Full opinion text
MEMORANDUM WILLIAM J. HAYNES, JR., District Judge. TABLE OF CONTENTS I. Procedural History.........................................................825 II.Defendants’ Motion to Dismiss and for Summary Judgment On Relator’s Retaliation Claim.........................................................826 III. United States’s and Defendants’ Motions for Summary Judgment................828 A. Findings of Fact.......................................................828 1. MedQuest........................................................828 2. The Medicare Enrollment Process...................................830 3. MedQuest’s Medicare Applications for the Nashville Area IDTFs........835 4. MedQuest’s Nashville Area IDTFs’ Performance ......................836 5. Expert Proof on Medicare Administrative Practices Approving Supervising Physicians...........................................842 6. Damages Proof....................................................845 B. Conclusions of Law................................................ 845 1. The Necessity of a Statute or Regulation........................ 850 2. The Governing Medicare Regulations and Rules.................. 852 3. The FCA Violations.........................■.................. 862 a. MedQuest’s Nashville Area IDTFs’ Testing.................. 864 b. MedQuest’s Medicare Billings with Dr. Witt’s Billing Number 865 4. Damages and Penalties........................................ 868 IV. Relief.............................. 870 I. Procedural History Plaintiff, Karen Hobbs, a former employee of MedQuest Associates, Inc. filed this action as Relator on behalf of the United States, under the False Claims Act, (“FCA”), 31 U.S.C. §§ 3729 through 3733 against the Defendants: MedQuest Associates, Inc., (“MedQuest”), Bioimaging at Charlotte, Inc., (“Charlotte Center”), Bioimaging of CoolSprings, Inc. (“CoolSprings Center”) and Bioimaging at Harding, Inc. (“Harding Center”). On March 31, 2009, the Government notified the Court of its decision to intervene and filed its intervening complaint on May 22, 2009. (Docket Entry No. 49). In essence, the Relator’s and United States’s common claims are first that the Defendants unlawfully conducted diagnostic tests of Medicare beneficiaries at its Nashville area testing centers without the required and appropriate physician supervision and that MedQuest caused false claims to be submitted and paid by Medicare for such testing in violation of 31 U.S.C. § 3729(a)(1). At its Charlotte center, the Relator and the United States also assert that Med-Quest caused false claims to be submitted and paid by Medicare by using another Medicare vendor’s billing number in violation of 31 U.S.C. § 3729(a)(1). The Relator also asserts a FCA claim for retaliatory discharge after she complained about Defendants’ testing practices. In addition to its FCA claims, the United States asserts common law claims for unjust enrichment, payment by mistake and recoupment. In earlier proceedings, the Court denied the Defendants’ motion to dismiss (Docket Entry No. 95) concluding that Medicare regulations on physician supervision of diagnostic tests are a condition of payment and that under the factual allegations and relevant Medicare regulations, the United States and the Relator stated claims, for violations of the FCA. (Docket Entry No. 94, Memorandum at 15-19). Before the Court are the United States’s motion for summary judgment (Docket Entry No. 127); the Defendants’ motion for summary judgment on Relator’s claims (Docket Entry No. 128); Defendants’ motion to dismiss Relator’s amended complaint (Docket Entry No. 148); and the Defendants’ motion for summary judgment on the United States’s claims. (Docket Entry No. 149). In its motion for ■ summary judgment, the United States contends, in essence, that the undisputed facts establish that the Defendants submitted claims for payment to Medicare for diagnostic tests of Medicare beneficiaries conducted at its Nashville area facilities without the required physician supervision and by physicians who were not approved by Medicare’s designated carrier. The United States also contends that the undisputed facts are that from January, 2004 to July 1, 2005, Med-Quest used a physician’s Medicare billing number for its Medicare billings for tests of Medicare beneficiaries at its Charlotte facility. In their motions for summary judgment and motion to dismiss and in their response to the United States’s motion, the Defendants argue first that the Relator’s retaliation claim lacks factual bases and is time barred. As to the United States’s claims, Defendants contend, in sum: (1) that the FCA claims fail as a matter of law, for lack of proof of a violation of a federal statute or regulation; (2) that the cited Medicare regulations do not require a board certified radiologist as a supervising physician at its Nashville area centers; (3) that any physician can supervise the diagnostic tests at issue; (4) that other Medicare carriers permit any physician to supervise these diagnostic tests; (5) that Medicare regulations and expert testimony support the allowance of any physician, as defined by the Medicare Act, to supervise these tests; and (6) that for the times at issue, the Charlotte center was a physician’s office rendering appropriate the billings with Dr. Witt’s Medicare number. For these reasons, Defendants assert the Government and Relator cannot prove any FCA violation. In their responses, the United States contends that its FCA claims are supported by undisputed facts that establish violations of controlling Medicare regulations. The Relator asserts that the Defendants’ motion to dismiss that is supported by evidentiary materials, is a motion for summary judgment. Relator argues that material factual disputes exist on the merits of Relator’s retaliation claim under the FCA as well as the nature of her employment relationship with MedQuest to bar summary judgment on Defendants’ statute of limitations defense. In a supplemental submission, Relator argues additional precedent supports the timeliness of her FCA retaliation claim. II. Defendants’ Motion to Dismiss and for Summary Judgment On Relator’s Retaliation Claim MedQuest hired Relator in December, 2002 as a lead technologist and later, promoted her to chief technologist. Med-Quest’s November, 2002 offer of employment included a “Termination” provision that “MedQuest is an at will employer, which means that either you or MedQuest may terminate the employment agreement at any time with or without notice or cause.” (Docket Entry No. 148-3 at 2) (emphasis added). According to this offer, Relator’s “signature on this letter indicates [Relator’s] acknowledgment and acceptance of these as the full and complete terms of our employment offer.” Id. Relator signed the November, 2002 offer letter on November 27, 2002. Id. at 3. MedQuest also provided Relator its employee handbook that has an “Acknowledgment and Disclaimer of Employment Contract,” to be signed by its employees. This disclaimer also provides that “either the employee or the Company may terminate the employment relationship at will, with or without cause or advance notice, at any time." (Docket Entry No. 148^4 at 1) (emphasis added). This disclaimer also reads in relevant part, that MedQuest’s employee handbook does not create “an employment contract, a right of employment, or any other type of contract” and that “the Company ... reserves the right to