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The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more
In this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth...more
On July 7, 2021, the U.S. District Court for the District of Columbia ruled in favor of HHS and upheld HHS’s 2013 rule readopting its policy of including Part C days in the Medicare fraction of the disproportionate share...more
THE ONLY EVENT WHERE YOU'LL HEAR FROM Government, In-house Counsel, The Judiciary, the Defense & Relator’s Bar - ACI’s 8th Annual Advanced Forum on False Claims and Qui Tam Enforcement will address the underlying...more
The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants. In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice...more
As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of...more
Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...more
The Department of Justice (DOJ) appears to be taking to heart the policy articulated in what has come to be called the Granston Memo, as it has recently sought dismissal of 11 False Claims Act (FCA) cases in various federal...more
The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more
As of March 3, Solvay Pharmaceuticals is ready to second P.T. Barnum’s famous dictum that there’s no such thing as bad publicity. That’s the day a federal court in Texas dismissed a qui tam action against Solvay....more
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more