Case: 23-2086 Document: 00118158433 Page: 1 Date Filed: 06/20/2024 Entry ID: 6650052
`
`No. 23-2086
`
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FIRST CIRCUIT
`
`
`UNITED STATES OF AMERICA,
`
`Plaintiff-Appellant,
`
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Defendant-Appellee.
`
`
`
`On Appeal from the United States District Court
`for the District of Massachusetts
`
`
`REPLY BRIEF FOR APPELLANT
`
`
`
`BRIAN M. BOYNTON
`Principal Deputy Assistant Attorney
`General
`JOSHUA S. LEVY
`Acting United States Attorney
`MICHAEL S. RAAB
`CHARLES W. SCARBOROUGH
`DANIEL WINIK
`Attorneys, Appellate Staff
`Civil Division, Room 7245
`U.S. Department of Justice
`950 Pennsylvania Avenue, NW
`Washington, DC 20530
`(202) 305-8849 
`
`
`
`
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`

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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ................................................................................................. ii 
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`INTRODUCTION .................................................................................................................. 1 
`
`ARGUMENT ............................................................................................................................ 3 
`
`A. 
`
`B. 
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`The Phrase “Resulting From” Is Not Dispositive ........................................ 3 
`
`The AKS’s Text And Context Favor Our Alternative Causal
`Standard ............................................................................................................... 7 
`
`CONCLUSION ..................................................................................................................... 23 
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`CERTIFICATE OF COMPLIANCE
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`TABLE OF AUTHORITIES
`
`Cases:
`
`Page(s)
`
`Becker v. FEC,
` 230 F.3d 381 (1st Cir. 2000) .............................................................................................. 18
`Bittner v. United States,
` 598 U.S. 85 (2023) ......................................................................................................... 13-14
`Brotherston v. Putnam Investments, LLC,
` 907 F.3d 17 (1st Cir. 2018) .................................................................................................. 4
`Burrage v. United States,
` 571 U.S. 204 (2014) .................................................................................................. 1, 2, 3, 7
`Clement v. United States,
` 980 F.2d 48 (1st Cir. 1992) .................................................................................................. 4
`Guerrero-Lasprilla v. Barr,
` 589 U.S. 221 (2020) ...................................................................................................... 15, 17
`Guilfoile v. Shields,
` 913 F.3d 178 (1st Cir. 2019) ........................................................................ 7, 8, 17, 18, 19
`Harrison v. Westinghouse Savannah River Co.,
` 176 F.3d 776 (4th Cir. 1999) ............................................................................................. 14
`Kenna v. U.S. District Court for the Central District of California,
` 435 F.3d 1011 (9th Cir. 2006) ........................................................................................... 18
`Leocal v. Ashcroft,
` 543 U.S. 1 (2004) ................................................................................................................. 14
`Midlantic National Bank v. New Jersey Department of Environmental Protection,
` 474 U.S. 494 (1986) ...................................................................................................... 15, 16
`Parker Drilling Management Services, Ltd. v. Newton,
` 139 S. Ct. 1881 (2019) ........................................................................................................ 15
`Paroline v. United States,
` 572 U.S. 434 (2014) ............................................................................... 1, 2, 3, 5, 6, 7, 9, 10
`Pfizer, Inc. v. HHS,
` 42 F.4th 67 (2d Cir. 2022) .................................................................................................. 21
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`Pharmaceutical Coalition for Patient Access v. United States,
` 2024 WL 187707 (E.D. Va. Jan. 17, 2024) ................................................................ 21-22
`Pugin v. Garland,
` 599 U.S. 600 (2023) ............................................................................................................. 19
`Ramirez-Burgos v. United States,
` 313 F.3d 23 (1st Cir. 2002) .................................................................................................. 4
`Sheehan v. North American Marketing Corp.,
` 610 F.3d 144 (1st Cir. 2010) ................................................................................................ 4
`Timothy W. v. Rochester School District,
` 875 F.2d 954 (1st Cir. 1989) .............................................................................................. 18
`United States v. Castleman,
` 572 U.S. 157 (2014) ............................................................................................................. 14
