Administrative Law Judges (ALJs) in several Medicare Appeals have found the Axon-II “reasonable and necessary” and “entitled to payment” based on the following science:
• Large fibers, up to 100 times large than pain fibers, require >50% myelin loss before EMG-type NCS can begin to detect any change in velocity, latency or configuration.
• Because small pain fibers are up to 100 times smaller, they are too small for these responses to be of any diagnostic significance.
• ALJs have found recording the objective increase in voltage AMPLITUDE is the measurement necessary to verify small pain fiber threshold.
• 2013 NCS Codes: 95907 (1 to 2 nerves), 95908 (3-4), 95909 (5-6), 95910 (7-8), 95911 (9-10) 95912 (11-12), 95913 (13 or more) Depending on the region: Medicare (95908 or 95909) $250 to $400. Other Insurance 95912 $500 to $700+
BECOME AN EXPERT AT NO COST
Purchase the Axon-II (new or used) from PainDx, Inc. and we covers your 5 year certification fees through the American Association of Sensory Electrodiagnostic Medicine (AASEM) www.sensorymedicine.org. Once certified, for a small fee, staff members can also be certified.
Call (800) 766-0884 for details
DON’T BE CONFUSED BY OTHER DEVICES
Only The Axon-II Locates And Quantifies Pain Nerve Fiber Pathology Prior to the ALJ Medicare Decisions a few insurers confused the Axon-II with a simple motor fiber EMG device, the NC-Stat. Being handheld and automated with remote analysis, insurers denied coverage for the NC-Stat. It hard to understand how one could confused these devices. See the comparison below.
• Not Reimbursed
• Simple tests large motor nerve fibers
• Handheld – Weighs 1 lb.
• Fixed Electrode Array (glove-like electrode)
• Automated Test – Press a button
• Remote Analysis (Phone/Fax)
• Limited to motor Carpal Tunnel Entrapment
• Reimbursed by all types of insurance
• Small pain fiber pathology location quantification
• 2 hands required to operate – weights 30-50 lbs.*
• Both electrodes moved by examiner for each nerve
• Examiner controls stimulus Onsite Analysis
• Tests all type of peripheral neuropathies
* Total weight depends on the type of cart, computer and printer used. Alone the Axon-II weighs 12 lbs.
AXON-II - FDA CLASS II MEDICAL DEVICE (SAFE & EFFECTIVE)
NOT CLASS A (EXPERIMENTAL)
CMS cannot classify medical devices nor can insurance carriers. Under Title 42 of the Social Security Act** the exclusive authority to classify medical devices has been granted by the United States Congress to the Food & Drug Administration (FDA).
• Axon-II: FDA Class II (Safe & Effective)
• Experimental devices: FDA Class A
** Title 42: Public Health, Subpart B – Medical Service Coverage Decisions That Relate to Health Care Technology, Authority: Sections 1102, 1862 and 1871 of the Social Security Act as amended (42 U.S.C. 1302 and 1395hh). Source: 60 FR 48423, Sept. 19, 1995 – SS 405.201.
AXON-II ADVANTAGE OVER EMG-TYPE TESTS
AXON—II LOCATES – QUANTIFIES PAIN PATHOLOGY
NO EMG, NCV OR OTHER TEST CAN DO WHAT THE AXON-II CAN DO IN MINUTES
50% OF SPINE PAIN IS REFERRED TO HEALTHY NERVE ROOTS, SO TESTING, LOCATING & QUANTIFYING PAIN PATHOLOGY IS IMPORTANT.
A peer-reviewed multicenter study (Click on Studies in the above banner) has shown that increasing pain is transmitted by the POOR LOCALIZING C-TYPE (SLOW PAIN) FIBERS, which explains why 50% of patients (ones with the worst pain) have referred pain. It is the consensus of pf-NCS certified providers that 15% or more of spinal pain is referred to the opposite side form the injured nerve root. This is doubly important when it is understood that 58% of patients see doctors because they have spine or joint pain. (2013 Mayo Clinic study of 142,337 patients)
A National Institute of Health studies (2002) found 43% of pain patients become chronic and over 50% of spinal surgeries end in failure with the patient in the same or worse pain. These chronic patient are often put on pain medicines that are now responsible for more deaths than the combined deaths caused by auto accidents, heroin and cocaine.
You cannot find the cause of pain by relying on conventional diagnostic methods. MRI cannot image pain and EMG-type tests are basically useless.
The journal Physical Medicine & Rehabilitation published a “State- Of-The-Art-Review”:
“EVALUATING RADICULOPATHY: HOW USEFUL IS ELECTRODIAGNOSTIC TESTING?"
Page 255 – Painful Radiculopathy
“In chronic cases, particularly in individuals with predominantly sensory symptoms, it is difficult or impossible to clinically estimate the type or severity of nerve injury.
Motor (rare) Only if there is observable muscle atrophy can one know for certain that motor axon degeneration has occurred. The electrodiagnostic (EMG) study can be normal in the face of known pathology.”
Page 255 - H & F Wave:
“H wave is named after Hoffman (1918). Used with any regularity in assessment of S1 fibers. Many would argue that the H wave is simply a neurophysiologic ankle stretch reflex and therefore does not have added value in the evaluation of radiculopathy.” F Wave: “Despite the theoretical advantage of using the F response it is of little practical application in the evaluation of radiculopathy, especially a lesion of a single level. If even a few large myelinated motor fibers are preserved, the F wave latency will remain normal. Severe nerve- root damage at multiple levels is necessary to prolong the (F wave) latency. . . . .
Page 258 – Sensitivity & Specificity
“Sensitivities typically reported in the literature are falsely elevated and tend to lull us into thinking that electrodiagnostic evaluation of radiculopathy is both sensitive and specific. Most reports . . . used surgical confirmation as the gold standard, although some used imaging. The specificity of imaging studies is low, with up to 50% of asymptomatic subjects having an anatomic abnormality noted on random screening. . . . Using surgery as a gold standard will skew the population tested because they are typically the most severe cases. If only sensory fibers are involved or if the motor involvement is mild . . . the EMG will be normal while the person actually has radiculopathy.”
Radiculopathy: How Useful that using EMG-type tests to diagnosing painful radiculopathic “is difficult or impossible.” If spinal motor pathology is suspected, “Only if there is observable muscle atrophy can one know for certain that motor axon degeneration has occurred.” “Sensitivities typically reported in the literature are falsely elevated and tend to lull us into thinking that electrodiagnostic evaluation of radiculopathy is both sensitive and specific.
Since EMG-type tests have remain unchanged since the 1960s the above review is as important today as it was when published in 1999.
Mayo Clinic Internal Medicine Board Review (2004)
“EMG is limited to the motor nerves, anterior horn cells and neuro-muscular junction.”
Massachusetts General Hospital Handbook of Pain Management (2002)
“These tests [EMG/NCV] cannot assess the small pain fibers or access the pre-dorsal root ganglionic (DRG) fibers causing most radicular pain.”
“In most cases [over 50%] of neck and back pain the anatomic and pathologic diagnosis remains unclear.” “History and physical examinations have a limited role in neck and back pain, the main purpose is to detect serious pathology.”
Neurology For The Non-Neurologist (2005)
“EMG/NCV in the evaluation of neck shoulder and back pain in the absence of motor deficit [muscle weakness or atrophy] is costly, time-consuming and seldom benefits the patient.”
Mayo Clinic study; “Why Patients See Doctors” (2013)
57.5% of 142,377 patients saw a doctor for spine and joint pain. The symptoms suggesting EMG is necessary (muscle weakness and atrophy) were so rare this was not a category.