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Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

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

Government turns up the heat with the False Claims Act – 5 action steps for healthcare providers

Forbes magazine has dubbed 2014 “The Year of the Whistleblower.” For healthcare providers, this designation has translated into millions of dollars in fines and penalties and the initiation of criminal investigations. ...more

DOJ Criminal Division Renews Efforts to Investigate Whistleblower Allegations

The Department of Justice (DOJ) has signaled a heightened effort to bring criminal prosecutors into the loop regarding False Claims Act referrals and other whistleblower complaints. In recent remarks at a conference comprised...more

U.S. Accuses NYC of Massive Fraud in Program for Developmentally Challenged Toddlers

It’s the city that never sleeps. So when it does something, it can do it in a big way. That applies to Medicaid fraud, according to a suit filed yesterday by the U.S. Attorney for the Southern District of New York....more

OIG Releases New Proposals on Anti-kickback Statute Safe Harbors, Exceptions to the CMP Law and the Gainsharing Prohibition

On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a long-awaited proposed rule for implementing amendments to safe harbors under the Anti-kickback Statute and...more

Whistleblower Goes It Alone to Secure $5 Million Settlement under False Claims Act

The potential success of a whistleblower lawsuit filed under the False Claims Act (FCA) is significantly reduced when the government fails to intervene because such cases are often assumed to lack merit. However, a plaintiff...more

White Collar Watch - September 2014

In This Issue: - Conditions of participation vs. conditions of payment – a recent trend in False Claims Act cases - SEC gives first whistleblower award to audit and compliance employee - Whistleblower...more

Healthcare Industry Faces Heightened Criminal Exposure Under New Criminal Division Review Process for Qui Tam Suits

The Assistant Attorney General for the Criminal Division, Leslie Caldwell, announced on September 17, 2014, that criminal prosecutors at the Justice Department in Washington will automatically review all new qui tam (i.e.,...more

Department of Justice Criminal Division Will Increase its Review of False Claims Act Cases for Criminal Prosecution

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

DOJ Announces Recently Implemented Procedure for Reviewing False Claims Act Suits for Criminal Prosecution

During a speech at the annual Taxpayers Against Fraud Education Fund conference this week, Assistant Attorney General Leslie R. Caldwell announced that the U.S. Department of Justice’s (DOJ) Criminal Division “recently...more

False Claims Act Update

New Criminal Division Review Process for Qui Tam Complaints Expands Main Justice Involvement and Threatens Greater Criminal Exposure in Whistleblower Investigations. The Assistant Attorney General for the Criminal...more

Blog Exclusive: Government Sues Hospital for Birthing Mama’s Babies

The Clinica de la Mama case could well serve as an instruction manual of what not to do to stay out of the government’s crosshairs. In this case, several hospitals entered into contracts for Clinica de la Mama to provide...more

Government Sues Hospital for Birthing Mama’s Babies

The Clinica de la Mama case could well serve as an instruction manual of what not to do to stay out of the government’s crosshairs. In this case, several hospitals entered into contracts for Clinica de la Mama to provide...more

Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

White Collar Watch - February 2014

Contents - False Claims Act ruling opens door to large damage awards... pages 1 - 2 - Supreme Court asked if state universities are exempt from liability under the False Claims Act... pages 2 - 4 -...more

The Government’s Unrelenting Reliance On Anti-Kickback Prosecutions

Below the radar screen of aggressive FCPA enforcement, US Attorneys, HHS-OIG and State Attorney Generals are pushing an aggressive agenda using federal and state anti-kickback laws. It is hard to keep it all in perspective...more

Doctors Corralled for Kickbacks

The U.S. Department of Health and Human Services Office of Inspector General's (OIG) chief counsel indicated in 2007 that the government's fraud enforcement focus on large organizations was an "ineffective strategy" and that...more

False Claims Act Focus - November 2013

EDITOR’S NOTE - Recent months have provided interesting developments in the False Claims Act (“FCA”) case law, and the future promises even more. Defendants in many FCA cases that proceed to litigation file...more

Whistleblowing to the Tune of $6 Million

In early July 2013, Baxano Surgical Inc., formerly known as TranS1 Inc., agreed to pay $6 million to settle charges that it encouraged doctors to overcharge Medicare and other federal health programs and paid kickbacks to...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

Illegal Commission Arrangements: Appeals Court Reinstates Jury's Verdict Against Pharmacy Executive

In United States v. Vernon, the Eleventh Circuit Court of Appeals reversed an Alabama district court's judgment of acquittal following a jury's guilty verdict against a pharmacy executive charged with anti-kickback statute...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

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

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

Healthcare Providers And Self-Disclosure Of Violations

The healthcare industry has a long history of innovative compliance policies and strategies. ...more

Federal Court Cases May Have Some Healthcare Providers Asking for Peace, Not War

Last summer, a federal judge in Houston ruled that the Wartime Suspension of Limitations Act (WSLA), found in Title 18, § 3287 of the U.S. Criminal Code, applied to a civil False Claims Act (FCA) case and suspended the...more

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