgery o Except when failure of identified implant instrumentation o Low back pain improvement for at least 3 months following the prior surgery o Imaging studies confirm a pseudarthrosis (x-rays and/or CT) or presence of failed instrumentation demonstrated on plain x-ray and/or CT LSF-6.23: Adjacent Segment Disease  Other terms for Adjacent Segment Disease (ASD) include Adjacent Level Disease and Transitional Syndrome. Adjacent Segment Disease is defined as the degenerative changes that take place over time above and/or below a spinal fusion as a result of transferred stress. An additional fusion procedure directed at the involved single level may be considered if all of the following criteria are met: o LSF-1.2: General Requirements o It has been greater than 12 months from the prior fusion procedure and the prior fusion procedure was successful (solid fusion with significantly decreased pain and increased function) o 6 months of ongoing non-operative care without improvement

o If 6 months of ongoing non-operative care occur less than 12 months after the first procedure, the patient must still wait the full 12 months before being considered for follow-up surgery o Significant degeneration is confined to one identifiable level and is reasonably expected to be the source of pain based on clinical evaluation and advanced imaging (MRI or CT or discography) LSF-6.24: Recurrent Herniated Disc  The surgical treatment for most cases of recurrent herniated discs (involving neurological compression) does not require adjunctive spinal fusion. However, an adjunctive fusion procedure directed at the involved single level may be

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considered if all of the following criteria are met: o LSF-1.2: General Requirements o The patient has had prior discectomy at the same level o It has been greater than 3 months from the prior procedure and the prior procedure was initially successful for radicular pain relief o Recurrent symptoms and pathology with neurological compression confined to one identifiable level which is reasonably expected to be the source of pain based on clinical evaluation and advanced imaging (MRI or CT or myelography) o The patient has new pain or neurological symptoms consistent with the level of recurrence. o There is associated foraminal stenosis, concomitant segmental instability, or spondylolisthesis or resultant instability from the procedure itself o 3 months of non-operative care without improvement

LSF-6.3: Not Indicated  Prior lumbar laminectomy without instability, or where the currently proposed surgery would not be expected to result in instability  Prior hemilaminectomy, partial laminectomy, laminotomy or foramintomy without instability, or where the currently proposed surgery would not be expected to result in instability  Prior routine discectomy without instability or where the currently proposed surgery would not be expected to result in instability, single or multiple levels  Routine instrumentation removal without cause

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LSF -6.4: References 1. Lee C, Dorcil J, Radomisli TE (2004). Nonunion of the Spine: A Review. Clin Orthop, 419: 71-75.Orthopaedic Knowledge Update Spine 4, AAOS, 2012. 2. Hu SS, Tribus CB, Tay BK, Bhatia NN. Chapter 5. Disorders, Diseases, & Injuries of the Spine. In: Skinner HB, ed. CURRENT Diagnosis & Treatment in Orthopedics. 4th ed. New York: McGraw-Hill; 2006. 3. http://www.accessmedicine.com/content.aspx?aID=2319334. Accessed May 9, 2013. 4. Resnick DK, Choudri TF, Dailey AT, Groff MW, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neursurg: Spine 2, 2005, 673-678. 5. Lee JK, Amorosa L, Cho SK, Weidenbaum M, Kim Y. Recurrent lumbar disk herniation. J Am Acad Orthop Surg 2010, 18(6), 327-337 6. International Society for the Advancement of Spine Surgery (ISASS). Policy Statement on Lumbar Spinal Fusion Surgery. http://www.isass.org/public_policy/2011-07- 15_policy_statement_lumbar_surgery.pdf, accessed June 18, 2013.

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LSF-7: DEFORMITY

LSF-7.1: Background

This particular section refers to spinal deformities that result from scoliosis and kyphosis, not deformities that are caused by one or two motion segments that have become unstable.

Scoliosis is a lateral (sideways) spinal curvature in the frontal plane. Kyphosis is a forward curvature (rounding or ‘humpback’) of the spine in the sagittal plane. Progressive deformities are documented with sequential radiographs.

Pain associated with scoliosis will be due to facet/ disc degenerative changes from asymmetric forces on the deformed segment of the spine or from compression or stretching of neural elements and/or other soft tissue structures.

