United States ex rel. Modglin v. DJO Global Inc. (48 F. Supp. 3d 1362, 2014)

ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS THE SECOND AMENDED COMPLAINT

MARGARET M. MORROW, District Judge.

Qui tam relators Doris Modglin and Russ Milko filed this action against defendants DJO Global Inc. (“DJO Global”), DJO, LLC (“DJO”), DJO Finance LLC (“DJO Finance”), Orthofix, Inc. (“Ortho-fix”), Biomet, Inc. (“Biomet”), and EBI, LP (“EBI”) under seal and in camera on August 20, 2012. Relators invoked the court’s federal question jurisdiction under 28 U.S.C. § 1331, and alleged a single claim for violation of the False Claims Act (“FCA”), 31 U.S.C. § 3729(a)(1)(A) & (B). On December 26, 2012, they filed a first amended complaint, realleging the federal FCA claim and alleging state FCA claims under the equivalent statutes of 29 states: California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Virginia, and Wisconsin. On May 17, 2013, the United States declined to intervene in the case. On July 19, 2013, each of the 29 states also declined to intervene. The court unsealed the amended complaint that day.

On October 3, 2013, pursuant to a request by relators, the court dismissed Or-thofix. On November 8, 2013, relators filed a second amended complaint, restating their federal and state FCA claims and adding EBI, LLC (also “EBI”) as a defendant. On January 22, 2014, the parties filed a stipulation to dismiss DJO Global and DJO Finance as defendants; the court entered an order on the stipulation on January 28, 2014. On February 20, 2014, the court granted defendants’ motion to stay discovery until it decided their pending motion to dismiss the second amended complaint.' Relators oppose the dismissal motion. On May 5, 2014, the court held a hearing on the motion. Following the hearing, the court took the motion under submission and directed the parties to file supplemental briefs addressing four questions. The parties did so on July 7, 2014.

I. FACTUAL BACKGROUND

Relators assert that defendants — manufacturers and distributors of durable medical equipment (“DME”) — fraudulently caused the government to disburse money by filing claims with Medicare and other federal healthcare plans for reimbursement ' of their provision of noninvasive, bone-growth stimulators (“stimulators”) which they knew had been prescribed by physicians for an off-label purpose, i.e., one not specifically approved by the Food and Drug Administration (“the FDA”). Defendants allegedly failed to reveal to Medicare and other federal healthcare plans that the stimulators were to be used for off-label purposes. Before one can understand the allegations in the complaint, it is necessary to provide an overview of the statutory and regulatory scheme that governs both FDA approval of medical devices and the coverage of such devices by Medicare and other federal programs. The court begins with background on FDA approval of medical devices.

A. Background Regarding FDA Approval of Medical Devices

One of the “core objectives” of the Food, Drug, and Cosmetic Act (“the FDCA”), 21 U.S.C. § 301 et seq., is to ensure that “there is reasonable assurance of the safety and effectiveness of devices intended for human use.” Food and Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133-34, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (citing 21 U.S.C. § 393(b)(2)). To that end, the FDCA classifies medical devices in three categories: Classes I, I, and III. 21 U.S.C. § 360c(a). Class III devices include those that present a potential unreasonable risk of illness or injury. Id., § 360c(a)(l)(C). Because of the risk associated with such devices, the FDA has determined that manufacturers of such devices must submit premarket approval- (“PMA”) applications to the FDA and obtain premarketing clearance before offering the devices for sale. 42 C.F.R. § 405.201(b). Class III devices that do not have PMA approval cannot be marketed and are considered “adulterated.” 21 U.S.C. § 351(f)(1)(B) (“A ... device shall be deemed to be adulterated ... if it is a class III device ... which ... is required to have in effect an approved application for premarket approval ... and ... which has an application which has been suspended or is otherwise not in effect”); 42 C.F.R. § 405.201(b).

PMA approval is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is “a ‘rigorous’ process in which the manufacturer submits to the FDA extensive study reports, design specifications and descriptions, samples of the device, and proposed labeling, and the FDA conducts a comprehensive review and evaluation of all the submitted documents and materials[.]” Kashani-Matts v. Med-tronic, Inc., No. SACV 13-01161-CJC (RNBx), 2013 WL 6147032, *1 (C.D.Cal. Nov. 22, 2013).

If a medical device is used for a purpose other than that for which it has obtained PMA approval, the usage is “off-label.” Carson v. Depuy Spine, Inc., 365 Fed. Appx. 812, 815 (9th Cir.2010) (Un-pub.Disp.) (“Drugs and medical devices are approved or cleared by the FDA for marketing with labels describing the uses and the patient conditions which have been reviewed in the approval or clearance process. Any use by a physician which differs from the use described in the label or from the patient conditions described in the label is called ‘off-label’ ”). The FDCA explicitly protects physicians’ abilities to prescribe devices for such use. 21 U.S.C. § 396 (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship”); see also Houston v. Medtronic, Inc., No. 2:13— cv-01679-SVW (SHx), 2014 WL 1364455, *1 n. 1 (C.D.Cal. Apr. 2, 2014) (“Physicians are permitted to use Class III devices in off-label manners”). Indeed, off-label use of medical devices is “generally accepted” within the medical community, and section 396 of the FDCA “expressly disclaims any intent to directly regulate the practice of medicine.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 & n. 5, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (citing Beck & Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 FOOD & DRUG L.J. 71, 72 (1998) (“Off-label use is widespread in the medical community and often is essential to giving patients optimal medical care, both of which medical ethics, FDA, and most courts recognize”)); see also Kashani-Matts, 2013 WL 6147032 at * 1 n. 4 (“The FDA does not prohibit or regulate off-label use of medical devices by medical professionals, and the Supreme Court has emphasized that off-label use is not merely legitimate but important in the practice of medicine,” citing Buckman, 531 U.S. at 350,121 S.Ct. 1012).

