Local Coverage Article Response to Comments

Response to Comments: Corneal Hysteresis

A56529

Expand All | Collapse All

Contractor Information

Article Information

General Information

Article ID
A56529
Article Title
Response to Comments: Corneal Hysteresis
Article Type
Response to Comments
Original Effective Date
08/01/2019
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Article Guidance

Article Text

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

NumberCommentResponse
1

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.

2

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.

3

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.

Associated Documents

Related Local Coverage Documents
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
06/05/2019 08/01/2019 - N/A Currently in Effect You are here

Keywords

N/A