Circuit Split Regarding But-For Causation in False Claims Act/Anti-Kickback Act Cases: Are There Two Pathways to Establish FCA Falsity in These Cases or Just One?

- Courts have split regarding whether a 2010 amendment to the AKS, which mandates that a “claim that includes items or services resulting from a violation of [the AKS] constitutes a false or fraudulent claim” under the FCA, means that a plaintiff must establish but-for causation to demonstrate that a violation of the Anti-Kickback Statute (AKS) resulted in a False Claims Act (FCA) violation.
- In the majority of appellate cases, courts have ruled that in an FCA case under the 2010 AKS Amendment, a plaintiff must prove that a kickback is the but-for cause of the presentation of a false or fraudulent claim.
- But, in some of these cases, courts have also concluded that plaintiff can bypass establishing but-for causation by invoking alternative theories of FCA liability.
- These courts appear mistaken. Based upon the statutory language and history, the best reading of the 2010 AKS Amendment is that a plaintiff must prove but-for causation when asserting an FCA violation based on an AKS violation, no matter what the theory of liability.
Historically, the vast majority of revenue that the False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, generates has arisen from cases brought against the health care industry.1 And a substantial number of FCA actions include allegations that defendants violated the Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b.2
In 2010, Congress amended the AKS, providing that a claim presented to the government that “includes items or services resulting from” an AKS violation constitutes a “false or fraudulent” claim under the FCA.3
Courts have split regarding the meaning of this amendment. One issue on which courts have diverged concerns whether plaintiff must prove—based on the “resulting from” language—that but for the alleged kickback, the referral of a health care claim would not have occurred.4This issue is significant because, as the Department of Justice (DOJ) has explained to courts, if Congress has imposed this requirement on DOJ, it “would significantly complicate the litigation of FCA cases based on AKS violations, requiring extensive efforts to disentangle the motivations of treating physicians (who may not even be among the defendants) for every treatment decision or referral at issue (often numbering in the hundreds or thousands).”5 DOJ, and private plaintiffs bringing FCA actions under its qui tam provisions, would much prefer to litigate these cases by simply asserting that an AKS violation occurred and that the AKS violation necessarily tainted each claim that was presented to the government, rather than have to prove, on a claim-by-claim basis, that the referral would not have occurred but for the kickback.
Another issue on which courts have split concerns whether, if an FCA plaintiff must show but-for causation, the FCA provides the plaintiff with an alternative pathway to establish an FCA violation under a “false certification” theory of liability, which would not require plaintiff to plead but-for causation. That is, does the 2010 AKS Amendment, which specifically links the AKS to the FCA, provide the exclusive pathway through which a “false or fraudulent” claim can be established under the FCA, or did Congress intend, without so stating, that the application of the amendment would turn on what theory of FCA liability the plaintiff invoked?
On these issues, as detailed below, the finding by the majority of appellate courts that the 2010 AKS Amendment requires but-for causation is the better interpretation of the amendment because it best accords with the statute’s plain language. As the last three appellate courts considering this issue have concluded, the amendment plainly applies only to claims “resulting from” an AKS violation, and courts have historically found that the phrase “resulting from,” based on its dictionary definition, entails but-for causation. However, two of the latest three appellate courts considering the but-for causation issue have indicated that a plaintiff can assert alternative theories of FCA liability to prove an AKS/FCA6 violation that do not require but-for causation. This approach, as indicated below, is contrary to statutory text and history and results in absurd consequences; hence, it should be rejected.
Statutory Language and History
The False Claims Act
As the FCA’s title makes clear, it is a “False Claims Act.” The word “claim,” since 1986, has been a defined term in the FCA, meaning any “request or demand” for “money or property” from the government. Given the title and statutory language, “[i]t seems to be a fairly obvious notion that a False Claims Act suit ought to require a false claim.”7 This is because the “[FCA] attaches liability, not to the underlying fraudulent activity or to the government’s wrongful payment, but to the ‘claim for payment’.”8 “Therefore, a central question in False Claims Act cases is whether the defendant ever presented a ‘false or fraudulent claim’ to the government.”9
Today, to determine whether a claim is “false,” courts generally inquire into plaintiff’s theory of falsity—specifically, whether the allegation is that the claim is factually false, submitted via fraud in the inducement, or legally false (that is, submitted via an express or implied false certification).10
But notwithstanding the FCA’s existence since 1863, the practice of classifying types of false claims, such as express false certifications, is of recent vintage and was hotly contested at the time of the 2010 AKS Amendment, which expressly describes the circumstances when an AKS violation will result in an FCA violation.
The first use of “legal falsity” as a distinct category, including both express and implied false certifications, can be traced back to the Second Circuit’s 2001 decision in U.S. ex rel. Mikes v. Straus.11 Before the 2010 AKS Amendment, some courts adopted this theory of legal falsity, while others declined.12 The unsettled nature of the doctrine is further illustrated in post-2010 case law, such as the First Circuit’s decision in Hutcheson, which refused to adopt the doctrine of false certification, as well as in amicus briefs filed by DOJ, which asserted that these doctrines had no place in FCA jurisprudence and that there was only one pathway to establish FCA falsity.13 It was not until 2016—long after the 2010 AKS Amendment—when the unsettled nature of the doctrine was clarified in the Supreme Court’s decision in Universal Health Servs. v. U.S. ex rel. Escobar.14There, the court ruled that under certain circumstances, FCA plaintiffs can assert a valid implied false certification theory.15 Since Escobar, courts have routinely and uniformly applied false certification (express and implied) classifications.
