Harrow announced that the Centers for Medicare & Medicaid Services (CMS) granted transitional d for Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3%, indicated for ocular surface anesthesia.
Tell me more about Iheezo.
Approved by the FDA in September 2022, Iheezo is a sterile, single-use, physician-administered, preservative-free ophthalmic gel for the treatment of ocular surface anesthesia.
Of note, Iheezo is the first branded ocular anesthetic approved in the United States in nearly 14 years.
How did it perform in clinical trials?
Iheezo’s safety and efficacy were demonstrated in three clinical studies. See here for more details.
What does this new status mean?
A pass-through status is typically meant to encourage the use of recently FDA-approved medical devices, drugs, or biologics in all fields of medicine as well as increase access to such therapies for Medicare patients by temporarily paying more than the pre-established facility fees.
How long can it last?
This status can be conferred for, at a minimum, 2 years and typically not longer than 3 years—allowing physicians to be educated more on the products and their real-world performance.
What about in Iheezo’s case?
For Iheezo, the status will begin on April 1, 2023, through a 3-year period, in which Iheezo will be eligible for separate reimbursements other than the already established surgical bundled payment (which includes the Ambulatory Surgery Center [ASC] and Hospital Outpatient Department [HOPD] care settings).
Prior to this approval, the CMS granted Iheezo a permanent, product-specific J-code (J2403) in February 2023, enabling a more efficient billing process for eyecare professionals. This will also take effect on April 1, 2023.
Iheezo’s newly-approved status makes it the only ocular anesthetic in the U.S. with a separate reimbursement in all traditional care settings.