Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 234

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 234
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 payment limits
on certain drugs in state regulated plans. Other states may consider implementing similar policies and laws. Additionally, Colorado,
Florida, Maine, New Hampshire, New Mexico and Vermont have enacted laws, and several other states have proposed bills, to implement importation
of drugs from Canada. The FDA has met with representatives from Colorado, Florida, Maine and New Mexico to discuss those states’
proposed importation programs, and the FDA may be working towards approving such plans. Other states could adopt similar approaches or
could pursue different policy changes in a continuing effort to reduce their costs. Ultimately, as with U.S. federal government actions,
existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business
and results of operations.

U.S. commercial payor
actions have affected and may continue to affect access to and sales of our products

Payors, including healthcare
insurers, pharmacy benefit managers (“PBMs”), integrated healthcare delivery systems (vertically-integrated organizations
built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, increasingly seek ways to reduce their
costs. With increasing frequency, payors are adopting benefit plan changes that shift a greater proportion of drug costs to patients.
Such measures include more limited benefit plan designs, high deductible plans, higher patient co-pay or coinsurance obligations and
more significant limitations on patients’ use of manufacturer commercial co-pay assistance programs. Further, government regulation
of payors may affect these trends. For example, CMS finalized a policy for plan years starting on or after January 1, 2021 that has caused
commercial payors to more widely adopt co-pay accumulator adjustment programs. Payors, including PBMs, have sought, and continue to seek,
price discounts or rebates in connection with the placement of our branded products on their formularies or those they manage, and to
also impose restrictions on access to or usage of our branded products (such as step therapy), require that patients receive the payor’s
prior authorization before covering the product, and/or chosen to exclude certain indications for which our products are approved. In
an effort to reduce barriers to access, we may reduce the net price of some of our branded products by providing greater discounts and
rebates to payors (including PBMs that administer Medicare Part D prescription drug plans), and we may introduce a set of new National
Drug Codes to make our branded products available at a lower list price. However, affordability of patient out-of-pocket