Business Context and Reporting Period
This Form 8-K was filed by Second Sight Medical Products, Inc. on November 2, 2018. The report addresses the finalization of Medicare payment rates for the company's Argus II Retinal Prosthesis System for the calendar year 2019. Note: The request metadata listed "Vivani Medical, Inc.", but the filing text explicitly identifies the registrant as Second Sight Medical Products, Inc.
Key Financial Metrics and Rates
The filing details specific Medicare payment rates finalized by the Centers for Medicare & Medicaid Services (CMS) effective January 1, 2019:
- Hospital Outpatient Rate: Approximately $152,500 for the Argus II system and surgical implantation procedure.
- Ambulatory Surgical Center (ASC) Rate: Approximately $134,051 for the Argus II system and related implantation procedure.
- Initial Programming (CPT 0472T): $280.41 national average hospital outpatient rate.
- Reprogramming (CPT 0473T): $117.54 national average hospital outpatient rate.
The filing does not provide data on the company's total revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes Versus Prior Period
CMS reassigned CPT code 0100T from Ambulatory Payment Classification (APC) 1904 to APC 1908. This change resulted in an increase in the Medicare payment rate from approximately $122,500 in CY 2018 to approximately $152,500 in CY 2019. Additionally, CMS utilized equitable adjustment authority to stabilize rates and proposed excluding New Technology APC procedures from being packaged with "J1" coded services to ensure sufficient claims data.
Outlook, Risks, and Management Commentary
Management notes that the new payment methodology is expected to stabilize rates at the current level for the foreseeable future. The filing clarifies that these final rules apply only to Medicare hospital outpatient departments and ambulatory surgical centers under the OPPS and ASC prospective payment systems. They do not directly alter payments from Medicare Advantage, private U.S. health insurance, or non-U.S. reimbursement sources.
Investor Verification Checklist
- Verify the impact of the $152,500 hospital rate increase on projected 2019 revenue.
- Confirm the extent of reimbursement from private insurers and Medicare Advantage, as these are not covered by the CMS final rule.
- Assess the operational impact of the new packaging rules regarding "J1" coded procedures.
- Review the attached press release (Exhibit 99.1) for additional management commentary on the rate finalization.