LCD Reference Article Response To Comments Article

Response to Comments: Visual Electrophysiology Testing

A55475

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Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
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Article ID
A55475

Article Title
Response to Comments: Visual Electrophysiology Testing

Article Type
Response to Comments

Original Effective Date
03/16/2017

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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Visual Electrophysiology Testing LCD. The official notice period for the final LCD begins on December 29, 2016 and the final determination will become effective on March 16, 2017.

Response To Comments

Number	Comment	Response
1	We received two identical comments advocating inclusion of “all clinical indications confirmed by the International Society for Clinical Electrophysiology of Vision (ISCEV)”, but is primarily focused on glaucoma. The main basis cited for including glaucoma is that “Visual Electrophysiology is defined by the American Academy of Ophthalmology (AAO) as an ancillary test for neuro-ophthalmic conditions.”	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 carrier advisory committee (CAC) ophthalmology CAC 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 contraindications and patient selection, 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 thickness (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.
2	Three other commenters cited ISCEV alone, requesting coverage based on its “referral indications.”	See Response 1.
3	We received identical comments from the Connecticut and Illinois Optometric Association requesting general inclusion of all diagnoses mentioned in the following sources: AOA Clinical Practice Guidelines: Supplemental testing – Electrophysiology; NCD 160.10 for Evoked Response Tests; ISCEV guidelines; the following commercial policies (Aetna CPB 0181, Aetna CPB 0854, BCBS FL# 01-92000-28); and the three other MAC LCDs already cited in the draft. The only specific diagnoses cited, apparently for both ERG and VEP tests, are Multiple Sclerosis (G35), Glaucoma (H40), Visual Disturbances (H53), Optic Nerve Injury (S04) and Conversion Disorders (F44).	The AOA guideline referenced wasn’t found but guidelines relating to glaucoma were. However, these guidelines (AOA Primary Open Angle Glaucoma Care Process, AOA Open Angle Glaucoma Care Process) specifically did not endorse the use of either ERG or VEP for use in glaucoma. The ISCEV guideline was discussed in Response 1. NCD 160.10 for Evoked Response Tests only indicates these tests may be a covered benefit but doesn’t specify indications. Regarding the commercial policies cited, while we do note a very recent (10/1/16) update to the Florida BCBS policy that now lists the glaucoma codes (H40.1110-H40.1194, Primary open-angle glaucoma, staged), the others (including the Anthem policy cited in the draft but not in the comment), remain with non-coverage. None of the three MAC LCDs list glaucoma as a covered indication. The only other diagnoses specifically cited besides glaucoma were Multiple Sclerosis (G35), Optic Nerve Injury (S04), Visual Disturbances (H53), and Conversion Disorders (F44). The first two are listed in our current draft as indications for VEP but their ICD-10 codes were inadvertently omitted. This will be corrected. Regarding Visual Disturbance (H53) and Conversion Disorders (F44), no commercial or MAC policy cited covers except Aetna for VEP. Due to lack of consensus these will remain non-covered.
4	One commenter requested coverage of glaucoma and visual disturbances, citing ISCEV and other MAC LCDs.	See Responses 1 and 3.
5	Four optometrists in a Wisconsin optometry practice requested general inclusion of any and all diagnoses mentioned in various optometric references (e.g., AOA Care of the Patient with Visual Impairment, AOA Comprehensive Adult Eye and Vision Examination).	See Responses 1 and 3.
6	Another commenter communicated generally how helpful visual electrophysiology testing is in patient care and requested to “please make every effort to continue coverage and expand its indications for usage.” Although not specifically cited, some examples given involved the use of VEP and ERG in glaucoma.	We appreciate the comment and will continue to update coverage as evidence evolves.
7	One commenter requested inclusion of all diagnoses mentioned in either the American Academy of Neurology or American Academy of Ophthalmology resident or fellow curriculum, with only glaucoma being specifically cited. The reason given is that both curriculum “support the use of electrophysiology testing in patients with neurological problems.”	We don’t dispute these tests can be useful in patients with neuro-ophthalmological conditions, but do dispute that all tests are useful for all diagnoses. The AAO Resident’s Content Outline has long lists of tests and separate lists of diagnoses, without necessarily pairing them. However, with respect to glaucoma, its section on diagnostics in glaucoma includes neither VEP nor ERG. The American Academy of Neurology, Neuro-ophthalmology Fellow Core Curriculum, makes no specific recommendations with respect to either glaucoma testing or specific indications for VEP/ERG testing. Also see Response 1 with regard to the AAO’s Preferred Practice Policies on glaucoma.
8	One commenter requested for VEP, inclusion of all diagnoses listed in other MAC LCDs on Neurophysiology Evoked Potentials, citing specifically Visual Disturbances (H53), Optic nerve injury (S04), Multiple sclerosis (G35) and Conversion Disorders (F44). He also requested ERG indications be changed to include all those included in the ISCEV Procedure Guide, BCBS of Florida policy, and the AAO Basic Clinical Science Course for Visual Field. The only specific diagnoses cited were: Vascular diseases including diabetes E08-E11, Opaque media and trauma S06, I60-I66, S04, Unexplained visual loss H53, Glaucoma H40, Toxic and nutritional disease G61, Suspected intracranial lesions G35-G37.	Regarding the four diagnoses requested to be added for VEP, see Response 3. As for the ERG recommendations, some of the requested diagnoses are already covered (e.g., vascular diseases including diabetes E08-E11). In fact the draft includes the code range E08-E13, consistent with the BCBS FL and Aetna policies cited in the draft. Conversely, none of the other diagnoses requested (Opaque media and trauma S06, I60-I66, S04, Unexplained visual loss H53, Glaucoma H40, Toxic and nutritional disease G61, Suspected intracranial lesions G35-G37) are listed in those commercial policies. See Responses 1 and 3 for more on glaucoma. Due to lack of consensus these will remain non-covered.
