We recently co-authored an article published by Law360 detailing what the $12 million settlement of the U.S. Department of Justice’s (DOJ) case against medical device maker Innovasis Inc. may mean for other Anti-Kickback Statute (AKS) cases.

The case involved DOJ allegations that Innovasis and two of its executives gave surgeons gifts, including payments and a trip to a ski resort so that they would use the company’s spinal devices.

We wrote that the settlement comes amid a circuit split over language added to the AKS in a 2010 amendment and is also a further indication of the DOJ’s effort to ramp up AKS enforcement. The Innovasis settlement offered some takeaways for companies and executives facing the decision of whether or not to self-disclose to the government a violation of the AKS.

“The Innovasis settlement demonstrates that effectively navigating a self-disclosure requires striking the right balance of cooperation and client advocacy,” we explained in the article.

The full article, “DOJ Innovasis Settlement Offers Lessons on Self-Disclosure,” was published by Law360 on July 29 and is available online. The Innovasis settlement was previously discussed on our Inside the False Claims Act blog and GovCon & Trade blog.

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Photo of Denise Barnes Denise Barnes

Denise Barnes counsels clients in high-stakes matters related to fraud allegations, including in healthcare, federal contract procurement, and securities and financial services. A former trial attorney with the U.S. Department of Justice (DOJ), she has extensive experience handling issues related to compliance, white-collar…

Denise Barnes counsels clients in high-stakes matters related to fraud allegations, including in healthcare, federal contract procurement, and securities and financial services. A former trial attorney with the U.S. Department of Justice (DOJ), she has extensive experience handling issues related to compliance, white-collar and regulatory investigations, and complex commercial litigation. Denise represents businesses in public and non-public investigations, regulatory inquiries, and proceedings involving federal and state agencies. She frequently assists clients navigating government investigations related to allegations arising under the False Claims Act (FCA), Anti-Kickback Statute (AKS), Stark Law, and Financial Institutions Reform, Recovery, and Enforcement Act (FIRREA). Notably, during her tenure at the DOJ, she spearheaded numerous multi-district investigations that resulted in over $2.7 billion in recoveries for federal taxpayers.

Photo of Scott Gallisdorfer Scott Gallisdorfer

Scott Gallisdorfer focuses his practice on complex litigation and government and internal investigations, with an emphasis on matters related to the healthcare industry. Scott has significant experience in False Claims Act (FCA) litigation and healthcare fraud and abuse investigations, including civil and criminal…

Scott Gallisdorfer focuses his practice on complex litigation and government and internal investigations, with an emphasis on matters related to the healthcare industry. Scott has significant experience in False Claims Act (FCA) litigation and healthcare fraud and abuse investigations, including civil and criminal investigations by the U.S. Department of Justice (DOJ), U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and other federal and state regulators.