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United States ex rel El-Amin v. George Washington University

February 4, 2008

UNITED STATES OF AMERICA EX REL. SHEILA EL-AMIN, ET AL., PLAINTIFFS/RELATORS,
v.
THE GEORGE WASHINGTON UNIVERSITY, DEFENDANT.



The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge

MEMORANDUM OPINION

There are a number of evidentiary-related motions presently before the Court that will, when resolved, narrow the parties' focus as we move towards trial. The Court therefore resolves the following motions: (1) Relators' Motion In Limine [653], (2) Defendant GW's Motion In Limine No. 1: Motion to Limit Relator Testimony to Anesthesia Procedures in Which They Participated [655], (3) Defendant GW's Motion In Limine No. 2: Motion to Preclude Relators from Testifying Regarding GW's Billing Practices [656], (4) Defendant GW's Motion In Limine No. 3: Motion to Preclude Relators from Offering Irrelevant and Prejudicial Evidence [657], (5) Defendant GW's Motion In Limine No. 4: Motion to Preclude Relators from Offering Evidence Regarding the Locke Reports [700], (6) Defendant GW's Motion to Sequester Relator Witnesses During Trial [660], (7) Relators' Motion for Order Setting Trial by Representative Sample [687], and (8) Relators' Motion for Leave to Submit Relators' Filing Pursuant to the Court's March 1, 2007 Bench Order under Seal [705]. The Court will examine each motion in turn, after providing a brief factual summary.

BACKGROUND*fn1

Plaintiffs, four certified registered nurse anesthetists ("CRNAs") who were formerly employed by the George Washington University Hospital, brought suit on behalf of the United States under the qui tam provision of the False Claims Act ("FCA"). See 31 U.S.C. §§ 3729-3733. The qui tam plaintiffs ("Relators") allege that from 1989 to 1995 George Washington University ("Defendant") bilked the federal treasury out of thousands, if not millions, of dollars by routinely submitting false claims for anesthesia services to Medicare. These claims were false, the Relators allege, because the Defendant sought reimbursement from Medicare under the guise that each anesthesia procedure had been wholly performed by a licensed anesthesiologist, when in fact portions of the procedure had been performed by residents or CRNAs.

Medicare regulations then in effect did not prohibit the Defendant from using residents or CRNAs in rendering anesthesia services; the regulations did, however, provide guidelines establishing the amount of reimbursement the Defendant was entitled to receive for anesthesia procedures rendered, even in part, by a resident or CRNA. At bottom then, this case tests the merits of the Defendant's billing practices for reimbursement under Medicare; it does not impeach the efficacy of the anesthesiologists' medical care or the Defendant's treatment of Medicare patients.

At trial, it will be incumbent upon the Relators to show, under 31 U.S.C. § 3729(a)(1), that "(1) the defendant submitted a claim to the government, (2) the claim was false, and (3) the defendant knew the claim was false," or alternatively, under section § 3729(a)(2), that "(1) the defendant created a record and used this record to get the government to pay its claim, (2) the record was false, and (3) the defendant knew the record was false." United States ex rel. Harris v. Bernad, 275 F. Supp. 2d 1, 6 (D.D.C. 2003) (citing United States v. Southland Mgmt. Corp., 288 F.3d 665, 674-75 (5th Cir. 2002), aff'd en banc, 326 F.3d 669 (5th Cir. 2003)).

To demonstrate the Defendant submitted "false" claims to Medicare, the Relators will attempt to show that the Defendant's anesthesiologists failed to meet the requirements of a billing regulation commonly known as the "seven steps" regulation. See 42 C.F.R. § 405.552. The seven steps regulation required anesthesiologists to perform several specific tasks for each patient to be eligible to receive reimbursement from Medicare at the highest reimbursement level, i.e., reasonable charge. See El-Amin, supra, 2005 U.S. Dist. LEXIS 18886 at *17. Under the seven steps regulation the anesthesiologist was required to:

(i) Perform a pre-anesthetic examination and evaluation;

(ii) Prescribe the anesthesia plan;

(iii) Personally participate in the most demanding procedures in the anesthesia plan, including induction and emergence;

(iv) Ensure that any procedures in the anesthesia plan that he or she does not perform are performed by a qualified individual. . . .;

(v) Monitor the course of anesthesia administration at frequent intervals;

(vi) Remain physically present and available for immediate diagnosis and treatment of emergencies; and

(vii) Provide indicated [post-anesthesia] care.

See 42 C.F.R. § 405.552(a)(1)(i)-(vii) (1989-95). For each allegedly fraudulent claim, the Relators will attempt to show the attending anesthesiologist failed to satisfy one or more of the seven steps.

