Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2562

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2562
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 laws governing international business practices may result in substantial civil and criminal penalties and suspension
or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on United States exchanges
for violations of the FCPA’s accounting provisions.

Coverage
and Reimbursement

Successful
commercialization of new drug products depends in part on the extent to which reimbursement for those drug products will be available
from government health administration authorities, private health insurers, and other organizations. Government authorities and third-party
payors, such as private health insurers and health maintenance organizations, decide which drug products they will pay for and establish
reimbursement levels. The availability and extent of reimbursement by governmental and private payors is essential for most patients
to be able to afford a drug product. Sales of drug products depend substantially, both domestically and abroad, on the extent to which
the costs of drugs products are paid for by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations,
or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors.

A
primary trend in the United States healthcare industry and elsewhere is cost containment. Government authorities and third-party payors
have attempted to control costs by limiting coverage and the amount of reimbursement for particular drug products. In many countries,
the prices of drug products are subject to varying price control mechanisms as part of national health systems. In general, the prices
of drug products under such systems are substantially lower than in the United States. Other countries allow companies to fix their own
prices for drug products, but monitor and control company profits. Accordingly, in markets outside the United States, the reimbursement
for drug products may be reduced compared with the United States.

In
the United States, the principal decisions about reimbursement for new drug products are typically made by CMS, an agency within the
HHS. CMS decides whether and to what extent a new drug product will be covered and reimbursed under Medicare, and private payors tend
to follow CMS to a substantial degree. However, no uniform policy of coverage and reimbursement for drug products exists among third-party
payors and coverage and reimbursement levels for drug products can differ significantly from payor to payor. As a result, the coverage
determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for
the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied
consistently or obtained in