July 12, 2017
In our 2016 Year-End Update, we noted that 2016 was a year full of change—including significant Supreme Court False Claims Act rulings and the election—and raised questions regarding the application and enforcement of the False Claims Act ("FCA") going forward. The first half of 2017 has answered some of those questions, but many remain.
First, some consensus has developed among the courts as to how to apply the Supreme Court’s decision in Universal Health Services v. United States ex rel. Escobar. Nevertheless, certain federal courts have adopted different approaches to key issues implicated by Escobar. Next, Congress continues to consider legislation that would repeal and/or replace the Patient Protection and Affordable Care Act—and potentially reshape the FCA, at least on the margins. That said, the current versions of the repeal-and-replace legislation do not appear to directly impact the FCA itself. Also, senior Trump Administration officials have touted stringent enforcement of the FCA. But FCA enforcement policy remains largely inchoate. Finally, the Administration’s overarching commitment to overhauling and reducing regulations may diminish the number of potential violations that could arguably serve as predicates for FCA actions.
Other FCA-related developments have been in line with our predictions. As we previewed in January, state legislative activity has increased in response to calls by the Centers for Medicare and Medicaid Services ("CMS") for states to increase civil penalties to match federal law. The Government has continued to recover substantial settlements based on alleged FCA violations. And several courts have interpreted Escobar as a call to strengthen the materiality analysis under the FCA, reviving a defense that had been rendered effectively non-existent in many circuits.
We address these and other important developments in greater depth below. We focus first on legislative activity at the federal and state levels, then turn to important FCA settlements that have been announced thus far in 2017, and conclude with an analysis of significant jurisprudence from the past six months.
We note at the outset of this update that Gibson Dunn’s recent publications on the FCA, including more in-depth discussions of the FCA’s framework and operation, along with practical guidance to help companies avoid or limit FCA liability, may be found on our website. Additionally, this year we will host a series of webinars about the FCA and how it may impact certain industries. The upcoming schedule for these webinars is below:
In our previous update, we raised the possibility that legislation repealing the Patient Protection and Affordable Care Act ("ACA") could implicate components of the FCA—notably the "public disclosure bar." Although the ACA has not been repealed to date, neither the bill passed by the House nor the draft currently under consideration by the Senate appears to impact the FCA. A number of states, however, have initiated amendments to state false claims acts.
Although the Trump Administration has not issued any formal policy statements regarding the FCA. Nevertheless, the few public statements made by officials during their Senate confirmation hearings indicate that the administration intends to enforce the FCA vigorously.
During his Senate confirmation hearing in January, then-nominee for U.S. Attorney General, Senator Jeff Sessions (R-AL) stated, "this government must improve its ability to protect the United States Treasury from waste, fraud, and abuse. This is a federal responsibility. We cannot afford to lose a single dollar to corruption, and you can be sure that if I am confirmed, I will make it a high priority of the department to root out and prosecute fraud in federal programs and to recover any monies lost due to fraud or false claims."[1] With regard to the qui tam provisions of the FCA, Attorney General Sessions, who represented a qui tam relator while in private practice, noted that he "think[s] that they are a valid and effective method of rooting out fraud and abuse. . . . It has saved this country lots of money. And probably has caused companies to be more cautious because they could have a whistleblower that would blow the whistle on them if they try to do something that’s improper. So I think it’s been a very healthy thing and . . . I do support the Act." Confirming that he would provide Congress with regular, timely updates on the status of FCA cases, including statistics as to how many are under seal and the average length of seal time, then-Senator Sessions added that, in his experience, the seal period stretches "an awfully long time."
Rod Rosenstein, the former U.S. Attorney for the District of Maryland, also testified before the Senate Judiciary Committee about the FCA in connection with his nomination for Deputy Attorney General. In response to a question regarding waste and fraud related to government grants, Mr. Rosenstein identified the FCA as one of the "tools" for policing compliance with grant rules.[2] The Senate Judiciary Committee Chairman, Senator Grassley (R-IA), also asked Mr. Rosenstein directly if he would vigorously enforce the FCA to recover taxpayer dollars, and Mr. Rosenstein was unequivocal in his response. "Yes, senator," Rosenstein replied. "We have enforced that in my office in the District of Maryland . . . and we certainly will continue to enforce that." Senator Grassley followed up, asking if Mr. Rosenstein would commit to ensuring that DOJ attorneys would work collaboratively with whistleblowers in regard to the fraud under the FCA and whistleblowers generally. Mr. Rosenstein responded that he would ensure that "whistleblowers receive any protection they are entitled to by law or regulation."
Deputy Attorney General Rosenstein is no stranger to the FCA. His office resolved several FCA claims during his tenure as U.S. Attorney for the District of Maryland. For example, in February, before he was confirmed as Deputy Attorney General, Mr. Rosenstein announced a settlement that required a health services contractor to pay $3.81 million to settle FCA allegations related to double billing and mischarging for medical services in connection with work performed on an Internal Revenue Service contract. In announcing the settlement, Mr. Rosenstein stated that "[b]usinesses that knowingly overcharge the government should be held accountable and penalized," and that "[w]histleblower lawsuits are a valuable tool to deter fraud and punish perpetrators."[3] In another example, in December 2016 Mr. Rosenstein announced a settlement that required a defense contractor to pay $4.43 million to settle alleged FCA violations related to the submission of false invoices that allegedly included inflated hours and exaggerated job classification rates. In the press release, Mr. Rosenstein stated that "[f]ederal authorities will vigorously investigate and prosecute defense contractors that cheat the government."[4] In both of these instances, however, the settlement agreements contain no admission of liability, and the press release for one of the settlements notes that "[t]he claims resolved by this settlement are allegations; there has been no determination of liability and [the defendants] cooperated in the investigation."[5]
The Attorney General and Deputy Attorney General were not the only Trump appointees to field questions on the FCA. During Tom Price’s confirmation hearing, Senate Finance Committee Chairman Orrin Hatch (R-UT) asked President Trump’s then-nominee for Secretary of the Department of Health and Human Services ("HHS") whether "as a former practicing physician who has experience with Medicare and Medicaid programs, [] you have any insights into steps you think should be taken to address the multibillion dollar problem of waste, fraud and abuse in these programs?"[6] Then-Representative Price responded that he supports aggressive enforcement against "bad actors" and "real time" monitoring of potential fraud and abuse:
Nobody supports care being billed for [w]hat isn’t needed or . . . hasn’t been provided. And this is one of those areas that I think we need to be very, very focused. I’m . . . certain that there are some bad actors out there. I think they’re a minority, but there’s some bad actors out there. And I’m certain that if we were to focus specifically on those bad actors in real time, which is what happens in every other industry in our country that real time information is . . . available and acted upon. Instead of . . . trying to determine whether every single incident of care is necessary. If we were to focus on those individuals that were the bad actors specifically, then I think we could do a much better job of not just identifying the fraud that exists out there, but ending that fraud.[7]
In our 2016 Year-End Update, we reported that President Trump’s promise to repeal and replace the ACA implicated various components of the FCA that were amended by the ACA, including the FCA’s "public disclosure bar" and the standard for relators to qualify as an "original source." On May 4, 2017, the House of Representatives passed the American Health Care Act of 2017,[8] and on June 22, 2017, the Senate unveiled its version of the bill, overhauling many of the ACA’s prescriptions. Both versions, however, left the FCA unaltered.[9] As such, the first half of 2017 has been surprisingly quiet on the federal legislative front. Although there was no new legislation on the federal level, there were a few regulations of note early in the year:
Opponents of the rule argue that its definition of intended use is overbroad—allowing the FDA "to consider any evidence, including knowledge"—and would lead to a growth in FCA litigation.[11] Indeed, following the transition of the new presidential administration and its regulatory freeze of finalized rules that had yet to take effect, various industry organizations submitted a petition requesting the FDA to reconsider and permanently stay the rule based on such an argument.[12] On March 20, 2017, the FDA further delayed the rule’s effective date until March 19, 2018 to allow for public comments on the issues raised in the petition.[13]
The first half of 2017 brought some notable legislative activity at the state level. As predicted in our previous update, part of this activity resulted from states introducing amendments in response to CMS’s September 2016 announcement that states should amend their false claims acts to mirror the increased civil penalties available under federal law.[17]
Since CMS’s announcement, HHS OIG analyzed all previously reviewed state false claims acts, and determined that the following states’ false claims acts complied, in their current form, with the increased civil penalties under the federal FCA: Colorado,[18] Connecticut,[19] Indiana,[20] Iowa,[21] Massachusetts,[22] Montana,[23] Nevada,[24] Oklahoma,[25] Tennessee,[26] Texas,[27] and Vermont.[28]
HHS OIG determined that the following states’ false claims acts needed to be amended to mirror the civil penalties allowed under federal law: California,[29] Delaware,[30] Florida,[31] Georgia,[32] Hawaii,[33] Illinois,[34] Michigan,[35] Minnesota,[36] New Hampshire,[37] New York,[38] North Carolina,[39] Rhode Island,[40] Virginia,[41] Washington,[42] and Wisconsin.[43] HHS OIG provided most of these states until December 31, 2018 to amend and resubmit their false claims acts for approval.[44]
Four of these states are currently considering legislation that conforms their false claims acts to the federal FCA:
States that do not amend their false claims acts to comply may be deemed by the DOJ and HHS OIG to be less effective than the federal FCA in facilitating qui tam actions and thereby lose the ability to increase by 10% their share of recoveries in cases that prosecute Medicaid fraud.
