Proposed LCD - Cervical Fusion (DL39799)

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.LimitationsCervical Fusion for the decompression or stabilization of the cervical spineis not medically reasonable and necessary when all the above criteria are not fulfilled.Provider QualificationsThe 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 providers 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.DefinitionsAcute Painan unpleasant sensory and emotional experience associated with actual or potential tissue damage which is present for up to six weeks.7Baseline 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.8Chronic PainThe temporal definition of pain persisting at least 12 weeks after the onset of the acute pain.Conservative TherapyConsists 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 (PT), spinal manipulation therapy, cognitive behavioral therapy (CBT), home exercise program, acupuncture, or other interventions based on the individuals 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.9Functional 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 one or more of the following areas: physical and motor tasks; independent movement; performing basic life functions.9GRADE 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.Hangmans 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).10Multidisciplinary 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.11,12Nonspecific low back painBack 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., sacro-iliac joint injections and radiofrequency 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 surgeryorwith radiographic evidence of hardware failure (fracture or displacement).13Unstable 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.1,14General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Cervical Fusion (DA59674) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliography