Cervical Fusion

Jurisdiction: JK MAC Part B. States: Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, Vermont. Type: Active LCD

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 Indications of Coverage A. Cervical fusion surgery is considered medically 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 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 AND All other potential sources of pain/neurological deficit have been excluded AND Imaging (MRI or CT) evidence of central, lateral recess or foraminal stenosis at the level corresponding with clinical myotome signs or symptoms and including at least one of the following: Cervical degenerative disc disease as indicated by the presence of one 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 activities of daily living (AOLs) and ≥7/10 on VAS or equivalent scale2 AND associated with confirmatory imaging (computed tomography, magnetic resonance imaging) and clinical-radiological correlation Loss of bladder or bowel function due to cervical spinal cord compression B. Cervical fusion surgery is considered reasonable and necessary for the decompression of symptomatic cervical canal stenosis when the following requirements are met: 1. Persistent or recurrent moderate or severe arm pain (4 or more on the visual analog scale or equivalent) present for a minimum of 12 weeks within the episode of arm pain with documented failure to respond to multimodal conservative management (as tolerated) in the absence of exceptional circumstances (below) OR 2. Nerve compression negatively impacts activities of daily living OR 3. Spastic gait, loss of manual dexterity, problems with sphincter control AND 4. All other potential sources of pain/neurological deficit have been excluded AND 5. Imaging (MRI or CT) evidence of central stenosis at the level corresponding with clinical signs or symptoms and including at least one of the following: Cervical degenerative disc disease as indicated by the presence of one 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 activities of daily living (AOLs) and ≥7/10 on Visual Analog Scale (VAS) or equivalent scale 2 AND associated with confirmatory imaging (computed tomography, magnetic resonance imaging) and clinical-radiological correlation. Loss of bladder or bowel function due to cervical spinal cord compression C. Cervical fusion surgery is considered reasonable and necessary for the decompression or stabilization of the cervical spine for the following indications: 1. Traumatic injuries including fractures, dislocations, facture-dislocations, or traumatic ligamentous disruption when 3 : Fractures or dislocations which are likely to result spinal instability without neurological defects OR Fractures or dislocations associated with neurological defects at the affected level OR Instability is present. 2. Spinal tumors involving the spine or spinal canal when: 3 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. 3.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. 4. Deformities that include the cervical spine including 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 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). OR Spinal instability after laminectomy OR Rheumatoid arthritis with associated instability OR Cervical degenerative spondylolisthesis with spinal instability (Anterolisthesis/Posterolisthesis) AND: Substantial functional limitation is present such as severe neck pain, or difficulty ambulating, or decreased ability to perform ADLs or to maintain forward gaze. OR Progression of deformity 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. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this policy only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging, ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities. 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 one or both upper extremities related to compression and irritation of one 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 or 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 one 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 Multidisciplinary Biopsychosocial Rehabilitation (MBR ) – Targets physical as well as psychological and social aspects of pain and involves a team of healthcare providers with different professional backgrounds and training. Myelopathy- An inclusive term describing a compression of the spinal cord resulting in neurological deficits e.g., spasticity (sustained muscle contractions), hyperreflexia, pathologic reflexes, paresthesia affecting the extremities, muscle weakness, digit/hand clumsiness, or gait disturbance. 11,12 Nonspecific low back pain – Back pain that cannot be attributed to a specific disease or spinal pathology . Session- A session is a time period, which includes all procedures (e.g., SIJIs and RFA ablations) that are performed during the same day. Sustained and Constant Pain Relief - The pain relief must continue for the defined time period and without interruption or regression to the primary (index) pain. 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) 12 months or more since fusion surgery or with radiographic evidence of hardware failure (fracture or displacement). 13 Unstable Spine- cervical spinal instability 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 one vertebra in relation to another or greater than 11 degrees of rotational difference between adjacent vertebrae. 1,14 Contractor Advisory Meeting A Multi-MAC Contractor Advisory Committee (CAC) Meeting was hosted by Noridian and included Noridian Healthcare Solutions, CGS Administrators, National Government Services, Palmetto GBA, WPS Government Health Administrators, First Coast Service Options and Novitas Solutions on August 16, 2023. The transcript and audio for this meeting is posted on each MACs website. Feedback from the subject matter experts is included through the evidence summary.