Omeros Provides Update on Separate Payment for OMIDRIA® in the ASCs
—OMIDRIA meets all objective criteria established by CMS—
Omeros 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 memorandum from the law firm
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. 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.
CMS is the primary insurer for 40-45 percent of cataract surgery patients. The large majority of cataract surgery procedures are performed in ASCs. In addition to Omeros’ current request with CMS and HHS for confirmation of separate payment in the ASCs, the Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act (H.R.5172 and S. 3067) is continuing to make progress through both chambers of
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company’s lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the
Omeros’ OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the
Important Safety Information for OMIDRIA®
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “prospects,” “scheduled,” “should,” “slated,” “targeting,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding payment and reimbursement status, expectations for continued separate payment for OMIDRIA and expected qualification for an exception from packaged payment, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, availability and timing of data from ongoing clinical trials and the results of such trials, changes in regulatory policy, political factors, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K filed with the
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