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United States Court of Appeals for the Ninth Circuit
February 18, 2022, Argued and Submitted, Pasadena, California; March 10, 2022, Filed
Charles M. Holzner, M.D., appeals the dismissal of claims brought on behalf of himself and the United States alleging three interconnected frauds designed to optimize appellees' profits by providing medically unnecessary products and services and/or unreasonably expensive medications. Holzner argues that the district court erred in dismissing the claims under the False Claims Act ("FCA"), 31 U.S.C. § 3729, and in denying him leave to further amend [*2] the complaint.
"The essential elements of an FCA claim are (1) a false statement or fraudulent course of conduct, (2) made with requisite scienter, (3) that was material, causing (4) the government to pay out money or forfeit moneys due." United States v. Corinthian Colls., 655 F.3d 984, 992 (9th Cir. 2011) (citation omitted). "[A] false certification of medical necessity can give rise to FCA liability." Winter ex rel. United States v. Gardens Reg'l Hosp. & Med. Ctr., Inc., 953 F.3d 1108, 1118 (9th Cir. 2020), cert. denied sub nom. RollinsNelson LTC Corp. v. United States ex rel. Winters, 141 S. Ct. 1380, 209 L. Ed. 2d 124 (2021). The false statement need not deal with purely objective facts, but rather can involve a subjective opinion or an expression of clinical judgment. Id. at 1119. A provider's opinion or certification that a certain treatment or service is medically necessary can be false or fraudulent "if the opinion is not honestly held, or if it implies the existence of facts—namely, that [the service] is needed to diagnose or treat a medical condition, in accordance with accepted standards of medical practice—that do not exist." Id.
Holzner's Fourth Amended Complaint does not contain sufficient facts, accepted as true, to state a plausible claim of false or fraudulent billing related to the appellees' provision of dialysis treatments, the prescription drug Sensipar, or the prescription drug Renagel. The medical literature on which Holzner relies is not [*3] as definitive as he would have it: it does not establish new guidelines for practitioners or otherwise compel a change of practice among nephrologists. Holzner is attempting to use the FCA to force dialysis facilities to reject the considered opinions of treating nephrologists regarding the need for dialysis treatments, Sensipar, and/or Renagel based on his reading of the relevant literature. The allegations of the Fourth Amended Complaint show no more than a disagreement in clinical judgment. Holzner has not raised a plausible inference that the nephrologists' certifications that these interventions are medically necessary—or appellees' reliance on those certifications—were false or fraudulent.3
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2022 U.S. App. LEXIS 6228 *; 2022 WL 726929
CHARLES M. HOLZNER, M.D., Relator, individually, Plaintiff-Appellant, and UNITED STATES OF AMERICA, ex rel, Plaintiff, v. DAVITA INC., a Delaware Corporation; et al., Defendants-Appellees, and LIFELINE VASCULAR CARE; SOUTHWEST KIDNEY INSTITUTE, PLC, Defendants.
Notice: PLEASE REFER TO FEDERAL RULES OF APPELLATE PROCEDURE RULE 32.1 GOVERNING THE CITATION TO UNPUBLISHED OPINIONS.
Prior History: [*1] Appeal from the United States District Court for the Central District of California. D.C. No. 8:18-cv-01250-JLS-DFM. Josephine L. Staton, District Judge, Presiding.
certification, fraudulent, dialysis, false statement, district court, nephrologists, prescription drug, give rise, allegations, clinical, scienter, argues, amend