Federal prosecutors announced yesterday the Government’s settlement with electronic health records (“EHR”) vendor Greenway Health, LLC (“Greenway”) of False Claims Act (“FCA”) allegations for a payment of $57.25 million and
Continue Reading Government Puts Electronic Health Records Companies “on Notice” of Vigorous False Claims Act Enforcement

When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from customized compounded drugs. Medicare Part D, the prescription drug
Continue Reading OIG Report on Topical Compounded Drug Prescribing, Marketing and Billing Practices Signals Heightened Administrative and Enforcement Scrutiny

In Part II of our series, we discussed government knowledge. When the government knows of a claim’s falsity, but nevertheless pays the claim, the falsity of the claim is not material to the government’s decision to pay. In other words, the falsity of the claim must not matter to the government and, consequently, there can be no liability under the implied certification theory.

But what about the situation in which the government could have refused payment, but did not have actual knowledge relating to the claim’s alleged falsity? Could the fact that the government retains the option to refuse payment be sufficient to establish materiality? Escobar says no. In so holding, Escobar rejected the Government’s and First Circuit’s pre-Escobar view of materiality (that any statutory, regulatory, or contractual violation is material so long as the defendant knows that the Government would be entitled to refuse payment were it aware of the violation).
Continue Reading Materiality Part III: It Is Not Enough That The Government Could Refuse Payment—The Question Is Whether The Government Would Refuse Payment

In United States, et al., ex rel. Ruckh v. Salus Rehabilitation, LLC, et al., Case No. 8:11-cv-1303-T-23TBM (M.D. Fl. Jan. 11, 2018), a federal district court judge offered a thoughtful, cogent analysis of both the letter and spirit of the Supreme Court’s decision in Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016) to reverse a jury’s $350 million verdict in favor of the United States and Florida (as well as the relator). The decision provides valuable guidance concerning how the Escobar holding should be applied to analyzing the actual evidence established under a False Claims Act (“FCA”) case, as distinguished from mere allegations. The lesson is that while Escobar will undoubtedly affect the standard of pleading required in motions to dismiss, its greater potential impact is on motions for summary judgment, where mere allegations without substantiating evidence will be insufficient to survive dismissal.
Continue Reading FCA Materiality: It’s One thing to Proclaim but It’s Another Thing to Prove

Editor’s Note: This is the second in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016).

In the context of implied certification cases brought under the False Claims Act (FCA), materiality is simply whether an alleged statutory, regulatory, or contractual violation has some bearing on the government’s decision to pay claims. It follows that when the government knows of an alleged statutory, regulatory, or contractual violation and pays a claim anyway, then that violation could not possibly have been material to the government’s payment decision. For this reason, the government’s knowledge of alleged violations and its subsequent behavior in the face of that knowledge have tremendous implications for false certification defendants.
Continue Reading Materiality Part II: Government Knowledge

The story behind the Trinity Industries False Claims Act (FCA) litigation is one that is becoming too familiar for companies that do business with federal and state governments. Luckily, that story now has some silver lining, after the Fifth Circuit recently overturned a massive $663 million jury verdict against the company.
Continue Reading Head on Collision: 5th Circuit Crashes Into Massive $663M Guard Rail Jury Verdict on Materiality Grounds

Editor’s Note: This is the first in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal Health Services, Inc. v. U.S. ex rel. Escobar.

In Escobar, the Supreme Court described several factors that a district court should consider in assessing whether a particular contractual, regulatory, or statutory violation was material to a government’s decision to pay. One of those factors was whether a “reasonable man [acting on the Government’s behalf] would attach importance to [the representation] in determining his choice of action in the transaction.” at 2003.  It follows that a reasonable person would not attach importance to a violation that is “minor or insubstantial.” Universal Health Servs., Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989, 2003 (2016) (emphasis added). So how have the district courts handled this “reasonable man” objective standard? And what types of violations are minor or insubstantial? This article explores the answers to those questions.
Continue Reading Materiality Part I: Distinguishing Important Representations from the Minor or Insubstantial

Statistical sampling is always a hot topic in False Claims Act (FCA) litigation.  Courts have allowed statistical extrapolation from samples of claims to determine damages in cases where FCA liability was already established.[1]  But courts are reluctant to allow the use of sampling for determining liability in the first instance.[2]  Since the FCA’s monetary penalty per “violation” has been held to apply to each individual claim submitted for reimbursement, it seems only natural that relators and the government be required to prove the FCA’s various elements for each individual claim.[3] But, in a series of recent rulings, some district courts have acquiesced to – or at least been open to – the idea of using statistical sampling to establish liability.[4]  Other courts have rejected statistical sampling to prove liability, especially when all the claims alleged to contain falsehoods remain available for a full review.[5]

Continue Reading Fourth Circuit Punts at Rare Opportunity to Rule on Statistical Sampling