Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 12

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 12
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care practitioners; are provided in connection with certain durable medical equipment; or are certain oral anti-cancer drugs and certain
oral immunosuppressive drugs. Medicare Part B pays for such drugs under a payment methodology based on the average sales price of the
drugs. Manufacturers, including us, are required to report average sales price information to the Centers for Medicare & Medicaid
Services (“CMS”) on a quarterly basis. The manufacturer-submitted information may be used by CMS to calculate Medicare payment
rates. Starting in 2023, manufacturers are now required to pay refunds to Medicare for single-source drugs or biological products, or
biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units
of discarded drug reimbursed by Medicare Part B in excess of 10% of total allowed charges under Medicare Part B for that drug. Manufacturers
that fail to pay refunds could be subject to civil monetary penalties. Further, starting in 2023, the Inflation Reduction Act of 2022
(“IRA”) established a Medicare Part B inflation rebate scheme, effective in 2023, under which, generally speaking, manufacturers
will owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation. Failure to timely pay a Part
B inflation rebate is subject to a civil monetary penalty.

The
IRA also created a drug price negotiation program under which, after being on the market for a certain period of time, the prices for
certain high Medicare spending drugs and biological products provided to Medicare patients without generic or biosimilar competition
will be capped by reference to, among other things, a specified non-federal average manufacturer price, starting in 2026. Failure to
comply with requirements under the drug price negotiation program is subject to an excise tax and a civil monetary penalty. This or any
other legislative change could impact the market conditions for our products.

IHEEZO
and TRIESENCE are covered under Medicare Part B and we may develop other product candidates and/or acquire drug products that are
also covered under Medicare Part B. In February 2023, we announced that CMS had issued a permanent, product specific J-code for
IHEEZO (J2403) which became effective under the Healthcare Procedure Coding System (HCPCS) on April 1, 2023. TRIESENCE has a
permanent product specific J-code (J3300) as well, which physicians can use for reimbursement purposes