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Doe v. Rogers

United States District Court, D. Columbia

June 17, 2015

JOHN DOE, et al., Plaintiffs,
v.
JUDITH ROGERS, M.H.A., et al., Defendants

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          For JOHN DOE, JOHN DOE, PLLC, Plaintiffs: Barry Coburn, LEAD ATTORNEY, COBURN & GREENBAUM, PLLC, Washington, DC; Lloyd Liu, LEAD ATTORNEY, COBURN & GREENBAUM PLLL, Washington, DC; William Thomashower, PRO HAC VICE, SCHWARTZ & THOMASHOWER, LLP, New York, NY.

         For JUDITH RODGERS, M.H.A. as Senior Advisor in Division of Practitioner Data Banks, KATHLEEN SEBELIUS, M.P.A., Secretary, U.S. Department of Health and Human Services and her Successors, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, United States Department Of Health and Human Services, Division of Practitioner Data Banks, NATIONAL PRACTITIONER DATA BANK, CYNTHIA GRUBBS, J.D., As the Director of the Division of Practitioner Data Banks, ANASTASIA TIMOTHY, M.D., M.P.H., As NPDB Dispute Resolution Manager, Defendants: Peter C. Pfaffenroth, LEAD ATTORNEY, U.S. ATTORNEY'S OFFICE, Civil Division, Washington, DC.

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          REDACTED

         MEMORANDUM OPINION

         THOMAS F. HOGAN, SENIOR UNITED STATES DISTRICT JUDGE.

         This lawsuit was commenced by Dr. John Doe and Dr. Doe's limited liability company (" the plaintiffs" ) to recover damages and secure declaratory and injunctive relief against the Secretary of the Department of Health and Human Services, the National Practitioner Data Bank, and three officials who administer the National Practitioner Data Bank (collectively " the defendants" ). The plaintiffs allege that the defendants unlawfully accepted, maintained, and continue to release an inaccurate, fraudulent and untimely Adverse Action Report that was submitted to the National Practitioner Data Bank by Dr. Doe's prior employer, Peconic Bay Medical Center (the " Hospital" or " PBMC" ). Pending before the Court are a Motion to Dismiss or, Alternatively, for Summary Judgment [ECF No. 26] that was filed by the defendants and a Cross-Motion for Summary Judgment [ECF No. 45 (Sealed)] that was filed by the plaintiffs.

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For the reasons that follow, the Court will grant in part and deny in part the defendants' Motion to Dismiss or, Alternatively, for Summary Judgment, and deny the plaintiffs' Cross-Motion for Summary Judgment. The Court will also remand to the Secretary for further proceedings consistent with this Opinion.

         BACKGROUND AND PROCEDURAL POSTURE

         I. The Health Care Quality Improvement Act

         Nearly three decades ago. Congress enacted the Health Care Quality Improvement Act of 1986, 42 U.S.C. § § 11101-11152 (West 2014) (the " Act" or " HCQIA" ), to address the nationwide problem of medical malpractice and the " need to restrict the ability of incompetent physicians to move from State to State without disclosure or discovery of the physician's previous damaging or incompetent performance." 42 U.S.C. § 11101(1)-(2). Congress found that professional review conducted by peers could remedy the medical malpractice problem but incentives and protections to encourage effective professional peer review needed to be established. Id. § 11101(3)-(5). The Health Care Quality Improvement Act promotes effective professional peer review by prescribing mandatory review and reporting requirements for health care entities, id. § § 11131, 11132, 11133, setting standards to govern a professional review action, id. § 11112, and, significantly, providing immunity from damages liability to professional review bodies and designated participants if the professional review action complies with certain standards enumerated in the statute, id. § 11111(a)(1).

         Relevant to this case, the Health Care Quality Improvement Act compels " [e]ach health care entity which . . . accepts the surrender of clinical privileges of a physician . . . while the physician is under an investigation by the entity relating to possible incompetence or improper professional conduct" to report such action or surrender of clinical privileges to the Secretary of the Department of Health and Human Services.[1] Id. § § 11133(a)(1)(B)(i) (quotation), 11134(b). The Health Care Quality Improvement Act also obligates hospitals to request reported information about a physician who seeks clinical privileges or applies to join a hospital's medical staff, id. § 11135(a), and establishes a presumption that a hospital knows information that has been reported about a physician regardless of whether the hospital actually obtains the information as required by the Act, id. § 11135(b). The Health Care Quality Improvement Act recognizes, however, that there might be disputes about the accuracy of reported information, so it directs the Secretary of the Department of Health and Human Services to issue regulations that provide procedures to dispute a report's accuracy. Id. § 11136(2).

         II. The National Practitioner Databank

         In accordance with the delegations contained in the Health Care Quality Improvement Act, the Secretary of the Department of Health and Human Services promulgated regulations that established the National Practitioner Data Bank. 45 C.F.R. § 60.1. The National Practitioner Data Bank collects and releases information that the Health Care Quality Improvement

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Act requires health care entities to report regarding the " professional competence and conduct of physicians, dentists, and other health care practitioners." Id.

