A civil investigative demand (CID) is a tool, like a subpoena, that the government uses to obtain documents and information to investigate potential violations of the False Claims Act.Continue Reading False Claims Act Fundamentals: How to Respond to a Civil Investigative Demand
We wanted to update readers on improvements to our blog that you will see over the next few months.
Along with giving the web page a new look, we will be publishing a series of posts to enhance our readers’ understanding of key False Claims Act issues. Each series will serve a different purpose, and the series will focus on the following:Continue Reading A New Year of Changes at Inside the FCA
On January 25, in a 2-1 decision in U.S. ex rel. Sheldon v. Allergan Sales, LLC, 2022 WL 211172, the Fourth Circuit became the most recent federal appellate court to hold that the objective scienter standard in the Supreme Court’s Safeco decision applies to the False Claims Act (FCA). Under the Fourth Circuit’s decision, the FCA’s scienter element cannot be met if the defendant’s interpretation of applicable statutory or regulatory requirements was objectively reasonable and no authoritative guidance from a circuit court or government agency warned the defendant away from its interpretation.
Continue Reading Fourth Circuit Adopts Safeco’s Objective Reasonableness Standard for False Claims Act
The Eleventh Circuit has become the first federal court of appeals to directly address whether the Eighth Amendment’s Excessive Fines Clause applies to the monetary award in a declined False Claims Act (FCA) case. And in an opinion issued December 29, 2021, the court held that it does. See U.S. ex rel. Yates v. Pinellas Hematology & Oncology, P.A., __ F. 4th __, 2021 WL 6133175 (11th Cir. 2021).
Continue Reading Eleventh Circuit Becomes First Appeals Court to Hold that Excessive Fines Clause Applies in Declined FCA Cases
Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention Act (IFPA).
Continue Reading The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute
How should a court evaluate the FCA’s materiality requirement when the government’s ability to deny claims is constrained? According to a recent decision from the Eleventh Circuit, the court should “broadly” consider the government’s “pattern of behavior as a whole,” and may find evidence of materiality in administrative actions that might not support materiality in other cases.
The case, U.S. ex rel. Donnell v. Mortgage Investors Corporation, was brought by two mortgage brokers who specialized in originating mortgage loans guaranteed by the United States Department of Veterans Affairs (VA). Under the program at issue, VA regulations limited the fees and costs lenders could collect from veterans and required lenders seeking VA guarantees to certify compliance with the fee-and-cost restrictions. The relators alleged that the defendant, Mortgage Investors Corporation (MIC), defrauded the VA by charging veterans prohibited fees and falsely certifying they had not done so.
After originating loans and obtaining VA guarantees, MIC typically sold its loans on the secondary market to holders in due course. This introduced an “important wrinkle,” the appeals court noted, because the VA is statutorily required to honor its guarantee when borrowers default on loans possessed by holders in due course.Continue Reading Eleventh Circuit Broadens Materiality Analysis for Some Cases
In our previous article, we outlined steps companies can take now to protect themselves during later government investigations and enforcement actions related to COVID-19 relief funding. These steps include: leverage compliance resources, document the application/funding process, document how money is used, schedule an interim internal review, and respond to employee complaints. In this article we focus specifically on the health care industry and how companies can protect against inevitable government scrutiny after receiving COVID-19 relief funding.
The health care industry must be particularly vigilant about protecting against future enforcement risks because it is a highly regulated industry facing an enforcement perfect storm—fast cash, poor guidance and retrospective review. Congress allocated $175 billion to the U.S. Department of Health and Human Services (HHS) through the Coronavirus Aid, Relief and Economic Security Act Provider Relief Fund (Relief Fund). To support an industry hurt by COVID-19-related patient surges, stay-at-home driven closures and elective procedure treatment delays, HHS adopted a strategy to release relief funds quickly and perform reconciliation on the back end. As a result, HHS released what it touted as “no strings attached” relief funds through a series of general and targeted allocations each with a list of somewhat vague terms and conditions. The only other guidance available were application instructions, where applicable, and a continuously evolving set of frequently asked questions.
Of course, no government funding comes with “no strings attached.” The government inevitably will review whether recipients of HHS relief funds met the eligibility requirements and complied with the terms and conditions for using relief funds. Given that any deliberate omission, misrepresentation or falsification of information related to the HHS relief funds comes with potentially severe consequences—including but not limited to revocation of Medicare billing privileges; exclusion from federal health care programs; and/or the imposition of fines, civil damages and/or imprisonment—health care companies should consider the following steps to support their acceptance and use of the funds:Continue Reading How Health Care Companies Can Protect Against Government Scrutiny of COVID-19 Relief Funding
This article is the first in a series addressing what companies can do now to protect themselves during later government investigations and enforcement actions related to COVID-19 relief funding. In this article, we provide general practice tips applicable to all industries. Future articles will target compliance issues related to specific areas and industries—healthcare, finance, government contracting, and labor and employment—and what companies can do to reduce the risk when accepting government aid. Don’t miss the second article in this series that discusses what companies can do now to protect themselves during later government scrutiny related to COVID-19 relief funding.
The government has distributed an unprecedented amount of money in response to the COVID-19 pandemic. Under the Coronavirus Aid, Relief and Economic Security (CARES) Act, for example, the government is providing over $1 trillion through loans, grants and tax credits. Companies in the healthcare and financial industries, government contractors and many other businesses have all received government help.
The government, to its credit, has moved quickly to make funding available to companies in need. As a result, many government agencies have shifted their focus to responding to the pandemic and distributing allocated funds—with all requests and distributions of money completed as quickly as possible.Continue Reading The Government Is Here to Help—For Now: What Your Company Should Be Doing Today to Protect Against Inevitable Government Scrutiny of COVID-19 Relief Funding
On May 6, the U.S. District Court for the District of South Carolina entered final judgment dismissing with prejudice a relator’s qui tam False Claims Act (FCA) suit against the defendant wholesale pharmacy. The relator, a former pharmacist who worked for the defendant, alleged that the defendant submitted false claims to government healthcare programs in connection with prescription medications dispensed for use at nursing homes and assisted living facilities. The relator alleged a scheme in which the defendant manually filled “thousands” of prescriptions with less-expensive generic medications while billing for more-expensive alternative medications stocked in its automated dispensing system.
A qui tam complaint containing similar allegations filed against Omnicare Inc. in the U.S. District Court for the District of New Jersey resulted in an $8 million settlement in 2017. In this lawsuit, however, the defendant, represented by Bass, Berry & Sims and others, obtained full dismissal with prejudice of the relator’s FCA and retaliation claims.Continue Reading Qui Tam Complaint Against Pharmacy Dismissed for Lack of Particularity
The Tenth Circuit recently affirmed the dismissal of a declined qui tam False Claims Act lawsuit filed against Lawrence Memorial Hospital (LMH) by a former LMH employee, reasoning that the materiality inquiry focuses on the likely reaction of the Government. In U.S. ex rel. Janssen v. Lawrence Memorial Hospital, 949 F.3d 533 (10th Cir. 2020), the relator alleged that over a period of years LMH engaged in two fraud schemes:
Continue Reading Tenth Circuit Strictly Enforces Materiality Requirement to Nix FCA Lawsuit