Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 170

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 170
---
 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.                                                                                                          |

106 Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030 unless additional Congressional action is taken. The reductions have been suspended temporarily through December 2021 in response to the COVID-19 pandemic. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Since enactment of the ACA, there have been numerous legal challenges and Congressional actions to repeal and replace provisions of the law. In May