United States Ex Rel. Greenfield v. Medco Health Solutions, Inc.
880 F.3d 89
3rd Cir.2018Background
- Accredo Health Group, a specialty pharmacy for hemophilia patients, made substantial annual charitable donations (≈$200k–$550k) to Hemophilia Services, Inc. (HSI) and Hemophilia Association of New Jersey (HANJ).
- HSI/HANJ identified Accredo as an “HSI-approved” vendor on member-facing lists and webpages, and circulated a letter criticizing Accredo when it reduced donations—leading Accredo to restore funding after a ROI market-share analysis by employee Steve Greenfield.
- Greenfield (a former Accredo VP) filed a qui tam False Claims Act (FCA) suit alleging Accredo’s donations were kickbacks that induced referrals/recommendations in violation of the Anti-Kickback Statute (AKS), and that Accredo’s Medicare claims falsely certified compliance with the AKS.
- The Government declined to intervene. At summary judgment the district court assumed (but did not decide) a possible AKS violation and granted judgment for Accredo because Greenfield failed to link any federal reimbursement claim to an HSI/HANJ-induced referral or recommendation.
- The Third Circuit considered whether a relator must show that a federally reimbursed claim “resulted from” an AKS violation (and if so, what degree of causal connection is required) and whether Greenfield produced at least one claim tied to an AKS-tainted recommendation.
Issues
| Issue | Plaintiff's Argument (Greenfield) | Defendant's Argument (Accredo) | Held |
|---|---|---|---|
| Whether FCA liability under 42 U.S.C. § 1320a‑7b(g) requires proof that a federal claim was caused by the AKS violation | No specific patient causation required; temporal/aggregate evidence suffices | Relator must show each federal beneficiary would not have used defendant absent the kickback (but‑for causation) | Court rejects but‑for standard; causation not required to be subjective patient choice, but some connection is needed |
| What quantum of linking evidence is required at summary judgment to show an FCA violation based on AKS allegations | Temporal proximity and aggregate submission of federal claims are sufficient to survive summary judgment | Relator must identify at least one false claim tied to an AKS‑tainted referral | Relator must point to at least one specific federal claim that covered a patient exposed to the AKS‑tainted referral/recommendation; Greenfield failed to do so |
| Whether proof of an AKS violation alone renders all submitted federal claims false for FCA purposes | Yes—any claims submitted while paying kickbacks are false regardless of exposure | No—there must be a link between the particular claim and the kickback-influenced referral or recommendation | Court: AKS violations render resulting claims ineligible, but plaintiff must show a particular claim “resulted from” the violation (i.e., patient exposure to the tainted referral) |
| Whether relator satisfied FCA materiality and falsity requirements where no specific linked claim was shown | Materiality presumed because government would not have paid claims tainted by kickbacks | Absent a linked false claim, FCA elements are unmet | Court: even if falsity could be shown, relator still must identify at least one linked claim and satisfy materiality; failure to do so defeats summary judgment challenge |
Key Cases Cited
- Wilkins v. United Health Grp., 659 F.3d 295 (3d Cir.) (AKS‑tainted services make government payments not what it bargained for; FCA liability requires at least one false claim)
- Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (U.S. Supreme Court) (materiality requirement for FCA claims premised on legal falsity)
- Burrage v. United States, 134 S. Ct. 881 (U.S. Supreme Court) (but‑for causation language in statutory "results from" contexts)
- Quinn v. Omnicare, 382 F.3d 432 (3d Cir.) (to survive summary judgment relator must produce an actual false claim linking misconduct to reimbursement)
- Hutcheson v. Blackstone Med., Inc., 647 F.3d 377 (1st Cir.) (rejecting need for plaintiff to prove each referral actually caused the patient’s choice for FCA liability tied to AKS)
- Clausen v. Laboratory Corp. of Am., 290 F.3d 1301 (11th Cir.) (relator cannot merely describe a scheme; must show actual submission of false claims)
- Booker v. Pfizer, Inc., 847 F.3d 52 (1st Cir.) (aggregate expenditure data insufficient to prove individual false claims)
- Crews v. NCS Healthcare of Ill., Inc., 460 F.3d 853 (7th Cir.) (failure to present any specific false claim is fatal to FCA suit)
- United States v. Kitsap Physicians Serv., 314 F.3d 995 (9th Cir.) (a FCA action requires identification of at least one false claim)