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Medical Policy 1 7.01.145 Laminectomy Section 7.0 Surgery Effective Date February 27, 2015 Subsection Original Policy Date March 5, 2012 Next Review Date February 2016 Description Laminectomy is a surgical procedure in which a portion of the vertebra, the lamina, is removed to decompress the spinal cord. Removal of the lamina allows greater space for the spinal cord and the nerve roots, thus relieving compression on these structures. Laminectomy is typically performed when there is compression of the spinal cord due to spinal stenosis or a mass occupying lesion. Related Policies Image-Guided Minimally Invasive Lumbar Decompression for Spinal Stenosis Lumbar Spinal Fusion Policy Laminectomy (cervical, thoracic, lumbar) may be considered medically necessary for mass occupying lesions of the spinal cord and/or spinal canal including any of the following: Primary or metastatic tumors Abscesses, or other localized infections Trauma or other disease processes that have led to the need to surgically decompress the spinal canal Cervical laminectomy may be considered medically necessary when all of the following conditions are met: Spinal cord or nerve root compression due to one of the following conditions: o Spinal stenosis (with or without spondylolisthesis) o Ossification of the posterior longitudinal ligament or the yellow ligament; or hypertrophy of the ligamentum flavum Signs and/or symptoms that meet at least one of the following criteria: o Neurologic deficits that are rapidly progressive o Symptoms of cervical myelopathy (see Policy Guidelines) or cervical cord compression, (with or without radiculopathy) o Persistent debilitating pain that is refractory to at least 6 weeks of conservative nonsurgical therapy (see Policy Guidelines)

Transcript of Medical Policy - Blue Shield CA

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7.01.145 Laminectomy Section 7.0 Surgery

Effective Date February 27, 2015

Subsection

Original Policy Date March 5, 2012

Next Review Date February 2016

Description

Laminectomy is a surgical procedure in which a portion of the vertebra, the lamina, is removed to decompress the spinal cord. Removal of the lamina allows greater space for the spinal cord and the nerve roots, thus relieving compression on these structures. Laminectomy is typically performed when there is compression of the spinal cord due to spinal stenosis or a mass occupying lesion.

Related Policies

• Image-Guided Minimally Invasive Lumbar Decompression for Spinal Stenosis

• Lumbar Spinal Fusion

Policy

Laminectomy (cervical, thoracic, lumbar) may be considered medically necessary for mass occupying lesions of the spinal cord and/or spinal canal including any of the following:

• Primary or metastatic tumors

• Abscesses, or other localized infections

• Trauma or other disease processes that have led to the need to surgically decompress the spinal canal

Cervical laminectomy may be considered medically necessary when all of the following conditions are met:

• Spinal cord or nerve root compression due to one of the following conditions:

o Spinal stenosis (with or without spondylolisthesis)

o Ossification of the posterior longitudinal ligament or the yellow ligament; or hypertrophy of the ligamentum flavum

• Signs and/or symptoms that meet at least one of the following criteria:

o Neurologic deficits that are rapidly progressive

o Symptoms of cervical myelopathy (see Policy Guidelines) or cervical cord compression, (with or without radiculopathy)

o Persistent debilitating pain that is refractory to at least 6 weeks of conservative nonsurgical therapy (see Policy Guidelines)

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• Imaging studies (preferably MRI) with findings of spinal cord compression, nerve root compression, and/or myelographic changes, at a level corresponding to the patient’s signs and symptoms.

Lumbar laminectomy may be considered medically necessary when all of the following conditions are met:

• Spinal cord or nerve root compression due to spinal stenosis (with or without spondylolisthesis):

• Signs and/or symptoms that meet at least one of the following criteria:

o Neurologic deficits that are rapidly progressive

o Neurologic claudication that is persistent and refractory to at least 6 weeks of conservative nonsurgical therapy (see Policy Guidelines)

o Persistent debilitating pain that is refractory to at least 6 weeks of conservative nonsurgical management (see Policy Guidelines)

• Imaging studies (preferably MRI) with findings of spinal cord or nerve root compression, at a level corresponding to the patient’s signs and symptoms

Laminectomy, cervical or lumbar, is considered not medically necessary for spinal stenosis when the above criteria are not met.

Laminectomy is considered investigational for all other indications. Policy Guidelines

Cervical Myelopathy and/or Cord Compression

Signs and symptoms of cervical myelopathy and/or cord compression include the following(1):

• Difficulty with fine movements of the hand and upper extremity

• Incoordination of the hand and upper extremity

• Atrophy of the thenar and hypothenar eminence

• Diffuse hyperreflexia and bilateral Babinski responses

• Decreased sensation, vibratory sense, and proprioception at a level of C5 or below

• Inability to perform tandem walk

• Bowel and bladder incontinence

Radiculopathy

The diagnosis of radiculopathy is typically made by a combination of suggestive signs and symptoms in conjunction with imaging that demonstrates compression of a spinal nerve root. Symptoms are due to irritation of the spinal nerve root (e.g., L4, L5, or S1). For the purpose of this policy, radiculopathy is defined as the presence of any of the following:

1. Loss of strength of specific named muscle(s) or myotomal distribution(s) demonstrated on detailed neurologic examination (within the prior 3 months)

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concordant with nerve root compression of the involved named spinal nerve root(s).

2. Altered sensation to light touch, pressure, pin prick or temperature demonstrated on a detailed neurologic examination (within the prior 3 months) in the sensory distribution concordant with nerve root compression of the involved named spinal nerve root(s).

