No. 23-2086

UNITED STATES OF AMERICA,

Plaintiff, Appellant,

v.

REGENERON PHARMACEUTICALS, INC.,

Defendant, Appellee.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. F. Dennis Saylor IV, U.S. District Judge]

Before

Montecalvo, Thompson, and Kayatta, Circuit Judges.

Daniel Winik, Attorney, Civil Division, U.S. Department of Justice, with whom Brian M. Boynton, Principal Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice, Joshua S. Levy, Acting U.S. Attorney, District of Massachusetts, Michael S. Raab, Attorney, Civil Division, U.S. Department of Justice, and Charles W. Scarborough, Attorney, Civil Division, U.S. Department of Justice, were on brief, for appellant.

Paul D. Clement, with whom Matthew D. Rowen, Clement & Murphy, PLLC, Theodore V. Wells, Jr., H. Christopher Boehning, Paul Weiss Rifkind Wharton & Garrison LLP, Richard L. Scheff, Katharine Ladd, Faegre Drinker Biddle & Reath LLP, Brien T. O'Connor, John P. Bueker, and Ropes & Gray LLP were on brief, for appellee.

Tara S. Morrissey, Andrew R. Varcoe, U.S. Chamber Litigation Center, Jeffrey S. Bucholtz, Matthew V.H. Noller, and King & Spalding LLP on brief for Chamber of Commerce of the United States of America, amicus curiae.

February 18, 2025 KAYATTA, Circuit Judge. This appeal calls for us to determine the meaning of the words "resulting from" as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b. 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)). That 2010 amendment states that "a claim [for payment by a federal healthcare program] that includes items or services resulting from a violation of [the AKS] constitutes a false or fraudulent claim for purposes of" the False Claims Act (FCA), 31 U.S.C. §§ 3729-33. Id. (emphasis added). The FCA, in turn, imposes civil liability on anyone who "knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval" or "knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim." 31 U.S.C. § 3729(a)(1)(A), (a)(1)(B). Whether a violation of the AKS is also a false claim under the FCA makes a difference because the FCA allows both the government and whistleblowers to bring civil actions for damages.

The government alleges that, in violation of the AKS, Regeneron Pharmaceuticals knowingly induced prescriptions of a drug called Eylea by covering copayments for certain patients who received the drug. Further, contends the government, when doctors filed Medicare claims for Eylea prescribed to patients receiving copayment assistance, those claims "resulted from" a violation of

- 3 - the AKS whether or not those claims would have been made even had Regeneron not covered the co-pay. Accordingly, as the government sees it, those Medicare claims were "false or fraudulent" for purposes of the FCA.

Regeneron begs to differ. The company says that a claim only "result[s] from" an AKS violation if it includes "items or services" that would not have been paid for by the government absent the AKS violation. Put differently, Regeneron contends that an AKS violation must be a but-for cause of the challenged claim. So, reasons Regeneron, if a doctor would have purchased (and sought reimbursement for) Eylea anyway, then the subsequent Medicare claim cannot have "result[ed] from" Regeneron's allegedly illicit payments. As we will explain, we agree with Rege