| MP 9.03.15 | Retinal Prosthesis | |
| Medical Policy | ||
| Section Miscellaneous Policies |
Original Policy Date 41/05 |
Last Review Status/Date Reviewed with literature search/10:2009 |
| Issue 10:2009 |
Return to Medical Policy Index |
Disclaimer
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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, which will permit the distinction between the presence and absence of light. 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 the context of 2 Investigational New Device Trials approved by the U.S. Food and Drug Administration (FDA). Second Sight Medical Products is the sponsor for these trials. The first trial is a short-term feasibility study, in which the device is removed at the end of the trial. The second study is a long-term trial in which the electrodes remain implanted for the duration of the study. At the present time, no device has received final FDA approval.
Policy
Retinal prostheses are considered investigational.
Policy Guidelines
This policy is created in response to a new category III CPT, introduced in July 2005.
0100T: Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy.
Benefit Application
BlueCard/National Account Issues
At the present time, the IDE limits the use of this device to the Doheny Eye Institute at the University of Southern California. Therefore, out of network referral may be requested.
Rationale
Second Sight Medical Products reports that the Argus 16 was implanted in 6 subjects with retinitis pigmentosa between 2002 and 2004; the study is ongoing with 5 of 6 subjects wearing the retinal prosthesis at home. (1) The company is currently recruiting 10 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. (2)
An updated literature search through August 2009 indicates that initial results from the phase I/II study of the Argus 16 devices implanted between 2002 and 2004 have now been published. (1) In a summary of their work to date, Chader et al. report 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 1000-electrode prosthesis could potentially be achieved within 5-10 years. (3) Initial results from a 4-week implantation study of another retinal prosthesis, the EPI-RET-3, have also been reported. (4)
No device has final U.S. Food and Drug Administration (FDA) approval. This is considered investigational.
References:
- Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa. Available at: http://clinicaltrials.gov/ct2/show/NCT00279500?term=NCT00279500&rank=1 Last accessed September 2009.
- ArgusTM II Retinal Stimulation System Feasibility Protocol. Available at: http://clinicaltrials.gov/show/NCT00407602. Last accessed September 2009.
- Chader GJ, Weiland J, Humayun MS. Artificial vision: needs, functioning, and testing of a retinal electronic prosthesis. Prog Brain Res 2009; 175:317-32.
- Mokwa W, Goertz M, Koch C et al. Intraocular epiretinal prosthesis to restore vision in blind humans. Conf Proc IEEE Eng Med Biol Soc 2008; 2008:5790-3.
Codes |
Number |
Description |
| CPT | 0100T | Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy |
| ICD-9 Diagnosis | 362.51 | Nonexudative senile macular degeneration |
| 362.70 | Hereditary retinal dystrophy | |
| 362.74 | Pigmentary retinal dystrophy (retinitis pigmentosa) |
Index
Retinal Prosthesis
Second Sight, Retinal Prosthesis
Subconjunctival Retinal Prosthesis
Policy History
| Date | Action | Reason |
| 04/1/05 | Add policy to Other section, Vision subsection | New policy |
| 03/7/06 | Replace policy | Policy updated with literature search; no change in policy statement |
| 10/06/09 | Replace policy | Policy updated with literature search through August 2009; references 1, 3 and 4 added; policy statement unchanged. Policy title changed – “Subconjunctival” removed from title. |
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