Pfizer Inc. v. Department of Health and Human Services, et al.

The Anti-Kickback Statute (AKS) makes it a felony to “knowingly and willfully offer[] or pay[] any remuneration (including any kickback, bribe, or rebate) * * * to induce” the purchase or recommendation of federally insured medicines. 42 U.S.C. 1320a-7b(b)(2). Petitioner is the manufacturer of the only FDA-approved drug that provides life-extending treatment for a rare, devastating, and fatal cardiac condition. Petitioner seeks to provide financial assistance to needy Medicare patients to help them access this breakthrough treatment when appropriately prescribed by a physician. Respondents, however, adopted the position that it is a crime to provide such assistance under the AKS, which they interpret to outlaw the provision of anything of value that merely influences a Medicare patient’s ability to access necessary, prescribed medical treatment, without any requirement of an intent to improperly skew medical decision-making. The courts below endorsed that interpretation. The question presented is: Whether the AKS is violated only if the person offering the “remuneration * * * to induce” the purchase of federally reimbursed healthcare intends to corrupt the recipient’s medical decision-making. (I)