Health Criminal Law

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"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

You Can Pay Your Lawyer: Supreme Court Recognizes Limits on Pretrial Asset Restraints

Before the U.S. Supreme Court’s ruling last week in Luis v. United States, the government could freeze a criminal defendant’s assets before trial even if they bore no connection to the alleged crimes. With the ruling, if the...more

Supreme Court Update: Luis V. United States (14-419)

Here's a line-up you don't see in every (read: any) syllabus: "BREYER, J., announced the judgment of the Court and delivered an opinion, in which ROBERTS, C.J., and GINSBURG and SOTOMAYOR, JJ., joined. THOMAS, J., filed an...more

Department of Justice Launches 10 Regional Elder Justice Task Forces

On March 30, the Department of Justice (DOJ) announced the launch of 10 regional Elder Task Forces, including one in Washington state, for the purpose of coordinating and enhancing efforts to pursue nursing homes “that...more

Howard Young on Coming Changes To The Healthcare Space [Video]

Howard Young, co-head of the healthcare practice at Morgan Lewis, talks about some of the major forces driving change and consolidation within the healthcare industry. According to Young, innovations in technology and changes...more

Committee OK's Bill to Address Suicide Among Correction Officers and Prisoners

Here’s a thumbs-up to the legislature’s Joint Committee on Public Safety and Homeland Security. Last week, the committee rightly gave a favorable report to a bill, SB 1284, mandating a study of how to keep prisoners and...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

Health Care Fraud and Abuse Control (HCFAC) Program Logs $2.4 Billion in Recoveries for FY 2015

The federal government won or negotiated more than $1.9 billion in judgments and settlements, and attained additional administrative impositions in health care fraud cases and proceedings in FY 2015, according to the latest...more

The Downside of Being Number One

Americans are competitive. We generally think there’s nothing better than being number one—and not just at NCAA bracket time. But being number one isn’t always great. Just ask Dr. Michael Reinstein. He was the...more

Masked Man Robs Government; Faces 10 Years

The mask itself didn’t raise any suspicions. After all, the man wearing it—Richard Toussaint–was an anesthesiologist. But like so many other masked men, he turned out to be a thief. That’s why on March 4 he was convicted in...more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

K&S Effort Leads to Acquittal in Conspiracy and Misbranding Case Against Medical Device Company

On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more

Health Care Fraud and Abuse Enforcement Priorities in Minnesota

United States Attorney for the District of Minnesota, Andrew Luger, spoke at a public event on March 3, 2016, at Mitchell-Hamline School of Law on the topic of health care fraud & abuse enforcement priorities in Minnesota....more

The Olympus Debacle: Why Internal Whistleblowing is a Good Thing for Compliance

The U.S. Department of Justice announced last week that Olympus Corporation of the Americas (OCA) agreed to pay $646 million to resolve three cases relating to its longstanding practice to bribe doctors and hospitals in the...more

Mitigating FCA Whistleblower Risk When Employees Leave

Over the past decade, efforts to enforce health care fraud regulations have been bolstered significantly with increased government funding and a dramatic increase in whistleblower claims filed under the False Claims Act’s qui...more

Maker of dirty medical device hit with $623 million in penalties for kickbacks

Can the sleaze get any worse with the maker of a dirty medical device that investigators say sickened dozens and played a role in killing 21? Sadly, it can. Federal prosecutors say that the maker of a flexible scope used in...more

Acquittals in Vascular Solutions Case Deal Setback to DOJ

On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow...more

Drug and Alcohol Rehab Facilities Under Increasing Fire in California – Are You in Compliance?

A recent Los Angeles Times report confirms what most legal experts have been forecasting for quite some time; the drug and alcohol rehabilitation industry in California is likely to face increased regulatory scrutiny and, in...more

Are Compliance Officers the New Enforcement Targets?

For years health care compliance officers have worried about personal liability for the misdeeds of the companies they serve. And why not? Health care is the most heavily regulated of all major industries, and the compliance...more

Health Alert (Australia) - February 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: South Australia 28 January 2016 - Inquest into the death of Ebony Simone Napier The South Australian Coroner has...more

Catching up on developments posted on the blog

Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more

Criminal Conviction Leaves Defendant Defenseless in FCA Civil Action

Pity Dr. Christina Clardy. In 2011 she was convicted of health care fraud, sentenced to 135 months in prison, and ordered to pay $16 million in restitution. Then in 2014 the government added Christina as a defendant in its...more

Employment Law This Week: FTC on Big Data, DOJ/DOL on Safety Violations, External Whistleblowers, NRF Fights Scheduling [Video]

We invite you to view Employment Law This Week - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

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