change, revise, add, or delete policies and guidelines without notice when such action is deemed necessary by the Company.” Id. As relevant to these motions, during the course of her employment, Relator was informed and informed her supervisors as well as MedQuest’s higher management that MedQuest’s Nashville area centers were conducting diagnostic tests using contrast without trained physicians approved by Medicare and in some instances by the centers’ staff members who are not physicians. (Docket Entry No. 166-1, Hobbs affidavit). Although Relator received some favorable assessments of her work, (Docket Entry No. 166-11), there were complaints about Relator’s work. (Docket Entry No. 130-20). On October 26, 2004, after an action plan deadline (Docket Entry No. 130-3), Ruth Giorgtio, Relator’s supervisor, terminated Relator for “Poor job performance conduct.” (Docket Entry No. 148-5). A defendant can file a motion to dismiss based upon statute of limitation defense. Jones v. Bock, 549 U.S. 199, 215, 127 S.Ct. 910, 166 L.Ed.2d 798 (2007) (“If the allegations ... show that relief is barred by the applicable statute of limitations, the complaint is subject to dismissal fox failure to state a claim,.”) (emphasis added). Yet, the Court agrees with Relator that given the supporting evidentiary materials that are considered by the Court, Defendants’ motion to dismiss is converted into a motion for summary judgment. Fed.R.Civ.P. 12(d). When this action was filed, the FCA lacked a limitations period for retaliation claims and the Court would “borrow” the applicable state statute of limitations for a retaliatory discharge claim. See Graham County Soil & Water Conservation Dist. v. United States ex rel. Wilson, 545 U.S. 409, 417-18, 125 S.Ct. 2444, 162 L.Ed.2d 390 (2005). Tennessee law has two statutes of limitation for retaliatory discharge claims based upon the nature of the plaintiffs employment. See Gunter v. Laboratory Corp. of America, 121 S.W.3d 636, 642 (Tenn.2003). In selecting among these statutes of limitations, the issue is whether Plaintiffs injury was to his property or person. Id. at 641. For injury to one’s property, the three-year statute of limitations applies, but for personal injury, the one-year statute of limitations governs. Id. Claims of employees who are terminable at will are deemed personal injury claims. Weber v. Moses, 938 S.W.2d 387, 393 (Tenn.1996). If the employment relationship is contractual, then the injury is characterized as a property right. See Gunter 121 S.W.3d at 642. In either instance, the limitation period for a retaliatory discharge commences on the date of a plaintiffs termination. Weber, 938 S.W.2d at 391-92 (“[A] discriminatory termination ceases and is complete, when the plaintiff is given unequivocal notice of the employer’s termination decision.”). Here, the documentary evidence of Med-Quest’s November 2002 Offer Letter and employee handbook establishes that Plaintiff was an employee at will. MedQuest’s handbook stated that “neither this handbook nor any provision of this handbook creates an employment contract, a right of employment, or any other type of contract.” Under Whittaker v. Care-More, Inc., 621 S.W.2d 395, 397 (Tenn.Ct.App.1981), an employee handbook must contain “guarantees or binding commitments” for an employment contract. Thus, Plaintiffs retaliation claim is governed by a one year statute of limitation. Here, MedQuest terminated Relator on October 26, 2004, but Relator did not file this action until 2006. The facts involving her termination were known at the time of her termination. Plaintiff contends that material factual disputes exist, but the Court is unable to discern the factual bases for any such dispute. Accordingly, the Court concludes that Relator’s retaliation claim under the FCA is time-barred. Relator’s supplemental filing contends that her retaliation claim is governed by FCA’s new three years statute of limitation for retaliation claims in the “Dodd-Frank Wall Street Reform Act and Consumer Protection Act”, Pub. L. 111-203, 124 Stat. 1376 (2010), amending 31 U.S.C. § 3730(h)(3). By its express provisions, that Act has an effective date of July 22, 2010. Id. Congress’s statement of the effective date of an Act is not dispositive. Immigration and Naturalization Serv. v. St. Cyr., 533 U.S. 289, 318, 121 S.Ct. 2271, 150 L.Ed.2d 347 (2001). Graham County’s holding on the “borrowing” of state statutes of limitation was clearly established in 2005. Statutes of limitation represent a public policy favoring the filing of timely claims. Burnett v. New York Cent. R. Co., 380 U.S. 424, 429, 85 S.Ct. 1050, 13 L.Ed.2d 941 (1965). To apply the FCA’s new three years limitations would have the effect of reviving an otherwise time-barred claim for non-continuing conduct that occurred in 2004. Thus, the Court concludes that FCA’s new three years limitation period should not be applied here. III. United States’s and Defendants’ Motions for Summary Judgment A. Findings of Fact 1. MedQuest MedQuest is the leading diagnostic testing firm in the United States that operates more than ninety “Independent Diagnostic Testing Facilities” (“IDTFs”) throughout the United States in thirteen states. MedQuest establishes the procedures for each of its IDTF’s operations; hires their managers and radiologists; enrolls and provides credentialing for their staffs for Medicare and commercial insurers. For each facility, MedQuest leases or purchases the building, provides payroll services, purchases or rents diagnostic equipment, obtains insurance, and provides compliance and training for its testing centers’ employees. MedQuest’s centers’ managers lack money to purchase large equipment, or pay physicians for services both of which MedQuest pays. (Docket Entry No. 140-5, Schaefer Deposition at 19-23, 50-54). None of the MedQuest Nashville area centers has a separate bank fund. (Docket Entry No. 132, Just Declaration at 2 and Docket Entry No. 140-9, Dunphy Deposition at 8). MedQuest bills the Medicare program for diagnostic testing of Medicare beneficiaries at its IDTFs. MedQuest’s Nashville area IDTFs are the Defendants: Bioimaging of Cool Springs, Inc., Bioimaging at Harding, Inc., now Edmondson and Bioimaging at Charlotte, Inc. For the damages period at issue, January 2004 through 2006, MedQuest’s Harding and CoolSprings centers were enrolled and operated as IDTFs with CIGNA, Medicare’s carrier for Tennessee. (Docket Entry Nos. 150-13 and 150-14). The Harding center’s Medicare provider number was 3790454 and subsequently 3790906. (Docket Entry No. 138, Haines Declaration). The CoolSprings center’s Medicare provider number was 3790904 and subsequently 3790907. Id. From January 2004 until July 1, 2005, MedQuest used another provider’s Medicare billing number for payment of its claims for testing of Medicare beneficiaries at its Charlotte center. Id. at 3. MedQuest’s Charlotte center arises out of its past relationship with Dr. William Witt, a board certified radiologist and former chief radiologist at a Veterans’ Administration (“VA”) hospital. In November 1998, Nashville Diagnostic Imaging (“NDI”), a management company affiliated with MedQuest, entered into an agreement with Dr. Witt “to provide management and related services to Dr. Witt at the site of his outpatient physician practice.” (Docket Entry No. 150-15, 1998 Management Agreement at 1). Under this agreement, Dr. Witt would “continue to practice radiological medicine and