Policy 201208: Lumbar Spinal Fusion

Policy: 201208 Initial Effective Date: 01/01/2013 SUBJECT: Lumbar Spinal Fusion

Annual Review Date: 04/25/2018

Last Revised Date: 011/02/2020

Prior approval is required for some or all procedure codes listed in this Corporate Medical Policy.

Some or all procedure codes listed in this Corporate Medical Policy may be considered experimental/investigational.

Definition: Lumbar spinal fusion (interbody fusion, lumbar arthrodesis) is the surgical immobilization (fixation) of two or more adjacent vertebral bodies of the lumbar spine. Although decreased spinal flexibility may result, vertebral fusion is designed to alleviate pain, improve function, restore stability and produce a more anatomically correct vertebral alignment. Conditions that may require lumbar spinal fusion include, but are not limited to: spinal instability, spinal stenosis, spinal cord compression and vertebral destruction caused by infection and tumors.

Several surgical approaches and techniques exist in treatment of spinal conditions. Minimally invasive approaches and devices, e.g., Anterior Lumbar Interbody Fusion (ALIF®), Axial Lumbar Interbody Fusion (AxiaLIF, TranS1®), Direct Lateral Interbody Fusion (DLIF), Extreme Lateral Interbody Fusion (XLIF), Maximal Access Surgery® MAS Interlaminar Lumbar Instrumented Fusion (ILIF™) (e.g., Coflex-F® Implant System), Laparoscopic Anterior Lumbar Interbody Fusion (LALIF), Posterior Lumbar Interbody Fusion (PLIF), Posterior Lumbar Intertransverse Process Fusion (PLIT), Transforaminal Lumbar Interbody Fusion (TLIF), Dynamic Spine Stabilization Device Systems (e.g., Dynesys®, Stabilimax NZ®) and Total Facet Arthroplasty (e.g., Total Facet Arthroplasty System™, SPIRE™ Stabilization System) can also be utilized as an alternative to or part of spinal fusion surgery.

Medical Necessity: The Company considers lumbar spinal fusion (CPT 22533, 22534, 22558, 22585, 22612, 22614, 22630, 22632, 22633, 22634, 22800, 22808, 22840, 22845, 22853, 22854, 22859 and applicable ICD-10-CM Procedure Codes) medically necessary and eligible for reimbursement providing at least one of the following medical criteria is met:

• Radiographic evidence (e.g., x-ray, computed tomography scan, magnetic resonance imaging) of lumbar spinal instability and at least one of the following:

1. Acute spinal fracture; or 2. Progressive neurological impairment (e.g., increasing weakness, bladder instability); or 3. Neural compression after spinal fracture; or 4. Epidural compression or vertebral destruction from tumor; or

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5. Spinal tuberculosis; or 6. Spinal debridement following infection (e.g., osteomyelitis); or 7. Spinal deformity (e.g., idiopathic scoliosis >40°, progressive degenerative scoliosis);

• Spinal stenosis and associated spondylolisthesis with radiographic evidence (e.g., x-ray, computed tomography scan, magnetic resonance imaging) of instability and all of the following:

1. Back pain with neurogenic claudication or radicular pain; and 2. Continued significant functional impairment despite ≥3 months of conventional medical therapy, including trials of all of the following (unless contraindicated):

a. Anti-inflammatory medications; and b. Analgesics; and c. Supervised physical therapy program; and d. Daily exercise routine; and e. Lifestyle activity modification (e.g., weight loss program); and

3. Individual must agree to discontinue smoking for six weeks before and six weeks after surgery unless surgery is urgent or emergent;

• Radiographic evidence (e.g., x-ray, computed tomography scan, magnetic resonance imaging) of spondylolisthesis and all of the following:

1. Symptoms and signs of neurological compromise are clinically associated with this area of spondylolisthesis; and 2. Spondylolisthesis-associated pain and significant functional impairment despite >3 months of conventional medical therapy, including trials of all of the following (unless contraindicated):

a. Anti-inflammatory medications; and b. Analgesics; and c. Supervised physical therapy program; and d. Daily exercise routine; and e. Lifestyle activity modification (e.g., weight loss program); and

