Florida International University Starke Law Case Study Discussion
Description
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Scenario #1: Your client/employer ABC hospital enters into an agreement with Novarmints pharma company to participate in a drug study. To conduct the study at the hospital, ABC asks physician Dr. No to serve as the principal investigator to conduct the pharma study for ABC. Dr. No is not a hospital employee but is on staff at the hospital and does refer his patients for defined health services when hospitalization is necessary for treatment. As part of his contract negotiations with the hospital, Dr. No asks the hospital to pass along to him 50% of the contract fees that Novarmints has promised to ABC for conducting the study. Would Dr. Nos proposed split be lawful under the Stark law? Do any of the 35 exceptions apply and if so, which one(s)? Explain your answer using the readings. What could be the potential consequences of a violation?
Scenario #2: Dr. No is invited by Novarmints to take part in a study involving a recently FDA-approved drug that it is in the process of marketing to the public. Dr. No would be required to prescribe the drug for his patients and then complete a brief questionnaire about each patients experience with the drug. The questionnaire for each patient is expected to take about 15-20 minutes to complete. Novarmints will pay Dr. No $3,000 for each completed questionnaire. Dr. No sees this as easy money and a great way to increase practice revenues. Would this arrangement be lawful under the Anti-kickback statute? Explain your answer. What could be the potential consequences of a violation?
Hint: Is this a real drug study?
