{"id":57798,"date":"2025-05-29T16:10:00","date_gmt":"2025-05-29T16:10:00","guid":{"rendered":"https:\/\/www.dinsmore.com\/?post_type=publications&p=57798"},"modified":"2025-12-31T15:51:45","modified_gmt":"2025-12-31T15:51:45","slug":"first-circuit-requires-but-for-causation-for-aks-based-fca-liability-bolsters-majority-view","status":"publish","type":"publications","link":"https:\/\/www.dinsmore.com\/publications\/first-circuit-requires-but-for-causation-for-aks-based-fca-liability-bolsters-majority-view\/","title":{"rendered":"First Circuit Requires but-for Causation for AKS-Based FCA Liability, Bolsters Majority View"},"content":{"rendered":"\n
\"\"\/<\/figure>\n\n\n\n

What is the proper causation standard for an Anti-Kickback Statute violation to trigger liability under the False Claims Act? The First Circuit has answered that question in a much anticipated interlocutory decision in Regeneron. <\/em>The court held that, to prove FCA falsity under the AKS, the government must show an illicit kickback was the but-for <\/em>cause of a submitted claim\u2014rather than meet a more relaxed \u201clink\u201d or \u201cexposure\u201d standard. The First Circuit joined the Sixth and Eighth Circuits, forming a 3\u20131 majority favoring but-for causation.<\/strong><\/p>\n\n\n\n

For years, courts have wrestled with determining when the criminal Anti-Kickback Statute (AKS)[1]<\/a> imposes additional, civil False Claims Act (FCA) liability for claims for goods or services \u201cresulting from\u201d an illegal kickback. In an interlocutory appeal in United States v. Regeneron Pharmaceuticals, Inc.<\/em>,[2]<\/a> the First Circuit decided in favor of but-for causation, meaning the government must prove the AKS violation actually caused submission of a false claim\u2014giving that view an enhanced, 3\u20131 majority among circuits that have considered the issue.[3]<\/a> The FCA bar has been closely watching the appeal, where an alternative decision would have created a 2\u20132 circuit split.<\/p>\n\n\n\n

Background<\/strong><\/p>\n\n\n\n

In modern AKS-predicated FCA cases, the government must show the defendant submitted payment claims for items or services \u201cresulting from<\/em>\u201d a prohibited kickback.[4]<\/a> In 2018, the Third Circuit interpreted that causation language as requiring plaintiffs to show \u201ca link\u201d between the AKS violation and presentment of a payment claim.[5]<\/a> In 2022, the Eighth Circuit (and the Sixth Circuit the following year) rejected that standard, interpreting \u201cresulting from\u201d to require but-for causation,[6]<\/a> i.e.<\/em>, the claim would not have been submitted \u201cin the absence of\u2014that is, but for<\/em>\u201d the alleged kickback.[7]<\/a><\/p>\n\n\n\n

The circuit division is echoed at the trial court level, sometimes within the same district: Regeneron <\/em>was one of two District of Massachusetts AKS\/FCA cases where the causation issue was decided in opposite ways just two months apart in 2023,[8]<\/a> leading to twin interlocutory appeals.<\/p>\n\n\n\n

The Regeneron <\/em>defendant, a pharmaceutical manufacturer of a macular degeneration drug, made donations to a foundation that helps cover co-pays for patients with that disease. The foundation distributes donated funds, first-come first-served, to patient applicants. The government alleges the donations were kickbacks intended to induce providers to prescribe defendant\u2019s drug, and that Medicare claims the providers filed therefore \u201cresulted from\u201d an AKS violation, making them \u201cfalse or fraudulent\u201d claims under the FCA.<\/p>\n\n\n\n

