Full opinion text
ORDER KATHLEEN M. WILLIAMS, UNITED STATES DISTRICT JUDGE THIS MATTER came before the Court on Defendants Lineare Holdings, Inc. and Lineare, Inc. d/b/a Diabetic Experts of America’s motion for summary judgment (Lineare, Inc. is referred to as “Lineare;” Lineare Holdings, Inc. is referred to as “Holdings”), on Relators Matt Peoples and Gerry Phalp’s six threshold exemplars. (DE 74). The Court granted Relators’ Federal Rule of Civil Procedure 56(d) motion for additional discovery and allowed supplemental briefing. (DE 118). Accordingly, the motion is fully briefed. (DE 75, 100, 101, 105, 194, 195, 196, 199, 206, 207, 209). Defendants’ motion to strike expert report from the Relators’ summary judgment briefing on the exemplars is also before the Court and ripe for disposition. (DE 104,117,123). (I) Background The dispute in this case involves how Diabetic Experts marketed its diabetic testing supplies to six Medicare beneficiaries and then billed Medicare for the supplies that it provided. (Second Amended Complaint (“SAC”) DE 43). Relators did not plead facts indicating that Diabetic Experts failed to send the billed-for items — blood-testing strips, lancets, disposable lancet devices, and testing solution — to the Medicare beneficiaries or that the items provided were of inferior quality or overpriced. Rather, in Count I, Rela-tors argue that Diabetic Experts violated the False Claims Act, 31 U.S.C. § 3729(a)(1)(A), by presenting false claims to Medicare for sales that arose out of allegedly illegal and unsolicited telephone calls and that relied on purportedly false assignments of benefits (“AOBs”) given to Lineare. In Count II, Relators argue that Holdings and Diabetic Experts violated 31 U.S.C. § 3729(a)(1)(B) by making or using improper sales leads generated from Holdings’ database of patient information and by using the purportedly false AOBs given to Lineare. For the reasons discussed below, the Court grants Defendants’ motion for summary judgment on the six exemplars. The Court concludes that Lineare and Diabetic Experts are a single supplier for the purposes of the Medicare statutes, regulations, and supplier standards at issue and that their reliance on AOBs for provision of diabetic supplies was not inconsistent with the Center for Medicare and Medicaid Services’ (“CMS”) implementation of the Medicare statutes. Because Diabetic Experts is the same supplier as Lineare, Holdings did not violate the False Claims Act by sharing Lincare’s patient information and documents with Diabetic Experts. (I)(A) Pertinent Medicare Statutes And Regulations “The Medicare Program is a system of health insurance administered by the United States Department of Health and Human Services, through the Center for Medicare and Medicaid Services.” See United States ex rel. Walker v. R & F Props, of Lake Cnty., Inc., 433 F.3d 1349, 1351 (11th Cir.2005). It is a “vast and complicated” program. United States ex rel. Wilkins v. United Health Group, Inc., 659 F.3d 295, 310-11 (3d Cir.2011). Part B, the part of the Medicare program at issue here, is “voluntary supplemental medical insurance covering ... durable medical equipment.” Int’l Rehabilitative Sciences Inc. v. Sebelius, 688 F.3d 994, 997 (9th Cir.2012). To provide context, the Court highlights a number of pertinent provisions from the complex regime found in the United States Code, the Code of Federal Regulations, and the Federal Register. (I )(A)(1) Defínition of DMEPOS: Supplies and Equipment Medicare Part B pays for “covered items.” 42 U.S.C. § 1395m(a)(13) (“[T)he term ‘covered item’ means durable medical equipment.”)- Title 42. U.S.C. § 1395x describes durable medical equipment (“DME”), which includes “blood-testing strips and blood glucose monitors.” The only durable medical equipment, prosthet-ics, orthotics, and supplies (“DMEPOS”) at issue are: blood-testing strips, lancets, disposable lancet devices, and testing solution supplied to 'the exemplar beneficiaries. Diabetic Experts did not submit any claims to Medicare for blood glucose home testing monitors — they were provided free of charge. (See DE 75 ¶ 20; see also DE 101 ¶20 (“disputing] as written” Defendants’ statement of facts, but not disputing the underlying facts)). The Parties cite to various statutes, regulations, and agency interpretations to support their respective theories of whether covered items such as testing strips or lancets are supplies or equipment. That classification — supplies vs. equipment — goes to the issue of whether the AOBs used by Diabetic Experts were consistent with regulations. Under the subheading of “payment for durable medical equipment,” 42 U.S.C. § 1395m provides that testing strips are included in diabetic supplies, which is a subset of durable medical equipment. 42 U.S.C. §. 1395m(a)(l)(H)(i) (“[T]he payment amount under this part for diabetic supplies, including testing strips, ... shall be equal to the single payment amounts established ... under section 1395w-3 of this title.”). As referenced, 42 U.S.C. § 1395w-3(a)(2)(A) ■ describes “durable medical equipment and medical supplies” as “covered items (as defined in section 1395m(a)(13) of this title),” including '“supplies used in conjunction with durable medical equipment.” Thus, the terms supplies and equipment are both used when referring to items like blood-testing strips. While the statutes describe general categories of covered items, including durable medical equipment, the applicable regulations provide a more precise definition that is informed by the expertise of CMS. Supplies are those items necessary for the effective use of durable, equipment. 42 C.F.R. § 414.402(2). The Medicare regulations define durable medical equipment as “equipment furnished' by a supplier [that] can withstand repeated use.” 42 C.F.R. § 414.202(1). Thus, the applicable regulations support a distinction between equipment as reusable implements and supplies as materials that may be used to replenish or augment the equipment. This represents a qualitative judgment by CMS that distinguishes equipment, which can withstand repeated usage, from more ephemeral supplies. As a result, “[supplies necessary for the effective use of DME” are listed separately from durable medical equipment in the regulations. 42 C.F.R. § 414,402; see also 42 C.F.R. § 400.202 (definitions specific to Medicare: “Services means medical care or services and items, such as ... supplies, appliances, and equipment.”). (T)(A)(2) DMEPOS Supplier Rules Title 42 C.F.R, § 424.57 sets out the “special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges.” A DMEPOS supplier is “an entity or individual, which sells or rents Part B covered items to Medicare beneficiaries and which meets the standards in paragraphs (c) and (d) of this section.” 