Omeros Corporation (OMER) this month provided an update regarding reimbursement for its cataract surgery drug OMIDRIA after expiry of a two-year pass-through status for the same. The status was provided by the Congress through the Consolidated Appropriations Act of 2018 for OMIDRIA which expired on October 1, 2020.
The company is actively engaged in seeking separate payment status for OMIDRIA in the ambulatory surgery center (ASC) setting. Omeros requested the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to confirm that status for Q4 2020.
Along with its request to CMS, the company also submitted a letter commenting 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. The legal firm in its opinion reiterated the stance of Omeros that as per CMS regulations, non-opioid drugs including OMIDRIA which fulfill the CMS-specified objective regulatory criteria are eligible to be paid separately upon their usage in ASC setting.
OMER and its advisors are in opinion that CMS is in legal obligation to apply its separate payment policy for non-opioid pain management surgical drugs to OMIDRIA for 4Q 2020 and for CY 2021. Also CMS is to address the issue on or before CY 2021Final Rule which is likely to be released around first week of next month.
Non-opioid pain management surgical drugs used in the ASC setting fall under CMS’s policy for separate payment and are policy-packaged under Outpatient Prospective Payment System of CMS. With the expiry of pass-through status, OMIDRIA now meets the CMS’ objective regulatory criteria. The makes the drug eligible for separate payment in the ASC payment system to be paid both for the remainder of 2020 and for CY 2021.
In its previous annual rules, CMS has acknowledged OMIDRIA as a non-opioid pain management drug used in the ASC setting.