Bass, Berry & Sims attorneys John Kelly and Rob Platt authored an article in Life Science Compliance Update outlining risk areas faced by pharmaceutical and medical device manufacturers related to False Claims Act (FCA) violations. According to Department of Justice data, these manufacturers accounted for nearly half of FCA recoveries within the healthcare industry in 2016. As John and Rob discuss, last year’s enforcement targeted several key risk areas, including speaker programs and off-label promotions, discount pricing programs, and violations of current good manufacturing practices (cGMP). Continue Reading John Kelly and Rob Platt Author Article on FCA Liability for Pharmaceutical and Device Manufacturers

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we continue to take a closer look at recent legal developments involving the FCA. This week, we examine developments regarding penalties and damages under the FCA, which make the FCA such a potent enforcement tool for the government.

For providers facing potential FCA liability, the potential scope of exposure will continue to expand, whether driven by a nearly doubled increase in the penalties recoverable under the FCA, large negotiated settlements backed-up by statistical extrapolation of false claims, or the significant increase in relator-driven litigation in government-declined cases. Questions regarding the manner in which FCA damages should be calculated also are likely to persist.

Continue Reading FCA Deeper Dive: Developments Regarding Penalties and Damages

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we continue to take a closer look at recent legal developments involving the FCA. This week, we examine the FCA’s first-to-file rule and its impact on a relator’s right to pursue FCA claims.

Continue Reading FCA Deeper Dive: FCA’s First-to-File Bar

A unanimous panel of the U.S. Court of Appeals for the Eleventh Circuit (Eleventh Circuit) recently affirmed two grants of summary judgment in favor of defendant Lincare, Inc. d/b/a Diabetic Experts of America (collectively, “Diabetic Experts”) by the U.S. District Court for the Southern District of Florida (District Court).  Diabetic Experts provided diabetic supplies to Medicare patients, some of whom had previously ordered medical supplies from Diabetic Experts for chronic obstructive pulmonary disease (COPD).  To promote sales, staff at Diabetic Experts would place calls to individuals who had previously ordered COPD-related equipment regarding a need for diabetic supplies.

Continue Reading Eleventh Circuit Affirms Two Grants of Summary Judgment in Favor of Diabetic Experts

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we continue to take a closer look at recent legal developments involving the FCA. This week, we examine the FCA’s public disclosure bar and recent cases considering whether disclosures are sufficient to bar FCA claims.

The FCA’s public disclosure bar prevents a relator from filing a qui tam complaint based on information previously disclosed to the public, thereby dissuading parasitic lawsuits based on publicly available information. In cases considering the scope of the public disclosure bar, courts have continued to examine the issue of how or to whom information must be disseminated in order to constitute a “public disclosure,” which often has resulted in a narrowing of the public disclosure bar’s scope in a given case. Such cases marked a shift away from decisions favorable to FCA defendants toward a more nuanced and specific application of the public disclosure bar.

Continue Reading FCA Deeper Dive: Original Sources under the FCA’s Public Disclosure Bar

The DOJ’s recent complaint-in-intervention in US ex rel. Poehling v. United Health Group—one of two qui tam cases against United Health currently pending in the Central District of California—emphasizes the government’s view that, in order to avoid FCA liability based on allegedly inflated risk adjustment scores for Medicare Advantage members, health plans must follow up on any information they know or have reason to know indicating that providers are submitting or have submitted invalid codes to the health plan.

Continue Reading Second DOJ Complaint: Knowledge of Invalid Codes Requires Follow-Through to Avoid Liability

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will continue to take a closer look at recent legal developments involving the FCA.  This week, we examine the requirement that a relator plead and prove that a defendant acted with the requisite level of knowledge to establish an FCA claim and evaluate how courts have evaluated this issue in recent cases.

To prevail in FCA cases, relators or the government must prove that the defendant acted with the requisite level of knowledge in connection with the FCA allegations at issue. In a number of cases, defendants made considerable headway in convincing courts to scrutinize allegations of knowledge closely, particularly in instances where defendants argued that the underlying conduct at issue was governed by ambiguous statutes or regulations.

Continue Reading Deeper Dive: Meeting the FCA’s Intent Requirement

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will continue to take a closer look at recent legal developments involving the FCA. This week, we examine recent court decisions that considered the question of objective falsity in connection with FCA cases based on an alleged lack of medical necessity of the healthcare services provided to beneficiaries of federal healthcare programs.

Continue Reading FCA Deeper Dive: Objective Falsity and Medical Necessity Cases

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we are taking a closer look at recent legal developments involving the FCA. This week, we examine recent court decisions following Escobar that considered the express certification theory of FCA liability.

Continue Reading FCA Deeper Dive: Express Certification

In the recent past, the government has racked up a number of FCA settlements based on alleged violations of the Anti-Kickback Statute (AKS).  This focus undoubtedly will remain a high enforcement priority.

In U.S. ex rel. Williams v. Health Management Associates Inc. and U.S. v. Atlanta Medical Center, Inc., Tenet Healthcare Corporation and two of its Atlanta-area hospitals, Atlanta Medical Center and North Fulton Hospital, agreed to pay more than $513 million to resolve civil and criminal allegations of AKS and FCA violations.  Between 2000 and 2013, Atlanta Medical and North Fulton allegedly paid prenatal clinics for referring patients, many of whom were undocumented and indigent, to its labor and delivery, postnatal and infant services.  Using sham contracts, the hospitals allegedly paid the clinics for unnecessary, duplicative or substandard translation services, which in certain cases were not actually provided.  Tenet allegedly concealed the underlying purpose of the contracts from its legal counsel and violated the terms of its previously-entered CIA with HHS-OIG, which related to a 2006 settlement for $900 million to resolve allegations of fraudulent billing and AKS violations.

Continue Reading FCA Issues to Watch: Intersection of the FCA and the Anti-Kickback Statute