DESCRIPTION
Keratoprosthesis (KP) is an artificial cornea that is intended to replace the opacified corneal tissue and restore vision when severe bilateral corneal disease exists (e.g. prior failed corneal transplant, chemical injury or certain immunological condition). KP has been developed for use when corneal transplant is not an option. A permanent keratoprosthesis device is implanted in the eye to allow the transmission of light through an opacified cornea. Permanent devices vary in design but in general consist of a central rigid polymethylmethacrylate (PMMA) optical cylinder that replaces the cornea and are anchored in place by a biological support.
POLICY
Keratoprosthesis (e.g., Boston KPro) for the treatment of corneal blindness may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Keratoprosthesis for all other conditions is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Keratoprosthesis for the treatment of corneal blindness is considered medically appropriate if ALL of the following criteria are met:
The cornea is severely opaque and vascularized
Two or more failed corneal transplants
Individual can comply with post operative care
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
A keratoprosthesis is a Class II U.S. Food and Drug Administration (FDA) device intended to provide a transparent optical pathway through an opacified cornea, in an eye that is not a reasonable candidate for a corneal transplant. Two permanent keratoprostheses have received 510(k) marketing clearance by the FDA. The Dohlman Doane Keratoprosthesis, also referred to as the Boston Keratoprosthesis (KPro), is manufactured under the auspices of the Harvard Medical School-affiliated Massachusetts Eye and Ear Infirmary. The AlphaCor, previously known as the Chirila keratoprosthesis (Chirila KPro) marketed by Argus Biomedical was cleared for marketing by the FDA in 2002. According to the 510(k) summary, the AlphaCor keratoprosthesis was shown to be substantially equivalent to the Dohlman Doane Type I keratoprosthesis. Both devices are indicated as permanent implantable keratoprosthesis for eyes that are not corneal transplant candidates and are made of materials that have been proven to be biocompatible.
The keratoprosthesis is considered to be a salvage procedure where no acceptable alternatives exist. For this reason, comparative studies are lacking.
SOURCES
Akpek, E. K., Harissi-Dagher, M., Petrarca, R., Butrus, S. I., Pineda, II, R., & Aquavella, J. V., et al. (2007). Outcomes of Boston keratoprosthesis in Aniridia: A retrospective multicenter study. American Journal of Ophthalmology, 144 (2), 227-231. (Level 4 Evidence - Independent study)
Ament, J., Stryjewski, J., Ciolini, J., Todani. A., Chodosh, J., & Dohlman, C. (2010) Cost-effectiveness of Boston Keratoprosthesis. American Journal of Ophthalmology, 149 (2), 221-228. (Level 4 Evidence - Independent study)
American Academy of Ophthalmology. (2008). Preferred practice pattern: Conjunctivitis. Retrieved April 1, 2011 from http://one.aao.org/CE/PracticeGuidelines/PPP_Content.aspx?cid=9d9650fb-39a3-439c-9225-5fbb013cf472.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2011). Keratoprosthesis (9.03.01). Retrieved June 6, 2011 from BlueWeb. (19 articles and/or guidelines reviewed)
Bradley, J., Hernandez, E., Schwab, I., & Mannis, M. (2009). Boston type 1 keratoprosthesis: the University of California Davis experience. Cornea, 28 (3) 321-327. (Level 4 Evidence - Independent study)
National Institute of Clinical Excellence. (2004, June). Insertion of hydrogel keratoprosthesis. Retrieved April 1, 2011 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG069guidance.pdf.
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K013756. Retrieved March 31, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=6447.
ORIGINAL EFFECTIVE DATE: 8/1988
MOST RECENT REVIEW DATE: 9/11/2011
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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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