The Qui Tam Blog

$176,000 was just paid to qui tam whistleblower who filed a lawsuit against Cochlear Americas on behalf of the federal government. Whistleblower Brenda March filed the lawsuit as the company allegedly paid illegal remuneration to health care providers as an incentive to sell Cochlear devices.

The total settlement with Cochlear Americas was worth $880,000. The defendant company is a subsidiary of the Australian company Cochlear Limited.

March originally filed using provision in the Anti-Kickback Act and False Claims Act, saying that the company was clearly paying kickbacks to physicians who sold Cochlear devices to Medicare and Medicaid patients.

Signed into law on March 23, 2010, the Patient Protection and Affordable Care Act (the “Affordable Care Act”) narrowed the bar against bringing suits based on public disclosure by restricting the public disclosure bar to only information publically disclosed at the Federal level – not at the State or Local level.

The Affordable Care Act, however, broadened the definition of an “original source” to include, not only a relator with direct and independent knowledge of the information on which the allegations were based and that voluntarily provided that information to the government before filing suit, but also a relator who provides knowledge to the government before filing suit that is “independent of and materially adds to the publically disclosed allegations or transactions.”

The Affordable Care Act amends the Anti-Kickback Statute to provide that items or services resulting from an Anti-Kickback Statue violation are false for purposes of the FCA, disposing of the need to rely on a false certification theory of FCA liability.

Additionally, the Affordable Care Act settles the circuit split regarding the definition of “willfulness” in the Anti-Kickback Statute. Some courts required the government to prove that a defendant knew that the Anti-Kickback Statute prohibited the conduct at issue, while other courts disagreed. The new law, however, makes it clear that the Anti-Kickback Statute does not require the government to prove actual knowledge of a “known legal duty” that was being violated.

Earlier this week AtriCure, Inc. executed a settlement with the Department of Justice in a case brought to court by a relator in 2007. AtriCure, primarily a manufacturer of cardiac surgical ablation systems, settled with the Department of Health and Human services for $3.8 million plus interest covering a five year period.

The case was filed in the United States District Court for the Southern District of Texas and charges AtriCure in violation of the Federal False Claims Act. By using illegal kickbacks and sponsoring non-branded marketing, AtriCure coaxed medical practices into favoring the corporation’s costly in-patient cardiac surgical ablation procedure over a clinically more effective out-patient catheter process.

Compensation for the costs incurred to Medicare because of the more costly treatment being falsely preferred are being sought by the relator and the Department of Justice on behalf of the Department of Health and Human Services.

In a press release earlier this week, the Department of Justice stated that this case is part of a larger movement to fight healthcare fraud. In the last year alone, the legal jurisdiction granted by the False Claims Act has been used by the US Government to recover approximately $2.2 billion in cases of fraud towards United States health care programs.

By: Joel Androphy, Rachel Grier, and Scott Braden

Medicaid can only reimburse drugs that are used for a medically accepted indication, meaning an indication that is either approved by the FDA or supported by one of three drug compendia. In Rost, the whistleblower, a former Pfizer marketing executive, brought a qui tam suit alleging that Pfizer unlawfully promoted the off-label use of Genotropin (human growth hormone) for treatment of short stature in children. Pfizer argued that one of the compendia, DRUGDEX, cited Genotropin as “possibly effective” for short stature in children.  Citing to a recent statement by the Center for Medicaid and State Operations, the court pointed out that to be reimbursable, an off-label use must be supported by the compendia as opposed to merely listed.  It was unclear from the record whether being cited by DRUGDEX as “possibly effective” could be read to “support” an off-label use. 

The court stated that Pfizer’s stronger argument was that the off-label claims were not false because they were approved by Indiana Drug Utilization Review (“DUR”) Board.  For example, if a state knowingly reimburses for the off-label use of a drug “after a prior authorization review,” the government knowledge could “negate the intent requirement under the FCA.”  This argument, however, was trumped by the allegations (and potential proof) that the false qui tam claims were caused by unlawful kickbacks.