42 C.F.R. § 424.57(a). In addition to meeting those standards, all DMEPOS suppliers must also comply with the general rules in paragraph (b) of the section in’ order to be eligible to participate in Medicare and receive payment for a covered item. See 42 C.F.R. § 424.57(b). This is an ongoing obligation; at the time of its application, the supplier promises that it will continue to meet the standards set forth in section (c) of the special payment rules. See 42 C.F.R. § 424.57(c). (l )(A)(2)(a) Supplier Identifícatíon The general rules found in section (b) of the DMEPOS supplier special payment rules require that the supplier meet certain conditions to be “eligible to receive payment for a Medicare-covered item.” 42 C.F.R. § 424.57(b). One such condition is that a supplier is not eligible to be paid unless it obtains a supplier number. See 42 U.S.C. § 1395m(j)(l)(A). Accordingly, before submitting claims to Medicare, each DMEPOS-selling business location that meets the eligibility requirements receives a supplier number from the National Supplier Clearinghouse (“NSC”). CMS uses the term subpart to refer to the “separate physical locations” of health care providers. See HIPAA Administrative Simplification: Standard Unique Health Identifier for Health .Care Providers, 69 Fed.Reg. 8434-01, 3438 (Jan. 23, 2004) (to be codified at 45 C.F.R. Part 162). Furthermore,- pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), suppliers are required to obtain National Provider Identifiers (“NPI”) from the National Plan and Provider Enumeration System (“NPPES”). See 45 C.F.R. § 162.408; 45 C.F.R. § 162.406; (DE 75 ¶ 13). DME-POS suppliers like Lineare are known as organization health care providers, which may be eligible for multiple NPIs based on the number and nature of their subparts. (DE 75 ¶ 14; 75-3 at 83, 85,, Centers for Medicare and Medicaid Services, Medicare Learning Network, The National Provider Identifier (NPI): .What You Need to Know (2012); CMS Medicare Program Integrity Manual Ch. 15 .§ 15.3 DE 195-4). At the provider’s request, the NPPES may assign an NPI, which is always an identifier specific to a location, “to a subpart of a health care provider ... if the identifying data for the subpart are unique.” 45 C.F.R. § 162.408(a)(1); § 162.408(g). Moreover, if that subpart “would be a covered health care provider if it were a separate legal entity,” then the supplier “must” obtain an NPI. 45 C.F.R. § 162.410(a)(1). The subpart enrollment requirement is echoed elsewhere in the. DMEPOS supplier special payment rules, which: provide that a supplier must enroll each “separate physical location it uses to furnish Medicare-covered DMEPOS” and that “CMS issues only one supplier number for each location.” 42 C.F.R.' § 424.57(b). Although all DMEPOS • supplier subparts must comply with the “DMEPOS quality standards and be separately accredited,” the regulations make provision for how “multisite supplier^]” can satisfy those standards. See id. CMS has spoken clearly on the topic in a Special CMS Communication Regarding the NPI and Medicare DME Suppliers: “Medicare DME suppliers are required to obtain an NPI for every location.” This is not a new position; the special communication regarding NPI references a January 2006 paper (“Subpart Paper”) entitled Medicare Expectations On Determination Of Sub-parts By Medicare Organization Health Care Providers Who Are Covered Entities Under HIPAA that contains the same interpretation. Furthermore, the Subpart Paper is incorporated into the NPI section of the CMS Medicare Program Integrity Manual Chapter 15. The Subpart Paper was explicit in both its purpose and guidance. CMS stated that “[t]his- paper reflects- the Medicare program’s expectations on how its enrolled organization health care providers who are covered entities under HIPAA will determine, subparts and obtain NPIs for themselves and any subparts.” See Subpart Paper at 1. The Subpart Paper directed that “[e]ach ¿nrolled supplier of DMEPOS that is a covered entity under HIPAA must designate each practice location (if it has more than one) as a subpart and ensure that each subpart obtains its own unique NPI.” Id. at 8. The result is that a supplier must determine how to apply for NPIs, but “Medicare regulations require that each practice location of a supplier of DMEPOS (if it has more than one) must, by law, be separately enrolled in Medicare and have its own unique Medicare identification number.” Id. Therefore, it is clear that a single supplier can have multiple subparts that have their own NPIs. Id.; see also Medicare Program; Additional Supplier Standards, 65 Fed.Reg. 60366-01, 60371 (Oct. 11, 2000) (to be codified at 42 C.F.R. Part 424) (noting that “some suppliers may have multiple sites from which they do business”). (I)(A)(2)(b) Prohibition On Unsolicited Telephone Contacts - The standards require that the supplier operate its business and furnish covered items in compliance with “federal regulatory requirements that specify requirements for the provision of DMEPOS.” 42 C.F.R. § 424.57(c). The supplier standard at issue in this case is 42 C.F.R. § 424.57(c)(ll), which requires a supplier to “agree not to contact a beneficiary by telephone when supplying a Medicare-covered item” unless one of three exceptions applies. This prohibition on certain telephone marketing is also codified in 42 U.S.C. § 1395m(a)(17). Under both the statute and the regulation, a supplier is prohibited from making unsolicited telephone contacts with customers who are enrolled in Medicare unless one of three exceptions applies: (i) The individual has given written permission to the supplier to make contact by telephone regarding the furnishing of a covered item. (ii) The supplier has furnished a covered item to the individual and the supplier is contacting the individual only regarding the furnishing of such covered item. (iii) If the contact is regarding the furnishing of a covered item other, than a covered item already furnished to the individual, the supplier has furnished at least 1 covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact. 42 U.S.C. § 1395m(a)(17); 42 C.F.R. § 424.57(c)(ll). Only the third exception is at issue here. ■ (I)(A)(2)(c) Assignment Of Benefits And Maintaining Signatures On File One of the other federal regulatory requirements identified in 42 C.F.R. § 424.57(c) that governs suppliers is that a claim submitted to Medicare on behalf of a customer must be authorized by that customer. This authorization can be made by the Medicare beneficiary customer’s signature on the claim. See 42 C.F.R, § 424.36. In the alternative, there is a procedure where “Medicare pays the supplier for covered services if the beneficiary .-.. assigns the claim to the supplier and the' supplier accepts assignment.” 42 C.F.R. § 424.55(a).' Consequently, a beneficiary need not sign every single claim or individually assign each one. Rather, a supplier may maintain the customer’s signature on file using a form “that contains adequate notice to the beneficiary ... that the purpose of the signature is to authorize a provider or supplier to submit a claim to Medicare for specified services furnished to the beneficiary.” 42 C.F.R. § 424.36(a). The CMS Claims Manual does not require “that the services be itemized or that the information submitted be complete.” (CMS Claims Processing Manual Ch. 1 § 50.1.7 — Definition of Claim for Payment DE 206-2 at 2)/ The authorization may be incorporated by reference into subsequent claims. See 42 C.F.R. § 424.40(a). Furthermore, the supplier can retain an authorization in the supplier’s file, which “may be effective indefinitely.” 42 C.F.R. § 424.40(d). The indefinite effectiveness provision is not unlimited, however, and “a new statement is required if another item of equipment is rented or purchased.” 