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 for preparing donor tissue include Descemet stripping endothelial keratoplasty (DSEK), Descemet stripping automated endothelial keratoplasty (DSAEK), or Descemet’s membrane endothelial keratoplasty (DMEK). Laser procedures called femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer laser-assisted endothelial keratoplasty (FELEK) have also been proposed for utilization in tissue preparation.
POLICY
Endothelial keratoplasty is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Other endothelial keratoplasty donor tissue preparation techniques, including, but not limited to, the following are considered investigational:
Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK)
Femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK)
MEDICAL APPROPRIATENESS
Endothelial keratoplasty is considered medically appropriate if ALL of the following are met:
Endothelial dysfunction is the primary cause of diseased cornea
Donor tissue preparation techniques include ANY ONE of the following:
Descemet’s stripping endothelial keratoplasty (DSEK)
Descemet’s stripping automated endothelial keratoplasty (DSAEK)
Descemet’s membrane endothelial keratoplasty (DMEK)
Descemet’s membrane automated endothelial keratoplasty (DMAEK)
For the treatment of endothelial dysfunction related to ANY ONE of the following conditions:
Ruptures in Descemet’s membrane
Endothelial dystrophy
Aphakic and pseudophakic bullous keratopathy
Iridocorneal endothelial (ICE) syndrome
Corneal edema attributed to endothelial failure
Failure or rejection of a previous corneal transplant
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The evidence is insufficient to determine if Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) and femtosecond and excimer lasers‒assisted endothelial keratoplasty (FELEK) improve health outcomes.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Endothelial keratoplasty (9.03.22). Retrieved February 29, 2024 from https://www.evidencepositioningsystem.com/. (36 articles and/or guidelines reviewed)
Deng, S. X., Lee, W. B., Hammersmith, K. M., Kuo, A. N., Li, J. Y., Shen, J. F., Weikert, M. P., & Shtein, R. M. (2018). Descemet membrane endothelial keratoplasty: Safety and outcomes: A report by the American Academy of Ophthalmology. Ophthalmology, 125(2), 295–310. (Level 2 evidence)
Dunker, S. L., Dickman, M. M., Wisse, R., Nobacht, S., Wijdh, R., Bartels, et al. (2020). Descemet membrane endothelial keratoplasty versus ultrathin descemet stripping automated endothelial keratoplasty: A multicenter randomized controlled clinical trial. Ophthalmology, 127(9), 1152–1159. Abstract retrieved November 17, 2021 from PubMed database.
Li, S., Liu, L., Wang, W., Huang, T., Zhong, X., Yuan, J., Liang, L. (2017). Efficacy and safety of descemet’s membrane endothelial keratoplasty versus descemet’s stripping endothelial keratoplasty: A systematic review and meta-analysis. PLoS One, 12 (12), e0182275. (Level 1 evidence)
Matsou, A., Pujari, R., Sarwar, H., Rana, M., Myerscough, J., Thomson, S. M., Nandakumar, G., Zhang, J., & Rajan, M. S. (2021). Microthin descemet stripping automated endothelial keratoplasty versus descemet membrane endothelial keratoplasty: A randomized clinical trial. Cornea, 40(9), 1117–1125. Abstract retrieved November 17, 2021 from PubMed database.
Mohebbi, M., Mehrpour, M., Sanji, AD., Mohammadi, N., & Mirghorbani, M. (2022). Pediatric endothelial keratoplasty: a systematic review and individual participant data meta – analysis. Graefe’s Archive for Clinical and Experimental Ophthalmology, 260 (4), 1069-1082. Abstract retrieved January 13, 2023 from PubMed database.
Nanavaty, M., Wang X., & Shortt, A. (2014). Endothelial keratoplasty versus penetrating keratoplasty for Fuchs endothelial dystrophy. Cochrane Database System Review, 2:CD008420. Doi.10.1002/14651858.CD008420.pub3 (Level 2 evidence)
National Institute for Health and Care Excellence. (2009, June). Interventional procedure guidance: Corneal endothelial transplantation. Retrieved July 13, 2016 from http://nice.org.uk.
Nielsen, E., Ivarsen, A., Kristensen, S., & Hjortdal, J. (2016). Fuchs’ endothelial corneal dystrophy: a controlled prospective study on visual recovery after endothelial keratoplasty. Acta Opthalmologica, 94 (8), 780-787. Abstract retrieved July 13, 2016 from PubMed database.
ORIGINAL EFFECTIVE DATE: 4/14/2011
MOST RECENT REVIEW DATE: 4/11/2024
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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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