Companies that have entered into Settlement Agreements with the federal government may be subject to a Corporate Integrity Agreement (CIA). CIAs require that companies file annual reports to the OIG and may also require an on-site visit by the OIG. Check whether the company is subject to a CIA, or any other requirements as a result of an enforcement action.
OIG Compliance Checklist
Is there a comprehensive compliance program in place?
Does it include the seven elements?
Has the Company or any Person been excluded or debarred from FDA or OIG?
System in place to check semi-annually status on OIG and FDA lists
Compliance with state reporting (VT, MN, CA)
Is there a report of any violations of the code of conduct?
Define any “reportable events” (i.e., anything brought to the attention of senior management that a reasonable person thinks could be a violation of criminal, civil or administrative law)
If there are any reportable events, what corrective action has been taken?
Is there a confidential disclosure program (for overpayments or other issues)?