Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2144

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2144
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 increasing pharmaceutical manufacturers’ rebate liability by
    raising the minimum basic Medicaid rebate on most branded prescription drugs to 23.1% of average manufacturer price, or AMP, and
    adding a new rebate calculation for “line extensions”(i.e., new formulations, such as extended release formulations)
    of solid oral dosage forms of branded products, as well as potentially impacting their rebate liability by modifying the statutory
    definition of AMP.

    ●
    imposed
    a requirement on manufacturers of branded drugs to provide a 70% point-of-sale discount off the negotiated price of branded drugs
    dispensed to Medicare Part D beneficiaries in the coverage gap (i.e., “donut hole”) as a condition for a manufacturer’s
    outpatient drugs being covered under Medicare Part D.

    ●
    extended
    a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care
    organizations.

    ●
    expanded
    the entities eligible for discounts under the 340B Drug Discount Program.

    ●
    established
    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.

58

    ●
    imposed
    an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these
    entities according to their market share in certain government healthcare programs.

    ●
    established
    a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness
    research, along with funding for such research. The research conducted by the Patient-Centered Outcomes Research Institute may affect
    the market for certain pharmaceutical products.

    ●
    established
    the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare
    and Medicaid spending, potentially including prescription drug spending.

While
Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have
been signed into law. For example, the Tax Act includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility
payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly
referred to as the “individual mandate.” Additionally, the 2020 federal spending package permanently eliminated, effective
January 1,