Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2655

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2655
---
 2022; 1% payment
adjustment April 1 - June 30, 2022; and 2% payment adjustment beginning July 1, 2022. The sequester may be delayed by future legislation.
The BBA also amended the ACA, effective January 1, 2019, by increasing the point-of-sale discount that is owed by pharmaceutical manufacturers
who participate in Medicare Part D and closing the coverage gap in most Medicare drug plans, commonly referred to as the “donut
hole.” On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced
Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, 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,
incent