The FDCA does, however, expressly prohibit class III device manufacturers from marketing a PMA-approved device for an off-label use. 21 U.S.C. § 331 (proscribing, inter alia, “[t]he introduction ... into interstate commerce of any ... device ... that is adulterated or misbranded”); 21 C.F.R. § 814.80 (stating that once the FDA has approved a PMA application, the manufacturer of the approved device may not manufacture, package, store, label, distribute, or advertise the device in a manner that is inconsistent with any conditions of approval specified in the PMA approval order for the device). Because off-label usage of medical devices “is an accepted and necessary corollary of the FDA’s mission to regulate in th[e] [medical field] without directly interfering with the practice of medicine,” however, Buckman, 531 U.S. at 349-50,121 S.Ct. 1012, “a manufacturer is not liable [for having violated the FDCA] merely because it sells a device with knowledge that the prescribing doctor intends an off-label use,” Carson, 365 Fed. Appx. at 815. The manufacturer can only be liable for violating the FDCA if it markets or promotes the device for that purpose. If a device manufacturer wishes to market a device for an off-label purpose, it must submit a PMA supplement for review and approval by the FDA. 21 C.F.R. § 814.39.

B. Facts Alleged in the Second Amended Complaint Regarding FDA Approval of Defendants’ Stimulators

Relators allege that DJO, Biomet, and EBI — a wholly owned subsidiary of Biom-et' — manufacture and market DME, including stimulators, throughout the United States. They assert that the FDA categorizes stimulators as class III devices, meaning that they must receive PMA approval before they can be marketed. More specifically, they allege that DJO manufactures and markets a stimulator called the SpinaLogic, and that the FDA has approved the SpinaLogic as an adjunct electrical treatment to primary lumbar spinal fusion surgery under PMA Number P910066. Biomet and EBI allegedly manufacture and market a stimulator called the SpinalPak. The FDA has approved the SpinalPak as an adjunct electrical treatment to primary lumbar spinal fusion surgery under PMA Number P850022.

C. Background Regarding Medicare Coverage of Medical Devices

1. Coverage Determinations by Medicare

The Medicare program is a fed- • erally funded health insurance program for the aged and disabled created by the Social Security Act (“the Medicare Act”), 42 U.S.C. § 1395 et seq. See International Rehabilitative Sciences Inc. v. Sebelius, 688 F.3d 994, 997 (9th Cir.2012) (“Medicare is the federal health insurance program for the elderly and disabled”). Part B of the Medicare Act provides medical insurance for medical and other health services obtained by individual plan participants; this includes stimulators and other DME provided to Medicare patients by a DME provider. Id. (citing 42 U.S.C. §§ 1395j, 1395k(a)(2), 1395m). Under Part B, “Medicare beneficiaries receive medical treatment and the providers submit claims for government reimbursement.” Id. (citing § 1395n). Under the Medicare Act, only devices that are “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member” can be reimbursed. 42 U.S.C. § 1395y(a)(l)(A). This limitation on coverage is a method of controlling Medicare costs. International Rehabilitative Sciences, 688 F.3d at 997. Under the Act,

“[a] device is not ‘reasonable and necessary1 — and thus is not eligible for Medicare coverage — if it is: [1) ] Not ‘safe’ and ‘effective’ — that is, if the device has not ‘been proven safe and effective based on authoritative evidence’ or is not ‘generally accepted in the medical community as safe and effective for the condition for which it is used’; [2) ] ‘[Experimental’ — that is, ‘investigational’; [3) ] Not ‘[appropriate’ for the individual beneficiary’s needs; or [4) ] ‘[Substantially more costly than a medically appropriate and realistically feasible alternative pattern of care.’ ” Id. (citing § 1395y(a)(l)(A) and 54 Fed.Reg. 4302, 4303-04 (Jan. 30, 1989); 60 Fed.Reg. 48417, 48418 (Sept. 19,1995)). '

Cf. Medicare Program Integrity Manual § 13.7.1. (stating that “[i]n order of preference, [local coverage determinations] should be based on: [1] Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and [2] General acceptance by the medical community (standard of practice), as supported by sound medical evidence”). “[The Centers for Medicare and Medicaid Services (‘CMS’) ] uses the FDA categorization of a device as a factor in making Medicare coverage decisions.” 42 C.F.R. § 405.201(a)(1). Thus, under this scheme, “FDA clearance [ ] is necessary, but not sufficient, for Medicare coverage .... To be ‘reasonable and necessary’ for treatment, a device must be ‘safe and effective,’ but other considerations are also relevant — like whether there are less costly but equally effective devices available.” International Rehabilitative Sciences, 688 F.3d at 1002 (emphasis omitted).

In its Medicare National Coverage Determinations Manual (“the Medicare Manual”), the Department of Health and Human Services (“HHS”) has considered the FDA categorization of devices and determined generally that “[d]evices that may be covered under Medicare include the following categories: [1] Devices approved by the FDA through the Pre-Market Approval (PMA) process; [2] Devices cleared by the FDA through the 510(k) process; [3] FDA-approved IDE Category B devices; and [4] Hospital Institutional Review Board (IRB) approved IDE devices.”

Within these general categories of devices eligible for coverage, HHS “may make [Medicare] coverage determinations [for certain types of devices] via up-front rules.” The agency, however, has “discretion ... whether to make [broad] determinations [as to whether a particular device is reimbursable] ... or [whether to have Medicare contractors make that decision based on a] case-by-case adjudication.” Id. at 1001. When HHS engages in rule-making regarding the scope of coverage for certain devices, it issues National Coverage Decisions (“NCDs”). “An NCD is a determination ... of whether a particular item or service is covered nationally under Medicare.” 42 C.F.R. § 405.1060(a)(1). NCDs are compiled in the Medicare Manual. “Once published ..., an NCD is binding on all Medicare carriers.” Almy v. Sebelius, 679 F.3d 297, 299 (4th Cir.2012) (“[T]he Secretary [of HHS] can make a ‘national coverage determination’ (NCD) binding throughout the Medicare system and not subject to review by administrative law judges”); see also 42 C.F.R. § 405.1060(a)(4) (“An NCD is binding on fiscal intermediaries, carriers, ... [administrative law judges], and the [Medicare Appeals Council],” among others). Additionally, individual carriers — the private insurance carriers with whom HHS contracts to administer claims — can issue Local Coverage Determinations (“LCDs”). LCDs address local coverage issues. Almy, 679 F.3d at 299-300. If no NCD or LCD addresses a particular device, contractors determine coverage on a case-by-case basis. Id. at 300 (“Finally, if no NCD ar LCD is in place, ‘contractors may make individual claim determinations,’ including whether a particular DME meets the statutory requirement of being ‘reasonable and necessary’ ” (citing 68 Fed.Reg. 63,-693)).