AKS Statutory Language
The AKS prohibits a person from “knowingly and willfully” paying “remuneration” to “induce” the “refer[ral] of an individual” for which payment is made under a federal health care program.16 It is a criminal statute, subjecting a person found guilty to a fine of not more than $100,000, imprisonment for not more than 10 years, or both.17 Congress’s 2010 AKS Amendment provides that a “claim that includes items or services resulting from a violation of [the AKS] constitutes a false or fraudulent claim for purposes of [the FCA].”18
Congress did not define “resulting from” in the statute, so courts give the phrase its ordinary meaning.19 In assessing the ordinary meaning of the phrase “results from,” the Supreme Court ruled that, as a general matter, “results from” entails but-for causation.20Specifically, in Burrage, the Court reasoned that a “thing ‘results’ when it ‘[a]rise[s] as an effect, issue, or outcome from some action, process, or design’.”21 “‘In the usual course,’ this requires proof ‘that the harm would not have occurred’ in the absence of—that is, but for—the defendant’s conduct.”22 “In sum, it is one of the traditional background principles ‘against which Congress legislate[s],’ … that a phrase such as ‘results from’ imposes a requirement of but-for causation.”23
Because of the AKS’s expansive language, courts have observed that Congress erected its high “knowing and willful” intent standard to prevent expansive constructions of the AKS that would otherwise be a “trap for the unwary” and could result in the prosecution of those acting with “good intent” and “deter socially beneficial conduct.”24 The same logic applies, of course, to Congress erecting the AKS’s high but-for causation standard. As another court observed, with an expansive reading of the AKS, “[m]uch of the workaday practice of medicine might fall within an expansive interpretation of the [AKS], …sweeping the vice-ridden and virtuous alike.”25
Further, Congress did not define “claim” as used in the amendment differently than the word “claim” is defined in the FCA, or purport to limit the application to some subset of claims submitted under the FCA. Instead, the amendment, on its face, appears to describe precisely when claims in violation of the AKS will, in fact, constitute false or fraudulent claims under the FCA. Similarly, the provision, on its face, does not limit the application of the AKS amendment to certain theories of FCA liability (for example, providing that the amendment will not apply to false certification claims). Instead, the AKS amendment, on its face, purports to address when liability under the FCA will “result[] from” an AKS violation because the underlying claim is “false or fraudulent.”26 Ultimately, the AKS amendment touches on two elements of FCA liability: falsity and causation. It creates a blanket, per se, taint rule that all claims resulting from an AKS violation are false for purposes of the FCA. But in applying that blanket, per se, taint rule to a penal statute—the FCA27 —Congress also required that a plaintiff be able to link the unlawful AKS violation to claims for payment for a court to find that defendant breached the FCA based upon a violation of the AKS.
History Behind the Statutory Amendment
Courts have observed that the 2010 AKS Amendment can be traced to the district court’s decision in U.S. ex rel. Thomas v. Bailey, No. 4:06CV00465 JLH, 2008 WL 4853630 (E.D. Ark. Nov. 6, 2008).28
In Thomas, a district court rejected the relator’s contention that the hospitals’ claims for payment were knowingly false when a device manufacturer allegedly entered into a sham consulting agreement with a physician who performed surgeries at hospitals using the manufacturer’s products and the costs associated with those surgeries were incorporated into the hospitals’ claims.
The court found that while the hospitals impliedly certified that they were in compliance with the AKS, they did not impliedly or expressly certify that the physicians who attended patients in their hospitals complied with the AKS.29 Inasmuch as the relator had expressly disclaimed any contention that the hospitals violated the AKS or knew that the physician had done so, the court ruled that the hospitals’ claims were not false or fraudulent claims within the meaning of the FCA.30
The court noted that if the government were to impose a duty on hospitals to certify that every physician who performed services at their hospitals complied with all laws, one would expect such a duty to be stated “unambiguously.”31 There is no doubt, however, that the physicians would be liable for any false claims they submitted for their professional services.32 That is, under these circumstances, as to the two buckets of potentially actionable claims presented for payment—the hospitals’ claims and the physicians’ claims—the government could pursue, under the FCA, the claims the physicians presented (because their certifications that they complied with the AKS are false) but could not pursue the hospitals’ claims under a false certification theory (because the hospitals do not certify that all admitting physicians comply with the AKS, so there is no false certification).
Shortly after the case was published, Congress proposed legislation to address the district court’s ruling that claims tainted by an AKS violation may not be actionable under the FCA if submitted by an innocent third party. But in the relevant legislative history, Congress did not indicate that its amendment would apply under some theories of FCA liability but not others, or that it would apply to some claim forms submitted in violation of the AKS but not to other claim forms submitted in violation of the AKS.
Instead, from the limited history, it appears that Congress’ intent was to reach only those guilty parties that actually breached the AKS and not innocent third parties that tendered the actual claims. Sen. Kaufman, a sponsor, reiterated this intent when he described the district court case (Thomas) that gave rise to the legislation:33
For example, a court recently held that, even though a device company may have paid a kickback to a doctor to use a particular medical device, the bill to the government for the procedure to implant the device was not false or fraudulent because the claim was submitted by the innocent hospital, and not by the guilty doctor. In other words, a claim that results from a kickback and that is fraudulent when submitted by a wrongdoer is laundered into a “clean” claim when an innocent third party finally submits the claim to the government for payment. This has the effect of insulating both the payor and the recipient of the kickback from False Claims Act liability. This obstacle to a successful action particularly limits the ability of the Department of Justice to recover from pharmaceutical and device manufacturers, because in such instances the claims arising from the illegal kickbacks typically are not submitted by the doctors who received the kickbacks, but by pharmacies and hospitals that had no knowledge of the underlying unlawful conduct.34
This bill remedies the problem by amending the anti-kickback statute to ensure that all claims resulting from illegal kickbacks are “false or fraudulent,” even when the claims are not submitted directly by the wrongdoers themselves. I want to emphasize that in such circumstances, neither antikickback nor False Claims Act liability will lie against the innocent third party that submitted the claim.
To the extent statutory history is relevant to the inquiry, it appears the purpose of the legislation was twofold: (1) to expand the universe of claims that could be actionable in AKS/FCA cases by reaching separate hospital claims, even though the hospital had no knowledge of the alleged kickbacks while (2) ensuring that, notwithstanding this expansion, Congress did not intend that AKS/FCA actions reach “innocent” conduct by specifically requiring, in AKS/FCA cases, the government to prove that the improper submission of the claim “result[ed] from” the AKS violation.
