In a decision issued on September 30, Judge Andrew Carter of the U.S. District Court for the Southern District of New York denied Anthem Inc.’s motion to dismiss a government lawsuit filed in March 2020 claiming Anthem submitted inaccurate diagnosis data in conjunction with its Medicare Part C plans that resulted in alleged overpayments in violation of the False Claims Act (FCA).

Continue Reading SDNY Ruling in Anthem Sends a Signal to Medicare Advantage Litigants

In a September 2022 filing in U.S. ex rel. Osinek v. Kaiser Permanente, the Kaiser Permanente consortium defendants (Kaiser) highlighted the distinction between clinically inaccurate diagnoses (factual falsity) and clinically accurate but incorrectly coded diagnoses (legal falsity) and its relevance in False Claims Act (FCA) actions.

Continue Reading Medicare Advantage Plan Highlights Distinction for FCA Purposes between Clinically Inaccurate Diagnoses and Clinically Accurate Diagnoses that Allegedly Violate Subregulatory Guidelines

As previously discussed as a part of our ongoing FCA Fundamentals series, the False Claims Act (FCA) is the federal government’s most important and most effective tool for fighting fraud. While Congress has substantially expanded the scope of the FCA since its inception during the Civil War, courts have recognized that the FCA was “not designed to reach every kind of fraud practiced on the Government” and is not intended to be a “vehicle for punishing garden-variety breaches of contract or regulatory violations.” Rather, the FCA applies only to false or fraudulent claims or omissions that are “material” to the government. So what is materiality?

Continue Reading False Claims Act Fundamentals:  What is Materiality?

The False Claims Act, 31 U.S.C. § 3729, et seq. is the federal government’s primary and most effective tool for fighting fraud. This post provides an overview of the elements that plaintiffs must satisfy to establish liability under the False Claims Act and common defenses related to the elements.

Continue Reading False Claims Act Fundamentals: Elements of the False Claims Act

The final months of 2021 saw a flurry of noteworthy False Claims Act (FCA) activity. Among other developments, appellate courts issued important decisions concerning materiality, the government’s qui tam dismissal authority, and the application of the Eighth Amendment’s Excessive Fines Clause. The fourth quarter also brought news of several significant settlements, including a group of eight- and nine-figure resolutions of alleged Anti-Kickback Statute violations by pharmaceutical manufacturers and the latest example of a private equity firm paying a substantial sum to resolve FCA allegations leveled against one of its portfolio companies.

This post summarizes key developments from the year’s final quarter and identifies important takeaways for healthcare providers and government contractors.

Continue Reading False Claims Act Decisions and Settlements to Know from Q4 2021

As we have previously covered in a blog post dated August 25, 2021, the Senate is currently considering Senate Bill 2428, the False Claims Amendments Act of 2021 (FCAA), which would cause several significant changes that would make it more difficult for defendants in False Claims Act (FCA) cases.  On October 28, 2021, Senate Judiciary Committee (Committee) considered the bill originally introduced by Senator Chuck Grassley (R-IA) in July of this year.

Continue Reading False Claims Act Amendments Take More Direct Attack at Escobar and Pass Senate Judiciary Committee

On December 2, the U.S. District Court for the Western District of Virginia granted a motion to dismiss a False Claims Act (FCA) lawsuit brought by the United States and the Commonwealth of Virginia, which alleged that a Walgreens clinical pharmacy manager falsified hepatitis C drug prior authorization submissions to Virginia Medicaid. See United States v. Walgreen Co., 2021 WL 5760307 (W.D. Va. Dec. 3, 2021).

Continue Reading FCA Lawsuit Against Walgreens Dismissed Because Government Fails to Plead Materiality

On July 26, Senator Chuck Grassley (R-IA) introduced a long-promised bill to amend the False Claims Act (FCA).  Not-so-creatively entitled the False Claims Act Amendments Act of 2021 (S.B. 2428), the proposed legislation is notably co-sponsored by a prominent—and bipartisan—group of senators.  The text of the bill, available here, would most importantly bring changes to the analysis of the FCA’s materiality element while also affecting the process through which defendants may obtain discovery from the government.

According to a press release issued by Senator Grassley, the legislation is mainly intended to “clarif[y] the current law following confusion and misinterpretation of the Supreme Court decision in United Health Services v. United States ex rel. Escobar.”  As we have previously covered at length (in blog posts dated June 23, 2016; March 20, 2020; April 8, 2020; and June 25, 2021) the U.S. Supreme Court’s 2016 decision in Escobar confirmed that the FCA’s materiality element is “rigorous” and “demanding,” and that it cannot be satisfied simply by showing that the government would have had the “option” to decline payment had it known the facts underlying an allegedly fraudulent claim.

Instead, Escobar focuses the materiality inquiry on the government’s actual or likely response to alleged fraud: if the government regularly pays similar claims with knowledge of the facts, that is “strong evidence” that the alleged misrepresentations are not material; on the other hand, if the government often denies payment under similar circumstances, that supports a finding of materiality.

In Senator Grassley’s view, however, Escobar has given way to “confusion” and “misinterpretation” that “has made it all too easy for fraudsters to argue that their obvious fraud was not material simply because the government continued payment.”   Consistent with that view, the proposed legislation appears calculated to make materiality-based dismissals—as well as other kinds of dismissals—more difficult for FCA defendants to obtain.  Whether it would succeed in that aim, however, is open to debate.

Continue Reading Changes Coming to the FCA?  Proposed Amendments Would Impact Materiality Analysis, Government Discovery, Among Other Issues