Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 169

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 169
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 requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended 
 by the Health Care Education Reconciliation Act (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 (“CMS”),                      
 within the U.S. Department of Health and Human Services, information related to payments and other transfers of value to physicians 
 and teaching hospitals and information regarding ownership and investment interests held by physicians and their immediate family   
 members; and                                                                                                                        |

| ● | 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.                                                    |

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 pre-empted by HIPAA, thus complicating compliance efforts. Healthcare Reform A primary trend in the United States healthcare industry and elsewhere is cost containment. There have been a number of federal and state proposals during the last few years regarding the pricing of pharmaceutical and biopharmaceutical products, limiting coverage and reimbursement for drugs and other medical products, government control and other changes to the healthcare system in the United States. In March 2010, the United States Congress enacted the Affordable Care Act (the “ACA”_, which, among other things, includes changes to the coverage and payment for drug products under government health care programs. Among the provisions of the ACA of importance to our potential product candidates are:

| ● | an annual, non-deductible                                                                                                        
 fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these 
 entities according to their market share in certain government healthcare programs;                                              |

| ● | expansion of eligibility                                                                                                             
 criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income 
 at or below 133% of the federal poverty level, thereby potentially increasing a