2014

Medicare Establishes Reimbursement for VisionCare's Implantable Telescope for Macular Degeneration Approval of device pass-through payment allows eligible Medicare beneficiaries new AMD treatment option access

SARATOGA, Calif., Sept. 8, 2011 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced that the Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through payment status and established a billing code for the Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) under the Hospital Outpatient Prospective Payment System.  The new pass-through code, C1840, is effective October 1, 2011 and will enable outpatient facilities to obtain reimbursement for the telescope implant for covered procedures.

The telescope implant is approved by the U.S. Food and Drug Administration to improve vision in patients with end-stage age-related macular degeneration (AMD), the most advanced form of AMD.   Eligible patients must have associated central vision blindness and either stopped responding to AMD medications, or have a form of the disease for which no treatment is available.  

"The CMS determination that our intraocular telescope meets the criteria for transitional pass-through payment and the October availability of reimbursement are very positive developments for AMD patients and the ophthalmology community," said Allen W. Hill, CEO of VisionCare.  "The new code will provide a payment mechanism for the telescope implant for Medicare beneficiaries visually debilitated by end-stage AMD.  We are training providers and working with the ophthalmic community so that eligible patients can begin receiving treatment next month."

CMS pass-through payments provide reimbursement for a new technology that offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments, or significantly improves clinical outcomes for a patient population as compared to other treatments.

VisionCare's clinical trial results, which have been published in peer-reviewed articles, demonstrated improved visual acuity and quality of life in patients with end-stage AMD.  In this month's issue of Ophthalmology, the journal of the American Academy of Ophthalmology, a study reports the intraocular telescope improves quality of life and is cost effective. A summary of the article can be found at: http://www.ophsource.org/periodicals/ophtha/article/S0161-6420(11)00171-0/abstract.

CentraSight Treatment Program
The first-of-kind telescope implant is integral to a new patient care program, CentraSight, for patients with end-stage macular degeneration.  The CentraSight treatment program involves a patient management process and access to reimbursement information for patients and physicians. The telescope implantation is performed by a specially trained ophthalmic surgeon as an outpatient procedure.

Patients and physicians can find more information about the telescope implant and related treatment program at www.CentraSight.com.

About the Telescope Implant
The Implantable Miniature Telescope (by Dr. Isaac Lipshitz) is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe to profound vision impairment (best-corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas (blind areas) associated with end-stage AMD. This level of visual impairment constitutes statutory (legal) blindness.

Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.

The risks and benefits associated with the telescope implant are discussed in the Patient Information Booklet available at www.CentraSight.com.

About End-Stage Macular Degeneration
AMD is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like recognizing faces and watching television. The National Eye Institute estimates that over 1.7 million Americans over age 50 suffer vision loss from advanced AMD, which frequently culminates as end-stage AMD (visual impairment due to untreatable advanced AMD in both eyes). These patients often experience a loss of independence and social isolation, and have difficulty with activities of daily living. Approximately half of the individuals living with advanced AMD are affected in both eyes.

About VisionCare
VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA, is a privately-held company focused on development, manufacturing, and marketing of implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. The company's R&D and manufacturing facility is located in Petah Tikva, Israel. VisionCare's investors include Saints Capital, Pitango Venture Capital, Three Arch Partners, ONSET Ventures, BSI Healthcapital, Giza Venture Capital, and Infinity Private Equity Fund. VisionCare's Implantable Miniature Telescope was invented by company founders Yossi Gross and Isaac Lipshitz. Information on VisionCare can be found at www.visioncareinc.net.

SOURCE VisionCare Ophthalmic Technologies, Inc.



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