Notification

Spinal Fusion


Notification Issue Date: 10/16/2018

This version of the policy will become effective on 01/14/2019.

Lumbar Spinal Fusion

Policy language was revised for Lumbar Spinal Stenosis, Instability of the Lumbar Spine, and Iatrogenic or Degenerative Flat Back Syndrome.

Lumbar Synovial Cyst was added as a Medically Necessary indication.

Criteria was added for Recurrent, Same Level Lumbar Disc Herniation and Symptomatic Lumbar Pseudarthrosis.

Language was added to the description section regarding lumbar synovial cyst.



Medical Policy Bulletin


Title:Spinal Fusion

Policy #:11.14.27c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

CERVICAL SPINAL FUSION

MEDICALLY NECESSARY
Cervical spinal fusion is considered medically necessary and, therefore, covered when any of the following criteria are met:
  • Symptomatic cervical radiculopathy documented with both of the following:
    • Neurologic deficit at initial presentation, progressive numbness or weakness, or persistent radicular pain refractory to at least 6 weeks of conservative treatment (e.g., nonsteroidal anti-inflammatory drugs [NSAIDS], oral corticosteroids, physical therapy) AND
    • Nerve root compression documented radiographically (e.g., computed tomography [CT] or magnetic resonance imaging [MRI]
  • Symptomatic cervical pseudoarthrosis, documented radiographically, with all of the following are present:
    • The subsequent cervical spinal fusion is no less than 6 months after the initial fusion procedure
    • Persistent pain (with or without neurogenic symptoms) or severe or rapidly progressive symptoms of motor loss
    • Impairment or loss of function in individuals who had experienced significant interval relief of prior symptoms
  • Symptomatic spondylotic myelopathy, with or without kyphosis, and both of the following:
    • Individual has corresponding clinical symptoms (e.g., bowel or bladder incontinence, gait abnormality, frequent falls) and neurologic signs (e.g., hyperreflexia, increased tone or spasticity of lower and upper extremities) AND
    • Radiographic documentation of cord compression (e.g., CT, MRI, x-ray) due to either of the following:
      • Herniated nucleus pulposus OR
      • Osteophyte formation
  • Symptomatic nontraumatic cervical spondylosis with instability, documented radiographically, with either of the following:
    • Sagittal plane angulation of greater than 11 degrees between adjacent segments OR
    • Subluxation or translation of greater than 3.5 millimeters on static lateral views or dynamic radiographs
  • Degenerative cervical kyphosis with spondylosis causing cord compression
  • Degenerative spinal segment adjacent to prior decompression or fusion and either of the following:
    • Symptomatic myelopathy corresponding clinically to adjacent level OR
    • Symptomatic radiculopathy corresponding clinically to adjacent level and is unresponsive to nonoperative treatment
  • Infection of the cervical spine requiring decompression or debridement when vertebral body destruction or abscess is documented radiographically (e.g., MRI)
  • Nontraumatic atlantoaxial (i.e., C1-C2) instability, cord compression, or subluxation (i.e., greater than 5 millimeters documented radiographically [MRI]) with any of the following:
    • Connective tissue disorders (e.g., rheumatoid arthritis)
    • Down syndrome
    • Os odontoideum
    • Skeletal dysplasia (e.g., congenital abnormality of C1-C2)
  • Posttraumatic cervical instability (e.g., fracture, subluxation, dislocation, major posterior ligamentous instability) documented radiographically
  • Ossification of the posterior longitudinal ligament, with or without kyphosis, associated with cervical stenosis or myelopathy
  • Spinal repair with fusion (e.g., as part of a stabilization procedure due to extensive surgery) performed in conjunction with other procedures (e.g., laminectomy) for abscess, dislocation, fracture, infection, neural decompression, or tumor
  • Tumor of the cervical spine causing cord compression, instability, or pathologic fracture documented radiographically (e.g., MRI)
  • Deformity or progressive neck pain following prior posterior cervical decompressive laminectomy or laminoplasty

NOT MEDICALLY NECESSARY
All other uses for cervical spinal fusion are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

LUMBAR SPINAL FUSION

MEDICALLY NECESSARY
Lumbar spinal fusion is considered medically necessary and, therefore, covered when any of the following criteria are met:
  • Lumbar spinal stenosis with both of the following:
    • Any one of the following:
      • Associated spondylolisthesis demonstrated radiographically (e.g., x-rays)
      • Spinal instability (anterolisthesis) demonstrated radiographically
      • Spinal instability is anticipated due to a need for bilateral or wide decompression with facetectomy or resection of pars interarticularis AND
    • Either of the following:
      • Neurogenic claudication or radicular pain that results in significant functional impairment (e.g., documentation of inability or significantly decreased ability to perform normal activities of daily living) in individuals who have failed at least 3 months of conservative treatment (e.g., NSAIDS, oral corticosteroids, physical therapy) and has central/lateral recess/or foraminal stenosis on magnetic resonance imaging (MRI), computed tomography (CT) or CT myelography performed within the past 6 months
      • Severe or rapidly progressive symptoms of motor loss (e.g., difficulty with walking or balance), neurogenic claudication, or cauda equina syndrome
  • Severe, progressive idiopathic scoliosis with either of the following:
    • Cobb angle greater than 40
    • Spinal cord compression with neurogenic claudication or radicular pain that results in significant functional impairment in individuals who have failed at least 3 months of conservative treatment (e.g., NSAIDS, oral corticosteroids, physical therapy)
  • Severe degenerative scoliosis (i.e., lumbar or thoracolumbar) with both of the following:
    • Either of the following:
      • A minimum Cobb angle of 30
      • Significant sagittal imbalance (e.g., sagittal vertical axis > 5 cm) AND
    • Any one of the following:
      • Documented progression of deformity with persistent axial (i.e., nonradiating) pain and impairment or loss of function unresponsive to at least 12 months of conservative treatment (e.g., NSAIDS, oral corticosteroids, physical therapy)
      • Persistent and significant neurogenic symptoms (e.g., claudication or radicular pain) with impairment or loss of function, unresponsive to at least 12 months of conservative nonsurgical treatment (e.g., NSAIDS, oral corticosteroids, physical therapy)
      • Severe or rapidly progressive symptoms of motor loss, neurogenic claudication or cauda equina syndrome
  • Isthmic lumbar spondylolisthesis, when all of the following are present:
    • Congenital (i.e., Wiltse type I) or acquired pars defect (i.e., Wiltse II), documented radiographically
    • Persistent back pain (with or without neurogenic symptoms), with impairment or loss of function
    • Unresponsive to at least 3 months of conservative nonsurgical treatment (e.g., NSAIDS, oral corticosteroids, physical therapy) or with severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome
  • Lumbar synovial cyst, when all of the following are present:
    • Radicular pain (with or without demonstrable neurologic deficits) or neurogenic claudication which has not responded to at least 6 weeks of conservative nonsurgical treatment
    • Documentation of a synovial cyst on CT or MRI performed within the past 6 months which correlates with symptoms and exam findings
  • Recurrent, same level lumbar disc herniation, at least 3 months after previous disc surgery, when all of the following are present:
    • Recurrent neurogenic symptoms (e.g., radicular pain or claudication) or evidence of nerve-root irritation, as demonstrated by a positive nerve-root tension sign or positive femoral tension sign or a corresponding neurologic deficit
    • Impairment or loss of function
    • Unresponsive to at least 3 months of conservative nonsurgical treatment (e.g., NSAIDS, oral corticosteroids, physical therapy) or with severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome
    • Neural structure compression and instability documented radiographically at a level and side corresponding to the clinical symptoms
    • The individual experienced significant relief of symptoms following the procedure
  • Symptomatic lumbar pseudarthrosis, documented radiographically, when all of the following are present:
    • The subsequent lumbar spinal fusion is no less than 6 months after the initial fusion procedure
    • Persistent axial back pain (with or without neurogenic symptoms) or severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome
    • Recurrent symptoms or functional impairment has not responded to at least 3 months of conservative nonsurgical treatment following confirmation of the diagnosis
    • Impairment or loss of function in individuals who had experienced significant interval relief of prior symptoms
  • Instability of the lumbar spine due to any of the following conditions, where instability is caused by the condition, or when extensive surgery is required that could create an unstable spine:
    • Tumor of the spine or spinal canal
    • Infection (osteomyelitis, discitis, or spinal abscess)
    • Fracture or dislocation; may be traumatic or pathologic
    • Degenerative spondylolisthesis with flexion and extension lateral spine x-rays showing a fixed slip or movement of at least 3 mm.
  • Iatrogenic or degenerative flat back syndrome with significant sagittal imbalance, as demonstrated by a vertical axis > 5 cm, when lumbar spinal fusion is performed with spinal osteotomy or interbody spacers
  • Adjacent level disease when all of the following are present:
    • Persistent back pain (with or without neurogenic symptoms) with impairment or loss of function that is unresponsive to at least 3 months of conservative treatment (e.g., NSAIDS, oral corticosteroids, physical therapy)
    • Eccentric disc space collapse, spondylolisthesis, acute single level scoliosis, or lateral listhesis demonstrated radiographically
    • Symptoms and functional measures correlate with imaging
    • The previous lumbar spinal fusion fusion resulted in significant relief for at least 6 months

EXPERIMENTAL/INVESTIGATIONAL
Lumbar spinal fusion is considered experimental/investigational and, therefore, not covered because the
safety and/or
effectiveness of this service cannot be established by review of the available published peer-reviewed literature for any of the following sole indications:
  • Disc herniation
  • Chronic nonspecific low back pain without radiculopathy
  • Degenerative disc disease
  • Initial discectomy/laminectomy for neural structure decompression
  • Facet syndrome