practice as a physician practicing outpatient radiological medicine at 1800 Charlotte Avenue, Nashville, Tennessee” Id. After 1998, Dr. Witt converted his outpatient diagnostic center into a professional corporation, William S. Witt, M.D., P.C., and thereafter to a general business corporation, William S. Witt, Inc. (Docket Entry No. 150-16, Stock Purchase Agreement at 1). On January 14, 2004, Dr. Witt sold all of his shares in William S. Witt, Inc. to Bioimaging at Charlotte, Inc. for five hundred sixty thousand dollars ($560,000.00). MedQuest paid the $560,000.00 for this purchase that included MedQuest’s ownership of Dr. Witt’s Certificate of Need issued by State health care officials for the diagnostic testing center at that location. (Docket Entry No. 140-6, Schaefer Deposition at 4, 12-13). After the stock sale, according to Dr. Witt, “my physician practice no longer existed at the 1800 Charlotte center.” (Docket Entry No. 133, Witt declaration at 2). Dr. Witt, however, agreed to provide physician services “in a manner consistent with the past practices and procedures utilized by [Dr. Witt] while engaged by the Corporation.” (Docket Entry No. 150-19, Reading Agreement). Under this latter agreement, Dr. Witt would set diagnostic/radiological standards and maintain professional and clinical standards. Id. at ¶ l(e)-(d). Dr. Witt leased his building to the Charlotte Center. (Docket Entry No. 150-18, Lease Agreement at 1-2). The lease agreement was between “William S. Witt, M.D., maintaining a principal office and place of business” at his home address, as “Landlord,” and Bioimaging at Charlotte, Inc., with its principal office and place of business at 1800 Charlotte Avenue, Nashville, Tennessee (“Tenant”). Id. John K. Luke, president of Bioimaging at Charlotte, Inc., signed the lease. Id. at 20, 21. As discussed in more detail infra, MedQuest controlled the business and employee operations at the Charlotte center. MedQuest used Dr. Witt’s Medicare provider number to bill Medicare for all diagnostic testing of Medicare patients at its Charlotte facility until July 1, 2005. (Docket Entry No. 140-1, Blank Deposition at 25). As to MedQuest’s key officers for the issues here, Dan Schaefer is MedQuest’s chief operating officer for the diagnostic centers; is listed as the authorized official on all three defendant Bioimaging centers’ Medicare applications that he also signed; and is responsible for Medicare billings. (Docket Entry No. 140-5, Schaefer Deposition 38^0, 43 and Docket Entry No. 140-6, 15-16, 45-56, 61-70). Wayne Blank was MedQuest’s chief compliance officer for Medicare. (Docket Entry No. 140-1, Blank deposition). Marcy Burke, now Marcy Burke Delozier, was a MedQuest employee in its credentialing department and worked at its corporate headquarters. (Docket Entry No. 137, Delozier declaration at 1). Sally Bradley was Delozier’s supervisor in 2002 and reported to Schaefer, but Bradley left MedQuest in 2005. (Docket Entry No. 131, Bradley Declaration at 1). Kim Hounshell was a diagnostic testing center manager and marketer at a MedQuest diagnostic testing centers until February 2005, when she became assistant director of credentialing at Med-Quest’s corporate headquarters. (Docket Entry No. 144, Hounshell Deposition at 3, 5). Hounshell had training on Medicare CMS 855, the IDTF application form for Medicare participation as well as instructions on enrollment of IDTFs and physician practices for IDTFs in the Medicare program. Id. at 13-16. Chris Wicker was director of financial services. (Docket Entry No. 141-3, Dozier Deposition at 2). Christina Dozier worked in the billing department before her transfer to its credentialing department where she worked from April 2005 until October, 2007 with Hounshell as her supervisor. Id. at 2-3. 2. The Medicare Enrollment Process Medicare has a multi-layered administrative management structure. The Secretary of the Department of Health and Human Services (“DHHS”) is responsible for the administration of the Medicare program and is authorized to issue regulations and rules. The Center for Medicare and Medicaid Services (“CMS”), an agency within DHHS, actually administers the Medicare and Medicaid programs. CMS acts for the Secretary and sets policies, issues manuals and forms, conducts research and establishes procedures for Medicare enrollment by health care providers as entities or individual providers. CMS also employs private insurance companies as carriers to implement Medicare regulations and policies, as well as to monitor and to pay billings of health care providers enrolled in Medicare. Medicare established the IDTF as a health care provider category in July 1998, (Docket Entry No. 140-2 at 14) and as discussed infra, the Secretary issued an extensive regulation for IDTFs. CMS form 855 is the application form with instructions for enrollment of facility as an IDTF. CMS form 855 requires, inter alia, the names of the physicians who will provide the supervision for the IDTF’s testing. (Docket Entry Nos. 150-13 at 22, 24-25 and 150-14 at 20, 23). This CMS form 855 has a section entitled “Authorized Official Signature” that Daniel J. Schaefer, MedQuest’s chief operating officer signed. In this statement, Schaefer agreed that: “If I become aware that any information in this application is not true, correct or complete, I agree to notify the Medicare program contractor of this fact immediately.” Id. at 13,19. CMS had to be informed if a physician is being added, deleted or changed with the effective date, and the name of the supervising physician and related information, including his/her Medicare number. (Docket Entry No. 137, Burke Declaration at 2, 6). As to supervising physicians, CMS form 855 informs applicants: “Note: Personal/Direct: If this Supervising Physician performs Personal or Direct Supervision, he!she must be currently enrolled in Medicare with the Medicare carrier to which this application is being submitted.” (Docket Entry No. 141-5 at 19) (emphasis added). An attachment to CMS 855 for IDTFs also instructs that “[T]his section is to be completed with information about all supervising physicians. If there is more than one supervising physician, copy and complete this section for each.” Id. On the supervising physician page, the applicant for Medicare enrollment as an IDTF must state whether the level of supervision to be provided by the supervising physician will be general, direct, or personal supervision. Id. In addition, Medicare’s IDTF application requires for Medicare enrollment that each physician must attest that he or she is “proficient” with the tests to be supervised and must specifically exclude any tests that the physician will not supervise at the facility. Id. at 24-25. The CMS Medicare enrollment form for an IDTF facility also requires a listing of the specific Current Procedural Terminology codes (“CPT”) that the IDTF will provide; the names and credentials of the technologists performing the diagnostic tests for those CPT codes; the name and Medicare provider number of all physician(s) who would be providing the interpretations of the diagnostic tests; and the name and Medicare number of the physicians) who supervise the diagnostic tests to be billed. (Docket Entry No. 150-14 at 21-25). CMS publishes manuals, policies and procedures for an IDTF compliance with the Medicare program. The CMS Manual on supervising physicians at IDTFs reads, in relevant part, as follows: 4.19.5-Supervising