evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Nathan DM. Long-Term Complications of Diabetes Mellitus.N Engl J Med. 1993;328(23):1676-1685.lafsdttir AF, Polonsky W, Bolinder J, et al. A Rrandomized Clinical Trial of the Effect of Continuous Glucose Monitoring on Nocturnal Hypoglycemia, Daytime Hypoglycemia, Glycemic Variability, and Hypoglycemia Confidence in Persons with Type 1 Diabetes Treated with Multiple Daily Insulin Injections (GOLD-3).Diabetes Technol Ther. 2018;20(4):274-84.Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self- monitoring of blood glucose: meta-analysis of randomized controlled trials using individual patient data.BMJ. 2011;343:d3805. doi: 10.1136/bmj.d3805Puhr S, Derdzinski M, Welsh JB, Parker AS, Walker T, Price DA. Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring Systems Predictive Low Glucose Alert.Diabetes Technol Ther. 2019; 21(4). doi: 10.1089/dia.2018.0359Quilliam BJ, Simeone JC, Osbay AB, Kogut SJ. The Incidence and Costs of Hypoglycemia in Type 2 Diabetes.AJMC. 2011;17(10):673-680.Runge AS, Kennedy L, Brown AS, et al. Does Time-in-Range Matter? Perspectives from People with Diabetes on the Success of Current Therapies and the Drivers of Improved Outcomes.Clin Diabetes. 2018;36(2):112119.Tamborlane WV, Beck RW, Bode BW, et al. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes.N Engl J Med. 2008;359:1464-76.Umpierrez GE, Klonoff DC. Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital.Diabetes Care. 2018;41:1579-1589.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Umpierrez GE, Klonoff DC. Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital.Diabetes Care. 2018;41:1579-1589.Vigersky RA, McMahon C. The relationship of hemoglobin A1c to time-in-range in patients with diabetes.Diabetes Technol Ther. 2019;21:81- 85.Yeh HC, Brown TT, Maruthur N, et al. Comparative Effectiveness and Safety of Methods of Insulin Delivery and Glucose Monitoring for Diabetes Mellitus: A Systematic Review and Meta-analysis.Ann Intern Med.2012;157:336-47.Yoo EH, Lee SY. Glucose Biosensors: An Overview of Use in Clinical Practice.Sensors. 2010;10:45584576.Pratley RE, Kanapka LG, Rickels MR, et al. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes.JAMA. 2020;323(23):2397-2406. doi:10.1001/jama.2020.6928.
Proposed LCD - Cervical Fusion (DL39793)
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 Necessity
Proposed LCD - Cervical Fusion (DL39793)
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:
Proposed LCD - Cervical Fusion (DL39793)
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 excludedAND
Proposed LCD - Cervical Fusion (DL39793)
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 (DL39793)
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 (DL39793)
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 (DL39793)
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 (DL39793)
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 (DL39793)
General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Cervical Fusion (DA59668) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliography
Proposed LCD - Cervical Fusion (DL39793)
White III AA, Johnson RM, Panjabi MM, Southwick WO. Biomechanical analysis of clinical stability in the cervical spine.Clinical Orthopaedics and Related Research.1975;109:85-96.Boonstra AM, Preuper HRS, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain.Pain.2014;155(12):2545-2550.(NASS) NASS. Cervical fusion: defining appropriate coverage positions. NASS Coverage Recommendations 2023 (May). North American Spine Society (NASS). www.spine.org. Accessed November 21, 2023.Surgeons AAoN. Spinal Tumors. https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Tumors. Accessed November 2, 2023.Nagashima H, Tanishima S, Tanida A. Diagnosis and management of spinal infections.J Orthop Sci.2018;23(1):8-13.Elmajee M, Munasinghe C, Aljawadi A, Elawady K, Shuweihde F, Pillai A. Posterior stabilisation without formal debridement for the treatment of non-tuberculous pyogenic spinal infection in frail and debilitated populationA systematic review and meta-analysis.Journal of Clinical Orthopaedics and Trauma.2021;15:9-15.Raja SN CD, Cohen M, Finnerup NB, et al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises.Pain.2020;161(9):1976-1982.Bono CM, Ghiselli G, Gilbert TJ, et al. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders.The Spine Journal.2011;11(1):64-72.Rondinelli RD, Genovese E, Katz RT, et al.AMA guides to the evaluation of permanent impairment, Sixth Edition.2008.Menger DLSGWSMRP. Hangman's Fractures. Published 2023. Updated August 13, 2023. Accessed January 2023.
Proposed LCD - Cervical Fusion (DL39793)
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 (DL39793)
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.Walker MJ, Boyles RE, Young BA, et al. The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Pain: A Randomized Clinical Trial.Spine.2008;33(22):2371-2378.Kuijper B, Tans JT, Beelen A, Nollet F, de Visser M. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial.Bmj.2009;339:b3883.Engquist M, Lfgren H, berg B, et al. Factors Affecting the Outcome of Surgical Versus Nonsurgical Treatment of Cervical Radiculopathy.Spine.2015;40(20):1553-1563.Engquist M, Lfgren H, berg B, et al. A 5-to 8-year randomized study on the treatment of cervical radiculopathy: anterior cervical decompression and fusion plus physiotherapy versus physiotherapy alone.Journal of Neurosurgery: Spine.2017;26(1):19-27.Harrop JS, Mohamed B, Bisson EF, et al. Congress of neurological surgeons systematic review and evidence-based guidelines for perioperative spine: preoperative surgical risk assessment.Neurosurgery.2021;89(Supplement_1):S9-S18.Thoomes E, Thoomes-de Graaf M, Cleland JA, Gallina A, Falla D. Timing of evidence-based nonsurgical interventions as part of multimodal treatment guidelines for the management of cervical radiculopathy: a Delphi study.Physical Therapy.2022;102(5):pzab312.Berman D, Holtzman A, Sharfman Z, Tindel N. Comparison of Clinical Guidelines for Authorization of MRI in the Evaluation of Neck Pain and Cervical Radiculopathy in the United States.Journal of the American Academy of Orthopaedic Surgeons.2023;31(2):64-70.