Harrow announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through reimbursement status for Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3%, which is indicated for ocular surface anesthesia.
Beginning April 1, 2023, and for the three years thereafter, Iheezo will be eligible for separate reimbursement outside of the surgical bundled payment in both the Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) settings of care. CMS previously approved the issuance of a permanent, product-specific J‑Code (J2403), enabling access to Iheezo for ophthalmologists, optometrists, and retina specialists for the in‑office setting of care.
This new CMS pass-through approval makes Iheezo the only ocular anesthetic with separate reimbursement in all traditional settings of care – the eyecare professional’s office, the ASC, and the HOPD.
CMS grants pass-through status to certain new and innovative medical devices, drugs, and biological products. Drugs that are administered in the ASC and HOPD settings can have pass‑through status and be reimbursed accordingly by Medicare.
By having pass-through status, Iheezo will be separately reimbursed by Medicare at Average Sales Price (ASP) +6% in both the ASC and HOPD settings of care. Until an ASP is established, Iheezo will be reimbursed accordingly at Wholesale Acquisition Cost (WAC) +3%.
“We are grateful to CMS for their approval of transitional pass-through reimbursement status for Iheezo and for their support of our mission to make innovative ophthalmic prescription medications accessible and affordable,” said Mark L. Baum, chairman and CEO of Harrow. “With approximately 5 million cataract surgeries and more than 8 million intravitreal injections performed each year in the U.S., we believe that Iheezo’s receipt of both a permanent J‑Code, which we announced on February 2, 2023, and now, pass‑through reimbursement status, will contribute to greater patient access to this important new treatment to anesthetize the eye. We remain on track for the commercial launch of IHEEZO at the May 2023 American Society of Cataract and Refractive Surgery (ASCRS) meeting in San Diego.”
About Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3%
- Iheezo is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, for ocular surface anesthesia.
- Iheezo was approved by the FDA on September 26, 2022.
- In a clinical trial of Iheezo in patients undergoing routine cataract surgery, patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure.
- Iheezo represents the first branded ocular surface anesthetic approved for the U.S. market in nearly 14 years.
- Iheezo is protected by an Orange Book-listed patent that is valid until 2038.