8-K: Harrow Inc. Secures Medicare Increase for IHEEZO, Allowing for Bilateral Procedures

Harrow Inc. has received approval from the Centers for Medicare & Medicaid Services (CMS) to increase the Medically Unlikely Edits (MUE) for its IHEEZO product, enabling reimbursement for bilateral procedures.

Summary

• Harrow, Inc. requested that the Centers for Medicare & Medicaid Services (CMS) increase the Medically Unlikely Edits (MUE) for IHEEZO's J-Code (J-2403) from 1 to 2.
• The request was made because the previous MUE of 1 only allowed for a single IHEEZO administration, while many ophthalmologists perform bilateral ocular procedures requiring two vials.
• On March 20, 2024, CMS communicated that they would increase the MUE for IHEEZO's J-Code (J2403) from 1 to 2.
• The MUE edit will be effective in July 2024 and will be retroactive for procedures dating back to January 1, 2024.

Sentiment

Score: 8

Explanation: The document conveys positive news regarding a favorable regulatory decision that will likely increase revenue. The retroactive application of the change is also a positive.

Positives

• The increase in MUE allows for proper reimbursement for bilateral procedures using IHEEZO.
• The retroactive application of the new MUE will allow for reimbursement of previously performed procedures.
• This change should increase revenue for Harrow, Inc. due to increased usage and reimbursement of IHEEZO.

Risks

• The change is not final until published by CMS, which introduces a small risk of reversal.
• There may be a delay in the implementation of the new MUE.

Future Outlook

The company anticipates increased revenue from IHEEZO due to the increased MUE and retroactive reimbursement.

Management Comments

• Harrow, Inc. made a request to the Centers for Medicare & Medicaid Services (CMS) to consider increasing the Medically Unlikely Edits (MUE) for IHEEZOs J-Code (J-2403) from 1 to 2.

Industry Context

This announcement is significant for the ophthalmology sector as it addresses a reimbursement issue that was limiting the use of IHEEZO in bilateral procedures. This change could set a precedent for other similar products and procedures.

Comparison to Industry Standards

• The increase in MUE for IHEEZO is a positive development as it aligns with standard medical practice for bilateral procedures.
• Many ophthalmic procedures are performed bilaterally, and reimbursement policies should reflect this.
• This change puts Harrow in a better position compared to competitors who may not have the same reimbursement coverage for their products.

Stakeholder Impact

• Shareholders will likely benefit from increased revenue and profitability.
• Ophthalmologists will be able to properly bill for bilateral procedures using IHEEZO.
• Patients will have better access to IHEEZO for bilateral procedures.

Next Steps

• CMS will publish the final MUE change.
• Harrow, Inc. will implement the new MUE for billing purposes.
• Harrow, Inc. will seek reimbursement for procedures performed since January 1, 2024.

Key Dates

Keywords

IHEEZO, CMS, Medically Unlikely Edits, MUE, J-Code, J2403, Ophthalmology, Bilateral Procedures, Reimbursement, Medicare