Harrow Health says CMS notification ‘very important development for IHEEZO’

In a letter to stockholders disclosed by Harrow Health in a regulatory filing, the company stated: “As we have gotten deeper into the IHEEZO launch and I’ve visited more customers, my belief about how inefficient ophthalmic anesthesia has been historically delivered is being validated. Customers who use IHEEZO love its efficiency and simplicity, knowing that with IHEEZO, they only need a single dose of one anesthetic medicine to rapidly provide about 22 minutes of anesthetic effect – without any supplementation! Updates related to IHEEZO and the Centers for Medicare and Medicaid Services – CMS: In the second half of 2023, we requested that CMS add IHEEZO’s J-Code, J-2403, to its Average Sales Price – ASP – Pricing File. Publishing IHEEZO’s ASP to physicians is critical for its use in physician offices. Our initial request to CMS was not acted upon; As discussed in my last Letter to Stockholders, we requested a meeting with CMS to clarify that IHEEZO could be appropriately billed and reimbursed for procedures in physician offices. This meeting took place on January 9, 2024. During this meeting, we also discussed the ASP File request; I am pleased to report that CMS recently published a notification that J-2403 has been added to the ASP File. This is a very important development for IHEEZO, and we expect to hear from CMS soon about the remaining open clarification request regarding billing and reimbursement in the physician’s office setting of care. In the meantime, we continue to serve hospital and ASC accounts using IHEEZO in all settings of care; Finally, some retina offices perform bilateral intravitreal procedures in the office (e.g., both eyes during one office visit). Today, CMS policy for IHEEZO only allows a single IHEEZO administration (equal to one single-use vial) to be billed. In early March of this year, because many customers wished to use IHEEZO for bilateral procedures, we requested that CMS allow two units of IHEEZO to be used and billed in a single day. We expect to hear back from CMS on this issue soon.”