Insights on False Claims Act Investigations & Litigation

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.

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).

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.

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 an important development, the Centers for Medicare and Medicaid Services (CMS) has issued additional final regulations implementing the Stark Law as part of the Physician Fee Schedule for calendar year 2016 (see 80 Fed. Reg. 70,886 (Nov. 16, 2015)).

The Department of Justice recently announced that Tuomey Healthcare System has agreed to pay $72.4 million and enter into a five-year Corporate Integrity Agreement to finally resolve the long-running U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc. False Claims Act/Stark Law litigation.

US Department of Health and Human Services Office of Inspector General released an OIG Alert reminding the public that electronic health records furnished to referral sources may not meet the federal anti-kickback statute’s EHR safe harbor if EHR system has limited or restricted interoperability.

On September 21, 2015, the US DOJ and whistleblowers’ counsel announced that Florida-headquartered Adventist Health System (Adventist) had agreed to pay $118.7 million to resolve allegations that it violated the FCA by submitting claims in violation of the Stark law and by miscoding claims.

Joyce Branda, the Deputy Assistant Attorney General for the Commercial Litigation Branch of the DOJ, gave the keynote address on September 28, 2015, at the American Health Lawyers Association Fraud and Compliance Forum in Baltimore, providing conference attendees with an update from DOJ.

The US Department of Justice (DOJ) recently announced that Columbus Regional Healthcare System (Columbus Regional) has agreed to pay up to $35 million and enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General.

On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 15-11.

On Monday, a federal district court judge in New York issued a ruling that, if adopted broadly, will have a significant – and potentially nightmarish – impact on any provider who receives an overpayment from Medicare or Medicaid.  Kane v. Healthfirst, Inc. and U.S. v. Continuum Health Partners Inc. 

In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

On July 7, 2015, the US Court of Appeals for the Ninth Circuit overruled a 23-year-old False Claims Act precedent, relaxing its test for deciding when a whistleblower can overcome a motion to dismiss because the allegations in the complaint were publicly disclosed. 

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced the creation of a new litigation team focused solely on using the OIG’s authority to impose civil monetary penalties and exclude individuals and businesses from Medicare and Medicaid.

The United States Court of Appeals for the District of Columbia Circuit released a decision requiring the Department of Health and Human Services to reconsider a 2008 rule prohibiting certain per-click leasing arrangements under the Stark Law.

The US Attorney General announced a “takedown” of 243 defendants over the last three days, representing the largest health care fraud enforcement effort in the Medicare Fraud Strike Force’s eight-year history and the largest criminal health care fraud action in the history of the Justice Department.

The United States Department of Justice (DOJ) announced that pharmacy benefits manager Medco Health Solutions Inc. (Medco) agreed to pay the government $7.9 million to resolve allegations that Medco’s arrangements with pharmaceutical manufacturer AstraZeneca violated the False Claim Act.