News & Analysis as of

Corporate Integrity Agreement

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Six Specific Areas to Embed and Promote Business Ethics (Part III of IV)

by Michael Volkov on

The challenge for corporations is to build practical approaches to business ethics and its specific corporate values. Business ethics as a field is all well and good but we need to start sharing specific and practical...more

Vitas Hospice and Chemed Corporation Settle Largest-Ever FCA Claim Against a Hospice

by Baker Ober Health Law on

Vitas Hospice, the largest for-profit hospice chain in the United States, and its owner, Chemed Corporation, agreed to pay $75 million to settle allegations that Vitas Hospice submitted false claims for hospice services...more

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

by Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

Yates Memo's Influence Felt in DOJ Health Care Enforcement

by Jones Day on

In September 2015, Deputy Attorney General Sally Yates issued a memorandum titled "Individual Accountability for Corporate Wrongdoing." In it, she stressed that one of the most effective ways to combat corporate misconduct is...more

Anti-Corruption Enforcement in Mexico: Your Integrity Policy Matters

by Bracewell LLP on

On July 19, 2017, Mexico’s General Law of Administrative Accountability will go into effect. It is the final part of a historic package of far-reaching anti-corruption laws, dubbed the National Anti-Corruption System, that...more

Avoiding Risks with Referring Physician Compensation Arrangements

by Hinshaw & Culbertson LLP on

The settlement described below highlights the importance of carefully structuring compensation arrangements with referring physicians, and the risk involved in trying to work backwards to achieve a desired level of...more

Electronic Health Records Vendor Agrees to $155 Million Settlement to Resolve FCA Allegations, Required to Make Free Upgrades to...

by King & Spalding on

On May 31, 2017, the DOJ announced a $155 million settlement with eClinicalWorks (ECW), one of the nation’s largest electronic health records (EHR) vendors, to resolve a False Claims Act lawsuit brought by a whistleblower. ...more

Genesis Healthcare Enters $53.6 Million Settlement

by King & Spalding on

On June 16, 2017, the Department of Justice announced that Genesis Healthcare paid $53.6 million to resolve six False Claims Act whistleblower lawsuits filed by seven of Genesis’ former employees. The lawsuits alleged that...more

Patient Safety Issues Highlighted in DOJ Settlement and Health Care Industry Cybersecurity Task Force Report

by Pierce Atwood LLP on

As we know, the move away from fee for service reimbursement models is not only intended to reduce costs by no longer paying providers based on the volume of services performed, but is also intended to improve the overall...more

A Striking EHR Settlement: The DOJ pursues an EHR Vendor for "Causing the Submission" of False EHR Incentive Payment Claims

by Bass, Berry & Sims PLC on

On May 31, 2017, the U.S. Department of Justice (DOJ) announced a $155 million settlement with eClinical Works (ECW), a nationally-known electronic health records (EHR) software vendor. The settlement arises out of a lawsuit,...more

Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated...

Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an...more

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

Featured Unsealed Cases United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) - Complaint Filed: May 6, 2013 - Complaint Unsealed: October 24, 2016...more

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

First Circuit Tells False Claims Act Relators To “Put Up or Shut Up”

The U.S. Court of Appeals for the First Circuit recently called summary judgment “the put up or shut up moment in litigation.” On January 30, 2017, the relators in U.S. ex rel. Booker v. Pfizer – a long-running False Claims...more

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

by Sherman & Howard L.L.C. on

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Tenet Healthcare Settles Fraud Case for $514 Million

by Michael Volkov on

If you work in compliance in the healthcare industry, you have a tough job. The number and variety of risks that healthcare providers face is daunting. The False Claims Act is a mighty weapon in the hands of federal...more

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

by McDermott Will & Emery on

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

by Reed Smith on

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

by Arnall Golden Gregory LLP on

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

by McDermott Will & Emery on

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

by Mintz Levin on

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

by Poyner Spruill LLP on

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

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