3. Diminished, absent or asymmetric reflex(es) within the prior 3 months concordant with nerve root compression of the involved named spinal nerve root(s).

4. Pain or other dysaesthesia/paraesthesia reported by the patient in a sensory distribution(s) (specific dermatone[s]) of the involved named spinal nerve root(s) with either of the following:

a. A concordant radiologist’s interpretation of an advanced diagnostic imaging study (MRI or CT) of the spine demonstrating compression of the involved named spinal nerve root(s). (Performed within the past 12 months)

b. Electrodiagnostic studies (EMG/NCV’s) diagnostic of nerve root compression of the involved named spinal nerve root(s). (Performed within the past 12 months)

Conservative Nonsurgical Therapy

Conservative nonsurgical therapy for the duration specified should include all of the following:

• Use of prescription strength analgesics for several weeks at a dose sufficient to induce a therapeutic response

o 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 physical therapy (including active exercise) or documentation of why the patient could not tolerate physical therapy

• Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues

• Documentation of patient compliance with the preceding criteria

Persistent Debilitating Pain

Persistent debilitating pain is defined as:

• Significant level of pain on a daily basis defined on a visual analog scale (VAS) 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 patient.

Laminectomy may occasionally be performed for the sole indication of radiculopathy due to herniated disc. In these cases, discectomy alone is not sufficient to relieve compression on vital structures, and laminectomy is required for adequate decompression. This is expected to be an uncommon situation for patients with

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radiculopathy due to herniated disc, and there are no standardized preoperative criteria to determine which patients may require laminectomy in addition to discectomy.

The following procedures can be considered as alternatives to laminectomy for decompression of the spinal cord. The specific indications for these alternative procedures are not standardized, and the evidence is not sufficient to determine the comparative effectiveness of these different procedures compared with laminectomy.

• Hemi-laminectomy

• Laminotomy

• Foraminotomy

Medical Necessity Documentation

Medical necessity is established by documentation of medical history, physical findings, and diagnostic imaging results that demonstrate spinal nerve compression and support the surgical treatment intervention. Documentation in the medical record must clearly support the medical necessity of the surgery and include the following information:

Medical History

• Patient has been screened/evaluated for clinically significant medical comorbidities (e.g., morbid obesity, current smoking, diabetes, renal disease, osteoporosis, and severe physical deconditioning) and undergone thorough medical clearance, if applicable

• Documentation from a primary care physician, neurologist, physiatrist, psychiatrist or psychologist, supports the absence of untreated, underlying psychological conditions or psychosocial issues (e.g., depression, drug and alcohol abuse) as contributors to chronic pain

• History of back surgery, including minimally invasive back procedures

• Prior trial, failure, or contraindication to conservative medical/non-operative interventions that may include but are not limited to the following:

o Activity modification for at least 6 weeks

o Oral analgesics and/or anti-inflammatory medications

o Physical therapy

o Chiropractic manipulation

o Epidural steroid injections

Physical Examination

• Clinical findings including the patient’s stated symptoms and duration

Diagnostic Testing

• Radiologist’s report of a magnetic resonance image (MRI) or computerized tomography (CT) scan with myelogram of the spine within the past 12 months showing a spine abnormality

• Report of the selective nerve root injection results, if applicable to the patient’s diagnostic workup.

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Benefit Application

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Some state or federal mandates (e.g., Federal Employee Program (FEP)) prohibit Plans from denying Food and Drug Administration (FDA) - approved technologies as investigational. In these instances, plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone.

Rationale

Background

Laminectomy is a surgical procedure in which a portion of a vertebra, the lamina, is removed to decompress the spine. Removal of the lamina allows greater space for the spinal cord and the nerve roots, thus relieving compression on these structures.

Laminectomy is generally indicated as a decompressive procedure, (i.e., to relieve pressure on the spinal cord and/or spinal nerve roots). The most common diagnosis for which laminectomy is performed is spinal stenosis. In spinal stenosis, the spinal canal (vertebral foramen) is narrowed, thus causing compression of the spinal cord. Narrowing of the spinal canal may be congenital in origin or may arise from degenerative changes in the spine. Other conditions that cause pressure on the spine and spinal nerve roots include conditions in which a mass lesion is present, such as a tumor, abscess, or other localized infection.

Laminectomy is an inpatient procedure performed under general anesthesia. An incision is made in the back over the affected region, and the back muscles are dissected to expose the spinal cord. The lamina is then removed from the vertebral body, along with any inflamed or thickened ligaments that may be contributing to compression. Following resection, the muscles are reapproximated and the soft tissues sutured back into place. The extent of laminectomy is variable, but most commonly extends 2 levels above and below the site of maximal cord compression.(1)

There are numerous variations on the basic laminectomy procedure. The procedure can be performed by minimally invasive techniques, although the extent of resection is less when minimally invasive techniques are used. Laminoplasty is a more limited procedure in which the lamina are cut but not removed, thus allowing expansion of the spinal cord. Foraminotomy and/or foramenectomy, which involve partial or complete removal of the facet joints, may be combined with laminectomy when the spinal nerve roots are compressed at the foramen. Spinal fusion is combined with laminectomy when instability of the spine is present preoperatively, or if the procedure is extensive enough to expect postoperative spinal instability.