The goal and primary indication of arthrodesis in these types of spinal deformities is to stop progression of the deformity. Conditions in which deformity progression may occur include the following:

 Progression of idiopathic scoliosis

 Degenerative scoliosis in association with neurological compromise (spinal stenosis-central, lateral recess, or foraminal in association with scoliosis)

 Acquired progressive spinal deformity in the face of a neurologic deficit or disease (e.g. traumatic neurological deficit, neuromuscular scoliosis) with or without progression of neurological or functional deficit:

 Iatrogenic flat back syndrome, acquired loss of lumbar lordosis, and loss of sagittal plane balance secondary to a pre-existing spinal fusion where initial balance was not achieved or maintained over time.

LSF-7.2: Indicated

 Instrumented arthrodesis: anterior, posterior or combined

LSF-7.3: Not Indicated

 As indicated under LSF-11 and LSF-12 below

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LSF -7.4: References

1. Oskouia RJ, Shaffrey CI (2006). Degenerative Lumbar Scoliosis. Neurosurg Clin North America 2006;17(3):299-315.

2. Ploumis A, Transfledt, Denis F (2007). Degenerative lumbar scoliosis associated with spinal stenosis. Spine, 7(4):428-36.

3. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. 4. Bridwell K P (2012). What's New in Spine Surgery. Journal of Bone and Joint Surgery , 1140-1148.

5. Kalantar SB, Laurman WC (2012). Adult Scoliosis: Etiology and Management. Orthopaedic Knowledge Online Journal .

6. Deviren V, Metz LN. Anterior instrumented arthrodesis for adult idiopathic scoliosis (2007). Neurosurg Clin N Am, 18(2):273-80.

7. Gelalis ID, Kang JD (1998). Thoracic and lumbar fusions for degenerative disorders: rationale for selecting the appropriate fusion techniques. Orthop Clin North Am, 29(4):829- 42.

8. Gupta M (2003). Degenerative scoliosis: options for surgical management. Orthop Clin North Am, 34(2):269-79.

9. Kim et al. Scoliosis Imaging: What Radiologists Should Know. RadioGraphics, 2010, 30, 1823-1842.

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LSF-8: TRAUMA

LSF-8.1: Background Disruption of the bony and/or ligamentous structures of the spine may lead to instability, either acute or chronic. Neurological compromise may necessitate decompression of neural elements which may cause additional potential for instability. This often requires reduction and arthrodesis to restore stability and spinal balance. The most common fracture patterns are at the level of the thoracolumbar junction: acute compression fractures, burst fractures, fractures of the posterior elements, and Chance fractures. These fractures also occur below L2. LSF-8.2: Indicated  Three spinal column injuries Burst fractures (burst fractures by definition involve two of the three spinal columns)  Compression fractures with severe posterior ligamentous disruption and/or kyphotic deformity with likelihood of chronic instability with further segmental angulation  Chance fractures with primarily soft tissue disruption and/or significant angular deformity with potential for further chronic progression of deformity

 In conjunction with neurologic decompression when iatrogenic instability is necessary Techniques include:  Fracture reduction and/or instrumented arthrodesis: posterior, anterior or combined

 Decompression (as indicated) combined with arthrodesis but not as an isolated procedure

 PMMA (polymethylmethacrylate)supplementation for pedicle screws in osteopenic bone

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LSF -8.3: Not Indicated  Dynamic Spine Stabilization Devices (e.g., Dynesys® , Stabilimax NZ®)

 Interlaminar/ Interspinous Internal Fixation Devices (e.g., ILIF™)

 Axial Lumbar Interbody Fusion (AxiaLIF)

 Dynamic Spine Stabilization Device Systems (e.g., Dynesys®, Stabilimax NZ®)

LSF-8.4: References

1. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

2. Bridwell K P (2012). What's New in Spine Surgery. Journal of Bone and Joint Surgery , 1140-1148.

3. Kalantar SB, Laurman WC (2012). Adult Scoliosis: Etiology and Management. Orthopaedic Knowledge Online Journal .

4. Bambakidis NC, Feiz-Erfan I, Klopfenstein JD, Sonntag VK. Indications for surgical fusion of the cervical and lumbar motion segment. Spine 2005, 30(16 suppl), S2-6.

5. Sasagawa T, Kawahara N, Murakami H, Demura S, Tomita K. Decompression, correction, and interbody fusion for lumbar burst fractures using a single posterior approach. Orthopedics 2009, 32(10).

