SPINAL FUSION SURGERY

Transcription

1 SPINAL FUSION SURGERY Policy Number: 2015M0052A Effective Date: July 1, 2015 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION 2 Spinal Cord Stimulator, 2014M0002B COVERAGE RATIONALE/CLINICAL CONSIDERATIONS 2 Epidural Steroid Injections For Low Back Pain BACKGROUND 9 And Sciatica, 2012M0014A REGULATORY STATUS 11 Interspinous Spacers In The Lumbar Spine, CLINICAL EVIDENCE M0017A APPLICABLE CODES 16 Radiofrequency Ablation For Chronic Spinal REFERENCES 23 Pain, 2013M0019A POLICY HISTORY/REVISION INFORMATION 26 Artificial Intervertebral Disc Replacement, 2015M0006B Percutaneous Vertebroplasty, Kyphoplasty and Sacroplasty, 2013M0026A Sacroiliac Fusion, 2013M0029A INSTRUCTIONS: Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations. Page. 1 of 26

2 POLICY DESCRIPTION: Spinal fusion (also known as spinal arthrodesis) is a surgical treatment utilized for neck or back pain that fuses (unites) two or more vertebral bodies in the spinal column. The goal of spinal fusion surgery is to permanently restrict spinal column vertebrae motion between the fused vertebras, in order to relieve painful symptoms. Spinal fusion surgery is generally utilized to treat degenerative disc disease (DDD), spondylolisthesis, trauma resulting in spinal nerve compression, abnormal spinal curvatures (scoliosis or kyphosis) and vertebral instability caused by infections or tumors. Spinal fusion should only be considered as a last step in the treatment of chronic back pain and is not indicated for most persons suffering from back pain. COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: I. LUMBAR SPINAL FUSION Lumbar spinal fusion surgery may be considered MEDICALLY NECESSARY for the following indications: 1. Lumbar spinal instability. ANY of the following indications when confirmed by appropriate diagnostic testing (e.g., radiographic imaging, biopsy, bone aspirate, bone scan and gallium scan): Acute spinal fracture Progressive neurological impairment (e.g., increased weakness or bladder instability) Neural compression after spinal fracture Epidural compression or vertebral destruction from tumor or abscess Spinal tuberculosis Spinal debridement for infection (e.g., osteomyelitis) Spinal deformity (e.g., idiopathic scoliosis over 40, progressive degenerative scoliosis) 2. Spinal stenosis (single level) associated with spondylolisthesis or other evidence of instability. When ALL of the following criteria are met: Back pain with symptoms of neurogenic claudication or radicular pain Radiographic evidence of spondylolisthesis when applicable - Classification of slippage in spondylolisthesis is defined as follows: Grade I =1% to 25%; Grade II=26% to 50%; Grade III=51% to 75%; Grade IV= 76% to 100%; Grade V = spondyloptosis and occurs when the L5 vertebra completely slides over the top of the sacrum Pain and significant functional impairment despite a history of 3 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following: Anti-inflammatory medications Analgesics Daily exercise Activity lifestyle modification Weight reduction as appropriate Supervised physical therapy (PT) [Activities of daily living (ADLs) diminished despite completing a plan of care Patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to planned surgery, or has received counseling on the effects of smoking on surgical outcomes and Page. 2 of 26

3 treatment for smoking cessation if accepted If cognitive, behavioral, or addiction issues are identified, the documentation should support assessment and treatment prior to surgical management 3. Spondylolysis and isthmic spondylolisthesis. When ANY of the following criteria are met: Confirmed progressive deformity Neurologic compromise Symptomatic high grade spondylolisthesis demonstrated on plain x-rays Multilevel spondylolysis Symptomatic low-grade spondylolisthesis associated with pain and significant functional impairment, despite a history of 3 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following: Anti-inflammatory medications Analgesics Daily exercise Activity lifestyle modification Weight reduction as appropriate Supervised PT [ADLs diminished despite completing a plan of care] Patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to planned surgery, or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted If cognitive, behavioral, or addiction issues are identified, the documentation should support assessment and treatment prior to surgical management 4. Degenerative disc disease (DDD) (in the absence of instability). When All of the following criteria have been met as clinically appropriate for the patient s current episode of care: Single level DDD demonstrated on imaging studies (e.g., CT scan, MRI, or discography) as the likely cause of pain. The case specific indications for two level or the rare three or more level planned fusion procedure must be directly addressed in the pre-procedure record with clinical correlation to diagnostic testing results (such as disk-space narrowing, end plate changes, annular changes, etc.) Patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to any planned surgery, or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted If cognitive, behavioral, or addiction issues are identified, the documentation should support assessment and treatment prior to surgical management Pain and significant functional impairment despite a history of at least 6 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following: Anti-inflammatory medications Analgesics Daily exercise Activity lifestyle modification Page. 3 of 26

