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
As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care...more
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims...more
9/12/2019
/ Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Medical Necessity ,
Motion for Summary Judgment ,
Physicians ,
Qui Tam ,
Relators ,
Remand ,
Sua Sponte
Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more
6/26/2019
/ Chapter 11 ,
Commercial Bankruptcy ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Compensation ,
False Claims Act (FCA) ,
Guilty Pleas ,
Healthcare ,
Kickbacks ,
OIG ,
Qui Tam ,
Racketeering
On June 3, 2019, the U.S. Supreme Court issued a decision in Azar v. Allina Health Services. The case involved a challenge by hospitals over whether the Department of Health and Human Services (“HHS”) was required to proceed...more
6/5/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
The U.S. Department of Justice (DOJ) issued policy guidance on May 6, 2019, about providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation." DOJ has never previously...more
5/13/2019
/ 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
On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive...more
2/5/2019
/ Administrative Procedure Act ,
Appeals ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Health Care Providers ,
Hospitals ,
Interpretive Rule ,
Medicare ,
Medicare Part C ,
Notice and Comment ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Provider Payments ,
Rulemaking Process ,
SCOTUS
On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus...more
1/16/2019
/ Administrative Procedure Act ,
Appeals ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Health Care Providers ,
Hospitals ,
Interpretive Rule ,
Medicare ,
Medicare Part C ,
Notice and Comment ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Provider Payments ,
Rulemaking Process ,
SCOTUS