3. Individual must agree to discontinue smoking for six weeks before and six weeks after surgery unless surgery is urgent or emergent;

• Radiographic evidence (e.g., computed tomography scan, magnetic resonance imaging or discography) of single level degenerative disc disease without instability and all of the following:

1. Chronic, unrelenting pain likely caused by a degenerated disc despite >6 months of conventional medical therapy, including trials of all of the following (unless contraindicated):

a. Anti-inflammatory medications; and b. Analgesics; and c. Supervised, structured physical therapy program; and d. Daily exercise routine; and e. Lifestyle activity modification (e.g., weight loss program); and

2. Individual must agree to discontinue smoking for six weeks before and six weeks after surgery unless surgery is urgent or emergent; and 3. Degenerative disc disease at the targeted level has been documented by the treating physician to be responsible for significant, definable functional impairment and chronic pain; and 4. Degenerative disc disease is confined to a single lumbar disc;

• Post-lumbar spinal surgery (≥3 months previously) recurrent disc herniation and all of the following:

1. Symptoms and signs of neurological compromise are clinically associated with recurrent disc herniation; and 2. Significant functional impairment; and 3. Neural compression and/or instability confirmed by recent radiographic imaging (e.g., x-ray, computed tomography scan, magnetic resonance imaging); and 4. Worsening neurological function despite >3 months of conventional medical therapy, including trials of all of the following (unless contraindicated):

a. Anti-inflammatory medications; and b. Analgesics; and c. Supervised physical therapy program; and d. Daily exercise routine; and e. Lifestyle activity modification (e.g., weight loss program); and

5. Individual must agree to discontinue smoking for six weeks before and six weeks after surgery unless surgery is urgent or emergent;

• Radiographic evidence (e.g., computed tomography scan, magnetic resonance imaging or discography) of adjacent degenerative disc disease and all of the following:

1. Chronic, unrelenting pain likely caused by an adjacent degenerated disc despite ≥6 months of conventional medical therapy, including trials of all of the following (unless contraindicated):

a. Anti-inflammatory medications; and b. Analgesics; and c. Supervised physical therapy program; and d. Daily exercise routine; and e. Lifestyle activity modification (e.g., weight loss program); and

2. Individual must agree to discontinue smoking for six weeks before and six weeks after surgery unless surgery is urgent or emergent; and 3. Adjacent degenerated disc disease has produced significant definable functional impairment; and 4. Postoperative lumbar spinal surgery (≥6 months previously);

• Pseudoarthrosis (non-union of prior attempted vertebrae fusion) ≥6 months since previous surgery and all of the following:

1. Radiographic evidence (e.g., x-ray, computed tomography scan, magnetic resonance imaging) of nonunion; and 2. Prior surgery resulted in relief of some pain symptoms; and 3. Worsening neurological function despite >3 months of conventional medical therapy, including trials of all of the following (unless contraindicated):

a. Anti-inflammatory medications; and b. Analgesics; and c. Supervised physical therapy program; and d. Daily exercise routine; and e. Lifestyle activity modification (e.g., weight loss program); and

4. Individual must agree to discontinue smoking for six weeks before and six weeks after surgery unless surgery is urgent or emergent;

AND

At least one of the following clinical conditions is present:

