Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 70

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 70
---
 information
    regarding ownership and investment interests held by physicians and their immediate family members; and

    ●
    analogous state and foreign laws and regulations, such as state anti-kickback
    and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors,
    including private insurers.

Some state laws require pharmaceutical companies
to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by
the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other
health care providers or marketing expenditures. State and foreign laws also govern the privacy and security of health information in
some circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating
compliance efforts.

Healthcare Reform 

A primary trend in the United States healthcare
industry and elsewhere is cost containment. There have been a number of federal and state proposals during the last few years regarding
the pricing of pharmaceutical and biopharmaceutical products, limiting coverage and reimbursement for drugs and other medical products,
government control and other changes to the healthcare system in the United States.

In March 2010, the United States Congress enacted the Affordable Care
Act (the “ACA”), which, among other things, includes changes to the coverage and payment for drug products under government
health care programs. Among the provisions of the ACA of importance to our potential product candidates are:

    ●
    an annual, non-deductible fee on any entity that manufactures or imports
    specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain
    government healthcare programs;

    ●
    expansion of eligibility criteria for Medicaid programs by, among other
    things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level,
    thereby potentially increasing a manufacturer’s Medicaid rebate liability;

37

    ●
    expanded manufacturers’ rebate liability under the Medicaid Drug
    Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average
    manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices;

    ●
    addressed a new methodology by which rebates owed by manufacturers
    under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

    ●