Second Sight Medical Products has secured Medicare coverage for its Argus II retinal prosthesis system (Argus II) designed to treat the patients affected with blindness from the untreatable orphan disease retinitis pigmentosa in both the US and Europe.
Beginning October 1, 2013, the Centers for Medicare and Medicaid Services (CMS) will cover Argus II as a new technology for both inpatient and outpatient settings.
Under the Medicare Inpatient Prospective Payment System in the US, cases involving the Argus II System are now eligible for new technology add-on payments.
Also, CMS has established a transitional pass through payment for Argus II which will be available to all hospital outpatient facilities and ambulatory surgical centers that perform this procedure for Medicare beneficiaries.
This approval follows German's annual NUB funding approval for Argus II for the last three years and limited local government funding in the NHS Hospital of Pisa in Italy.
These payments are designed to support timely access to new technologies for insured patients.
The company is also awaiting approval in France following the ongoing assessment by the Ministry of Health.
Second Sight European Operations vice president Gregoire Cosendai noted the company is excited that Medicare in the USA has recognized that the Argus II provides a substantial clinical benefit to patients.
"After these markets we hope to have government funding approvals in France, England, Netherlands and other global markets," Cosendai added.
The Argus II received FDA approval earlier this year under a humanitarian device exemption to help patients in Europe blinded from outer retinal degenerations.