Pending Policies - Other


Electroretinography (ERG), Multi-focal Electroretinography (mfERG) And Pattern Electroretinography (PERG)

Number:OTH903.036

Effective Date:11-01-2018

Coverage:

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I. Electroretinography (ERG)

ERG may be considered medically necessary as an acceptable alternative adjunctive modality to establish loss of retinal function or to distinguish between retinal lesions and optic nerve lesions.

ERG is considered experimental, investigational and/or unproven for all other indications, including but not limited to the diagnosis and evaluation of glaucoma and the evaluation of childhood brain tumor(s).

II. Multi-focal Electroretinography (mfERG)

mfERG may be considered medically necessary for detecting chloroquine (Aralen) and hydroxychloroquine (Plaquenil) toxicity.

mfERG is considered experimental, investigational and/or unproven for all other indications, including but not limited to the diagnosis and evaluation of glaucoma and the prediction of visual acuity decline in age-related macular degeneration.

III. Pattern Electroretinography (PERG)

PERG is considered experimental, investigational and/or unproven for all indications

Description:

 

Electroretinography (ERG) is a diagnostic test used to measure electrical activity generated by neural and non-neuronal cells in the retina in response to a light stimulus. ERGs are obtained by using electrodes embedded in a corneal contact lens, or a thin wire inside the lower eyelid, which measures retinal electrical activity at the corneal surface. A standard ERG measures five retinal responses by isolating rod (scotopic) and cone (photopic) circuits following dark and light adaptation. Currently, ERGs are used to detect loss of retinal function or to distinguish between retinal and optic nerve lesions. In 1989, the International Society for Clinical Electrophysiology of Vision (ISCEV) established minimum standards for the use of ERG testing. (1)

Multi-focal electroretinography (mfERG) is a higher resolution form of ERG, enabling assessment of ERG activity in small areas of the retina. (1) Electrical responses from the retina are recorded with a corneal electrode as in conventional ERG recording. However, the nature of the stimulus and the form of the analysis differ. These differences allow a topographic map of the local ERG activity to be measured. mfERG also allows the stimulation of multiple spots simultaneously, producing a changing pattern that is supposed to provide more diagnostic information. (2)

Pattern electroretinogram (PERG) is a retinal bio-potential test evoked by a temporally modulated patterned stimulus (e.g. checkerboard or grating) of constant mean luminance. The standard PERG is recorded to abrupt contrast reversal of a black and white checkerboard pattern with central fixation. The PERG arises largely in the ganglion cells, driven by the photoreceptors and corresponding retinal cells. Since the PERG (in contrast to the flash ERG) is a local response from the area covered by the retinal stimulus image, it can be used as a sensitive indicator of dysfunction within the macular region and it reflects the integrity of the optics, photoreceptors, bipolar cells and retinal ganglion cells (RCG). (3) PERG is currently being investigated to assess RGC function in patients with glaucoma. (1)

Regulatory Status

The following class II devices are United States Federal Drug Administration (FDA) approved for use under the 510(k) summary. This is not an all-inclusive list.

Electroretinograph (Mchenry, IL) was approved under the 510(k) summary in 1976. (4)

GLAID Ocular Electrophysiology Device (Clearwater, FL) was approved in 2004 for use in the measurement of visual electrophysiologic potentials, including ERG, PERG, VEP and electrooculogramn (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management. (5)

EDI VERIS System (Los Altos,CA.) was approved under the 510(k) summary in 1999 (K983983) and modified in 2001 (K003442). (6)

RETeval Visual Electrodiagnostic Device was approved under the 510(k) summary in 2015. The RETeval-DR™ is not currently marketed in the U.S. (7)

Rationale:

This policy was created in August 2017 with current literature from the MEDLINE database. Following is a summary of the key literature to date.