The district court, deciding twin summary judgment motions, conducted a careful statutory analysis regarding the causation standard. The court was unpersuaded by the Third Circuit\u2019s reasoning in Greenfield<\/em>, finding the lack of analysis of the statute\u2019s causal language, the foray into legislative history, and the ill-defined \u201cexposure\u201d standard there all problematic. In contrast, the court found (following Cairns <\/em>and Martin<\/em>) that, given an \u201cunambiguous\u201d statutory text, there was no basis for questioning the default meaning of \u201cresulting from\u201d as but-for causation. In the end, the court denied summary judgment to the government, rejecting its assertion of the Greenfield <\/em>\u201cexposure\u201d standard. The appeal to the First Circuit followed (we covered the district court decision and certification of the interlocutory appeal here<\/a>).[9]<\/a><\/p>\n\n\n\n

Interlocutory Appeal to First Circuit<\/strong><\/p>\n\n\n\n

Meaning of \u201cresulting from.\u201d <\/em><\/strong>On appeal, the government argued, first, that but-for causation is merely a \u201cdefault,\u201d and that \u201ctextual and contextual indications\u201d can\u2014and here do\u2014dictate alternative standards. The government relied on the Supreme Court\u2019s holdings in Burrage v. United States <\/em>and Paroline v. United States <\/em>for support.[10]<\/a> In describing Burrage <\/em>as holding that courts \u201cread phrases like \u2018results from\u2019 to require but-for causality\u2019 only if<\/em> \u2018there is no textual or contextual indication to the contrary,\u201d it arguably framed but-for causality as an exception rather than a default.[11]<\/a><\/p>\n\n\n\n

The defendant, in contrast, emphasized the strong presumption favoring but-for causality absent some contrary \u201coverriding textual or contextual indication\u201d and noted that Burrage <\/em>\u201chardly broke new ground on this point.\u201d Because \u201cresulting from\u201d is not defined in the statute, the defendant argued that courts assume the words carry \u201ctheir plain and ordinary meaning.\u201d The defendant acknowledged the Supreme Court\u2019s recognition that special circumstances may warrant departing from but-for causation, but emphasized such circumstances are \u201cquite rare.\u201d And, in such unusual circumstances, courts typically move to a more<\/em>, not less, demanding standard\u2014such as proximate causation.<\/p>\n\n\n\n

The First Circuit agreed with the defendant regarding the existence of a strong presumption that \u201cresulting from\u201d in the 2010 AKS amendment requires but-for causation.[12]<\/a> And the court found no \u201ctextual indication\u201d in the statute\u2019s plain language to support departing from that standard.[13]<\/a><\/p>\n\n\n\n

Statutory purposes. <\/em><\/strong>The government also argued the 2010 amendment\u2019s \u201cresulting from\u201d language cannot mean but-for causation because that standard would defeat the AKS\u2019s purpose of facilitating kickback-based whistleblower actions. Since the AKS imposes criminal<\/em> liability for kickbacks \u201cwithout requiring a showing that the kickbacks actually changed medical decisionmaking,\u201d the government reasoned there is no basis for believing Congress meant to require a heightenedshowing for FCA civil<\/em> liability. To supplement this argument, the government also invoked legislative history: \u201cCongress meant to make it easier <\/em>to prove \u2018whistleblower actions based on medical care kickbacks\u2019\u201d and therefore it \u201cdefies reason\u201d that Congress intended to add \u201can onerous element of proof\u201d for civil liability.<\/p>\n\n\n\n

The court rejected these arguments, noting the government\u2019s concession that \u201cthe words \u2018resulting from\u2019 require proof of some type of actual causality\u201d while \u201cAKS liability . . . does not require any causal link between an inducement and any payment\u201d\u2014and concluding, therefore, that \u201cthe premise that the 2010 amendment\u2019s causation requirement must track that of the AKS fails to get out of the starting blocks.\u201d[14]<\/a> The court similarly rejected the government\u2019s invitations to consider legislative history and statutory history, and the contention that proving but-for causation \u201ccan sometimes be difficult.\u201d[15]<\/a><\/p>\n\n\n\n

