Medicare Designates Argus II Retinal Prosthesis System as New Technology and Provides Payment

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SYLMAR, Calif.— Second Sight Medical Products, based here, announced that its 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. These payments are designed to support timely access to innovative technologies for Medicare beneficiaries.

According to the CMS, cases involving the Argus II System that are eligible for new technology add-on payments under the Medicare Inpatient Prospective Payment System will be identified by a new ICD-9-CM procedure code 14.81. 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 (ASCs) that perform this procedure for Medicare beneficiaries, and 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. This news greatly facilitates access to the Argus II for Medicare beneficiaries regardless of the setting of care in which the system is provided,” said Brian Mech, vice president of business development at Second Sight.

Guideline information on billing, coding and payment for hospital outpatient departments and ASCs will be provided by CMS in the October quarterly update, which will be released on or before September 1.

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 the most severely affected RP patients. In the U.S. this includes patients with bare light perception or worse vision.