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
Violations of the federal Anti-Kickback Statute (the “AKS”) have long served as a basis for liability under the federal False Claims Act (the “FCA”). Recently, however, there has been increasing uncertainty regarding how far...more
The False Claims Act’s (FCA) materiality requirement as articulated by the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel. Escobar, 579 U.S. 176 (2016) was again front and center, this time in a...more
As part of the Fiscal Year (FY) 2024 New York State Budget, New York adopted legislation that granted the Department of Health (DOH or Department) oversight of certain health care transactions involving physician practices...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
E. False Claims Act: Materiality - 1. False Claims Amendments Act of 2021 (S.2428) - • The Senate Committee on the Judiciary has approved for the Senate’s full consideration an amendment to the FCA that would...more
On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that...more
In July 2021, Senator Chuck Grassley led a bipartisan group of senators in introducing S.B. 2428, the “False Claims Amendments Act of 2021,” which aims to address legal developments in FCA doctrine that, according to the...more
The large volume of relief funding distributed by the government in connection with the COVID-19 pandemic will be the source of enforcement and regulatory scrutiny for years to come. During this webinar – the first in a...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 year 2019 was another active year in False Claims Act (FCA) investigations and litigation. Although the year lacked a singular blockbuster case, there were decisions of particular note. The Supreme Court clarified the...more
Editors’ Note: This is the fourth in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed anti-corruption trends in 2020. Up next: a look...more
Following the passage of the Affordable Care Act (“ACA”), which placed new limits on physician-owned hospitals, St. Luke’s Health System (“System”) took action to change one of its hospital’s ownership structures through a...more
With more than 34.8 billion recovered by the government since 2010 under the federal False Claims Act, it has never been more crucial for private practitioners and corporate in-house counsel to keep abreast of the changes and...more
The Supreme Court denied a petition for certiorari last Monday in U.S. ex rel. Prather v. Brookdale Senior Living Communities, Inc., No. 17-5826 (6th Cir. June 11, 2018), again declining to revisit or clarify the False Claims...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
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
Since the 2016 Supreme Court decision in Universal Services Inc. v. United States ex rel. Escobar, courts have wrestled with exactly how to apply the unanimous decision. This post highlights developments across the country in...more
This week I am running a series of posts on healthcare fraud enforcement and the False Claims Act. With all the controversy swirling around the Mueller investigation and prosecutions, the Justice Department continues its...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
Summer is almost here. For some, that means planning vacations to the beach, hitting the gym to shed that winter weight, or perhaps hitting the golf course—but for us at the Sheppard Mullin Healthcare Law Blog and the False...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