Full opinion text
ORDER Amy Totenberg, United States District Judge This qui tarn action arises out of allegations that Defendant Fresenius Medical Care Holdings, Inc. d/b/a Fresenius Medical Care North America (“Fresenius” or “FMCNA”) violated the False Claims Act (“FCA”), 31 U.S.C. § 3729, on a'regular basis when it submitted requests for reimbursement for lucrative dialysis drugs that it received for free. Relator Chester Sal-divar alleges that Fresenius billed Medicare for administration of overfill — a varying amount of extra medicine contained in individual vials the purpose of which is to facilitate extraction of the labeled amount on-the vial. The Court previously held, that because overfill did not represent a •cost incurred by Fresenius, Fresenius’s overfill billing practices were impermissible under the applicable Medicare rules and regulations from 2006 through 2010. Thus, billing for overfill during this time constituted a “false claim” under the FCA. However, to prevail on an FCA claim, Relator must also prove that Fresenius knowingly submitted the false claims. Under the FCA, “knowingly” “means that a person, with respect to information (i) has actual knowledge of the information; (ii) acts in deliberate ignorance of the truth or falsity of the information; or (iii) acts in reckless disregard of the truth or falsity of the information.” 31 U.S.C. § 3729(b)(1)(A). The parties have filed cross-motions for summary judgment addressing this additional element of Relator’s FCA claim [Docs. 217, 221]. After a thorough review of the extensive record, and with the benefit of oral argument, the Court GRANTS Fresenius’s motion [Doc. 221] and DENIES Relator’s motion [Doc. 217]. Although the record contains some evidence that Fresenius had the necessary information at its disposal to deduce that billing for overfill was impermissible, there is no evidence that Fresenius actually knew that billing for administered overfill was impermissible, and insufficient evidence from which a reasonable jury could find Fresen-ius acted with deliberate ignorance or reckless disregard as to the impermissibility of billing for administered overfill. Contents Í. Legal Standard ... 1223 II. Overview ... 1223 A. Epogen and Zemplar Use ... 1224 B. Medicare Reimbursement for Epo-gen and Zemplar ... 1227 C. The 2011 Regulation Prohibiting Overfill Billing ... 1228 D. First Cross-Motions for Summary Judgment: Falsity ... 1229 III. Factual Background ... 1231 A.Fresenius’s Belief Regarding Overfill Billing ...1231 B. OIG Reviews and Investigations and CMS’s Reimbursement Calculations ...1233 1. 1997 OIG Review of Epogen Reimbursement ...1233 2. The Medicare Modernization Act of 2003, the 2004 OIG Review of Medicare Reimbursement for ESRD Drugs, and the 2005 Average Acquisition Cost Rule ...1234 3. The ASP Methodology and its Disregard for Overfill ... 1237 4. Other OIG Investigations ... 1238 C. CMS Cost Reports ... 1239 D. CDC and CMS Changes to the Reentry Protocol ... 1239 E. Investigations and Other Qui Tam Actions ... 1240 1. Ecksel and Zwiek ... 1240 2. NMC and the Corporate Integrity Agreement (CIA), 2000-2008 ... 1241 3. Hamel ... 1244 4. Gambro ... 1244 5. Renal Care Group ... 1245 6. Woodard ... 1245 7. State Medicaid Investigations ...1245 F. MedPAC Presentations .. .1246 G. SEC Filings ...1246 H. TrailBlazer ... 1247 I. The 2010 Rule .. .1250 J. CMS’s Knowledge ...1252 ' K. Expert Testimony ... 1253 IV. Fresenius’s Motion for Summary Judgment .,. 1254 A. Falsity ... 1254 B. Knowledge ... 1255 1. Recklessness ... 1257 2. Actual Knowledge ... 1267 C. Conclusion ... 1268 V. Relator’s Motion for Partial Summary Judgment ... 1268 VI. Conclusion ... 1270 I. Legal Standard The Court may grant summary judgment only if the record shows “that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A factual dispute is genuine if there* is sufficient evidence for a reasonable jury to return a verdict in favor of the non-moving party. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A factual dispute is material if resolving the factual issue might change the suit’s outcome under the governing law. Id. The motion should be granted only if no rational fact finder could return a verdict in favor of the nonmoving party. Id. at 249, 106 S.Ct. 2505. When ruling on the motion, the Court must view all the evidence in the record in the light most favorable to the non-moving party and resolve all factual disputes in the non-moving party’s favor. See Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000). The moving party need not positively disprove the opponent’s case; rather, the moving party must establish the lack of evidentiary support for the non-moving party’s position. See Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). If the moving party meets this initial burden, in order to survive summary judgment, the non-moving party must then present competent evidence beyond the pleadings to show that there is a genuine issue for trial. M. at 324-26, 106 S.Ct. 2548. The essential question is • “whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.” Anderson, 477 U.S. at 251-52, 106 S.Ct. 2505. The standard of review for cross-motions for .summary judgment does not differ from the standard applied when only one party files a motion, but simply requires a determination of whether either of the- parties deserves judgment as a matter of law on the facts’ that are not disputed. Am. Bankers Ins. Group v. United States, 408 F.3d 1328, 1331 (11th Cir.2005). The Court must consider each motion on its own merits, resolving all reasonable inferences against the party whose motion is under consideration. Id.' The Eleventh Circuit has explained that “[cjross-motions for summary judgment will not, in themselves, warrant the court in granting summary judgment unless one of the parties is entitled to judgment as a matter of law on facts that are not genuinely disputed.” United States v. Oakley, 744 F.2d 1553, 1555 (11th Cir.1984). Cross-motions may, however, be probative of the absence of a factual dispute where they reflect general agreement by the parties as to the controlling legal theories and material facts. Id. at 1555-56. II. Overview To contextualize the instant. cross-motions for summary judgment addressing Fresenius’s corporate intent, the Court provides an overview of 'the factual and legal background of this case. The Court begins first with a general description- of the drugs at issue — epoten alpha, commer-: daily sold as Epogen®, (“Epogen” or “EPO”), and paricalcitrol (a Vitamin D supplement), commercially sold as Zem-plar® (“Zemplar”) — and Fresenius’s practice of utilizing, administering and billing Médicare for overfill of these drugs. The Court then briefly describes the most relevant Medicare reimbursement rules applicable to the administration- of these drugs by facilities such as Fresenius. The Court next highlights the 2011 Centers for Medicare & Medicaid Services (“CMS”) rule, which retrospectively announced that overfill had not been reimbursable under, the Medicare rules since at least 2006 and prospectively, expressly prohibited billing for overfill starting January 1, 2011. The Court finally, summarizes this Court’s previous decision that, consistent with CMS’s retrospective explanation of the Medicare landscape, overfill administration was not reimbursable from 2006 through 2010. The Court then provides a description