First Circuit’s Decision Interpreting the Statutory Language and Related District Court Case Law
The First Circuit, in Regeneron,35 is the latest appellate court to address whether the 2010 AKS Amendment requires but-for causation, and whether but-for causation is not required if plaintiff pursues alternative theories of FCA falsity rather than invoking the statutory provision.36
First, as to whether the 2010 AKS Amendment requires but-for causation, the court found that but-for causation is required by the language “resulting from.”37 In Regeneron, the government contended that contributions that the defendant drug manufacturer made to charitable foundations to help patients with co-payment obligations for medication were “kickbacks” under the AKS, and that such kickbacks resulted in a per se FCA violation.38 The government contended that when doctors filed claims for the defendant’s drug, those claims “resulted from” an AKS violation—whether or not those claims would have been made even had the defendant not paid the kickback to the charitable foundation.39 The defendant, by contrast, contended that a claim only “result[s] from” an AKS violation if it includes “items or services” that would not have been paid by the government absent the AKS violation.40 Under this construction, if a doctor would have purchased, and sought reimbursement, for the drug anyway, then the subsequent Medicare claim cannot have “result[ed] from” defendant’s allegedly illicit payments.41
On this issue, the court agreed with defendant, ruling “that to treat an AKS violation as a false or fraudulent claim under the FCA, the government must prove that the AKS violation was a but-for cause of the false claim.”42 The court reached this conclusion because the Supreme Court had held that “resulting from” “imposes … a requirement of actual causality.”43 This creates a “default assumption, not an immutable rule” that “resulting from” is read as calling for but-for causation in the “the usual course,”44 and thus a court may deviate from this assumption if there are “textual or contextual indication[s]” supporting that approach.45
But the court, in Regeneron, found neither textual nor contextual indications that it should deviate from reading “resulting from” as requiring but-for causation. As to textual indications, the court noted that it looked to the statutory text’s plain language and concluded that from the plain language, there was nothing that would cause it to deviate from the default assumption because “[s]imply put, there is no language in the 2010 amendment that by itself runs counter to the presumption that ‘resulting from’ calls for proof of but-for causation.”46
The court then reviewed the three contextual indicators the government asserted to rebut the application of but-for causation and found that each lacked merit. Specifically, the government had contended that Congress could not have intended “resulting from” to create a but-for causation standard because (i) the AKS itself, as a criminal statute, did not require but-for causation; (ii) Congress merely intended to codify existing FCA false certification case law, which also did not require but-for causation, and (iii) the statutory history shows that Congress only intended to address the factual situation in Thomas and did not intend to impose a but-for causation standard.
First, as to the government’s contention that the civil FCA should not require but-for causation in AKS cases because the AKS, in a criminal action, would not require but-for causation, the court pointed out that when “Congress wants to make a violation of one statute or statutory section generate liability under another statute or section, it may or may not require proof of added elements not required to prove a predicate violation.”47 Indeed, the court found that adding the additional element in FCA civil actions to attach AKS liability made sense because “the chief purpose” of the FCA’s civil penalties is “to provide for restitution to the government of money taken from it by fraud” and the FCA allows for private enforcement.48 Thus “it makes sense for the 2010 amendment to render a claim false (for FCA purposes) only when a kickback is the cause of that claim’s submission to the government.”49
Second, as to the government’s contention that Congress, in 2010, merely intended to codify prior FCA false certification cases, and thus that no but-for causation should be required because false certification FCA cases do not require but-for causation, the court noted that false certification (including AKS/FCA false certification) cases ran on a “separate track” than AKS/FCA cases brought under the 2010 AKS Amendment and hence that “[t]here is no reason to think that, because false certification claims require no proof of causation, Congress therefore eschewed any actual causation requirement under the 2010 amendment” when “[b]y its own terms, the 2010 amendment requires some proof of causation,” concluding that “the statutory history provides no reason to deviate from the ordinary course.”50
Third, as to the government’s contention that the 2010 legislative history supports its position that but-for causation is not required, the court noted that, even assuming it is proper to consider legislative history in construing the phrase “resulting from,” there is nothing in the legislative history that “is inconsistent with an interpretation of the 2010 amendment that imposes but-for causation.”51
District courts have been split on the issue of whether false certification exists as an “alternative pathway” that does not require but-for causation under the 2010 AKS Amendment. Some courts have likewise found that plaintiffs may still rely on a false certification theory without establishing but-for causation.52 In U.S. ex rel. Louderback v. Sunovion Pharms., Inc., the court rejected this line of reasoning, holding as follows:53
Louderback and the United States imply that Louderback’s claims in this case, or at least some of them, are independent of “the 2010 amendment”—i.e., the current version of 42 U.S.C. § 1320a-7b(g). They also rely on a decision from this District accepting this argument, United States ex rel. Fesenmaier v. Cameron-Ehlen Grp., Inc., No. 13-cv-3003 (WMW/DTS), 2023 WL 36174, at *1–3 (D. Minn. Jan. 4, 2023).
This argument is not persuasive. It rests on a flawed interpretation of 42 U.S.C. § 1320a-7b(g). The statute is better construed to mean that [an FCA] case premised on an underlying [AKS] violation must satisfy § 1320a-7b(g)’s requirements. In other words, there is no such thing as [an FCA] case premised on an [AKS] violation that need not go through § 1320a-7b(g). See Martin, 63 F.4th at 1052 (“When it comes to violations of the Anti-Kickback Statute, only submitted claims ‘resulting from’ the violation are covered by the False Claims Act.”). If § 1320a-7b(g) didn’t mean that and left the door open to a “material violations” theory, the statute would have little practical effect. What [AKS]/[FCA] relator would go to the trouble of attempting to allege a claim under § 1320a-7b(g) and meet its but-for causation standard when a less demanding path is available?
Causation Under Other AKS/FCA Theories of Liability and Alternative Pathways to FCA Liability
Is But-For Causation Required Under 2010 AKS Amendments?
The plain language of the 2010 AKS Amendment and case law appear correct in concluding that the 2010 AKS Amendment requires but-for causation.
The 2010 AKS Amendment expressly specifies that only claims for items or services “resulting from” an AKS violation “constitutes a false or fraudulent claim for purposes of [the FCA].”54 As the Supreme Court noted, a background principle against which Congress legislates is that a phrase such as “results from” imposes a requirement of but-for causation.55 Congress is presumed to know the law when it legislates,56 and it appears inconceivable that if it intended any other result, it would have employed the “resulting from” language in its amendment. Accordingly, it appears that the last three appellate courts to consider the issue correctly concluded that the 2010 AKS Amendment requires but-for causation.57
Are Alternative Pathways Available to Prove FCA Causation in AKS/FCA Cases?
