Business Context and Reporting Period
This Form 8-K was filed by Second Sight Medical Products, Inc. (noting the metadata reference to Vivani Medical, Inc. appears to be a discrepancy as the filing text explicitly names Second Sight) on November 18, 2015. The report addresses a meeting with the Centers for Medicare & Medicaid Services (CMS) regarding the Argus II retinal prosthesis.
Key Financial Metrics
The filing does not provide specific revenue, profit, cash flow, margin, debt, or liquidity figures for the current period. It notes that for the first nine months of fiscal 2015 (ended September 30, 2015), implants in patients covered by Medicare fee-for-service accounted for 13% of the company's global implant volume.
Material Changes and Events
- CMS Meeting Outcome: The company met with CMS on November 18, 2015, to discuss Medicare hospital outpatient payment policy for the Argus II retinal prosthesis.
- Regulatory Status: The meeting did not result in a revision of the published final rule establishing 2016 Medicare reimbursement to hospital outpatient departments.
- Scope of Impact: The final rule affects payments under the Medicare Outpatient Prospective Payment System and Ambulatory Surgical Center (ASC) Payment System. It does not directly alter payments from Medicare Advantage, private U.S. health insurance, or non-U.S. business.
Outlook, Risks, and Management Commentary
Management stated that the long-term impact of the CMS final rule on the company's financial position and results of operations will depend on the mix of implants covered by Medicare fee-for-service, Medicare Advantage, private U.S. health insurance, and non-U.S. business. The company plans to continue working to ensure hospitals and providers obtain appropriate reimbursement levels to maintain access to the technology for patients with no other treatment options.
Investor Verification Checklist
- Verify the exact impact of the 2016 Medicare final rule on hospital reimbursement rates for the Argus II prosthesis.
- Assess the current and projected mix of revenue sources (Medicare fee-for-service vs. Medicare Advantage, private insurance, and international) to gauge sensitivity to the CMS rule.
- Confirm the company's ongoing strategy for engaging with providers to secure appropriate reimbursement levels.
- Clarify the discrepancy between the metadata company name (Vivani Medical, Inc.) and the registrant name in the filing (Second Sight Medical Products, Inc.).