Latest Review Date: September 2023

Category: Surgery                                                                  

 

POLICY:

These criteria only apply to individuals aged 18 years and older.

Medical clearance is required for individuals with moderate to severe co-morbid conditions (e.g., cardiac disease, pulmonary disease, or diabetes) for assessment of pre-surgical risk and/or individual's ability for compliance with postoperative rehabilitation activities.

Effective for dates of service after July 1, 2022:

Lumbar spinal fusion surgery may be considered medically necessary for ANY of the following indications regardless of smoking status:

1. Emergency Situations
   1. Acute spinal fractures of less than three months duration with instability resulting in neural compression or spinal dislocation; or
   2. Trauma (e.g., motor vehicle collisions, vertical fall)
   3. Rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome.
2. Tumors
   1. Primary spinal tumor(s); or
   2. Metastasis to the spine; or
   3. Abscess or other growth creating a mass affect that damages or displaces the spine/spinal cord /nerves.
3. Infections affecting the spine (e.g., spinal tuberculosis, vertebral osteomyelitis, discitis).

 

Lumbar spinal fusion surgery may be considered medically necessary when a statement is provided from the physician that the individual is a non-smoker OR the individual will refrain from smoking for eight weeks prior to the planned surgery for ANY of the following indications: 

NOTE: Smoking cessation applies to smoking of tobacco products (e.g., cigarettes, cigars, and/or pipe)

1. Degenerative disc disease (DDD) of the lumbar spine in the absence of instability when ALL of the following apply:
   1. Maximum of two level fusion; AND
   2. The individual presents with discogenic pain for greater than 6 consecutive months; AND
   3. MRI (or other imaging) demonstrates morphological disc degeneration; AND
   4. Individual has previously not shown improvement from a minimum of six consecutive months of conservative therapy**

2. Recurrent Lumbar disc herniation when ALL of the following apply: A single level fusion is requested; AND
   1. The individual has previously been operated on for disc herniation on two separate occasions and experienced relief of pain symptoms for a minimum of three consecutive months; AND
   2. The third disc herniation is seen on imaging at the same level of previous disc herniation surgeries; AND
   3. Individual presents with recurrent neurogenic symptoms (e.g., radicular pain) with impairment or loss of function consistent with the level of recurrence; AND
   4. Individual is at least six months status post previous back surgery and symptoms have been unresponsive to at least three consecutive months of conservative therapy**.

3. Lumbar spondylolisthesis with or without spinal stenosis when ALL of the following apply:
   1. The spondylolisthesis has been radiographically documented in an anatomic area consistent with the location of these symptoms; AND
   2. Any one of the following
      1. Neurogenic claudication or radicular pain that results in significant functional impairment in a individual who has failed at least three consecutive months of conservative therapy**, OR
      2. Severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome.

4. Lumbar spondylolysis when ALL of the following apply:
   1. The individual presents with pain in back and/or leg(s); AND
   2. The spondylolysis has been radiographically documented in an anatomic area consistent with the location of the pain; AND
   3. The individual has failed to improve from a minimum of six consecutive months of conservative therapy**.

5. Severe, progressive idiopathic scoliosis (i.e., lumbar or thoracolumbar) with radiographically documented Cobb angle of > 35 degrees (this criteria only applies to individuals age 18 and older).

6. Severe degenerative scoliosis with EITHER of the following:
   1. Documented progression of deformity with persistent axial pain (non-radiating) and impairment or loss of function unresponsive to at least three consecutive months of conservative therapy**; OR
   2. Persistent and significant neurological impairment* or loss of function, unresponsive to at least three consecutive months of conservative therapy**.

7. Flat-back syndrome (iatrogenic loss of lumbar lordosis, accompanied by back pain, forward inclination of the trunk, and inability to stand erect) due to a previous spinal surgery, degenerative condition, post-traumatic, post-infectious, or congenital etiologies when the individual presents with clinical symptoms or with sagittal imbalance.

8. Pseudoarthrosis of prior fusion at the same level when ALL of the following apply:
   1. The individual is greater than six months out from previous spinal fusion; AND
      1. Radiographic imaging indicates that fusion has not been achieved at attempted fusion level under consideration; AND
      2. The individual has pain with or without significant  neurological impairment* from the spinal level of the prior fusion; AND
      3. Persistent pain despite at least three consecutive months of conservative therapy**.
9. Adjacent Segment Degeneration when ALL of the following apply:
   1. The individual is greater than six months out from previous fusion with recurrent neurogenic symptoms; AND
   2. Loss of function or impairment; AND
   3. Individual experienced significant interval relief of prior symptoms for a minimum of six months; AND
   4. Imaging demonstrates disc degeneration, instability, and/or stenosis at a level immediately adjacent to the fusion; AND
   5. The individual presents with pain or neurological symptoms, which have been unresponsive to a minimum of three consecutive months of conservative therapy**.
10. Lumbar Fusion Revisions when ALL of the following apply:

    NOTE: Refraining from smoking is not required prior to lumbar fusion revision.

    1. Must be at the same level of a previous surgery; AND
    2. Must show evidence of complications, either causing significant neurological impairment* or risking harm to the individual (e.g., device failure from a previous lumbar surgery or iatrogenic instability). This indication does not include cases where there is a mere lack of clinical improvement from an initial surgery.
11. Surgical procedures that create an unstable spine***:
    1. Pre-operatively, for anticipated creation of spine instability when performing a decompression surgery for spinal stenosis. OR
    2. Intra-operatively, when spinal instability occurs because adequate decompression required creation of a pars defect or removal of either 75% of one facet joint or >50% of both facet joints.