The reimbursement of stimulators is covered by NCD 150.2. NCD 150.2 states that stimulators are covered by Medicare for six uses, one of which is “as an adjunct to spinal fusion surgery” for certain patients. There are also four LCDs that address the coverage of stimu-lators. Each mirrors the criteria set forth in NCD 150.2, in that it provides that stimulators are covered, inter alia, “as an adjunct to spinal fusion surgery.” Neither NCD 150.2 nor the four LCDs covering stimulators distinguish between stimu-lators used on one part of the spine, e.g., the cervical spine, versus another, e.g., the lumbar spine. Nor do they distinguish between stimulators based on on-label versus off-label use.

NCD 280.1, the “Durable Medical Equipment Reference List” is a “quick reference tool” that applies “(where appropriate) to all DME national coverage determinations (NCDs).” It provides a list of

“generic categories of equipment on which NCDs have been made by ... CMS.... In the case of equipment categories that have been determined by CMS to be covered under the DME benefit, the list outlines the conditions of coverage that must be met if payment is to be allowed for the rental or purchase of the DME by a particular patient, or cross-refers to another section of the manual where the applicable coverage criteria are described in more detail. With respect to equipment categories that cannot be covered as DME, the list includes a brief explanation of why the equipment is not covered.... When the contractor receives a claim for an item of equipment which does not appear to fall logically into any of the generic categories listed, the contractor has the authority and responsibility for deciding whether those items are covered under the DME benefit. These decisions must be made by each contractor based on the advice of its medical consultants, taking into account: [1] The Medicare Claims Processing Manual, Chapter 20, ‘Durable Medical Equipment, Prosthet-ics and Orthotics, and Supplies’ (DME-POS)[;] [2] Whether the item has been approved for marketing by the Food and Drug Administration (FDA) and is otherwise generally considered to be safe and effective for the purpose intended; and [3] Whether the item is reasonable and necessary for the individual patient.”

NCD 280.1 thus serves as a first point of reference for contractors attempting to determine whether a certain device or a certain use of a device is covered. Specifically, it provides an index of some of the national coverage determinations Medicare has made. It lists some devices that are covered and refers the reader to the NCD controlling that device. It also lists some devices that are not covered and articulates why HHS has determined that that device cannot be covered. For devices that HHS has not explicitly declared covered or uncovered, NCD 280.1 sets forth the factors a contractor must consider in making a case-by-case coverage determination. NCD 280.1 is not comprehensive, however. Certain devices that are covered by a particular NCD are not referenced in NCD 280.1. This is because NCD 280.1 was meant only to aid in determining coverage for “certain pieces of DME and especially for those items commonly referred to by both brand and generic names.” As the NCDs are binding on Medicare contractors, the contractors must follow an NCD dictating coverage for a certain device, even if that device is not listed in NCD 280.1.

2. The Reimbursement Process

To submit a claim for reimbursement, DME providers fill out and submit to Medicare CMS Form 1500. Section 23 of the form includes a space for the provider to list any PMA approval number covering the device for which it seeks reimbursement. Providers seeking reimbursement for stimulators must also include a “KF” modifier on CMS Form 1500, which indicates that the provider is billing Medicare for a Class III device.

Together with CMS Form 1500, the provider must submit a Certificate of Medical Necessity. The Certificate of Medical Necessity used for class III stim-ulators is CMS 847. CMS 847 has four sections. Section A seeks general information concerning the patient, physician, and supplier. Section B requests information regarding the medical necessity for the device, and states: “Information in this Section May Not Be Completed by the Supplier of the Items/Supplies.” Section C provides space for a “Narrative Description of Equipment and Cost.”• Section C of CMS 847 instructs the person completing the form to provide a “(1) Narrative description of all items, accessories and options ordered; (2) [the] Supplier’s charge; and (3) [the] Medicare Fee Schedule Allowance for each item, accessory, and option.” Section D is the physician’s attestation and signature.

The DME provider must also include the Healthcare Common Procedure Coding System (“HCPCS”) number for the device for which it is requesting reimbursement on both CMS Form 1500 and CMS 847. There is a generic HCPCS code number for all stimulators: E0748.

By regulation, DME providers seeking reimbursement must furnish sufficient information to Medicare’s claim processing contractors that they can determine whether payment is due. 42 C.F.R. § 424.5(a)(6) (“As a basis for Medicare payment, the following conditions must be met: ... The provider, supplier, or beneficiary, as appropriate, must furnish to the intermediary or carrier sufficient information to determine whether payment is due and the amount of payment”).

D. Facts Alleged in the Second Amended Complaint Regarding Defendants’ Submission of Claims to the Medicare Program

Relators allege that defendants are approved Medicare DME providers. To retain that status, defendants purportedly must certify every three years that they meet and will continue to meet all applicable federal and state licensure and regulatory requirements.

Relators allege that when a physician prescribes a stimulator manufactured by one of the defendants, a local distributor under contract to the defendant collects relevant medical records and prescriptions and forwards them to an insurance administrator at the defendant’s home offices. The insurance administrator and claims processor then prepare and submit claims to Medicare and other insurance carriers. Relators assert that since approximately September 18, 2001, defendants have routinely submitted false or fraudulent claims for stimulators to Medicare. Specifically, they allege that defendants have requested reimbursement for stimulators approved for lumbar spinal use only when they knew, and did not reveal, that the stimu-lators had been distributed for off-label cervical spinal use. Relators contend that stimulators are nonreimbursable if they are not distributed for the use for which they have PMA approval. They allege that, by indicating on CMS Form 1500 a PMA approval number for a stimulator approved only for lumbar, and not for cervical, spinal use, defendants expressly or implicitly misrepresent the device’s intended use. Stated differently, they contend that by reporting their stimulator’s PMA approval number on CMS Form 1500, defendants affirmatively represent that the stimulator will be used on the lumbar spine when they know it will be used on the cervical spine instead. Rela-tors assert that, because there is only one HCPCS code covering stimulators used on all parts of the spine, and because defendants’ stimulators are only approved for use on the lumbar spine, unless defendants specifically indicate in the narrative description portion of CMS 847 that the device has been distributed for an off-label use, they violate the requirement that they furnish sufficient information for Medicare’s claim processing contractors to determine whether payment is due. Rela-tors also contend that by not indicating in the narrative description portion of CMS 847 that the stimulator is being distributed for an off-label use, defendants expressly and/or impliedly misrepresent that the stimulator is being distributed and used as indicated in the PMA approval and that it is therefore reimbursable.

