Business Context and Reporting Period
This Form 8-K Current Report was filed by Glaukos Corporation on November 2, 2021. The filing addresses the publication of Final Rules by the Centers for Medicare & Medicaid Services (CMS) regarding 2022 Medicare physician and facility fee payment rates. These rules impact reimbursement for Glaukos' trabecular micro-bypass technologies (iStent, iStent inject, and iStent inject W) when used in combination with cataract surgery.
Key Financial Metrics and Reimbursement Rates
The filing does not provide consolidated revenue, profit, cash flow, or debt metrics. Instead, it details specific 2022 Medicare reimbursement rates established by CMS:
- Physician Fee Payment Rates (Incremental for device insertion):
- CPT 66991 (Cataract + aqueous drainage device): Approximately $134.73 incremental fee (Total rate: ~$663.57).
- CPT 66989 (Complex cataract + aqueous drainage device): Approximately $107.18 incremental fee (Total rate: ~$831.56).
- Facility Fee Payment Rates (ASC and HOPD):
- CPT 66991 and 66989 in Ambulatory Surgical Center (ASC) setting: $3,245.55.
- CPT 66991 and 66989 in Hospital Outpatient (HOPD) setting: $4,250.50.
- CPT 0671T (Standalone insertion, iStent infinite): $1,601.18 (ASC) and $2,120.86 (HOPD).
Material Changes Versus Prior Period
The Final Rules supersede the proposed rates issued in July 2021. A material change involves the transition from Category III CPT codes (0191T and 0376T) to new Category I CPT codes (66991 and 66989) as the primary codes for reimbursement. The filing notes that approximately 80% of procedures utilizing these technologies are performed in the ASC setting, with the remaining 20% in the HOPD setting.
Guidance, Outlook, and Risks
Outlook and Commentary: The new rates take effect on January 1, 2022, subject to potential updates or corrections by CMS prior to that date. The filing highlights that the iStent infinite product, associated with CPT code 0671T, is not yet approved by the U.S. Food & Drug Administration (FDA).
Risks and Contingencies: The primary risk is the potential for CMS to issue updates or corrections to the Final Rules before the effective date. Additionally, the reimbursement for the iStent infinite product is contingent upon future FDA approval.
Investor Verification Checklist
- Verify the final effective date of the 2022 CMS rules and check for any post-filing updates or corrections issued by CMS before January 1, 2022.
- Confirm the FDA approval status of the iStent infinite product to validate the applicability of the CPT 0671T reimbursement rates.
- Monitor the actual adoption rate of the new Category I CPT codes (66991 and 66989) versus the legacy Category III codes in the market.
- Review the specific breakdown of Glaukos' procedure volume between ASC and HOPD settings to assess the weighted average impact of the facility fee rates.