***Selection of either of these criteria requires submission of medical records.

Lumbar spinal fusion surgery is considered not medically necessary when ANY of the following contraindications apply (this section does not apply to individuals with trauma, tumor(s), or infection):

1. Individual smokes or does not refrain from smoking for eight weeks prior to spinal fusion surgery.
2. Chronic low back pain, without a clear cause demonstrated on imaging studies.
3. Treatment of spinal stenosis without instability or spondylolisthesis.
4. Present alcohol or drug abuse/dependency or history within the past six months.
5. History of noncompliance with conservative therapy**.
6. Severe (T score ≤ - 2.5 SD with 1or more fragility fractures) osteoporosis.
7. Systemic infection.

 

Effective for dates of service prior to July 1, 2022:

Lumbar spinal fusion surgery may be considered medically necessary for ANY of the following indications regardless of smoking status:

1. Emergency Situations
   1. Acute spinal fractures of less than three months duration with instability resulting in neural compression or spinal dislocation; or
   2. Trauma (e.g., motor vehicle collisions, vertical fall).
2. Tumors
   1. Primary spinal tumor(s); or
   2. Metastasis to the spine; or
   3. Abscess or other growth creating a mass affect that damages or displaces the spine/spinal cord /nerves.
3. Infections affecting the spine (e.g., spinal tuberculosis, vertebral osteomyelitis, discitis).

 

Lumbar spinal fusion surgery may be considered medically necessary when a statement is provided from the physician that the individual is a non-smoker OR the individual will refrain from smoking for eight weeks prior to the planned surgery for ANY of the following indications:

1. Degenerative disc disease (DDD) of the lumbar spine in the absence of instability when ALL of the following apply:
   1. Maximum of two level fusion; AND
   2. The individual presents with discogenic pain for greater than 6 consecutive months; AND
   3. MRI (or other imaging) demonstrates morphological disc degeneration; AND
   4. Individual has previously not shown improvement from a minimum of six consecutive months of conservative therapy**

NOTE: A pre-operative mental health screening is not required, but may be covered when requested by the surgeon for those individuals with a history of substance abuse or severe psychiatric illness (i.e., schizophrenia, borderline personality disorder, suicidal ideation, severe depression), and those individuals currently under the care of a psychiatrist/psychologist or on psychotropic medications. Any of the above conditions may impair the ability to give consent or be compliant post-operatively.

 

2. Recurrent Lumbar disc herniation when ALL of the following apply: A single level fusion is requested; AND
   1. The individual has previously been operated on for disc herniation on two separate occasions and experienced relief of pain symptoms for a minimum of three consecutive months; AND
   2. The third disc herniation is seen on imaging at the same level of previous disc herniation surgeries; AND
   3. Individual presents with recurrent neurogenic symptoms (e.g., radicular pain) with impairment or loss of function consistent with the level of recurrence; AND
   4. Individual is at least six months status post previous back surgery and symptoms have been unresponsive to at least three consecutive months of conservative therapy**.

 

3. Lumbar spondylolisthesis with or without spinal stenosis when ALL of the following apply:
   1. The spondylolisthesis has been radiographically documented in an anatomic area consistent with the location of these symptoms; AND
   2. Any one of the following
      1. Neurogenic claudication or radicular pain that results in significant functional impairment in a individual who has failed at least three consecutive months of conservative therapy**, OR
      2. Severe or rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome.

 

4. Lumbar spondylolysis when ALL of the following apply:
   1. The individual presents with pain in back and/or leg(s); AND
   2. The spondylolysis has been radiographically documented in an anatomic area consistent with the location of the pain; AND
   3. The individual has failed to improve from a minimum of six consecutive months of conservative therapy**.

 

5. Severe, progressive idiopathic scoliosis (i.e., lumbar or thoracolumbar) with radiographically documented Cobb angle of > 35 degrees (this criteria only applies to individuals age 18 and older).

 

6. Severe degenerative scoliosis with EITHER of the following:
   1. Documented progression of deformity with persistent axial pain (non-radiating) and impairment or loss of function unresponsive to at least three consecutive months of conservative therapy**; OR
   2. Persistent and significant neurological impairment* or loss of function, unresponsive to at least three consecutive months of conservative therapy**.

 

7. Flat-back syndrome (iatrogenic loss of lumbar lordosis, accompanied by back pain, forward inclination of the trunk, and inability to stand erect) due to a previous spinal surgery, degenerative condition, post-traumatic, post-infectious, or congenital etiologies when the individual presents with clinical symptoms or with sagittal imbalance.

 

8. Pseudoarthrosis of prior fusion at the same level when ALL of the following apply:
   1. The individual is greater than six months out from previous spinal fusion; AND
      1. Radiographic imaging indicates that fusion has not been achieved at attempted fusion level under consideration; AND
      2. The individual has pain with or without significant  neurological impairment* from the spinal level of the prior fusion; AND
      3. Persistent pain despite at least three consecutive months of conservative therapy**.
9. Adjacent Segment Degeneration when ALL of the following apply:
   1. The individual is greater than six months out from previous fusion with recurrent neurogenic symptoms; AND
   2. Loss of function or impairment; AND
   3. Individual experienced significant interval relief of prior symptoms for a minimum of six months; AND
   4. Imaging demonstrates disc degeneration, instability, and/or stenosis at a level immediately adjacent to the fusion; AND
   5. The individual presents with pain or neurological symptoms, which have been unresponsive to a minimum of three consecutive months of conservative therapy**.
10. Lumbar Fusion Revisions when ALL of the following apply:

    NOTE: Refraining from smoking is not required prior to lumbar fusion revision.