         The Department of Health and Human Services also published an NPDB Guidebook to " inform the United States health care community about the NPDB and what is required to comply with the requirements established by Title IV of Public Law 99-660, the Health Care Quality Improvement Act of 1986, as amended." [2] U.S. Dep't of Health & Human Servs., Health Resources & Servs. Admin., NPDB Guidebook A-1 (2001).[3] The NPDB Guidebook states that " [t]he establishment of the NPDB represents an important step by the U.S. Government to enhance professional review efforts by making certain information concerning medical malpractice payments and adverse actions available to eligible entities and individuals." Id. at A-3. As one federal appellate court explained:

The Data Bank prevents a physician who applies to become a member of a hospital's medical staff or for clinical privileges from being able to hide disciplinary actions that have been taken against him. Information in the Data Bank is intended " only to alert . . . health care entities that there may be a problem with a particular practitioner's professional competence or conduct" because the practitioner has been the subject of a disciplinary action. The Data Bank contains not only the hospital's side of the story but also the physician's response. What the requesting hospital does with the information it obtains from the Data Bank is entirely up to that hospital. It could completely discount the information, or it could back off from any professional relationship with the physician, or it could make further inquiries to determine what had actually happened.

Leal v. Secretary, U.S. Dep't of Health & Human Servs., 620 F.3d 1280, 1283-84 (11th Cir. 2010).

          The review, reporting and disclosure regulations that apply to the National Practitioner Data Bank are codified at 45 C.F.R. § § 60.1-60.22 and " establish procedures to enable individuals or entities to obtain information from the NPDB or to dispute the accuracy of NPDB information." 45 C.F.R. § 60.2. The details of the procedures to dispute the accuracy of an Adverse Action Report are discussed infra at part B(5). With respect to the relevant requirement for reporting, the National Practitioner Data Bank regulations mirror the Health Care Quality Improvement Act by stating that hospitals must report to the National Practitioner Data Bank the " [a]cceptance of the surrender of clinical privileges or any restriction of such privileges by a physician . . . [w]hile the physician . . . is under investigation by the health care entity relating to

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possible incompetence or improper professional conduct . . . ." 45 C.F.R. § 60.12(a)(i)(A).

         III. The Surgical Incident and Resulting Adverse Action Report

         On Friday, October 2, 2009, Dr. Doe commenced a late-night emergency laparoscopic appendectomy on a 14-year-old girl who had acute appendicitis. First Am. Compl. ¶ ¶ 48, 49; Administrative Record (" AR " ) 0153 [ECF No. 19-4 (Sealed)]; Pls.' Statement of Undisputed Material Facts Pursuant to Local R. 7(h) ¶ 4 [ECF No. 45-2 (Sealed)]. During the surgery, Dr. Doe removed what he characterized as an " inflamed band" but the anesthesiologist protested was the patient's Fallopian lube. AR 0101 [ECF No. 19-3 (Sealed)] (" During the procedure it was noted by [the anesthesiologist] that [Dr. Doe] removed segment of Fallopian tube." (capitalization formatting omitted)); AR 0143 [ECF No. 19-3 (Sealed)] (stating that the anesthesiologist " shouted loudly" at Dr. Doe); AR 0283 [ECF No. 32-1 (Sealed)] (stating that " the error was immediately detected by the anesthesiologist during the procedure" ). A subsequent pathology report confirmed that the " inflamed band" was part of the patient's right Fallopian tube. First Am. Compl. ¶ 51 [ECF No. 23]; AR 0142-0143 at ¶ 85 [ECF No. 19-3 (Sealed)]; [4] AR 0181 [ECF No. 19-4 (Sealed)]; AR 0185 [ECF No. 19-4 (Sealed)]: AR 0219 [ECF No. 19-5 (Sealed)]; Pls.' Statement of Undisputed Material Facts Pursuant to Local R. 7(h) ¶ 4 [ECF No. 45-2 (Sealed)]. There is no dispute that Dr. Doe failed to recognize the anatomical identity of the " inflamed band" before he intentionally cut and removed it.[5] Pls.' Mem. In Opp'n to Defs.' Mot. to Dismiss 3-4 [ECF No. 45 (Sealed)] (stating that " [t]he surgery included the surgeon's considered medical judgment that it was necessary to remove an inflamed band, which was later conclusively identified as a damaged Fallopian tube . . ." ); AR 0010 [ECF No. 19-1 (Sealed)] (asserting that the decision to cut and remove the " inflamed band" was an intentional exercise of his medical judgment); AR 0143 [ECF No. 19-3 (Sealed)] (" As it turned out, the pathologist later identified this inflamed band as the right Fallopian lube." ); AR 0158 [ECF No. 19-4 (Sealed)] (" Pathological analysis of the inflamed

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band indicated that it was the right Fallopian tube." ); AR 0169 [ECF No. 19-4 (Sealed)] (stating that he cut " an inflamed band" ); AR 0180 [ECF No. 19-4 (Sealed)] (referring to the cut organ as an " adherence" ); AR 0219 [ECF No. 19-5 (Sealed)] (stating that the " band was later identified as a portion of the Fallopian tube" ); Pls.' Statement of Undisputed Material Facts Pursuant to Local R. 7(h) ¶ 4 [ECF No. 45-2 (Sealed)] (stating that an " inflamed band . . . was later conclusively identified as a severely inflamed Fallopian tube" ).

         The following Monday, Dr. Doe met with three Hospital officials to discuss the surgical incident,[6] which the Hospital claims was reported by both the anesthesiologist and a nurse who was present during the surgery.[7] Dr. Doe claims that, during that meeting, the Vice President for Medical Affairs told Dr. Doe that he was being fired. AR 0143 at ¶ 87 [ECF No. 19-3 (Sealed)] (stating that the Vice President of Medical Affairs " told the plaintiff that he was fired" ); AR 0203 [ECF No. 19-5 (Sealed)] (stating that Dr. Doe " called me a few hours later on October 5th and told me that he had just met with [the Vice president of Medial Affairs] and he had been fired from his position at the hospital" ). The hospital claims that the officials " informed [Dr. Doe] that he could not exercise his surgical privileges pending further investigation of the care he provided to [the] patient." AR 0084 [ECF No. 19-2 (Sealed)]. Regardless of who said what, it is undisputed that, at some point that day, the Vice President of Medical Affairs told Dr. Doe that the Hospital was required to report the surgical incident to the New York State Department of Health and that such a report was necessary " 'whenever an organ other than the organ operated is injured." AR 0161 [ECF No. 19-4 (Sealed)]; AR 0203 [ECF No. 19-5 (Sealed)]. The hospital did, in fact, file a report that day via the New York Patient Occurrence Reporting and Tracking System (" NYPORTS" )[8] and stated in the report that " [t]he physician has been placed on suspension pending completion of the investigation and the family notified." AR 0108 [ECF No. 19-3 (Sealed)]. The Hospital also submitted a Sentinel Event Self-Report to The Joint Commission[9] that contained the same statement that " [t]he physician has been placed on suspension pending completion of the investigation and the family notified." AR 0109 [ECF No. 19-3 (Sealed)].

         Later that same day, Dr. Doe executed a letter voluntarily suspending his surgical privileges and stating " I will not operate at Peconic Bay Medical Center for the next two weeks effective October 5, 2009 through October 19, 2009. or until mutually agreed upon. I will however, finish the follow-up care on patients that I am currently involved with on the clinical floors without performing any surgery." AR 0110 [ECF No. 19-3 (Sealed)]. Dr. Doe claims that this letter was prompted by his

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discovery " that he was going to have to return to the University of Tennessee to complete another year of cardiothoracic surgery fellowship in preparation for his Board exam." First Am. Compl. ¶ 53.

         Two days later, on October 7, 2009, Dr. Doe tendered a short letter of resignation that stated " [e]ffective October 16, 2009, I resign from Peconic Bay Medical Center." AR 0113 [ECF No. 19-3 (Sealed)].

         On December 3, 2009, about two months after Dr. Doe resigned, the Hospital submitted an Adverse Action Report to the National Practitioner Data Bank. AR 0132 [ECF No. 19-3 (Sealed)]. The Adverse Action Report stated:

In June 2009, the physician commenced practice at the Hospital in thoracic and general surgery. On Friday, October 2, 2009, the physician performed a laparoscopic appendectomy on a 14-year-old female. In the course of performing the procedure, the physician inadvertently removed part of one of the patient's fallopian tubes. On or about Monday, October 5, 2009, the physician agreed to refrain from exercising his surgical privileges pending the Hospital's investigation of this matter. By letter dated October 7, 2009, the physician advised the Hospital that he resigned from the Hospital effective October 16, 2009. Accordingly, the Hospital took no further action regarding the physician's privileges or employment. However, the Hospital's quality assurance review of this matter indicates departures by the physician from standard of care with regard to the laparoscopic appendectomy that he performed on October 2, 2009.

AR 0002 [ECF No. 19-1 (Sealed)].

         Dr. Doe contends that he was unaware of the Adverse Action Report until June 2010, when a prospective employer cited it as the reason for declining to meet with him. AR 0017 [ECF No. 19-1 (Sealed)]; AR 0018 [ECF No. 19-1 (Sealed)]; First Am. Compl. ¶ ¶ 83-86 [ECF No. 23]; Pls.' Statement of Undisputed Material Facts Pursuant to Local R. 7(h) ¶ 13 [ECF No. 45-2 (Sealed)]. Upon discovering the report, Dr. Doe contacted the Hospital and requested that it retract the report because it was factually inaccurate. AR 0008 [ECF No. 19-1 (Sealed)]; AR 0013 [ECF No. 19-1 (Sealed)]. Dr. Doe also submitted a Subject Statement to the National Practitioner Data Bank and placed the Adverse Action Report in a disputed status " challenging both the factual accuracy of the report and whether the report was submitted in accordance with the [National Practitioner Data Bank's] reporting requirements." First Am. Compl. ¶ 89 [ECF No. 23]; see also AR 0018-27 [ECF No. 19-1 (Sealed)].