NOT MEDICALLY NECESSARY
Multiple level lumbar spinal fusion is considered not medically necessary when the criteria listed above are not met for all levels because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

All other uses for lumbar spinal fusion are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.
Guidelines

Persistent debilitating pain is defined as:
  • Significant level of pain on a daily basis defined on a visual analog scale (VAS; 0 to 10, representing increasing degree of pain) as greater than 4 AND
  • Pain on a daily basis that has a documented impact on activities of daily living in spite of optimal conservative nonsurgical therapy as outlined above and appropriate for the individual.

Conservative nonsurgical treatment typically includes all of the following:
  • Use of prescription strength analgesics for several weeks at a dose sufficient to induce a therapeutic response
    • Analgesics should include anti-inflammatory medications with or without adjunctive medications such as nerve membrane stabilizers or muscle relaxants
  • Participation in at least 6 weeks of a medically prescribed physical therapy program (including active exercise) or documentation of why the individual could not tolerate physical therapy
  • Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues
  • Documentation of the individual's compliance with the preceding criteria.

Smoking within the previous 3 months is a contraindication for spinal fusion.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, spinal fusion is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

Description

CERVICAL SPINAL FUSION

Conditions such as cervical radiculopathy and myelopathy may occur when spinal cord and/or nerves become compressed, particularly in older individuals. As the discs in the spine age, they may lose height and begin to bulge. They may also lose water content, begin to dry out, and become stiffer. This causes the vertebrae to move closer together. The body may respond to the collapsed disc by forming more bone (i.e., bone spurs) to strengthen the disc. This may contribute to spinal stiffness and pinched nerve roots. Symptoms may include pain in a radicular pattern in one or both upper extremities related to the compression and/or irritation of one or more cervical nerve roots. There may be varying degrees of sensory, motor, and reflex changes.

For individuals refractory to conservative treatment (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], physical therapy), cervical spinal fusion (i.e., arthrodesis) is a well-established surgical technique attempting to relieve spinal cord or nerve root pressure while stabilizing and eliminating the motion between the adjacent vertebral segments of the spine by fusing two or more cervical vertebrae. It is often performed in conjunction with anterior cervical discectomy (i.e., ACDF), during which a cervical herniated or degenerative disc may be removed or decompressed, while fusion is performed in order to stabilize the cervical segment.

PEER-REVIEWED LITERATURE
In a retrospective study, Faldini et al. (2010) evaluated the safety and effectiveness of ACDF for the treatment of segmental cervical degenerative pathology. Fifty-one individuals affected by single-level cervical degenerative pathology were followed for a minimum of 10 years, and were treated between C4 and C7. Outcome measurements included the visual analog scale (VAS; increasing measure of pain) and neck disability index (NDI; increasing measure of disability). At final follow-up, the outcomes were rated according to Odom's critiera (i.e., scale from Excellent to Poor based on symptom improvement). On radiographs, the saggital segmental alignment (SSA) of the affected level and the sagittal alignment of the cervical spine (SACS) were assessed. Average NDI improved from 34 preoperatively to 11 at last follow-up; average VAS improved from 7 preoperatively to 1 at final follow-up. According to Odom's criteria, the outcome was considered excellent in 18 cases, good in 22, and fair in 11. Degenerative changes at the adjacent levels were observed in 35.3% of individuals (n=18). The authors concluded that ACDF was a safe and effective technique for treating segmental cervical degenerative pathology, with good clinical outcomes at long-term follow-up. The study is limited in its lack of comparative controls.

In a retrospective study, Chen et al. (2011) compared the surgical outcomes of anterior or posterior cervical fusion for the treatment of multi-level severe ossification of the posterior longitudinal ligament (OPLL). A total of 75 individuals with multi-level severe OPLL were included in the study, with 22 individuals undergoing anterior cervical fusion, 28 undergoing posterior cervical fusion with laminectomy, and 25 undergoing posterior cervical fusion and laminoplasty. Surgical outcomes were assessed radiographically and using the Japanese Orthopedic Association scoring system (i.e., JOA; score of 0 to 17, with lower scores indicating more severe deficits). There was a statistically significant improvement in neurologic function of the postoperative JOA after anterior cervical fusion when compared to posterior cervical fusion. The posterior approach had a higher incidence of C5 palsy and axial pain. The authors concluded that anterior cervical fusion was significantly more effective for multi-level severe OPLL when compared with posterior laminoplasty in the cervical spine. The study is limited in its retrospective study design, lack of comparisons to conservative treatment, and heterogeneous treatment design.

