ROCHESTER, NEW YORK - Bausch & Lomb announced today that the Centers for Medicare and Medicaid Services (CMS) has established a product specific J-Code for the Retisert fluocinolone acetonide intravitreal implant 0.59 mg. The Retisert implant was approved as a single indication orphan drug by the U.S. Food and Drug Administration for the treatment of chronic noninfectious posterior segment uveitis, a sight threatening inflammatory disease and a major cause of blindness in patients 20-50 years of age.
The new J-Code, J7311 Fluocinolone acetonide intravitreal implant, replaces the Medicare hospital outpatient code, C9225, which had been available to hospitals for billing Medicare when the Retisert implant is implanted in a hospital outpatient setting. The J7311 code should be recognized by all health care insurers as they add this code to their respective billing systems. CMS also has published a payment rate for J7311 of $19,345, or 106% of the average sales price (ASP) for the product.
“This is an important milestone, which recognizes the national utilization of the Retisert implant and the critical and unique role it may play in preventing cumulative damage to the visual system caused by recurrent episodes of inflammation,” said Michael O’Rourke, general manager of the U.S. Pharmaceutical business for Bausch & Lomb. “Importantly, the establishment of a product-specific J-Code should help patients get timely access to this innovative therapy. It will also help hospitals and physicians bill accurately and uniformly for the product across the country.”
The J-Code and Medicare payment rate are effective as of January 1, 2007. Private insurers may pay at different rates than Medicare.
Please see full prescribing information.
As with other steroid ophthalmic drugs, Retisert is contraindicated in most viral diseases of the cornea and conjunctiva and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma, as well as increase the hazard of secondary ocular infections.
Based on clinical trials with Retisert, the most frequently reported ocular adverse events were cataract, increased intraocular pressure, procedural complication, and eye pain. These events occurred in approximately 50-90% of patients. Procedural complication includes cataract fragments in the eye post-op, implant expulsion, injury, mechanical complication of implant, migration of implant, post-op complications, post-op wound complications, and wound dehiscence. Within 34 weeks of implantation, approximately 60% of patients will require IOP lowering medications to control intraocular pressure. Within an average post-implantation period of approximately two years, approximately 32% of patients are expected to require filtering procedures to control intraocular pressure, and nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York. Bausch & Lomb's 2004 revenues were $2.2 billion; it employs approximately 12,400 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com . Copyright Bausch & Lomb Incorporated.
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This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of Bausch & Lomb. Such statements involve a number of risks and uncertainties including those concerning economic conditions, currency exchange rates, product development and introduction, the financial well-being of key customers, the successful execution of marketing strategies, the continued successful implementation of its efforts in managing and reducing costs and expenses, as well as the risk factors listed from time to time in the Company’s SEC filings, including but not limited to filings on Form 8-K and on Form 12b-25, each dated August 8, 2006.