Full opinion text
MEMORANDUM AND OPINION LEE H. ROSENTHAL, District Judge. This case raises the question of when a manufacturer’s promotion of a medical device for an “off-label” use may provide the basis for a qui tarn action by private plaintiffs suing under the False Claims Act. The relators, Elaine Bennett and Donald P. Boone, allege that Medtronic, Inc. improperly promoted its Cardioblate system device for an off-label use and that the promotional activities caused physicians and hospitals to submit false claims for reimbursement from Medicare or Medicaid. The FDA has approved the Cardioblate system for the general uses of ablating tissue to control bleeding during general surgery and to coagulate cardiac tissue during general surgery. The relators allege that Medtronic has improperly promoted the use of the device for surgical ablation to treat atrial fibrillation, both in conjunction with other cardiac surgery and as a standalone procedure, which are off-label uses. Medtronic has moved to dismiss under Rule 12(b)(6) and Rule 9(b) of the Federal Rules of Civil Procedure. Medtronic argues that the allegations of off-label promotional activities are insufficient to plead that it caused physicians or hospitals to submit false reimbursement claims to Medicare. (Docket Entry No. 30). The relators responded, (Docket Entry No. 41), and Medtronic replied, (Docket Entry No. 47). Based on the pleadings, the motion, the responses, and applicable law, this court grants Medtronic’s motion to dismiss, for the reasons explained in detail in this Memorandum and Opinion. Because there has been only one amendment, and because Rule 15 embodies a liberal amendment policy, the relators may amend no later than October 29, 2010, consistent with this Memorandum and Opinion. 1. Background A. Procedural History The relators filed their complaint on November 17, 2008, under seal, to allow the United States to decide whether it wanted to intervene. This is one of five qui tam actions filed by one of the relators, Elaine Bennett, against medical-device manufacturers. (Docket Entry No. 4). Bennett also filed qui tam actions against Boston Scientific Corp. and Guidant Corp., United States of America ex rel. Bennett v. Boston Sci. Corp., Civil Action No. H-07-2467; Atricure, Inc., United States of America ex rel. Bennett v. Atricure, Inc., Civil Action No. H-07-2702; St. Jude’s Medical, Inc. and Epicor Medical, Inc., United States of America ex rel. Bennett v. St. Jude’s Med. Inc., Civil Action No. H-07-2704; and Endoscopic Technologies, Inc., United States ex rel. Bennett v. Endoscopic Tech., Inc., Civil Action No. H-07-2705. All these suits alleged off-label promotion of surgical-ablation devices to treat atrial fibrillation. The Boston Science allegations involved a “microwave ablation device,” (Civil Action No. H-07-2467, Docket Entry No. 58, at 3); the Atricure allegations involved a “bipolar ablation system,” (Civil Action No. H-07-2702, Docket Entry No. 23, at 1); the St. Jude allegations involved “Epicor’s cardiac ablation products,” (Civil Action No. H-07-2704, Docket Entry No. 25, at 2); and the Endoscopic Tech, allegations involved “Cobra ablation products,” (Civil Action No. H-07-2705, Docket Entry No. 26, at 2). In each complaint, the alleged unlawful promotional tactics included: encouraging sales representatives to promote the device for off-label use in treating atrial fibrillation; training doctors to use the device to treat atrial fibrillation; encouraging physicians and hospitals to “upcode” minimally invasive, stand-alone surgical ablations as open-chest procedures to obtain favorable Medicare reimbursement rates; marketing the high reimbursement-to-cost ratio of ablation devices compared to other atrial fibrillation treatments; encouraging the off-label use of the device by providing remuneration in forms that included (for physicians) referrals, free advertising, and direct payments, and (for hospitals) free products, volume discounts, and “lock-in” arrangements, all outside the antikickback statute’s safe harbors. On the government’s motion, the cases were placed under joint administration. (Docket Entry Nos. 4, 6). The United States declined to intervene in this suit against Medtronic on August 2009. The relators filed an amended complaint in July 2009, (Docket Entry No. 12), and an unredacted version of that complaint in December 2009, (Docket Entry No. 27). B. The Parties Medtronic develops, manufactures, and markets medical devices, including surgical devices. The relators, Elaine Bennett and Donald P. Boone, describe themselves as “industry insiders” who have never worked for Medtronic but have worked for other medical-device manufacturers. Bennett alleges that she worked for Boston Scientific for four months as a sales representative. She alleges that she has knowledge of Medtronic’s “illegal billing and coding practices.” Boone alleges that he worked as a sales representative for Guidant, in a management position for St. Jude Medical, and most recently at Endoscopic Technologies, which manufactures devices that compete with Medtronic in treating atrial fibrillation. (Id. at ¶¶ 16-17). Boone alleges that he became familiar with the practices alleged in this complaint while working for Guidant and St. Jude. C. The False Claims Act The False Claims Act prohibits the knowing submission of false or fraudulent claims for payment, or causing the submission of such claims, to the federal government, and prescribes fines and treble damages to penalize offenders. 31 U.S.C. § 3729(a). The FCA establishes liability for “[a]ny person who ... knowingly presents or causes to be presented, a false or fraudulent claim for payment or approval ... [or] knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the government.” 31 U.S.C. § 3729(a)(l-2), amended by 31 U.S.C. § 3729(a)(l)(A-B). When a qui tam suit is brought by a private relator and the government declines to intervene, the relator is entitled to between 25 and 30% of the recovery, § 3730(d)(2), as well as attorneys’ fees. As has often been pointed out, the Act does not create a cause of action against all fraudulent conduct affecting the government. Rather, FCA liability attaches to a “false or fraudulent claim for payment” or to a “false record or statement [made] to get a false or fraudulent claim paid by the government.” 31 U.S.C. § 3729(a)(l)-(2), amended by 31 U.S.C. § 3729(a)(l)(A-B). “Evidence of an actual false claim is the ‘sine qua non of a False Claims Act violation.’ ” United States ex rel. Clausen v. Lab. Corp. of Am., Inc., 290 F.3d 1301, 1311 (11th Cir.2002). In this case, there are no specific allegations that Medtronic itself submitted false claims. Instead, the complaint alleges that Medtronic knowingly caused the submission of fraudulent claims by physicians and hospitals in the form of claims for reimbursement for off-label uses of a Medtronic device. The complaint does not identify any specific false claim presented by others to Medieare/Medicaid. Nor does the complaint identify any entity or person who actually submitted such a claim. Instead, the complaint alleges that as a result of Medtronic’s marketing campaign and illegal kickbacks, the Medtronic Cardioblate system has been widely used for the off-label purpose of treating atrial fibrillation by physicians and hospitals and that this use “would result in the submission of fraudulent claims.” (Docket Entry No. 27, ¶ 136). D. Off-Label Use of Medical Devices The FDA approves products for specific indications, which are stated in the label. When a medical device is approved for one purpose or indication and used outside this approved purpose, that use is deemed “off label.” Off-label promotion involves disseminating information about product uses not approved by the FDA. The FDA generally restricts a manufacturer from marketing for off-label purposes but does not restrict a hospital from purchasing or a doctor from prescribing or using a medical device for an off-label purpose. Off-label use of many products and drugs is an accepted medical practice. Courts recognize that off-label use of a drug or medical device is not the same as a medically unnecessary use of that drug or device. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 1018, 148 L.Ed.2d 854 (2001) (“ ‘[O]ff-label’ usage of medical devices ... is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”); Svidler v. United States Dep’t of Health and Human Servs., No. C-03-3593 MJJ, 2004 WL 2005781, at *5 (N.D.Cal. Sept. 8, 2004) (“[T]he FDA can restrict a company from marketing off-label uses, but cannot prevent a doctor from prescribing a device for an off-label use for any purpose she deems medically necessary.”) (citing Washington Legal Foundation v. Friedman, 13 F.Supp.2d 51 (D.D.C.1998)); United States ex rel. Polansky v. Pfizer, No. 04-cv-0704 (ERK), 2009 WL 1456582, at *6 (E.D.N.Y. May 22, 2009) (“[T]he FDA has acknowledged that ‘accepted medical practice often includes drug use that is not reflected in approved drug labeling.’”) (citing Food & Drug Admin., Use of Approved Drugs for Unlabeled Indications, 12 FDA Drug Bulletin 4, 5 (1982)); United States ex rel. Stephens v. Tissue Sci. Labs., Inc., 664 F.Supp.2d 1310, 1318-19 (N.D.Ga.2009) (noting that DRG payment may be made for hernia care even if noncovered care — the use of the device at issue — was present). Medicare reimbursements for off-label uses of medical devices are not addressed within the Medicare Act itself. See generally Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71, 73 (2d Cir.2006). Broad wording excludes from Medicare coverage “any expenses incurred for items or services ... which ... are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” 42 U.S.C. § 1395y(a)(l)(A). The Secretary of the Department of Health and Human Services “is responsible for specifying those services that are covered under the ‘reasonable and necessary’ standard” and “has wide discretion in selecting the means for doing so.” Yale-New Haven Hosp., 470 F.3d at 74 (citing 42 U.S.C. § 1395ff(a); Heckler v. Ringer, 466 U.S. 602, 617, 104 S.Ct. 2013, 80 L.Ed.2d 622 (1984)). Traditionally, the Secretary has acted through “formal regulations and (informal) instructional manuals and letters.” Id. Before 1995, the Medicare Hospital Manual, the Medicare Carriers Manual, and the Intermediary Manual stated that payment could not be made for devices not approved by the FDA for commercial distribution because “they were not considered ‘reasonable and necessary’ under 42 U.S.C. § 1395y(a)(l).” In re Cardiac Devices Qui Tam Litig., 221 F.R.D. 318, 323 (D.Conn.2004) (citing Medicare Hospital Manual § 260.1(B) (effective July 15, 1986); Medicare Carriers Manual § 230.1; Intermediary Manual § 3151.1); see also Yale-New Haven Hosp., 470 F.3d at 74 (discussing the history of the manual provisions). In 1995, the Secretary of the United States Department of Health and Human Services published regulations superseding the manual provisions and allowing Medicare coverage for Category B investigational devices under the “reasonable and necessary” standard. Yale-New Haven Hosp., 470 F.3d at 71. As one court has summarized: On September 19, 1995, after completing a formal notice-and-comment rule-making process regarding coverage for investigational devices under the statutory ‘reasonable and necessary’ standard, the Secretary of HHS published final regulations addressing the coverage of medical devices categorized by the FDA as ‘investigational.’ The new regulations provided Medicare coverage for those ‘ndnexperimental/investigational’ devices as to which the initial questions about the devices’ safety and effectiveness had been resolved. See 42 C.F.R. §§ 405.201(b), 405.203, 405.211(b). In contrast to the total exclusion from coverage of such devices under the Manual provision, the new regulations classified such devices as either experimental/investigational (‘Category A’) for which there continued to be no coverage, or non-experimental investigational (‘Category B’) which are eligible for Medicare coverage. See 42 C.F.R. §§ 405.201, 405.203(a), 405.205, 405.209, 405.211. In re Cardiac Devices Qui Tam Litig., 221 F.R.D. 318, 325 (D.Conn.2004). The allegations in this case are that a Category B non-experimental/investigational medical device the FDA approved for a general use — to ablate tissue, including cardiac tissue, in surgical procedures— is being marketed for an off-label, specific use that the FDA has not approved — to ablate cardiac tissue to treat atrial fibrillation. Atrial fibrillation is a fast and irregular beating of the heart’s atria. The first-line treatments for atrial fibrillation are nonsurgical and include using drugs. (Docket Entry No. 27, ¶ 47). According to the relators, a recognized surgical treatment is an open-heart procedure known as the “maze.” In a maze procedure, a cardiothoracic surgeon makes strategic incisions in both atria and uses a “cut and sew” technique to repair the heart. The maze procedure is effective but also dangerous and difficult. (Id. at ¶ 48). As a result, the medical community has continued efforts to find less invasive, more effective methods of treatment. Two newer forms of treatment for atrial fibrillation are catheter ablation and surgical ablation. In catheter ablation, an electrophysiologist — a specialized cardiologist — threads a catheter through the patient’s leg and into the heart. The catheter is equipped with a device that delivers radiofrequency waves to ablate heart tissue. The relators allege that catheter ablation is often an outpatient procedure. (Id. at ¶¶ 50-52). The relators allege that a large number of studies and scientific organizations have recently recognized catheter ablation as an effective procedure to treat atrial fibrillation. In 2006, catheter ablation was included within the “Guidelines” for treating atrial fibrillation as a “third-tier treatment option, following drug therapy and cardioversion.” (Id. at ¶¶ 52-53). The relators allege that surgical ablation is a more recent ablation method. Surgical ablation treats atrial fibrillation by using radiofrequency waves to ablate heart tissue to disrupt the normal pathways for electrical impulses. (Id. at ¶¶ 46, 54-55). It is typically an inpatient procedure performed by cardiothoracic surgeons. It can be performed as an additional procedure during open-chest surgery for other cardiac conditions or as a stand-alone procedure. As part of other open-chest procedures, a surgeon uses the cardiac ablation device to create incisions on tissue similar to the incisions made in a “maze” procedure. In a stand-alone surgical ablation, sometimes referred to as a “mini maze” procedure, a surgeon makes three to four incisions on a patient’s chest and directs an ablation device through those incisions to the heart. According to the relators, stand-alone surgical ablation “unlike traditional open heart surgery, does not require opening the thoracic cavity to expose the heart and lungs and does not require a heart-lung machine.” (Id. at ¶ 65). It is an inpatient but minimally invasive surgery. As the relators acknowledge, Cardioblate system devices are classified for Medicare reimbursement purposes as Class II devices. (Id. at ¶ 75); see also 21 C.F.R. § 878.4400 (identifying “electrosurgical cutting and coagulation device and accessories ... intended to remove tissue and control bleeding by use of high-frequency electrical current” as a Class II device). Under Medicare regulations, a device “believed to be in ... Class II” is a Category B — “nonexperimental/investigational” — device. 