of the factual background in Part III, starting with a summary of the direct evidence of Freseniüs’s corporate knowledge, including testimony of Fresenius’s executives and attorneys. The Court then' dives into the record, detailing, for example, evidence of -Office, of Inspector General (“OIG”) and CMS reports addressing Epo-gen or Zemplar and related overfill issues, government investigations and other qui tam actions involving overfill, communications between Fresenius and government officials, Fresenius internal communications regarding overfill and concerns that at least one Medicare fiscal intermediary may have considered prohibiting billing for administered overfill, and testimony of CMS Rule 30(b)(6) representatives and the parties’ proffered experts. • ■ Part IV addresses Fresenius’s Motion for Summary Judgment, concluding that, based on' this record, no reasonable jury could find that Fresenius acted recklessly regarding its overfill billing practices. Part V the briefly rejects Relator’s argument raised in his Motion for Partial Summary Judgment. ■ A. Epogen and Zemplar Use ■' Fresenius is the country’s largest'owner of outpatient renal dialysis facilities. Fre-senius’s patients suffer from chronic renal failure that has advanced to End Stage Renal Disease (“ESRD”). As part of their treatment, these ESRD patients often require hemodialysis. Hemodialysis uses artificial methods to clean and filter the blood. In connection with this ESRD treatment, physicians often prescribe ESRD patients intravenous drugs, including the two at issue in this case, epoten alpha, commercially sold as Epogen, and paricalcitrol, commercially sold as Zemp-lar. Fresenius’s nurses then administer these drugs at an outpatient dialysis facility by injecting them through syringes inserted into plastic blood lines (tubing) that are connected to patients’ vascular access points. For patients covered by Medicare, Fresenius then submits a request for reimbursement to Medicare for the provision of these drugs. Manufacturers of Epogen and Zemplar distribute the drugs in individual vials with the amount of drug contained in the vial labeled on the vial itself. However, consistent with industry standards and federal regulations, the manufacturers also include in each vial a surplus volume of each drug, referred to as “overfill.” For example, a 5-unit vial of Zemplar may, in fact, contain 6 units of the drug. This overfill ensures that the nurses administering the drug will be able to extract at least the labeled amount from the vial. The amount of overfill is determined by the manufacturer and can vary, but this amount is not included in the amount appearing on the drug’s label. ESRD drugs generally come in two types of vials: single-use and multi-use. Despite the name, single-use vials have not historically been limited to a single use. Under certain conditions, providers have been authorized to reenter single-use vials in order to capture contents, including overfill, not initially extracted and then administer the contents to patients. This ability to reenter single-use and multi-use vials allows providers to minimize waste. For example, depending on the amount of drug contained in the vials and the prescribed amount to administer to individual patients, nurses do not always extract all of the available drug from the vial to administer one dose of the drug. If the nurse is prohibited from reentering the vial a second time to extract the remaining drug, then the remaining drug is wasted. Thus, to avoid waste, providers have in the past had an incentive to reenter vials and extract the remaining medicine. Fresenius and other dialysis centers have routinely, lawfully reentered single-use vials of both Epogen and Zemplar and multi-use vials of Epogen in order to extract and administer all contents to patients, including overfill. For example, in the early 1990s, dialysis facilities were regularly reentering single-use vials of Epo-gen in order to minimize waste and maximize profits. The Office of Inspector General (“OIG”) and the predecessor agency to the Centers for Medicare & Medicaid Services (“CMS”) were aware of this widespread, industry practice. While at certain times providers were legally allowed to reenter single-use vials, providers could also receive reimbursement for a certain portion of unused medicine in an individual single-use vial. (See 2004 Medicare Claims Processing Manual, Chapter 17, Section 40, Doc. 251-1.) During the relevant time period, Medicare reimbursed providers for the entire amount of Zemplar or Epogen as indicated on the label of the single-use vial (i.e. excluding overfill) even if the provider only utilized a portion of the contents. (See, e.g. id. (“[I]f a physician must discard the remainder of a vial or other package after administering it to a Medicare patient, the program covers the amount of drug discarded along with the amount administered.”); Relator Ex. 33 (May 25, 2007 CMS Manual System, Pub 100-04 Medicare Claims Processing) at 5 (“[T]he program provides payment for the amount of drug or biological discarded along with the amount administered, up to the amount of the drug or biological as indicated on the vial or package label.”)) In other words, Medicare would reimburse providers for not only the amount of the medication they used, but also the amount of the medication they were unable to use, up to the labeled amount. The amount of the drug remaining in the vial, up to the labeled amount on the vial, is sometimes referred to as “waste” or “wastage.” To be clear, under this policy, Medicare did not reimburse providers for overfill (the amount of drug over the labeled amount) that was thrown away. The following distinguishes between overfill and wastage: Fresenius complied with the wastage rules and, on occasion, billed for units of wasted drug up to the labeled amount on the vial in accordance with CMS rules. Fresenius did not bill for discarded overfill. (See Def. Resp. Relator SUMF ¶ 36.) On the other hand, Fresenius did bill for overfill that was not discarded. According to Fresenius’s Senior Vice President and Deputy General Counsel for Litigation, Ron Castle, during the relevant time periods (2005 through 2010), Fresenius has openly, routinely, and regularly directed its nurses to utilize as much overfill as possible. Fresenius then sought and received reimbursement from Medicare for all covered medications administered to patients, “without regard to whether some or all of the medication actually administered to particular patients can literally be attributable to the ’overfill’ portion of the medication in the vial.” (Def. Ex. 1 (“2011 Castle Aff.’’