• Tuberculoma of spinal cord, unspecified

• Tuberculous abscess of spinal cord • Malignant neoplasm of vertebral column, excluding sacrum and coccyx • Malignant neoplasm of spinal meninges • Secondary malignant neoplasm of brain and spinal cord • Secondary malignant neoplasm of other parts of the nervous system • Secondary malignant neoplasm of bone and bone marrow • Benign neoplasm of bone and articular cartilage, vertebral column, excluding sacrum and coccyx • Benign neoplasm of pelvic bones, sacrum and coccyx • Benign neoplasm of spinal cord • Benign neoplasm of spinal meninges • Neoplasm of uncertain behavior of brain and spinal cord • Neoplasm of uncertain behavior of meninges • Neoplasm of uncertain behavior of bone and articular cartilage • Intracranial and intraspinal abscess of unspecified site • Cauda equina syndrome, without mention of neurogenic bladder • with neurogenic bladder • Lumbosacral spondylosis without myelopathy • Spondylosis with myelopathy, lumbar region • Traumatic spondylopathy • Displacement of lumbar intervertebral disc without myelopathy • Degeneration of thoracic or lumbar intervertebral disc, lumbar or lumbar sacral intervertebral Disc • Intervertebral disc disorder with myelopathy, lumbar region • Postlaminectomy syndrome, unspecified region • lumbar region • Other and unspecified disc disorder, lumbar region • Spinal stenosis, lumbar region, without neurogenic claudication • with claudication • Thoracic or lumbosacral neuritis or radiculitis, unspecified • Disorders of sacrum • Other unspecified back disorders • Acute osteomyelitis, other specified site • Chronic osteomyelitis, other specified sites • Unspecified osteomyelitis, other specified sites • Osteopathy resulting from poliomyelitis, other specified sites

• Other infections involving bone diseases classified elsewhere, other • specified sites • Unspecified infection of bone, other specified site • Pathologic fracture of vertebrae • Nonunion of fracture • Kyphosis (acquired) (postural) • Scoliosis [and kyphoscoliosis], idiopathic • Resolving infantile idiopathic scoliosis • Progressive infantile idiopathic scoliosis • Scoliosis due to radiation • Thoracogenic scoliosis • Kyphoscoliosis and scoliosis, other • Curvature of spine, unspecified, associated with other conditions • Kyphosis associated with other conditions • Lordosis associated with other conditions • Scoliosis associated with other conditions • Curvature of spine, other • Unspecified curvature of spine • Acquired spondylolisthesis • Other acquired deformity of back or spin • Anomalies of spine, spondylolysis, lumbosacral region • Spondylolisthesis • fusion of spine [vertebra], congenital • other • Fracture of vertebral column without mention of spinal cord injury, • lumbar, closed • Open • Fracture of vertebral column with mention of spinal cord injury, lumbar, • Closed • Open • Dislocation of lumbar vertebra, closed • Open • Injury to nerve roots and spinal plexus, lumbar root • sacral root • lumbosacral plexus

NOTE: Minimally invasive spinal fusion techniques: The Company considers extreme lateral interbody fusion (XLIF), direct lateral interbody fusion (DLIF) or transforaminal lumbar interbody fusion (MITLIF) with direct visualization (CPT Codes 22558, 22585, 22630, 22632, 22845 and applicable ICD-10-CM Procedure Codes) medically necessary and eligible for reimbursement providing that all medical criteria listed above for lumbar spinal fusion are met.

Based upon our findings, the Company has determined all other minimally invasive spinal fusion techniques have not demonstrated equivalence or superiority to currently accepted standard means of treatment. The Company considers all other minimally invasive spinal fusion techniques (Including but not limited to CPT Codes 22533, 22534, 22558, 22585, 22586, 22612, 22614, 22630, 22632, 22633, 22634, 22800, 22808, 22840, 22845, 22853, 22854, 22859, 22867, 22868, 22869, 22870, Category III Codes 0195T, 0196T, 0309T and Applicable ICD-10-CM Procedure Codes) investigational and not eligible for reimbursement.

Based upon our findings, the Company has determined lumbar spinal fusion has not been accepted in the medical community as the standard or appropriate means of treatment when performed with initial primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without documented spondylolisthesis or instability. The Company considers lumbar spinal fusion (CPT Codes 22533, 22534, 22558, 22585, 22612, 22614, 22630, 22632, 22633, 22634, 22800, 22808, 22840, 22845, 22853, 22854, 22859 and Applicable ICD-10-CM Procedure Codes) when performed with initial primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without documented spondylolisthesis or instability not medically necessary and not eligible for reimbursement.

