In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more
1/17/2025
/ Anti-Kickback Statute ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Hospitals ,
Medicaid ,
Medical Bills ,
Medicare ,
Physicians ,
Stark Law
In 2024, federal courts issued a number of important decisions in False Claims Act (FCA) cases that are particularly noteworthy for the health care and life sciences industries. We focus here on decisions that further develop...more
1/17/2025
/ Anti-Kickback Statute ,
Article II ,
Causation ,
Compliance ,
Constitutional Challenges ,
Eighth Amendment ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Healthcare Fraud ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Medicare Advantage ,
Qui Tam ,
Scienter ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
Whistleblowers
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 January 2023, the Criminal Division of the Department of Justice (DOJ) announced revisions to its Corporate Enforcement Policy (CEP), which we previously summarized here and discussed in further detail as part of...more
As discussed in EnforceMintz – Significant 2022 Regulatory and Policy Developments, the Department of Justice (DOJ) issued several memoranda in late 2022 and early 2023, reinforcing DOJ’s approach to individual accountability...more
2/14/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Crimes ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Individual Accountability ,
Policies and Procedures ,
Regulatory Agenda ,
Settlement
The Physician Self-Referral Law — known as the “Stark Law” — broadly prohibits physicians from profiting from self-referrals for “designated health services” (DHS) payable by Medicare or Medicaid. For example, the Stark Law...more
2/13/2024
/ Anti-Kickback Statute ,
Compensation ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Liability ,
Medicaid ,
Medicare ,
Physicians ,
Stark Law
In 2023, the Supreme Court and the United States Courts of Appeals published a number of significant decisions with implications for entities in the health care and life science industries facing False Claims Act (FCA)...more
2/12/2024
/ Anti-Kickback Statute ,
Appeals ,
Causation ,
False Claims Act (FCA) ,
Healthcare ,
Life Sciences ,
Scienter ,
SCOTUS ,
Teva Pharmaceuticals ,
United States ex rel Polansky v Executive Health Resources Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more
2/3/2022
/ Anti-Kickback Statute ,
Appeals ,
CARES Act ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Opioid ,
Paycheck Protection Program (PPP) ,
Purdue Pharma ,
Settlement ,
TRICARE ,
Whistleblowers
In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more
11/30/2020
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Remuneration ,
Speaker Programs
On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback...more
9/16/2020
/ Anti-Kickback Statute ,
Breach of Duty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Patient Referrals ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law
As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators,...more
1/16/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Petition for Writ of Certiorari ,
Solicitor General ,
Universal Health Services Inc v United States ex rel Escobar
Last year, as we previously discussed, there were two significant Department of Justice (DOJ) policy developments that are applicable to False Claims Act (FCA) litigation: (1) the “Granston Memo” (issued by DOJ Civil Fraud...more
1/14/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
Qui Tam ,
Relators
Along with most of us, last January DOJ set its own goals for 2018: new policies related to False Claims Act (“FCA”) enforcement. One such “resolution” for 2018 was the DOJ Civil Fraud section’s instruction to its attorneys...more
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
Regulatory Requirements ,
Remuneration ,
Safe Harbors ,
Secretary of HHS
In this month’s issue of our Qui Tam Update, we review an unusual cluster of five cases alleging that common defendants — a health care provider and its subsidiaries — provided medically unnecessary services to hospice,...more
A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated...more