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Response to Comments: Visual Electrophysiology Testing (L37015)

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A55533
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Response to Comments: Visual Electrophysiology Testing (L37015)
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Response to Comments
Original Effective Date
07/17/2017
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Visual Electrophysiology Testing, DL37015. Thank you for the comments.

Response To Comments

Number Comment Response
1 Regarding VEP testing: the suggested parameters make perfect sense from a neurological perspective. I like how it is written. Thank you for the comments.
2 Eyelid skin electrodes are now used in ERG assessments in a number of cases, especially with the new RETeval hand held ERG instrument sold by LKC and the RETeval is now used for diagnosis of diabetic retinopathy and also has the ISCEV protocol in the instrument for use if needed. It also provides the Photopic Negative Response (PNR) protocol, which is sometimes used either with this instrument or standard ERG instruments to quantify both inner and outer retinal responses (the inner retinal photopic negative response corresponds to retinal ganglion cell response). So both the PERG (which in many cases also uses eyelid skin electrodes) and the PNR are sometimes used to measure responses in any type of optic neuropathy, in addition to glaucoma. We appreciate the comment and will continue to update coverage as evidence evolves. Further studies on the prognostic value of the PNR and Pattern ERG (PERG) in these diseases are required to establish their clinical utility.
3 One commenter requested the following codes be added. Congenital nystagmus is the most common reason for ERG in infant/children and it is not on there. Please add the following codes to Group 1 for Visual Evoked Potential (VEP):
E70.319Ocular albinism – unspecified
E70.329Oculocutaneous albinism – unspecified
H54.7Cortical visual loss
Please add the following codes to Group 2 for Electroretinography (ERG):
H47.61Cortical blindness
H55.01Congenital nystagmus
L10.4Pemphigus erythematosus (Senear-Usher syndrome)
 The code L10.4 for Usher syndrome is mentioned in the narrative section of the draft LCD but was inadvertently left out of the table of codes. Code L10.4 will be added to Group 2 for ERG for CPT code 92275. Regarding the other diagnosis codes, due to lack of consensus the other codes will remain non-covered.
4 A commenter indicated that although she does not have this technology, it is an objective means of evaluating glaucoma patients. Although she does not disagree that it is still investigative at this time, she and her colleagues take care of a lot of glaucoma patients who are unable to perform visual field testing, which is the current gold standard. She asked if WPS GHA could include an exception in the LCD to allow testing under these special circumstances. Some preliminary information indicates this testing can be an important tool for managing these patients. Electrophysiological Testing is an objective and reliable means to assess the function of the visual system from the retinal cells to the visual cortex. It has been around for many years, but in the last few years, newer models are making it more practical for the average practitioner to utilize this technology in their office. The above mentioned LCD for Electrophysiology Testing specifically denies the use of this testing for diagnosis and management of glaucoma and glaucoma suspects. I feel that there are many instances when this testing could be beneficial, if not crucial in identifying those patients who could or who are losing vision to glaucoma. Unfortunately, glaucoma is a leading cause of permanent vision loss in the United States. Current testing strategies are to monitor the: Optic Nerve and Nerve Fiber structure: via direct observation or imaging via photography and scanning computerized ophthalmic diagnostic imaging (SCODI)/OCT. Visual function can be determine via visual fields and electrophysiological testing. When fields are reliable, they give an excellent information about whether the glaucoma has progressed from mild to severe glaucoma. However, not all patients can perform field reliably and that ability decreases as a patient ages (when the risk for glaucoma and glaucoma progression goes up). Visual fields are a subjective test, the patient has to respond (click a button) when they see a series of lighted dots. Also, many factors can affected the quality of a field, including refractive error, cataracts and corneal problems, in addition to the patient’s attention span and ability to simply sit in the instrument for the 15 plus minutes needed to complete the test. In order for a field to show a field changes, 50% of the nerve fibers have to be lost. Electrophysiological testing could identify those changes much early… up to 4 years earlier (#2). Lowering the Intraocular Pressure is the only means we currently have to reduce a patient’s risk of losing vision from glaucoma. Electrophysiological testing is an objective test has much few issues for patient reliability. Yes, they have to sit and be attentive, but there is NOT a subjective response. The electrical activity of their visual path is being recorded. In summary:
  1. Electrophysiology testing determines functional changes in glaucoma
  2. Those changes change be found earlier (up to 4 years) that visual field testing
  3. Electrophysiclogy testing is an objective test of visual function and has fewer obstacles for reliable testing compared to and visual fields.
  4. Electrophysiology testing is a function vision test. SCODI/Scanning Lasers-OCT is an image to evaluate the structure.
  5. Combined with our current technology, Electrophysiological testing will improve the outcome for patients with glaucoma and who are being monitored as glaucoma suspects.