^ 24.) B. Medicare Reimbursement for Ep-ogen and Zemplar Before 2005, Medicare generally reimbursed providers for the provision of separately billed Part B drugs, including Epogen and Zemplar, based upon the manufacturers’ Average Wholesale Price (“AWP”) or a statutorily set fee schedule. See 42 C.F.R. § 405.517; Medicare Payment Advisory Commission (“Med-PAC”), Report to the Congress: Medicare Payment Policy, § 2F: Outpatient dialysis services, at 104-105 (March 2002) (hereinafter “2002 MedPAC Report). The AWP prices were published in drug pricing publications but did not accurately reflect the actual costs to providers. MedPAC Report at 105 (concluding that it was “highly probable that Medicare [was paying] too much for certain inject-able medications”). (See also Relator Ex. 9 at iii (“[I]n 2003, the 4 largest dialysis providers paid, on average, 22 percent less than the Medicare reimbursement amount for 10 drugs.”).) To address this and similar problems, as part of the Medicare Modernization Act of 2003 (“MMA”), Congress instituted changes to the ESRD program. See In re Pharm. Indus. Average Wholesale Price Litigation, 460 F.Supp.2d 277, 283 (D.Mass.2006) (noting that Congress responded to the disconnect between the AWP and the actual price paid by purchasers by passing the MMA). In addition to increasing the composite rate of reimbursement (the rate' at which Medicare reimburses for bundled dialysis services), the MMA changed the way Medicare reimbursed freestanding dialysis centers like Fresenius for the cost of separately billable drugs and biologies. Beginning in 2005, Medicare reimbursed for Epogen and Zemplar based on “acquisition cost as determined by the Inspector General report.” 42 C.F.R. § 414.904(d)(2)(i). Medicare reimbursed most other Medicare Part B drugs based on the “Average Sales Price” (“ASP”). 42 U.S.C. § 1395w-3a; 42 C.F.R. § 414.904. And this ASP methodology began to apply to Zemplar and Epogen furnished by dialysis facilities like Fresenius on January 1, 2006. See 42 U.S.C. § 1395rr(b)(13)(A)(iii); 42 -C.F.R. § 414.904(d)(2)(iii). The ASP methodology endeavored to more accurately reflect the costs of drugs to individual providers. “In simplified terns, a drug’s ASP represents the manufacturer’s total sales divided by the total number of units of the drug sold in a quarter.” United States ex rel. Westmoreland v. Amgen, Inc., 812 F.Supp.2d 39, 65 (D.Mass.2011) (citing 42 U.S.C. § 1395w-3a(c)(1)(A)-(B.)). Thus, if the sales price (the numerator) increases but the total number of units sold (the denominator) stays the same, the ASP increases. Congress delegated the task of calculating the ASP to the Secretary of Health and Human Services (the “Secretary”). See 42 U.S.C. §§ 1395w-3a(b)(6)(A)(i)(I), (b)(6)(B), (c)(3); 42 U.S.C. § 1395rr(b)(2)(B). To calculate the ASP, the Secretary collects data from the drug manufacturers. By statute, this data must take into account “volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase requirement, chargebacks, and rebates (other than rebates under section 1396r-8).” 42 U.S.C. § 1395w-3a(c)(3). The statute authorizes the Secretary to also “include in such price other price concessions, which may be based on recommendations of the Inspector General, that would result in a reduction of the cost to the purchaser.” Id. During the relevant time period, the Secretary never identified overfill as a price concession that would result in a reduction of the cost to the purchaser, because accounting for overfill would be operationally infeasible. See 75 Fed.Reg. 73461-73471 (Nov. 29, 2010) (“[W]e have authority under section 1847A(c)(3) of the Act to identify price concessions that must be included in the ASP calculation. However, we have a practical reason for declining to consider overfill, to be a discount for purposes of the ASP calculation — namely, operational feasibility.”). C. The 2011 Regulation Prohibiting Overfill Billing No rule or regulation expressly prohibited billing for overfill until'January 1, 2011. Then, effective January 1, 2011, CMS issued a regulation specifically and clearly addressing overfill. “No payment is made for amounts of product in excess of that reflected on the FDA-approved label.” 42 C.F.R. 414:904(a)(3)(iii). Although the rule was not effective until January 1, 2011, according to CMS, the prohibition against billing for overfill was not a new policy. This prohibition was instead a clarification of existing policy. CMS explained by first recognizing the “longstanding Medicare policy that in order to meet the general requirements for coverage under the ‘incident to’ provision, services or supplies should represent an expense incurred by the physician or entity billing for the services or supplies.” 75 Fed.Reg. 73170, 73468 (Nov. 29, 2010). As Defendant had previously argued, and the Court agreed, the “incident to” provision refers to § 1395x(s)(2)(A), which covers “services and'supplies (including drugs and biologicals which are not usually self-administered by the patient) furnished as an incident to a physician’s professional service, of kinds which are commonly furnished in physicians’ offices and are commonly either rendered without charge or included in the physicians’ bills (or would have been so included but for the application of section 1395w-3b of this title).” 42 U.S.C. § 1395x(s)(2)(A). ESRD drugs provided in dialysis clinics- are not “furnished as an incident to a physician^ professional service”. (See infra Part V.) Nonetheless, CMS affirmed the general Medicare principle that it would not reimburse providers, including ESRD clinics, for medicine the providers received at no cost. CMS then explained that, under the current ASP reimbursement methodology, CMS disregarded overfill and thus, so should providers when submitting bills to Medicare. See 75 Fed.Reg. at 73466-67. “Our ASP payment calculations are based on data reported to us by manufacturers,” CMS explained. Id. at 73466. The Secretary chose not to include overfill as a “price concession,” because, as mentioned above, it was operationally infeasible to, do so. See 75 Fed.Reg. at 73461-73471. Thus, the data CMS used to calculate ASP excluded the financial impact of overfill. The Secretary calculates ASP based on the amount of product in the vial “as indicated on the FDA approved label,” and as such, excludes overfill. Id, Because overfill is included in the ASP calculation, CMS did not recognize it as an incurred cost to providers. For this reason, CMS promulgated the 2011 rule “merely to clarify the Medicare ASP payment limit is based on the amount of drug conspicuously indicated on the FDA label, and that no payment will be made for any intentional overfill included as free drag for the proper preparation of a single therapeutic dose.” Id. at 73467. Under the new rales, however, ESRD clinics could opt in to a bundled fee reimbursement scheme under an ESRD. composite rate. See 42 C.F.R. § 414.900(b) (listing examples of drags subject to the ASP reimbursement methodology). Fre-senius opted in to this composite rate and thus, as of January 1, 2011, Fresenius was no' longer reimbursed for Epogen or Zemplar based on the ASP. D. First Cross-Motions for Summary Judgment: Falsity Relator filed this qui tam action in 2010. Relator argues that the practice of billing Medicare for overfill from 2005 through 2006 violated the relevant Medicare rules and regulations prohibiting reimbursement for drugs providers receive for free. Upon the parties’ request, the Court bifurcated the summary judgment briefing schedule to first consider whether the submission of a request for payment for overfill administration satisfied the .threshold falsity element of a False Claims Act claim, i.e. whether overfill administration was reimbursable under the Medicare rules and regulations- existing at the time. The parties agreed that only if the Court answered this question in the affirmative would they engage in additional discovery on the remaining elements of a False Claims Act claim. Thus, whether Freseni-us acted with the requisite level of scienter to be liable under the False Claims Act was not before the Court. On