42 C.F.R. § 405.201(b). Class II devices “require special controls, such as performance standards or post-market surveillance, to provide reasonable assurance of safety and effectiveness.” 42 C.F.R. § 405.201(b). Medicare contractors may approve coverage for Category B devices. Id. at § 405.211(b). The relators acknowledge that there is no “national coverage determination” for reimbursement for surgical ablation using radiofrequency devices. “Accordingly, the Medicare Carrier in each state or region determines the conditions for coverage and reimbursement of physician charges for surgical cardiac ablation.” (Docket Entry No. 27, ¶ 67). While there is no FDA approval for using the Cardioblate system to treat atrial fibrillation, there is no identified statutory, regulatory, or other prohibition on reimbursement to physicians or hospitals for using the Cardioblate system for this purpose. While Medicare and Medicaid typically do not reimburse off-label prescriptions for drugs, see United States ex rel. Franklin v. Parke — Davis, 147 F.Supp.2d 39, 44-45 (D.Mass.2001); United States ex rel. Hess v. Sanofi—Synthelabo Inc., No. 4;05CV570MLM, 2006 WL 1064127, at *10 (E.D.Mo. Apr. 21, 2006), the relators have not pointed to a similar categorical restriction on reimbursement for Category B medical devices. For medical devices, eligibility for reimbursement depends on whether the procedure performed is “medically necessary” or “reasonable and necessary.” E. The Medicare Billing System The Medicare billing scheme is the context for this FCA suit. Under its “prospective payment system,” Medicare prepays hospitals specific predetermined amounts based on codes for the diagnosis and procedure performed. (Docket Entry No. 27, ¶¶ 25, 29). The complex billing scheme includes a lengthy list of codes that reflect medical and administrative judgments. The amounts hospitals receive for inpatient procedures depend on the Diagnosis Related Group (“DRG”) code assigned to a patient. In addition to basic information about the patient and the diagnosis, the procedure performed on the patient is a factor in determining a patient’s DRG. 42 C.F.R. § 412.60(c)(1) (stating that the DRG is based on “essential data extracted from the inpatient bill for that discharge” including “the patient’s age, sex, principal diagnosis, ... secondary diagnoses, procedures performed, and discharge status”). Hospitals enter a procedure code when they submit Form HCFA-1450 (UB-92) to obtain reimbursement for items and services provided to a patient. Cardiac Devices, 221 F.R.D. at 328-29; United States ex rel. Smith v. Yale Univ., 415 F.Supp.2d 58, 91-92 (D.Conn.2006). These codes are based on the International Classification of Diseases, Ninth Revision, Clinical Modification (“ICD-9-CM”) system. (Docket Entry No. 27, ¶¶27). In addition to Forms UB-92, hospitals annually submit a Hospital Cost Report, Form HCFA-2552, which summarizes the amounts of interim payments received and the amounts the hospital claims from Medicare. Cardiac Devices, 221 F.R.D. at 328-29 The amounts Medicare pays physicians for services provided in conjunction with a procedure performed at a hospital are based on Current Procedural Terminology (“CPT”) codes published by the American Medical Association. Physicians typically provide the CPT code and submit claims for payment on Form CMS-1500. (Docket Entry No. 27, ¶¶ 29-33). F. The Mtedical Device at Issue The Medtronic Cardioblate system includes a radiofrequency-power generator, surgical probes to create lesions, and a MAPS device that evaluates the effectiveness of ablation. (Id. at ¶¶ 62-65). Medtronic’s Cardioblate system can be used either in conjunction with other cardiac surgical procedures or for stand-alone surgical ablation. As noted, the FDA has approved Medtronic’s Cardioblate system for the coagulation of cardiac tissue using radiofrequency [] energy during cardiac surgery”; for use “during general surgery to coagulate soft tissues; and “to remove tissue and control bleeding by use of high-frequency electrical current.” (Id. at ¶ 76); see also 510(k) Premarket Submission — Medtronic—Cardioblate System (Jan. 25, 2002) (granting premarket approval for the Medtronic Cardioblate Radiofrequency Ablation System “to ablate cardiac tissue during cardiac surgery using radiofrequency energy”); 510(k) Summary of Safety and Effectiveness (May 5, 2008) (granting premarket approval for the Cardioblate Surgical Ablation System “to ablate cardiac tissue during cardiac surgery using radiofrequency energy”). The FDA has approved one Cardioblate system for a “minimally invasive, closed-chest” stand-alone surgical procedure. Medtronic Cardioblate Gemini Surgical-Ablation Device 510(k) Premarket Notification, (Apr. 24, 2007). The FDA has denied general approval for the Cardioblate system as a treatment for atrial fibrillation three times. (Docket Entry No. 27, ¶ 81). The relators allege, and Medtronic accepts as true for the purpose of this motion, that because the FDA has approved the Cardioblate system for use during “open surgical procedures,” and has not approved the Cardioblate system for treating atrial fibrillation, Medtronic may not market the Cardioblate devices for use in minimally invasive closed-chest surgical procedures for treating atrial fibrillation. (Docket Entry No. 27, ¶ 85); see 21 C.F.R. § 812.7(a). The relators allege facts showing disagreement and uncertainty in the medical community about surgical ablation’s efficacy in treating atrial fibrillation. The relators allege that at a May 2007 American Association of Thoracic Surgeons Society meeting, several surgeons reported the efficacy rate of surgical ablation to treat atrial fibrillation to be under 50% in some clinical studies. (Docket Entry No. 27, ¶ 59). The relators also cite a joint statement by the Heart Rhythm Society, European Heart Rhythm Association, and European Cardiac Arrhythmia Society that “prospective multicenter clinical trials are needed to better define the relative safety and efficacy of surgical [ablation] tools and techniques,” and that “[t]he true success rates of these procedures are likely to be lower than reported.” (Id. at ¶ 60). The relators also allege facts showing competition among hospitals and physicians for atrial fibrillation patients. The competition is particularly acute between physicians who