At the forefront of the debate over the anti-kickback statute, and the topic of this Note, is the mens rea, or mental state, that is required for a violation of the law. According to the statute, an individual must "knowingly and willfully" solicit or receive, or offer to pay, remuneration in order to induce business reimbursed under any federal health care program. The interpretation of these terms by the federal courts has varied wildly, as have the underlying Supreme Court cases cited as precedent for such interpretations. However, in June of 1998, the Supreme Court defined the meaning of "willfully" under a federal criminal statute in Bryan v. United States. Although the criminal statute in Bryan was unrelated to health care fraud, the Eleventh Circuit has adopted the Bryan Court's definition of "willfully" in a case involving the anti-kickback statute. Whether Bryan will resolve the split between the circuit courts is unclear; however, this case is certain to significantly influence the debate. The following Section of this Note briefly summarizes the legislative development of the federal anti-kickback statute including the 1980 amendment adding the mens rea requirement. Section II also summarizes the 1996 amendment requiring that the Secretary of the DHHS (Department of Health and Human Services) issue advisory opinions in response to requests for guidance about whether specific business arrangements are within the limits of the anti-kickback statute. Section III examines the various federal court interpretations of the mens rea requirement of the statute. As described in this Section, there is a split of authority as to the meaning of the word "willfully" under the statute. Because the Supreme Court has not interpreted the meaning of the mens rea requirement of the anti-kickback statute, this Section also examines the principal cases that have defined "willfully" in the context of other federal criminal statutes, that have been relief upon in interpreting the anti-kickback statute. Section IV analyzes Bryan v. United States, where the Supreme Court defined "willfully" under the Firearms Owners' Protection Act, as acting with a "bad purpose" or with the intent to do something which the law forbids. Section V analyzes United States v. Starks, the first, and to date only circuit court decision to interpret the mens rea standard of the statute in light of the Bryan decision to interpret the mens rea standard of the statute in light of the Bryan decision. Section VI analyzes the alternative interpretations of the mens rea standard of the anti-kickback statute, and the reasons that federal courts will likely adopt the Bryan court's definition of "willfull." Finally, this Note concludes, that, despite its factual distinction from health care fraud and abuse litigation, the Supreme Court's recent decision in Bryan will greatly impact the current debate about the proper interpretation of "willfully" under the anti-kickback statute.
Note, Defining Willful Remuneration: How Bryan v. United States Affects the Scienter Requirement of the Medicare/Medicaid Anti-Kickback Statute, 14 J.L. & Health 271 (1999-2000)