DESCRIPTION
Endothelial keratoplasty, also referred to as posterior lamellar keratoplasty, is a form of corneal transplantation in which the diseased inner layer of the cornea, the endothelium, is replaced with healthy donor tissue.
The cornea, a clear, dome-shaped membrane that covers the front of the eye, is a key refractive element of the eye. Layers of the cornea consist of the epithelium (outermost layer); Bowman’s layer; the stroma, which comprises approximately 90% of the cornea; Descemet’s membrane; and the endothelium. The endothelium removes fluid from the stroma and limits its entry, thereby maintaining the ordered arrangement of collagen and preserving the cornea’s transparency. Diseases that affect the endothelial layer include Fuchs’ endothelial dystrophy, aphakic and pseudophakic bullous keratopathy (corneal edema following cataract extraction), and failure or rejection of a previous corneal transplant.
Specific techniques include Descemet stripping endothelial keratoplasty (DSEK), Descemet stripping automated endothelial keratoplasty (DSAEK), or Descemet’s membrane endothelial keratoplasty (DMEK). A laser may also be utilized for stripping in a procedure called femtosecond laser-assisted corneal endothelial keratoplasty (FLEK).
POLICY
Endothelial keratoplasty for the treatment of endothelial dysfunction (e.g., Fuchs’ endothelial dystrophy, aphakic and pseudophakic bullous keratopathy) is considered medically necessary.
Endothelial keratoplasty for the failure or rejection of a previous corneal transplant is considered medically necessary.
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.
SOURCES
American Academy of Ophthalmology. (2010, January). Policy statement. Tissue procurement for corneal transplantation. Retrieved November 18, 2010 from http://one.aao.org/asset.axd?id=55bba7cb-a208-4291-881f-3aa82dae945b.
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2010). Endothelial keratoplasty (9.03.22). Retrieved November 16, 2010 from BlueWeb. (11 articles and/or guidelines reviewed)
Cheng, Y. Y., Hendrikse, F., Pels, E., Wildh, R. J., van Cleynenbreugel, H., Eggink, C. A., et al. (2008). Preliminary results of femtosecond laser-assisted descemet stripping endothelial keratoplasty. Archives of Ophthalmology, 126 (10), 1351-1356. (Level 3 Evidence - Independent study)
Cheng, Y. Y., Schouten, J. S., Tahzib, N. G., Wijdh, R. J., Pels, E., van Cleynenbreugel, H. (2009). Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: A randomized multicenter clinical trial. Transplantation, 88 (11), 1294-1302. (Level 1 Evidence - Independent study)
Eye Bank Association of America. (2010). Learn the facts. Retrieved November 18, 2010 from http://www.restoresight.org/donation/learnthefacts.
Fernandez, M. M., & Afshari, N. A. (2010). Endothelial keratoplasty: From DLEK to DMEK. Middle East African Journal of Ophthalmology, 17 (1), 5-8.
Lee, W. B., Jacobs, D. S., Musch, D. C., Kaufman, S. C., Reinhart, W. J., & Shtein, R. M. (2009). Descemet's stripping endothelial keratoplasty: Safety and outcomes: A report by the American Academy of Ophthalmology. Ophthalmology, 116 (9), 1818-1830.
National Eye Institute. (2010, February). Facts about the cornea and corneal disease. Retrieved November 18, 2010 from http://www.nei.nih.gov/health/cornealdisease/#e.
National Institute for Health and Clinical Excellence (NICE). (2009, June). Corneal endothelial transplantation. Retrieved November 18, 2010 from http://www.nice.org.uk/nicemedia/live/12077/44650/44650.pdf.
Price, M. O., Price, D. A., Fairchild, K. M., & Price, F. W. (2010). Rate and risk factors for cataract formation and extraction after Descemet stripping endothelial keratoplasty. The British Journal of Ophthalmology, 94 (11), 1468-1471. (Level 3 Evidence - Independent study)
Price, M. U., Giebel, A. W., Fairchild, K. M., & Price, F. W. (2009). Descemet's membrane endothelial keratoplasty: Prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology, 116 (12), 2361-2368. (Level 2 Evidence - Independent study)
Shah, A. K., Terry, M. A., Shamie, N., Chen, E. S., Phillips, P. M., Hoar, K. L., et al. (2010). Complications and clinical outcomes of descemet stripping automated endothelial keratoplasty with intraocular lens exchange. American Journal of Ophthalmology, 149 (3), 390-397. (Level 4 Evidence - Industry sponsored)
Terry, M. A. (2009). Endothelial keratoplasty: A comparison of complication rates and endothelial survival between precut tissue and surgeon-cut tissue by a single DSAEK surgeon. Transactions of the American Ophthalmological Society, 107, 184-191.
Yi, C. H., Lee, D. H., Chung, E. S., & Chung, T. Y. (2010). A comparison of posterior lamellar keratoplasty modalities: DLEK vs. DSEK. Korean Journal of Ophthalmology, 24 (4), 195-200. (Level 2 Evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 4/14/2011
MOST RECENT REVIEW DATE: 4/14/2011
ID_BT
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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