Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2547

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2547
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 enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition,
certain state laws govern the privacy and security of health information in certain circumstances, some of which are more stringent than
HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Failure to comply with these laws, where applicable, can result in the imposition of significant civil and criminal penalties.

Additionally,
the federal Physician Payments Sunshine Act, or the Sunshine Act, within the ACA, and its implementing regulations, require that certain
manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s
Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers
of value made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching
hospitals, or to entities or individuals at the request of, or designated on behalf of, physicians, and teaching hospitals and to report
annually certain ownership and investment interests held by physicians, certain other healthcare professionals, and their immediate family
members. Beginning in 2022, applicable manufacturers will also be required to report information regarding payments and other transfers
of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse
anesthetists, anesthesiologist assistants, and certified nurse-midwives. In addition, many states also govern the reporting of payments
or other transfers of value, many of which differ from each other in significant ways, are often not pre-empted, and may have a more
prohibitive effect than the Sunshine Act, thus further complicating compliance efforts.

Similar
federal, state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, may apply to sales
or marketing arrangements and claims involving healthcare items or services. Such laws are generally broad and are enforced by various
state agencies and private actions. Also, many states have similar fraud and abuse statutes or regulations that may be broader in scope
and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Some state laws
require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant
federal government compliance guidance, and require drug manufacturers to report information related to payments and other