It’s Time to Review Your Compliance, Data and Auditing Plans -
As we near the end of 2018, healthcare providers and companies are understandably focused on 2019 and the trends ahead. In planning for next year, however,...more
12/17/2018
/ Audits ,
Criminal Prosecution ,
Data Management ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Medicare Fraud Strike Force ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Risk Mitigation
Since early 2018, federal health care regulators and enforcers have seemingly sung a new tune. The Centers for Medicare & Medicaid Services’ (CMS’) walls bear posters inscribed with the phrase “Patients Over Paperwork.” The...more
8/7/2018
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicaid ,
Medicare ,
OIG ,
Qui Tam ,
Safe Harbors ,
Value-Based Care
The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more
7/19/2018
/ Civil Liability ,
Criminal Prosecution ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug & Alcohol Abuse ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Agency Taskforce ,
Health Care Providers ,
Investigations ,
Law Enforcement ,
OIG ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Supply Chain
In a speech before the American Bar Association’s Antitrust in Healthcare conference, held last week in Virginia, Deputy Assistant Attorney General Barry Nigro offered the Department of Justice’s (DOJ) most recent statement...more
5/25/2018
/ Anti-Competitive ,
Antitrust Division ,
Antitrust Violations ,
Competition ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Professional Conferences
In a pair of recent speeches, Deputy Attorney General Rod Rosenstein announced a new Department of Justice (DOJ) policy aimed at encouraging coordination among DOJ and other enforcement agencies and avoiding “unfair...more
Last week, the Department of Justice (DOJ) issued two separate memoranda with potentially far-reaching consequences. While the practical effect of these documents remains to be seen, they may provide another avenue of...more
The federal government continues to use the False Claims Act (FCA) as one of its prime enforcement tools against government contractors. To keep you informed on the status of the law, Bradley’s Government Enforcement and...more
1/30/2018
/ Causation ,
Damages ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
First-to-File ,
FRCP 9(b) ,
Materiality ,
Objective Falsity ,
Overpayment ,
Pro Se Litigants ,
Reverse False Claims ,
Settlement ,
Universal Health Services Inc v United States ex rel Escobar ,
Yates Memorandum
Bradley’s Government Enforcement and Investigations practice group is pleased to present the 2017 False Claims Act Year in Review, our annual review of significant False Claims Act (FCA) cases, developments, and trends. The...more
1/24/2018
/ Causation ,
Damages ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
First-to-File ,
Health Care Providers ,
Healthcare Fraud ,
Materiality ,
Pro Se Litigants ,
Retaliation ,
Rule 9(b) ,
Universal Health Services Inc v United States ex rel Escobar
We are pleased to present Bradley’s annual review of significant False Claims Act (FCA) cases, developments, and trends. From a relatively short article several years ago, the Review has grown to a significant publication...more
1/10/2017
/ Anti-Kickback Statute ,
Appeals ,
Calculation of Damages ,
Civil Monetary Penalty ,
Defense Contracts ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Federal Contractors ,
FRCP 9(b) ,
Healthcare Fraud ,
Materiality ,
Objective Falsity ,
Off-Label Promotion ,
Overpayment ,
Public Disclosure ,
Qui Tam ,
Retaliation ,
SCOTUS ,
Standard of Review ,
Successor Liability ,
Transfer of Venue ,
United States ex rel Nelson v Sanford-Brown ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers ,
Yates Memorandum
According to articles in Missouri newspapers and other news outlets, federal agents recently executed search warrants in several counties in Missouri to probe possible criminal violations of the Federal Insecticide,...more
Last week, in McDonnell v. United States, the U.S. Supreme Court vacated the bribery convictions of Bob McDonnell, the former governor of Virginia. In doing so, the unanimous Court rejected prosecutors’ expansive...more
The False Claims Act (FCA) is the federal government’s chief weapon to combat false or fraudulent claims made to the government and has resulted in billions of dollars of recoveries. In recent years, broad interpretation of...more
The Supreme Court’s decision in Universal Health Services v. United States ex rel. Escobar reframes when falsity may be implied under the False Claims Act (FCA) and raises the bar for materiality under the statute. Though the...more
In a humorous yet stern rebuke of the government’s damages theory, the Sixth Circuit in United States ex rel. Wall v. Circle C Construction, LLC, No. 14-6150, 2016 WL 423750 (6th Cir. Feb. 4, 2016), reversed a lower court’s...more
This year continued the trend of aggressive False Claims Act (FCA) enforcement by the Department of Justice (DOJ) and high volumes of qui tam lawsuits brought by whistleblowers. In fiscal year 2015, the DOJ marked the fourth...more
12/22/2015
/ Anti-Kickback Statute ,
Certiorari ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Federal Contractors ,
First-to-File ,
Implied Certification ,
Public Disclosure ,
Qui Tam ,
SCOTUS ,
Split of Authority ,
Stark Law ,
Whistleblowers
As its name implies, the False Claims Act (FCA) prohibits false or fraudulent claims to the federal government. Broadly construed, the FCA can apply to anyone receiving federal funds, but it is especially critical to...more
In what is becoming an annual refrain, 2014 marked another year of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and mushrooming qui tam lawsuits by whistleblowers. Indeed, fiscal year 2014...more
1/19/2015
/ Bank of America ,
Banking Sector ,
Banks ,
BNP Paribas ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Janssen Pharmaceuticals ,
JPMorgan Chase ,
KBR (formerly Kellogg Brown & Root) ,
Qui Tam ,
Settlement Agreements ,
SunTrust ,
US Bank ,
Wartime Suspension of Limitations Act ,
Whistleblower Awards ,
Whistleblowers
Every company, large or small, will eventually face a problem that requires an internal investigation. Boiled to its essence, an internal investigation is really nothing more than a way to obtain information to avoid or solve...more
On Aug. 20, 2014, the Seventh Circuit struck another blow against relators’ and the federal government’s increasingly aggressive False Claims Act theories of liability. Rejecting the relators’ use of the “worthless services”...more
On August 20, 2014, the Seventh Circuit struck another blow against relators’ and the federal government’s increasingly aggressive False Claims Act theories of liability. Rejecting the relators’ use of the “worthless...more
Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more
1/15/2014
/ Calculation of Damages ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
FERA ,
Fines ,
First-to-File ,
Fraud ,
Halliburton ,
Healthcare ,
Medicare ,
Off-Label Use ,
Overpayment ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Public Disclosure ,
Qui Tam ,
Wells Fargo ,
Whistleblowers ,
WSLA
The First Circuit has become the fourth federal court of appeals to address whether a first-filed yet insufficient complaint still qualifies as a pending action under the first-to-file rule of the False Claims Act....more
This spring saw two significant victories for health care providers in the federal courts of appeals. In both cases, the courts rejected an aggressive government theory under the False Claims Act (FCA), the first related to...more
From the perspective of False Claims Act (FCA) results, 2012 was a decidedly mixed year for healthcare providers. The bad news was quite bad—increased FCA scrutiny by the Department of Justice (DOJ) led to $3 billion of...more