Intraoperative Neurophysiological Testing

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for intraoperative neurophysiological testing services. 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 intraoperative neurophysiological testing services 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 100-04, Medicare Claims Processing Manual,
  • Chapter 1, Section 30.2.9, Payment to Physician or Other Supplier for Purchased Diagnostic Tests Subject to the Anti-Markup Payment Limitation-Claims Submitted to A/B MACs (B)
  • Chapter 13, Section 10.1, Billing Part B Radiology Services and Other Diagnostic Procedures
  • Chapter 16, Section 40.2, Payment Limit for Purchased Services
• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
• 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.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Intraoperative neurophysiological testing may be used to identify/prevent complications during surgery on the nervous system, its blood supply, or adjacent tissue. Monitoring can identify new neurologic impairment, identify or separate nervous system structures (e.g., around or in a tumor) and can demonstrate which tracts or nerves are still functional. Intraoperative neurophysiological testing may provide relative reassurance to the surgeon that no identifiable complication has been detected up to a certain point, allowing the surgeon to proceed further and provide a more thorough or careful surgical intervention than would have been provided in the absence of monitoring. Monitoring, if used to assess sensory or motor pathways, should assess the appropriate sensory or motor pathways. Incorrect pathway monitoring could miss detection of neural compromise and has been shown to have resulted in adverse outcomes.

Some high-risk patients may be candidates for a surgical procedure only if monitoring is available.

Covered Indications

Based on information in the scientific literature, intra-operative testing may be considered reasonable and necessary for the following:

• Surgery of the aortic arch, its branch vessels, or thoracic aorta, including carotid artery surgery, when there is risk of cerebral or spinal cord ischemia
• Resection of epileptogenic brain tissue or tumor
• Resection of brain tissue close to the primary motor cortex and requiring brain mapping
• Protection of cranial nerves:
  
  • Resection of tumors involving the cranial nerves
  • Cavernous sinus tumors
  • Microvascular decompression of cranial nerves
  • Skull base surgery in the vicinity of the cranial nerves and surgeries of the foramen magnum
  • Oval or round window graft
• Endolymphatic shunt for Meniere's disease
• Vestibular section for vertigo
• Correction of scoliosis or deformity of spinal cord involving traction of the cord
• 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
• Spinal instrumentation requiring pedicle screws or distraction
• Decompressive procedures on the spinal cord or cauda equina carried out for myelopathy or claudication where function of spinal cord or spinal nerves is at risk
• Spinal cord tumors and spinal fractures (with the risk of cord compression)
• Neuromas of peripheral nerves of brachial plexus, when there is risk to major sensory or motor nerves
• Surgery or embolization for intracranial AV malformations
• Surgery for arteriovenous malformation of spinal cord
• Embolization of bronchial artery AVMs or tumors
• Cerebral vascular aneurysms
• Surgery for intractable movement disorders
• Arteriography, during which there is a test occlusion of the carotid artery
• Circulatory arrest with hypothermia (does not include surgeries performed under circulatory bypass [e.g., CABG, ventricular aneurysms])
• Distal aortic procedures, where there is risk of ischemia to spinal cord
• Leg lengthening procedures, where there is traction on sciatic nerve or other nerve trunks
• Basal ganglia movement disorders
• Surgery as a result of traumatic injury to spinal cord/brain
• Deep brain stimulation, and
• Certain thyroid surgeries (see below for additional guidance)

Thyroid Surgery

Intraoperative neurophysiologic monitoring during thyroid surgery is considered reasonable and necessary if the monitoring service adheres to the essential standards described above, and the surgical procedure involves the high-risk total removal of a complete lobe of the thyroid, removal of the entire gland, or involves re-entry (re-operation) to a prior surgical field where scar tissue obscures the visual path of the recurrent laryngeal nerve. The surgeries described here are most appropriately reported as a total removal of thyroid lobe on one side of the neck, removal of thyroid, removal of thyroid and surrounding lymph nodes or removal of remaining thyroid tissue. The contractor reserves the right to remove coverage for monitoring during thyroid surgery if the literature ultimately does not support this monitoring.

Limitations

1. This test must be ordered by the operating surgeon and the monitoring must be performed by a physician who is other than:
   • the operating surgeon;
   • the technical/surgical assistant; or
   • the anesthesiologist rendering the anesthesia.
     
     
2. The benefits of intraoperative neurophysiologic testing are attainable under optimal recording and interpreting conditions. The beneficial results of monitoring demonstrated by the 1995 multicenter study of this technique were realized under the following conditions in a hospital setting:
   • A well trained, experienced technologist was present at the operating site recording and monitoring a single surgical case.
   • A physician who is a trained clinical neurophysiologist (MD/DO) supervised the technologist.
   • The surgical team and the monitoring staff were always in immediate contact.
     