9	Another commenter offered a number of references to support expansion of coverage broadly, but primarily directed at glaucoma: “Please add all supportive references to the LCD and, at a minimum, add all ICD-10-CMs for glaucoma to the policy, H40-H42.” References included various clinical education materials, NCD 90.10 (Evoked Response Tests), NCD 80.9 (Computer Enhanced Perimetry), and the Statement of the American Medical Association to the Institute of Medicine’s Committee on Determination of Essential Health Benefits January 14, 2011.	Most of these curricula include general mentions of visual electrophysiology testing without specific endorsement of use in glaucoma. For example, the American Academy of Ophthalmology Preferred Practice Pattern, Comprehensive Adult Medical Eye Evaluation 2015 is cited because it “defines electrophysiology as an additional test” which might be “required to detect and diagnose risk factors, other diseases (systemic) or cause of abnormalities of the visual system and related structures (retina and brain) to initiate an appropriate management plan, including determination of the frequency of future visits, further diagnostic tests, referral, or treatment.” However, as stated in the LCD draft, the AAO PPP specific to glaucoma, mentions neither VEP nor ERG (see Response 1). The NCDs cited include NCD 90.10 (Evoked Response Tests) which says these tests may be a covered benefit but doesn’t specify indications, and NCD 80.9 (Computer Enhanced Perimetry) which isn’t relevant to VEP/ERG testing.
10	Another commenter cites six AOA Guidelines (all general except for amblyopia), and the national board of examiners in optometry. They are cited to support the use of VEP or ERG potentially as an ancillary test in “all ophthalmic and systemic/traumatic concerns as well as diagnostic circumstances (e.g. questionable visual function) that require this level of testing for diagnosis, treatment or referral.” He also requested all diagnoses for VEP in other MAC LCDs and “both VEP and ERG will need to be covered for questionable diagnostic circumstances related to ophthalmic imaging and visual function findings found in LCDs L33574, L34380 and LCD L33567.”	See Responses 1 and 3. Regarding LCDs (L33574, L34380 and LCD L33567), these are NGS LCDs related to other testing (Visual Field Testing, SCODI, and Posterior Segment Imaging (Extended Ophthalmoscopy and Fundus Photography) with different evidentiary support.
11	One commenter, specializing in neuro-rehabilitation, requested coverage of glaucoma, multiple sclerosis, and Lyme disease.	Regarding glaucoma and multiple sclerosis, see Responses 1 and 3. No evidence was supplied to support the inclusion of testing for Lyme disease. Nor was it covered in any of the commercial or Medicare policies cited in the draft except Aetna policy #0181 on Evoked Potential Studies (not cited in the draft). Due to lack of consensus Lyme will remain non-covered.
12	One commenter requested coverage of indications for ERG testing of night blindness (H53.6), "other visual disturbances" (H53.8), and "unspecified visual disturbance" (H53.9). The reasons given are the following: “Night blindness is a common reason for referral to our IRD clinic, and electroretinography (ERG) is an essential diagnostic tool for evaluating the function of rod photoreceptors in this clinical context. ERG testing to evaluate night blindness can lead to a diagnosis of retinitis pigmentosa or a different type of genetic photoreceptor degeneration (including H53.63, congenital stationary night blindness), but we are sometimes unable to refine the diagnosis beyond the options presented by the other H53.6 codes. If these codes are not added to the LCD, then we will not be able to bill for performing an ERG for this important and commonly-encountered group of indications.” “Similarly, patients are sometimes referred for visual complaints such as those specified within the H53.8 and H53.9 codes with concern by the referring provider for an occult retinal process. The results of ERG testing in these situations are important in honing the diagnosis and guiding additional evaluation even if the ERG is normal. When the ERG is normal, we would not be able to bill for this testing without inclusion of the H53.8 and H53.9 codes.”	These diagnoses are not currently covered by the policies cited in the draft LCD references. However, we might consider adding night blindness (H53.6) in the future if evidence is presented that this is an issue in the Medicare population. The other diagnoses requested are too nonspecific.
13	One commenter requested elecro-oculography (EOG) be added, noting “Electro-oculography is a test occasionally used to identify Best’s disease. It involves measurement of voltage change, (obtained from skin electrodes attached over the temples and bridge of the nose) acquired over time and with side-to-side eye movements. We also think that multifocal electroretinography (mfERG) needs special emphasis with regard to hydroxychloroquine (Plaquenil) toxicity screening. This is mentioned, but, perhaps a separate paragraph is needed.”	There is already specific mfERG coverage for chloroquine and hydroxychloroquine toxicity per AAO guidelines. We are happy to review other specific toxicities based on available evidence. Regarding Electro-oculography, addition of a test not addressed in the policy is outside the scope of a comment response. We will review for possible future addition to the LCD.

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