    1. Must be at the same level of a previous surgery; AND
    2. Must show evidence of complications, either causing significant neurological impairment* or risking harm to the individual (e.g., device failure from a previous lumbar surgery or iatrogenic instability). This indication does not include cases where there is a mere lack of clinical improvement from an initial surgery.
11. Surgical procedures that create an unstable spine***:
    1. Pre-operatively, for anticipated creation of spine instability when performing a decompression surgery for spinal stenosis. OR
    2. Intra-operatively, when spinal instability occurs because adequate decompression required creation of a pars defect or removal of either 75% of one facet joint or >50% of both facet joints.

***Selection of either of these criteria requires submission of medical records.

Lumbar spinal fusion surgery is considered not medically necessary when ANY of the following contraindications apply (this section does not apply to individuals with trauma, tumor(s), or infection):

1. Individual smokes or does not refrain from smoking for eight weeks prior to spinal fusion surgery.
2. Chronic low back pain, without a clear cause demonstrated on imaging studies.
3. Treatment of spinal stenosis without instability or spondylolisthesis.
4. BMI greater than or equal to 50.
5. Present alcohol or drug abuse/dependency or history within the past six months.
6. History of noncompliance with conservative therapy**.
7. Severe (T score ≤ - 2.5 SD with 1or more fragility fractures) osteoporosis.
8. Systemic infection.
9. Psychiatric issues (e.g., drug seeking behavior, malingering, body image disorder, concerns regarding cosmetic results, Munchausen syndrome) diagnosed by a qualified provider.

*Significant neurological impairment or loss of function must include documentation of the inability or decreased ability to perform normal activities of daily living.

**Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; participation in therapeutic physical medicine modality(ies) and/or manipulations when rendered by an eligible provider (including active exercise); evaluation and appropriate management of associated cognitive, behavioral and addiction issues when present.

***Medical record documentation maintained by the physician must substantiate the medical need for lumbar spinal fusion surgery and must include the following:

• Office notes/hospital record, including history and physical by the attending/treating physician; and

• Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management) when applicable. Interpretation and reports for X-rays, MRI’s, CT’s, etc.; and

• Medical clearance reports (as applicable); and

• Documentation of smoking history, and that the individual has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted (if applicable).

DESCRIPTION OF PROCEDURE:

Low back pain is a common affliction affecting 80% of the general population at some time in the course of life.  Low back pain can be caused by a variety of conditions including muscle strain, skeletal trauma, skeletal deformities, degenerative disc disease, tumors, and infection. Many individuals can be managed with non-surgical conservative treatments. These treatments include, but are not limited to, physical therapy, exercise, and the use of analgesics for six or more weeks. A small subset of individuals will not respond to medical or conservative management and may need to resort to surgical intervention(s).

Lumbar spinal fusion (arthrodesis) is a surgical technique that involves fusing 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. There are numerous potential indications for lumbar spinal fusion. These procedures may be used to treat spine instability, cord compression due to severe degenerative disc disease, fractures in the lumbar spine or destruction of the vertebrae by infection or tumor. Some of these indications are controversial, for example when lumbar spinal fusion is performed in combination with discectomy for either herniated discs or degenerative disc disease, or in combination with decompression of the spinal canal for spinal stenosis when there is no suggestion of instability.

Fusion of the lumbar spine can be approached from anterior, lateral, or posterior direction. Anterior or posterior lumber interbody fusion (ALIF/PLIF) are traditionally performed with an open approach (long incision with wide retraction of the musculature), but can also be performed through minimally invasive/minimal access procedures. Minimally invasive approaches that use specialized retractors include lateral transpsoas interbody fusion/lateral interbody fusion (e.g., lateral transpsoas interbody fusion [LTIF], extreme lateral interbody fusion [XLIF], direct lateral lumbar interbody fusion [DLIF]), and transforaminal interbody fusion (TLIF). Posterolateral fusion (PLF) fuses the transverse processes alone and should be differentiated from the interbody procedures (e.g., PLIF) just described. Interbody cages, instrumentation such as plates, pedicle screws, or rods, and osteoinductive agents such as recombinant human bone morphogenetic protein (rhBMP) may be used to stabilize the spine during the months that fusion is taking place and to improve fusion success rates.

The objective of interbody fusion is to permanently immobilize the functional spinal unit (two adjacent vertebrae and the disc between them) that is believed to be causing pain and/or neurologic impingement. An alternative or supplemental approach is fusion of the transverse processes. Lumbar fusion is most commonly accepted when it is used to stabilize an unstable spine or to correct deformity. Scoliosis, an abnormal lateral and rotational curvature of the vertebral column, can result in severe deformity that is associated with back pain in adulthood and may lead to compromised respiratory function if it is not corrected. Scoliosis with severe deformity is also an accepted indication for spinal fusion.

