Response to Comments: Nerve Conduction Studies and Electromyography

A comment was received from a neurologist requesting to expand the use of needle electromyography (NEMG) without a nerve conduction study (NCS) in the proposed LCD to include the diagnosis of peripheral nerve injuries that are difficult to test with NCSs. The commenter states: “This would include, but not be limited to, nerve injury of the long thoracic nerve in the shoulder girdle region, dorsal scapular nerve injury in the shoulder blade/middle scalenes, and superior and inferior gluteal nerve injuries in the gluteal region. Injury to these nerves is best detected by electromyography (EMG) findings of denervation because the NCS is difficult to perform and has not been standardized. It would be medically necessary to perform the needle exam to establish a diagnosis and treatment plan for these individuals.” The commenter requested that the LCD be revised to allow for NEMG without NCSs in these “unusual nerve injuries.” No references were cited or included with this comment.

The comment is appreciated. However, in the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

Comments were received from a physician representing physical therapist members of ‘Hands-On Diagnostics’, a physical therapist representing the Clinical Electrophysiology section of the American Physical Therapy Association, and the Director (a physical therapist) for West Park Rehab Physical Therapy. The commenters request coverage for blink reflex testing (CPT code 95933) which is in the associated billing and coding draft article in the non-covered Group 7 Codes. The commenters state “The blink reflex test is an integral component of the evaluation process for facial neuropathy, providing valuable insights. Furthermore, there is a compelling case to consider its utility in assessing polyneuropathy as well.” No references were cited or included with this comment.

The comments are appreciated. During the revision of this article, no evidence was found to support electrodiagnostic testing for blink reflex testing. In the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

Comments were received from a physician representing physical therapist members of ‘Hands-On Diagnostics’, a physical therapist representing the Clinical Electrophysiology section of the American Physical Therapy Association, and the Director (a physical therapist) for West Park Rehab Physical Therapy. The commenters have concerns regarding Limitation #2 in the proposed LCD that states: “EDX studies (NCS and NEMG) not performed by a physician or under direct supervision of a physician in the office setting (Refer to the CMS IOM Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests) are considered not medically reasonable and necessary.”

The commenters indicate that EDX studies are currently performed by American Board of Physical Therapy Specialties (ABPTS) certified physical therapists when provided in accordance with state law. The commenters request that the language in this limitation be revised to include physical therapists as outlined in the CMS Transmittal B-01-28.

The comments are appreciated. Following further review of the comment and associated evidence, we agree that a revision to the LCD is warranted. Limitation #2 has been revised in the finalized LCD to: “EDX studies (NCS and NEMG) not performed in accordance with the CMS regulations defined for supervision for diagnostic tests (Refer to the CMS IOM Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests) are considered not medically reasonable and necessary.”

Please note that the language included in the CMS Transmittal B-01-28 was incorporated into Section 80 of the Medicare Benefit Policy Manual.

A comment from the American Academy of Neurology (AAN), American Academy of Physical Medicine & Rehabilitation (AAPM&R), and the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) signifies disappointment that they were not “officially engaged in any capacity to provide input during the revision process” for this proposed LCD.  

Thank you for the comment. Stakeholder involvement is assured through their participation in the open meeting and through the public comment process. In accordance with the LCD development process, open meetings were held regarding this LCD prior to receipt of this comment, and there were no representatives from the above-mentioned organizations in attendance at those meetings.

A comment from the AAN, AAPM&R, and AANEM indicates concern regarding references to non-physician providers in the proposed LCD. The commenters state “Our societies agree that only a qualified physician with training in neurological and musculoskeletal disorders should perform the NEMG portion of an EDX study and directly supervise a qualified technician for the NCS portion of the study.”

The commenters state that they “do not support coverage of NEMG performed by a non-physician even if that non-physician is under the direct supervision of a physician. NCSs can be performed by a qualified technician under the direct supervision of a physician.”

The commenters recommend removing ‘qualified healthcare practitioner’ in the last sentence in the second paragraph under the ‘Radiculopathy’ subheader: “Radiculopathies cannot be diagnosed by NCS alone; NEMG must be performed to confirm a radiculopathy. Therefore, these studies should be performed together by one physician/qualified health care practitioner supervising and/or performing all aspects of the study.”