Hemilaminotomy and laminotomy, sometimes termed laminoforaminotomy, are less invasive than laminectomy. These procedures focus on the interlaminar space, where most of the pathologic changes are concentrated, minimizing resection of the stabilizing posterior spine. A laminotomy typically removes the inferior aspect of the cranial lamina, superior aspect of the subjacent lamina, ligamentum flavum, and the medial aspect of

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the facet joint. In contrast to laminectomy, laminotomy does not disrupt the facet joints, supra- and interspinous ligaments, a major portion of the lamina, or the muscular attachments. Muscular dissection and retraction are required to achieve adequate surgical visualization.

Microendoscopic decompressive laminotomy (MEDL) is similar to laminotomy but uses endoscopic visualization. The position of the tubular working channel is confirmed by fluoroscopic guidance, and serial dilators (METRx™ lumbar endoscopic system, Medtronic) are used to dilate the musculature and expand the fascia. For MEDL, an endoscopic curette, rongeur, and drill are used for the laminotomy, facetectomy, and foraminotomy. The working channel may be repositioned from a single incision for multilevel and bilateral dissections.

Complications of laminectomy can include injuries to the spinal cord and nerve roots, which occur at rates from 0% to 10%.(1) Worsening myelopathy and/or radiculopathy can occur in a small percentage of patients independent of surgical injuries. Worsening of symptoms is usually temporary, but in some cases has been permanent. Infection and bleeding can occur, hematomas following surgery often require reoperation if they are close to critical structures. Leakage of spinal fluid may occur and occasionally be persistent requiring treatment. Instability of the spine can result from extensive laminectomy involving multiple levels. This is usually an indication for spinal fusion as an adjunct to laminectomy, but if fusion is not performed, the instability may lead to progressive symptoms and a need for reoperation. The specific rates of these complications depend on the indication and location being treated, the specific surgical approach, and the extent of surgery.

Regulatory Status

Laminectomy is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Some of the instrumentation used during laminectomy may be subject to FDA approval.

Literature Review

Assessment of efficacy for therapeutic intervention involves a determination of whether the intervention improves health outcomes. The optimal study design for this purpose is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as noncomparability of treatment groups, placebo effect, and variable natural history of the condition.

Laminectomy is a surgical procedure that has been accepted as standard of care for patients requiring surgical decompression of the spine. As such, this procedure will be assumed to be medically necessary for at least some indications, and the review of evidence will focus on determining appropriate indications for use of laminectomy. Key trials for specific conditions will be reviewed, as well as existing clinical practice guidelines.

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Spinal Stenosis

Lumbar Spinal Stenosis

Two RCTs of laminectomy versus nonsurgical management for patients with spinal stenosis were identified. In the larger trial, Weinstein et al reported findings from the multicenter controlled trial (Spine Patient Outcomes Research Trial [SPORT]) that compared surgical and nonsurgical treatment for lumbar degenerative spondylolisthesis.(2,3) All patients had neurogenic claudication or radicular leg pain associated with neurologic signs, spinal stenosis shown on cross-sectional imaging, and degenerative spondylolisthesis shown on lateral radiographs with symptoms persisting for at least 12 weeks. There were 304 patients in a randomized cohort and 303 patients in an observational cohort. About 40% of the randomized cohort crossed over in each direction by 2 years of follow-up. At the 4-year follow-up timepoint, 54% of patients randomized to nonoperative care had undergone surgery. Five percent of the surgically-treated patients received decompression only and 95% underwent decompression with fusion.

Analysis of results by intent-to-treat analysis did not show any differences in outcomes between the surgical and nonsurgical groups. However, this analysis was limited by the high rate of crossover, with the rate of surgery in the patients assigned to nonsurgical management only slightly lower than the rate of surgery in patients assigned to surgical management (54% vs 66%). Therefore, analysis by treatment received was also performed. This analysis, controlled for baseline factors, showed a significant advantage for surgery at up to 4 years of follow-up for all primary and secondary outcome measures. The differences on the primary outcomes were: 17 points on the 36-Item Short-Form Health Survey (SF-36) bodily pain score (0-100 scale; 95% confidence interval [CI]: 13 to 20.9); 16.1 points on the SF-36 physical function score (0-100 scale; 95% CI: 12.3 to 19.8); and -12.6 points on the Oswestry Disability Index (ODI; 0-100 scale; 95% CI: -15.5 to -9.7). All of these group differences are substantially larger than the minimally important clinical change for these measures.

In a small RCT from Finland, 94 patients from 4 university hospitals were randomized to laminectomy with or without fusion versus conservative therapy and followed for 2 years.(4) All patients had lumbar spinal stenosis, persistent back pain for at least 6 months, and imaging studies demonstrating spinal stenosis at a level corresponding with the patient’s symptoms. Crossover was allowed for progressive symptoms, and 4 of 44 patients assigned to nonoperative treatment underwent surgery over the 2 years of follow-up. The primary outcomes were the ODI (0-100 scale) and visual analog scales (VAS) of leg pain and back pain (0-10 scale). At 2 years follow-up, the surgical group showed greater improvement on all 3 of these primary outcome measures. The mean difference in the ODI was 7.8 points (95% CI: 0.8 to 14.9); the mean difference in leg pain was 1.51 points (95% CI: 0.25 to 2.77); and the mean difference in back pain was 2.13 points (95% CI: 0.98 to 3.28). There were 8 perioperative complications, 7 of 8 of these were injuries to the dural sac. An additional 4 complications occurred postoperatively, 1 hematoma requiring reoperation, 1 respiratory distress due to pulmonary edema, and 2 additional reoperations.