perform catheter ablations (electrophysiologists) and those who perform surgical ablations (cardiothoracic surgeons). The relators unabashedly take the electrophysiologists’ side in this competition. The relators accuse Medtronic of, among other things, seeking to change the referral patterns so that physicians will refer atrial fibrillation patients directly to cardiothoracic surgeons for treatment, rather than to cardiologists, who according to the relator are more likely to refer patients to electrophysiologists for treatment. (Id. at ¶¶ 90-91,108). G. The Alleged Improper Promotional Activities The relators allege four categories of what they characterize as actionable conduct by Medtronic promoting off-label use of the Cardioblate systems. • Medtronic sales representatives provided physicians and hospitals with patient-education brochures about the use of stand-alone surgical ablation to treat atrial fibrillation. These brochures included statements that: “[e]xperience to date indicates that Mini-Maze surgery eliminates afib in more than 85% of patients who undergo the procedure”; “[m]ost patients with afib are candidates for Mini-Maze. Together, you and your doctor can determine if this surgery is right for you.”; “Mini-Maze surgery is the first treatment that can safely, easily and reliably eliminate afib, helping patients avoid lifelong drug therapy and reducing the high risk of stroke and other complications that are associated with afib.”; “Catheter Ablation destroys the source of abnormal electrical signals v. Mini-Maze Surgery, which creates a ‘zone of defense’ to permanently eliminate afib”; and “Catheter Ablation procedures take hours to perform, may require a pacemaker, and can cause life-threatening damage to organs near the heart. As a result, they are reserved for the most severe cases of afib. The Mini-Maze experience to date indicates that the surgery corrects afib in more than 85% of patients.” (Id. at ¶¶ 88-91). The complaint alleges that these statements are misleading because there is no “safety and efficacy study submitted to the FDA” and no “conclusive consensus of clinical studies documenting 85% efficacy or cure rate” (although the brochures do not make such claims). The complaint alleges that the statements equate to a statement that stand-alone surgical ablation is recommended other than as a last resort, while acknowledging that in 2006, cardiology peer groups recommended that surgical ablation should be performed in conjunction with other open heart procedures taking place. The complaint alleges that the comparisons between surgical ablation and catheter ablation are misleading because the procedures are similar in effect and similar in the identified risks. (Id). There is no allegation, however, that the patient brochures falsely identified the FDA-approval status of the Cardioblate system. • Medtronic, like “other minimally invasive surgical ablation companies,” on “information and belief’ marketed its devices to hospitals by emphasizing the high reimbursement-to-cost ratio available through using surgical ablation to treat atrial fibrillation in minimally invasive procedures. This is part of the “upcoding” allegations set out below. The relators also allege that this promotion of the “high profit margin hospitals can expect to see” in using the Cardioblate system to treat atrial fibrillation “demonstrate^] that Defendant intends off-label use of their product.” (Id at ¶¶ 93-95). The relators also allege that Medtronic’s promotion activities included requiring its sales representatives to accompany new surgeons into the operating room to provide them with instructions on administering the Cardioblate system to treat atrial fibrillation and using this “Experts in the OR” Program to provide direct training on using the Cardioblate system to treat atrial fibrillation. (Id at ¶¶ 97,112). • Medtronic “coached” hospitals to “up-code” and overcharge Medicare for closed-chest stand-alone procedures by billing them with a DRG and procedure code for open-chest surgery. The relators allege that Medtronic told its sales representatives to tell hospitals that they could bill Medicare for closed chest stand alone procedures using DRG 108 (excision or destruction of other lesion or tissue of heart, open approach), which is a code for “open chest” approaches, including the Maze procedure. The relators acknowledge that the DRG code associated with procedure code 37.33 is DRG 108. The relators allege that the ICD-9 procedure code and the DRG codes are incorrect for closed-chest procedures. The relators allege that because there is no procedure code that provides reimbursement for the closed-chest surgical ablation, “a more appropriate code ... would be procedure code 37.99 (other operations on heart and pericardium),” and DRG 110 or 111 (respectively, major cardiovascular procedures with and without complications and comorbidities).” The relators allege that the average reimbursement for a hospital under DRG 108 is $30,289 and the average cost to the hospital for patients who require procedures qualifying under that DRG is $31, 074. In contrast, the average cost of a closed-chest standalone surgical ablation is $10,650. The relators allege that by training sales representatives to tell hospitals that they could bill Medicare for closed-chest stand-alone procedures using DRG and procedure codes for open-chest procedures, Medtronic improperly promoted its Cardioblate surgical-ablation system. (Id. at ¶¶ 121-30). This category of alleged actionable promotion by Medtronic only applies to stand-alone procedures; the use of the Cardioblate in open-chest procedures that also treat other cardiac conditions is properly billed using the codes for such procedures. • The relators also allege that Medtronic provided remuneration to physicians and hospitals to encourage them to use the Cardioblate system device, in violation of the antikickback statute, 42 U.S.C. § 1320a-7b(b). The relators allege that Medtronic provided in-kind services to physicians, particularly cardiothoracic surgeons, including referral services, marketing, and direct payments. (Docket Entry No. 27, ¶ 102). The relators allege that Medtronic sponsored meetings to screen candidates for surgical ablation and referred them to cardiothoracic surgeons who used the Cardioblate system. (Id. at ¶ 109). The relators allege that Medtronic “endow[ed] elaborate dinner programs” to present information about Cardioblate to physicians who could make referrals, paying Medtronic-trained surgeons to put on the programs. (Id. at ¶ 105). The relators allege that Medtronic also helped cardiothoracic surgeons advertise “minimally invasive” surgical ablation to treat atrial fibrillation. The relators allege that Medtronic provided cardiothoracic surgeons using the Cardioblate system free advertising by paying for brochures describing their use of the device. Finally, the relators allege that Medtronic provided direct payments to physicians in the form of grants to physicians who promoted the Cardioblate system to other physicians. (Id. at ¶¶ 102-04; 108-11). As to hospitals, the relators allege that Medtronic paid kickbacks in the forms of discounts for buying large amounts of the Cardioblate equipment, loans to purchase the equipment contingent on a minimum number, and free