Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 68

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 68
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 our business, including, without limitation, our ability to commercialize and the prices we may obtain for any product candidates that are approved for sale, are the following:

| ● | an                                                                                                                             
 annual, nondeductible 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, although this      
 fee does not apply to sales of certain products approved exclusively for orphan indications;                                   |

| ● | 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;                                                                                                  |

| ● | expansion                                                                                                            
 of manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both  
 branded and generic drugs, revising the “average manufacturer price” definition, and extending rebate liability      
 from fee-for-service Medicaid utilization to include the utilization of Medicaid managed care organizations as well; |

| ● | expansion                                                                                                                         
 of the list of entity types eligible for participation in the Public Health Service 340B drug pricing program, or the 340B        
 program, to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community 
 hospitals, but exempting “orphan drugs” from the 340B ceiling price requirements for these covered entities;                      |

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

| ● | establishment                                                                                                                 
 of the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower 
 Medicare and Medicaid spending, including prescription drug spending.                                                         |

Since its enactment, certain provisions of the ACA have been subject to judicial, executive, and legislative challenges and may be subject to additional challenges in the future. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory Medicaid drug rebate cap, beginning January 1, 2024. Previously, the Medicaid rebate was capped at 100% of a drug’s average manufacturer price.

The cost of prescription pharmaceuticals in the United States has also been the subject of considerable discussion in