January 27, 2021
Looking back on the incredible year that was 2020, some observers of the False Claims Act (“FCA”) enforcement space may note that the year’s FCA recoveries were the lowest they have been in twelve years, but the most important takeaway for those who deal in government funds is this: the government opened the most new FCA investigations ever in 2020. Despite the global pandemic, closed courts, and the realities of remote work (including remote investigations and litigation), the government and qui tam relators still opened 922 new FCA cases last year. This is the largest single-year total ever by a substantial margin and brings the total number of new FCA cases opened in the last 5 years to more than 4,100.
If the government’s enforcement activity around past economic crises and resulting government stimulus programs is any indication, the stage is set for FCA cases to surge further still in the next few years. Last year, the government enacted legislative stimulus packages totaling nearly $4 trillion in COVID-relief funds, and anytime the government spends money, FCA cases follow. A huge portion of that spending, moreover, has been in health care and health care-adjacent fields, areas which have accounted for more than 80% of all FCA recoveries over the last four years. Further, the Department of Justice (“DOJ”) swiftly prioritized rooting out COVID-related fraud in 2020—a focus that we expect to continue and likely intensify under the Biden administration. As the incoming administration’s enforcement priorities solidify, we also will monitor any efforts to change course from steps previously taken by the Trump administration toward reining in FCA enforcement through various policy changes, such as the Brand Memorandum’s prohibition of DOJ enforcement actions predicated on violations of non-binding agency guidance.
Meanwhile, 2020 saw no major legislative developments relating to the FCA at the federal level. But states continue to enact or amend false claims statutes that enable states to receive a higher percentage share of recoveries and expand potential liability. On the judicial front, courts issued a number of significant decisions in 2020, including important decisions exploring the FCA’s materiality and scienter requirements, and several decisions regarding DOJ’s discretion to dismiss qui tam cases where the government has not intervened.
As always, Gibson Dunn’s recent publications on the FCA may be found on our website, including industry-specific articles, webcasts, presentations, and practical guidance to help companies avoid or limit liability under the FCA. And, of course, we would be happy to discuss these developments—and their implications for your business—with you.
The government and qui tam relators filed more FCA cases in 2020 (922) than in any other year since Congress enacted the FCA during the Civil War. Although that figure is staggering in and of itself, equally surprising is who drove the increase in cases.
During the last five years, there has been an average of approximately 800 new FCA cases a year, with qui tam relators filing approximately 660 cases on average and the government filing approximately 135 cases on average. But in 2020, the federal government was the impetus behind the increase to more than 900 new cases. These non-qui tam cases may arise from a variety of sources, including referrals from government agencies based on their program oversight activities or from mining government spending data for leads. With 250 cases last year, federal enforcement attorneys filed 120 more cases than in an average year, a mark last seen in 1994 when the modern qui tam provisions were still relatively new. As discussed below in the following section, cases where the government is involved—either because the government brought the case, or later intervened—typically account for 90% of all FCA cases with a recovery. The fact that the government brought so many new cases in 2020 suggests that recoveries in years to come will be robust.
Some of the government’s new cases stem from COVID relief efforts and a desire to police fraud in the government’s massive spending programs during the last year. But it does not appear that COVID-related cases account for the entirety of the nearly 100% increase in cases by the government. As more details are released about those cases, we will be watching carefully to identify where the government’s actions are focused.
Number of FCA New Matters, Including Qui Tam Actions
Source: DOJ “Fraud Statistics – Overview” (Jan. 14, 2021)
The federal government also recovered more than $2.2 billion during fiscal year 2020, which ended September 30, 2020. Of this amount, more than 90% was recovered in intervened cases, underscoring that companies face more significant exposure in cases in which the government initiated the case or intervened.
The total of $2.2 billion is down from recent years, as shown in the chart below. Given the continued high number of new investigations being opened, this is likely a reflection of disruptions caused by the COVID-19 pandemic. Although COVID never resulted in a total work stoppage, investigations were delayed as were court proceedings in the middle of 2020. As noted, however, the overall pace of FCA litigation has not slowed whatsoever, and the pipeline of new cases is as full as ever. Significant settlements entered into after the close of fiscal year 2020, such as the $2.8 billion settlement entered into with an opioid manufacturer discussed below, are likewise poised to boost next fiscal year’s figures drastically.
Settlements or Judgments in Cases Where the Government Declined Intervention as a Percentage of Total FCA Recoveries
Source: DOJ “Fraud Statistics – Overview” (Jan. 14, 2021)
While filings are up and recoveries are (perhaps temporarily) down, the industry breakdown of recoveries remains largely unchanged. As Assistant Attorney General Michael D. Granston recently remarked at the ABA Civil False Claims Act and Qui Tam Enforcement Institute, “[o]f the $11.4 billion recovered over the last four years, approximately 80 percent, or $9 billion, was recovered in health care fraud matters,” while “procurement fraud and mortgage fraud” marked the next two largest categories.
2020 was no exception: Health care cases comprised 83% of total recoveries, Department of Defense procurement issues made up 3%, and the remaining 14% was split among other areas.
FCA Recoveries by Industry
Source: DOJ “Fraud Statistics – Overview” (Jan. 14, 2021)
We summarize below some of the notable FCA settlements announced since July 2020 (we covered notable settlements and judgments from the first half of 2020 in our 2020 Mid-Year False Claims Act Update). These summaries provide insight into the theories of liability and industries that have been a focus of government (and relator) enforcement efforts during the last year.
As we have reported previously, several COVID-19 related federal legislative developments in 2020—economic spending and stimulus packages—are likely to spur FCA enforcement. We have covered these developments in detail in updates throughout the COVID‑19 crisis (available here and here). The most notable legislation, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), marked the largest emergency stimulus package in history, providing $2.2 trillion worth of government funds to mitigate the effects of COVID-19. The Act provides relief for businesses, industries, individuals, employers, and states in a number of ways, including a Small Business Administration (“SBA”) loan program offering up to $350 billion in relief, the Paycheck Protection Program (“PPP”), as well as economic stabilization programs to provide loans, loan guarantees, and funding for eligible industries, businesses, states, and municipalities.
