Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 104

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 104
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 and Affordable Care Act, as amended by the Health Care Education Reconciliation  
  Act, or collectively the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment         
  is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually                
  to the Centers for Medicare & Medicaid Services, or CMS, within HHS, information related to payments and other transfers of value              
  to certain healthcare providers and teaching hospitals and information regarding ownership and investment interests held by physicians         
  and their immediate family members; and                                                                                                        
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  analogous state and foreign laws and regulations, such as state                                                                           
  anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party  
  payors, including private insurers.                                                                                                       
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Some state laws require pharmaceutical companies to comply with
the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government
in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or
marketing expenditures. State and foreign laws also govern the privacy and security of health information in some circumstances, many
of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

U. S. Healthcare Reform

A primary trend in the U. S. healthcare industry and elsewhere is
cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount
of reimbursement for particular medical products. For example, in March 2010, the ACA was enacted, which, among other things, increased
the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which
rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted
or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care
plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs
coverage under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales
to federal healthcare programs;