A number of nonrandomized comparative studies have been published, and some representative studies are reviewed here. The Maine Lumbar Spine Study was a prospective comparative cohort study of patients with lumbar spinal stenosis followed over a period of 10 years.(5) Clinical data at baseline was obtained from a physician questionnaire, and follow-up surveys to patients were performed by mail at regular intervals. The surveys evaluated the main outcomes of back pain, leg pain, functional

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status, and satisfaction with treatment. A total of 148 patients were initially enrolled, 105 patients (67.7%) were alive at 10 years, and 97 (65.5%) had long-term follow-up data. At baseline, patients who underwent surgery were more severely ill, as evidenced by worse symptoms and functional status compared with patients who underwent nonsurgical care. At follow-up between 1 and 4 years, there was greater improvement in the surgical groups, but at longest follow-up of 8 to 10 years, the groups had similar results on improvement in pain, functional status and satisfaction with care.

Amundsen et al reported a nonrandomized comparison of long-term outcomes of 100 patients with symptomatic lumbar spinal stenosis.(6) Patients were allocated to surgery if severe symptoms were present. An additional 31 patients with intermediate symptoms were randomized to surgery or conservative care. A total of 31 patients were treated with surgery and 68 were treated conservatively. After a period of 4 years, the authors reported a satisfactory result in 80% of patients treated with surgery compared with 50% of patients treated conservatively (p value not reported).

Cervical Spinal Stenosis

There is a lack of controlled trials on laminectomy versus conservative management for patients with symptomatic cervical spinal stenosis. One small RCT was identified comparing decompressive surgery versus nonsurgical treatment for patients with mild or moderate cervical myelopathy.(7) The surgical techniques used in this trial were either anterior decompression with fusion, corpectomy or laminoplasty, and laminectomy was not used. Other published RCTs compare variations of surgical technique and therefore do not address the efficacy of surgery itself.(8-11)

One small, prospective, nonrandomized, multicenter study evaluated surgical versus nonsurgical treatment in 62 patients with cervical myelopathy.(12) Follow-up data was obtained on 43/62 patients (69%), 20 of whom underwent surgery and 23 of whom underwent nonsurgical treatment. Details on the specific types of surgery were lacking, but the authors stated that the primary procedure was posterior laminotomy/laminectomy with or without foraminotomy. Patients in the surgical group had significant improvements in the overall functional status measure, the worst pain rating, and the average pain rating, while patients in the nonsurgical group had significant improvements on only the average pain rating. There were no between-group comparisons reported. Complications were not reported.

The AOSpine North America Prospective Multi-Center Study was a prospective, single-arm cohort study that evaluated outcomes of surgical decompression for cervical myelopathy.(13) A total of 278 consecutive patients presenting to 12 North American centers were enrolled, with symptomatic cervical myelopathy, objective cord compression on magnetic resonance imaging (MRI), and no evidence of lumbar spinal stenosis. The specific approach to surgery was left to the discretion of the treating surgeon. Details on surgical approach were not reported, but it appeared that approximately one third of enrolled patients received laminectomy. At 1-year follow-up, there was significant improvement on multiple measures of symptoms and functional status, including improvement on 7/8 subscales of the SF-36. Complications occurred in 18.7% of patients. The most common complications were postoperative dysphagia (3.6%), superficial infection (2.9%), and need for revision surgery (2.2%). Worsening myelopathic symptoms postoperatively developed in 3 patients, 2 of whom returned to baseline by 1 year.

A separate publication from the AOSpine study was reported on short- and long-term complications of surgery.(14) Perioperative complications occurred in 15.6% of patients.

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The most common perioperative complications were minor cardiopulmonary events (3.0%), dysphagia (3.0%), and superficial wound infection in 2.3%. Worsening of preoperative myelopathy occurred in 1.3% of patients. Of patients who completed 2 years of follow-up, late complications occurred in 4.4%. Of the late complications, approximately 40% were considered major and the remaining were considered minor.

Section Summary

There is some evidence from RCTs on the efficacy of laminectomy versus nonsurgical treatment for lumbar spinal stenosis, but the RCTs have methodologic limitations. One RCT was small, with follow-up limited to 2 years, and the second RCT had a very high rate of crossover that may have subverted the randomization process. Both of the RCTs reported that improvements in pain and functional status were greater with surgery compared with nonsurgical treatment over the 2 to 4 year time frame. Results of nonrandomized comparative studies corroborate the findings of the RCTs, reporting greater improvement with surgical treatment. The benefit of surgery may diminish over time, with one long-term cohort study reporting that the initial benefit of surgery was no longer present at the 8 to 10-year time frame.

For cervical spinal stenosis, the evidence is more limited with no published RCTs. Some nonrandomized comparative evidence is available on treatment of cervical spondylotic myelopathy with decompressive surgery versus nonsurgical management, but this is limited by the inclusion of other etiologies in addition to spinal stenosis, and the use of a variety of different techniques for decompression, without reporting on laminectomy separately. Single-arm studies report significant improvements postsurgery in pain and functional status, but do not provide relevant evidence on the comparative efficacy of surgery versus nonsurgical management.

Other Etiologies

For indications other than spinal stenosis, the evidence consists primarily of case reports and retrospective case series. Representative examples of the types of studies available for specific indications are provided next.

Ossification of the Posterior Longitudinal Ligament

Lee et al published a retrospective study of 57 patients who underwent surgery for cervical myelopathy caused ossification of the posterior longitudinal ligament and had at least 24 months of follow-up.(15) Three variations of surgery were used: laminectomy alone, laminectomy plus fusion, and laminoplasty. Outcomes reported included radiographic evidence of cervical sagittal balance, neck disability index, and VAS pain scales. Progressive improvements were reported in the radiographic and clinical outcomes over time in all groups. Progression of posterior longitudinal ligament ossification was seen more commonly in the group treated with laminectomy alone compared with laminectomy plus fusion.

