Local Coverage Article Response to Comments

Response to Comments: Corneal Hysteresis


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Response to Comments: Corneal Hysteresis
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Response to Comments
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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 Corneal Hysteresis LCD. The official notice period for the final LCD begins on June 16, 2019, and the final determination will become effective on August 1, 2019.

Response To Comments


A presentation by an ophthalmologist, who has published on corneal hysteresis, and is a paid consultant for Reichart, Inc., (the manufacturer of the Ocular Response Analyzer (ORA)), reiterated the existing studies claim that corneal hysteresis “provides new and independent information that helps predict glaucoma development and progression” as well as “aids in determining the eye’s response to IOP-lowering therapy.” The presentation did not refer to co-submitted Canadian Association of Optometrists (CAO) Glaucoma guidelines.

NGS appreciates the comment. However, it does not address the primary deficiencies cited in the draft, namely “the lack of level I evidence, absence of proven clinical utility, no clinical practice guideline endorsement.” As noted in the LCD: “Neither the current (2015) nor most recent updates (2017) to the American Academy of Ophthalmology (AAO) Preferred Practice Pattern (PPP) guidelines for glaucoma recommend measurement of corneal hysteresis in the management or risk assessment of glaucoma, glaucoma suspect, or ocular hypertension.” The submitted CAO guidelines, addressed in the draft LCD, is also not supportive, stating that “despite the association between corneal hysteresis and glaucoma onset and progression, there is still a paucity of clinical evidence to support adding corneal hysteresis measurement to the standard glaucoma workup.” With over a decade of evidence linking corneal hysteresis with glaucoma (highlighted by the commenter), oft-cited sluggish guideline updates cannot be blamed for lack of endorsement. If there are guideline changes, or published Level I evidence, we will reconsider the noncoverage LCD.


Another ophthalmologist consultant for Reichart, Inc., commented that: 1/ the lack of corneal hysteresis Level I outcomes data applies to all existing standard of care measures currently covered by Medicare; and 2/ such a study would be unethical and “patients wouldn’t agree to be randomized to a non-optimal treatment arm.” The commenter also requested consideration of three studies already detailed in the draft LCD.

NGS disagrees. Both commenter arguments, that evidentiary standards should remain static, and that clinical equipoise is forfeit because some patients might balk at randomization, are flawed. Evidentiary standards change and equipoise exists when clinical efficacy is uncertain. The commenter also cites membership in several ophthalmology and glaucoma professional societies, including the AAO, but fails to cite a single guideline in support of corneal hysteresis. See comment # 1 response.


Five optometrist testimonials claim a benefit of using corneal hysteresis for their patients. All contain some similar, or even identical, statements including that “corneal hysteresis has repeatedly been shown to be more associated with, and more predictive of, future visual field loss than other risk factors,” and “it is the ONLY test that is PREDICTIVE of the progression of Glaucoma in my patients.” Two of the commenters are officers of patient advocacy groups, one a paid consultant for Reichart Inc.; the other failed to send in a disclosure. We received only one disclosure that claimed no conflict of interest. Commenters did not cite specific studies or guidelines.

NGS appreciates the comments. See comment #1 response.

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