Is It Reportable? HRSA Updates NPDB Guidebook for the First Time in Three Years

The updates make changes to a broad swath of Guidebook topics, from its introduction and general information, to registration renewal for eligible entities, to queries, to the dispute process, to fees, and even updates to the glossary. Most significant to entities that report adverse clinical privileges actions, however, are the updates to interpretations of NPDB reporting requirements and new answers to commonly-asked questions about when a report is required. The 2018 updates reflect HRSA’s continued far-reaching interpretation of what constitutes an “adverse action” affecting a physician’s status or privileges that must be reported.  

Theme of the Changes: When in Doubt, Report

Like prior Guidebook revisions, this latest round of guidance reflects HRSA’s interpretations of the statute favoring reporting. For example, in the April 2015 Guidebook, HRSA explained that any time a physician resigns during a patient-care “investigation”—which the NPDB warned it would interpret “expansively”—the resignation must be reported. The 2018 Guidebook similarly interprets “investigation” expansively, stating it includes a medical staff’s review of reappointment applications, where the review goes beyond systematic or routine queries. The 2018 Guidebook also clarifies that, during an investigation, even indirect actions taken by the physician, such as informally agreeing not to exercise privileges or taking a leave of absence, may be reportable.

Questions and Answers

The revised 2018 NPDB Guidebook provides the following specific clarifications of reporting requirements, among others:

Informal Agreements Not to Exercise Privileges: Where a physician formally surrenders his or her privileges while under investigation, the surrender is reportable. The updated Guidebook clarifies that even if the practitioner merely agrees not to exercise privileges while under investigation, without formally surrendering them, that agreement is reportable. (New Q&A No. 22)

Leaves of Absence: If the practitioner takes a leave of absence while under investigation that has the effect of surrendering his or her privileges, that leave is reportable. Where the Bylaws permit the practitioner to take a leave of absence without affecting his or her privileges, however, the leave would not be reportable. (New Q&A No. 23) In light of this interpretation, it will be important for medical staffs to review their bylaws provisions carefully regarding leaves of absence. As an aside, it is difficult to conceive of a leave of absence that does not, in some way, have the same effect as an agreement not to exercise privileges, which under New Q&A No. 22 is reportable if initiated while under investigation.  

Reappointment Application Review: Even a review of a practitioner’s reappointment application, as opposed to an initial application, may become an “investigation,” such that a practitioner’s resignation during the review is reportable. If the medical staff asks follow-up questions during the reappointment process that are simply “automatic” or “routine,” then the request would likely not be considered an investigation. However, if the hospital had “specific concerns” about the practitioner, then the request may not appear to be a “routine review” and instead “may be seen as an investigation,” even if the questions are posed by the credentials committee. (New Q&A No. 24)

Quality Improvement Plans: A “quality improvement plan”—for example, requiring the practitioner to discuss cases beforehand with the department chair—may constitute either a reportable restriction or investigation. The Guidebook suggests that if the Quality Improvement Plan warns that the practitioner may be disciplined if the Plan is not followed, the Plan might constitute an investigation, and any resignation during the course of the Plan would be reportable. (New Q&A No. 25)

Restrictions Versus Generally-Applicable Guidelines: The Guidebook addresses whether a requirement that a surgeon operate with a qualified first assistant is reportable. The Guidebook states that if all new surgeons are required to operate only with qualified first assistants, the requirement is not a reportable restriction. If, however, the requirement is imposed on one specific surgeon as a professional review action, it is a restriction of privileges and thus reportable. Although the Guidebook addresses only first assistants, the same rationale would apply to other practitioner-specific requirements as well. Thus, while generally-applicable requirements are likely not reportable restrictions, if the requirement applies only to one practitioner as a result of professional review, the requirement is likely a reportable restriction. (New Q&A No. 31)

Lapses in Reappointment Term: If the Medical Executive Committee recommends that a physician not be reappointed, and the physician’s two-year appointment term ends while the parties are waiting for a hearing, the lapse is reportable. (New Q&A No. 46)

Length of Restriction

HRSA also added an entirely new “Length of Restriction” section to the Guidebook. This new section clarifies that it is the impact of the restriction, and not how the restriction is written, that determines whether the restriction is in effect for more than 30 days. Therefore, a restriction becomes reportable on the 31st day it is in effect, regardless of whether the length of the restriction is specified in writing, or whether the length of the restriction is described as dependent on a number of cases, rather than a number of days. The updates also provide that summary suspensions can be reported prior to the 31st day if they are expected to be in effect for more than 30 days. Although this is a new section, HRSA has for several years interpreted the way to determine the length of the restriction for the sake of reporting in this manner.

Reporting is Always Fact Specific

As always, whether an action taken against a practitioner must be reported to the NPDB is highly fact-specific and many circumstances need not be reported. The NPDB’s 2018 Guidebook updates emphasize, however, that the NPDB will continue to interpret the reporting mandate broadly.