In late December 2020, then President Trump signed a second massive stimulus bill, providing $900 billion of additional relief. Among other things, this new legislation renewed the PPP program, providing an additional $285 billion for additional loans for small businesses. The new economic relief program tightened the funding terms and conditions in some respects, an effort apparently aimed at correcting some of the elements of the original program that were subject to criticism. The legislation caps new loans at $2 million, for example, and makes them available only to borrowers with fewer than 300 employees that experienced at least a 25% drop in sales from a year earlier in at least one quarter. In addition, publicly traded companies will not be eligible to apply for loans.
Before taking office on January 20, 2021, President Biden also announced a $1.9 trillion COVID relief plan that he aims to pass during his first 100 days in office. Among other things, the plan provides $416 billion to launch a national vaccination program, $35 billion to make low-interest loans available to certain businesses, and sets aside another $1 trillion in additional stimulus checks for Americans.
There were no major developments with respect to federal FCA legislation in 2020. This may change soon, however. For example, in July, Senator Chuck Grassley (R-IA)—the original author of the FCA’s 1986 amendments—announced he is drafting legislation that would “clarify[y]” purported “ambiguities created by the courts” regarding the proper interpretation of the FCA. In particular, Senator Grassley’s remarks highlighted his concerns about DOJ’s authority to dismiss FCA cases despite relators’ objections, as well as DOJ’s practice of increasingly exercising that authority following DOJ’s issuance of the Granston Memo, on which we have reported previously. We will closely monitor this and other developments at the federal level in the coming year.
Under the outgoing administration, DOJ focused on preventing and punishing COVID-19-related fraud. To date, DOJ has scrutinized several aspects of the stimulus funding under the CARES Act, in particular, such as in connection with certifications of compliance with loan program requirements, as well as submission of false claims allegedly kickback-tainted, medically unnecessary, and/or otherwise not provided as represented.
This policy played out in 2020, with DOJ officials announcing plans to “deploy the [FCA] against those who commit fraud related to the various COVID-19 stimulus programs,” particularly the Provider Relief Fund (“PRF”) and the Paycheck Protection Program—funding programs put into place by the CARES Act. These programs, which impose numerous requirements on funding recipients, make available significant sums of money that DOJ considers may provide “a number of opportunities for fraud.”
The Biden administration will almost certainly continue to focus on COVID-19 enforcement. What other enforcement changes or priorities come from the Biden administration remain to be seen.
As an incentive for seeking HHS-OIG approval of their false claims act statutes, states can receive “a 10-percentage-point increase in their share of any amounts” recovered under the relevant laws. To receive approval, state statutes must (among other requirements) contain provisions that are “at least as effective in rewarding and facilitating qui tam actions” as those in the federal FCA, and must contain civil penalties at least equivalent to those imposed by the federal FCA. A similar requirement is that a given state’s statute must provide for civil penalty increases “at the same rate and time as those authorized under the [federal] FCA” pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Currently, the total number of states with approved statutes stands at twenty-one (California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Illinois, Indiana, Iowa, Massachusetts, Montana, Nevada, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Washington). Eight states have laws that have not yet been deemed to meet the federal standards (Florida, Louisiana, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, and Wisconsin). Thirty-one states have enacted some version of the False Claims Act.[50
Several jurisdictions also enacted or advanced false claims act legislation in 2020. In the District of Columbia, the D.C. Council enacted legislation amending the District’s existing false claims act (D.C. Code Ann. § 2-381.01 et seq.) to expressly authorize tax-related false claims actions against persons who “reported net income, sales, or revenue totaling $1 million or more in a tax filing to which [the relevant] claim, record, or statement pertained, and the damages pleaded in the action total $350,000 or more.” The bill authorizes treble damages for tax-related violations, meaning District taxpayers could be liable for three times the amount not only of any taxes, but also of any interest and tax penalties. Because the District’s existing false claims statute excluded tax-related claims from false claims liability, the new legislation represents a major policy shift. In amending its false claims statute in this fashion, the District joins Illinois and New York as jurisdictions that provide for tax-related FCA liability.
In Pennsylvania, which has no statute analogous to the FCA, the legislature advanced a false claims act bill that would enable private citizens to bring lawsuits on behalf of the state against anyone who “[k]nowingly presents or causes to be presented a false or fraudulent claim for payment or approval” or “[k]nowingly makes, uses or causes to be made or used, a false record or statement material to a false or fraudulent claim.” The bill would also require the Attorney General to make recommendations to state agencies on how to prevent false claims violations from occurring. The new law would empower the Pennsylvania Office of the Attorney General to enforce its provisions, including via civil investigative demands. The bill largely mirrors the FCA and was first referred to the House Human Services Committee on May 21, 2020. In September 2020, the House committee approved an amended bill to include limited civil liability protections for entities that follow all state and federal directives regarding COVID-19, along with civil fraud provisions matching federal law. To date, the bill is awaiting a vote in the Pennsylvania General Assembly.
We also reported in our 2020 Mid-Year Update on a bill passed by the California Assembly, Assembly Bill No. 1270, which would alter the state’s false claim act considerably, including by amending the act to limit the definition of materiality to include only “the potential effect” of an alleged false record or statement “when it is made,” without consideration—contrary to the U.S. Supreme Court’s 2016 decision in Universal Health Services v. United States ex rel. Escobar—of “the actual effect of the false record or statement when it is discovered.” The amendments would also extend the act to tax-related cases where the damages pleaded exceed $200,000 and a defendant’s state-taxable income or sales exceed $500,000. After the bill stalled in the State Senate, a California Assembly member (Mark Stone, D-Monterey Bay) introduced a substantially similar bill, Assembly Bill No. 2570. As with its predecessor, AB-2570 stalled in the State Senate in 2020.