`United States v. De La Cruz,
` 514 F.3d 121 (1st Cir. 2008) ............................................................................................ 3, 4
`United States v. Hayes,
` 555 U.S. 415 (2009) ............................................................................................................. 18
`United States v. Kilmartin,
` 944 F.3d 315 (1st Cir. 2019) ................................................................................................ 3
`United States v. Krizek,
` 111 F.3d 934 (D.C. Cir. 1997) ........................................................................................... 14
`United States v. Mann,
`26 F. Cas. 1153 (C.C.D.N.H. 1812) ................................................................................. 13
`United States v. Teva Pharmaceuticals USA, Inc.,
` 2019 WL 1245656 (S.D.N.Y. Feb. 27, 2019) .................................................................. 20
`United States v. Wiltberger,
` 18 U.S. (5 Wheat.) 76 (1820) ............................................................................................. 13
`United States ex rel. Greenfield v. Medco Health Solutions, Inc.,
` 880 F.3d 89 (3d Cir. 2018) ............................................................................................ 7, 20
`United States ex rel. Hutcheson v. Blackstone Medical, Inc.,
` 647 F.3d 377 (1st Cir. 2011) ....................................................................................... 15, 16
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`United States ex rel. Thomas v. Bailey,
` 2008 WL 4853630 (E.D. Ark. Nov. 6, 2008) ........................................................... 17, 18
`United States ex rel. Westmoreland v. Amgen, Inc.,
`812 F. Supp. 2d 39 (D. Mass. 2011) ................................................................................. 16
`United States ex rel. Witkin v. Medtronic, Inc.,
` 2024 WL 1892405 (D. Mass. Mar. 31, 2024) .................................................................... 8
`Universal Health Services, Inc. v. United States,
` 579 U.S. 176 (2016) ............................................................................................................. 21
`Yates v. United States,
` 574 U.S. 528 (2015) ............................................................................................................. 17
`
`Statutes:
`
`8 U.S.C. § 1252(a)(2)(D) ......................................................................................................... 15
`18 U.S.C. § 1716(j)(3) ................................................................................................................ 3
`18 U.S.C. § 2259(b)(1)-(2) (2012) ............................................................................................ 5
`18 U.S.C. § 3664 ........................................................................................................................ 5
`18 U.S.C. § 3664(e) .................................................................................................................... 5
`31 U.S.C. § 3729(a)(1) ............................................................................................................. 12
`31 U.S.C. § 3729(a)(1)(A) ....................................................................................................... 17
`42 U.S.C. § 1320a-7b(b)(2) .......................................................................................... 9, 12, 19
`42 U.S.C. § 1320a-7b(g) ................................................................................................... 1, 2, 7
`
`Legislative Material:
`
`155 Cong. Rec. S10,853 (daily ed. Oct. 28, 2009)............................................................... 17
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`INTRODUCTION
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`Regeneron’s brief reflects the same basic error as the Sixth and Eighth Circuit
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`opinions on which it relies: It misunderstands what is and is not resolved by the phrase
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`“resulting from.” That language “imposes … a requirement of actual causality,” or
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`causation in fact. Burrage v. United States, 571 U.S. 204, 211 (2014). On that, everyone
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`agrees. But Burrage goes on to make clear, as our opening brief explained, that such
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`language does not dictate the applicable standard of causation in fact. To the contrary,
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`Burrage explains that courts “read phrases like ‘results from’ to require but-for causality”
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`only if “there is no textual or contextual indication” that a different standard is more
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`appropriate. Id. at 212. And the Court underscored that point months later in Paroline
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`v. United States, 572 U.S. 434 (2014), where it declined to read the word “result” as im-
`
`plying a but-for standard of causation. Id. at 449-462.
