These activities plainly qualify both as “arranging for” the ordering or purchasing of FPS items or goods and “recommending” the ordering or purchasing of FPS items or goods, and therefore McFarland has adequately alleged AKS violations against Defendants under Section 1320a-7b(b)(1)(B).6 II. McFarland Has Also Sufficiently Pleaded a Violation of Section 1320a-7b(b)(1)(A): “Referring an Individual” McFarland has also adequately pleaded that Defendants violated Section 1320a- 7b(b)(1)(A) by receiving remuneration in return for “referring” TRICARE beneficiaries to FPS.

During the time period 1997 through 2004, cardiologists received $2,468,555 from the Medicare program (Part B) for the services they provided in the Heart Station based on the submission of 132, 631 claims. The receipt of the Heart Station panel time in exchange for referrals causes any representations of compliance with the AKS to be false, see 42 U.S.C. §1320a-7b(b)(1), and the government’s damages could include these amounts. Case: 1:03-cv-00167-SAS-TSB Doc #: 249 Filed: 11/24/09 Page: 81 of 84 PAGEID #: 6308 70 money.

But the AKS criminalizes the receipt of “any remuneration,” whether “overtly or covertly.” 42 U.S.C. § 1320a–7b(b)(1). Case 8:15-cv-01708-SDM-TGW Document 421 Filed 01/14/19 Page 43 of 49 PageID 3432 37 shows that it was Defendants who selected FPS as the pharmacy and provided FPS-branded prescription pads and FPS’s fax number to prescribers for the submission of prescriptions.

38. Vernon stands for the proposition that if a non-physician defendant is conclusively shown to be in control of a patient referral stream, to include control of the physicians who are actually “referring” the patients, then such non-physicians can be guilty under 42 USC § 1320a-7b(b)(1). United States v. Vernon, 723 F.3d 1234, 1255- 56; United States v. Starks, 157 F.3d 833 (11th Cir. 1998) (Two non-physicians convicted for directly and personally brokering substance abuse patients); United States v. Miles, 360 F.3d 472, 480 (5th Cir. 2004) (No non-physician kickbacks found because Case 8:15-cv-01708-SDM-TGW Document 347 Filed 10/10/17 Page 12 of 16 PageID 1845 13 “[t]he payments from APRO were not made to the relevant decisionmaker as an inducement or kickback for sending patients to APRO.”)

That is undisputed; there are no other items or services referenced anywhere in the Amended Complaint. The AKS violations alleged by the Government (42 U.S.C. § 1320a-7b(g)) are the supposed kickback payments NPC made to specialty pharmacies to induce the pharmacies improperly to influence doctors to prescribe Myfortic and patients to order Exjade refills. That too is undisputed; the Government does not point to any other purported AKS violation, nor does it allege that NPC made kickback payments to any physician or Exjade patient.

Thus, claims are false for purposes of FCA to the extent they include Exjade and Myfortic shipments connected to or tainted by Novartis’s offer of kickbacks to the pharmacies in the forms of patient referrals and rebates. See 42 U.S.C. § 1320a-7b(g); see also Lincare, 2014 WL 1225660, at *4. Here, the Government’s allegations – considered in their entirety rather than the misleading version presented by Novartis, see supra at 4-6 – show that the requisite connection or taint exists between the kickbacks offered by Novartis and the Exjade and Myfortic shipments giving rise to the claims cited in the complaint.

Pursuant to the statutory exception, the AKS: [s]hall not apply to a discount or other reduction in price obtained by a provider of services or other entity under a Federal health care program if the reduction of price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity under a Federal health care program. 42 U.S.C. § 1320a-7b(b)(3)(A). The corresponding discount safe harbor regulation at 42 C.F.R. § 1001.

A violation of the anti-kickback statute requires a showing of four elements: (1) knowingly and willfully, (2) offering or paying remuneration, (3) to induce another to purchase or order a good or service, (4) for which payment may be made by a federal healthcare program. 42 U.S.C. §1320a-7b(b)(2)(B). Mr. Solis has detailed in the SAC how Defendants willfully and knowingly targeted hospitals with a high volume of Medicare patients and paid for physicians’ meals.

As 41 Case 1:11-cv-08196-CM Document 192 Filed 05/29/14 Page 41 of 45 part of the Patient Protection and Affordable Care Act ("PP ACA"), it amended the AKS to read: "a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of [the False Claims Act]." 42 U.S.C. § 1320a-7b(g) (emphasis added). Novartis seizes on the phrase "resulting from" to argue a version of "but for" causation- only claims directly caused by (and hence, "resulting from") an illegal recommendation are inconsistent with the certification of AKS compliance, and so are "false.

58. Vernon stands for the proposition that if a non-physician defendant is conclusively shown to be in control of a patient referral stream, to include control of the physicians who are actually “referring” the patients, then such non-physician can be guilty under 42 USC § 1320a-7b(b)(1). U.S. v. Vernon, 723 F.3d at 1255-56; U.S. v. Starks, 157 F.3d at 833 (Two non-physicians convicted for directly and personally brokering substance abuse patients); U.S. v. Miles, 360 F.3d 472, 480 (5th Cir. 2004) (No non-physician kickbacks found because “[t]he payments from APRO were not made to the relevant decisionmaker as an inducement or kickback for sending patients to APRO.”)