Three abstracts of articles were listed to support the position. 		We appreciate the comment and will continue to update coverage as evidence evolves. However, at present this technology (VEP and ERG) is experimental for glaucoma patients. Reconsideration requests can be submitted with supporting data per CMS requirements at any time. The beneficiaries, physicians, and suppliers may request an appeal on any service processed for them by MACs. Appeals activities conducted by MACs are governed by instructions from CMS.
5 A commenter noted that her colleagues have shown concern about losing the ability to bill for the use of this technology for glaucoma patients. While it doesn’t necessarily show the progression from a glaucoma suspect to a diagnosed case, it can be used with a known glaucoma patient that can’t do a visual field to help providers decide how aggressively to pursue treatment. She stated that there is no definitive line between suspect and confirmed glaucoma, and when a visual field test cannot be performed, it is important to have other options available. Although neither the American Academy of Ophthalmology (AAO) nor the American Optometric Association (AOA) list this service as the standard of care, there is published research in the Investigative Ophthalmology and Visual Science (IOVS) journal to show that electrophysiology could show glaucoma up to 8 years sooner than a visual field test. These treatments are important. The commenter further stated that many of them do, however, sometimes the shape of the optic nerve is unusual, which makes use of OCT questionable. Results may fall against the normal or show thinning compared to age normal, whereas electrophysiology will tell if the nerve is conducting to the brain properly or if it is damaged. We appreciate the comment and will continue to update coverage as evidence evolves. The beneficiaries, physicians, and suppliers may request an appeal on any service processed for them by MACs. Appeals activities conducted by MACs are governed by instructions from CMS. Simply because a test may be approved for a given condition (by FDA, ISCEV, or others), or generally considered as a potential ancillary test for neuro-ophthalmic conditions by the AAO, does not necessarily guarantee clinical utility for a specific diagnosis as defined by Medicare. Those indications included in the draft LCD were considered to have met the Medicare standard of “medically reasonable and necessary” based on a consensus among cited Medicare contractor and commercial related policies, along with consultation with contractor advisory committee (CAC) ophthalmology members and other regional experts. With respect to the specific diagnosis of glaucoma, these experts maintained that questions remain around clinical use of VEP and ERG testing, including reproducibility, contraindications and patient selection (including confounding factors such as blurring or retinal images due to cataract and maculopathy, etc.), what constitutes a significant change, and progression analysis. The AAO position on glaucoma is defined in the two 2015 published Preferred Practice Pattern reports “American Academy of Ophthalmology (AAO), Glaucoma Panel. Primary Open-Angle Glaucoma Suspect. Preferred Practice Pattern,” and “American Academy of Ophthalmology (AAO), Glaucoma Panel. Primary Open-Angle Glaucoma”. Both were cited in draft LCD but neither were cited in the comment and, as stated in the LCD, neither mention VEP or ERG as diagnostic tools”. Instead, they specifically list as diagnostic testing components central corneal thickenss (CCT) measurement, visual field evaluation, and optic nerve head/retinal nerve fiber layer (ONH/RNFL) imaging. While AAO endorsement is not necessarily sufficient for Medicare coverage, it would normally be necessary.
6 A commenter has spoken with her colleagues who treat glaucoma, and they are in agreement with the designation as investigational for monitoring progressive changes of glaucoma. These tests are not yet considered to be the standard of care. She and her colleagues agree with the wording of the LCD. Thank you for the comments.
7 A commenter agreed with the LCD. He indicated that some doctors in his area are doing these studies with nonspecific results. He indicated that the LCD is very well written. He wanted to reiterate ophthalmology’s support for the recent LCD regarding ERG/VEP testing. That was well done. As I mentioned, we are seeing providers buy machines and then doing the tests on lots of patients. It is not clear that is really helpful (although no doubt the docs doing the tests will say so). The LCD is written in a way that keeps an open mind about the utility the testing depending on future research, yet will also hopefully discourage indiscriminate use of what are rather specialized tests. Thanks to everyone for being good stewards of the public’s money! Thank you for the comments.
8 A commenter concurred that from a neurological standpoint these tests are still investigative for glaucoma patients. Thank you for the comments.
