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Health Resources and Services Agency Issues New National Practitioner Data Bank Guidebook
LEGAL COUNSEL PETER J. MILLOCK, ESQ, LAURIE T. COHEN, ESQ
Health Resources and Services Agency Issues New National Practitioner Data Bank Guidebook Lindsay Maleson, Esq, Laurie Cohen, Esq, Christopher Porzio, Esq, Michal Ovadia, Esq The Health Resources and Services Agency within the US Department of Health and Human Services released earlier this year the 2015 edition of the National Practitioner Data Bank (NPDB) guidebook. It replaces the original 2001 edition of the guidebook, incorporating 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 affect how hospitals and other health care entities handle professional review actions and related reporting to the NPDB. Some highlights, which are summarized here, include an expanded definition of an investigation, clarifications of the reporting of summary suspensions and the assignment of a proctor, and clarification of the distinction between employment actions versus professional review actions. 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 by-laws 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, 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 for the surrender or failure to renew to be reportable. The new guidebook clarifies that an investigation begins
ª 2015 American College of Radiology 1546-1440/15/$36.00 n http://dx.doi.org/10.1016/j.jacr.2015.07.023
when the health care entity “begins an inquiry” and does not end until there is “final action” or closure of the matter. 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 (eg, “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 by-laws to review suspensions, the surrender would be reportable as a surrender while under investigation or to avoid an investigation. The new guidebook addresses the role of proctors and explains that the obligation to report to the
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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 and is reportable. 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. 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 by-laws, such loss of privileges is not reportable to the NPDB because it
was not based on a professional review action. The 2015 edition of the NPDB Guidebook is available online at http://www.npdb.hrsa.gov/resources/ NPDBGuidebook.pdf. In addition to the NPDB reporting obligations, hospitals and health care entities remain subject to applicable state reporting obligations, which are not affected by the changes contained in the new guidebook.
Lindsay Maleson, Esq, Laurie Cohen, Esq, Christopher Porzio, Esq, and Michal Ovadia, Esq, are from Nixon Peabody LLP, Albany, New York. The authors have no conflicts of interest related to the material discussed in this article. Laurie T. Cohen, Esq: Nixon Peabody LLP, 677 Broadway, 10th Floor, Albany, NY 12207; e-mail: lauriecohen@nixonpeabody. com.
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Journal of the American College of Radiology Volume 12 n Number 12PA n December 2015
Health Resources and Services Agency Issues New National Practitioner Data Bank Guidebook Lindsay Maleson, Esq, Laurie Cohen, Esq, Christopher Porzio, Esq, Michal Ovadia, Esq The Health Resources and Services Agency within the US Department of Health and Human Services released earlier this year the 2015 edition of the National Practitioner Data Bank (NPDB) guidebook. It replaces the original 2001 edition of the guidebook, incorporating 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 affect how hospitals and other health care entities handle professional review actions and related reporting to the NPDB. Some highlights, which are summarized here, include an expanded definition of an investigation, clarifications of the reporting of summary suspensions and the assignment of a proctor, and clarification of the distinction between employment actions versus professional review actions. 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 by-laws 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, 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 for the surrender or failure to renew to be reportable. The new guidebook clarifies that an investigation begins
ª 2015 American College of Radiology 1546-1440/15/$36.00 n http://dx.doi.org/10.1016/j.jacr.2015.07.023
when the health care entity “begins an inquiry” and does not end until there is “final action” or closure of the matter. 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 (eg, “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 by-laws to review suspensions, the surrender would be reportable as a surrender while under investigation or to avoid an investigation. The new guidebook addresses the role of proctors and explains that the obligation to report to the
1347
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 and is reportable. 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. 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 by-laws, such loss of privileges is not reportable to the NPDB because it
was not based on a professional review action. The 2015 edition of the NPDB Guidebook is available online at http://www.npdb.hrsa.gov/resources/ NPDBGuidebook.pdf. In addition to the NPDB reporting obligations, hospitals and health care entities remain subject to applicable state reporting obligations, which are not affected by the changes contained in the new guidebook.
Lindsay Maleson, Esq, Laurie Cohen, Esq, Christopher Porzio, Esq, and Michal Ovadia, Esq, are from Nixon Peabody LLP, Albany, New York. The authors have no conflicts of interest related to the material discussed in this article. Laurie T. Cohen, Esq: Nixon Peabody LLP, 677 Broadway, 10th Floor, Albany, NY 12207; e-mail: lauriecohen@nixonpeabody. com.
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Journal of the American College of Radiology Volume 12 n Number 12PA n December 2015