Anti-Kickback Statute Dept. of Justice

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
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OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Joint Enforcement of the Anti-Kickback Statute and the Foreign Corrupt Practices Act

On March 1, 2016, the Department of Justice (“DOJ”) announced that Olympus Corporation of the Americas (“Olympus”) entered into two deferred prosecution agreements with DOJ, under which Olympus will pay a total of $646...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...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

Compliance Lessons from the Olympus Corporate Integrity Agreement – Part I

The recent Olympus Corporation and related entities (collectively ‘Olympus’) enforcement action demonstrated a company seemingly dedicated to lying, cheating and stealing its way across the globe in search of almighty dollar....more

Anti-Kickback Enforcement – Steady and Aggressive

When commentators criticize the FCPA for its broad coverage of international business operations, these same commentators would have real trouble with the US Anti-Kickback statute. Talk about broad coverage and then...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

Olympus Settles FCPA Charges with DOJ

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

False Claims Act: 2015 Year in Review

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

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

DOJ and OIG Launch Wave of Aggressive Prosecutions Targeting Entities and Individuals for Illegal Health Care Marketing Practices

In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more

Justice Department Charges Pharma President with Kickback Conspiracy

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

PharMerica Corporation Settles Anti-Kickback Allegations by Paying Over $9 Million to Government

On October 7, 2015, the Department of Justice announced that PharMerica Corporation (“PharMerica”), the nation’s second-largest nursing home pharmacy, agreed to pay $9.25 million to resolve allegations that it received...more

KMART Settles False Claims Act Allegations for $1.4 Million

The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more

Florida Nursing Home Pays Record Settlement to Resolve Federal Anti-Kickback Case

In a recent case Hebrew Homes Health Network, Inc. and its former president and executive Director agreed to pay $17 million to settle allegations that Hebrew Homes violated the federal anti-kickback statute. According to the...more

Time to Revisit Your Physician Relationships

On June 9, 2015, the Department of Health and Human Services, Office of Inspector General issued a new Fraud Alert entitled "Physician Compensation Arrangements May Result in Significant Liability" (Alert) in the wake of 12...more

Record $17M Settlement Of False Claims Act Lawsuit Alleging Doctor Kickbacks

Hailed as “another achievement” for the government’s Health Care Fraud Prevention and Enforcement Action Team (referred to as “HEAT”), the U.S. Department of Justice has announced that a Florida skilled nursing company and...more

Recent DOJ and OIG Actions Show Growing Federal Scrutiny of Physician Financial Arrangements

Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial...more

OIG Warns Physicians of Potential Exposure for Unlawful Compensation Arrangements

While the Department of Justice and the Department of Health and Human Services Office of Inspector General (OIG) have long scrutinized physician compensation arrangements, including medical director agreements, penalties...more

The False Claims Act and the Health Care Industry: 2014 Year in Review

On Nov. 20, 2014, the U.S. Department of Justice (“DOJ”) announced settlements and judgments for False Claims Act (“FCA”) cases totaling $5.7 billion (compared to $3.8 billion in fiscal year 2013), $2.3 billion of which was...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

Whistleblower Receives More Than $17 Million in Omnicare Case

A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement. The settlement with the Department of Justice orders Omnicare,...more

Anti Kickback and Stark Law Enforcement and Compliance Issues [Video]

The Department of Justice and the Health and Human Services-Office of Inspector General have aggressively been enforcing anti-kickback (AKS) and Stark laws. DOJ and HHS-OIG have combined these prohibitions with The False...more

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