4 Weight reduction as appropriate Supervised PT [ADLs diminished despite completing a plan of care] OR Unsuccessful improvement after completion of intense multidisciplinary rehabilitation (IMR). IMR is defined as onsite program that includes supervised PT, cognitive behavior component, and other coordinated interventions by health care professionals 5. Lumbar fusion following prior spinal surgery. Recurrent disc herniation despite clinically appropriate post operative nonsurgical medical management Adjacent segment degeneration despite clinically appropriate post-operative nonsurgical medical management (post-operative case specific conservative therapy is prescribed as clinically appropriate in addition to documentation of pain and functional impairment). Associated spondylolisthesis (e.g., anterolisthesis) after prior spinal surgery with ALL the following as clinically appropriate: Recurrent symptoms consistent with neurological compromise Significant functional impairment Neural compression is documented by recent post-operative imaging Unsuccessful improvement despite 3 months of clinically appropriate post-operative nonsurgical medical management Instability is documented by appropriate imaging Patient had some relief of pain symptoms following the prior spinal surgery 6. Treatment of pseudoarthrosis (e.g., nonunion of prior fusion at the same level after 12 months from prior surgery). ALL of the following are met: Imaging studies confirm evidence of pseudoarthrosis (e.g., radiographs, CT) Unsuccessful improvement despite 3 months of clinically appropriate post-operative nonsurgical medical management Patient had some relief of pain symptoms following the prior spinal surgery Patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to any planned surgery, or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted. Note: Spinal instrumentation and/or tissue grafting are considered MEDICALLY NECESSARY when all of the medical necessity criteria listed above are met. LUMBAR SPINAL FUSION is considered NOT MEDICALLY NECESSARY for the following conditions: 1. When performed with initial primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without documented spondylolisthesis or documentation of instability (e.g., documented intraoperative iatrogenic instability) 2. Lumbar fusion at multi-levels (2 or more) for pure DDD unless case specific indications for two level or the rare three or more level planned fusion procedure is directly addressed in the pre-procedure record Page. 4 of 26

5 II. CERVICAL SPINAL FUSION Cervical fusion surgery may be considered MEDICALLY NECESSARY for any of the following indications: 1. Acute instability with ONE of the following: Acute disc herniation; OR Acute radicular weakness or numbness 2. As a concurrent stabilization procedure with a corpectomy or laminectomy 3. Cervical instability in Down syndrome 4. Cervical instability in skeletal dysplasia or connective tissue disorders 5. Degenerative spinal segment adjacent to a previously decompressed or fused spinal segment with ONE of the following: Symptomatic myelopathy corresponding to the adjacent level; OR Symptomatic radiculopathy corresponding to the adjacent level and unresponsive to conservative treatment 6. Degenerative spondylosis with kyphosis that is causing spinal cord compression 7. Disc herniation with radiculopathy and BOTH of the following: Failure of conservative treatment (e.g., rest, medication and/or physical therapy); AND Unremitting radicular pain secondary to nerve root compression 8. Klippel-Feil syndrome 9. Multilevel spondylotic myelopathy, as evidenced by ONE of the following: Corresponding clinical symptoms (including, but may not be limited to, bowel or bladder incontinence, clumsiness of hands, frequent falls, urinary urgency) and corresponding objective neurologic signs (including, but may not be limited to, hyperreflexia, Hoffman sign, increased tone or spasticity); OR Diagnostic imaging positive for cord compression from either herniated disc or osteophyte 10. Multilevel spondylotic radiculopathy 11. Ossification of the posterior longitudinal ligament up to and including three levels 12. Spinal abscess/infection 13. Spinal tumor (primary or metastatic) with associated cord compression, pathologic fracture or instability 14. Subluxation or compression due to rheumatoid arthritis 15. Symptomatic pseudoarthrosis from a prior procedure 16. Symptomatic spondylosis with instability, as evidenced radiographically by ONE of the following: Subluxation or translation of more than 3.5 mm on static lateral views or dynamic radiographs; OR Sagittal plane angulation of more than 11 degrees between adjacent segments; OR More than 4 mm of motion (subluxation) between the tips of the spinous processes on dynamic views 17. Traumatic disc herniation Page. 5 of 26

