In April, the National Practitioner Data Bank (NPDB) released a revised version of the NPDB Guidebook. The revised version of the Guidebook includes significant revisions to the chapter addressing reports of adverse actions by health care entities.
The NPDB Guidebook’s chapter on reports assists health care entities in complying with the reporting obligations set forth under the Health Care Quality Improvement Act (HCQIA). Generally, health care entities have a statutory duty to report certain actions taken against the clinical privileges of physicians and dentists. Such actions include the denial, restriction, reduction, suspension, or termination of a practitioner’s clinical privileges. These actions are reportable under HCQIA when they (1) last more than more than 30 days; (2) result from a professional review action; and (3) are based on the practitioner’s professional competence or conduct that affects or could affect the health or welfare of a patient. HCQIA also requires health care entities to report a practitioner’s resignation during an investigation. The NPDB Guidebook’s chapter on reports provides the NPDB’s interpretation of these rules.
In the revised chapter on reports, the NPDB expanded the existing sections regarding investigations, suspensions, and denials. The NPDB added new sections on residents and interns, proctors, administrative actions, nonrenewals, and laws concerning the confidentiality of drug and alcohol treatment programs. Lastly, the NPDB significantly increased the number of questions and answers at the end of the chapter. The chapter now includes 42 questions and answers. This article provides a brief summary of some of these revisions.
In the expanded sections on investigations and suspensions, the NPDB explained that the terms in medical staff bylaws will not control whether an investigation or a summary suspension has taken place. Rather, the facts of the situation will reveal whether a practitioner is subject to an investigation or a summary suspension. The NPDB recognizes that suspensions are often called “immediate, summary, emergency, or precautionary” in medical staff bylaws. Regardless of the name, the suspension is reportable if it is based on concerns for patient safety and it lasts more than 30 days. Likewise, the facts of an inquiry, rather than the terms used in the bylaws, will determine whether a practitioner is subject to an investigation: “For NPDB reporting purposes, the term ‘investigation’ is not controlled by how that term may be defined in a health care entity’s bylaws or policies and procedures.”
The NPDB’s revised section on investigations clarifies that the NPDB interprets the term “investigation” expansively. Furthermore, the NPDB cautions that it “retains the ultimate authority to determine whether an investigation exists.” According to the NPDB, “an investigation is not limited to a health care entity’s gathering of facts or limited to the manner in which the term ‘investigation’ is defined in a hospital’s bylaws. An investigation begins as soon as the health care entity begins an inquiry and does not end until the health care entity’s decision-making authority takes a final action or makes a decision to not further pursue the matter.”
Hospitals have a duty to report a practitioner who resigns or restricts his or her clinical privileges during an investigation or to avoid an investigation. Hospitals must also report practitioners who fail to renew their clinical privileges during an investigation. The fact that a practitioner is unaware of the investigation is inconsequential, according to the NPDB. In a new question and answer, the NPDB addresses a situation in which a practitioner resigns for personal reasons. If at the time of the resignation, the practitioner was subject to an investigation of which he was not aware, then the hospital must report the resignation.
While the NPDB appears to be limiting a health care entity’s discretion in determining the existence of an investigation, the NPDB recognizes the health care entity’s discretion in other areas. Specifically, a health care entity determines when an activity qualifies as professional review and when a practitioner’s conduct could affect the health or welfare of a patient. In a question and answer, the NPDB addressed a situation in which a practitioner’s clinical privileges were terminated because the practitioner’s employment contract was terminated. The NPDB indicated that the action was not reportable because it did not result from a professional review action. “In order to be reportable to the NPDB, adverse actions must be the result of professional review. Generally, the reporting entity decides when a professional review has occurred.” Similarly, the NPDB indicates that “[w] hether a practitioner’s behavior affects or could affect patient health or welfare is a determination that generally must be made by the entity taking the action.” In questions and answers addressing adverse actions resulting from a practitioner’s (1) falsification of an application and (2) failure to complete medical records, the NPDB indicated that the reporting obligation will depend on whether the health care entity believes the conduct could affect patient welfare.
In addition to new questions and answers, the NPDB added several new sections to the chapter on reports. In the new section addressing administrative actions, the NPDB clarifies that administrative actions that adversely affect a practitioner’s clinical privileges are not reportable. For example, if the medical staff bylaws at a hospital require practitioners to maintain board certification, then the hospital should not report the termination of a practitioner’s clinical privileges based on the expiration of the practitioner’s board certification. In a separate example, the NPDB explained that if the medical staff bylaws provide that a practitioner will be automatically suspended if the practitioner is suspended at another hospital, then such automatic suspension is an administrative action and should not be reported.
In the new section regarding proctors, the NPDB explained that the role of the proctor will determine the hospital’s reporting obligation. If as a result of a professional review, the health care entity assigns a proctor to a practitioner and the proctor must either approve of or be present for the practitioner’s cases for a period of time lasting more than 30 days, then the assignment of the proctor must be reported to the NPDB. On the other hand, if the proctor will not restrict the practitioner’s ability to exercise clinical privileges, then the assignment of the proctor is not reportable. Furthermore, in a new question and answer, the NPDB indicated that if a proctor is routinely assigned to newly appointed members of the medical staff, then the assignment of the proctor is not reportable even if the proctoring lasts for more than 30 days. Hospitals and health care entities should review the NPDB Guidebook’s revised chapter on reports and ensure that the entity’s bylaws and policies are consistent with the Guidebook. Failure to comply with HCQIA’s reporting obligations can result in grave consequences for a health care entity. If the Department of Health and Human Services determines that a health care entity “substantially failed to report,” then the health care entity will lose the ability to claim immunity from liability under HCQIA for three years.