In a literature review, Song and Choi (2014) evaluated the available published evidence on ACDF. They noted that it has been established as a safe and effective procedure for degenerative cervical spinal disease unresponsive to conservative management and outstanding results have been reported in the literature. To increase fusion rates and decrease complications, numerous graft materials, cage, and anterior plating have been developed. The use of cervical plates in ACDF has also been proposed as having a theoretical advantage of reducing adjacent segment disease by maintaining cervical lordosis.

GUIDELINES
In 2010, the North American Spine Society (NASS) developed evidence-based recommendations for the treatment of cervical radiculopathy. They provided a grade B recommendation (i.e., fair evidence based on level II or III studies with consistent findings) for surgical intervention for cervical radiculopathy from degenerative disorders when compared to conservative medical or interventional management. They also noted that both anterior cervical discectomy and ACDF were comparable treatment strategies producing similar outcomes for the treatment of single-level cervical radiculopathy (grade B recommendation). In 2011, the American College of Occupational and Environmental Medicine (ACOEM) published practice guidelines on cervical and thoracic spine disorders. They provided consensus-based recommendations, noting that for radicular pain syndromes, ACDF was recommended in individuals with chronic radiculopathy due to ongoing nerve root compression, with persistent and debilitating pain, refractory to at least 6 weeks of non-operative therapy. Decompressive surgery, including discectomy with fusion, was recommended for individuals with myelopathy.

LUMBAR SPINAL FUSION

Low back pain (i.e., lumbago) is a common condition with a lifetime prevalence estimated at 60% to 90% in industrialized countries. It typically involves the muscles and bones of the back, though in many episodes of lumbago, a specific underlying cause is unidentified. Acute lumbago is classified as pain lasting less than 6 weeks. It may be experienced as aching, burning, stabbing, sharp, or dull pain, with intensity ranging from mild to severe. The pain may radiate into one or both buttocks, or even into the thigh and hip region. In most cases of acute lumbago, diagnostic imaging is not required. Symptoms typically resolve with conservative treatment, which often consists of NSAIDs, physical therapy, and rest. However, for individuals with chronic lumbago (i.e., pain lasting more than 3 months), surgical treatment is often considered.

Lumbar spinal fusion is a surgical technique that involves the fusion of two or more lumbar vertebrae using local bone, autologous bone taken from the iliac crest of the individual, allogeneic donor bone, or bone graft substitutes. In preparation for the procedure, a layer of bone from the affected spinal column is removed and bone grafts are placed over the now exposed surface of the spinal column. As healing occurs, the bone grafts will fuse across the intervertebral space (e.g., disc or facet joint spaces). Fusion of the lumbar spine can be approached from an anterior, lateral, or posterior direction. Anterior or posterior lumbar interbody fusion is traditionally performed with an open approach (i.e., long incision with wide retraction of the musculature), but can also be performed through minimally invasive procedures.

Lumbar fusion is most commonly performed when it is used to stabilize an unstable spine or to correct deformity. Symptoms for individuals who do not have neurologic deficits will typically resolve with conservative treatment. However, individuals who present with sensory changes, muscle weakness, or cauda equina syndrome may progressively decline in function. Scoliosis, an abnormal lateral and rotation curvature of the vertebral column, can result in severe deformity that is associated with lumbago in adulthood and may lead to compromised respiratory function if uncorrected. Various practice guidelines also note that lumbar fusion is accepted for the treatment of spinal infections and tumors. The primary focus of treatment of a spinal infection is to address impending neurological deficits from progressive deformity or expanding infections. Additionally, the removal of soft-tissue tumors often requires techniques that may result in spinal destabilization.

Lumbar fusion is also used to treat pain or discomfort caused by a synovial cyst. A synovial cyst is a benign condition that can cause spinal stenosis in the lumbar spine. Synovial cysts develop as a result of degeneration in the facet joint in the lumbar spine. It is typically a process that only happens in the lumbar spine, and it almost always develops at the L4-L5 level (rarely at L3-L4). The most reliable treatment method for a synovial cyst is to remove the cyst and then fuse the joint. Fusing the joint stops all the motion at that level of the spine, and without any motion, the cyst should not regenerate.

Lumbar fusion is more controversial when performed in individuals without neurologic deficits or spinal instability (e.g., scoliosis, spondylolisthesis). In the United States, there is wide variation in the rates of lumbar spinal fusion, with many experts considering the procedure to be overused. These experts cite a need for better standardization and uniformity in the application of the procedure. For example, lumbar fusion is frequently performed in combination with discectomy or laminectomy when these procedures do not result in spinal instability. It has also been performed for degenerative disc disease (DDD) as a sole indication. DDD is an age-related condition resulting in discogenic back pain and consists of morphologic changes in the lumbar motion segment. Most degenerative changes are asymptomatic. A large number of lumbar fusion procedures are being performed for nonspecific low back pain when defined indications for fusion are not present. Nonspecific chronic low back pain is persistent low back pain that is not attributable to a recognizable, known specific pathology such as infection, tumor, osteoporosis, structural deformity (e.g., spondylolisthesis, scoliosis), inflammatory disorder, radiculitis, or cauda equina syndrome.