     
3. Due to the nature of these services and the potential for significant morbidity, in procedures requiring intraoperative monitoring, these services are considered reasonable and necessary only when performed in the inpatient and outpatient hospital settings or Ambulatory Surgical Center. Please note, the outpatient settings are only considered reasonable and necessary for intraoperative monitoring of procedures that are not designated as inpatient-only procedures. As the level of anesthesia may significantly impact the ability to interpret intraoperative studies, continuous communication between the anesthesiologist and the monitoring physician is expected when medically indicated.
   
   
4. It is also required that a specifically trained technician, preferably registered with one of the credentialing organizations such as the American Board of Neurophysiologic Monitoring or the American Board of Registration of Electrodiagnostic Technologists will be in continuous attendance in the operating room, recording and monitoring a single surgical case, with either the physical or electronic capacity for real-time communication with the supervising neurologist or other physician trained in neurophysiology.
   
   
5. Intraoperative monitoring is not medically necessary in situations where historical data and current practices reveal no potential for damage to neural integrity during surgery. Monitoring under these circumstances will exceed the patient's medical need.
   
   
6. Due to the potential risk for morbidity with many of the above noted surgeries and the need for explicit and focused attention to both the monitoring and the procedure, it is not reasonable and necessary for the operating surgeon to perform this service. Monitoring may be performed from a remote site, as long as a trained technician (see detail above) will be in continuous attendance in the operating room, with either the physical or electronic capacity for real-time communication with the supervising physician (MD/DO). Technical criteria (mandatory) include that at least eight recording channels be available (16 if EEG is monitored) for all intraoperative neurophysiological monitoring. The remotely supervising physician must watch the tracings as they are obtained in real-time in the operating room, as well as the baseline electrophysiological test and the monitoring tracings from earlier in the case.
   
   Technical criteria (mandatory) for remote monitoring also include (a) routine real-time auditory or written communication between the supervising physician and the operating room and (b) the capability for telephone communications as needed between the supervising physician and the monitoring technologist, operating surgeon and the anesthesiologist.
   
   
7. The equipment must also provide for all of the monitoring modalities that may be applied with codes for auditory-evoked response, electroencephalography/electrocorticography, electromyography and nerve conduction and somatosensory-evoked response.
   
   
8. Undivided attention to a unique patient will be required during surgeries covered for this procedure. The monitoring physician must have a plan in place to transfer care to another physician, should any other situation arise during those times. When paying undivided attention to a unique patient, the physician must report services for only that one case during those times. Medicare will no longer consider it reasonable and necessary to reimburse additionally for this service in those cases where undivided attention is not required for one unique patient and will no longer reimburse a physician who performs more than one intraoperative neurophysiologic monitoring case simultaneously. All cases monitored, remote or those performed in the operating room require the exclusive undivided attention of the monitoring physician for consideration of Medicare coverage.
   
   
9. Medicare does not provide for reimbursement of “incident to” care in the hospital setting. More than one patient can no longer be monitored during the same fifteen minute interval of time. Claims for physician services must be submitted only for the time devoted to monitoring. This time, however, may be cumulative, and does not have to be continuous, i.e., two fifteen minute sessions or one-half hour of continuous attendance followed by another one-half hour later in the procedure will constitute one hour of monitoring.
   
   
10. Procedure codes for continuous intraoperative neurophysiological monitoring in operating room and continuous intraoperative neurophysiology monitoring, from outside the operating room describe ‘ongoing monitoring’. This does not include services in which the information is stored and forwarded for a different time of review, or those services in which information is relayed by the technician to the physician who is not actually monitoring at the time.

Place of Services (POS)

The following POS may be allowed when covered indications and limitations are met:

• Off Campus-Outpatient Hospital
• Inpatient Hospital
• On Campus-Outpatient Hospital
• Ambulatory Surgical Center

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Intraoperative Neurophysiological Testing, A56722, for applicable CPT/HCPCS codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD. 

N/A

N/A

Refer to the Local Coverage Article: Billing and Coding: Intraoperative Neurophysiological Testing, A56722, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. The medical record must support the time spent in monitoring and correlate to the surgery being performed.
5. Any documentation requests not submitted will be considered not meeting the medical necessity for the service and will be denied based on lack of verification of the service being done.
6. If chat logs are available, they must include ongoing times of conversation and reflect the dedicated time for that particular beneficiary.
7. If requested, records for a given day of practice should be available in order to determine if there was devoted time for a particular patient and not simultaneous services.
8. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the appeal request, this would include the formal baseline neurophysiologic study with requirements noted above.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Contractor is not responsible for the continued viability of websites listed.

