False Claims Act Insights - If Everything Matters, Nothing Does: Parsing Materiality in FCA Disputes
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
On June 1, 2023, the Supreme Court decided a pair of closely watched False Claims Act (FCA) cases, U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326, and U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111....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
Walmart successfully ended eight years of protracted litigation under the False Claims Act (“FCA”) on June 4, 2021, when the Sixth Circuit affirmed dismissal of Medicare and Medicaid fraud allegations against the major...more
This year saw substantial activity in FCA settlements and litigated court cases. Although no single case or development dominated the discourse this year, several important court decisions were issued, including two that may...more
On October 5, 2020, the U.S. Supreme Court declined to review a case questioning the materiality standard for Medicare fraud cases under the False Claims Act (FCA). The case involved allegations that Lawrence Memorial...more
The Northern District of Illinois is the latest court to grant a defendant’s motion to dismiss in a False Claims Act (FCA) case, after the relator failed to meet the substantial pleading burden established in the U.S. Supreme...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
The Decision: A divided Sixth Circuit panel held that allegations of submitting late-signed supporting documents to Medicare could plead False Claims Act ("FCA") materiality and scienter. The Reasoning: Timing regulations...more
On June 11, 2018, the United States Court of Appeals for the Sixth Circuit sustained a complaint against a home health care agency alleging that the agency had violated the False Claims Act (the “FCA”) by submitting numerous...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
In January 2018, the Department of Justice (DOJ) issued two memoranda that, taken together, may usher in a new era of False Claims Act (FCA) enforcement in the health care industry. The first memorandum, dated January 10,...more
We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more
In February of 2018, a United States District Court in the Central District of California dismissed only half of the claims in a qui tam case against United Health Group, Inc. (UHG), a Medicare Advantage plan provider. United...more
Last month, a U.S. District Court in the Middle District of Florida overturned judgments totaling $347,864,285 returned by a jury under the federal False Claims Act (FCA) and Florida’s state equivalent against the owners and...more
If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a...more
The False Claims Act (FCA), initially enacted in 1863 during the Civil War, was sponsored by the Lincoln administration to curtail the rampant fraud and excessive profiteering being perpetuated by government contractors, who,...more
On October 5, a federal district court in California dealt a significant setback to the government’s efforts to extend False Claims Act (FCA) liability to Medicare risk adjustment submissions....more
The District Court for the Middle District of Tennessee held on June 22, 2017, that the timing requirements related to a physician's certification of need for home health services were not "material" to the Centers for...more
It’s been just over a year since the Supreme Court’s seminal False Claims Act (“FCA”) decision Universal Health Servs., Inc. v. United States ex rel. Escobar. In the wake of Escobar, the lower courts are confronted with...more
The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we are...more
We are pleased to present our annual review of developments in the field of health law. The year was marked by key changes in False Claims Act jurisprudence and Medicare payment policy. 2016 also brought with it focused...more
In June, I published a blog article on a decision of the United States Supreme Court that appeared to change the law applicable to “false certification” in the 7th Judicial Circuit Circuit. The Supreme Court decision in...more
This summer, the Northern District of California issued an opinion in an intervened case that expanded the theory of express false certification to a startling degree. Ruling on a motion to dismiss, the court in U.S. ex rel....more
On Tuesday, October 25, 2016, a three-judge panel of the United States Court of Appeals for the First Circuit heard argument in United States ex rel. Escobar, et al. v. Universal Health Services, Inc. This case was sent back...more
The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more