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`Paroline forecloses Regeneron’s argument (Br. 17-29) that Burrage, and the plain
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`meaning of “resulting from,” determine the standard of causation under 42 U.S.C.
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`§ 1320a-7b(g). Paroline says the opposite. It explains that the word “result” does not
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`“by its terms require[] a showing of strict but-for causation,” because “the availability
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`of alternative causal standards where circumstances warrant is, no less than the but-for
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`test itself as a default, part of the background legal tradition against which Congress
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`has legislated.” 572 U.S. at 458. And it holds that courts cannot properly “adopt a
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`causal standard so strict that it would undermine congressional intent where neither the
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`plain text of the statute nor legal tradition demands such an approach.” Id. If
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`Regeneron were correct, then the Supreme Court would have had little difficulty inter-
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`preting the statute in Paroline to require but-for causation. Yet not a single Justice found
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`the statutory reference to a “result” to be dispositive.
`
`Regeneron largely ignores Paroline—to the point of asserting (Br. 30) that “the
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`government has yet to point to any precedential opinion” construing “the phrase ‘re-
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`sulting from’ or its cognates to refer to anything other than but-for causation,” when
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`Paroline is precisely such an opinion. Paroline is as precedential as Burrage is, and the two
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`cases together make clear that the phrase “resulting from” is only the beginning of the
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`analysis—not, as Regeneron would have it, the end. The phrase implies a causation
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`requirement, but it does not specify what standard of causation applies.
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`To answer that question, the Court must consider “textual [and] contextual” fac-
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`tors, Burrage, 571 U.S. at 212, to determine whether § 1320a-7b(g) is one of those pro-
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`visions for which “circumstances warrant” an “alternative” to the “default” but-for
`
`standard, Paroline, 572 U.S. at 458. The “circumstances” of § 1320a-7b(g), and the
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`“text[]” and “context[]” of the statute in which it appears, yield only one plausible an-
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`swer: If kickbacks are given to induce the purchase of a drug, and the purchase then
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`happens, a claim seeking reimbursement for the purchase “includes items or services
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`resulting from a violation of [the AKS],” 42 U.S.C. § 1320a-7b(g). At bottom, Regen-
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`eron’s argument is that the statutory text leaves no choice but to adopt an interpretation
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`that defies common sense. But that rationale was wrong when the Sixth and Eighth
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`Circuits adopted it, and this Court should join the Third Circuit in rejecting it.
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`ARGUMENT
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`A.
`
`1.
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`The Phrase “Resulting From” Is Not Dispositive
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`As noted above, all agree that the phrase “‘[r]esults from’ imposes … a
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`requirement of actual causality,” or causation in fact, Burrage, 571 U.S. at 211, and that
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`but-for causation is the “default” standard of causation in fact, Paroline, 572 U.S. at 458.
`
`For that reason, “courts regularly read phrases like ‘results from’ to require but-for cau-
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`sality” as long as “there is no textual or contextual indication to the contrary.” Burrage,
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`571 U.S. at 212. And there often is no contrary indication.
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`Regeneron errs, however, in suggesting (Br. 22-23) that this Court has frequently
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`read “result” language to imply a but-for causation standard as opposed to some other
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`standard. None of the cases cited for that proposition supports it. In United States v.
`
`Kilmartin, 944 F.3d 315 (1st Cir. 2019), the question was whether 18 U.S.C. § 1716(j)(3)—
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`which imposes a sentence enhancement when a crime under § 1716 “has resulted in the
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`death of any person”—requires only factual causation or, as the defendant argued, “the
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`same causation as murder.” See 944 F.3d at 330-331, 331 n.5.1 Much the same was true
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`in United States v. De La Cruz, 514 F.3d 121 (1st Cir. 2008): The jury had found that “the
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`ingestion of heroin was a but-for cause of ” a person’s death, id. at 128, and the question
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`was whether that was enough for a sentence enhancement or whether proof of
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`
`1 Contrary to Regeneron’s suggestion (Br. 22), the government’s argument that
`factual causation was enough was consistent with our arguments here. See U.S. Br.,
`United States v. Kilmartin, 2019 WL 2524976, at *51-57 (1st Cir. June 14, 2019).
