Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 152

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 152
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and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and
regulations on some issues. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare
companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare
industry.

Ensuring that business arrangements with third parties
comply with applicable healthcare laws and regulations is costly and time consuming. If a medical device manufacturer’s operations
are found to be in violation of any of the laws described above or any other governmental regulations that apply to it, it may be subject
to civil, criminal and administrative penalties, damages, fines, disgorgement, substantial monetary penalties, individual imprisonment,
exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, additional reporting obligations and oversight
if it becomes subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws,
reputational harm, diminished profits and future earnings, and the curtailment or restructuring of operations, any of which could adversely
affect the ability of a medical device manufacturer to operate its business and the results of its operations.

United States Healthcare Reform

In the United States, a number of legislative and
regulatory proposals have been considered or enacted to change the healthcare system in ways that could affect a medical device manufacturer’s
business. Among policy makers and governmental and private insurers in the United States, there is significant interest in promoting changes
in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. For example, in 2010,
the PPACA was enacted, which includes measures to significantly change the way healthcare is financed by both governmental and private
insurers, and significantly impacts the medical device industry. Among other ways in which it may impact a medical device manufacturer’s
business, the PPACA:

  establishes a new Patient-Centered Outcomes Research Institute to oversee and identify                      

  implements payment system reforms including a national pilot program on payment bundling                                                     

  expands the eligibility criteria for Medicaid programs.  

Some of the provisions of the PPACA have yet to be
implemented, and there have been judicial and Congressional challenges to modify, limit, or repeal certain aspects of the PPACA since
its enactment and it has continued to evolve. During his first term as president, President Trump supported the repeal of all or portions
of the PPACA, and in January 2017, he signed Executive Orders designed to delay