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Subsequent Event | 9 Months Ended
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Sep. 30, 2023
Subsequent Events [Abstract] |
Subsequent Event | 13. Subsequent Event On November 1, 2023, the Company filed Form 8-K that on October 26, 2023, WPS Government Health Administrators, (“WPS”), a Medicare Administrative Contractor (“MAC”) published “Local Coverage Determination L39620 Micro-Invasive Glaucoma Surgery (MIGS)” (the “LCD”), with a future effective date of December 24, 2023. WPS administers Part B Medicare benefits in Kansas, Nebraska, Missouri, Iowa, Indiana, and Michigan. In November 2023, four of the six other MACs, including Palmetto GBA, Celerian Group Company, National Government Services and Noridian Healthcare Solutions, published the same LCD. These five MACs are referred to as the “MACs” in the risk factors section below. The Company has consulted with expert external reimbursement advisors in an effort to evaluate the potential impact of the LCD on the Company’s business in the United States with respect to the Cyclo G6 Laser System and Probe Delivery Devices, which has been authorized by FDA to deliver laser energy to soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/otolaryngology, and ophthalmology, including for the intended use of transscleral cyclophotocoagulation of the ciliary processes and for the treatment of glaucoma, including primary open-angle, closed-angle, and refractory. Although the LCD does not deny coverage, it imposes additional requirements for reimbursement. Among the issues examined are (i) the intent of the LCD; (ii) the use and application of definitions within the LCD (e.g., how a determination expressly defined as relating to incisional surgical techniques pulled within its scope non-incisional transscleral cyclophotocoagulation); and (iii) the LCD’s failure to recognize any distinctions among (a) endo cyclophotocoagulation and (b) transscleral cyclophotocoagulation, or (x) continuous wave cyclophotocoagulation and (y) MicroPulse cyclophotocoagulation. As a result of its consultation with expert external advisors, the Company currently believes that the LCD will likely be interpreted to materially limit the patient types for which WPS will reimburse cyclophotocoagulation procedures after December 24, 2023 – that is, based the criteria set forth in the LCD. At this time, the Company cannot estimate what full impact this LCD will have on its glaucoma business in the United States. We and other stakeholders plan to challenge the LCD. Outside the U.S., where the Company currently receives approximately 50% of its glaucoma revenue, neither the LCD nor any future local coverage determination are expected to materially impact that business. Reimbursement payments outside the U.S. are generally lower and more restrictive in scope, with TLT’s successful and growing penetration within those markets providing further support for the demand for our products and perceived utility and efficacy of Iridex’s offerings. Iridex intends to assess and adjust its domestic glaucoma operations from time-to-time as appropriate in response to any changed reimbursement policies that materially impact its ability to maintain and expand its glaucoma business. For the past several years, sales and marketing expenses relating to the Company’s domestic glaucoma efforts have involved significantly larger expenditures compared to the Company’s retina and international operations. Refer to our Form 8-K filed on November 1, 2023 for further details.

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- Definition The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 855 -Name Accounting Standards Codification -Publisher FASB -URI https://asc.fasb.org//855/tableOfContent Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Topic 855 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 2 -Subparagraph (a) -Publisher FASB -URI https://asc.fasb.org//1943274/2147483399/855-10-50-2 + Details
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