Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 92

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 92
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 criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which prohibit,
among other things, individuals or entities from knowingly presenting, or causing to be presented, false 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 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. Manufacturers
can be held liable under the FCA even when they do not submit claims directly to government payers 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
actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;

●The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for executing
a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

●HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, also
imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually
identifiable health information;

●The federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices,
biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Centers for Medicare and Medicaid
Services (“CMS”) information related to payments and other transfers of value to physicians, certain advanced non-physician
healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, such physicians,
non-physician healthcare practitioners, and teaching hospitals as well as certain ownership and investment interests held by physicians
and their immediate family members; and

●Analogous state and international laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing
arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.

The majority of state governments have statutes
or regulations similar to the aforementioned federal laws, some of which are broader in scope and apply to items and services reimbursed