VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced that First Coast Service Options, Inc., Medicare administrative contractor for Florida, established a local coverage determination (LCD) that allows patients with untreatable end-stage age-related macular degeneration access to the Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) technology. Patients must meet criteria noted in the contractor's LCD policy.
The telescope implant, an integral component of a new patient care program called CentraSight®, 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 must have either stopped responding to AMD medications, or have a form of the disease for which no treatment is available.
"Patients living with end-stage macular degeneration have extreme difficulty performing simple, everyday tasks. Both eyes have central visual loss, so recognizing faces of friends and family, performing activities of daily living, and safely crossing the street becomes impossible. This can have a debilitating effect, both physically and psychologically," said Marc H. Levy, M.D., a surgeon at Sarasota Retina Institute. "For many, this device has made a marked improvement in their lives," said Dr. Levy. "We are very encouraged that Medicare has granted access for this new treatment option to eligible patients in the State of Florida."
Approximately two million Americans have advanced forms of AMD with associated vision loss. Over a half million of these individuals have end-stage AMD and may be candidates for the telescope implant. Despite the availability of new drug treatments that slow the progression of AMD, the number of people with end-stage AMD is expected to double by the year 2050.
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 the July 2011 issue of Ophthalmology, the journal of the American Academy of Ophthalmology, a study reported 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.
More details on First Coast Service Options' medical policy can be found at: http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=32822&ContrId=197&ver=3&ContrVer=1&CntrctrSelected=197*1&Cntrctr=197&name=First+Coast+Service+Options%2c+Inc.+(09102%2c+MAC+-+Part+B)&DocStatus=Future&LCntrctr=197*1&bc=AgACAAIAAAAA&
About the 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 or 1-877-99-SIGHT.
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.