• The commenters indicate that this should be limited to a physician.
• The commenters state, “Technologists can only provide the NCS component of EDX under the direct supervision of a physician. Technologists cannot perform NEMG with or without supervision.”

The commenters also recommend “clarifying the definition of appropriately trained providers. The policy should require EDX providers to be physicians with training in neurological and musculoskeletal disorders. Physicians with the necessary qualifications to provide EDX are typically neurologists and physical medicine and rehabilitation physicians.” The commenters request a revision to the LCD in response to their concerns. No references were cited or included with this comment.

Thank you for the comment. In response to your concerns, we refer to the ‘Provider Qualifications’ section of the proposed LCD that states: “Services provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.” This language has been revised in the finalized LCD to: “Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.”

In addition, as noted above in the Response to Comment #3, Limitation #2 has been revised in the finalized LCD to: “EDX studies (NCS and NEMG) not performed in accordance with the CMS regulations defined for supervision for diagnostic tests (Refer to the CMS IOM Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests) are considered not medically reasonable and necessary.”

A comment was received from the AAN, AAPM&R, and AANEM regarding the coverage in the proposed LCD for evaluating tarsal tunnel syndrome. The commenters recommend that the ‘Covered Indications’ and ‘Analysis of Evidence’ sections of the proposed LCD be revised to indicate: “NCSs and NEMG should be performed together when evaluating patients for tarsal tunnel syndrome.” The commenters indicate that tarsal tunnel syndrome is more complex than carpal tunnel syndrome. No references were cited or included with this comment.

Thank you for your comment. Evidence reviewed during the revision of this proposed LCD indicates the following (as cited in the proposed LCD): “Patel et al¹¹ provides an AANEM practice topic regarding an evidence-based practice parameter that addresses the effectiveness of EDX testing in the diagnosis of TTS (tibial neuropathy at the ankle). The AANEM indicates that NCSs can be beneficial to substantiate the diagnosis of tibial neuropathy at the ankle. But the efficacy for NEMG in the evaluation of TTS is uncertain.”

Providers may use their clinical judgement as to whether to use a NCS with or without NEMG as indicated in the proposed LCD by the following: The ‘Covered Indications’ (Section A) indicates “NCSs and NEMG are considered medically reasonable and necessary when they are performed and interpreted at the same time, on site, and in real time for tarsal tunnel syndrome.”¹¹ The ‘Covered Indications’ (Section C) indicates “NCSs when performed without NEMG are considered medically reasonable and necessary for individuals being evaluated for carpal tunnel syndrome or tarsal tunnel syndrome.”^3,11

In the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

A comment from the AAN, AAPM&R, and AANEM regarding the ‘Indications’ section of the proposed LCD indicates “Our societies are unclear on how an NCS could be useful in the guidance of botulinum toxin treatment injection. NEMG would need to be used in order to isolate the affected muscles.” No references were cited or included with this comment.

Thank you for the comment. Following further review of the comment and associated evidence, we agree that a revision to the LCD is warranted. The finalized LCD has been revised for the ‘Covered Indications’ (Section C) to remove: “NCSs when performed without NEMG are considered medically reasonable and necessary for guidance for botulinum toxin treatment injections when it is difficult to isolate affected muscles.” The finalized associated billing and coding article has been revised accordingly.

A comment from the AAN, AAPM&R, and AANEM regarding the ‘Indications’ section of the proposed LCD recommends “specifying a caveat that single fiber electromyography (SFEMG) should be used for ocular myasthenia only when repetitive stimulation is inconclusive.” No references were cited or included with this comment.

Thank you for the comment. The American Academy of Ophthalmology Adult Strabismus Preferred Practice Pattern (2019) was reviewed during the revision of this proposed LCD, which states: “Repetitive nerve stimulation testing (positive in only one-third of patients with ocular myasthenia) and the far more sensitive single fiber electromyography (positive in over 90% of patients with ocular myasthenia) may also assist in diagnosis. In many centers, single fiber EMG is considered the gold standard for diagnosis.”^45(p396)

In the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

A comment was received from the AAN, AAPM&R, and AANEM recommending the addition of ‘SFEMG’ in the first sentence, along with ‘repetitive nerve stimulation’ under the ‘NMJ Disorders’ section in the ‘Summary of Evidence’ section of the proposed LCD: “Neuromuscular junction testing, also known as repetitive nerve stimulation, is an electrodiagnostic test that is used to diagnose NMJ disorders such as myasthenia gravis and Lambert-Eaton myasthenic syndrome.”