As noted, in Regeneron, the court, in the context of ruling whether “resulting from” requires but-for causation, also indicated that the FCA provides an alternative pathway to establishing an AKS/FCA violation. The court reasoned that Congress passed the 2010 AKS Amendment against a backdrop of false certification FCA cases which did not require causation to prove falsity because a material misrepresentation of compliance with the AKS was enough.58 The court then concluded, relying on the government’s assertion, that Congress “did not clearly intend to alter false certification caselaw by imposing a but-for causation requirement.”59 The court reasoned that under a false certification pathway, “it is not the AKS violation itself that renders the claim false”; instead, “it is the false representation that there is no AKS violation.”60
However, the court’s conclusion that there are alternative pathways to prove FCA causation in AKS/FCA cases is undermined by the statutory language, history, and the doctrine of absurdity.
Statutory Language Undermining Multiple Pathways to FCA Liability
In adopting its statutory language in 2010 that a “claim” for items or services “resulting from” an AKS violation “constitutes a false or fraudulent claim for purposes of [the FCA],” Congress did not limit the application of the plain language to particular theories of FCA liability or state that this language only applied to a subset of all FCA claims. Instead, it purported to describe when an AKS violation could result in an FCA violation.61
In support of multiple pathways to FCA liability, the First Circuit in Regeneron seemed to advance two grounds to support its position: (i) that Congress “did not clearly intend to alter false-certification caselaw by imposing a but-for causation requirement,” and (ii) that under a false certification pathway, “it is not the AKS violation itself that renders the claim false”; instead, “it is the false representation that there is no AKS violation.”62
As noted, as to the first contention, there was not a uniform, consistently applied false certification theory of FCA liability at the time of the 2010 AKS Amendment.63 Indeed, even after the 2010 Amendment, DOJ maintained its view that the FCA had no false certification theory of liability but only provided one theory of liability: the establishment of a false or fraudulent claim.64 It is difficult to discern that Congress intended to carve out an exception for false certification cases to the application of the AKS statutory language made in the 2010 Amendment, when there was no judicial consensus regarding how a false certification theory applied at that time, the theory was rejected by the very government agency charged with enforcing the statute (DOJ), and Congress did not express such an intent in its language but purported to cover all claims resulting from an AKS violation.65 As to the Regeneron court’s viewpoint, that, for falsity purposes, a false certification theory applies because “it is the false representation that there is no AKS violation,” the Court conflates the falsity element with the causation element. The 2010 AKS Amendment, in plain language, defined the instances in which claims would be “false or fraudulent” based upon an AKS violation. In this sense, Congress supplanted prior FCA case law that held that claims were false because of the person’s false certification. In its place, Congress, as to falsity, created a per se, taint rule which provides that all claims are false, but to protect against over-breadth, supplied a causation element that the claim must “result[] from” the AKS violation.66 The court ignores the causation element that Congress applied in its amendment.
Statutory History Does Not Support the View of Multiple Pathways
Some courts have ruled that the AKS should be read broadly in the context of FCA actions. For example, in Greenfield, the Third Circuit rejected but-for causation because it believed that based on the “broad statutory context” of the FCA and AKS, such a reading would be “inconsistent with the drafters’ intentions underlying both statutes,” thus ruling instead that although “a ‘link’ is required,” that causal link “is less than” but-for causation.67
This reliance on statutory history appears misplaced for at least a couple of reasons. First, as the Sixth Circuit concluded in Martin, courts “generally do not consider legislative history in construing a statute with criminal applications, the idea being that no one should be imprisoned based on a document or statement that never received the full support of Congress and was presented to the President for signature.”68 Second, even if statutory history is considered, that history does not support the view that Congress simply sought to expand the scope of the AKS as used in FCA actions. Indeed, this viewpoint ignores that while one member of Congress expressed the need to broaden the AKS application to reach hospital claims in Thomas and render those claims per se false, he also expressed the need to ensure that the statute not reach “innocent” conduct and that, to effectuate that intent, Congress used the “resulting from” phrase to require but-for causation.69
The Doctrine That Absurd Consequences Should Not Attach Supports Finding That Multiple Pathways Do Not Exist
Under Regeneron’s reasoning, Congress, in drafting the 2010 Amendment, although not using narrowly tailored language, intended that the phrase “resulting from” would only surgically fix the situation in Thomas by allowing an FCA plaintiff to reach hospital claims submitted to the government as a result of a kickback between a medical device company and physicians, but otherwise intended to leave AKS/FCA law unaffected.
Recall that in Thomas, there were two buckets of potentially false claims stemming from the alleged kickback from two distinct factual situations: (1) the claims that the physician submitted for professional services (which everyone agrees can be reached under the FCA false certification theory because the physician would expressly or impliedly certify that the claims he submitted complied with the AKS); and (2) the claims that the hospitals submitted, which the court stated in Thomas could not be reached under a false certification theory because the hospitals’ certifications were not broad enough to encompass the conduct of every physician who provided hospital services.
The court in Regeneron theorizes that Congress (without so stating) amended the statute such that the 2010 AKS Amendment does not reach or address Situation One (involving the physician claims) because the government simply invokes a false certification theory of FCA liability, which, according to the court, does not require causation. On the other hand, in Situation Two (involving the hospitals’ claims), the 2010 AKS Amendment kicks in to reach those claims (because a false certification theory will not reach the claims), but there is only liability under the FCA if now, as to those claims, the plaintiff proves that but-for the kickback, the referrals reflected on the hospital’s claim forms would not have occurred (i.e., that the “resulting from” language means that but-for causation must be established).
Plainly, the logic of Regeneron, when applied to concrete cases, like Thomas, would result in absurdity. 70 In a case like Thomas itself, for instance, presumably, a plaintiff would assert two separate theories against the physician: (1) involving physician claims where no causation is required and (2) involving hospital claims where the plaintiff would have to set forth evidence that but-for the kickback, those referrals would not have occurred. In this situation, the defendant would be the same, and the alleged improper conduct would be the same (in Thomas, the surgery the defendant physician performed in the hospital using the defendant manufacturer’s device), but in determining liability, there would be two entirely different sets of jury instructions describing which claims are false. There is no rational reason why the two separate buckets of claims would have two different causation standards. As to the hospital claims, the additional protection of requiring but-for causation is not needed to protect the innocent party (the hospital). The hospital has no liability in the first instance because it did not participate in the kickback scheme, let alone know, as the AKS requires, that a wrongful scheme existed. As such, under such a reading of the 2010 Amendment, rather than providing as a surgical fix for the scenario in Thomas, the AKS provision would merely serve to add additional barriers to bringing a successful case.