Lumbar spinal fusion is more controversial when the conditions previously described are not present. For example, fusion is frequently performed in combination with discectomy or laminectomy when these procedures do not result in instability of the spine. Fusion has also been performed for degenerative disc disease (DDD). DDD is a universal age-related condition consisting of morphologic changes in the lumbar motion segment. As many degenerative changes seen on imaging are asymptomatic, and invasive provocative discography has variable accuracy in the ability to localize the pain generator, identifying the source of low back pain can be difficult. A large number of fusion operations are also performed for nonspecific low back pain that is not responsive to nonsurgical measures (e.g., nonsteroidal antiinflammatory drugs, analgesics, physical therapy), when definite indications for fusion are not present. Across the United States, there is wide variation in the rates of lumbar spinal fusion, and many experts consider lumbar fusion to be overused, indicating a need for better standardization and uniformity in the application of this procedure.

Smoking and Neurosurgery

The NIH also recommends all smokers should quit smoking due to the high risk smoking adds to all individuals. Smoking is a risk factor for post-operative pulmonary complications as has been demonstrated repeatedly since the first report in 1944. Smoking increases risks even among those without chronic lung disease. The relative risk of pulmonary complications among smokers as compared with non-smokers ranges from 1.4 to 4.3. The risk declines only after 8 weeks of pre-operative cessation. Warner et al prospectively studied 200 smokers preparing for coronary bypass surgery and found a lower risk of pulmonary complications among those who have stopped smoking at least eight weeks before surgery than among current smokers.

Expanding evidence demonstrates that active tobacco smoking is a major risk factor for perioperative morbidity and complications after neurosurgical intervention. In regards to spinal surgery, smoking is associated with delayed spinal fusion, poor spinal fusion rates and higher rates of pseudarthrosis following spinal instrumentation. There is also an increased risk for higher subsidence rates in the placement of carbon fiber cages following anterior cervical discectomy and fusion. The mechanism behind poor fusion and greater rates of subsidence in smokers is related to poor bone quality secondary to tobacco smoking. Reduced levels of osteogenesis and hypocellular fusion mass can result from delayed vascularization and smaller areas of revascularization associated with nicotine exposure. Evidence also suggests that smokers have higher rates of recurrent lumbar disc herniation after surgery due to nicotine-induced vasoconstriction and decreased blood flow to the area of prior surgery. This results in the inhibition of the annular healing process and degeneration. Smoking cessation should be encouraged preoperatively to mitigate the associated risk for complications and to reap the long-term benefits of neurosurgical treatment.

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through July 21, 2023.

Summary of Evidence

Lumbar spinal fusion (arthrodesis) is a surgical technique that involves fusion of two or more lumbar vertebrae using local bone, autologous bone taken from the iliac crest of the individual, or allogeneic donor bone. The literature was examined on the use of fusion for the following indications:

• Spinal Stenosis. There are 2 RCTs that compared decompressive surgery plus fusion to decompressive surgery alone. These trials reached different conclusions on the benefit of adding fusion to decompression in individuals with low-grade (0%-25% slippage) spondylolisthesis. Both trials reported a larger number of operative and perioperative adverse outcomes with the addition of fusion. The third trial, a small trial conducted in Japan, also found no difference in lower back pain or leg pain scores between laminectomy alone and laminectomy plus posterolateral fusion in individuals with 1-level spinal stenosis and grade 1 spondylolisthesis. About 40% of the individuals also had dynamic instability. In individuals with spinal stenosis and grade 1 spondylolisthesis and without instability, the evidence does not support routine addition of fusion to decompression surgery. The Swedish Spinal Stenosis Study (SSSS), included individuals who did not have spondylolisthesis. The addition of fusion to laminectomy resulted in similar patient-reported outcomes, longer operating time, more bleeding, higher surgical costs, and longer hospitalization but did not result in better functional disability and pain scores. In individuals with spinal stenosis and no spondylolisthesis who receive decompression, the evidence suggests that routine fusion is not better than decompression alone. The evidence is insufficient to determine the effects of the technology on health outcomes.
• Spinal Stenosis with Spinal Instability. Findings from the SPORT trial, in which 95% of individuals in the surgical group underwent decompression with fusion, and a smaller study that specifically assessed the addition of fusion to decompression, support that fusion in individuals with spinal stenosis associated with spondylolisthesis improves outcomes and therefore may be considered medically necessary for this indication.
• Idiopathic Scoliosis. Long-term follow-up of a large case series and guidelines from the Scoliosis Research Society provide support that fusion can reduce curve progression in individuals with curves greater than 40°. Therefore, lumbar spinal fusion may be considered medically necessary for this population.
• Degenerative Scoliosis. No randomized controlled trials (RCTs) were identified on the treatment of adult symptomatic lumbar scoliosis with fusion. A cohort study found superior outcomes in individuals treated with fusion compared with nonoperative controls. Based on this evidence, clinical input, and the strong rationale for its efficacy, spinal fusion may be considered medically necessary for adults with degenerative scoliosis.
• Isthmic Spondylolisthesis. One RCT was identified that compared fusion versus an exercise program in individuals with symptomatic isthmic spondylolisthesis. Results of this trial support that fusion may be considered medically necessary for this condition.
• Spinal Fracture. Results of 1 small randomized trial indicate that spinal fusion for individuals with spinal fracture without instability or neural compression may result in worse outcomes than nonsurgical management, and therefore spinal fusion is considered not medically necessary for this indication.
• Herniated Discs. Current evidence, which includes the large SPORT RCT, supports surgical treatment with discectomy for lumbar disc herniation. Evidence is insufficient to conclude that the addition of fusion to discectomy improves outcomes in individuals with lumbar disc herniation without instability. As a result, lumbar spinal fusion is considered investigational for this indication.
• Nonspecific Chronic Low Back Pain. Meta-analysis of results from 4 RCTs found no clinically significant advantage of lumbar fusion over conservative therapy in individuals with nonspecific chronic low back pain that is unresponsive to conservative management. While some trials have reported a benefit, others have not. Due to the uncertainty as to whether outcomes are improved, spinal fusion is considered investigational for this population.

