    
Final Comments Avail
Board Administrator
Username: Admin
Post Number: 66
Registered: 10-2002
| | Posted on Monday, June 09, 2008 - 01:30 pm: | 
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Comments NEURO-005 Nerve Conduction Studies and Electromyography
April 1, 2008
WPS was asked to evaluate for coverage the NC-stat® System and other similar automated nerve conduction devices. As part of the evaluation process on whether or not to allow payment for this and/or similar products WPS medical staff has worked with multiple professional societies, independent consultants in a variety of specialties, paid consultants from this industry, multiple Contractor Advisory Committee (CAC) members, and other Medical Directors. In addition, WPS received and reviewed hundreds of letters, and met multiple times with the manufacturer of the NC-stat® System.
The final decision is on the WPS web site and was published in the 2008 Communiqué:
Nerve conduction studies performed using automated devices (for example devices such as NeuroMetrix, Neuropath) cannot support testing of other locations other than for carpal tunnel evaluation, and other similar testing should not be billed to Medicare with the current CPT codes (95900, 95903, or 95904). Until a specific code for this service is established that describes automated testing, this procedure must be billed with procedure code 95999 and "Automated NCS Device" indicated in Item 19 of the CMS-1500 form. If filing electronically, the description should be included in the comment field.
When the beneficiary has a high pre-test or a priori probability for having the diagnosis of Carpal Tunnel Syndrome, the NC-stat® System or similar automated nerve conduction device (alone, without any additional nerve conduction studies) will be allowed, one service per arm, using CPT code 95999. The diagnosis ICD-9 354.0 should be used and the type of nerve conduction machine should be place in Item 19 of the CMS-1500 form. If filing electronically, the description should be included in the comment field.
In most instances, both NCS and usually EMG are necessary to perform diagnostic testing. While a provider may choose to perform just a NCS, when performed alone it is usually considered be a screening exam. The only exception to this is a situation when a provider may consider it appropriate to perform a NCS without doing an EMG for the diagnosis of carpal tunnel syndrome with a high pre-test probability.
Below is a summary of the comments WPS received:
Comment:
We feel that all surface electrodiagnostic technologies leave much to be desired and only provide partial information. Therefore, when tests of nerve function are indicated, needle EMG/NCV is the appropriate test. Again, this does not single out a single technology, but the NC Stat provides very limited information on nerve conduction only. We would not support its use.
Comment:
The NC-Stat System should not specifically be solely singled out. Rather, there should be a larger list of products, as well as a comment that the list is not inclusive.
Comment:
We understand that the Carrier Medical Director must make the final determination that a treatment/service is standard verses experimental/investigational. However we feel the denial of NC-Stat should be based on the fact that it is a screening test. Nerve conduction studies performed independent of needle electromyography EMG) may only provide a portion of the information needed to diagnose muscle, nerve root, and most nerve disorders. When the nerve conduction study (NCS) is used on its own without integrating needle EMG findings or when an individual relies solely on a review of NCS data, the results can be misleading, and important diagnoses may be missed.
Comment:
We have both the NeuroMetrix and the Needle EMG tests in our office. We feel the NeuroMetrix is more useful for our patients that need to be tested for Diabetic Neuropathy. These patients need to be tested once per year and we don't want to torture them by using the needle EMG. Please pass on our concerns at the draft.
Response:
While providers may wish to perform annual testing, it is not covered under Medicare. Published in Wisconsin Physicians Service August 2004 Communiqué:
NCD: SENSORY NERVE CONDUCTION THRESHOLD TEST which states:
Provider Action Needed
This instruction reaffirms the existing Medicare non-coverage policy on any type of Sensory Nerve Conduction Threshold Test (sNCT), and the device(s) used to perform the test, to diagnose sensory neuropathies or radiculopathies. This instruction constitutes a technical correction to previously issued Change Request (CR) 2988, and CR2988 should be discarded and replaced with this instruction. CR2988 was issued on March 19, 2004.
Background
As a result of reconsideration, this instruction reaffirms the existing Medicare non-coverage policy on any type of Sensory Nerve Conduction Threshold Test (sNCT), and the device(s) used to perform the test, to diagnose sensory neuropathies or radiculopathies.
The revision to Section 160.23 of Pub. 100-03 is a National Coverage Determination (NCD), and NCDs are binding on all Medicare carriers, fiscal intermediaries, quality improvement organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans. Under 42 CFR 422.256(b), an NCD that expands coverage is also binding on a Medicare Advantage Organizations. In addition, an administrative law judge may not review an NCD. (See the Social Security Act, Section 1869(f)(1)(A)(i))
Comment:
As an endocrinologist with a large diabetes practice, I see many patients with symptoms of neuropathy. In my office, we are able to use Neuro Metrix testing on select patients to distinguish those who have neuropathy most likely from diabetes versus those who might have another cause for their neuropathic symptoms. With that information, I can better care for my patients by directing them to a neurologist for further evaluation if their symptoms are likely non-diabetic.