products. The relators allege that Medtronic offered these inducements on the condition that a hospital use the Cardioblate system for at least ninety percent of surgical ablation procedures. (Id. at ¶¶ 113-20). The relators allege that Medtronic’s kickbacks caused false or fraudulent claims for payment to be submitted because certification of compliance with all applicable laws and regulations, including the antikickback statute, is a condition for payment under Medicare. (Id. at ¶ 141— 43). The relators allege that these promotional efforts “caused physicians and hospitals to perform an increased number of costly inpatient surgical ablation procedures in cases where less costly and less invasive treatments otherwise have been performed.” (Id. at ¶ 140). The relators allege that Medtronic “knowingly made, used, and caused to be made and used false records and statements in order to obtain reimbursement from the United States for surgical ablation services performed with [Medtronic’s] surgical ablation products.” (Id. at ¶ 143). To support its allegations, Medtronic does not allege specific instances of false claims. Instead, Medtronic points to the high number of surgical ablations performed at LDS Hospital in Salt Lake City, at Scott & White Healthcare in Central Texas, and by eight individual physicians. (Id. at ¶ 132-35). In its motion to dismiss under Rule 12(b)(6), Medtronic argues that the relators have not alleged that it made or caused any false claim to be submitted to Medicare. Medtronic emphasizes both that the complaint does not link Medtronic’s marketing practices to the submission of a false claim and that Medtronic’s promotional tactics are not “material” to the government’s decisions to pay Medicare claims for surgical ablations. Medtronic also argues that the relators did not allege sufficient facts to support a reasonable inference that hospitals or physicians falsely certified compliance with the antikickback statute. Finally, Medtronic argues that the relators have not met Federal Rule of Civil Procedure 9(b)’s heightened pleading requirements for fraud because they fail to identify the “who, what, when, where, and how of the alleged fraud.” See United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899, 903 (5th Cir.1997). The relators respond that Medtronic’s promotional efforts caused physicians and hospitals to perform more surgical ablations to treat atrial fibrillation than would otherwise have been performed and, as a result, more that were not medically necessary. As a result, physicians and hospitals submitted claims for reimbursement for procedures that were not medically necessary and that would not have been submitted but for the off-label promotion. (Docket Entry No. 45, at 8); 42 U.S.C. § 1320c-5(a)(3) (“medically necessary”); 42 U.S.C. § 1395y(a)(l)(A) (“reasonable and necessary”). The relators argue that using the Cardioblate system in minimally invasive closed-chest procedures to treat atrial fibrillation is never medically necessary because the Cardioblate system is not FDA approved, is experimental, and is not a first-line treatment for this purpose. The relators also argue that by marketing hospitals’ ability to upcode stand-alone ablation procedures using the Cardioblate system, Medtronic was the “but for” cause of hospitals and doctors submitting claims for payment with three false statements: that the code used accurately represented the procedure performed; that the procedure was the most economical, as required by 42 U.S.C. § 1320c-5(a)(l), and that the procedure was “medically necessary,” as required by 42 U.S.C. § 1320c-5(a)(3). The relators also argue that Medtronic’s kickbacks caused physicians and hospitals to falsely certify — either implicitly in claims for payment, or expressly in annual compliance statements — compliance with the antikickback statute. The relators argue that Medtronic’s promotional efforts were material because their “natural tendency” was to cause the submission of false claims. Finally, the relators respond that they have provided sufficient factual allegations to demonstrate a scheme to defraud. In its reply, Medtronic argues that although the FDA has not specifically approved the Cardioblate system for surgically treating Atrial Fibrillation, such use can be and often is “medically necessary.” Medtronic emphasizes that the decision whether to use its device in surgically treating atrial fibrillation is a medical decision, made by a physician, and that nothing in the complaint alleges that any physician made such a decision knowing that it was not a medically necessary treatment in the specific use. Medtronic argues that the relators’ failure to plead any specific unnecessary procedure means that they cannot meet Rule 9(b)’s particularity requirement. For both relators’ antikickback claims and upcoding claims, Medtronic argues that the relators have failed to meet Rule 9(b) because they fail to identify any physicians or hospitals who upcoded or submitted false certifications — implied or express — of compliance. Each argument and response is analyzed below. II. The Legal Standards for a Motion to Dismiss Medtronic moves to dismiss the allegations based solely on the alleged off-label promotion of the Cardioblate surgical ablation devices and the allegations of the antikickback statute in connection with the sale of these devices under Rule 12(b)(6). Medtronic also moves to dismiss under Rule 9(b) because of the failure to plead fraud with the requisite particularity. Claims brought under the FCA are fraud claims that must comply with the requirements of Rule 9(b). Hopper v. Solvay Pharms., 588 F.3d 1318, 1325 (11th Cir.2009); Thompson, 125 F.3d at 903; United States ex rel. Longhi v. Lithium Power Techs., Inc., 575 F.3d 458, 468 (5th Cir.2009). The parties also analyze the application of 31 U.S.C. § 3729(a). A. Rule 12(b)(6) Rule 12(b)(6) allows dismissal if a plaintiff fails “to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). In Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), and Ashcroft v. Iqbal, — U.S. —, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009), the Supreme Court confirmed that Rule 12(b)(6) must be read in conjunction with Rule 8(a), which requires “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). To withstand a Rule 12(b)(6) motion, a complaint must contain “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570, 127 S.Ct. 1955. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (citing Ttoombly, 550 U.S. at 556, 127 S.Ct. 1955). “To survive a Rule 12(b)(6) motion to dismiss, a complaint ‘does not need detailed factual allegations,’ but must provide the plaintiffs grounds for entitlement to relief — including factual allegations that when assumed to be true ‘raise a right to relief above the speculative level.’ ” Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir.2007) (footnote omitted) (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955); see also S. Scrap Material Co. v. ABC Ins. Co. (In re S. Scrap Material Co.), 541 F.3d 584, 587 (5th Cir.2008) (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955), cert. denied, — U.S. —, 129 S.Ct. 1669, 173 L.Ed.2d 1036 (2009). “Conversely, ‘when the allegations in a complaint, however true, could not raise a claim of entitlement to relief, this basic deficiency should ... be exposed at the point of minimum expenditure of time and money by the parties and the court.’ ” Cuvillier, 503 F.3d at 401 (quoting Twombly, 550 U.S. at 558,127 S.Ct. 1955). When a plaintiffs complaint fails to state a claim, the court should generally give the plaintiff at least one chance to amend under Rule 15(a) before dismissing with prejudice. See Great Plains Trust Co. v. Morgan Stanley Dean Witter & Co., 313 F.3d 305, 329 (5th Cir.2002) (“[District courts often afford plaintiffs at least one opportunity to cure pleading deficiencies before dismissing a case, unless it is clear that the defects are incurable or the plaintiffs advise the court that they are unwilling or unable to amend in a manner that will avoid dismissal.”); see also United States ex rel. Adrian v. Regents of the Univ. of Cal., 363 F.3d 398, 403 (5th Cir.2004) (“Leave to amend should be freely given, and outright refusal to grant leave to amend without a justification ... is considered an abuse of discretion.” (internal citation omitted)). However, a plaintiff should be denied leave to amend a complaint if the court determines that “the proposed change clearly is frivolous or advances a claim or defense that is legally insufficient on its face ....” 6 Charles A. Wright, Arthur R. Miller & Mary Kay Kane, Federal Practice and Procedure § 1487 (2d ed.1990); see also Ayers v. Johnson, 247 Fed.Appx. 534, 535 (5th Cir.2007) (unpublished) (per curiam) (“ ‘[A] district court acts within its discretion when dismissing a motion to amend that is frivolous or futile.’ ”) (quoting Martin’s Herend Imports, Inc. v. Diamond & Gem Trading United States of Am. Co., 195 F.3d 765, 771 (5th Cir.1999)). B. Rule 9(b) “In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. Malice, intent, knowledge, and other conditions of a person’s mind may be alleged generally.” Fed. R. Civ. P. 9(b). “At a minimum, Rule 9(b) requires that a plaintiff set forth the ‘who, what, when, where, and how’ of the alleged fraud.” Thompson, 125 F.3d at 903 (quoting Williams v. WMX Techs., Inc., 112 F.3d 175, 179 (5th Cir.1997)). The pleader must “specify the statements contended to be fraudulent, identify the speaker, state when and where the statements were made, and explain why the statements were fraudulent.” Williams, 112 F.3d at 177. “ ‘Rule 9(b)’s ultimate meaning is context specific, and thus there is no single construction of Rule 9(b) that applies in all contexts.’ ” United States ex rel. Grubbs v. Kanneganti, 565 F.3d 180, 188 (5th Cir.2009) (quoting Williams, 112 F.3d at 178). In the context of the FCA, the parties dispute whether it is appropriate to relax the Rule 9(b) standard. The relators acknowledge that they have failed to identify a specific false claim but argue that this should not be required because the facts relating to the alleged fraud are “peculiarly within the perpetrator’s knowledge” and the alleged fraud occurred over a multi-year period. (Docket Entry No. 45, at 20-22). Medtronic responds that, to the contrary, the relevant information on billing and reimbursements are in the hands of third parties, including physicians, hospitals, and Medicare; and that there is no basis in the case law to relax the Rule 9(b) requirements in such circumstances. (Docket Entry No. 47, at 13-15). III. The False Claims Act In United States ex rel. Longhi v. Lithium Power Techs., Inc., the Fifth Circuit adopted a four-prong test for § 3729(a) claims. 575 F.3d 458 (5th Cir.2009). The Fifth Circuit requires: “(1) a false statement or fraudulent course of conduct; (2) made or carried out with the requisite scienter; (3) that was material; and (4) that caused the government to pay out money or to forfeit moneys.” Id. at 467 (adopting the test stated in United States ex rel. Wilson v. Kellogg Brown & Root, Inc., 525 F.3d 370, 376 (4th Cir.2008)). A. Which Version of the FCA Applies? A threshold issue is whether the amended or earlier version of 31 U.S.C. § 3729 applies. The Fraud Enforcement Recovery Act of 2009 (FERA) amended sections of the False Claims Act, including two subsections implicated in this action, 31 U.S.C. § 3729(a)(1) and (2). Pub.L. No. 111-21, § 386, 123 Stat. 1617 (2009). FERA became law on May 20, 2009. It contained a retroactivity provision stating as follows: The amendments made by this section shall take effect on the date of enactment of this Act and shall apply to conduct on or after the date of enactment, except that (1) subparagraph (B) of section 3729(a)(1) of title 31, United States Code, as added by subsection (a)(1), shall take effect as if enacted on June 7, 2008, and apply to all claims under the False Claims Act (31 U.S.C. 3729 et seq.) that are pending on or after that date. 123 Stat. 1617 § 4(f). For the § 3729(a)(1) claim, this court must apply the pre-FERA version of § 3729(a)(1) because the relators filed this suit in November 2008, before the “date of [FERA’s] enactment.” Section 4(f)’s exception — “subparagraph (B) of section 3729(a)(1)” — applies to the § 3729(a)(2) claim. Section 4(f) states that the amended version of subsection (a)(2), now found at 31 U.S.C. § 3729(a)(1)(B), applies to all “claims” under the FCA pending on or after June 7, 2008. The pre- and post-FERA versions of the FCA define “claim” similarly. The pre-FERA FCA defines claim as [A]ny request or demand, whether under a contract or otherwise, for money or property which is made to a contractor, guarantee, or other recipient if the United States Government provides any portion of the money or property which is requested or demanded, or if the Government will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded. 31 U.S.C. § 3729(c), amended by 31 U.S.C. § 3729(b)(2). The post-FERA amendments define “claim” as “any request or demand, whether under a contract or otherwise, for money or property ... [that] is presented to an officer, employee, or agent of the United States .... ” 31 U.S.C. § 3729(b)(2). Neither definition refers to cases or causes of action under the FCA. Instead, both definitions refer to claims “for money or property” from the government. Because “claim” is a defined term in the FCA, the reference to “claims” in FERA § 4(f)(1) must be read in accordance with that definition. See United States ex rel. Gonzalez v. Fresenius Med. Care N. Am., No. EP-07-CV-247-PRM, 748 F.Supp.2d 95, 107-08, 2010 WL 1645971, at *9 (W.D.Tex. Mar. 31, 2010) (reaching the same conclusion). Under this approach, the post-FERA version of § 3729(a)(2), 31 U.S.C. § 3729(a)(1)(B), applies if the false claims alleged by the relators were pending on or after June 7, 2008. Most of the district courts that have ruled on this issue have reached the same conclusion. See, e.g., United States ex rel. Compton v. Circle B Enters., Inc., No. 7:07-CV-32, 2010 WL 942293, at *2 n. 5 (M.D.Ga. Mar. 11, 2010) (“The revised version of section (a)(1)(B) does not apply to this case because none of Defendants’ claims (the ... reimbursement claims) at issue here were pending on or after June 7, 2008.”); United States ex rel. Putnam v. E. Idaho Reg’l Med. Ctr., 696 F.Supp.2d 1190, 1196 (D.Idaho 2010) (“[B]ecause the claims for Medicaid reimbursement at issue in this case were neither pending on nor filed after June 7, 2008, the pre-FERA version of § 3729(a)(2) governs ....”); Mason v. Medline