The second half of 2020 saw a number of important case law developments, including with respect to falsity, materiality, and the FCA’s important threshold bars. We cover the most notable cases below.
As discussed in our Mid-Year Update, the issue of whether and when differences in physician medical opinions may satisfy the FCA’s “falsity” element is driving critical developments in FCA jurisprudence. In particular, a circuit split emerged after the Eleventh Circuit’s decision in United States v. AseraCare, Inc., in which the court held that claims cannot be “deemed false” under the FCA based solely on “a reasonable disagreement between medical experts” as to a medical provider’s clinical judgment. 938 F.3d 1278, 1281 (11th Cir. 2019). By contrast, the Third Circuit held in United States ex rel. Druding v. Care Alternatives that a “physician’s judgment may be scrutinized and considered ‘false’” and that a “difference of medical opinion is enough evidence to create a triable dispute of fact regarding FCA falsity.” 952 F.3d 89, 100–01 (3d Cir. 2020). The Ninth Circuit reached a similar result in Winter ex rel. United States v. Gardens Regional Hospital and Medical Center, holding that an FCA claim based on an alleged lack of medical necessity may suffice to survive a motion to dismiss. 953 F.3d 1108, 1117 (9th Cir. 2020).
In September 2020, Care Alternatives petitioned the Supreme Court for a writ of certiorari to challenge the Third Circuit’s rejection of the AseraCare “objective falsity” standard. Specifically, Care Alternatives asked the Court to decide “[w]hether a physician’s honestly held clinical judgment regarding hospice certification can be ‘false’ under the False Claims Act based solely on a reasonable difference of opinion among physicians.” Pet. for Writ of Cert., Care Alternatives v. United States, et al., No. 20-371 (U.S. Sept. 16, 2020).
In its petition, Care Alternatives contended that the Third Circuit’s recent decision created a “square split” with the Eleventh Circuit’s AseraCare decision “on an issue of critical importance to the millions of Americans who require hospice care annually and the thousands of hospices and physicians who provide that care.” Id. at 1–2. Care Alternatives also argued that the Third Circuit’s rejection of an objective falsity standard “opens up hospices and physicians to crushing financial liability and reputational harm, notwithstanding near universal acknowledgment that determinations about life expectancy are notoriously difficult and inexact.” Id. at 2. Further, it highlighted the “untenable prospect . . . that hospices in New Jersey [because of the Third Circuit’s decision] will face treble damages for the same difficult medical judgments that cannot be second-guessed in Florida,” in light of the Eleventh Circuit’s AseraCare case. Id. at 3.
Given the stakes, the case has attracted attention from industry participants. After Care Alternatives filed its petition, two groups submitted amicus briefs: one by a group of Hospice, Health Care, and Physician Organizations, and the other from the Chamber of Commerce of the United States of America and the Pharmaceutical Research and Manufacturers of America (“PhRMA”). See Br. for the Hospice, Health Care, and Physician Organizations as Amici Curiae, Care Alternatives v. United States, et al., No. 20-371 (U.S. Oct. 23, 2020) (“Hospice Brief”); Br. of Chamber of Commerce of the United States et al. as Amici Curiae, Care Alternatives v. United States, et al., No. 20-371 (U.S. Oct. 23, 2020) (“Chamber of Commerce Brief”). The briefs highlighted the risks the Third Circuit’s decision poses for providers and for recipients of government benefits more broadly (such as government contractors). See generally Hospice Brief; Chamber of Commerce Brief. The amici likewise cited the broader developing circuit split over “objective falsity” as another reason why the Court should grant Care Alternatives’ petition. Chamber of Commerce Brief at 8–10.
In the latter half of 2020, federal appellate courts continued to weigh in on the critical issues of materiality and scienter under the FCA in the wake of the Supreme Court’s seminal decision in Universal Health Services v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). The Court’s clear directive in Escobar was that courts should scrutinize whether plaintiffs have alleged facts sufficient to satisfy the “rigorous” and demanding materiality standard the FCA imposes. See id. at 2004 n.6 (rejecting the notion that materiality cannot be decided at the pleadings stage). Two Circuit Courts of Appeals took up this task in notable ways in the latter half of 2020.
First, in United States v. Strock, the Second Circuit considered what counts as a “payment decision” for purposes of assessing materiality under a fraudulent inducement theory of FCA liability. 982 F.3d 51 (2d Cir. Dec. 3, 2020). Under a fraudulent inducement theory, “FCA liability attaches not because a defendant has submitted any claim for payment that is ‘literally false,’ but instead because ‘the contract under which payment [is] made is procured by fraud.’” Id. at 60 (quoting United States ex rel. Longhi v. United States, 575 F.3d 458, 467–68 (5th Cir. 2009)). In Strock, the court evaluated whether Escobar materiality analysis applied to the government’s initial decision to award the contract, the government’s subsequent decision to pay claims under the contract, or both. The government alleged that a putatively service-disabled veteran-owned small business (“SDVOSB”) was used “as a front to funnel [government] contract work” to another contractor. Id. at 56. The U.S. District Court for the Western District of New York granted the defendants’ motion to dismiss and concluded that Escobar only required a showing of materiality in connection with the government’s initial awarding of the contract. Id. at 58–60.
On appeal, the Second Circuit reversed the district court’s dismissal of the FCA claims against one individual defendant and vacated the district court’s dismissal of the FCA claims against the corporate defendant under a vicarious liability theory. The Second Circuit reasoned that the nature of fraudulent inducement cases required it to assign the meaning of “payment decisions” subject to Escobar analysis a “broader scope” than the lower court had. Id. at 60. The Second Circuit interpreted both the government’s initial contract award and subsequent payments of claims as “payment decisions” requiring a materiality analysis under Escobar. Id. at 59–60.