         When the Hospital refused to revise or void the Adverse Action Report, Dr. Doe submitted a letter to the National Practitioner Data Bank requesting that the Secretary of the Department of Health and Human Services review and remove the report. First Am. Compl. ¶ 91 [ECF No. 23]; AR 0007-17 [ECF No. 19-1 (Sealed)]. On June 25, 2012, Judy Rodgers, Senior Advisor for the Division of Practitioner Data Banks at the Department of Health and Human Services, issued a Secretarial Review Decision denying Dr. Doe's request and stating that the Secretary found that " [t]here is no basis on which to conclude that the Report should not have been filed in the NPDB or that it is not accurate, complete, timely or relevant." AR 0268-73 [ECF No. 19-6 (Sealed)].

         One month later, on July 25, 2012, the plaintiffs filed this lawsuit claiming that the defendants' acceptance, maintenance, and disclosure of the disputed Adverse Action Report in the National Practitioner Data Bank " has for the last two and one half years caused all prospective employers

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in the United States to reject plaintiff physician's applications for employment and medical staff privileges." First Am. Compl. ¶ 4 [ECF No. 23]. The plaintiffs advanced six causes of action alleging that (1) the defendants' actions with respect to the Adverse Action Report were unlawful and should be set aside in accordance with the Administrative Procedure Act (the " APA" ), (2) the Health Care Quality Improvement Act and the implementing regulations that apply to the National Practitioner Data Bank violate the Due Process Clause both facially and (3) as applied by the defendants, (4) the Secretary's actions violated § § 552a(g)(1)(A) and (C) of the Privacy Act, (5) the defendants' interpretation and application of the Health Care Quality Improvement Act and the implementing regulations constitute an unconstitutional Bill of Attainder, and (6) the defendants' interpretation and application of the Health Care Quality Improvement Act and the implementing regulations violate the Eighth Amendment's prohibition on cruel and unusual punishments. Id. ¶ ¶ 102-84. In lieu of an answer, the defendants moved to dismiss the entirety of the First Amended Complaint or, alternatively, for summary judgment. Mem. In Support of Defs.' Mot. to Dismiss or, Alternatively, for Summ. J. 2-3 [ECF No. 33 (Sealed)]. The plaintiffs countered with a Cross-Motion for Summary Judgment [ECF No. 45 (Sealed)] and also tiled a Motion for Leave to Supplement the Record of Continuing Constitutional Deprivation [ECF No. 58], which was opposed by the defendants.

         DISCUSSION

         A. Whether the Agency's Actions Regarding the Adverse Action Report were Arbitrary, Capricious, an Abuse of Discretion or Unlawful

         The plaintiffs' first cause of action invokes the APA and alleges that the defendants' actions with regard to the Adverse Action Report should be set aside because (1) there was no " investigation" by the Hospital, (2) Dr. Doe's resignation was obtained by fraud and therefore not " voluntary," (3) NPDB Guidebook Rule F-8 is overly broad, overly inclusive, and contrary to the purposes of the Health Care Quality Improvement Act, (4) the Adverse Action Report was untimely because it was not filed within 30 days of the adverse action as required by 45 C.F.R. § 60.5(d). and (5) the Hospital's quality assurance review was not a reportable event because it did not result in the suspension of Dr. Doe's privileges given that he had already resigned. First. Am. Compl. ¶ ¶ 102-125. The government moved to dismiss this cause of action on the grounds that the Secretary's review is limited to a determination about whether the report accurately describes the actions the Hospital took and the reasons for those actions, the scope of the Secretary's review does not involve an evaluation of the merits of the Hospital's findings, the administrative record reflects that there was an ongoing investigation at the time Dr. Doe surrendered his surgical privileges and resigned, any errors in the record evidence supplied by the Hospital were typographical and do not indicate fraud or that an investigation never occurred, the 30-day reporting deadline is not a legal bar to an otherwise valid adverse report, and there is no requirement that a physician know that an investigation is occurring before a voluntary suspension becomes reportable and, furthermore, to adopt such a requirement would be burdensome for the Secretary. Mem. In Support of Defs.' Mot. to Dismiss or, Alternatively, for Summ. J. 11-21 [ECF No. 33 (Sealed)].

          The APA provides that " [a] person suffering legal wrong because of agency action,

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or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof." 5 U.S.C. § 702. When exercising judicial review, " [t]he reviewing court shall . . . hold unlawful and set aside agency action, findings, and conclusions found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . ." 5 U.S.C. § 706(2)(A).

          It is well established that, when confronted with an APA case, " [t]he district court sits as an appellate tribunal in such a case, and the question whether [the defendants] acted in an arbitrary and capricious manner is a legal one which the district court can resolve on the agency record--regardless of whether it is presented in the context of a motion for judgment on the pleadings or in a motion for summary judgment (or in any other Rule 12 motion under the Federal Rules of Civil Procedure)." University Med. Ctr. of S. Nevada v. Shalala, 173 F.3d 438, 441 n.3, 335 U.S.App.D.C. 322 (D.C. Cir. 1999). Moreover, the court's determination about whether the defendants' actions were arbitrary and capricious is based on the evidence that was provided to the agency and the court's " concern is not whether the [defendants] might have reached a different decision had [they] considered additional evidence, but only whether the decision [they] did reach, based on the evidence that was before [them], was unreasonable." Conax Florida Corp. v. United States, 824 F.2d 1124, 1128, 263 U.S.App.D.C. 144 (D.C. Cir. 1987).

