On September 4, 2026, the D.C. Circuit affirmed a summary judgment ruling for the government in a case where Vertex Pharmaceuticals had challenged an unfavorable HHS-OIG advisory opinion. Vertex Pharmaceuticals Inc. v. HHS, No. 25-2133 (D.C. Cir. Sept. 4, 2026). Vertex had sought the advisory opinion for a program that would offer its federally-insured sickle cell gene therapy patients up to $70,000 to support fertility services. (Because the therapy involves chemotherapy that often results in infertility, some female patients may choose to freeze their eggs before starting the therapy.) HHS-OIG concluded that the Vertex program would violate the AKS because it would involve the provision of remuneration (the fertility services support) to induce patients to choose Vertex’s therapy, which then would be reimbursed by Federal health care programs.
In its challenge to the advisory opinion, Vertex argued that the anti-kickback statute (AKS) should not apply to the program because the AKS applies only when a party offers or pays remuneration that corrupts medical decision-making. Specifically, Vertex argued that the words “induce” and “remuneration” in the AKS imply an element of corruption, even though the AKS never uses that term. The Fourth and Second Circuits previously rejected the same argument. See Pharm. Coal. for Patient Access v. United States, 126 F.4th 947 (4th Cir. 2025); Pfizer, Inc. v. HHS, 42 F.4th 67 (2d Cir. 2022).
In making its argument, Vertex relied heavily on United States v. Hansen, 599 U.S. 762 (2023), a case holding that, in the context of an immigration law statute, 8 U.S.C. § 1324(a)(1)(A)(iv), “induce” is used in the “specialized, criminal-law sense” and means to encourage a person to commit a crime. In other words, under Vertex’s conception, the AKS would apply to a transaction only if both the payer and the recipient of the kickback had criminal intent. Adoption of Vertex’s argument would have upended decades of AKS enforcement practice, which commonly involves situations where only the payer of a kickback has criminal intent and where the recipient (e.g., a physician or patient) is induced by the remuneration but does not have criminal intent.
The D.C. Circuit did not extend the Hansen rationale to the AKS because other provisions of the AKS make clear that neither “induce” nor “remuneration” implies an element of corruption. The AKS, as the court observed, has a number of exceptions (e.g., for paying remuneration to an employee) that would be unnecessary if the statute required that the recipient of a kickback act with criminal intent: “[t]he safe harbors include many commonplace transactions that influence healthcare decisions and therefore accord with an understanding of ‘induce’ that means simply to influence another person.” Likewise, the court held that “remuneration” does not imply an element of corruption because the statute itself includes a “rebate” as a type of remuneration, and there is nothing inherently corrupt about a rebate.
Notably, the AKS has a separate intent requirement. It applies only if the defendant acts “knowingly and willfully.” 42 U.S.C. § 1320a-7b(b). The D.C. Circuit thus rejected Vertex’s attempt to add an additional scienter element to the statute.
Creative defense lawyers undoubtedly will continue trying to think of ways to undermine the AKS, but, for now at least, the AKS remains alive and well, without a requirement that the recipient of a kickback act corruptly.