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Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

The Government’s Generic Price-Fixing Investigation Targets Allergan’s Actavis Unit

This is our fourth post on the DOJ’s expanding investigation into possible price fixing by generic drug manufacturers. (Click here, here, and here to read our prior posts.) Since our last update, the DOJ has subpoenaed...more

CMS Announces Timeline for the DMEPOS Competitive Bidding Round 1 2017 Competition

On August 11, 2015, CMS announced the detailed timeline for “Round 1 2017” of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program. As previously reported, this...more

Blog: Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon,...more

Connecticut to Tighten Data Privacy Requirements

On June 1, 2015, the Connecticut Legislature passed S.B. 949, a comprehensive data privacy and security bill that tightens the state’s data breach response requirements and imposes new obligations on state contractors and the...more

Blog: OIG Reports Targeting Medicare Part D Fraud Issued on the Heels of National Medicare Fraud Sweep

The Health and Human Services (HHS) Office of Inspector General (OIG) released two reports yesterday related to Medicare Part D fraud. The OIG report, Ensuring the Integrity of Medicare Part D, “synthesizes numerous OIG...more

District Court Holds False Claims Act Applies to Employee Allegedly Terminated for Engaging in Protected Activity Against...

In a matter of first impression, the U.S. District Court for the Western District of Pennsylvania in Cestra v. Mylan Inc. No. 15-0873 (E.D. Pa., May 22, 2015) held that the antiretaliation provision of the False Claims Act...more

Blog: Key Takeaways from Government Enforcement Panel at ACI Sunshine Conference

Recently, representatives from the United States Attorney’s Office for the Northern District of Georgia, United States Attorney’s Office for the District of New Jersey, and Medicaid Fraud Control Unit (MFCU) for the Office of...more

Watch Out! Recent Government Settlements Implicate Referring Physicians and Laboratories

$48.5 million settlement with Health Diagnostics Laboratory, Inc. and Singulex, Inc. - On April 9, 2015, the U.S. Department of Justice ("DOJ") announced a $48.5 million settlement with two cardiovascular diagnostic...more

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

Blog: Trend Watch: Government Use Of Data Analytics To Identify Health Care Fraud

Data analytics is not a new concept within the health care industry. However, as data analytics tools become more accessible, government interest in using data analytics to detect health care fraud continues to increase. ...more

Two Laboratories Settle Claims Regarding Specimen Processing Fees

Continuing the scrutiny of laboratory arrangements with referring physician practices, the United States Department of Justice (DOJ) recently announced the settlement of False Claims Act allegations against two cardiovascular...more

What to Do if You Receive a Subpoena for Documents From the US Department of Justice

Receiving an unexpected Department of Justice (“DOJ”) subpoena for documents and testimony is a jarring experience for anyone in Government contracting. But more and more contractors may receive such subpoenas as the...more

MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,...more

CMS Announces Recompete of Round 1 of the Medicare DMEPOS Competitive Bidding Program for 2017

On April 21, 2015, CMS announced its plans to recompete the supplier contracts awarded under the Round 1 Recompete of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Whistleblower Pays Price for Frivolous Suit

On Wednesday of this week, the federal court for the Southern District of New York rejected Fox’s plea to spare it from the $169,000 bill submitted by the white shoe law firm that successfully defended Managed Health Care...more

Health Diagnostics Laboratory Agrees to Pay $47 Million to Settle Claims

Health Diagnostics Laboratory (HDL) of Richmond, Va., has agreed to pay $47 million to resolve allegations it violated the False Claims Act by compensating physicians for ordering tests, according to a U.S. Department of...more

Blog: The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? ...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

Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers

On March 19, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services issued their joint annual report on health care fraud and abuse control. The annual report states that during fiscal year...more

OIG: Exclusive laboratory arrangement may violate Antikickback Statute and result in exclusion for excessive charges

On March 25, 2015, the Office of Inspector General (“OIG”) issued Advisory Opinion 15-04, which found that an exclusive arrangement between a laboratory and its referring physician practices could violate the Federal...more

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

News from the Health Law Gurus™:

Reporting Deadline for HIPAA Breaches – March 1, 2015 – Did you have a HIPAA breach this year involving less than 500 individuals? If so, the deadline to report such a breach to the U.S. Department of Health and Human...more

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