September 17, 2013, the Court held, consistent with CMS’s 2011 retrospective description of the Medicare landscape, that Fresenius was not permitted to bill Medicare for Epogen and Zemplar overfill from January 1, 2006 through December 31, 2010, the time when ASP methodology applied. United States ex rel. Saldivar v. Fresenius Medical Care Holdings, Inc., 972 F.Supp.2d 1339 (N.D.Ga.2013). The Court recognized that, although the 2011 rule was not retroactive, according to CMS, the 2011 rale was a clarification of existing policy. The Court -then took a deeper look at the existing rales and regulations and agreed that since the application of the ASP methodology excluded overfill, overfill administration was not reimbursable.. The Court noted that no Medicare rule or regulation authorized reimbursement when the providers, whether ESRD clinics or physicians, incurred no expense. The Court relied on, inter alia, the assumption, implicit in Medicare reimbursement rules, that payments are generally made for “expenses incurred.” See 42 U.S.C. § 1395y(a); ' 42 U.S.C. § 1395rr(b)(2)(B) (directing - the Secretary to determine the reimbursement amount for ESRD separately billable, guided by the costs incurred by providers). (See also Alexander Dep. at 111 (“Carving out incident-to and wording about incident-to has no bearing on the fact that all entities in the Medicare system are, you know, prohibited from billing for things that are not an expense.”). Although the then-existing rules and regulations were ambiguous as to overfill billing, see Saldivar, 972 F.Supp.2d at 1358 n. 23, the Court held that a variety of Medicare principles, rules, and regulations, and in particular the changes to the reimbursement methodology that went into effect for Epogen and Zemplar in 2006, supported the conclusion that overfill administration was not reimbursable from 2006 through 2010. Because Relator had not sufficiently argued that overfill billing was impermissible before 2006, the Court did not address that possibility. ■ The Court’s decision resolved only the first threshold element of an FCA claim: whether the: request, for reimbursement for overfill administration, constituted a “false claim.” As the Court explained, Fresenius would not be.liable on an FCA claim, and not face treble damages, unless its submission of these “false claims” was done with knowledge of the falsity. See Saldivar, 972 F.Supp.2d at 1358 (“[Liability in this case may turn on whether CMS’s policy prohibiting reimbursement of overfill was sufficiently clear prior to the issuance of its November 2010 rule, such that [Fresenius’s conduct] if proved, must have been undertaken a t least in reckless disregard of the policy.” (quoting United States ex rel. Westmoreland v. Amgen Inc., 812 F.Supp.2d 39, 71 (D.Mass.2011))). The Court did not consider, at that time, any evidence of Fresénius’s knowledge or recklessness. The parties have now moved for summary judgment on the knowledge element of Relator’s FCA claim. Specifically, the question before the Court is whether Fre-senius submitted requests for reimbursement for overfill administration knowing, or recklessly disregarding, that' overfill was not reimbursable under the Medicare rules and regulations. Upon a thorough consideration of the factual record, which the Court describes next, and with the benefit of oral argument, the Court holds that no reasonable jury could find Fresenius acted knowingly or recklessly such that it could be held liable under the False Claims Act. III. Factual Background The record contains evidence suggesting that Fresenius’s executives and attorneys believed at all relevant times that billing Medicare for overfill was permissible. Relator does not meaningfully disagree that the record contains such evidence. Instead, Relator argues that Fresenius’s belief that billing:for overfill was permissible was unreasonable. According to, Relator, other evidence in the record proves that Fresenius’s executives and attorneys knew that, after the implementation of the ASP methodology in 2006, and perhaps even before, billing for overfill was not allowed. Relator also suggests that evidence of Fre-senius’s disclosures to the government or knowledge of overfill permissibility before Medicare adopted the ASP methodology for Epogen and Zemplar is immaterial to the parties’ cross-motions for summary judgment. The Court first summarizes evidence of Fresenius’s belief regarding overfill billing, based primarily on testimony of Freseni-us’s executives and attorneys. The Court then details more thoroughly how Freseni-us’s executives and attorneys came to this belief, and evidence that arguably contradicts this belief. A. Fresenius’s Belief Regarding Overfill Billing Fresenius’s executives and attorneys unquestionably understood that reentry of Epogen and Zemplar vials and administration of overfill was consistent with (and in fact may have been required by) Medicare guidance to avoid drug wastage and to act as an efficient provider. Relator does not dispute this, expressly agreeing that utilization and administration of overfill “is and always has been legal.” (Relator Resp. DSUMF ¶ 692.) ■ Fresenius executives and attorneys also believed that Medicare rulés and regulations did not prohibit billing Medicare for the extracted overfill. Tracy Franklin is Fresenius’s Director of Collections. From 2004 through 2010, she oversaw responsibility for Fresenius’s Medicare billing to fiscal intermediaries including TrailBlazer Health Enterprises, LLC (“TrailBlazer”). (Def. Ex. 184 (“Franklin Deck”) ¶3.) Franklin authorized the submission of claims for Epogen and Zemplar without regard to whether some of the medicine constituted overfill, and during this time, she believed that such claims were in compliance with all applicable rules. (Id. ¶ 34.)' She explained, “No, statute, regulation or guidance instructed an independent dialysis facility to treat administered doses of overfill any differently than any other administered dose.” (Id. ¶ 11.). And the claim form supplied by CMS did not request information about whether overfill was included in the units administered. (Id.) On the contrary, based on CMS guidance, Franklin understood that Fresenius should bill fqr the amount of the drug that was administered to each patient, period. (Id.) Likewise, Robert McGorty, Fresenius’s Senior Vice President for Finance and Administration, believed that at all relevant times, the use and Medicare billing of overfill was permissible and consistent with industry practice; (See Def. Ex. 116 (“2013 McGorty Deck”) ¶ 23.) To be sure, much of McGorty’s belief appears to be based on facts that predate the ASP methodology. Nonetheless, McGorty avers that Fresenius “openly and widely discussed” its use of overfill and overfill’s impact on profits with CMS and the Medicare Payment Advisory Commission (“MedPAC”) both prior to and during the years at issue in this case. (Id. ¶32.) McGorty also testified that Fresenius never considered overfill “free.” (Id. ¶¶ 14-16; see also Def. Ex. 176 (“Snail Report”) at 29 — 34; Def. Ex! 177 (“Expert Report of Alan Bruce Steinwald”) ¶¶ 9-10, 33-36.) Fresenius at all times believed that, regardless of the amount Fresenius was reimbursed for the administration of ESRD drugs, Fresenius itself incurred an expense associated with the purchase of all the medicine in an ESRD vial, including overfill. (Def. Ex. 