United States ex rel. Saldivar v. Fresenius Medical Care Holdings, Inc.
972 F. Supp. 2d 1339
N.D. Ga.2013Background
- Relator Chester Saldivar sues Fresenius Medical Care Holdings, Inc. under the False Claims Act as a qui tam action.
- Relator alleges Fresenius billed Medicare for overfill from Epogen and Zemplar vials that the provider did not incur as an expense.
- Cross-motions for summary judgment address whether billing for overfill during 2006–2010 satisfies FCA falsity and related defenses.
- Fresenius admitted it used overfill to fill larger doses and billed Medicare for overfill surcharges during the period.
- Court focuses on whether Medicare rules in effect 2005–2010 treated overfill as a non-cost item not subject to reimbursement.
- Court ends analysis period on December 31, 2010, noting 2011 CMS bundled payments changed treatment of these drugs.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether billing for overfill from 2006–2010 constitutes a false claim | Saldivar claims Fresenius billed for non-incurred overfill costs. | Fresenius argues Medicare rules allowed reimbursement for ASP-based drugs, including overfill under prior rules. | Yes; billing for overfill during 2006–2010 constitutes a false claim. |
| Whether Fresenius incurred an expense for overfill during the period | Overfill is not an incurring expense to Fresenius; thus no reimbursement permitted. | Fresenius incurred an expense by purchasing vials including overfill and treats overfill as part of cost. | No; from 2006–2010 Fresenius did not incur an expense tied to overfill for ASP calculations, so billing was false. |
| Whether government knowledge/intent defenses affect liability | CMS knowledge could preclude fraud defenses or estoppel against government; intent is contested. | Fresenius contends government knowledge/intent defenses are relevant to falsity and intent elements. | Not properly before the court at this stage; intent and government-knowledge issues deferred for later proceedings. |
Key Cases Cited
- United States ex rel. Walker v. R&F Properties of Lake County, Inc., 433 F.3d 1349 (11th Cir. 2005) (presentment FCA elements; knowledge of falsity required)
- Bowen v. Georgetown Univ. Hosp., 488 U.S. 204 (U.S. 1988) (Medicare reimburses for expenses incurred)
- Hays v. Leavitt, 583 F. Supp. 2d 62 (D.D.C. 2008) (expenses incurred framework in Medicare context)
- United States ex rel. Westmoreland v. Amgen, Inc., 812 F. Supp. 2d 39 (D. Mass. 2011) (overfill not part of ASP; CMS rule 2011 affirmed prohibition on billing overfill)
- United States ex rel. Woodard v. DaVita, Inc., No official reporter cited (E.D. Tex. 2011) (similar overfill/ASP discussion in ESRD context)