 

Practice Guidelines and Position Statements

North American Spine Society

The North American Spine Society (NASS; 2021) published updated coverage policy recommendations for lumbar fusion and made the following recommendations.

1. In disc herniation who fulfill criteria for discectomy. The NASS recommends fusion for individuals who meet any of the following criteria:
   1. primary extraforaminal disc herniation is present at L5-S1, in which a far lateral approach is not feasible because of the presence of the iliac wings
   2. primary foraminal disc herniation for which facet resection is necessary to retrieve the disc, which will result in iatrogenic instability.
   3. recurrent disc herniation
   4. primary disc herniation in the lumbar spine that is at the level of the spinal cord (i.e., low lying conus medullaris)
   5. Lumbar spinal fusion is not recommended as an adjunct to primary excision of a central or posterolateral disc herniation at any level in the absence of instability or spondylolisthesis.

2. In lumbar spinal stenosis who fulfill criteria for decompression. The NASS recommends fusion for individuals who meet any of the following criteria:

1. dynamic instability is present, as documented by flexion-extension radiographs or comparison of a supine and upright image, defined as a difference in translational alignment between vertebrae greater than 3 mm between views
2. spondylolisthesis (defined as at least 3 mm of anterolisthesis of the upper vertebra in relation to the lower vertebra) is present, either isthmic (i.e., secondary to a posterior arch stress fracture) or degenerative type
3. cases in which decompression will likely result in iatrogenic instability, such as foraminal stenosis, during which greater than 50 percent of the facet joint will be removed to adequately decompress the exiting nerve root, or in which disc space distraction is intended (e.g., interbody fusion) to achieve indirect central or foraminal decompression in lieu of direct decompression via aggressive resection of the facet joints and lamina*
4. adjacent level disease, (e.g., stenosis) that has developed above or below a previous fusion
5. recurrent stenosis (e.g., that which developed at a level that has been previously operated)
6. Lumbar spinal fusion is not recommended as an adjunct to primary decompression of central and/or lateral recess stenosis, or spondylolisthesis and when greater than 50% bilateral facet resection is not required to achieve neurologic  decompression.

*For cases in which there is severe foraminal stenosis, adequate decompression often can require aggressive resection of one or both facet joints at a particular level. Removal of an entire facet joint, even unilaterally, is generally thought to be a destabilizing event in the lumbar spine. While most cases of unilateral foraminal stenosis can be adequately decompressed with a nondestabilizing procedure, such as a foraminotomy, there are some cases in which the compression can be so severe and the orientation of the joint is such that achieving adequate decompression without producing iatrogenic instability can be difficult, if not dangerous to the underlying nerve root. This is a particular clinical scenario that would be exceedingly difficult to study that will likely not be addressed by a prospective, randomized trial (or other comparative trial for that matter). Recognizing this limitation in the evidence, that will likely persist, evidence-based medicine surgeons have made it clear that this should be reserved as a potential indication for fusion in the setting of stenosis without obvious signs of preoperative spondylolisthesis or instability.

3. In individuals with pseudarthrosis in the lumbar spine. The NASS recommends fusion for individuals who meet all of the following criteria (a-d) or demonstrate presence of a gross failure of the instrumentation (e.g., pedicle screw breakage, screw loosening, curve/correction decompensation):

1. mechanical low back pain that is approximately at the level of the pseudarthrosis, qualified as pain that can be somewhat positionally abated
2. a period of time following the index surgery during which the individual had symptomatic relief
3. presence of symptoms for at least 6 months
4. failure of nonoperative treatment
5. CT or plain films that are highly suggestive of nonunion at a lumbar segment at which a fusion had been previous attempted. These criteria include:
   • Lack of bridging bone
   • Dynamic motion noted on flexion-extension radiographs.

Specific criteria were described for infection, tumor, traumatic injuries, deformity (e.g., scoliosis), stenosis, disc herniations, synovial facet cysts, discogenic low back pain, and pseudoarthrosis. NASS isolated situations where lumbar fusion would not be indicated: disc herniation in the absence of instability or spondylolisthesis; stenosis in the absence of instability; foraminal stenosis or spondylolisthesis; and discogenic low back pain.

Other 2014 guidelines from NASS have addressed the diagnosis and treatment of degenerative lumbar spondylolisthesis. NASS gave a grade B recommendation to surgical decompression with fusion for the treatment of individuals with symptomatic spinal stenosis and degenerative lumbar spondylolisthesis to improve clinical outcomes compared with decompression alone. A grade C recommendation was given to decompression and fusion as a means to provide satisfactory long-term results for the treatment of individuals with symptomatic spinal stenosis and degenerative lumbar spondylolisthesis.

The 2011 NASS guidelines (updated in 2013) addressed multidisciplinary spine care for adults with a chief complaint of degenerative lumbar spinal stenosis. The guidelines indicated that the nature of the pain and associated individual characteristics should be more typical of a diagnosis of spinal stenosis than a herniated disc. NASS addressed whether the addition of lumbar fusion to surgical decompression improved surgical outcomes in the treatment of spinal stenosis compared with treatment by decompression alone. NASS gave a grade B recommendation (fair evidence) to decompression alone for individuals with leg predominant symptoms without instability.

