Sight Sciences, Inc. and Iridex Corporation are supporting the decision of five Medicare Administrative Contractors (MACs) to withdraw their final local coverage determinations (LCDs) for specific micro-invasive glaucoma surgery (MIGS) procedures.
I need some background.
Back in October 2023, the WPS Government Health Administrators—a MAC—published a new LCD that identified certain glaucoma management procedures as investigational for patients aged 18+.
Such procedures included:
- Excimer laser trabeculostomy
- Viscocanaloplasty
- Canaloplasty in combination with trabeculectomy ab interno
- Gonioscopy-assisted transluminal trabeculotomy (GATT)
- Ab interno canaloplasty
- Transciliary fistulization
Refresh me on an LCD.
An LCD is essentially a decision made by a MAC on whether or not a particular service/item is “reasonable and necessary” and, as a result, covered by Medicare with a specific area overseen by the MAC.
And which states did this LCD apply to?
The WPS Health Administrators’ Medicare Part B benefits in Kansas, Nebraska, Missouri, Iowa, Indiana, and Michigan.
To note, these changes were originally scheduled to take effect in late December 2023.
Gotcha. And which other MACs included proposed LCDs changes?
- Palmetto GBA
- Celerian Group Company
- National Government Services
- Noridian Healthcare Solutions
These four MACs also published similar LCDs on MIGS that identified the aforementioned procedures as investigational, originally marking January 29, 2024, as the effective date.
How would this have impacted Sight Sciences?
In a word, significantly. Sight Sciences has two procedures which would not have been covered by Medicare in the affected states.
- OMNI Surgical System, which is the first and currently only implant-free, single-use therapeutic glaucoma device indicated for canaloplasty followed by trabeculotomy in order to reduce intraocular pressure (IOP).
- SION Surgical Instrument to excise trabecular meshwork through a goniotomy technique.
Plus, in response to the proposed LCD changes, the company announced it would be implementing a new targeted plan that includes:
- Reduction in operating expenses (specifically within the dry eye space)
- Improvement in cost efficiencies for long-term growth and profits
- 10% reduction of its global workforce
Go on …
CEO and co-founder Paul Badawi called these proposed changes “fundamentally flawed,” during a November 2023 conference call. “We strongly disagree with the LCD’s coverage limitations with respect to these procedures and we are pursuing all remediation possibilities to maintain Medicare coverage in the states administered by WPS,” Badawi stated in the call.
Now how about Iridex?
The company originally appealed in November 2023 for a revision to the new LCDs on criteria for cyclophotocoagulation (CPC) coverage, which the MACs granted, enabling a broader patient population to be eligible.
Iridex had also reported a second appeal to further broaden patient criteria for reimbursement. See here for those details.
And what impact would this have had on the company?
Of major concern was Iridex’s MicroPulse TLT laser therapy (MPTLT) as well as its other CPC products.
About this withdrawal update …
Per Sight Sciences, all five MACs have stated that the final LCDs will not go into effect at the end of January, as previously planned. “As a result, there will be no change in January 2024 to the current Medicare coverage for MIGS procedures performed with the OMNI Surgical System,” the company stated.
This also applies to Iridex’s MPTLT: patients will retain full access to the treatment.
Any input from the companies’ leaders?
Badawi expressed Sight Sciences’ appreciation that the MACs and CMS “carefully and thoughtfully considered all stakeholder concerns with the LCDs and the serious potential risks to patient health and access to effective glaucoma care,” he stated.
He further added that the company will continue to work with the MAC and CMS to “ensure glaucoma patients and their physicians maintain appropriate and fair access to medically reasonable and necessary MIGS procedures and technology.”
Iridex President and CEO David I Bruce also noted appreciation for, “the engagement with us by the MAC administrators, from the initial correction of criteria for coverage to the conference call with the group to discuss appropriate broadening of qualifying patients.”He added: “By retiring the LCDs, the MACs have supported continued access to advanced patient care like MPTLT.”
Sounds like a victory for the companies.
Indeed—and for glaucoma patients across the United States as these changes would have (potentially) severely impacted access to care and reimbursement.
Lastly, wasn’t there another policy change last year for the OMNI Surgical System?
There was! Back in June 2023, Sight Sciences announced that Cigna Healthcare’s Glaucoma Surgical Policy would cover both goniotomy (trabeculotomy) and ab interno canaloplasty procedures to treat open-angle glaucoma (OAG).
Click here for our coverage.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.