Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 96

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 96
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, using, or        
 causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money to the federal government, or knowingly and improperly avoiding or decreasing 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 healthcare programs if they are deemed to “cause” the submission of false or fraudulent claims. In             
 addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. 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;                                                                                                                |

60

| • |     | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional                                                                                                                                               
 federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the    
 money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), and knowingly and willfully falsifying, concealing or covering up by any trick or device a             
 material fact, or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can 
 be found guilty of violating the health care fraud statute under HIPAA without actual knowledge of the statute or specific intent to violate it;                                                                                                          |

| • |     | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its                                                                                                                                          
 implementing regulations, which also imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy and security of individually identifiable health information of covered entities subject to the rule,  
 including health plans, healthcare clearinghouses and certain healthcare providers and their business associates, independent contractors of a covered entity that perform certain services involving the use or disclosure of individually identifiable 
 health information for or on their behalf, as well as their covered subcontractors;                                                                                                                                                                      |

| • |     | the federal Physician Payments