Neoplasms of the Spine

Zong et al published a retrospective study of 110 patients with extramedullary Schwannomas treated surgically.(16) Three variations of laminectomy were used: laminectomy plus microscopic excision, hemilaminectomy plus microscopic excision, or laminectomy plus microscopic excision plus pedicle screw fixation. The authors compared various operative parameters between the types of procedures, such as blood loss, operative time, and length of stay. No clinical outcomes were reported.

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Tredway et al reported on 6 patients with intradural spinal neoplasms treated with laminectomy and dural resection by minimally invasive techniques.(17) There were 4 lumbar, 1 thoracic, and 1 cervical lesion. The authors reported that all patients underwent successful resection without complications. On follow-up MRI imaging, complete resection was seen in all cases with no evidence of residual tumor.

Epidural Abscess

Piccolo et al reported a series of 5 patients with cervical epidural abscess treated surgically.(18) Two patients were treated with surgical drainage plus laminectomy, and the other 3 were treated with surgical drainage alone. Laminectomy was chosen for more extensive involvement of the cervical spine, and surgical drainage alone for more localized infections. Surgical outcome was poor in 1 patient treated with laminectomy, who had extensive disease spanning more than 3 vertebral segments.

Clinical Input Received Through Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests from Blue Cross Blue Shield Association, input was received from 4 academic medical centers and 2 specialty societies. Based on input from reviewers, criteria for medical necessity were changed for the indications of mass lesions and cervical laminectomy.

Summary of Evidence

The best evidence on the efficacy of laminectomy for decompression of the spine exists for lumbar spinal stenosis. For this indication, 2 randomized controlled trials (RCTs) report that laminectomy is superior to nonsurgical management in improving pain and functional status. While the RCTs have some methodologic limitations, they both report significant benefits for surgery on their main outcomes. Most nonrandomized comparative studies also report greater benefit for surgery compared with conservative management. For cervical spinal stenosis, there is a lack of comparative evidence, although the small amount of available evidence reports outcomes that are similar to those reported for lumbar spinal stenosis. For other indications such as ossification of the spinal ligaments, spinal tumors, and localized infections, the evidence consists of case reports and small case series.

Among the published studies and clinical practice guidelines, there is consistency in the general indications for surgery. These include patients with progressive or persistent neurologic deficits despite conservative therapy. However, beyond these general guidelines, there is little standardization of recommendations for specific procedures in specific patient groups. There is a lack of standardized severity measures to judge the threshold for surgical intervention, and a lack of good risk prediction instruments to assess the risks of laminectomy.

Based on the available evidence, current standard of care, and clinical practice guidelines, laminectomy may be considered medically necessary for patients with spinal stenosis who have persistent or progressive symptoms despite conservative care. For patients with mass lesions of the spine due to tumors, infections or ossification of the spinal ligaments, there is a lack of comparative evidence on the benefit of laminectomy.

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However, based on the current standard of care, clinical practice guidelines, and lack of alternative treatments, laminectomy may be considered medically necessary for patients with mass lesions of the spinal cord.

Practice Guidelines and Position Statements

The North American Spine Society issued 2011 evidence-based clinical guidelines on the diagnosis and treatment of degenerative lumbar spinal stenosis.(19) The guidelines state that patients with mild symptoms of lumbar spinal stenosis are not considered surgical candidates, however, decompressive surgery is suggested to improve outcomes in patients with moderate to severe symptoms of lumbar spinal stenosis. (Grade B recommendation). At this time, there is insufficient evidence to recommend for or against the placement of interspinous process spacing devices as a treatment for spinal stenosis.

U.S. Preventive Services Task Force Recommendations

Laminectomy is not a preventive service.

Medicare National Coverage

There is no national coverage determination (NCD) for laminectomy. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References

1. Epstein NE. Laminectomy for cervical myelopathy. Spinal Cord. Jun 2003;41(6):317-327. PMID 12746738

2. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. May 31 2007;356(22):2257-2270. PMID 17538085

3. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. Jun 2009;91(6):1295-1304. PMID 19487505

4. Malmivaara A, Slatis P, Heliovaara M, et al. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phila Pa 1976). Jan 1 2007;32(1):1-8. PMID 17202885

5. Atlas SJ, Keller RB, Wu YA, et al. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). Apr 15 2005;30(8):936-943. PMID 15834339

6. Amundsen T, Weber H, Nordal HJ, et al. Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Spine (Phila Pa 1976). Jun 1 2000;25(11):1424-1435; discussion 1435-1426. PMID 10828926

7. Kadanka Z, Mares M, Bednanik J, et al. Approaches to spondylotic cervical myelopathy: conservative versus surgical results in a 3-year follow-up study. Spine (Phila Pa 1976). Oct 15 2002;27(20):2205-2210; discussion 2210-2201. PMID 12394893

8. Ghogawala Z, Benzel EC, Heary RF, et al. Cervical Spondylotic Myelopathy Surgical (CSM-S) Trial: Randomized Controlled Trial Design and Rationale. Neurosurgery. Jul 3 2014. PMID 24991714

