Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3550

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3550
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 and increased the
statute of limitations period for the government to recover overpayments to providers from three to five years.

Moreover,
increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause
such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover
or provide adequate payment for our product candidates. There has been increasing legislative and enforcement interest in the United
States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and
proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the
cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for drugs.

115

At
the federal level, the former Trump administration’s budget for fiscal year 2021 included a $135 billion allowance to support legislative
proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access
to lower-cost generic and biosimilar drugs. On March 10, 2020, the former Trump administration sent “principles” for drug
pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses,
provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases.
The former Trump administration previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of
drugs that contained proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs,
incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers.

On
November 30, 2020, HHS issued regulations excluding from the definition of a “discount” eligible for Anti-Kickback Statute
safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products
to plan sponsors under Medicare Part D or pharmacy benefit managers under contract with them, modifying the existing discount safe harbor
in particular contexts; and creating safe harbors for certain point-of-sale reductions in price on prescription pharmaceutical products
and for certain PBM service fees. Following a lawsuit brought by the Pharmaceutical Care Management Association, the Biden Administration
delayed the rule’s effective date to January 1, 2023