6 18. Unstable injury such as an atlas and axis fracture, burst fracture, facet fracture with dislocation 19. Other symptomatic instability or cord or root compression and BOTH of the following: Unresponsive to conservative treatment (e.g., rest, medication, cervical collar); AND Imaging study demonstrating corresponding pathologic anatomy III. THORACIC SPINAL FUSION Thoracic fusion surgery may be considered MEDICALLY NECESSARY for any of the following indications: 1. Degenerative spondylosis with kyphosis that is causing spinal cord compression 2. Severe scoliosis with ANY of the following: Progression of deformity to greater than 50 degrees with loss of function; OR Persistent significant pain or weakness unresponsive to conservative treatment 3. Spinal abscess or infection 4. Spinal fractures with instability or neural compression 5. Spinal tumor IV. SACROILIAC JOINT FUSION (Cross reference Policy Number: 2013M0029A, Sacroiliac Fusion). Sacroiliac joint fusion may be considered MEDICALLY NECESSARY for the following indications: 1. Adjunct to sacrectomy or partial sacrectomy for treatment of sacral tumors. Reconstruction is often required in individuals who require a radical resection with total sacrectomy for tumors such as chordoma, chondrosarcoma, Ewing sarcoma, and giant cell tumor of the sacrum. 2. Adjunct to the medical treatment of sacroiliac joint infection (e.g. osteomyelitis, pyogenic sacroiliitis, sepsis). These conditions generally respond to long-term antibiotics and occasionally require drainage for abscess. Additional surgical treatment may involve debridement, decompression, and internal screw fixation when symptoms do not resolve with initial intravenous antibiotic therapy. 3. Treatment of severe traumatic injuries associated with pelvic ring fracture. These are commonly associated with vascular injuries, mechanical instability, neurological impairment and increased morbidity. Unstable pelvic ring fractures can be treated by a variety of methods including operative stabilization with internal iliosacral screw fixation when other non-operative treatment modalities have failed. Sacroiliac joint fusion is considered EXPERIMENTAL AND INVESTIGATIONAL for all uses that do not meet the criteria identified as medically necessary listed above, including but not limited to: 1. Sacroiliac joint syndrome 2. Mechanical lower back pain 3. Sacral insufficiency fractures Sacroiliac Joint fusion including, but not limited to, minimally invasive (percutaneous) procedures with Page. 6 of 26

7 the ifuse system, the Silex Sacroiliac Joint System and the SImmetry Sacroiliac Joint Fusion System is considered INVESTIGATIONAL AND/OR EXPERIMENTAL. This technology is not identified as widely used and generally accepted for the proposed use as reported in published, peer-reviewed medical literature. Further controlled studies with long-term assessment of the results of percutaneous sacroplasty are needed to confirm that it is a safe and effective procedure for sacral insufficiency fractures. V. INVESTIGATIONAL AND/OR EXPERIMENTAL SPINAL PROCEDURES The following spinal procedures are considered INVESTIGATIONAL AND/OR EXPERIMENTAL: 1. SPINAL FUSION when performed via the following methods Laparoscopic anterior lumbar interbody fusion (LALIF) Transforaminal lumbar interbody fusion (TLIF) which utilizes only endoscopy visualization (such as a percutaneous incision with video visualization) Axial lumbar interbody fusion (AxiaLIF) Interlaminar lumbar instrumented fusion (for example ILIF) Oblique lumbar interbody fusion (OLIF) which utilizes only endoscopy visualization Presacral interbody techniques. This includes interbody cages (for example PEEK, titanium etc), screws or devices with any of the above procedures. Clinical evidence is limited primarily to retrospective studies and case series. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy. 2. SPINAL STABILIZATION Stabilization systems, such as the Dynesys Dynamic Stabilization System or the DSS Stabilization System for the treatment of degenerative spondylolisthesis Total facet joint arthroplasty, including facetectomy, laminectomy, foraminotomy, vertebral column fixation Percutaneous sacral augmentation (sacroplasty) with or without a balloon or bone cement for the treatment of back pain X Stop Interspinous Process Decompression (IPD) System Clinical evidence is limited to small, uncontrolled studies with lack of blinding and long-term followup. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy. The Total Facet Arthroplasty System (TFAS) has not been approved by the U.S. Food and Drug Administration (FDA). A single clinical trial is in progress, but no results have been published. 3. STAND ALONE FACET FUSION WITHOUT AN ACCOMPANYING DECOMPRESSIVE PROCEDURE This includes procedures performed with or without bone grafting and/or the use of posterior intrafacet implants such as fixation systems, facet screw systems or anti-migration dowels. Clinical evidence is limited primarily to case series and nonrandomized studies. Randomized, controlled trials comparing facet fusion to standard procedures are needed to determine impact on health Page. 7 of 26