One state also recently considered enacting a broader false claims act, and another is currently considering enacting a false claims act. Although Arkansas already has a Medicaid Fraud False Claims Act, on March 21, 2017, the Arkansas Senate introduced a bill that would create a broader Arkansas False Claims Act (S.B. 548).[49] After being referred to the Senate Judiciary Committee, the bill died upon adjournment of the Committee.[50] On January 26, 2017, S.B. 65, creating Michigan’s False Claims Act, was introduced to the State Senate and referred on the same day to the Committee on Judiciary.[51]
As for several items that we mentioned in previous updates:
Federal and state governments amassed nearly $1.3 billion in FCA recoveries from settlements in the first half of this year and obtained another $370 million in judgments from FCA cases. Although these figures standing alone are staggering, they fall off the pace of the $1.86 billion recovered at the mid-year mark in 2016. Nevertheless, DOJ remains on pace for an incredible eighth consecutive year exceeding $3 billion in total FCA recoveries. Below, we summarize notable settlements in the health care and life sciences, financial services, government procurement, and defense industries, as well as two notable judgments in FCA cases.
These settlements and judgments provide some insight into both the type of industries as well as the theories of liability on which the government and relators have focused so far this year. As in years past, companies in the health care industry continued to dominate the investigations and resolutions in the first half of 2017, whereas the flow of alleged FCA violations stemming from the financial crisis continues to dwindle.
Resolutions with government contractors so far this year have reflected the broad array of alleged misconduct that may lead to FCA liability, including cost inflation and procurement of allegedly defective products.
So far this year there have been two notable judgments, one of which involved the use of statistical sampling and is among the largest FCA judgments ever.
It has now been a year since the Supreme Court’s landmark decision recognizing, and broadly defining the elements of, the implied certification theory of FCA liability in Universal Health Services v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). As we have detailed previously, in Escobar, the Supreme Court held that there could be FCA liability under the so-called "implied certification" theory of liability "at least where two conditions are satisfied: first, the claim does not merely request payment, but also makes specific representations about the goods or services provided; and second, the defendant’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths." 136 S. Ct. at 2001. The Escobar Court also went on to "clarify how [the] FCA materiality requirement should be enforced[,]" notably stating that materiality is a "rigorous" and "demanding" requirement that requires a showing, by factual proof, more than that the government merely had the "option" to refuse payment had it known of the alleged noncompliance, but instead something more akin to a showing that the government did or actually would have refused payment had it known of the alleged matter at issue. Id. at 2002–03.
Two questions have stood at the forefront of discussion regarding Escobar over the past year. First, must both of Escobar‘s "two conditions" be satisfied to establish liability under an implied certification theory? Or, more specifically, is a "specific representation" about the goods or services a prerequisite to FCA liability, or does Escobar leave the door open for liability where the allegation is that the claim itself merely somehow "implies" compliance with some legal requirement? And second, what exactly must an FCA plaintiff plead or prove to establish that noncompliance with a legal requirement is "material"? Over the past six months, a number of appellate courts have had their first foray into the post-Escobar world and have begun to wrestle with these questions. There are some common themes, but differences are emerging as well.
The Fourth Circuit’s first engagement with Escobar this year came in the same case in which it first recognized the implied certification theory (albeit pre-Escobar)—United States ex rel. Badr v. Triple Canopy, Inc., 857 F.3d 174 (4th Cir. 2017). In Badr, the DOJ intervened in an FCA case alleging that the defendant violated the FCA by falsifying marksmanship scores of guards providing security for Government facilities in Iraq, thereby allegedly making its claims for payment of those guards false because the personnel were unqualified. Id. at 175–76. Before the Supreme Court’s decision in Escobar, the district court had dismissed the case, declining to recognize the implied certification theory. United States ex rel. Badr v. Triple Canopy, Inc., 950 F. Supp. 2d 888, 899 (E.D. Va. 2013). The Fourth Circuit reversed on appeal, affirming the validity of implied certification when the Government "alleges that the contractor, with the requisite scienter, made a request for payment under a contract and withheld information about its noncompliance with material contractual requirements." United States ex rel. Badr v. Triple Canopy, 775 F.3d 628, 636 (4th Cir. 2015) (citation and internal quotation marks omitted). Following its decision in Escobar, the Supreme Court vacated and remanded Badr for reconsideration.
On remand, the Badr court determined that Escobar did not alter its earlier decision and again reversed the district court. Badr, 857 F.3d at 177–78. First, the Fourth Circuit held, in effect, that both of Escobar‘s "two conditions" are not required for a valid implied certification claim. Specifically, the Badr panel rejected defendant’s argument that the case should be dismissed because defendant was not required to certify that the guard services complied with contractual responsibilities regarding marksmanship qualifications (instead only showing the number of guards and hours worked). The court found that defendant’s omissions regarding qualifications and marksmanship fell "’squarely within the rule that half-truths . . . can be actionable misrepresentations[,]’" id. at 178 (quoting Escobar, 136 S. Ct. at 2000), and it was not bothered that there was no "specific representation" of qualifications in the claims for payment, Id. at 178.
Addressing materiality, the Fourth Circuit also found unchanged its previous ruling that the alleged noncompliance was material to government payment based on "common sense and [defendant’s] own actions in covering up the noncompliance." Id. The court noted that in Escobar, the Supreme Court had explained materiality in part by stating that "'[i]f the Government failed to specify that guns it orders must actually shoot, but the defendant knows that the Government routinely rescinds contracts if the guns do not shoot, the defendant has actual knowledge’" that such a factor is material. Id. at 179 (quoting Escobar, 136 S. Ct. at 2001–02). The Badr court found a direct analogy to that hypothetical, holding that "[g]uns that do not shoot are as material to the Government’s decision to pay as guards that cannot shoot straight." Id. Notably, the court went on to find that the Government’s failure to renew its contract with the defendant and the DOJ’s intervention in the qui tam itself were evidence that defendant’s "falsehood affected the Government’s decision to pay." Id. Though the Fourth Circuit did not cite Escobar on that point, it stands to reason that the court was considering Escobar‘s admonition that "if the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material." Escobar, 136 S. Ct. at 2003.
