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L.9.03.409
A retinal prosthesis replaces lost photoreceptor function by transmitting external images to an array of electrodesor via light sensors placed in the epiretinal or subretinal space. The artificial retina could 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.
Two approaches are being explored to develop an artificial retina that could restore sight to patients with blindness secondary to retinal diseases, such as retinitis pigmentosa, hereditary retinal degeneration, and some forms of age-related macular degeneration. The first is implantation of electrode arrays in the epiretinal or subretinal space to stimulate retinal ganglion cells. A second approach is the implantation in the subretinal space of light-sensitive multiphotodiode arrays, which stimulate the remaining photoreceptors in the inner retina. Use of a multiphotodiode array does not require external image processing. The latter approach is being evaluated for degenerative retinal diseases such as retinitis pigmentosa, in which outer retinal cells deteriorate, but inner retinal cells remain intact for years.
Research in the United States began with a first-generation, 16-electrode device (e.g., the Argus 16, Second Sight Medical Products), which permitted the distinction between the presence and absence of light. Three government organizations provided support for the development of the Argus II: the Department of Energy, National Eye Institute at the National Institutes of Health, and National Science Foundation. They collaborated to provide grant funding, support for material design, and other basic research for the project.
Numerous retinal prosthesis have been developed or are in various stages of preclinical or clinical development; however, with the exception of Argus II, none are approved or cleared by the U.S. Food and Drug Administration (FDA).
In 2013, the Argus® II Retinal Prosthesis System (Second Sight Medical) was cleared for marketing by the FDA through a humanitarian use device exemption. This exemption is limited to devices that treat or diagnose fewer than 4,000 people in the United States each year. The Argus® II system is intended for use in adults, age 25 years or older, with severe-to-profound retinitis pigmentosa who have bare light perception (can perceive light, but not the direction from which it is coming) or no light perception in both eyes, evidence of intact inner layer retina function, and a history of the ability to see forms. Patients must also be willing and able to receive the recommended postimplant clinical follow-up, device fitting, and visual rehabilitation. Second Sight discontinued the Argus II in 2019. FDA product code: NBF.
Retinal prostheses are considered investigational.
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The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
7/21/2005: Approved by Medical Policy Advisory Committee (MPAC)
8/3/2007: Policy reviewed, no changes.
12/10/2009: Policy Title revised to remove Subconjunctival. Policy Description revised to add the definition of retinal prosthesis, information on the ArgusTM II, and current trial information. Policy Statement revise to remove Subconjunctival verbiage.
04/20/2011: Policy reviewed; no changes.
03/27/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes.
03/19/2014: Policy reviewed; description updated regarding FDA approval of a humanitarian use device exemption for the Argus II. Policy statement unchanged.
03/11/2015: Policy description revised to update retinal prosthesis definition and add research information and devices. Policy statement unchanged.
07/27/2015: Code Reference section updated for ICD-10.
04/22/2016: Policy description updated regarding devices. Policy statement unchanged. Investigative definition updated in policy guidelines section.
05/27/2016: Policy number A.9.03.15 added.
03/31/2017: Policy description updated regarding devices. Policy statement unchanged.
04/12/2018: Policy description updated. Policy statement unchanged. Code Reference section updated to add CPT codes 0472T and 0473T.
12/20/2018: Code Reference section updated to add new HCPCS code L8608, effective 01/01/2019.
04/09/2019: Policy description updated regarding devices. Policy statement unchanged.
04/17/2020: Policy reviewed; no changes.
05/28/2021: Policy reviewed; no changes.
05/20/2022: Policy reviewed; no changes.
04/19/2023: Policy description updated to change "patients" to "individuals." Policy statement unchanged.
04/26/2024: Policy description updated regarding devices. Policy statement unchanged.
07/26/2024: Policy updated to change the medical policy number from "A.9.03.15" to "L.9.03.409."
Blue Cross Blue Shield Association policy # 9.03.15
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
0100T | Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy |
0472T | Device evaluation, interrogation, and initial programming of intraocular retinal electrode array (eg, retinal prosthesis), in person, with iterative adjustment of the implantable device to test functionality, select optimal permanent programmed values with analysis, including visual training, with review and report by a qualified health care professional |
0473T | Device evaluation and interrogation of intraocular retinal electrode array (eg, retinal prosthesis), in person, including reprogramming and visual training, when performed, with review and report by a qualified health care professional |
HCPCS | |
L8608 | Miscellaneous external component, supply or accessory for use with the Argus II Retinal Prosthesis System |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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