2013-08-21 15:02:03 -
Second Sight Medical Products, Inc., the leading developer of retinal prostheses for the blind, today announced that The Argus® II Retinal Prosthesis System (Argus II) has been approved by the Centers for Medicare and Medicaid Services (CMS) for both a new technology add-on payment (inpatient setting of care) and a transitional pass through payment (outpatient setting of care) beginning October 1, 2013.
This decision follows the annual NUB funding approval for Argus II for the last three years in Germany and limited local government funding in the NHS Hospital of Pisa in Italy. These payments are designed to support timely access to innovative technologies for insured patients.
According to the recent CMS announcement, cases involving the Argus II System are
eligible for new technology add-on payments under the Medicare Inpatient Prospective Payment System in the USA. Additionally, CMS has also established a transitional pass through payment for Argus II. This payment will be available to all hospital outpatient facilities and Ambulatory Surgical Centers that perform this procedure for Medicare beneficiaries.
“We are excited that Medicare in the USA has recognized that the Argus II provides a substantial clinical benefit to patients. This news will facilitates access to the retinal implant for patients across the world.
After these markets we hope to have government funding approvals in France, England, Netherlands and other global markets,” said Gregoire Cosendai, VP of European Operations for Second Sight.
"After already being available & reimbursed in Germany and Italy for three years, the reimbursement approval for the Argus II Bionic Eye in the USA proves once again how important this technology is for the patients affected with blindness from the untreatable orphan disease Retinitis Pigmentosa. We hope that patients in France will also be able to get access to the only FDA & CE approved treatment in the world for patients suffering from RP. Physicians and patients are eagerly waiting for a similar decision in France, expected following the ongoing assessment by the Ministry of Health," said Professor José-Alain Sahel, Chairman, Department of Ophthalmology: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France.
About Retinitis Pigmentosa (RP)
RP is an inherited retinal degenerative disease that often results in near-complete blindness. It is caused by abnormalities of the photoreceptors (rods and cones) or the retinal pigment epithelium of the retina, leading to progressive loss of vision. It’s estimated that RP affects roughly 100,000 Americans and 200,000 Europeans.
About The Argus II System
The Argus II System works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells, resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function.
The Argus II, which received FDA approval earlier this year under a Humanitarian Device Exemption (HDE) following European approval (CE Mark) in 2011, is intended to help patients in Europe blinded from outer retinal degenerations, such as Retinitis Pigmentosa.
About Second Sight
Second Sight Medical Products, Inc., located near Los Angeles, Calif., was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations such as RP. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. US Headquarters are in Sylmar, Calif., and European Headquarters are in Lausanne, Switzerland.
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