Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2146

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2146
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 2011, the Budget Control
Act of 2011, among other things, created measures for spending reductions by Congress. The 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. This includes aggregate
reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect in April 2013, following passage of the
Bipartisan Budget Act of 2013, and will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020
through March 31, 2022, followed by a period of 1% payment adjustment April 1 - June 30, 2022, followed by a 2% payment adjustment beginning
July 1, 2022. Further, in January 2013, former President Obama signed into law the American Taxpayer Relief Act of 2012, which, among
other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers,
and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Any
reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors,
which may adversely affect our future profitability. Additionally, there has been increasing legislative and enforcement interest in
the United States with respect to specialty drug pricing practices.

59

Specifically,
there have been several recent United States Congressional inquiries and proposed bills designed to, among other things, bring more transparency
to drug pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement
methodologies for drugs. At the federal level, the Trump administration used several means to propose or implement drug pricing reform,
including through federal budget proposals, executive orders and policy initiatives. On September 24, 2020, HHS and FDA issued a final
rule under Section 804 of the Food, Drug, and Cosmetic Act allowing commercial importation of certain prescription drugs from Canada
without the manufacturer’s authorization. The validity of the final rule has been challenged in federal court by the Pharmaceutical
Research and Manufacturers of America, the Partnership for Safe Medicines and the Council for Affordable Health Coverage. Further, on
November 30, 2020, H