Electroretinography (ERG)

Jurisdiction: J9 MAC Part B. States: Florida, Puerto Rico, US Virgin Islands. Type: Active LCD

History/Background and/or General Information The full field electroretinogram (ERG) is used to detect loss of retinal function or distinguish between retinal and optic nerve lesions. ERG measures the electrical activity generated by neural and non-neuronal cells in the retina in response to a light stimulus. ERGs are usually obtained using electrodes embedded in a corneal contact lens, or a thin wire inside the lower eyelid, which measure a summation of retinal electrical activity at the corneal surface. The International Society for Clinical Electrophysiology of Vision (ISCEV) introduced minimum standards for the ERG in 1989. The ERG helps to distinguish retinal degeneration and dystrophies. Multi-focal electroretinography (mfERG) is a higher resolution form of ERG, enabling assessment of ERG activity in small areas of the retina. Pattern ERG (PERG) to assess retinal ganglion cell (RGC) function in glaucoma is being investigated. ERG in Glaucoma A 2011 report by the American Academy of Ophthalmology (AAO) on “Assessment of Visual Function in Glaucoma” 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. Since then several studies have investigated the use of ERG technology to differentiate between normal healthy eyes and eyes with early to advanced visual field loss resulting from glaucoma. The authors indicated that ERG may allow earlier diagnosis of glaucoma. However, First Coast Service Options, Inc. has determined that without larger studies, AAO’s 2011 conclusion, that ERG’s have yet to produce definitive guidance on the diagnosis of glaucoma or its progression over time, remains. This was also the conclusion of a 2013 study which prospectively monitored progressive changes of RGC function in early glaucoma using PERG. The authors concluded that further follow-up is required to determine whether PERG losses are predictors of future visual field loss. Neither of the 2015 AAO Preferred Practice Guidelines, “Primary Open-Angle Glaucoma Suspect” or “Primary Open-Angle Glaucoma,” mention ERG as a diagnostic tool. There remain no verified guidelines for normal vs abnormal that would be easily applicable to an individual patient. First Coast Service Option’s Inc., therefore, considers the use of ERG for either glaucoma diagnosis or management investigational. Covered Indications 1. To diagnose loss of retinal function or distinguish between retinal lesions and optic nerve lesions. Note: There are multiple retinal conditions that would be considered covered indications that may not be listed below. For a complete listing of covered diagnoses, please refer to the “ICD-10 Codes that Support Medical Necessity” section of the LCD. Toxic retinopathies, including those caused by intraocular metallic foreign bodies, Vigabatrin and Chlorpromazine Diabetic retinopathy Retinal vascular disease [e.g. Central Retinal Artery Occlusion (CRAO), Central Retinal Vein Occlusion (CRVO), Branch Vein Occlusion (BVO), and sickle cell retinopathy] Autoimmune retinopathies [e.g. Cancer Associated Retinopathy (CAR), Melanoma Associated Retinopathy (MAR), and Acute Zonal Occult Outer Retinopathy (AZOOR)] Retinal detachment Assessment of retinal function after trauma [e.g. vitreous hemorrhage, dense cataracts, and other conditions where the fundus cannot be visualized] Retinitis pigmentosa and related hereditary degenerations Retinitis punctata albescens Leber's congenital amaurosis Choroideremia Gyrate atrophy of the retina and choroid Goldman-Favre syndrome Congenital stationary night blindness X-linked juvenile retinoschisis Achromatopsia Cone dystrophy Disorders mimicking retinitis pigmentosa Usher Syndrome Retinal Dystrophies (e.g. Stargardt’s disease, Fundus Flavimaculata, North Carolina macular dystrophy, Best’s Vitelliform dystrophy, Sorsby’s macular dystrophy) 2. To detect chloroquine (Aralen) and hydroxychloroquine (Plaquenil) toxicity (mfERG) per AAO guidelines, which does not recommend mfERG for routine primary screening, but can provide objective confirmation of suspected visual loss. Limitations The following is considered not reasonable and necessary and therefore will be denied: The use of ERG for glaucoma (either diagnosis or management) is considered experimental and investigational as the available published clinical evidence does not support clinical value. Therefore, the use of ERG (all forms: ERG, mfERG, PERG, etc.) for glaucoma is non-covered and will be denied as not reasonable and necessary. There could be rare retinal conditions that with supporting documentation could be considered for coverage on appeal. As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual , Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary. Provider Qualifications Diagnostic ERG testing must be performed under the general supervision of and interpreted by a qualified physician as follows: General Supervision - means the procedure is furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the procedure. Under General Supervision, the training of the non-physician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician. Qualified Physicians - must possess evidence of knowledge, training, and expertise to perform and interpret these tests. This training and expertise must have been acquired within the framework of an accredited school, residency or fellowship program.