Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3551

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3551
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. Subsequently, the Infrastructure Investment and Jobs Act, signed by President
Biden on November 15, 2021, has further delayed implementation to January 2026.

On
September 24, 2020, HHS and FDA issued a final rule under Section 804 of the Food, Drug, and Cosmetic Act allowing commercial importation
of certain prescription drugs from Canada without the manufacturer’s authorization. The validity final rule has been challenged
in federal court by the Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines and the Council for
Affordable Health Coverage.

On
November 20, 2020, CMS announced a new payment model, the Most Favored Nation Model and issued a corresponding interim final rule, intended
to lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug
manufacturers receive in other similar countries. The interim rule was enjoined on December 29, 2020 and withdrawn by CMS on December
27, 2021.

On
November 20, 2020, CMS and the HHS Office of the Inspector General issued two final rules implementing changes to the Physician Self-Referral
Law, or Stark Law, and the Anti-Kickback Statute. These new rules codify new value-based exceptions and safe harbors to the Stark Law
and the Anti-Kickback Statute, as well as offer additional clarification in the form of updated definitions. We continue to analyze and
monitor the potential impact of these new and amended exceptions and safe harbors.

On
December 23, 2020, the Health Resources and Services Administration issued a final rule requiring federally qualified health centers
in the 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