 

The 2012 NASS guidelines (updated in 2014) addressed multidisciplinary spine care for the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guidelines indicated that “there is insufficient evidence to make a recommendation for or against fusion for specific individual populations with lumbar disc herniation with radiculopathy whose symptoms warrant surgery. Recommendation: I (Insufficient Evidence).”

In 2020, the NASS published guidelines on the diagnosis and treatment of low back pain. The guidelines included the following recommendations regarding the use of spinal fusion surgery:

• "There is insufficient evidence to make a recommendation for or against a particular fusion technique for the treatment of low back pain. (Grade of Recommendation: I)
• There is insufficient evidence to make a recommendation regarding whether radiographic evidence of fusion correlates with better clinical outcomes in patients with low back pain. (Grade of Recommendation: I)"

 

American Association of Neurological Surgeons

The 2014 guidelines from American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) addressed fusion procedures for the lumbar spine. The 2014 guidelines state that there is no evidence that conflicts with the recommendations formulated in the 2005 guidelines for fusion procedures for the lumbar spine (See Table 1).

Guidelines on Fusion Procedures for the Lumbar Spine

Recommendation	GOR	LOE
One- or 2-level degenerative disease without stenosis or spondylolisthesis (part 7)
Lumbar fusion should be performed for individuals whose low back pain refractory to conservative treatment (physical therapy or other nonoperative measures) and is due to 1- or 2-level DDD without stenosis or spondylolisthesis	B	Multiple level II studies
Discography degenerative disease of the lumbar spine (part 6)
Discoblock “(a procedure that involves injecting the disc with an anesthetic agent instead of a contrast agent in an effort to eliminate as opposed to reproducing a individual's pain)” is considered as a diagnostic option during the evaluation of a individual presenting with chronic low back pain, but that the potential for acceleration of the degenerative process be included in the discussion of potential risks.	C	Single level II study
Disc herniation and radiculopathy (part 8)
Lumbar spinal fusion is not recommended as routine treatment following primary disc excision in individuals with a herniated lumbar disc causing radiculopathy.	C	IV
Lumbar spinal fusion is recommended as a potential option in individuals with herniated discs who have evidence of significant chronic axial back pain, work as manual laborers, have severe degenerative changes, or have instability associated with radiculopathy caused by herniated lumbar discs.	C	IV
Reoperative discectomy combined with fusion is recommended as a treatment option in individuals with a recurrent disc herniations associated with lumbar instability or chronic axial low back pain.	C	III
Stenosis and spondylolisthesis (part 9)
Surgical decompression and fusion is recommended as an effective treatment alternative for symptomatic stenosis associated with degenerative spondylolisthesis in individuals who desire surgical treatment.	B	II
There was insufficient evidence to recommend a standard fusion technique.		Insufficient
Stenosis without spondylolisthesis (part 10)
Surgical decompression is recommended for individuals with symptomatic neurogenic claudication due to lumbar stenosis without spondylolisthesis who undergo surgical intervention.	B	II/III
In the absence of deformity or instability, lumbar fusion is not recommended because it has not been shown to improve outcomes in individuals with isolated stenosis.	C	IV

DDD: degenerative disc disease; GOR: grade of recommendation; LOE: level of evidence.

 

The 2 associations also provided recommendations on:

• Assessment of functional outcome following lumbar fusion (part 2),
• Assessment of economic outcome (part 3),
• Radiographic assessment of fusion status (part 4),
• Correlation between radiographic outcome and function (part 5),
• Interbody techniques for lumbar fusion (part 11),
• Pedicle screw fixation as an adjunct to posterolateral fusion (part 12),
• Injection therapies (part 13),
• Brace therapy (part 14),
• Electrophysiological monitoring (part 15),
• Bone growth extenders and substitutes (part 16), and
• Bone growth stimulators (part 17).

American Academy of Orthopaedic Surgeons

Information updated in 2021 from the American Academy of Orthopaedic Surgeons indicates that the type of treatment required for idiopathic scoliosis in children and adolescents depends on the kind and degree of the curve, child's age, and number of remaining growth years until the child reaches skeletal maturity.

• Observation is appropriate when the curve is mild (<25°) or if the child is near skeletal maturity.
• The goal of bracing is to prevent scoliotic curves from worsening. Bracing can be effective if the child is still growing and has a spinal curvature between 25° and 45°. There are several types of braces, most being the underarm type.
• Surgery may be recommended if the curve is greater than 45°and the child is still growing. If the individual has reached skeletal maturity, surgery may still be recommended for scoliotic curves that exceed 50° to 55°. An implant made up of rods, hooks, screws, and/or wires is used to straighten the spine. Bone graft from the bone bank, or from the individual's hip region, is also used to help the operated portion of the spine heal solid.
• At present, the main research focus in idiopathic scoliosis is investigation into genetic factors as a cause of scoliosis.

United Kingdom’s National Institute for Health and Clinical Excellence

The National Institute for Health and Care Excellence (NICE; 2017) provided guidance on lateral interbody fusion for lumbar spine low back pain. NICE stated that lumbar fusion may be appropriate for “people with severe, life-limiting, chronic low back pain that does not respond to conservative treatments.” The evidence on lateral interbody fusion was considered “adequate in quality and quantity.” Also in 2017, NICE reexamined lumbar disc replacement and reported higher complication rates were found in individuals who underwent fusion. The conclusion was that disc replacement was not warranted and spinal fusion for nonspecific low back pain should only be performed as part of a randomized controlled trial.