9. Wang L, Song Y, Liu L, et al. Clinical outcomes of two different types of open-door laminoplasties for cervical compressive myelopathy: a prospective study. Neurol India. Mar-Apr 2012;60(2):210-216. PMID 22626706

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10. Manzano GR, Casella G, Wang MY, et al. A prospective, randomized trial comparing expansile cervical laminoplasty and cervical laminectomy and fusion for multilevel cervical myelopathy. Neurosurgery. Feb 2012;70(2):264-277. PMID 22251974

11. Okada M, Minamide A, Endo T, et al. A prospective randomized study of clinical outcomes in patients with cervical compressive myelopathy treated with open-door or French-door laminoplasty. Spine (Phila Pa 1976). May 15 2009;34(11):1119-1126. PMID 19444058

12. Sampath P, Bendebba M, Davis JD, et al. Outcome of patients treated for cervical myelopathy. A prospective, multicenter study with independent clinical review. Spine (Phila Pa 1976). Mar 15 2000;25(6):670-676. PMID 10752097

13. Fehlings MG, Wilson JR, Kopjar B, et al. Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study. J Bone Joint Surg Am. Sep 18 2013;95(18):1651-1658. PMID 24048552

14. Fehlings MG, Smith JS, Kopjar B, et al. Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study. J Neurosurg Spine. May 2012;16(5):425-432. PMID 22324802

15. Lee CH, Jahng TA, Hyun SJ, et al. Expansive Laminoplasty Versus Laminectomy Alone Versus Laminectomy and Fusion for Cervical Ossification of the Posterior Longitudinal Ligament: Is There a Difference in the Clinical Outcome and Sagittal Alignment? J Spinal Disord Tech. Jul 29 2014. PMID 25075990

16. Zong S, Zeng G, Xiong C, et al. Treatment results in the differential surgery of intradural extramedullary schwannoma of 110 cases. PLoS One. 2013;8(5):e63867. PMID 23724010

17. Tredway TL, Santiago P, Hrubes MR, et al. Minimally invasive resection of intradural-extramedullary spinal neoplasms. Neurosurgery. Feb 2006;58(1 Suppl):ONS52-58; discussion ONS52-58. PMID 16479629

18. Piccolo R, Passanisi M, Chiaramonte I, et al. Cervical spinal epidural abscesses. A report on five cases. J Neurosurg Sci. Mar 1999;43(1):63-67. PMID 10494668

19. North American Spine Society. Clinical guideline: Diagnosis and treatment of spinal stenosis. 2011; https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf. Accessed July, 2014.

20. Blue Cross Blue Shield Association. Medical Policy Reference Manual, No. 7.01.145 (January 2015).

Documentation Required for Clinical Review

• History and physical and/or consultation notes including:

o Activity and functional limitations

o Comorbidities

o Pertinent past procedural and surgical history

o Prior conservative treatments, duration, and response

o Prior diagnostic testing and results

o Psychological and psychosocial assessment

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o Clinical findings and duration of pain

• If significant comorbidities, consultation and medical clearance report(s) (if indicated)

• Other pertinent multidisciplinary notes/reports: (e.g., psychological or psychiatric evaluation, physical therapy, multidisciplinary pain management) when applicable

• Radiology report(s) and interpretation (i.e., MRI, CT, discogram)

Post Service

• Operative report(s)

Coding

This Policy relates only to the services or supplies described herein. Benefits may vary according to benefit design; therefore, contract language should be reviewed before applying the terms of the Policy. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement.

MN/IE

The following service/procedure may be considered medically necessary in certain instances and investigational in others. Services may be medically necessary when policy criteria are met. Services are considered investigational when the policy criteria are not met or when the code describes application of a product in the position statement that is investigational.

Type Code Description

CPT®

22100 Partial excision of posterior vertebral component (e.g., spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; cervical

22101 Partial excision of posterior vertebral component (e.g., spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; thoracic

22102 Partial excision of posterior vertebral component (e.g., spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; lumbar

22103

Partial excision of posterior vertebral component (e.g., spinous process, lamina or facet) for intrinsic bony lesion, single vertebral segment; each additional segment (List separately in addition to code for primary procedure)

22110 Partial excision of vertebral body, for intrinsic bony lesion, without decompression of spinal cord or nerve root(s), single vertebral segment; cervical

22112 Partial excision of vertebral body, for intrinsic bony lesion, without decompression of spinal cord or nerve root(s), single vertebral segment; thoracic

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22114 Partial excision of vertebral body, for intrinsic bony lesion, without decompression of spinal cord or nerve root(s), single vertebral segment; lumbar

22116

Partial excision of vertebral body, for intrinsic bony lesion, without decompression of spinal cord or nerve root(s), single vertebral segment; each additional vertebral segment (List separately in addition to code for primary procedure)

22206 Osteotomy of spine, posterior or posterolateral approach, 3 columns, 1 vertebral segment (e.g., pedicle/vertebral body subtraction); thoracic

22207 Osteotomy of spine, posterior or posterolateral approach, 3 columns, 1 vertebral segment (e.g., pedicle/vertebral body subtraction); lumbar

22208

Osteotomy of spine, posterior or posterolateral approach, 3 columns, 1 vertebral segment (e.g., pedicle/vertebral body subtraction); each additional vertebral segment (List separately in addition to code for primary procedure)

22210 Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; cervical

22212 Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; thoracic

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)

22220 Osteotomy of spine, including discectomy, anterior approach, single vertebral segment; cervical

22222 Osteotomy of spine, including discectomy, anterior approach, single vertebral segment; thoracic

22224 Osteotomy of spine, including discectomy, anterior approach, single vertebral segment; lumbar

22226

Osteotomy of spine, including discectomy, anterior approach, single vertebral segment; each additional vertebral segment (List separately in addition to code for primary procedure)