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LSF-9: NEOPLASTIC DISORDERS

LSF-9.1: Background Neoplastic disorders frequently involve the spine and usually are metastatic, although primary bone tumors can also affect the spine. Tumors of the spinal column may destroy vertebrae and associated bony structures or result in epidural compression and/or spinal instability. When surgery is indicated, the procedure may result in instability requiring stabilization and fusion. This may be known prior to surgical intervention (based on structures destroyed by the tumor) or determined intraoperatively. LSF-9.2: Indicated  Established instability

o See LSF-2 above

o Spondylolisthesis

o Certain cases with associated spinal deformity: see LSF-7 above

o Certain cases with associated fracture: see LSF-8

 Surgically created instability:

o Unilateral facetectomy

o Bilateral partial facetectomy of 50% or greater

o Pars resection or fracture

o Corpectomy and vertebrectomy

o Any other decompression procedures known to cause instability

LSF-9.3: Not Indicated

 See LSF 2.3 above

LSF-9.4: References

1. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

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LSF-10: INFECTION

LSF-10.1: Background Infections involving the spine such as discitis and/or osteomyelitis may be bacterial or fungal in origin and primary or secondary. They may be a result of invasive procedures (e.g. epidural steroid injections) or prior surgery. Surgery is considered when medical management dictates tissue culture for diagnosis and/or drainage of associated abscess loss of structural integrity of the spine, progressive deformity, and/or neurologic compression.

LSF-10.2: Indicated

 Established instability

o See LSF-2 above

o Spondylolisthesis

o Certain cases with associated spinal deformity: see LSF-7 above

o Certain cases with associated fracture: see LSF-8

 Surgically created instability:

o Unilateral facetectomy

o Bilateral partial facetectomy of 50% or greater

o Pars resection or fracture

o Corpectomy and vertebrectomy

o Any other decompressive procedures known to cause instability

LSF-10.3: Not Indicated

 Initial routine laminectomy without instability

 Initial routine hemilaminectomy, partial laminectomy, laminotomy or foraminotomy without instability

 Initial routine discectomy without instability, single or multiple levels

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LSF -10.4: References 1. Dietz DD, Fessler RG, Jacob PR (1997). Primary reconstruction for spinal infections. J Neurosurg, 86:981-989.

2. Arnold PM, Baek PN, Bernardi RJ, et al (1997). Surgical management of nontuberculous thoracic and lumbar vertebral osteomyelitis: report of 33 cases. Surg Neurol , 47:551-561.

3. Kim CW, Perry A, Currier B, Yaszemski M, Garfin SR (2006). Fungal Infections of the Spine. Clinical Orthopaedics & Related Research, 444:92-99.

4. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

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LSF-11: APPENDIX - DEVICES

LSF-11.1: Background

A broad variety of internal fixation devices and interbody devices exists that is beyond the scope of these guidelines. However, some of the general and specific fusion devices that are covered and non-covered are mentioned below.

LSF-11.2: Indicated

LSF-11.21: Standard Pedicle Screw Rod/Plate Internal Fixation Devices

LSF-11.22: Standard Interbody Fusion Devices

LSF-11.3: Not Indicated

LSF-11.31: Dynamic Spine Stabilization Devices

(e.g., Dynesys® , Stabilimax NZ®)

LSF-11.32: Interlaminar/ Interspinous Internal Fixation Devices

(e.g., ILIF™)

LSF-11.33: Axial Lumbar Interbody Fusion (AxiaLIF)

LSF-11.34: Dynamic Spine Stabilization Device Systems (e.g., Dynesys®, Stabilimax NZ®)

LSF-11.4: References

1. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

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LSF-12: APPENDIX - ABBREVIATIONS

AAOS American Academy of Orthopaedic Surgeons

ACP American College of Physicians

ALIF Anterior lumbar interbody fusion

ASF Anterior spinal fusion

APS American Pain Society

AANS American Association of Neurological Surgeons

CNS Congress of Neurological Surgeons

DDD Degenerative disc disease

HWR Instrumentation removal

IF Internal fixation

LADR Lumbar Artificial Disc Replacement

NASS North American Spine Society

PLIF Posterior lumbar interbody fusion

PSF Posterior or posterolateral fusion

TLIF Transforaminal lumbar interbody fusion

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LSF-13: APPENDIX - GLOSSARY Adjacent Segment Degenerative changes that take place over time above and/or below a spinal Disease fusion as a result of transferred stress and/or natural progression of spinal degeneration, also called “Transition Syndrome” or “Adjacent Level Disease.”