Electroretinography (ERG)

In 2015, Tzekov and Madow (8) stated that birdshot chorioretinopathy (BSCR) is a rare form of autoimmune posterior uveitis that can affect the visual function and, if left untreated, can lead to sight-threatening complications and loss of central vision. The investigators performed a systematic search of the literature focused on visual electrophysiology studies, including ERG, electrooculography (EOG), and visual evoked potential (VEP), which is used to monitor the progression of BSCR and estimate treatment effectiveness. Many reports were identified, including using a variety of methodologies and patient populations, which made a direct comparison of the results difficult, especially with some of the earlier studies using non-standardized methodology. Several different electrophysiological parameters, like EOG Arden's ratio and the multi-focal ERG (mfERG) response densities, were reported to be widely affected. However, informal consensus emerged in the past decade that the full-field ERG light-adapted 30-Hz flicker peak time is one of the most sensitive electrophysiological parameters. As such, it has been used widely in clinical trials to evaluate drug safety and effectiveness and to guide therapeutic decisions in clinical practice. The authors concluded that despite its wide use, a well-designed longitudinal multi-center study to systematically evaluate and compare different electrophysiological methods or parameters in BSCR is still lacking; but would benefit both diagnostic and therapeutic decisions. The authors stated that, "until then, there is enough evidence to recommend the use of photopic 30 Hz flicker in the clinical management of BSCR."

In 2016, Kirkiewicz and colleagues (9) evaluated photopic negative response (PhNR) discrimination ability between healthy and glaucomatous patients. Ninety eyes of 50 patients with primary open angle glaucoma (POAG) and 45 eyes of 23 healthy age- and sex-matched controls were investigated. Based on European Glaucoma Society criteria, POAG patients were divided into 3 groups (early, moderate and advanced glaucoma). Following measurements were analyzed: mean defect (MD) from Humphrey Visual Field Analyzer, SITA standard 24-2 white on white perimetry; nerve fibre index (NFI) obtained from scanning laser polarimetry; and GDx and PhNR amplitude and PhNR/b-wave ratio. PhNR was elicited by red stimuli with flash strength of 1.6 cd s/m2 on blue background of 25 cd/m2. Correlations between retinal ganglion cells (RCG) function (PhNR), retinal sensitivity (MD) and structure (NFI) were calculated. Sensitivity and specificity of PhNR parameters were calculated with standard formulas. Receiver operating characteristic (ROC) curves were used to determine optimal cut-off values. The area under the curve (AUC) was used to compare the ROC curves results between PhNR amplitude and ratio. It was noted that the PhNR amplitude and ratio were significantly reduced in early, moderate and advanced glaucoma groups compared to controls. The sensitivity and specificity to detect glaucoma in early POAG were equal to 53.3 and 90.0% for PhNR amplitude and 60.0 and 70.0% for PhNR ratio; in moderate POAG 63.3 and 80.0% for PhNR amplitude and 60.0 and 86.7% for PhNR ratio; and in advanced POAG 76.6 and 80.0% for PhNR amplitude, 90.0 and 73.3% for PhNR ratio. There were no significant differences between AUC for PhNR amplitude (0.76-0.86) and PhNR ratio (0.78-0.86), p > 0.05. PhNR amplitudes and ratios correlated significantly with MD measured by SAP and NFI obtained from GDx (p < 0.05). PhNR amplitude significantly decreases with advancement of visual field defects in glaucoma patients. The study concluded that PhNR reveals dysfunction of RGCs in early, moderate and advanced stage of POAG. PhNR has good discrimination ability in detecting glaucomatous patients and might be a useful test in glaucoma diagnosis.

In 2016, Pietila et al. (10) performed a population-based cross-sectional study that evaluated the clinical value of ERG and VEP in childhood brain tumor survivors. A flash ERG and a checkerboard reversal pattern VEP (or alternatively a flash visual evoked potential) were performed on 51 survivors (age 3.8-28.7 years) after a mean follow-up time of 7.6 (1.5-15.1) years. Abnormal ERG was obtained in 1 case, bilaterally delayed abnormal VEPs in 22/51 (43%) cases. Nine of 25 patients with infratentorial tumor location, and altogether 12 out of 31 (39%) patients who did not have tumors involving the visual pathways, had abnormal VEP. Abnormal ERGs are rarely observed, but abnormal VEPs are common even without evident anatomic lesions in the visual pathway. Bilateral changes suggest a general and possibly multifactorial toxic/adverse effect on the visual pathway. The authors concluded that ERG and VEP may have clinical and scientific value while evaluating long-term effects of childhood brain tumors and tumor treatment.

