Proposed LCD - Cervical Fusion (DL39741)

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 procedures for pain management. 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, de?nitions and 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 EPIDURAL procedures for pain management 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 shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII 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 InformationCovered 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 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 livingANDAll other potential sources of pain/neurological deficit have been excludedANDImaging (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 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 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 ADLsSevere 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 correlationCauda equina syndromeB. 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)OR2. Nerve compression negatively impacts activities of daily livingOR3. Spastic gait, loss of manual dexterity, problems with sphincter controlAND4. All other potential sources of pain/neurological deficit have been excludedAND5. 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 pediclesTumors (primary or metastatic)Post infection radiographic findingsOssification 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.LimitationsThe following are considered not reasonable and necessary fordecompression 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: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 activities of daily living (AOLs) and 7/10 on Visual Analog Scale (VAS) or equivalent scale2AND associated with confirmatory imaging (computed tomography, magnetic resonance imaging) and clinical-radiological correlation.Cauda equina syndromeC. 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 when3:Fractures or dislocations which are likely to result spinal instability without neurological defectsORFractures or dislocations associated with neurological defects at the affected levelORInstability is present.2. Spinal tumors involving the spine or spinal canal when:3Malignant or benign tumors which have caused instability or neurologic deficit where treatment of the tumor will likely require stabilization of the spine.4ORExpected treatment of the tumor whether by chemotherapy or radiation therapy or surgery will likely cause spinal instability or neurologic deficits.4ORInstability is present.3.Infection involving the spine in the form of discitis, osteomyelitis, or epidural abscess when3:Imaging or other studies (MRI, biopsy, bone aspirate) demonstrating infectionANDImaging evidence of vertebral body destruction OR documentation that spinal debridement will cause vertebral instability5,6ORInstability is present.4. 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 deformity ORSymptomatic 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 surgeryorwith radiographic evidence of hardware failure (fracture or displacement). ORSpinal instability after laminectomyORRheumatoid arthritis with associated instabilityORCervical degenerative spondylolisthesis with spinal instability (Anterolisthesis/Posterolisthesis)ANDf. Substantial functional limitation is present such as severe neck pain, difficulty ambulating and decrease ability to perform ADLs or ability to maintain forward gaze.ANDg. Progression of deformityLimitationsCervical Fusion for the decompression or stabilization of the cervical spineis not 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. 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.DefinitionsAcute Painan unpleasant sensory and emotional experience associated with actual or potential tissue damage which is present for up to 6 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, 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 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.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., 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 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.1,14