Proposed LCD - Cervical Fusion (DL39799)

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for cervical fusion. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for cervical fusion and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13,  13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title 42 of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code of Federal Regulations (CFR) References:CFR, Title 42, Ch. IV,  410.74 Physician assistants services, 410.75 Nurse practitioners services and  410.76 Clinical nurse specialists services.Coverage Indications, Limitations, and/or Medical NecessityCompliance 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 InformationFusion 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 one vertebra in relation to another and/or greater than 11 degrees of rotational difference between adjacent vertebrae.1These 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 IndicationsA. 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 [VAS] or equivalent) present for a minimum of 12 weeks within the current episode of neck pain with documented failure to respond to multimodal conservative management (as tolerated) in the absence of exceptional circumstances (below)ANDNerve compression negatively impacts activities of daily living (ADLs)ANDAll other potential sources of pain/neurological deficit have been excludedANDImaging (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 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 findingsSpinal 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.1LimitationsThe following is considered not medically reasonable and necessary for the decompression of symptomatic cervical nerve root impingement:Isolated chronic axial cervical painExceptions to conservative therapy requirement for decompression of symptomatic cervical nerve root impingement:MyelopathyCervical myelopathy class III or aboveORProgression of neurological deficits during the trial of conservative treatment.RadiculopathyPresenting with progressive motor weaknessORSignificant motor weakness interfering with ADLsORSevere radicular pain defined as pain limiting ability to perform ADLs and 7/10 on VAS or equivalent scale2AND associated with confirmatory imaging (CT, MRI) and clinical-radiological correlation.Cauda equina syndromeB. Cervical fusion surgery is considered medically 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)ORNerve compression negatively impacts ADLsORSpastic gait, loss of manual dexterity, problems with sphincter controlANDAll other potential sources of pain/neurological deficit have been excludedANDImaging (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 pediclesTumors (primary or metastatic)Post infection radiographic findingsOssification of the posterior longitudinal ligamentSpinal 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 segments1Cord compression with or without increased cord signalLimitationsThe following are considered not medically reasonable and necessary fordecompression of symptomatic cervical canal stenosis:Isolated chronic axial cervical painAsymptomatic myelopathy (regardless of severity on imaging findings)Exceptions to conservative therapy requirement for decompression of symptomatic cervical canal stenosis:MyelopathyCervical myelopathy class III or aboveORProgression of neurological deficits during the trial of conservative treatment.RadiculopathyPresenting with progressive motor weaknessORSignificant motor weakness interfering with ADLsORSevere radicular pain defined as pain limiting ability to perform ADLs and 7/10 on VAS or equivalent scale2AND associated with confirmatory imaging (CT, MRI) and clinical-radiological correlation.Cauda equina syndromeC. Cervical fusion surgery is considered medically 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 when3:Fractures or dislocations are likely to result in spinal instability without neurological defectsORFractures or dislocations are associated with neurological defects at the affected levelORInstability is present.Spinal tumors involving the spine or spinal canal when3:Malignant or benign tumors have caused instability or neurologic deficit where treatment of the tumor will likely require stabilization of the spine4ORExpected treatment of the tumor whether by chemotherapy, radiation therapy, or surgery will likely cause spinal instability or neurologic deficits4ORInstability is present.Infection involving the spine in the form of discitis, osteomyelitis, or epidural abscess when3:Imaging or other studies (MRI, biopsy, bone aspirate) demonstrate infectionANDImaging demonstrates evidence of vertebral body destruction OR documentation that spinal debridement will cause vertebral instability5,6ORInstability is present.Deformities that include the cervical spine including when3:Cervical kyphosis associated with cord compression or Atlantoaxial (C1-C2) subluxation or Basilar invagination of the odontoid process into the foramen magnum;orSubaxial (C2-T1) instability kyphosis, head drop syndrome, post-laminectomy deformityORSymptomatic 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)ORSpinal instability is present after laminectomyORRheumatoid arthritis is present with associated instabilityORCervical degenerative spondylolisthesis is present with spinal instability (Anterolisthesis/Posterolisthesis)ANDSubstantial functional limitation is present such as severe neck pain, difficulty ambulating and decreased ability to perform ADLs or ability to maintain forward gazeANDProgression of deformity is present.