8 outcomes and long-term efficacy. 4. ARTIFICIAL LUMBAR INTERVERTEBRAL DISC REPLACEMENT Lumbar artificial total disc replacement is considered INVESTIGATIONAL for the treatment of degenerative disorders of the lumbar spine, single or multiple-level disc disease, or for any other indication. At the present time, there is insufficient clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature demonstrating their impact on improved health outcomes. Clinical Considerations: Spinal fusion should only be considered as a last step in the treatment of chronic back pain and is not indicated for most people suffering from back pain. Arthrodesis is usually performed for conditions that involve only one vertebral segment, however, it is necessary to fuse two segments in order to stop movement, which is referred to as a single level fusion. Lumbar fusion of more than a single level is not typically recommended except in some situations such as trauma, deformity, or for neoplasm. For the majority of Medicare population (age 65 or older) pure degenerative disc disease (DDD) without co-morbidities/co-diagnoses is rare and multilevel lumbar fusion in this population is not well studied. Prior to elective fusions, co-morbidities to be considered include: o Tobacco use o Cognitive, behavioral, or addiction issues o BMI = 30 or higher Medical record documentation should support assessment, treatment, and lifestyle modification, as appropriate, prior to surgical management. Documentation Requirements. Medical record documentation maintained by the physician must clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need for spinal fusion surgery. It must include the following: o Office notes/hospital record, including history and physical by the attending/treating physician o Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management) when applicable o Interpretation and reports for X-rays, MRI s, CT s, etc. o Medical clearance reports (as applicable) o Documentation of smoking abstinence (as applicable) o Complete operative report outlining operative approach used and all the components of the spine surgery Contraindications o Laminectomy or discectomy concurrent with fusion for nerve root decompression without instability o Multi-level DDD consisting of three or more levels/vertebrae o Pregnancy or lactation o Severe osteoporosis in which bones would not support instrumentation and fusion would not be Page. 8 of 26

9 expected to solidify without instrumentation o Infection of soft tissue adjacent to the spine or epidural infection that has not spread to the vertebral bones or discs Relative contraindications. Relative contraindications include, but are not limited to: o Member is less than 18 years of age o Body mass index (BMI) greater than or equal to 50 o Bone maturity has not been reached o Degenerative disc disease (DDD)/spinal degeneration without instability o Present alcohol or substance abuse/dependency, or history of alcohol or substance abuse within the past six months o History of smoking within the past six months o History of non-compliance with prior conservative or intensive medical management o Lack of functional recovery for a minimum of six months following the most recent spinal surgery o Severe physical or metabolic deconditioning (e.g., loss of cardiovascular capacity and strength/endurance of paraspinal muscles, malnutrition, anemia) o Disability for a minimum of one year prior to surgical consideration o Following primary disc excision for herniated lumbar disc causing radiculopathy o Minimally invasive facet fusion o Osteoporosis o Individuals with moderate to severe co-morbidities (e.g., cardiac disease, respiratory disease, chronic hypoxemia, diabetes) o Systemic infection o Documentation in the medical record of a psychiatric illness or psychological condition that would make compliance with an ongoing post-surgical pain management regimen highly improbable BACKGROUND: Low back pain is a common disorder affecting 80% of people at some point in their lives. Causes stem from a wide variety of conditions, although in some cases no specific etiology is identified. Age-related intervertebral disc degeneration, typically resulting in degeneration of the discs themselves, facet joint arthrosis and segmental instability are causative factors. Initial management can include rest, exercise program, avoidance of activities that aggravate pain, application of heat/cold modalities, pharmacotherapy, local injections, lumbar bracing, chiropractic manipulation, and physical therapy. When conservative therapy (non-surgical medical management) is unsuccessful after at least 3 to 12 months, depending on the diagnosis, lumbar spinal fusion may be considered for certain conditions. The goal of spinal fusion, also referred to as spinal arthrodesis, is to permanently immobilize the spinal column vertebrae surrounding the disc(s) that are causing the discogenic low back pain. Surgical techniques to achieve lumbar spinal fusion are numerous and may be done as an open or minimally invasive procedure. There are many different surgical approaches (anterior, posterior, lateral) to the spine, different areas of fusion (intervertebral body (interbody), transverse process (posterolateral), different fusion materials (bone graft and/or metal instrumentation), and a variety of ancillary techniques to augment fusion. All techniques involve removing the disc between two or more vertebrae and fusing the adjacent Page. 9 of 26

