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Nova Eye Medical says proposed changes to Medicare reimbursement of minimally invasive glaucoma surgery (MIGS) in several US states will not have an impact on its sales and could even be a bonus.
Wisconsin Physician Service Insurance Corporation (WPS) has announced local coverage determination (LCD) proposed changes concerning its coverage policies for MIGS procedures.
WPS is a Medicare Administrative Contractor (MAC), which administers the insurance reimbursement claims of healthcare facilities in Kansas, Nebraska, Missouri, Iowa, Indiana, and Michigan.
Medtech focused on advancing ophthalmic technologies Nova Eye Medical (ASX:EYE) says the actual impact of the proposed changes on the revenue is dependent upon the surgical technique with which surgeons are using its trademarked iTrack portfolio in those states.
In the final draft LCD from WPS, limited or denied coverage has been proposed for several MIGS procedures, including ab interno canaloplasty surgical procedure, effective December 24, 2023.
EYE says the proposed changes by WPS are expected to be heavily contested by various industry stakeholders, including the American Glaucoma Society.
EYE held the US launch of its latest iTrack Advance at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in May 2023 and has since seen sales in its key target market increase.
The iTrack Advance, a surgical device for canaloplasty, takes EYE’s globally used legacy product and makes it much more user-friendly for surgeons.
For MIGS iTrack Advance is a consumable surgical device that restores the eye’s natural outflow pathway to lower pressure inside the eye and reduce patient reliance on anti-glaucoma medications for mild-moderate glaucoma.
EYE was traditionally focussed on the specialised glaucoma surgeon market but following the launch of iTrack Advance sees real market growth via comprehensive ophthalmologists and cataract surgeons.
EYE believes it is these surgeons who are more likely to treat glaucoma in its early stages, which is where MIGS procedures are commonly deployed in clinical practice.
EYE says consequently surgeons enjoy flexibility to use the iTrack products in a variety of surgical techniques and to seek reimbursement accordingly.
EYE managing director Tom Spurling says the company is positioned well to adapt to the final draft LCD.
“Canaloplasty performed via an ab interno surgical technique, commonly referred to as ab interno canaloplasty, has been foreshadowed as excluded from coverage.
“However, the use of iTrack to perform canaloplasty via the ab externo surgical technique has been proposed as retaining coverage.”
He says the proposed LCD changes could even end up working in favour of EYE and its products.
“Should the LCD be implemented our suite of products, regulatory clearances, and IP portfolio, provide us with the opportunity to adapt to the proposed changes, take advantage of market consolidation and, ultimately, maintain sales and sales growth,” Spurling says.
Surgery with EYE’s trademarked Molteno3 product portfolio, which is typically used in cases of late-stage glaucoma, remains covered.
“The biggest challenge we see from the potential changes is the confusion it may cause with customers.
“Our priority is to educate our stakeholders on the implications of the proposed changes.”
This article was developed in collaboration with Nova Eye Medical, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.