Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2656

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2656
---
ivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers.

On
November 30, 2020, HHS issued regulations excluding from the definition of a “discount” eligible for Anti-Kickback Statute
safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products
to plan sponsors under Medicare Part D or pharmacy benefit managers under contract with them, modifying the existing discount safe harbor
in particular contexts; and creating safe harbors for certain point-of-sale reductions in price on prescription pharmaceutical products
and for certain PBM service fees. Following a lawsuit brought by the Pharmaceutical Care Management Association, the Biden Administration
delayed the rule’s effective date to January 1, 2023. 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 The interim rule was enjoined on December 29, 2020 and withdrawn by CMS on December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