Earlier in 2020, the Fifth Circuit in United States ex rel. Porter v. Magnolia Health Plan, Inc. also applied Escobar’s materiality standard to a case decided at the pleadings stage. 810 F. App’x 237 (5th Cir. 2020). There, a registered nurse alleged that her former employer violated the FCA by staffing care and case manager positions with licensed practical nurses in contravention of contractual requirements. The district court dismissed the FCA claims, concluding that “broad boilerplate language generally requiring a contractor to follow all laws” was “too general to support a FCA claim.” Id. at 242. In affirming, the Fifth Circuit agreed that the applicable contracts did not require the defendant to staff relevant positions with registered nurses and that the boilerplate language was not sufficient to establish an FCA claim. The Fifth Circuit also explained that the “continued payments to and contracts with” the defendant “substantially increase the burden . . . in establishing materiality,” which the plaintiff did not meet. Id. Specifically, the Fifth Circuit noted that “the Mississippi Division of Medicaid took no action after Plaintiff-Appellant informed the Division” of this alleged misconduct but rather “continued payment and renewed its contract with [the former employer] several times.” Id. Even after the plaintiff’s suit was unsealed, the third-party Medicaid contractor awarded the plaintiff’s former employer “a contract for the fourth time.” Id. The Fifth Circuit also affirmed the district court’s dismissal with prejudice, finding “no reasonable basis to predict that [the plaintiff] c[ould] recover on her claims” and that any amendment of the nurse’s complaint thus would be futile, in part, because of the government’s continued payments and contracting arrangements with the nurse’s former employer. Id. at 243.
On December 9, 2020, after the Fifth Circuit refused to rehear the case, the relator petitioned for a writ of certiorari, asking the Supreme Court to clarify to what extent Escobar altered the Rule 12(b)(6) plausibility standard the Court imposed in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009). Pet. for Writ of Cert., United States ex rel. Porter v. Magnolia Health Plan, Inc., No. 20-786 (U.S. Dec. 9, 2020). Specifically, the petition asked the Court to decide “whether the Supreme Court ruling in Escobar overruled or modified the standard of review to be used in ruling upon Rule 12(b)(6) motions to dismiss in cases involving the False Claims Act so as to require ‘proof’ or ‘evidence’ at the initial pleading stage above and beyond the plausibility standard set forth in Twombly and Iqbal.” Id. at iii. The Court denied the qui tam plaintiff’s petition on January 19, 2021.
In the wake of the 2018 Granston Memo, which instructed DOJ attorneys to consider dismissal of a qui tam case when recommending declination, DOJ has more regularly invoked its dismissal authority under 31 U.S.C. § 3730(c)(2)(A) than it did in for decades previously. Historically, courts have split based on whether they follow the Ninth Circuit’s Sequoia Orange test or the D.C. Circuit’s Swift test. Under the Sequoia Orange approach, the government may dismiss a qui tam case if: (1) it identifies a valid government purpose; (2) a rational relation exists between the dismissal and the accomplishment of that purpose; and (3) dismissal is not fraudulent, arbitrary and capricious, or illegal. United States ex rel. Sequoia Orange Co. v. Baird-Neece Packing Corp., 151 F.3d 1139, 1145 (9th Cir. 1998). The Swift test, by contrast, affords the government an “unfettered” right to dismiss a case such that the decision is “unreviewable” except in instances of “fraud on the court.” Swift v. United States, 318 F.3d 250, 252–53 (D.C. Cir. 2003). Both standards generally favor the government’s discretion, albeit to different degrees, and DOJ regularly argues in its motions to dismiss that it has sufficient discretion to dismiss a case under either standard.
This past August, the Seventh Circuit suggested that the split may have little practical significance. In United States ex rel. CIMZNHCA, LLC v. UCB, Inc., 970 F.3d 835 (7th Cir. 2020), the court reviewed a district court’s denial of the government’s attempt to dismiss the case, which concerned the alleged provision of kickbacks to physicians for prescriptions of a drug used to treat Crohn’s disease. Id. at 839. In moving for dismissal, the government argued that the allegations “lack[ed] sufficient merit to justify the cost of investigation and prosecution and [were] otherwise . . . contrary to the public interest.” Id. at 840. But the district court, applying the Sequoia Orange standard, deemed the government’s decision “arbitrary and capricious” and “not rationally related to a valid governmental purpose.” Id. (internal quotation marks omitted).
The Seventh Circuit reversed, calling the choice between the Sequoia Orange and Swift standards “a false one, based on a misunderstanding of the government’s rights and obligations under the False Claims Act.” Id. at 839. Instead, the court viewed the government’s motion as a motion to intervene and dismiss and held that Federal Rule of Civil Procedure 41 (which governs voluntary dismissal by plaintiffs generally) supplied “the beginning and end of [the court’s] analysis.” Id. at 849. While Rule 41(a)(1)(A) states that the voluntary dismissal right is “[s]ubject to . . . any applicable federal statute,” the “only authorized statutory deviation from Rule 41” in the FCA itself is the requirement that a relator be given notice and an opportunity to be heard in the event that the government seeks to dismiss the case over the relator’s objection. See id. at 850. The court acknowledged that such a hearing may amount to little more than formality in cases where there are no questions about the propriety of the government’s exercise of its dismissal authority; but the court noted that Rule 41’s conditions on the timing of voluntary dismissal motions could arise in Section 3730(c)(2)(A) hearings in cases where “the government’s chance to serve notice of dismissal has passed . . . and the relator . . . refuses to agree to dismissal.” Id. at 850–51.
Turning to the Sequoia Orange and Swift standards, the court held that Sequoia Orange simply means that dismissal “may not violate the substantive component of the Due Process Clause,” id. at 851, which the court characterized as a “bare rationality standard” targeting “only the most egregious official conduct” that “shocks the conscience” or “offend[s] even hardened sensibilities,” id. at 852 (internal quotation marks omitted) (alteration in original). The court found that the government’s dismissal decision, based as it was on the fact that agency guidance and rules had repeatedly “held that the conduct complained of is probably lawful,” did not rise to this level. See id. At the same time, the court rejected the idea that the relatively formal nature of Section 3730(c)(2)(A) hearings “justif[ies] imposing on the government in each case the burden of satisfying Sequoia Orange’s ‘two-step test’ before the burden is put back on the relator to show unlawful executive conduct.” Id. at 853.
