In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from enforcement actions related to health care marketing practices. Specifically, the government has recently announced enforcement actions against multiple pharmaceutical companies, a laboratory, and individual health care providers for alleged violations of federal fraud and abuse laws, including the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Signaling that these victories are only the beginning, DOJ has also announced a series of criminal prosecutions of employees of these entities and policy initiatives that demonstrate the government’s increased scrutiny of health care marketing practices.

The AKS is a criminal statute that prohibits knowingly and willfully offering, paying, soliciting, or receiving any remuneration to induce or reward the referral or generation of business reimbursed by a federal health care program (for example, Medicare or Medicaid). “Remuneration” is broadly defined under the AKS to include the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind. Violation of the AKS is a felony, subject to a maximum fine of $25,000 for each criminal act, up to five years of imprisonment, and exclusion from federal health care programs. All parties to an illegal arrangement under the AKS may be subject to AKS liability, which in part explains how DOJ was able to target parties on both sides of suspect arrangements in certain of the following cases. Additionally, violations of the AKS can subject parties to civil liability under the Civil Monetary Penalties Law (CMP) and the FCA. FCA liability carries monumental financial exposure, with the government entitled to treble damages as well as civil monetary penalties of up to $11,000 per false claim.