9 We received two identical letters from two different commenters: We have been using visual electrophysiology testing (VEP Testing) as part of our glaucoma management protocol for the past few years. Glaucoma is a vascular disease that affects the optic nerve and the relay of electro-physical signals to the visual centers of the brain. This test most certainly has benefited the care of our patients and certainly should be kept in the armamentarium that is reimbursed by insurance plans. Our basic knowledge of electrophysiology supports the use of VEP testing. While more studies most certainly will clarify the degree of change early in glaucoma, its usefulness, I believe, is integral to taking care of our patients. Prevention is the key in all areas of medicine and VEP is a tool to diagnosis problems before visual field loss is incurred. I would strongly support keeping VEP testing as part of an LCD. Preventive services are clearly defined by CMS. While glaucoma screening is listed as a Medicare preventive service it does not specify which method of testing is approved.
10 Include any and all ICDs that are associated with the visual pathway, including the retina, similar to visual field testing. Inclusion of all ophthalmic ICDs will also permit accurate coding order that is required based on ICD coding guideline “code first” rules for diagnosis and etiology/manifestation. Coverage for VEP and ERG is accepted and required for these reasons, in addition to the patient’s rights to medically necessary diagnostic tests under SSA 1682 (a)(1)(A). Please add the following codes to Group 1 codes for Visual Evoked Potential (VEP):
A39.82Meningococcal retrobulbar neuritis
C70-C72Malignant neoplasm of meninges, brain, spinal cord, cranial nerves and other parts of nervous system (Malignant neoplasm of meninges - Malignant neoplasm of brain, spinal cord, cranial nerves and other parts of nervous system)
D32-D33Benign neoplasm of meninges, benign neoplasm of brain and other parts of central nervous system
D44.3Neoplasm of uncertain behavior of endocrine glands (Neoplasm of uncertain behavior of pituitary gland)
F44.4-F44.7Dissociative and conversion disorders (Conversion disorder with motor symptom or deficit – Conversion disorder with mixed symptom presentation)
G35Multiple sclerosis
G36-G37Other acute disseminated demyelination - Other demyelinating disease of central nervous system
G45.8Other transient cerebral ischemic attacks and related syndromes
G61Inflammatory polyneuropathy
G80Cerebral palsy
G81Hemiplegia and hemiparesis
G93.2Benign intracranial hypertension
R42Dizziness and giddiness
S04Injury of cranial nerve
S06Intracranial injury
  1. Novitas Solutions Medicare – Neurophysiology Evoked Potential (NEPs) L34975
  2. Cahaba Medicare - Neurophysiology Evoked Potentials (NEPs) L34266
  3. Noridian – Sensory Evoked Potentials & Intraoperative Neurophysiology Monitoring L34072
Please add the following codes to Group 2 codes for Electroretinography (ERG):
E08-E13.9Secondary diabetes mellitus (Diabetes mellitus)
E14Diabetes mellitus (Not a true code per the ICD-10 book)
E56Other nutritional deficiencies (Other vitamin deficiencies)
E70.21-E70.8Other disturbances of aromatic amino-acid metabolism (Tyrosinemia - Other disorders of aromatic amino-acid metabolism)
G35Multiple sclerosis
G36.0Neuromyelitis optica
G61.0-G61.89Inflammatory and toxic neuropathy (Guillain-Barre syndrome – other inflammatory polyneuropathies)
H35.50-H35.54Hereditary retinal dystrophy (Unspecified hereditary retinal dystrophy – Dystrophies primarily involving the retinal pigment epithelium)
H40.001-H40.9Glaucoma (Preglaucoma, unspecified, right eye – Unspecified glaucoma)
H46.00-H47.9Disorders of optic nerve & pathway
H53.001-H53.9Visual disturbances (Unspecified amblyopia, right eye – Unspecified visual disturbance)
I60.00-I66.9Intracranial and cerebral disorder (Nontraumatic subarachnoid hemorrhage from unspecified carotid siphon and bifurcation – occlusion and stenosis of unspecified cerebral artery)
R47.01Aphasia
S04.011A-S04.042SInjury to optic nerve and visual pathway (Injury of optic nerve, right eye – injury of visual cortex, left eye)
S06.0X6A-S06.6X9SIntracranial injury, TBI (Concussion – Traumatic subarachnoid hemorrhage with loss of consciousness of unspecified duration)
T50.901Late effect of poisoning due to drug, medicinal or biological substance (Poisoning by unspecified drugs, medicaments and biological substances accidental (unintentional))
T50.905Late effect of adverse effect of drug, medicinal or biological substance (Adverse effect of unspecified drugs, medicaments and biological substances)
Z13.5Special screening for neuro/eyes (Encounter for screening for eye and ear disorders)
Z79.899Long term (current) drug use (Other long term (current) drug therapy)
  1. BSBS FL Policy #01-92000-28 includes Glaucoma (H40) updated 10/01/2016
  2. ISCEV Standards Recommendations and Guidelines – Appendix A
  3. ISCEV Standards for Clinical Pettern Electroretinography – PERG 2012 “It can also be used to detect and monitor dysfunction of retinal ganglion cells caused by conditions such as glaucoma, optic neuropathies and primary ganglion cell disease”.
