Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 72

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 72
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enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing
approvals of our drug candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process
may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing
and other requirements.

In the U.S., the Medicare Modernization
Act (the “MMA”) changed the way Medicare covers and pays for pharmaceutical products. The legislation expanded Medicare coverage
for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices for drugs. In addition,
this legislation authorized Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that
will be covered in any therapeutic class. As a result of this legislation and the expansion of federal coverage of drug products, we
expect that there will be additional pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this
legislation could decrease the coverage and price that we receive for our drug candidates and could seriously harm our business. While
the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations
in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction
in payments from private payors.

The Health Care Reform Law is
a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies
against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees
on the health industry and impose additional health policy reforms. The Health Care Reform Law revised the definition of “average
manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states. Further, the law
imposed a significant annual fee on companies that manufacture or import branded prescription drug products.

The Health Care Reform Law remains
subject to legislative efforts to repeal, modify or delay the implementation of the law. Efforts to date have generally been unsuccessful.
If the Health Care Reform Law is repealed or modified, or if implementation of certain aspects of the Health Care Reform Law are delayed,
such repeal, modification or delay may materially adversely impact our business, strategies, prospects, operating results or financial
condition. We are unable to predict the full impact of any repeal or modification in the implementation of the Health