Advance Imaging MRI, CT, CT/myelography, CT/discography, PET scans, etc.

Arthrodesis Bony fusion of a motion segment. In the spine, this means fusion of a vertebral motion segment which is two adjacent vertebrae and the associated intervertebral disc and facet joints. This may be accomplished by fusing one vertebral body to another and/or fusion of the facet joints and/or fusion of one transverse processes to another, as in a posterolateral fusion.

Arthroplasty Joint repair or replacement

Non-surgical treatment that may include activity modifications, weight loss, Non-Operative Care nicotine cessation, medications, physical therapy, medical exercise, bracing, spinal manipulation, injections, behavioral therapy, etc.

Degenerative Disc Degenerative disc disease refers to the degenerative changes that take place in a Disease (DDD) disc over time or as a result of trauma or altered stresses on the spine such as a transition syndrome.

Instability Instability refers to a loss of spinal integrity to withstand physiologic loads or stresses resulting in increased or abnormal motion between vertebral motion segments that result in pain, deformity and/or neurologic compromise, and/or significant angular and/or rotational and/or translational changes in the spine.

Kyphosis Convex posterior curvature in the sagittal plane

Pseudarthrosis Failure of bone graft to consolidate or fuse solidly between two vertebrae in the spine (non-union)

Spinal Stenosis Narrowing of the spinal canal and/or neuroforamina

Spondylolysis A defect of the pars intraarticularis

Spondylolisthesis Translation of one vertebral body relative to the vertebral body below (anterolisthesis=anterior translation; retrolisthesis=posterior translation) Scoliosis Lateral curvature in the coronal plain greater than 10 degrees

Transition Degenerative changes that take place over time above and/or below a spinal Syndrome fusion as a result of transferred stress and/or natural progression of spinal degeneration, also called “Adjacent Level Disease” or “Adjacent Segment Disease.”

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LSF-14: APPENDIX – CPT® CODES

Code Procedure 22533 Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic. 22534 Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic or lumbar, each additional vertebral segment. 22558 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar. 22585 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); each additional interspace. 22612 Arthrodesis, posterior or posterolateral technique, single level; lumbar (with or without lateral transverse technique). 22614 Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment. 22630 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar. 22632 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace. 0195T Arthrodesis, pre-sacral interbody technique, including instrumentation, imaging (when performed), and discectomy to prepare interspace, lumbar; single interspace 0196T Arthrodesis, each additional interspace (List separately in addition to code for primary procedure) 22633 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than decompression), single interspace and segment; lumbar. 22634 Each additional interspace and segment (List separately in addition to code for primary procedure)

CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT® five digit codes, nomenclature and other data are copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in the CPT® book. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

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LSF-15: APPENDIX – SUPPORTING LITERATURE

LSF-1: INTRODUCTION & GENERAL GUIDELINES Mirza SK, Deyo RA (2007). Systematic review of randomized trials comparing lumbar fusion surgery to nonoperative care for treatment of chronic back pain. Spine, 32:816-823. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. LSF-2: INSTABILITY Hu SS, Tribus CB, Tay BK, Bhatia NN. Chapter 5. Disorders, Diseases, & Injuries of the Spine. In: Skinner HB, ed. CURRENT Diagnosis & Treatment in Orthopedics. 4th ed. New York: McGraw-Hill; 2006. http://www.accessmedicine.com/content.aspx?aID=2319334. Accessed June 14, 2013. Dixit RK. Chapter 10. Approach to the Patient with Low Back Pain. In: Imboden JB, Hellmann DB, Stone JH, eds. CURRENT Rheumatology Diagnosis & Treatment. 2nd ed. New York: McGraw-Hill; 2007. http://www.accessmedicine.com/content.aspx?aID=2724130. Accessed June 14, 2013. Leone A, Guglielmi G, Victor N, Cassar-Pullicino VN, and Bonomo L (2007). Lumbar Intervertebral Instability: A Review. Radiology, 245:62-77. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Posner I, White AA 3rd, Edwards WT, Hayes WC (1982). A biomechanical analysis of the clinical stability of the lumbar and lumbosacral spine. Spine, 7:374–389. LSF-3: DEGENERATIVE DISC DISEASE Brox, J, et al. (2003). Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine, 28: p. 1913-1921. Fairbank J et al. (2005). Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ, 330:1233. Nguyen TH, Randolph DC, Talmage J, Succop P, Travis R. (2011). Long-term Outcomes of Lumbar Fusion Among Workers’ Compensation Subjects: A Historical Cohort Study. Spine, 36(4) 320-31.

