BlueCross BlueShield of Tennessee Medical Policy Manual

Retinal Prosthesis

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

IMPORTANT REMINDERS

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

Agency for Healthcare Research and Quality. (2016). Retinal prostheses in the Medicare population. Retrieved May 26, 2017 from https://www.ahrq.gov/research/findings/ta/index.html.

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2017). Retinal prosthesis (9.03.15). Retrieved May 26, 2017 from BlueWeb. (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)

da Cruz, L., Coley, B., Dorn, J., Merlini, F., Filley, E., Christopher, P., et al. (2013). The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss. British Journal of Ophthalmology, 97 (5), 632-636. (Level 3 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. Abstract retrieved May 26, 2017 from PubMed database.

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)

Humayun, M., Dorn, J., da Cruz, L., Dagnelie, G., Sahel, J., Stanga, P., et al. (2012). Interim results from the international trial of second sight’s visual prosthesis. Ophthalmology, 119 (4), 779-788. (Level 3 evidence)

Kotecha, A., Zhong, J., Stewart, D., & da Cruz, L. (2014). The Argus II prosthesis facilitates reaching and grasping tasks: a case series. BMC Ophthalmology, 2014, 14:71. (Level 4 evidence)

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:  7/13/2017

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.