Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 55

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 55
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 enrollment
period for purposes of obtaining health insurance coverage through the PPACA marketplace, which began on February 15, 2021, and remained
open through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing
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, 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 (DHHS) 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.

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It is possible that such 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