Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 154

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 154
---
policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs
that include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through
Medicaid or the PPACA. On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in
relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price,
for single source drugs and innovator multiple source drugs, beginning January 1, 2024. And, on August 16, 2022, the Inflation Reduction
Act of 2022 (IRA) was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations
with Medicare (with negotiated drug prices beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price
increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program
beginning in 2025. The IRA also authorizes the United States Department of Health and Human Services to implement many of these provisions
through guidance, as opposed to regulation, for the initial years. We cannot yet assess the impact that the IRA will have on the medical-products
industry, but it will likely be significant.

There is seemingly constant evolution with regard
to healthcare in the United States, and we cannot predict what healthcare programs and regulations may be implemented or changed at the
federal and/or state level or the effect of any future legislation or regulation on our business or that of our current or prospective
customers, suppliers, and/or the U. S. healthcare industry as a whole.

It is possible that recent and/or future initiatives
could have an adverse effect on our ability to obtain or maintain approvals and/or successfully commercialize products in the United States
in the future. For example, any changes that reduce, or impede the ability to obtain, reimbursement for the type of products we currently
market, or may commercialize in the future (as applicable), in the United States would likely have an adverse effect on our business and
profitability.

Outside
of the United States

In addition to U. S. regulations, we are subject to
a variety of regulations in other jurisdictions governing clinical trials and commercial sales and distribution of our products. Whether
or not we obtain