In sum, while the court recognized the value of a Sequoia Orange-type standard focused on the outer constitutional limits on the exercise of the government’s prosecutorial discretion, the court’s holding suggested that it believes that limit lies closer to the even‑more‑forgiving Swift standard than to the “two-step” approach set forth in Sequoia Orange. The Seventh Circuit seems to have believed that the district court lost sight of the constitutional underpinnings of the “rational basis” test—and that a focus on the procedural parameters of Rule 41 can help avoid this error, insofar as they are consistent with a very forgiving approach to the government’s exercise of its dismissal authority. Accordingly, going forward we may well see DOJ intervene for the purposes of dismissal to exercise its (c)(2)(A) dismissal authority more often, at least in Seventh Circuit courts.
In another notable case regarding DOJ’s dismissal authority, the Ninth Circuit issued a decision that could create more pressure for DOJ, when it wishes to dismiss a case, to intervene in the action first. In United States v. Academy Mortgage Corp., 968 F.3d 996 (9th Cir. 2020), the district court denied DOJ’s motion to dismiss on the ground that the government’s cost-benefit justification was insufficient to satisfy the Sequoia Orange standard. Id. at 1001. The government had claimed that discovery would be burdensome, but the court believed that the government had an incomplete understanding of the potential monetary recovery in the case given the limited nature of the government’s investigation. Id. The government appealed the denial of its motion under the collateral order doctrine, rather than seek to have the issue certified for interlocutory review. See id.
The Ninth Circuit dismissed the appeal for lack of jurisdiction, holding that the collateral order doctrine does not apply to denials of motions to dismiss under Section 3730(c)(2)(A), “at least in cases where the Government has not exercised its right to intervene.” Id. at 1005. Citing the government’s professed concern regarding discovery burdens, the court reasoned that, when the government has not intervened in a qui tam action, it is not a party to the action and its discovery obligations accordingly are the same as those of any other non‑party under Federal Rule of Civil Procedure 45. Id. at 1006. The court noted that the path to appellate review of a question of discovery burdens on a third party typically is to defy a subpoena and appeal the resulting contempt citation; orders merely denying motions to quash under Rule 45 “generally cannot be immediately appealed under the collateral order doctrine.” Id. at 1006–07. The court stated the core of its concern as follows: “It would be incongruous to hold, as we are asked to do here, that the Government’s interest in dismissing the case to avoid the possibility of future onerous discovery requests is important enough to merit an immediate appeal, when third parties actually faced with burdensome subpoenas have no such right.” Id. at 1007 (emphases in original). Although the court stated that the government could pursue interlocutory review, the court’s opinion could be read to suggest that the case does not present a “controlling question of law as to which there is substantial ground for difference of opinion” where the government’s rationale for dismissal is a mere “run-of-the-mill litigation burden.” Id. at 1009.
The courts in both Academy Mortgage and UCB treated the question of DOJ’s intervention as affecting which legal framework should apply to the analysis of DOJ’s dismissal authority. Practically speaking, that reasoning may encourage DOJ to intervene in cases in which it otherwise would not seek to do so, for the limited purpose of strengthening its posture in moving to dismiss the case.
Under Section 3730(b)(5) of the FCA, “[w]hen a person brings an [FCA] action . . . no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.” 31 U.S.C. § 3730(b)(5). The Circuits have split over whether this “first-to-file bar” is jurisdictional. The First, Second, and D.C. Circuits have held that the bar is not jurisdictional, whereas the Fourth, Fifth, Sixth, Ninth, and Tenth Circuits have concluded that the bar is a matter of courts’ subject‑matter jurisdiction. See In re Plavix Marketing, Sales Practices & Products Liability Litig., 974 F.3d 228, 232 (3d Cir. 2020) (collecting cases).
In a September 1, 2020 opinion, the Third Circuit joined the former camp, relying primarily on the “clear statement rule”: “As the Supreme Court has recently instructed, unless Congress states clearly that a rule is jurisdictional, we will treat it as nonjurisdictional. . . . [Defendants] point to no language in § 3730(b)(5), nor do we see any, that ‘plainly show[s] that Congress imbued [the first-to-file] bar with jurisdictional consequences.’” Id. at 232 (second and third alterations in original) (citation omitted). The court also rejected the defendants’ argument that the bar is a matter of constitutional standing, concluding instead that it “asks only ‘whether [the relator] falls within the class of plaintiffs whom Congress has authorized to sue,’ which is another way to ask whether the statute gives it a cause of action.” Id. (alteration in original) (citation omitted). Accordingly, a motion to dismiss under the first‑to‑file bar “falls under Rule 12(b)(6) for failure to state a claim.” Id. at 233.
In a separate case, the State of New Mexico filed a complaint in state court while the Plavix litigation was pending but after the State declined to intervene in that litigation. See State ex rel. Balderas v. Bristol-Myers Squibb Co., 436 P.3d 724, 727 (N.M. Ct. App. 2018). The state trial and appellate courts held that the dismissal of the Plavix relator’s claims with prejudice did not act as dismissal with prejudice as to the government. Id. at 734. The court cited favorably to other decisions reasoning that a non-intervention decision does not automatically mean the government does not see merit in the case in question, and that “perverse incentives” would arise if dismissal with prejudice as to a relator also precluded claims by the government. Id. at 731. For example, the government essentially would have to intervene in every case simply to protect its ability to sue a defendant later, id., which would defeat the purpose of statutory provisions granting the government discretion to intervene.
