IRIDEX Corporation (NASDAQ/NMS:IRIX) announced that HGSAdministrators (HGSA), the Medicare Part B Carrier for Pennsylvania, published a Local Medical Review Policy (LMRP) that will allow reimbursement to ophthalmologists performing Transpupillary Thermotherapy (TTT) treatment of wet age-related macular degeneration (AMD) and certain intraocular tumors effective December 29, 2003. The TTT protocol primarily uses the IRIS Medical OcuLight SLx laser by IRIDEX to treat AMD and tumors. TTT may be a more cost effective method to treat AMD than alternative methods.
The HGSA policy (S-135) states, “TTT has been proposed as an alternative to photodynamic therapy, as TTT is not associated with the high expense of a photosensitizing drug. TTT has also been proposed as an alternative to laser photocoagulation due to its ability to treat the leakage with less overlying retinal damage….Based on peer-reviewed literature, payment will be allowed for TTT as a treatment method for certain intraocular tumors such as small choroidal melanomas, exudative CNV (wet AMD) and retinoblastoma.” Claims should be submitted under CPT Level III code 0016t and ICD 9 codes 190.5, 190.6 or 362.52.
Theodore A. Boutacoff, President and CEO of IRIDEX commented, “We believe that a growing body of evidence of favorable clinical outcomes and enthusiasm from ophthalmologists in Pennsylvania provided HGSA with sufficient information to cover the TTT treatment method. We are especially pleased that Medicare is covering TTT for wet AMD because the treatment will provide a cost effective alternative that otherwise might not be available to certain AMD patients.”
Medicare coverage and payment for TTT has been determined on a carrier-by-carrier basis since September 2000 when the Centers for Medicare and Medicaid Services (CMS) issued a program memorandum listing these procedures. As elaborated in the 2001 Federal Register, Medicare Part B Carriers were given the freedom to establish relative value units and payment amounts for these services, generally on a case-by-case basis following review of documentation such as an operative report. There are now 16 states with written reimbursement coverage policies on TTT: Alaska, Arizona, California, Colorado, Hawaii, Iowa, Idaho, North Carolina, North Dakota, Nevada, Oregon, Pennsylvania, South Dakota, Tennessee, Washington and Wyoming.
IRIDEX Corporation is a leading worldwide provider of semiconductor-based laser systems for the ophthalmology and aesthetics markets. IRIDEX products are sold in the United States through a direct sales force and internationally through a network of independent distributors into more than 100 countries. Visit IRIDEX' website at www.iridex.com or www.treatmyamd.com for additional information on TTT treatment, or view the HGSA Bulletin at for additional coverage details.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, as amended. Actual results could differ materially from forward-looking statements contained or implied in this news release, such as any favorable sales impact on the Company's products as a result of favorable Medicare coverage decisions. Risks and uncertainties to which the Company is subject may include, but may not necessarily be limited to, results of clinical trials and further validation of the treatment of wet AMD with TTT, the speed at which other local carriers, other than those mentioned in this release, and the Center for Medicare and Medicaid Services (CMS) are willing to address AMD reimbursement issues and their internal policies regarding the matter. Please see a detailed description of these and other risks that we face contained in our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K for the year ended December 28, 2002 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated

