Full opinion text
OPINION WOLFSON, District Judge. This qui tam action, a member case of the Multi-District Litigation, In re: Pla-vix Marketing, Sales Practices and Products. Liability Litigation, involves the alleged wrongful marketing and sales of Plavix (clopidogrel bisulfate), a prescription blood thinner manufactured by Defendant Bristol-Myers Squibb Company (“BMS”) and marketed in the United States by BMS and Defendants Sanofi-Aventis U.S. LLC, Sanofí U.S. Service Inc., and Sanofí-Synthelabo Inc. (collectively “Sanofi”) (collectively “Defendants”). Relator Elisa Dickson (“Relator”) brought this ease on behalf of the United States and various states, asserting claims under the following statutes: (Count 1) the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733; (Count 2) Conspiracy under the FCA, 31 U.S.C. § 3729(a), as well as 26 separate state law claims. Defendants move to dismiss the Third Amended Complaint (“TAC”) on the basis that Relator’s allegations — namely, that Defendants engaged in false marketing causing physicians to submit claims to Medicaid and Medicare Part D that were not “medically necessary” or “reasonable and necessary”-^are insufficient to state a claim undér the 'FCA and thé state statutes. As a' threshold issue, however, Defendants maintain that Relator’s state and federal claims are barred by the applicable statute of limitations, and by the doctrine of public disclosure set forth in the FCA. For the reasons expressed herein, Relator’s Motion to Dismiss is GRANTED in part and DENIED in part. Specifically, the following categories of Relator’s claims are dismissed: (1) federal FCA claims based on Medicare Part D; (2) federal FCA claims based on the Medicaid plans of thirty-three states, including the District of Columbia; and (3) claims based on state formularies. The only surviving federal claims are Relator’s FCA claims related to the Medicaid plans of the following states: Connecticut, Delaware, Idaho, Kansas, Maryland, Massachusetts, Mississippi, Montana, Nebraska, North Carolina, Ohio, Oklahoma, Rhode Island, South Dakota, Utah, Washington and Wyoming. Additionally, all claims arising under state law are dismissed, except .for the following states: Delaware, Montana, Massachusetts, Rhode Island, Oklahoma, North Carolina, and Connecticut. Moreover, Relator has also filed a Motion for Reconsideration of this Court’s previous denial of her Motion for Suggestion of Remand. For the reasons stated herein, this motion is DENIED. BACKGROUND 1. Factual Background The relevant facts alleged in the Third Amended Complaint, which I must take as true for the purpose of this Motion, are as follows. Plavix, clopidogrel bisulfate, is a FDA-approved prescription blood thinner, which is marketed for the treatment of Acute Coronary Syndrome, and used by patients following the occurrence of myocardial, infarction, stroke or established peripheral artery disease. See TAC at ¶ 1. While under patent, Plavix was BMS’s top-selling product, with sales accounting for 30% of its gross revenue ($1.67 biliion). Id. BMS and Sanofi market Plavix jointly. Id. at ¶ 2. Plavix costs approximately four dollars per pill. Id. at ¶ 3. Since 1998, the FDA has sent three letters to Sanofi involving the allegedly misleading promotion of Pla-vix. Id. at ¶¶ 4-14. Relator' worked in the pharmaceutical industry for twelve years, and was employed by Sanofi as a sales representative specializing in selling Plavix. Id. at ¶ 16. Relator alleges that she was instructed by Sanofi to promote Plavix as having certain characteristics that Sanofi knew were not true. Id. at ¶ 19. For example, while trial data found non-significant efficacy in stroke victims, Relator was instructed to promote Plavix as superior to aspirin in stroke patients. Id. at ¶ 20. Relator also promoted Plavix as comparably safe to aspirin, based on a study which compared Plavix to a more toxic dose of aspirin not normally prescribed today. Id. Relator further alleges that she was instructed to focus sales calls on physicians who wrote significant numbers of prescriptions submitted to government payors. Id. at ¶ 22. In that regard, according to Relator, Defendants engaged in a comprehensive scheme to defraud federal and state governments by illegally and deceptively promoting Plavix. Id. at ¶ 23. Relator claims that Plavix is no more effective than aspirin, while being many times more expensive. Id. at ¶24. Thus, Relator alleges, Defendants’ actions caused states to include Plavix on their Medicaid formularies for indications for which Plavix was not medically necessary. Id. Plaintiff further asserts that Medicare Part D requires prescriptions to be' “reasonable and necessary” to be reimbursable, and that Medicaid requires prescriptions be “medically necessary” to be reimbursable. Id. at ¶26. According to Relator, Defendants’ false marketing prevented physicians from making an informed decision as to Plavix’s reasonable or medical necessity, and therefore caused physicians to submit numerous false claims for reimbursement to Medicaid and Medicare Part D. Id. at ¶¶ 27-28. II. Procedural History Relator filed the original complaint in the United States District Court for the Southern District of Illinois on March 30, 2011. First and Second Amended Complaints were filed in that court in 2011 and 2012, respectively. Defendants moved to dismiss the Second Amended Complaint in December 2012. On January 30, 2013, the Hon. David R. Herndon, U.S.D.J., denied the Motion in part, and granted it in part, dismissing only a claim on which Relator had requested a voluntary dismissal. On February 14, 2013, the case was transferred to this Court by the Judicial Panel on Multidistrict Litigation. Defendants then filed a Motion for Reconsideration before this Court on the denial of their Motion to Dismiss, on the basis that Judge Herndon’s January 30 Order incorrectly assumed that a “reasonable and necessary” standard applied to Medicaid and Medicare Part D. Following a hearing on August 22, '2013, this Court granted the Motion for Reconsideration, vacated the prior denial of the Order to Dismiss with respect to the FCA claims under Medicaid and Medicare Part D, and granted the Motion to Dismiss with respect to the FCA claims under those programs. The Court granted Relator leave to amend her Complaint. Relator filed the TAC on September 20, 2013; this Motion to Dismiss followed. DISCUSSION I. Standard of Review A. Rule 12(b)(6) When considering amotion to dismiss a complaint for failure to state a claim upon which relief can be granted, pursuant to Fed.R.Civ.P. 12(b)(6), a court must accept all well-pleaded allegations in the complaint as true and view them in the light most favorable to the plaintiff. Evancho v. Fisher, 423 F.3d 347, 351 (3d Cir.2005). It is well settled that a pleading is sufficient if it contains “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). However, “[a]lthough the Federal Rules of Civil Procedure do not require a claimant to set forth an intricately detailed description of the asserted basis for relief, they do require that the pleadings give defendant fair notice of what the plaintiffs claim is and the grounds upon which" it rests.” Baldwin Cnty. Welcome Ctr. v. Brown, 466 U.S. 147, 149-50 n. 3, 104 S.Ct. 1723, 80 L.Ed.2d 196 (1984) (quotation and citation omitted). A district court, in weighing a motion to dismiss, asks “‘not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claim.”’ Bell Atlantic v. Twombly, 550 U.S. 544, 583, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974)); see also Ashcroft v. Iqbal, 556 U.S. 662, 684, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (“Our decision in Twombly expounded the pleading standard for all civil actions.”) (internal citations omitted); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.2009) (“Iqbal ... provides the final nail-in-the-coffin for the ‘no set of facts’ standard that applied to federal complaints before Twombly.”). Following the Twombly/Iqbal standard, the Third Circuit applies a two-part analysis in reviewing a complaint under Rule 12(b)(6). First, a district court must accept all of the complaint’s well-pleaded facts as true, but may disregard any legal conclusions. Fowler, 578 F.3d at 210. Second, a district court must determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a “plausible claim for relief.” Id. A complaint must do more than allege the plaintiffs entitlement to relief. Id. However, this standard “ ‘does not impose a probability requirement at the pleading stage,’ but instead ‘simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element.’” Phillips v. Cnty. of Allegheny, 515 F.3d 224, 234 (3d Cir.2008) (quoting Twombly, 127 S.Ct. at 1965); see also Covington v. Int'l Ass’n of Approved Basketball Officials, 710 F.3d 114, 118 (3d Cir.2013) (“[A] claimant does not have to set out in detail the facts upon which he bases his claim.... The pleading standard is not akin to a probability requirement, ... to survive a motion to dismiss, a complaint merely has to state a plausible claim for relief.” (citations omitted)). Nonetheless, a court need not credit either “bald assertions” or “legal conclusions” in a complaint when deciding a motion to dismiss. In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1429-30 (3d Cir.1997). The defendant bears the burden of showing that no claim has been presented. Hedges v. U.S., 404 F.3d 744, 750 (3d Cir.2005) (citing Kehr Packages, Inc. v. Fidelcor, Inc., 926 F.2d 1406, 1409 (3d Cir.1991)). Finally, a court in reviewing a Rule 12(b)(6) motion must only consider the facts alleged in the pleadings, the documents attached thereto as exhibits, and matters of judicial notice. Southern Cross Overseas Agencies, Inc. v. Kwong Shipping Grp. Ltd., 181 F.3d 410, 426 (3d Cir.1999). B. Rule 12(b)(1) A defendant may move to dismiss a claim for lack of subject matter jurisdiction under Fed.R.Civ.P. 12(b)(1). There is no presumption of truthfulness that attaches to the allegations of the complaint when determining a challenge to the court’s subject matter júrisdiction. Mortensen v. First Federal Sav. & Loan Ass’n, 549 F.2d 884, 891 (3d Cir.1977). Once a 12(b)(1) challenge is raised, the plaintiff bears the burden of demonstrating the existence of subject matter jurisdiction. See McCann v. Newman Irrevocable Trust, 458 F.3d 281, 286 (3d Cir.2006). A Rule 12(b)(1) motion to dismiss is treated as either a “facial or factual challenge to the court’s subject matter jurisdiction.” Gould Electronics, Inc. v. United States, 220 F.3d 169, 176 (3d Cir.2000). Under a facial attack, the movant challenges the legal sufficiency of the claim, and the court considers only “the allegations of the complaint and documents referenced therein and attached thereto in the light most favorable to the plaintiff.” Id. Under a factual attack, however, “the challenge is to the actual alleged jurisdictional facts.” Id. “Because at issue in a factual 12(b)(1) motion is the trial court’s jurisdiction — its very power to hear the case — there is substantial authority that the trial court is free to weigh the evidence and satisfy itself as to the existence of its power to hear the case.” Mortensen, 549 F.2d at 891. II. Public Disclosure Bar At the outset, I note that Defendants’ motion to dismiss for lack of subject matter jurisdiction is based on the public disclosure bar of the FCA, 31 U.S.C. § 3730(e)(4). This is an attack on the “actual alleged jurisdictional facts,” and therefore, the Court is permitted to weigh the evidence presented. The FCA bars qui tdm actions where the allegations have previously been publically disclosed: However, the public disclosure bar was amended in 2010 by the Patient Protection and Affordable Care' Act, Pub.L. No. 111—148, 124 Stat. 119 (2010). The original statute contained a jurisdictional limitation, stating “No court shall have jurisdiction over an action under this section based upon the public disclosure of allegations or transactions.... ” 31 U.S.C. § 3730(e)(4). The amended statute, however, merely mandates dismissal: “The court shall dismiss an action or claim under this section, unless opposed by the Government, if substantially the same allegations or transactions as alleged in the action or claim were publicly disclosed....” 31 U.S.C. § 3730(e)(4)(A). Additionally, changes were made to the sections defining the sources that constitute a public disclosure, see id. at § 3739(e)(4)(A)(i)-(iii), and to the definition of “original source.” Id. at § 3739(e)(4)(B). Both parties primarily analyze their respective arguments under the pre-2010 statute, though Defendant asserts that “the result is the same under the post-2010 FCA because Relator has failed to allege sufficient facts to demonstrate that she had knowledge independent of the publicly disclosed allegations.” Def. Br. at 22. On the other hand,. Relator briefly discusses “claims governed by the post-PPACA statute,” Rel. Opp. at 31 n. 82. To the extent that the TAC alleges conduct which resulted in false claims being made prior to the 2010 amendments, I agree that the pre-2010 statute should apply- The Supreme Court has declined to apply the amended statute in cases filed pri- or to the Amendment because “[t]he legislation makes no mention of retroactivity, which would be necessary for its application to pending eases .given that it eliminates petitioners’ claimed defense to a qui tarn suit.” Graham Cnty. Soil and Water Conservation Dist. v. United States ex rel. Wilson, 559 U.S. 280, 283 n. 1, 130 S.Ct. 1396, 176 L.Ed.2d 225 (2010). While Relator’s case here was filed after the 2010 amendment, the question of a statute’s retroactive effect looks to the date of the underlying conduct, not the date a complaint was filed. United States ex rel. May v. Purdue Pharma L.P., 737 F.3d 908, 916 (4th Cir.2013) (citing Landgraf v. USI Film Prods., 511 U.S. 244, 265, 114 S.Ct. 1483, 128 L.Ed.2d 229 (1994) (“[T]he legal effect of conduct should ordinarily be assessed under the law that existed when the conduct took place.... ”)). For that reason, the Fourth Circuit declined to apply the 2010 amendment to a case where the underlying conduct took place prior to the amendments. Id. Similarly, with regard to false claims which occurred prior to 2010, I find that the pre-amendment statute applies. However, I note that the allegations in the TAC appear to also include conduct by Defendants which occurred after the 2010 amendment to the FCA. See Compl. ¶¶ 118-19 (discussing studies published in 2010). I therefore also must discuss the application of the post-2010 statute. According to Defendants, the allegations in Relator’s complaints are supported by, or substantially similar to, allegations which were previously disclosed by the news media, federal government reports, or previously filed lawsuits. Defendants further contend that Relator' is not an original source of the information, because she has not pleaded how and when she obtained direct and independent. knowledge of the alleged fraud. In response, Relator maintains that she is an original source of the information, because she was a sales representative who participated in Defendants’ alleged scheme to defraud the government. Rel. Opp. at 29. Relator additionally argues that there was no public disclosure because the “critical element” of fraud was not disclosed in the publicly disclosed sources. Id. at 30. ’ Finally, Relator contends that the allegations in the TAC are not “based bn” or “substantially similar” to the prior disclosures because her “eyewitness accounts provide far more than the general notion of misconduct that can be gleaned from public sources.” Id. at 34-35. A. Pre-2010 Claims The pre-2010 statute provided that [n]o court shall have jurisdiction over an action under this section based upon the public disclosure of allegations or transactions in a criminal,, civil, or administrative hearing, in a congressional, administrative, or Government Accounting Office report, hearing, audit, or investigation, or from the news media, unless the action is brought by the Attorney General or the person bringing the. action is an original source of-the information. 31 U.S.C. § 3730(e)(4). The statute further defined “original source” as “ah individual who has direct and independent knowledge of the information on which the allegations are based and has voluntarily provided the information to the Government before filing an action under this section which is .based on the information.” Id. According to the Third Circuit, the public disclosure bar requires a court to determine whether a disclosure “issue[d] from a source or occur[ed] in a context specifically recognized by the Act” and is “sufficient to support the conclusion that the information contained therein is now public within the meaning of the Act.” United States ex rel. Paranich v. Sorgnard, 396 F.3d 326, 332-33 (3d Cir.2005). A disclosure is “sufficiently public” if the information therein “would have been equally available to strangers to the fraud transaction had they chosen to look for it as it was to the relator.” Id. (internal quotation marks and citation omitted). In addition, the Third Circuit has held that “a complaint in a civil action falls into the context of ‘criminal, civil, or administrative healings’ and is sufficiently public within the meaning of the Act to constitute a public disclosure.” Id. at 334. Defendants argue that the following public disclosures bar Relator’s claims: the Second Amended Complaint filed in Hall v. Bristol-Myers Squibb Co., Civ. No. 06-5203, 2009 WL 3071052 (D.N.J. May 1, 2009), Watson Cert., Ex. B; a newspaper article published in the Madison-St. Clair Record on November 4, 2010, id. at Ex. C; a report by the American Association for Justice, published online March 1, 2007, id. at Ex. E; a newspaper article published in the St. Petersburg Times and Associated Press on January 20, 2005, id. at Ex. F; and an article published in Internal Medicine News on March 1, 2005, id. at Ex. G. As to the first inquiry — whether a document constitutes a public disclosure — I find that the Hall Complaint is a public disclosure as defined by the Third Circuit in Paranich. Similarly, the remaining documents clearly fall within the “news media” category of the statute, and the information contained therein was available to strangers to the fraud. The next question is whether the TAC is “based on” these disclosures; “based on” is defined as “supported by” or “substantially similar to.” United States ex rel. Atkinson v. PA. Shipbuilding Co., 473 F.3d 506, 519 (3d Cir.2007). The Third Circuit has followed the D.C. Circuit in using “an algebraic representation of the nature and extent of disclosure required to raise the jurisdictional bar.” Id. That is “[I]f X + Y = Z, Z represents the allegation of fraud and X and Y represent its essential elements”; then, in order to “draw an inference of fraud, both a misrepresented [X] and a true [Y] state of facts must be publicly disclosed.” Id. Thus, “if either Z (fraud) or both X (misrepresented facts) and Y (true facts) are disclosed by way of a listed source, then a relator is barred from bringing suit under § 3730(e)(4)(A) unless [s]he is an original source.” Id. The public sources, including the Hall Complaint, cited above, discuss the findings of a study known as “CAPRIE,” which compared Plavix to aspirin, and the “Chan study,” which compared the effects of Plavix and aspirin on patients who previously had stomach ulcers, as well as FDA letters sent to Defendants; all the facts from the sources are presented in the TAC. See Watson Cert, Ex. D (comparing Hall Complaint, TAC, and media reports). Essentially, these sources indicate that Plavix is no more effective or safer than aspirin. Id. To use the algebraic formula presented by the Third Circuit, the misrepresented facts (X) are Defendants’ representations that Plavix is more effective and safer than aspirin; the true facts (Y) are that Plavix is neither more effective nor safer than aspirin. Both sets of facts are alleged in the public disclosures provided by Defendants. Thus, I find .that the TAC is substantially similar to, and therefore based on, these public disclosures. Although Relator’s complaint is substantially similar to the information in the public disclosures, Relator argues that she is an original source of the information. “To be an original source, a relator’s knowledge must be both direct and independent.” Atkinson, 473 F.3d at 520, “Independent knowledge” is defined as “knowledge that does not depend on public disclosures,” while “direct knowledge” is defined as “knowledge obtained without any intervening agency, instrumentality or influence: immediate.” Id. (internal quotation marks-and citation omitted). A party has direct knowledge of a fraudulent scheme when the party was involved in the scheme. Paranich, 396 F.3d at 336. However, “[i]f the relator’s knowledge of the- element is based solely on a § 3730(e)(4)(A) public disclosure, the relator is not an original source.” Id. Moreover, “[t]o establish original source status knowledge, a qui tarn plaintiff must allege specific facts — as opposed to mere conclusions — showing exactly how and when he or she obtained direct and independent knowledge of the fraudulent acts alleged in the complaint.” Id. Here, Relator alleges that she had direct and independent knowledge of Defendants’ alleged fraud because she was involved in it. Specifically, the TAC states that Relator worked as- a sales representative at Sanofi beginning in 2003. TAC at ¶ 16. - Relator alleges that she was trained and instructed “to confuse physicians and to focus sales calls-on physicians and preservers whose patients relied on Medicaid and Medicare.” Id. at ¶ 110. Relator specifically alleges that she. received the CA-PRIE Road Map for training purposes, “which revealed Plavix’s non-significant efficacy data, and yet was instructed by BMS/Sanofi to promote Plavix in direct contradiction to its results.” Id. at ¶ 111. She also states that she was “instructed to present the data from yet another study [the PRoFESS Study, TAC, Ex. E] in a manner designed to confuse physicians and make them believe that [another drug] was inferior to Plavix.” Id. at ¶ 21. Based on these allegations, Relator has sufficiently alleged that she is an independent source of the information revealed in the public disclosures. . Indeed, Relator had direct knowledge of Defendants’ alleged fraudulent scheme because she was involved in it. Moreover, Relator was given the CAPRIE study independently of the public disclosures — in fact,.she claims to have been given the study by Defendants themselves, as part of her training. While Defendants argue that Relator “does not claim direct or independent knowledge of any false statements made to any particular physician,” Def. Repl. at 8, this does not undermine Relator’s status as an original source. See Atkinson, 473 F.3d at 520. Thus, while the TAC is “based on” public disclosure of allegations within the meaning of the pre-2010 version of 31 U.S.C. § 3730(e)(4)(A), I find that Relator is an original, source of the information. As such, the public disclosure bar does not apply to prohibit allegations of Defendant’s conduct prior to 2010, and therefore the 12(b)(1) motion is denied on that basis. B. Post-2010 Conduct Because the TAC also alleges that Defendants’ allegedly fraudulent conduct continued after 2010, I also determine whether Relator’s claims based on that conduct must be dismissed under the updated public disclosure bar. The post-2010 statute states that: The court shall dismiss an action or claim under this section, unless opposed by the Government, if substantially the same allegations or transactions as alleged in the action or claim were' publicly disclosed— (i) in a Federal criminal, civil, or administrative hearing in which the Government or its agent is a party; (ii) in a congressional, Government Accountability Office, or other Federal report, hearing, audit, or investigation; or (iii) from the news media, unless the action is brought by the Attorney General or the person bringing the action is ail original source of the information; 31 U.S.C. § 3730(e)(4)(A). An individual may be an “original source” in two ways: first, if the individual “prior to a public disclosure under subsection (e)(4)(A), has voluntarily disclosed to the Government the information on which allegations hr transactions in a claim are based” or, second, if the individual “has knowledge that is independent of and materially adds to the publicly disclosed allegations or transactions, and ... has voluntarily provided the information to the Government before filing an action under this section.” Id. at § 3730(e)(4)(B). The first question, again,-is whether the sources cited by Defendants are “public disclosures.” Under the current definition of public disclosure, all of the news articles cited by Defendants remain public disclosures, as .they are “from the news media.” The Hall complaint, however, is not a public disclosure as that term is currently defined, because the Government was not a party to that action. The second question, under the amended statute, is whether those public disclosures contain “substantially the same allegations or transactions as alleged in the action or claim.” Again, as discussed above, both the public disclosures and the TAC describe, the findings of the CAPRIE and Chan studies. These claims are “substantially the same.” The TAC additionally alleges that Defendants instructed Relator to present data from the “PRoFESS” study (TAC, Ex. E) in such a way as to make physicians believe that another drug, Aggrenox, was inferior to Plavix. TAC at ¶,21. However, the statute does not require that the allegations be identical. See United States ex rel. Osheroff v. Humana Inc., 776 F.3d 805, 814 (11th Cir.2015) (stating that “the significant overlap between [the relator’s] allegations and the public disclosures is sufficient to show that the disclosed information ... is substantially similar to the allegations in the complaint,”). I therefore find that the addition of the PRoFESS study does not alter the conclusion that Relator’s allegations are “substantially the same” as those made in the prior disclosures. The final question, then, is whethér Relator is an “original source.” Relator does not allege that she informed the government of the information contained in the TAC prior to the public disclosures. Thus, only the second ground applies and, correspondingly, Relator must show that her knowledge “is independent of and materially adds to the publicly disclosed allegations or transactions.” I have already found that Relator’s knowledge was independent of the public disclosures. I must therefore determine whether Relator’s information “materially adds” to the information in the public disclosures. There is scant case law on the definition of the phrase “materially adds” in the amended FCA statute. The Eleventh Circuit has found- that a relator as not an original source where the..information in the public disclosures was “sufficient to give rise .to an inference” of illegality without the Relator’s additional facts. Osheroff, 776 F.3d at 815. Similarly, the Eighth Circuit has held that where the “key facts” to an FCA claim have already been “thoroughly revealed,” the relator’s knowledge, “even if gained early and independently,” does not “materially contribute[ ] anything of import to the public knowledge about the alleged fraud.” United States ex rel. Paulos v. Stryker. Corp., 762 F.3d 688, 694 (8th Cir.2014). The Eastern District of Virginia applied the public disclosure bar where “all essential elements of the ... scheme were disclosed,” and “relators’ knowledge appears to add only illustrative examples of the specific behavior that the [prior disclosure] describes with specificity.” United States ex rel. Beauchamp v. Academi Training Ctr., Inc., 933 F.Supp.2d 825, 843 (E.D.Va.2013). In contrast, the District of Massachusetts found that a relator qualified as an original source when prior disclosures had focused on “the fraud committed on patients and doctors,” and the relator’s suit “provided information on the alleged fraud on the government for the first time.” United States ex rel. Hagerty v. Cyberonics, Inc., 95 F.Supp.3d 240, 261-62 (D.Mass.2015). Here, Relator asserts that she “is the first person to inform the government that Defendants affirmatively defrauded the government, knew the truth about Plavix, [and] disregarded that truth.” .Rel. Opp... at 33. Indeed, Relator’s Complaint, unlike the news articles, alleges that Defendants were aware that the claims their salesforce were making about Plavix were false. See TAC at ¶21. Moreover, the TAC states that defendants explicitly instructed their sales force to “focus sales calls on physicians who wrote significant numbers of prescriptions for patients covered by certain Government Payors.” Id. at ¶ 22., Indeed,.based on Relator’s allegations, Relator has “provided information [regarding] the alleged,fraud on,the government for the first time.” Hagerty, 95 F.Supp.3d at 261-62. These allegations, which tend to show that. Defendants had knowledge that their claims were false and were intended to have physicians make false claims to .the government involving Plavix prescriptions, provide “essential elements .of the fraudulent scheme” which were missing from the prior disclosures. See id. Taken together, these facts materially add to the previously disclosed information. In addition, Relator sufficiently alleges in the Complaint that, she voluntarily provided the information contained in the TAC- to the Government prior to filing the action, as required by 31 U.S.C. §§ 3730(b) and (e). See TAC at ¶108. Accordingly, Relator also qualifies as an original source under the post-2010 statute. Having determined that Relator is an original source under both the pre- and post-2010 statutes, I find that the public disclosure bar does not apply in this case. III. The False Claims Act Defendants advance several arguments in support of their dismissal motion regarding. Relator’s claims under the FCA: first, Defendants argue that, on their face, Relator’s allegations that Defendants’ marketing caused physicians to make false certifications about Plavix’s efficacy or necessity for treatment is insufficient to state a claim; second, Defendants argue that Medicaid .. and Medicare Part D cannot deny reimbursement of a covered prescription because FDA approval of a particular drug is sufficient to render a drug “reasonable and necessary” under these government programs when such a drug is prescribed for its on-label use; and finally, Defendants assert that Relator’s allegations regarding the state formularies are insufficient to state a claim under the FCA. After discussing the law applicable to the False Claims Act, I will address each argument in turn. A. Applicable Law ■The FCA imposes civil liability on any person who “(A) knowingly presents, dr causes to be presented, a false or fraudulent claim ■ for payment or approval” or “(B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.” 31 U.S.C. § 3729(a)(1). This Act was amended in 2009; prior to the amendment, the statute imposed liability on any person who “(1) knowingly presents, or causes to be presented, to an officer or employee of the United States Government'or a member of the Armed Forces of the United States a false or fraudulent claim for' payment or approval” or “(2) 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 2009). “A plaintiff, in order to establish a prima facie FCA violation under section 3729(a)(1), must prove that “(1) the defendant presented or caused to be presented to an agent of the United States a claim for payment; (2) the claim was false or fraudulent; and (3) the defendant knew the claim was false or fraudulent.” United States ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 304-05 (3d Cir. 2011). A false claim under the FCA may be either “factually false” — “when the claimant misrepresents what goods or services that it provided to the Government” — or “legally false” — “when the claimant knowingly falsely certifies that it has complied with a statute or regulation’ the compliance with which is a condition for Government payment.” Id. at 305. Additionally, within the false certification context, there are two categories, express and implied. Id. An entity makes an express false certification when it “falsely certifies] that it is in compliance with regulations which are prerequisites to Government payment in connection with the claim for payment of federal funds,” while an entity makes an implied false certification when it “seeks and makes a claim for payment from the Government without disclosing that it violated regulations that affected its eligibility for payment.” Id. I note that the TAC asserts only legally false claims, as the claimants provided the goods or services for which the claims were made, and the TAC relies on an implied false certification theory. In that regard, The Third Circuit has stated that the implied false certification theory of liability “should not be applied expansively, particularly when advanced on the basis of FCA allegations arising from the Government’s payment of claims under federally funded health care programs.” Id. at 307. Furthermore, in order to make a claim for an implied false certification, “it is necessary to állege not only a receipt of federal funds and a failure to comply with applicable regulations, but also that payment of the federal funds was in some way conditioned on compliance with those regulations.” Id. (citing Rodriguez v. Our Lady of Lourdes Med. Ctr., 552 F.3d 297, 304 (3d Cir.2008)). That is, “a plaintiff must [allege] that if the Government had been aware of the defendant’s violations of the Medicare laws and regulations that are the bases of a plaintiffs FCA claims, it would not have paid the defendant’s claims.” Id. B. Facial Viability of the FCA Claims I first address the parties’ arguments based on the holding in United States ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295 (3d Cir.2011). Defendants assert that the allegations in the TAC are insufficient on their face to state a claim for a violation of the FCA. According to Defendants, Medicaid and Medicare Part D are required to reimburse for Plavix prescriptions which are prescribed for indications approved by the FDA, regardless of marketing or the doctor’s reasons for the prescription; indeed, Relator concedes that the Plavix prescriptions here were for indications approved by the FDA. Therefore, because the submitted claims were for prescriptions for indications which were FDA-approved, Defendants argue, there can be no FCA liability. On the other hand, Relator "argues that the marketing techniques did not themselves constitute false claims, but that the marketing caused claims to be submitted for payment which did not comply with the federal and state conditions for payment. Both parties rely on the Third Circuit’s decision in Wilkins. In that case, a relator filed a qui tam action alleging that the defendants, organizations which provided services under Medicare, violated the FCA by offering physicians illegal kickbacks and that the defendants there violated Medicare marketing rules. Wilkins, 659 F.3d at 300. The circuit court held that the allegations that the defendants “violated the [marketing] regulations do not state a plausible claim for relief under the FCA inasmuch as the Government’s payments of appellees’ Medicare claims were not conditioned on their compliance with the' marketing regulations.” Id. at 308. In that regard, the court “distinguished between regulations which are conditions of participation in the Medicare programs and conditions of Government payment of Medicare funds.” Id. at 309. “‘Conditions of participation ... are enforced through administrative mechanisms, and the ultimate sanction for violation of such conditions is removal from the government program,’ while ‘[cjonditions of payment are those which, if the government knew they were not being followed, might cause it to actually refuse payment.’ ” Id. (quoting United States ex rel. Conner v. Salina Reg’l Health Ctr., Inc., 543 F.3d 1211, 1220 (10th Cir.2008)). The court reasoned that “the fundamental flaw in appellants’ allegations is that the amended complaint does not cite to any regulation demonstrating that a participant’s compliance with Medicare marketing regulations is a condition for its receipt of payment from the Government.” Id. at 309-10. Here, in contrast, Relátor has alleged that Defendants caused physicians to make implied false certifications about the medical necessity of Plavix. According to the Complaint, prescription drugs must be “reasonable and necessary” to be covered by Medicare Part D, see TAC at ¶¶ 44-45, and all fifty states have established limits on Medicaid requiring services to be medically necessary. See id. at ¶¶ 52-102. As alleged, the limits on Medicare and Medicaid regarding medical necessity are necessarily conditions of payment, not conditions of participation. Wilkins, 659 F.3d at 309. Thus, contrary to Defendant’s contention, Plaintiffs allegations, on their face, are different from those asserted in Wilkins. C. “Reasonable and Necessary” or “Medically Necessary” Conditions for Payment 1. Medicare Part D The thrust of Relator’s position with respect to her FCA claims under Medicare Part D is that Defendants’ fraudulent marketing of Plavix caused physicians to make false certifications when requesting reimbursements in connection with prescribing Plavix for its on-label use. Specifically,’ Relator argues that Defendants represented to physicians that Plavix was the “only option for effective patient care in a host of contexts.” However, Relator alleges that there were other drugs, such as Aspirin, as effective — if not more effective — than' Pla-vix at a far lower cost. Thus, prescribing Plavix for its on-label- use, Relator reasons, was not “reasonable. and necessary” or “medically necessary.” To illustrate, Relator, names four Medicare Part D plans which require that a drug be “medically necessary,” which is defined as “reasonable and necessary for treatment” in order to.be covered. TAC at ¶ 45. .On other hand, Defendants argue that under Part D, prescription drug plans are permitted to exclude from coverage drugs which are not. “reasonable and necessary,” but argue that Relator has not alleged that any such plan has restricted coverage of Plavix. Def. Br. at 10. Absent any exclusions, Defendants argue, when physicians prescribed Plavix for its on-label, FDA approved use, such a prescription should be considered “reasonable and necessary” under Medicare. In light of the. parties’ arguments, the question before the Court centers, on the definition of “reasonable and necessary” in the Medicare statute. It is true that the Medicare statute permits reimbursement only for medical treatments which are “reasonable and necessary.” 42 U.S.C. § 1395y. Relator cites to a number of cases that dealt'with the reasonableness of prescribing off-label drugs in the context of Medicare, but, as I will discuss further, infra, none of those cases address how “reasonable and necessary” is defined for on-label prescription drugs. Tellingly, the Court’s research did not reveal any case law on that issue, nor has Relator supported her position with any authority. As a result, this Court must examine the statutory language of Medicare and the FDA approval scheme, to determine whether there is any circumstance in which a prescription drug would not be “reasonable and necessary” when that-drug is prescribed by a physician for a FDA approved, on-label usé. To begin, Medicare is a federally funded and administered health insurance program for certain groups, primarily elderly and disabled persons. See Heckler v. Ringer, 466 U.S. 602, 605, 104 S.Ct. 2013, 80 L.Ed.2d 622 (1984). The Department of Health and Human Services (“HHS”) administers the Medicare program through the Centers for Medicare and Medicaid Services (“CMS”). See id. Four major components make up the Medicare program: (1) Part A, the hospital insurance benefits program, 42 U.S.C. §§ 1395c, 1395d; (2) Part B, the supplemental medical insurance benefits' program, which generally pays for a percentage of certain medical and other health services, including physician sérvices, 42 U.S.C. §§ 1395j, 1395k, 1395l; (3) Part C, the Medicare Advantage program, which allows CMS to contract with public and private entities to provide, at a minimum, Medicare Part A and B benefits to certain Medicare beneficiaries, 42 U.S.C, § 1395w-21-28 et seq.; and (4) Part D, the voluntary prescription drug benefit program. 42 U.S.C. § 1395w-101 et seq. Here, Relator’s FCA claims are premised on Medicare Part D. Medicare Part D was established in 2003 by the Medicare Prescription Drug, Improvement, and Modernization Act, Pub.L. 108-173, 117 Stat.2066, which set up a voluntary prescription drug benefits program for Medicare enrollees. United States ex rel. Spay v. CVS Caremark Corp., 913 F.Supp.2d 125, 131 (E.D.Pa.2012). Unlike Parts A and B, Medicare Part D is based on a private market model, wherein Medicare contracts with private entities, known as Part D “sponsors” to administer prescription drug plans. See United States ex rel. Fox Rx, Inc. v. Omnicare, Inc., 38 F.Supp.3d 398, 402-403 (S.D.N.Y.2014). Part D benefits are provided by a Part D plan sponsor, which is either a prescription drug plan (“PDP”), a Medicare Advantage organization that offers a Medicare Advantage prescription drug plan (“MA-PD plan”), a Program of All-Inclusive Care for the Elderly (“PACE”) organization offering a PACE plan including qualified prescription drug coverage, or a cost plan offering qualified prescription drug coverage. See 42 C.F.R. § 423.4; Spay, 913 F.Supp.2d at 131. Part D plan sponsors subcontract with pharmaceutical entities to provide drugs to beneficiaries, including pharmacy benefit managers (“PBM”) who provide drugs through mail order and pharmacies. See Spay, 913 F.Supp.2d at 133. As a condition for payment from CMS, the sponsor must certify the accuracy, completeness and truthfulness of all data related to the payment, which may include enrollment information, claims data," bid submission data, and any other data specified by CMS. See 42 C.F.R. § 423.505(k)(1). A subcontractor entity must “similarly certify” that the claims data it has generated is accurate, complete and truthful, and must' acknowledge that it will be used to obtain federal reimbursement. See 42 C.F.R. § 423.505(k)(3). Indeed, the sponsors and their subcontractors must contractually agree to comply with all federal laws and regulations designed to prevent fraud, waste, and abuse. See 42 C.F.R. § 423;505(h)(1); 42 C.F.R. § 423.505(i)(4)(iv). With respect to coverage, a plan sponsor must provide quálified prescription drug which includes “standard prescription drug coverage” or “alternative prescription drug coverage” with at least actuarially. equivalent benefits. See 42 U.S.C. § 1395w-102; 42 C.F.R. § 423.104(c). The requirements for standard or alternative prescription drug coverage relating to deductibles, benefit structure, initial coverage limits, out-of-pocket expenditures, etc., are, set out in the Medicare Statute and its regulations. See 42 U.S.C. § 1395w-102(b); 42 C.F.R. § 423.104(d)(3). Plans may also provide supplemental prescription coverage, which can include reductions in cost-sharing (such as deductibles or coinsurance percentages) or covering certain drugs that would qualify as covered Part D drugs if they were not among the drugs described at 42 U.S.C. § 1396r — 8(d)(2), (d)(3) and excluded from the definition of a Part D drug at 42 U.S.C. § 1395w-102(e)(2)(A). More specifically, Part .D covers a range of outpatient prescription drugs, which previously had been covered only in select instances. Kilmer v. Leavitt, 609 F.Supp.2d 750, 751 (S.D.Ohio 2009). However, a Part D plan sponsor need not provide coverage for a Part D drug that is “not reasonable and necessary” for circumstances specified in the statutory, framework or that, is not prescribed; in accordance with the plan or,the Medicare Act. See 42 U.S.C. §§ 1395w-102(e)(3) and 1395y(a); Kilmer, 609 F.Supp.2d at 751. Rather, to qualify for coverage, an outpatient prescription drug must be used for a medically accepted indication, see 42 U.S.C. §§ 1395w-102(e)(1), (e)(4), which means that it can be used for treatment purposes, inter alia, approved under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. See 42 U.S.C. § 1396r-8(k)(6) (“The term ‘medically accepted indication’ means any use for a covered outpatient drug which is approved under the [FDCA] or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i) of this section.”). Indeed, under Medicare, “Covered part D drug” is defined as “a drug that may be dispensed upon a prescription,” 42 U.S.C. § 1395w-102(e)(1)(A), that is “approved for safety and effectiveness as a prescription drug under section 505 or 507 of the [FDCA].” 42 U.S.C. § 1396r-8(k)(2)(A)(i). Moreover, regulations promulgated by the Secretary further clarify the scope of what is considered a Part D drug. Title 42, Code of Federal Regulations, section 423.100, states, in relevant part: Part D drug means— (1) Unless excluded under paragraph (2) of this definition, any of the following if used for a medically accepted indication (as defined in [42 U.S.C. § 1395w-102(e)(4)])- (i) A drug that may be dispensed only upon a prescription and that is described in sections [42 U.S.C. § 1396r-8(k)(2)(A)]. 42 C.F.R. § 423.100 (emphasis added). Based on the above-outlined statutory scheme, a reasonable and necessary covered drug under Part D includes a drug prescribed for uses that are approved by the FDA, i.e., on-label use. See Planned Parenthood Ariz., Inc. v. Humble, 753 F.3d 905, 907 (9th Cir.2014). Indeed, a drug prescribed for its on-label use-^-by definition — means that the prescription is medically reasonable for its intended purpose by virtue of the FDA approval process. As the Supreme Court has explained, the FDA approval process of a new drug is “both onerous and lengthy.” Mut. Pharm. Co. v. Bartlett, — U.S. -, 133 S.Ct. 2466, 2471, 186 L.Ed.2d 607 (2013). Under the FDCA, 21 U.S.C. § 301 et seq., ding manufacturers must gain FDA approval before marketing any drug in interstate commerce. See 21 U.S.C. § 355(a). In the case of a new brand-name drug, such as Plavix, FDA approval can be secured only by submitting a new-drug application (“NDA”). The application is a compilation of materials that must include “full reports of [all clinical] investigations,” 21 U.S.C. § 355(b)(1)(A), relevant nonclinical studies, and “any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source,” 21 C.F.R. §§ 314.50(d)(2) and (5)(iv); see Bartlett, 133 S.Ct. at 2470-71 (explaining the FDA approval process). The NDA must also include “the labeling proposed to be used for such drug,” 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i), and “a discussion of why the [drug’s] benefits exceed the risks under the conditions stated in the labeling,” 21 C.F.R. § 314.50(d)(5)(viii); § 314.50(c)(2)(ix). Importantly, the FDA may approve an NDA only if it determines that the drug in question is “safe for use” under “the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” 21 U.S.C. § 355(d); Bartlett, 133 S.Ct. at 2470. In order for the FDA to consider a drug safe, the drug’s “probable therapeutic benefits must outweigh its risk of harm.” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 140, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000). In that regard, “Congress made its ‘purpose’ plain in authorizing the FDA — not [] tort juries — to determine when and under what circumstances a drug is ‘safe.’ ” Wyeth v. Levine, 555 U.S. 555, 607, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). And, in that connection, “[w]here the FDA determines, in accordance with its statutory mandate, that a drug is on balance ‘safe,’ [the] conflict preemption cases prohibit any State from countermanding that determination.” See, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (after the FDA has struck “a somewhat delicate balance of statutory objectives” and determined that petitioner submitted a valid application to manufacture a medical device, a State may not use common law to negate it). Significantly, after the FDA approves a drug, “the manufacturer remains under an obligation to investigate and report any adverse events associated with the drug, see 21 C.F.R. § 314.80, and must periodically submit. any new information that may affect the FDA’s previous conclusions about the safety, effectiveness, or labeling of the drug.” Wyeth, 555 U.S. at 608, 129 S.Ct. 1187 (citing 21 U.S.C. § 355(k)). If the FDA finds that the drug is not “safe,” the agency “shall” withdraw its approval of the drug. See 21 U.S.C. § 355(e). The FDA also “shah” deem a drug “misbranded” if “it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j). From a plain reading of the Medicare statute regarding the Part D prescription drug coverage, I find that a FDA approved drug that is prescribed for its on-label use is “reasonable and necessary.” I come to this conclusion because, for one, the statute is explicit in stating that one of the “medically accepted indications” for a prescribed drug includes any usé that has been approved by the FDA. See 42 U.S.C. § 1396r-8(k)(6) (“The term ‘medically accepted indication’ means any use for a covered outpatient drug which is approved under the [FDCA].”). And, the Regulations- accompanying the Medicare requirements in this context mirror the definition of “medically accepted indication” as it appears in § 1396r-8(k)(6). See 42 C.F.R. § 423.100. Moreover, the hallmark of the “reasonable and necessary” requirement under Medicare Part D' is the effectiveness and safety of a particular prescription drug. See 42 U.S.C. § 1396r-8(k)(2)(A)(i). The FDA approval process — -as outlined above — ensures that an approved drug meets the “reasonable and necessary” standard. Thus, by operation of the Medicare statute, this Court holds that a FDA approved drug that has been prescribed for its on-label use is necessarily covered under Medicare Part D. See United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694, 701 (4th Cir.2014) (“[t]o qualify as a ‘covered outpatient drug* as defined in the Medicare and Medicaid statutes, a drug merely must be approved by the FDA.”). My conclusion in this regard in consistent with the findings of those courts that have dealt with Part D drugs that have been prescribed for- “off-label” purposes. At the outset, I note that “off-label” use is the use of a particular drug “for some other purpose than that for which it has been approved by the FDA.