A better explanation that does not result in absurdity is that consistent with the statutory language, statutory history and the FCA’s purpose of reaching and imposing liability for false claims, the language Congress chose to use should be taken literally to apply but-for causation in all FCA cases alleging an AKS violation. Under this approach, again applying Thomas, all claims (physician claims and hospital claims) are false if the plaintiff establishes that but for the kickback, the referral would not have occurred, and if the plaintiff cannot make this causal link, there is no liability. This approach makes the best use of language and history, and it does not reach the absurd result of creating two sets of theories of liability where one can engage in the same conduct under the same statute and be innocent on one bundle of claims and guilty on a second set of claims.
Read Past Issues of The Salcido Report
March 15, 2024 - Courts Should Finally Rule That the False Claims Act Qui Tam Provisions Are Unconstitutional
July 12, 2023 - False Claims Act Knowledge Element after Schutte: What Is Lost, What Remains, What Companies Should Do Next to Minimize Exposure to Liability
January 18, 2022 - OIG Joint Venture Advisory Opinion Does Not Consider Multiple Court Decisions That Undermine the Conclusions in Its Opinion
November 24, 2020 - When Can Opinions be “False” and Result in False Claims Act Liability: Three Circuit Courts Provide Conflicting Guidance
January 27, 2020 - False Claims Act – Year In Review: Five Decisions That Will Affect the Future of FCA Litigation
February 12, 2018 - False Claims Act Circuit Splits—FCA Issues That May Soon Reach The Supreme Court Or Lead To Congressional Amendment
September 26, 2016 - Recent Significant Case Law Developments Regarding What Constitutes a Reckless Interpretation of a Law and When Retention of an Overpayment Violates the False Claims Act
February 25, 2016 - What Must the Government Prove to Establish that a Defendant Recklessly Interpreted a Statute or Regulation in Violation of the False Claims Act?
December 21, 2015 - Understanding When An Overpayment Can Result in False Claims Liability and Why Current Court Precedent and Regulatory Guidance Is Mistaken
October 1, 2015 - When a Violation of a Rule or Regulation Becomes an FCA Violation: Understanding the Distinction Between Conditions of Payment and Conditions of Participation
September 25, 2015 - False Claims Act Public Disclosure Alert
About the Author
Robert Salcido is a leading FCA practitioner.
Mr. Salcido has been lead counsel in several FCA actions in which he successfully defended clients in FCA actions that the government or relator filed at trial or summary judgment. Some of those cases include:
- Mr. Salcido was lead counsel for Golden Living in an FCA action where the federal government had sued Golden Living’s predecessor company, Beverly Enterprises, for $895 million, alleging that Beverly had engaged in an unlawful kickback scheme with McKesson Corp. in violation of the Anti-Kickback Act and the FCA. After 14 days of trial, the court ruled that Beverly and McKesson did not violate the FCA or the Anti-Kickback Act because their business negotiations were fair, reasonable and conducted in good faith. See United States of America ex rel. Jamison v. McKesson Corp., 900 F. Supp. 2d 683 (N.D. Miss. 2012).
- Mr. Salcido was lead counsel for Aegis Therapies and a Golden Living skilled nursing facility where the federal government had alleged that defendants provided medically unnecessary rehabilitation therapy. The district court granted defendants’ summary judgment motion, ruling that the government had used the wrong standard to assess whether the services were medically necessary and failed to prove that defendants’ certification regarding medical necessity was objectively false. See United States ex rel. Lawson v. Aegis Therapies, Inc., 2014 U.S. Dist. LEXIS 45221 (S.D. Ga. Mar. 31, 2015).
- Mr. Salcido was lead counsel for a defendant physician and multispecialty group practice that the government accused of FCA violations. The district court dismissed all the government’s claims on summary judgment. Ultimately, because the United States’ action lacked “substantial justification,” the U.S. was ordered to pay defendants more than $500,000 in legal fees. In making the ruling, the court ruled that Medicare fraud law is an area of expertise and ruled that it was undisputed that Mr. Salcido possessed such expertise. See United States v. Prabhu, 442 F. Supp. 2d 1008 (D. Nev. 2006).
- Mr. Salcido was lead counsel for Golden Living in an action where the relator and the government sued multiple defendants alleging that they violated the FCA because they knowingly created and operated a supply company in violation of Medicare Supplier Standards. The district court granted defendants’ FCA summary judgment motion regarding the Supplier Standards allegations, finding that the government’s prior administrative proceedings demonstrated that the defendant supply company was entitled to payment. See United States ex rel. Jamison v. McKesson Corp., 784 F. Supp. 2d 664 (N.D. Miss. 2011).
Mr. Salcido has authored a number of books and chapters in leading publications (including the American Health Lawyers Association, BNA Books and Bloomberg BNA) regarding the application of the FCA, including:
- False Claims Act & the Health Care Industry: Counseling & Litigation (5th ed. American Health Law Ass’n 2024).
- “The False Claims Act in Health Care Prosecutions: Application of the Substantive, Qui Tam and Voluntary Disclosure Provisions” in Health Care Fraud and Abuse: Practical Perspectives, Ch. 3 (3d ed. BNA Books 2013).
- “False Claims Act: Health Care Applications and Defenses” in Bloomberg BNA Health Law and Bus. Series No. 2650 (2012).
Because of his work successfully defending a number of FCA lawsuits, Mr. Salcido has been recognized in:
- Recognized by BTI Consulting Group as 2020 Client Service All-Star which is based on in-depth interviews with general counsel and recognizes lawyers who have been identified as “delivering the absolute best levels of client service.”
- Recognized by The National Law Journal in its 2019 inaugural list of Health Care Law Trailblazers regarding those who have made an impact through new strategies or innovative court cases for several notable FCA wins.
- Recognized by The National Law Journal in its 2018 Winning Litigators chosen for their “great results for clients in high stakes matters” for obtaining a successful trial verdict in an FCA lawsuit.
- Chambers USA: America’s Leading Lawyers for Business (2006-2024). In the 2011-2024 editions of Chambers USA, Robert is as Healthcare Leading Individuals (District of Columbia) (Band 1).
