Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of...more
Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more
7/27/2016
/ Acquittals ,
CEOs ,
Corporate Executives ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Felonies ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Medical Devices ,
Misdemeanors ,
Off-Label Promotion ,
Personal Liability ,
Yates Memorandum
On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim...more
The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device...more
Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
12/31/2015
/ Aetna ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CIGNA ,
CLIA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
OIG ,
PAMA ,
Stark Law
Last week, a jury in Alabama federal court sided with the Department of Justice (DOJ) and qui tam relators in the first part of a False Claims Act (FCA) case against AseraCare Inc., a provider of hospice and palliative care...more
10/21/2015
/ Bifurcation ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Hospice ,
Jury Trial ,
Medicare ,
Qui Tam ,
Relators ,
Statistical Sampling ,
Treble Damages
Trends & Analysis -
Since our last Qui Tam Update, we have identified 39 health-related False Claims Act (“FCA”) qui tam cases that have been unsealed. Of those cases...more
9/22/2015
/ ACOs ,
Anti-Kickback Statute ,
Controlled Substances ,
False Billing ,
False Claims Act (FCA) ,
Falsified Documents ,
Former Employee ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Internal Controls ,
Medicaid ,
Medicare ,
Medicare Shared Savings Program ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Relators ,
Retaliation ,
Settlement ,
State False Claims Acts ,
Stipulations ,
Third-Party Service Provider ,
TRICARE ,
Whistleblowers ,
Wrongful Termination
The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations...more
In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more
Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more
Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over...more
Trends & Analysis -
Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more
Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 claims submitted by Life Care Centers of America, Inc. (a nursing...more
On Wednesday, during a speech before the Taxpayers Against Fraud Education Fund conference in Washington, D.C., Leslie R. Caldwell, Assistant Attorney General for the Department of Justice’s (DOJ) Criminal Division, announced...more
This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more
Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a decision in Walsh et al. v. Amerisource Bergen Corp. et al denying the Relator’s motion to dismiss a counterclaim that alleged the Relator...more
Trends and Analysis:
..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more
This past Friday, hospital company HCA Holdings, Inc. asked a federal court judge to dismiss a False Claims Act (FCA) suit filed by whistleblower and former employee, Stephen McMullen. Mr. McMullen worked for an...more
Trends and Analysis:
..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013.
..Among the cases unsealed in July, the government has declined to...more
8/20/2013
/ Amgen ,
Anti-Kickback Statute ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Kickbacks ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Relators ,
Retaliation ,
Sealed Records ,
Stark Law ,
TRICARE ,
Whistleblowers
Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more
2/26/2013
/ Anti-Kickback Statute ,
Compliance ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Fraud ,
Healthcare ,
Home Health Care ,
Medicare ,
Off-Label Promotion ,
OIG ,
Pharmaceutical Industry ,
Whistleblowers