In February, the D.C. Circuit applied Escobar for the first time in United States ex rel. McBride v. Halliburton Co., 848 F.3d 1027 (D.C. Cir. 2017). In McBride, the relator had alleged that a contractor providing recreation services to the U.S. military in Iraq inflated headcounts detailing the amount of personnel it served. Id. at 1029. According to the relator, this made the costs the contractor submitted "unreasonable," in violation of the Federal Acquisition Regulations. Id. at 1032.
In affirming the motion for summary judgment against the relator, the D.C. Circuit found that it did not need to address whether a "specific representation" was required for liability under the implied certification theory, because the lack of evidence of materiality alone was dispositive of the relator’s claims. Id. at 1031 n.4. The McBride court noted Escobar‘s statement that the materiality question was not too "fact intensive" to decide on a motion for summary judgment, id. at 1032 (quoting Escobar, 136 S. Ct. at 2004 n.6), and, in fact, the court repeatedly stressed that FCA materiality had to be supported by evidence, rather than the relator’s speculation and say-so. For example, the McBride court noted that there was no record evidence establishing that the allegedly inflated headcount made any of defendant’s costs "unreasonable" and thus that the government would not have paid for them. Id. at 1033. Because the relator’s claim was insufficiently based on "the far-too-attenuated supposition that the Government might have had the ‘option to decline to pay[,]’" the D.C. Circuit held there was no dispute of material fact as to the materiality of the alleged conduct to Government payment, and affirmed summary judgment under Escobar. Id. at 1033–34 (quoting Escobar, 136 S. Ct. at 2003).
Two post-Escobar cases in recent months were particularly notable for bringing into relevance the knowledge and inaction not only of the government’s payment officials, but also of the government agencies later investigating the alleged noncompliance at issue.
First, in United States ex rel. Petratos v. Genentech Inc., 855 F.3d 481, 485 (3d Cir. 2017), the Third Circuit affirmed the district court’s decision to grant a motion to dismiss the relator’s claims that the defendant pharmaceutical company "had suppressed data that caused doctors to certify incorrectly that [a drug] was ‘reasonable and necessary’ for certain at-risk Medicare patients." Specifically, according to the relator, the defendant was liable under the FCA because, if it had disclosed certain data showing more common and severe side effects of its cancer drug, that "would have required the company to file adverse-event reports with the FDA, and could have resulted in changes" to the drug’s FDA label. Id. Relator further alleged that had the side-effect information been disclosed, physicians would have prescribed different doses of the drug, or not prescribed it at all. Id. at 486.
In affirming the district court’s dismissal of the relator’s allegations for failure to state a claim, the Third Circuit found that the alleged data suppression was not material to payment under Escobar. Citing Escobar, the court noted that the relator’s claims must fail, in large part, because he "not only fails to plead that CMS ‘consistently refuses to pay’ claims like those alleged . . . but essentially concedes that CMS would consistently reimburse these claims with full knowledge of the purported noncompliance." Id. at 490 (quoting Escobar, 136 S. Ct. at 2003). On the relevance of the government’s knowledge to materiality, the court went even further, observing that the relator had disclosed the allegations to the FDA and the DOJ, but that neither of those agencies took any adverse action. Id. In fact, the court noted, the FDA added more approved indications for the drug and the DOJ declined to intervene in the qui tam suit. Id. The court thereby concluded that since the relator "concedes that the expert agencies and government regulators have deemed these violations insubstantial (or at least would do so if made aware), we do not think it appropriate for a private citizen to enforce these regulations through the [FCA]." Id.
The Fifth Circuit seemingly employed similar reasoning in Abbott v. BP Exploration & Production, Inc., 851 F.3d 384 (5th Cir. 2017). There, the relator appealed a summary judgment in favor of defendant on his claims that the defendant had "falsely certified compliance with various regulatory requirements" for one of its oil production facilities. Id. at 386. The Fifth Circuit affirmed under Escobar for a lack of evidence of materiality, concluding that the fact that there had been both a congressional and a Department of the Interior investigation into the allegations, and yet the government still had not taken any action against the defendant (such as a revocation of the company’s drilling rights), represented "strong evidence" that the regulations the defendant had allegedly violated were "not material." Id. at 388.
While Escobar clearly stated that the Government’s continuing to pay despite knowledge of the alleged noncompliance is "strong evidence" of immateriality, it did not as clearly say that inaction by the agencies investigating the same alleged noncompliance would also potentially negate FCA materiality. That some courts seem to be extending Escobar‘s comments on Government knowledge even to the DOJ’s intervention decision is a notable development, though it seems only to underscore what the case data already show—that Government intervention is the most important inflection point in the life of an FCA case. Whether these cases are the start of a trend is worth watching.
In January, the Ninth Circuit applied Escobar for the first time in a published opinion in United States ex rel. Kelly v. Serco, Inc., 846 F.3d 325 (9th Cir. 2017). In Kelly, the relator alleged that his former employer, a technology services provider, had failed to use a particular cost and progress tracking system, called the earned value management ("EVM") system, required by industry cost guidelines, and had failed to make required EVM reports to the prime contractor under a Government contract. According to relator, this failure made defendant’s payment vouchers false under an implied certification theory. Id. at 329. The district court granted summary judgment for the defendants, and in Kelly, the Ninth Circuit affirmed. Id.
The Kelly court structured its analysis around Escobar‘s "two conditions." Although it did not expressly rule on whether both of the conditions are required, the Kelly court took the trouble to analyze whether the first condition was met, and found that it was not. Id. at 332–33. The court explained that the defendant’s claims included no representations about its "performance"; rather, they merely contained the time period of the work and total costs and fees incurred. Id. Nor was there any evidence that the defendant’s vouchers "contained any false or inaccurate statements." Id. at 333. Noting that the relator’s dispute was really about the "format that [defendant] used to report costs incurred," the Ninth Circuit went on to reason that "his FCA claim fails because the FCA attaches liability, not to the underlying fraudulent activity or to the government’s wrongful payment, but to the claim for payment—here, [defendant’s] public vouchers." Id. (citation and internal quotation marks omitted).
Apparently on alternative grounds, and citing Escobar, the Kelly court also affirmed on the basis that the relator had failed to plead materiality. The relator had argued that the alleged false statements were material because they were contained within reports that the government supposedly "relied on" to manage the project under contract. Id. at 333. The court rejected that argument and emphasized that the government knew that some of the reports it received from the defendant were not compliant with industry standards, but accepted the reports and continued making payments to the defendant for its work anyway. Id. at 334. It did not help the relator’s case that there was evidence cited by the court that the government did not even find the compliant "reports helpful[,] and did not use them to manage the . . . [p]roject." Id.
More recently, the Ninth Circuit applied Escobar in the context of allegations involving a drug manufacturer and certain applicable FDA regulations, but to strikingly different results from the court’s approach in Kelly. In United States ex rel. Campie v. Gilead Sciences, Inc., No. 15-16380, 2017 WL 2884047, at *2–3 (9th Cir. July 7, 2017), the relators alleged that the defendant biotechnology company fraudulently obtained approval for certain of its drugs by making false statements to the FDA about the manufacturing source of the drugs’ active ingredient and negative results of internal quality testing of the products. According to the relators, although the defendant later sought (and obtained) FDA approval of the manufacturing site, if the FDA had been aware of the alleged quality issues, it would not have granted that approval. Id. The relators also alleged that the defendant took various steps to fraudulently conceal that, prior to approval, it was obtaining the active ingredient from unapproved manufacturing sites. Id. at *3.
