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Keeping you afloat amidst the rising sea of regulations

Some Things Never Change: Lavish Meals Result in Significant FCA Liability for Device Manufacturer

A recent settlement announced by the US Department of Justice serves as a warning to pharmaceutical and device manufacturers that the government remains concerned about the provision of expensive meals to physicians and the impact such meals may have on a physician’s independent medical judgment.

Fighting the Opioid Epidemic: New DOJ Prescription Interdiction & Litigation Task Force To Target Drug Manufacturers & Distributors

On February 27, 2018, Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force (PIL Task Force), which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors. This is the latest development in the government’s increasing focus over the past year on the opioid epidemic.  

Is DOJ Changing Its Approach to Enforcement? What Regulated Entities Need to Know

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies—two published memos that restrict DOJ’s use of agency guidance, and one leaked memo that directs DOJ attorneys to consider moving to dismiss meritless qui tam (i.e., whistleblower) complaints brought under the federal False Claims Act.   

Another One Bites the Dust: Court Tosses Nearly $350 Million False Claims Act Verdict Under Escobar

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act (“FCA”) award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court in United States ex rel. Escobar v. Universal Health Services, 136 S. Ct. 1989 (2016). Together with the Fifth Circuit’s recent decision in United States ex rel. Harman v.

DOJ Reports $3.7 Billion in False Claims Act Recoveries in FY 2017

The Department of Justice recently published its annual False Claims Act (FCA) recoveries statistics for Fiscal Year 2017, reporting $3.7 billion in FCA settlements and judgments in FY 2017. That number brings DOJ’s total FCA recoveries since FY 1987 to more than $56 billion, and its total since 2009 to nearly $34.5 billion.

Not Just for Health Care Providers Anymore: Health IT Vendor Pays $155 Million to Settle False Claims Act Case

Last week, eClinicalWorks (ECW)—an electronic health records (EHR) vendor—settled an intervened False Claims Act case with the Department of Justice for $155 million.

Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices

Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with the Department of Justice (DOJ) for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

Supreme Court Declines to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal, but instead the district court has discretion to determine the appropriate sanction under the circumstances – whether it be dismissal or a less severe sanction.

OIG 2017 Work Plan Lists New Enforcement Priorities

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for fiscal year 2017 (2017 Work Plan), which furnishes key guidance to providers and suppliers (collectively referred to here as “providers”) and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.