No. 22-339

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

Lower Court: Second Circuit
Docketed: 2022-10-12
Status: Denied
Type: Paid
Amici (5) Experienced Counsel
Tags: advisory-opinion-process anti-kickback-statute criminal-intent healthcare-fraud medical-decision-making medicare mens-rea remuneration rule-of-lenity statutory-interpretation
Key Terms:
AdministrativeLaw SocialSecurity FifthAmendment DueProcess JusticiabilityDoctri
Latest Conference: 2023-01-06
Question Presented (AI Summary)

Whether the Anti-Kickback Statute is violated only if the person offering the remuneration intends to corrupt the recipient's medical decision-making

Question Presented (OCR Extract)

QUESTION PRESENTED 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. (D

Docket Entries

2023-01-09
Motion for leave to file amicus brief filed by National Minority Quality Forum GRANTED.
2023-01-09
Petition DENIED.
2022-12-21
DISTRIBUTED for Conference of 1/6/2023.
2022-12-21
2022-12-20
Waiver of the 14-day waiting period for the distribution of the petition pursuant to Rule 15.5 filed by petitioner.
2022-12-14
Brief of respondents United States Department of Health and Human Services, et al. in opposition filed.
2022-11-14
2022-11-14
Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
2022-11-14
Motion for leave to file amicus brief filed by National Minority Quality Forum.
2022-11-14
Brief amici curiae of Johnson & Johnson Patient Assistance Foundation, Inc. and Janssen Pharmaceuticals, Inc. filed.
2022-10-24
Motion to extend the time to file a response is granted and the time is extended to and including December 14, 2022.
2022-10-21
Motion to extend the time to file a response from November 14, 2022 to December 14, 2022, submitted to The Clerk.
2022-10-07
Petition for a writ of certiorari filed. (Response due November 14, 2022)

Attorneys

Johnson & Johnson Patient Assistance Foundation, Inc.; Janssen Pharmaceuticals, Inc.
Paul J. ZidlickySidley & Austin, Amicus
National Minority Quality Forum
Kelly Patrick DunbarWilmer Cutler Pickering Hale and Dorr LLP, Amicus
Pfizer Inc.
Douglas Harry Hallward-DriemeierRopes & Gray, LLP, Petitioner
Pharmaceutical Research and Manufacturers of America
Jeffrey S. BucholtzKing & Spalding LLP, Amicus
TrialCard Inc.
Carter G. PhillipsSidley Austin LLP, Amicus
United States Department of Health and Human Services, et al.
Elizabeth B. PrelogarSolicitor General, Respondent