Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 153

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 153
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 the implementation of certain provisions of the PPACA
or otherwise circumvent some of the requirements for health insurance mandated by the PPACA to the maximum extent permitted by law. Due
to such efforts, certain elements of the PPACA have been invalidated or suspended, which has, in turn, led to additional challenges against
the law as a whole. For example, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based
shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part
of a year that is commonly referred to as the “individual mandate”. As a result, there is significant uncertainty regarding
future healthcare reform and its impact on our operations. In December 2018, a district court in Texas held that the individual mandate
is unconstitutional and that the rest of the PPACA is, therefore, invalid. On appeal, the Fifth Circuit Court of Appeals affirmed the
holding on the individual mandate but remanded the case back to the lower court to reassess whether and how such holding affects the validity
of the rest of the PPACA. The Fifth Circuit’s decision on the individual mandate was appealed to the U. S. Supreme Court. On June
17, 2021, the Supreme Court held that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals)
did not have standing to challenge the constitutionality of the PPACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s
decision and instructed the district court to dismiss the case. As a result, the PPACA will remain in-effect in its current form for the
foreseeable future; however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact
any such actions may have on our business, and there is even greater uncertainty given the recent election of President Trump for a second
term.

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The Biden administration also introduced various measures in 2021 with a focus on healthcare and drug
pricing, in particular. For example, on January 28, 2021, President Biden issued an executive order that initiated a special 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