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Clinical Policy Bulletin:
Artificial Retina
Number: 0713


Policy

Aetna considers artificial retina devices experimental and investigational because there is insufficient scientific evidence of the safety and effectiveness of these devices in restoring vision.



Background

Researchers have been testing microelectronic retinal implants as a method of restoring vision in patients rendered blind by degenerative diseases of the retina such as retinitis pigmentosa and macular degeneration.  Tests of electrical stimulation of the retinal surface have demonstrated that such stimulation may induce light sensation.  These studies have shown that retinal neurons are preserved after death of photoreceptors in retinitis pigmentosa. 

Two types of retinal implant systems are under development: (i) epiretinal implants, designed to communicate directly with the ganglion and bipolar cells; and (ii) subretinal implants, designed to replace photoreceptors in the retina.  Both types of implants are intended to restore some vision through electrical stimulation of functional neurons in the retina.  Retinal implants require an intact optic nerve pathway to allow them to function.  Both systems translate incoming light, whether from a camera or the environment, to electrical stimulation of the functional neurons in the retina.

Epiretinal implants are positioned on the surface of the retina and receive light signals from external camera systems.  An electronic chip camera mounted in the frame of special glasses captures images and transmits the images via electrical impulses to a second chip, which is implanted in the retina.  Epiretinal implant systems may include other components such as image processing electronics, a telemetry system to provide power and data to the implanted subsystems, implanted electronics for signal decoding and stimulus generation, and an electrode array to deliver the electrical charge to the retina.

Subretinal implants are positioned behind the retina and receive light directly from the environment.  In this approach, light is converted into electrical signals that stimulate remnant cell layers of the retina. 

Artificial retina devices are not currently approved for marketing by the U.S. Food and Drug Administration.  Clinical trials of artificial retinal devices are currently ongoing.One trial is a Phase II feasibility study to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profound retinitis pigmentosa. While this is a technology that may be shown in the future to be effective, at this time the effectiveness, safety, and durability of artificial retina devices need to be established.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes not covered for indications listed in the CPB:
0100T
Other ICD-9 codes related to the CPB:
361.00 - 362.89 Retinal detachments and defects, and other retinal disorders


The above policy is based on the following references:
  1. American Academy of Ophthalmology (AAO). Microelectronic retinal implants. AAO Rapid Clinical Report. San Francisco, CA: AAO; August 2000. http://www.aao.org/education/library/rapid/retinal.cfm. Accessed July 11, 2005.
  2. Lee PJ. ARMD, retinal electronic prosthesis and RPE transplantation. eMedicine Ophthalmology Topic 763. Omaha, NE: eMedicine.com; updated October 4, 2004. Available at: http://www.emedicine.com/oph/topic763.htm. Accessed July 11, 2005.
  3. Breault Research Organization. Optoelectronic implants to treat visual diseases. Optics Report: Healthcare. Tucson, AZ: opticesreport.com; updated June 14, 2003. Available at: http://www.opticsreport.com/content/article.php?article_id=1007. Accessed July 11, 2005.
  4. Chow AY, Chow VY, Packo KH, et al. The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa. Arch Ophthalmol. 2004;122(4):460-469.
  5. Alteheld N, Roessler G, Vobig M, et al. The retina implant--new approach to a visual prosthesis. Biomed Tech (Berl). 2004;49(4):99-103.
  6. Optobionics Corporation. ASR® device [website]. Naperville, IL: Optobionics; updated March 11, 2004. Available at: http://www.optobionics.com. Accessed July 11, 2005.
  7. Hornig R, Laube T, Walter P, et al. A method and technical equipment for an acute human trial to evaluate retinal implant technology. J Neural Eng. 2005;2(1):S129-S134.
  8. Gekeler F, Zrenner E. Status of the subretinal implant project. An overview. Ophthalmologe. 2005;102(10):941-949.
  9. Weiland JD, Liu W, Humayun MS. Retinal prosthesis. Annu Rev Biomed Eng. 2005;7:361-401.
  10. Viola MV, Patrinos AA. A neuroprosthesis for restoring sight. Acta Neurochir Suppl. 2007;97(Pt 2):481-486.  
  11. Asher A, Segal WA, Baccus SA, et al. Image processing for a high-resolution optoelectronic retinal prosthesis. IEEE Trans Biomed Eng. 2007;54(6 Pt 1):993-1004.
  12. Mokwa W. An implantable microsystem as a vision prosthesis. Med Device Technol. 2007;18(6):20, 22-23.
  13. Alteheld N, Roessler G, Walter P. Towards the bionic eye--the retina implant: surgical, opthalmological and histopathological perspectives. Acta Neurochir Suppl. 2007;97(Pt 2):487-493.
  14. Second Sight Medical Products. Argus™ II Retinal Stimulation System Feasibility Protocol. ClinicalTrials.gov. Identifier NCT00407602. Bethesda, MD: National Institutes of Health; updated August 28, 2008.
  15. Second Sight Medical Products. Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa. ClinicalTrials.gov. Identifier NCT00279500. Bethesda, MD: National Institutes of Health; updated January 8, 2007.
  16. Mokwa W, Goertz M, Koch C, et al. Intraocular epiretinal prosthesis to restore vision in blind humans. Conf Proc IEEE Eng Med Biol Soc. 2008;2008:5790-5793.
  17. Roessler G, Laube T, Brockmann C, et al. Implantation and explantation of a wireless epiretinal retina implant device: Observations during the EPIRET3 prospective clinical trial. Invest Ophthalmol Vis Sci. 2009;50(6):3003-3008.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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