International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (ISOSORT)

The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (ISOSORT) updated their guidelines on treatment of idiopathic scoliosis in 2018. In these guidelines fusion is discussed in the context of other treatments, as an outcome measure indicating treatment failure.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE; 2017) provided guidance on lateral interbody fusion for lumbar spine low back pain. NICE stated that lumbar fusion may be appropriate for "people with severe, life-limiting, chronic low back pain that does not respond to conservative treatments." The evidence on lateral interbody fusion was considered "adequate in quality and quantity." Also in 2017, NICE reexamined lumbar disc replacement and reported higher complication rates were found in individuals who underwent fusion. The conclusion was that disc replacement was not warranted and spinal fusion for nonspecific low back pain should only be performed as part of a randomized controlled trial.

U.S. Preventive Services Task Force Recommendations

Adolescent Idiopathic Scoliosis: The US Preventive Services Task Force updated their recommendations on screening for adolescent idiopathic scoliosis in 2018 and concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis in children and adolescents aged 10 to 18 years (I statement). The Task force surgical treatment in screening-relevant populations that met inclusion criteria.

KEY WORDS:

Spinal lumbar fusion, Lumbar fusion, Low back pain (LBP), Spondylolysis, Spondylolisthesis, Degenerative Disc Disease (DDD), Bone graft surgery, Pseudoarthrosis, Flat-back syndrome, Spinal arthrodesis, Vertebral interbody fusion, Spondylosyndesis, lumbar disc herniation, spinal stenosis, scoliosis, lumbar fusion revision

APPROVED BY GOVERNING BODIES:

Lumbar spinal fusion is a surgical procedure and does not require approval by FDA. A variety of instrumentation used in lumbar spinal fusion is cleared for marketing by FDA. Infuse (rhBMP-2) and OP-1(rhBMP-7) are approved by FDA for specified indications.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CODING:

CPT Codes:

20930	Allograft, morselized, or replacement of osteopromotive material, for spine surgery only (list separately in addition to code for primary procedure)
20931	Allograft, structural, for spine surgery only (list separately in addition to primary procedure)
20936	Autograft for spine surgery only (includes harvesting the graft); local (e.g., ribs, spinous process or laminar fragments) obtained from the same incision (list separately in addition to code for primary procedure)
20937	; morselized (through separate skin or fascial incision) (list separately in addition to code for primary procedure)
20938	; structural, bicortical, or tricortical (through separate skin or fascial incision) (list separately in addition to code for primary procedure)
20939	Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure)
22207	Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; lumbar
22214	Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; lumbar
22216	Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; each additional vertebral segment (List separately in addition to primary procedure)
22224	Osteotomy of spine, including discectomy, anterior approach, single vertebral segment; lumbar
22533	Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar
22534	Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression; thoracic or lumbar, each additional vertebral segment
22558	Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar
22585	Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); each additional interspace (List separately in addition to code for primary procedure)
22612	Arthrodesis, posterior or posterolateral technique, single interspace; lumbar (with lateral transverse technique)
22614	Arthrodesis, posterior or posterolateral technique, single interspace; each additional vertebral segment (List separately in addition to code for primary procedure)
22630	Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar
22632	Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace (List separately in addition to code for primary procedure)
22633	Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; lumbar
22634	Arthrodesis, combined posterior or posterolateral technique  with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; each additional interspace and segment (List separately in addition to code for primary procedure)
22800	Arthrodesis, posterior, for spinal deformity, with or without cast; up to 6 vertebral segments
22802	Arthrodesis, posterior, for spinal deformity, with or without cast; 7 to 12 vertebral segments
22804	Arthrodesis, posterior, for spinal deformity, with or without cast; 13 or more vertebral segments
22808	Arthrodesis, anterior, for spinal deformity, with or without cast; 2 to 3 vertebral segments
22810	Arthrodesis, anterior, for spinal deformity, with or without cast; 4 to 7 vertebral segments
22812	Arthrodesis, anterior, for spinal deformity, with or without cast; 8 or more vertebral segments
22840	Posterior non-segmental instrumentation (e.g., Harrington rod technique, pedicle fixation across 1 interspace, atlantoaxial transarticular screw fixation, sublaminar wiring at C1, facet screw fixation) (List separately in addition to code for primary procedure)
22841	Internal spinal fixation by wiring of spinous processes (list separately in addition to code for primary procedure)
22842	Posterior segmental instrumentation (e.g., pedicle fixation, dual rods with multiple hooks and sublaminar wires); 3 to 6 vertebral segments (List separately in addition to code for primary procedure)
22843	Posterior segmental instrumentation (e.g., pedicle fixation, dual rods with multiple hooks and sublaminar wires); 7 to 12 vertebral segments (List separately in addition to code for primary procedure)
22844	Posterior segmental instrumentation (e.g., pedicle fixation, dual rods with multiple hooks and sublaminar wires); 13 or more vertebral segments (List separately in addition to code for primary procedure)
22845	Anterior instrumentation; 2 to 3 vertebral segments (List separately in addition to code for primary procedure)
22846	Anterior instrumentation; 4 to 7 vertebral segments (List separately in addition to code for primary procedure)
22847	Anterior instrumentation; 8 or more vertebral segments (List separately in addition to code for primary procedure)
22853	Insertion of interbody biomechanical device(s) (e.g. synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g. screws, flanges), when performed, to intervertebral disc space in conjunction with interbody arthrodesis, each interspace
22854	Insertion of interbody biomechanical device(s) (e.g. synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g. screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect
22859	Insertion of interbody biomechanical device(s) (e.g. synthetic cage, mesh, methylmethacrylate) to intervertebral disc space or vertebral body defect without interbody arthrodesis, each contiguous defect
63052	Laminectomy, facetectomy, or foraminotomy with lumbar decompression of spinal cord, cauda equina and/or nerve root during posterior interbody arthrodesis, single segment
63053	Laminectomy, facetectomy, or foraminotomy with lumbar decompression of spinal cord, cauda equina and/or nerve root, during posterior interbody arthrodesis, each additional segment