After the government declined to intervene, the district court granted the defendant’s pre-Escobar motion to dismiss, finding primarily that the relators had not pled that the allegedly violated FDA regulations were a material condition of payment, and thus they had not stated a claim for relief under an implied certification theory. See id. at *5. The Ninth Circuit reversed. As to the relators’ implied certification theory, the court notably began its discussion by making explicit that "[t]o succeed on such a claim . . . [the defendant] must not merely request payment, but also make specific representations about the goods or services provided"—thus making explicit that both of Escobar‘s "two conditions" must be satisfied for implied certification liability. Id. at *7. But the court then indicated that the drug’s proprietary names alone could constitute a false representation, because they "necessarily refer to specific drugs under the FDA’s regulatory regime"—in other words, the drug names themselves represent FDA approval. Id. Accordingly, the court reasoned, the defendant "requested payment for drugs that fell outside of that approval and omitted critical information regarding compliance with FDA standards." Id.
The court also rejected the distinction, advanced by the defendant and adopted by the district court, that any misrepresentations were made to the FDA, not the government agency paying for the drugs. Id. at *8. The court, rather incredibly, stated that the fraud was "committed against the Department of Health and Human Services," which oversees the FDA, and thus indicated that a fraud on one large component agency amounts to a fraud on a separate component agency, as long as they are "overseen" by the same cabinet secretary. Id. In any event, the court went on to reason that "[i]t is not the distinction between the agencies that matters, but rather the connection between the regulatory omissions and the claim for payment." Id. More specifically, according to the Campie court, the crux of the inquiry is whether the false statement is "integral to [the] causal chain leading to payment[.]" Id. (citation and internal quotation marks omitted).
Turning to the second condition of implied certification liability, materiality, the court found that condition was met because "FDA approval is the sine qua non of federal funding here." Id. at *9 (citation and internal quotation marks omitted). The court then rejected the defendant’s argument—similar to the one employed by the court in Kelly—that the FDA’s choice not to withdraw approval, even after it became aware of the unsanctioned manufacturing site and the alleged quality issues, showed that the alleged conduct was not material. Id. at *9–10. The court noted that "there are many reasons the FDA may choose not to withdraw a drug approval," and unlike the situation in Kelly, in this case the FDA’s continued approval of the drugs was unremarkable since the company had stopped using the manufacturing site in question. Id. at *11.
The Campie court’s analysis of materiality was, at best, half-baked because although it recognized that FDA approval was material to payment, it never analyzed how the alleged statements or regulatory violations were material to the FDA approval, or whether the relators’ pleading had established those seemingly required facts. Nevertheless, the court concluded—citing Kelly—that the "issues raised by the parties here are matters of proof, not legal grounds to dismiss relators’ complaint." Id. The procedural posture of Campie (a motion to dismiss) may distinguish it from Kelly (summary judgment), but regardless the Campie court did not give much regard to Escobar‘s admonition that questions about materiality in the implied certification context are "[not] too fact intensive for courts to dismiss [FCA] cases on a motion to dismiss . . . ." 136 S. Ct. at 2004 n.6.
In sum, it remains to be seen whether the Ninth Circuit’s different attitude toward implied certification claims in Kelly and Campie reflect mere factual differences. The commonality in the Ninth Circuit appears to be that both of Escobar‘s "two conditions" are required for implied certification liability, though what exactly is a "specific representation" remains somewhat open to interpretation. Given how the Fourth Circuit seemingly took a different stance on the "two conditions" issue, there may be a circuit split brewing on Escobar‘s "two conditions."
As we have logged extensively in these pages, circuit courts around the country have taken varying approaches to whether Federal Rule of Civil Procedure 9(b)—which requires fraud, and FCA, claims to be pled with particularity—requires FCA plaintiffs to plead specific, representative examples of false claims in their complaints. In recent years, some circuits that previously appeared to set such a requirement showed some flexibility, adding further variability to the circuit split that has developed around the contours of Rule 9(b). For example, last year, the Sixth Circuit held a relator need not identify the specifics of a false claim to survive a Rule 9(b) motion to dismiss, at least where he or she had personal knowledge "that support[s] a strong inference that specific false claims were submitted[.]" United States ex rel. Prather v. Brookdale Senior Living Cmtys., Inc., 838 F.3d 750, 773 (6th Cir 2016). But in its recent decision in United States ex rel. Hirt v. Walgreen Co., 846 F.3d 879 (6th Cir. 2017), the Sixth Circuit refused to extend such a "relaxed" pleading standard to other contexts. In Hirt, the relator, a pharmacy owner, alleged that a rival pharmacy chain offered gift cards to lure customers in violation of the Anti-Kickback Statute and FCA. Id. at 880. Yet the relator’s complaint "d[id] not identify a single false claim[,]" and he described only "the unlawful distribution of gift cards in general but not the submission of any claims obtained with those gift cards." Id. at 881. The Sixth Circuit distinguished the relator in Hirt from the relator in Prather because the latter "had sufficient personal knowledge of the defendant’s claims submission and billing processes" and held a job whose "sole purpose [was] submitting the claims to Medicare" for government payment. Id. at 881–82. It appears that the Hirt court viewed that as the line in the sand, stressing that its decision in Prather did not "relax" Rule 9(b)’s requirements and that the court had "no more authority to ‘relax’ the pleading standard . . . than we do to increase it." Id. at 881.
Since it was amended in 2010, the FCA’s public disclosure bar has mandated that a court "shall dismiss" a relator’s FCA action if "substantially the same allegations or transactions" were publicly disclosed in certain enumerated sources, such as news media or government hearings or reports, unless the relator qualifies as an "original source" of the information. 31 U.S.C. § 3730(e)(4). A number of circuit courts weighed in on the contours of the public disclosure in the past six months, with some particularly notable decisions in the Eighth and Ninth Circuits interpreting the scope of information to which the bar applies and when relators can qualify for the "original source" exception to the bar.
First, the Eighth Circuit recently provided some useful fodder for determining how specific a public disclosure must be for the bar to be triggered, in United States ex rel. Lager v. CSL Behring, L.L.C., 855 F.3d 935 (8th Cir. 2017). In CSL Behring, the relator alleged that the defendant, a maker of protein-based therapies and related equipment, reported an average wholesale price ("AWP")—the price at which Medicare would reimburse the products—far in excess of its actual costs. Id. at 938–39. According to the relator, the defendant then marketed the "spread" by promoting that customers buy its products at close to actual cost and thereby make a profit when the products were reimbursed at the higher AWP amount. Id. at 939. The district court found that the allegations of fraudulent marketing the spread, and the inference that they could apply to the defendant, were publicly disclosed in a wide variety of government reports, CMS data, and news media. Id. Accordingly, the district court granted the defendant’s motion to dismiss. Id. at 940.
The Eighth Circuit affirmed. First, in response to the relator’s argument that he added value by pointing to the specific defendant in question, the court held that to trigger the statutory bar, a public disclosure must either "explicitly identify" the defendant or "provide enough information about the participants in the scheme such that the defendant is identifiable." Id. at 944. The court then agreed with the district court that collectively, the various sources speaking to AWP issues, including CMS data showing the defendant’s prices and a government report identifying the same class of products, "provide enough information" to "directly identify" the defendant and its products. Id. at 945–46 (citation and internal quotation marks omitted). The court went on to find that the same sources disclosed the concept of marketing the spread and the potential for fraudulent AWP reporting, and thus the "elements critical to [relator’s] complaint theory were already in the public domain before [he] brought suit" and the statutory bar applied. Id. at 948–49.
