Iridex Confirms Medicare Administrative Contractors Retired Local Coverage Determinations that Restricted Cyclophotocoagulation
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The decision by Medicare Administrative Contractors to retire their local coverage determinations for Iridex Corporation's MicroPulse® Transscleral Laser Treatment (MPTLT) represents a significant development for the company. This action ensures the continuation of Medicare reimbursement for procedures using Iridex's technology, which is crucial for the company's revenue stream. As reimbursement often drives the adoption of medical technologies, this news could positively influence Iridex's market position and financial performance. Moreover, the sustained coverage may encourage further investment in the development of advanced glaucoma treatments, potentially leading to long-term growth in the ophthalmic medical devices sector.
The retirement of LCDs by the MACs following advocacy from Iridex and other stakeholders underscores the importance of policy engagement in the healthcare sector. This outcome not only impacts Iridex's business but also has broader implications for patient access to glaucoma treatments. By maintaining coverage, Medicare patients will continue to benefit from MPTLT, which is considered a clinically safe and effective option. This decision reflects the MACs' recognition of the clinical value of MPTLT and the importance of stakeholder feedback in shaping healthcare policy. It also suggests that the healthcare regulatory environment remains adaptable to stakeholder input, which is a positive sign for other medical device companies facing similar challenges.
The announcement from Iridex Corporation regarding the retention of full patient access to its cyclophotocoagulation products has direct financial implications. The potential restriction on Medicare coverage could have led to a decrease in the utilization of Iridex's G6 laser system and probes, negatively impacting the company's sales and earnings. With the LCDs retired, Iridex avoids what could have been a substantial headwind to its revenue. Investors should note that the company's financial outlook may now be more favorable than previously anticipated, as the risk of reduced Medicare reimbursements has been mitigated. This development could lead to a reassessment of the company's valuation and future earnings projections.
Action Retains Full Patient Access to MicroPulse® Transscleral Laser Treatment
MOUNTAIN VIEW, Calif., Dec. 28, 2023 (GLOBE NEWSWIRE) -- 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 Contact
Steven Koufos
skoufos@iridex.com
Investor Relations Contact
Philip Taylor
Gilmartin Group
investors@iridex.com
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