Indus., Inc., No. 07-C-5615, 731 F.Supp.2d 730, 735, 2010 WL 653542, at *3 (N.D.Ill. Feb. 18, 2010) (“The court interprets § 4(f)(1) to apply to ‘claims’ as defined in the FCA. Accordingly, FERA’s amendment does not apply retroactively to this case.”); United States ex rel. Sanders v. Allison Engine Co., Inc., 667 F.Supp.2d 747, 752 (S.D.Ohio 2009) (“[T]he clear indication from Congress is that the revised language at issue here is applicable to ‘claims’ pending on June 7, 2008, and not to ‘cases’ pending on June 7, 2008. Since the Defendants in this case had no ‘claims’ pending on June 7, 2008, the retroactivity clause does not apply to them____”); United States v. Sci. Applications Int’l Corp., 653 F.Supp.2d 87, 107 (D.D.C.2009) (“[S]ection 4(f)(1) will be interpreted to apply to ‘claims’ as defined in § 3729, that is, requests or demands for money or property. Thus, FERA has no impact on the present action.”). The relators’ amended complaint does not appear to involve claims pending on or after June 7, 2008. The amended complaint refers to 31 U.S.C. § 3729(a)(2), not 31 U.S.C. § 3729(a)(1)(B). The relators’ allegations of unlawful promotional tactics date back to 2001. (Docket Entry No. 12, ¶ 17). The relators’ allegations of false or fraudulent claim submission refer to 1,000 claims submitted at various times before February 2008 by physicians at LDS Hospital in Salt Lake City. (Id. at ¶ 132). Finally, the amended complaint contains no allegations of false claims pending after June 7, 2008. Medtronic has pointed out that the FCA has been amended, (Docket Entry No. 30, at 6 n. 6). The relators have not argued whether the amended FCA or the prior version applies to their claims. Medtronic argues that the result is the same under either version and the relators have not addressed this issue. (Docket Entry No. 30, at 6 n. 6). In an abundance of caution, the analysis is conducted under both the pre- and postFERA versions of the FCA because the amended complaint may cover claims pending on or after June 7, 2008. B. The Elements of An FCA Claim 1. A False or Fraudulent Claim The Supreme Court has cautioned that the FCA does not punish every type of fraud committed upon the government. See United States v. McNinch, 356 U.S. 595, 599, 78 S.Ct. 950, 2 L.Ed.2d 1001 (1958). “The [FCA] attaches liability, not to the underlying fraudulent activity, but to the ‘claim for payment.’ ” United States ex rel. Hopper v. Anton, 91 F.3d 1261, 1266-67 (9th Cir.1996) (finding on summary judgment that violation of Individuals with Disabilities Education Act regulations is not also an FCA violation unless compliance certification is a prerequisite to receive federal funds); see also United States ex rel. Siewick v. Jamieson Sci. and Eng., Inc., 214 F.3d 1372, 1376-77 (D.C.Cir.2000) (upholding district court’s determination on summary judgment that even if the defendants had violated 18 U.S.C. § 207, “a criminal statute aimed at ‘revolving door’ abuses by former government employees,” there was no fact issue as to an FCA violation because defendants were not required to certify compliance with the statute); United States ex rel. Willard v. Humana Health Plan of Tex. Inc., 336 F.3d 375, 382-83 (5th Cir.2003) (upholding district court’s dismissal because the plaintiff only alleged violations of HMO enrollment antidiscrimination laws but did not allege that the United States “conditioned payment ... on any implied certification of compliance with the anti-discriminatory provisions”); United States ex rel. Roop v. Hypoguard USA Inc., 559 F.3d 818, 824 (8th Cir.2009) (upholding district court’s dismissal because the plaintiff alleged violations of the FDA medical-device-reporting regulations by selling defective products but did not allege that certification with these regulations was a prerequisite to payment). In the specific context of reimbursement claims for using a drug or device in a way that violates the FDA, the courts have held that the “mere fact” of “violating FDA regulations does not translate into liability for causing a false claim to be filed.” United States ex rel. Polansky v. Pfizer, No. 04-cv-0704 (ERK), 2009 WL 1456582, at *7 (E.D.N.Y. May 22, 2009); see also United States ex rel. Rost v. Pfizer, 507 F.3d 720, 732 (1st Cir.2007), overruled on other grounds by Allison Engine Co. v. United States ex rel. Sanders, 553 U.S. 662, 128 S.Ct. 2123, 170 L.Ed.2d 1030 (2008) (noting that the alleged marketing practices, “while illegal, are not a sufficient basis for an FCA action because they do not involve claims for government reimbursement”); Thompson, 125 F.3d at 902 (“[C]laims for services rendered in violation of a statute do not necessarily constitute false or fraudulent claims under the FCA.”). The courts have held that a claim may be false or fraudulent under the FCA because it includes a certification of compliance with a federal statute, regulation, or contract that is a prerequisite to obtaining the government benefit. United States ex rel. Graves v. ITT Educ. Servs., Inc., 284 F.Supp.2d 487, 497 (S.D.Tex. 2003), aff'd, 111 Fed.Appx. 296 (5th Cir.2004). Such “legally false” certification differs from “factually false” certification, which involves an incorrect description of goods or services provided or a request for reimbursement for goods or services never provided. See Mikes v. Straus, 274 F.3d 687 (2d Cir.2001). The Fifth Circuit has held that a claim is “legally false” only when a party affirmatively and explicitly certifies compliance with a statute or regulation and the certification is a condition to receiving the government benefit. See Thompson, 125 F.3d at 902. In addition to express certifications of compliance, other circuits have found that FCA liability may exist under an “implied theory” of certification. See Willard, 336 F.3d at 382 (discussing cases). “The theory of implied certification rests on the notion that ‘where the government pays funds to a party, and would not have paid those funds had it known of a violation of a law or regulation, the claim submitted for those funds contained an implied certification of compliance with the law or regulation and was fraudulent.’ ” United States ex rel. Foster v. Bristol — Myers Squibb Co., 587 F.Supp.2d 805, 823 (E.D.Tex.2008) (citing United States ex rel. Barrett v. Columbia/HCA Healthcare Corp., 251 F.Supp.2d 28, 33 (D.D.C.2003)). For example, the Sixth Circuit has found that FCA liability “can attach if the claimant violates its continuing duty to comply with the regulations on which payment is conditioned.” Willard, 336 F.3d at 382 (quoting United States ex rel. Augustine v. Century Health Servs., Inc., 289 F.3d 409, 415 (6th Cir.2002)). The Fifth Circuit has never adopted implied certification as a theory of FCA liability. United States ex rel. Marcy v. Rowan Cos., Inc., 520 F.3d 384, 389 (5th Cir.2008) (citing Willard, 336 F.3d at 381-82); United States v. Southland Mgmt. Corp., 326 F.3d 669, 679 (5th Cir.2003) (en banc) (Jones, J. concurring). Instead, the Fifth Circuit has held that “[t]he violation of the statute or regulation does not create a cause of action under the False Claims Act; liability arises only if the defendant has made a false certification of compliance with the statute or regulation, when payment is conditioned on that certification.” Graves, 284 F.Supp.2d at 497. 