Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 31

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 31
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 claim including items or services resulting from a violation of the
    federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. There are a number of statutory
    exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors
    are drawn narrowly and require strict compliance in order to offer protection.

    ●
    The federal civil
    and criminal false claims laws, including the FCA, which can be enforced through civil “whistleblower” actions,
    and civil monetary penalty laws, impose criminal and civil penalties against individuals or entities for, among other things,
    knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal
    health care programs that are false or fraudulent; knowingly making or causing a false statement material to a false or fraudulent
    claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding
    or decreasing such an obligation. Manufacturers can be held liable under the FCA even when they do not submit claims directly
    to government payors if they are deemed to “cause” the submission of false or fraudulent claims. When an entity
    is determined to have violated the federal civil FCA, the government may impose civil fines and penalties for each false claim,
    plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.

    ●
    The federal civil
    monetary penalties laws impose civil fines for, among other things, the offering or transfer or remuneration to a Medicare
    or state healthcare program beneficiary, if the person knows or should know it is likely to influence the beneficiary’s
    selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care
    program, unless an exception applies.

    ●
    The federal Health
    Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes
    that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program
    or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by,
    or under the custody or control of, any healthcare benefit program, regardless of the payor (including, public or private)
    and knowingly and willfully falsifying, concealing or covering up by any trick