Implications<\/strong><\/p>\n\n\n\n

With the First Circuit\u2019s Regeneron <\/em>decision, a clear majority has now coalesced around but-for causation in AKS-predicated FCA cases\u2014with the Eighth, Sixth, and First Circuits all endorsing that standard and the Third Circuit standing as the lone outlier. While a circuit split obviously remains, the majority view appears to be moving in the direction of becoming settled law.[16]<\/a> Moreover, beginning with the Eighth Circuit\u2019s Cairns <\/em>decision in 2022, the appellate opinions on this issue provide careful statutory interpretation and have had the benefit of analyzing the contrary holding in Greenfield<\/em>, which they have ultimately rejected.<\/p>\n\n\n\n

Companies defending AKS\/FCA actions can now draw on a strengthened body of case law endorsing the but-for standard, controlling in three circuits and constituting persuasive authority elsewhere. However, defendants need to be wary of forum shopping by relators seeking venue within the Third Circuit, where the minority view is precedential\u2014although Regeneron <\/em>and its forerunners should still be invoked there for their persuasive weight. Dinsmore will continue to monitor this and other key FCA litigation issues.<\/p>\n\n\n\n

\n\n\n\n

[1]<\/a> 42 U.S.C. \u00a7 1320a-7b. The AKS criminalizes offering or paying \u201cany kickback, bribe, [] rebate,\u201d or other \u201cremuneration\u201d to induce a person to purchase any good or service \u201cfor which payment may be made\u201d under a Federal health care program. \u00a7 1320a-7b(b)(2) (alteration added).<\/p>\n\n\n\n

[2]<\/a> Civ. A. No. 20-11217-FDS, 2023 U.S. Dist. LEXIS 172618 (D. Mass. Sept. 27, 2023); the decision on appeal was 128 F.4th 324 (1st Cir. 2025).<\/p>\n\n\n\n

[3]<\/a> The previous three circuit court decisions:U.S. ex rel. Greenfield v. Medco Health Sols., Inc.<\/em>, 880 F.3d 89, 98, 100 (3d Cir. 2018) (requiring only \u201ca link\u201d or \u201csome connection\u201d between an alleged kickback and a subsequent claim for payment); U.S. ex rel. Cairns v. D.S. Med. LLC<\/em>, 42 F.4th 828, 834\u201336 (8th Cir. 2022) (finding the statute\u2019s \u201cresulting from\u201d language \u201cunambiguously causal\u201d and holding that establishing FCA falsity under the 2010 AKS amendment requires \u201cbut for\u201d causal proof); U.S. ex rel. Martin v. Hathaway<\/em>, 63 F.4th 1043, 1052\u201355 (6th Cir. 2023) (same holding).<\/p>\n\n\n\n

[4]<\/a> 42 U.S.C. \u00a7 1320a-7b(g) (emphasis added). This language was added by amendment in 2010.<\/p>\n\n\n\n

[5]<\/a> See Greenfield<\/em>, 880 F.3d at 100. The court also articulated plaintiff\u2019s causation hurdle as that of establishing \u201csome connection\u201d between kickback and subsequent reimbursement claim, by showing that at least one patient to whom services were provided and for whom reimbursement claim was submitted was \u201cexposed\u201d to a referral or recommendation of the service provider). At the same time, the court rejected the idea that the mere \u201ctaint <\/em>of a kickback renders every reimbursement claim false.\u201d  Id.<\/em> (emphasis added); see also Regeneron<\/em>, 2023 U.S. Dist. LEXIS 172618, at *27\u201329 (discussing uncertainty of boundary between \u201ctaint\u201d and \u201cexposure\u201d in Greenfield<\/em>).<\/p>\n\n\n\n

[6]<\/a> See Cairns<\/em>, 42 F.4th at 834\u201336; Martin<\/em>, 63 F.4th at 1052\u201355.<\/p>\n\n\n\n

