LCD L39799: Cervical Fusion

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and General Information

Fusion of the cervical spine alone or in conjunction with other cervical spine procedures is performed for the management and treatment of various spinal conditions such as cervical radiculopathy, cervical myelopathy, and unstable spine. Cervical radiculopathy is pain that radiates from the neck through the arm. Cervical myelopathy describes compression of the spinal cord at the cervical level that results in neurologic deficits. Unstable spine has been defined as destruction of either the anterior or posterior elements of the spine making them nonfunctional, more than 3.5 mm of displacement of 1 vertebra in relation to another and/or greater than 11 degrees of rotational difference between adjacent vertebrae. 1 These three conditions may have multiple etiologies including herniated disc, spinal stenosis, spinal degeneration, synovial cyst, and symptomatic pseudoarthrosis from non-union of prior fusion. Physical assessment and imaging findings must correspond with the deficits attributable to the affected region of the cervical spine.

Covered Indications

A. Cervical fusion surgery is considered reasonable and necessary for the decompression of symptomatic cervical nerve root impingement when all of the following requirements are met:

• Persistent or recurrent moderate or severe arm pain (4 or more on the visual analog scale [VAS] or equivalent) present for a minimum of 12 weeks within the current episode of arm pain with documented failure to respond to multimodal conservative management (as tolerated) in the absence of exceptional circumstances (below) AND

• Nerve compression negatively impacts activities of daily living (ADLs) AND

• All other potential sources of pain/neurological deficit have been excluded AND

• Imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) evidence of central, lateral recess or foraminal stenosis at the level corresponding with clinical myotome signs or symptoms and including at least 1 of the following:

• Cervical degenerative disc disease as indicated by the presence of 1 or more of the following findings: herniated nucleus pulposus, narrowing of the intervertebral disc, disc osteophytes, facet hypertrophy, or synovial cysts.

• Tumors (primary or metastatic)

• Post infection radiographic findings

• Spinal instability as defined by subluxation or translation more than 3.5 mm on static lateral views or dynamic radiographs OR sagittal plane angulation of more than 11 degrees between adjacent segments. 1

Limitations

The following is considered not reasonable and necessary for the decompression of symptomatic cervical nerve root impingement:

• Isolated chronic axial cervical pain

Exceptions to conservative therapy requirement for decompression of symptomatic cervical nerve root impingement:

• Concomitant myelopathy or myeloradiculopathy

• Cervical myelopathy class III or above OR

• Progression of neurological deficits during the trial of conservative treatment.

• Isolated radiculopathy

• Presenting with progressive motor weakness OR

• Significant motor weakness interfering with ADLs OR

• Severe radicular pain defined as pain limiting ability to perform ADLs and ≥7/10 on VAS or equivalent scale 2 AND associated with confirmatory imaging (CT, MRI) and clinical-radiological correlation.

• Loss of bowel or bladder control

B. Cervical fusion surgery is considered reasonable and necessary for the decompression of symptomatic cervical canal stenosis when the following requirements are met:

• Persistent or recurrent moderate or severe arm pain (4 or more on the VAS or equivalent) present for a minimum of 12 weeks within the current episode of arm pain with documented failure to respond to multimodal conservative management (as tolerated) in the absence of exceptional circumstances (below) OR

• Nerve compression negatively impacts ADLs OR

• Spastic gait, loss of manual dexterity, problems with sphincter control AND

• All other potential sources of pain/neurological deficit have been excluded AND

• Imaging (MRI or CT) evidence of central stenosis at the level corresponding with clinical signs or symptoms and including at least 1 of the following:

• Cervical degenerative disc disease as indicated by the presence of 1 or more of the following findings: herniated nucleus pulposus, narrowing of the intervertebral disc, disc osteophytes, facet hypertrophy or synovial cysts.

• Congenital short pedicles

• Tumors (primary or metastatic)

• Post infection radiographic findings

• Ossification of the posterior longitudinal ligament.

• Spinal instability as defined by subluxation or translation more than 3.5 mm on static lateral views or dynamic radiographs OR sagittal plane angulation of more than 11 degrees between adjacent segments.

• Cord compression with or without increased cord signal.

Limitations

The following are considered not reasonable and necessary for decompression of symptomatic cervical canal stenosis:

• Isolated chronic axial cervical pain.

• Asymptomatic myelopathy (regardless of severity on imaging findings).

Exceptions to conservative therapy requirement for decompression of symptomatic cervical canal stenosis:

• Myelopathy

• Cervical myelopathy class III or above OR

• Progression of neurological deficits during the trial of conservative treatment.

• Radiculopathy

• Presenting with progressive motor weakness OR

• Significant motor weakness interfering with ADLs OR

• Severe radicular pain defined as pain limiting ability to perform ADLs and ≥7/10 on VAS or equivalent scale 2 AND associated with confirmatory imaging (CT, MRI) and clinical-radiological correlation.

• Loss of bowel or bladder control

C. Cervical fusion surgery is considered reasonable and necessary for the decompression or stabilization of the cervical spine for the following indications:

• Traumatic injuries including fractures, dislocations, facture-dislocations, or traumatic ligamentous disruption when 3 :

• Fractures or dislocations are likely to result in spinal instability without neurological defects OR

• Fractures or dislocations associated with neurological defects are present at the affected level OR

• Instability is present.