Physicians (Rev. 277; Issued: 12-19-08; Effective/Implementation Date: 01-20-09) A. General Principles Under 42 CFR § 410.33(b)(1), an IDTF must have one or more supervising physicians who are responsible for: The direct and ongoing oversight of the quality of the testing performed; The proper operation and calibration of equipment used to perform tests; and The qualifications of non-physician IDTF personnel who use the equipment. Of course, not every supervising physician has to be responsible for all of these functions. For instance, one supervising physician can be responsible for the operation and calibration of equipment, while other supervising physicians can be responsible for test supervision and the qualifications of non-physician personnel. The basic requirement, however, is that all the supervisory physician functions must be properly met at each location, regardless of the number of physicians involved. This is particularly applicable to mobile IDTF units that are allowed to use different supervisory physicians at different locations. They may have a different physician supervise the test at each location. The physicians used need only meet the proficiency standards for the tests they are supervising. Under 42 CFR § 410.33(b)(1), each supervising physician must be limited to providing supervision to no more than three IDTF sites. This applies to both fixed sites and mobile units where three concurrent operations are capable of performing tests. B. Information about the Supervising Physicians The carrier shall check and document that each supervisory physician: (1) is licensed to practice in the State(s) where the diagnostic tests he or she supervises will be performed, (2) is Medicare enrolled, and (3) is not currently excluded or debarred. The physician(s) need not necessarily be Medicare enrolled in the State where the IDTF is enrolled. In addition: The carrier shall verify the licensure for the State where the IDTF is being enrolled for each supervisory physician enrolled with another carrier, based upon the physician’s license submission and discussions with the carrier where they are enrolled. Each physician of the group who actually performs an IDTF supervisory function must be listed. If a supervising physician has been recently added or changed, the updated information must be reported via a CMS-855B change request. The new physician must have met all the supervising physician requirements at the time any tests were performed. If the carrier knows that a listed supervisory physician has been listed with several other IDTFs, the carrier shall check with the physician to determine whether the physician is still acting as supervisory physician for the previously enrolled IDTFs. C. General, Direct, and Personal Supervision Under 42 CFR § 410.33(b)(2), if a procedure requires the direct or personal supervision of a physician as set forth in 42 CFR § 410.32(b)(3), the carrier shall ensure that the IDTF’s supervisory physician furnishes this level of supervision. The carrier’s enrollment staff shall be familiar with the definitions of personal, direct and general supervision set forth at 42 CFR § 410.32(b)(3), and shall ensure that the applicant has checked the highest required level of supervision for the tests being performed. Each box that begins with — Assumes responsibility, II must be checked. However, as indicated previously, the boxes can be checked through the use of more than one physician. (Docket Entry No. 150-11 at 5-7) (emphasis added). In its Medicare “Program Integrity Manual (“PIM”), CMS requires the supervising physician to acknowledge that he or she is aware of the responsibilities on that capacity.” (Docket Entry No. 141-6 at 7). CMS’s PIM also requires its Medicare carrier to document that each supervisory physician: “(1) is licensed to practice in the State(s) where the diagnostic tests he or she supervises will be performed, (2) is Medicare enrolled, and (3) is not currently excluded or debarred.” (Docket Entry No. 141-6 at 6) (emphasis added). In addition, for the Medicare program “[i]f a supervisory physician has been recently added or changed, the update information is required to be reported via Form CMS-855 Change of Information form within 90 days of the change.” Id. (italics in the original). CMS’s PIM also contains instructions on the supervising physician page that includes an “Attestation” by which the supervising physician described the CPT codes that he or she will supervise or exclude specific codes that the supervising physician will not supervise. (Docket Entry No. 150-14 at 24; Docket Entry No. 150-13 at 23). Defendants knew Medicare’s requirements for physician supervision of diagnostic tests with contrast and provided the Medicare carrier with the lists of CPT codes of the diagnostic testing services to be provided at its Bioimaging centers in the Nashville area. (Docket Entry No. 137, Delozier Declaration at 2-3). CIGNA is Medicare’s carrier for Tennessee and decides requirements for health care providers at IDTFs. (Docket Entry No. 150-6 at 7). In 2000, CIGNA published a “Local Medical Review Policy” (“LMRP”) for Tennessee Medicare providers, including IDTFs. (Docket Entry No. 139-82). This Medicare Bulletin dated November/December 2000, (Docket Entry No. 139 at 32-39), includes a section entitled “Independent Diagnostic Testing Facility (IDTF),” with an effective date of December 15, 2000. Id. at 32. This Medicare Bulletin parallels CMS’s Manual quoted supra at 831-32, and describes the credential requirements for IDTFs, where diagnostic tests are performed by non-physicians, citing 42 C.F.R. § 410.33. Id. Medicare will cover diagnostic tests performed by an IDTF when the medical necessity set forth in the individual Local Medical Review Policies are met and when furnished in accordance with the criteria listed below: Supervising physician An IDTF must have one or more supervising physicians who are responsible for the direct and ongoing oversight of the quality of the testing performed, the proper operation and calibration of the equipment used to perform tests, and the qualification of non-physician personnel who use the equipment. This level of supervision is the requirement for general supervision. The supervising physician must evidence proficiency in the performance and interpretation of each type of diagnostic procedure performed by the IDTF. In the case of a procedure requiring the direct or personal supervision of a physician, the IDTF’s supervising physician must furnish this level of supervision whether the procedure is performed in the IDTF or, in the case of mobile services, at the remote location. Id. at 32 (emphasis added) Under the heading “Documentation Requirements,” CIGNA’s bulletin also requires an IDTF to maintain documentation “to demonstrate sufficient physician attendance during all hours of operation to assure that the required physician supervision is furnished. In cases of procedures requiring direct supervision, the supervising physician may oversee concurrent procedures. When direct or personal supervision is required, the record must clearly state this requirement was fulfilled.” (Docket Entry No. 139 at 34). Appendix I to CIGNA’s LMRP bulletin also lists CPT codes, id., at 37-39 and the corresponding level of physician supervision during the performance of the diagnostic test, as well as the physician qualifications for the supervising physician for that test. The “MD