The New NPDB Guidebook brings changes for hospital and health care entity reporting of adverse clinical privileges actions



June 19, 2015

Health Care Alert

Author(s): Lindsay Maleson, Laurie T. Cohen, Christopher J. Porzio, Michal E. Ovadia

The 2015 edition of the National Practitioner Data Bank Guidebook (the “New Guidebook”) was released this spring, replacing the original 2001 edition. The New Guidebook incorporates legislative and regulatory changes that have taken place since 2001, including the merger between the NPDB and the Healthcare Integrity and Protection Data Bank. There are also additional substantive changes to the New Guidebook that will likely impact how hospitals and other health care entities handle professional review actions and related reporting to the NPDB. Some highlights include:

Definition of an investigation and reporting

The New Guidebook reiterates that investigations relating to a practitioner’s professional conduct or competence alone are not reportable to the NPDB. A practitioner’s “surrender of clinical privileges or failure to renew clinical privileges while under investigation or to avoid investigation,” however, must be reported. Importantly, in the New Guidebook, the term “investigation” is interpreted “expansively” and is not limited to the definition ascribed by a health care entity in its medical staff bylaws or policies and procedures. The NPDB may look to those sources “for assistance in determining whether an investigation has started or is ongoing,” but these sources are not determinative. The New Guidebook defines an investigation as a “formal, targeted process . . . used when issues related to a specific practitioner’s professional competence or conduct are identified.”

The simultaneously broad but imprecise definition of the term “investigation” in the New Guidebook raises concerns (and potential confusion) about when the NPDB’s reporting requirements may be triggered. For example, if a hospital initiates a Focused Professional Practice Evaluation (“FPPE”), and during such evaluation the subject practitioner resigns from the medical staff or does not seek renewal of his or her privileges, this may be reportable. A practitioner need not be aware of the pending investigation in order for the surrender or failure to renew to be reportable. The New Guidebook clarifies that an investigation begins when the health care entity “begins an inquiry” and does not end until there is “final action” or closure of the matter.

Summary suspensions

Summary suspensions that are expected to last more than 30 days, and are otherwise reportable, may now be reported to the NPDB before the 30 days have elapsed. If the suspension ultimately does not last more than 30 days, the adverse action report must be voided. The New Guidebook also clarifies that an adverse action must be reported if it satisfies reporting requirements, despite what it is called. Therefore, a suspension by any name (e.g., “precautionary” or “emergency” or “summary” suspension) is reportable because it “typically means that a serious question has been raised and must be addressed quickly.”

The New Guidebook clarifies that if a practitioner surrenders his or her privileges during a summary suspension, even if that suspension has not been confirmed by the medical executive committee or other group that is required under the medical staff bylaws to review suspensions, the surrender would be reportable as a surrender while under investigation or to avoid an investigation.

Proctors

The New Guidebook addresses the role of proctors in a new subsection and explains that the obligation to report to the NPDB the assignment of a proctor to a practitioner to the NPDB is dependent upon the role of the proctor. For example, if for a period lasting more than 30 days the proctor must approve and/or supervise certain procedures performed by the practitioner, the assignment of the proctor is an action constituting a restriction of privileges that must be reported to the NPDB. On the other hand, if the proctor’s role is limited to reviewing the physician’s records or procedures retrospectively, such action is not reportable.

Employment actions versus professional review actions

The New Guidebook clarifies the difference between employment actions and professional review actions. If a practitioner loses his or her privileges pursuant to an employment termination process that the hospital chose to use rather than the professional review process under the medical staff bylaws, such loss of privileges is not reportable to NPDB because it was not based on a professional review action.

This alert is not an exhaustive discussion of the many changes to the NPDB Guidebook. The 2015 edition of the NPDB Guidebook is available online at: http://www.npdb.hrsa.gov/resources/NPDBGuidebook.pdf.

In addition to considering NPDB reporting obligations, hospitals and health care entities must also remember to consider state reporting obligations, which are not impacted by the changes contained in the New Guidebook.

The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.

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