Corporate Integrity Agreement

News & Analysis as of

When Outside Compliance Monitors May Be a Blessing: Companies Subjected to Corporate Integrity Agreements May Be Undone by Rogue...

Companies face ever-increasing pressures to implement mechanisms designed to prevent or effectively address employee malfeasance. In today’s environment, even companies who appear to be cooperating with investigative and...more

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more

OIG Updates Corporate Integrity Agreement Independent Review Organization Guidance

The OIG has updated its guidance for providers under Corporate Integrity Agreements regarding the circumstances that might affect the independence and objectivity of independent review organizations (IROs). ...more

OIG Releases Revised Guidance on Independent Review Organization Independence and Objectivity

On August 22, 2016, the Office of Inspector General of the Department of Health and Human Services (OIG) released updated guidance on Independent Review Organization (IRO) independence and objectivity (the “Guidance”). The...more

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

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: April 2016

Trends & Analysis - ..We have identified 42 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. Included in that count is one proceeding (the...more

End Notes April 2016 - News for North Carolina’s Hospice and Palliative Care Community

Hospice Providers – Step Up to the “MIC” - After a period of relative calm on the audit front, many signs point to an increase in audit activity. According to the Program Integrity Section of the Division of Medical...more

Examining The Amarin/FDA Off-Label Promotion Settlement

A lot of firms have already expended a lot of ink discussing the proposed memorandum of settlement filed on March 8, 2016 in Amarin Pharma’s First Amendment litigation against the FDA We’ll try not to be repetitive of what...more

Practical Management of Your Company’s Culture

I attended the SCCE’s recent Utilities and Energy Compliance conference in Houston. It is always a great meeting with terrific speakers and content. I was fortunate to attend a session, Taking the Pulse of Corporate...more

Compliance Lessons from the Olympus Corporate Integrity Agreement – Part II

Sir George Martin died yesterday. For anyone born after the break up of the Beatles, this name is probably not too familiar. However, even more than Brian Epstein, the band’s first professional manager, Martin truly was 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

Recent Corporate Integrity Agreements Highlight HHS OIG’s Compliance Program Priorities

Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the health care industry....more

Novartis Pharmaceuticals Settles $390MM FCA Allegations

Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...more

Parallel Lives: How Brazil and the United States Consider Leniency Agreements and Compliance Programs

In today’s global environment, conduct in one country can potentially violate anti-corruption laws of more than one country. When faced with this possibly debilitating scenario, companies need to understand both the...more

Final Curtain Call for Tuomey: Long-Running FCA/Stark Case Settled

After 10 years of litigation, including two trials and appeals to the 4th Circuit Court of Appeals, the U.S. Department of Justice (DOJ) and Tuomey Healthcare System (Tuomey) have entered into a settlement of DOJ's action...more

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

Millennium Health and DOJ Settle False Claims Act Allegations for $256 Million

On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more

Tuomey Resolves Stark Law and False Claims Act Judgment for $72.4 Million

The Department of Justice announced on October 16, 2015 a settlement agreement with Tuomey Healthcare System that resolves a $237 million judgment against the system involving claims submitted to the Medicare program in...more

Toumey Healthcare Settles False Claims Act Suit for $72 Million

In a long-running False Claims Act case with significant implications for hospitals, Toumey Healthcare System last week agreed to settle its case by paying $72.4 million to the government. While this sum is significant, it is...more

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases: October 2015

Trends & Analysis: ..We have identified 15 health care–related qui tam cases that were unsealed since our last Qui Tam Update. Of those, 12 were filed from 2012 to the present. All but two cases had been pending more...more

Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post-Tuomey?

After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...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

Court Concludes that Violation of a Corporate Integrity Agreement May Form the Basis for Reverse False Claim Liability

In late July, a federal district court in Pennsylvania denied a motion to dismiss brought by pharmaceutical company Cephalon, Inc., concluding that violations of a corporate integrity agreement (“CIA”) entered into by...more

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