DISCUSSION

I. Introduction

Although the Court takes this opportunity to resolve the parties' outstanding pretrial motions, and certainly does not foresee a need to revisit these evidentiary issues, the Court nonetheless recognizes that it is not prescient and cannot predict with absolute certainty how events will unfold at trial. This opinion sets forth the Court's analysis based on the current record before the Court and the arguments articulated by the parties in their respective motions. As evidence and witness testimony are presented at trial, however, either party may find it desirable to revisit discrete evidentiary rulings addressed here. The parties are not foreclosed from doing so. A party desiring to revisit an evidentiary ruling should, conspicuously, bring the matter to the Court's attention and be prepared to summarize the Court's original ruling and explain why the original ruling should be modified in light of new evidence or testimony or a change in circumstances. The parties are cautioned that this is not an invitation to recycle old arguments.

A key purpose of motions in limine is to resolve specific evidentiary issues in advance of trial. To this end, each party was obligated to demonstrate why certain categories of evidence should (or should not) be introduced at trial and to direct the Court to specific evidence, by pointing to specific parts of the record, that would favor or disfavor the introduction of that particular category of evidence. The Court expected the Relators to respond to the Defendant's motions in limine with citations to the record linking evidence of the Defendant's conduct to specific allegedly fraudulent claims, so it could decide whether this evidence would be allowed at trial. As described more fully below, however, the Relators have failed in many instances to provide the Court with the essential link between their arguments and the evidence in the record that would support their arguments.

Too frequently the Relators make bald assertions or generalized arguments without directing the Court to the part of the record that would support their assertions or arguments. In some instances the Relators fail to even controvert the basic arguments raised by the Defendant, essentially conceding the point. For example, while the Relators assert they would like to introduce evidence of the routine practice of the Defendant's anesthesiologists, they do not identify the specific practice that is allegedly routine, provide the Court with any evidence that the anesthesiologists' conduct was habitual or uniform, or controvert the Defendant's argument that the anesthesiologists' conduct varied with each patient and procedure, and was therefore not routine. In these situations, which are painfully common, the Court has no choice but to conclude the Relators do not support their arguments with specific evidence and references to the record because they cannot -- the evidentiary foundation is not there. It is not the Court's responsibility to formulate the Relators' arguments for them or to scour the record for evidence that will support their assertions, and it will not do so here. Nor will the Court delay the resolution of these important evidentiary issues until trial on the slim hope the Relators will be able to cobble together the evidentiary support necessary to make their case. Each party will go to trial with the evidence they have, not with the evidence they wish they had.

II. Evidentiary Standard: Relevance

Because the parties' motions test the basic relevancy of several categories of evidence that may be admitted at trial, a brief summary of the evidentiary standard for relevance is appropriate. Rule 401 of the Federal Rules of Evidence defines relevant evidence as "having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." FED. R. EVID. 401. "The Advisory Committee Notes to [the] Rule . . . explain that 'relevant evidence' permits the use of evidence that is 'admitted as an aid to understanding.'" United States v. Holton, 325 U.S. App. D.C. 360, 116 F.3d 1536, 1542 (D.C. Cir. 1997) (quoting Id., advisory committee's note). "The basic concept is that an item of proof is relevant if it tends to prove or disprove any material issue of fact in a case." 2 WEINSTEIN'S FEDERAL EVIDENCE § 401.02. Because the rule is "silent as to what factors the court must consider in determining whether an item of evidence is relevant[,] . . .[c]courts cannot employ a precise, technical, legalistic test for relevance; instead, they must apply logical standards applicable in every day life." Id. at § 401.04.

III. Relators' Motion In Limine

In Relators' Motion In Limine [653], the Relators move to preclude the Defendant from presenting any evidence at trial regarding three separate topics, each of which is addressed below. For the following reasons, this motion is granted in part and denied in part.

A. The Government's Investigation and Non-Intervention

First, the Relators move to preclude the Defendant "from presenting evidence or argument on the Government's investigation and decision not to intervene in this case." Rels.' Mot. at 2. The Relators argue that evidence of the government's non-intervention "fails the basic test of relevancy under [Federal Rules of Evidence] 401 and 402" because it is not probative of any of the "elements to be proved" at trial. Id. at 2 n.3. See also Rels.' Reply Br. at 3-4 (explaining how evidence of non-intervention "undermines" the FCA and "is irrelevant to any element of the [Relators'] case"). The Relators note the government may have had "numerous reasons" for electing not to intervene in this case; without knowing the actual reason the government elected not to intervene, however, this evidence has no probative value. Rels.' Reply at 2. The Court agrees.