- Recognized by The National Law Journal in its 2014 Litigation Trailblazers & Pioneers as one of 50 “people who have made a difference in the fight for Justice” for his outstanding work in defending FCA lawsuits.
- Law360, which selected Robert as one of the four Health Care MVPs for 2012 based upon a successful trial verdict obtained in defense of a national skilled nursing facility chain in a $895 million FCA lawsuit the government filed.
- Recognized by Washington, D.C., Super Lawyers in the health care practice area (2008-2011; 2013-2020).
Robert also won awards for his governmental service, including:
- 1993 Department of Health and Human Services Office of Inspector General (OIG) Integrity Award (highest award OIG bestows to individuals outside of the OIG).
- 1992 United States Department of Justice Special Achievement Award (for Sustained Superior Performance of Duty).
- 1991 United States Department of Justice Special Achievement Award (for Sustained Superior Performance of Duty).
Before entering private practice, Mr. Salcido served as trial counsel for the U.S. Department of Justice Civil Fraud Section, which has nationwide jurisdiction over the FCA, where he led several successful prosecutions of the FCA on the U.S.’ behalf.
1 DOJ statistics from the 1986 FCA amendments through September 2022 show that of the roughly $72 billion recovered in FCA actions, roughly $50.5 billion resulted from recoveries from the health care industry—roughly 70% of all FCA recoveries. See DOJ FRAUD STATISTICS – OVERVIEW: October 1, 1986 – September 30, 2022 (Feb. 7, 2023).
2 For example, of the 878 FCA cases listed on Lexis during 2024, 112 also referenced the AKS.
3 See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, 759 (2010) (codified at 42 U.S.C. § 1320a-7b(g)) (emphasis added).
4 To date, the First, Sixth, and Eighth circuits have interpreted the 2010 AKS Amendment as requiring “but for” causation. See United States v. Regeneron Pharms., Inc., 128 F.4th 324, 328 (1st Cir. 2025) (“[T]o treat an AKS violation as a false or fraudulent claim under the FCA, the government must prove that the AKS violation was a but-for cause of the false claim.”); U.S. ex rel. Martin v. Hathaway, 63 F.4th 1043, 1052 (6th Cir. 2023) (“Congress added the ‘resulting from’ language in 2010, against the backdrop of a handful of cases that observed similar language as requiring but-for causation.”) (citations omitted); U.S. ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828, 836 (8th Cir. 2022) (“[W]hen a plaintiff seeks to establish falsity or fraud through the 2010 amendment, it must prove that a defendant would not have included particular items or services but for the illegal kickbacks.”) (citation omitted).
The Third Circuit—ruling before the other three Circuits—rejected the “but-for” standard. See U.S. ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96–98 (3d Cir. 2018) (concluding that based upon legislative history that but-for causation would prove “inconsistent with the drafters’ intentions” and ruling that “a ‘link’ is required” but that causal link “is less than” but-for causation).
The Seventh Circuit, although not reaching whether but-for causation is required, ruled in Stop Illinois Health Care Fraud, LLC v. Sayeed, 100 F.4th 899, 908–09 (7th Cir. 2024), that not “every claim for payment following an anti-kickback violation is automatically false” and that the “phrase ‘resulting from’ requires that there be some causal nexus between the allegedly false claims and the underlying kickback violation. It is not enough to show that a defendant both engaged in unlawful kickbacks and submitted false claims. The latter must ‘result[] from’ the former. This means that, at a minimum, every claim that forms the basis of FCA liability must be false by virtue of the fact that the claims are for services that were referred in violation of the [AKS].”
5 See Br. for United States, at 22, U.S. ex rel. Martin v. Hathaway, No. 22-1463 (6th Cir. Sept. 13, 2022), 2022 WL 4291838, at *22 (emphasis added).
6 “AKS/FCA” as used throughout refers to FCA actions that are based on an alleged AKS violation.
7 U.S. ex rel. Cafasso v. Gen. Dynamics C4 Sys., 637 F.3d 1047, 1055 (9th Cir. 2011) (quoting U.S. ex rel. Aflatooni v. Kitsap Physicians Serv., 314 F.3d 995, 997 (9th Cir. 2002)); see also U.S. ex rel. Hendow v. Univ. of Phx., 461 F.3d 1166, 1173 (9th Cir. 2006) (“[F]or a false statement or cause of action to be actionable … , it is necessary that it involve an actual claim …”) (emphasis in original); U.S. ex rel. Hopper v. Anton, 91 F.3d 1261, 1265 (9th Cir. 1996) (“The FCA … requires a false claim.”).
8 Cafasso, 637 F.3d at 1055 (quoting United States v. Rivera, 55 F.3d 703, 709 (1st Cir. 1995); see also In re: Baycol Prods. Litig., 732 F.3d 869, 875 (8th Cir. 2013).
9 Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 785 (4th Cir. 1999).
10 In a case alleging factual falsity, the plaintiff attempts to prove that the defendant incorrectly described the goods or services provided. See, e.g., U.S. ex rel. Conner v. Salina Reg’l Health Ctr., 543 F.3d 1211, 1217 (10th Cir. 2008) (noting that in a factually false case, “proving falsehood is relatively straightforward: A [plaintiff] must generally show that the payee has submitted an incorrect description of goods or services provided or a request for reimbursement for goods or services never provided”) (internal quotation omitted) (abrogated in part on other grounds by Universal Health Servs. v. U.S. ex rel. Escobar, 579 U.S. 176 (2016)). In a fraud-in-the-inducement case, the plaintiff must show that false statements or fraudulent conduct caused the government to award a contract or extend a benefit under a contract. See, e.g., Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 787 (4th Cir. 1999).
Legally false certification claims “can rest on one of two theories—express false certification, and implied false certification.” Conner, 543 F.3d at 1217; see also U.S. ex rel. Wilkins v. United Health Grp., 659 F.3d 295, 305 (3d Cir. 2011) (“There is a further division of categories of claims as the courts have recognized that there are two types of false certifications, express and implied.”) (citation omitted) (abrogated in part on other grounds by Escobar, 579 U.S.). “An express false certification theory applies when a government payee falsely certifies compliance with a particular statute, regulation or contractual term, where compliance is a prerequisite to payment.” Conner, 543 F.3d at 1217 (internal quotation and citation omitted). In its 2016 decision, Escobar, the Court ruled that an implied certification theory can be a basis for FCA liability if two conditions are satisfied: (1) “the claim does not merely request payment, but also makes specific representations about the goods and services provided”; and (2) “the defendant’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths.” 579 U.S. at 190 (footnote omitted). See also generally Robert Salcido, False Claims Act & the Healthcare Industry: Counseling & Litigation, § 2:03 (5th ed. American Health Law Ass’n 2024) (setting forth categories of falsity under the FCA).
