Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 62

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 62
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ologic, such as limiting prescribing
to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use
criteria and requiring treated patients to enroll in a registry. These limitations and restrictions may limit the size of the market
for the product and affect reimbursement by third-party payors.

38

If
we or our collaborators, manufacturers or service providers fail to comply with healthcare laws and regulations, we or they could be
subject to enforcement actions, which could affect our ability to develop, market and sell our products and may harm our reputation.

We
and our collaborators are subject to federal, state, and foreign healthcare laws and regulations pertaining to fraud and abuse and patients’
rights. These laws and regulations include:

    ●
    the
    U.S. federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing
    remuneration, directly or indirectly, to induce either the referral of an individual for a healthcare item or service, or the purchasing
    or ordering of an item or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid;

    ●
    the
    U.S. federal false claims law, which prohibits, among other things, individuals or entities from knowingly presenting or causing
    to be presented, claims for payment by government funded programs such as Medicare or Medicaid that are false or fraudulent, and
    which may apply to us by virtue of statements and representations made to customers or third parties;

    ●
    the
    U.S. federal Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical
    Health (HITECH) Act, which prohibit executing a scheme to defraud healthcare programs, impose requirements relating to the privacy,
    security, and transmission of individually identifiable health information, and require notification to affected individuals and
    regulatory authorities of certain breaches of security of individually identifiable health information;

    ●
    the
    federal Open Payments regulations under the National Physician Payment Transparency Program have been issued under the Patient Protection
    and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, and will require that manufacturers
    of pharmaceutical and biological drugs covered by Medicare, Medicaid, and Children’s Health Insurance Programs report all consulting
    fees, travel reimbursements, research grants, and other payments or gifts with values over $10 made to physicians and teaching hospitals;
    and

    ●