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Omeros Provides Update on Separate Payment for OMIDRIA® in the ASCs
—OMIDRIA meets all objective criteria established by CMS— SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today provided an update on the status
About this update from Omeros Corporation
[{"type":"text","content":"\n—OMIDRIA meets all objective criteria established by CMS—\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today provided an update on the status of reimbursement for its cataract surgery drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. The two-year extension of pass-through status provided by Congress through the Consolidated Appropriations Act of 2018 for OMIDRIA expired today. Omeros is actively engaged in requesting from the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) confirmation of separate payment status for OMIDRIA in the ambulatory surgery center (ASC) setting for 4Q 2020.\n\nOmeros has also submitted to CMS both a comment letter on the proposed Outpatient Prospective Payment System/ASC Rule for Calendar Year (CY) 2021 and a legal opinion from the law firm Foley Hoag LLP, reiterating that CMS regulations require non-opioid drugs that meet the objective regulatory criteria specified by CMS, including OMIDRIA, to be paid separately when used in the ASC setting. Omeros and its advisors are confident that (1) CMS is required by law to apply its separate payment policy for non-opioid pain management surgical drugs to OMIDRIA for 4Q 2020 and for CY 2021 and (2) CMS will address this issue soon and no later than its CY 2021 Final Rule, which is expected to be released on or shortly after November 1.\n\nCMS’ 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. Now that its pass-through status has expired, OMIDRIA meets each of the objective regulatory criteria established by CMS for separate payment in the ASC payment system both for the remainder of 2020 and for CY 2021 – CMS has confirmed in previous annual rules that OMIDRIA is 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. For further details, please see the comment letters referenced above, which can be found on the investor relations section of Omeros’ website at www.investor.omeros.com under “featured reports” or, once posted by the government, at https://www.regulations.gov/docket?D=CMS-2020-0090.\n\nCMS is the primary insurer for 40-45...