A number of courts have interpreted the scope of the FCA’s enumerated sources of public disclosures to encompass pleadings and other public filings in civil litigation. In Amphastar Pharmaceuticals Inc. v. Aventis Pharma SA, 856 F.3d 696 (9th Cir. 2017),[90] the Ninth Circuit examined the application of the public disclosure bar in that context and concluded that it precludes allegations and transactions the bases for which were developed by the relator itself during discovery in a prior suit. In Amphastar, the relator, a generic pharmaceutical manufacturer, alleged that the defendant innovator manufacturer violated the FCA by submitting false information to the U.S. Patent and Trademark Office in obtaining a patent for one of its drugs, which then allowed the defendant to maintain a monopoly in the market for this drug and thus allegedly overcharge the government. Id. at 702. These claims echoed the relator’s earlier assertion of inequitable conduct as an affirmative defense to a patent infringement suit brought by the defendant, which the relator eventually won after obtaining discovery. Id. at 701. The government declined to intervene in the FCA case, and the district court dismissed, finding that the FCA claims were publicly disclosed in the earlier litigation and the relator was not an "original source" of the information. Id. at 702.
The relator appealed, and the Ninth Circuit affirmed the dismissal. After observing that "pleadings or other public filings" can provide the basis for public disclosures that trigger the statutory bar, id. at 703, the court held that the relator’s amended answer and counterclaim for inequitable conduct in the prior suit "made nearly identical allegations to those made" in the FCA case, id. at 704. The court rejected the relator’s argument that it had not previously raised FCA claims, reasoning that an allegation "need not include an express reference to the [FCA,]" nor must it contain "every specific detail" for the bar to apply. Id. at 704 (citation and internal quotation marks omitted). The court also noted that although the relator had not previously alleged that the government was buying the drug in question while the defendant asserted its patent, that was "an obvious inference based on the publicly disclosed allegations." Id.
Moving to its analysis of the "original source" exception, the Amphastar court found, applying the pre-2010 version of the rule, that the relator lacked the required "direct and independent knowledge" of the allegations because the underlying information was developed during the earlier litigation. Id. at 706–-08. Specifically, the court refused to overturn the district court’s factual findings on this issue, noting in particular that when the relator raised its affirmative defenses in the prior litigation, it did so "based on facts recently developed in th[e] litigation[.]" Id. at 707. Notably, the court also recognized as evidence of the lack of direct and independent knowledge the relator’s mandatory disclosure statement to the DOJ in the qui tam case, in which it stated that it discovered the alleged fraud "during [its] litigation" with the defendant. Id.
The Ninth Circuit had another recent opportunity to examine the contours of the public disclosure bar and, in particular, a unique question: can a relator satisfy the statute’s requirement of voluntarily disclosing the allegations to the government prior to suit, if the pre-suit disclosure occurs as part of the relator’s government employment? In Prather v. AT&T, Inc., 847 F.3d 1097 (9th Cir. 2017), the relator, a former prosecutor in the organized crime section of the New York Office of Attorney General, alleged that the defendant telecommunications company overcharged the government for costs associated with law enforcement wiretapping activities. The relator conceded that the public disclosure bar applied to his claims, which were publicized before his suit. Applying the pre-amendment version of the statute, the court affirmed the district court’s dismissal of the relator’s claims because he did not qualify as an original source of the information about wiretapping charges in part because he did not "voluntarily provide[] the information to the Government before filing [his] action." Id. at 1105. Noting that the relator had developed his knowledge of wiretapping from his work prosecuting organized crime, the court reasoned that although that work did not "include[] a duty to report fraud against the government," the relator’s disclosures of fraud were made in response to a request from his employer; they were accomplished during the ordinary course of his work and in his official capacity; and he was compensated by a government salary. Id. at 1107–08. The court held that under these circumstances, a relator cannot be said to have "voluntarily provided" the allegations of fraud prior to suit, as the public disclosure bar requires.
In April, the Second Circuit joined the D.C. Circuit in finding that the FCA’s first-to-file rule is not jurisdictional. In United States ex rel. Hayes v. Allstate Ins. Co., 853 F.3d 80, 84 (2d Cir. 2017), the relator alleged that defendant liability insurance companies engaged in a nationwide scheme to defraud Medicare. Finding that the relator had no personal knowledge of the alleged scheme, the district court had dismissed the action with prejudice. Id. On appeal, defendants contended the court correctly dismissed the complaint, and a small group of defendants advanced a separate basis for affirming the decision—"that the district court lacked subject matter jurisdiction over Hayes’s action because Hayes did not satisfy the FCA’s first-to-file rule," as he raised a similar action that was already pending in the same district. Id. at 84–85.
The Second Circuit affirmed the dismissal on the grounds addressed by the district court. But in addressing jurisdiction, the Second Circuit held that "a district court does not lack subject matter jurisdiction over an action that may be barred on the merits by the first-to-file rule." Id. at 86. The Second Circuit found persuasive the D.C. Circuit’s observation that the language of 31 U.S.C. § 3730(b)(5) "’speaks only to who may bring a private action and when’" but "’does not speak in jurisdictional terms or refer in any way to the jurisdiction of the district courts[.]’" Id. (quoting United States ex rel. Heath v. AT&T, Inc., 791 F.3d 112, 120 (D.C. Cir. 2015)).
Meanwhile, in United States ex rel. Carson v. Manor Care, Inc., 851 F.3d 293 (4th Cir. 2017), the Fourth Circuit addressed a different issue under the first-to-file rule, and refused to take a strict approach to application of the bar, finding that it applies when allegations cover conduct occurring in different states and when the lower court consolidates competing claims. Carson involved two competing FCA actions against the defendant nursing facility operator alleging similar violations of Medicare regulations, including overbilling and providing unnecessary patient services. Id. at 300–01. The second relator, filing two years after the initial qui tam action, attempted to distinguish the claims through factual additions, the occurrence of alleged violations in Pennsylvania rather than Virginia, and the novel defense that the district court’s consolidation of the two claims prevented dismissal under the first-to-file bar. Id. at 300, 303–05.
To determine whether the later-filed complaint bore enough similarity to the earlier-filed complaint to trigger the first-to-file bar, the Fourth Circuit applied the "material elements test," which bars a later suit "if it is based upon the same material elements of fraud as the earlier suit, even though the subsequent suit may incorporate somewhat different details." Id. at 302. The Fourth Circuit found the later complaint’s claims "are essentially the same as those found in [the initial] complaint," and neither "factual additions nor the fact that [the second relator’s] experience took place in Pennsylvania . . . saves him from the first-to-file bar." Id. at 303–04. Regarding the consolidation argument, the Fourth Circuit definitively held "[t]he FCA does not make an exception to the first-to-file rule for consolidated complaints," and, as such, the district court properly dismissed the case. Id. at 305.
In United States ex rel. Phalp v. Lincare Holdings, Inc., 857 F.3d 1148 (11th Cir. 2017), the relators alleged that defendants, suppliers of oxygen and respiratory therapy services, submitted claims without authorization from the relevant Medicare beneficiaries and after making unsolicited telemarketing calls to Medicare beneficiaries, thereby allegedly violating Medicare regulations and the FCA. The district court granted summary judgment for defendants, finding that the relators had failed to present evidence of the defendants’ scienter under the FCA because "a defendant’s reasonable interpretation of any ambiguity inherent in the regulations belies the scienter necessary to establish a claim of fraud under the FCA." Id. at 1155. The Eleventh Circuit affirmed, but rejected "that a finding of scienter can be precluded by a defendant’s identification of a reasonable interpretation of an ambiguous regulation that would have permitted its conduct." Id. The court clarified that instead, the relevant inquiry is whether the defendant "actually knew or should have known that its conduct violated a regulation in light of any ambiguity at the time of the alleged violation." Id. The Phalp court explained that a contrary holding would allow defendants to escape FCA liability by manufacturing—post hoc—a supposedly reasonable interpretation "despite having actual knowledge of a different authoritative interpretation." Id. (emphasis added). However, the court went on to find that the evidence adduced by the relators—two emails that dealt with different issues or time periods from the case in question—did not permit a reasonable jury to conclude that the defendants knowingly submitted false claims.
