Company: PTHS
Filing Date: 2025-09-29
Form Type: 424B3
Source: 0001753926-25-001561
Chunk: 44

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-29
Form: 424B3
Chunk 44
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-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 the United States. There have been several Congressional inquiries, as well as legislative and regulatory initiatives and executive orders designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

Most significantly, in August 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); redesigns the Medicare Part D benefit (which began in 2024); and replaces the Part D coverage gap discount program with a new manufacturer discount program (which began in 2025). CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and the list of the