mp-627 - mp-627 - Medical Policies
Policy Number: MP-627
Latest Review Date: March 2021
Policy Grade: D
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 patients 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 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: 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.
Devices in development, none of which are approved or cleared by the U.S. Food and Drug Administration (FDA), include the following.
- The Alpha IMS was developed at the University of Tubingen, with the electronic chip design provided by the Institute for Microelectronics (IMS), Stuttgart. The second-generation Alpha IMS device has wireless power and signal transmission and is produced by Retina Implant AG (Germany). The microchip is implanted sub-retinally and receives input from a multiphotodiode array with 1500 elements that moves with the eye, senses incident light, and applies a constant-voltage signal at the respective 1500 electrodes. The multiphotodiode array transforms visual scenes into corresponding spatial patterns (38’40 pixels) of light intensity-dependent electric stimulation pulses with a maximum visual field of 15°.
- The Boston Retinal Implant Project (BRIP) uses an external camera mounted on a pair of glasses and a 100-electrode array. The image obtained by the external camera is translated into an electromagnetic signal transmitted from the external primary data coil mounted on a pair of glasses to the implanted secondary data coil attached to the cornea. Most of the volume of the implant lies outside the eye, with transscleral cables connected to a subretinal electrode array. The BRIP is a joint effort of MIT, the Massachusetts Eye and Ear Infirmary, the VA Boston Healthcare System, and the NanoScale Science & Technology Facility at Cornell University.
- EPIRET3 retinal implant (Philipps-University Marburg, Germany) is a wireless system that consists of a semiconductor camera on the frame of a pair of glasses and a transmitter coil outside the eye, which sends electromagnetic signals to a receiver coil in the anterior vitreous (similar to an intraocular lens), which passes them on to a receiver microchip. A stimulator chip then generates the stimulation pulses and activates a selection of 25 electrodes placed on the epiretinal surface via a connecting micro cable.
- Intelligent Retinal Implant System (IRIS; Pixium Vision, Paris, France) uses an external camera integrated with a pair of glasses and linked by wire to a pocket computer. Receiver electronics connect via a scleral tunnel to an electrode array on the surface of the retina. Pixium Vision is also developing PRIMA, which uses a subretinal implant.
- Learning Retinal Implant (Intelligent Medical Implants, Zug, Switzerland) uses an external camera on the frame of a pair of glasses and wireless data and power transfer. Receiver electronics connect via a scleral tunnel to an epiretinal implant. A retinal encoder with 100 to 1000 tunable spatiotemporal filters simulates the filtering operations performed by the ganglion cell and allows individual calibration to improve each patient’s visual perception.
- Microelectrode-STS (suprachoroidal-transretinal stimulation) system (Osaka University, Japan) places its 9- electrode retinal prosthesis in a scleral pocket with a reference electrode in the vitreous cavity. A video camera is used to detect a visual object. Because the electrodes are at a greater distance from the retina, the resolution of the image may be lower than other devices. A proposed advantage of the STS prosthesis over epi- or subretinal prostheses is the safety of the surgical procedure, because the electrodes do not touch the retina.
The most recent literature review was performed through December 13, 2020.
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 the Food and Drug Administration (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 U.S.; the overall conclusion was that the evidence on retinal prostheses is insufficient on all outcomes of interest. One study with 30 patients has evaluated the single FDA-approved device (the Argus II) and numerous articles on this study have been published. Primary outcomes included three computer-based visual acuity tests. At three- and five-year follow-up visits, patients performed significantly better on the three computer tasks with the device on compared with off. Performance on the most difficult task, grating discrimination, was still relatively low with the device on. Sub-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 30 patients 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 with 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
No guidelines or statements were identified.
U.S. Preventive Services Task Force Recommendations
Argus II, Retinal prosthesis, Boston Retinal Implant, Intelligent Retinal Implant System, EPIRET3 Retinal Implant, Alpha IMS Subretinal Implant
APPROVED BY GOVERNING BODIES:
In 2013, the Argus® II retinal prosthesis (Second Sight Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through a humanitarian use device exemption (HDE). HDE approval is limited to those 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 previous history of the ability to see forms. Patients must also be willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.
FDA product code: NBF
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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Placement of subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy
Device evaluation, interrogation, and initial programming of intra-ocular retinal electrode array (e.g. 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.
Device evaluation and interrogation of intra-ocular retinal electrode array (e.g. retinal prosthesis), in person, including reprogramming and visual training, when performed, with review and report by a qualified health care professional.
Miscellaneous external component, supply or accessory for use with the argus II retinal prosthesis system (eff 01/01/2019)
Vision item or service, miscellaneous
- 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.
- 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.
- 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.
- 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.
- Fujikado T, Kamei M, Sakaguchi H, et al. Testing of semichronically implanted retinal prosthesis by suprachoroidal-transretinal stimulation in patients with retinitis pigmentosa. Invest Ophthalmol Vis Sci. Jun 2011; 52(7):4726-4733.
- 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. Jan 24 2016.
- 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.
- 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.
- Klauke S, Goertz M, Rein S, et al. Stimulation with a wireless intraocular epiretinal implant elicits visual percepts in blind humans. Invest Ophthalmol Vis Sci. Jan 2011; 52(1):449-455.
- 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.
- Ong JM, da Cruz L. The bionic eye: a review. Clin Experiment Ophthalmol. Jan-Feb 2012; 40(1):6-17.
- Stingl K, Bartz-Schmidt KU, Besch D, et al. Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS. Proc Biol Sci. Apr 22 2013; 280(1757):20130077.
- Stingl K, Bartz-Schmidt KU, Gekeler F, et al. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. Nov 2013; 54(12):7658-7665.
- Zrenner E, Bartz-Schmidt KU, Benav H, et al. Subretinal electronic chips allow blind patients to read letters and combine them to words. Proc R Soc Biol Sci. May 22 2011; 278(1711):1489-1497.
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.
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.