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); In re Neurontin Mktg. & Sales Practices Litig., 712 F.3d 21, 27-28 (1st Cir.2013) (“[o]ff-label use marketing is for those conditions or diseases not included in the official label approved by the FDA”). In the context of Medicare- Part D, numerous courts have been called upon to resolve the issue whether drugs prescribed for their off-label uses are “reasonable and necessary.” See, e.g., United States ex rel. Bergman v. Abbot Labs., 995 F.Supp.2d 357, 369 (E.D.Pa.2014); United States ex rel. Cestra v. Cephalon, Inc., Civ. No. 141842, 2015 WL 3498761, at *8 (E.D.Pa. June 3, 2015); United States ex rel. Petratos v. Genentech, Inc., Civ. No. 11-3691, 2014 WL 7331945, at *4 (D.N.J. Dec. 18, 2014); United States ex rel. Simpson v. Bayer Corp., Civ. No. 05-3895 JLL, 2013 WL 4710587, at *11 (D.N.J. Aug. 30, 2013); see also United States ex rel. Brown v. Celgene Corp.,. Civ. No. 10-3165-GHK SSX, 2014 WL 3605896, at *4 (C.D.Cal. July 10, 2014); United States ex rel. Nathan v. Takeda Pharm. N. Am., Inc., Civ. No. 1:091086(AJT), 2011 WL 2182422, at *3 (E.D.Va. May 4, 2011). These courts’ decisions are-in unison that if the particular use of the drug is supported by a listing in a major drug compendium,— even if the use is for an off-label purpose — that drug may fall within the “reasonable and necessary” standard of Medicare. See, e.g., Simpson, 2013 U.S. Dist. LEXIS 124928, at *35-*36. Significantly, this finding is taken from, and supported by, the definition of “medically accepted indication,” under 42 U.S.C. § 1396r-8(k)(6), see Bergman, 995 F.Supp.2d at 369, which definition also includes any drug approved by the FDA. See 42 U.S.C. § 1396r-8(k)(6). Simply put, in those courts’ view, a “reasonable and necessary” prescription is equivalent to one given for “a medically accepted indication.” See, e.g., Cestra, 2015 WL 3498761, at *8 (“Whether prescribing a drug for a particular condition is reasonable and necessary is typically determined by considering whether the drug is prescribed for a ‘medically accepted indication’ that is reimbursable under Medicare and Medicaid.”). And, because a medically accepted indication is also equivalent to a use of a drug that is approved by the FDA, by definition, any on-label drug prescription is, under the statute, reasonable and necessary. Accordingly, because Relator has not alleged that Plavix is excluded from Medicare Part D coverage, or that Plavix was not prescribed for any purpose other than its on-label use, this Court finds that as a matter of law, any prescription of Plavix, written for its on-label use during the time period alleged, was reasonable and necessary under Medicare Part D. Consequently, Plaintiff cannot a state a claim under the FCA.in this context. 2. Medicaid Under, Medicaid, Relator’s , position is two-fold; first, Relator argues that Medicaid requires that drugs be “medically necessary” in order to be covered, and that Defendants’ • misrepresentations caused physicians to falsely write prescriptions for Plavix under circumstances that did not comply with Medicaid’s requirements. Second, Relator argues that each of the fifty states’ Medicaid plans also imposes a “medically necessity” requirement. To counter, Defendants maintain — just as they did under Medicare — that Medicaid does not deny the reimbursement of a FDA approved prescription drug for its on-label use. Defendants submit that in the absence of kickbacks, reimbursement for a drug. prescribed for an FDA-approved indication, i.e. an on-label prescription, cannot also be the basis for a claim under the FCA in the context of Medicaid. Moreover, Defendants contend that the states’ Medicaid plans do. not impose an additional “medically necessary” requirement as a precondition for payment for on-label drug prescriptions. To begin, the Medicaid Act, 42 U.S.C. § 1396 et seq., established.the Medicaid program which is separate from the Medicare program. Under the Medicaid Act, the federal government and the states jointly fund the Medicaid program, with the federal government contributing approximately between 50% and 83% of the funding, with the states responsible for the rest. 42 U.S.C, § 1396d(b); Pennsylvania Medical Soc. v. Snider, 29 F.3d 886, 888-89 (3d Cir.1994). Eligibility for Medicaid benefits is based on need. Id. “A state is not required to participate in the Medicaid program, but if it decides to participate; it must comply with the Medicaid Act and its implementing regulations.” Snider, 29 F.3d at 889 (citing 42 U.S.C. § 1396c). A participating state must propose a plan that meets certain statutory' requirements set forth in § 1396a(a). For such a plan to become effective, the plan must be approved by the Secretary of the HHS. See 42 U.S.C. § 1396a(b). “To gain payment under Medicaid for covered drugs, a manufacturer must enter a standardized agreement with HHS; in the agreement,, the manufacturer undertakes to provide rebates to'States on their Medicaid drug purchases.” Astra USA, Inc. v. Santa Clara County, 563 U.S. 110, 131 S.Ct. 1342, 1346, 179 L.Ed.2d 457 (2011) (citing 42 U.S.C.A. § 1396r-8(a)); see United States ex rel. Schumann v. AstraZeneca Pharms. L.P., 769 F.3d 837, 841 (3d Cir.2014). “Once a drug manufacturer enters into a rebate agreement, the law requires the State to provide coverage for that drug under its' plan unless the State complies with one of the exclusion or restriction' provisions in the Medicaid Act.” Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 652, 123 S.Ct. 1855, 155 L.Ed.2d 889 (2003) (citing 42 U.S.C. § 1396r-8(d)). For example, a State may exclude covérage for drugs such as “agents ... used for cosmetic purposes or hair growth.'’ 42 U.S.C. § 1396r-8(d)(2)(C). Here, Relator has not alleged that Plavix, during the relevant timé period/was on any state or federal exclusion lists. Importantly, similar to Medicare’s requirement, the Medicaid statute is clear that a plan participant will receive reimbursements only for a “covered outpatient drug.” United States ex rel. Campie v. Gilead Sci., Inc., No. 11-941, 2015 WL 3659765, at *5, 2015 U.S. Dist. LEXIS 77261, at *17 (N.D.Cal. Jun. 12, 2015). Identical to Medicare’s definition, all drugs approved as safe and effective by the FDA since 1962 qualify as “covered outpatient drugs” under Medicaid. See 42 U.S.C. § 1396r-8(k)(2); United States ex rel. Conrad v. Abbott Labs., Inc., No. 02-11738, 2013 WL 682740; at *1, 2013 U.S. Dist. LEXIS 26048, at *10 (D.Mass. Feb. 25, 2013) (finding that “[a]ll drugs approved .as safe and effective by the FDA since 1962 qualify as covered, outpatient drugs” under Medicaid); Campie, 2015 WL 3659765, at *5, 2015 U.S. Dist. LEXIS 77261, at *17; In re Rezulin Products Liab. Litig., 524 F.Supp.2d 436, 439 (S.D.N.Y.2007); United States v. Ortho-McNeil Pharm., Inc., No. 038239, 2007 WL 2091185, at *2 (N.D.Ill. Jul. 20, 2007); United States ex rel. Conrad v. Health- point, Ltd., No. 02-11738, 2012 WL 1004775, at *1 (D.Mass. Mar. 26, 2012); Rostholder, 745 F.3d at 701. Indeed, also like -Medicare, Medicaid reimburses “covered outpatient drugs” that are prescribed for a “medically accepted indication,” which is defined as “any use for a covered outpatient drug ... approved under the [FDCA],” See 42 U.S.C. § 1396r-8(k)(6). Accordingly, during the relevant time period, Plavix was considered a “covered outpatient drug” reimbursable under Medicaid. Therefore, I reject Relator’s argument that upder the federal Medicaid act, a drug prescribed for its on-label, FDA-approved use can be found to be not “medically necessary.” Relator nonetheless argues that the requirement that a drug be a “covered outpatient drug” is merely a prerequisite to payment coverage, and-that state Medicaid plans additionally require, pursuant to 42 C.F.R. § 440.230(d), that