Evidence showing the government decided not to intervene in the Relators' case is not relevant because there is no evidence linking the government's nonintervention with its actual motivation for doing so. Without knowing the actual motivation behind the government's nonintervention, evidence of its nonintervention is not probative of how the government appraised the merits of this case and is therefore not relevant. A brief summary of the FCA's qui tam provision demonstrates this point.

The FCA expressly authorizes private individuals to bring a civil action for alleged violations of the FCA. See 31 U.S.C. § 3730(b)(1). The action, while litigated by a private party, is brought on behalf and in the name of the United States. Subsection (b)(2) requires the complaint to be filed under seal. It also requires the private individuals bringing the action to furnish a "copy of the complaint" and a "written disclosure of substantially all material evidence and information" in their possession to the government. Once filed, the complaint remains under seal for 60 days, and is not served on the defendant during this period. Congress provided "numerous reasons for mandating that the complaint be filed initially under seal." John T. Boese, CIVIL FALSE CLAIMS AND QUITAM ACTIONS § 4.04[B] (3rd ed. 2007 Suppl.). The "primary purpose" of the 60-day seal requirement "was to allow the government to ascertain privately 'whether it was already investigating the claims stated in the suit and then to consider whether it wished to intervene.'" Id. (quoting Erickson ex rel. United States v. American Inst. of Biological Sciences, 716 F. Supp. 908, 912 (D. Va. 1989)).

The government must respond to the qui tam complaint at the conclusion of the 60-day sealing period. Section 3730 of the FCA gives the government, expressly or impliedly, five options: (i) request an extension of the 60-day period, see § 3730(b)(3); (ii) intervene in the action, see § 3730(b)(4)(A); (iii) decline intervention*fn2 and allow the relators to conduct the action, see § 3730(b)(4)(B); (iv) move to dismiss the action, see § 3730(c)(2)(A); or (v) attempt to settle the action before formally intervening. See generally Boese, CIVIL FALSE CLAIMS AND QUI TAM ACTIONS § 4.05[A]. If the government elects to intervene, sections 3730(b) and (c) of the Act "clearly provide that the government controls the action." Id. So while a qui tam complaint is filed by a private citizen, the action may, at the government' s election, ultimately be conducted by the United States. See 31 U.S.C. § 3730(b)(4) (" Before the expiration of the 60-day period or any extensions obtained under paragraph (3), the Government shall . . . proceed with the action, in which case the action shall be conducted by the Government[.]"). It is only where the government notifies the court during the 60-day evaluation period or during an extension of that period that it is declining to intervene, that " the person bringing the action shall have the right to conduct the action." 31 U.S.C. § 3730(b)(4)(B).

As other courts have noted, the government " may have a host of reasons for not pursuing a claim." United States ex rel. Atkins v. McInteer, 470 F.3d 1350, 1360 n.17 (11th Cir. 2006). This is why the Court " do[es] not assume that in each instance in which the government declines intervention in an FCA case, it does so because it considers the evidence of wrong doing insufficient or the qui tam relator' s allegations [of] fraud to be without merit." Id. See also United States ex rel. DeCarlo v. Kiewit/AFC Enters., 937 F. Supp. 1039, 1047 (S.D.N.Y. 1996) (noting government' s " [n]on-intervention does not necessarily signal governmental disinterest in an action"). Indeed, assuming the government looked unfavorably upon each qui tam action in which it did not intervene would seem antithetical to the purpose of the qui tam provision -- to encourage private parties to litigate on behalf of the government. See United States ex rel. Berge v. Bd. of Trustees, 104 F.3d 1453, 1458 (4th Cir. 1997), cert denied, 522 U.S. 916 (1997) (" [T]he plain language of the Act clearly anticipates that even after the Attorney General has 'diligently' investigated a violation [of the FCA], the Government will not necessarily pursue all meritorious claims; otherwise there is little purpose to the qui tam provision permitting private attorneys general."). Similarly, the Court will not presume that because the government did not move to dismiss the action, see § 3730(c)(2)(A), that it concluded the Relators' allegations were meritorious.

Simply put, the Court will not allow either party to use the government' s investigation and/or inaction as evidence of how the government appraised the merits of the Relators' case. Without evidence tending to show the actual reason the government elected not to intervene in this case -- and the Defendant has not offered any evidence other than speculation on this point -- the simple fact that the government did not intervene has no probative value and is not relevant. As such, it is inadmissible at trial. See FED. R. EVID. 401 & 402.