UpToDate

In 2017, UpToDate published guidance on the epidemiology, clinical presentation, and diagnosis of open-angle glaucoma. (11) The guidance stated that there is no "gold standard" test for identifying glaucoma. It remains controversial which (if any) populations should be screened, what screening tests should be performed, and with what frequency. There is significant variation in screening recommendations from different organizations, partly since no randomized controlled trials have evaluated screening strategies for the prevention of open-angle glaucoma.

Professional Guidelines and Position Statements: ERG

American Academy of Ophthalmology (AAO)

A 2011 report by the AAO on “Assessment of Visual Function in Glaucoma” (12) noted that while ERG, as objective measures of visual function, provided testing free of patient input, issues prevent their adoption for glaucoma management. It concluded that advances in technology have yet to produce definitive guidance on the diagnosis of glaucoma or its progression over time and that further research on an objective measure of visual function is needed.

Neither the 2015 AAO Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern Guideline (13) or the 2015 AAO Primary Open-Angle Glaucoma Preferred Practice Pattern Guideline (14) mention ERG as a diagnostic tool.

The 2016 AAO Primary Open-Angle Glaucoma Preferred Practice Pattern Guideline (11, 15) recommends comprehensive eye examinations for patients that have risk factors for glaucoma and screening only by measuring the intraocular pressure (IOP) is not appropriate since a substantial number of patients with glaucomatous visual field changes have a normal IOP. The guideline does not address ERG as a diagnostic tool.

United States Preventive Services Task Force (USPSTF)

In 2013, the USPSTF (11, 16) found insufficient evidence to recommend for or against screening adults for glaucoma. The authors thought that the available evidence was insufficient to determine the extent to which screening would reduce impairment in vision-related function or quality of life. They noted that harms associated with treatment for increased IOP and early open-angle glaucoma include local eye irritation and an increased risk for cataracts. The USPSTF does not specifically address ERG as a diagnostic tool.

Multi-focal Electroretinography (mfERG)

In 2010, Dale et al. (17) compared the ability of mfERG to frequency domain optical coherence tomography (fdOCT) to detect retinal abnormalities. A total of 198 eyes (100 patients) were included in the study to rule out a retinal etiology of visual impairment. All patients were evaluated with static automated perimetry (SAP), mfERG, and fdOCT. Local mfERG and fdOCT abnormalities were compared to local regions of visual field sensitivity loss measured with SAP and categorized as normal/inconclusive or abnormal. One hundred and forty six eyes were categorized as normal retina on both fdOCT and mfERG; 52 eyes (36 patients) were categorized as abnormal based upon mfERG and/or fdOCT. Of this group, 25 eyes (20 patients) were abnormal on both tests. However, 20 eyes (13 patients) were abnormal on mfERG, while the fdOCT was normal/inconclusive; and 7 eyes (7 patients) had normal or inconclusive mfERG, but abnormal fdOCT. According to the authors, considerable disagreement exists between these 2 methods for detection of retinal abnormalities. The authors stated that mfERG tends to miss small local abnormalities that are detectable on the fdOCT. On the other hand, fdOCT can appear normal in the face of clearly abnormal mfERG and SAP results. The authors concluded that while improved imaging and analysis may show fdOCT abnormalities in some cases, in others early damage may not appear on structural tests.

