evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Cervical Fusion (DL39799)
Nerve 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.
Proposed LCD - Cervical Fusion (DL39799)
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.
Proposed LCD - Cervical Fusion (DL39799)
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.9
Proposed LCD - Cervical Fusion (DL39799)
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.
Proposed LCD - Cervical Fusion (DL39799)
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
Proposed LCD - Cervical Fusion (DL39799)
General 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
Proposed LCD - Cervical Fusion (DL39799)
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Proposed LCD - Cervical Fusion (DL39799)
Menger DLSGWSMRP. Hangman's Fractures. Published 2023. Updated August 13, 2023. Accessed January 2023.Donnally III CJ, Hanna A, Odom CK. Cervical myelopathy. StatPearls Publishing. StatPearls [Internet] Web site. https://www.ncbi.nlm.nih.gov/books/NBK482312/ Published 2023. Accessed October 27, 2023.Marquis BO, Capone PM. Myelopathy.Handbook of clinical neurology.2016;136:1015-1026.Wirth FP, Dowd GC, Sanders HF, Wirth C. Cervical discectomy: a prospective analysis of three operative techniques.Surgical neurology.2000;53(4):340-348.Panjabi MM, White III AA. Basic biomechanics of the spine.Neurosurgery.1980;7(1):76-93.Kothari MJ, Chuang K. Treatment and prognosis of cervical radiculopathy. UpToDate. https://www.uptodate.com/. Published 2023. Updated February 28, 2023. Accessed November 1, 2023.Corp N, Mansell G, Stynes S, et al. Evidence-based treatment recommendations for neck and low back pain across Europe: a systematic review of guidelines.European Journal of Pain.2021;25(2):275-295.Nikolaidis I, Fouyas IP, Sandercock PAG, Statham PF. Surgery for cervical radiculopathy or myelopathy.Cochrane Database of Systematic Reviews.2010(1).Plener J, Csiernik B, To D, et al. Conservative Management of Cervical Radiculopathy: A Systematic Review.Clin J Pain.2023;39(3):138-146.Liang L, Feng M, Cui X, et al. The effect of exercise on cervical radiculopathy: A systematic review and meta-analysis.Medicine (Baltimore).2019;98(45):e17733.
Proposed LCD - Cervical Fusion (DL39799)
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Proposed LCD - Cervical Fusion (DL39799)
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Proposed LCD - Cervical Fusion (DL39799)
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Proposed LCD - Cervical Fusion (DL39799)
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Proposed LCD - Cervical Fusion (DL39799)
Gillick JL, Wainwright J, Das K. Rheumatoid arthritis and the cervical spine: a review on the role of surgery.International journal of rheumatology.2015;2015.Nunez JH, Escudero B, Omiste I, et al. Outcomes of cervical arthroplasty versus anterior cervical arthrodesis: a systematic review and meta-analysis of randomized clinical trials with a minimum follow-up of 7-year.Eur J Orthop Surg Traumatol.2022.Peng Z, Hong Y, Meng Y, Liu H. A meta-analysis comparing the short- and mid- to long-term outcomes of artificial cervical disc replacement(ACDR) with anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease.Int Orthop.2022;46(7):1609-1625.Xing D, Ma XL, Ma JX, Wang J, Ma T, Chen Y. A meta-analysis of cervical arthroplasty compared to anterior cervical discectomy and fusion for single-level cervical disc disease.J Clin Neurosci.2013;20(7):970-978.Zhang Y, Lv N, He F, et al. Comparison of cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of cervical disc degenerative diseases on the basis of more than 60 months of follow-up: a systematic review and meta-analysis.BMC Neurol.2020;20(1):143.Fehlings MG, Martin AR, Tetreault LA, et al. A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role of Baseline Magnetic Resonance Imaging in Clinical Decision Making and Outcome Prediction.Global Spine J.2017;7(3 Suppl):221S-230S.Zileli M, Maheshwari S, Kale SS, Garg K, Menon SK, Parthiban J. Outcome Measures and Variables Affecting Prognosis of Cervical Spondylotic Myelopathy: WFNS Spine Committee Recommendations.Neurospine.2019;16(3):435-447.
Proposed LCD - Cervical Fusion (DL39799)
Costa F, Anania CD, Agrillo U, et al. Cervical Spondylotic Myelopathy: From the World Federation of Neurosurgical Societies (WFNS) to the Italian Neurosurgical Society (SINch) Recommendations.Neurospine.2023;20(2):415-429.Watanabe M, Chikuda H, Fujiwara Y, et al. Japanese Orthopaedic Association (JOA) Clinical practice guidelines on the Management of Cervical Spondylotic Myelopathy,2020 - Secondary publication.J Orthop Sci.2023;28(1):1-45.Youssef JA, Heiner AD, Montgomery JR, et al. Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis.Spine J.2019;19(10):1714-1729.Mahmoud A, Shanmuganathan K, Montgomery A. Surgical Management of Hangman's Fracture: A Systematic Review.Int J Spine Surg.2023.Lee DY, Park YJ, Song MG, Kim KT, Kim DH. Comparison of anterior-only versus combined anterior and posterior fusion for unstable subaxial cervical injuries: a meta-analysis of biomechanical and clinical studies.Eur Spine J.2021;30(6):1460-1473.Yang JS, Liu P, Liu TJ, et al. When is the circumferential stabilization necessary for subaxial cervical fracture dislocations? The posterior ligament-bone injury classification and severity score: a novel treatment algorithm.Eur Spine J.2021;30(2):524-533.Madan A, Thakur M, Sud S, Jain V, Singh Thakur RP, Negi V. Subaxial Cervical Spine Injuries: Outcomes after Anterior Corpectomy and Instrumentation.Asian J Neurosurg.2019;14(3):843-847.Zheng HL, Li B, Song SK, Chen PB, Jiang LS, Jiang SD. Anterior cervical discectomy and fusion to treat cervical instability with vertigo and dizziness: A single center, retrospective, observational study.Front Surg.2022;9:1047504.