Latest Review Date: April 2024

Category: Vision

POLICY:

Retinal prostheses are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

A retinal prosthesis replaces lost photoreceptor function by transmitting external images to an array of electrodes or 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 by the U.S. Food and Drug Administration (FDA).

Two approaches are being explored to develop an artificial retina that 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. 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: 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 development; however, with the exception of Argus, none are approved or cleared by the U.S. Food and Drug Administration (FDA).

KEY POINTS:

This evidence review has been updated regularly using searches of the PubMed database. The most recent literature update was performed through January 22, 2024.

Summary of Evidence

For individuals who have blindness secondary to retinal diseases who receive a retinal prosthesis, the evidence includes a prospective single-arm study evaluating the device approved by FDA and a systematic review of studies on various devices. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. A 2016 systematic review included studies on the FDA-approved retinal prosthesis device as well as devices unavailable in the United States; the overall conclusion was that the evidence on retinal prostheses is insufficient on all outcomes of interest. One study with 30 individuals has evaluated the single FDA-approved device (the Argus II); numerous articles on this study have been published. Primary outcomes included 3 computer-based visual acuity tests. At 3 and 5 -year follow-up visits, individuals performed significantly better on the three computer tasks with the device on versus off. Performance on the most difficult task (grating discrimination) was still relatively low with the device on. Subgroup studies have tested performance on more practical tasks. These studies tended to find significantly better performance with the device on but differences between groups may not be clinically meaningful. The same thirty individuals have been evaluated multiple times and as a result of multiple testing, their performance may differ from other individuals with the device. Additional prospective studies and additional evaluations of the ability to perform practical tasks that have a clinically meaningful impact on health outcomes are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Argus II, Retinal prosthesis, Boston Retinal Implant, Intelligent Retinal Implant System, EPIRET3 Retinal Implant, Alpha IMS, Subretinal Implant artificial vision

APPROVED BY GOVERNING BODIES:

In 2013, the Argus® II retinal prosthesis (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 4000 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. Individuals must also be willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation. Second Sight discontinued the Argus II in 2019 FDA product code: NBF

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

HCPCS Codes:

Previous Codes:

REFERENCES:

1. da Cruz L, Coley BF, Dorn J, et al. The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss. Br J Ophthalmol. May 2013; 97(5):632-636.
2. da Cruz L, Dorn JD, Humayun MS, et al. Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial. Ophthalmology. Oct 2016; 123(10):2248-2254.
3. Dagnelie G, Christopher P, Arditi A, et al. Performance of real-world functional vision tasks by blind subjects improves after implantation with the Argus(R) II retinal prosthesis system. Clin Exp Ophthalmol. 2017;45(2):152-159.
4. Fontanarosa J, Treadwell JR, Samson DJ, et al. Retinal Prostheses in the Medicare Population. (AHRQ Technology Assessment). Rockville, MD: Agency for Healthcare Research and Quality;U.S.; September 30, 2016.
5. Geruschat DR, Richards TP, Arditi A, et al. An analysis of observer-rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years. Clin Exp Optom. May 2016; 99(3): 227-32
6. Ho AC, Humayun MS, Dorn JD, et al. Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind. Ophthalmology. Aug 2015; 122(8):1547-1554.
7. Humayun MS, Dorn JD, da Cruz L, et al. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. Apr 2012; 119(4):779-788.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Kotecha A, Zhong J, Stewart D, et al. The Argus II prosthesis facilitates reaching and grasping tasks: a case series. BMC Ophthalmol. 2014; 14:71.

POLICY HISTORY:

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Newly adopted policy; currently on investigational listing.

Medical Policy Administration Committee, April, 2016

Available for comment March 18 through May 1, 2016

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (6):  Updates to Description, Key Points, and References; No change to Policy statement.

Medical Policy Group, June 2017: Quarterly coding update.  Added CPT codes 0472T and 0473T to Current Coding.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Key Points.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added HCPC code L8608 to the Current coding section.

Medical Policy Panel, March 2019

Medical Policy Group, March 2019 (6): Updates to Description, Key Points, and added HCPC Codes C1841 and C1842. No change to Policy Statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (9): 2021 Updates to Key Points, Description. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (9): 2022 Updates to Key Points, Description, References. Added HCPCS C1841 & C1842 codes to current coding section. No change to policy statement.

Medical Policy Panel, March 2023

Medical Policy Group, March 2023 (9): Updates to Description, Key Points, and Benefit Application. Codes C1841 and C1842 were moved to Previous Coding as of 12/31/22. No change to policy statement.

Medical Policy Panel, March 2024

Medical Policy Group, April 2024 (9): Updates to the Description, Key Points, Approved by Governing Bodies, Benefit Applications, and References. No change to the policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.