In 2012 Kandel et al. (18) evaluated the effects of ethambutol therapy in visual functions in bilateral eyes in 44 patients. Parameters evaluated in this prospective study included mfERG with Roland-RETI scan. Based on the outcomes of the study, the authors concluded that visual acuity, contrast sensitivity, and mfERG are sensitive tests to detect ethambutol toxicity in subclinical stages and hence very useful tools for monitoring patients under ethambutol therapy for ocular toxicity. These findings require confirmation in a larger study.

In a 2015 prospective study conducted by Ambrosio et al., the investigators examined the role of mfERG for predicting visual acuity (VA) decline in early age-related macular degeneration (ARMD) with time. (19) A total of 26 early ARMD patients (12 males and 14 females, mean age of 66.9 ± 9.8; range of 46 to 82 years) were included in the study. A complete ophthalmic examination and mfERG (Retiscan, Roland Germany, ISCEV standard protocol) were performed at the study entry (baseline), after 20 and 24 months. The first-order kernel mfERG responses were analyzed by ring analysis. The amplitude density (AD) of the first positive peak (P1, nV/deg2), the P1 amplitude (μV) and P1 implicit time (ms) for Rings 1 (central) to 6 (most peripheral) were evaluated. Data were statistically analyzed by analysis of variance and ROC curves. The loss in the mfERG Ring 1 AD from normal control values, recorded at baseline, was correlated with the decrease in ETDRS VA with time (p = 0.004); ROC analysis showed that, after 24 months, the average decline in VA was greater (3 letters versus 0.4 letters, p = 0.0021) in patients whose Ring 1 P1 AD at baseline was equal to or less than 65.9 nV/deg2, compared to those with higher AD values. Both P1 amplitude and AD of Ring 1 had an AUC of 0.702 (95% CI: 0.50 to 0.92) with a sensitivity of 64.3% (35.14 to 87.24%) and a specificity of 91.7% (61.52 to 99.79%). The authors concluded that these results indicate that mfERG P1 amplitude and AD of Ring 1 may be highly specific to predict visual acuity decline in early ARMD. This was a nonrandomized study design without a control group, and small patient sample size.

UpToDate

A UpToDate review on “Antimalarial drugs in the treatment of rheumatic disease” states that “The earliest retinal abnormalities are asymptomatic and can only be detected by ophthalmologic examination. (20) These “premaculopathy” changes consist of macular edema, increased pigmentation, increased granularity, and loss of the foveal reflex. Subtle functional loss in the paracentral retina can occur before biomicroscopic changes in the retinal pigment epithelium. Detection of changes at this stage, using techniques such as multifocal electroretinography, is desirable since they may be completely reversible upon discontinuation of the medication”.

 

Chloroquine (Aralen) and Hydroxychloroquine (Plaquenil) Toxicity

In 2013, Roque published a review on “Chloroquine and Hydroxychloroquine Toxicity” which listed full-field ERG or electro-oculogram as one of the ancillary tests. (21) The article stated although not recommended for toxicity screening because of sensitivity, specificity and reliability issues, it may be used in diagnosing toxicity. The review article also indicated that the ophthalmic examination should also include a Humphrey visual field central 10-2 white-on-white pattern, and at least 1 of the following objective tests, if available:

Spectral domain optical coherence tomography (SD-OCT);

Fundus autofluorescence (FAF) test;

mfERG.

