The Development: On August 1, 2024, the Department of Justice's ("DOJ") Criminal Division announced its Corporate Whistleblower Awards Pilot Program ("Pilot Program"), designed to reward whistleblowers who report information...more
8/20/2024
/ CFTC ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Financial Crimes ,
Financial Institutions ,
FinCEN ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare Fraud ,
Money Laundering ,
Pilot Programs ,
Securities and Exchange Commission (SEC) ,
Whistleblower Awards ,
Whistleblowers ,
White Collar Crimes
The Situation: The False Claims Act ("FCA") imposes treble damages on defendants, as well as mandatory penalties per false claim. Because alleged false claims often involve much smaller amounts—for example, in cases with a...more
8/19/2024
/ Corporate Counsel ,
Due Process ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Treble Damages
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral for an item or service reimbursable by a...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
4/8/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more
4/1/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more
3/4/2024
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Qui Tam ,
Settlement ,
Whistleblowers ,
White Collar Crimes
The False Claims Act's ("FCA") use of qui tam relators (private individuals bringing suit on behalf of the government) has long raised both procedural and substantive challenges....more
The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more
The decision should prove helpful for those in the health care and life sciences industries whose daily operations require compliance with the federal Anti-Kickback Statute ("AKS")....more
In Short -
The Situation: The Anti-Kickback Statute ("AKS") prohibits a defendant from willfully paying or receiving "remuneration" in exchange for referrals—and, in addition, also specifies that any claims "resulting...more
In Short: -
The Situation: The United States Department of Justice ("DOJ") recently issued statistics and a related press release regarding its fiscal year ("FY") 2022 enforcement activity under the False Claims Act...more
In a momentous event for False Claims Act cases throughout the country, the Supreme Court has granted certiorari to decide the applicable scienter standard....more
In Short -
The Situation: The federal False Claims Act ("FCA") allows the United States to dismiss the action if the qui tam relator "has been notified by the Government of the filing of the motion and the court has...more
In Short -
The Situation: Under 42 U.S.C. § 1320a-7b(g), a claim that "includes items or services resulting from a violation" of the Anti-Kickback Statute ("AKS") is a false claim for purposes of the False Claims Act...more
DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. -
The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more
2/23/2022
/ Anti-Kickback Statute ,
Cyber Crimes ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicare Advantage ,
Paycheck Protection Program (PPP) ,
Qui Tam
Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more
2/14/2022
/ False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Liability ,
Qui Tam ,
Regulatory Standards ,
Regulatory Violations ,
Relators ,
Scienter ,
Statutory Interpretation
A defendant who violates the FCA can be liable for treble damages plus a civil penalty of $5,500 to $11,000 (adjusted for inflation) for each false claim. Meanwhile, FCA lawsuits often involve tens of thousands of alleged...more
2/3/2022
/ Civil Monetary Penalty ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Fines ,
Health Care Providers ,
Medicare ,
Qui Tam ,
Reimbursements ,
Relators ,
Statutory Violations ,
Treble Damages
In July 2021, a bipartisan group of senators introduced a bill, S. 2428, entitled the False Claims Amendments Act of 2021 ("S. 2428"), which proposed substantive and procedural amendments to the False Claims Act ("FCA")....more
11/2/2021
/ Burden of Proof ,
Burden-Shifting ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Authority ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Materiality ,
Proposed Legislation ,
Qui Tam ,
Regulatory Reform ,
Relators ,
Whistleblower Protection Policies
Federal government enforcement in the telemedicine space continues to escalate, with three separate announcements in just the last three weeks regarding criminal and civil telemedicine-related actions. These enforcement...more
9/23/2021
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Qui Tam ,
Relief Measures ,
Telehealth ,
Telemedicine
A recent action by the Department of Justice ("DOJ") rescinds two prior policies (commonly referred to as the Brand Memo and the Sessions Memo) that had established limits on the federal government's use of agency guidance...more
A recent split decision from the United States Court of Appeals for the Seventh Circuit strengthens an argument many defendants of False Claims Act ("FCA") cases have been advancing for years: the violation of an ambiguous...more
8/23/2021
/ Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
Medicaid ,
Medicare ,
Pharmacies ,
Qui Tam ,
Relators ,
Safeco ,
Statutory Requirements
The Situation: In March 2020, the Third and Ninth Circuits held, in two cases in which the government had declined to intervene, that a mere difference of medical opinion may be enough to satisfy the falsity element of the...more
The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021.
The...more
3/12/2021
/ Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare Part C ,
Opioid ,
Prescription Drugs
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more