When a physician resigns his or her clinical privileges during the course of a healthcare entity's1 investigation into the physician's competence or professional conduct, the Healthcare Quality Improvement Act (HCQIA) requires the entity to report the resignation to the National Practitioner Data Bank (NPDB), operated by the Department of Health and Human Services (HHS). 42 U.S.C. §§ 11133(a)(1)(B)(i), 11134(b); 45 C.F.R. § 60.12(a)(1)(ii). The term "investigation," however, is undefined under HCQIA and its implementing regulations, and until recently has received little attention from the courts. A recent decision from the United States District Court for the District of Columbia provides much-needed judicial guidance into when an "investigation" begins, and adds authority to the HHS's interpretation provided in the NPDB Guidebook.
In Doe v. Rogers, No. 1:12-cv-01229 (D.D.C., June 17, 2015, order unsealed October 9, 2015), the physician plaintiff had removed part of a patient's fallopian tube by mistake, and in response the hospital immediately began gathering all necessary documentation regarding the erroneous procedure, conferred with hospital executives, met with other physicians who were involved, reported the incident to the state health department, and organized a team to conduct a root cause analysis.
The physician resigned his clinical privileges shortly thereafter, and the hospital submitted an Adverse Action Report to the NPDB concerning the physician's resignation during a pending investigation. After the HHS and the NPDB rejected the physician's challenges to the report, the physician sued the HHS's Secretary and the NPDB for damages, claiming that the report was improper because there was no evidence that he was under investigation by the hospital when he submitted his resignation.
The District Court, recognizing that Congress left the term "investigation" undefined under HCQIA, looked to the common meaning of the term (defined in the dictionary as a "systematic examination") and found the actions taken by the hospital between the time of the surgical procedure and the physician resigning his privileges to be "fundamental characteristics of an 'investigation.'" Accordingly, there was sufficient evidence to support the conclusion that the HHS Secretary's determination that an investigation had commenced was "rationally conceived."
The court also noted, in a footnote, that the most recent revised version of the NPDB Guidebook "contains a more fulsome explanation" of how the HHS interprets the term "investigation," and includes the following language: "if a formal, targeted process is used when issues related to a specific practitioner's professional conduct are identified, this is considered an investigation for the purposes of reporting to the NPDB." The court did not consider this language in its analysis because it was not in effect when the relevant events took place, but even so, the NPDB Guidebook does not explain what is meant by a "formal, targeted process." Thus, the court's analysis remains a useful and significant interpretation of the term "investigation," even under the latest revised version of the NPDB Guidebook.
Given that entities that engage in formal peer review are obligated to report a physician's resignation of his or her clinical privileges during a pending investigation to the NPDB, this decision provides helpful guidance as to when such an investigation has commenced. Specifically, an "investigation" is more likely to have commenced if the entity has already done some or all of the following regarding the procedure/incident:
- Gathered the necessary documentation;
- Conferred with hospital executives;
- Met with other physicians who were involved;
- Reported the incident to the state health department; and/or,
- Organized a team to conduct a root cause analysis.
In sum, entities should ensure that there is a process in place to quickly initiate these actions, or at least some of them, following a problematic procedure or incident involving a physician. Doing so will help to protect the entity's decision to file a report should the physician resign during the pendency of the investigation and then later attempt to challenge the report.