Medical Affairs Policy

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1 Medical Affairs Policy Service: Intraoperative Neurophysiologic Monitoring (IONM, Multimodal Intraoperative Neuromonitoring) PUM Medical Policy Committee Approval 12/09/16 Effective Date 01/01/17 Prior Authorization Needed Yes- For Spinal Procedures Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, [email protected]. Description: Intraoperative neurophysiologic monitoring (IONM) encompasses a variety of neurologic testing modalities used during surgery to monitor, identify, and potentially prevent complications to the nervous system, the blood supply to the nervous system, or adjacent tissue. It has been used to monitor neural integrity during spinal, neurologic, cranial and vascular procedures. The specific type of test is tailored to the clinical circumstances of the surgery. Modalities may include: Somatosensory evoked potentials (SSEPs), Motorevoked potentials (MEPs), Brainstem auditory-evoked potentials (BAEPs), Electomyelogram (EMG), Visual Evoked Potentials (VEPS), Electroencephalogram (EEG) and Electrocorticography (ECoG). IONM has been shown to have the potential to detect impending adverse neurologic situations and alert the surgical team to take action to avoid neural injury in some surgeries. There is evidence that rapid response to notification of changes in intra operative neurologic status during high risk surgery may improve neurologic outcomes. However, the criteria for triggering an evoked potential alert during surgery varies across the literature, and intervention protocols once an alert has been triggered vary across institutions and surgeons. The American Academy of Neurology does not recommend routine use of IONM for all spinal surgery. Increased frequency of instrumented spinal surgeries over the past few decades has resulted in increased use of IONM services. Accompanying this rise in use has been an increase in the number of modalities monitored. Providers of this service initially were in the operating room with the patient and surgeon. Providers of this service may include PhD Page 1 of 6

2 neurophysiologists, audiologists, physicians, and trained technicians. There is no standardized health care licensing requirement for providers of IONM, and a variety of certifications are available. Technology advancements have made it possible to monitor remotely. Physician oversight of a technician in the operating room has allowed for multiple patients to be monitored at once. The need for real time immediate communication with the surgeon has raised safety concerns which, in turn led to recommended limits on the number of patients that can be monitored at one time. Indications of Coverage: Process: The surgeon performing the operative procedure documents in the priorauthorization request for the primary surgical procedure the intent to involve IONM. Prior authorization requests received from the monitorist will be processed upon approval of the primary surgery. A. IONM is considered medically necessary for a covered surgery with high risk for compromise of neurologic function such as any of the following: 1. Arteriography, during which there is a test occlusion of the carotid artery 2. Basal ganglia movement disorders 3. Cavernous sinus tumors 4. Cerebral vascular aneurysms 5. Chiari malformations 6. Circulatory arrest with systemic hypothermia 7. Correction of scoliosis or deformity of spinal cord involving traction on the cord 8. Deep Brain Stimulation 9. Decompressive procedures on the spinal cord carried out for myelopathy or claudication where function of spinal cord or spinal nerves is at risk 10. Distal aortic procedures, where there is risk of ischemia to spinal cord (includes spinal arteriography) 11. Endolymphatic shunt for Meniere's disease 12. Leg lengthening procedures, where there is traction on sciatic nerve or other nerve trunks Page 2 of 6

3 13. Microvascular decompression of cranial nerves 14. Neuromas of peripheral nerves of brachial plexus, when there is risk to major sensory or motor nerves 15. Oval or round window graft 16. Protection of spinal cord where work is performed in close proximity to cord as in the placement or removal of old hardware or where there have been numerous interventions 17. Protection of the cranial nerves 18. Resection of brain tissue close to the primary motor cortex and requiring brain mapping 19. Resection of epileptogenic brain tissue or tumor 20. Spinal cord tumors (includes chordomas) 21. Spinal instrumentation requiring pedicle screws or distraction 22. Surgery for arteriovenous malformation of spinal cord 23. Surgery for intracranial AV malformations 24. Surgery for intractable movement disorders 25. Surgery of the aortic arch, its branch vessels, or thoracic aorta, including carotid artery or carotid endarterectomy surgery where there is risk of cerebral ischemia 26. Surgery for spinal trauma (injury to spinal cord/brain) 27. Tumors that affect optic, trigeminal, facial or auditory nerves (also includes cholesteatoma and acoustic neuroma) 28. Vestibular section for vertigo B. Intraoperative somatosensory evoked potentials (SSEPs) or SSEPs in combination with motor evoked potentials (MEPs) are considered medically necessary when the following criteria are met: 1. There is documentation of the need for monitoring the integrity of the spinal cord during the spinal, intracranial, orthopedic, or vascular procedure; and Page 3 of 6