 

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POLICY HISTORY:

Medical Policy Group, June 2013 (4)

Medical Policy Administration Committee, June 2013

Available for comment June 18 through August 1, 2013

Medical Policy Group, August 2013 (2): Policy updated based on Provider comments

Medical Policy Administration, September 2013

Available for comment September 19 through November 2, 2013

Medical Policy Group, September 2014 (3): added word “modality(ies)” to description of physical therapy in conservative therapy definition per Medical Director

Medical Policy Panel, November 2014

Medical Policy Group, October 2015 (2): 2015 Updates to Description, Key Points, Approved by Governing Bodies, References, and policy statement revised with criteria update to recurrent lumbar disc herniation, spinal stenosis with lumbar spondylolisthesis, pseudoarthrosis, adjacent segment degeneration, and surgical procedures that create an unstable spine.

Medical Policy Administration Committee, October 2015

Available for comment October 6 through November 19, 2015

Medical Policy Group, March 2016 (2): updated Degenerative Disc Disease section- changed the 12 months of consecutive pain to greater than 6 months of consecutive pain and removed the age requirement of 25-65.

Medical Policy Group, April 2016 (2)- updates to Key Words and  Policy section on Pseudoarthrosis with effective date of May 26, 2016.

Medical Policy Administration Committee, April 2016

Available for comment April 11 through May 25, 2016

Medical Policy Panel, May 2016

Medical Policy Group, May 2016 (7): Updates to Description, Key Points, and References. Policy statement- smoking criteria updated, changed from six weeks to eight weeks.

Medical Policy Group, October 2016 (7): Clarification to Policy Statement- under Degenerative Disc Disease, removed screening requirement for mental illness and/or substance abuse issues; Included verbiage regarding pre-operative mental health screening. Replaced ‘disk’ with ‘disc’.

Medical Policy Administration Committee, October 2016

Available for comment October 13 through November 26, 2016

Medical Policy Group, December 2016: Annual Coding Update. Added CPT codes 22853, 22854, and 22859.  Created Previous Coding section and moved deleted code 22851 to this new section.

Medical Policy Group, April 2017 (7): Clarification to lumbar fusion revision criteria- refraining from smoking cessation not required prior to revision. 

Medical Policy Panel, April 2017

Medical Policy Group (7):  Updates to Key Points and References. Clarified conservative therapy definition; No change in intent of Policy Statement.

Medical Policy Group, December 2017: 2018 Annual Coding Update.  Added new code 20939 under Current Coding.

Medical Policy Panel, June 2018.

Medical Policy Group, July 2018 (7): 2018 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (7): Updates to Key Points and References. Removed previous policy statements prior to May 2016. No change in intent of Policy Statement.

Medical Policy Panel, September 2020

Medical Policy Group, October 2020 (7): Updates to Key Points and References. Removed previous Policy Statements prior to October 9, 2016. Deleted Previous Coding Section- CPT 22851 deleted effective 12/31/2016. No change intent of Policy Statement.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (7): Updates to Key Points and References. No change in intent of Policy Statement.

Medical Policy Group, November 2021 (7): Updates to Coding section- added CPT codes 22207, 22214, 22216 and 22224. No change in policy intent.

Medical Policy Group, December 2021: 2022 Annual Coding Update. Revised CPT codes 22612 and 22614-  “level” changed to “interspace” in the code descriptors. Added CPT codes 63052, 63053 to the Current coding section.

Medical Policy Group, July 2022 (7): Removed contraindication-“BMI greater than or equal to 50” from Policy Statement. Available for comment July 1, 2022 through August 15, 2022.

Medical Policy Administrative Committee: June 2022.

Medical Policy Panel, September 2022

Medical Policy Group, October 2022 (7): Updates to Key Points and References. No change in intent of Policy Statement.

Medical Policy Panel, September 2023

Medical Policy Group, September 2023 (7): Updates to Key Points and References. Clarification to Policy Statement- Added “Rapidly progressive symptoms of motor loss, neurogenic claudication, or cauda equina syndrome” to Emergency Situations. No change in Policy Intent.

Medical Policy Group, October 2023 (7): Clarification to Policy Statement- added note that “smoking cessation applies to smoking of tobacco products (e.g., cigarettes, cigars, and/or pipe).” Also removed the note related to mental health screening and removed the contraindication regarding “psychiatric issues.”

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (I) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

 

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1.  The technology must have final approval from the appropriate government regulatory bodies;
2.  The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3.  The technology must improve the net health outcome;
4.  The technology must be as beneficial as any established alternatives;
5.  The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1.  In accordance with generally accepted standards of medical practice; and
2.  Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3.  Not primarily for the convenience of the patient, physician or other health care provider; and
4.  Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.