Omeros seeks new payment status for Omidria after pass-through expires
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Omeros Corporation’s 2-year extension of pass-through status for Omidria provided by Congress through the Consolidated Appropriations Act of 2018 expired Oct. 1.
Omeros requested confirmation of a separate payment status for the phenylephrine 1% and ketorolac 0.3% intraocular solution from the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services for use in ambulatory surgery centers (ASCs) for the fourth quarter of 2020, according to a company press release.
Omidria meets the objective regulatory criteria from CMS for separate payment in the ASC payment system for the remainder of 2020 and the calendar year 2021, according to Omeros.
“CMS’ policy for separate payment applies to non-opioid pain management surgical drugs that are used in the ASC setting and that are policy-packaged under CMS’ Outpatient Prospective Payment System,” the release said. In previous annual rules, CMS considered Omidria to be “a non-opioid pain management drug used in the ASC setting that is policy packaged as a drug that functions as a supply in a surgical procedure.”
Additionally, the Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act (H.R. 5172 and S. 3067), which is under consideration in Congress, would provide separate Medicare reimbursement for non-opioid treatments to manage pain in ASCs and hospital outpatient departments. If approved, it would be renewable every 5 years, according to Omeros.
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Eric D. Donnenfeld, MD
Omeros is actively seeking to unbundle the use of its product Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution) for use in the balanced salt solution in the operating room during intraocular surgery. CMS provides a global fee to ambulatory surgical centers and hospital outpatient departments for cataract surgery and innovative medications are given a pass-through for generally 3 years. After that the medications that may have tremendous value to patients have no way of being paid for and become an added expense in the operating room. Omidria has been approved to prevent pupillary miosis, increasing the safety of cataract surgery, and to reduce pain. Omidria has been shown to reduce the need for opioids during cataract surgery at the time of a national epidemic. In addition, Omidria achieves high levels of ketorolac in the vitreous and retina and has been shown to reduce the incidence of cystoid macular edema, which is not an intraoperative, but a postoperative concern. Bundling is also a concern for drug delivery medications such as Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals) and Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix), which are used intraoperatively but replace a medication used postoperatively. To improve patient care and allow innovation to continue, I wish Omeros success in their quest to allow us to continue to use Omidria as well as other innovative medications in the future.
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