116 (“2013 McGorty Decl.”) ¶¶ 14 — 16; see also Def, Ex. 2Í7 at 2.) According to McGorty, “Fresenius has, in its own books and' records always treated overfill as something that it pays for and that must be counted as part of the overall costs incurred by Fresenius.” (2013 McGorty Decl. ¶ 16.) Fresenius’s lawyers also believed that overfill billing was permissible at all relevant times. For example, Fresenius’s in-housé counsel, Ronald L. Castle avers that at all relevant times, he believed billing for overfill was lawful and advised Fresenius as such. (Def. Ex. 51 (“2015 Castle Decl.”) ¶ 6.) Castle has sewed as Fresenius’s Deputy General Counsel for' Litigation since July 1, 2005. He bases his opinion on a variety of factors including: (1) multiple disclosures to the government regarding the use and billing of overfill pursuant to numerous investigations from the 1990s through 2008 and the government’s decision not to pursue claims based. on this practice, and in-particular not to pursue claims against Fresenius based on its extraction, -utilization or billing of overfill; and (2) the Jack of any statute or regulation specifically prohibiting billing for overfill. Another Fresenius in-house attorney, David Kembel, stated'that in 2006, in connection with reviewing Zemplar overfill capturing procedures arid providing legal advice regarding such procedures, he “understood there was no prohibition on using and billing for Epogen and Zemplar overfill administered to patients and that CMS was aware that Fresenius was using and billing for Epogen and Zemplar overfill.” (Def. Ex. 9 (“2015 Kembel Deck”) ¶¶ 37-39.) He further testified that, as far as he understood, “at all’times prior to January 1, 2011, that there was no regulation or statute that prohibited dialysis facilities from billing Medicare for Epogen or Zemplar overfill administered to patients in furnishing prescribed dosages of these separately billable drugs.” (Id. ¶ 4.) The record also contains instances in which Fresenius’s attorneys advised Fre-senius that overfill billing was permitted. Attorneys so advised in connection with several qui tam actions involving overfill predating the 2006 ASP Methodology’s application to Epógen and 'Zemplar. These attorneys advised Fresenius that, at least at the time of those complaints, oyerfill utilization and billing was permissible. (See 2015 Castle Deck ¶¶ 12-13, 20, 24, 46.) Likewise, in connection with Fresenius’s merger with Renal Care Group, Freseni-us’s outside counsel Hawey Yampolsky stated in 2006 that overfill billing is appropriate if actually administered to the patient; (Def. Ex. 198 (“[T]he bottom line is that today it is still possible to bill for ‘wastage’ (although not for overfill unless it is actually utilized to fill a prescription).”) And when, in 2005, Fresenius was presented with a document suggesting that a Medicare intermediary would not reimburse physicians for overfill administered in their offices, Fresenius’s counsel advised the company that the policy did not seem to .apply to ESRD facilities. Other examples are provided below, but it is fair to say that Fresenius’s inside and outside counsel believed overfill, billing .was permissible throughout the relevant time period. Relator has identified no evidence to the contrary. While the record contains no evidence of Fresenius’s specific knowledge that overfill billing was impermissible, Fresenius’s executives and counsel were aware of certain facts that could have arguably led them to conclude that billing for free overfill was impermissible. For example, some evidence suggests that Fresenius knew its clinics could not bill for certain free drugs or services. (See Markus Dep. at 12-13 (testifying that while “it is permissible to bill for services in connection with a clinical trial” it was not permissible to do so if “any of the costs are furnished by the research funder”).) And Fresenius appears to have understood that physicians billing under what those in the industry call the “incident tó” provision, 42 U.S.C. § 1395x(s)(2)(A), had to incur an expense in order to bill Medicare for a drug. (2012 Kembel Dep. at 105; 2014-Kembel Dep. at 71.) Finally, viewed in the light most favorable to Relator, Fresenius understood that CMS did not account for overfill when setting the Epogen or Zemplar reimbursement rates from 2005 through 2010. B; OIG Reviews and Investigations and CMS’s Reimbursement Calculations From the late 1990s through 2009, OIG has engaged in several reviews of ESRD reimbursement and investigations into Fresenius’s billing practices. CMS also changed its methodology for setting reimbursement rates during this time. Fre-senius was actively monitoring or participating in these reviews and changes, which provide some insight into whether Freseni-us had the requisite intent necessary to support an FCA claim based on overfill billing.- 1. 1997 OIG Review of Epogen Reimbursement In 1997, OIG undertook a review of the price dialysis facilities paid for Epogen to determine if Medicare’s reimbursement for Epogen should be reduced.- The purpose of OIG’s 1997 report was to-provide cost information to CMS along with’ a recommendation regarding an appropriate reimbursement rate. At that time, the reimbursement rate for Epogen was $10 per 1,000 units administered.. The 1997 OIG report and accompanying drafts -and work papers recognized the cost-savings potential for utilization of overfill, both to providers and to the government. (See Def. SUMF ¶¶ 134-161.) The report notes that its cost information consisted “of the amount providers paid to wholesalers for EPO as well as the actual amount of EPO administered during the year.” (Def. Ex. 3 at 8.) Thus, the data in the 1997 report “would also contain the amount of any additional EPO that providers extracted from each vial.” (Id.) After reviewing, among other things, applicable Medicare laws and regulations, cost reports from free-standing dialysis clinics, and current invoices and information regarding year-end rebates or free product, OIG recommended that CMS reduce the Medicare reimbursement amount to $9 per 1,000 units in order to capitalize on savings resulting from overfill utilization. (Def. Ex. 3 at 1, 8.) It is fair to say that in 1997, OIG understood that dialysis clinics were capturing, administering and billing for overfill and that OIG did not view overfill as a separable “free product,” but rather as a mechanism to reduce the acquisition cost. CMS reviewed and commented on the 1997 report. (Def. Ex. 3 at 17-18.) It did not suggest in its comments that dialysis facilities should refrain from billing for administered overfill. (Id.) 2. The Medicare Modernization Act of 2003, the 2004 OIG Review of Medicare Reimbursement for ESRD Drugs, and the 2005 Average Acquisition Cost Rule In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”). The MMA contemplated that reimbursement for most ESRD drugs would be based on the average acquisition costs (“AAC”) and ultimately average sales price (“ASP”) rather than the average wholesale price (“AWP”). 