1: Under what circumstances might a payment to a clinical investigator violate the Anti-Kickback Statute? Why is the risk of Anti-Kickback violations greater in post-marketing research? 2: Why are waivers of Medicare copayments for research participants a potential Anti-Kickback violation? Under what circumstances might the OIG permit the waiver of Medicare copayments for research participants? 3: Under what circumstances might a payment to a clinical investigator violate the Stark Law?

If a payment to an investigator satisfies the personal services safe harbor under the Anti-Kickback Statute, is it also likely to satisfy the personal services exception to the Stark Law?

Are the consequences of failing to satisfy a Stark Law exception the same as the consequences of failing to satisfy an Anti-Kickback Statute safe harbor? 4: What must the government prove to establish that the submission of a claim for Medicare reimbursement of clinical-trial related expenses violates the False Claims Act?