LCD Reference Article Response To Comments Article

Response to Comments: Corneal Hysteresis L38211

A56917

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A56917
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Response to Comments: Corneal Hysteresis L38211
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Response to Comments
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10/14/2019
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Corneal Hysteresis DL38211. Thank you for the comments.

Response To Comments

Number Comment Response
1

I feel the current ophthalmic research supports the clinical benefits of corneal hysteresis (CH) for use with glaucoma management. (See below). CH has been shown to be one of the few tests available to identify those patients who are at most risk for glaucoma progression and vision loss.

Similar to central corneal thickness, the corneal hysteresis measurement would NOT be performed on a regular basis. Most of the current tests used to manage glaucoma are used to document and monitor the loss of function (visual fields) or structural changes (scanning laser optical coherence).

Overall savings would be achieved when the patient’s most at risk are identified early and treated aggressively to minimize permanent vision loss and blindness. Many others, who are not at high risk, would have less frequent provider visits, less testing and fewer medications, thus offsetting the costs.

If corneal hysteresis cannot be approved for all glaucoma patients and glaucoma suspects, I would strongly support corneal hysteresis for those who are currently at the highest risk. That includes those patients who are currently diagnosed with mild, moderate and severe glaucoma. Also for those groups currently identified as high risk (African American, Family history of Glaucoma, Diabetics and Hispanics*) by Medicare.

*https://www.medicare.gov/coverage/glaucoma-tests

Respectfully submitted,

Janet R. Fett, OD

Nebraska Optometry Carrier Advisory Committee Member: J5 WPS


References Supporting Clinic use of Corneal Hysteresis

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4323574/

    It is widely accepted that central corneal thickness is a predictive factor for the risk of glaucoma progression. Recent evidence shows that corneal hysteresis also provides valuable information for several aspects of glaucoma management. In fact, corneal hysteresis may be more strongly associated with
    1. Presence of Glaucoma
    2. Risk of progression, and
    3. Effectiveness of glaucoma treatments than central corneal thickness.

      In several studies comparing the two variables, corneal hysteresis was more strongly related to progression than CCT.
  2. https://www.reviewofophthalmology.com/article/hysteresis-a-powerful-tool-for-glaucoma-care

    Are corneal thickness and hysteresis related? They do correlate to a small degree, but they are definitely not the same thing.

    Corneal thickness has been tied to risk of progression, but in the three studies mentioned above that compared hysteresis and corneal thickness, hysteresis has turned out to be a more powerful predictor of progression.

    …measuring corneal hysteresis can be profoundly useful in the assessment of an individual’s glaucoma risk, and it also provides an objective measurement of IOP.
  3. https://eyewiki.aao.org/The_Role_of_Cornea_in_Glaucoma_Management 3A_Central_Corneal_Thickness_and_Corneal_Hysteresis

    Clinical Application of Corneal Hysteresis in Glaucoma Management

    Corneal hysteresis (CH) is lower in glaucoma and has been shown in various studies to be more strongly associated with structural and functional changes in glaucoma compared to central corneal thickness. In addition, CH has also been shown to predict glaucoma progression and response to glaucoma therapy. For this reason, despite our lack of understanding about the true nature of this variable, it is an important clinical measurement that can help risk stratify and set therapy goals for glaucoma patients.

We appreciate the detailed and thoughtful response. We have reviewed the submitted studies. The studies are relatively small, observational, often confounded by lack of treatment control, uniformly citing simple correlations, precluding cause-and-effect conclusions. Not only are there no Level I studies, none of the reviewed studies demonstrate that CH measurement alters clinical management and improves clinical outcomes. A wide array of tests are accepted for detection and monitoring of glaucoma (tonometry for IOP, perimetry to assess visual field, ophthalmoscopy to detect a glaucomatous optic nerve head (ONH) and RNFL changes, and pachymetry for CCT). It is still unclear whether CH provides useful additional information, much less its optimal role in any diagnostic, prognostic, and treatment algorithm. Randomized controlled trials (RCTs) that compare outcomes in patients whose treatment is selected based on CH are needed to determine definitive patient selection criteria and clinical utility. The lack of level I evidence, absence of proven clinical utility, no clinical practice guideline endorsement (18-20,23), as well neither Medicare (24-27) nor commercial (28-30) coverage, argue strongly against current CH coverage as reasonable and necessary for treatment of Medicare patients.

2

The American Academy Of Ophthalmology agrees with your LCD determination. The research is promising but not definitive.

Luisa Di Lorenzo

Thank you for the comment.

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