4 2. A specially trained physician or a certified professional practicing within the scope of their license, who is not a member of the surgical team interprets the intraoperative evoked potentials during the operation; and 3. The evoked potential monitoring is performed in the operating room by a dedicated trained technician or physician; and 4. The clinician performing the interpretation is monitoring no more than 3 surgical procedures at the same time; and 5. If clinician performing the interpretation is NOT in the operating room, there must be a mechanism for direct, immediate communication of intraoperative evoked potential results to the technician and surgeon during the operation. Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, deny as experimental, investigational, and unproven to affect health outcomes. C. If used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, deny as not medically necessary D. Intraoperative neurophysiological monitoring used during routine lumbar or cervical laminectomy, disc surgery, fusion, or lumbar surgery below the L1/L2 level is considered not medically necessary E. Intraoperative neurophysiological monitoring will not be covered for a surgery that was not covered F. If the servicing provider does not meet the member s certificate definition of physician, deny as not a covered provider G. Nerve Integrity Monitoring (NIM) Systems for Intraoperative neuromuscular monitoring of motor nerve function during thyroidectomy is considered experimental, investigational, and unproven to affect health outcomes. Systems include but are not limited to NIM 3.0 Nerve Monitoring System, NIM-PRS, Prass monopolar nerve (Medtronic Xomed Inc.); NIM4, NIM-Response 2.0 System (Xomed Inc.); Nerve Integrity Monitor-2, NIM-2XL, NIM 2.0 EMG Endotracheal tube (Xomed-Treace Inc.) Page 4 of 6

5 Documentation Required: Pre-operative notes from the surgeon indicating that IONM is planned, including the diagnosis, type and location of surgery, need for intra-operative monitoring including mention of the monitorable structure at risk. Pre authorization request from the monitorist identifies the monitoring modalities to be used based on the peer reviewed literature describing monitoring of the at risk structures. Operative and monitoring procedure notes are needed if claims are reviewed. References: 1. Center for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) Evoked Response Tests (160.10) 2. Center for Medicare and Medicaid Services (CMS) Wisconsin Physician Services Local Coverage Determination (LCD) L Intraoperative Neurophysiological Testing. Revision Effective 10/1/ Hayes Search and Summary: Intraoperative Neurophysiological Monitoring (IONM) During Spinal Surgery. November 6, 2014, October 27, Hayes Health Technology Brief Nerve Integrity Monitoring (NIM) Systems (Medtronic Inc.) for Intraoperative Monitoring of Motor Function during Thyroidectomy. Annual Review Nov 6, 2014 Archived Dec 5, Hayes Medical Technology Directory. Multimodality Intraoperative Monitoring (MIOM) During Corrective Surgery for Spinal Deformities Publication Date February 18, Hayes Medical Technology Directory. Multimodal Intraoperative Monitoring (MIOM) During Cervical Spinal Surgery. Publication Date March 31, Ney J, van der Goes D, Nuwer A. Does Intraoperative neurophysiologic monitoring matter in non-complex spine surgeries? Comparative Effectiveness, Cost and Outcomes Research Center University of WA Seattle, W, Neurology 85, Dec Accessed Nov 10, Available at Page 5 of 6

6 Review History: Implemented 01/16/15, 04/01/16, 01/01/17 Medical Policy 12/11/15, 12/09/16 Committee Approval Reviewed 12/11/15, 12/09/16 Developed 12/12/14 Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin Approved by the Medical Director Page 6 of 6