Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2657

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2657
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 340B Drug Pricing Program to pass drug discounts on to certain low-income patients as a condition of receiving federal grant funding.

HHS
has solicited feedback on some of these measures and has implemented others under its existing authority. For example, in May 2019, CMS
issued a final rule that would allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part
B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. Although a
number of these and other measures may require additional authorization to become effective, Congress has indicated that it will continue
to seek new legislative measures to control drug costs. Any reduction in reimbursement from Medicare and other government programs may
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