Other Contractor's Policies

Contractor Medical Directors

Original JH ICD-9 Source LCD L32605, Intraoperative Neurophysiologic Monitoring

First Coast Service Options, Inc, Local Coverage Determination (LCD): Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions (L32074), Revision Date 01/01/2013

1. American Academy of Neurology Professional Association May, 2008
2. Bose B, Sestokas, AK, Schwartz DM. Neurophysiological Detection of Iatrogenic C-5 Nerve Deficit During Anterior Cervical Spinal Surgery. J Neurosurg: Spine 2007; 6:381-385.
3. Bose B, Wierzbowski LR, Sestokas AK. Neurophysiologic Monitoring of Spinal Nerve Root Function During Instrumented Posterior Lumbar Spine Surgery. Spine 2002; 27 (13):1444-1450.
4. Devlin VJ, Schwartz DM. Intraoperative Neurophysiologic Monitoring During Spinal Surgery. Journal of the American Academy of Orthopaedic Surgeons 2007; 15 (9):549-560.
5. Dralle H, Sekulla C, Lorenz K et al. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66.
6. Fan D, Schwartz D, Vaccaro A, et al. Intraoperative Neurophysiologic Detection of Iatrogenic C5 Nerve Root Injury During Laminectomy for Cervical Compression Myelopathy. Spine 2002; 27 (22): 2499-2502.
7. Gonzalez AA, Jeyanandarajan D, Hansen C, et al. “Intraoperative neurophysiological monitoring during spine surgery: a review” Neurosurg Focus, 2009; 27 (4): E6.
8. Isley MR, Zhang X, et al. “”Current Trends in Pedicle Screw Stimulation Techniques: Lumbosacral, Thoracic, and Cervical Levels” American Journal of Electroneurodiagnostic Technology
9. Krassioukov AV, Sarjeant R, Arkia H, et al. “Multimodality intraoperative monitoring during complex lumbosacral procedures: indications, techniques, and long-term follow-up review of 61 consecutive cases”, J Neurosurg (Spine 1), 2004; 3: 243-253.
10. Lesser RP, Raudzens P, Luders H, et al. Postoperative neurological deficits may occur despite unchanged intraoperative somatosensory evoked potential. Annals of Neurology, 1986; 19, 22-25.
11. Leung YL, Grevitt M, Henderson L, et al. Cord monitoring changes and segmental vessel ligation in the "at risk" cord during anterior spinal deformity surgery. Spine 2005; 30 (16): 1870-1874.
12. Nuwer MR ed. Intraoperative monitoring of Neural Function, Handbook of Clinical Neurphysiology, Vol 8.
13. Nuwer MR, Dawson EG, Carlson LG, Kanim LEA , et al. Somatosensory evoked potential spinal cord monitoring reduces neurologic deficits after scoliosis surgery: Results of a large multicenter survey. Electroencephalography and Clinical Neurophysiology 1995; 96:6-11.
14. Nuwer MR, Emerson RG, Galloway G, et al. Evidence-based guideline update: Intraoperative spinal monitoring with somatosensory and transcranial electrical motor evoked potentials: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the American Clinical Neurophysiology Society. Neurology 2012 (78); 585-589. American Academy of Neurology guidelines www.neurology.org/content/78/8/585.full.pdf+html (date accessed 11/25/13)
15. Principles of Coding for Intraoperative Neurophysiologic Monitoring (IOM) and Testing. American Academy of Neurology Professional Association May 2008.
16. Randolph GW, Dralle H et al. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. International Intraoperative Monitoring Study Group, Laryngoscope. 2011 Jan;121 Suppl 1:S1-16.
17. Sala F, Dvorak J, Faccioli F, “Cost effectiveness of multimodal intraoperative monitoring during spine surgery” Eur Spine J, 2007; 16(Suppl 2): S229-S231.
18. Schwartz DM, Sestokas AK, Hilibrand AS, et al. “Neurophysiological Identification of Position-Induced Neurologic Injury During Anterior Cervical Spine Surgery” Journal of Clinical Monitoring and Computing, 2006; 20: 437-444.
19. Uribe JS, Kolla J, et al. “Brachial plexus injury following spinal surgery” J Neurosurg Spine, 2010; 13:552-558.
20. Uribe JS, MD, Vale FL, et al. “Electromyographic Monitoring and Its Anatomical Implications in Minimally Invasive Spine Surgery” Spine, 2010; 35(26S).
21. XU R, Ritzl EK, et al. “A role for motor and somatosensory evoked potentials during anterior cervical discectomy and fusion for patients without myelopathy: Analysis of 57 consecutive cases” Surgical Neurology International 2011; 2:133.