Full opinion text
MEMORANDUM YOUNG, District Judge. I. INTRODUCTION Relator Kassie Westmoreland (“the Relator”) brings this qui tarn action against Amgen, Inc. (“Amgen”), International Nephrology Network (“INN”), and ASD Healthcare (“ASD”) (collectively, “the Defendants”) for violations of the federal False Claims Act, 31 U.S.C. §§ 3729-33. In her Fourth Amended Complaint, the Relator alleges that the Defendants knowingly caused health care providers to make false representations material to the payment of Medicare claims and conspired to get false claims paid by Medicare. Specifically, the Relator alleges that, in violation of the federal Anti-Kickback Statute, the Defendants encouraged providers to submit claims for payment by Medicare for the value of the excess product, or “overfill,” contained in the vials of their drug Aranesp but not included in Aranesp’s average sales price (“ASP”). This Court has upheld the Relator’s allegations as sufficient to state a claim under the False Claims Act. There are now a number of other motions pending decision by the Court. First, the Defendants move for partial judgment on the pleadings under Federal Rule of Civil Procedure 12(c). It is undisputed that health care providers, in signing mandatory Medicare Enrollment Form CMS-855 (“the Provider Agreement”), agree to comply with the Anti-Kickback Statute as a precondition of Medicare payment. The Defendants, however, argue (1) that the clause in the Provider Agreement requiring a certification of compliance with the Anti-Kickback Statute is contrary to the Medicare statutes and regulations, which do not establish Anti-Kickback Statute compliance as a precondition of payment, and (2) that the adoption by the Centers for Medicare and Medicaid Services [“CMS”] of the version of the Provider Agreement that includes the certification clause was procedurally improper and outside the scope of its authority. The Relator, in opposition to the Defendants’ motion, argues (1) that the Anti-Kickback Statute itself establishes compliance as a precondition of Medicare payment, and (2) that the certification of compliance in the Provider Agreement is a valid agency interpretation of the regulations. The United States, while not a party to the action, has filed a statement of interest supporting the Relator’s position. Second, the Relator and Amgen bring cross-motions for partial summary judgment as to Count IV of the Fourth Amended Complaint, which alleges that Amgen artificially inflated Aranesp’s ASP by failing to include overfill as a “price concession,” in violation of the False Claims Act, 31 U.S.C. § 3729(a)(1)(A). In her memorandum in support of her motion, the Relator argues that, because Aranesp’s ASP was artificially inflated, claims submitted by providers based on this ASP were false and fraudulent as matter of law. Amgen asserts that federal rules and regulations make clear that overfill is not to be included in a drug’s ASP and that there is no evidence that Amgen intended to submit an inaccurate ASP for Aranesp. Third, INN and ASD move for partial summary judgment on the theory that they are shielded from liability by the Anti-Kickback Statute’s “safe harbor” provisions for group purchasing organizations (“GPOs”), 42 U.S.C. § 1320a-7b(b)(3)(C), and discounts, id. § 1320a-7b(b)(3)(A). The Relator brings a cross-motion for partial summary judgment, arguing that the GPO safe harbor is inapplicable to INN due to its failure to comply with the formalities set forth in the federal regulations and due to its impermissibly close relationships with Amgen and ASD. With respect to ASD and the discount safe harbor, the Relator argues that the “pass through” of an administrative fee paid by Amgen to INN to ASD, who utilized the funds to provide discounts to providers, was unlawful and indicative of the conspiracy to defraud Medicare in which the Defendants allegedly have engaged. A. Procedural Posture In June 2006, the Relator filed this qui tarn, action against Amgen, INN, ASD, and two other corporate defendants under the federal False Claims Act and various related state laws on behalf of the United States, fifteen states, and the District of Columbia. Relator’s Compl., ECF No. 1. In September 2009, the United States notified the Court that it was not intervening in the action at that time. U.S. Notice Non-Intervention, ECF No. 71. The states and the District of Columbia (collectively, the “States”) intervened by filing a separate Multi-State Complaint in October 2009, which they amended in December 2009. Multi-State Compl. Intervention, ECF No. 85; Multi-State First Am. Compl., ECF No. 112. Subsequently, several states voluntarily dismissed, including Delaware, Florida, Louisiana, Nevada, New Hampshire, and Texas. Notices Voluntary Dismissal, ECF Nos. 120, 123, 148, 153, 156, 163. The Relator filed her Third Amended Complaint in December 2009, bringing claims on behalf of herself, the United States, Georgia, and New Mexico. Relator’s Third Am. Compl., ECF No. 113. The Defendants subsequently moved to dismiss Counts I-VI of the Third Amended Complaint and the entirety of the Multi-State First Amended Complaint. Am-gen’s Mot. Dismiss Relator’s Third Am. Compl., ECF No. 139; Amgen’s Mot. Dismiss Multi-State First Am. Compl., ECF No. 142; INN & ASD’s Mot. Dismiss Relator’s Third Am. Compl., ECF No. 138; INN & ASD’s Mot. Dismiss Multi-State First Am. Compl., ECF No. 135. The Court dismissed the Multi-State First Amended Complaint and some of the Relator’s federal claims under the federal False Claims Act’s first-to-file bar and the remainder of her claims without prejudice under Federal Rule of Civil Procedure 12(b)(6). United States ex rel. Westmoreland v. Amgen, Inc., 707 F.Supp.2d 123 (D.Mass.2010). The First Circuit has since reversed the dismissal of the States’ claims under the state False Claims Acts of California, Illinois, Indiana, Massachusetts, New Mexico, and New York, and affirmed the dismissal of the States’ claims under Georgia’s False Claims Act. New York v. Amgen, Inc., 652 F.3d 103 (1st Cir.2011). In May 2010, the Relator filed her Fourth Amended Complaint, and the Defendants again moved to dismiss. Relator’s Fourth Am. Compl, ECF No. 238; Amgen’s Mots. Dismiss Relator’s Fourth Am. Compl., ECF Nos. 251, 253; INN & ASD’s Mot. Dismiss Relator’s Fourth Am. Compl, ECF. No. 256. On July 21, 2010, the Court denied the Defendants’ Motions to Dismiss the Relator’s Fourth Amended Complaint. See United States ex rel. Westmoreland v. Amgen, Inc., 738 F.Supp.2d 267 (D.Mass.2010). On August 4, 2010, the Defendants answered the Relator’s Fourth Amended Complaint. Amgen’s Answer Relator’s Fourth Am. Compl., ECF No. 286; INN & ASD’s Answer Relator’s Fourth Am. Compl., ECF No. 285. INN and ASD asserted their compliance with certain safe harbor provisions of the federal Anti-Kickback Statute as their Ninth Affirmative Defense. INN & ASD’s Answer Relator’s Fourth Am. Compl., Affirmative Defenses ¶ 15. On February 18, 2011, INN and ASD filed their Motion for Partial Judgment on the Pleadings. INN & ASD’s Mot. Partial J. Pleadings, ECF No. 367; Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings, ECF No. 368. Amgen then moved to join INN and ASD’s motion on March 1, 2011, and this Court allowed it the following day. Amgen’s Mot. Joinder INN & ASD’s Mot. Partial J. Pleadings, ECF No. 385; Mem. Supp. Amgen’s Mot. Joinder INN & ASD’s Mot. Partial J. Pleadings, ECF No. 387. On March 11, 2011, the Relator opposed the Defendants’ joint motion. Mem. Opp’n Defs.’ Mot. Partial J. Pleadings, ECF No. 408. The Court granted the Defendants leave to file a joint reply brief, which they did on March 17, 2011. Joint Reply Mem. Supp. Defs.’ Mot. Partial J. Pleadings, ECF No. 419. On March 18, 2011, the United States filed its statement of interest. U.S. Br. Statement Interest INN & ASD’s Mot. Partial J. Pleadings, ECF No. 421. At oral argument on March 24, 2011, the Court denied the motion, and this opinion announces the Court’s reasoning for that denial. On March 1, 2011, the parties brought their various Motions for Partial Summary-Judgment. Amgen’s Mot. Partial Summ. J., ECF No. 376; Mem. Supp. Amgen’s Mot. Partial Summ. J., ECF No. 377; INN & ASD’s Mot. Partial Summ. J., ECF No. 379; Mem. Supp. INN & ASD’s Mot. Partial Summ. J., ECF No. 380; Relator’s Mot. Partial Summ. J. Amgen, ECF No. 383; Mem. Supp. Relator’s Mot. Partial Summ. J. Amgen, ECF No. 388; Relator’s Mot. Partial Summ. J. INN & ASD, ECF No. 384; Mem. Supp. Relator’s Mot. Partial Summ. J. INN & ASD, ECF No. 386. On March 22, 2011, the parties filed memoranda in opposition. Mem. Opp’n Relator’s Mot. Partial Summ. J. Amgen, ECF No. 429; Mem. Opp’n Relator’s Mot. Partial Summ. J. INN & ASD, ECF No. 434; Mem. Opp’n Amgen’s Mot. Partial Summ. J., ECF No. 431; Mem. Opp’n INN & ASD’s Mot. Partial Summ. J., ECF No. 437. Reply briefs were filed on April 1, 2011. Reply Mem. Supp. Amgen’s Mot. Partial Summ. J., ECF No. 450; Reply Mem. Supp. INN & ASD’s Mot. Partial Summ. J., ECF No. 453; Reply Mem. Supp. Relator’s Mot. Partial Summ. J. Am-gen, ECF No. 452; Reply Mem. Supp. Relator’s Mot. Partial Summ. J. INN & ASD, ECF No. 454. At the hearing on April 11, 2001, the Court orally denied the Defendants’ Motions for Partial Summary Judgment on Counts I, II, III, V, VI, and VII of the Relator’s Fourth Amended Complaint. Mot. Hearing Tr. (“Tr. Summ. J. Mots.”) 21:25 to 22:1-4, 22:13-20, ECF No. 463. It took under advisement the remaining motions concerning Count IV of the Fourth Amended Complaint and INN and ASD’s Ninth Affirmative Defense. Id. In an order dated August 25, 2011, the Court denied the Relator’s Motion for Partial Summary Judgment that Amgen Artificially Inflated the Average Sales Price of Aranesp in Violation of the False Claims Act, while allowing Amgen’s Motion for Partial Summary Judgment as to Count IV of the Fourth Amended Complaint insofar as it alleges that Amgen artificially inflated the Average Sales Price of Aranesp. Order, ECF No. 481. Additionally, the Court denied the Relator’s Motion for Partial Summary Judgment as to INN & ASD’s Ninth Affirmative Defense as well as INN & ASD’s Motion for Partial Summary Judgment with respect to its Ninth Affirmative Defense. Id. This opinion explains the Court’s rulings. B. Legal Framework 1. False Claims Act The False Claims Act prohibits false or fraudulent claims for payment to the federal government and permits civil actions based on such claims to be brought by the Attorney General or by private individuals, referred to as “relators,” acting in the government’s name. 31 U.S.C. § 3730(a)-(b). Where the government elects not to intervene, the so-called qui tam plaintiff may proceed with the action as the government’s assignee. Id. § 3730(b)(4)(B). At the time the Relator filed her complaint, the False Claims Act imposed liability on any person who either “knowingly presents, or causes to be presented to an officer or employee of the United States Government ... a false or fraudulent claim for payment or approval,” 31 U.S.C. § 3729(a)(1), 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,” id. § 3729(a)(2). See United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 727 (1st Cir.2007). A claim is “materially false or fraudulent” if it “represents] compliance with a material condition of payment that was not in fact met.” United States ex rel. Hutcheson v. Blackstone Med. Inc., 647 F.3d 377, 379 (1st Cir.2011). Determination of whether a claim is materially false or fraudulent “is a fact-intensive and context-specific inquiry.” Amgen, 652 F.3d at 111. The first step of the analysis is to identify preconditions of payment under the relevant government program. See id. Preconditions of payment, however, need not “be expressly designated as such to give rise to false or fraudulent claims.” Blackstone Med., 647 F.3d at 387 (citing United States v. Science Applications Int’l Corp. (“SAIC”), 626 F.3d 1257, 1269 (D.C.Cir.2010)). The First Circuit has declined to adopt a categorical rule that preconditions of payment must derive verbatim from a statute or regulation. Id. at 388, 391, 393-94. A claim also may be false or fraudulent for non-compliance with a contractual term, even if the contract does not specify compliance as a precondition of payment. Id. at 387 (citing SAIC, 626 F.3d at 1269); see United States ex rel. Saltzman v. Textron Sys. Corp., No. 09-11985-RGS, 2011 WL 2414207, at *3 (D.Mass. June 9, 2011) (Stearns, J.). But see Amgen, 652 F.3d at 115-16 (suggesting that a precondition of payment must be established by clear authority). Yet, “noncompliance with a contractual condition is [no] more necessary to establish that a claim is false or fraudulent than non-compliance with an express statute or regulation, or an express misrepresentation on a form submitted with payment.” Blackstone Med., 647 F.3d at 394. The First Circuit’s rejection of “a circumscribed view of what it means for a claim to be false or fraudulent,” id. at 387-88 (quoting SAIC, 626 F.3d at 1270), reflects a belief that “other means exist to cabin the breadth of the phrase ‘false or fraudulent’ as used in the [False Claims Act],” id. at 388. See United States ex rel. Nowak v. Medtronic, Inc., 806 F.Supp.2d 310, 343-44 (D.Mass.2011) (Woodlock, J.). Specifically, liability may be imposed only where the defect in the claim is material and where the defendant acts knowingly. Id. Longstanding First Circuit precedent establishes “that the [False Claims Act] is subject to a judicially-imposed requirement that the allegedly false claim or statement be material.” United States ex rel. Loughren v. Unum Group, 613 F.3d 300, 307 (1st Cir.2010). “[A] false statement is material if it has ‘a natural tendency to influence, or [is] capable of influencing, the decision of the decisionmaking body to which it was addressed.’” Id. (quoting Neder v. United States, 527 U.S. 1, 16, 119 S.Ct. 1827, 144 L.Ed.2d 35 (1999)). Thus, the second step of the analysis is to determine whether compliance with the identified precondition of payment is “material,” i.e., capable of influencing the government’s decision to pay the claim. Amgen, 652 F.3d at 110-12. The First Circuit has observed that “[ejxpress contractual language may ‘constitute dispositive evidence of materiality,’ but materiality may be established in other ways, ‘such as through testimony demonstrating that both parties to the contract understood that payment was conditional on compliance with the requirement at issue.’ ” Blackstone Med., 647 F.3d at 394. In addition to materiality, the False Claims Act’s knowledge requirement operates as another constraint on liability under the statute. A person acts “knowingly” if he or she “(1) has actual knowledge of the information; (2) acts in deliberate ignorance of the truth or falsity of the information; or (3) acts in reckless disregard of the truth or falsity of the information.” 31 U.S.C. § 3729(b). “Knowingly” does not require “proof of specific intent to defraud.” Id. Under Supreme Court and First Circuit case law, a non-submitting entity may be liable for knowingly causing a submitting entity to submit a false or fraudulent claim, regardless whether the submitting entity knew or should have known about the non-submitting entity’s unlawful conduct. Blackstone Med., 647 F.3d at 390 (citing United States ex rel. Marcus v. Hess, 317 U.S. 537, 544-45, 63 S.Ct. 379, 87 L.Ed. 443 (1943)). “[Unlawful acts by non-submitting entities may give rise to a false or fraudulent claim even if the claim is submitted by an innocent party.” Id. Representations by the submitting entity as to its own compliance with preconditions of payment do not “somehow immunize a non-submitting entity from liability under the ‘causes’ clause of the [False Claims Act].” Id. This is consistent with the congressional intent in passing the False Claims Act “to reach all types of fraud, without qualification, that might result in financial loss to the Government.” Id. at 392 (quoting Cook Cnty., Ill. v. United States ex rel. Chandler, 538 U.S. 119, 129, 123 S.Ct. 1239, 155 L.Ed.2d 247 (2003)). 2. Anti-Kickback Statute The federal Anti-Kickback Statute provides that: (2) whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both. 42 U.S.C. § 1320A-7b(b). The statute has been interpreted to cover any arrangement where one purpose of the remuneration was to obtain money for the referral of services or to induce further referrals. United States v. Kats, 871 F.2d 105, 108 (9th Cir.1989); United States v. Greber, 760 F.2d 68, 69 (3d Cir.1985); see United States v. Bay State Ambulance & Hosp. Rental Serv., Inc., 874 F.2d 20, 33 (1st Cir.1989) (“The key to a Medicare Fraud case is the reason for the payment — was the purpose of the payments primarily for inducement.”). A number of statutory and regulatory safe harbors protect certain business arrangements that might otherwise violate the Anti-Kickback Statute. See 42 U.S.C. § 1320a-7b(b)(3)(A)-(J). These safe harbors “apply only in very specific instances,” United States v. Shaw, 106 F.Supp.2d 103, 113 (D.Mass.2000) (Keeton, J.), to “exempt ] only a small subset of such transactions,” Bay State Ambulance, 874 F.2d at 31. Relevant here, such transactions include the common business arrangements of GPOs, 42 U.S.C. § 1320a-7b(b)(3)(C); 42 C.F.R. § 1001.952(j), and discounts, 42 U.S.C. § 1320a-7b(b)(3)(A); 42 C.F.R. § 1001.952(h). To receive protection, a business arrangement must fit squarely within a safe harbor; substantial compliance is not enough, although compliance is voluntary and failure to comply is not a per se violation of the statute. OIG Compliance Program for Pharmaceutical Manufacturers, 68 Fed.Reg. 23731, 23734 (May 5, 2003). “Whether a particular payment practice violates the statute is a question that can only be resolved by an analysis of the elements of the statute as applied to that set of facts.” Medicare and State Health Care Programs: Fraud and Abuse; Clarification of the OIG Safe Harbor Anti-Kickback Provisions, 59 Fed.Reg. 37202, 37203 (July 21, 1994). “[T]he gravamen of a violation of the statute is ‘inducement’ and not necessarily the structure of the arrangement,” such that “case by case inquiries must necessarily focus on the intent of the parties.” Medicare and State Health Care Programs: Fraud and Abuse; OIG Anti-Kickback Provisions, 56 Fed. Reg. 35952, 35955 (July 29, 1991) (citing Bay State Ambulance, 874 F.2d at 29); see Shaw, 106 F.Supp.2d at 114 (“[T]he fundamental analysis required of a trier of fact is ‘to recognize that the substance rather than simply the form of the transaction should be controlling.’ ” (quoting 56 Fed. Reg. at 35957)). “The reason behind the transaction and the requisite state of mind underlying the criminal act are more significant than form and label.” Shaw, 106 F.Supp.2d at 116. If the requisite intent to -willfully or knowingly solicit or offer a kickback is present, formal compliance with a safe harbor is not sufficient to avoid liability under the Anti-Kickback Statute. Cf. Medicare and State Health Care Programs: Fraud and Abuse; Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions Under the Anti-Kickback Statute, 64 Fed.Reg. 63518, 63530 (Nov. 19, 1999). II. MOTION FOR PARTIAL JUDGMENT ON THE PLEADINGS A. Facts The underlying facts are not relevant to the Court’s resolution of the Defendants’ Motion for Partial Judgment on the Pleadings. Instead, the issue here is the legal validity of the certification of compliance with the Anti-Kickback Statute that is contained in the Provider Agreement and to which health care providers attest in signing the form. The certification reads: I agree to abide by the Medicare laws, regulations and program instructions that apply to [me]. The Medicare laws, regulations, and program instructions are available through the [Medicare] contractor. I understand that payment of a claim by Medicare is conditioned upon the claim and the underlying transaction complying with such laws, regulations, and program instructions (including, but not limited to, the Federal anti-kickback statute and the Stark law), and on the provider’s compliance with all applicable conditions of participation in Medicare. Relator’s Fourth Am. Compl., Exs. I-J (“Provider Agreement”), ECF Nos. 238-9, 238-10 (emphasis added). The Provider Agreement further states that this certification is one of the “requirements that the provider must meet and maintain in order to bill the Medicare program.” Id. B. Standard of Review A Rule 12(c) motion implicates the pleadings as a whole. Aponte-Torres v. University of P.R., 445 F.3d 50, 54-55 (1st Cir.2006). Because a motion for judgment on the pleadings, like a motion to dismiss a complaint, “involves some assessment of the merits,” the Court must “view the facts contained in the pleadings in the light most favorable to the party opposing the motion — here, the plaintiff — and draw all reasonable inferences in the plaintiffs favor.” Curran v. Cousins, 509 F.3d 36, 43 (1st Cir.2007). A “court may not grant a defendant’s Rule 12(c) motion ‘unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.’ ” Rivera-Gomez v. de Castro, 843 F.2d 631, 635 (1st Cir.1988) (quoting George C. Frey Ready-Mixed, Concrete, Inc. v. Pine Hill Concrete Mix Corp., 554 F.2d 551, 553 (2d Cir.1977)). While this is the standard of review under Rule 12(c), and while both the Relator and the Defendants accept it as such, here there are no factual inferences to draw. Rather, the parties present differing views on purely legal questions of statutory interpretation and administrative law. See Skinner v. Salem Sch. Dist., 718 F.Supp.2d 186, 188 (D.N.H.2010) (“Questions of statutory interpretation are ‘ripe for resolution at the pleadings stage.’ ” (quoting Simmons v. Galvin, 575 F.3d 24, 30 (1st Cir.2009))). Unlike factual allegations, “[m]ere legal conclusions ‘are not entitled to the assumption of truth.’ ” Sanchez v. Esso Standard Oil De P.R., Inc., Civ. No. 08-2151-JAF, 2010 WL 3069551, at *2 (D.P.R. Aug. 2, 2010) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009)). “[T]he Court is not required to adopt purely legal conclusions asserted by the moving party.” Crooker v. United States, Civ. No. 08-10149-PBS, 2010 WL 3860597, at *5 (D.Mass. Sept. 29, 2010) (Saris, J.) (citing Phoung Luc v. Wyndham Mgmt. Corp., 496 F.3d 85, 88 (1st Cir.2007)). C. Analysis 1. Compliance with the Anti-Kickback Statute as a Precondition of Medicare Payment The Defendants ask this Court to hold that, contrary to conventional wisdom, compliance with the Anti-Kickback Statute is not and cannot be a precondition of Medicare payment because it has no legal basis, express or implied, in the Medicare statutes or regulations. In United States ex rel. Hutcheson v. Blackstone Medical, Inc., 694 F.Supp.2d 48 (D.Mass.2010), this Court acknowledged that “[t]he Medicare statutes and regulations do not expressly contain a precondition of compliance with the Anti-Kickback Statute.” Id. at 66. In the same case on appeal, the First Circuit declined to address whether, without express statutory or regulatory authorization, compliance with the Anti-Kickback Statute is nonetheless a precondition of payment. Blackstone Med., 647 F.3d at 392. It was unnecessary for the court to decide the issue because the certification clause in the Provider Agreement was “sufficiently clear to establish that the claims submitted by physicians represented that the underlying transactions did not involve kickbacks to physicians prohibited by the [Anti-Kickback Statute].” Id. at 393 (emphasis in original omitted). The physicians, in signing the Provider Agreement, agreed that payment is conditioned on Anti-Kickback Statute compliance, and therefore they were bound to abide by the certification clause as matter of contract law. Id. This Court could adopt the same approach here and go no further. But the Defendants’ argument is effectively a challenge to the validity of the contractual term making compliance with the Anti-Kickback Statute a precondition of payment. The Defendants argue that, even if health care providers agreed to it, the certification clause in the Provider Agreement is inconsistent with the legal framework governing Medicare payment and reflects improper agency rulemaking. These are novel claims fit for decision by this Court. The Defendants first contend that the absence of an express condition in the Medicare statutes makes clear that Congress meant to preclude compliance with the Anti-Kickback Statute as a precondition of payment. See Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 5-7. The Medicare statutes contain various provisions specifying conditions of Medicare payment, see, e.g., 42 U.S.C. § 1395f (“Conditions of and limitation on payment for services”); id. § 1395m (“Special payment rules for particular items and services”), but only one of them relates to the Anti-Kickback Statute, see id. § 1395y (“Exclusions from coverage and medicare as secondary payer”). It reads: No payment may be made under this title with respect to any item or service ... furnished ... by an individual or entity during the period when such individual or entity is excluded pursuant to section 1320a-7, 1320a-7a, 1320c-5, or 1395u(j)(2) of this title from participation in the program under this subchapter. Id. § 1395y(e)(l)(A). The Defendants suggest that this provision banning payment to providers who violate the Anti-Kickback Statute is meant to cover only the period that these providers are actually excluded from participating in the Medicare program. In other words, the payment ban would not include the period before providers formally are excluded but during which they are engaged in conduct in violation of the Anti-Kickback Statute. To the extent that the Provider Agreement makes compliance with the Anti-Kickback Statute a precondition of payment, and not just participation, see Amgen, 707 F.Supp.2d at 136 n. 4, it therefore goes beyond what the Medicare statutes intended. The Defendants reach this interpretation of 42 U.S.C. § 1395y(e)(l)(A) by contrasting it to id. § 1395nn(g)(l), which prohibits payment for “a designated health service which is provided in violation of [the Stark Act],” and to id. § 1395nn (a)(1)(B), which prohibits submission of a claim for a service furnished in violation of the Stark Act. The Defendants argue that these subsections of 42 U.S.C. § 1395nn demonstrate that, had Congress intended to ban payment of a claim made in violation of the Anti-Kickback Statute, it could have done so as it did with respect to the Stark Act. Instead, Congress elected not to condition Medicare payment on Anti-Kickback Statute compliance, unless and until the provider has been excluded from participation for an Anti-Kickback Statute violation. See Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 7. The Defendants’ argument amounts to an “absurdity.” United States ex rel. Pogue v. Diabetes Treatment Ctrs. of Am., 565 F.Supp.2d 153, 159 (D.D.C.2008) (noting that to hold that compliance with the Anti-Kickback Statute is not a precondition of Medicare payment would result in the government funding illegal kickbacks). Preservation of the public fisc would be undermined if a provider could engage in conduct warranting exclusion from the program altogether yet still demand payment until the time of formal exclusion. See United States ex rel. Wilkins v. Unit ed Health Grp., Inc., No. 10-2747, 659 F.3d 295, 313-14 (3d Cir.2011); United States v. Rogan, 517 F.3d 449, 452 (7th Cir.2008); cf. Amgen, 652 F.3d at 110-12 (rejecting the Defendants’ position that a distinction between conditions of Medicaid payment and conditions of Medicaid participation is relevant where providers, in signing forms akin to the Provider Agreement at issue here, have represented their compliance with the Anti-Kickback Statute). Congress cannot have intended that those brazen enough to violate the Anti-Kickback Statute (thereby risking criminal penalties), yet clever enough not to be caught (thereby avoiding exclusion from participation), would have their claims for Medicare payment paid with government funds. See United States ex rel. Bidani v. Lewis, 264 F.Supp.2d 612, 615 (N.D.Ill.2003) (holding that to reimburse a claimant “for supplies purchased illegally only because the claimant had the luck of not being caught and convicted in the first place .... would put the government in the position of funding illegal kickbacks after the fact”). Not only would this run counter to public policy, but also it would belie commonsense. See U.S. Br. Statement Interest INN & ASD’s Mot. Partial J. Pleadings 10-11. The Defendants have failed to identify how or why Anti-Kickback Statute compliance as an implied precondition of payment is contrary to the Medicare statutes. Similar to their argument with respect to the Medicare statutes, the Defendants next argue that to deem compliance with the Anti-Kickback Statute a precondition of Medicare payment would be to directly contravene the Medicare regulations. See Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 7-9. The Secretary of HHS has promulgated regulations governing Medicare participation and payment for health care providers, including the contents of the Provider Agreement. Under 42 C.F.R. § 424.510(d)(3), when a provider signs the Provider Agreement, he or she “attests that the information submitted is accurate and that [he or she] is aware of, and abides by, all applicable statutes, regulations, and program instructions.” The Defendants do not contest the validity of this regulation, but rather note the conspicuous absence of any mention of the Anti-Kickback Statute within it. See Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 8. It is difficult to see, however, how this regulation could be read not to include the Anti-Kickback Statute. The regulation states that a provider who signs the Provider Agreement is certifying that he is in compliance with “all applicable statutes.” 