Business Context and Reporting Period
This Form 8-K was filed by Second Sight Medical Products, Inc. on June 2, 2015. The report addresses a significant regulatory development regarding Medicare coverage for the company's Argus II retinal prosthesis system. Note: The request metadata references "Vivani Medical, Inc.," but the filing text explicitly identifies the registrant as Second Sight Medical Products, Inc.
Key Financial Metrics
The filing text does not provide specific financial data such as revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on a coverage event rather than financial performance.
Material Changes
CGS Administrators, LLC, the Medicare Administrative Contractor (MAC) for Ohio and Kentucky, removed CPT code 0100T from the Non-Covered Services Local Coverage Determination. Consequently, CGS agreed to cover the implantation of the Argus II retinal prosthesis system for FDA-approved indications in these two states. This decision enables the treatment of Medicare beneficiaries in Ohio and Kentucky, leveraging local university surgical retina departments.
Guidance, Outlook, and Management Commentary
Management notes that CGS published Article ID #54326 outlining the specific coding and indications for the new coverage. Currently, two MACs provide coverage for the Argus II: CGS (Ohio and Kentucky) and Palmetto GBA (Virginia, West Virginia, North Carolina, and South Carolina). The company states it continues to work with other Medicare Administrative Contractors and payers to secure further positive coverage.
Investor Verification Checklist
- Verify the specific CPT code (0100T) and its removal from the Non-Covered Services list on the CMS website.
- Confirm the geographic scope of the new coverage (Ohio and Kentucky) and the specific MAC involved (CGS Administrators, LLC).
- Review the published Article ID #54326 for detailed coding requirements and clinical indications.
- Monitor ongoing efforts to secure coverage from the remaining 10 Medicare Administrative Contractor jurisdictions.