In 2014, Browning et al. (22) analyzed the relative sensitivity and specificity of 10-2 visual fields (10-2 VFs), mfERG, and SD-OCT in detecting Hydroxychloroquine (HCQ) retinopathy. A total of 121 patients taking HCQ (n = 119) or chloroquine (CQ; n = 2) with 10-2 VF, mfERG, and SD-OCT tests were retrospectively examined. Rates of test abnormality were determined. Retinopathy was present in 14 and absent in 107; 11 of 14 (78.6 %) patients with retinopathy were over-dosed; 12 (85.7 %) had cumulative dosing greater than 1,000 g. The sensitivities of 10-2 VF, mfERG, and SD-OCT in detecting retinopathy were 85.7 %, 92.9 %, and 78.6 %, respectively. The specificities of 10-2 VF, mfERG, and SD-OCT in detecting retinopathy were 92.5 %, 86.9 %, and 98.1 %, respectively. Positive-predictive values (PPVs) of 10-2 VF, mfERG, and SD-OCT in detecting retinopathy were less than 30 % for all estimates of HCQ retinopathy prevalence. Negative-predictive values (NPVs) were greater than 99 % for all tests. The authors concluded that estimates of HCQ retinopathy prevalence, all 3 tests are most reliable when negative, allowing confident exclusion of retinopathy in patients taking less than or equal to 6.5 mg/kg/day. Each test is less useful in allowing a confident diagnosis of retinopathy when positive, especially in patients taking less than or equal to 6.5 mg/kg/day. This study is limited by a small study population.

In 2015, Tsang et al. (23) assessed the validity of mfERG as a screening tool for detecting CQ and HCQ retinal toxicity in patients using these medications. The objective was to evaluate the sensitivity and specificity of mfERG when compared with automated visual fields (AVFs), FAF, and OCT. The study noted the 2011 AAO recommendations on screening for CQ/HCQ retinopathy which recommended a shift toward objective testing modalities. MfERG may be effective in detecting functional change before irreversible structural damage from CQ/HCQ toxicity. The investigators performed a search for records reporting the use of mfERG for screening CQ/HCQ retinopathy in MEDLINE (PubMed and OVID), EMBASE, and Web of Science, and assessed these using the QUADAS-2 risk of bias tool. They conducted an analysis of 23 individual studies and their reported individual patient data (449 eyes of 243 patients) published from January 2000 to December 2014. MfERG had the greatest proportion of positive test results, followed by AVF. The pooled sensitivity and specificity of mfERG were 90% (95% confidence interval [CI]: 0.62 to 0.98) and 52% (CI: 0.29 to 0.74), respectively, with AVF as reference standard (13 studies). Sensitivity was high, but specificity was variable when OCT, FAF, and the positivity of 2 of 3 tests was used as the reference standard. When verified against AVF as the reference test, patients with a false-positive mfERG result received higher HCQ cumulative doses (1,068 g) than patients with true-negative (658 g, p < 0.01) and false-negative (482 g, p < 0.01) results. The authors concluded that mfERG was shown to have a high sensitivity but variable specificity when verified against AVF, OCT, FAF, and a combination of tests. The greater average cumulative dose in the false-positive group compared with the true-negative group when mfERG was verified against AVF suggested that mfERG may have the ability to detect cases of toxicity earlier than other modalities. In addition, they state that there is an unclear risk of bias in the available evidence, and future studies should adhere to Standards for Reporting of Diagnostic Accuracy reporting guidelines.

Professional Guidelines and Position Statements: mfERG

American Academy of Ophthalmology (AAO)

A 2011 report by the AAO (12) reviewed the published literature to summarize and evaluate the effectiveness of visual function tests in diagnosing glaucoma and in monitoring progression. The report indicated that objective visual field tests that do not depend on patient responses, such as mfERG are under development.

In 2016 AAO (24) revised recommendations for screening of CQ and HCQ retinopathy asserts the primary screening tests are AVFs plus SD-OCT. The mfERG can provide objective corroboration for visual fields, and FAF can show damage topographically. Modern screening should detect retinopathy before it is visible in the fundus.

Pattern Electroretinogram (PERG)

