Insights on Government Investigations

As the dust settles on a campaign cycle that was unprecedented in many ways, we have composed this biennial post-election analysis to assist our clients in assessing the potential impact of the elections on their organizations and their industries.

The ABA Young Lawyers Division Health Law Committee and ABA Health Law Section is hosting a networking reception followed by a roundtable discussion with senior government attorneys from CMS, DOJ, and OIG.

On June 20, 2018, the Centers for Medicare & Medicaid Services issued a Request for Information seeking input from the public on how to address the undue regulatory impact and burden imposed on health care providers under the Stark Law.

Geoffrey Starks testified on Wednesday, June 20, 2018 before the Senate Committee on Commerce, Science, and Transportation.

A development out of the Ninth Circuit makes relators more likely to qualify as an original source under the False Claims Act and thus survive the public disclosure bar.

The latest False Claims Act settlements indicate that the Anti-Kickback Statute continues to be an enforcement priority and a key tool for identifying and prosecuting healthcare fraud.

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.

Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force, which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors.

Please join Arent Fox in San Francisco for our annual Medical Staff Leaders and the Law Conference.

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.

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.