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`“foreseeability” was also required, see id. at 136-138. And in Ramirez-Burgos v. United
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`States, 313 F.3d 23 (1st Cir. 2002), and Brotherston v. Putnam Investments, LLC, 907 F.3d 17
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`(1st Cir. 2018), the Court stated that “results” language required proof of causation,
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`not that that language required a but-for standard. See 313 F.3d at 30; 907 F.3d at 34.
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`Regeneron is correct that the Court has sometimes used “but-for causation” as
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`shorthand for “factual causation.” See, e.g., Sheehan v. North Am. Mktg. Corp., 610 F.3d
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`144, 150 n.10 (1st Cir. 2010). But that is unsurprising, since but-for causation is the
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`default standard. And elsewhere, when the Court was focusing more precisely on the
`
`issue, it has recognized that but-for causation is not the only standard of factual causa-
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`tion. For example, in Clement v. United States, 980 F.2d 48 (1st Cir. 1992), the Court stated
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`that “[c]ausation-in-fact is … a factual inquiry which requires a court to determine if
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`an injury would not have occurred but for a defendant’s negligence, or, in the situation
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`where there are two or more causes, each of which by itself is sufficient to bring about
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`an injury, whether the defendant’s conduct was a substantial factor in bringing about
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`the injury.” Id. at 54 (emphasis added). Regeneron quotes the first part of that sen-
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`tence—characterizing it as going “out of it[s] way to explain” that causation in fact
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`necessarily means but-for causation (Br. 26)—without referencing the second part,
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`which refutes that characterization.
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`2.
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`Regeneron’s selective reading of this Court’s precedents is compounded
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`by its inattention to Paroline—one of the Supreme Court’s seminal pronouncements on
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`factual causation, and a focus of our opening brief.
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`The petitioner in Paroline had pleaded guilty to possessing pornographic images
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`of a child, and the question was what restitution he could be ordered to pay. The rele-
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`vant statute provided that restitution should be ordered in “the full amount of the vic-
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`tim’s losses” and that the loss amount should be “determined … pursuant to” a sub-
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`paragraph stating that a restitution order should “be issued … in accordance with” 18
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`U.S.C. § 3664. 18 U.S.C. § 2259(b)(1)-(2) (2012). That provision, in turn, required proof
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`of “the amount of the loss sustained by a victim as a result of the offense.” Id. § 3664(e)
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`(emphasis added).
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`The petitioner argued that the word “result” implied a but-for standard of cau-
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`sation and thus that he could not be ordered to pay any restitution, because the victim—
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`whose images were possessed by thousands of others—would have suffered the same
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`harm absent his offense. See, e.g., Pet’r Supp. Br., 2014 WL 950793 (U.S. Mar. 7, 2014)
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`(invoking Burrage). That argument clearly would have prevailed if Regeneron were cor-
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`rect that “result” language necessarily implies a but-for standard.
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`Yet not a single Justice accepted that argument. The majority opinion recognized
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`that “[t]he words ‘as a result of ’ plainly suggest causation,” 572 U.S. at 445, but it pro-
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`ceeded to analyze the standard of causation at length, recognizing that “such unelabo-
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`rated causal language by no means requires but-for causation by its terms,” id. at 458.
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`The majority recognized that “courts have departed from the but-for standard where
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`circumstances warrant,” id. at 451; that “alternative and less demanding causal standards
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`are necessary in certain circumstances to vindicate the law’s purposes,” id. at 452; and
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`that “the availability of alternative causal standards where circumstances warrant is, no
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`less than the but-for test itself as a default, part of the background legal tradition against
`
`which Congress has legislated,” id. at 458. And the majority refused “to adopt a causal
`
`standard so strict that it would undermine congressional intent where neither the plain
`
`text of the statute nor legal tradition demands such an approach.” Id. Rather, the
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`majority instructed courts to “order restitution in an amount that comports with the
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`defendant’s relative role in the causal process that underlies the victim’s general losses.”
