Business Context and Reporting Period
This Form 8-K is filed by Second Sight Medical Products, Inc. (not Vivani Medical, Inc.) for the reporting period ending June 30, 2017. The filing addresses a significant regulatory development regarding Medicare coverage for the company's Argus II Retinal Prosthesis System.
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 regulatory event rather than financial performance.
Material Changes
Novitas Solutions, Inc., the Medicare Administrative Contractor (MAC) for Jurisdictions H and L, removed CPT code 0100T from the list of services deemed "not reasonable and necessary." This change enables Medicare coverage for the Argus II implantation procedure in 11 states (Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, Texas, Delaware, Maryland, New Jersey, Pennsylvania) and the District of Columbia, effective April 26, 2017.
Outlook, Commentary, and Risks
- Management Commentary: The company continues to work with other MACs and payers to secure additional positive coverage policies for the Argus II.
- Current Coverage Status: Following this update, seven Medicare jurisdictions now provide coverage for the Argus II in 28 states, two territories, and the District of Columbia when medically necessary.
- Conditions: Coverage is contingent upon the procedure meeting all regulatory requirements, including the "reasonable and necessary" threshold.
Investor Verification Checklist
- Verify the specific list of 11 states and the District of Columbia where coverage was expanded.
- Confirm the effective date of the coverage expansion (April 26, 2017) versus the announcement date (July 3, 2017).
- Review the attached press release (Exhibit 99.1) for detailed commercial implications.
- Monitor ongoing efforts to secure coverage in the remaining Medicare jurisdictions not yet listed.