42 C.F.R. § 424.40(d)(2). (I)(B) Relevant Facts Not In Material Dispute During the time period at issue, Lin-eare supplied Medicare beneficiaries suffering from chronic obstructive pulmonary disease with .oxygen, respiratory, and other therapy services. (DE 75 ¶¶ 5-7). Diabetic Experts supplied Medicare beneficiaries suffering from diabetes with diabetic-testing supplies.. (Id. ¶ 21). Lineare was (and remains today) a DMEPOS supplier. (DE 75 ¶ 7; DE 199 Additional Facts ¶¶ 1, 21 (noting that Lineare is. subject .to the supplier standards)). Holdings acts as a holding company; Lineare is one of its wholly-owned subsidiaries. (DE 75 ¶¶ 1, 3; SAC DE, 43 ¶ 78; DE 57 ¶78; DE 101 ¶ 12). Holdings supports Lincare’s information systems, including a database called “ABA,” which “contains telephone numbers for customers of Diabetic Experts.” (DE 199 ¶ 4). Only Diabetic Experts, Lineare, and Holdings had access to the ABA; other entities in the Holdings corporate structure did not. (DE 197-2 at 15-16). Relators begin from the premise that Diabetic Experts is a separate supplier from Lineare. (SAC DE 43 ¶2). Although the Parties vigorously dispute whether Lineare and Diabetic Experts are, as a matter of law, separate suppliers for the purposes of Medicare eligibility, marketing, billing, and the propriety of using general AOBs, the following facts are un-controverted. (See, e.g., DE 101 ¶ 12; DE 199 ¶¶ 4, 8, Additional Facts ¶¶ 2-5, 11, 13, 15, 18, 21, 26, 29-31; DE 207 at 1-3). On March 18, 2004, Lineare registered the fictitious name Diabetic Experts of America to do business in Missouri. (DE 75 ¶ 10; Affidavit of Don Crisp, Director of Taxes, Lineare Holdings, Inc. DE 75-1 ¶ 15). There is no separate Diabetic Experts of America company, affiliate, or entity listed on Holdings’ corporate organization chart for 2008 or 2009 (DE 100-11 at 2-3); Diabetic Experts is a fictitious name used by Lineare. (Crisp Aff. DE 75-1 ¶ 16; DE 75 ¶ 12; DE 101 ¶ 6 (“It is undisputed that ‘Diabetic Experts of America’ is a d/b/a of Lineare, Inc.”)). Lineare’ registered with the NSC as a DMEPOS supplier, (DE 75 ¶ 7). Lineare maintains' subparts like Diabetic Experts throughout the United States. (Id. ¶¶9, 17; see also Affidavit of Stacey Murphy, Division Reimbursement Manager, Lin-eare Holdings, Inc. DE 195-6 ¶ 9 (testifying that Lineare has over 800 subparts operating throughout the United States, each, with its own unique-NPI)). In accordance with the Medicare statutes and regulations, Lineare enrolled each of those subparts with the NSC. (DE 75 ¶ 9). In 2004, Lineare enrolled its Kansas City, Missouri brand, Diabetic Experts, with the NSC and obtained an NSC number for it. (Id. ¶ 10). Lincare’s 2004 CMS-855S enrollment form for its Kansas City subpart reflected that: .(a) Lineare was enrolling a “New Location for a Currently Enrolled DMEPOS Supplier”; (b) the legal name of that business was “Lineare Inc., d/b/a Diabetic Experts of America”; and (c) the Tax ID number used for the “Supplier IRS Identification” information was Lincare’s: nó. xx-xxx2900. (Id. ¶ 10). During one onsite inspection of Diabetic Experts, NSC completed- the field for supplier name: “Lineare, Inc.” (May 19, 2014 NSC onsite inspection of Diabetic Experts DE 100-5 at 2). In 2006, Lineare also obtained an NPI for Diabetic Experts. (DE 75 ¶ 15). At each subsequent NSC inspection, Diabetic Experts certified that it had been provided with a copy of the supplier standards (listed in 42 C.F.R. § 424.57(e)) and acknowledged that its NSC number could be revoked if, at any time, it was determined that Diabetic Experts was noncom-pliant. (See May 19, 2014 NSC onsite inspection of Diabetic Experts DE 100-5 at 6; see also Mar. 22, 2012 NSC onsite inspection of Diabetic Experts DE 100-5 at 26). Diabetic Experts also agreed to “abide by the Medicare laws, regulations, and program instructions applicable to DMEPOS suppliers.” (2004 CMS-855S enrollment form DE 75-2 at 34). Diabetic Experts further expressed its understanding that “payment of a claim by Medicare is conditioned upon the ciaim and the underlying transaction complying with such laws, regulations, and program insteuc-tions (including but not limited to, the federal anti-kickback statute and the Stark law), and on the supplier’s compliance with all applicable conditions of participation in Medicare:” Id, ; During 2008 and 2009, Relators placed sales calls to Medicare beneficiaries — the six exemplars identified in the SAC — who had previously received covered items from Lineare. (DE 75 ¶ 20;. DE 199 Additional Facts ¶2). Using sales leads from Lincare’s oxygen services business, Diabetic Experts made phone calls to each of the six exemplar Medicare beneficiaries. (DE 75 ¶ 20; DE 199 Additional Facts ¶ 12). This was done for the purpose of offering them a free diabetic-testing monitor and to sell them diabetic-testing supplies. (DE 75 ¶20). These beneficiaries had not previously obtained diabetic testing supplies from Diabetic Experts. (DE 199 Additional Facts ¶¶ 5,13). Diabetic Experts then made the sales to the beneficiaries and submitted claims to Medicare for diabetic-testing supplies, e.g,, testing strips and lancets used in testing blood glucose levels, which Medicare paid relying on the fact that the telephone contacts and AOBs were both compliant with applicable statutes and regulations. (DE 75 ¶ 20). Diabetic Experts used its NPI, which is different from Lincare’s, to bill Medicare for the diabetic testing supplies on behalf of the six exemplar beneficiaries. (DE 199 Additional Facts- ¶¶ 11,15). The sales history is represented in a table, below: (DE 75 ¶ 20). There is no material dispute about three salient facts presented by the exemplars. (DE 101 ¶20 (“The content of the sales history with the six exemplars is undisputed.”)). First, Diabetic Experts contacted the beneficiaries, sold the supplies, and billed Medicare. (DE 75 ¶20). Second, Diabetic Experts billed for testing strips, lancets, disposable lancet devices, and testing solution, but not for the diabetic-testing monitor. (Id.). It is uncontroverted that the billed-for DMEPOS at issue here are not durable. The “lancet device” is necessarily “disposable.” (Id.). And nobody suggests that the blood-testing strips can be reused. Third, Lineare provided a Medicare covered item to the exemplar Medicare beneficiaries in the 15-month period prior to the date of the telephone contact. (DE 75 ¶¶ 20-21; DE 101 ¶21 (disputing the legal issue of whether the identity of the supplier is determined by reference to the federal tax identification number, but not the facts of the sales); DE 101 Additional Facts ¶ 10; DE 199 Additional Facts ¶ 13). Before the sale of diabetic supplies to the six exemplar Medicare beneficiaries, each of the six beneficiaries executed a patient agreement and consent form that contained, among other things, an assignment of benefits in favor of Lineare and its affiliates. (DE 75 ¶ 33). In those consent forms, the six beneficiaries agreed: (i) to rent or purchase covered items from either “Lineare and its affiliates” or from “Supplier and its affiliates”; (ii) that Lineare would provide “HME and Supplies” or “DME;” (iii) to the release of their health information for treatment, payment and health care operations; and (iv) to