2. Materiality Liability under both the pre- and post-FERA versions of the FCA requires that an actionable false statement be “material.” Longhi, 575 F.3d at 467 (citing Thompson, 125 F.3d at 899); see also Allison Engine Co., Inc. v. United States ex rel. Sanders, 553 U.S. 662, 128 S.Ct. 2123, 2126, 170 L.Ed.2d 1030 (2008) (explaining that a § 3729(a)(2) “plaintiff must prove that the defendant intended that the false statement be material to the Government’s decision to pay or approve the false claim”). The Fifth Circuit applies the “natural tendency” test to determine materiality. Longhi, 575 F.3d at 470. This test asks whether “the false or fraudulent statements either (1) make the government prone to a particular impression, thereby producing some sort of effect, or (2) have the ability to effect the government’s actions, even if this is a result of indirect or intangible actions on the part of the Defendants.” Id. “All that is required under the test for materiality, therefore, is that the false or fraudulent statements have the potential to influence the government’s decisions.” Id. 3. Knowingly An FCA claim must allege that the false statements were “knowingly” made or caused to be made. The FCA defines “knowing or knowingly” to mean “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)(l-3). Because an FCA claim alleges a fraudulent or false statement knowingly made or caused to be made, Longhi, 575 F.3d at 468, “[c]laims brought under the FCA must comply with Rule 9(b).” Thompson, 125 F.3d at 903 (5th Cir.1997); see also Hopper v. Solvay Pharms., 588 F.3d 1318, 1325 (11th Cir.2009). However, “[i]n contrast to common law fraud, the FCA “lacks the element of reliance and damages.” Grubbs, 565 F.3d at 189. “It is adequate to allege that a false claim was knowingly presented regardless of its exact amount; the contents of the bill are less significant because a complaint need not allege that the Government relied on or was damaged by the false claim.” Id. “To plead with particularity the circumstances constituting fraud for a FCA section [3729(a)(1)(A) ] claim, a relator’s complaint, if it cannot allege the details of an actually submitted false claim, may nevertheless survive by alleging particular details of a scheme to submit false claims paired with reliable indicia that lead to a strong inference that claims were actually submitted.” Id. at 190. To plead with the requisite particularity a § 3729(a)(1)(B) claim, the complaint need not “allege details of fraudulent bills actually presented to the government.” Id. at 192. The relators must, however, allege facts linking a scheme to submit false claims to the submission of false claims. Solvay Pharms., 588 F.3d at 1325. 4. The Application of the Pleading Standards to FCA Claims Although the parties’ discussion of Rule 12(b)(6) cites Twombly and Iqbal as the most recent statements by the Supreme Court under the rule, the arguments do not turn on a claim that the analysis and result in this case are different under those decisions than they would have been earlier. The parties’ briefs do not argue whether the facts alleged are sufficient to make the claim of an FCA violation “plausible.” Rather, Medtronic argues that taking the facts alleged as true, as a matter of law, the FCA does not provide a basis for relief for the promotional activities and remuneration alleged. (Docket Entry No. 30, at 14, 22). The relators do argue for a relaxed application of Rule 9(b). The cases are clear that Rule 9(b) applies in FCA cases. Longh% 575 F.3d at 468, Thompson, 125 F.3d at 903; Hopper, 588 F.3d at 1325. The cases also recognize two exceptions that the relators urge. “It is possible that the pleading reqxiirements of Rule 9(b) may be relaxed in certain circumstances — when, for instance, the facts relating to the fraud are ‘peculiarly within the perpetrator’s knowledge.’ ” United States ex rel. Doe v. Dow Chem. Co., 343 F.3d 325, 330 (5th Cir.2003) (quoting United States ex rel. Russell v. Epic Healthcare Mgmt. Grp., 193 F.3d 304, 308 (5th Cir.1999)). “Fraud may be pleaded on information and belief under such circumstances.” United States ex rel. Willard v. Humana Health Plan of Texas Inc., 336 F.3d 375, 385 (5th Cir.2003). But the Fifth Circuit has held that a plaintiff should not be relieved from complying with the Rule 9(b) requirements “where the documents containing the requisite information are in the possession of, and presumably available from, other sources.” United States ex rel. Rafizadeh v. Cont’l Common, Inc., 553 F.3d 869, 873 n. 6 (5th Cir.2008) (citing Doe, 343 F.3d at 330); see also Polansky, 2009 WL 1456582, at *8 (“The rationale for reducing the pleading burden when information is in the defendant’s possession appears to spring from the fact that an adverse party would not willingly divulge incriminating information. Where the information needed to fill out the complaint is in the hands of third parties, rather than defendants, this rationale for reducing the pleading burden does not apply.”). The Eleventh Circuit has held that the pleading standard should not be relaxed for qui tam plaintiffs who may only have access to information through discovery in suits where the government refuses to intervene, even though the government would have access to those documents without discovery. Atkins, 470 F.3d at 1360 & n. 17. The court reasoned, The qui tam relator bring the action on behalf of the federal government. The relator stands in the government’s shoes — in neither a better nor worse position than the government stands when it brings suit. Accordingly, we cannot furnish a qui tam relator with an easier burden than the government would bear if it intervened and assumed the prosecution of the case. Permitting a qui tam relator to go forward with his complaint, when we would not allow the government to proceed, might encourage the government to evade its burden by merely recruiting a willing relator to file a qui tam action. United States ex rel. Atkins v. McInteer, 470 F.3d 1350, 1360 (11th Cir.2006). The relators argue that this court should relax the pleading standard because they do not have access to certain information. In the Fifth Circuit, the pleading standard is not relaxed when such information is available from third party entities and individuals. Rafizadeh, 553 F.3d at 873 n. 6. Medtronic notes that it does not have billing or reimbursement information; doctors, hospitals, and government agencies do. There is no basis to relax the Rule 9(b) pleading standard in this case under the applicable precedents. See Polansky, 2009 WL 1456582, at *8 (refusing to relax the pleading the standard in off-label qui tam against drug manufacturer because the needed information available was in the hands of third parties). Even under a relaxed pleading standard, the relators must still state a factual basis for their beliefs. See United States ex rel. King v. Alcon Labs., Inc., 232 F.R.D. 568, 572 (N.D.Tex.2005) (finding that even under a relaxed pleading standard, the relators failed to plead fraud with particularity because the relator did not identify a single person involved in the alleged fraud, did not did not identify specific fraudulent claims, and did not identify a single date on which fraudulent activity occurred); United States e