As proof that defendants have submitted such claims for reimbursement, rela-tors plead facts concerning their interactions with defendants over the years. They allege that in 1997, relator Milko was hired as a direct sales representative for Orthofix to promote and sell stimulators. Orthofix is a major manufacturer and distributor of stimulators and defendants’ primary competitor. Orthofix manufactures and distributes the only stimulator with PMA approval for cervical use: the Cervical-Stim. Orthofix developed the Cervical-Stim after the FDA issued a public warning in 1997 that Orthofix had been unlawfully marketing its Physio-Stim stimulator for cervical use because it did not have PMA approval for the use of the device in that manner; Orthofix’s PMA approval for the Physio-Stim covered only use for “the treatment of nonunion of long bone fractures acquired secondary to trauma and for the treatment of flat bones, excluding vertebra.” The warning letter concluded that use of the Physio-Stim for treatment of cervical spine fusion was “a change in indication that require[d] a PMA supplement” if Orthofix intended to continue marketing the device for that purpose.

Relators allege that on July 1, 2005, Milko became an Orthofix distributor and that he has continued in that capacity since then, marketing and selling the Cervical-Stim and Orthofix’s other, non-cervical stimulators. They assert that because of his position with Orthofix, Milko learned that defendants were distributing their stimulators for off-label, cervical use. Specifically, they allege that Milko heard that PJO sales personnel verbally instructed patients to use the SpinaLogic by folding it up, placing a pillow over it, and lying their head on the pillow for 30 minutes and that they reassured doubtful patients that the device worked better on the cervical spine than on the lumbar spine although not approved for that use because the cervical spine was a smaller area to heal.

In April 2011, a sales associate working for Milko left his employ and went to work for DJO; the associate sold the SpinaLogic in the same geographic area in which Mil-ko sold Orthofix products. • Milko lost “some of his best physician referral sources, including physicians who regularly referred Medicare patients for cervical bone growth stimulators, even though [as noted,] Orthofix sold the only approved cervical device.” As a result, Milko concluded that DJO must have filled cervical stimulator prescriptions for his former physician clients with the SpinaLogic and charged Medicare and other federally sponsored health care programs for it.

Relators assert that Milko sued his former associate for violating a non-competition agreement. During the lawsuit, Mil-ko deposed two referring physicians, both of whom are Medicare providers who perform lumbar and cervical spine fusion surgeries. Both doctors testified that they had ordered stimulators from Milko’s former associate.

Relators allege that on June 21, August 30, and September 1, 2011, the Spine and Brain Institute in Las Vegas, Nevada,' faxed prescriptions on behalf of Dr. John Anson, the ordering physician, to the local DJO sales representative for SpinaLogic; the institute indicated that the patients were Medicare beneficiaries and were diabetic. On February 2, 2012, DJO submitted a claim to the Minnesota Health Care Programs for a stimulator to be used following cervical fusion surgery. The Minnesota program paid DJO $835.82.

In August 2012, DJO’s Regional Sales Director and a DJO sales representative told relator Modglin, a private investigator licensed by the state of California, that DJO routinely billed federally sponsored health care programs like Medicare and Medicaid for off-label distribution of Spina-Logic for use on the cervical spine. In March 2013, Milko attended the national convention of the American Academy of Orthopedic Surgeons in Chicago. There, he spoke with DJO representatives, who told him that in some areas of the country, at least 75 % of DJO’s business came from selling the SpinaLogic for cervical use. Relators assert that at some point, two patients told Milko when he fitted them with lumbar stimulators that they had previously been fitted with the SpinaLogic following prior, cervical spinal surgeries.

In May 2013, Orthofix’s sales representative in Temecula, California, switched companies and began to sell the SpinaLogic. After two weeks, the representative returned to Orthofix. Relators contend that while working for DJO, DJO upper management told the sales representative that 40% of the company’s SpinaLogic business involved off-label, cervical spine applications. •

As respects the SpinalPak manufactured by Biomet and EBI, relators allege that Milko has provided replacement Cervical-Stims to Medicare patients who complained that their use of the SpinalPak on the cervical spine caused skin irritation on their necks. Relators assert that Milko confirmed these complaints by observing large, red skin irritations on the patients. The patients purportedly said that Biomet and EBI representatives told them to use the SpinalPak only for a couple of hours per day, as tolerated.

On February 16 and March 10, 2010, and on March 18, 2011, Biomet and EBI submitted claims to the Minnesota Health Care Programs for off-label stimulators under Code E0748, for use following cervical spinal fusion surgery. They were paid $817.05, $3,901.41, and $3,897.50 on the claims, respectively.

Relators allege that on September 5, 2012, Dr. David Ketroser, a neurologist, contacted the office of a neurosurgeon in Minnesota. An employee confirmed that the office routinely prescribed the Spinal-Pak for cervical and lumbar fusions, for both Medicare and non-Medicare patients, and that it had done so for a particular patient Ketroser had referred.

On May 20, 2013, Milko asked a former Biomet distributor who now sells Orthofix devices how Biomet succeeded in securing Medicare payment for a lumbar-only device when the physician’s order indicated cervical application. The individual purportedly told him that neither the CMS 847 Form nor the E0748 billing code reveal the level of the spine for which the device was ordered. On May 29, 2013, a former Biomet sales representative told Modglin that she had sold Biomet’s devices off-label to Medicare patients for use on the cervical spine. On May 31, 2013, a former Biomet sales representative told Modglin that he had sold the SpinalPak to Medicare and Medicaid patients in Texas between 2009 and 2011 for use on the cervical spine.

E. The Parties’ Requests for Judicial Notice

The parties request, in both their original and supplemental briefs, that the court take judicial notice of certain documents they contend are relevant to this motion. All of the applications are unopposed. In deciding a Rule 12(b)(6) motion, the court generally looks only to the face of the complaint and documents attached thereto. Van Buskirk v. Cable News Network, Inc., 284 F.3d 977, 980 (9th Cir. 2002); Hal Roach Studios, Inc. v. Richard Feiner & Co., Inc., 896 F.2d 1542, 1555 n. 19 (9th Cir.1989). A court normally must convert a Rule 12(b)(6) motion into a Rule 56 motion for summary judgment if it “considers evidence outside the pleadings .... A court may, however, consider certain materials — -documents attached to the complaint, documents incorporated by reference in the complaint, or matters of judicial notice — without converting the motion-” United States v. Ritchie, 342 F.3d 903, 907-08 (9th Cir.2003). See Tel-labs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007) (a court may consider “other sources courts ordinarily examine when ruling on Rule 12(b)(6) motions to dismiss, in particular, documents incorporated into the complaint by reference, and matters of which a court may take judicial notice”); Branch v. Tunnell 14 F.3d 449, 453 (9th Cir.1994) (noting that a court may consider a document whose contents are alleged in a complaint, so long as no party disputes its authenticity), overruled on other grounds in Galbraith v. County of Santa Clara, 307 F.3d 1119 (9th Cir.2002). Under Rule 201, the court may judicially notice a fact that is “not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed. R.Evid. 201(b).

