DESCRIPTION
A retinal prosthesis is a device that purportedly replaces lost photoreceptor function by transmitting computer-processed video images to an array of electrodes or via light sensors placed in the epiretinal or subretinal space. The artificial retina is being investigated to restore sight to individuals with blindness secondary to retinal diseases such as retinitis pigmentosa, hereditary retinal degeneration, and some forms of age-related macular degeneration. Several models of retinal prostheses are in development in the United States, Europe, and Asia. Only the Argus II system has been cleared for use by the U.S. Food and Drug Administration.
POLICY
Retinal prostheses are considered investigational.
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 Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, CA), received a Humanitarian Device Exemption from the FDA in February 2013.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Retinal prosthesis (9.03.15). Retrieved April 10, 2023 from https://www.evidencepositioningsystem.com/. (8 articles and / or guidelines reviewed)
Cheng, D., Greenberg, P., & Borton, D. (2017). Advances in retinal prosthetic research: a systematic review of engineering and clinical characteristics of current prosthetic initiatives. Current Eye Research, 42 (3), 334-347. Abstract retrieved May 26, 2017 from PubMed database.
da Cruz, L., Dorn, J., Humayun, M., Dagnelie, G., Handa, J., Barale, P., et al. (2016). Five-year safety and performance results from the Argus II retinal prosthesis system clinical trial. Ophthalmology, 123 (10), 2248-2254. (Level 3 evidence)
Dagnelie, G., Christopher, P., Arditi, A., da Cruz, L., Duncan, J., Ho, A., et al. (2017). Performance of real-world functional vision tasks by blind subjects improves after implantation with the Argus® II retinal prosthesis system. Clinical and Experimental Ophthalmology, 45, 152-159. (Level 2 evidence)
Fontanarosa, J., Treadwell, J., Samson, D., VanderBeek, B, Schoelles, K. Retinal Prostheses in the Medicare Population (AHRQ Technology Assessment Report). Agency for Healthcare Research and Quality, Publication No. XXX; 2016. (Level 1 evidence)
Geruschat, D., Richards, T., Arditi, A., da Cruz, L., Dagnelie, G., Dorn, J., et al. (2016). An analysis of observer-rated functional vision in patients implanted with the Argus II retinal prosthesis system at three years. Clinical and Experimental Optometry, 99 (3), 227-232. (Level 4 evidence)
Ho, A., Humayun, M., Dorn, J., da Cruz, L., Dagnelie, G., Handa, J., et al. (2015). Long-term results from an epiretinal prosthesis to restore sight to the blind. Ophthalmology, 122 (8), 1547-1554. (Level 3 evidence)
Ostad-Ahmadi, Z., Daemi, A., Modabberi, M., & Mostafaie, A. (2021). Safety, effectiveness, and cost-effectiveness of Argus II in patients with retinitis pigmentosa: a systematic review. International Journal of Ophthalmology, 14 (2), 310-316. (Level 2 evidence)
Palmetto Government Benefit Administrators. (2019). Local Coverage Article for ArgusM II retinal prosthesis system (A53044). Retrieved February 1, 2022 from www.cms.gov.
U. S. Food and Drug Administration. (2013, February). Center for Devices and Radiological Health. Argus® II retinal prosthesis system - H110002. Retrieved April 16, 2014 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 7/3/2011
MOST RECENT REVIEW DATE: 5/11/2023
ID_BA
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.
This document has been classified as public information.