Corneal Endothelial Microscopy
DESCRIPTION
Corneal endothelial microscopy (also known as specular microscopy and endothelial cell photography) involves the use of a specular microscope to visualize the cornea and perform an endothelial cell count. The cornea is a transparent structure that forms the anterior one-sixth of the outer coat of the eye and is responsible for more than two-thirds of its refractive power. The cornea consists of several layers, including the epithelium, stroma, and single-celled endothelium. The endothelium is the most posterior layer, interfacing with the aqueous humor of the anterior chamber of the eye.
When disease or surgery destroys endothelial cell, the cells that remain do not normally divide. The cells will instead enlarge and spread to cover the posterior corneal surface. This can result in decompensation, swelling, and cloudiness. A cataract removal will usually cause some decrease in the endothelial cell density. The specular microscope provides a magnified view of a small area of corneal endothelial cells in order to measure and record endothelial cell counts of the cornea. Images of the endothelium seen with specular microscopy can then be recorded on video or photographed in order to facilitate estimates of endothelial cell density and configuration. Corneal endothelial microscopy is used by ophthalmologists as a predictor of success of ocular surgery or certain other ocular procedures.
POLICY
Corneal endothelial microscopy as a pre-operative test before intra-ocular surgery (i.e., cataract surgery) in order to identify individuals at risk for post-surgical corneal decompensation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Corneal endothelial microscopy for the diagnosis and management of corneal dystrophy or other corneal abnormalities is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Corneal endothelial microscopy is considered medically appropriate if ALL of the following criteria are met:
ANY ONE of the following:
A pre-operative test before intra-ocular surgery (i.e., cataract surgery) in order to identify individuals at risk for post-surgical corneal decompensation
Diagnosis and management of corneal dystropy or other corneal abnormalities
ANY ONE of the following criteria:
The individual has slit lamp evidence of endothelial dystrophy
The individual has slit lamp evidence of corneal edema
The individual is about to undergo a secondary intraocular lens implantation
The individual has had previous intraocular surgery and requires cataract surgery
The individual is about to undergo a surgical procedure associated with a higher risk to corneal endothelium (ex: phacoemulsification or refractive surgery)
There is evidence of posterior polymorphous dystrophy of the cornea or Irrigo-corneal-endothelium syndrome
The individual is about to be fitted with extended wear contact lenses after intraocular surgery
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Corneal endothelial microscopy, performed as a part of a work-up prior to cataract extraction, should be considered an integral part of the pre-surgical comprehensive eye examination.
SOURCES
American Academy of Ophthalmology. (2008). Corneal endothelial photography. Three-year revisions. Ophthalmology, 104 (8), 1360-1365.
American College of Eye Surgeons. (2001). Guidelines for cataract practice. Retrieved November 10, 2011 from http://www.aces-abes.org/guidelines_for_cataract_practice.htm.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2003) Corneal endothelial microscopy/specular microscopy. (9.03.04). Retrieved November 10, 2011 from BlueWeb. (2 articles and/or guidelines reviewed
Completed Guide to Medicare Coverage Issues [Computer software]. (2011, November). Endothelial cell photography (NCD 80.8, p. 2-45). Ingenix.
National Guideline Clearinghouse. (2010). Comprehensive adult medical evaluation. Retrieved November 10, 2011 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2007). Refractive errors and refractive surgery. Retrieved November 10, 2011 from http://www.guidelines.gov.
Ranno, S., Fogagnolo, P., Rossetti, L., Orzalesi, N., & Nucci, P. (2011). Changes in corneal parameters at confocal microscopy in treated glaucoma patients. Clinical Ophthalmology, 5, 1037-1042.
Trinh, L., Brignole-Baudouin, F., Labbe, A., Raphael, M., Bourges, J. L., Baudouin, C. (2008). The corneal endothelium in an endotoxin-induced uveitis model: Correlation between in vivo confocal microscopy and immunohistochemistry. Molecular Vision, 14, 1149-1156.
U. S. Food and Drug Administration. (2008, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062763. Retrieved November 10, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062763.pdf.
U. S. Food and Drug Administration. (2004, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040373. Retrieved November 10, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040373.pdf.
ORIGINAL EFFECTIVE DATE: 7/1986
MOST RECENT REVIEW DATE: 12/8/2011
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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