Sight Sciences Announces Withdrawal of Final LCDs on Micro-Invasive Glaucoma Surgery from Five Medicare Administrative Contractors
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The withdrawal of the final local coverage determinations (LCDs) for Micro-Invasive Glaucoma Surgery (MIGS) by the Medicare Administrative Contractors (MACs) represents a significant policy shift with direct implications for the healthcare industry, particularly in the sector of ophthalmic surgery and medical device manufacturers like Sight Sciences. The decision to maintain Medicare coverage for MIGS procedures, specifically those performed with the OMNI Surgical System, safeguards the company's market within the Medicare demographic, which is substantial given the prevalence of glaucoma in the aging population.
This development is poised to influence the financial stability and growth potential of companies involved in the MIGS space. By ensuring continued Medicare coverage, these entities are protected against the risk of reduced utilization of their technologies, which could have resulted from the initially proposed LCDs. The decision underscores the importance of stakeholder engagement in the healthcare policy-making process and highlights the influence of professional societies and advocacy groups in shaping coverage decisions that affect patient care and industry economics.
The recent announcement by MACs to maintain Medicare coverage for MIGS procedures, which include Sight Sciences' OMNI Surgical System, has immediate and long-term ramifications for the medical device industry. The initial threat of losing Medicare coverage for certain MIGS procedures could have led to a significant reduction in the adoption and usage of these technologies, negatively impacting device manufacturers' revenue streams and investment in innovation.
With the LCDs no longer taking effect, Sight Sciences and other players in the MIGS market can expect stability and potential growth in demand. This outcome may also encourage continued investment in research and development within the sector, as the perceived risk of regulatory and reimbursement challenges diminishes. The decision by the MACs may serve as a precedent for future coverage determinacies, suggesting that robust clinical evidence and active advocacy can effectively influence policy to favor continued innovation and patient access to advanced medical technologies.
From a health economics perspective, the decision to continue Medicare coverage for MIGS procedures, including those enabled by the OMNI Surgical System, has implications for the cost-effectiveness of glaucoma management. By allowing continued access to these minimally invasive surgeries, Medicare is supporting a treatment option that may offer cost savings compared to traditional glaucoma surgeries, both in terms of direct procedure costs and long-term management of the disease.
Furthermore, the decision potentially reflects a recognition of the value of MIGS in preventing more severe glaucoma complications that could result in higher treatment costs and poorer patient outcomes. The maintenance of coverage can be seen as an investment in preventive health measures that align with the broader goals of Medicare to provide cost-effective and quality care. This event may encourage further economic analyses to quantify the value of MIGS and similar innovative treatments in terms of their impact on the overall healthcare expenditure and patient quality of life.
Decision ensures continued access to comprehensive outflow procedure enabled by OMNI® Surgical System technology for glaucoma patients
MENLO PARK, Calif., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, supports the decision announced by five Medicare Administrative Contractors (“MACs”) to withdraw their final local coverage determinations (“LCDs”) for Micro-Invasive Glaucoma Surgery (“MIGS”) that were scheduled to take effect on January 29, 2024.
These five MACs, WPS Government Health Administrators, Palmetto GBA, Celerian Group Company, National Government Services, and Noridian Healthcare Solutions, previously published LCDs on MIGS, which identified certain procedures as investigational for glaucoma management in patients over the age of 18, including canaloplasty in combination with trabeculotomy ab interno, which is a procedural description associated with the Company’s OMNI Surgical System (“OMNI”). All five MACs 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 the OMNI Surgical System.
“We appreciate that the MACs and the Centers for Medicare & Medicaid Services (“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,” said Paul Badawi, co-founder and CEO of Sight Sciences. “We look forward to continued engagement with the MACs and CMS to ensure glaucoma patients and their physicians maintain appropriate and fair access to medically reasonable and necessary MIGS procedures and technology. We would like to thank the many passionate glaucoma surgeons around the country and the national and state eye care societies including notably the American Academy of Ophthalmology, the American Glaucoma Society, the American Society of Cataract and Refractive Surgery, and the Outpatient Ophthalmic Surgery Society, who all worked collaboratively and tirelessly to provide valuable and critical feedback to the MACs, CMS, and Congressional offices during this rigorous review process. Additionally, we appreciate the support from the Medical Device Manufacturers Association (MDMA) and numerous patient advocacy groups.”
About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative solutions to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional, outdated approaches. The Company’s OMNI® Surgical System is a MIGS technology indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (“POAG”), the world’s leading cause of irreversible blindness. The Company’s TearCare® System technology is 510(k) cleared for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (“MGD”) when used in conjunction with manual expression of the meibomian glands, enabling office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease. The Company’s SION® Surgical Instrument is a manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork.
For more information, visit www.sightsciences.com.
OMNI, TearCare, and SION are registered trademarks of Sight Sciences, Inc.
© 2023 Sight Sciences. All rights reserved.
Forward-Looking Statements
This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which statements are subject to considerable risks and uncertainties. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements herein include, without limitation, statements concerning no change in January 2024 to the current Medicare coverage for MIGS procedures performed with the OMNI Surgical System, and the Company's intent to continue to engage with the MACs to ensure appropriate and fair access to medically reasonable and necessary MIGS procedures. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although management believes these forward-looking statements are based upon reasonable assumptions at the time they are made, management cannot guarantee their accuracy or completeness. Forward-looking statements are subject to and involve risks, uncertainties and assumptions that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance, or achievements predicted, assumed or implied by such forward-looking statements. Some of the risks and uncertainties that may cause actual results to materially differ from those expressed or implied by these forward-looking statements are discussed under the caption “Risk Factors” in the Company’s filings with the SEC, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this press release. Sight Sciences undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com
Media contact:
pr@SightSciences.com
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