In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead.
Hear from a dynamic group of...more
In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead....more
In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and...more
In 2024, the Department of Justice (DOJ) pursued significant enforcement activity under its Civil Cyber-Fraud Initiative (CCFI). As our readers know, the Deputy Attorney General announced the creation of the CCFI in October...more
1/17/2025
/ Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare ,
PHI ,
Settlement
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
On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the United States District Court for the District of Columbia. The lawsuit...more
The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically...more
8/14/2024
/ Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Fair Market Value ,
False Claims Act (FCA) ,
Healthcare ,
Hospitals ,
Physicians ,
Public Health ,
Stark Law
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 government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
2/9/2024
/ Anti-Fraud Provisions ,
Biden Administration ,
CARES Act ,
Civil Monetary Penalty ,
Coronavirus/COVID-19 ,
Criminal Penalties ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Financial Fraud ,
Fraud ,
Health Care Providers ,
HRSA ,
Investigations ,
OIG ,
Popular ,
Qui Tam
In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
1/18/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
OIG ,
Overpayment ,
Proposed Rules ,
Reimbursements
A district court in the Southern District of New York recently unsealed a qui tam case brought by relator GNGH2, Inc., a for-profit company, against 15 entities that allegedly operated nursing homes in the Bronx, New York and...more
The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
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
Last week, a bipartisan group of Senators led by Senator Chuck Grassley (R-Iowa) introduced two pieces of proposed legislation, one of which would amend the False Claims Act (FCA) and the other of which would amend the...more
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
The Seventh Circuit Court of Appeals recently decided a case that created a new standard to assess requests by the Department of Justice (DOJ) to dismiss declined qui tam (whistleblower) suits under the False Claims Act...more
8/26/2020
/ Collateral Order Doctrine ,
Department of Justice (DOJ) ,
Dismissals ,
Equal Protection ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
FRCP 41 ,
Jurisdiction ,
Motion for Summary Judgment ,
Qui Tam ,
Relators ,
The Granston Memo
As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services...more