11 See U.S. ex rel. Hutcheson v. Blackstone Med. Inc., 647 F.3d 377, 385 (1st Cir. 2011) (“The distinction between factually and legally false or fraudulent claims appears to derive from a 2001 decision of the Second Circuit.”) (citing Mikes, 274 F.3d 687, 696 (2d Cir. 2001)).
12 See, e.g., U.S. ex rel. Marcy v. Rowan Cos., 520 F.3d 384, 389 (5th Cir. 2008) (declining to resolve issue that would “necessarily require [the court] to determine whether implied certifications may be claims under the Act”).
13 Hutcheson, 647 F.3d at 385–86 (refusing to adopt district court’s “categories” regarding “distinctions between (1) factually false or fraudulent claims and legally false or fraudulent claims, as well as, (2) claims rendered legally false or fraudulent by an ‘express certification’ and claims rendered legally false or fraudulent by an ‘implied certification’” because these “[j]udicially-created categories” “do more to obscure than clarify the issues” and are not based on the “text of the FCA.” See also Br. for United States, at 15–16, United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., Nos. 13-1886, 13-1936, 2013 WL 5537459 (7th Cir. Sept. 26, 2013) (asserting that court should reject defendant’s assertion that there was no false “certification of compliance” because “nothing in the False Claims Act requires proof that a defendant affirmatively ‘certified’ its compliance with anything” but, instead, the “False Claims Act prohibits any knowing demand for payment to which a defendant is not entitled, whether or not the claim is accompanied by an express ‘certification of compliance’,” which “follows directly from the text of the FCA, which separately prohibits making or using a false statement material to a false claim”) (citation omitted).
14 Indeed, it was the split in the circuits regarding false certification cases, and the extent to which the doctrine applies, that resulted in the Court granting certiorari in Escobar. See 579 U.S. at 186 (“We granted certiorari to resolve the disagreement among the Courts of Appeals over the validity and scope of the implied false certification theory of liability…. The Seventh Circuit has rejected this theory, reasoning that only express (or affirmative) falsehoods can render a claim ‘false or fraudulent’ under [the FCA]… Other courts have accepted the theory, but limit its application to cases where defendants fail to disclose violations of expressly designated conditions of payment…. Yet others hold that conditions of payment need not be expressly designated as such to be the basis for False Claims Act liability.”) (citations omitted).
15 Id. at 190 (footnote omitted).
16 42 U.S.C. § 1320a-7b(b).
17 Id.
18 See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, 759 (2010) (codified at 42 U.S.C. § 1320a-7b(g) (emphasis added)).
19 Burrage v. United States, 571 U.S. 204, 210 (2014) (“The Controlled Substances Act does not define the phrase ‘results from,’ so we give it its ordinary meaning.”) (citation omitted).
20 Id. at 214.
21 Id. at 210–11 (emphasis in original) (quoting The New Shorter Oxford English Dictionary 2570 (1993)).
22 Id. at 211 (quoting University of Tex. Southwestern Med. Ctr. v. Nassar, 570 U.S. 338, 346–47 (2013) (quoting Restatement of Torts § 431, Comment a (1934)).
23 Id. at 214 (citation omitted).
24 U.S. ex rel. Hart v. McKesson Corp., 96 F.4th 145, 155–57 (2d Cir. 2024) (ruling that plaintiff must show defendant acted with a “bad purpose,” that is, “the defendant must act with knowledge that his conduct was unlawful” and concluding that the AKS’s purpose is to punish those who act with a “vicious will” and observing that a more expansive reading “would risk creating a trap for the unwary and deter socially beneficial conduct,” such as offering discounts or lower prices for preferred customers) (citations and internal quotations omitted).
25 Martin, 63 F.4th at 1054 (concluding that “reading causation too loosely or remuneration too broadly appear as opposite sides of the same problem. Much of the workaday practice of medicine might fall within an expansive interpretation of the [AKS]. Worse still, the statute does little to protect doctors of good intent, sweeping the vice-ridden and virtuous alike,” providing an example of a potential AKS/FCA violation to a physician who informs a hospital that she will only send referrals if hospital upgrades its facilities and potential liability would otherwise apply “even if the doctor’s only motivation is ensuring the highest quality equipment for her patients”) (citation omitted).
26 42 U.S.C. § 1320a-7b(g).
27 As the Supreme Court observed in Escobar, 579 U.S. at 182, and Vermont Agency of Natural Resources v. U.S. ex rel. Stevens, 529 U.S. 765, 784 (2000), FCA liability—treble damages and civil penalties—is “essentially punitive in nature.”
28 See, e.g., U.S. ex rel. Kester v. Novartis Pharms. Corp., 41 F. Supp. 3d 323, 332–35 (S.D.N.Y. 2014) (tracing discussion in legislative history regarding amending the AKS to the district court’s decision in Thomas).
29 Thomas, 2008 WL 4853630, at *9–10.
30 Id. at *12–13.
31 Id. at *12.
32 As a general matter, hospitals, under these circumstances, would submit claims to Medicare for payment related to hospital services provided to the patient. See id. at *2–3. Physicians, by contrast, would submit a separate stream of claims for their professional services. See id. at *3.
33 See 155 Cong. Rec. S10853 (Oct. 28, 2009).
34 It is unclear what Sen. Kaufman meant in stating that “illegal kickbacks typically are not submitted by the doctors who received the kickbacks.” Indeed, as was true in the case (Thomas) he is describing, physicians frequently provide claims for their professional services that are separate from hospital claims.
35 128 F.4th 324 (1st Cir. 2025).
36 See also U.S. ex rel. Flanagan v. Fresenius Med. Care Holdings, Inc., 142 F.4th 25, 35–37 (1st Cir. 2025) (applying Regeneron holding to dismiss claims under two separate causation pathways).
37 128 F.4th at 325.