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`Id. The majority described this as a “causal standard,” id. at 462, though all agreed that
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`the petitioner’s conduct was not a but-for cause of the victim’s injuries, see id. at 450.
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`Four Justices dissented, but none of them concluded that the word “result” re-
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`quired but-for causation. Justice Sotomayor would have adopted a standard of “aggre-
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`gate causation,” under which the petitioner would have had to pay restitution in the full
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`amount of the victim’s losses. Id. at 473-477 (Sotomayor, J., dissenting). And although
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`the other dissenters reached the bottom-line conclusion urged by the petitioner—i.e.,
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`that he could not be ordered to pay restitution—they did not do so by embracing his
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`(and Regeneron’s) logic that the statutory language required but-for causation. To the
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`contrary, they concluded that Congress had “provided no mechanism for answering”
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`the question of what “amount of … losses” the petitioner’s offense had “caused.” Id.
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`at 466-467 (Roberts, C.J., dissenting). They said so even while recognizing that the
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`answer to that question (namely, zero dollars) would be clear “[i]f actual causation
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`[were] to be determined using the traditional, but-for standard.” Id. at 467.
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`Paroline thus forecloses Regeneron’s argument that statutory text resolves this
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`case. If that were true of the “resulting” language here, it would have been equally true
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`of the “result” language in Paroline. See Regeneron Br. 20 (it is “obvious” that “there is
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`no delta between ‘resulting’ and ‘results’”). That language undisputedly requires some
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`form of factual causation, but it does not resolve the applicable standard of causation.
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`B.
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`The AKS’s Text And Context Favor Our Alternative Causal
`Standard
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`The standard of factual causation under § 1320a-7b(g) must instead be resolved
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`by considering “textual [and] contextual” factors, Burrage, 571 U.S. at 212, to determine
`
`whether “circumstances warrant” an “alternative” to the “default” but-for standard,
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`Paroline, 572 U.S. at 458. And as our opening brief explained, the text and context of
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`§ 1320a-7b(g), as well as the surrounding provisions of the AKS, make clear that the
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`answer is yes. If kickbacks are given to induce the purchase of a particular drug, and
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`the intended purchase then happens, a claim seeking reimbursement for the purchase
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`“includes items or services resulting from a violation of [the AKS],” 42 U.S.C. § 1320a-
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`7b(g). That is the standard adopted in United States ex rel. Greenfield v. Medco Health Solu-
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`tions, Inc., 880 F.3d 89, 98 (3d Cir. 2018)—cited approvingly in Guilfoile v. Shields, 913 F.3d
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`178, 190 (1st Cir. 2019)—and by several district courts within this Circuit.2 Opening
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`2 Regeneron’s amicus points (Br. 5 n.2) to a portion of the analysis in Guilfoile
`stating that “the complaint permits the reasonable inference that, if not for the agree-
`ment with [the kickback recipient], the [kickback payor] would not have been in a posi-
`tion to benefit from federal health care payments arising from its work with the
`Continued on next page.
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`Br. 15-18; see also United States ex rel. Witkin v. Medtronic, Inc., 2024 WL 1892405, at *18-
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`19 (D. Mass. Mar. 31, 2024) (rejecting a but-for standard, after the filing of our opening
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`brief). Regeneron’s objections are unpersuasive.
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`1.
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`Regeneron argues that what we are “advocating is not a standard of cau-
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`sation at all.” Br. 31. But the analogies on which Regeneron bases that argument (Br.
