Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 150

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 150
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 safe harbor protection from anti-kickback liability. Moreover, there are no safe harbors for many common             
  practices, such as reimbursement support programs, educational or research grants, or charitable donations;                                       
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  the federal civil False Claims Act (FCA), which prohibits, among other things, individuals                                                    

  the federal Physician Self-Referral Law, commonly known as the Stark Law, which prohibits physicians                                           
  from referring Medicare and Medicaid patients to healthcare entities in which they or any of their immediate family members have ownership     
  interests or other financial arrangements, if these entities provide certain designated health services reimbursable by Medicare or Medicaid,  
  unless an exception applies. The Stark Law also prohibits entities that provide designated health services reimbursable by Medicare and        
  Medicaid from billing the Medicare and Medicaid programs for any items or services that result from a prohibited referral and requires         
  the entities to refund amounts received for items or services provided pursuant to the prohibited referral on a timely basis. Sanctions        
  for violating the Stark Law include denial of payment, civil monetary penalties and exclusion from the federal healthcare programs. Failure    
  to refund amounts received as a result of a prohibited referral on a timely basis may constitute a false or fraudulent claim and may result    
  in civil penalties and additional penalties under the federal False Claims Act;                                                                
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  87  

  the federal Anti-Inducement Law (also known as the Civil Monetary Penalties Law), which prohibits                                          
  a person from offering or transferring remuneration to a Medicare or State healthcare program beneficiary that the person knows or should  
  know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of any item or service          
  for which payment may be made, in whole or in part, by Medicare or a State healthcare program;                                             
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  HIPAA, which prohibits and imposes criminal liability for, among other things, knowingly                                                    

  HIPAA, as amended by the Health Information Technology for Economic and Clinical Health                                                         
  Act (HITECH), and their implementing regulations, which imposes privacy, security, transmission, and breach reporting obligations with          
  respect to individually identifiable health information upon entities subject to the law