In This Issue:

- Interpretation and Clarification of Key Definitions

..Applicable Manufacturers

..Applicable GPOs

..Covered Drug, Device, Biological or Medical Supply

..Covered Recipients

..Payment or Other Transfers of Value

..Ownership or Investment Interest

- Payment and Other Transfer of Value Report Content Reports

..High Level Outline of Report Content

..Reportable Categories

..Exceptions to Reporting Obligations

- Reports of Physician Ownership and Investments

- Report Submission Process

- Review and Corrections Process

- Public Availability

- Record Retention and Audits

- Penalties

- Preemption

- Practical Effects

..Applicable Manufacturers and GPOs

..Covered Recipients and Physician Owners or Investors

- Excerpt from Interpretation and Clarification of Key Definitions:

The Rule retains the definition of the term “applicable manufacturer” as set forth in the Act; however, the Rule more clearly defines the entities required to make reports under the Act. Under the Rule, an “applicable manufacturer” is an entity operating in the United States that is either: (1) engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply; or (2) under common ownership with an applicable manufacturer that provides assistance or support to the applicable manufacturer with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply.