Latest Review Date: March 2025

Category: Vision                                                              

POLICY:

Corneal hysteresis measurement is considered investigational for all indications.

DESCRIPTION OF PROCEDURE OR SERVICE:

Corneal hysteresis (CH) measurement assesses corneal resistance to deformation. CH has been proposed as a possible indicator of the viscoelastic properties in the cornea. Two independent pressure values are derived from the inward and outward applanation events. The difference between these two pressure values is CH. Low CH demonstrates that the cornea is less capable of absorbing (damping) the energy of the air pulse. Abnormalities in CH have been detected in a variety of corneal diseases, including glaucoma, keratoconus, Fuchs' dystrophy, and in individuals who have had laser in situ Keratomileusis (LASIK).

Currently, intraocular pressure (IOP) is the most significant risk factor for glaucoma and is the only parameter for which treatment has been demonstrated to decrease glaucoma incidence and progression. IOP is the only modifiable risk factor for the development and progression of glaucoma.

The Goldman applanation tonometer (GAT) is currently, the most widely used method of measuring fluid inside the eye (intraocular pressure). GAT is considered the gold standard for evaluating IOP, which can lead to glaucoma.

KEY POINTS:

This policy is based on a review of current literature as of March 4, 2025.

Summary of Evidence

For individuals who receive CH testing for the diagnosis of glaucoma, the evidence includes prospective observational cohort studies and retrospective cohort studies. Current evidence for corneal hysteresis measurement focuses on the risk, diagnosis and progression of glaucoma. However, these studies do not demonstrate how corneal hysteresis measurement influences clinical management or outcomes. Additional randomized controlled trials with larger sample size are necessary to determine its benefit in clinical practice. The evidence is insufficient to determine that technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Ophthalmology (AAO)

The AAO Preferred Practice Pattern (PPP) for POAG states that CH, which is a measure of the viscoelastic dampening of the cornea, has been shown to be associated with the risk of glaucoma progression. In addition, it states that low CH is associated with glaucoma progression (2021).

2023 Corneal Hysteresis for the Diagnosis of Glaucoma and Assessment of Progression Risk OTA

… “measurement of CH complements current structural and functional assessments in determining disease risk in glaucoma suspects and patients.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Glaucoma, corneal hysteresis, corneal, intraocular pressure, IOP, primary open angle glaucoma, POAG, keratoconus, Goldmann tonometer, Reichert Ocular Response Analyzer, ORA, ORA G3, Ocular Response Analyzer

APPROVED BY GOVERNING BODIES:

The Ocular Response Analyzer (ORA) (Reichert Inc., Buffalo, New York, USA) is a non-contact tonometer that measures CH. The ORA received FDA 510(k) clearance in 2004 for the intended use of measurement of IOP and biomechanical response of the cornea “for the purpose of aiding in the diagnosis and monitoring of glaucoma.” This device measures CH by measuring the difference of 2 applanation event pressures taken during the inward and outward movement of the cornea following delivery of a metered pulse of air.

An FDA approved update (2008) was received allowing for measurement of intraocular pressure of the eye and biomechanical response of the cornea.

