This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Lumbar spinal fusion surgery may be considered medically necessary when ANY ONE of the following conditions are met:

• Spinal tuberculosis, or
• Spinal stenosis with ANY ONE of the following:
  • Associated spondylolisthesis demonstrated on plain x-rays; or
  • Spinal instability demonstrated on imaging studies; or
  • Spinal instability is anticipated due to need for bilateral or wide decompression with facetectomy or resection of pars interarticularis; and ANY ONE of the following:
    • Neurogenic claudication or radicular pain that results in significant functional impairment in a patient who has failed at least 3 months of conservative management* and has documentation of central/lateral recess/or foraminal stenosis on MRI or other imaging, or
    • Severe or rapidly progressive symptoms of motor loss, neurogenic claudication or cauda equina syndrome; or
• Severe degenerative scoliosis with either of the following:
  • Cobb angle of 40°, or
  • Spinal cord compression with neurogenic claudication or radicular pain that results in significant functional impairment in a patient who has failed at least 3 months of conservative treatment.*; or
• Severe degenerative scoliosis (i.e. lumbar or thoracolumbar) with a minimum Cobb angle of 30°, or significant sagittal imbalance (e.g. Sagittal vertical axis >5 cm) any one of the following:
  • Documented progression of deformity with persistent axial (non-radiating) pain and impairment or loss of function unresponsive to at least 1 year of conservative management*, or
  • Persistent and significant neurogenic symptoms (claudication or radicular pain) with impairment or loss of function, unresponsive to at least 1 year of conservative management*, or
  • Severe or rapidly progressive symptoms of motor loss, neurogenic claudication or cauda equine syndrome; or
• Isthmic spondylolisthesis when ALL of the following are present:
  • congenital (Wiltse type I) or acquired pars defect (Wiltse II), documented on x-ray, and
  • Persistent back pain (with or without neurogenic symptoms), with impairment or loss of function, and
  • Either unresponsive to at least 3 months of conservative nonsurgical care or with severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome; or
• Recurrent, same level, disk herniation, at least 3 months after previous disk surgery  when ALL of the following are present:
  • Recurrent neurogenic symptoms (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, and
  • Impairment or loss of function, and
  • Unresponsive to at least 3 months of conservative management* or with severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome, and
  • Neural structure compression and instability documented by imaging at a level and side corresponding to the clinical symptoms; or
• 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 management*, and
  • Eccentric disc space collapse, spondylolisthesis, acute single level scoliosis, or lateral listhesis on imaging, and
  • Symptoms and functional measures correlate with imaging findings, and
  • The previous fusion resulted in significant relief for at least 6 months; or
• Pseudarthrosis, documented radiographically when ALL of the following are present:
  • No less than 6 months after initial fusion; and
  • With persistent axial back pain, with or without neurogenic symptoms, or with severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome; a
  • Impairment or loss of function, in a patient who had experienced significant interval relief of prior symptoms; or Iatrogenic or degenerative flatback syndrome with significant sagittal imbalance; when fusion is performed with spinal osteotomy or interbody spacers; or
• Iatrogenic or degenerative flatback syndrome with significant sagittal imbalance; when fusion is performed with spinal osteotomy or interbody spacers; or
• Instability due to fracture, dislocation, infection, abscess, or tumor when extensive surgery is required that could create an unstable spine.
  
  *Conservative management typically includes ALL 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) and
  • Participation in at least 6 weeks of physical therapy (including active exercise and bracing - especially for scoliosis, adjacent segment instability etc.) or documentation of why the patient could not tolerate physical therapy, and
  • Evaluation and appropriate management of associated cognitive, behavioral or addiction issues when present, and
  • Documentation of patient compliance with the preceding criteria.

Lumbar spinal fusion performed for any other indication will be considered not medically necessary.

Multiple level lumbar spinal fusions are considered not medically necessary when the criteria listed above are not met for all levels.

Note: Smoking within the previous 6 weeks is a contraindication for lumbar spinal fusion. (Tobacco use is considered a risk factor for poor healing and is associated with nonunion.)

Note: Significant functional impairment or loss of function should generally include documentation of the following: Inability or significantly decreased ability to perform normal daily activities of work, school or at home duties.

Lumbar spine fusion surgery is considered experimental/investigational if the sole indication is ANY ONE of the following conditions:

• Disc Herniation, or
• Chronic nonspecific low back pain without radiculopathy, or
• Degenerative Disc Disease, or
• Initial discectomy/laminectomy for neural structure decompression, or
• Facet Syndrome

Sacroiliac Joint Fusion - Open

Sacroiliac joint fusion may be considered medically necessary when ALL of the following criteria are met:

• Appropriate imaging studies demonstrate localized sacroiliac joint pathology: and
• The individual is a nonsmoker, or in the absence of progressive neurological compromise will refrain from use of tobacco products for at least 6 weeks prior to the planned surgery: and ANY of the following:
  • Post-traumatic injury of the SI joint (e.g., following pelvic ring fracture); or
  • As an adjunctive treatment for sacroiliac joint infection or sepsis ; or
  • Management of sacral tumor (e.g., partial sacrectomy); or
  • When performed as part of multisegmental long fusions for the correction of spinal deformity (e.g., idiopathic scoliosis, neuromuscular scoliosis).

Sacroiliac joint fusion is considered experimental/investigational for ALL of the following conditions:

• Mechanical low back pain; and
• Sacroiliac joint syndrome; and
• Degenerative sacroiliac joint; and
• Radicular pain syndromes.

Sacroiliac joint fusion performed for any other indication not listed above will be considered not medically necessary.

Sacroiliac Joint Fusion – Percutaneous or Minimally Invasive

Percutaneous or minimally invasive sacroiliac joint fusion may be considered medically necessary when ALL of the following criteria are met:

·         Failure to respond (i.e., continued pain that interferes with activities of daily living and/or results in functional disability) to a minimum of six (6) months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint (SIJ) and hip including a home exercise program; and

·         Reported pain is typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain; and.

·         Thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point, ie, at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g., greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist; and.

·         Positive response to a cluster of three (3) provocative tests (e.g., thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test),

o    Note: thrust test is not recommended in pregnant patients or those with connective tissue disorders; and

·         Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); and.

·         Diagnostic imaging studies that include ALL of the following:

o    Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion; and

o    Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology; and.

o    Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; and

o    Imaging of the SIJ that indicates evidence of injury and/or degeneration; and

·         Diagnostic confirmation of the SIJ as the pain generator demonstrated by at least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on two (2) separate occasions; and

·         A trial of at least one (1) therapeutic intra-articular SIJ injection (i.e., corticosteroid injection).

Percutaneous or minimally invasive sacroiliac joint fusion for the following indications is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this procedure cannot be established by the available published peer-reviewed literature:

·         Use of minimally invasive or percutaneous SIJ fusion products other than titanium triangular implants/devices (e.g., iFUSE implant system); or

·         Systemic arthropathy, (e.g., ankylosing spondylitis or rheumatoid arthritis); or

·         Acute, traumatic instability of the SIJ; or

·         Other pathology which would prevent deriving benefit from SIJ fusion; or

·         When the above criteria have not been met.

 (axial LIF) is considered experimental/investigational and therefore non-covered.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Lumbar spine/sacroiliac fusion surgery and axial-lumbosacral interbody fusion is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

06/2015, Lumbar Spine/Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbody Fusion: Title and Criteria Revised

08/2015, Correction: Lumbar Spine/Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbody Fusion Title and Criteria

• Link to References