63001

Laminectomy with exploration and/or decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), 1 or 2 vertebral segments; cervical

63003

Laminectomy with exploration and/or decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), 1 or 2 vertebral segments; thoracic

63005 Laminectomy with exploration and/or

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decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), 1 or 2 vertebral segments; lumbar, except for spondylolisthesis

63011

Laminectomy with exploration and/or decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), 1 or 2 vertebral segments; sacral

63012

Laminectomy with removal of abnormal facets and/or pars inter-articularis with decompression of cauda equina and nerve roots for spondylolisthesis, lumbar (Gill type procedure)

63015

Laminectomy with exploration and/or decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), more than 2 vertebral segments; cervical

63016

Laminectomy with exploration and/or decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), more than 2 vertebral segments; thoracic

63017

Laminectomy with exploration and/or decompression of spinal cord and/or cauda equina, without facetectomy, foraminotomy or discectomy (e.g., spinal stenosis), more than 2 vertebral segments; lumbar

63045

Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral recess stenosis]), single vertebral segment; cervical

63046

Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral recess stenosis]), single vertebral segment; thoracic

63047

Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral recess stenosis]), single vertebral segment; lumbar

63048

Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral recess stenosis]), single vertebral segment; each additional segment, cervical, thoracic, or lumbar (List separately in addition to code for primary procedure)

63050 Laminoplasty, cervical, with decompression of the

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spinal cord, 2 or more vertebral segments;

63051

Laminoplasty, cervical, with decompression of the spinal cord, 2 or more vertebral segments; with reconstruction of the posterior bony elements (including the application of bridging bone graft and non-segmental fixation devices [e.g., wire, suture, mini-plates], when performed)

63081

Vertebral corpectomy (vertebral body resection), partial or complete, anterior approach with decompression of spinal cord and/or nerve root(s); cervical, single segment

63082

Vertebral corpectomy (vertebral body resection), partial or complete, anterior approach with decompression of spinal cord and/or nerve root(s); cervical, each additional segment (List separately in addition to code for primary procedure)

63085

Vertebral corpectomy (vertebral body resection), partial or complete, transthoracic approach with decompression of spinal cord and/or nerve root(s); thoracic, single segment

63086

Vertebral corpectomy (vertebral body resection), partial or complete, transthoracic approach with decompression of spinal cord and/or nerve root(s); thoracic, each additional segment (List separately in addition to code for primary procedure)

63087

Vertebral corpectomy (vertebral body resection), partial or complete, combined thoracolumbar approach with decompression of spinal cord, cauda equina or nerve root(s), lower thoracic or lumbar; single segment

63088

Vertebral corpectomy (vertebral body resection), partial or complete, combined thoracolumbar approach with decompression of spinal cord, cauda equina or nerve root(s), lower thoracic or lumbar; each additional segment (List separately in addition to code for primary procedure)

63090

Vertebral corpectomy (vertebral body resection), partial or complete, transperitoneal or retroperitoneal approach with decompression of spinal cord, cauda equina or nerve root(s), lower thoracic, lumbar, or sacral; single segment

63091

Vertebral corpectomy (vertebral body resection), partial or complete, transperitoneal or retroperitoneal approach with decompression of spinal cord, cauda equina or nerve root(s), lower thoracic, lumbar, or sacral; each additional segment (List separately in addition to code for primary procedure)

63101 Vertebral corpectomy (vertebral body resection), partial or complete, lateral extracavitary approach with decompression of spinal cord and/or nerve

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root(s) (e.g., for tumor or retropulsed bone fragments); thoracic, single segment

63102

Vertebral corpectomy (vertebral body resection), partial or complete, lateral extracavitary approach with decompression of spinal cord and/or nerve root(s) (e.g., for tumor or retropulsed bone fragments); lumbar, single segment

63103

Vertebral corpectomy (vertebral body resection), partial or complete, lateral extracavitary approach with decompression of spinal cord and/or nerve root(s) (e.g., for tumor or retropulsed bone fragments); thoracic or lumbar, each additional segment (List separately in addition to code for primary procedure)

63170 Laminectomy with myelotomy (e.g., Bischof or DREZ type), cervical, thoracic, or thoracolumbar

63172 Laminectomy with drainage of intramedullary cyst/syrinx; to subarachnoid space

63173 Laminectomy with drainage of intramedullary cyst/syrinx; to peritoneal or pleural space

63180 Laminectomy and section of dentate ligaments, with or without dural graft, cervical; 1 or 2 segments

63182 Laminectomy and section of dentate ligaments, with or without dural graft, cervical; more than 2 segments

63185 Laminectomy with rhizotomy; 1 or 2 segments 63190 Laminectomy with rhizotomy; more than 2 segments 63191 Laminectomy with section of spinal accessory nerve