  4. AAO Basic and Clincial Science Course Visual Field indicate ERG and VEP “may be a useful objective test for assessing RGC function”.
  5. AAO Basic and Clincial Science Course on Glaucoma – Chapter 4 Section: The Glaucoma Suspect “Increasing the use of short-wavelength automated perimetry (SWAP) and frequency-doubling technology (FDT) perimetry, as well as assessment of the pattern electroretinogram, may improve the ophthalmologists’ability to recognize early glaucomatous visual function loss in patients considered to be glaucoma suspects because of a suspicious optic disc appearance.”
  6. Bach, M, Hoffmann. MB Update of the pattern electroretinogram in glaucoma. Optom Vis Sci. 2008 Jun;85(6):386-95. “PERG assists in identifying those patients with elevated intraocular pressure in whom glaucoma damage is incipient before visual filed changes occur.”
  7. Bach, M. Unsoeld AS, Philippin H, Staubach F, Maier P, Walter HS, Bomer TG, Funk Invest Ophthalmol Vis Sci. 2006 “The PERG can help to predict stability or progression to glaucoma in OHT at least 1 year ahead of conversion.”
Thank you for your consideration. Expanding coverage will result in earlier diagnosis and better managment for our patients and the lives you cover. 		Multiple sclerosis (G35) and optic nerve injuries (some S04 codes) were inadvertently omitted from our draft and will be added to the Group 1 codes for VEP 95930. Codes E08.311-E13.3593, H35.50-H35.54, H46.01 - H47.393, H53.60, and Z79.899 are already in our Group 2 codes for ERG 92275 in the draft LCD. Regarding the other diagnosis codes, some are non specific and would not be added. Some are not related to the optic nerve or the retina and would not be added to the LCD at this point. Z13.5 is screening and screening under Medicare has limited benefits for only certain items. Injury to the optic nerve or diseases specific to the optic nerve would not be added for ERG testing.
11 In my opinion as a neuro-ophthalmologist, optometrists should not be performing VEP or ERG testing, only medical doctors should be performing these retina and optic nerve-specific tests. These tests should have very low utilization, even among neurologists and ophthalmologists (MD, DO) and any increase in utilization or over utilization is likely due to optometrists now performing VEP and/or ERG in their offices. As a neuroophthalmologist, I find VEP an essentially useless test, although many neurologists see it as helpful in identifying an optic neuropathy. Thank you for the comments.
12 A commenter stated: We do both, visual evoked potential and pattern ERG, in our clinic. An exlusion of pattern ERG is not wise for glaucoma patients. There are patients who do not respond well to traditional visual field testing in glaucoma and even they can’t respond. They just don’t respond well or they can’t respond. And the pattern ERG measures ganglion cell function which are cells that are damaged in glaucoma. So the pattern ERG has been determined to assess ganglion cell function and that is – there are numerous studies that have shown that. And to eliminate the pattern ERG as a possibility to cover these patients that cannot respond to other testing is not advisable. We appreciate the comment and will continue to update coverage as evidence evolves. However, at present this technology (VEP and ERG) is experimental for glaucoma patients. Reconsideration requests can be submitted with supporting data per CMS requirements at any time. The beneficiaries, physicians, and suppliers may request an appeal on any service processed for them by MACs. Appeals activities conducted by MACs are governed by instructions from CMS.
13 A commenter stated: As experts in the field of visual electrophysiology, our company performs extensive research on the clinical applications for visual evoked potential testing and electroretinography. We submit the attached evidence for inclusion and coverage in the policy: Attachment 1: ISCEV standards - see appendix A to confirm accepted clinical indications for standardized visual electrophysiology technology; EOG, ERG, PERG and VEP. Attachments 2 & 3: Clinical evidence includes use of VEP for visual disturbances that lead to the diagnosis of other disorders of the pathway, including amblyopia. Attachment 4: Pattern ERG is not experimental for detection of disorders that target retinal ganglion cell function. Clinical evidences supports coverage for disorders of the retinal ganglion cells including glaucoma. Attachment 5: Pattern ERGs are performed after an abnormal VEP to isolate the area of dysfunction. R94.112 abnormal VEP and R94.111 abnormal ERG need to be added to the policy to properly reflect the reason for the test based on standards for use of this technology and sequential testing during a working diagnosis. Attachment 6: Section VIII Neuro-ophthalmology of the AAO Ophthalmologist Resident Content Outline instructs residents and includes electrophysiology as an ancillary method of testing. VEP and ERG are medically required when a patient presents with neuro-ophthalmic symptoms and signs, disorders of the afferent visual pathway, disorders with neuro-ophthalmic manifestations, systemic, ocular or neurologic disorders known to affect visual function. Visual electrophysiology is historically accepted in neurology and ophthalmology for these purposes. The tests are the only diagnostic method we have to objectively identify and measure dysfunction for diagnosis. We asked Certified Professional Coders to code Neuro-ophthalmic indications taught to ophthalmologist for ancillary visual evoked potential and electroretinogram testing. The addition of these codes to the policy is vital for vision specialists to evaluate visual function for confident diagnosis.
