Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 35

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 35
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 things, includes changes to the coverage and payment for products under government
health care programs. The ACA includes provisions of importance to our potential compounds that:

    ●
    created an annual,
    nondeductible fee on any entity that manufactures or imports specified branded prescription drug products, apportioned among
    these entities according to their market share in certain government healthcare programs;

    ●
    expanded 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 point-of-sale-discounts 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

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

Since
its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of
the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. For example, various portions
of the ACA have faced legal and constitutional challenges, including in the United States Supreme Court; the Trump administration
issued various Executive Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden
on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers
of pharmaceuticals or medical devices; and Congress introduced several pieces of legislation aimed at significantly revising or
repealing the ACA. It is unclear whether the ACA will be overturned