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OIG Issues Revised Policy Statement Regarding Permissive Exclusion

On April 18, 2016, the Office of Inspector General of the United States Department of Health and Human Services (“OIG”) issued a revised policy statement containing the new criteria that OIG intends to use in implementing its...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

Illinois Governor Initiates Fight Against Health Care Fraud Amid Growing Deficit

As Illinois' finances continue to deteriorate and the budget crisis remains unsolved, the Rauner administration recently announced an initiative to focus on identifying and recouping health care fraud in Illinois. On April 5,...more

Implied Fraud Under the False Claims Act Hangs in the Balance

On April 19, 2016, the United States Supreme Court heard oral arguments in a hotly anticipated False Claims Act (FCA) case: Universal Health Services, Inc. v. United States ex rel. Escobar. The Court will decide whether the...more

Supreme Court Hears Oral Arguments in Significant False Claims Act Case

Our colleagues Jackie Baratian and Jason Popp summarize...the oral argument for Universal Health Services v. United Sates ex rel. Escobar heard by the U.S. Supreme Court on Tuesday, April 19th, laying out the various...more

"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

Did the FCA’s “Implied Certification” Theory Dodge a Bullet?

Yesterday’s argument before the Supreme Court in Universal Health Services, Inc. v. U.S. ex rel. Escobar had the potential to put false claims based on an “implied certification” in the crosshairs. Instead, based on the...more

Jury Sides with Defendant in Whistleblower's Suit Alleging Defendant "Caused" False Claims

Abbott Laboratories recently won a jury verdict in a high profile qui tam lawsuit alleging that Abbott “caused” health providers to submit false Medicare payment claims for off-label use of biliary stents. U.S. ex rel....more

Health Care/Health Care Litigation Advisory: Update on the AseraCare False Claims Act Litigation – A Win for AseraCare and Health...

In November 2015, we published a client advisory on the closely watched AseraCare litigation and its potential impact on the falsity element under the False Claims Act (FCA). AseraCare involves allegations that a hospice...more

False Claims Act Trial Sets Precedent for Future Cases

The DOJ’s theory of falsity based on clinical disagreement alone fails as a matter of law. In a closely watched False Claims Act (FCA) proceeding by the healthcare industry and FCA practitioners, the US District Court...more

Supreme Court to Hear False Claims Act "Implied Certification" Appeal

The U.S. Supreme Court will hear oral argument on April 19, 2016, in United Health Services v. United States ex rel. Escobar, No. 15-7, a case likely to resolve the current split among federal appellate courts on the...more

U.S. Supreme Court’s Upcoming Ruling on False Claims Act Case May Have Major Impact on Government Contractors

The U.S. Supreme Court is set to hear oral arguments next month in a False Claims Act (“FCA”) case that could significantly broaden the scope of the statute and resolve a split among the U.S. Circuit Courts. If the Supreme...more

Will the Supreme Court Put the Brakes on False Claims Act Litigation?

Later this term, in Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7 (S.Ct.), the Supreme Court will consider the validity, and possibly the contours, of the “implied certification” theory of False...more

The Medicare Overpayment Rule: Implications for Compliance and Health Care Enforcement

As has been widely discussed, the Centers for Medicare & Medicaid Services (‘‘CMS’’) Feb. 12 published the long-awaited final rule governing the return of Medicare Part A and Part B overpayments within 60 days (the...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

Whistleblower Filed Too Early & Too Late for Share of $322M SCAN Scam Recovery

During his days as a data encounter manager at SCAN, Jim suspected the company had been double-billing Medicare and Medicaid for years. He expressed his concerns within SCAN. When he refused a job reassignment, he was fired....more

Fourth Circuit Affirms $237 Million Jury Verdict for Stark and FCA Violations; Rejects Advice-of-Counsel Defense

On July 2, the U.S. Court of Appeals for the Fourth Circuit affirmed a jury verdict of more than $237 million against Tuomey Healthcare System, a nonprofit hospital in South Carolina, based on Stark Law and False Claims Act...more

Dialysis Provider Settles Whistleblower Lawsuit for $450 Million

The Department of Justice and dialysis provider DaVita Healthcare Partners recently finalized a $450 million agreement settling claims that the company intentionally inflated Medicare billings. The parties had filed a joint...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

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

New Jersey Federal Court Allows “Self-Help” Counterclaims Against Potential FCA Whistleblowers To Proceed

Last week, a New Jersey federal court allowed medical device maker Boston Scientific Neuromodulation Corp. (“Boston Scientific”) to proceed with counterclaims against two of its former employees for violating their contracts...more

In Government's Shoes: The Continuing Force Behind the False Claims Act & Qui Tam Complaints

To combat fraud by contractors selling faulty war supplies to the Union Army, in 1863 President Abraham Lincoln signed into law the False Claims Act (the “FCA”). Designed to root out fraud on the federal government, this act...more

Eighth Circuit Addresses Scope of False Claims Act Liability

Last month, the Eighth Circuit Court of Appeals addressed the scope of “fraud-in-the-inducement” liability under the False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, and, in doing so, reversed the dismissal of a claim related...more

Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

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