Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 74

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 74
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 federal HIPAA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, including  
 private third-party payors, or for knowingly and willfully falsifying, concealing or covering up a material fact or making      
 any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document    
 knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery   
 of or payment for healthcare benefits, items or services. Similar to the federal healthcare Anti-Kickback Statute, a person     
 or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; |

| ● | the                                                                                                                               
 federal Physician Payments Sunshine Act, implemented as the Open Payments Program, requires certain manufacturers of drugs,       
 devices, biologics and medical supplies to report payments and other transfers of value to physicians for which payment is        
 available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually        
 to CMS information related to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors),    
 certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse       
 anesthetists, anesthesiology assistants and certified nurse-midwives) and teaching hospitals, as well as ownership and investment 
 interests held by physicians and their immediate family members. Manufacturers must submit reports on or before the 90th day      
 of each calendar year disclosing reportable payments made in the previous calendar year;                                          |

| ● | analogous                                                                                                                          
 state laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed     
 under Medicaid and other state programs or, in several states, regardless of the payer, including private insurers. Some state     
 laws require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products        
 and to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain   
 marketing- related activities including the provision of gifts, meals, or other items to certain health care providers. Some       
 states restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs. Some states       
 require the posting of information relating to clinical studies and their outcomes. Other states and cities require identification 
 or licensing of sales representatives. In addition, several states require pharmaceutical companies to implement compliance        
 programs