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`33-34) underscore Regeneron’s misunderstanding. It is obviously true that if “a diehard
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`Red Sox fan … turn[s] his baseball cap inside out and backwards in hopes of sparking
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`a come-from-behind win,” “only a truly delusional fan … would say that the win ‘re-
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`sult[ed] from’ the fan’s rally cap” (Br. 33). It is equally true that “if a crime lord pays a
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`hitman to take out a rival and the rival happens to drop dead of a heart attack seconds
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`later,” the heart attack could not be said to result from the hitman’s hiring (id.). But that
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`is because there is no plausible connection rooted in reality (as opposed to superstition)
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`between these outcomes and their putative causes.
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`By contrast, if a drug company pays doctors to prescribe a drug, and a doctor
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`does so—or if the company subsidizes the cost of a drug for patients, and a patient
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`hospitals” that the recipient was paid a kickback to refer. 913 F.3d at 191. But that part
`of the opinion does not suggest that any such inference was necessary to establish the
`requisite degree of “causal connection.” The preceding sentence stated that it was “rea-
`sonabl[e]” to “infer from the complaint’s allegations that the [kickback payor] paid [the
`recipient] to induce him to use his position with the hospitals to influence them to select
`the [payor] for the contracts at issue.” Id. The sentence on which amicus relies was
`simply a “[f]urther” observation. Id. If the Court believed that the but-for connection
`was essential, it would have omitted the first of the two sentences, as only the second
`would have been relevant.
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`buys the drug—there is an obvious connection between the company’s conduct and the
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`outcome: The company’s conduct gives doctors an additional incentive to prescribe, or
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`patients an additional incentive to purchase, the drug. Congress enacted the AKS to
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`forbid kickbacks, in themselves, because it wanted medical decisions to be made without
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`these sorts of illicit financial considerations. Regeneron’s hypotheticals not only miss
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`the point; they trivialize the real-world concerns animating this statutory scheme.
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`It is true that the additional incentive provided by a kickback may or may not
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`make a dispositive difference to a doctor’s prescribing decision, or a patient’s purchasing
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`decision, in any given case. But in Paroline, the fact that the victim’s harm would have
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`been equally bad absent the petitioner’s conduct did not stop the Supreme Court from
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`treating that conduct as a cause of the victim’s injury. As the Paroline majority explained,
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`courts adopt alternative standards for causation-in-fact as “a kind of legal fiction or
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`construct,” reflecting the need “to vindicate the law’s purposes” in “circumstances”
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`where a but-for standard would produce “anomalous” or “nonsensical” results. 572
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`U.S. at 452. The Court adopted such a construct in Paroline because a but-for standard
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`would have produced a result at odds with Congress’s intent. And numerous courts
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`have done the same in this context. For good reason: As in Paroline, there is no question
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`that the conduct here—paying remuneration “to induce” the purchase of federally re-
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`imbursable items or services, or referrals for such items or services, 42 U.S.C. § 1320a-
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`7b(b)(2)—tends to increase the likelihood of those outcomes. It may be unclear
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`whether the incentive provided by a kickback makes a dispositive difference to a
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`particular purchase, prescription, or referral. But as Paroline recognizes, the additional
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`incentive can be treated as a component of a “causal process” that produces one of
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`those outcomes whether or not the outcome might have occurred even without the
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`addition of that component. 572 U.S. at 458.
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`A baseball analogy more apposite than Regeneron’s may help to illustrate the
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`point. Suppose the Yankees arrange to give an umpire a $1000 kickback for each call
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`he makes in their favor during an important series with the Red Sox. At a crucial junc-
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`ture, the umpire ejects a Red Sox player for arguing balls and strikes, thus earning $1000.
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`The Yankees could argue that the umpire would have ejected the player absent the bribe,
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`but many players are not ejected for similar conduct; umpires have significant discretion.
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`Under these circumstances, it would hardly be strange to say that the ejection “resulted
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`from” the bribe, because the bribe provided an additional incentive for the ejection; it
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`was a component of the broader “causal process,” Paroline, 572 U.S. at 458, that pro-
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`duced that result, whether or not it would be possible to prove that the umpire would
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`have exercised his discretion differently had he not been bribed.