an assignment of benefits wherein the patient requests that the “payment of benefits be made to” either Lineare or the Supplier. (Id. ¶ 34). The consent forms, which the Parties and the Court have referred to as the AOBs, provided that they were to be used in lieu of the beneficiaries’ signatures on claims forms and Lineare kept them on file for this purpose. (DE 75 35-36). Diabetic Experts used the AOBs as signatures on file for the claims it submitted to obtain payment from Medicare for the diabetic testing supplies sold to the six exemplar Medicare beneficiaries. (DE 75 ¶ 37; DE 199 Additional Facts ¶¶ 16-18, 20, 31, 33-34). Although Diabetic Experts had its own form AOBs, it is undisputed that it “did not obtain AOBs that were specifically for diabetic testing supplies from Medicare beneficiaries — including the six exemplar beneficiaries — for its claims to Medicare for payment,” but rather used the Lineare AOBs it had on file. (DE 199 Additional Facts ¶¶ 32-33, 36; DE 75 1134; DE 101 Additional Facts ¶ 19). In October 2009, months after the submission of the claims for the six exemplar transactions, members of Holdings’ compliance department discussed generally — that is, not directly concerning diabetic supplies — whether their AOBs may need to be “item specific.” (DE 199 Additional Facts ¶¶ 40-43). Relators identify this discussion as evidence supporting the legal conclusion that Defendants “had actual knowledge of the requirement that AOBs must be item-specific.” (DE 199 Additional Facts ¶40). However, Defendants correctly point out that the discussion was prompted by an educational webinar, which cited no authority for the item-specificity requirement, presented by Cigna in its capacity as a durable medical equipment Medicare Administrative Contractor (“MAC”). (DE 207 at 7-8). Cigna did not state that the Medicare regulations “required” item-specific AOBs. (DE 207 at 7; DE 199 ¶ 40 (citing Oct. 5, 2009 Cigna presentation DE 197-10 at 22)). In fact, the October 2009 email exchange reported that the presenter emphasized that while “equipment needed to be named specific[ally],” in the AOBs, DMEPOS suppliers “could add ‘supplies’ to cover any/all supplies related to the specific named equipment.” (Oct. 9, 2009 Lineare internal email DE 197-10 at 2). (II) Discussion (II)(A) Summary Judgment Standard Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). The movant “bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). “An . issue of fact is ‘material’ if, únder the applicable .substantive law, .it might affect the outcome of the case. An issue of fact is ‘genuine’ if the record taken as a whole could lead a rational trier of fact to find for the nonmoving party.” Urquilla-Diaz, 780 F.3d at 1050 (quoting Harrison v. Culliver, 746 F.3d 1288, 1298 (11th Cir.2014)). After the movant has met its burden under Rule 56(c), the burden shifts to the nonmoving party who “must do more than simply show that there is some metaphysical doubt as to the material facts.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The non-moving party “may not rely merely on allegations or denials.in its. own pleading,” but,instead must come .forward with “specific facts showing a genuine issue for trial”. Fed. R.CivJP. 56(e); Matsushita, 475 U.S. at 587, 106 S.Ct. 1348. “Thus, to survive summary judgment, the nonmoving party must offer more than a mere scintilla of evidence for its position; indeed, the non-moving party must make a showing sufficient to permit the jury to reasonably find on its behalf.” Urquilla-Diaz, 780 F.3d at 1050 (citing Brooks v. Cnty. Comm’n of Jefferson Cnty., Ala., 446 F.3d 1160, 1162 (11th Cir.2006)); Allen v. Tyson Foods, Inc., 121 F.3d 642, 646 (11th Cir.1997) (quoting Matsushita, 475 U.S. at 587, 106 S.Ct. 1348) ’(“Where the record -taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no genuine issue for trial.”). In evaluating ,a motion for summary judgment, the Court considers the evidence in the record, “including depositions, documents, electronically stored information, affidavits or declarations, stipulations ..admissions, interrogatory answers, or other materials.... ” Fed. R. Civ. P. 56(c)(1)(A). The Court “must view all the evidence and all factual inferences reasonably drawn from the evidence in the light most-favorable to the nonmoving party, and must resolve all: reasonable doubts about the facts in favor of the non-mov-ant.” Rioux v. City of Atlanta, 520 F.3d 1269, 1274 (11th Cir.2008) (quotation marks and citations omitted). However, “the existence of a difficult or complicated question of law, when there is no issue as to the facts, is not a bar to a summary judgment.” Shotz v. City of Plantation, Fla., 344 F.3d 1161, 1166 (11th Cir.2003) (quoting Ammons v. Franklin Life Ins. Co., 348 F.2d 414, 417 (5th Cir.1965)). The Court notes that the Parties are not in complete accord regarding the operative facts, but their disputes either do not pose genuine issues material to the resolution of the motion or are not actually factual in nature. An example of a disputed, but not material, factual issue is the business relationship between Defendants (Holdings and Lineare) and two entities not mentioned or named as parties in the SAC (Med4Home, Inc. and Reliant Pharmacy Services) and how these non-parties participated in the alleged scheme of false bill,ing. (See, e.g., DE 75 ¶ 4; DE 101 ¶ 4; DE 199 ¶4; DE 207 ¶4 (concerning phone numbers of Med4Home, Inc. and Reliant Pharmacy Services customers)). First; allegations,!regarding non-parties Med4Home, Inc. and Reliant Pharmacy Services have nothing to do with the exemplars. (See generally SAC DE 43; DE 199 Additional Facts ¶¶13,15). Second, claims regarding the previously unidentified entities Med4Home, Inc. and Reliant Pharmacy Services were not pleaded with specificity in the SAC.. (See generally SAC DE 43). As discussed at the June 19, 2014 and March 19, 2015 status confer-. enees, the pleadings are closed and the Court does not find “extraordinary” grounds justifying the inclusion of additional parties and claims. (See DE 97-1 at 20:17-21:3); see also Urquilla-Diaz, 780 F.3d at 1057 (holding that dismissal with prejudice. of deficient claims in second amended complaint was appropriate because “[t'jhree attempts at proper pleading are enough.”). Finally, a relator cannot raise a new theory of the case in response to a dispositive motion when that theory does not appear in the pleadings. See United States ex rel. Graves v. Plaza Med. Centers Corp., Case No. 10-23882-CIV, 2014 WL 5040284, at *4 n. 4 (S.D.Fla. Oct. 8, 2014) (Moreno, J.) (preventing relator from arguing new insider theory for the first time in her omnibus response and dismissing amended complaint, but allowing a second amended complaint). Whether "or not the theory may potentially have merit is of no moment because “[a] relator 'may not assert new theories of liability based on information learned during-discovery.” United States ex rel. Estate of Donegan v. Anesthesia Assocs. of Kansas City, PC, Case No. 4:12-CV-0876-DGK, 2015 WL 3616640, at *7 (W.D.Mo. June 9, 2015). And as the Eleventh Circuit observed in Keeler, the district courts must guard against the “situation where a plaintiff does not specifically plead the minimum elements of their .allegation, and is able to learn the complaint’s bare essentials through discovery.” United States ex rel. Keeler v. Eisai, Inc., 568 Fed.Appx. 783, 805 (11th Cir.2014) (quoting United States ex. rel. Clausen v. Laboratory Corp. of Am., Inc., 290 F.3d 1301, 1313 (11th Cir.2002)). Consequently, despite the Parties’ vigorous disagreement about other entities allegedly included or alluded to in the pleadings, that disagreement has no bearing on the issues regarding the exemplars pending before the Court. Similarly, the Court need not dwell on the legal disputes presented in the Parties’ statements of facts. An example of a nonfactual dispute in the statements of material facts is the Parties’ competing interpretation of what weight federal agencies place on tax identification numbers (“TIN” or “EIN”) in determining whether an entity is a separate “supplier” under the applicable regulations. (DE 75 ¶ 8; DE 101 ¶ 8; .DE 199 ¶ 8; DE 207-¶ 8). It is an undisputed -fact'that Diabetic Experts is a d/b/a of Lineare.