Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 188

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 188
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 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, 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 manufacturer’s Medicaid rebate liability;            |

| ● | expanded manufacturers’                                                                                                                  
 rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising 
 the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient                
 prescription drug prices;                                                                                                                |

| ● | addressed a new methodology                                                                                                       
 by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, 
 instilled, implanted or injected;                                                                                                 |

| ● | expanded the types of entities               
 eligible for the 340B drug discount program; |

| ● | established the Medicare                                                                                                         
 Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price 
 of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’       
 outpatient drugs to be covered under Medicare Part D; and                                                                        |

| ● | a new Patient-Centered                                                                                                              
 Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with 
 funding for such research.                                                                                                          |

112 Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. In August 2011,