Qualification” represents the medical specialties that would be accepted as possessing the skill and competency necessary to supervise adequately the respective tests. Id. at 36. Physicians who were not board certified in the specified specialty in a State, had to present proof of additional continuing medical education or participation in a certification programs specific to the skills involved in the tests at issue. Id. During the relevant time, CPT codes with the corresponding level of physician supervision were published in a Medicare bulletin or CMS’s or CIGNA’s website with the corresponding level of physician supervision and qualifications of the supervising physician and administering technician for each CPT code, id. at 37-39 that CMS approves. (Docket Entry No. 141-1, Winter deposition at 4-5, 14, 24-25). The CPT codes include one for the diagnostic tests requiring Level 2 supervision or direct supervision, as reflected in the physician fee schedule and CIGNA’s publications. (Docket Entry No. 138, Haines Declaration at 2-3 and Docket Entry No. 137, Delozier Declaration at 2-5). CIGNA consults with CMS and other Medicare carriers’ medical directors and medical specialty boards on the appropriate qualification requirements for supervising physicians at IDTFs. One such collaboration was CIGNA’s 2006 working group on supervising physicians at IDTFs that found, in pertinent part: [T]he proficiency or expertise in the performance and interpretation of the procedure being performed by the physician must be documented. This role of the Supervising Physician in an IDTF clearly precludes any physician who does not have the specialized training required for the specific procedure from “supervising” the testing without documentation of additional training in this exclusive area of proficiency. A statement of ‘considerable experience ... related to imaging ... ’ does not suffice as evidence of proficiency in the performance of such testing. In order to assist providers in meeting these requirements and determining the required board certifications for supervising physicians, the national carrier workgroup with the assistance of carrier medical directors and medical specialty boards, assigned a listing of physician qualifications to each diagnostic CPT code. (Docket Entry No. 150-5 at 3) (emphasis added). As to the rationale of the importance of the supervisory physician’s qualifications for an IDTF, this working group study found that: An IDTF by virtue of its ‘independent status’ does not have the availability of numerous medical specialists to consult with each other in decision making as would be the case in a hospital or large medical clinic, and the physicians who refer their patients to an IDTF are relying on the expertise of the supervising/interpreting physician at that IDTF to assist them in making a medical diagnosis that will be used in treating the patient. To this end, it is expected that the highest level of expertise be available, therefore alternatives to board certification in the specialty required is not a viable option for physicians or technologists. This would also exclude “Residents” or those physicians who are “Board eligible” until such time as they attain certification status. The rampant proliferation of IDTFs nation wide has only served to increase the need for more stringent criteria to assure our beneficiaries of the best possible diagnostic services, not the most numerous. Id. at 4. (emphasis added). See also Docket Entry No. 169-3 at 2. Defendants note that a CIGNA representative requested guidance from CMS on whether a board certified radiologist is actually required for contrast coverage, but did not get a response. (Docket Entry No. 150-6, Guerrero Deposition at 10-12). There are not any published CMS criteria for the proficiency requirements for direct or personal physician supervision at an IDTF. (Docket Entry No. 150-2, Bossenmeyer Deposition at 3). Defendants knew Medicare required direct physician supervision of diagnostic tests with contrast and provided CIGNA with the lists of CPT codes of the diagnostic testing services Bioimaging centers. (Docket Entry No. 137, Delozier declaration at 3; Docket Entry No. 144, Hounshell Deposition at 12, 46 and 47). Christina Dozier, a former MedQuest credentialing specialist and a MedQuest contact with CIGNA, understood that the supervising physician on MedQuest’s CMS 855 form had to provide the services to bill Medicare for the service, unless the physician coverage was locum tenens coverage. “If it’s not a locum tenens, then Medicare needs to know about the doctor before we can bill for it.” (Docket Entry No. 141-3, Dozier Deposition at 6-7). 3. MedQuest’s Medicare Applications for the Nashville Area IDTFs During the IDTF application process, CIGNA informed MedQuest that “a physician of an IDTF must be proficient in the performance and interpretation of each type of diagnostic p[er]formed by the IDTF and provide documentation evidencing proficiency.” (Docket Entry No. 141-2 at 2, 34). On May 10, 2002 and June 6, 2005, MedQuest submitted to CIGNA the CMS 855 change of information forms for its Bioimaging IDTFs at Cool Springs and Harding. (Docket Entry Nos. 150-13 at 1, 13 and 150-14 at 1, 13, 19). As to supervising physicians, MedQuest’s 2002 CMS 855 change of information form for supervising physicians listed two supervising physicians for its Cool Springs IDTF, Dr. Witt and Dr. Robert A. Cooney. (Docket Entry No. 150-14 at 24-25). CIGNA approved both doctors, but Med-Quest withdrew Dr. Cooney as a supervising physician on November 15, 2002. (Docket Entry No. 137 at 6). Effective April 27, 2003, MedQuest submitted a CMS 855 change of information form listing Dr. Jean Tan, an internist, as a supervising physician at its Cool Springs IDTFs. (Docket Entry No. 140-7 at 1-5). Dr. Tan marked those sections of the form under general, personal and direct supervision that would enable her to provide general supervision over the equipment, supplies and training of non-physicians personnel performing diagnostic studies. Id. CIGNA approved Dr. Tan as a supervising physician, but only after proof of her additional training for diagnostic testing. (Docket Entry No. 131 at 2-4, Bradley Declaration, and Docket Entry No. 151-6, Dunphy deposition at 4). On July 18, 2005, CIGNA denied Med-Quest’s request for approval of Dr. Thomas Henry, as a supervising physician at MedQuest’s Cool Springs facility because he was “not board certified in Radiology” as required by 42 C.F.R. § 410.33. (Docket Entry No. 140-2 at 2, 34). CIGNA informed MedQuest of the appeal process for its denial. Id. CIGNA denied other MedQuest’s informal telephonic requests for approval of physicians as supervising physicians who were not board certified radiologist or a physician trained for IDTF testing. (Docket Entry No. 169-2 at 3). Effective July 1, 2005, Defendant Bioimaging at Charlotte enrolled with CIGNA as an IDTF with the Medicare program. (Docket Entry No. 151-20). After its earlier purchase of William S. Witt, Inc. in January 2004, MedQuest billed the Medicare program for diagnostic testing of Medicare beneficiaries at the Charlotte facility, but used Dr. Witt’s Medicare provider number from January 15, 2004 through June 30, 2005. (Docket Entry No. 146, Haines Deposition at 2, 14; Docket Entry No. 138, Haines Declaration at 3; and Docket Entry No. 64, Defendant’s Answer at 45). Before January 2004, Dr. Witt was enrolled with