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Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Whang W, Erens G, Jarrett CD, Hoffler CE. Chapter 65. Common Orthopedic Surgical Procedures. In: Lawry GV, McKean SC, Matloff J, Ross JJ, Dressler DD, Brotman DJ, Ginsberg JS, eds. Principles and Practice of Hospital Medicine. New York: McGraw-Hill; 2012. http://www.accessmedicine.com/content.aspx?aID=56195770. Accessed June 14, 2013. LSF-4: SPONDYLOLYSIS & SPONDYLOLISTHESIS NASS Clinical Practice Guidelines, Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis http://www.spine.org/Documents/Spondylolisthesis_Clinical_Guideline.pdf. Accessed June 2011 Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Weinstein JN, Lurie JD, Tosteson TD, et al. (2007). Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med, 356:2257-70. Weinstein JN, Lurie JD, Tosteson TD, et al. (2009). Surgical versus non- operative treatment for lumbar degenerative spondylolisthesis: four-year results of the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am, 91:1295–304. Herman MJ, Pizzutillo PD, Cavalier R. Spondylolysis and spondylolisthesis in the child and adolescent athlete. Orthop Clin North Am 2003, 34, 461-467. LSF-5: STENOSIS Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F (2000). Lumbar spinal stenosis: conservative or surgical management: a prospective 10-year study. Spine, 25(11):1424-1435. Chou et al (2007). Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medicine , 147(7): 478-491. Hurri H, Slatis P, Soini J, et al. (1998). Lumbar spinal stenosis: assessment of long-term outcome 12 years after operative and conservative treatment. J Spinal Disord, 11(2):110-115. NASS Clinical Practice Guidelines .Diagnosis and treatment of degenerative lumbar spinal stenosis. 2007 Jun http://www.spine.org/Documents/NASSCG_Stenosis.pdf. Accessed June

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2011 Resnick DK et al. (2005). American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg Spine, 2(6):686-91. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Weinstein JN et al. (2010). Surgical Versus Nonoperative Treatment for Lumbar Spinal Stenosis Four-Year Results of the Spine Patient Outcomes Research Trial. Spine, 35(14)1329–1338. Yone K, Sakou T. (1999). Usefulness of Posner's definition of spinal instability for selection of surgical treatment for lumbar spinal stenosis. J Spinal Disord, 12:40–44. LSF-6: PRIOR LUMBAR SPINE SURGERY Hu SS, Tribus CB, Tay BK, Bhatia NN. Chapter 5. Disorders, Diseases, & Injuries of the Spine. In: Skinner HB, ed. CURRENT Diagnosis & Treatment in Orthopedics. 4th ed. New York: McGraw-Hill; 2006. http://www.accessmedicine.com/content.aspx?aID=2319334. Accessed May 9, 2013. Lee C, Dorcil J, Radomisli TE (2004). Nonunion of the Spine: A Review. Clin Orthop, 419: 71-75. Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Resnick DK, Choudri TF, Dailey AT, Groff MW, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neursurg: Spine 2, 2005, 673-678. Lee JK, Amorosa L, Cho SK, Weidenbaum M, Kim Y. Recurrent lumbar disk herniation. J Am Acad Orthop Surg 2010, 18(6), 327-337 International Society for the Advancement of Spine Surgery (ISASS). Policy Statement on Lumbar Spinal Fusion Surgery. http://www.isass.org/public_policy/2011-07- 15_policy_statement_lumbar_surgery.pdf, accessed June 18, 2013. LSF-7: DEFORMITY Bridwell K P (2012). What's New in Spine Surgery. Journal of Bone and Joint Surgery , 1140-1148.