10 vertebrae together using bone grafts and/or spacers placed where the disc used to be. Spacers can be made of bone or bone substitutes, metal (titanium), carbon fiber, polymers or bioresorbable materials and are often supported by plates, screws, rods and/or cages. Several minimally invasive spinal fusion procedures have been developed and include the following: Laparoscopic anterior lumbar interbody fusion (LALIF) is a minimally invasive alternative to an open surgical approach to spinal fusion. The vertebrae are reached through an incision in the lower abdomen or side. Transforaminal lumbar interbody fusion (TLIF) is a modification of the posterior lumbar interbody fusion (PLIF) that gives unilateral access to the disc space to allow for fusion of the front and back of the lumbar spine. The front portion of the spine is stabilized with the use of an interbody spacer and bone graft. The back portion is secured with pedicle screws, rods and additional bone graft. TLIF is performed through a posterior incision over the lumbar spine and can be done as an open or percutaneous procedure. Axial lumbar interbody fusion (AxiaLIF), also called trans-sacral, transaxial or para-coccygeal interbody fusion, is a minimally invasive technique used in L5-S1 (presacral) spinal fusions. The technique provides access to the spine along the long axis of the spine, as opposed to anterior, posterior or lateral approaches. The surgeon enters the back through a very small incision next to the tailbone and the abnormal disc is taken out. Then a bone graft is placed where the abnormal disc was and is supplemented with a large metal screw. Sometimes, additional, smaller screws are placed through another small incision higher on the back for extra stability. Interlaminar lumbar instrumented fusion (ILIF) combines direct neural decompression with an allograft interspinous spacer to maintain the segmental distraction, and a spinous process fixation plate to maintain stability for eventual segmental fusion. Spinal Stabilization The Dynesys Dynamic Stabilization System was designed as a means to provide stability during spinal fusion to stabilize the spine; however, is currently being investigated as a substitute for spinal fusion. The Dynesys Dynamic Stabilization System is intended for use in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Total facet joint arthroplasty, such as the Total Facet Arthroplasty System (TFAS ) is a non-fusion spinal implant developed to treat patients with moderate to severe spinal stenosis. TFAS replaces the diseased facets (and lamina, if necessary) following surgical removal. Percutaneous sacroplasty is a minimally invasive surgical treatment that attempts to repair sacral insufficiency fractures using polymethylmethacrylate (PMMA) bone cement. For this procedure, 2 thin, hollow tubes are placed in the lower back, over the left half and right half of the sacrum, guided by images from x-rays or computed tomography scans. The surgeon then advances a needle through each tube to the site of the sacral fracture and injects 2 to 5 ml of bone cement (Hayes, 2009). Facet Fusion Facet fusion is a procedure that uses an allograft to fuse the joint together to provide spinal column Page. 10 of 26

11 stability and pain reduction. Facet fusion has been proposed as a treatment option for individuals with facet joint pain that does not respond to conservative treatment. REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): The FDA has approved numerous devices and instruments used in lumbar spinal fusion. Additional information, using product codes HRX, KWQ and MAX, is available at: Accessed February 8, The FDA issued 510(k) approval (K050965) for the TranS1 AxiaLIF System on June 14, AxiaLIF is an anterior spinal fixation device intended for patients requiring spinal fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade I or 2), or degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-SI in conjunction with legally marketed facet and pedicle screw systems. The AxiaLif System (Trans1 Inc, Wilmington, NC) was developed for creating a pre-sacral access in order to perform percutaneous fusion. The system is described by the U.S. Food and Drug Administration (FDA) as an anterior spinal fixation device composed of a multi-component system, including implantable titanium alloy devices and instrumentation made of titanium alloy and stainless steel. The device includes instruments for creating a small axial-track to the L5 S1 disc space. According to the FDA, the device is used for distracting the L5 S1 vertebral bodies and inserting bone graft material into the space. The device also includes an anterior fixation rod that is implanted through the same track. On March 14, 2011, the TranS1 AxiaLIF Plus (TranS1 Inc.) received FDA 510(k) clearance (K102334). According to the clearance summary: Indications and Intended use: TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L-5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. The AxiaLlF Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2 if singlelevel; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic Studies, Its usage is limited to anterior supplemental Fixation of the lumbar spine at L-5-S1 or L-4-S1 in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF. Device Description: The TranS1 AxiaLIF Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L-5-S1 or L4-S1 disc space(s). The device's instruments are used for independently distracting the L-5-S1 or L4-S1 vertebral bodies and inserting bone graft material (DBM, autograft or autologous blood) into the disc space. The device includes an anterior fixation rod that is implanted through the same approach and is used to lock the construct together The DSS Stabilization System (Paradigm Spine, LLC) received 501(k) approval on May 2, 2008 as a Class III device. The rigid design, to be used with autograft and/or allograft, is intended as a single-level system for non-cervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments, as an adjunct to fusion. The slotted Page. 11 of 26

