Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2252

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2252
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result in a similar reduction in payments from private payers. In addition, individual states in the United States have also increasingly
passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some
cases, designed to encourage importation from other countries and bulk purchasing.

Further,
on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients
to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation
for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without
obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its
drug products available to eligible patients as a result of the Right to Try Act.

116

In
November 2021, the Departments of Health and Human Services, Labor, the Treasury, and the Office of Personnel Management proposed rules
under the Consolidated Appropriations Act of 2021 requiring health plans, health insurance issuers offering group or individual health
insurance coverage, and health benefits plans offered to federal employees to submit key drug pricing data with a goal of increasing
transparency of drug cost, with the ultimate goal of promoting competition and bringing down overall health care costs.

On
August 16, 2022 the Inflation Reduction Act of 2022 was passed, which among other things, allows for CMS to negotiate prices for certain
single-source drugs and biologics reimbursed under Medicare Part B and Part D, beginning with ten high-cost drugs paid for by Medicare
Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029
and beyond. The legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply
with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the
law or for taking price increases that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket
drug expenses at $2,000. The effect of the Inflation Reduction Act of 2022 on our business and the healthcare industry in general is