NOTE: The following Corporate Medical Policies address back procedures: Corporate Medical Policy 200403: Recombinant Human Bone Morphogenetic Protein-2 and Protein-7, Corporate Medical Policy 201540: Disc Decompression Procedures, Corporate Medical Policy 201022: Spinal Unloading Device, Corporate Medical Policy 200813: Artificial Intervertebral Disc Replacement, InterQual® Procedures: Vertebroplasty or Kyphoplasty (available via ReviewLink), Corporate Medical Policy 2005-J: Mechanized Vertebral Axial Spinal Distraction Therapy Devices and Corporate Medical Policy 200522: Percutaneous or Endoscopic Epidural Adhesiolysis.

Documentation Requirements:

The Company reserves the right to request additional documentation as part of its coverage determination process. The Company may deny reimbursement when it has determined that the services performed were not medically necessary, investigational or experimental, not within the scope of benefits afforded to the member and/or a pattern of billing or other practice has been found to be either inappropriate or excessive. Additional documentation supporting medical necessity for the services provided must be made available upon request to the Company. Documentation requested may include patient records, test results and/or credentials of the provider ordering or performing a service. The Company also reserves the right to modify, revise, change, apply and interpret this policy at its sole discretion, and the exercise of this discretion shall be final and binding.

Prior approval is required for CPT Codes 22533, 22558, 22585, 22612, 22630, 22632, 22633, 22634, 22800, 22808, 22845, 22867, 22868, 22869, 22870 and Applicable ICD-10-CM Procedure Codes. CPT Code 22586 is considered investigational and not eligible for reimbursement.

Sources of Information:

• American Academy of Neurological Surgeons. (2005, September 08). 2005 Lumbar fusion guidelines. Retrieved from http://www.spinesection.org/fusion_guidelines.php. • American Academy of Orthopedic Surgeons. (2011, May). Lumbar spinal stenosis: the growing epidemic. Retrieved from http://www.aaos.org/news/aaosnow/may11/clinical10.asp. • Aryan, H. E, Newman, C. B., Gold, J. J., Acosta, F. L., Coover, C., & Ames, C. P. (2008). Percutaneous axial lumbar interbody fusion (AxiaLIF) of the L5-S1 segment: initial clinical and radiographic experience. Minim Invasive Neurosurg, 51(4), 225-230. • Centers for Medicare and Medicaid Services: lumbar spinal fusion. No national or local coverage determination found in the coverage database. April 25, 2018. • Deyo, R. A., Mirza, K. A., Turner, J. A.,& Martin, B. I. (2009). Over-treating chronic back pain: Time to back off? J Am Board Fam Med, 22, 62-68. • Greenleaf, R.M., & Altman, D.T. (2011). Evaluation and treatment of spinal injuries in the obese patient. Orthop Clin North Am, 42(1), 85-93, vi-vii. • Hayes, Inc., Lansdale, PA: Author. - Extreme lateral interbody fusion (XLIF; NuVasive Inc.) for treatment of degenerative spinal disorders. (2017, June 01). - Minimally invasive transforaminal lumbar interbody fusion (MITLIF) versus open transforaminal lumbar interbody fusion (OTLIF) for treatment of lumbar disc disease: a review of reviews. (2016, September 22). Update search (2017, August 30). • Institute for Clinical Systems Improvement. (2012). Healthcare guideline: Adult acute and subacute low back. Retrieved from https://www.icsi.org/_asset/bjvqrj/LBP.pdf. • Knight, R. Q., Schwaegler, P., Hanscom, D., & Roh, J. (2009). Direct lateral lumbar interbody fusion for degenerative conditions: early complication profile. J Spinal Disord Tech, 22(1), 34-37. • Miller, K., Alongi, W., & Bonanno, L.S. (2010). Management of surgical procedures common in men. Part 2: orthopedic procedures. JMH, 7(4), 406-412. • Murtaugh, R. D., Quencer, R. M., Castellvi, A. E., Yue, J. J. (2011). New techniques in lumbar spinal instrumentation: What the radiologists need to know. Radiology, 260(2), 317-330. • North American Spine Society. (2011). Evidence-based clinical guidelines for multidisciplinary spine care: diagnosis and treatment of degenerative lumbar spinal stenosis. Retrieved from https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf. • North American Spine Society. (2012). Evidence-based clinical guidelines for multidisciplinary spine care: diagnosis and treatment of degenerative lumbar spondylolisthesis. Retrieved from https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarDiscHerniation.pdf. • Parker, S. L., Shau, D. N., Mendenhall, S. K., & McGirt, M.J. (2012). Factors influencing 2-year healthcare costs in patients undergoing revision lumbar fusion procedures. J Neurosurg: Spine, 16(4), 323-328. • Ragab, A. & deShazo, R. D. (2008). Management of back pain in patients with previous back surgery. Am J Med, 121(4), 272-278.

