Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2549

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2549
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’s attention from the business.

Current
and Future Legislation

In
the United States and some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and regulatory
changes and proposed changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality
of healthcare, and containing or lowering the cost of healthcare.

For
example, in March 2010, the ACA was enacted in the United States. The ACA includes measures that have significantly changed, and are
expected to continue to significantly change, the way healthcare is financed by both governmental and private insurers. Among the provisions
of the ACA of greatest importance to the pharmaceutical industry are that the ACA:

    ●
    made
    several changes to the Medicaid Drug Rebate Program, including 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