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Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Statistical Sampling Debate: A Growing Web Of FCA Cases

The government and qui tam plaintiffs are increasingly employing statistical sampling in False Claims Act cases, particularly in cases where addressing and analyzing large numbers of allegedly false claims poses substantial...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

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

First Circuit Applies Kellogg Brown & Root to Allow Relator to File Motion to Supplement Previously Dismissed Complaint

In United States ex rel. Gadbois v. PharMerica Corp., — F.3d —- (1st Cir. 2015), the First Circuit, in a matter of first impression, held that a relator’s complaint was not subject to dismissal under the first-to-file bar...more

Federal Government Continues to Bring Actions Against Pharmaceutical and Medical Device Companies and Individuals for Alleged...

The Office of Inspector General (OIG) for the Department of Health and Human Services recently released its Semiannual Report to Congress. Through the first three quarters of 2015, OIG announced recoveries of $3.35 billion...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

DOJ and OIG Launch Wave of Aggressive Prosecutions Targeting Entities and Individuals for Illegal Health Care Marketing Practices

In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

Millennium Health and DOJ Settle False Claims Act Allegations for $256 Million

On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more

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

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

A Recap of National Health IT Week

National Health IT Week wrapped up on Friday. This may have been the most eventful week in the ten year history of the event, which is organized by the Health Information Management Systems Society (HIMSS). Below are a few...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

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

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