Medicare as a physician practice for diagnostic services at 1800 Charlotte. (Docket Entry No. 140-1, Blank deposition at 59). The Medicare number for billing for an IDTF refers to a facility rather than to an individual. (Docket Entry No. 144, Hounshell Deposition at 43). Medicare billing numbers can be researched from public records. (Docket Entry No. 140-2, Blank deposition at 5-6). MedQuest’s enrollment of its Charlotte facility as an IDTF arose after Aetna, a private insurer, was processing Medicare claims and raised issues about MedQuest’s billing for testing at its Charlotte facility, using a Medicare billing number that belonged to Dr. Witt. (Docket Entry No. 139 at 17, 18). When Dozier first attempted to change the tax identification number with CIGNA, CIGNA instructed Dozier that Medicare required a CMS 855 enrollment change form for this change. (Docket Entry No. 141-3, Delozier deposition at 14-20). An executive report from Choice Point, a computer research firm employed by CIGNA, identified all persons or entities previously associated with the Charlotte Center provider number and identified the prior providers as William Witt, M.D. and William Witt, Inc. (Docket Entry No. 151-3). CIGNA’s files did not reflect its awareness of MedQuest’s classification of the center as a physician’s practice. MedQuest did not inform Medicare of its purchase until July 1, 2005. (Docket Entry No. 140-1 at 47). As to why the Charlotte center did not apply as an IDTF in 2004, Wayne Blank, MedQuest’s chief compliance officer explained that “they just messed up and didn’t get it enrolled until they decided to do the tax ID, and that’s when they saw it was still enrolled as William Witt.” (Docket Entry No. 140-2 at 2). Blank described the Charlotte center as operating as an IDTF as of January, 2004, id. at 2, but did not consider “a lot of difference” between a physician practice and an IDTF. Id. As quoted earlier supra at 829, as of January, 2004, Dr. Witt considered his prior physician practice ended with MedQuest’s stock purchase of his corporation. MedQuest submitted a new enrollment application for its Charlotte facility and filed the Choice Point report with its new application. (Docket Entry No. 140-1, Blank deposition at 47 and Docket Entry No. 140-2 at 1). MedQuest also consolidated all of the Nashville area Bioimaging Centers under one tax identification number. Chris Wicker, MedQuest’s director of accounts receivables, changed the tax identification number for the Bioimaging Centers effective July 1, 2005, and consolidated all Bioimaging centers with a single tax identification number. 4. MedQuest’s Nashville Area IDTFs’ Performance MedQuest operated the Bioimaging IDTFs’, including the Charlotte Center and provided administrative services to all Bioimaging Centers, including information technology. At MedQuest’s Nashville area IDTFs, the standard procedure was for a physician to supervise contrast studies regardless of payor, and the IDTF staff selected physicians for contrast studies. (Docket Entry No. 151-5, Baggett’s Deposition at 6 and Docket Entry No. 151-6 Dunphy’s Deposition, at 4). MedQuest’s IDTFs retained radiologists to read diagnostic images off-site so as to allow on-site radiologists more time to provide contrast coverage. (Docket Entry No. 151-6 at 8). Yet, the standard practice did not require a radiologist who was already on-site at one of MedQuest’s Nashville area IDTFs to perform a diagnostic procedure and/or to read or interpret a diagnostic image or to sign the physician log. (Docket Entry No. 151-6, Dunphy Deposition at 5). In 2003, a MedQuest memorandum instructed its IDTF centers’ staffs that only physicians on MedQuest’s Medicare applications should be used for contrast studies of Medicare patients. (Docket Entry No. 137, Delozier declaration at 12-14). For its Nashville area IDTFs, MedQuest had Medicare’s approval of Dr. Witt as a supervising physician beginning in 2002 and Dr. Tan in 2003. Problems arose in ensuring the availability of Dr. Witt who was responsible for all three MedQuest centers in the Nashville area, for contrast injection coverage. (Docket Entry No. 169-1 at 4 and Docket Entry No. 139 at 4). Dr. Witt failed to give MedQuest’s Nashville area IDTFs’ staffs notice of when he would take a day off or would leave early or arrive late. (Docket Entry No. 140-6 at 42 and Docket Entry No. 141-10 at 10-12). Dr. Witt was also unavailable during “after hours,” (Docket Entry No. 141-7, Baggett deposition at 7) as MedQuest Nashville area IDTFs remained open until 8:00 or 9:00 p.m. (Docket Entry No. 166-1, Hobbs Affidavit at 4). In 2003, Dr. Witt was seriously injured in an accident and was unable to provide diagnostic coverage services for a time, but provided reading services from his residence. (Docket Entry No. 140-5, Schaefer deposition at 65-67). When Dr. Witt returned to work, by separate agreement, Dr. Witt agreed to provide supervision at MedQuest’s three Nashville area IDTFs. (Docket Entry No. 163, Roberts’s declaration at 3). When Drs. Witt and Tan were unavailable to provide the physician supervision of contrast tests billed to Medicare, Med-Quest’s Nashville IDTFs’ staffs would contact several physicians to provide contrast coverage at MedQuest’s Nashville area IDTFs. (Docket Entry No, 132, Just declaration at 2). MedQuest’s corporate compliance officer and regulatory counsel, Wayne Blank, conceded that Medicare required such supervision to be covered by a physician on its IDTF’s CMS 855 form, unless there was locum tenens coverage. (Docket Entry No. 140-1, Blank-Deposition at 41-42). At some point, MedQuest’s Nashville area IDTF managers and employees began to list contrast alerts on the daily calendar to inform staff of the time and location of scheduled contrast studies so as to ensure a supervising physician for that procedure. (Docket Entry No. 151-6 Dunphy Deposition at 6). The schedulers, the technologists, and the local IDTF staff had access to the IDTF’s daily calendar, including contrast alerts. Id. at 6-7. These contrast alerts were to avoid scheduling conflicts in arranging for physician supervision of contrast studies at the different centers. Id. Technologists who were unable to schedule a supervising physician for a contrast procedure would reschedule the patient for the contrast procedure rather than inject the patient with contrast material. Id. at 9-10. MedQuest’s Nashville area IDTFs maintained a list of physicians for staff to contact and that list was posted at its individual IDTF. (Docket Entry No. 150 at 21-22 and Baggett Transcript at 44:9-23). To document these physicians’ supervision of contrast studies where a radiologist was unavailable, MedQuest’s Nashville IDTF’s staff utilized sign-in logs for these physicians, but some physicians did not sign the log sheets for their contrast coverage. (Docket Entry No. 151-5, Baggett deposition at 2-7 and Docket Entry No. 151-6, Dunphy deposition at 6). All of these Bioimaging Centers used this same supervising physician logbook form to record physician supervision of diagnostic tests administered. This log also recorded the patient’s name, the names or initials of the physician who injected the contrast and provided coverage of the contrast injection and the date of the contrast tests. (Docket Entry No. 151-5, Baggett deposition at 3-4). This log did not require a radiologist to sign and does not reflect whether the signing physician was approved by