In 2009, Bowd et al. (25) assessed the ability of PERG optimized for glaucoma detection (PERGLA) paradigm for glaucoma detection to discriminate between healthy individuals and individuals with glaucomatous optic neuropathy (GON). This cross-sectional study evaluated 142 eyes of 71 participants (42 healthy and 29 with GON in at least 1 eye) at the University of California, San Diego. Healthy individuals were identified as those with healthy-appearing optic disc by examination and masked stereoscopic optic disc photograph evaluation. Glaucomatous optic neuropathy was defined based on stereophotograph evaluation. The PERGLA recordings were obtained within 6 months of standard automated perimetry (SAP) testing. Dependent variables were PERGLA amplitude, phase, amplitude asymmetry, phase asymmetry, and SAP pattern standard deviation (PSD) and mean deviation (MD). Diagnostic accuracy (sensitivity and specificity) of the PERGLA normative database for classifying healthy and glaucomatous individuals was determined. In addition, performance (areas under receiver operating characteristic curves [AUCs]) of PERGLA amplitude and phase for classifying healthy (n=84) and GON (n=50) eyes was determined. Results from both analyses were compared with those from SAP. Outcomes of the study identified sensitivity and specificity of the PERGLA normative database were 0.76 and 0.59, respectively, compared with 0.83 and 0.77 for SAP. The AUCs for PERGLA amplitude and phase were 0.75 and 0.50 (chance performance). The AUCs for SAP PSD and MD were 0.83 and 0.78. The study concluded that PERG recorded using the PERGLA paradigm can discriminate between healthy and glaucoma eyes, although this technique performed is no better than SAP at this task. Low specificity of the PERGLA normative database suggests that the distribution of recordings included in the database is not ideal.

Another study in 2009 was performed by Sehi et al. (26) which examined RCG function measured by using a PERGLA in 29 normal individuals, 28 glaucoma patients, and 37 glaucoma suspect volunteers. According to the authors, RCG function measured using PERGLA is reduced in glaucoma but only demonstrates modest correlations with central SAP sensitivity values and structural measures of optic nerve topography and retinal nerve fiber layer thickness.

Tafreshi et al. (27) compared the diagnostic accuracy of the PERG to that of SAP, short-wavelength automated perimetry (SWAP), and frequency-doubling technology (FDT) perimetry for discriminating between healthy and glaucomatous eyes in 83 eyes of 42 healthy individuals and 92 eyes of 54 glaucoma patients. This cross-sectional study concluded that the diagnostic accuracy of the PERG amplitude was similar to that of SAP and SWAP, but somewhat worse than that of FDT. Agreement among the tests was characterized as slight to moderate.

In 2013, Jafarzadehpour et al. (28) evaluated RGC dysfunction in glaucoma suspects and patients with early POAG using PERG. Transient PERG was recorded in response to 0.8° and 16° black and white checkerboard stimuli. Amplitude and peak time (latency) of the P50 and N95 components of the PERG response, and the ratio of N95 amplitude in response to 0.8° and 16° checks were measured. Twenty glaucoma suspects, 15 early POAG and 16 normal controls were enrolled. N95 peak time (latency) was significantly increased in both early manifest POAG and glaucoma suspects as compared to normal controls. In early POAG, N95 amplitude in response to small (0.8°) checks and the small/large check ratio were reduced in comparison to normal eyes. However, in glaucoma suspects no significant N95 amplitude reduction was observed. No significant difference was observed among the study groups in terms of P50 amplitude or peak time. According to the authors, PERG may detect RGC dysfunction (increased latency) before cell death (decreased amplitude) occurs. The sample size in this study is too small to prove efficacy of PERG as a diagnostic tool.

In 2013, Preiser et al. (2013) compared PhNR and PERG in different stages of the disease. (29) Eleven eyes with preperimetric glaucoma (glaucomatous optic disc with normal field); 18 with manifest glaucoma; and 26 normals were included in the study. Based on the results of the study, the authors concluded that both PhNR and PERG performed similarly to detect glaucoma; for both, ratios performed better than amplitudes. The authors stated that the PhNR has the advantage of not requiring clear optics and refractive correction. PERG has the advantage of being recorded with natural pupils. This study is also limited by a small study population.