1. Relators’ Request for Judicial Notice

Relators request that the court judicially notice thirty-two documents. The documents fall into several general categories:

(1) Documents available on the FDA’s website: Comments by the BGS Reclassification Opposition Group in opposition to a petition for reclassification of bone-growth stimulators from Class III to Class II; FDA guidance on the PMA requirement; FDA guidance on PMA Supplements and Amendments; FDA guidance on “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices;” Implementation of the FDA/HCFA Interagency-Agreement Regarding Reimbursement Categorization of Investigational Devices; “Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices”; “Guidance for Industry and FDA Staff: Modifications to Devices Subject to Pre-market Approval (PMA) — The PMA Supplement Decision-Making Process”; FDA Docket re: petition that “Non-invasive Bone Growth Stimu-latorfs] be reclassified from Class III to Class II”; FDA decision denying “Orthopedic Devices: Reclassification of Non-invasive Bone Growth Stimulator”; PMA Supplements filed by DJO Global; FDA Approval Materials for SpinaLogic; PMA Supplements filed by EBI/Biomet; FDA Approval Materials for SpinalPak; FDA Approval Materials for Cervical-Stim;

(2) Documents available on the CMS Website: Medicare National Coverage Determinations Manual, Forward; Medicare National Coverage Determinations Manual, NCD 280.1; Medicare Program Integrity Manual, Chapter 13 — Local Coverage Determinations; Medicare Benefit Policy Manual, Chapter 14 — Medical Devices; Durable Medical Equipment, Prosthetics, Orthot-ics, and Supplies Quality Standards; Medicare Enrollment Application — Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Supplier; CMS Form 1500;

(3) A document available on the MediCal website: Medi-Cal Provider Agreement;

(4) Defendants’ SEC filings: DJO Finance’s Form 10-K for the fiscal year ending December 31, 2013, Biomet’s Form 10-K for fiscal year ending May 31, 2013;

(5) Court filings in other cases: Complaint in United States ex rel. Allen v. Guidant LLC, et al.; Order in United States ex. rel. Bui v. Vascular Solutions, Inc.; Brief for the United States as Amicus Curiae in United States ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., et al.; State of Texas’ Statement of Interest in United States ex. rel. Bergman v. Abbott Laboratories;

(6) Various insurance policies excluding from coverage stimulators used on the cervical spine: Federal Employee Program Policy Statement, Lifewise Health-plan of Oregon Policy Statement, Pre-mara Blue Cross Policy Statement; and

(7)Documents available on defendants’ and Orthofix’s websites: “CMF Spina-Logic” on DJO Global’s website; “Patient FAQ Brochure,” on Biomet’s website; Image of Cervical-Stim on Orthofix’s website. 113

Under Rule 201, the court can take judicial notice of “[pjublic records and government documents available from reliable sources on the Internet,” such as websites run by governmental agencies. See Hansen Beverage Co. v. Innovation Ventures, LLC, No. 08-CV-1166-IEG, 2009 WL 6597891, *1 (S.D.Cal. Dec. 23, 2009) (citing Jackson v. City of Columbus, 194 F.3d 737, 745 (6th Cir.1999)). See also Daniels-Hall v. National Education Association, 629 F.3d 992, 999 (9th Cir.2010) (taking judicial notice of information on the websites of two school districts because they were government entities); Paralyzed Veterans of Am. v. McPherson, No. C 06-4670, 2008 WL 4183981, *5 (N.D.Cal. Sept. 8, 2008) (“Information on government agency websites has often been treated as properly subject to judicial notice”). The court could, therefore, take judicial notice of the documents relators proffer from the websites of the FDA, CMS, Medi-Cal, and the SEC. The court will take judicial notice of most of these documents. Because the court declines to exercise supplemental jurisdiction over relators’ state law claims infra, it need not consider the Medi-Cal Provider Agreement relators ask the court to notice from the Medi-Cal website. To the extent rela-tors request that the court do so, the court denies their request for judicial notice.

As respects court orders and filings in other FCA cases, these documents, too, are the proper subject of judicial notice. See Reyn’s Pasta Bella, LLC v. Visa USA, Inc. 442 F.3d 741, 746 n. 6 (9th Cir.2006) (taking judicial notice of pleadings, memoranda, and other court filings); Asdar Group v. Pillsbury, Madison & Sutro, 99 F.3d 289, 290 n. 1 (9th Cir.1996) (court may take judicial notice of pleadings and court orders in related proceedings); United States ex rel. Robinson Ranchería Citizens Council v. Borneo, Inc., 971 F.2d 244, 248 (9th Cir.1992) (a court may take judicial notice “of proceedings in other courts, both within and without the federal judicial system, if those proceedings have a direct relation to matters at issue”). The court, however, declines to do so as it concludes that the documents are not relevant. The position the government took in the complaint in United States ex rel. Allen v. Guidant Corp. and the court’s analysis in the order issued in United States ex rel. Bui v. Vascular Solutions are not relevant to decision of the motion because both involved the marketing of a device for . off-label use, something relators do not allege here. The government’s position regarding the requirements of Rule 9(b) in United States ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., et al. is not binding on the court and thus is not relevant in deciding the motion. Finally, because the court declines to exercise supplemental jurisdiction over rela-tors’ state law claims, it need not consider the State of Texas’ Statement of Interest in United States, ex rel. Bergman v. Abbott Laboratories.