Medicare. (Docket Entry No. 151-6, Dunphy deposition at 4, 5). The undisputed facts are that the physicians on these logs were not approved by Medicare for these tests. (Docket Entry No. 141-9, Defendants’ Response to the United States Requests for Admissions at ¶¶ 4-24). These physicians who provided direct supervision of diagnostic tests of Medicare patients using contrast at these MedQuest centers, were not disclosed to CIGNA and CIGNA had not evaluated these physicians’ “proficiency” to supervise these tests as Medicare providers. (Docket Entry No. 138, Haines Declaration at 1-6, 37-38; Docket Entry No. 146, Haines Deposition at 13-14, 19). Yet, MedQuest billed and Medicare paid for these non-Medicare approved physicians’ supervision of the tests at its Nashville area IDTFs. Id. At times, IDTF managers and technicians began to inject patients for contrast studies without a physician present because they felt pressured to do so. (Docket Entry No. 141-8, Hobbs deposition at 17, 18; Docket Entry No. 141-7, Baggett deposition at 9, 10, 15). Baggett reported her injections without a physician to her supervisors Hobbs, Just and Dunphy. (Docket Entry No. 141-7 at 10). Med-Quest’s managers’ responses to technician injections were to provide names of more physicians. Id. at 11-12. Defendants’ employees at these Nashville area centers refer to obtaining physician coverage of diagnostic tests involving contrast as “difficult to schedule.” (Docket Entry No. 166-1, Hobbs Affidavit at ¶ 9). According to Dunphy, appropriate physician supervision of contrast coverage at all their Nashville area centers was “always a concern.” (Docket Entry No. 140-9 at 3). Dunphy described securing a qualified supervising physician as “difficult” and “definitely not an easy task to get contrast coverage.” Id. at 17. Hobbs complained to her Med-Quest supervisors about technicians injecting patients without supervision. (Docket Entry No. 166-1, Hobbs Affidavit at ¶ 18). MedQuest’s Nashville area IDTFs staff employees did so because they were pressured to generate billings. Id. at ¶ 10. According to Hobbs, MedQuest’s Nashville area physicians credentialed by Medicare could not cover all three MedQuest IDTFs as supervising physicians. (Docket Entry No. 166-1, Hobbs Affidavit at ¶¶ 5,7, 9). Sally Bradley, MedQuest’s director of credentialing attributed these coverage issues to CIGNA. “The problem lies in the Local Medical Review Policies for Medicare of Tennessee. They require that virtually all tests at an IDTF be supervised by a radiologist, which is much more stringent than other states.” (Docket Entry No. 131, Bradley declaration at 5). On January 28, 2003, Marcy Burke Delozier, an employee in MedQuest’s corporate credentialing department, issued a Memorandum to “All Center Managers” and all “Regional Managers” regarding Medicare requirements for physician supervision of diagnostic tests and copied MedQuest’s management. (Docket Entry No. 137 at 3, 12-18). Delozier, a compliance officer, described “extensive” discussions with Schaefer and other MedQuest management about the lack of supervising physicians at MedQuest’s Nashville area IDTFs. One of the issues that I discussed extensively with Dan Schaefer and others while I worked at MQA [MedQuest] was about physician supervision at the centers. I spoke at length about physician supervision with various center managers as well as with MQA managers, including Mr. Schaefer and Mr. Villa. It was my understanding that supervising physicians had to be proficient with respect to the particular tests they were supervising in order for the test to be billed to Medicare. Level 2 required direct supervision, and Level 3 required personal supervision. This requirement was discussed at MQA with management, including Mr. Schaefer. The CMS 855 forms also contained a physician attestation about the type of supervision the physician is going to provide. It was also clear to me that if a physician was not listed on the CMS 855 forms provided to Medicare, or was not shown to be proficient for the tests the physician was supervising, the physician could not provide the supervision of tests given to Medicare patients for billing to Medicare. I felt that when I raised concerns about Medicare requirements to Mr. Schaefer and other members of MQA management, the requirements were not taken seriously. I also was concerned that others at MQA were giving center managers information that conflicted with the Medicare requirements that I understood. Many of the centers wanted to use non-radiologists for physician supervision. Therefore, in January 2003, I sent out a memorandum to all center managers and regional managers clearly stating the Medicare requirements for physician supervision. Copies of my memorandum, with its attachments, that I distributed to all of the centers and to MQA management are attached to this declaration. I explained in the memorandum the physician supervision that was required for the three levels of supervision, and reminded everyone that only those physicians credentialed on the center’s Medicare applications could be used for services provided to Medicare patients. I tried to stress that following the memorandum’s instructions was very important and had to be followed or the centers would not be in compliance with Medicare rules and regulations. I also attached and provided to the center managers an example of the Medicare CMS 855 physician attestation that had to be completed by the physicians, and the template of a physician supervision log sheet for each center to document the physician supervision. (Docket Entry No. 137 at 3). Burke’s January 2003 Memorandum, entitled “Medicare Supervising Physician Information,” included among other things the following: Attached you will find several pages of very important information to be followed for compliance with Medicare. Probably most important is the section on Supervising Physicians, their responsibilities and the Levels of Supervision they provide to Medicare patients. You will also find information on the following: Supervision Physician Log, Physician Orders, Emergency Phone Numbers, Technologist’s Certification, Site Visits and Return Site Visits. I have attached copies of the following documents: Medicare Supervising Physician Attestation, Supervising Physician Log and Supervising Physician/Emergency Phone Numbers form. You must ensure that your site(s) comply with the requirements. These requirements and compliance with them are critical. Feel free to call me if you need additional information. * * * The supervising physicians have to meet only the proficiency standards for the tests they are supervising. If they are supervising all tests they have to meet the proficiency standards for all tests. See attached copy of Medicare’s Supervising Physician Attestation that each supervising physician must sign. Please Note: The supervising physician/s that I have listed on your Medicare application is the only physician/s you should use for contrast enhanced studies on Medicare patients. If you use other physicians not listed with Medicare, you are not in compliance. Id. at 12, 13 (emphasis in the original). Burke’s memorandum attached copies of the CMS 855 IDTF Attachment 2 Supervising Physician form with the physician attestation, and a copy of a Supervising Physician Logbook page. Id. at 16-18. On November 7, 2005, MedQuest expressed its concerns to CMS about CIGNA’s requirement of a board