| Medicine Section - Subconjunctival Retinal Prosthesis
| Topic: Subconjunctival Retinal
Prosthesis |
Date of Origin: 07/05/2005 |
| Section: Medicine |
Policy No: 123 |
| Approved Date: 12/09/2008 |
Effective Date: 01/01/2009 |
| Next Review Date: 01/2012 |
|
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
Description
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
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
two 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/Criteria
Subconjunctival retinal prostheses are considered investigational.
Scientific Background
A search of the MEDLINE database through October 26,
2008 did not identify any published clinical studies
of retinal prostheses. Therefore, it is not possible
to reach scientific conclusions concerning whether
or not these devices result in improved health outcomes.
Second Sight Medical Products has reported 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
ten subjects for a National Institutes of Health-sponsored
phase II multicenter safety and effectiveness study
of the second generation Argus II Retinal Stimulation
System (NCT 00407602). (2)
References
- BlueCross BlueShield Association Medical Policy
Reference Manual, Policy No. 9.03.15
- Argus™ II Retinal Stimulation System Feasibility
Protocol available online at http://www.clinicaltrials.gov/ct2/show/NCT00407602?term=argus&rank=1
Cross References
None
| 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 |
|
HCPCS |
None |
|
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