Lumbar foraminotomy and laminotomy involve removal of a portion of the bony arch, or lamina, on the dorsal surface of a vertebra. These are typically performed to access the disc space and relieve pressure on the nerve roots and spinal cord.

PEER-REVIEWED LITERATURE
In a long-term retrospective comparative study, Danielsson and Nachemson (2001) evaluated 156 individuals with adolescent idiopathic scoliosis who underwent fusion using Harrington rods and 127 individuals who were treated with brace. Of these individuals, 252 attended a clinical and radiologic follow-up assessment by an unbiased observer. Ninety-one percent of the surgical treatment group and 87% of the brace treatment group were assessed, with a mean follow-up time of 23 years and 22 years, respectively. Outcome measurements included curve size as measured by the Cobb method and occurrence of any degenerative changes or complications. The deterioration of the curves was 3.5 degrees for all the surgically treated curves and 7.9 degrees for all the brace-treated curves, representing a statistically significant difference (p < 0.001). Five individuals, all within the brace group, had a curve increase of 20 degrees of more. The overall complication rate after surgery was low, with pseudoarthrosis occurring in 3 individuals and flat back syndrome developing in 4. Five percent of individuals (n=8) treated with fusion underwent additional curve-related surgical procedures. The authors concluded that although more than 20 years had passed since the completion of surgical treatment of scoliosis with fusion, most of the curves did not increase and the complication rate was low.

In a multi-center controlled trial from 13 centers in the United States (Spine Patient Outcomes Research Trial [SPORT]), Weinstein et al. (2009) compared the safety and effectiveness of nonsurgical conservative treatment with standard decompressive laminectomy with or without fusion. Ninety-five percent of individuals underwent decompression with lumbar fusion. There were two cohorts in the SPORT study, with 304 individuals enrolled in a randomized cohort with an intent-to-treat design and 303 individuals enrolled in an observational cohort. Surgical candidates were participants with symptoms of at least 12 week's duration as well as radiographically confirmed degenerative spondylolisthesis with spinal stenosis. Primary outcome measurements included the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and yearly up to 4 years. At 4 year follow-up, 54% of individuals randomized to nonsurgical treatment underwent surgery. The authors found that previously reported clinically relevant advantages of surgery at 2-year follow-up were maintained at 4 years, with treatment effects of 15.3 (95% CI: 11 to 19.7) for bodily pain, 18.9 (95% CI: 14.8 to 23) for physical function, and -14.3 (95% CI: -17.5 to -11.1) for the ODI. They concluded that, compared with individuals who received nonsurgical treatment, individuals with degenerative spondylolisthesis and associated spinal stenosis who received surgical treatment maintained substantially greater pain relief and improvement at up to 4 years. The study is limited in its heterogeneous treatment design.

In a randomized controlled trial, Fritzell et al. (2001) compared lumbar spinal fusion with nonsurgical treatment in individuals with severe chronic lumbago. A total of 294 individuals with lumbago for at least 2 years and radiologic evidence of disc degeneration at L4-L5, L5-S1, or both were randomized into 4 treatment groups. The surgical treatment group (n=222) included three different fusion techniques, though not analyzed separately in this study. Individuals in the nonsurgical treatment group (n=72) were treated with different types of physical therapy. Study participants suffered from low back pain for a mean of 7.8 and 8.5 years, respectively. Outcome measurements included VAS to measure pain and ODI. Ninety-eight percent of all study participants (n=289) were assessed at 2-year follow-up. Back pain was reduced in the surgical group by 33%, compared with 7% in the nonsurgical group, representing a statistically significant difference (p < 0.0002). Pain improved mostly during the first 6 months and then gradually deteriorated. Disability measured by ODI was reduced by 25% and 6%, respectively (p = 0.015). The early complication rate in the surgical group was 17%. A statistically significantly greater number of individuals treated with surgery returned to work (36% vs. 13%) and reported an outcome as better or much better (63% vs. 29%). The authors concluded that lumbar fusion was a well-informed treatment and in select individuals with severe chronic lumbago, fusion may diminish pain and decrease disability more efficiently than nonsurgical treatment. The study is limited in its heterogeneous treatment design and relatively mid-term follow-up period.