    Neuro-ophthalmic symptoms and signs
      Visual loss and visual field loss     H53-H54 Positive visual phenomena and hallucinations     R44, H53 Higher cortical dysfunction     G93 Optic nerve abnormalities     H46-H47 Oscillopsia and nystagmus     H55 Double vision and abnormal extraocular movements     H53 Ptosis and lid retraction     H02 Proptosis and endophthalmos     H05 Pupillary changes     H21 Facial movements and weakness     I69, R29.81x Pain     H57.1x
    Disorders of the afferent and efferent visual pathways
      Diseases of the optic nerve
      • Ischemic optic neuropathy     H47.01x
      • Inflammation     H46
      • Compression / Infiltration     H47.09x
      • Paraneoplastic     H47.52x, C72
      • Traumatic     S04
      • Toxic or Nutritional     H46-H47
      • Metabolic     H46-H48
      • Hereditary or Congenital     H46-H47
      • Glaucoma     H40-H42
      • Raised intracranial pressure (papilledema)     H47.1x, G93.2
      Orbital pathology causing neuro-ophthalmic manifestations
      • Trauma     S04, S06
      • Mass lesions     C70-C72, D32-D33, D44
      • Inflammation     H05
      • Infection     H05
      Diseases of the chiasm
      • Chiasmal visual field defects     H53
      • Compression/infiltration     H47.4x
      • Inflammation     H47.4x
      • Trauma     S04.02Xx
      • Ischemia/hemorrhage     H47.4x
      Diseases of the retrochiasmal visual pathways
      • Optic tract     H47, S04
      • Lateral geniculate     H47, S04
      • Radiations     H47, S04
      • Calcarine cortex     H47, S04
      • Association areas     H47, S04
      • Specialized syndromes     code specific disease
      Pupillary pathology
      • Normal pupillary responses     Z01.00
      • Effects of drugs     T36-T50
      • Congenital pupillary abnormalities     H21
      • Traumatic and secondary pupillary changes     H21
      • Evaluation and management      Z00-Z13
      Eye movement systems pathology
      • Vestibular ocular system     H55
      • Optokinetic nystagmus     H55
      • Saccades     H56
      • Pursuit     H55
      • Convergence     H51
      • Divergence     H51
      • Specific syndromes     code specific disease
      • Ocular motility disturbance by location     H51, H55
      Nystagmus and disorders of ocular stability
      • Jerk nystagmus     H55
      • Pendular nystagmus     H55
      • Congenital vs acquired nystagmus      H55
      • Central vs peripheral nystagmus     H55
      • Specific types of nystagmus and their localizing value     H55
      • Induced nystagmus     H55
      • Ocular oscillations     H55
      Eyelid position abnormalities
      • Eyelid retraction     H02
      • Ptosis     H02
      • Eyelid nystagmus     H55
      Facial nerve dysfunction
      • Central and peripheral facial palsy     G51
      • Blepharospasm     G24.5
      • Hemifacial spasm     G51.3
      • Facial myokymia, tics, and myotonia     G51.4, G71.1x
      • Oculomasticatory myorhythmia (Whipple's)     K90.8
    Disorders with neuro-ophthalmic manifestations
      Developmental and congenital anomalies
      • Visual maturation     H53
      • Prematurity and birth injuries     P07, P15
      • Cerebral palsy     G80
      • Congenital hydrocephalus     Q03
      • Cranial dysostoses (craniosynostosis)     Q75
      • Amblyopia     H53
      • Congenital optic nerve anomalies     Q14
      • Common malformations of the eye and orbit     Q10-Q18
      • Skull base malformations. Chiari malformation     Q75
      • Fibrous dysplasia     M85.0x, K10.8
      • Child abuse     T76
      Systemic disorders
      • Hereditary     G11.4-G11.8, G60.0-G60.8, H47.22
      • Neurocutaneous     Q85, G11.3,
      • Vascular     G95.19, H47.53x, I67.84x
      • Metabolic     code specific disease
