CMS Grants Pass-through Reimbursement for Iheezo

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Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.

The Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through reimbursement status for Harrow’s Iheezo (chloroprocaine hydrochloride ophthalmic gel), 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.

Iheezo will be reimbursed using the average sales price (pricing is the average sales price after considering any discounts) +6% but the ASP price won’t be established until the beginning of next year. Until then, it will be reimbursed at wholesale acquisition cost ($544) +3%.

CMS grants pass-through status to certain new and innovative medical devices, drugs, and biological products. Drugs that are administered in the hospital-based outpatient department and ambulatory surgical center settings can have pass-through status. CMS collects utilization data during this pass-through period, and the agency uses this information when determining how to adjust the payment rate for the service using the product after transitional pass-through status expires.

For pass-through products used in a hospital setting, CMS reimburses 100% of the cost for Medicare Part B patients, and no copayment applies. When a pass-through drug or device is used in an ambulatory surgical center, however, the 20% copayment does apply.

Iheezo is a single-patient use, physician‑administered, ophthalmic gel preparation for ocular surface anesthesia. It was approved by the FDA on Sept. 26, 2022. The safety and efficacy were demonstrated in three human clinical studies, including an active-controlled, observer‑masked study that evaluated the administration of Iheezo in patients undergoing cataract surgery. This study demonstrated that Iheezo worked rapidly (about 1 to 1.5 minutes) and provided sufficient anesthesia to successfully perform the surgical procedure (on average lasting 22 minutes). Additionally, no patient required a supplemental treatment to complete the surgical procedure.

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