         The Court is mindful that " [t]he scope of review under the 'arbitrary and capricious' standard is narrow and a court is not to substitute its judgment for that of the agency. Nevertheless, the agency must examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made." Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mat. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983).

         1. Whether it was arbitrary and capricious for the Secretary to determine that the Hospital was conducting an investigation when Dr. Doe suspended his surgical privileges

          When a hospital accepts a physician's surrender of clinical privileges while the physician is the subject of a pending investigation relating to possible incompetence or improper conduct the hospital must report that event to the National Practitioner Data Bank. 42 U.S.C. § 11134(b); 45 C.F.R. § 60.12. The Adverse Action Report submitted by the Hospital in this case was classified as a " voluntary surrender of clinical privilege(s), while under, or to avoid, investigation relating to professional competence or conduct." AR 0002 [ECF No. 19-1 (Sealed)] (capitalization formatting omitted). Although the plaintiffs concede that surrendering clinical privileges while under investigation is a reportable event, First Am. Compl. ¶ 57, they nonetheless challenge the defendants' actions with respect to the Adverse Action Report on the ground that there was no evidence that an investigation was occurring either before or at the time Dr. Doe surrendered his surgical privileges and resigned, id. ¶ ¶ 105-107. The Secretary concluded otherwise and found that an investigation commenced 011 October 5, 2009, as demonstrated by several documents contained in the Administrative Record. AR 0256 [ECF No. 19-6 (Sealed)].

         The term " investigation" is not defined in either the Health Care Quality Improvement Act or the regulations that implement it. Doe v. Leavitt, 552 F.3d 75, 79-80 (1st Cir. 2009) (" [T]he secretary has not

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exercised [the] rulemaking authority to set forth [her] interpretation of the word 'investigation.' Instead, the Secretary's interpretation must be gleaned from (i) an agency manual, the NPDB Guidebook . . . and (ii) the Secretary's decision in this case." ); Simpkins v. Shalala, 999 F.Supp. 106, 115 (D.D.C. 1998) (" Neither the statute nor the regulations promulgated in furtherance of the HCQI Act define an investigation." ). The 2001 version of the NPDB Guidebook that was in effect at the time of the challenged Secretarial Review also did not define the term " investigation," although it gave the following examples of types of evidence that might demonstrate that an investigation was occurring: [10]

A health care entity that submits an AAR based on surrender or restriction of a physician's . . . privileges while under investigation should have contemporaneous evidence of an ongoing investigation at the time of surrender . . . . The reporting entity should be able to produce evidence that an investigation was initiated prior to the surrender of clinical privileges by a practitioner. Examples of acceptable evidence may include minutes or excerpts from committee meetings, orders from hospital officials directing an investigation, and notices to practitioners of an investigation.

NPDB Guidebook E-19. The 2001 NPDB Guidebook further stated that an investigation " must be carried out by the health care entity, not an individual on the staff," " must be focused on the practitioner in question," " must concern the professional competence and/or professional conduct of the practitioner in question," and " a routine or general review of a particular practitioner is not an investigation." Id.

         The Court's consideration begins with the accepted principle that " [t]he views of agencies charged with implementing a statute are entitled to deference."

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Bragdon v. Abbott, 524 U.S. 624, 626, 118 S.Ct. 2196, 141 L.Ed.2d 540 (1998). With respect to the interpretation of " investigation" found in the NPDB Guidebook, the plaintiffs maintain that the Guidebook is not entitled to the deference announced in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). but they offer no further suggestion about the level of deference that they argue should be applied, if any. Pls.' Mem. In Opp'n to Defs.' Mot. to Dismiss 41 [ECF No. 45 (Sealed)]. The defendants do not contest that Chevron deference is not applicable, Defs.' Combined Reply Br. 30 [ECF No. 48], and they concede that the NPDB Guidebook " do[es] not have the force of law," but they argue that the NPDB Guidebook's interpretation of the term " investigation" is entitled to " substantial deference," Mem. In Support of Defs.' Mot. to Dimiss 12 [ECF No. 33 (Sealed)], which is a reference to the deference that applies to an agencies' interpretation of its own regulations, see, e.g., Shalala v. Guernsey Mem 7 Hosp., 514 U.S. 87, 115 S.Ct. 1232, 131 L.Ed.2d 106 (1995).

