LCD L37371: Electroretinography (ERG)

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

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. The focal or foveal ERG (fERG) is useful in providing information regarding diseases limited to the macula. 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) uses pattern-reversal stimuli and is used to detect subtle optic neuropathies.

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, Novitas 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. Novitas, therefore, considers the use of ERG for either glaucoma diagnosis or management investigational.

Covered Indications

• 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 Local Coverage Article: Billing and Coding: Electroretinography (ERG), A56672 for all billing and coding information.

• 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)

• 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, fERG, mfERG, PERG, etc.) for glaucoma is non-covered and will be denied as not reasonable and necessary.

Place of Services (POS)

For additional information on services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to Local Coverage Determination (LCD) L35448 Independent Diagnostic Testing Facility (IDTF) and Local Coverage Article A53252 Independent Diagnostic Testing Facility (IDTF).

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to the Local Coverage Article: Billing and Coding: Electroretinography (ERG), A56672, for applicable CPT/HCPCS codes and diagnosis codes.

Provider Qualifications

• Diagnostic ERG testing must be performed under the general supervision of and interpreted by a qualified 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.

• Please refer to CMS IOM Pub. 100-02, Chapter 15, Section 80 for the definition of General Supervision.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Please refer to the “History/Background and/or General Information” section for general information on ERG including full field ERG, focal ERG, multi-focal ERG, and pattern ERG.

Multiple sources of literature (Bach et al. [2013]; Barrett et al. [2014]; CK et al. [2011]; Creel; Hood et al. [2012]; Incesu [2013]; International Society for Clinical Electrophysiology of Vision [ISCEV]; Jacobs; John et al. [2009]; Kumar et al.; Maa et al. [2016]; Marmor et al. [2016]; McBain et al. [2007]; McCulloch et al. [2015]; Perlman; Whatham et al. [2014]) were submitted for consideration. These were mostly descriptive of how ERG should be performed, the history of the testing procedures involved with ERG and sources for the “Covered Indications” section.

This is a new LCD for Novitas JH and JL developed as a national MAC LCD workgroup collaboration based on information from data analysis revealing that a significant percentage of the diagnoses reported on ERG claims contained some form of a glaucoma diagnosis. These findings were not consistent with current literature and guideline recommendations for ERG use.

The following is a summary of the evidence for exclusion of glaucoma-related diagnoses for testing by ERG (except glaucomatous optic atrophy):