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Health Civil Remedies Government Contracting

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...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

False Claims Act Dangers on Display in Ruckh

by Bass, Berry & Sims PLC on

A recent jury verdict in an FCA lawsuit pending in the United States District Court for the Middle District of Florida resulted in a not-so-subtle reminder of just how high the stakes can be in such litigation....more

CMS Revokes Billing Privileges for Competitive Bid Supplier

by Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of...more

False Claims Act: 2016 Year in Review

We are pleased to present Bradley’s annual review of significant False Claims Act (FCA) cases, developments, and trends. From a relatively short article several years ago, the Review has grown to a significant publication...more

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

by Dorsey & Whitney LLP on

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims...more

Ninth Circuit Rejects FCA Suit Alleging Medical Device Inaccuracies

by Ropes & Gray LLP on

In United States ex rel. Ruhe v. Masimo Corp., 640 Fed. App’x 666 (9th Cir. 2016), the Court of Appeals for the Ninth Circuit affirmed a grant of summary judgment for defendant Masimo Corporation, a medical device...more

Eighth Circuit Affirms that Retaliation Under False Claims Act Requires Showing that Retaliation Was Motivated Solely by...

by Ropes & Gray LLP on

On May 20, 2016, the Eighth Circuit affirmed the District Court’s grant of summary judgment to defendant on Plaintiff’s False Claims Act (“FCA”) retaliation claim against his former employer. In Elkharwily v. Mayo Holding...more

First Circuit Adopts “Arm of the State” Test to Affirm Dismissal of FCA Complaint

by Ropes & Gray LLP on

In January 2016 in a matter of first impression, the First Circuit held that the University of Massachusetts Medical School is a state agency, and therefore not a “person” subject to liability in a False Claims Act (“FCA”)...more

DOJ Files FCA Complaint Against Recipient of Grant Funding

by Dorsey & Whitney LLP on

The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

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

by Mintz Levin on

Since our last issue, we have identified 31 recently unsealed health care-related whistleblower cases. In this Qui Tam Update, we analyze the trends and take an in-depth look at a few noteworthy cases....more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

DOJ Rule Increases FCA Penalties to Over $20,000 Per Claim

Effective August 1, 2016, the False Claims Act’s (FCA) civil penalty will double.  As it currently stands, the FCA’s civil penalty ranges from $5,500 to $11,000 per violation.  But as of August 1, the FCA’s civil penalty...more

Second Circuit Affirms Dismissal of False Claims Act Suit Based on “Off-Label” Marketing

by Arnall Golden Gregory LLP on

The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more

AGG Food and Drug Newsletter - May 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

First Agency Publishes Significant Increase in FCA Penalties; Others Expected to Follow

by King & Spalding on

On May 2, 2016, the Railroad Retirement Board (Board) published an interim final rule in the Federal Register amending its regulations to increase the minimum and maximum civil monetary penalty amounts under the Board’s...more

Already Enormous False Claims Act Penalties Set to Increase

The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device...more

Attorneys Pay Heavy Price for Block-Billing

by Faegre Baker Daniels on

Lawyers are aware of the increasing sensitivity—and hostility—of clients to block-billing: lumping more than one activity into a single time entry. A new Fifth Circuit decision shows that courts can be equally sensitive—and...more

DOJ Briefing Attempts to Avert Fourth Circuit Ruling on Use of Statistical Sampling in FCA Cases

by King & Spalding on

On March 17, 2016, the U.S. Department of Justice (“DOJ”) filed a brief in an eagerly anticipated case that addresses the use of statistical sampling in FCA cases for the first time at the appellate level. The case is United...more

Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

by Polsinelli on

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a...more

Federal Government Recovers $3.5 Billion from False Claims Cases in 2015

by McGuireWoods LLP on

The United States Department of Justice has announced that it has recovered over $3.5 Billion from cases brought under the False Claims Act (FCA) in fiscal year 2015. This significant aggregate recovery is a slight decline...more

Services that are Worth Less Aren’t Necessarily Worthless

by Faegre Baker Daniels on

The Sixth Circuit brought a refreshing sense of reality to the government’s sometimes unreal calculation of damages in False Claims Act (FCA) cases. In this case the government had sought, and won at the trial level, an award...more

Public disclosure bar prohibits "bounty-hunting" relators from filing duplicative FCA claims

by DLA Piper on

The United States Court of Appeals for the Seventh Circuit has issued an opinion that underscores the importance of the "public disclosure bar" in False Claims Act (FCA) litigation. The court affirmed a lower court’s...more

Court Rules that Medicare and Medicaid Payments to Nursing Home Must Continue Pending Jurisdictional Dispute

by Arnall Golden Gregory LLP on

On October 27, 2015, United States District Judge James S. Moody, Jr. extended a stay of proceedings thereby permitting Bayou Shores SNF, LLC (“Bayou Shores”) to remain viable and continue receiving Medicare and Medicaid...more

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

by Arnall Golden Gregory LLP on

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

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