The court also declines to take judicial notice of the sixth category of documents relators identify because there is no basis upon which to take judicial notice of these documents. Policy statements by private insurance companies are not information generally known within the geographic territory of the court. Nor are they capable of accurate and ready determination .by resort to sources whose accuracy cannot reasonably be questioned. Although relators argue that they, offer the documents “for the limited purpose of demonstrating that not all insurance carriers will cover use of an osteogenic stimulator when the device is to be used for the cervical area of the spine,” they do not identify a basis upon which the documents can be judicially noticed. The fact that relators seek to have the court notice the documents for “a limited purpose” only does not make them a proper subject of judicial notice. Even if the court could take judicial notice of the insurance documents, moreover, it would conclude that they are irrelevant for purposes of deciding this motion. Whether other healthcare insurance plans cover a particular treatment is not probative as to whether Medicare likewise covers it. Accordingly, the court denies relators’ request that it take judicial notice of these documents.

Finally, the cohrt declines to take judicial notice of the seventh category of documents: documents available on defendants’ and Orthofix’s websites. Relators contend that courts can take judicial notice of “commercial website posts and product labeling.” In one of the cases they cite, the court did consider product labels under the incorporation by reference doctrine. See McMahon v. Take-Two Interactive Software, Inc., No. EDCV 13-02032-VAP (SPx), 2014 WL 324008, *2 (C.D.Cal. Jan. 29, 2014) (“WTien a complaint alleges UCL and FAL claims, a court may take judicial notice of and consider ‘advertising,’ including product labeling and promotional announcements, [under the incorporation by reference doctrine] even where those materials are not attached to a complaint, because those documents are central to the UCL and FAL claims”). The other decision in which a court judicially noticed product labeling does not articulate why the court did so, and it is therefore unpersuasive. See Stephenson v. Neutrogena Corporation, No. C 12-0426 PJH, 2012 WL 8527784, *2 (N.D.Cal. July 27, 2012) (“Defendant also requests that the court take judicial notice of the product labeling and/or packaging for the Neutrogena Naturals products at issue.... As to the purifying cleanser, the court grants defendant’s request to take judicial notice of the product’s label”). The incorporation by reference doctrine “permits a district court to consider documents “whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the [plaintiffs] pleadings.’ ” In re Silicon Graphics Inc. Securities Litigation, 183 F.3d 970, 986 (9th Cir.1999) (citing Branch, 14 F.3d at 454). Relators rely on documents from defendants’‘websites and Orthofix’s website to show that the design of each of the three stimulators is different. The contents of the documents are not alleged in relators’ second amended complaint, however, and relators’ claims do not rely on them. It would thus be inappropriate to consider them under the incorporation by reference doctrine. Moreover, although the court could perhaps take judicial notice of the designs of the three stimulators on the basis that the designs are capable of ready and accurate determination from sources whose accuracy cannot reasonably be questioned, the fact that the three stimulators manufactured by defendants and Orthofix have different designs is not relevant to the court’s decision. Relators have submitted judicially noticeable evidence that the stimulators use different technologies; this fact alone is sufficient to support their allegation that determining one is safe and effective does not mean that all are safe and effective. For this reason as well, therefore, the court denies relators’ request that it judicially notice these documents.

2. Defendants’ Request for Judicial Notice

In their opposition, defendants request that the court take judicial notice of seven documents, all of which are available either on the CMS or FDA website, or on the website of CMMS’ Durable Medical Equips ment Medicare Administrative Contractor, NHIC Corp.: (1) The NCD for Osteogenic Stimulation (NCD 150.2); (2) Form CMS 847; (3) LCD L11501; (4) LCD L11490; (5) LCD L5012; (6) LCD L27026; and (7) the FDA’s July 3, 1997 warning letter to Orthofix. In their supplemental request for judicial notice, defendants ask that the court judicially notice ten additional documents, all of which are available on either the CMS or FDA website: from the CMS website, (1) the entire Medicare National Coverage Determinations Manual; (2) CMS’ Coverage Decision Memorandum for Reconsideration of Electrostimulation (Electrical Stimulation) for the Treatment of Chronic Wounds; (3) LCD L32220; (4) LCD L30312; (5) LCD L35084; (6) LCD L33500; (7)- LCD L32038; and from the FDA website: (8) “Overview of Medical Device Regulation, Classify Your Medical Device”; (9) “Medical Devices, Premarket Approval”; and (10) Premarket Notification (510k). Because all of these documents are available on the websites of government agencies or a government contractor, they are appropriate subjects of judicial notice. Because the court finds the documents relevant to decision of the motion, it agrees with defendants that judicial notice is proper and it therefore grants their request.

II. DISCUSSION

A. Legal Standard Governing Motions to Dismiss

A Rule 12(b)(6) motion tests the legal sufficiency of the claims asserted in the complaint. A Rule 12(b)(6) dismissal is proper only where there is either a “lack of a cognizable legal theory,” or “the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pa-cifica Police Dept., 901 F.2d 696, 699 (9th Cir.1988). The court must accept all factual allegations pleaded in the complaint as true, and construe them and draw all reasonable inferences from them in favor of the nonmoving party. Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 337-38 (9th Cir.1996); Mier v. Owens, 57 F.3d 747, 750 (9th Cir.1995).

The court need not, however, accept as true unreasonable inferences or conclusory legal allegations cast in the form of factual allegations. See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 553-56, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (“While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiffs obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do”). Thus, a plaintiffs complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ... A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009); see also Twombly, 550 U.S. at 545, 127 S.Ct. 1955 (“Factual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact)” (citations omitted)); Moss v. United States Secret Service, 572 F.3d 962, 969' (9th Cir.2009) (“[F]or a complaint to survive a motion to dismiss, the non-conclusory ‘factual content,’ and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief,” citing Iqbal and Twombly).

B. Relators’ Federal FCA Claim

Because relators’ FCA claim provides the only basis for subject matter jurisdiction, the court addresses it first.

1. Legal Standard Governing Federal FCA Claims

The FCA, 31 U.S.C. §§ 3729 et seq., provides for “the recovery of civil penalties from those who knowingly present a false or fraudulent claim to the federal government for payment, or knowingly use a false record to avoid or decrease an obligation to pay the federal government.” Hagood v. Sonoma County Water Agency, 81 F.3d 1465, 1467 n. 1 (9th Cir.), cert, denied, 519 U.S. 865, 117 S.Ct. 175, 136 L.Ed.2d 116 (1996). Originally enacted to^ punish and prevent massive frauds perpetrated by large contractors during the Civil War, the FCA’s chief goal was to provide for restitution to the government of money taken from it by fraud. See United States v. Bomstein, 423 U.S. 303, 309, 96 S.Ct. 523, 46 L.Ed.2d 514 (1976): The Supreme Court has refused to adopt a restrictive reading of the statutp, however, holding that the FCA is a “remedial statute [that] reaches beyond ‘claims’ which might be legally enforced, to all fraudulent attempts to cause the Government to pay out sums of money.” United States v. Neifert-White Co., 390 U.S. 228, 233, 88 S.Ct. 959, 19 L.Ed.2d 1061 (1968); United States v. McLeod, 721 F.2d 282, 284-85 (9th Cir.1983).