• Kreiner, D.S., Hwang, W., Easa, J.F., Resnick, D.K., Baisden, J.L., Shay, B.,… Toton, J.F. (2014). An evidence- based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 14(1), 180-191. • Weinstein, J. N., Tosteson, T. D., Lurie, J. D., Tosteson, A. N., Blood, E., Hanscom, B., … An, H. (2008). Surgical versus nonsurgical therapy for lumbar spinal stenosis. New England Journal of Medicine, 358(8), 794-810. • Weinstein, J.N., Tosteson, T.D., Lurie, J.D., Tosteson, A. N., Blood, E., Herkowitz, H., … An, H. (2010). Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the spine patient outcomes research trial. Spine, 35(14), 1329-1339.

Applicable Code(s): CPT: 22533, 22534, 22558, 22585, 22586, 22612, 22614, 22630, 22632, 22633, 22634, 22800, 22808, 22840, 22845, 22853, 22854, 22859, 22867, 22868, 22869 and 22870

HCPCS: N/A

ICD-10-CM Procedure: 0RGA070, 0RGA071, 0RGA07J, 0RGA0A0, 0RGA0A1, 0RGA0AJ, 0RGA0J0, 0RGA0J1, 0RGA0JJ, 0RGA0K0, 0RGA0K1, 0RGA0KJ, 0RGA0Z0, 0RGA0Z1, 0RGA0ZJ, 0RGA370, 0RGA371, 0RGA37J, 0RGA3A0, 0RGA3A1, 0RGA3AJ, 0RGA3J0, 0RGA3J1, 0RGA3JJ, 0RGA3K0, 0RGA3K1, 0RGA3KJ, 0RGA3Z0, 0RGA3Z1, 0RGA3ZJ, 0RGA470, 0RGA471, 0RGA47J, 0RGA4A0, 0RGA4A1, 0RGA4AJ, 0RGA4J0, 0RGA4J1, 0RGA4JJ, 0RGA4K0, 0RGA4K1, 0RGA4KJ, 0RGA4Z0, 0RGA4Z1, 0SG00A0, 0SG00A1, 0SG00AJ, 0SG03A0, 0SG03A1, 0SG03AJ, 0SG04A0, 0SG04A1, 0SG04AJ, 0SG10A0, 0SG10A1, 0SG10AJ, 0SG10KJ, 0SG10Z0, 0SG10Z1, 0SG13A0, 0SG13A1, 0SG13AJ, 0SG13KJ, 0SG13Z0, 0SG13Z1, 0SG14A0, 0SG14A1, 0SG14AJ, 0SG14KJ, 0SG14Z0, 0SG14Z1, 0SG30A0, 0SG30A1, 0SG30AJ, 0SG33A0, 0SG33A1, 0SG33AJ, 0SG34A0, 0SG34A1 and 0SG34AJ