12 design is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities' of the thoracic, lumbar, and sacral spine. Additional information is available at: Accessed February 8, The XLIF procedure utilizes instrumentation, implants, and accessories that are regulated by the FDA (NuVasive Inc., 2007). Products developed by NuVasive to support the XLIF procedure are the CoRoent XL device, the SpheRx DBR II System, and the XLP Lateral Plate: The NuVasive SpheRx received its original substantial equivalence clearance on April 12, 2006, and is a pedicle screw system: click here. The NuVasive Lateral Plate System received substantial equivalence clearance on August 10, 2006, as a spinal intervertebral body fixation orthosis, consisting of plates, screws, bolts, and locking nuts. The NuVasive CoRoent System received substantial equivalence clearance on December 4, 2007, and is intended for the intervertebral body fusion of the spine along with autogenous bone graft in skeletally mature patients. The NuVasive Systems have been updated since and have received various additional or supplemental 510(k) clearances. The Dynesys Dynamic Stabilization System is classified by the FDA as a posterior metal/polymer spinal fusion system and it is regulated by the FDA as a Class II device. The Dynesys System received 510(k) approval on March 5, 2004 (Centerpulse Spine-Tech Inc., d/b/a Zimmer Spine; Minneapolis, MN). Zimmer acquired Centerpulse in October Additional information is available at: Accessed February 8, The 510(k) approval letter from the FDA to Zimmer Spine was dated March 11, The indications of use for the Dynesys Spinal System (#K043565) are as follows: When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudarthrosis). Additional information is available at: Accessed February 8, In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients: Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; Who are having the device removed after the development of a solid fusion mass. The Total Facet Arthroplasty System (Archus Orthopedics, Inc.) device is currently limited by the FDA to investigational use within the U.S. Percutaneous sacroplasty involves injection of polymethylmethacrylate (PMMA) bone cement to repair the fracture. This type of cement is regulated as a Class II (moderate risk) device that is regulated via the FDA 510(k) process. Although the list of commercially available PMMA bone cements is too extensive for inclusion here, recently approved cement that appears suitable for sacroplasty is Vertaplex Radiopaque Bone Cement (Stryker Instruments) (K072118), which was approved for Page. 12 of 26

13 vertebroplasty on December 7, See the following Web site for more information: Accessed February 8, Facet fusion systems include TruFuse and NuFix which the FDA classifies as biologics. Additional information is available at: Accessed February 8, The CoRoent interbody implant is also required for XLIF. The most recent version of this implant, the CoRoent No-Profile System, was cleared for marketing in According to FDA 510(k) documentation, The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S I). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CoRoent No-Profile System. PEEK interbody cages are regulated via the FDA 510(k) process as Class II (moderate-risk) devices and the FDA has classified them as lumbar intervertebral fusion devices (Product Code MAX), cervical intervertebral fusion devices (Product Code ODP), and spinal vertebral body replacement devices (Product Code MQP). The complete list of approved PEEK interbody cages is too long for inclusion here. Additional Medical Products Spinal fusion: Atavi, MaXcess System, PathFinder Cages - BAK Interbody Fusion System, INTERFIX RP, INFUSE Bone Graft/LT-CAGE, Lumbar I/F Cage, Ray TFC. 2. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): No CMS National Coverage Determination (NCD) or applicable Local Coverage Determination (LCD) was identified for spinal fusion procedures using the following methods: Extreme lateral interbody fusion (XLIF) or direct lateral interbody fusion (DLIF) Laparoscopic anterior lumbar interbody fusion (LALIF) Transforaminal lumbar interbody fusion (TLIF) and the axial lumbar interbody fusion (axialif) Spinal stabilization systems Total facet joint arthroplasty Vertebral column fixation Percutaneous sacral augmentation (sacroplasty) Stand-alone facet fusion without accompanying decompressive procedures 3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Lumbar Fusion Authorization Criteria MHCP will approve lumbar fusions as medically necessary for any of the following conditions when confirmed by radiographic studies: Epidural compression or vertebral destruction from tumor Idiopathic scoliosis over 40 degrees or progressive degenerative scoliosis Instability after debridement for infection Page. 13 of 26

14 Neural compression after spinal fracture (involving 2 or 3 spinal levels) Other causes of objectively documented symptomatic instability with compression of either the nerve root or the cauda equina Pseudarthrosis Spinal tuberculosis MHCP will approve lumbar fusions as medically necessary for the treatment of degenerative conditions with spinal instability when all of the following criteria are met: 7. Documented unremitting pain and disability that is refractory to intensive conservative therapy for at least 8 weeks. The course of intensive conservative therapy must include all of the following: An active, organized, and progressive strength and flexibility program A psycho-educational component that deals with patient expectations and perceptions as well as the anatomic sources of back pain A minimum of two sessions per week over the 8 week period Radiographic documentation (plain radiographs, MRI/CT scans) of spinal instability (> 3 mm of translation and 10 degrees or more of angulation of one vertebra compared to the adjacent vertebra in a spinal motion segment) Absence of untreated, underlying, contributory mental health conditions or psychosocial issues (including but not limited to depression, drug or alcohol abuse) Absence of provider suspicion of secondary gain such as litigation or narcotic use One of the following: Post-laminectomy instability Spinal stenosis decompression for any one of the following: o Associated radical discectomy o Flexible or progressive degenerative scoliosis or kyphosis o Intraoperative excessive facet removal o Multiple recurrent disc herniation with failed laminectomy o Recurrent spinal stenosis at the same segment o Removal of par interaticularis or pars fracture o Spondylolisthesis Lumbar fusions will be approved as medically necessary for chronic discogenic back pain alone (without instability) when all of the following criteria are met: Documented unremitting pain and disability that is refractory to intensive conservative therapy for at least 8 weeks. The course of intensive conservative therapy must include all of the following: o An active, organized, and progressive strength and flexibility program o A psycho-educational component that deals with patient expectations and perceptions as well as the anatomic sources of back pain o A minimum of two sessions per week over the 8 week period Degenerative disc disease limited to 1 or 2 lumbar levels, documented by appropriate diagnostic imaging Page. 14 of 26