Thank you for the comment. Following further review of the comment and associated evidence, we agree that a revision to the LCD is warranted. The following language has been added to the ‘NMJ Disorders’ section in the ‘Summary of Evidence’ section in the finalized LCD: “Evidence-based guidelines recommend NMJ or SFEMG to confirm a clinical diagnosis of myasthenia gravis or Lambert-Eaton myasthenic syndrome.”²⁷

In this regard, the ‘Covered Indications’ (Section E) has been revised in the finalized LCD: “Single fiber electromyography (SFEMG) is considered medically reasonable and necessary for ocular myasthenia” has been changed to: “Single fiber electromyography (SFEMG) is considered medically reasonable and necessary for ocular myasthenia, myasthenia gravis and myasthenic syndrome (e.g., Lambert-Eaton myasthenic syndrome).” The associated billing and coding article is in agreement.

A comment was received from the AAN, AAPM&R, and AANEM regarding ‘Limitation #10’ in the proposed LCD that states: “Studies performed beyond the reasonable maximum number of studies recommended in the Current Procedural Terminology (CPT^®) Codebook, Appendix J, Electrodiagnostic Medicine Listing of Sensory, Motor, and Mixed Nerves are considered not medically reasonable and necessary. These recommendations are supported by the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Additional studies may be considered upon redetermination.”

The commenters denote, “The table in Appendix J of the CPT Codebook was designed as a tool to identify outlier trends. It does not reflect absolute maximum thresholds and should not be used to automatically deny reimbursement.” No references were cited or included with this comment.

Thank you for the comment. As noted in ‘Limitation #10’ in the proposed LCD: “Additional studies may be considered upon redetermination.”

A comment was received from the AAN, AAPM&R, and AANEM regarding the following language in the ‘Limitations’ section of the proposed LCD:

“Repeat EDX assessment may be needed in certain circumstances. The frequency for repeating EDX studies in a given patient by a given EDX provider for a given diagnosis per year can be reasonably limited. The following number of studies per 12-month period per diagnosis per provider are suitable: 1) Two studies for carpal tunnel-unilateral, carpal tunnel-bilateral, radiculopathy, mononeuropathy, polyneuropathy, myopathy, and NMJ disorders. 2) Three studies for motor neuron disease and plexopathy. These limits should not apply if the patient requires assessment by more than one EDX provider (i.e., a second opinion or an expert opinion at a tertiary care center) in a given year or if the patient requires evaluation for a second diagnosis in a given year.”

The commenters signify that this limitation is “overly prescriptive and recommend that it be stricken.” No references were cited or included with this comment.

Thank you for the comment. As noted in the paragraph following the language referenced by the commenters in the proposed LCD, “Repeat EDX studies are rare and should not be necessary in a 12-month period in 80% of all cases. Additional studies may be considered upon redetermination. In such circumstances, the rationale for the repeat study should be included in the medical record. Comparison with the previous study findings should be documented.”

A comment was received from the AAN, AAPM&R, and AANEM regarding language in the first paragraph under the ‘On-Site in Real Time’ subheader in the proposed LCD that refers to NCSs. The commenters indicate that “These statements actually refer more broadly to EDX studies, inclusive of NCS and NEMG. We recommend revising to EDX in both paragraphs.” No references were cited or included with this comment.

The paragraph in question reads as follows: “The AANEM⁸ indicates that when performing NCSs the waveform must be reviewed on site and in real time, with reports prepared onsite by the examiner, consistent with the AMA CPT^® Professional Codebook descriptions. The AANEM defines the use of the term onsite as that where the history and physical examination, performance of NCS and NEMG, analysis of electrodiagnostic data and determination of diagnosis occur in the same location, usually an electrodiagnostic laboratory. Similarly, real time is defined as that which allows for information from the history and physical to be integrated with the performance of testing, allowing for the testing of both NCS and NEMG to be tailored/modified to the individual situation as needed before leaving the lab.”²

This language is inclusive of NCS and NEMG as the commenters recommended therefore no change to the LCD language is necessary.