[7]<\/a> Cf. <\/em>Cairns<\/em>, 42 F.4th at 834.<\/p>\n\n\n\n

[8]<\/a> Compare United States v. Teva Pharms. USA, Inc.<\/em>, 682 F. Supp. 3d 142, 145\u201346 (D. Mass. 2023) (Gorton, J.) (quoting Guilfoile v. Shields<\/em>, 913 F.3d 178, 190 (1st Cir. 2019)) (endorsing, in FCA retaliation case, the view that FCA falsity requires plaintiff to establish a \u201csufficient causal connection between an AKS violation and a claim [for payment] submitted to the federal government\u201d) (alteration added) with <\/em>Regeneron<\/em>, Civ. A. No. 20-11217-FDS, 2023 U.S. Dist. LEXIS 172618, at *27-31, 39 (D. Mass. Sept. 27, 2023) (Saylor, C.J.) (construing \u201cresulting from\u201d as requiring but-for causation).<\/p>\n\n\n\n

[9]<\/a>Citing the circuit split and contrary decisions within the district, both judges certified the cases for interlocutory appeal of the statutory interpretation issue. See Teva<\/em>, Civ. A. No. 20-11548-NMG (D. Mass.), DE 235 (Aug. 14, 2023); Regeneron<\/em>, 2023 U.S. Dist. LEXIS 191418, at *2 (D. Mass. Oct. 25, 2023). Originally the Regeneron <\/em>and Teva <\/em>interlocutory appeals were paired; subsequently, however, Teva <\/em>was placed in abeyance while settlement negotiations took place in that case, culminating in eventual settlement. This left Regeneron <\/em>as the lone case in the appeal.<\/p>\n\n\n\n

[10]<\/a> Burrage<\/em>, 571 U.S. 204 (2014); Paroline<\/em>, 572 U.S. 434 (2014).<\/p>\n\n\n\n

[11]<\/a> Cf. Burrage<\/em>, 571 U.S. at 212(\u201c<\/em>Where there is no textual or contextual indication to the contrary, courts regularly read phrases like \u2018results from\u2019 to require but-for causality.\u201d). The Burrage <\/em>Court\u2019s further discussion of the issue made clear its view that the presumption in favor of but-for causation is a strong one. See<\/em>, e.g.<\/em>, id. <\/em>at 212\u201313 (discussing courts\u2019 routine application of but-for causality to statutory terms \u201cbecause,\u201d \u201cby reason of,\u201d and \u201cbased on\u201d); id. <\/em>at 213\u201314 (\u201cState courts . . . usually interpret similarly worded criminal statutes in the same manner.\u201d); id. <\/em>at 214\u201315 (observing that instances of multiple sufficient causes independently, but concurrently, producing a result form the \u201cmost common (though still rare<\/em>)\u201d exception to \u201cstrict but-for causality\u201d) (emphasis added).<\/p>\n\n\n\n

[12]<\/a> Regeneron<\/em>, 128 F.4th at 328\u201330.<\/p>\n\n\n\n

[13]<\/a> Id. <\/em>at *329, 330.<\/p>\n\n\n\n

[14]<\/a> Id. <\/em>at 331. The court also agreed that Congress sometimes \u201crequire[s] proof of added elements\u201d for violation of a statute beyond those required to prove the predicate statute. Id. <\/em>(alteration added).<\/p>\n\n\n\n

[15]<\/a> Id. <\/em>at 334\u201335.<\/p>\n\n\n\n

[16]<\/a> Cf. Hood v. Capstone Logistics LLC<\/em>, No. 3:22-cv-00292-RJC-SCR, 2022 U.S. Dist. LEXIS 239400, at *9 (W.D.N.C. Dec. 2, 2022) (finding decision of \u201cthree out of four circuits\u201d and, additionally, a district court within the Fourth Circuit, placed \u201cweight of authority\u201d in favor of a particular statutory interpretation), declined adoption on other grounds by Hood v. Capstone Logistics LLC<\/em>, 2023 U.S. Dist. LEXIS 147559 (W.D.N.C. Aug. 22, 2023).<\/p>\n","protected":false},"excerpt":{"rendered":"

What is the proper causation standard for an Anti-Kickback Statute violation to trigger liability under the False Claims Act? The First Circuit has answered that question in a much anticipated interlocutory decision in Regeneron. 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