Reimbursement for Omidria (Omeros)

FREQUENTLY ASKED QUESTIONS: 

REIMBURSEMENT FOR OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%

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Q  What is Omidria®?

Omidria (phenylephrine and ketorolac injection) 1% / 0.3% is used during cataract and lens replacement surgery (i.e., refractive lens exchange or IOL exchange) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain.1 Each 4-ml single-patient-use vial of Omidria is diluted in a standard 500-ml container of irrigation solution for use during the procedure; it requires no change in the surgeon’s operating routine. The Food and Drug Administration2 (FDA) approved Omidria on May 30, 2014.

 

Q  Is Omidria indicated for intra-ocular surgery other than lens extraction or lens exchange?

A  No.  The only FDA approved indications are cataract surgery, refractive lens exchange, or IOL replacement.

 

Q  What CPT code(s) describes cataract surgery with IOL placement?

A  In the vast majority of cases, cataract surgery is described by CPT 66984. In about 10% of cases, cataract surgery is considered complex and identified as CPT 66982.3  CPT 66986 describes an IOL exchange.

 

Q  What CPT code describes refractive lens exchange?

A  No specific code describes clear lens extraction or refractive lens exchange. In the absence of a code match, CPT instructs billers to use an unlisted code.4  In this case, 66999 likely applies.

 

Q  Do Medicare and other third party payers cover Omidria?

A  Yes, when medically necessary and used for FDA-approved indications. Coverage does not guarantee separate payment; payers’ policies differ.

 

Q  Is there separate payment to the HOPD or ASC for Omidria?

A  Sometimes.  For Part B Medicare beneficiaries, there was separate payment until December 31, 2017 because Omidria qualifies as a pass-through drug5 under the Outpatient Prospec-tive Payment System (OPPS) that governs reimbursement to HOPDs and ASCs.6 The pass-through provision of OPPS was extended for two years by the 2018 Consolidated Appropriation Act effective October 1, 2018.7,8 For dates of service between 1/1/18 and 9/30/18, Medicare Administrative Contractors will not pay claims for Omidria.
Other payers may follow CMS’ policy but are not obliged to do so.

 

Q  What is the Medicare facility reimbursement for Omidria?

A  Effective January 1, 2015, CMS assigned Omidria to APC 1663 within the national OPPS payment schedule for facilities (HOPD or ASC).9.  The reimbursement rate changes periodically and depends on the manufacturer’s average selling price as reported to CMS.

 

Q  What HCPCS code is used on claims for reimbursement for Omidria?

A  On facility claims, the HCPCS C-code, C9447 (injection, phenylephrine and ketorolac, 4 ml vial) denotes the use of Omidria during surgery for cataract or lens replacement surgery. Use of this C-code does not guarantee payment.

 

Q  Is Omidria subject to the Medicare copayment rule?

A  Drugs having pass-through status are subject to the 20% Medicare copayment in an ASC but not in an HOPD.

 

Q  Does the use of Omidria affect the surgeon’s reimbursement?

A  Irrigation in the eye during cataract surgery is an inherent part of the procedure, and there is no separate professional service or fee for the use of Omidria.

Under the Resource Use component of the Merit-Based Incentive Payment System (MIPS), the cost of Omidria is a small contributing factor during CY 2018 that affects physician reimbursement in CY 2020.

 

Q  Are there purchasing concerns related to Omidria?

A  When surgery is performed in an ASC or HOPD, only the facility should purchase Omidria under Medicare’s Conditions for Coverage (CfC). The CfCs also require that a single-use vial must be used and charged for only one patient. It is important to note that the surgeon should not purchase Omidria for later sale to a facility, nor should the facility seek payment from the surgeon as a way to decrease costs.

 

1.  FDA-approved full prescribing information.  Link here.

2.  FDA. NDA 205388. Approval letter for Omidria. May 30, 2014.  Link here.  Accessed 04/05/18.

3.  CMS. PSPS data for claims adjudicated in 2016.

4.  American Medical Association.  Current Procedural Terminology (CPT), Introduction.

5.  Omeros.  Press Release.  October 30, 2014.  Link here.  Accessed 04/05/18.

6.  Social Security Act §1833(t)(6).  Link here.  Accessed 04/05/18.

7.  Federal Register.  April 7, 2000.  65 FR 18478.  Link here.  Accessed 04/05/18.

8.  CMS.  Process and Information Required to Determine Eligibility of Drugs … Transitional Pass-Through Status under the Hospital OPPS.  February 2014.  Link here.  Accessed 04/05/18.

9.  2018 Consolidated Appropriation Act. p 2029. Link here. Accessed 04/05/18.

 

Provided Courtesy of Omeros Corporation. (844) 663-7671

 

Last updated April 5, 2018

 

The reader is strongly encouraged to review federal and state laws, regulations, code sets (including ICD-9 and ICD-10), and official instructions promulgated by Medicare and other payers.  This document is not an official source nor is it a complete guide on reimbursement.  The reader is reminded that this information, including references and hyperlinks, changes over time, and may be incorrect at any time following publication.

 

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