In a multi-center randomized controlled trial from the English Spine Stabilisation Trial Group, Fairbank et al. (2005) evaluated the clinical effectiveness of lumbar fusion compared with intensive rehabilitation for individuals with chronic low back pain. A total of 349 participants with chronic lumbago with at least a year's duration were assigned to surgery (n=176) or rehabilitation for approximately 75 hours (n=173). Eighty-one percent of participants (n=284) were assessed at 2-year follow-up. Primary outcome measurements included ODI and a shuttle walking test. The mean ODI changed from 46.5 to 34 in the surgery group and 44.8 to 36.1 in the rehabilitation group, with an estimated mean difference of -4.1 (p = 0.045). There were no statistically significant differences between the treatment groups in the shuttle walking test or any other outcome measurements. The authors concluded that both groups reported reductions in disability at 2-year follow-up and that it may be possibly unrelated to both interventions as the statistical difference between treatment groups was marginal and only just reached the predefined minimal clinical difference. It was recommended that the potential risk of surgery be considered in addition to noting that there was no clear evidence that lumbar spinal fusion was any more beneficial than intensive rehabilitation. The study is limited in its relatively mid-term follow-up period.

In a 4-year follow-up study of 2 randomized controlled trials, Brox et al. (2010) compared the long-term effectiveness of lumbar fusion with nonsurgical treatment in individuals with chronic lumbago. A total of 124 individuals with DDD and at least 1 year of symptoms were evaluated from two previous randomized controlled trials. The main outcome measurement was ODI. At 4-year follow-up, 24% of individuals (n=14) assigned to nonsurgical treatment (e.g., cognitive intervention and exercise) underwent surgery. Additionally, 23% of individuals (n=15) assigned to fusion had undergone re-surgery. The mean treatment effect for ODI was 1.1 (95% CI: -5.9 to 8.2) according to the intent-to-treat analysis and -1.6 (CI: -8.9 to 5.6) in the as-treated analysis, representing no statistically significant difference between the surgical and nonsurgical groups. There was no difference in return to work. The authors concluded that long-term improvement was not improved after fusion when compared with nonsurgical treatment. The study is limited in its heterogeneous design, relatively small sample size, and high percentage of cross-over.

In a randomized controlled trial, Ohtori et al. (2011) compared discectomy and fusion with walking and stretching in 41 individuals with discogenic lumbago without radiculopathy for at least 2 years. The study participants were randomized to a minimal treatment group (n=20) or a fusion group (n=21), of which the majority were performed with anterior lumbar interbody fusion (ALIF; n=15) or posterolateral fusion (PLF; n=6) if the anterior approach was technically difficult due to blood vessel anatomy. Outcome measurements included VAS pain and ODI. At 2-year follow-up there were improvements for all groups, with the 2 surgical groups having a statistically significantly better outcome. VAS pain scores improved from 7.7 to 4.7 in the minimal treatment group, 7.4 to 1.3 in the ALIF group, and 6.5 to 3.5 in the PLF group. The study is limited in its relatively small sample size, mid-term follow-up period, and the minimal treatment provided to the conservative therapy group.

In a follow-up study of three randomized controlled trials, Mannion et al. (2013) compared the clinical outcomes of individuals randomized with either spinal fusion or multi-disciplinary cognitive-behavioral and exercise rehabilitation for chronic lumbago. A total of 473 individuals with lumbago of at least 1 year's duration were evaluated at a mean of 11.4 years [8 to 15] after initial treatment. The primary outcome measurement was ODI. Secondary outcomes included VAS pain intensity, pain frequency, medication use, and work status. Of the 473 enrolled participants, 55% completed long-term follow-up, representing 140 individuals in the surgical group and 121 in the rehabilitation group. Intent-to-treat analyses indicated no statistically or clinically significant differences between treatment groups for ODI scores at long-term follow-up. The results for secondary outcomes were consistent with the ODI as well, revealing no relevant group differences. The authors concluded that at an average of 11 years follow-up, there were no difference in participant self-reported outcomes between fusion and multi-disciplinary cognitive-behavioral and exercise rehabilitation for chronic lumbago. Given the increased risks of surgery and the lack of deterioration in nonoperative outcomes over time, the authors noted that the use of lumbar fusion in individuals with chronic lumbago should not be favored when rehabilitation programs are available. The study is limited in its heterogeneous design and high loss to follow-up.

In a systematic review, Andrade et al. (2013) evaluated the body of literature involving individuals with chronic nonspecific lumbago to further define the role for lumbar fusion surgery. The authors identified 33 technical randomized controlled trials (i.e., comparisons between different surgical techniques, adjuncts, or procedures) and 6 indication randomized controlled trials (i.e., evaluation of the effectiveness of surgical treatment vs. nonsurgical treatment), representing 3,790 and 981 study participants, respectively. Of the technical studies, types of instrumentation (13 studies; 1,332 participants), bone graft materials (11 studies; 833 participants), and disc arthroplasty compared with fusion (5 studies; 1,337 participants) were the most common comparative studies performed. The authors concluded that the objectives for randomized controlled trials evaluating lumbar fusion in individuals with chronic nonspecific lumbago have not changed substantially in the last 20 years. The majority of studies appear to assess variation in surgical technique rather than clarifying what, if any, indications for surgery exist for individuals with chronic nonspecific lumbago. As a result, the authors noted that clinicians have little evidence regarding surgical intervention for chronic nonspecific lumbago.