The FCA authorizes individuals, known as “relators,” to file civil suits, known as “qui tam actions,” against persons who present false claims to the government. 31 U.S.C. § 3730. It makes liable any person who has (1) knowingly presented or caused to be presented a false or fraudulent claim; (2) knowingly made, used or caused to be made or used a false record or statement to get a false or fraudulent claim paid; or (3) conspired to defraud the government by getting a false or fraudulent claim paid. 31 U.S.C. § 3729(a)(l)-(3). The FCA defines “knowing” as having actual knowledge of information, or acting in either deliberate ignorance or reckless disregard of the information’s truth or falsity. 31 U.S.C. I 3729(b). Congress amended the FCA to include this definition to make “‘firm ... its intention that the act not punish honest mistakes or incorrect claims submitted through mere negligence.’ ” United States ex rel. Hochman v. Nackman, 145 F.3d 1069, 1073 (9th Cir.1998) (quoting S.Rep. No. 99-345 at 7 (1986), reprinted in 1986 U.S.C.C.A.N. 5266, 5272); see also United States ex rel. Hagood v. Sonoma County Water Agency, 929 F.2d 1416, 1421 (9th Cir.1991) (“[T]he statutory definition of ‘knowingly1 requires at least ‘deliberate ignorance’ or ‘reckless disregard’ ”). Thus, “[t]he phrase ‘known to be false’ ... means [known to be] ‘a lie.’ ” Wang v. FMC Corp., 975 F.2d 1412, 1421 (9th Cir.1992); see United States ex rel. Anderson v. Northern Telecom, Inc., 52 F.3d 810, 815-16 (9th Cir.1995). “The FCA does not define false. Rather, courts decide whether a claim is false or fraudulent by determining whether a defendant’s representations are accurate in light of applicable law.” United States v. Bourseau, 531 F.3d 1159, 1170-71 (9th Cir.2008).

“A civil action for False Claims Act liability requires four essential elements: ‘(1) a false statement or fraudulent course of conduct, (2) made with scienter, (3) that was material, causing (4) the government to pay out money or forfeit moneys due.’ ” United States ex rel. Ruhe v. Masimo Corp., 977 F.Supp.2d 981, 991 (C.D.Cal.2013) (citing United States ex rel. Hendow v. University of Phoenix, 461 F.3d 1166, 1174 (9th Cir.2006)); see also Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993, 997 (9th Cir.2010) (same). A plaintiff “must show an actual false claim for payment being made to the Government”; “[e]vidence of an actual false claim is the sine qua non of a False Claims Act violation.” United States ex rel. Aflatooni v. Kitsap Physicians Serv., 314 F.3d 995, 1002 (9th Cir.2002); see also, Cafasso, United States ex rel. v. General Dynamics Cl Systems, Inc., 637 F.3d 1047, 1055 (9th Cir.2011) (“ ‘It seems to be a fairly obvious notion that False Claims Act suit ought to require a false claim.’ ‘[T]he [FCA] attaches liability, not to the underlying fraudulent activity or to the government’s wrongful payment, but to the “claim for payment,” ’ ” citing Aflatooni 314 F.3d at 997, and United States v. Rivera, 55 F.3d 703, 709 (1st Cir.1995) (internal alterations original)); United States ex rel. Hopper v. Anton, 91 F.3d 1261, 1266-67 (9th Cir.1996) (“Violations of laws, rules, or regulations alone do not create a cause of action under the FCA. It is the false certification of compliance which creates liability when certification is a prerequisite to obtaining a government benefit.... [Thus there is no FCA liability] where regulatory compliance was not a sine qua non of receipt of state funding”).

Relators who assert that a defendant has made a false claim can allege that defendant has submitted a factually false claim, or that defendant has given a false certification. The prototypical false claims action alleges a factually false claim, i.e., an explicit lie in a claim for payment, such as an overstatement of the amount due. See Maa v. Ostroff, No. 12-cv-00200-JCS, 2013 WL 1703377, *15 n. 3 (N.D.Cal. Apr. 19, 2013) (“The ‘factually false’ theory refers to the ‘archetypal qui tam False Claims Action’ in which ‘a private company overcharges under a government contract, [and] the claim for payment itself is literally false or fraudulent,’ ” citing Hendow, 461 F.3d at 1170 (alteration original)). Re-lators relying on a false certification theory allege that defendant’s claim is false because defendant certified to a government agency that it had complied with laws, rules, or regulations governing the reimbursement of claims or other provision of benefits when it had not. See Hopper, 91 F.3d at 1266 (“Violations of laws, rules, or regulations alone do not create a causé of action under the FCA. It is the false certification of compliance [with those rules] which creates liability when certification Is a prerequisite to obtaining a government benefit”). There are two types of false certification claims— expressly false certification and impliedly false certification.

“Express certification simply means that the entity seeking payment certifies compliance with a law, rule or regulation as part of the process through which the claim for payment is submitted. Implied false certification occurs when an entity has previously undertaken to expressly comply with a law, rule, or regulation, and that obligation is implicated by submitting a claim for payment even though a certification of compliance is not required in the process of submitting the claim.” Ebeid, 616 F.3d at 998.

To show that claims were false under a false certification theory, a complaint “must plead with particularity allegations that provide a reasonable basis to infer that (1) the defendant explicitly undertook to comply with a law, rule or regulations that is implicated in submitting a claim for payment and that (2) claims were submitted (3) even though the defendant was not in compliance with that law, rule or regulation.” Id.

