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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Core Decompression For Avascular Necrosis - Commercial Medical Management Guideline TITLE: Corneal Hysteresis Measurement Authorized By: Medical Management Guideline Committee

Adoption Date: 10/14/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements Corneal Hysteresis Measurement - Commercial Medical Management Guideline and the plan benefit coverage prior to use of this policy.

Coverage Rationale Measurement of corneal hysteresis is unproven for the diagnosis and management of corneal disorders and glaucoma. There is insufficient evidence to evaluate corneal hysteresis measurement for the purpose of assessing corneal viscoelasticity. Studies do not demonstrate how the measurement of corneal hysteresis can benefit health outcomes.

Further investigation is needed before the clinical usefulness of this procedure is proven.

See the medical policy titled Excimer Laser for Ophthalmic Procedures for information regarding corneal topographyguided ablation.

Regulatory Requirements U.S. Food and Drug Administration (FDA): On January 20, 2004, the Ocular Response Analyzer® (ORA) by Reichert Inc. received FDA clearance for the intended use to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma. See the following Web site for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=12942. Accessed June 2009.

Research Evidence Background Corneal hysteresis (CH) measurement assesses corneal resistance to deformation. CH has been proposed as a possible indicator of the viscoelastic properties in the cornea. The Ocular Response Analyzer® is an instrument that measures corneal hysteresis by using a rapid air impulse to apply force to the cornea. An advanced electro-optical system then monitors the deformation. Two independent pressure values are derived from the inward and outward applanation events.

The difference between these two pressure values is corneal hysteresis. Low CH demonstrates that the cornea is less capable of absorbing (damping) the energy of the air pulse. Abnormalities in corneal hysteresis have been detected in a variety of corneal diseases, including keratoconus, Fuchs' dystrophy, and in post-LASIK patients. Glaucoma is another potential indication for corneal hysteresis measurement. The preferred method of measuring intraocular pressure is using a contact applanation method such as a Goldmann tonometer. Corneal compensated intraocular pressure (IOP), derived from the CH measure has been suggested as a superior measurement of IOP compared to the Goldmann tonometer measurement.

Research Evidence Published evidence for measurement of corneal hysteresis consists of observational studies in different populations performed in a research setting.

del Buey et al. (2009) investigated the effects of Fuchs' corneal dystrophy (FCD) on corneal biomechanical properties and the results of intraocular pressure (IOP) readings in relation to changes in corneal hysteresis (CH) and central corneal thickness (CCT). Corneal biomechanical properties, including CH, corneal resistance factor (CRF), and CCT, were measured with the ocular response analyzer (ORA) in 11 eyes of 11 patients with clinically confirmed FCD and 12 eyes of 12 healthy subjects. CH measured 10.3 +/- 1.6 mm Hg (range, 8.7-13.8) in normal eyes and 6.9 +/- 1.8 mm Hg (range, 4.6-11.7) in FCD eyes (P = 0.001). The investigators concluded that FCD led to a change of corneal biomechanical properties. CH and CRF were significantly lower in FCD eyes than in normal eyes. These values may be useful in addition to CCT when assessing corneal rigidity.





Sun et al. (2009) measured corneal hysteresis (CH) in unilateral chronic primary angle-closure glaucoma (CPACG) patients to determine if it was affected by high intraocular pressure (IOP) in a prospective interventional case series. CH and Goldmann-correlated IOP (IOPg) were obtained with the Ocular Response Analyzer and central corneal thickness

Corneal Hysteresis Measurement - Commercial Medical Management Guideline

(CCT) was measured by optical coherence tomography. Baseline CH, IOPg, and CCT were measured in 40 CPACG eyes and compared to the fellow eyes and 40 normal controls. Reduction of IOPg in CPACG eyes was achieved medically, followed by trabeculectomy and peripheral iridectomy. Measurements were repeated at 2 and 4 weeks posttherapy. IOPg decreased significantly from 31.55 +/- 10.48 mm Hg (mean +/- standard deviation) before therapy to 11.47 +/- 4.71 mm Hg, and CH increased significantly from 6.83 +/- 2.08 mm Hg to 9.22 +/- 1.80 mm Hg at 2 weeks, with no further changes after that. However, the CH in the treated eyes remained significantly lower compared with that of fellow and normal eyes. Before treatment, CH was negatively correlated with IOPg; however, there was no correlation after treatment. CCT was not affected by the reduced IOPg in the CPACG eyes. The investigators concluded that CH was significantly lower in CPACG patients, and partial recovery occurred after successful IOP-lowering therapy. Alternations affecting corneal biomechanical properties appear to occur during glaucoma development.