15 Absence of untreated, underlying, contributory mental health conditions or psychosocial issues (including but not limited to depression, drug or alcohol abuse) Absence of provider suspicion of secondary gain (such as litigation, narcotic use, etc.) MHCP will not approve lumbar fusions as medically necessary for the management of the following conditions: With initial primary laminectomy/discectomy for nerve root decompression without documented instability Multiple-level degenerative disc disease (more than 2 levels) Note: Documentation must include Oswestry Disability Index (ODI) scores from the first and last therapy visits CLINICAL EVIDENCE: SUMMARY: AxiaLIF (Axial Lumbar Interbody Fusion): The overall quality of the evidence was low. The published studies included small study populations, lacked control groups, and reported on relatively short-term outcomes. Due to the lack of comparative studies, there is no evidence to determine if AxiaLIF confers any health benefits compared with standard open and other minimally invasive fusion procedures. In addition, questions regarding long-term improvement in functional status and quality of life have not been adequately addressed. Randomized controlled trials are needed to better define patient selection criteria and the optimal clinical role of AxiaLIF compared with other fusion techniques. The evidence is currently insufficient to allow conclusions regarding the long-term health benefits, relief of symptoms, improvement in functional levels, complication and failure rates, and the need for additional surgery. extreme Lateral Interbody Fusion: The literature search identified six prospective case series that evaluated the safety and efficacy of XLIF for treatment of degenerative diseases of the lumbar spine. There is insufficient evidence to draw conclusions regarding the clinical effectiveness of XLIF for treating lumbar spinal disease or to compare relevant health outcomes with those resulting from other approaches to spinal fusion. While randomized controlled trials are necessary to demonstrate the impact of XLIF on health outcomes and the frequency of early and late complications, the available evidence suggests that in the short-to-intermediate term, lateral XLIF may offer a feasible alternative to other surgical fusion procedures for patients with a variety of lumbar spinal conditions. Interbody Cages for Spinal Fusion: Results of the available studies provide preliminary evidence that interbody fusion cages are beneficial for patients who are undergoing spinal fusion. Although PEEK cages are associated with some benefits, the available controlled studies were relatively small, PEEK cages were not compared with titanium cages, all of the controlled studies involved < 2 years of follow-up, and some studies evaluated cervical fusion while others evaluated lumbar fusion. Additional controlled studies are needed to confirm that PEEK cages provide long-term benefits that are comparable to those provided by titanium cages. Moreover, controlled studies are needed to confirm that spinal fusion provides benefits that equal or exceed the benefits provided by other standard surgical treatments for degenerative disc disease. Page. 15 of 26

16 Laparoscopic Anterior Lumbar Interbody Fusion: A few small, uncontrolled studies reported relatively high rates of fusion and good symptomatic relief in patients who underwent laparoscopic ALIF for treatment of degenerative disc disease. However, there is insufficient evidence from the available studies to conclude that the laparoscopic approach provides overall health outcomes that are equivalent or superior to those obtained with open surgical approaches to spinal fusion. Although there are some data to indicate that intraoperative blood loss and postoperative morbidity may be reduced in patients who undergo laparoscopic rather than open ALIF for single-level, uncomplicated disc disease, the long-term efficacy of the laparoscopic procedure has not been proven, and there is very limited evidence regarding magnitude of pain relief, fusion rates, or frequency of return to work following laparoscopic ALIF. Moreover, there is a significant learning curve associated with laparoscopic ALIF, and a number of technical difficulties are associated with laparoscopic technique in patients with multilevel disease, in obese patients, in patients with intra-abdominal scarring or adhesions, and in patients with L4-L5 disc disease. Sacroiliac Joint Fusion: Overall, the quality of the evidence is low. The results are mixed (positive and negative) and insufficient to support the long-term efficacy and safety of sacroiliac joint fusion for the treatment of LBP, or to establish its effectiveness compared with more conservative alternatives. The surgery should be thought of as a procedure of last resort when treating only the symptom of LBP. Additional studies are needed to determine whether sacroiliac joint fusion provides clinically significant, long-term benefits for patients with LBP. APPLICABLE CODES: The Current Procedural Terminology (CPT ) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply. HCPCS Codes Description ICD-9 Codes Description Spinal fusion, not otherwise specified Lumbar and lumbosacral fusion of the anterior column, anterior technique Lumbar and lumbosacral fusion of the posterior column, posterior technique Lumbar and lumbosacral fusion of the anterior column, posterior technique Refusion of lumbar and lumbosacral spine, anterior column, anterior technique Refusion of lumbar and lumbosacral spine, posterior column, posterior technique Refusion of lumbar and lumbosacral spine, anterior column, posterior technique Fusion or refusion of 2-3 vertebrae Fusion or refusion of 4-8 vertebrae Fusion or refusion of 9 or more vertebrae Insertion of interbody spinal fusion device ICD-10 Codes Description ICD-10 Procedure Lumbar and lumbosacral fusion code range Page. 16 of 26

