Iridex Confirms Medicare Administrative Contractors Retired Local Coverage Determinations that Restricted Cyclophotocoagulation
29 Dicembre 2023 - 12:00AM
Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing
innovative and versatile laser-based medical systems, delivery
devices, and procedure probes for the treatment of glaucoma and
retinal diseases, today announced all five Medicare Administrative
Contractors (“MACs”) retired their local coverage determinations
(“LCDs”) that were scheduled to take effect on January 29,
2024. Iridex and other stakeholders opposing the LCDs
have engaged with the MACs throughout the comment period to
advocate for continued patient access to clinically proven safe and
effective glaucoma treatments. The Company applauds the decision
which effectively retains reimbursement and full access for
Medicare patients to all Iridex cyclophotocoagulation products.
“We appreciate 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. By retiring the LCDs, the MACs have supported
continued access to advanced patient care like MPTLT,” said David
I. Bruce, President & CEO, Iridex Corporation.
“We thank the numerous glaucoma surgeons across the country, as
well as the various societies, notably the American Academy of
Ophthalmology, the American Glaucoma Society, the American Society
of Cataract and Refractive Surgery, and the Outpatient Ophthalmic
Surgery Society for their support and advocacy throughout the
process. The groundswell of reaction to the LCDs was critical in
providing persuasive feedback during the Notice Period before
effectiveness, leading to this action in support of glaucoma
patient care."
Between October 24th, 2023 and November 9th, 2023, five of the
seven MACs published LCDs targeting MIGS procedures, which also
partially restricted criteria for coverage of cyclophotocoagulation
reimbursement. Due to these proposed LCDs, the
cyclophotocoagulation procedures performed by Iridex’s G6 laser
system and probes would have been partially affected by
restrictions of the criteria to deem the procedure medically
necessary and provide coverage.
As of today, all five MACs, WPS Government Health
Administrators, Palmetto GBA, Celerian Group Company, National
Government Services, and Noridian Healthcare Solutions, have now
issued statements that the final LCDs will not go into effect on
January 29, 2024. As a result, there will be no change in January
2024 to the current Medicare coverage for MIGS procedures performed
with Iridex MicroPulse® TLT.
About Iridex Corporation
Iridex Corporation is a worldwide leader in developing,
manufacturing, and marketing innovative and versatile laser-based
medical systems, delivery devices and consumable instrumentation
for the ophthalmology market. The Company’s proprietary MicroPulse®
technology delivers a differentiated treatment that provides safe,
effective, and proven treatment for targeted sight-threatening eye
conditions. Iridex’s current product line is used for the treatment
of glaucoma and diabetic macular edema (DME) and other retinal
diseases. Iridex products are sold in the United States through a
direct sales force and internationally primarily through a network
of independent distributors into more than 100 countries. For
further information, visit the Iridex website at
www.iridex.com.
Iridex, and MicroPulse® are registered trademarks of Iridex
Corporation, Inc. © 2023 Iridex Corporation. All rights
reserved.
Safe Harbor Statement
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Act of 1934, as amended,
including those statements concerning clinical expectations and
commercial trends, market adoption and expansion, demand for and
utilization of the Company's products and results and expected
sales volumes. These statements are not guarantees of future
performance and actual results may differ materially from those
described in these forward-looking statements as a result of a
number of factors. Please see a detailed description of these and
other risks contained in our Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on November 20, 2023.
Forward-looking statements contained in this announcement are made
as of this date and will not be updated.
Media ContactSteven
Koufosskoufos@iridex.com
Investor Relations ContactPhilip
TaylorGilmartin Groupinvestors@iridex.com
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