      • Autoimmune     code specific disease
      • Neoplastic     G13
      • Infectious     A18.53, A39.82, A69.2x, B50
      Neurologic disorders commonly
      • Head and ocular injury     S00-S09
      • Increased intracranial pressure     G93.2
      • Vascular disease of the brain and the eye     I60-I69
      • Seizures     G40
      • Neoplasms     C70-C72, D32-D33, D44
      • Demyelinating disease     G35-G37
      • Infections     A39.82, A69
      • Metabolic diseases     E70-E88
      • Neuro-degenerative diseases      G30-G32
      • Hereditary ataxias     G11
      • Polyradiculopathies     M54
      • Neuro-muscular transmission deficits     G70
      • Myopathies (involving the extraocular muscles)     H05.82x
      • Headache and facial pain     R51, G50
      Ocular diseases
      • Ocular neoplasms     C70-C72, D32-D33, D44
      • Ocular infection or inflammation     H57.8, H10, H20 (code specific disease)
      • Retinal disorders     H30-H36
      • Glaucoma     H40-H42
      Neuro-ophthalmic manifestations of iatrogenic diseases
      • Radiation     Z51, code problem secondary
      • Chemotherapy     Z51, code problem secondary
      • Drugs     code specific drug
      • Surgical procedures      code specific disease
Attachment 7: The AAO confirms use of electrophysiology in the Preferred Practice Pattern for the Comprehensive Adult Eye Exam. This following language needs to be contained in the policy. "Based on the patient's history and findings, additional tests or evaluations might be indicated to evaluate further a particular structure or function. These are not routinely part of the comprehensive medical eye clinical evaluations." However, "additional diagnostic testing may include the following:" " ...electrophysiology" We thank you, in advance, for including these reasonable and necessary indications, ICDs and evidence of practice acceptance into the policy. To properly diagnose neuro-ophthalmic disorders of the retina with ERG (flash or pattern) or retrobulbar concerns using VEP (flash or pattern), an accurate policy will include all suggested indications and ICDs in attachment 6 to allow precise diagnoses and care of disorders that damage visual function in the visual pathway. 		Many codes for H46 and H47, H53, and T37 are already listed in the draft LCD. Multiple sclerosis (G35) and optic nerve injuries (some S04 codes) were inadvertently omitted from our draft and will be added to the Group 1 codes for VEP 95930. Regarding the other diagnosis codes, due to lack of consensus and that the majority are not diseases of the optic nerve or retina, they will remain non-covered.
14 A commenter stated: WPS has proposed to include “malingering/functional vision loss (to rule out)” as a covered indication for Visual Evoked Potential or Responses (VEPs/VERs). Based on our review, it is possible that hysterical blindness may be considered a subset of malingering/functional loss. However, WPS has not listed hysterical blindness as a covered condition. Therefore, we respectfully request that hysterical blindness be added as a covered indication for Visual Evoked Potentials/Responses. We further request that the appropriate ICD-10-CM diagnosis code representing the condition (F44.6 - Conversion disorder with sensory symptom or deficit) be included as a covered diagnosis for CPT code 95930. We appreciate the opportunity to comment and your consideration of our request. The narrative section of the draft LCD, under Visual Evoked Potential (VEPs) 2. Evaluate diseases of the optic nerve, does list: g. Malingering/functional vision loss (to rule out). Diagnosis code F44.6 (Conversion disorder with sensory symptom or deficit) was inadvertently omitted from our draft LCD and will be added to the Group 1 table of codes for VEP 95930.