63194 Laminectomy with cordotomy, with section of 1 spinothalamic tract, 1 stage; cervical

63195 Laminectomy with cordotomy, with section of 1 spinothalamic tract, 1 stage; thoracic

63196 Laminectomy with cordotomy, with section of both spinothalamic tracts, 1 stage; cervical

63197 Laminectomy with cordotomy, with section of both spinothalamic tracts, 1 stage; thoracic

63198 Laminectomy with cordotomy with section of both spinothalamic tracts, 2 stages within 14 days; cervical

63199 Laminectomy with cordotomy with section of both spinothalamic tracts, 2 stages within 14 days; thoracic

63200 Laminectomy, with release of tethered spinal cord, lumbar

63250 Laminectomy for excision or occlusion of arteriovenous malformation of spinal cord; cervical

63251 Laminectomy for excision or occlusion of arteriovenous malformation of spinal cord; thoracic

63252 Laminectomy for excision or occlusion of arteriovenous malformation of spinal cord; thoracolumbar

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63265 Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; cervical

63266 Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; thoracic

63267 Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; lumbar

63268 Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; sacral

63270 Laminectomy for excision of intraspinal lesion other than neoplasm, intradural; cervical

63271 Laminectomy for excision of intraspinal lesion other than neoplasm, intradural; thoracic

63272 Laminectomy for excision of intraspinal lesion other than neoplasm, intradural; lumbar

63273 Laminectomy for excision of intraspinal lesion other than neoplasm, intradural; sacral

63275 Laminectomy for biopsy/excision of intraspinal neoplasm; extradural, cervical

63276 Laminectomy for biopsy/excision of intraspinal neoplasm; extradural, thoracic

63277 Laminectomy for biopsy/excision of intraspinal neoplasm; extradural, lumbar

63278 Laminectomy for biopsy/excision of intraspinal neoplasm; extradural, sacral

63280 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, extramedullary, cervical

63281 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, extramedullary, thoracic

63282 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, extramedullary, lumbar

63283 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, sacral

63285 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, intramedullary, cervical

63286 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, intramedullary, thoracic

63287 Laminectomy for biopsy/excision of intraspinal neoplasm; intradural, intramedullary, thoracolumbar

63290 Laminectomy for biopsy/excision of intraspinal neoplasm; combined extradural-intradural lesion, any level

63295

Osteoplastic reconstruction of dorsal spinal elements, following primary intraspinal procedure (List separately in addition to code for primary procedure)

63300 Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; extradural, cervical

63301 Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion,

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single segment; extradural, thoracic by transthoracic approach

63302

Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; extradural, thoracic by thoracolumbar approach

63303

Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; extradural, lumbar or sacral by transperitoneal or retroperitoneal approach

63304 Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; intradural, cervical

63305

Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; intradural, thoracic by transthoracic approach

63306

Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; intradural, thoracic by thoracolumbar approach

63307

Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; intradural, lumbar or sacral by transperitoneal or retroperitoneal approach

63308

Vertebral corpectomy (vertebral body resection), partial or complete, for excision of intraspinal lesion, single segment; each additional segment (List separately in addition to codes for single segment)

HCPC None

ICD-9 Procedure

03.09 Other exploration and decompression of spinal canal

03.4 Excision or destruction of lesion of spinal cord or spinal meninges

ICD-10 Procedure

For dates of service on or after 10/01/2015 00BW0ZZ Excision of Cervical Spinal Cord, Open Approach 00BY0ZZ Excision of Lumbar Spinal Cord, Open Approach 00NW0ZZ Release Cervical Spinal Cord, Open Approach 00NY0ZZ Release Lumbar Spinal Cord, Open Approach

ICD-9 Diagnosis All Diagnoses

ICD-10 Diagnosis

For dates of service on or after 10/01/2015 All Diagnoses

Policy History

This section provides a chronological history of the activities, updates and changes that have occurred with this Medical Policy.

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Effective Date

Action Reason

3/5/2012 New Policy Adoption Triad Healthcare Inc., Musculoskeletal Health Services Medical Policy

Medical Policy Committee

5/8/2012 Administrative Update Administrative Review 5/18/2012 Administrative Update Administrative Review 7/14/2014 Policy revision with position change Medical Policy Committee 2/27/2015 Policy title change from

Laminectomy/Discectomy/Decompression

Policy revision with position change

Medical Policy Committee

Definitions of Decision Determinations

Medically Necessary: A treatment, procedure or drug is medically necessary only when it has been established as safe and effective for the particular symptoms or diagnosis, is not investigational or experimental, is not being provided primarily for the convenience of the patient or the provider, and is provided at the most appropriate level to treat the condition.

Investigational/Experimental: A treatment, procedure or drug is investigational when it has not been recognized as safe and effective for use in treating the particular condition in accordance with generally accepted professional medical standards. This includes services where approval by the federal or state governmental is required prior to use, but has not yet been granted.

Split Evaluation: Blue Shield of California / Blue Shield of California Life & Health Insurance Company (Blue Shield) policy review can result in a Split Evaluation, where a treatment, procedure or drug will be considered to be investigational for certain indications or conditions, but will be deemed safe and effective for other indications or conditions, and therefore potentially medically necessary in those instances. Prior Authorization Requirements

This service (or procedure) is considered medically necessary in certain instances and investigational in others (refer to policy for details).

For instances when the indication is medically necessary, clinical evidence is required to determine medical necessity.

For instances when the indication is investigational, you may submit additional information to the Prior Authorization Department.

Within five days before the actual date of service, the Provider MUST confirm with Blue Shield that the member's health plan coverage is still in effect. Blue Shield reserves the right to revoke an authorization prior to services being rendered based on cancellation of the member's eligibility. Final determination of benefits will be made after review of the claim for limitations or exclusions.

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Questions regarding the applicability of this policy should also be directed to the Prior Authorization Department. Please call 1-800-541-6652 or visit the Provider Portal www.blueshieldca.com/provider.

The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illness or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. These Policies are subject to change as new information becomes available.