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`Regeneron is thus incorrect to suggest (Br. 31) that the standard adopted by
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`Greenfield and many other cases is “not a standard of causation at all.” The only way to
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`reach that conclusion is by equating “causation” with “but-for causation”—which, as
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`discussed above, is the basic error that pervades Regeneron’s brief.
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`2.
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`Regeneron next contends (Br. 35-37) that it is “hardly irrational” to “re-
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`quir[e] proof of something more” in a civil FCA action based on an AKS violation
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`than in a criminal prosecution under the AKS. Regeneron notes that civil actions for
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`violations of various laws may require proof that a given plaintiff has been injured by
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`the defendant’s conduct, whereas parallel criminal prosecutions would not.
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`But under our construction, § 1320a-7b(g) performs the same function of limit-
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`ing FCA liability to a subset of AKS violations. As discussed in our opening brief, the
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`AKS forbids giving a kickback to induce the provision of a federally reimbursable item
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`or service regardless of whether the item or service is provided or whether a claim for
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`it is submitted. If the desired result of the kickback does not come to pass, or no claim
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`for it is submitted, then the AKS violation does not create FCA liability. Like the pro-
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`visions that Regeneron invokes, § 1320a-7b(g) reserves FCA liability for a subset of
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`kickbacks, where the intended result comes to pass and a claim for it is submitted.
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`The key question is whether, instead of allowing FCA liability in that subset of
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`cases, Congress meant to limit it much more narrowly to the subset of kickbacks for
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`which one could show that a medical decision would have been different absent the
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`kickback. Regeneron makes no argument to that effect. For good reason: It would be
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`implausible to argue that, if a drug company pays a kickback for each prescription of a
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`drug, and a doctor’s prescriptions of the drug increase from 50 in one year to 75 in the
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`next (to use the district court’s hypothetical, A21), Congress would have wanted only
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`25 claims for those prescriptions to be treated as false. Each of those prescriptions
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`would be a financially conflicted medical decision—exactly what the AKS proscribes.
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`That is why Regeneron devotes so much of its brief to arguing (incorrectly) that the
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`statutory text leaves the Court no choice but to impose that outcome, rather than argu-
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`ing that Congress could possibly have intended it.3
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`3.
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`Regeneron next (Br. 37-38) invokes 31 U.S.C. § 3729(a)(1), which states
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`that a person who violates the FCA is liable for civil penalties “plus 3 times the amount
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`of damages which the Government sustains because of the act of that person.” Re-
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`generon points to the “because of ” language as implying a but-for causation require-
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`ment. That misses the point for two reasons.
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`First, as its language makes clear, the provision addresses the question of when
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`treble damages are available for an FCA violation—not the question of when the FCA
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`is violated in the first place. The latter, not the former, is the question before this Court.
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`3 Regeneron’s amicus makes a broader statement (Br. 13) that “an unsuccessful
`kickback scheme might violate the AKS” but “does not violate the FCA.” To the extent
`amicus means for “an unsuccessful kickback scheme” to refer to the paying of kick-
`backs that do not alter medical decisions—in other words, kickbacks that were unnec-
`essary because the results the payor meant to induce would have occurred even without
`the kickback—it is incorrect for the reasons discussed above.
`To the extent amicus means to refer to kickbacks that are “unsuccessful” in the
`sense that the recipient rejects the kickback, or accepts it but does not take the actions
`that the payor intended, we agree with amicus’s statement. We do not contend that a
`kickback can create FCA liability under § 1320a-7b(g) if it is merely “offer[ed]” but not
`actually “pa[id],” 42 U.S.C. § 1320a-7b(b)(2). If the kickback is offered but rejected,
`then the person to whom the offer is made may well have no subsequent conflict of
`interest. And as discussed above, we do not contend that a kickback can create FCA
`liability under § 1320a-7b(g) if the desired result of the kickback does not come to pass
`or no claim for it is submitted.