Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 205

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 205
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 or concealing an obligation    
 to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to     
 government payers if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private               
 individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA                 
 and to share in any monetary recovery;                                                                                                     |

| • | the Civil Monetary Penalties Law, which prohibits, among other things, the offering or giving of remuneration,                               
 which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), 
 to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of             
 a particular supplier of items or services reimbursable by a federal or state governmental program;                                          |

| • | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and                                     
 civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |

| • | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing                                  
 regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission 
 of individually identifiable health information;                                                                                                  |

| • | the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering                                
 up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items 
 or services;                                                                                                                             |

| • | the federal transparency requirements of the Physician Payment Sunshine Act, which requires manufacturers                                    
 of drugs, devices, biologics and medical supplies covered by Medicare, Medicaid or a state plans under CHIPs to report to the Centers        
 for Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, certain non-physician advanced    
 healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, the physicians 
 and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members; and      |

| 102 |

| • | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may                              
 apply to sales or marketing arrangements and claims involving healthcare items or