News & Analysis as of

False Claims Act (FCA)

CMS Publishes RADV Medical Reviewer Guidance

by Dentons on

In the Medicare Advantage (MA) context, "risk adjustment" is the process by which the Centers for Medicare & Medicaid Services (CMS) reimburses Medicare Advantage Organizations (MAOs) based on demographic factors and the...more

Early Victory: Judge Dismisses Qui Tam Suit Against UnitedHealthcare

by Arnall Golden Gregory LLP on

On October 5, 2017, in United States of America ex rel. Swoben v. Scan Health Plan, et al. (“Swoben”), Judge John F. Walter of the United States District Court for the Central District of California granted United Health...more

Corporate Actors Held Individually Accountable in Recent False Claims Act Settlement

The Department of Justice (“DOJ”) has sent a clear message that individuals cannot hide behind the corporate shield in its recent settlement with Med-Fast Pharmacy, Inc. and the charges brought against its associated...more

Physicians in the Bulls-eye

by BakerHostetler on

Several recently reported cases highlight the growing risk physicians face if they succumb to competitive pressures, especially offers of remuneration from labs, pharmacies, home health agencies and other providers to whom...more

Federal Court Strikes DOJ's Risk Adjustment False Claims Act Case - For Now

by Pepper Hamilton LLP on

On October 5, a federal district court in California dealt a significant setback to the government’s efforts to extend False Claims Act (FCA) liability to Medicare risk adjustment submissions....more

Dismissal of Medicare Advantage FCA Suit Marks Significant Defeat for Government

by Bass, Berry & Sims PLC on

The U.S. District Court for the Central District of California recently dismissed a complaint-in-intervention filed by the U.S. Department of Justice (DOJ) in U.S. ex rel. Swoben v. Secure Horizons. As previously reported,...more

FY 2018 Forecasts: Winds Shifting on Data Security, Industry Consolidation, and DOJ Enforcement Efforts

In the second of our series about what to watch for in government contracts in fiscal year 2018, we focus on Cybersecurity, Cloud-Based Services, Employment Regulations, M&A, FCA enforcement, and Block Chain....more

“No Fraud at All:” Fifth Circuit Reverses $663 Million False Claims Act Jury Verdict Based on Government’s Actual Knowledge

by Arnall Golden Gregory LLP on

On September 29, 2017, in United States ex rel. Harman v. Trinity Indus. Inc. (“Trinity”), the Fifth Circuit Court of Appeals reversed a $663 million jury verdict in a False Claims Act (FCA) case brought against Trinity...more

Under What Circumstances Can a Private Qui Tam Plaintiff Overrule Government Agency Experts' Use of Administrative Discretion to...

• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: September 2017

by Mintz Levin on

In this month’s issue of our Qui Tam Update, we review an unusual cluster of five cases alleging that common defendants — a health care provider and its subsidiaries — provided medically unnecessary services to hospice,...more

Red Notice Newsletter - Chinese

ANTICORRUPTION DEVELOPMENTS - Alere Inc. Agrees to Pay More Than $13 Million to Resolve SEC FCPA Enforcement Action - On September 28, 2017, Alere Inc. (“Alere”), a Massachusetts based manufacturer of medical diagnostic...more

Red Notice Newsletter - Russian

ANTICORRUPTION DEVELOPMENTS - Alere Inc. Agrees to Pay More Than $13 Million to Resolve SEC FCPA Enforcement Action - On September 28, 2017, Alere Inc. (“Alere”), a Massachusetts based manufacturer of medical diagnostic...more

False Claims Act Watch: California Federal Judge Dismisses DOJ Complaint Alleging Medicare Advantage Fraud

by Kelley Drye & Warren LLP on

On October 5, the U.S. Department of Justice suffered a setback when a California federal judge dismissed its complaint under the civil False Claims Act (“FCA”). Billed as a test case for the Government, it marked the first...more

Alert: In a Surprise Decision Issued on October 5, 2017, Honorable John Walter, United States District Judge, Dismissed a Medicare...

On October 5, 2017, the Honorable Judge John Walter of the United States District Court, Central District of California, granted the Defendants’ Motion to Dismiss the Medicare Advantage (“MA”) Federal False Claims Act (“FCA”)...more

Simpson v. Bayer Healthcare and the “Original Source” Exception: Eighth Circuit’s Interpretation Ups the Ante for Defendants in...

The Eighth Circuit in Simpson v. Bayer Healthcare became the latest circuit court to weigh in on the meaning of the “original source” exception to the False Claims Act’s public disclosure jurisdictional bar. The public...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Significant FCA Decision Affirms the Importance of Materiality

by Reed Smith on

The U.S. Court of Appeals for the Fifth Circuit recently issued a well-reasoned decision that takes the rare step of overruling a jury finding of False Claims Act (FCA) liability, and erasing the damages award of more than...more

Government Contracts M&A Moving at Breakneck Speed: Contractors Advised to Slow Down and Ensure Compliance

by Reed Smith on

The pace at which government contractors are engaging in mergers & acquisitions has increased notably in recent years, as a stream of recent stories in the Washington Post and New York Times have reported. The acquisition of...more

Red Notice Newsletter - September 2017

ANTICORRUPTION DEVELOPMENTS - Alere Inc. Agrees to Pay More Than $13 Million to Resolve SEC FCPA Enforcement Action - On September 28, 2017, Alere Inc. (“Alere”), a Massachusetts based manufacturer of medical...more

FY 2018 Forecasts: Cloudy Skies for False Claims and Storms on the Protest Horizon?

This is the first in a short series of forecasts from our Government Contracts partners on things to watch for in government contracts in Fiscal Year 2018. For more in-depth discussions of current events and trends, please...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

Fraud on the FDA? If Not Preempted, It Is Trumpery

by Reed Smith on

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

Chris Lazarini Examines Dismissal of Claims Applying Res Judicata Standard

by Bass, Berry & Sims PLC on

Bass, Berry & Sims attorney Chris Lazarini examined a case filed by Morgan Stanley against Defendant in a FINRA arbitration over an un-paid promissory note. The Defendant answered without asserting counterclaims, but later...more

Implied Certification Theory Loses Some of Its Fangs, but Is Another False Claims Act Theory Lurking Just Around the Corner?

Federal courts across the country are wrestling with the uncertainty caused by the Supreme Court’s holding in Universal Health Services, Inc. v. United States ex rel. Escobar regarding the requirements to state an implied...more

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