LCD Reference Article Response To Comments Article

Response to Comments: Electroretinography (ERG)

A58943

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Source Article ID
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Article ID
A58943
Original ICD-9 Article ID
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Article Title
Response to Comments: Electroretinography (ERG)
Article Type
Response to Comments
Original Effective Date
12/16/2021
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We received four comments which contained 72 papers (number excludes papers received that were already referenced in the draft LCD). Peer-reviewed published papers with 30 or more eyes were reviewed and added to the evidence analysis in LCD. Unpublished papers, small studies with <30 eyes, review papers, and articles that mention PERG but PERG was not part of the primary or secondary variables being studied were reviewed but not added to LCD. Retrospective studies and case series were excluded due to low quality. 

Response To Comments

Number Comment Response
1

Four comments were received regarding supporting coverage of PERG for early disease detection and management of glaucoma.

Thank you for your comments and submitted literature. There is a lack of high-quality evidence to support the use of PERG for glaucoma detection and management. The literature, while abundant, is low quality with the highest rating of II+ per SIGN scale, the grading system used by the American Academy of Ophthalmology, which is well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal. The published peer-reviewed literature available for this topic fails to define the appropriate patient, including the impact of co-morbidities on the test results. There are no standards for appropriate timing and frequency of PERG testing required for early disease detection or management of glaucoma. The technique, such as reproducibility of skin electrodes compared to corneal electrodes, has not been solidified. There is a lack of evidence on using PERG for clinical glaucoma management and if the use of PERG changes or improves outcomes. There is also a lack of support for this technology as part of the routine evaluation of glaucoma by AAO and other guidelines. Therefore, CGS Administrators considers the use of ERG for either glaucoma diagnosis or management investigational. If additional literature addresses these shortcomings, it can be submitted through the LCD reconsideration process after the policy is active.

2

Three comments were received stating the literature presented in the draft LCD confirms the clinical needs for PERG.

See Comment #1.

3

A single commenter stated, “Measures of ganglion cell function are medically necessary under Sec. 1862. [42 U.S.C. 1395y] (a) “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” unless CGS can recommend an alternative diagnostic test for ganglion cell function within the retina.”

 

CGS agrees that the use of electroretinography to measure ganglion cell function within the retina is reasonable and necessary for multiple indications. The positive coverage for these indications is reflected within the LCD and associated Billing and Coding article. The definition of reasonable and necessary per Section 1862(a) (1) (A) of the Social Security Act also states that a service will not be covered if it is considered investigational. 

4

A single comment was received requesting uniform coverage across all states. The comment states explicitly: “Why wouldn’t CGS beneficiaries get the same access to diagnostic ERGs as other states? All ICDs covered by First Coast Service Option Medicare Carrier in Florida need to be covered for CGS beneficiaries.”

Thank you for your comment. Each MAC has the responsibility and discretion to compose Local Coverage Determinations (LCDs) as needed by their jurisdiction, but we strive for compatibility across the states where applicable. Please see First Coast Service Option LCD 37398 and A57677, which is a limited coverage policy for ERG and states, “First Coast Service Option’s Inc., therefore, considers the use of ERG for either glaucoma diagnosis or management investigational.”

5

One commenter totaled the number of eyes across all studies to demonstrate the number of eyes studied in the literature favorable for the use of PERG for glaucoma detection. 

We appreciate this information; however, this would need to be in the form of a systematic review and meta-analysis to be valid evidence. The literature is accessed through the systematic review process for quality, risk of bias, and degree of heterogenicity to determine if the data can be pooled to conclude statically significant results. There was no reported meta-analysis in our literature search, likely due to the low quality of the literature, lack of standardized protocols, small sample sizes, high heterogenicity, and risk of bias among the studies, which are barriers to conducting meta-analysis with meaningful results. Additionally, even though the literature suggests a pattern that PERG can detect early changes of glaucoma, the lack of standardized protocols to address patient selection, frequency, and evidence that the test can indeed improve outcomes has not been adequately addressed in current literature. 

6

One commenter shared the Ocular Hypertension Treatment Study, a twenty-year follow-up study published in JAMA in 2021. This was shared as evidence of the importance of determining what individuals need treatment and that PERG can aid in that determination. Another commenter asked, “What test do we use to determine if an elevated IOP patient needs to be treated and if the treatment was effective?”

 

Thank you for sharing this study, and we hope it can further aid providers in managing glaucoma/glaucoma suspects. Looking at the study criteria PERG was not included as a test used in this trial. Per the study protocol, “each semiannual examination included an ocular and medical history, refraction, best-corrected visual acuity, full-threshold Humphrey white-on-white 30-2 visual field tests, slit lamp examination, IOP measurement, and direct ophthalmoscopy. Additional evaluations at annual visits included a dilated fundus examination and stereoscopic optic disc photographs.” We did not find PERG listed in the study protocol and do not find this study as evidence to support the role of PERG in early detection in glaucoma. However, it does provide multiple tests that can aid in determining if elevated IOP needs treatment and access effectiveness that is within the standard of care armamentarium. 

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L38992 - Electroretinography (ERG)
Related National Coverage Documents
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Updated On Effective Dates Status
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