17 Refusion lumbar and lumbosacral fusion code range (for pseudarthrosis) M Scoliosis code range (codes ending in 5 are thoracolumbar, ending in 6 are lumbar and M41.9 ending in 7 are lumbosacral) M Spondylolisthesis, thoracolumbar, lumbar or lumbosacral region code range M43.17 M Spinal stenosis, thoracolumbar, lumbar or lumbosacral region code range M48.07 M53.2X5- Spinal instabilities, thoracolumbar, lumbar or lumbosacral region code range M53.2X7 ICD-10 Diagnosis 0SG0070 Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Anterior Approach, Anterior Column, Open Approach 0SG0071 Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Open Approach 0SG007J Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Anterior Column, Open Approach 0SG00A0 Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Anterior Approach, Anterior Column, Open Approach 0SG00A1 Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Posterior Column, Open Approach 0SG00AJ Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Anterior Column, Open Approach 0SG00J0 Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Anterior Approach, Anterior Column, Open Approach 0SG00J1 Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Posterior Approach, Posterior Column, Open Approach 0SG00JJ Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Posterior Approach, Anterior Column, Open Approach 0SG00K0 Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Anterior Approach, Anterior Column, Open Approach 0SG00K1 Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Posterior Approach, Posterior Column, Open Approach 0SG00KJ Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Posterior Approach, Anterior Column, Open Approach 0SG00Z0 Fusion of Lumbar Vertebral Joint, Anterior Approach, Anterior Column, Open Approach 0SG00Z1 Fusion of Lumbar Vertebral Joint, Posterior Approach, Posterior Column, Open Approach 0SG00ZJ Fusion of Lumbar Vertebral Joint, Posterior Approach, Anterior Column, Open Approach 0SG0370 Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Approach 0SG0371 Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Approach 0SG037J Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Approach 0SG03A0 Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Anterior Approach, Anterior Column, Percutaneous Approach 0SG03A1 Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Posterior Column, Percutaneous Approach Page. 17 of 26

18 0SG03AJ 0SG03J0 0SG03J1 0SG03JJ 0SG03K0 0SG03K1 0SG03KJ 0SG03Z0 0SG03Z1 0SG03ZJ 0SG0470 0SG0471 0SG047J 0SG04A0 0SG04A1 0SG04AJ 0SG04J0 0SG04J1 0SG04JJ 0SG04K0 0SG04K1 0SG04KJ 0SG04Z0 0SG04Z1 0SG04ZJ 0SG1070 Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Synthetic Substitute, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint with Nonautologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of Lumbar Vertebral Joint, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Anterior Approach, Page. 18 of 26

19 0SG1071 0SG107J 0SG10A0 0SG10A1 0SG10AJ 0SG10J0 0SG10J1 0SG10JJ 0SG10K0 0SG10K1 0SG10KJ 0SG10Z0 0SG10Z1 0SG10ZJ 0SG1370 0SG1371 0SG137J 0SG13A0 0SG13A1 0SG1070 0SG13AJ 0SG13J0 0SG13J1 0SG13JJ 0SG13K0 Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Posterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Anterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Posterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Anterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Posterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Anterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Posterior Approach, Posterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Posterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints, Anterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints, Posterior Approach, Posterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints, Posterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Anterior Approach, Anterior Column, Open Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Anterior Page. 19 of 26

20 0SG13K1 0SG13KJ 0SG13Z0 0SG13Z1 0SG13ZJ 0SG1470 0SG1471 0SG147J 0SG14A0 0SG14A1 0SG14AJ 0SG14J0 0SG14J1 0SG14JJ 0SG14K0 0SG14K1 0SG14KJ 0SG14Z0 0SG14Z1 0SG14ZJ 0SG13AJ 0SG13J0 0SG13J1 0SG13JJ Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Autologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Nonautologous Tissue Substitute, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints, Anterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints, Posterior Approach, Posterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints, Posterior Approach, Anterior Column, Percutaneous Endoscopic Approach Fusion of 2 or more Lumbar Vertebral Joints with Interbody Fusion Device, Posterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Anterior Approach, Anterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Posterior Column, Percutaneous Approach Fusion of 2 or more Lumbar Vertebral Joints with Synthetic Substitute, Posterior Approach, Page. 20 of 26