On July 10, the Department of Justice (DOJ) announced a nearly $410 million settlement with Rite Aid Corporation to resolve allegations that Rite Aid and its affiliates ignored red flags and knowingly dispensed unlawful...more
7/12/2024
/ Controlled Substances Act ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacist ,
Rite Aid ,
Settlement
False Claims Act (FCA) practitioners have been closely watching cases in which courts address the causation requirement in FCA actions based on Anti-Kickback Statute (AKS) violations....more
6/24/2024
/ Anti-Kickback Statute ,
Causation ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Care Violations ,
Healthcare ,
Kickbacks ,
Regeneron ,
SCOTUS ,
Teva Pharmaceuticals
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
2/27/2024
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Settlement ,
Stark Law ,
Telemedicine
A qui tam False Claims Act (FCA) complaint was recently unsealed against Cerebral, a telehealth startup that provides virtual mental-health therapy, in the U.S. District Court for the Northern District of Iowa....more
The United States recently intervened in a False Claims Act lawsuit accusing Rite Aid of defrauding federal healthcare programs by seeking reimbursement for opioids the pharmacy allegedly dispensed in violation of the...more
7/11/2023
/ Controlled Substances Act ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Objective Falsity ,
Opioid ,
Private Equity ,
Rite Aid
On June 16, the U.S. Supreme Court issued its opinion in U.S. ex rel. Polansky v. Executive Health Resources, a closely watched case about the government’s power to dismiss a False Claims Act (FCA) qui tam lawsuit over a...more
6/21/2023
/ Constitutional Challenges ,
Dismissals ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Healthcare ,
Qui Tam ,
Relators ,
Rule 41 ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
Whistleblowers
On June 1, the U.S. Supreme Court unanimously refused to apply the Safeco objective knowledge standard to the False Claims Act (FCA), holding instead in U.S. ex rel. Schutte v. Supervalu Inc. that the FCA’s scienter element...more
On March 28, the Sixth Circuit issued an important decision on the meanings of “remuneration” and “causation” under the Anti-Kickback Statute (AKS), holding that remuneration “covers just payments and other transfers of...more
On August 30, the U.S. Court of Appeals for the D.C. Circuit held, as a matter of first impression, that damages in False Claims Act cases are subject to pro tanto (dollar-for-dollar) settlement offsets in cases involving...more
On August 25, the U.S. Court of Appeals for the Ninth Circuit issued an opinion in which it held that ex parte patent prosecutions by the Patent and Trademark Office (PTO) qualify as “other Federal . . . hearing[s]” under...more
On March 24, the U.S. Court of Appeals for the Fifth Circuit affirmed the criminal healthcare fraud convictions of two individuals who ran a network of home health and hospice centers in Texas. According to the Fifth Circuit,...more
A civil investigative demand (CID) is a tool, like a subpoena, that the government uses to obtain documents and information to investigate potential violations of the False Claims Act. The False Claims Act expressly...more
On January 25, in a 2-1 decision in U.S. ex rel. Sheldon v. Allergan Sales, LLC, 2022 WL 211172, the Fourth Circuit became the most recent federal appellate court to hold that the objective scienter standard in the Supreme...more
The Eleventh Circuit has become the first federal court of appeals to directly address whether the Eighth Amendment’s Excessive Fines Clause applies to the monetary award in a declined False Claims Act (FCA) case. And in an...more
Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention...more
12/16/2021
/ Anti-Kickback Statute ,
California ,
False Claims Act (FCA) ,
Fraud Prevention ,
Health Care Providers ,
Hospitals ,
Insurance Fraud ,
Jurisdiction ,
Managed Care Contracts ,
Manufacturers ,
Pharmaceutical Industry ,
Qui Tam ,
Settlement ,
State and Local Government
How should a court evaluate the FCA’s materiality requirement when the government’s ability to deny claims is constrained? According to a recent decision from the Eleventh Circuit, the court should “broadly” consider the...more
On May 6, the U.S. District Court for the District of South Carolina entered final judgment dismissing with prejudice a relator’s qui tam False Claims Act (FCA) suit against the defendant wholesale pharmacy. The relator, a...more
The U.S. Department of Justice (DOJ) routinely encourages the subjects of False Claims Act (FCA) enforcement actions to make voluntary disclosures and fully cooperate with the government on the premise that cooperation leads...more
5/23/2019
/ Compliance ,
Cooperation ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Agencies ,
Government Investigations ,
New Guidance ,
Remedial Actions ,
Risk Mitigation ,
Voluntary Disclosure
The U.S. District Court for the Eastern District of Pennsylvania recently refused to extend the period during which a False Claims Act (FCA) action remains under seal while the government investigates and decides whether to...more
On August 24, 2018, the Ninth Circuit addressed the Supreme Court’s decision in Universal Health Services, Inc. v. U.S. ex rel. Escobar, holding that Escobar sets forth the exclusive test for establishing FCA liability under...more
8/30/2018
/ College Admissions ,
Colleges ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Federal Funding ,
Financial Aid ,
Higher Education Act ,
Incentives ,
Interlocutory Appeals ,
Materiality ,
Student Enrollment ,
Title IV ,
Universal Health Services Inc v United States ex rel Escobar
U.S. ex rel. Badr v. Triple Canopy, Inc., an intervened case arising out of the Fourth Circuit, has been one of the more closely-watched recent FCA cases. Previously, the Fourth Circuit held that the government’s complaint...more
In June, the Supreme Court issued Universal Health Services, Inc. v. U.S. ex rel. Escobar, a landmark opinion in which the Supreme Court addressed the standard for pleading materiality in FCA implied certification cases. The...more
11/30/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
Remand ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
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