It is interesting, and perhaps surprising, that the Eleventh Circuit did not cite the Supreme Court’s opinion in Safeco Ins. Co. of Am. v. Burr, 551 U.S. 47 (2007), which clarified the application of a scienter requirement under the Fair Credit Reporting Act that is identical to the FCA’s standard. The Safeco court held that a defendant is not reckless if it adopts an interpretation of a regulation that is not objectively unreasonable, even if it turns out to be erroneous. The court explained that "where . . . the statutory text and relevant court and agency guidance allow for more than one reasonable interpretation, it would defy history and current thinking to treat a defendant who merely adopts one such interpretation as a knowing or reckless violator." Id. at 70 n.20.
Two cases in the past six months—one from the Eleventh Circuit and one from the Ninth—addressed the relatively unusual questions of when nonparties—either a private party or the government after it initially declines—can intervene in an ongoing FCA case.
First, in United States v. Everglades College, Inc., 855 F.3d 1279 (11th Cir. 2017), the Eleventh Circuit clarified the situations in which the FCA’s good-cause intervention requirement applies. The case arrived at the Eleventh Circuit by a winding path. The relators had brought their FCA allegations to the government, but the government declined to intervene, and thus the relators litigated the case on their own. Though the relators won at trial, they were unsatisfied with the outcome, and they appealed. The United States then, apparently concerned that the Eleventh Circuit would affirm the district court (which had adopted a somewhat narrow view of FCA liability), stepped in and settled with the defendants. Id. at 1283–84.
The relators cried foul and appealed to the Eleventh Circuit for relief, arguing that the United States had no good reason to intervene, and had thus violated the FCA’s provision at 31 U.S.C. § 3730(c)(3), which allows the government—once it has declined to pursue a case—to intervene only upon a showing of "good cause." Id. at 1285. By settling with the defendants, the relators alleged, the government had deprived the relators of their chance at a greater recovery upon reversal and remand. Id. The Eleventh Circuit disagreed. Joining with the D.C. and Fifth Circuits, the court held that the good-cause intervention provision does not apply when the government steps in to settle and end litigation; the provision applies only when the government steps in to proceed with the litigation. Id. at 1285–86. The Eleventh Circuit affirmed the lower court’s dismissal of the case, as a result of the settlement between the United States and the defendants.
In a case involving the opposite situation (where the government, not a relator, has brought an FCA suit), the Ninth Circuit prohibited a private party from intervening. In United States v. Sprint Communications, Inc., 855 F.3d 985, 987 (9th Cir. 2017), the private party had brought a similar qui tam action against the same defendant several years earlier, and failed. When the government subsequently sued the same defendant, the party attempted to intervene. Id. at 988. The Ninth Circuit found that where an earlier qui tam action has been unsuccessful, the relator has no "significantly protectable interest," as required by Federal Rule of Civil Procedure 24(a)(2), and thus the relator cannot intervene in, nor does he or she have a claim for monetary recovery from, the government’s separate action. Id. at 990–91.
As was widely expected, the Fourth Circuit refused to issue a decision on the merits regarding the validity of relator’s use of statistical sampling to establish liability and damages in an FCA case when it ruled in United States ex rel. Michaels v. Agape Senior Community, Inc., 848 F.3d 330 (4th Cir. 2017). Instead, the Fourth Circuit ruled on jurisdictional grounds, finding that the appeal before it was not jurisdictionally appropriate. Id. at 341 (citing McFarlin v. Conseco Servs., LLC, 381 F.3d 1251, 1259 (11th Cir. 2004)).
On a separate matter, the Fourth Circuit in Michaels joined a growing number of circuits ruling on the authority of the United States Attorney General to veto voluntary settlements in qui tam actions. In Michaels, a proposed settlement between the relator and defendants emerged from mediation, but the DOJ, which had not intervened in the case, objected. Id. at 335. The Fourth Circuit, affirming the district court and agreeing with the Fifth and Sixth Circuits, found that "the Attorney General possesses an absolute veto power over voluntary settlements in FCA qui tam actions," basing its judgment on a plain reading of 31 U.S.C. § 3730(b)(1), which directs that an action "may be dismissed only if the court and the Attorney General give written consent to the dismissal." Id. at 339.
In so ruling, the Fourth Circuit gives broad authority to the Attorney General to reject any qui tam settlement under § 3730(b) whether or not the Government has intervened, finding the statute "is not temporally qualified or explicitly limited in any other manner" and "does not overtly require the Government to satisfy any standard or make any showing reviewable by the court." Id. The decision in Michaels is yet another sign that even long after declination, parties likely have no choice but to engage with the Government as another negotiating party to ensure their settlements can be finalized.
The first half of 2017 ushered in the Trump Administration and saw notable developments in FCA jurisprudence on both the legislative and judicial fronts. As the new administration’s enforcement policy coalesces and the courts continue to construe the FCA in a post-Escobar world, we will monitor FCA legislative activity, settlements, and jurisprudence throughout the year. You can look forward to a comprehensive summary in our 2017 False Claims Act Year-End Update, which we will publish early in January 2018.
[1] Senate Judiciary Committee Hearing on Nomination of Sen. Jeff Sessions to be U.S. Attorney General, 115th Cong. (Jan. 10, 2017), https://www.c-span.org/video/?420932-1/attorney-general-nominee-jeff-sessions-testifies-confirmation-hearing.
[2] Senate Judiciary Committee Hearing on Nominations of Rod Rosenstein and Rachel Brand to be Deputy Attorney General and Associate Attorney General, 115th Cong. (Mar. 7, 2017), https://www.c-span.org/video/?424989-1/deputy-associate-attorneys-general-testify-confirmation-hearing.
[3]See Press Release, U.S. Atty’s Office for the Dist. of Md., U.S. Dep’t of Justice, Health Services Contractor Agrees to Pay $3.818 Million to Settle False Claims Act Allegations for Double-Charging And Mischarging Medical Services on Internal Revenue Service Contract (Feb. 8, 2017), https://www.justice.gov/usao-md/pr/health-services-contractor-agrees-pay-3818-million-settle-false-claims-act-allegations.
[4]See Press Release, U.S. Atty’s Office for the Dist. of Md., U.S. Dep’t of Justice, Defense Contractor Agrees to $4.535 Million Settlement for Alleged False Claim Act Violations (Dec. 28, 2016), https://www.justice.gov/usao-md/pr/defense-contractor-agrees-4535-million-settlement-alleged-false-claim-act-violations.
[5]See Press Release, U.S. Atty’s Office for the Dist. of Md., U.S. Dep’t of Justice, Health Services Contractor Agrees to Pay $3.818 Million to Settle False Claims Act Allegations for Double-Charging And Mischarging Medical Services on Internal Revenue Service Contract (Feb. 8, 2017), https://www.justice.gov/usao-md/pr/health-services-contractor-agrees-pay-3818-million-settle-false-claims-act-allegations.
[6] Senate Finance Committee Hearing on Nomination of Rep. Price to be Health and Human Services Secretary, 115th Cong. (Jan. 24, 2017), https://www.c-span.org/video/?422427-1/hhs-nominee-representative-tom-price-testifies-confirmation-hearing.
[7]Id.
[8] H.R.1628 — 115th Congress (May 4, 2017).
[9] As of the date of this publication, Congress had not voted on the bill.
[10] 82 Fed. Reg. 2194 (Jan. 9, 2017).
[11]See Petition to Stay and for Reconsideration, Ropes & Gray and Sidley Austin LLP on behalf of the Medical Information Working Group, the Pharmaceutical Research and Manufacturers of America, and the Biotechnology Innovation Organization (Feb. 8, 2017), available in Docket Nos. FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149 at https://www.regulations.gov.
[12]See id.