42 U.S.C. § 1395rr(b)(13)(A)(iii). Congress delegated to the Secretary of Health and Human Services (the “Secretary”) the task of calculating the ASP. The MMA also mandated that OIG again review acquisition cost to facilities for certain drugs, including Epogen and Zemplar. See MMA, Pub. L. 108-173, § 623(c). Thus, in 2004, OIG began such a review. The purpose of the 2004 OIG study was twofold. (Def. Ex. 5 at 1.) First, the study endeavored “to determine the difference between the Medicare payment amount for separately billable end-stage renal disease drugs and the acquisition costs of these drugs for facilities.” (Id.) Second, the study estimated the rate of growth of facilities’ expenditures for these drugs. (Id.) The result of this study was to form the basis for both the 2005 dialysis payment rate and the separately billable drug reimbursement rate. At the outset, OIG met with CMS and industry representatives. Based on its initial meeting with CMS, OIG understood that CMS would use the results of the study “to promulgate a new rule, receive comments, and publish it before the end of 2004.” (Def.Ex. 117.) Then in February 2004, OIG held two meetings with industry representatives. (Def.Ex. 119.) A Fre-senius representative participated in these meetings. OIG informed participants that it would “most likely not include spoilage, waste, etc. [i]n [its] definition of acquisition cost” because it was “too difficult to get an accurate gauge of, and most likely varies between companies.” (Id.) Companies were, however, encouraged to include such information in their reports to OIG and were also reminded that they could add information about additional cost factors during the comment period for the new rule. (Id.) OIG later provided the companies with a request for information on the acquisition costs of the separately billable drugs and biologicals. (Def.Exs.120121.) In a March I, 2004 letter, OIG requested information on Fresenius’s drug acquisition costs in connection with the 2004 OIG study. (Def.Ex. 121.) The letter reiterated that the purpose of the study was to “determine the difference between the Medicare payment amount for separately billable end stage renal disease (’ESRD’) drugs and the acquisition costs of these drugs for facilities.” {Id. at 1.) The letter further explained that CMS would use data from this study “to set calendar year 2005 reimbursement rates for all ESRD drugs, including EPO.” (Id.) Included in the March 2004 letter were instructions setting out OIG’s definition of acquisition cost and the requested data. (Id. at 2.) Respondents were instructed to calculate average acquisition cost by dividing the total amount paid by all facilities owned or managed by the company for 2003 by the total number of units bought by the facilities owned or managed by the company in that year. Consistent with the provisions of the MMA regarding ASP, 42 U.S.C. § 1395w-3a(c)(3), the average acquisition costs was to be “net of volume discounts, prompt pay discounts, cash discounts, free goods contingent on any purchase requirement, chargebacks, and rebates (other than rebates under the Medicaid drug rebate program).” (Id.) Although the instructions did not mention overfill, they invited respondents to “provide separate information on other costs associated with the acquisition of drugs in the space provided on the worksheet.” (Id.) Fresenius’s Senior Vice President for Finance and Administration, Robert McGorty emailed Kathleen Smith, another Fresenius executive, asking for guidance on how to handle overfill in Fresenius’s acquisition cost reporting. (Relator Ex. II.) Her initial response was to “ignore the overfill,” but Smith said she would check with Fresenius’s counsel, Ron Castle, who would address this issue with David Tawes, OIG’s project leader for the 2004 audit. {Id.) The next day, Smith responded that “Ron had heard back from Dave Tawes” who instructed Fresenius to footnote achievable utilization of overfill for those drugs for which it captured overfill. (Def.Ex. 122.) Fresenius then responded to OIG’s request for information by letter to Mr. Tawes dated March 12, 2004. (Def.Ex. 123.) ■ In its letter, Fresenius expressly stated that its -use of overfill should be considered when analyzing acquisition cost for Epogen and Zemplar. (Id.) FMCNA’s profit margin on EPO administration is partly derived from overfill utilization. Any analysis that attempts to quantify margin on EPO should consider this. For the full year 2003, FMC achieved a 13.8 overfill utilization percentage. For Q4 of 2003, the overfill utilization was down to 13.2%. It should be noted that in 2003, Amgen reduced the targeted overfill amount by 3% and could reduce overfill even further in the future. It is not clear if FMCNA has seen the full impact of the 3% decline in our Q4 number. The company' also utilizes overfill for Zemplar. This practice began in January 2003. The company’s Zemplar overfill experience for 2003 was 12.9%. {Id. (emphasis added); see also Def. Ex. 124 (revised letter 'to OIG reiterating the statements regarding overfill usage).) Fresenius was not the only large dialysis company to report its utilization of overfill to OIG. Both Renal Card Group (“RCG”) and DaVita reported the use of overfill to offset Epogen acquisition costs. (Def.Exs.125,126.) That three of the largest dialysis companies reported overfill percentages to OIG was memorialized by OIG in the work papers associated with the 2004 OIG audit. A fourth large dialysis center, Gambro, did not include overfill information in its report to OIG. Neither the reports by the companies, nor the OIG work papers, suggested that the cómpanies utilized overfill but only billed private payors, as opposed to" Medicare. Mr. Tawes testified that he understood from these disclosures that Freseni-us; RCG and DaVita were all using and billing Medicare for overfill. (Tawes Dep. at 79-81, 99, Def. Ex. 38.) Mr. Tawes notes, however, that OIG did not request or receive any information from Fresenius regarding overfill practices after 2004, and Tawes had no knowledge as to whether Fresenius continued to bill Medicare for overfill after 2004. - (See Tawes Dep. at 114-415.) Although OIG was aware that dialysis facilities included overfill in their own determination of profit margins, the 2004 OIG report to CMS did not account'for overfill in any of the acquisition cost calculations. OIG explained that the amount of overfill varies and facilities have different practices regarding the utilization .of overfill. (Def. Ex. 5 at 8-9.) Viewed in the light most, favorable to Relator, the record suggests that Fresenius .knew OIG’s calculations did not consider overfill. (Relator Ex. 22; see also Relator Ex. 23) CMS reviewed the 2004 OIG report and provided its written response on April 15, 2004, indicating that it had read and considered the report. (Id. at 1415.) CMS’s proposed rule setting reimbursement amounts, 69 Fed.Reg. 47488 (Aug. 5, 2004), did not consider overfill amounts in determining acquisition costs for Epogen. (See Relator Ex. 23.) Nonetheless, according to John Warren, CMS’s Rule 30(b)(6) des-ignee, CMS did “take ... into account” the information regarding overfill supplied by OIG when setting the reimbursement rate for ESRD drugs. (See 2014 Warren Dep. at 116.) In other words, according to Warren; CMS considered the fact that dialysis centers were using overfill to lower acquisition costs when it set reimbursement rates for Epogen. (Id. at 64, 116-117.) Fresenius objected to CMS’s proposed rule. (Relator Ex. 23.) Fresenius’s CEO explained'to CMS that “providers generally utilize the overfill amount to minimize cost and wastage.” (Id. at 4.) He disclosed that this was “a widely and accepted practice in the dialysis