The defendants filed a petition in the Supreme Court for a writ of certiorari in early September, a request which remains pending. See generally Pet. for Writ of Cert., State ex rel. Balderas v. Bristol-Myers Squibb Co., No. 20-293 (U.S. Sept. 3, 2020). If the Court takes the case, it will be an opportunity to resolve a Circuit split over whether the government is bound by with-prejudice dismissals of qui tam complaints. The Fifth and Eleventh Circuits have answered that question in the negative, the Seventh and Ninth Circuits in the affirmative. See id. at 13–19.
It is difficult for any plaintiff to prevail on a motion for summary judgment. This is particularly so in FCA actions, which demand that plaintiffs prove various rigorously construed and fact‑intensive elements, including materiality and scienter.
In August 2016, however, the U.S. District Court for the District of Columbia granted the government’s motion for summary judgment in a case against a home health care company alleged to have submitted claims for reimbursement to the District of Columbia Medicaid Program for services that purportedly lacked adequate documentation. United States v. Dynamic Visions Inc., 220 F. Supp. 3d 16, 22 (D.D.C. 2016).
The district court’s opinion is notable given how rarely these motions are granted. Just as noteworthy is the fact that, in August 2020, the D.C. Circuit largely affirmed the lower court’s award of summary judgment in the government’s favor. United States v. Dynamic Visions Inc, 971 F.3d 330, 338–40 (D.C. Cir. 2020). The D.C. Circuit highlighted that, on appeal, the defendant-appellant had failed to meaningfully address the government’s theory that patients had inadequate “plan of care” documentation in several different regards, having chosen instead to “respond only with highly generalized statements to the effect that they submitted plans of care for Medicaid recipients signed by their physicians, . . . that they maintained a policy and procedure manual that was compliant with [Department of Health Care Finance] regulations[,] and [that they] followed the policy and procedures stated in the manual.” Id. at 337 (internal quotation marks omitted). Because the defendant-appellant failed to provide supporting evidence for those assertions—namely, the manual in question—the court held that “[t]hose statements are too conclusory to create a genuine issue.” Id.
As always, Gibson Dunn will continue to monitor these developments and others in the FCA space and stands ready to answer any questions you may have. We will report back to you on the latest news mid-year, in July 2021.
 See U.S. Dep’t of Justice, Memorandum from Rachel Brand, Associate Attorney General (Nov. 16, 2017), https://www.justice.gov/opa/press-release/file/1012271/download.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Justice Department Recovers Over $2.2 Billion from False Claims Act Cases in Fiscal Year 2020 (Jan. 14, 2021), https://www.justice.gov/opa/pr/justice-department-recovers-over-22-billion-false-claims-act-cases-fiscal-year-2020 [hereinafter DOJ FY 2020 Recoveries Press Release].
 See U.S. Dep’t of Justice, Fraud Statistics Overview (Jan. 14, 2021), https://www.justice.gov/opa/press-release/file/1354316/download [hereinafter DOJ FY 2020 Stats].
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Remarks of Deputy Assistant Attorney General Michael D. Granston at the ABA Civil False Claims Act and Qui Tam Enforcement Institute (Dec. 2, 2020), https://www.justice.gov/opa/speech/remarks-deputy-assistant-attorney-general-michael-d-granston-aba-civil-false-claims-act.
 See DOJ FY 2020 Stats.
 See Press Release, U.S. Atty’s Office for the W. Dist. Of Ky., California Genetic Testing Company Agrees To Pay $8.25 Million To Resolve False Claims Allegations; Paducah, Ky, Area Hospital Also Settles (July 1, 2020), https://www.justice.gov/usao-wdky/pr/california-genetic-testing-company-agrees-pay-825-million-resolve-false-claims.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Novartis Pays Over $642 Million to Settle Allegations of Improper Payments to Patients and Physicians (July 1, 2020), https://www.justice.gov/opa/pr/novartis-pays-over-642-million-settle-allegations-improper-payments-patients-and-physicians; Press Release, U.S. Atty’s Office for the S. Dist. of N.Y., Acting Manhattan U.S. Attorney Announces $678 Million Settlement Of Fraud Lawsuit Against Novartis Pharmaceuticals For Operating Sham Speaker Programs Through Which It Paid Over $100 Million To Doctors To Unlawfully Induce Them To Prescribe Novartis Drugs (July 1, 2020), https://www.justice.gov/usao-sdny/pr/acting-manhattan-us-attorney-announces-678-million-settlement-fraud-lawsuit-against.
 See Press Release, U.S. Atty’s Office for the Middle Dist. of Fla., Hope Hospice Agrees To Pay $3.2 Million To Settle False Claims Act Liability (July 8, 2020), https://www.justice.gov/usao-mdfl/pr/hope-hospice-agrees-pay-32-million-settle-false-claims-act-liability.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Oklahoma City Hospital, Management Company, And Physician Group To Pay $72.3 Million To Settle Federal And State False Claims Act Allegations Arising From Improper Payments To Referring Physicians (July 8, 2020), https://www.justice.gov/opa/pr/oklahoma-city-hospital-management-company-and-physician-group-pay-723-million-settle-federal.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Universal Health Services, Inc. And Related Entities To Pay $122 Million To Settle False Claims Act Allegations Relating To Medically Unnecessary Inpatient Behavioral Health Services And Illegal Kickbacks (July 10, 2020), https://www.justice.gov/opa/pr/universal-health-services-inc-and-related-entities-pay-122-million-settle-false-claims-act.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Twenty-Seven Skilled Nursing Facilities Controlled By Longwood Management Corporation To Pay $16.7 Million To Resolve False Claims Act Allegations (July 13, 2020), https://www.justice.gov/opa/pr/twenty-seven-skilled-nursing-facilities-controlled-longwood-management-corporation-pay-167.
 See Press Release, U.S. Atty’s Office for the W. Dist. of Wash., DOJ settles False Claims Act allegations against drug testing lab with operations in Tacoma and Denver (July 20, 2020), https://www.justice.gov/usao-wdwa/pr/doj-settles-false-claims-act-allegations-against-drug-testing-lab-operations-tacoma-and.