38 Id. at 327.
39 Id. at 326.
40 Id.
41 Id.
42 Id. at 328.
43 Id. at 329 (quoting Burrage v. United States, 571 U.S. 204, 211 (2014)).
44 Id. (quoting Univ. of Tex. Sw. Med. Ctr. v. Nassar, 570 U.S. 338, 346–47 (2013)).
45 Id. (quoting Burrage, 571 U.S. at 212).
46 Id. at 330.
47 Id. at 331 (citing multiple examples).
48 Id. at 332 (quoting United States v. Bornstein, 423 U.S. 303, 314 (1976)).
49 Id.
50 Id. at 333–34.
51 Id. at 334–35.
52 See U.S. ex rel. Schroeder v. Hutchinson Reg'l Med. Ctr., 777 F. Supp. 3d 1256, 1262–63, 1275–79, 1281–84 (D. Kan. 2025) (granting summary judgment on the basis of the 2010 Amendment and false certification pathways, where the complaint included separate counts based on each); U.S. ex rel. Heller v. Guardian Pharmacy of Atlanta, LLC, No. 1:18-CV-03728-SDG, 2024 WL 102211, at *3 (N.D. Ga. Jan. 9, 2024) (holding implied false certification is a separate pathway based on finding 11th Circuit case law post-dating the 2010 Amendment confirming implied false certification as a theory to be controlling on the elements of an implied false certification claim) (citing Urquilla-Diaz v. Kaplan University, 780 F.3d 1039, 1045 (11th Cir. 2015)); U.S. ex rel. Fesenmaier v. Cameron-Ehlen Grp., Inc., No. 13-CV-3003 (WMW/DTS), 2023 WL 36174, at *1 (D. Minn. Jan. 4, 2023) (denying defendant’s motion in limine to exclude evidence of claims for which but-for causation was not established); cf. United States v. Regeneron Pharms., Inc., No. CV 20-11217-FDS, 2025 WL 2207299, at *4–5 (D. Mass. Aug. 4, 2025) (permitting, on remand, the government to move for partial summary judgment a second time on a false certification theory).
53 703 F. Supp. 3d 961, 979–80 (D. Minn. 2023).
54 42 U.S.C. § 1320a-7b(g).
55 Burrage, 571 U.S. at 214.
56 See, e.g., Merck & Co., Inc. v. Reynolds, 559 U.S. 633, 648 (2010) (courts “assume that, when Congress enacts statutes, it is aware of relevant judicial precedent”).
57 Regeneron, 128 F.4th at 328; Martin, 63 F.4th at 1052; Cairns, 42 F.4th at 836.
58 Regeneron, 128 F.4th at 333.
59 Id. (citation omitted).
60 Id. at 333.
61 42 U.S.C. § 1320a-7b(g).
62 Regeneron, 128 F.4th at 333 (citation omitted).
63 See text above at notes 11–14.
64 See text above at note 13.
65 The court, in Regeneron, in concluding otherwise—that is, that a false-certification pathway remained available notwithstanding the 2010 AKS Amendment based upon pre-2010 FCA case law—quoted from Midlantic Nat’l Bank v. N.J. Dept’t of Env’t Prot., 474 U.S. 494, 501 (1986), which observed that the “normal rule of statutory construction is that if Congress intends for legislation to change the interpretation of a judicially created concept, it makes that intent specific.” Regeneron, 128 F.4th at 333. But, as noted, there was no uniform application of a false-certification theory at that time of the 2010 AKS Amendment; indeed, the split in its application was so severe, the Supreme Court ultimately granted certiorari to resolve the split. See Escobar, 579 U.S. at 186. So, there was no occasion for Congress to announce that it was departing from a judicially created concept at the time of the 2010 AKS Amendment because there was no accepted judicially created concept from which to depart. This is also reflected in the district court’s decision in Thomas, which resulted in Congress’s 2010 AKS Amendment. Indeed, the lack of judicial consensus was the catalyst for Congress modifying the AKS to address specifically when the AKS would apply to FCA violations. It adopted a uniform approach and did not provide carve-outs or exceptions. That it would adopt this approach is not surprising because, as courts have recognized, when “Congress wants to make a violation of one statute or statutory section generate liability under another statute or section, it may or may not require proof of added elements not required to prove the predicate violation,” and, conversely, “if Congress wants to make a violation of one statute a per se violation of another, it can easily say so.” Regeneron, 128 F.4th at 331 (citing examples). Similarly, it is not surprising that, in the FCA context, Congress would require that plaintiff link the AKS violation to the “claim” for “items and services” and, specifically, show that the “claim” “result[s] from” the AKS violation because the “sine qua non” of an FCA action is “the act of submitting a fraudulent claim to the government.” U.S. ex rel. Grant v. Zorn, 107 F.4th 782, 795 (8th Cir. 2024); U.S. ex rel. Cafasso v. Gen. Dynamics C4 Sys., 637 F.3d 1047, 1055 (9th Cir. 2011) (same); U.S. ex rel. SNAPP, Inc. v. Ford Motor Co., 618 F.3d 505, 513 (6th Cir. 2010) (same); U.S. ex rel. Grubbs v. Kanneganti, 565 F.3d 180, 185 (5th Cir. 2009) (same); U.S. ex rel. Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220, 225 (1st Cir. 2004) (same); U.S. ex rel. Clausen v. Lab. Corp. of Am., 290 F.3d 1301, 1311 (11th Cir. 2002) (same).
66 42 U.S.C. § 1320a-7b(g).
67 U.S. ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96–98 (3d Cir. 2018).
68 Martin, 63 F.4th at 1054 (citations omitted).
69 Finally, applying the statutory text to require but-for causation does not undermine the government’s efforts to enforce the statute. As the Sixth Circuit noted in Martin, in rejecting the government’s contention, a “faithful” interpretation of “resulting from” “still leaves plenty of room to target genuine corruption…. [s]o long as proof exists that the referrals would not have been made without the remuneration, and that claims not have been submitted to the government without those referrals, causation for False Claims lawsuits would be satisfied too.” Id. at 1055 (citation omitted).
70 When determining the scope of a statute, “absurd results are to be avoided[.]” United States v. Turkette, 452 U.S. 576, 580 (1981); accord, e.g., McNeill v. United States, 563 U.S. 816, 822 (2011); Nixon v. Missouri Mun. League, 541 U.S. 125, 138 (2004).