Perspectives on Government Investigations

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court.

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.

AnMed Health, a hospital located in South Carolina, recently agreed to pay almost $1.3 million dollars and enter into a settlement agreement with the HHS Office of Inspector General to resolve allegations that it violated the Emergency Medical Treatment and Labor Act.

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.

The Department of Health and Human Services recently issued an important new compliance guide, called Measuring Compliance Program Effectiveness: A Resource Guide.

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

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,

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 com

The Department of Health and Human Services Office of Inspector General recently published its 2017 Work Plan, which furnishes key guidance to providers and suppliers and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

On November 1, 2016, the Supreme Court heard argument in a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement and publicly disclosed the complaint.

Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.), an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).

Kindred Healthcare, Inc., the country’s largest provider of post-acute care, recently paid over $3 million for violating its Corporate Integrity Agreement, the largest issued for a violation of a CIA to date.

In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment.

Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs).

On July 6th, CMS released a proposed rule (expected to appear in the Federal Register on July 15th) that, if it takes effect, could be devastating to hospital off-campus outpatient department reimbursement – an effect not intended by Congress, and certainly unwelcome to the healthcare industry.

In a surprising and promising development, the Senate Finance Committee released a Majority Staff Report on June 30, 2016 that gives the health care industry some hope that Congress may finally address some of the serious concerns with the implementation and enforcement of the Stark law.

In a highly anticipated decision, the United States Supreme Court issued a unanimous opinion in Universal Services, Inc. v. United States ex rel. Escobar that threw out existing law related to the implied certification theory of liability under the False Claims Act.

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

Partners Jacques Smith and David Greenberg spoke with AHLA Weekly after the US Supreme Court heard oral argument on April 19 in a major False Claims Act case that has far-reaching implications for the health care industry and other highly-regulated sectors reliant on government funding.

The US Supreme Court is set to hear oral arguments on April 19 in Universal Health Services, Inc. v. United States ex rel. Escobar, a key case addressing the implied certification theory of liability under the False Claims Act. 

Federal prosecutors appearing at the American Conference Institute’s 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices earlier this month outlined recent enforcement trends that should catch the attention of the health care industry.

In a recent decision, a US Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) agreed with the HHS Office of Civil Rights (OCR) that Lincare, Inc. d/b/a United Medical had violated HIPAA.