For the February 2023 issue of the American Bar Association’s (ABA) Health Lawyer, the flagship publication of the ABA Health Law Section, I authored an article entitled “Recent False Claims Act Developments at the Supreme Court.”
Whistleblower
False Claims Act Fundamentals: What Is a Relator?
By Taylor Sample on
A relator is a private person or entity who files a False Claims Act (FCA) lawsuit on behalf of the United States in exchange for receiving a portion any recovery from the defendant. The FCA was enacted in 1863 in response to defense contractors defrauding the Union Army during the Civil War. But, it wasn’t until 1986, when Congress supercharged the FCA by incentivizing more private whistleblowers to file lawsuits on behalf of the government, that the FCA became the Department of Justice’s (DOJ) primary enforcement tool for combatting fraud against the government.
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False Claims Act Fundamentals: What Is the False Claims Act?
By Jeff Gibson on
The False Claims Act, 31 U.S. C. § 3729, et seq., is the federal government’s most important and most effective tool for fighting fraud. This post provides a high-level overview of the False Claims Act and highlights key aspects of this statute.
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Relator Cannot Maintain Dismissed Qui Tam Action Under Seal, District Court Rules
By Hannah Webber on
The United States District Court for the Northern District of Alabama recently ordered that a relator’s qui tam lawsuit must be unsealed upon the case’s voluntary dismissal, denying the relator’s request to maintain the action under seal post-dismissal. This ruling in U.S. ex rel. Meythaler v. Encompass Health Corporation serves as an important reminder that public access to court records is vitally important and that whistleblowers’ allegations and identities will almost certainly be made public, even where the case is dismissed without litigation.
FCA Complaint Filed Under Seal
The relator, a physician formerly employed by the defendant, filed suit under the False Claims Act (FCA) against an inpatient rehabilitation facility operator and the CEOs of two of its Alabama facilities. The complaint alleged numerous schemes, including allegations that the defendants sought reimbursement for treatment of patients who were not eligible for rehabilitation benefits, delayed discharges and other orders to increase reimbursement, and made improper referrals to a home health agency. Per the FCA’s procedural requirements, 31 U.S.C. § 3730(b)(2), the relator filed his complaint under seal, giving the government a statutory period of at least 60 days to investigate the allegations and determine whether to intervene in the case.
The government declined to intervene in the action last fall. The relator then filed a notice of voluntary dismissal with prejudice, to which the government later consented. The relator also filed a motion asking the court to maintain the action under seal even after the case was dismissed to prevent the defendants from learning that the relator had filed a qui tam action against them. The government took no position on the relator’s motion.…
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How Health Care Companies Can Protect Against Government Scrutiny of COVID-19 Relief Funding
By Brian Irving, Lisa Rivera & Danielle Sloane on
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:…
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
By Brian Irving & Lisa Rivera on
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.
Unprecedented 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.…
DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this total recovery, the vast majority—$2.6 billion—arose from matters related to different sectors of the healthcare industry. DOJ noted that 2019 was the tenth consecutive year that recoveries from civil healthcare fraud cases have exceeded $2 billion, indicating that the government’s enforcement efforts remain focused on allegations of fraud in the healthcare sector.
Large Recoveries Related to Drug Manufacturers & EHR
Within the healthcare industry, the government reported significant recoveries against pharmaceutical manufacturers. Insys Therapeutics paid $195 million to resolve civil False Claims Act (FCA) allegations that it paid kickbacks to induce healthcare providers to inappropriately prescribe its fentanyl product, Subsys, to their patients. This civil settlement was part of a larger global resolution of civil and criminal allegations, with Insys agreeing to pay a total of $225 million. Reckitt Benckiser Group agreed to pay $1.4 billion to resolve criminal and civil allegations related to the marketing of the addition treatment drug Suboxone, a buprenorphine product. The global resolution included a $500 million civil settlement with the federal government.…
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Myriad Genetics Settlement Illustrates FCA Risks Posed by Government and Other Non-Traditional Relators
On July 19, 2019, Myriad Genetics disclosed a $9.1 million settlement agreement to resolve a False Claims Act (FCA) qui tam lawsuit alleging that it engaged in a scheme to fraudulently bill Medicare for certain hereditary cancer tests.
Notably, the qui tam relator in the case was not a Myriad corporate insider, but rather a medical director for Palmetto GBA, the Medicare Administrative Contractor (MAC) responsible for overseeing the program through which Myriad’s tests are covered by Medicare. In this way, the settlement illustrates the often overlooked risk that individuals other than conventional corporate whistleblowers—including even government employees or employees of government administrative contractors—may serve as FCA relators.…
District Courts Hold that DOJ Lacks “Unfettered” Discretion to Preemptively Dismiss Qui Tam Actions
By Scott Gallisdorfer on
In two recent decisions, federal district courts in the Eastern District of Pennsylvania and the Southern District of Illinois, respectively, considered the Government’s motions to dismiss False Claims Act (FCA) lawsuits against pharmaceutical companies and marketing consultants alleging violations of the Anti-Kickback Statute (AKS) related to patient assistance programs. As discussed in our previous post, the two lawsuits were among 11 similar qui tam actions filed by corporate relators described by the Department of Justice (DOJ) as “shell companies,” and which DOJ sought to preemptively dismiss based on its view that the claims lacked merit and that litigation of the actions would waste “scarce government resources.”
In the Pennsylvania case, U.S. ex rel. Harris v. EMD Serono, Inc., the court granted DOJ’s motion to dismiss over the relators’ objection. In the Illinois case, U.S. ex rel. CIMZNHCA, LLC v. UCB, Inc., the court denied DOJ’s motion, declining to dismiss the case. Although reaching different dispositions, both courts parted ways with a prior decision of the U.S. Court of Appeals for the D.C. Circuit by holding that the Government does not possess “unfettered” discretion to dismiss FCA actions. Instead, the courts joined two other circuits in requiring the Government to demonstrate that its decision to dismiss an FCA action has “a rational relationship to a government interest.”
The circuit split highlighted by the decisions in EMD Serono and UCB is one of increasing importance in light of indications that the Government may be more aggressive in seeking preemptive dismissals of qui tam actions following the January 2018 Granston Memo.…
DOJ Moves to Dismiss 11 Patient Assistance Services FCA Cases
In a remarkable move, the Department of Justice (DOJ) recently sought dismissal of 11 False Claims Act (FCA) cases, each of which assert that patient assistance services supplied by pharmaceutical manufacturers constitute unlawful kickbacks. The 11 complaints were brought against various pharmaceutical companies by what DOJ described as “shell companies” backed by the National Healthcare Analysis Group, a company formed for the purpose of filing FCA cases. In seeking dismissal, DOJ argued that the suits ran counter to government interests and wasted “scarce government resources.”
According to the DOJ, the 11 lawsuits involved “essentially the same theories of FCA liability” concerning “white coat marketing,” free “nurse services,” and “reimbursement support services.” Specifically, in a motion to dismiss filed on December 17, 2018, in the Eastern District of Texas, DOJ seemingly defended these manufacturer programs noting the government’s “strong interest” in ensuring that “patients have access to basic product support related to their medication, such as access to a toll-free patient-assistance line or instructions on how to properly inject or store their medication.” The government further argued that the allegations “conflict with important policy and enforcement prerogatives” of federal healthcare programs, and asserted that the relators “should not be permitted to indiscriminately advance claims…against an entire industry that would undermine common industry practices the federal government has determined are, in this particular case, appropriate and beneficial to federal healthcare programs and their beneficiaries.”…
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