 See Press Release, U.S. Atty’s Office for the S. Dist. of N.Y., Acting Manhattan U.S. Attorney Announces $49 Million Settlement With Biotech Testing Company For Fraudulent Billing And Kickback Practices (July 23, 2020), https://www.justice.gov/usao-sdny/pr/acting-manhattan-us-attorney-announces-49-million-settlement-biotech-testing-company.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Indivior Solutions Pleads Guilty To Felony Charge And Indivior Entities Agree To Pay $600 Million To Resolve Criminal And Civil Investigations As Part Of DOJ’s Largest Opioid Resolution (July 24, 2020), https://www.justice.gov/opa/pr/indivior-solutions-pleads-guilty-felony-charge-and-indivior-entities-agree-pay-600-million.
 See Press Release, U.S. Atty’s Office for the Dist. of N.J., Pharmaceutical Company Agrees to Pay $3.5 Million to Resolve Allegations of Violating False Claims Act (July 28, 2020), https://www.justice.gov/usao-nj/pr/pharmaceutical-company-agrees-pay-35-million-resolve-allegations-violating-false-claims.
 See Press Release, U.S. Atty’s Office for the E. Dist. of N.Y., New York Hospice Provider Settles Civil Healthcare Fraud Allegations (Aug. 19, 2020), https://www.justice.gov/usao-edny/pr/new-york-hospice-provider-settles-civil-healthcare-fraud-allegations.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act Allegations Relating To Promotion Of Unsupported Drug Administration Process (Aug. 24, 2020), https://www.justice.gov/opa/pr/dusa-pharmaceuticals-pay-us-2075-million-settle-false-claims-act-allegations-relating.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, West Virginia Hospital Agrees To Pay $50 Million To Settle Allegations Concerning Improper Compensation To Referring Physicians (Sept. 9, 2020), https://www.justice.gov/opa/pr/west-virginia-hospital-agrees-pay-50-million-settle-allegations-concerning-improper.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, William M. Kelly, M.D., Inc And Omega Imaging, Inc. Agree To Pay $5 Million To Resolve Alleged False Claims For Unsupervised And Unaccredited Radiology Services (Sept. 9, 2020), https://www.justice.gov/opa/pr/william-m-kelly-md-inc-and-omega-imaging-inc-agree-pay-5-million-resolve-alleged-false-claims.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, The Scripps Research Institute To Pay $10 Million To Settle False Claims Act Allegations Related To Mischarging NIH-Sponsored Research Grants (Sept. 11, 2020), https://www.justice.gov/opa/pr/scripps-research-institute-pay-10-million-settle-false-claims-act-allegations-related.
 See Press Release, U.S. Atty’s Office for the S. Dist. of N.Y., Acting Manhattan U.S. Attorney Announces $11.5 Million Settlement With Biotech Testing Company For Fraudulent Billing And Kickback Practices (Sept. 22, 2020), https://www.justice.gov/usao-sdny/pr/acting-manhattan-us-attorney-announces-115-million-settlement-biotech-testing-company.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Gilead Agrees To Pay $97 Million To Resolve Alleged False Claims Act Liability For Paying Kickbacks (Sept. 23, 2020), https://www.justice.gov/opa/pr/gilead-agrees-pay-97-million-resolve-alleged-false-claims-act-liability-paying-kickbacks.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Lakeway Regional Medical Center LLC And Co-Defendants Agree To Pay Over $15.3 Million To Resolve Allegations They Fraudulently Obtained Government-Insured Loan And Misused Loan Funds (Sept. 28, 2020), https://www.justice.gov/opa/pr/lakeway-regional-medical-center-llc-and-co-defendants-agree-pay-over-153-million-resolve.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Medical Device Maker Merit Medical To Pay $18 Million To Settle Allegations Of Improper Payments To Physicians (Oct. 14, 2020), https://www.justice.gov/opa/pr/medical-device-maker-merit-medical-pay-18-million-settle-allegations-improper-payments.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Justice Department Announces Global Resolution of Criminal and Civil Investigations with Opioid Manufacturer Purdue Pharma and Civil Settlement with Members of the Sackler Family (Oct. 21, 2020), https://www.justice.gov/opa/pr/justice-department-announces-global-resolution-criminal-and-civil-investigations-opioid.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Medtronic to Pay Over $9.2 Million To Settle Allegations of Improper Payments to South Dakota Neurosurgeon (Oct. 29, 2020), https://www.justice.gov/opa/pr/medtronic-pay-over-92-million-settle-allegations-improper-payments-south-dakota-neurosurgeon.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Medicare Advantage Provider to Pay $6.3 Million to Settle False Claims Act Allegations (Nov. 16, 2020), https://www.justice.gov/opa/pr/medicare-advantage-provider-pay-63-million-settle-false-claims-act-allegations.
 See Press Release, U.S. Atty’s Office for the E. Dist. of Pa., Former Owners of Therakos, Inc. Pay $11.5 Million to Resolve False Claims Act Allegations of Promotion of Drug-Device System for Unapproved Uses to Pediatric Patients (Nov. 19, 2020), https://www.justice.gov/usao-edpa/pr/former-owners-therakos-inc-pay-115-million-resolve-false-claims-act-allegations.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Home Health Agency and Former Owner to Pay $5.8 Million to Settle False Claims Act Allegations (Nov. 20, 2020), https://www.justice.gov/opa/pr/home-health-agency-and-former-owner-pay-58-million-settle-false-claims-act-allegations.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Biogen Agrees To Pay $22 Million To Resolve Alleged False Claims Act Liability For Paying Kickbacks (Dec. 17, 2020), https://www.justice.gov/opa/pr/biogen-agrees-pay-22-million-resolve-alleged-false-claims-act-liability-paying-kickbacks.
