Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 204

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 204
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 defraud any healthcare benefit program, including private third-party 
 payors or making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits,          
 items or services;                                                                                                                             |

| ● | HIPAA, as amended by the Health                                                                                                               
 Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, imposes obligations on certain        
 covered healthcare providers, health plans, and healthcare clearinghouses and their respective business associates and covered subcontractors 
 types of individuals and entities regarding the electronic exchange of information in common healthcare transactions, as well as standards    
 relating to the privacy and security of individually identifiable health information;                                                         |

| ● | The federal Physician Payments                                                                                                               
 Sunshine Act 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 and            
 Medicaid Services (“CMS”), information related to payments or other transfers of value made to physicians (defined to include                
 doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists,      
 anesthesiologist assistants, certified nurse anesthetists and certified nurse-midwives and teaching hospitals, as well as ownership and      
 investment interests held by physicians and their immediate family members.;                                                                 |

| ● | Federal and state laws that                                                     
 require pharmaceutical manufacturers to report product pricing information; and |

| ● | The Foreign Corrupt Practices                                                                                                             
 Act prohibits U.S. businesses and their representatives from offering to pay, paying, promising to pay or authorizing the payment of      
 money or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official 
 capacity or to secure any other improper advantage in order to obtain or retain business.                                                 |

Many states have similar laws and regulations, such as anti-kickback and false claims laws, that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Additionally, we may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines, state laws that require drug and biologics manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many