Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 748

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 4
Chunk 748
---

billing policy which has historically not allowed for the separate billing of anesthesia services in the physician’s office. During
the meeting we requested that CMS clarify that J-Code 2403, IHEEZO’s permanent J-Code, is appropriate to be billed for the anesthesia
product itself (i.e., IHEEZO in our case) in the physician office setting. In March 2024, we received communication from a representative
at CMS that the inclusion of J-Code 2403 in CMS’s April 2024 quarterly drug pricing file of the average sales prices (ASP) of some
Medicare Part B-covered drugs and biologicals confirms that IHEEZO is separately payable in the physician office setting.

In February
2024, we made a request to CMS to consider increasing the Medically Unlikely Edits (“MUE”) for IHEEZO’s J-Code from
1 to 2. This request was made because the limitation of one MUE only allowed a single IHEEZO administration (equal to one single-use
vial) to be used and billed, while many ophthalmologists perform bilateral ocular procedures, which would require two vials of IHEEZO
to be used. On March 20, 2024, we received communication from the National Correct Coding Initiative (NCCI) program of CMS stating that
CMS decided to increase the MUE for IHEEZO’s J-Code (J2403) from 1 to 2. The MUE edit was made effective on July 1, 2024.

VEVYE U.S. Launch

In January
2024, we launched VEVYE (cyclosporine ophthalmic solution) 0.1%, the first and only water-free cyclosporine dissolved in a semifluorinated
alkane approved to treat both the signs and symptoms of dry eye disease in the U.S. We partnered with various entities including PhilRx,
Apollo Care and PARx Solutions to enhance our market and patient access program for VEVYE.

 56 

Results of Operations

The following period-to-period
comparisons of our financial results are not necessarily indicative of results for any future period.

Comparison of Years Ended December 31, 2024
and 2023

Revenues 

Our revenues include amounts
recorded from sales of branded products to wholesalers through a third-party logistics facility, sales of proprietary compounded formulations,
and revenues received from royalty payments