In a meta-analysis, Saltychev et al. (2013) compared the clinical effectiveness of lumbar fusion with conservative treatment to treat individuals with chronic lumbago. Meta-analysis was conducted on the basis of a systematic review with research quality grading according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Controlled studies were included if study participants had a history of chronic lumbago due to DDD and had been treated with lumbar fusion. Studies were also included if they compared fusion to conservative treatment. The primary outcome measurement was ODI, with a minimal clinically significant difference in ODI of 10 points. Analysis included 4 randomized controlled trials, representing 666 study participants. ODI score was reduced in both the fusion and conservative treatment groups, with a mean reduction in ODI of -2.91 (95% CI: -6.66 to 0.84) in favor of fusion at a mean follow-up of 1.5 years. However, the difference between the groups was statistically and clinically insignificant. The authors concluded that there was strong evidence that lumbar fusion was not more effective than conservative treatment in reducing perceived disability for individuals with chronic lumbago due to DDD. They also noted that further research on the subject would be unlikely to considerably affection such a conclusion.

GUIDELINES
In 2005, the American Association of Neurological Surgeons (AANS) provided a series of recommendations for lumbar fusion procedures. Specific to 1- or 2-level DDD without stenosis or spondylolisthesis, AANS recommended lumbar spinal fusion in carefully selected individuals. They did not recommend the procedure as a treatment standard for individuals with disc herniation causing radiculopathy, though did note that it may be recommended as an adjunct in individuals with preoperative lumbar spinal deformity and instability.

In 2006, the Medicare Evidence Development and Coverage Advisory Committee was convened to provide recommendations on the quality and strength of evidence regarding the safety and effectiveness of lumbar spinal fusion for chronic lumbago secondary to DDD. This was primarily based on an Agency for Healthcare Research and Quality (AHRQ) technology assessment evaluating the treatment of DDD affecting the lumbar spine. AHRQ noted that with respect to axial back pain due to isolated DDD without spinal instability, four randomized controlled trials failed to demonstrate clinically meaningful improvements in disability indices for spinal fusion when compared to rehabilitation. They concluded that the evidence for lumbar spinal fusion did not conclusively demonstrate short- or long-term benefits compared with non-surgical treatment, especially when considering individuals with DDD as a sole indication.

In 2009, the American Pain Society (APS) published clinical practice guidelines regarding interventional therapies, surgery, and interdisciplinary rehabilitation for lumbago. APS provided a strong recommendation for intensive interdisciplinary rehabilitation with a cognitive and behavioral emphasis in individuals with non-radicular lumbago. A weak recommendation was provided for clinicians to discuss the risks and benefits of surgery as an option for individuals with non-radicular lumbago and common degenerative spinal changes.

In 2009, the National Institute for Health and Clinical Excellence (NICE) published clinical guidelines on the early management of persistent, nonspecific lumbago. NICE recommended that for individuals who had completed a combined physical and psychological treatment program and have refractory, severe, nonspecific lumbago, referral for spinal fusion be considered. However, NICE did not provide recommendations on specific indications for which spinal fusion should be considered.

In 2014, NASS developed evidence-based recommendations for lumbar fusion. NASS noted that lumbar fusion may be indicated with specific criteria for infection, tumor, traumatic injuries, and stenosis when spinal deformity or instability was present. Additionally disc herniations were recommended as an adjunct to disc excision for individuals with recurrent disc herniation present at L5-S1 or for which facet resection was necessary to retrieve the disc. NASS provided recommendations with specific criteria for discogenic low back pain secondary to DDD, though did not recommend lumbar fusion for discogenic back pain in individuals with significant psychiatric disorders, smoking, or presence of advanced multi-level DDD. Lumbar fusion was also not recommended for disc herniations or stenosis in the absence of instability or spondylolisthesis.

OSTEOTOMY & CORPECTOMY
  • Osteotomy: Spinal osteotomy procedures are reported when a portion or portions of the vertebral segment or segments is (are) cut and removed in preparation for realigning the spine as part of a spinal deformity correction. These procedures may be required for congenital, developmental, and degenerative spinal deformities.
  • Corpectomy: Corpectomy typically reflects a longitudinal resection of the vertebral body from disc space to disc space often resulting in a destabilization of the complex. In the cervical spine, at least 50% of the vertebral body is removed and in the thoracic/lumbar spine, at least 30% of the corpus is removed.