I feel the addition of this testing for those patients with neuropathic symptoms has enhanced their care and allowed me to identify who would most benefit from further neurologic assessment versus those who could be treated for diabetic neuropathy.
I would like to be able to continue to offer this level of care to my patients and ask that you vote to allow me, as an endocrinologist, to monitor my patients for diabetic complications as I have been doing.
Response:
This service considered to be a screening test, and as such is not covered under Medicare.
Comment:
I am alarmed to learn of the movement requesting all nerve conduction testing to be performed by either neurology or physiatry. My practice has actively been using a NeuroMetrix testing machine for the past few years. It has assisted on numerous diagnostic dilemmas and saved thousands of dollars on further testing allowing us to manage these issues ourselves. I feel this is another attempt by specialists being motivated purely by financial gain, at the expense of the primary care physicians who are adequately managing issues.
Comment:
Nerve conduction testing is not limited to any particular specialty group or groups. Any practitioner is able to bill for procedures if the procedures are medically necessary, covered by Medicare, and properly billed.
Response:
From Medicare's perspective, the heart of the issue is that any automated nerve conduction device is only semi-equivalent to an EMG nerve conduction study. This is similar to the issues surrounding bone density testing, and the issues of low specificity and high false positive rates associated with some testing devices. The papers NeuroMetrix cites, specifically includes statements from the researchers that, at best, recommend that it be further studied for potential applicability in patient care -- not statements endorsing its accuracy in those settings, or for the patients for which the company advocates its use. It measures certain parameters, and has certain limitations in its accuracy and applicability. The studies were done in normal, asymptomatic patients -- not in patients with diabetic neuropathy, carpal tunnel, etc. As with any test, the clinical applicability is determined by the sensitivity and specificity, compared to a gold standard, and we have not seen any peer-reviewed clinically relevant scientific medical journal articles documenting any such studies for automated nerve conduction devices. The FDA which issued only a 510k status (not approval) for the equipment to be used in conjunction with EMG testing, not as a substitute.
There is no question that accurate, rapid neurologic diagnostic tools, in the hands of primary care clinicians or other practitioners, would be a great benefit -- and it is possible that automated nerve conduction devices, used appropriately in selected patients, could produce limited, but valid information. However, currently the medical evidence does not supports the equivalence in billing claimed by the company of automated nerve conduction devices compared to the nerve conduction services billed as CPT 95900, 95903, or 95904. Based on the above facts, a decision has been made that this is to be considered a non-covered screening diagnostic test, unless used for carpal tunnel syndrome, as described above.
Comment:
Our group of six board certified family physicians has utilized (NC-STAT) this test for over four years in accessing and diagnosing carpal tunnel syndrome, cervical and lumbar radiculopathy and diabetic peripheral neuropathy. The test is also used at the occupational medicine department at St. Louis University School of medicine and by several orthopedic groups in the St. Louis metro area. It s not an experimental device. It is backed by multiple scientific studies in peer reviewed journals. It is a FDA approved test and it's removal as a stand alone test would be a detriment to the care of many patients. I know that in my practice many patients refuse needle EMGs and accurate diagnoses! can often be made without them. There is no evidence based guidelines to support the necessity of needle EMGs for the diagnoses of neuropathies. I would appreciate it if you could convey these comments to your committee. I greatly appreciate your time in considering this and for your giving of your time to serve on this important committee.
Response:
Automated nerve conduction devices is now covered for the diagnosis of carpal tunnel syndrome. This test is not covered for the diagnosis of cervical and lumbar radiculopathy and diabetic peripheral neuropathy. By definition since it is a 510(k) product and does not have a FDA Premarket Approval number, it is NOT FDA approved. It is allowed to be sold, but not with a designation of FDA approval.
Comment:
After reviewing the updated NEURO-005, we fully agree with this policy change.
Response:
Thank you
Comment:
Why does WPS require both EMG and nerve conduction studies?
Response:
Nerve conduction studies performed independent of needle electromyography (EMG) may only provide a portion of the information needed to diagnose muscle, nerve root, and most nerve disorders. When the nerve conduction study (NCS) is used on its own without integrating needle EMG findings or when an individual relies solely on a review of NCS data, the results can be misleading, and important diagnoses may be missed. We do agree that there are times that both are not needed, although typically both should be done together.
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