Ocular Response Analyzer® (ORA) G3 is the only device that measures Corneal Hysteresis (CH) and Corneal Compensated IOP (IOPcc).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Bayer A, Sahin A, Hürmeric V, et al. Intraocular pressure values obtained by ocular response analyzer, dynamic contour tonometry, and Goldmann tonometry in keratokonic corneas.  J Glaucoma.  2010 Oct-Nov; 19(8):540-5.
2. Bayoumi NH, Bessa AS, El Massry AA.  Ocular response analyzer and Goldmann applanation tonometry: a comparative study of findings.  J Glaucoma. 2010 Dec; 19(9):627-31.
3. Carbonaro F, Andrew T, Mackey DA, et al.  Comparison of three methods of intraocular pressure measurement and their relation to central corneal thickness. Eye (Lond). 2010 Jul; 24(7):1165-70.
4. Congdon NG, Broman AT, et al.  Central corneal thickness and corneal hysteresis associated with glaucoma damage.  American Journal of Ophthalmology, May 2006, Vol. 141, Issue 5.
5. ECRI Institute. Hotline Response. Central Corneal thickness measurement for the diagnosis of glaucoma and ocular hypertension.  April 2010.
6. Fontes BM, Ambrósio R Jr, Velarde GC, et al. Ocular response analyzer measurements in keratoconus with normal central corneal thickness compared with matched normal control eyes.  J Refract Surg, 2011 Mar; 27(3):209-15.
7. Hayes, Inc. Medical Technology Directory. Measurement of Corneal Hysteresis for the Diagnosis and Management of Glaucoma. Lansdale, PA: Hayes, Inc.; December 6, 2018.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Jammal AA, Medeiros FA. Corneal Hysteresis and Rates of Neuroretinal Rim Change in Glaucoma. Ophthalmol Glaucoma. 2022;5(5):483-489.
10. Janulevičiene I, Ehrlich R, Siesky B, et al. Evaluation of hemodynamic parameters as predictors of glaucoma progression. J Ophthalmol. 2011; 2011:164320.
11. Katiyar S, Tong J, Pensyl D, Sullivan-Mee M. Corneal Biomechanical Changes Caused by Acute Elevation of IOP in Eyes with and without Glaucoma. Optom Vis Sci. 2021;98(4):367-373.
12. Kopito R, Gaujoux T, Montard R, et al.  Reproducibility of viscoelastic property and intraocular pressure measurements obtained with the Ocular Response Analyzer.  Acta Ophthalmol. 2010 Aug 25.
13. Lau W, Pye D.  Changes in corneal biomechanics and applanation tonometry with induced corneal swelling.  Invest Ophthalmol Vis Sci. 2011 Feb 23.
14. Liang L, Zhang R, He LY. Corneal hysteresis and glaucoma. Int Ophthalmol. 2019;39(8):1909-1916.
15. Masiwa LE, Moodley V. A review of corneal imaging methods for the early diagnosis of pre-clinical Keratoconus. J Optom. 2020;13(4):269-275.
16. Murphy ML, Pokrovskaya O, Galligan M, et al. Corneal hysteresis in patients with glaucoma-like optic discs, ocular hypertension and glaucoma. BMC Ophthalmol. 2017 Jan 10; 17(1):1.
17. Nossair AA, Kassem MK, Eltanamly RM, Alahmadawy YA. Corneal Hysteresis, Central Corneal Thickness, and Intraocular Pressure in Rheumatoid Arthritis, and Their Relation to Disease Activity. Middle East Afr J Ophthalmol. 2021;28(3):174-179. Published 2021 Dec 31.
18. Prum BE Jr, Herndon LW Jr, Moroi SE, et al. Primary Angle Closure Preferred Practice Pattern (®) Guidelines. Ophthalmology. 2016 Jan; 123(1):P1-P40.
19. Renier C, Zeyen T, Fieuws S, et al.  Comparison of ocular response analyzer, dynamic contour tonometer and Goldmann applanation tonometer Int Ophthalmol. 2010 Dec; 30(6):651-9.
20. Sallam MA, Elghareib ME. Use of corneal hysteresis and corneal resistance factor in target intraocular pressure estimation in patients with early primary open-angle glaucoma. Int Ophthalmol. 2022;42(3):891-902.
21. Schweitzer C, Roberts CJ, Mahmoud AM, et al.  Screening of forme gruste keratoconus with the ocular response analyzer. Invest Ophthalmol Vis Sci.  2010 May; 51(5):2403-10.
22. Sit AJ, Chen TC, Takusagawa HL, et al. Corneal Hysteresis for the Diagnosis of Glaucoma and Assessment of Progression Risk: A Report by the American Academy of Ophthalmology. Ophthalmology. 2023;130(4):433-442.
23. Susanna CN, Diniz-Filho A, Daga FB, et al. A Prospective Longitudinal Study to Investigate Corneal Hysteresis as a Risk Factor for Predicting Development of Glaucoma. Am J Ophthalmol. 2018 Mar; 187:148-152.
24. Zhang C, Tatham AJ, Abe RY, et al. Corneal hysteresis and progressive retinal nerve fiber layer loss in glaucoma. Am J Ophthalmol. 2016 Mar 3. pii: S0002-9394(16)30084-8.
25. Zimprich L, Diedrich J, Bleeker A, Schweitzer JA. Corneal Hysteresis as a Biomarker of Glaucoma: Current Insights. Clin Ophthalmol. 2020;14:2255-2264. Published 2020 Aug 10.

POLICY HISTORY:

Medical Policy Group, April 2009 (1)

Medical Policy Administration Committee, May 2009

Available for comment May 12-June 24, 2009

Medical Policy Group, July 2011; Updated Key Points and References

Medical Policy Group, September 2012: Effective September 14, 2012 this policy is no longer scheduled for regular literature reviews and updates.

Medical Policy Group, November 2014: 2015 Annual Coding update. Added code 92145 to current coding and added Previous Coding section to include deleted code 0181T.

Medical Policy Group, December 2019 (6): Updates to Description, Key Points, Governing Bodies, Key Words (Goldmann tonometer) and References. No change to policy intent.

Medical Policy Group, March 2021 (9): Updates to Description, Key Points, References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, March 2023 (9): Updates to Key Points and Benefit Application. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.  

Medical Policy Group, April 2024 (9): Reviewed by consensus. Updates to Key Points; Practice Guidelines and Position Statements, Key Words: ORA G3, Benefit Application, and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.  

Medical Policy Group, March 2025 (9): Reviewed by consensus. Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References.  No new published peer-reviewed literature available that would alter the coverage statement in this policy.  

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.