- (DE 75-¶ 6; DE 101 ¶ 6). However, Relators dispute that Lineare and Diabetic Experts are the same supplier as that term is used in the federal regulations governing Medicare supplier eligibility and billing. Id. This is a legal— not Tactual — -issue. Accordingly, there is no genuine issue of material fact prevént-ing-the Court from deciding the motion for summary judgment on the six exemplars as a matter of law. (II)(B) Expert, Opinion On Legal Conclusions Before . turning to the merits, the Court addresses whether- Relators’ expert report is appropriately considered with the motion for summary judgment on the exemplars. Federal Rule-of Evidence-704 allows an expert to “testify as to his opinion on an ultimate issue of fact,” but an expert may not tell the judge or jury what result to reach under the law. Montgomery v. Aetna Cas. & Sur. Co., 898 F.2d 1537, 1541 (11th Cir.1990) (finding error in district court’s- admission of-expert testimony concerning legal conclusions). The Court determines the applicable law and expert opinions regarding the legal standards applicable to a case must be excluded. City of Tuscaloosa v. Harcros Chems., Inc., 158 F.3d 548, 565 (11th Cir.1998); United States v. Hunter, 373 Fed.Appx. 973, 978 (11th Cir.2010) (“The witness also cannot testify to the legal implications of conduct because the court must be the jury’s only source of law.”) (citing Montgomery, 898 F.2d at 1541). Since Relators’ expert Charles Waldhauser’s report consists primarily of impermissible legal conclusions, the Court finds his testimony in this regard to be excludable. Harcros Chems., 158 F.3d at 565; see also Pleasant Valley Biofuels, LLC v. Sanchez-Medina, Case No. 13-23046-CIV, 2014 WL 2855062, at *5 (S.D.Fla. June 23, 2014) (“An expert witness may not testify as to the state of the law, however; this is the Court’s duty.”); Cordoves v. Miami-Dade County, 104 F.Supp.3d 1350, 1365-66, Case No. 14-20114-CIV, 2015 WL 2258457, at *12 (S.D.Fla. Mar. 2, 2015) (excluding expert’s opinions consisting of impermissible legal conclusions regarding ADA compliance). Therefore, Defendants’• motion to strike Waldhauser’s expert report (DE 104) is GRANTED IN PART. All opinions in the report regarding the legal standards and regulatory interpretation applicable to this case are stricken. Notwithstanding that determination, the Court agrees with the Parties that Waldhauser’s extensive background and experience may make him an appropriate expert witness, able to offer permissible and helpful opinions to the trier of fact. (DE 104 at 2 n. 1; DE 117 at 1, 3). Thus, for the purposes of the instant motion, the Court will - consider the nonlegal opinions expressed in Waldhauser’s report and grant them whatever weight they merit. And, while Waldhauser’s impermissible legal conclusions will not be considered by the Court, he may testify regarding other, permissible opinions in his final expert report should any issues remain following the resolution of the instant motion for summary judgment. (IIXC) The False Claims Act The False Claims Act “was enacted in 1863 with the principal goal of stopping the massive' frauds perpetrated by large private contractors during the Civil War.” Vt. Agency of Natural Res. v. Stevens, 529 U.S. 765, 781, 120 S.Ct. 1858, 146 L.Ed.2d 836 (2000) (quotations omitted); see also Ragsdale v. Rubbermaid, Inc., 193 F.3d 1235, 1237 n. 1 (11th Cir.1999) (“The purpose of the Act, then and now, is to encourage private individuals who are aware of fraud being perpetrated against the government to bring such information forward.”) (citation omitted). The False Claims Act imposes liability on any person who, inter alia: (a)(1)(A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; or (a)(1)(B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim. ■ 31 U.S.C. § 3729. The False Claims Act does not deal with all non-compliance and “[t]he fact that there may have been a violation of the laws governing Medicare ... is not enough, standing alone, to sustain a cause of action under the False Claims Act.” United States ex rel. Ortolano v. Amin Radiology, Case No. 5:10-CV-583-OC-PRL, 2015 WL 403221, at *3 n. 3 (M.D.Fla. Jan. 28, 2015) (citing Mikes v. Straus, 274 F.3d 687, 697 (2nd Cir.2001)). Instead, there must be a falsehood that affects the government’s,, willingness to pay, because “[ijmproper practices standing alone are insufficient.” Hopper, 588 F.3d at 1328. To prevail, a relator must provide details of a link between improper practices and the submission of false claims. See United States ex rel. Klusmeier v. Bell Constructors, Inc., 469 Fed.Appx. 718, 721 (11th Cir.2012). False Claims Act liability should not be invoked lightly; it is “not a vehicle to police technical compliance with complex federal regulations.” United States ex rel. Hobbs v. MedQuest Assocs., Inc., 711 F.3d 707, 717 (6th Cir.2013) (quoting United States ex rel. Williams v. Renal Care Grp., Inc., 696 F.3d 518, 532 (6th Cir.2012)). Nonetheless, “a process tainted by fraud impairs the integrity of the government program.” United States ex rel. Sharp v. Consol. Med. Transp., Inc., Case No. 96 C 6502, 2001 WL 1035720, at *8 (N.D.Ill.2001). Accordingly, in Clausen, the Eleventh Circuit sought a balanced approach:“[t]he False Claims Act does not create liability merely for a health care provider’s disregard of Government regulations or improper internal policies unless, as a result of such acts, the provider knowingly asks the Government to pay amounts it does not owe.” Clausen, 290 F.3d at 1311. The Eleventh Circuit recently reiterated that liability under the False Claims Act does hot arise solely from “the disregard of government regulations or failure to maintain proper internal procedures.” Urquilla-Diaz, 780 F.3d at 1045, 1051-52 (quoting Corsello v. Lincare, Inc., 428 F.3d 1008, 1012 (11th Cir.2005)); see also Jallali v. Nova Se. Univ., Inc., 486 Fed.Appx. 765, 766 (11th Cir.2012) (same). And the Second Circuit admonished that the False Claims Act is not a “blunt instrument” to be used for every false certifica-" tion of compliance with the vast and complicated Medicare program. Mikes, 274 F.3d at 699 (cited with approval, by Wilkins, 659 F.3d at 307). In Count I, Relators argue that Diabetic-Experts knowingly submitted false claims for payment — a so-called presentment claim — because the claims arose out of calls with beneficiaries that violated the unsolicited telephone contact rules and because Diabetic Experts used AOBs that could only be used by Lineare. In Count II, Relators argue that Holdings knowingly provided Diabetic Experts with improper sales leads- generated from Holdings’ database of patient information and Diabetic Experts knowingly used those leads to make the unsolicited sales calls alleged in Count I; and Holdings knowingly provided the purportedly false AOBs to Diabetic Experts, which Diabetic Experts used to submit false claims. Count II is commonly referred to as a make-or-use claim. The two types of claims in the two counts have different elements, but both require objective falsehood and that the defendant act knowingly, that is to say, with scienter. R & F Props., 433 F.3d at 1355; Mastej, 591 Fed.Appx. at 710; United States ex rel. Mastej v. Health Mgmt. Assocs., Inc., Case No. 2:11-CV-89-FTM-29DNF, 2013 WL 1149255, at *6 (M.D.Fla. Mar. 19, 2013) aff'd in part, rev’d in part on other grounds, 591 Fed.Appx. 693 (11th Cir.2014) (citing Hooper v. Lockheed Martin Corp., 688 F.3d 1037, 1047-48 (9th Cir.2012)); United States ex rel. Wilson v. Kellogg Brown & Root, Inc., 525 F.3d 370, 376 (4th Cir.2008); A1 Procurement, LLC v. Hendry Corp., Case No. 11-23582-CIV, 2012 WL 6214546, at *4 (S.D.Fla.2012) (“A fundamental requirement of the FCA, regardless of the section allegedly violated, is that the false or fraudulent claims or statements at issue must be objectively false.”). ■ Thus, as to Count I, the Court must determine whether Diabetic Experts had the requisite scienter when it-called the six beneficiaries and used the Lineare AOBs to submit claims following those calls; and for Count II, whether Holdings and Diabetic Experts - had the requisite scienter when they shared the patient information database and allegedly used false AOBs. For the AOBs to have been “false,” either the six exemplar beneficiaries must not have had adequate notice that Diabetic Experts would submit their claim or the items provided must have been new pieces of equipment such that the regulations would preclude using the old AOBs. (II)(C)(1) Factually False Claims Or Legally False Claims In order to succeed on a presentment claim, a relator must prove three things: (1) a false or fraudulent claim (2) was presented, or caused to be presented, by the defendant to the United States for payment or approval (3) with knowledge that the claim was false. R & F Props., 433 F.3d at 1355 (citing 31 U.S.C. § 3729(a)(1) (pre-FERA);- 31 U.S.C. § 3729(a)(1)(A) (post-FERÁ)). In order to prevail on a make-or-use claim, a relator must establish: “(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.” Urquilla-Diaz, 780 F.3d at 1045. These elements, including the scienter/knowledge element, must be proven by a preponderance of the evidence. See 31 U.S.C. § 3731(d); Absher, 764 F.3d at 710-11. There are two types of false or fraudulent claims that may be alleged by plaintiffs pursuing presentment or make-or-use claims under the False Claims Act: factually false claims and legally false claims. A factually false claim occurs, for example, when a supplier submits a claim that misidentifies the goods supplied or requests reimbursement for goods that it never provided. See Mikes, 274 F.3d at 697. Simply, put, the supplier falsely bills the government for something not received. See, e.g., United States ex rel. Kirk v. Schindler Elevator Corp., 601 F.3d 94, 114 (2d Cir.2010), rev’d on other grounds 563 U.S. 401, 131 S.Ct. 1885, 179 L.Ed.2d 825 (2011). Courts agree that application of the False Claims Act in factually false cases is “fairly straightforward.” Amin Radiology, 2015 WL 403221, at *3; United States ex rel. Conner v. Salina Reg’l Health Ctr., Inc., 543 F.3d 1211, 1217 (10th Cir.2008); Kirk, 601 F.3d at 114. Here, there are no allegations that the supplies were not provided or that the supplies provided were counterfeit or of inferior quality. Although Relators claim in their supplemental facts that Defendants’ phone calls to Medicare beneficiaries regarding diabetic supplies “resulted] in overutilization and frequent overbilling of Medicare,” this claim is not supported by the record. (DE 199 Additional Facts K.3). The citations refer to a collection of redacted, unlabeled, and barely legible screenshots from Defendants’ customer service interface, which show that some customers had supplies on hand when they received the shipments. But these screenshots do not show that the supplies sent to these customers went to waste, that Defendants persisted in shipping additional supplies when clearly told to stop, or that Medicare was double-billed for supplies. (DE 64-2; DE 64-3; DE 195-5). And the excerpts from Relator Phalp’s deposition cited in support of this proposition do not demonstrate overutilization, but instead describe how calls were made without Relators knowing that the Lineare customers were diabetic. (Oct. 16, 2014 Gerry Phalp Deposition DE 197-5 at 89:12-23). Thus, Relators’ unsupported claims regarding overbilling or overutilization do not affect the Court’s summary judgment analysis regarding legally false claims. See Fed.R.Civ.P. 56(e); S.D. Fla. L.R. 56.1. A legally false claim is actionable when the supplier has falsely certified compliance with the applicable statutes and regulations, but nevertheless has submitted a claim. Mastej, 591 Fed.Appx. at 705-06. “The violation of the regulations and the corresponding submission of claims for which payment is known by the claimant not to be owed make the claims false.” McNutt ex rel. United States v. Haleyville Med. Supplies, Inc., 423 F.3d 1256, 1259 (11th Cir.2005) (affirming denial of a motion to dismiss in anti-kickback statute case and finding that alleged kickbacks disqualified the defendants’ medical services from reimbursement under the Medicare program). The Eleventh Circuit recognizes both varieties of false certification: express false certification and implied false certification. See Keeler, 568 Fed.Appx. at 798-99; Urquilla-Diaz, 780 F.3d at 1045 (expressly adopting the false certification theory of liability). (II)(C)(2) Liability For False Certification ■ Although only implied certification is at issue here, it is more easily understood in juxtaposition with express certification.. Express certification means that the supplier- has certified compliance with applicable laws and regulations as part of the claims submission process. Keeler, 568 Fed.Appx. at 798-99; Mastej, 591 Fed.Appx. at 702, 705 n. 19 (discussing express certification in context of make-or-use claims). Verification of compliance with applicable laws and regulations is not always expressly required as part of .the submission of claims for payment; sometimes it may .only be an implied condition of payment or a condition of eligibility to participate in Medicare. Urquilla-Diaz, 780 F.3d at 1044-45; McNutt, 423 F.3d at 1259. As the Court explained in Keeler, an implied certification theory “recognizes that the FCA is violated where compliance with a law, rule, or regulation is a prerequisite to payment but a claim is made when a participant has engaged in a knowing violation.” Keeler, 568 Fed.Appx. at 799 (citing Wilkins, 