industry.” (Id.) And he encouraged CMS to factor overfill utilization into its acquisition cost estimates. CMS should include, as a factor for overfill utilization, a 10 percent reduction in acquisition costs and should include a similar factor reflecting changes in overfill as a component of future acquisition cost updates. Failure to recognize the impact of overfill utilization on acquisition cost will result in an initially overstated acquisition cost and hidden cost increases as manufacturers continue to reduce overfill amounts, which has been the history with EPO. (Id. (emphasis added).) CMS was apparently not persuaded by Fresenius’s objection. Its final rules setting reimbursement calculation for average acquisition cost (which would be used for Epogen and Zemplar reimbursements in 2005) and average sales price (which would be used for Epogen and Zemplar from 2006 through 2010) did not take overfill into account. As Relator notes, had CMS included overfill in its reimbursement calculations, the reimbursement amount would have been lower (and thus dialysis facilities would have, received less per dose). (See also Tawes Dep. at 87-88 (testifying that CMS’s reimbursement amount was higher because it did not factor overfill into the reimbursement calculation).) 3. The ASP Methodology and its Disregard for Overfill By 2006, Medicare was using the ASP methodology for ESRD drugs. Although the Secretary was authorized to consider overfill as a price concession in determining the ASP for reimbursement purposes, the Secretary did not do so. And, with one exception, the record suggests that Fresenius understood, or should have understood, that overfill was not factored into the ASP determination or OIG’s acquisition cost reports in .2006, 2008 and 2010. For example, in October 2005, Fresenius executives considered a memorandum that “thorough[ly] review[ed]” the ASP methodology. (Relator Ex. 27.) The memorandum indicates that manufacturers report ASP to CMS. According to the memorandum, manufacturers calculate ASP by dividing the “total U.S. sales for a National Drug Code (NDC’) by the total number of units sold (a unit is defined as the lowest identifiable quantity of the drug or biological by NDC that is dispensed, exclusive of diluents).” (Relator Ex. 27 at 1-2.) The memorandum tracks the language of the statute and regulation, noting that the ASP must include several price concessions including discounts and free goods contingent on any purchase requirement. (Id. at 2.) The memorandum does not mention overfill, suggesting that overfill was not factored into the ASP calculations. Communications in connection with the 2010 OIG acquisition cost report likewise suggest Fresenius understood overfill was not factored into acquisition cost. In 2009, in response to a request from a congressperson, OIG sent Fresenius another request for information about its acquisition costs for separately billable ESRD drugs. (Def.Ex. 178.) Similar to the 2004 OIG ■request, the 2009 request asked independent dialysis facilities to report the total amount paid by the facility for a product for the first quarter of 2009 divided by the total number of units bought by the facility for that quarter. Again, facilities were instructed that the average acquisition cost “should be net of volume discounts, prompt pay discounts, cash discounts, free goods contingent on any purchase requirement, chargebacks, and rebates (other than rebates under the Medicaid drug rebate program).” (Def. Ex. 178 at 4.) Unlike the 2004 request, however, this time OIG did not invite respondents to provide separate information on other costs. Accordingly, this time, dialysis facilities did not include overfill information in their report to OIG. Nonetheless, at no point during the OIG cost report study in 2004, or in subsequent studies in 2006, 2008 or 2010, did Mr. Tawes become aware of any rule or regulation that would prohibit using or billing overfill, nor was he aware of anything that would put a provider on notice that such a rule existed. (Tawes Dep. 106-109.) In October 2008, Fresenius became licensed to sell Venofer, a different ESRD drug subject to ASP reimbursement requirements. (Relator Ex. 28 at 9.) Fre-senius thus began reporting Venofer ASP to CMS, and in doing so, reported the price for a package of vials, along with the volume per vials and vials per National Drug Code. (Id. at 3.) It does not appear that the ASP for Venofer accounted for overfill. Fresenius’s internal ASP compliance policy, adopted in 2008, recognizes that ASP is “performed at the package level, characterized by an 11-digit NDC number (the ’NDC-11’) and representing a single package size.” (Relator Ex. 29 at 15.) The policy continues, “Therefore, an ASP value is calculated and reported for each package size.” (Id.) Thus, based on this evidence, a jury could easily infer that Fresenius understood ASP was based on the amount of drug in a single package, as labeled on the package, exclusive of overfill. Despite the evidence above, Ron Castle, Fresenius’s in-house counsel, testified in 2012 that he believed Medicare factored in overfill in setting its reimbursement amount. (2012 Castle Dep. at 84-86.) He explained that Fresenius’s “costs are not in any direct way part of our charge or allowable payment from Medicare.” (Id. at 85.) In other words, reimbursement for Epogen and Zemplar is based on a value CMS calculates, but not on the actual cost to any one provider. And in Castle’s view, providers reported their use of overfill to CMS, and CMS knew providers utilized overfill, during the relevant time periods. (Id.) Thus, although overfill was not “accounted for” in the acquisition cost calculations, Castle still apparently believed CMS factored it in when setting the ASP reimbursement rate. (Id.) 4. Other OIG Investigations OIG also investigated and reported on payments made for Epogen administered at seven Fresenius dialysis facilities. Between October 2007 and April 2009, Fre-senius provided a series of documents related to Epogen billing practices. (Def.Exs.91, 152-153.) These included a copy of the Fresenius 2006 Annual Report it had previously provided to OIG in connection with a Corporate Integrity Agreement. (See Def. Ex. 153 (noting that the “FMCNA 2006 OIG Annual Report” was produced to OIG in 2009); see Part III.E.2 below).) Somewhat buried in this Annual Report is a document referencing Freseni-us’s practice of utilizing the “maximum amount of overfill [f]or the billing of Epo-gen to the payor.” (Def. Ex. 152, Doc. 221-36 at 121.) This document does not indicate the date when Fresenius was billing Epogen overfill to the payor. In June 2008, Fresenius also supplied OIG with a copy of its Epogen administration policies dated October 14, 2002 and May 12, 2004. (Def.Ex. 153.) These policies directed clinics to reenter vials in order to capture “residual” Epogen and achieve “maximum withdrawal of vial contents.” (Def. Ex. 23 at 2-3, 5.) The policies do not address billing for overfill. And although Freseni-' us states that these policies were still in effect when they were provided to OIG in 2008, Fresenius does not direct the Court to evidence to support this or evidence suggesting that OIG understood the 2004 policies were still in effect in 2008. C. CMS Cost Reports In addition to the OIG reports discussed above, dialysis companies like. Fresenius submit cost reports to