Like other allegations of fraud in federal court, claims “brought under the FCA must fulfill the requirements of Rule 9(b)” of the Federal Rules of Civil Procedure. United States ex rel. Lee v. Smith-Kline Beecham, Inc., 245 F.3d 1048, 1051 (9th Cir.2001); see also Cafasso, 637 F.3d at 1054 (“The heightened pleading standard of Rule 9(b) governs FCA claims”). Under Rule 9(b), “[i]n all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particúlarity.” Fed. R.CrvPROC. 9(b). Conclusory allegations are insufficient, and the facts constituting the fraud must be alleged with specificity. Moore v. Kayport Package Exp., Inc., 885 F.2d 531, 540 (9th Cir.1989). “A pleading is sufficient under Rule 9(b) if it identifies the circumstances constituting fraud so that a defendant can prepare an adequate answer to the allegations. While statements of the time, place and nature of the alleged fraudulent activities are sufficient, mere conclusory allegations of fraud are insufficient.” Id. at 540 (citation omitted). See also Cooper v. Pickett, 137 F.3d 616, 627 (9th Cir.1997) (to satisfy Rule 9(b), “the complaint [must] identify] the circumstances of the alleged fraud so that defendants can prepare an adequate answer” (internal quotations omitted)); DiLeo v. Ernst & Young, 901 F.2d 624, 627 (7th Cir.1990) (“Although states of mind may be pleaded generally, the ‘circumstances’ must be pleaded in detail. This means the who, what, when, where, and how”); Walling v. Beverly Enters., 476 F.2d 393, 397 (9th Cir.1973) (concluding that allegations stating the time, place, and nature of allegedly fraudulent activities met Rule 9(b)’s particularity requirement).

Thus, to satisfy Rule 9(b), a plaintiff must specify the content of the fraudulent representation, the person who made it, when and where the representation was made, and the manner in which it was untrue and misleading, or the circumstances indicating that it was false. See In re GlenFed Securities Litigation, 42 F.3d 1541, 1548 (9th Cir.1994) (en banc). See also Vess v. Ciba-Geigy Corp., 317 F.3d 1097, 1107 (9th Cir.2003) (plaintiff “alleges that the APA misrepresented its connection to Novartis, but he does not identify any specific misrepresentations or specify when and where they occurred. These allegations are not particular enough to satisfy Rule 9(b)”).

“The knowledge or scienter element of a fraud claim need not be pleaded with particularity, but may be [] alleged generally pursuant to Rule 9(b). However, knowledge must still be pleaded sufficiently to make entitlement to relief plausible.” Owens v. Bank of America, N.A., No. ll-cv-4580-YGR, 2013 WL 1820769, *4 (N.D.Cal. Apr. 30, 2013); see also Odom v. Microsoft Corp., 486 F.3d 541, 554 (9th Cir.2007) (“While the factual circumstances of the fraud itself must be alleged with particularity, the state of mind — or scienter — of the defendants may be alleged more generally”); In re GlenFed Inc. Securities Litigation, 42 F.3d at 1547 (“We conclude that plaintiffs may aver scienter generally, just as the rule states — that is, simply by saying that scienter existed”).

2. Whether Relators Have Adequately Alleged the Submission of False Claims to Medicare

The parties’ primary point of disagreement is whether claims submitted to Medicare for reimbursement of stimulators that had been approved by the FDA for lumbar use, but that defendants knew had been prescribed by physicians for cervical use, can under any circumstances and regardless of the nature of defendants’ certifications or disclosures to Medicare, constitute false claims. Defendants argue that claims seeking reimbursement for cervical use of their stimulators can never be “false claims” under the FCA because Medicare specifically authorizes reimbursement of all stimulators for all uses, regardless of the use for which the FDA approved them. For this reason, they argue, they had no duty to disclose to Medicare that the stimulators have been prescribed for off-label use, and the claims they purportedly submitted for reimbursement cannot have been false claims even though they allegedly failed affirmatively to disclose the use for which the devices were prescribed, and even though defendants allegedly certified that they were in compliance with Medicare rules and regulations.

Relators disagree. They argue that when prescribed for cervical use, defendants’ stimulators are categorically excluded from Medicare coverage. As a result, they contend, defendants’ submission of claims that did not disclose the stimulators would be used on the cervical spine, and that certified compliance with Medicare rules and regulations, were false. To show that off-label use of stimulators is not covered by Medicare, relators advance two alternative arguments. First, they contend that properly understood, the provision in the Medicare Manual that limits reimbursement, inter alia, to devices that have been approved by the FDA through the PMA process means that Medicare covers only on-label use of devices — i.e., uses approved by the FDA in a PMA, PMA Supplement, or other type of clearance allowing them to be marketed or used in clinical trials. Because cervical use of defendants’ stimulators is an off-label use, and because defendants allegedly have not filed a PMA supplement or otherwise received FDA approval or certification of their stimulators for cervical use, relators assert that reimbursement is not available when the devices are prescribed for that purpose.

Relators’ second argument — which appears to assume that the Medicare Manual’s limitation of coverage to PMA-approved devices does not preclude coverage for off-label use of defendants’ stimu-lators — is that NCD 150.2 is only the first step in the coverage determination. They contend NCD 150.2 must be read in conjunction with NCD 280.1, which prohibits coverage for off-label use of a stimulator. This is so, they argue, because NCD 280.1 explicitly applies to all DME, and requires a case-by-case determination of coverage for devices like stimulators that are not explicitly identified in NCD 280.1 as covered or uncovered. In making this cáse-by-case determination, NCD 280.1 instructs carriers to consider “[wjhether the item has been approved for marketing by the Food and Drug Administration (FDA) and is otherwise generally considered to be safe and effective for the purpose intended.” Relators assert that because the FDA has not approved the marketing of defendants’ stimulators for cervical use, and because the FDA has therefore not determined that the device is safe and effective for that purpose, NCD 280.1mandates- that a carrier conclude that cervical use of defendants’ stimulators is not covered by Medicare. Because this is so, relators contend, claims for reimbursement that do not disclose that stimulators have been prescribed for cervical use or that certify that a provider has submitted the claim in compliance with all Medicare rules and regulations are false.

Based on their view that off-label use of defendants’ stimulators is not reimbursable, relators allege that defendants have submitted false claims for reimbursement of stimulators they knew were prescribed for off-label use both because such claims are factually false and because they constitute a false certification that defendants have complied with all Medicare rules and regulations. They assert the claims are factually false because they listed the PMA-approval number for the stimulators on CMS Form 1500 but did not explicitly disclose in the narrative portion of CMS 847 that the stimulators were intended for cervical use. In combination, relators assert,