A comment was received from the AAN, AAPM&R, and AANEM regarding language in the second paragraph under the ‘NCSs’ subheader in the proposed LCD: “While the stimulation of nerves is similar across all NCSs, the attributes of motor, sensory, and mixed NCSs are different; a) Motor NCSs are conducted by applying electrical stimulation at different points along the course of a motor nerve while recording the electrical response from an appropriate muscle. Response parameters include amplitude, latency, configuration, and motor conduction velocity. b) Sensory NCSs are performed by applying electrical stimulation near a nerve and recording the response from a distant site along the nerve. Response parameters comprise amplitude, latency, and configuration. c) Mixed NCSs are achieved by applying electrical stimulation near a nerve containing both motor and sensory fibers (a mixed nerve) and recording from a different location along that nerve that also contains motor and sensory nerve fibers. Response parameters comprise amplitude, latency, configuration, and motor conduction velocity.”

The commenters recommend “removing motor conduction velocity from the list of response parameters.” No references were cited or included with this comment.

Thank you for the comment. The AANEM Position Statement for Recommended Policy for Electrodiagnostic Medicine (2019) and the AANEM Model Policy for Nerve Conduction Studies and Needle Electromyography (2021) (both cited in the proposed LCD) were reviewed during the revision of this proposed LCD. The language referred to by the commenters came directly from these references.

In the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

A comment was received from the AAN, AAPM&R, and AANEM regarding language under the ‘H-reflex/F-wave Study’ subheader in the proposed LCD. The commenters recommend deleting “involves the assessment of the gastrocnemius/soleus muscle complex in the calf in order to allow for testing of the median H-reflex.” No references were cited or included with this comment.

Thank you for the comment. It appears that the language in the proposed LCD referred to by the commenters is: “The H-reflex study involves the assessment of the gastrocnemius/soleus muscle complex in the calf and is usually performed bilaterally due to the need to assess symmetrical results in determining abnormalities.”

The AANEM Position Statement for Recommended Policy for Electrodiagnostic Medicine (2019) (cited in the proposed LCD) was reviewed during the revision of this proposed LCD. The language referred to by the commenters came directly from this reference.

In the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

A comment from the AAN, AAPM&R, and AANEM recommends adding Motor Neuron Disease under the ‘Conditions Recommended for Electrodiagnostic Testing’ section of the proposed LCD.

Thank you for the comment. Motor neuron disease is included in the proposed LCD in the ‘Covered Indications’ section A for NCSs and NEMG and section B for Neuromuscular junction (NMJ) testing. The ‘Summary of Evidence’ section in the proposed LCD provides discussion for this condition under the sections for ‘EDX Studies’ and ‘NCS’. Therefore, the finalized LCD will not be revised as requested.

A comment from the AAN, AAPM&R, and AANEM recommends removing the term ‘in general’ from the second sentence of the third paragraph under the ‘EDX Studies’ section in the ‘Summary of Evidence’ section of the proposed LCD: “In general, the NCS should be conducted and interpreted with complementary NEMG on site and in real time.”

The commenters state “This procedure should be performed this way all of the time and the current wording only gives an “out” for fraud and abuse to occur.” No references were cited or included with this comment.

Thank you for the comment. Following further review of the comment and associated evidence, we agree that a revision to the LCD is warranted. The language referred to by the commenters has been revised in the finalized LCD to: “It is expected that EDX studies are performed and interpreted on site and in real time. In accordance with the AMA CPT^® Codebook, “Waveforms must be reviewed on site in real time…”

A comment from the AAN, AAPM&R, and AANEM recommends replacing the term “entrapment neuropathies” with “carpal tunnel syndrome” in the last sentence of the third paragraph under the ‘EDX Studies’ section in the ‘Summary of Evidence’ section of the proposed LCD: “NCSs may be conducted without NEMG in some situations, such as entrapment neuropathies, but this should be the exception rather than the normal practice pattern.” No references were cited or included with this comment.

Thank you for the comment. The AANEM Model Policy for Nerve Conduction Studies and Needle Electromyography (2021) (cited in the proposed LCD) was reviewed during the revision of this proposed LCD. The language referred to by the commenters came directly from this reference.

In the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.