Goldich et al. (2009) assessed changes in biomechanical properties of human cornea after treatment of keratoconus with UV-A-riboflavin corneal collagen cross-linking (CXL) in a single-center, prospective, interventional study. Ten eyes of 10 patients with progressive keratoconus were treated with UV-A-riboflavin CXL and assessed with the Ocular Response Analyzer (ORA) that measured corneal hysteresis (CH), corneal resistance factor (CRF), Goldmann-correlated intraocular pressure (IOPg), and corneal compensated intraocular pressure (IOPcc). Patients were assessed with ORA preoperatively, at week 1, months 1, 3, and 6 after treatment. Postoperative measurements at each visit were compared with preoperative values. CH and CRF were transiently elevated after cross-linking treatment, with the difference not statistically significant (P 0.3). IOPcc and IOPg were statistically significantly higher at 1 week and 1 month but not subsequently (P 0.04). Goldmann applanation tonometry (GAT-IOP) was statistically significantly higher at 1 week and at 1 and 3 months (P 0.01). The investigators concluded that there were no significant differences in corneal biomechanical properties, as measured with the ORA parameters CH and CRF, after CXL in keratoconus. IOPcc, IOPg, and GAT-IOP values were transiently elevated after CXL treatment in our study. Whether this reflects a measurement artifact resulting from corneal changes or true elevation of intraocular pressure is unclear.

Luce (2005) found that corneal hysteresis varied over a dynamic range of 1.8 to 14.6 mm Hg and was only weakly correlated with corneal thickness. Corneal hysteresis changes diurnally, presumably as a result of hydration changes.

Keratoconus, Fuchs' dystrophy, and post-LASIK patients demonstrated low corneal hysteresis. Luce concluded that corneal hysteresis may prove valuable for qualification and predictions of outcomes of refractive surgery and in other cases in which corneal biomechanics are important.

Congdon et al. (2006) measured the impact of central corneal thickness and corneal hysteresis on various indicators of glaucoma damage. Thinner central corneal thickness was associated with the state of glaucoma damage as indicated by cup-to-disk ratio (CDR). Corneal hysteresis was associated with progressive field worsening.

Pepose et al. (2006) compared the preoperative and postoperative measurement of corneal biomechanical properties in eyes undergoing myopic LASIK. LASIK produced a marked decline in corneal hysteresis which may reflect respective changes in the viscous and elastic qualities of the post-LASIK cornea.

Shah et al. (2008) compared hysteresis and corneal resistance factor (CRF) in normal tension glaucoma (NTG), primary open angle glaucoma (POAG) and ocular hypertension (OHT) eyes measured by the ocular response analyser (ORA) as part of a prospective, cross-sectional and comparative clinical trial that included 216 eyes with POAG, 68 eyes with NTG and 199 eyes with OHT. The investigators found that hysteresis and CRF were highest in OHT eyes. These factors may prove to be useful measurements of ocular rigidity and may help to understand role of the corneal rigidity in monitoring the progress of conditions such as NTG, POAG and OHT.

There is insufficient evidence available from the peer-reviewed literature to validate the clinical role for measurement of corneal hysteresis.

Corneal Hysteresis Measurement - Commercial Medical Management Guideline References and Resources Resources Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. Epub 2006 Mar 9.

del Buey MA, Cristobal JA, Ascaso FJ, Lavilla L, Lanchares E. Biomechanical properties of the cornea in Fuchs' corneal dystrophy. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3199-202.

Goldich Y, Barkana Y, Morad Y, Hartstein M, Avni I, Zadok D. Can we measure corneal biomechanical changes after collagen cross-linking in eyes with keratoconus?--a pilot study. Cornea. 2009 Jun;28(5):498-502.

Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62.

Pepose JS, Feigenbaum SK, Qazi MA, Sanderson JP, Roberts CJ. Changes in corneal biomechanics and intraocular pressure following LASIK using static, dynamic, and noncontact tonometry. Am J Ophthalmol. 2007 Jan;143(1):39-47.

Shah S, Laiquzzaman M, Mantry S, Cunliffe I. Ocular response analyser to assess hysteresis and corneal resistance factor in low tension, open angle glaucoma and ocular hypertension. Clin Experiment Ophthalmol. 2008 Aug;36(6):508-13.

Sun L, Shen M, Wang J, Fang A, Xu A, Fang H, Lu F. Recovery of corneal hysteresis after reduction of intraocular pressure in chronic primary angle-closure glaucoma. Am J Ophthalmol. 2009 Jun;147(6):1061-6, 1066.e1-2.

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Contact Information For questions regarding this policy, send an email to the Medical Technology Interpretation Service at medical_drug_interpretation@uhc.com with the word "Medical" in the subject line.

Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.

Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.

CPT Codes 0181T Corneal hysteresis determination, by air impulse stimulation, bilateral, with interpretation and report This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Corneal Hysteresis Measurement - Commercial Medical Management Guideline TITLE: Cryopreservation of Reproductive Tissue Authorized By: Medical Management Guideline Committee

Adoption Date: 08/11/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.



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