Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 233

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 233
---
 and results
of operations.

Changing U.S. federal
coverage and reimbursement policies and practices have affected and are likely to continue to affect access to, pricing of and sales
of our products.

A substantial portion of our
branded product portfolio relies on reimbursement from federal government healthcare programs and commercial insurance plans regulated
by federal and state governments. Our business has been and will continue to be affected by legislative actions changing U.S. federal
reimbursement policy. The IRA’s drug pricing controls and Medicare redesign is likely to have a material adverse effect on our
sales (particularly for our branded products that are more substantially reliant on Medicare reimbursement), our business and our results
of operations. However, as the degree of impact from this legislation on our business depends on a number of implementation decisions,
the extent of the IRA’s impact on our sales and, in turn, our business remains unclear.

 32 

Changing reimbursement
and pricing actions in various states have negatively affected and may continue to negatively affect access to and have affected and
may continue to affect sales of our products.

At the state level, government
actions or ballot initiatives can also affect how our branded products are covered and reimbursed and/or create additional pressure on
our pricing decisions. Existing and proposed state pricing laws have added complexity to the pricing of drugs and may already be affecting
industry pricing decisions. A number of states have adopted, and many other states are considering, drug importation programs or other
pricing actions, including proposals designed to require biopharmaceutical manufacturers to report to the state proprietary pricing information
or provide advance notice of certain price increases. For example, a California law requires biopharmaceutical manufacturers to notify
health insurers and government health plans at least 60 days before scheduled prescription drug price increases that exceed certain thresholds.
Similar laws exist in Oregon and Washington. Additional proposals directed at Medicaid seek to penalize manufacturers for pricing drugs
above a certain threshold or limit spending on biopharmaceutical products. States are also seeking to change the way they pay for drugs
for patients covered by state programs. New York has established a Medicaid drug spending cap, and Massachusetts implemented a new review
and supplemental rebate negotiation process. Six states (Colorado, Maine, New Hampshire, Maryland, Oregon and Washington) have enacted
laws that establish Prescription Drug Affordability Boards (“PDABs”) to study drug prices and identify drugs that pose affordability
challenges, and in three states (Colorado, Maryland and Washington) include authority for the state PDABs to set upper