BlueCross and BlueShield of Montana Medical Policy/Codes
Retinal Prosthesis
Chapter: Surgery: Procedures
Current Effective Date: September 24, 2013
Original Effective Date: November 01, 2012
Publish Date: September 24, 2013
Revised Dates: August 28, 2013
Description

A retinal prosthesis is a device that replaces lost photoreceptor function by transmitting computer-processed video images to an array of electrodes placed on the retinal surface.

There is ongoing research interest in developing an artificial retina that could potentially 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.  As currently investigated, the artificial retina consists of a small external video camera, held on eyeglass frames, that captures images that are then processed by an externally worn microcomputer.  These signals are transmitted to an electrode array implanted in the back of the eye, which in turn stimulates the optic nerve.

Research has begun with a first generation, 16-electrode device (e.g., the Argus™ 16), which is expected to permit the distinction between the presence and absence of light, and the second generation (e.g., Argus™ II), which has 60 electrodes.  It is hoped that further generation devices, containing more than 1,000 electrodes, will provide more useful vision.  The first and second generation devices are currently being studied in two Investigational New Device trials approved by the U.S. Food and Drug Administration (FDA).  Second Sight Medical Products and the National Institutes of Health are partnering sponsors for these feasibility studies.  At the present time, no device has received final FDA approval.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there is any exclusion or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross Blue Shield of Montana (BCBSMT) considers placement of a retinal prosthesis experimental, investigational and unproven.

Rationale

Update and revision of the entire rationale using a literature search through July 2011.

Second Sight Medical Products reports that the Argus 16 was implanted in six subjects with retinitis pigmentosa between 2002 and 2004; the study is ongoing with five of six subjects wearing the retinal prosthesis at home.  The company is currently recruiting 30 subjects for a National Institutes of Health-sponsored Phase II multicenter safety and effectiveness study of the second generation Argus II Retinal Stimulation System. 

Initial results from the Phase I/II study of the Argus 16 devices, implanted between 2002 and 2004, had been published.  Two publications were with the Argus™ II (60 electrode) device, one of which was a conference proceeding.  Preliminary six-month results in 17 subjects showed improvement in high-contrast localization and orientation.  For example, the success rate of reaching a door improved from 32% with the system off to 59% with the system on.  The average success rates of following a white line on a dark floor improved from 26% to 44%, respectively.  Localization of a high-contrast target on a computer monitor was also found to improve with the Argus™ II in 27 subjects implanted with the device.

In a summary of their work, Chader et al. (2009) reported that the 60-electrode device is currently in a Phase II/III clinical trial, a 250-electrode unit is “on the drawing board,” and functional vision with a thousand electrode prosthesis could potentially be achieved within 5-10 years.  Initial results from a four-week implantation study of another retinal prosthesis, the EPI-RET-3, have also been reported.

No device has final U.S. Food and Drug Administration (FDA) approval.  This treatment is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

Rationale for Benefit Administration
 
ICD-9 Codes

362.51, 362.70, 362.74

ICD-10 Codes

H35.31, H35.50, H35.42, 08UE0JZ, 08UE3JZ, 08UF0JZ, 08UF3JZ

Procedural Codes: 0100T
References
  1. Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa.  Available online at: http://clinicaltrials.gov .  Last accessed August 2011.
  2. Argus ™ II Retinal Stimulation System Feasibility Protocol. Available online at: http://clinicaltrials.gov .  Last accessed August 2011.
  3. Chader, G.J., and J. Weiland.  Artificial vision: needs, functioning, and testing of a retinal electronic prosthesis.  Prog Brain Res (2009) 175:317-32.
  4. Mokwa, W., Goertz, M., et al.  Intraocular epiretinal prosthesis to restore vision in blind humans. Conf Proc IEEE Eng Med Biol Soc (2008) 2008:5790-3.
  5. Humayun, M.S., Dorn, J.D., et al.  Preliminary 6 month results from the Argus II epiretinal prosthesis feasibility study.  Conf Proc IEEE Eng Med Biol Soc. (2009) 2009:4566-8.
  6. Ahuja, A.K., Dorn, J.D., et al.  Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task.  Br J Ophthalmol (2011 April) 95(4):539-43. 
  7. Retinal Prosthesis, Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 February) 9.03.15.
History
July 2012  New Policy for BCBSMT: Policy added with literature search through November 2011; Policy statement is investigational
September 2013 Policy formatting and language revised.  Policy statement unchanged.
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Retinal Prosthesis