[13]See U.S. Food & Drug Admin., Opportunities to Comment Closing – July 2017 (last updated May 8, 2017), https://www.fda.gov/ForPatients/CommentonGuidance/ucm557924.htm.
[14] 82 Fed. Reg. 4100 (Jan. 12, 2017).
[15] 82 Fed. Reg. 9131 (Feb. 3, 2017).
[16]Id.
[17]See U.S. Dep’t of Health & Human Servs., Office of Inspector Gen., State False Claims Act Reviews, https://oig.hhs.gov/fraud/state-false-claims-act-reviews/index.asp.
[18]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Cynthia H. Coffman (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Colorado.pdf.
[19]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. George C. Jepsen (Dec. 30, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Connecticut.pdf.
[20]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Greg Zoeller (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Indiana.pdf.
[21]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Tom Miller (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Iowa.pdf.
[22]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Maura Healey (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Massachusetts.pdf.
[23]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Tim Fox (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Montana.pdf.
[24]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Adam Paul Laxalt (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Nevada.pdf.
[25]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Mike Hunter (June 6, 2017), https://oig.hhs.gov/fraud/docs/falseclaimsact/Oklahoma.pdf.
[26]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Herbert H. Slatery III (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Tennessee.pdf.
[27]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Ken Paxton (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Texas.pdf.
[28]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. William H. Sorrell (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Vermont.pdf.
[29]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Kamala D. Harris (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/California.pdf.
[30]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Matt Denn (Dec. 28 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Delaware.pdf.
[31]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Pam Bondi (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/florida-supplement2.pdf.
[32]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Samuel S. Olens (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Georgia.pdf.
[33]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Douglas S. Chin (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Hawaii.pdf.
[34]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Lisa Madigan (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Illinois.pdf.
[35]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Bill Schuette (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Michigan-supplement2.pdf.
[36]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Lori Swanson (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Minnesota.pdf.
[37]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Joseph Foster (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/NewHampshire-supplement.pdf.
[38]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Eric T. Schneiderman (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/NewYork.pdf.
[39] See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Roy Cooper (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/NorthCarolina-supplement.pdf.
[40]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Peter Kilmartin (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/RhodeIsland.pdf.
[41]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Mark Herring (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Virginia.pdf.
[42]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Bob Ferguson (Dec. 30, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Washington.pdf.
[43]See Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Brad Schimel (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/Wisconsin-supplement.pdf.
[44]See, e.g., Letter from Daniel R. Levinson, Inspector Gen., U.S. Dep’t of Health & Human Servs., to Att’y Gen. Kamala D. Harris (Dec. 28, 2016), https://oig.hhs.gov/fraud/docs/falseclaimsact/California.pdf.
[45] S.B. 1577, 100th Gen. Assembly (Ill. 2017), http://www.ilga.gov/legislation/billstatus.asp?DocNum=1577&GAID=14&GA=100&DocTypeID=SB&LegID=104225&SessionID=91.
[46] B. A07989, 240th Leg. (N.Y. 2017), https://www.nysenate.gov/legislation/bills/2017/a7989.
[47] S.B. 387, 2017-2018 Reg. Sess. (Cal. 2017), https://leginfo.legislature.ca.gov/faces/billHistoryClient.xhtml?bill_id=201720180SB387.
[48] S.B. 378, 2017-2018 Reg. Sess. (N.C. 2017), https://legiscan.com/NC/bill/S378/2017.
[49] S.B. 548, 91st Gen. Assembly (Ark. 2017), http://www.arkleg.state.ar.us/assembly/2017/2017R/Pages/BillInformation.aspx?measureno=SB548.
[50]See id.
[51] S.B. 0065, 2017 Reg. Sess. (Mich. 2017), http://www.legislature.mi.gov/(S(3d2ghsmxrnnd3b1kucty2df4))/mileg.aspx?page=getObject&objectName=2017-SB-0065
[52] S.B. 216, 2016 Reg. Sess. (Ala. 2016), https://legiscan.com/AL/bill/SB216/2016.
[53] S.B. 2645, 216th Leg. (N.J. 2015); S.B. 326, 217th Leg. (N.J. 2016), http://www.njleg.state.nj.us/bills/BillView.asp?BillNumber=S326.
[54] B. A07304, 238th Leg. (N.Y. 2015), http://assembly.state.ny.us/leg/?default_fld=&bn=A07304&term=2015&Summary=Y&Text=Y.
[55] 2015 S.C. S.B. 223, S.C. Gen. Assembly 121st Session 2015-2016, http://www.scstatehouse.gov/sess121_2015-2016/bills/223.htm.
[56]See Press Release, U.S. Atty’s Office for the Northern Dist. of Tex., U.S. Dep’t of Justice, Texas Dental Management Firm, 19 Affiliated Dental Practices, and Their Owners and Marketing Chief Agree to Pay $8.45 Million to Resolve Allegations of False Medicaid Claims for Pediatric Dental Services (Jan. 9, 2017), https://www.justice.gov/usao-ndtx/pr/texas-dental-management-firm-19-affiliated-dental-practices-and-their-owners-and.
[57]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Shire PLC Subsidiaries to Pay $350 Million to Settle False Claims Act Allegations (Jan. 11, 2017), https://www.justice.gov/opa/pr/shire-plc-subsidiaries-pay-350-million-settle-false-claims-act-allegations.
[58]See Press Release, U.S. Atty’s Office for the Dist. of Conn., U.S. Dep’t of Justice, Connecticut Home Health Agency and its Owners Pay $5.25 Million to Settle False Claims Act Violations (Jan. 12, 2017), https://www.justice.gov/usao-ct/pr/connecticut-home-health-agency-and-its-owners-pay-525-million-settle-false-claims-act.
[59]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Baxter Healthcare Corporation to Pay More Than $18 Million to Resolve Criminal and Civil Liability Relating to Sterile Products (Jan. 12, 2017), https://www.justice.gov/opa/pr/baxter-healthcare-corporation-pay-more-18-million-resolve-criminal-and-civil-liability.
[60]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Medstar Ambulance to Pay $12.7 Million to Resolve False Claims Act Allegations Involving Medically Unnecessary Transport Services and Inflated Claims to Medicare (Jan. 13, 2017), https://www.justice.gov/opa/pr/medstar-ambulance-pay-127-million-resolve-false-claims-act-allegations-involving-medically.
[61]See Press Release, U.S. Atty’s Office for the Southern Dist. of N.Y., U.S. Dep’t of Justice, Manhattan U.S. Attorney Announces $50 Million Settlement With Walgreens For Paying Kickbacks To Induce Beneficiaries Of Government Healthcare Programs To Fill Their Prescriptions At Walgreens’ Pharmacies (Jan. 19, 2017), https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-announces-50-million-settlement-walgreens-paying-kickbacks-induce.
[62]See Press Release, U.S. Atty’s Office for the Eastern Dist. of Ky., U.S. Dep’t of Justice, Pain Management Physician Resolves False Claims Act Allegations (Feb. 1, 2017), https://www.justice.gov/usao-edky/pr/pain-management-physician-resolves-false-claims-act-allegations.
[63]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Healthcare Service Provider to Pay $60 Million to Settle Medicare and Medicaid False Claims Act Allegations (Feb. 6, 2017), https://www.justice.gov/opa/pr/healthcare-service-provider-pay-60-million-settle-medicare-and-medicaid-false-claims-act.
[64]See Press Release, U.S. Atty’s Office for the Southern Dist. of Fla., U.S. Dep’t of Justice, Dr. Gary Marder and the United States Consent to a Final Judgment of Over $18 Million to Settle False Claims Act Allegations (Feb. 7, 2017), https://www.justice.gov/usao-sdfl/pr/dr-gary-marder-and-united-states-consent-final-judgement-over-18-million-settle-false.
