Since Omidria’s FDA approval in 2014, ophthalmic surgeons have been using the drug intraoperatively to reduce the need for pupil-expanding devices in femtosecond laser-assisted cataract surgery and standard phacoemulsification, as well as reduce surgical complications and postoperative pain. Here are the ins and outs of reimbursement.

Q. What is Omidria?

A. Omidria (phenylephrine and ketorolac intraocular solution, Rayner Surgical Group) 1%/0.3% is used during cataract and lens replacement surgery (ie, 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.

Q. Is Omidria indicated for intraocular surgery other than lens extraction or lens exchange?

A. No. At this time, the only FDA-approved indications are cataract surgery, refractive lens exchange or IOL replacement.

Q. What CPT codes describe the procedures?

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. Cataract surgery combined with endoscopic cyclophotocoagulation is identified by CPT 66988 or 66987 — again, depending on if it is considered complex — and cataract surgery combined with insertion of an anterior segment aqueous drainage device (MIGS) is coded as CPT 66989 or 66991. CPT 66986 describes an IOL exchange. A relatively small number of cases are coded with other cataract or IOL-related procedure codes.

No specific CPT code describes clear lens extraction or refractive lens exchange. In the absence of an accurate code match, CPT instructs billers to use an unlisted code.² In this case, 66999 applies.

Q. Do Medicare and other third-party payers cover Omidria?

A. Medicare covers Omidria, when medically necessary and used for FDA-approved indications. For other payers, including Medicare Advantage plans, policies differ and can change over time.

Coverage does not guarantee separate payment, as some payers might bundle the drug.

Q. How does Medicare reimburse for Omidria?

A. Since Oct. 1, 2019, HCPCS code J1097 (Phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml) is used to describe the supply of the drug. Effective Jan. 1, 2021, CMS reimburses ASCs for Omidria as a surgical supply item.³ As of April 1, 2022, this payment was $98.53 per unit. The ASC reimbursement rate changes periodically based on the manufacturer’s average selling price +6% as reported to CMS.

For Part B Medicare beneficiaries, there was separate payment as a pass-through drug through Sept. 30, 2020, because Omidria formerly qualified⁴ for pass-through under the Outpatient Prospective Payment System (OPPS) that governs reimbursement to facilities.⁵ The type of coverage changed for dates of service on or after Oct. 1, 2020; Omidria now has Medicare coverage for ASCs as a non-opioid drug supplied for pain management.

Although Medicare coverage for Omidria changed from being a new drug with pass-through status to non-opioid pain management, ASCs continue to report four units on claims as they have since Oct. 1, 2019 with this J-code. Use of the J-code does not guarantee payment.

In the hospital outpatient department (HOPD), under OPPS rules, payment for the drug is included in the facility reimbursement, not separate.

Q. Is Omidria subject to the Medicare 20% copayment rule?

A. Yes. Drugs with reimbursement are subject to the usual Medicare copayment in a facility.

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

A. Not directly. 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.

Q. Are there purchasing concerns for facilities 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.

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. OM

REFERENCES

1. FDA-approved prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205388s006lbl.pdf . Accessed June 17, 2022.
2. American Medical Association. Current Procedural Terminology (CPT), Introduction.
3. Federal Register. Vol 85, No. 249 See page 85898. Published December 29, 2020. https://www.govinfo.gov/content/pkg/FR-2020-12-29/pdf/2020-26819.pdf . Accessed June 17, 2022.
4. Omeros. Letter to CMS Administrator. Sept 25, 2020. https://investor.omeros.com/static-files/c52a1739-a46f-4cf5-b50f-f91fdcae0e4c . Accessed June 17, 2022.
5. Social Security Act §1833(t)(6). https://www.ssa.gov/OP_Home/ssact/title18/1833.htm . Accessed June 17, 2022.

Suzanne L. Corcoran, COE is vice president of Corcoran Consulting Group. She can be reached at (800) 399-6565 or www.corcoranccg.com .