SUMMARY

CERVICAL SPINAL FUSION
For individuals who have persistent or progressive symptoms of cervical radiculopathy or myelopathy despite conservative treatment, cervical spinal fusion has been well-established as a surgical technique to relieve spinal cord or nerve root pressure while stabilizing the spine. In addition to its evaluation for a variety of indications including, but not limited to, spondylosis, os odontoideum, cervical instability, and OPLL, the majority of more recent literature compares different approaches and techniques associated with cervical fusion. There are also numerous studies that exist comparing artificial intervertebral disc replacement to conventional anterior cervical discectomy and fusion. Based on the available literature and relevant published guidelines, cervical spinal fusion appears to be effective in improving outcomes among individuals with persistent and debilitating functional status due to spinal cord compression and instability, refractory to conservative nonsurgical management.

LUMBAR SPINAL FUSION
In the absence of spinal instability or deformity, questions remain regarding the use of lumbar spinal fusion for chronic low back pain secondary to DDD. There appears to be a wide variation in the perceived indications for spinal fusion, with many experts considering the procedure to be overused, citing a lack of standardization in the application of the procedure. The current available published peer-reviewed literature does not clearly establish the clinical effectiveness of lumbar spinal fusion for sole indications of disc herniation, chronic nonspecific low back pain without radiculopathy, DDD, or facet syndrome. A lack of relevant guidelines also suggests that the current clinical evidence remains limited and insufficient to permit conclusions regarding the long-term safety and effectiveness of lumbar spinal fusion for these sole indications, in the absence of spinal instability and deformity.

However, lumbar spinal fusion appears to be a viable surgical option for individuals with spinal instability or deformity and persistent lumbar spine pain refractory to conservative nonsurgical management. Based on numerous guidelines and the available published peer-reviewed literature, lumbar spinal fusion may provide successful outcomes that are maintained at long-term follow-up in select individuals with spinal stenosis and instability, scoliosis, spondylolisthesis, and fracture. The current available evidence also suggests that for individuals with recurrent neurogenic symptoms despite conservative treatment, lumbar spinal fusion may be appropriate to treat recurrent disc herniation or pseudoarthrosis after initial fusion.
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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

CERVICAL SPINE
22210, 22216, 22220, 22226, 22548, 22551, 22552, 22554, 22585, 22590, 22595, 22600, 22614, 22830, 63081, 63082, 63300, 63304, 63308

THORACIC SPINE
22206, 22208, 22212, 22216, 22222, 22226, 22610, 63085, 63086, 63087, 63088, 63090, 63091, 63101, 63103, 63301, 63302, 63305, 63306, 63308

LUMBAR SPINE
22207, 22208, 22214, 22216, 22224, 22226, 22533, 22534, 22558, 22585, 22612, 22614, 22630, 22632, 22633, 22634, 63087, 63088, 63090, 63091, 63102, 63103, 63303, 63307, 63308

SACRAL SPINE
63090, 63091, 63303, 63307, 63308

THE FOLLOWING CODES ARE USED TO REPRESENT SPINAL FUSION FOR A SPINAL DEFORMITY AT ANY LEVEL
22800, 22802, 22804, 22808, 22810, 22812, 22818, 22819, 22830

THE FOLLOWING CODES ARE USED TO REPRESENT ALLOGRAFTS & AUTOGRAFTS FOR SPINAL FUSION
20930, 20931, 20936, 20937, 20938

THE FOLLOWING CODES ARE USED TO REPRESENT INSTRUMENTATION USED IN SPINAL FUSION
22840, 22841, 22842, 22843, 22844, 22845, 22846, 22847, 22848, 22849, 22850, 22852, 22853, 22854, 22855, 22859


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions for 11.14.27c:
01/14/2019This version of the policy will become effective on 01/14/2019.

Lumbar Spinal Fusion

Policy language was revised for Lumbar Spinal Stenosis, Instability of the Lumbar Spine, and Iatrogenic or Degenerative Flat Back Syndrome.

Lumbar Synovial Cyst was added as a Medically Necessary indication.

Criteria was added for Recurrent, Same Level Lumbar Disc Herniation and Symptomatic Lumbar Pseudarthrosis.

Language was added to the description section regarding lumbar synovial cyst.

Revisions for 11.14.27b:
01/02/2018This version of the policy will become effective on 01/02/2018.

The policy has been reviewed to communicate the Company’s continuing position on Spinal Fusion.

The following language was added to the description section:

Lumbar foraminotomy and laminotomy involve removal of a portion of the bony arch, or lamina, on the dorsal surface of a vertebra. These are typically performed to access the disc space and relieve pressure on the nerve roots and spinal cord.

Additional procedures codes related to foraminotomy and laminotomy were added to the policy.

Effective 10/05/2017 this policy has been updated to the new policy template
format.


Effective 10/05/2017 this policy has been updated to the new policy template format.



Version Effective Date: 01/14/2019
Version Issued Date: 01/14/2019
Version Reissued Date: N/A

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.