Second Sight's Argus II Bionic Eye Approved for Medicare Codes

Beginning October 1, Medicare beneficiaries will have access to Second Sight Medical Products’ Argus II Retinal Prosthesis System for treatment of blindness caused by retinitis pigmentosa (RP).

The Sylmar, CA-based company announced today the Argus II has been approved for payment in both inpatient and outpatient care settings. Under the Medicare Inpatient Prospective Payment System, cases involving the Argus II will be identified by the new procedure code 14.81. Cases through hospital outpatient facilities and ambulatory surgical centers will be identified by the 0100T CPT code.

“We are excited that CMS recognizes that the Argus II provides a substantial clinical benefit to patients and meets all of the criteria for both of these payments,” Brian Mech, vice president of business development at Second Sight, said in a statement. “This news greatly facilitates access to the Argus II for Medicare beneficiaries regardless of the setting of care in which the system is provided.”

Last month, I spoke with Mech for a story on what’s holding back progress in the realm of bionic medical devices. He and others cited the difficulty firms face in gathering clinical data as one factor impeding advancement of the technology. (Some people, such as these makers of DIY implants, aren't letting that get in their way, though.)

Because the Argus II is the first device of its kind, Mech said there were no validated endpoints for its clinical study, as there are for, say, devices to treat diabetes or heart disease.

He told me Second Sight chose to apply for an HDE for treatment of RP rather than a PMA, which could have opened the door to larger patient populations, in part because the PMA would have required a much larger clinical study.

“In principle, we could also help patients with age-related macular degeneration, but we haven’t tested it yet in a clinical setting.”

There was also less risk involved in targeting RP. People with RP tend to go completely blind, whereas those with age-related macular degeneration typically retain their peripheral vision.

“[With RP patients,] we’re not putting anything at risk from a visual standpoint; they would be no worse off if the device robbed them of all their vision,” Mech said.

Mech also cited funding as a challenge faced by firms developing bionic medical devices. He said Second Sight was lucky to get backing from private investors, including medtech entrepreneur Alfred Mann. Asked if Second Sight would be able to get the Argus II to market in today’s funding climate, Mech wasn’t optimistic.

“I’m not sure that the answer to that would be yes,” Mech said. “I think it would be very hard to start this project today in this economic environment”

Mech told me the company’s “last challenge” involved insurance and reimbursement. “It’s still too early to tell how that’s going to shake out,” he told me at the time.

It looks like it has shaken out in Second Sight’s favor.

—Jamie Hartford, managing editor, MD+DI
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