Banitt et al. (30) conducted a longitudinal cohort study in 2013 that included 107 adults (201 eyes) at risk of glaucoma and compared PERG amplitudes and optical coherence tomography (OCT) imaging of retinal nerve fiber layer (RNFL) over a 4-year period in order to determine the time lag between loss of RGC function and loss of RNFL thickness. The RNFL thickness did not decrease until the PERG amplitude had lost at least 50% of its normal value for age, indicated by post hoc comparisons showing highly significant differences between RNFL thicknesses of eyes in the stratum with the most severely affected PERG amplitude (≤ 50% of normal) and the two strata with the least affected PERG amplitudes (> 70%). The authors concluded from the results of the study that there was an approximate time lag of 8 years between a 10% loss in PERG amplitude and a 10% loss in RNFL thickness. In patients who are glaucoma suspects, PERG signal anticipates an equivalent loss of OCT signal by several years although this study did not confirm the utility of such findings in improving care and outcome of patients.

Professional Guidelines and Position Statements: PERG

American Academy of Ophthalmology (AAO)

The 2015 and the 2016 Preferred Practice Pattern for Comprehensive Adult Medical Eye Evaluation (13, 15), the 2015 Preferred Practice Pattern for Primary Open Angle Glaucoma (14) and the 2014 AAO Preferred Practice Pattern for Diabetic Retinopathy (31) do not mention PERG as a treatment modality.

American Optometric Association (AOA)

The 2010 AOA Clinical Practice Guideline on the Care of the Patient with Open Angle Glaucoma (32) lists PERG as supplemental testing and states other procedures may be used to detect the earliest loss of visual function from glaucoma. Although measurement of color vision, contrast sensitivity, and dark adaptation, in addition to PERG and VEPs, have been thoroughly studied, none has proven ability to distinguish glaucoma suspects from individuals with primary open angle glaucoma.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0509T, 92273, 92274, 92275, 92499

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. CMS—Local Coverage Determination for Electroretinography (ERG). (2003 July 1) Centers for Medicare and Medicaid Services. Available at <http://www.cms.hhs.gov> (accessed August 14, 2017).

2. Hood DC, Bach M, Brigell M, et al. ISCEV standard for clinical multifocal electroretinography (mfERG) (2011 edition). Doc Ophthalmol. 2012 Feb; 124(1):1-13. PMID 22038576

3. Bach M, Brigell M, Hawlina M, et al. ISCEV standard for clinical pattern electroretinography (PERG): 2012 update. Documenta Ophthalmologica. 2013 Feb; 126 (1): 1–7. PMID: 23073702

4. FDA 510(k) summary: ELECTRORETINOGRAPH (K760199). Available at <https://www.accessdata.fda.gov> (accessed August 17, 2017).

5. FDA 510(k) summary: GLAID Ocular Electrophysiology Device (K043367). Available at <https://www.accessdata.fda.gov> (accessed August 17, 2017).

6. FDA 510(k) summary: EDI VERIS System (K003442). Available at <https://www.accessdata.fda.gov> (accessed August 17, 2017).

7. FDA 510(k) summary: RETeval Visual Electrodiagnostic Device (K142567). Available at <https://www.accessdata.fda.gov> (accessed August 17, 2017).

8. Tzekov R, Madow B. Visual electrodiagnostic testing in birdshot chorioretinopathy. J Ophthalmol. 2015; 2015:680215. PMID 26246903

9. Kirkiewicz M, Lubi?ski W, Penkala K, et al. Photopic negative response of full-field electroretinography in patients with different stages of glaucomatous optic neuropathy. Doc Ophthalmol. 2016 Feb; 132(1):57-65. PMID 26831670

10. Pietilä S, Lenko HL, Oja S, et al. Electroretinography and Visual Evoked Potentials in Childhood Brain Tumor Survivors. J Child Neurol. 2016 Jul; 31(8):998-1004. PMID 26945030

11. Jacobs DS. Open-angle glaucoma: Epidemiology, clinical presentation, and diagnosis. UpToDate Inc., Waltham, MA. Topic last updated: August 2, 2017. Available at <http://www.uptodate.com> (accessed on August 17, 2017).