The Defendant argues that the " government' s investigation and subsequent . . . inaction are . . . relevant to the materiality of the allegedly false claims." Def.' s Opp' n at 2 (emphasis added). The Defendant reasons that the government' s decision not " to reopen any claim determinations or to recoup as overpayments any Medicare monies already paid to GW[U]" suggests that even if some of these claims were false " the alleged falsity . . . was immaterial to the government' s decision to pay." Id. at 3-4. " If the claims that relators allege to have been false were ineligible for Medicare payment," GWU explains, " one would reasonably expect the government to take some [enforcement or protective] action." Id. at 3. The fact that the government " continued to pay [GWU' s] claims . . . and elected not to exercise even one of its various administrative remedies" shows that the falsity, if any, was immaterial. Id.

The Court is not swayed by this argument. The Defendant' s argument is implicitly based on the premise that the government would not have remained idle had the allegedly fraudulent claims been " materially" false. The Defendant offers no actual evidence that would support this premise however. It would have the Court assume that the government always takes action whenever a claim is materially false and, conversely, that the government takes no action when a claim is not materially false. This effectively transforms the legal definition of materiality into a simple question of whether the government took enforcement action. The record before the Court is too paltry to support this inference. As explained above, the government may have had any number of reasons for not exercising " one of its various administrative remedies" in this case.

B. Documentary Evidence of the Defendant's Performance of the Seven Steps

Second, the Relators move to preclude the Defendant "from presenting any other documentary evidence" that would show the Defendant's anesthesiologists performed the seven steps apart from "the OR Circulating Records and Surgical Anesthesia Records." Rels.' Mot. at 3. The Defendant's documentary evidence should be limited to these two types of records, the Relators reason, because these were the only records the Defendant identified in responding to the Relators' First Set of Interrogatories. A brief review of the actual language of the Relators' interrogatories shows the weakness in this argument.

"In their Interrogatory No. 2, the Relators sought the name of the anesthesiologist, if any, that performed the Seven Steps on every Medicare patient requiring anesthesia since September 30, 1986." Rels.' Mot. at 3 (citing Relators' First Set of Interrogatories at 1) (emphasis added).*fn3 In response, the Defendant noted that the identity of the attending anesthesiologist for these procedures could be found on either the OR Circulating record or the first page of the Surgical Anesthesia Record. See Rels.' Reply Br. at 5. This interrogatory, by its express language, was focused exclusively on the "name" of each anesthesiologist who "performed the seven steps on every Medicare patient" during the relevant time period. It is not surprising, then, that the Defendant's response was equally narrow, directing the Relators to the specific documents that indicated the names of the anesthesiologists who had participated in the relevant procedures.

Despite the narrow focus of the interrogatory, the Relators now ask the Court to use the Defendant's response as a justification for imposing a blanket prohibition on all other forms of documentary evidence at trial other than the OR Circulating Records and Surgical Anesthesia Records. The Relators provide no reason based on law or common sense, however, why the Court should implement such a draconian measure, and the Court can see none. It would be patently unfair and nonsensical to strip the Defendant of its ability to defend itself on a key issue at trial based on a narrow interrogatory that focused exclusively on the names of the Defendant's anesthesiologists. Moreover, the Relators' offer no legal basis, such as a relevant case or a rule of evidence, which would authorize the Court to exclude relevant, exculpatory evidence en masse, essentially depriving the Defendant of a defense.

C. Evidence that the Defendant's Anesthesiologists' Work Comported with Generally Accepted Medical Practices

Third, the Relators move to preclude "any evidence" that "the Defendant's anesthesiologists conducted themselves in accordance with generally accepted or sound anesthesiology practices." See Rels.' Reply Br. at 5. This evidence "is entirely irrelevant to this action," the Relators explain, because it conflates the standard for reimbursement under the seven steps regulation, which is relevant to this case, with the anesthesiologist standard of care, which is not relevant to any issue at trial. Id. at 5-6. The Relators explain that whether the Defendant violated the FCA turns on whether the anesthesiologists complied with the seven steps regulation; whether the anesthesiologists adhered to generally accepted medical practices, by contrast, has no bearing on the seven steps regulation and may confuse the jury.

In opposition, the Defendant argues that generally accepted medical practices are "relevant" because they inform the "meaning of the seven steps regulation" and elucidate "the vocabulary the witnesses will use at trial." Def.'s Opp'n at 6-7. The Defendant asserts that granting the Relators' motion would lead to a "ludicrous result": "the jury would be required to assess allegations that [the Defendant's] anesthesiologists failed to perform anesthesia services without hearing evidence of what those anesthesia services were." Id. at 6. "To know what anesthesia services would be required by the seven steps regulation in any particular case," the Defendant explains, "the jury will have to hear from an anesthesiologist about the nature of the anesthesia services provided." Id.

