Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2243

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2243
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 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 material fact or making any materially false statements in connection
    with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal
    AKS, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate
    it;

    ●
    HIPAA,
    as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing
    regulations, which impose, among other things, requirements relating to the privacy, security and transmission of individually identifiable
    health information on certain covered healthcare providers, health plans, and healthcare clearinghouses, known as covered entities,
    as well as their respective “business associates,” those