42 C.F.R. § 424.510(d)(3) (emphasis added). Certainly, the Anti-Kickback Statute is “applicable” to Medicare. See Shaw, 106 F.Supp.2d at 110 (stating that the purpose of the Anti-Kickback Statute “was to address the ‘disturbing degree [of] fraudulent and abusive practices associated with the provision of health services financed by the medicare and medicaid programs’ ” (quoting H.R.Rep. No. 95-393, pt. 2, at 44 (1977), reprinted in 1977. U.S.C.C.A.N. 3039, 3047)). This is true even if “enforcement of the anti-kickback statute cannot be said to be the central purpose of the Medicare program.” Amgen, 707 F.Supp.2d at 138. Indeed, Medicare regulations specifically name the Anti-Kickback Statute as a statute that is “designed to prevent or ameliorate fraud, waste, and abuse.” 42 C.F.R. § 422.504(h); id. § 423.505(h). The broad language of 42 C.F.R. § 424.510(d)(3) does not foreclose — and in fact manifestly permits — the Secretary’s decision to require providers to certify their compliance with the Anti-Kickback Statute in signing the Provider Agreement. Additional regulatory support for Anti-Kickback Statute compliance as a precondition of payment can be found in 42 C.F.R. § 424.516(a)(1), which states that “CMS enrolls and maintains an active enrollment status for a provider or supplier when that provider or supplier certifies that it meets, and continues to meet, and CMS verifies that it meets, and continues to meet, ... [compliance with title XVIII of the [Social Security] Act and applicable Medicare regulations.” When the Anti-Kickback Statute was enacted in 1972, it was in fact part of Title XVIII of the Social Security Act. See Pub.L. No. 92-603, 86 Stat. 1419 (1972). Although it later was redesignated to a new section, Title XI, see Pub.L. No. 100-93, § 4(d), 101 Stat. 680, 688-89 (1989), Congress’ intent in doing so was to “broaden” “[t]he scope of these [kickback, bribe, and false statements] provisions ... to encompass offenses against” other federal entitlement programs, in addition to Medicare. S.Rep. No. 100-109 (1987), reprinted in 1987 U.S.C.C.A.N. 682, 698. There is no indication that Congress meant for 42 C.F.R. § 424.516(a)(1) to be read to exclude a reference to the Anti-Kickback Statute. Turning to the language of the Anti-Kickback Statute itself, the Defendants argue that “Congress’s recent amendment to the [statute] has laid to rest any argument that federal law (including Medicare statutes, regulations or other Medicare provisions) conditions Medicare payments upon [Anti-Kickback Statute] compliance.” Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 9. On March 23, 2010, Congress amended the Anti-Kickback Statute to state that: a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of [the False Claims Act]. Patient Protection and Affordable Care Act (“the PPACA”), Pub.L. No. 111-148, § 6402(f), 124 Stat. 119, 759 (2010), adding 42 U.S.C. § 1320a-7b(g). The Defendants contend that, prior to this amendment, Congress had not linked “illegal remuneration” under the Anti-Kickback Statute to making a “false claim” for payment under the False Claims Act. Because it is the first time that the Anti-Kickback Statute expressly has incorporated the False Claims Act, the Defendants view it as a “substantive alteration” of the law. See Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 10 (citing Liquilux Gas Corp. v. Martin Gas Sales, 979 F.2d 887 (1st Cir.1992)). In Liquilux Gas, the First Circuit looked to various factors in distinguishing an “alteration” from a “clarification”: whether it fits within the existing language of the statute; whether it clarifies an ambiguity and, if so, whether it follows fast upon the ambiguity’s discovery; whether it affirms an administrative agency’s interpretation; and whether it declares the statute’s original intent. Id. at 890. Here, the Defendants are correct that the PPA-CA did not purport to clarify an existing section of the Anti-Kickback Statute. Nor was it included alongside other penalties, but rather as its own new subsection. The amendment’s legislative history, however, evinces Congress’ intent to clarify, not alter, existing law that claims for payment made pursuant to illegal kickbacks are false under the False Claims Act. Senator Ted Kaufman stated that the PPACA’s purpose was to “ensure that all claims resulting from illegal kickbacks are ‘false or fraudulent,’ even when the claims are not submitted directly by the wrongdoers themselves” and to “strengthen ] whistleblower actions based on medical care kickbacks” “[b]y making all claims that stem from an illegal kickback subject to the False Claims Act.” 155 Cong. Rec. S10852, S10853 (daily ed. Oct. 28, 2009) (Sen. Kaufman). The Senator identified the specific impetus for the amendment as (1) “remed[ying]” a then-recent district court decision that had “defeated] legitimate [False Claims Act] enforcement efforts,” and (2) adopting the “successful]” position that the Department of Justice consistently has advanced in “pursuing False Claims Act matters based on underlying violations of the Anti-Kickback Statute.” Id. (Sen. Kaufman). Because the intent of Congress is to be culled from the events surrounding the passage of the PPACA, see Securities & Exch. Comm’n v. Capital Gains Research Bureau, Inc., 375 U.S. 180, 199-200, 84 S.Ct. 275, 11 L.Ed.2d 237 (1963), Senator Kaufman’s comments, made in advance of the PPACA being signed into law, reliably suggest that the amendment was intended not to create a new basis for liability but to clarify the reach of the Anti-Kickback Statute, which had been called into question by recent litigation. See also Wilkins, 659 F.3d 295 at 311 n. 19 (using the word “clarify” to describe the effect of this recent amendment to the Anti-Kickback Statute). The Relator, along with the United States, correctly suggests that the conclusion that compliance is precondition of payment is “rendered inescapable when the purpose of the [Anti-Kickback Statute] is considered within the context of the Medicare statute.” U.S. Br. Statement Interest INN & ASD’s Mot. Partial J. Pleadings 5. Medicare, facing literally millions of claims per day, see id. at 6 n. 4, relies on providers to seek payment only on items or services “reasonable and necessary for the diagnosis or treatment of illness or injury,” 42 U.S.C. § 1395y(a)(l)(A). Kickbacks are designed to influence providers’ independent medical judgment in a way that is fundamentally at odds with the functioning of the system as a whole. The Anti-Kickback Statute is intended not only to prohibit but also to prevent such fraudulent conduct. See United States v. Kruse, 101 F.Supp.2d 410, 413 (E.D.Va.2000) (stating that the Anti-Kickback Statute’s “legislative history also suggests a deterrent, and thus punitive, purpose”); H.R.Rep. No. 95-393, pt. 2, at 44, reprinted in 1977 U.S.C.C.A.N. 3039, 3040, 3047, 3050 (stating that the Anti-Kickback Statute was enacted to “strengthen the capability of the Government to detect, prosecute, and punish fraudulent activities under the medicare and medicaid programs”). If providers could demand payment for claims resulting from kickback violations, then the Anti-Kickback Statute would be meaningless legislation. Moreover, courts, "without exception, agree that compliance with the Anti-Kickback Statute is a precondition of Medicare payment, such that liability under the False Claims Act can be predicated on a violation of the Anti-Kickback Statute. See, e.g., Wilkins, 659 F.3d at 313 (“Compliance with the [Anti-Kickback Statute] is clearly a condition of payment under Parts C and D of Medicare and appellees do not refer us to any judicial precedent holding otherwise. In fact, the precedents hold the opposite.”); United States ex rel. Kosenske v. Carlisle HMA, Inc., 554 F.3d 88, 94 (3d Cir.2009) (“Falsely certifying compliance with the ... Anti-Kickback Act[ ] in connection with a claim submitted to a federally funded insurance program is actionable under the [False Claims Act].”); Pogue, 565 F.Supp.2d at 159 (“Legion other cases have held violations of [the Anti-Kickback Statute] ... can be pursued under the [False Claims Act], since they would influence the Government’s decision of whether to reimburse Medicare claims.”); Rogan, 517 F.3d at 452 (rejecting the argument that a kickback was immaterial to the validity of Medicare and Medicaid claims); McNutt ex rel. U.S. v. Haleyville Med. Supplies, Inc., 423 F.3d 1256, 1259 (11th Cir.2005) (“[C]ompliance with federal health care laws, including the [Anti-Kickback] Statute, is a condition of payment by the Medicare program.”); United States ex rel. Schmidt v. Zimmer, Inc., 386 F.3d 235, 243 (3d Cir.2004) (“A certificate of compliance with federal health care law is a prerequisite to eligibility under the Medicare program.”); United States ex rel. Ortega v. Columbia Healthcare, Inc., 240 F.Supp.2d 8, 13 n. 5 (D.D.C.2003) (holding that “[c]ompliance with [the Anti-Kickback Statute] is a condition for reimbursement under Medicare”); United States v. Ruttenberg, 625 F.2d 173, 177 n. 9 (7th Cir.1980) (stating that Congress need not “have spelled out duties, beyond the duty of avoiding receipt and payment of kickbacks”); United States ex rel. Lisitza v. Johnson & Johnson, 765 F.Supp.2d 112, 127 (D.Mass.2011) (Stearns, J.) (“The court agrees that in the case of the [Anti-Kickback Statute], compliance is not merely a condition of participation in federal health care programs, but is also material to the government’s decision to pay any claim resulting from a kickback.”); United States ex rel. Fry v. The Health Alliance of Greater Cincinnati No. L03-CV-00167, 2008 WL 5282139, at *12 (S.D.Ohio Dec. 18, 2008) (“The claims at issue in this case ... involve certification of compliance with the Anti-Kickback Statute, a condition of government payment.”); United States ex rel. Thomas v. Bailey, No. 4:06CV00465 JLH, 2008 WL 4853630, at *8 (E.D.Ark. Nov. 6, 2008) (“[C]ase law supports the proposition that compliance with the Anti-Kickback Statute is a condition of payment under [the federal health care programs, including Medicare].”); In re Pharmaceutical Indus. Average Wholesale Price Litig., 491 F.Supp.2d 12, 18 (D.Mass.2007) (Saris, J.) (“[T]he Medicare program requires providers to affirmatively certify that they have complied with the Anti-Kickback Statute; failure to comply with the kickback laws, therefore, is, in and of itself, a false statement to the government.”); United States ex rel. Smith v. Yale Univ., 415 F.Supp.2d 58, 91 (D.Conn.2006) (“Medicare Regulations and the CMS [Provider Agreement] expressly provide that certification is a precondition to governmental reimbursement. In order to obtain reimbursement and as a condition to governmental payment, providers must certify that they are in compliance with the terms on the [Provider Agreement].”); Bidani 264 F.Supp.2d at 615-16 (finding a violation of the Anti-Kickback Statute “material to the government’s treatment of claims for reimbursement” and that to find otherwise, “would put the government in the position of funding illegal kickbacks after the fact”); United States ex rel. Kneepkins v. Gambro Healthcare, Inc., 115 F.Supp.2d 35, 43 (D.Mass.2000) (O’Toole, J.) (holding that alleged violations of the Anti-Kickback Statute were sufficient to state a claim under the False Claims Act, despite no express certification of compliance with applicable law); United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 20 F.Supp.2d 1017, 1047 (S.D.Tex. 1998) (“[E]xplicit certifications of compliance with relevant healthcare laws and regulations ... provided evidence that the government conditioned its approval, payment and Defendants’ retention of payment funds on those certifications.”). The Defendants argue that none of these courts reached the “issue of first impression” whether the requirement of Anti-Kickback Statute compliance contained in the Provider Agreement’s certification “represents a lawful exercise of CMS’ administrative authority.” Joint Reply Mem. Supp. Defs.’ Mot. Partial J. Pleadings 1. Yet, even if no court explicitly undertook the analysis that the Defendants ask this Court to undertake today, it is difficult to imagine these judges all reaching the same conclusion if that conclusion were somehow contrary to the Medicare statutes and regulations. More importantly, the Defendants have cited no case reaching the opposite conclusion. This Court declines to deviate from well-established precedent that a provider must be in compliance with the Anti-Kickback Statute to seek and receive payment for a Medicare claim. Courts appear to have reached the conclusion that compliance with the Anti-Kickback Statute is a precondition of payment because, quite simply, kickbacks affect the government’s decision to pay. See, e.g., Rogan, 517 F.3d at 452 (“[I]nformation that a hospital has purchased patients by paying kickbacks has a good probability of affecting the [government’s] decision [to reimburse].”); Pogue, 238 F.Supp.2d at 264 (“Certification of compliance with the statute or regulation alleged to be violated must be so important to the contract that the government would not have honored the claim presented to it if it were aware of the violation.”); see also Lisitza, 765 F.Supp.2d at 127. This reasoning is consistent with the First Circuit’s focus on reading a materiality requirement into the False Claims Act as a limitation on the phrase “false or fraudulent,” rather than inquiring into the source of a particular precondition of payment. See Blackstone Med., 647 F.3d at 388 (citing Loughren, 613 F.3d at 306-07). Liability for the submission of a false claim can arise only where compliance with a precondition of payment is material, that is, capable of influencing the government’s decision to pay. See Amgen, 652 F.3d at 110-12; see also United States ex rel. Bierman v. Orthofix Int’l, N.V., 748 F.Supp.2d 123, 128 (D.Mass.2010) (Harrington, J.). Here, compliance with the Anti-Kickback Statute clearly factors into the government’s reimbursement decision; not only is the government unwilling to pay a claim that is the product of criminal conduct under the Anti-Kickback Statute, but also to submit such a claim for reimbursement is in effect to ask the government to fund criminality retroactively, a result specifically proscribed by the Anti-Kickback Statute. See 42 U.S.C. § 1320a-7b(b). “[T]he Government does not get what it bargained for when a defendant is paid by CMS for services tainted by a kickback.” Wilkins, 659 F.3d at 314; see Rogan, 517 F.3d at 452 (“The United States is entitled to guard the public fisc against schemes designed to take advantage of overworked, harried, or inattentive disbursing officers; the False Claims Act does this by insisting that persons who send bills to the Treasury tell the truth.”). The fact that the Provider Agreement identifies compliance with the Anti-Kickback Statute as a “requirement ] that the provider must meet and maintain in order to bill the Medicare program,” see Provider Agreement, is “dis-positive evidence” of its materiality. Blackstone Med., 647 F.3d at 394. Yet, even if the Provider Agreement did not identify compliance with the Anti-Kickback Statute as a precondition of payment, this materiality analysis strongly suggests that, because the government will not pay kickback-tainted claims, Anti-Kickback Statute compliance must be a precondition of payment. See id. (“If kickbacks affected the transaction underlying a claim, ... the claim failed to meet a condition of payment.”) 2. Legal Validity of CMS’s Procedure and Authority for Adopting the Provider Agreement The Defendants next contend that, even if Anti-Kickback Statute compliance as a payment precondition is not at odds with the Medicare statutes and regulations or the language of the Anti-Kickback Statute itself, the adoption of the Provider Agreement was procedurally flawed and undertaken without proper agency authority. Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 10-19. The Defendants acknowledge that, in adopting the Provider Agreement, CMS had to comply only with the Paperwork Reduction Act (“the PRA”) and did so, yet they argue that the agency’s procedure for including the certification of Anti-Kickback Statute compliance in the Provider Agreement “cast a heavy cloud over its purported administrative interpretation that Medicare conditions payment on [Anti-Kickback Statute] compliance.” Id. at 14. In making this argument, the Defendants recite the history of the creation of the Provider Agreement, which the Relator does not dispute. In February 2001, in accordance with the PRA, CMS published notice of revisions to the Provider Agreement, which included the addition of the certification. Agency Information Collection Activities: Proposed Collection; Comment Request, 66 Fed.Reg. 8807 (Feb. 2, 2001); Decl. James M. Becker (“Becker Deck”), Ex. 5 (“Supporting Statement for Paperwork Reduction Act Submissions”), ECF No. 369-5. In July 2001, also in accordance with the PRA, CMS submitted the revised form to the Office of Management and Budget (“OMB”) for approval. See Becker Deck, Exs. 6a-6b (“Medicare Federal Health Care Provider/Supplier Enrollment Application I”), ECF Nos. 369-6, 369-7. In September 2001, OMB approved the revised Provider Agreement, but “under the firm condition that in the next few months, [it is] republished and opened for public comment along with the proposed rules governing provider enrollment .... [because] it would have been most beneficial to initially release [the Provider Agreement] with [the] proposed rule[s] so that the public could review all of CMS’ enrollment policies as a comprehensive package.” Becker Deck, Ex. 3 (“Notice of Office of Management and Budget Action I”), ECF No. 369-3. Thus, although CMS had complied with the PRA with respect to developing the Provider Agreement, OMB gave it only conditional approval because CMS had yet to engage in Medicare enrollment rulemaking pursuant to the Administrative Procedure Act (“the APA”), and these rules would “have implications for the burden and practical utility of [the Provider Agreement].” Id. In 2003, in accordance with OMB’s mandate, CMS published its proposed rules, along with the Provider Agreement. Medicare Program; Requirements for Establishing and Maintaining Medicare Billing Privileges, 68 Fed.Reg. 22064 (Apr. 25, 2003). CMS explained that its proposed rules “would require that all providers and suppliers ... complete an enrollment form and submit specified information to us, and periodically update and certify to the accuracy of the enrollment information, to receive and maintain billing privileges in the Medicare program.” Id. at 22064. This time, however, the Provider Agreement did not contain the reference to compliance with the Anti-Kickback Statute within the certification clause. Rather, it stated simply: I agree to abide by the Medicare laws, regulations and program instructions that apply to me. The Medicare laws, regulations and program instructions are available through the Medicare contractor. Becker Deck, Exs. 7a-7c (“Medicare Federal Health Care Provider/Supplier Enrollment Application II”), ECF Nos. 369-8 to 369-10; see 68 Fed.Reg. at 22075. CMS explained that the form had been changed “to provide a better understanding of Medicare policy.” 68 Fed.Reg. at 22074. After receiving comments and republishing the enrollment application in July 2005, see Agency Information Collection Activities: Proposed Collection; Comment Request, 70 Fed.Reg. 39513 (July 8, 2005), CMS issued its final enrollment rules in April 2006, see Medicare Program; Requirements for Providers and Suppliers To Establish and Maintain Medicare Enrollment, 71 Fed.Reg. 20754 (Apr. 21, 2006). The rules added 42 C.F.R. § 424.510(d)(3), which states that a provider, in signing the certification clause of the Provider Agreement, attests to his compliance with “all applicable statutes, regulations, and program instructions.” This time the full certification was again included in the form; in other words, CMS reverted back to the 2001 version, which explicitly refers to the Anti-Kickback Statute. 71 Fed.Reg. at 20764. In so doing, CMS indicated that it had “considered” “comments regarding the provider/supplier enrollment applications that were published in 2001.” Id. OMB thereafter approved the final rules and the revised Provider Agreement. Becker Deck, Ex. 8 (“Notice of Office of Management and Budget Action II”), ECF No. 369-11. The Defendants argue that this amounts to a “checkered procedural history” because the only version of the Provider Agreement ever published in the Federal Register was the 2003 version that did not contain the certification of Anti-Kickback Statute compliance. Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 16. This is an inaccurate statement. In July 2005, in accordance with the PRA, CMS published in the Federal Register a “proposed collection[ ]” of information, inviting public comments on the Provider Agreement and including an online link to it. 70 Fed.Reg. at 39513. Not only did this satisfy the PRA, which even the Defendants concede is the applicable statute for publication of the Provider Agreement, but also it provided notice and an opportunity for comments under the more stringent, but ultimately inapplicable, requirements of the APA. Even though CMS, in its final publication of the form, did not specify what led it to revert back to the 2001 version, “ ‘notice’ provisions are neither invariably nor primarily designed to afford exhaustive disclosure, but to alert interested parties that their substantive rights may be affected” by the rule change. Visiting Nurse Ass’n of North Shore, Inc. v. Bullen, 93 F.3d 997, 1010 (1st Cir.1996), overruled on different grounds by Long Term Care Pharmacy Alliance v. Ferguson, 362 F.3d 50, 57 (1st Cir.2004); see Natural Res. Def. Council, Inc. v. United States Envtl. Prot. Agency, 824 F.2d 1258, 1283 (1st Cir.1987) (holding that even substantial changes to a proposed rule are allowed, so long as they keep with the character of the original scheme and extend logically from the notice and comment period); Athens Cmty. Hosp. v. Heckler, 565 F.Supp. 695, 699 (E.D.Tenn.1983) (“The Secretary [of HHS] need not respond to all specific issues raised in comments on [a] proposed rule.”). Because the Provider Agreement was properly enacted, the Court rejects the Defendants’ argument that it is procedurally infirm. Finally, the Defendants argue that CMS lacked authority under the Medicare statutes and regulations to adopt the Provider Agreement and that, accordingly, the form is not entitled to deference by this Court. Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 12-13. Each time CMS published the Provider Agreement pursuant to the PRA, it included a statement of its “[sjpecific [authority to [cjollect [ejnrollment [information.” See, e.g., 68 Fed. Reg. 22064. The most relevant statutory provision identified reads: The Secretary shall periodically determine the amount which should be paid under this part to each provider of services ... except that no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such providers under this part for the period with respect to which the amounts are being paid or any prior period. 42 U.S.C. § 1395g(a); see id. § 1395Z(e) (“No payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.”). The Defendants argue that this provision “is not a license for CMS to create payment conditions in addition to ones established by Congress.” Mem. Supp. INN & ASD’s Mot. Partial J. Pleadings 13. The First Circuit has interpreted 42 U.S.C. § 1395g(a) to “grant[] the Secretary broad discretion ... in determining what information is required from providers as a condition of payment.” Visiting Nurse Ass’n Gregoria Auffant, Inc. v. Thompson, 447 F.3d 68, 77 (1st Cir.2006) (emphasis added). This clearly supports the validity of CMS’s inclusion of the Anti-Kickback Statute certification in the Provider Agreement “as a condition of payment.” The Defendants, however, argue that this First Circuit precedent is inapposite because the court was interpreting a precondition of payment expressly stated in 42 U.S.C. § 1395f(b)(1)(A) regarding reimbursement only for “the reasonable cost” of Medicare services. See Joint Reply Mem. Supp. Defs.’ Mot. Partial J. Pleadings 4. While the Defendants are correct that the Visiting Nurse Association Gregoria Auffant court was interpreting an express precondition, here compliance with the Anti-Kickback Statute is an implied but nonetheless definitive precondition of government payment. To hold that the Secretary cannot require information from providers with respect to this firmly established precondition would be to undercut his “broad discretion as to what information to require as a condition of payment to providers under the Medicare program.” Community Hosp. of Monterey Peninsula v. Thompson, 323 F.3d 782, 790 (9th Cir.2003). “Since ‘Congress has explicitly left [this] gap for the agency to fill,’ any regulation regarding the issue must be ‘given controlling weight unless [it is] arbitrary, capricious, or manifestly contrary to the statute,’ ” which it is not. Id. (quoting Chevron U.S.A, Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843-44, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984)). CMS has not exceeded its authority under 42 U.S.C. § 1395g(a) by requiring providers to certify their compliance with the Anti-Kickback Statute as a precondition of Medicare payment. Furthermore, the Provider Agreement is a valid agency interpretation of its own regulation 42 C.F.R. § 424.510(d)(3), which states that, when a provider signs the Provider Agreement, he or she “attests that the information submitted is accurate and that the provider ... is aware of, and abides by, all applicable statutes, regulations, and program instructions.” “Where Congress has entrusted rulemaking and administrative authority to an agency, courts normally accord the agency particular deference in respect to the interpretation of regulations promulgated under that authority.” South Shore Hosp., Inc. v. Thompson, 308 F.3d 91, 97 (1st Cir.2002). “[S]o long as it is ‘reasonable,’ that is, so long as the interpretation ‘sensibly conforms to the purpose and wording of the regulations,’ ” courts should give effect to the meaning that an agency has attached to its own regulation. Martin v. Occupational Safety & Health Review Comm’n, 499 U.S. 144, 150-51, 111 S.Ct. 1171, 113 L.Ed.2d 117 (1991) (internal citations omitted). Here, CMS reasonably interpreted 42 C.F.R. § 424.510(d)(3), specifically its phrase “abides by ... all applicable statutes,” to include compliance with the Anti-Kickback Statute, such that providers may be required to certify their compliance to seek Medicare reimbursement. In the absence of any plain error or inconsistency with the Medicare statutes or regulations, see South Shore Hosp., 308 F.3d at 97, the Court defers to this reasonable interpretation of the agency’s own regulation, which itself properly was enacted pursuant to the Secretary’s statutorily-granted authority to administer the Medicare program. Although the Defendants attempt to style their motion as raising novel issues of law, this Court follows the well-established holding of numerous other circuit and district courts that compliance with the Anti-Kickback Statute is a precondition of Medicare payment, even if not expressly stated in the Medicare statutes and regulations or the Anti-Kickback Statute itself. The Provider Agreement, which requires providers to certify their compliance with the Anti-Kickback Statute, was adopted in accordance with the PRA and represents a valid exercise of CMS’s regulatory authority entitled to judicial deference. Its certification clause is consistent with the Medicare statutes and regulations as well as the purpose of the Anti-Kickback Statute. The Defendants’ Motion for Judgment on the Pleadings is denied. III. CROSS-MOTIONS FOR PARTIAL SUMMARY JUDGMENT ON COUNT IV OF RELATOR’S FOURTH AMENDED COMPLAINT A. Facts in the Light Most Favorable to Amgen Amgen manufactures biologies, including Aranesp and the related drug EPOGEN. Amgen’s Resp. Relator’s Rule 56.1 Statement Facts Supp. Mot. Partial Summ. J. (“Amgen’s Resp. SOF”) ¶ 1, ECF No. 430. In 1985, Amgen entered into a Product License Agreement with Ortho Pharmaceutical Corporation (“Ortho”), a subsidiary of Johnson & Johnson, by which Am-gen gained the exclusive right to market EPO (under the name “EPOGEN”) in the United States fo