Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2648

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2648
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 it. In addition, a claim submitted for payment to any federal health care program that includes items
    or services that were made as a result of a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim
    for purposes of the FCA. The Anti-Kickback Statute has been interpreted to apply to arrangements between biopharmaceutical manufacturers
    on the one hand and prescribers, purchasers, and formulary managers, among others, on the other. There are a number of statutory
    exceptions and regulatory safe harbors protecting some common activities from prosecution;

111

    ●
    the
    federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things,
    individuals or entities from knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment
    to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using or causing to be made or used
    a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money or property to the
    federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay
    money to the federal government. A claim that includes items or services resulting from a violation of the federal Anti-Kickback
    Statute constitutes a false or fraudulent claim under the FCA. 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.
    The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal
    government alleging violations of the FCA and to share in any monetary recovery;

    ●
    the
    federal Health Insurance Portability and Accountability Act of 1996, or 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 (e.g., public or private) and knowingly and willfully
    falsifying, concealing or covering up by any trick or device a