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DESCRIPTIONA 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 then processed by an externally worn microcomputer. These signals are transmitted to 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 ArgusTM 16), which will permit the distinction between the presence and absence of light, and the second generation (e.g., ArgusTM II), which has 60 electrodes. It is hoped that further generation devices, containing up to 1,000 electrodes, will provide more useful vision. The first-generation device is currently being studied in 2 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.
The Argus II device received commercial approval in Europe in March 2011. In 2013, the U.S. Food and Drug Administration (FDA) approved a humanitarian use device exemption (HDE) for the Argus II retinal prosthesis by Second Sight Medical. 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 postimplant clinical follow-up, device fitting, and visual rehabilitation.
POLICYRetinal prostheses are considered investigational.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/21/2005: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 9.03.15
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.