The company noted that the product is a sterile, single-patient use, physician administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.
Harrow today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent, product-specific J-code for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.
According to a news release, under the Healthcare Common Procedure Coding System (HCPCS), the IHEEZO J‑code (J2403) will become effective April 1.
Mark L. Baum, chairman and CEO of Harrow, pointed out that the company is committed to the accessibility of new therapies that benefit eyecare professionals and the patients they serve.
“As we prepare for the commercial launch of IHEEZO in the coming months, we are grateful that IHEEZO will have its own permanent, product-specific J-code beginning April 1, 2023, enabling a more efficient billing process for ophthalmologists, optometrists, and retina specialists, and creating greater accessibility to the many clinical benefits that Iheezo provides. We want to thank CMS for its consideration and timely review of our J-code application.”
According to the company, IHEEZO is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. It was approved by the FDA on September 26, 2022.
Moreover, the clinical trials of the ophthalmic gel showed that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure. The company also noted in its news release that the gel represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. It also is protected by an Orange Book-listed patent that is valid until 2038.
The company noted that IHEEZO is indicated for ocular surface anesthesia. It is contraindicated in patients with a history of hypersensitivity to any component of this preparation.