EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/569879
IMPORTANT SAFETY INFORMATION OMIDRIA must be added to irrigation solution prior to intraocular use. OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients. Systemic exposure of phenylephrine may cause elevations in blood pressure. Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-infl ammatories (NSAIDs), or have a past medical history of asthma. The most commonly reported adverse reactions at 2-24% are eye irritation, posterior capsule opacifi cation, increased intraocular pressure, and anterior chamber infl ammation. Use of OMIDRIA in children has not been established. Please see the Full Prescribing Information at www.omidria.com/prescribinginformation. You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. INDICATIONS AND USAGE OMIDRIA is added to ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. * Randomized, double-masked trial using a 4-arm factorial design to show that OMIDRIA is superior to either agent alone. Post hoc analysis of pupil diameter < 6 mm at any time during the procedure. 2 † Study of ketorolac levels in aqueous humor of 14 patients at the start and end of cataract surgery following multiday preoperative topical ketorolac administration. 7 ‡ Canine study assessing ketorolac levels in retina, choroid, ciliary body/iris, cornea, vitreous, lens capsule, and sclera samples following cataract surgery using OMIDRIA. COX-1 and COX-2 inhibition was estimated using IC50 values. 8,9 § Pooled analyses of post hoc analysis (Study 1) and secondary endpoint (Study 2). 10 II Based on current data; coverage may vary and is plan-specifi c. Individual patient coverage should be verifi ed. Reimbursement information is based on Omeros data on fi le. Omeros does not guarantee reimbursement for any particular patient. Contact 1-844-OMEROS1 (1-844-663-7671) for more information about how to submit for OMIDRIA reimbursement. The Centers for Medicare and Medicaid Services (CMS) granted pass-through reimbursement status to OMIDRIA. Under the Outpatient Prospective Payment System, pass-through products are paid separately by CMS. Have confi dence in reimbursement across payers OMEROS ® , OMIDRIA ® and the OMIDRIA logo ® are registered trademarks, and OMIDRIAssure™ is a trademark, of Omeros Corporation. © Omeros Corporation 2015, all rights reserved. 2015-199. ® NO EFFECT ON PHYSICIAN FEES 4 Payment to the surgeon for cataract surgery under Medicare's Physician Fee Schedule will be unaffected by the use of OMIDRIA or the pass-through payments related to OMIDRIA, now and in the future. REIMBURSABLE ACROSS SURGICAL FACILITY TYPES 4,5 OMIDRIA is also on the Federal Supply Schedule and on 340B formularies. 2 In partnership with ophthalmic surgeons and their teams, Omeros o ers billing support services (1-844-OMEROS1). To ensure access to OMIDRIA for all cataract patients, Omeros is establishing the OMIDRIAssure TM program that o ers a: • reimbursement hotline • patient assistance program based on fi nancial need • copay program for commercial benefi ciaries POSITIVE EFFECT ON FACILITY FEES 4 During the pass-through period, OMIDRIA is reimbursed separately, in addition to the bundled facility fee for the procedure. Following expiration of its pass-through status on December 31, 2017, OMIDRIA likely will be included in the bundled facility fees for cataract surgery. As a result, those fees will increase by an amount that correlates with the magnitude of OMIDRIA utilization during its pass-through status. NO EFFECT ON THE HEALTHCARE SYSTEM 4 The pass-through regulation is budget-neutral to the healthcare system. To the extent that ophthalmic surgeons/ facilities elect not to access pass-through payments, the funds set aside will be used by other specialties. Any remaining amount will be lost to the system. • No copay in hospital outpatient departments (HOPDs) 4 • 20% copay in ambulatory surgery centers (ASCs) 4 - Approximately 90% of Medicare Part B patients have some form of supplemental insurance, which covers copays 5 To ensure that patients under all payer types can benefi t from OMIDRIA, Omeros is establishing a patient assistance program and a commercial copay program. OMIDRIA is covered by 100% of Medicare contractors as well as by Medicare Advantage. 2 OMIDRIA also is covered for ~90% of the 153 million lives insured by the Top 30 commercial payers. 2,II across all 50 states and Puerto Rico TO FIND OUT MORE ABOUT OMIDRIA, GO TO WWW.OMIDRIA.COM