• Spinal tumors involving the spine or spinal canal when 3 :

• Presence of malignant or benign tumors which have caused instability or neurologic deficit where treatment of the tumor will likely require stabilization of the spine 4 OR

• Expected treatment of the tumor, whether by chemotherapy or radiation therapy or surgery will likely cause spinal instability or neurologic deficits 4 OR

• Instability is present.

• Infection involving the spine in the form of discitis, osteomyelitis, or epidural abscess when 3 :

• Imaging or other studies (MRI, biopsy, bone aspirate) demonstrating infection AND

• Imaging evidence of vertebral body destruction OR documentation that spinal debridement will cause vertebral instability 5,6 OR

• Instability is present.

• Deformities that include the cervical spine when 3 :

• Cervical kyphosis associated with cord compression or Atlantoaxial (C1-C2) subluxation or Basilar invagination of the odontoid process into the foramen magnum; or Subaxial (C2-T1) instability kyphosis, head drop syndrome, post-laminectomy deformity are present OR

• Symptomatic pseudarthrosis (non-union of prior fusion) with radiological (e.g., CT or MRI) demonstration of non-union of prior fusion (lack of bridging bone or abnormal motion at fused segment) after 12 months since fusion surgery or with radiographic evidence of hardware failure (fracture or displacement) is present OR

• Spinal instability is present after laminectomy OR

• Rheumatoid arthritis with associated instability is present OR

• Cervical degenerative spondylolisthesis with spinal instability (Anterolisthesis/Posterolisthesis) is present AND

• Substantial functional limitation is present such as severe neck pain or difficulty ambulating or decrease ability to perform ADLs or ability to maintain forward gaze OR

• Progression of deformity is present

Limitations

Cervical Fusion for the decompression or stabilization of the cervical spine is not reasonable and necessary when all the above criteria are not fulfilled.

Provider Qualifications

The Medicare Program Integrity Manual states services will be considered reasonable and necessary only if performed by appropriately trained providers.

Patient safety and quality of care mandate that healthcare professionals who perform cervical fusion are appropriately trained and credentialed by a formal residency/fellowship program. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.

All aspects of care must be within the provider’s medical licensure and scope of practice.

Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.

Definitions

Acute Pain – An unpleasant sensory and emotional experience associated with actual or potential tissue damage which is present for up to 6 weeks. 7

Baseline Pain - An initial measurement of the pain which is taken at a specified time point and used for comparison over time to look for changes in the pain levels.

Cervical Radiculopathy - Pain in a radicular pattern in 1 or both upper extremities related to compression and irritation of 1 or more cervical nerve roots. 8

Chronic Pain – The temporal definition of pain persisting at least 12 weeks after the onset of the acute pain.

Conservative Therapy – Consists of an appropriate combination of medication in therapeutic dosages (e.g., non-steroidal anti-inflammatory [NSAIDs], serotonin and norepinephrine reuptake inhibitors [SNRIs], analgesics, etc.) administered for a sufficient amount of time to determine efficacy, in combination with either physical therapy, spinal manipulation therapy, cognitive behavioral therapy (CBT), home exercise program, acupuncture, or other interventions based on the individual’s specific presentation, physical findings, and imaging results.

Consistent Improvement – The progressive, incremental, and clinically meaningful improvement of physical signs or symptoms.

Disability – Activity limitations or participation restrictions in an individual with a health condition, disorder or disease. 9

Functional Impairment - A physical, functional, or physiological impairment causing deviation from the normal function of a tissue or organ. This results in a significantly limited, impaired, or delayed capacity to move, coordinate actions, or perform physical activities and is exhibited by difficulties in 1 or more of the following areas: physical and motor tasks; independent movement; performing basic life functions. 9

GRADE – A system developed by the GRADE Working Group to address the shortcomings of present grading systems in healthcare. The GRADE system uses a common, sensible, and transparent approach to grading the quality of evidence. The results of applying the GRADE system to clinical trial data are displayed in a table known as a GRADE profile.

Hangman’s Fracture - A bilateral fracture traversing the pars interarticularis of cervical vertebrae 2 (C2) with an associated traumatic subluxation of C2 on cervical vertebrae 3 (C3). 10

Conservative Treatment

Treatment of cervical radiculopathy can range from conservative management to surgery. Conservative care is considered initial management for cervical radiculopathy from degenerative disorders as most cases will be self-limited and resolve spontaneously over a variable length of time without specific intervention. 8 Conservative management for cervical radiculopathy may include oral analgesics or short course of oral glucocorticoids, avoidance of provocative activities, short term immobilization with cervical collar or pillow, active physical therapy, manual therapy, and cervical traction. 15,16 In a published analysis of clinical practice guidelines for neck pain and radiculopathy the following interventions were listed as recommended components of conservative therapy 16 :

• Pharmacotherapies: analgesics, Paracetamol (Acetaminophen), NSAIDs, SNRIS, opioids (including tramadol), topical medications including NSAIDS.

• Non-Pharmacologic Interventions: exercise programs/physical therapy, thermotherapy, manual therapy (combined with other treatment), acupuncture, epidural steroid injection.