         Determining the appropriate level of deference to apply to agency interpretations in certain scenarios can be puzzling, to say the least. The general rule is that, when a statute is silent about an issue a court will defer to an agency's interpretation contained in a regulation if it is reasonable, based on a permissible construction of the statute, involves a statute the agency administers, and the regulations were promulgated pursuant to notice and comment so they have the force of law. Chevron, 467 U.S. at 842-43. When the agency's interpretation is derived from a source other than regulations that have the force of law, however, the landscape of legal principles that apply becomes somewhat tangled. In Christensen v. Harris County, 529 U.S. 576, 120 S.Ct. 1655, 146 L.Ed.2d 621 (2012), the Supreme Court cautioned that interpretations contained in " policy statements, agency manuals, and enforcement guidelines, all of which lack the force of law -- do not warrant Chevron -style deference," albeit such interpretations might be " entitled to respect under [its] decision in Skidmore v. Swift & Co., 323 U.S. 134, 140, 65 S.Ct. 161, 89 L.Ed. 124 (1944). . . ." 529 U.S. at 587 (internal quotation marks and parallel citation omitted). Under Skidmore, the deference owed to an agency interpretation that does not have the force of law " depend[s] 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." 323 U.S. at 140. " The Supreme Court later clarified, however, that 'the fact that [an] Agcncy . . . [reaches] its interpretation through means less formal than 'notice and comment' rulemaking, see 5 U.S.C.A § 553 (West 2014), does not automatically deprive that interpretation of the judicial deference otherwise its due." Fox v. Clinton, 684 F.3d 67, 77, 401 U.S.App.D.C. 271 (D.C. Cir. 2012) (quoting Barnhart v. Walton, 535 U.S. 212, 221, 122 S.Ct. 1265, 152 L.Ed.2d 330 (2002)). " Rather, 'the interstitial nature of the legal question, the related expertise of the Agency, the importance of the question to administration of the statute, the complexity of that administration, and the careful consideration the Agency has given the question over a long period of time [may] indicate that Chevron provides the appropriate legal lens through which to view the legality of [a disputed] Agency interpretation' of its authorizing statute." Id. (quoting Barnhart, 535 U.S. at 222). So the legal pronouncements have, in essence, helpfully advised courts that Chevron deference

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does not apply to agency interpretations that lack the force of law -- except when it does apply. Additionally, apart from these legal standards, an agency's interpretation of its own regulations (versus a statute), is also entitled to a measure of deference, which the Supreme Court has described as " substantial." Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512, 114 S.Ct. 2381, 129 L.Ed.2d 405 (1994).

         Which leads the Court to point out the puzzle in this case. The defendants appear to treat the NPDB Guidebook interpretation of the term " investigation" as though it is the agency's interpretation of its own regulation. Defs.' Combined Reply In Support of Mot. to Dismiss 30 -17-[ECF No. 48] (" [A]s subregulatory guidance, the Guidebook should be accorded substantial deference." ). But the regulations' use of the term " investigation" simply carries over the language of the statute, and nothing more. Compare 45 C.F.R. § 60.12(a)(1)(ii)(A), with 42 U.S.C. § 11133(a)(1)(B)(i). As a result, with respect to the term ''investigation," it seems to the Court that the NPDB Guidebook interpretation technically constitutes an interpretation of the statute and not an interpretation of the regulation. Thus, it is the Court's view that the NPDB Guidebook interpretation of " investigation" would fall under the rubric of Skidmore -style deference, which is what two federal courts of appeals appear to think as well, although neither expressly so held. Leal, 620 F.3d at 1282-83 (citing Christensen, 529 U.S. at 587, as " explaining that interpretations contained in enforcement guidelines get. Skidmore deference" ); Doe, 552 F.3d at 79-80 (finding that the NPDB Guidebook does not qualify for Chevron deference but indicating that it might qualify for a lesser degree of deference pursuant to Skidmore ). A resolution about the question of deference is unnecessary in this particular circumstance, though, because the Court concludes that " the level of deference is not determinative here; whether viewed through the prism of Chevron or the less forgiving prism of Skidmore, the Secretary's interpretation of the word 'investigation' withstands scrutiny." Id. at 80. Furthermore, the Court is not convinced that the 2001 NPDB Guidebook actually defines the term " investigation" in any event.

         Although the 2001 NPDB Guidebook provides examples of the types of evidence that might suggest that an investigation occurred, and presents generalized guidelines about who must conduct the investigation, who it must be about and what it must be about, it does not appear to the Court that the Guidebook actually sets forth an interpretative definition of what actions taken by a health care entity would, in fact, constitute an " investigation" -- given that the possibilities vary from the simple act of obtaining medical records to the formalized conduct of adversarial-type review proceedings, and there might be many stages in between from fact gathering to deliberations to formal resolution, with numerous individuals involved from nursing staff to executive officials. The Secretarial Review Decision also does not define the term " investigation" and, instead, simply identifies the documents that the Secretary deems to " demonstrate" the start of an investigation. AR 0256 [ECF No. 19-6 (Sealed)]. Consequently, it appears to the Court that neither the 2001 NPDB Guidebook nor the Secretarial Review Decision offer an interpretive definition of the term " investigation'' that warrants the Court wading into the legal morass of determining what deference to apply to that interpretation. See Doe, 552 F.3d at 79-80 (noting that " the level of deference owing to informal agency interpretations" such as the NPDB

