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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. At the present time, no device has received final FDA approval.
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.
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.