15 A commenter stated the current list of references provided in the draft LCD are few and limited and do not adequately represent the scope of clinical Visual Electrophysiology. A list of additional references that should be reviewed and considered when evaluating reasonable utilization was included. (V. Zemon, Kaplan, & Ratliff, 1980) Zemon, V., Kaplan, E., & Ratliff, F. (1980). Bicuculline enhances a negative component and diminishes a positive component of the visual evoked cortical potential in the cat. Proc Natl Acad Sci U S A, 77(12), 7476-7478. (F. Ratliff & Zemon, 1982) Ratliff, F., & Zemon, V. (1982). Some new methods for the analysis of lateral interactions thatinfluence the visual evoked potential. Ann N Y Acad Sci, 388, 113-124. (V. Zemon & Ratliff, 1982) Zemon, V., & Ratliff, F. (1982). Visual evoked potentials: evidence for lateral interactions. Proc Natl Acad Sci U S A, 79(18), 5723-5726. (V. Zemon, Gutowski, & Horton, 1983) Zemon, V., Gutowski, W., & Horton, T. (1983). Orientational anisotropy in the human visual system: an evoked potential and psychophysical study. Int J Neurosci, 19(1-4), 259-286. (V. Zemon & Ratliff, 1984) Zemon, V., & Ratliff, F. (1984). Intermodulation components of the visual evoked potential: responses to lateral and superimposed stimuli. Biol Cybern, 50(6), 401-408. (Victor & Zemon, 1985) Victor, J. D., & Zemon, V. (1985). The human visual evoked potential: analysis of componentsdue to elementary and complex aspects of form. Vision Res, 25(12), 1829-1842. (Gutowitz, Zemon, Victor, & Knight, 1986) Gutowitz, H., Zemon, V., Victor, J., & Knight, B. W. (1986). Source geometry and dynamics of the visual evoked potential. Electroencephalogr Clin Neurophysiol, 64(4), 308-327. (V. Zemon, Kaplan, E., Ratliff, F., 1986) Zemon, V., Kaplan, E., Ratliff, F. (1986). The role of GABA-mediated intracortical inhibition in the generation of visual evoked potentials. In: Evoked Potentials. Cracco R.Q., Rodis-Wollner I., eds. Frontiers of Clinical Neuroscience. Vol 3. New York: Alan R. Liss, 287-295. (V. Zemon, Victor, J.D. and Ratliff, F., 1986) Zemon, V., Victor, J.D. and Ratliff, F. (1986). Functional subsystems in the visual pathways of humans characterized using evoked potentials. In R. Q. C. a. I. Bodis-Wollner (Ed.), Frontiers of Clinical Neuroscience, Evoked Potentials (Vol. 3, pp. 203-210). New York: Alan R. Liss, Inc. (Kaplan & Shapley, 1986) Kaplan, E., & Shapley, R. M. (1986). The primate retina contains two types of ganglion cells, with high and low contrast sensitivity. Proceedings of the National Academy of Sciences, 83(8), 2755-2757. (V. Zemon, Gordon, & Welch, 1988) Zemon, V., Gordon, J., & Welch, J. (1988). Asymmetries in ON and OFF visual pathways of humans revealed using contrast-evoked cortical potentials. Vis Neurosci, 1(1), 145-150. (Jindra & Zemon, 1989) Jindra, L. F., & Zemon, V. (1989). Contrast sensitivity testing: a more complete assessment of vision. J Cataract Refract Surg, 15(2), 141-148. (Maccabee et al., 1991) Maccabee, P. J., Amassian, V. E., Cracco, R. Q., Cracco, J. B., Rudell, A. P., Eberle, L. P., & Zemon, V. (1991). Magnetic coil stimulation of human visual cortex: studies of perception. Electroencephalogr Clin Neurophysiol Suppl, 43, 111-120. (Dacey & Petersen, 1992) Dacey, D. M., & Petersen, M. R. (1992). Dendritic field size and morphology of midget and parasol ganglion cells of the human retina. Proc Natl Acad Sci U S A, 89(20), 9666- 9670. (Sokol, Zemon, & Moskowitz, 1992) Sokol, S., Zemon, V., & Moskowitz, A. (1992). Development of lateral interactions in the infant visual system. Vis Neurosci, 8(1), 3-8. (Prunte-Glowazki & Zemon, 1993) Prunte-Glowazki, A., & Zemon, V. (1993). [Sweep-VEP: a new method for objective visual assessment in small children]. Klin Monbl Augenheilkd, 202(5), 422-424. doi:10.1055/s-2008-1045618 (V. Zemon, Pinkhasov, & Gordon, 1993) Zemon, V., Pinkhasov, E., & Gordon, J. (1993). Electrophysiological tests of neural models: evidence for nonlinear binocular interactions in humans. Proc Natl Acad Sci U S A, 90(7), 2975-2978. (V. Zemon, Conte, & Camisa, 1993) Zemon, V., Conte, M. M., & Camisa, J. (1993). Stimulus orientation and contrast constancy. Int J Neurosci, 69(1-4), 143-148. (Grose-Fifer, Zemon, & Gordon, 1994) Grose-Fifer, J., Zemon, V., & Gordon, J. (1994). Temporal tuning and the development of lateral interactions in the human visual system. Invest Ophthalmol Vis Sci, 