Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2654

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2654
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 of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program,
in which manufacturers must agree to offer 70% (increased pursuant to the Bipartisan Budget Act of 2018, or BBA, effective as of 2019)
point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as
a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Since
its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA,
and we expect there will be additional challenges and amendments to the ACA in the future. Various portions of the ACA are currently
undergoing legal and constitutional challenges in the United States Supreme Court. It is unclear how such litigation and other efforts
to repeal and replace the ACA will impact the ACA and our business. In addition, the first Trump administration issued various Executive
Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden on states or a cost, fee, tax,
penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.
Additionally, Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA. It is unclear
whether the ACA will be overturned, repealed, replaced, or further amended. We cannot predict what affect further changes to the ACA
would have on our business.

Other
legislative changes have been proposed and adopted in the United States since the ACA was enacted. The Budget Control Act of 2011, among
other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending
a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach the required goals, thereby
triggering the legislation’s automatic reduction to several government programs, including aggregate reductions of Medicare payments
to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments
to the statute, including the BBA, will remain in effect through 2030, unless additional congressional action is taken. However, these
Medicare sequester reductions have been suspended multiple times. Most recently, the Protecting Medicare and American Farmers from Sequester
Cuts Act impacts payments for all Medicare Fee for Services claims as follows: no payment adjustment through March 31,