Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 32

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 32
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 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 Anti-Kickback Statute, 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 (“HITECH”), and their respective implementing
    regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses
    and their respective business associates that perform services for them that involve the use, or disclosure of, individually
    identifiable health information as well as their covered subcontractors, relating to the privacy, security and transmission
    of individually identifiable health information without appropriate authorization. HITECH also created new tiers of civil
    monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave
    state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal
    HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

18 

    ●
    The federal Physician
    Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and
    Education Reconciliation Act of 2010 (collectively, the “ACA”), imposed annual reporting requirements for certain
    manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid,
    or the Children’s Health Insurance Program, for certain payments and “transfers of value” provided to physicians
    (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well
    as ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these
    reporting obligations will extend to include transfers of value made in the previous year to certain non-physician providers
    such as physician assistants and nurse practitioners.

    ●
    Federal consumer
    protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers.

    ●
    Analogous state
    and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition
    laws which may apply to pharmaceutical business