certified radiologist as a supervising physician at its IDTFs. Citing 42 C.F.R. § 410.33(b)(2) as the governing regulation for an IDTF, Wayne Blank and Kimberly Hounshell of MedQuest wrote: Background Independent Diagnostic Testing Facilities (“IDTF”) is a relatively new category of provider. Effective July 1, 1998, Medicare provided for the implementation of this new provider designation of IDTF at 42 C.F.R. § 410.33. The IDTFs replaced the previous provider category of Independent Physiological Laboratory (“FPL”). The IDTF designation is described as fixed location, mobile entities and individual non-physician practitioners. * * * Clearly the regulations do not require that the supervising physician be a Board Certified Radiologist. Other physicians may have training or continuing medical education which provides them with proficiency to supervise the operation of the imaging equipment as well as, respond to any patient medical issues which may arise during the imaging procedure. The greatest concern with regard to patient safety in the imaging area concerns problems which may arise from a patient’s adverse allergic reaction to the administration of the contrast agent utilized for certain imaging procedures. The response to such a reaction would be handled by a qualified physician through administration of appropriate drugs required to control such allergic reaction. The IDTF Model By their very nature IDTFs are independent from diagnostic imaging services offered by facilities owned by hospitals or physicians. The cost structure is designed to provide quality imaging services at a cost far below that of an institutional setting. Furthermore, in many instances IDTF providers offer early morning, evening or weekend hours as a means of providing greater access and flexibility to patients which would not necessarily be available in a hospital or physician office setting. With staffing shortages in the field of radiology, for those hours outside of the core work hours of 8:00 a.m. to 5:00 p.m. it is difficult for IDTF providers (or other imaging providers) to find radiologists to staff a facility. Given that they will not be the one required to read or interpret images taken at these times, non-radiologist physicians (with appropriate proficiency) are more than capable of supervising the imaging operations and providing for the safety of the patients. * * * Recommended Solutions We would request that CMS instruct the carriers to re-evaluate the interpretation of supervising physician requirements and offer the following recommendation. We believe the following supervision levels provide the quality levels sought and while allowing IDTFs the flexibility to operate and provide needed diagnostic imaging assess to Medicare patients. (Docket Entry No. 140-2 at 16-17, 20). From 2003 to 2007, CIGNA’s requirement of a radiologist or a physician appropriately trained in diagnostic testing to be performed at an IDTF was not modified, amended or changed. (Docket Entry No. 176, Statement of Undisputed Facts at ¶¶ 79-80). As stated earlier, CIGNA approved Dr. Tan, an internist with additional training, as a supervising physician at MedQuest Nashville area IDTFs. (Docket Entry No. 131, Bradley declaration at 2). Finally, Defendants contend that Medicare did not suffer any adverse financial impact from MedQuest’s Charlotte’s facility’s lack of an IDTF status prior to July 1, 2005 and cite the Medicare policy that authorizes back-billing of testing at Witt’s Charlotte facility prior to its pre-IDTF approval. The CMS Manual authorizes back-billing for successor entities, but such authorization is not automatic. Medicare requires its carriers to certify that any successor facility met all requirements of an IDTF during the back-billing period. Moreover, the successor entity had to notify the Medicare carrier of the change of ownership and apply as an IDTF. A. Backbilling Like any other non-certified supplier, an IDTF applicant may back bill from the date it met all the IDTF requirements-assuming it can furnish reasonable evidence that it indeed met the applicable standards on that date. For example, suppose an applicant was granted an IDTF number on July 1, 2005, but met all of the necessary requirements-properly calibrated equipment, qualified technicians, qualified supervisory physicians, etc. — as of May 1, 2005. The applicant can back bill for IDTF services performed on or after May 1, 2005. Evidence that the carrier shall consider in determining whether such standards were met include payroll records, personnel records, contracts, equipment purchase records, etc. The carrier, when necessary, shall request such confirming documents from the applicant or, as an alternative, may review such documents as part of the site visit. The carrier shall also document the file with the method used for determining when the applicant is entitled to bill for services. Note that the applicable personnel and equipment do not have to be the same as those of July 1, 2005. An applicant that has purchased the assets of an existing IDTF is not automatically allowed to continue billing. It must apply as a new IDTF and may back bill once enrolled. Obviously, use of the same personnel and equipment as the previously enrolled IDTF can facilitate the determination that the new IDTF can bill as of the date of the sale. (Docket Entry No. 150-11 at 1). Defendants do not offer any proof that CIGNA made such inquiries or certified its Charlotte center for its operation during the back-billing period. 5. Expert Proof on Medicare Administrative Practice Approving Supervising Physicians Dr. Gary Oakes, CIGNA’s associate medical director, testified that a radiologist is the most proficient specialty to determine the modality, i.e., the type of diagnostic procedure and most appropriate treatment for a patient presenting a clinical condition during such testing. (Docket Entry No. 150-1, Oakes deposition at 2, 6, 9). Dr. Oakes admitted that the referring physician decides the type of test and when the test is ordered and that any state licensed physician can provide treatment in the event of a contrast reaction, id. at 11-12, but insisted some specialized training for physician supervision of diagnostic testing at an IDTF is necessary. Q. Okay. So is it fair to say that unless a physician can provide either board certification in a specialty attached to the CPT listings or some society that’s equivalent to a board certification you will not approve? A. Correct. Q. Has that always been the case? A. Since I’ve been here. Q. And if I understand your testimony, the reason for this is you believe that board certification provides the competency criteria that you’re looking for? A. It — yes. MR. MATHERNE: I think you said competency and proficiency, if there’s a difference. Q. (By Ms. Plowman) Is there a difference? A. They meet the standards of the board which would normally envelope the particular procedure. But, yes, we expect proficiency and competency, and we depend upon the board to determine what is appropriate for that particular specialty. Q. Let’s take, for example, a radiology code, let’s say MRI. A. Sure. Q. When you’re looking for competency and proficiency in the procedure, what are you looking for? A. Somebody that knows the mechanics of the MRI; the indications; and as important, if not more so, the contraindications; and which particular test is the best test given the clinical scenario. Q. And when you