Second Sight Medical Products has scored Medicare coverage for its new retinal implant designed to treat adults with a degenerative eye disease, a big win for a device company seeking to grow revenue and reach the widest audience possible with its products.
Beginning Oct. 1, the Centers for Medicare and Medicaid Services (CMS) will cover the company's Argus II Retinal Prosthesis System as a new technology for inpatient and outpatient settings, Second Sight said.
Device and diagnostics companies often hit a brick wall in the current healthcare environment, with the Affordable Care Act and insurers both public and private focused on cutting healthcare costs. As a result, insurance reimbursements have been increasingly hard to come by. CMS is key because private insurers often follow suit. Without either, patients must often pay for treatments or diagnostic tools out-of-pocket, which limits their use and revenue-generating potential for companies seeking to successfully launch new products.
Brian Mech, Second Sight's vice president of business development, acknowledged in a statement the impact that CMS coverage will make.
"This news greatly facilitates access to the Argus II for Medicare beneficiaries regardless of the setting of care in which the system is provided," he said.
It took a long time to reach this point. The FDA granted approval for Argus II back in February 2013. It's indicated to treat adults ages 25 or older with advanced retinitis pigmentosa, an inherited degenerative disease that can lead to blindness through damage to light-sensitive cells that line the retina. The approval is as a humanitarian use device, however, which limits treatment to fewer than 4,000 people in the U.S. each year. Argus II also has a CE mark.
Argus II consists of a retinal implant, glasses with an attached video camera and a wireless processing unit worn on a belt.
- read the release