regulatory
confidence high
sentiment negative
materiality 0.80
IRIDEX withdraws FY2023 guidance after Medicare LCD restricts glaucoma reimbursement
IRIDEX CORP
- WPS Medicare LCD effective Dec 24, 2023 will likely limit cyclophotocoagulation coverage to only refractory glaucoma patients meeting strict criteria.
- Company withdrawing previously announced 2023 annual guidance due to uncertainty from the LCD.
- WPS jurisdiction covers ~8% of US glaucoma probe sales; similar MAC actions could impact majority of US glaucoma revenue.
- IRIDEX plans to appeal LCD, engage with MACs, and initiate a clinical study to meet LCD evidence requirements.
- Outside US (50% of glaucoma revenue) not materially impacted by the LCD.