 See Press Release, U.S. Atty’s Office for the E. Dist. of Mich., CWD Holdings To Pay $8 Million To Resolve False Claims Act Allegations Relating To Unpaid Import Duties (July 22, 2020), https://www.justice.gov/usao-edmi/pr/cwd-holdings-pay-8-million-resolve-false-claims-act-allegations-relating-unpaid-import.
 See Press Release, U.S. Atty’s Office for the E. Dist. of Va., CDM Smith and CDM Federal Programs Agrees to $5.6 Million Settlement (Aug. 31, 2020), https://www.justice.gov/usao-edva/pr/cdm-smith-and-cdm-federal-programs-agrees-56-million-settlement.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Asphalt Contractor To Pay $4.25 Million To Settle Claims That It Misled The Government As To The Materials Used To Pave Road (Sept. 10, 2020), https://www.justice.gov/opa/pr/asphalt-contractor-pay-425-million-settle-claims-it-misled-government-materials-used-pave.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Quantadyn Corporation And Owner Settle False Claims Act Allegations of Bribery To Obtain Government Contracts For Simulators (Sept. 15, 2020), https://www.justice.gov/opa/pr/quantadyn-corporation-and-owner-settle-false-claims-act-allegations-bribery-obtain-government.
 See Press Release, U.S. Atty’s Office for the E. Dist. of Wash., Bechtel & Aecom, U.S. Department of Energy (DOE) Contractors, Agree to Pay $57.75 Million to Resolve Claims of Time Charging Fraud at Doe’s Hanford Waste Treatment Plant (Sept. 22, 2020), https://www.justice.gov/usao-edwa/pr/bechtel-aecom-us-department-energy-doe-contractors-agree-pay-5775-million-resolve-0.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Illinois-Based Charter School Management Company To Pay $4.5 Million To Settle Claims Relating To E-Rate Contracts (Nov. 3, 2020), https://www.justice.gov/opa/pr/illinois-based-charter-school-management-company-pay-45-million-settle-claims-relating-e-rate.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Federal Contractor Agrees to Pay $18.98 Million for Alleged False Claims Act Caused by Overcharges and Unqualified Labor (Nov. 20, 2020), https://www.justice.gov/opa/pr/federal-contractor-agrees-pay-1898-million-alleged-false-claims-act-caused-overcharges-and.
 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Workrite Companies to Pay $7.1 Million to Settle Alleged Furniture Overcharges (Dec. 3, 2020), https://www.justice.gov/opa/pr/workrite-companies-pay-71-million-settle-alleged-furniture-overcharges.
 See Press Release, U.S. Atty’s Office for the Dist. of Vt., Government Contractor Admits Scheme to Inflate Costs on Federal Projects and Pays $11 Million to Resolve Criminal and Civil Probes (Dec. 17, 2020), https://www.justice.gov/usao-vt/pr/government-contractor-admits-scheme-inflate-costs-federal-projects-and-pays-11-million.
 See Gibson, Dunn, & Crutcher LLP, Emergency Federal Measures to Combat Coronavirus (Mar. 18, 2020), https://www.gibsondunn.com/emergency-federal-measures-to-combat-coronavirus/.
 Consolidated Appropriations Act, 2021, Pub. L. No. 116-159, 116th Cong. (2019-2020).
 Build Back Better, President-elect Biden Announces American Rescue Plan (Jan. 14, 2021), https://buildbackbetter.gov/wp-content/uploads/2021/01/COVID_Relief-Package-Fact-Sheet.pdf.
 Senator Chuck Grassley, Prepared Floor Remarks by U.S. Senator Chuck Grassley of Iowa
Celebrating Whistleblower Appreciation Day (Jul. 30, 2020), https://www.grassley.senate.gov/news/news-releases/grassley-celebrating-whistleblower-appreciation-day.
 United States v. Mark Schena, Indictment (Jun. 8, 2020), https://www.justice.gov/opa/press-release/file/1283931/download.
 U.S. Dep’t of Justice, Principal Deputy Assistant Attorney General Ethan P. Davis delivers remarks on the False Claims Act at the U.S. Chamber of Commerce’s Institute for Legal Reform (June 26, 2020), https://www.justice.gov/civil/speech/principal-deputy-assistant-attorney-general-ethan-p-davis-delivers-remarks-false-claims.
 State False Claims Act Reviews, Dep’t of Health & Human Servs.–Office of Inspector Gen., https://oig.hhs.gov/fraud/state-false-claims-act-reviews/index.asp.
 National Whistleblower Center, The False Claims Act, https://www.whistleblowers.org/protect-the-false-claims-act/.
 DC B23-0035, 23d Council (2019-2020), https://lims.dccouncil.us/Legislation/B23-0035.
 See D.C. Code § 2-381.02(a) (2013).
 See D.C. Code § 2-381.02(d) (2013) (stating that “[t]his section shall not apply to claims, records, or statements made pursuant to those portions of Title 47 of the District of Columbia Official Code that refer or relate to taxation”).
 N.Y. State Fin. Law section § 189; 740 Ill. Comp. Stat. 175/3(c).
 See HB 2352 Pennsylvania General Assembly Bill Information (2019-2020), here.
 Id.; Press Release, Penn. State Rep. Seth Grove, House Advances Amended Grove Bill to Protect Small Businesses and Combat Fraud (Sept. 30, 2020), http://www.repgrove.com/News/18371/Latest-News/House-Advances-Amended-Grove-Bill-to-Protect-Small-Businesses-and-Combat-Fraud.
 Universal Health Servs. v. United States ex rel. Escobar, 136 S. Ct. 1989, 2002 (2016).
 See AB-1270 False Claims Act, California Legislative Information (2019-2020), https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB1270.
 See AB-2570 False Claims Act, California Legislative Information (2019-2020) http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2570.
The following Gibson Dunn lawyers assisted in the preparation of this article: John Partridge, James Zelenay, Jonathan Phillips, Ryan Bergsieker, Sean Twomey, Reid Rector, Allison Chapin, Michael Dziuban, Jasper Hicks, Julie Hamilton and Eva Michaels.
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