[65]See Press Release, U.S. Atty’s Office for the Northern Dist. of Tex., U.S. Dep’t of Justice, Hospice Companies To Pay $12.2 Million To Settle Kickback Claims (Apr. 18, 2017), https://www.justice.gov/usao-ndtx/pr/hospice-companies-pay-122-million-settle-kickback-claims.
[66]See Press Release, U.S. Atty’s Office for the Eastern Dist. of Cal., U.S. Dep’t of Justice, Walgreen Co. Pays $9.86M to Settle Allegations of Improper Medi Cal Billings (Apr. 20, 2017), https://www.justice.gov/usao-edca/pr/walgreen-co-pays-986m-settle-allegations-improper-medi-cal-billings.
[67]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Oxygen Equipment Provider Pays $11.4 Million to Resolve False Claims Act Allegations (Apr. 25, 2017), https://www.justice.gov/opa/pr/oxygen-equipment-provider-pays-114-million-resolve-false-claims-act-allegations.
[68]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Indiana University Health and HealthNet to Pay $18 Million to Resolve Allegations of False Claims (Apr. 27, 2017), https://www.justice.gov/opa/pr/indiana-university-health-and-healthnet-pay-18-million-resolve-allegations-false-claims.
[69]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Blood Testing Laboratory to Pay $6 Million to Settle Allegations of Kickbacks and Unnecessary Testing (Apr. 28, 2017), https://www.justice.gov/opa/pr/blood-testing-laboratory-pay-6-million-settle-allegations-kickbacks-and-unnecessary-testing.
[70]See Press Release, U.S. Atty’s Office for the Southern Dist. of N.Y., U.S. Dep’t of Justice, Acting U.S. Attorney Announces $54 Million Settlement Of Civil Fraud Lawsuit Against Benefits Management Company For Improper Authorization Of Medical Procedures (May 11, 2017), https://www.justice.gov/usao-sdny/pr/acting-us-attorney-announces-54-million-settlement-civil-fraud-lawsuit-against-benefits.
[71]See Press Release, U.S. Atty’s Office for the Dist. of N.J., U.S. Dep’t of Justice, Omnicare Inc. Agrees To $8 Million Settlement In False Claims Act Case (May 16, 2017), https://www.justice.gov/usao-nj/pr/omnicare-inc-agrees-8-million-settlement-false-claims-act-case.
[72]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Missouri Hospitals Agree to Pay United States $34 Million to Settle Alleged False Claims Act Violations Arising from Improper Payments to Oncologists (May 18, 2017), https://www.justice.gov/opa/pr/missouri-hospitals-agree-pay-united-states-34-million-settle-alleged-false-claims-act.
[73]See Nate Raymond, CVS’s Omnicare to pay $23 million to resolve U.S. kickback case, Reuters (May 26, 2017), http://www.reuters.com/article/cvs-health-lawsuit-idUSL1N1IS1P0.
[74]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Medicare Advantage Organization and Former Chief Operating Officer to Pay $32.5 Million to Settle False Claims Act Allegations (May 30, 2017), https://www.justice.gov/opa/pr/medicare-advantage-organization-and-former-chief-operating-officer-pay-325-million-settle.
[75]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Electronic Health Records Vendor to Pay $155 Million to Settle False Claims Act Allegations (May 31, 2017), https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-155-million-settle-false-claims-act-allegations.
[76]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Genesis Healthcare Inc. Agrees to Pay Federal Government $53.6 Million to Resolve False Claims Act Allegations Relating to the Provision of Medically Unnecessary Rehabilitation Therapy and Hospice Services (June 16, 2017), https://www.justice.gov/opa/pr/genesis-healthcare-inc-agrees-pay-federal-government-536-million-resolve-false-claims-act.
[77]SeeUnited States ex rel. Robins v. Lincare, Inc., No. 1:10-cv-12256-DPW (D. Mass. June 27, 2017).
[78]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Los Angeles Hospital Agrees to Pay $42 Million to Settle Alleged False Claims Act Violations Arising from Improper Payments to Physicians (June 28, 2017), https://www.justice.gov/opa/pr/los-angeles-hospital-agrees-pay-42-million-settle-alleged-false-claims-act-violations-arising.
[79]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Financial Freedom Settles Alleged Liability for Servicing of Federally Insured Reverse Mortgage Loans for $89 Million (May 16, 2017), https://www.justice.gov/opa/pr/financial-freedom-settles-alleged-liability-servicing-federally-insured-reverse-mortgage.
[80]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Washington River Protection Solutions Agrees to Pay $5.275 Million to Settle False Overtime and Premium Pay Allegations (Jan. 23, 2017), https://www.justice.gov/opa/pr/washington-river-protection-solutions-agrees-pay-5275-million-settle-false-overtime-and.
[81]See Press Release, U.S. Atty’s Office for the Eastern Dist. of Cal., U.S. Dep’t of Justice, Sierra Nevada Corporation Pays $14.9m to Settle Allegations of Improper Contract Billings (Feb. 15, 2017), https://www.justice.gov/usao-edca/pr/sierra-nevada-corporation-pays-149m-settle-allegations-improper-contract-billings.
[82]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, CA Inc. to Pay $45 Million for Alleged False Claims on Government-Wide Information Technology Contract (Mar. 10, 2017), https://www.justice.gov/opa/pr/ca-inc-pay-45-million-alleged-false-claims-government-wide-information-technology-contract.
[83]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Energy & Process Corp. Agrees to Pay $4.6 Million for Alleged False Claims Regarding Defective Steel Rebar and Quality Control Failures in Nuclear Waste Treatment Facility (Apr. 24, 2017), https://www.justice.gov/opa/pr/energy-process-corp-agrees-pay-46-million-alleged-false-claims-regarding-defective-steel.
[84]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Defense Contractor Resolves Criminal, Civil and Administrative Liability Related to Food Contracts (May 26, 2017), https://www.justice.gov/opa/pr/defense-contractor-resolves-criminal-civil-and-administrative-liability-related-food.
[85]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Virginia Department of Social Services Agrees to Pay $7.1 Million to Resolve Alleged False Claims for SNAP Funds (Apr. 10, 2017), https://www.justice.gov/opa/pr/virginia-department-social-services-agrees-pay-71-million-resolve-alleged-false-claims-snap.
[86]See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Wisconsin Department of Health Services Agrees to Pay Nearly $7 Million to Resolve Alleged False Claims for SNAP Funds (Apr. 12, 2017), https://www.justice.gov/opa/pr/wisconsin-department-health-services-agrees-pay-nearly-7-million-resolve-alleged-false-claims.
[87]See Press Release, U.S. Atty’s Office for the Southern Dist. of Fla., U.S. Dep’t of Justice, United States Prevails in Civil Suit Against For-Profit College Chain and its President for False Claims Act Violations (Feb. 21, 2017), https://www.justice.gov/usao-sdfl/pr/united-states-prevails-civil-suit-against-profit-college-chain-and-its-president-fals-0; United Statesv. FastTrain II Corp., No.: 1:12-cv-21431 (S.D. Fla. Feb. 15, 2017).
[88]SeeUnited States ex rel. Ruckh v. CMC II, LLC, No. 8:11-cv-01303-SDM-TBM (M.D. Fla. Feb. 15, 2017).
[89]See Press Release, N.Y. State Office of the Att’y. Gen, A.G. Schneiderman Announces $7.9 Million Settlement And State Prison Sentences In Major Illegal Prescription Buy-Back And Money Laundering Scheme (Mar. 2, 2017), https://ag.ny.gov/press-release/ag-schneiderman-announces-79-million-settlement-and-state-prison-sentences-major.
[90] Gibson, Dunn & Crutcher LLP represented the defendants-appellants in the district court and in their successful appeal of this matter in the Ninth Circuit.
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