Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 271

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 271
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 will affect our operations include,
but are not limited to:

    ●
    the federal Anti-Kickback
    Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering
    or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash
    or in kind, in return for the purchase, recommendation, leasing or furnishing of an item or service reimbursable under a federal
    healthcare program, such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements
    between pharmaceutical manufacturers on the one hand, and prescribers, purchasers and formulary managers on the other. The
    ACA amended the intent requirement of the federal Anti-Kickback Statute to clarify that a person or entity does not have to
    have actual knowledge of this statute or specific intent to violate it;

    ●
    federal civil and
    criminal false claims laws and civil monetary penalty laws which prohibit, among other things, individuals or entities from
    knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government
    payors that are false or fraudulent. The ACA provides that a claim for items or services resulting from an Anti-Kickback Statute
    violation is a false claim under the FCA. Cases against pharmaceutical manufacturers support the view that certain marketing
    practices, including off-label promotion, may implicate the FCA;

    ●
    HIPAA, which created
    new federal criminal statutes that prohibit a person from knowingly and willfully executing a scheme or from making false
    or fraudulent statements to defraud any healthcare benefit program, regardless of the payor (e.g., public or private);

    ●
    HIPAA, as amended
    by HITECH, and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA
    Privacy, Security, Enforcement, and Breach Notification Rules under HITECH and the Genetic Information Nondiscrimination Act;

    ●
    other modifications
    to HIPAA, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable
    health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses
    and health care providers.

    ●
    federal transparency
    laws, including the federal Physician Payment Sunshine Act