## Facts

- Certified registered nurse anesthetists (CRNAs) formerly employed by George Washington University (GWU) filed a qui tam action under the False Claims Act (FCA) alleging improper Medicare billing for anesthesia services.
- Relators alleged that, from 1989 to 1995, GWU billed Medicare as if anesthesia services were performed in compliance with anesthesiologist “medical direction/supervision” requirements when parts of the services were performed by CRNAs or residents without required physician involvement.
- Many original Medicare claim forms (HCFA-1500) were unavailable, and the parties relied on secondary materials such as anesthesia records, hospital billing records, and reconstructed datasets.
- In the February 2008 pretrial posture, the court addressed motions in limine and related trial-management questions governing what evidence could be presented and how relators could attempt to prove falsity, presentment, and damages.
- Relators sought to use habit/routine-practice testimony to show repeated noncompliance with supervision requirements and proposed proving the case through representative sampling rather than claim-by-claim proof.
- Relators also offered audit-style and financial materials (including “Locke reports”) purporting to show overpayments.

## Issues

1. Whether relators could use habit or routine-practice evidence to establish claim-specific noncompliance with Medicare anesthesia supervision/medical-direction requirements.
2. Whether relators could prove falsity and damages primarily through representative sampling of claims.
3. Whether broad financial/audit evidence was relevant and admissible to prove falsity or damages for particular Medicare claims.
4. What degree of linkage the FCA requires between proof of regulatory noncompliance and identifiable claims submitted to and paid by the government.

## Decision

- The court granted in part and denied in part the parties’ pretrial motions, setting limits on admissible proof at trial.
- The court required relators to connect proof of improper anesthesia practices to identifiable Medicare claims, not merely to generalized regulatory noncompliance.
- The court limited the use of habit/routine-practice evidence where it would function as a substitute for claim-specific proof of what occurred for particular procedures.
- The court declined to permit the case to proceed primarily through representative sampling because relators did not adequately define the universe of claims or present a reliable statistical methodology.
- The court excluded or restricted certain audit/overpayment and high-level financial materials as insufficiently probative of the claim-specific Medicare requirements and as posing risks of confusion and unfair prejudice under Rules 401–403.

## Legal Principles

- FCA liability turns on proof that false or fraudulent claims were presented (or false records were used to get claims paid); showing regulatory violations in the abstract is insufficient without claim-linked proof.
- When original claim documents are missing, secondary evidence may be used, but it must reliably reconstruct and connect the alleged misconduct to identifiable claim submissions.
- Federal Rule of Evidence 406 does not permit habit/routine-practice proof to replace claim-specific evidence when the disputed elements depend on individualized, procedure-by-procedure requirements.
- Representative sampling in FCA cases may be rejected where the proponent cannot define the relevant claim universe, show a statistically sound methodology, and explain how sampling accounts for claim-level regulatory variation.
- Evidence with limited probative value on claim-specific falsity or damages may be excluded if it risks confusing the issues or unfairly prejudicing the jury under Rules 401–403.

## Conclusion

The court’s pretrial rulings narrowed the proof available for the FCA claims by insisting on evidence tied to identifiable Medicare claim submissions, limiting habit evidence that would bypass claim-specific requirements, excluding or restricting certain audit and financial materials, and rejecting a sampling-driven trial strategy due to inadequate statistical and definitional support.


United States ex rel. El-Amin v. George Washington Univ., 533 F. Supp. 2d 12 (D.D.C. 2008)