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          Guidebook and the Secretary's decisions " is freighted with uncertainty" and poses " an interesting legal conundrum" ).[11]

          When a statute does not define a term, the Court " must presume that Congress intended to give the term its ordinary meaning." Aid Ass'n for Lutherans v. U.S. Postal Serv., 321 F.3d 1166, 1176, 355 U.S.App.D.C. 221 (D.C. Cir. 2003). The term " investigation" is ordinarily understood to mean a systematic examination. Merriam-Webster, http://www.merriam-webster.com/dictionary/ investigation (last visited May 8, 2015). Applying this common meaning of the term " investigation," the Court will consider whether the Secretarial Review Decision reasonably concludes that the Hospital was conducting a systematic examination of Dr. Doe's conduct before or at the time he surrendered his surgical privileges and resigned.

         The Secretarial Review' Decision states that the Secretary " review[ed] the information available and the record presented to this office," AR 0254 [ECF No. 19-6 (Scaled)], and found that there was an investigation occurring at the time Dr. Doe surrendered his privileges and resigned, AR 0256 [ECF No. 19-6 (Sealed)]. The Secretarial Review Decision notes that the following documents lend support to the finding that an investigation was underway at the time Dr. Doe voluntarily surrendered his privileges and resigned:

[T]he [Hospital's] meeting notes dated October 5, 2009 demonstrate the initial stage of the investigation, as indicated by the Quality Management (QM) Coordinator's handwritten note after a meeting with the Hospital's VPMA, Corporate Compliance Officer, Director of QM, and Medical Staff Coordinator. The notes state that " Dr. [Doe] voluntarily has agreed not to take any new surgical patients and pts currently on his service will be reassigned until investigation complete . . ." (Exhibit 6). Furthermore, the Root Cause Report submitted on November 3, 2009 confirms that you were under investigation at the time of your resignation. The Report states " On 10/5 the surgeon voluntarily suspended his surgical privileges pe[n]ding completion of the [Hospital's] investigation. On 10/07/2009, prior to the completion of the investigation and the meeting of the RCA Committee he submitted his resignation from the Medical Staff effective 10/16/2009" (Exhibit 15). It is clear from the documentation provided by PBMC that the review went beyond a routine or general review of your cases.

AR 0256 [ECF No. 19-6 (Sealed)]. The Court evaluated each of these documents, which consist of exhibits attached to a letter that that Hospital submitted as part of the adversarial Secretarial review process. See AR 0101-31 [ECF No. 19-3 (Sealed)]. With respect to the question of when the Hospital's investigation began, the Secretarial Review Decision states " the [Hospital's] meeting notes dated October 5, 2009 demonstrate the initial stage of the investigation, as indicated by the Quality Management (QM) Coordinator's handwritten note after a meeting with the Hospital's VPMA, Corporate Compliance Officer, Director of QM, and Medical Staff Coordinator." AR 0256 [ECF No. 19-6 (Sealed)]. The cited meeting notes state that, on October 5, 2009, the medical chart was copied, the patient was released, and the

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Vice President of Medical Affairs and other Hospital officials met at noon to discuss the case. AR 0105 [ECF No. 19-3 (Sealed)]. The notes also state that the Vice President of Medical Affairs planned to meet later that day with the physician who assisted Dr. Doe during the surgery and then with Dr. Doe. AR 0105 [ECF No. 19-3 (Sealed)]. The Secretarial Review Decision's quotation of part of the notes indicating that Dr. Doe voluntarily suspended his surgical privileges accurately reflects what is stated in the notes. AR 0105 [ECF No. 19-3 (Sealed)], 0256 [ECF No. 19-6 (Sealed)]. The notes also stale that the gross pathology report was received, a report was submitted to NYPORTS, and a physician and another individual were asked to form an " RCA team." AR 0105 [ECF No. 19-3 (Sealed)], which the record evidence and legal briefs indicate refers to a Root Cause Analysis given that a contemporaneous email from The Joint Commission stated that a Root Cause Analysis and Action Plan regarding the incident would be due in November, AR 0111 [ECF No. 19-3 (Sealed)]; Pls.' Reply Mem. In Support of Cross-Motion for Summ. J. 18 [ECF No. 56 (Scaled)] (indicating that " Root Cause Analysis" is abbreviated as " RCA" ).