The Relators have the stronger argument here. Judge Penn touched upon this issue in an earlier opinion when he rejected the Defendant's "theory" that the seven steps regulation "was intended to codify [] existing medical practices." See El-Amin, supra, 2005 U.S. Dist. LEXIS 18886 at *19. He explained:

Defendant's theory is incorrect because it confuses reimbursement standards with medical standards. In brief, the [seven steps] regulation was intended to change reimbursement standards, not to address medical standards. Thus, medical standards were not incorporated as 'terms of art' and there is no reason to look to defendant's experts to explain them.

Id. at *19-20 (emphasis added). Judge Penn also quoted then-president of the American Society of Anesthesiologists, who had clarified this distinction:

It is imperative that all Medicare providers . . . realize that these federal regulations are legal requirements only for receiving reimbursement for services rendered. In spite of an often voiced complaint from many physicians that the government is telling us how to practice medicine, the simple truth is: you can practice as you please; just do not send them the bill for payment.

Id. (quoting Phillip O. Bridenbaugh, "Knowingly?" -- Ignorance Is No Excuse!, ASA Newsletter, Vol. 61, No. 7, President's Page) (emphasis in original). This is why Judge Penn concluded that "the Seven Steps regulation was intended to change reimbursement practices, it was not composed of terms of art which simply codified existing medical standards." Id. at *21.

Given the distinction already drawn by the Court, the Defendant will be precluded from presenting evidence that its anesthesiologists adhered to generally accepted medical practices because such evidence is not relevant. FED. R. EVID. 401. For example, the Defendant may not demonstrate that it satisfied step one by presenting evidence that it was a generally accepted medical practice at the time for an anesthesiologist to review a pre-anesthesia examination prepared by another individual, when, in actuality, step one required the anesthesiologist to prepare the examination. See El-Amin, supra, 2005 U.S. Dist. LEXIS 18886 at *22 (finding "only an anesthesiologist, not a student or, by extension, a CRNA, could perform step one, or indeed, any step, if the procedure was to be eligible for charge reimbursement."). In other words, while it may have been an acceptable medical practice for an anesthesiologist to review a pre-anesthesia examination prepared by a resident or a CRNA, rather than prepare the examination himself or herself, this is not relevant to step one. To be eligible for charge reimbursement, step one required the anesthesiologist to prepare the pre-anesthesia examination; reviewing a resident's plan was insufficient. Evidence of the generally accepted medical practice at the time is therefore not relevant to this issue. The Defendant effectively acknowledges as much in other filings. See, e.g., Defendant GW's Motion In Limine No. 1, 11 n.7 ("The regulations on which relators rely do not establish standards of care for anesthesiology, but rather set forth Medicare billing standards."); Defendant GW's Reply In Support of its Motion In Limine No. 3, 4 (noting "the False Claims Act [] has nothing to say about standards of care [or] quality of care").

The Defendant's primary concern, that "the jury will be required to assess allegations that [its] anesthesiologists failed to perform anesthesia services without hearing evidence of what those anesthesia services were," is misplaced. See Def.'s Opp'n at 6-7. The Court is not precluding either party from educating the jury on the medical procedures that comprise the seven steps regulation. Indeed, the Court expects that the parties will want to describe some of the specific anesthesia procedures involved here, e.g., performing a pre-anesthesia examination. What the Defendant may not do however, because it is not relevant, is present evidence demonstrating that its anesthesiologists comported with generally accepted anesthesiology practices. This case tests the merits of the Defendant's billing practices for reimbursement under Medicare; it does not test the adequacy the Defendant's medical care.

D. Conclusion

The Relators' Motion In Limine is granted in part and denied in part. At trial, the Defendant shall be precluded as described above from presenting testimony, documents, or other direct or demonstrative evidence regarding (1) the Government's investigation into the alleged false claims and its subsequent decision not to intervene in this case; and (2) the anesthesiologists' practice of adhering to the generally accepted medical practices at the time, as opposed to testimony to educate the jury on the specific anesthesia procedures at issue through a description of the process. The Defendant shall, however, be permitted to present documentary evidence other than OR Circulating Records and Surgical Anesthesia Records to demonstrate that its anesthesiologists satisfied the seven steps regulation.

IV. Defendant GW's Motion in Limine No. 1: Motion to Limit Relator Testimony to Anesthesia Procedures ...


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