Must a defendant know their conduct violates the law to act 'willfully' under the Federal Anti-Kickback Statute?

QUESTIONS PRESENTED 1. Already pending before the Court is a Petition for a Writ of Certiorari docketed in United States ex rel. Hart v. McKesson Corp., 96 F.4th 145 (2d Cir. 2024), pet. for cert. docketed, June 7, 2024, that asks: To act “willfully” within the meaning of the Federal Anti-Kickback Statute, must a defendant know that its conduct violates the law? The instant case raises the same question. 2. In addition, the instant case provides an opportunity for the Court to assess the validity and scope of the Seventh Circuit’s broad construction of the Anti-Kickback Statute with respect to the concept of “indirect” referrals, which it characterized as “file access.” A related question therefore is whether the discovery of qualified seniors who happened to be in a data base provided to Petitioners constituted a “referral” under the Anti-Kickback and False Claims Acts even though they were not referred any particular person.