“Applicable Manufacturers” -

Common Ownership Considered to be Ownership by the Same Individuals or Entities of 5 Percent or More in Two Entities -

In the Final Rule, CMS defines “applicable manufacturer” as an entity operating in the United States that is (1)engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply for sale or distribution in the United States, or in a territory, possession, or commonwealth of the United States; or (2) under common ownership with an entity in the first paragraph of this definition, and which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply. The Final Rule defines "common ownership" as when the same individual, individuals, entity, or entities, directly or indirectly, own 5 percent or more total ownership of two entities (such as parent, brother/sister, and subsidiary relationships).