         Taken as a whole, these coincident notes reflect that, on October 5, 2009, Hospital officials[12] embarked on a systematic examination of Dr. Doe's conduct relating to the surgical incident by gathering the necessary documentation, conferring with the relevant Hospital executives, meeting with the physicians who were involved, reporting the incident to the state health department, and organizing a team to conduct a Root Cause Analysis. These activities on the part of the Hospital strike the Court as fundamental characteristics of an " investigation," at least as that term is commonly understood, so it was reasonable for the Secretary to conclude that they demonstrated the beginning of an investigation by the Hospital. That the Hospital viewed itself as conducting an investigation is corroborated by the following contemporaneous documents: the QM Coordinator's notes, AR 0105 [ECF No. 19-3 (Sealed)] (stating " Dr [Doc] voluntarily has agreed to not take any new surgical patients and pts currently on his service will be reassigned until investigation complete" ); an October 5, 2009 memorandum memorializing a meeting of the Vice President for Medical Affairs, Quality Management, and the Medical Staff Coordinator, AR 0106 [ECF No. 19-3 (Sealed)] (stating " [i]t was reported that a meeting took place this morning" and " [a]t this meeting, Dr. [Doe's] privileges were suspended while the case in question is undergoing investigation'); the submitted NYPORTS Short Form, AR 0107-08 [ECF No. 19-3 (Sealed)] (stating " [t]he physician has been placed on suspension pending completion of the investigation" ); and the Sentinel Event Self-Report submitted to the Joint Commission, AR 0109 [ECF No. 19-3 (Sealed)] (stating " [t]he physician has been placed on suspension pending completion of the investigation" ).

         The plaintiffs lake issue with the Secretary's reliance on the cited documents and argue that such reliance was arbitrary and capricious because " the Secretary ruled only on Hospital created, misdated documents and did not explain or consider the contrary evidence from Dr. Doe including that he never received the By-Laws or any other written notice of investigation 'to the practitioner.'" Pls.' Mem. In Opp'n to Defs.' Mot. to Dismiss 44-45 [ECF No. 45 (Seated)]. In particular, the plaintiffs contend

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that the type of evidence submitted by the hospital failed to comply with the NPDB Guidebook requirements, several documents were forged or otherwise not bona fide because they contained incorrect dates or parroted the same language found in the NYPORTS Short Form Report and Sentinel Even Self-Report, there was no evidence that the Hospital's Credentials Committee requested in writing that an investigation be commenced, there was no documentation of an October meeting of the Root Cause Analysis Committee, and the plaintiffs submitted evidence that individuals identified as being in attendance at the Root Cause Analysis Committee meeting were not there. Pls.' Reply Mem. In Support of Cross-Motion for Summ. J. 17-21. Upon review of the administrative record, however, the plaintiffs' allegations simply are not well founded or supported.

         First, the plaintiffs misconstrue the 2001 NPDB Guidebook as mandating that the Hospital submit minutes of committee meetings, orders from hospital officials, and notices to Dr. Doe in order to prove that an investigation was taking place. First Am. Compl. ¶ [ECF No. 23]; Pls.' Reply Mem. In Support of Cross-Mot. for Summ. J. 16-17 [ECF No. 56 (Sealed)]. The NPDB Guidebook contains no such command. The only source the plaintiffs cite for this premise is a provision that states " [e]xamples of acceptable evidence may include minutes or excerpts from committee meetings, orders from hospital officials directing an investigation, and notices to practitioners of an investigation." [13] Pls.' Reply Mem. In Support of Cross-Motion for Summ. J. 16 [ECF No. 56 (Sealed)] (citing NPDB Guidebook E-19). The terms of this provision make clear that the identified evidence serves only as expressed " examples" of what a hospital may submit, not as the sole requirements regarding what a hospital must submit. The use of the term " may" renders the examples permissive and not exclusive. Consequently, there simply is no basis to assert that it was unreasonable or irrational for the Secretary to consider other types of evidence in the Administrative Record. In fact, given that the provision identifies only permissive examples, an argument could be made that it would have been unreasonable for the Secretary to limit her consideration to only those cited examples while excluding other types of contemporaneous evidence.

         Turning to the plaintiffs' allegation that several documents were forged or otherwise not bona fide because they contained incorrect dates or simply echoed the same language found in the NYPORTS Short Form Report and Sentinel Even Self-Report, the Court finds that the Secretary reasonably relied on the challenged documents. The plaintiffs called into question the minutes of a Medical Staff Performance Improvement Committee meeting because it was dated September 2009 and not October 2009, as well as a memorandum memorializing a review meeting that was dated " Monday, October 6, 2009" when, in fact, October 6, 2009, fell on a Tuesday. Pls.' Reply Mem. In Support of Cross-Mot. for Summ. J. 18 [ECP No. 56 (Sealed)]; First Am. Compl. ¶ 63. The Hospital noted that the two dale discrepancies were typographical errors. AR 0084 n.1, 0085 n.3 [ECP No. 19-2 (Sealed)]. The plaintiffs' indictment of these documents as fakes involving " back-dating" [14] -- and their refusal to accept that

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the date errors might actually be mere typographical errors -- is surprising given that Dr. Doe himself submitted a document that suffered from the very same infirmity. With respect to a letter he wrote to the American Board of Thoracic Surgery, which he characterized as a " significant" piece of evidence during the Secretarial review process, he noted:

Although this letter was written late on October 5, 2009, it mistakenly bears the date October 6, 2009. While I drafted the letter to Dr. Baumgartner on October 5, I did not mail it until October 6. Prior to mailing it the next morning, I simply changed the date on the letter from " 5" to " 6" without thoroughly proofreading the letter again. I neglected to change the word " today" to " yesterday." This gives the impression that I learned of the ...

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