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Deviren V, Metz LN (2007). Anterior instrumented arthrodesis for adult idiopathic scoliosis. Neurosurg Clin N Am ,18(2):273-80. Gelalis ID, Kang JD (1998). Thoracic and lumbar fusions for degenerative disorders: rationale for selecting the appropriate fusion techniques. Orthop Clin North Am, 29(4):829-42. Gupta M (2003). Degenerative scoliosis: options for surgical management. Orthop Clin North Am, 34(2):269-79. Kalantar SB, Laurman WC (2012). Adult Scoliosis: Etiology and Management. Orthopaedic Knowledge Online Journal . Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Oskouian RJ, Shaffrey CI (2006). Degenerative lumbar scoliosis. Neurosurgery Clinics of North America,17(3):299-315, vii. Ploumis A, Transfledt EE, Denis F (2007). Degenerative lumbar scoliosis associated with spinal stenosis. Spine Journal, 2007;7(4):428-36. Kim et al. Scoliosis Imaging: What Radiologists Should Know. RadioGraphics, 2010, 30, 1823-1842. LSF-8: TRAUMA Bridwell K P (2012). What's New in Spine Surgery. Journal of Bone and Joint Surgery, 1140-1148. Kalantar SB, Laurman WC (2012). Adult Scoliosis: Etiology and Management. Orthopaedic Knowledge Online Journal . Orthopaedic Knowledge Update Spine 4, AAOS, 2012. Bambakidis NC, Feiz-Erfan I, Klopfenstein JD, Sonntag VK. Indications for surgical fusion of the cervical and lumbar motion segment. Spine 2005, 30(16 suppl), S2-6. Sasagawa T, Kawahara N, Murakami H, Demura S, Tomita K. Decompression, correction, and interbody fusion for lumbar burst fractures using a single posterior approach. Orthopedics 2009, 32(10).

LSF-9: NEOPLASTIC DISEASE Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

LSF-10: INFECTION Arnold PM, Baek PN, Bernardi RJ, et al. (1997). Surgical management of nontuberculous thoracic and lumbar vertebral osteomyelitis: report of 33

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cases. Surg Neurol, 47:551-561. Dietze DD Jr, Fessler RG, Jacob RP (1997). Primary reconstruction for spinal infections. J Neurosurg, 86:981-989. Kim CW, Perry A, Currier B, Yaszemski M, Garfin SR (2006). Fungal Infections of the Spine. Clinical Orthopaedics & Related Research , 444:92-99. Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

LSF-11: DEVICES Orthopaedic Knowledge Update Spine 4, AAOS, 2012.

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LSF-16: APPENDIX – PROCEDURE DEFINTIONS

LSF 12.5: Appendix - Procedure Definitions

This section provides terminology and context for procedures that are often used in lumbar spinal fusion surgery. This is intended for informational purposes only, and should not be used when adjudicating spine fusion surgery requests.

A number of procedures have been devised, with and without internal fixation devices and/or interbody devices, to accomplish the goal of a solid arthrodesis.

Basic Lumbar Procedures  Anterior Spinal Fusion (ASF)  Anterior Lumbar Interbody Fusion (ALIF)  Posterior or Posterolateral Spine Fusion (PSF)  Transforaminal Lumbar Interbody Fusion (TLIF)  Lateral Interbody Fusion  Direct Lateral Interbody Fusion (DLIF)  Extreme Lateral Interbody Fusion (XLIF)  Combined, Anterior/Posterior Fusion (also called a 360oFusion)  Interlaminar/ Interspinous Lumbar Instrumented Fusion (e.g., ILIF™)  Isolated Facet Fusions: Includes allograft bone graft substitutes used exclusively as stand-alone stabilization devices (e.g., TruFuse®, NuFix™)

A bone graft and/or bone graft substitute is the material that forms a bridge between vertebral segments, which facilitates the fusion of spinal segments. Bone graft types are generally categorized as autograft (harvested from the patient), allograft (harvested from a human cadaver) or synthetic (artificial, manufactured). They are further subcategorized as structural and non-structural. Autograft is generally recognized as the gold standard for spinal fusions because it possesses the key elements of fusion biology, including osteoconductivity, osteoinductivity and osteogenicity. Some of the shortcomings of autograft (such as availability and donor site morbidity) are addressed by the use of allografts and synthetic grafts.

Biological bone graft adjuvants such as rhBMP (e.g. INFUSE ® Bone Graft) can also serve as fusion adjuncts. However, recent data analysis has revealed that rhBMP-2 provides little benefit to patients compared to other graft procedures, and

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Additional Bone Graft Terms  Cell-based substitutes (e.g., mesenchymal stem cell therapy)

 Human growth factors (e.g., fibroblast growth factor, insulin-like growth factor)  Platelet rich plasma (e.g., autologous platelet derived growth factor)  Allograft bone graft substitutes (e.g., TruFuse® for isolated facet fusion, NuFix™ for isolated facet fusion, BacFast® HD for isolated facet fusion)  Bone graft substitutes used to reduce donor site morbidity (e.g., iliac crest donor site reconstruction)

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