12. Jampel HD, Singh K, Lin SC, et al. Assessment of visual function in glaucoma: A report by the American Academy of Ophthalmology. Ophthalmology. 2011; 118(5):986-1002. PMID 21539982

13. Feder R, Olsen T, Prum B, et al. Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern Guidelines. Ophthalmology. 2015. Available at <http://www.aao.org> (accessed August 17, 2017).

14. Prum B, Rosenberg L, Gedde S, et al. American Academy of Ophthalmology Primary Open-Angle Glaucoma Preferred Practice Pattern Guidelines. Ophthalmology. 2015. Available at <http://www.aao.org> (accessed August 17, 2017).

15. Feder RS, Olsen TW, Prum BE Jr, et al. American Academy of Ophthalmology Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern Guidelines. Ophthalmology. 2016; 123:P209. Available at <http://www.aaojournal.org> (accessed August 17, 2017).

16. Moyer VA, U.S. Preventive Services Task Force. Screening for glaucoma: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013; 159:484.

17. Dale EA, Hood DC, Greenstein VC, et al. A comparison of multifocal ERG and frequency domain OCT changes in patients with abnormalities of the retina. Doc Ophthalmol. 2010 Apr; 120(2):175-86. PMID 20043188

18. Kandel H, Adhikari P, Shrestha GS, et al. Visual function in patients on ethambutol therapy for tuberculosis. J Ocul Pharmacol Ther. 2012 Apr; 28(2):174-8. PMID 22136146

19. Ambrosio L, Ambrosio G, Nicoletti G, et al. The value of multifocal electroretinography to predict progressive visual acuity loss in early AMD. Doc Ophthalmol. 2015 Oct; 131(2):125-35. PMID 26135127

20. Wallace DJ. Antimalarial drugs in the treatment of rheumatic disease. In: UpToDate Post TW (Ed), UpToDate, Waltham, MA. Topic last updated: July 2017. Available at: <http://www.uptodate.com> (accessed on August 18, 2017).

21. eMedicine – Roque M. Chloroquine and Hydroxychloroquine Toxicity Workup. eMedicine Drugs & Diseases (May 11, 2017). Available at <http://www.emedicine.com> (accessed August 18, 2017).

22. Browning, DJ, Lee C. Relative sensitivity and specificity of 10-2 visual fields, multifocal electroretinography, and spectral domain optical coherence tomography in detecting hydroxychloroquine and chloroquine retinopathy. Dovepress. 2014 July 2014:8. Available at <https://www.ncbi.nlm.nih.gov> (accessed August 18, 2017). PMC4122553

23. Tsang AC, Admadi S, Virgili G, et al. Hydroxychloroquine and Chloroquine Retinopathy. Ophthalmology. 2015 Jun; 122(6):1239-1251. PMID 25824328

24. Marmor MF, Kellner U, Lai TY, et al. American Academy of Ophthalmology. Revised recommendations on screening for chloroquine and hydroxychloroquine retinopathy. Ophthalmology. 2011 (revised 2016); 118(2):415-422. Available at <http://www.aao.org> (accessed August 17, 2017).

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Policy History:

Date Reason
11/1/2018 Reviewed. No changes.
1/15/2018 New medical document. Electroretinography (ERG) may be considered medically necessary as an acceptable alternative adjunctive modality to establish loss of retinal function or to distinguish between retinal lesions and optic nerve lesions. ERG is considered experimental, investigational and/or unproven for all other indications, including but not limited to the diagnosis and evaluation of glaucoma and the evaluation of childhood brain tumor(s). 2) Multi-focal Electroretinography (mfERG) may be considered medically necessary for detecting chloroquine (Aralen) and hydroxychloroquine (Plaquenil) toxicity. mfERG is considered experimental, investigational and/or unproven for all other indications, including but not limited to the diagnosis and evaluation of glaucoma and the prediction of visual acuity decline in age-related macular degeneration. 3) Pattern Electroretinography (PERG) is considered experimental, investigational and/or unproven for all indications.

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