CMS. (Def. Ex. 116 (“2013 McGorty Decl.”) ¶¶ 46.) As part of the cost reports, dialysis facilities are instructed to include the total dollar amount spent on purchasing separately billable drugs such as Epogen and Zemplar, taking into account rebates and discounts. (Id. ¶8.) Fresenius’s cost reports during the relevant time period include the total amounts spent on all separately billed drugs. (Id.) And for Epogen, the cost reports also include the total number of units administered. (M; see also 2013 McGorty Decl. Ex. 1 at 4, 14.) Thus, according to Robert McGorty, Fresenius’s Senior Vice President for Finance and Administration, anyone reviewing the cost reports could determine the actual per-unit cost of Epogen independent of the number of “labeled” units in a vial. (2013 McGorty Decl. ¶9.) For this reason, McGorty understood that Medicare considers the impact of overfill on Fresenius’s costs when “considering the economies of dialysis reimbursement.” (Id. ¶ 12.) And CMS’s corporate designee, John Warren, agreed that the cost reports reflected the impact of overfill on reducing costs. Nonetheless, as noted previously, CMS did not factor overfill into its calculation of average acquisition cost or average sales price. D. CDC and CMS Changes to the Reentry Protocol The reentry protocols issued by the Centers for Disease Control and Prevention (“CDC”) and CMS are relevant to Fresenius’s understanding of overfill billing requirements. In the early 2000s, the CDC revised its recommendations regarding reentry into single-use vials, providing strict procedures to ensure patient safety and reduce the risk of infection. In response, Fresenius’s Chief Medical Officer, Dr. J. Michael Lazarus, consulted with Fresenius’s law department and issued a memorandum to the field instructing technicians to follow Fresenius policy and procedures when reentering single-use vials. (Def.Ex. 193.) In the letter, Dr. Lazarus stated that he had “been advised by [Fre-senius’s] Law Department that there is no regulation or ruling from any federal agency that restricts or prohibits use of overfill if carried out in [a] clinically appropriate manner.” (Id.) To be sure, the letter focused on CDC, not. CMS guidelines, and does not expressly address whether it is appropriate to bill Medicare for administered overfill. This letter also predates the application of the ASP methodology to Epogen and Zemplar. In January 2003, John Markus, Freseni-us’s then Vice President for Corporate Compliance, participated in an “Open Door Forum” with CMS. (Def. Ex. 19 (“Markus Deck”) ¶ 19.) At the Forum, CMS notified dialysis facilities that they could, and in fact were encouraged to, reenter vials where appropriate in order to reduce waste. (Id.; see also Warren 2014 Dep. at 96.) According to Markus, “[i]t was clearly understood by all knowledgeable participants in the Forum that the purpose of this guidance was to standardize industry practices relating to the capture and administration of overfill as part of the reentry process.” (Id.) Shortly thereafter, in. February 2003, CMS directed dialysis facilities to comply with the CDC procedures and, “in general ... bill what they administer to the patient.” (Def. Ex. 17 at 6; Def. Ex. 18.) Fiscal intermediaries likewise encouraged “efficient utilization” of medications including reentry where allowed to avoid waste. (See Def. Ex. 21 at 2.) Although providers could bill Medicare for wastage under some circumstances, intermediaries' discouraged doing so. (Id.; Def. Ex. 22 at 2.) Fresenius does not direct the Court to any evidence that fiscal intermediaries or CMS directed dialysis facilities to bill Medicare for overfill or expressly condoned the practice. Effective October 14, 2008, CMS adopted regulations which referred to a new CDC rulé prohibiting re-entry into single-use intravenous medication vials. (Def. Ex. 25.) See ‘42 C.F.R. § 494.30(a)(l)(i). The rule did not require immediate compliance. Fresenius, however,' immediately set forth company-wide plans for implementing the new policy prohibiting re-entry into' single use vials of Epogen and Zemplar. (Def.Ex. 28.) Fre-senius continued to allow for' reentry of multi-use vials. (Id.) Because Zemplar was only available in single-use vials, Fre-senius discontinued its practice of reentering Zemplar vials entirely. E. Investigations and Other Qui Tam Actions 1. Ecksel and Zwick In thé early 1990s, representatives of the National Kidney Patients Foundation (“NKPF”) notified the Department of Health and Human Services (“DHHS”) that they were preparing a qui tam lawsuit against National Medical Care (“NMC”), a predecessor-in-interest to Fresenius Medical Care Holdings, Inc. The main thrust of their complaint was that dialysis facilities were dangerously reentering single-use vials of erythropoietin (Epogen or “EPO”), salvaging overfill to use for other patients. They filed their qui .tam lawsuit in the United States, District Court for the District of Columbia in December 1991, United States ex rel. Ecksel and Rosen v. Amgen, Inc., et al., No. 91-3325 (D.D.C.1991). The relators alleged that NMC and Am-gen,- the manufacturer of EPO, violated the False Claims Act, by “entering into secret arrangements” whereby Amgen would overfill vials and providers like NMC would then capitalize on this overfill, providing the EPO at no extra cost. (Def. Ex. 46 ¶ 13.) “Thus the providers’ actual cost is lower than that disclosed to the United States.” (Id.) Six months after the NKPF qúi tam complaint was unsealed, the relators voluntarily dismissed the action. The United States did not object to dismissal. One month later, the United States House of Representatives, Committee on Ways and Means, Subcommittee on Health held a hearing on “Payment Under Part A of the Medicare Program and Payment for Hospital Outpatient and End-Stage Renal Disease Services.” (Def.Ex. 50.) Representatives of NKPF testified at the hearing, explaining how Amgen overfills EPO vials and “show[s] providers how they can bill the government for the excess in the vial.” (Id. at 136.) The NKPF representatives explained that EPO was “free” to the providers. And according to the NKPF representatives, simply reducing the reimbursement rate would not solve the problem. Instead, the representatives urged Congress to eliminate Overfill, which they characterized as a “kickback.” (Id.) NMC’s troubles did not end there. In February 1996, an Amgen salesperson, Eric Zwick, filed another qui tarn complaint. (Def.Ex. 52.) United States ex rel. Zwick v. Amgen, Inc. et al., No. 96-1169 (E.D.Pa. Feb. 15, 1996). Zwick alleged that Amgen “intentionally ’overfilled’ its Epogen vials by up to ■ 25 percent and provided the overfill quantity to customers at no extra charge.” (Id. ¶43.) Zwick further alleged that providers like NMC “billfed] Medicare for Epogen that they had received as free overfill.” (Id.) According to Zwick, Medicare regulations for EPO only allowed reimbursement “for use within the scope of FDA labeling,” and because the overfill was not part of the FDA label, providers “were not entitled to Medicare reimbursement for such use.” (Id. ¶¶ 47-48.) Zwick alleged that the practice of extracting and billing for overfill violated the False Claims Act. While the Zioick case was pending, Fre-senius acquired NMC in September 1996. Thus, Fresenius succeeded to the responsibility and liability for the qui tarn complaint. The Zwick