659 F.3d at 313); Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993, 998 (9th Cir.2010) (“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.”). There is no allegation in the SAC that Holdings or Diabetic Experts expressly certified compliance with supplier standards when submitting the six claims at issue. However, the application submitted to CMS in order to obtain billing privileges for 'Diabetic Experts certified that Diabetic Experts would comply with applicable statutes . and regulations and acknowledged that Medicare conditioned payment of- claims on continued compliance. {See 2004 CMS-855S enrollment form DE 75-2 at 34; see also, e.g., electronic data interchange (“EDI”) transmission agreement DE 195-7 at 6). As the Third Circuit held in Wilkins v. United Health Group, Inc., if a plaintiff can prove that the defendant submitted claims for payment at a time when defendant was “knowingly violat[ing] a law, rule, or regulation which was a condition for receiving payment from the Government,” that is sufficient to justify “relief under an implied false certification theory of liability.” Wilkins, 659 F.3d at 313. Courts limit implied false certification claims to situations where compliance is the sine qua non of receipt of federal funding. Urquilla-Diaz, 780 F.3d at 1052; United States ex rel. Osheroff v. Tenet Healthcare Corp., Case No. 09-22253-CIV, 2013 WL 1289260, at *4 (S.D.Fla. Mar. 27, 2013); United States ex rel. Hendow v. Univ. of Phoenix, 461 F.3d 1166, 1172 (9th Cir.2006); see also McNutt, 423 F.3d at 1259; Clausen, 290 F.3d at 1311. In Mikes v. Straus, an oft-cited, pre-FERA case developing what has come to be called the condition of payment analysis, the Second Circuit observed that it would be anomalous for an act aimed at retrieving ill-gotten funds to attach liability to false certifications, “when the alleged noncompliance would not have influenced the government’s decision to pay.” Mikes, 274 F.3d at 697. Although the telephone contact statute and regulation are enforced in slightly different ways, the Court assumes for purposes of this discussion that certification of compliance with the supplier standards affects the government’s decision to pay claims and therefore does not undertake the Mikes analysis. (See Supplier Enrollment Application DE 75-2 at 34 (conditioning payment of claims upon the “the claim and the underlying transaction complying with [Medicare] laws, regulations, and program instructions ... and on the supplier’s compliance with all applicable conditions of participation in Medicare.”)). And it is beyond cavil that a basic requirement for the payment of all claims is that they be signed by the beneficiary or that the supplier have an appropriate AOB on file. See 42 C.F.R. § 424.32; § 424.36 (“[T]he purpose of the signature is to authorize a provider or supplier to submit a claim to Medicare.”). Inasmuch as the Court assumes that the condition of payment or materiality element of the False Claims Act analysis is satisfied, the Court must determine whether the six exemplars are instances where Defendants submitted claims to the government, certified compliance, or made or used records with knowledge: 1) that Defendants were in violation of the unsolicited telephone contact proscription; or 2) that the AOBs did not meet Medicare requirements. Defendants argue that Rela-tors’ theory of liability rests on two faulty premises: 1) that Lineare and Diabetic Experts are two distinct legal suppliers for the purposes of providing DMEPOS supplies to beneficiaries and submitting claims for payment; and 2) that the diabetic testing supplies provided to the six exemplar beneficiaries are new pieces of “equipment.” The Court considers these arguments in turn. (II)(C)(3) Diabetic Experts: Subpart or Separate Supplier? The regulatory identity of the supplier is critical to the disposition of the instant motion. The Court starts from an uii-controverted fact sworn to by Holdings’ Director of Taxes: there is no separate Diabetic Experts of America company, affiliate, or entity (DE 75 ¶ 12; Crisp Aff., DE 75-1 IT 16); Diabetic Experts is a fictitious name used by Lineare (DE 75 ¶ 12). The Court must determine whether, pursuant to the Medicare statutes and regulations, Diabetic Experts is a separate and independent supplier from Lineare. If Lineare and Diabetic Experts are the same supplier, then the telephone contacts with the six exemplar beneficiaries were not violations; Lineare sold each a covered item of DMEPOS in the fifteen months prior to the billing at issue. Likewise, if they are the same supplier, Diabetic Experts’ submission of a claim based on an AOB provided by the exemplar beneficiary to Lineare also was not a violation. In summary, if Lineare and Diabetic Experts are one supplier, the claims submitted were not false and neither Holdings nor Diabetic Experts made or used false records when Diabetic Experts used Lin-care’s AOBs or accessed Lineare customer data that was managed by Holdings. (II)(C)(3)(a) Interpretation Of Medicare Statutes And Regulations The Court starts with the statutory text and proceeds from the “understanding that unless otherwise defined, statutory terms are generally interpreted in accordance with their ordinary meaning.” Sebelius v. Cloer, — U.S. ——, 133 S.Ct. 1886, 1893, 185 L.Ed.2d 1003 (2013) (citation omitted); Sumpter v. Sec’y of Labor, 763 F.3d 1292, 1296 (11th Cir.2014) (quoting Schwarz v. City of Treasure Island, 544 F.3d 1201, 1214 (11th Cir.2008)). Courts’ construction should avoid rendering any clause, sentence, or word superfluous, void, or insignificant. See United States v. Aldrich, 566 F.3d 976, 978 (11th Cir.2009). Words must be read “in their context and with a view to their place in the overall statutory scheme,” because a court’s duty, “after all, is to construe statutes, not isolated provisions.” King v. Burwell, — U.S. -, 135 S.Ct. 2480, 2489, 192 L.Ed.2d 483 (2015) (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000); Graham County Soil and Water Conservation Dist. v. United States ex rel. Wilson, 559 U.S. 280, 290, 130 S.Ct. 1396, 176 L.Ed.2d 225 (2010)) (internal quotation marks omitted). “The first rule' in statutory construction is to determine whether the language at issue has a plain and unambiguous meaning with regard to the particular dispute.” Shotz, 344 F.3d at 1167 (citation and internal quotation omitted). Similarly, when construing a regulation, a court looks to the “regulation’s plain language” and may consider “other indications of the Secretary’s intent at the time of the regulation’s promulgation.” Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512, 114 S.Ct. 2381, 129 L.Ed.2d 405 (1994); see also Urquilla-Diaz, 780 F.3d at 1053 (citing, without discussing degree of deference, agency responses to commentary published along with final regulation in the Federal Register). Statutes may lack sufficient clarity for practical application and “[executive actors often must interpret the.enactments Congress'has charged them-with enforcing and implementing.” Gonzales v. Oregon, 546 U.S. 243, 255, 126 S.Ct. 904, 163 L.Ed.2d 748 (2006). Accordingly, courts defer when the “regulations g[i]ve specificity to a statutory scheme the Secretary was charged with enforcing.” Id. at 257, 126 S.Ct. 904 (internal citation omitted). In general, agency interpretations are “entitled to respect ... to the extent that those interpretations have the power to persuade.” R & F Props., 433 F.3d at 1357 (internal citation and quotation marks omitted); Wis. Dept. of Health & Family Servs. v. Blumer, 534 U.S. 473, 497, 122 S.Ct. 962, 151 L.Ed.2d 935 (2002) (agency’s position, even if only presented in a proposed rule, “warrants respectful consideration.”). At least three levels of deference are relevant' to this discussion of the Medicare statutes and regulations. .Chevron deference applies to agency interpretations of ambiguous statutes; Auer deference applies to agency interpretations of the agency’s own ambiguous regulations; and Skid-more deference applies to less formal agency guidance documents and opinions. See 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); Auer v. Robbins, 519 U.S. 452, 461, 117 S.Ct. 905, 137 L.Ed.2d 79 (1997); Skidmore v. Swift & Co., 323 U.S. 134, 65 S.Ct. 161, 89 L.Ed. 124 (1944); United States v. Mead Corp., 533 U.S, 218, 234-35, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001); Ramos-Barrientos v. Bland, 661 F.3d 587, 598 (11th Cir.2011) (“Even if these interpretations [of the regulations] are not entitled to deference under Chevron or Auer, they are persuasive under Skidmore.”); Arriaga v. Fla. Pac. Farms, L.L.C., 305 F.3d 1228, 1238 (11th Cir.2002) (recognizing that Skidmore standard applicable to courts when considering the deference to be accorded to agency rulings, interpretations and opinions, dictates that, the “weight of such .[an agency] judgment in a particular, case, will depend upon the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control”). Under Chevron, courts give agency interpretations of an ambiguous statute “controlling weight unless they are arbitrary, capricious, or manifestly contrary to the statute.” Chevron, 467 U.S. at 843-44, 104 S.Ct. 2778. Although agency interpretations of ambiguous regulations contained in policy statements, manuals, and enforcement guidelines are not entitled to the force of law, R & F Props., 433 F.3d at 1357 (citing Christensen v. Harris County, 529 U.S. 576, 587, 120 S.Ct. 1655, 146 L.Ed.2d 621 (2000)), they are also “controlling unless plainly erroneous or inconsistent with the regulation.” Auer, 519 U.S. at 461, 117 S.Ct. 905. Under Skidmore, a court grants weight to an agency interpretation according’ to its “power to persuade.” Skidmore, 323 U.S. at 140, 65 S.Ct. 161. In Sarasota Mem’l Hosp. v. Shalala, 60 F.3d 1507 (11th Cir.1995), the Eleventh Circuit observed that deference to an agency interpretation is all the more appropriate when it concerns a complex and highly technical regulatory program, like Medicare, “in which the identification and classification of relevant criteria necessarily require significant expertise and entail the exercise of judgment grounded in policy concerns.” Id. at 1511 (citations and internal quotation omitted); accord Nat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs., 545 U.S. 967, 1002-03, 125 S.Ct. 2688, 162 L.Ed.2d 820 (2005) (reaffirming the principle of judicial deference to agency interpretations on questions involving subject matter that is technical, complex, and dynamic, because the agency is in a far better position to address such questions. than the courts are); see also Rehabilitation Ass’n of Va., Inc. v. Kozlowski, 42 F.3d 1444, 1450 (4th Cir.1994) (wryly observing that the various statutes and regulations governing Medicare are “among the most completely impenetrable texts within human experience”). The Secretary of Health and Human Services is charged by Congress vrith administering the Medicare - statute. See Almy v. Sebelius, 679 F.3d 297, 299 (4th Cir.2012) (citing 42 U.S.C. § 1395ff(a)(l)); see also 42 U.S.C. § 1395hh. To that end, “Congress vested in the Secretary large rulemaking authority” and the Medicare Act authorizes the Secretary to issue regulations “defining reimbursable costs and otherwise giving content to the broad outlines of the Medicare statute.” Sebelius v. Auburn Reg’l Med. Ctr., — U.S. -, 133 S.Ct. 817, 826, 184 L.Ed.2d 627 (2013); Tex. Alliance for Home Care Servs., v. Sebelius, 681 F.3d 402, 405 (D.C.Cir.2012) (citing Thomas Jefferson Univ., 512 U.S. at 506-07, 114 S.Ct. 2381). CMS, in turn, is given primary responsibility for regulating Medicare. See R & F Props., 433 F.3d at 1351. As the Court explained in Chevron, “[t]he power of an administrative agency to administer a congressionally created ... program necessarily requires the formulation of policy and the making of rules to fill any gap left, implicitly or explicitly,. by Congress.” Chevron, 467 U.S. at 842, 104 S.Ct. 2778. CMS has the relevant expertise and its published guidance and responses to specific comments— which are k byproduct, of the rulemaking process — regarding supplier identification and standards should be accorded due weight. See, e.g., United States ex rel. Smith v. Boeing Co., Case No. CIV.A. 05-1073-MLB, 2014 WL 5025782, at *24 (D.Kan. Oct. 8, 2014) (“[The agency] has the far-reaching technical expertise needed to judge compliance with its regulations” and to assess the impact of non-compliance.); United States v. Shaw, 106 F.Supp.2d 103, 113 (D.Mass.2000) (noting that a “court is wise to consider” the agency’s interpretation of the regulatory scheme discussed in the final rule). Nonetheless, judicial deference to CMS’ interpretation is not unlimited. It does not extend, for example, to an additional layer of analysis, such as when a Medicare contractor offers .a. non-binding interpretation of - Medicare compliance manuals. See Elgin Nursing & Rehab. Ctr. v. U.S. Dept. of Health & Human Servs., 718 F.3d 488, 493 (5th Cir.2013) (declining to accord deference to an agency’s “interpretation of its manual interpreting its interpretive regulation.”). And substantive changes in CMS manuals, interpretative rules, and general guidelines are not applied retroactively. See 42 U.S.C. § 1395hh(e). These limits are consonant with the recent Supreme Court decision in Young v. United Parcel Serv., Inc., — U.S. -, 135 S.Ct. 1338, 191 L.Ed.2d 279 (2015), where the Court reaffirmed the principle that agency rulings, interpretations, and opinions are accorded persuasive weight due in part to their “consistency.” Young, 135 S.Ct. at 1352. (II)(C)(3)(b) The Regulations Contemplate An Organization Like Lineare In the final rule establishing the supplier standards for DMEPOS suppliers, CMS opined that “[t]he single most striking characteristic of Medicare DME-POS suppliers is their diversity.” Medicare Program; Additional Supplier Standards, 65 Fed. Reg. 60366-01, 60374 (Oct. 11, 2000) (to be codified at 42 C.F.R. Part 424).' CMS illustrated the point with this example: “a firm dealing with the oxygen needs of the medical community may add a department that provides oxygen services and supplies as a medical supply as a logical extension of an existing business.” Id. In order to describe the relationship between the parent organizational health care providers and the separate physical locations at which durable medical equipment is actually dispensed to patients under the NPI regulations, CMS referred to the different components and physical locations as “subpa