35(7), 2999-3010. (V. Zemon et al., 1995) Zemon, V., Eisner, W., Gordon, J., Grose-Fifer, J., Tenedios, F., & Shoup, H. (1995). Contrast dependent responses in the human visual system: childhood through adulthood. Int J Neurosci, 80(1-4), 181-201. (V. Zemon, Hartmann, Gordon, & Prünte-Glowazki, 1997) Zemon, V., Hartmann, E. E., Gordon, J., & Prünte-Glowazki, A. (1997). An electrophysiological technique for assessment of the development of spatial vision. Optom Vis Sci, 74(9),708-716. (Kim, Zemon, Saperstein, Butler, & Javitt, 2005) Kim, D., Zemon, V., Saperstein, A., Butler, P. D., & Javitt, D. C. (2005). Dysfunction of earlystage visual processing in schizophrenia: harmonic analysis. Schizophr Res, 76(1), 55-65. doi:10.1016/j.schres.2004.10.011 (V. Zemon & Gordon, 2006) Zemon, V., & Gordon, J. (2006). Luminance-contrast mechanisms in humans: visual evoked potentials and a nonlinear model. Vision Res, 46(24), 4163-4180. doi:10.1016/j.visres.2006.07.007 (V. M. Zemon et al., 2009) Zemon, V. M., Gordon, J., O'Toole, L., Monde, K., Dolzhanskaya, V., Shapovalova, V., . . . Granader, Y. (2009). Transient Visual Evoked Potentials (tVEPs) to Contrast-Reversing Patterns: A Frequency Domain Analysis. Investigative Ophthalmology & Visual Science, 50(13), 5880-5880. (Garcia-Quispe, Gordon, & Zemon, 2009) Garcia-Quispe, L. A., Gordon, J., & Zemon, V. (2009). Development of contrast mechanisms in humans: a VEP study. Optom Vis Sci, 86(6), 708-716. doi:10.1097/OPX.0b013e3181a61673 (Yeh, Xing, & Shapley, 2009) (Salim et al., 2010) Salim, S., Childers, K., Lupinacci, A. P., Hu, G. Z., Zemon, V., & Netland, P. A. (2010). Influence of pupil size and other test variables on visual function assessment using visual evoked potentials in normal subjects. Doc Ophthalmol, 121(1), 1-7. doi:10.1007/s10633-010-9222-5 (Xing, Yeh, & Shapley, 2010) Xing, D., Yeh, C.-I., & Shapley, R. (2010). Recurrent amplification in V1 cortex as the mechanism of black-dominant visual perception. Journal of Vision, 10(7), 940-940. doi:10.1167/10.7.940 (V. M. Zemon et al., 2010) Zemon, V. M., Gordon, J., Dolzhanskaya, V., McCloskey-Chillemi, T., Marcus, E., Terentii, V., . .. Weinger, P. (2010). Transient Visual Evoked Potentials (tVEPs) to Pattern Onset/Offset: A Frequency Domain Analysis. Investigative Ophthalmology & Visual Science, 51(13), 1505-1505. (Naser, Zemon, Varghese, Keyser, & Hartmann, 2012) Naser, N. T., Zemon, V. M., Varghese, S. B., Keyser, K. T., & Hartmann, E. E. (2012). Effects of Nicotine on Processing in the Visual Pathways. Investigative Ophthalmology & Visual Science, 53(14), 5735-5735. (V. M. Zemon et al., 2012) Zemon, V. M., Weinger, P. M., Harewood, A., Nunez, V., Michel, J.-P., Azizgolshani, S., . . . Gordon, J. (2012). A short-duration visual evoked potential (VEP) test protocol. Investigative Ophthalmology & Visual Science, 53(14), 5719-5719. (Fu, 2011) Fu, V. L. (2011). Effect of Visual Acuity on Suppressive and Facilitatory Cortical Interactions. Investigative Ophthalmology & Visual Science, 52(14), 6342-6342. (Ridder, Waite, & Melton, 2014) Ridder, W. H., 3rd, Waite, B. S., & Melton, T. F. (2014). Comparing enfant and PowerDiva sweep visual evoked potential (sVEP) acuity estimates. Doc Ophthalmol, 129(2), 105-114. doi:10.1007/s10633-014-9457-7 References pertaining to five major categories were listed, one of which was Visual Electrophysiology. The other topics of Developmental Vision/Ambylopia/Pediatrics, Glaucoma, Retinal Processes and Disorders, and Neurological/Psychiatric Disorders are beyond the scope of this draft LCD. While 32 articles on the topic of Visual Electrophysiology were listed, none were provided to us to review. They range in date from 1980 to 2014. Only 3 three of the articles are less than five years old.
16 A commenter included a single page summary of a research study on the utility of the modified isolated-check visual evoked potential techhnique in functional glaucoma assessment. It was a prospective case-control study of 83 eyes. The conclusion is that the cortical response to low contract stimuli, as measure by icVEP tehnology, has the potential to provide functional assessment that may complement standard achromatic perimetry. We appreciate the comment and will continue to update coverage as evidence evolves. Reconsideration requests can be submitted with supporting data per CMS requirements at any time.
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