On April 6, 2015, the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration, released the new, updated National Practitioner Data Bank (NPDB) Guidebook (Guidebook), a manual to provide guidance on the requirements established by the laws governing the NPDB. This is the first update of this valuable tool to understanding NPDB related responsibilities and requirements in over 10 years. It will be particularly important for Medical Staffs and other peer review bodies to be familiar with the new Guidebook.
Many questions remain to be answered regarding some of the new information. We will be following up on an ongoing basis, and our attendance at the recent educational forum sponsored by HHS has given us valuable insights and access to information. Initially, however, we want to give clients and friends a preliminary summary of important areas from the new Guidebook.
Professional Review Action
Unchanged but still important is that a Professional Review Action continues to be defined in the NPDB regulations as an action or recommendation of a health care entity: (1) Taken in the course of professional review activity; (2) Based on the professional competence or professional conduct of an individual health care practitioner which affects or could affect adversely the health or welfare of a patient or patients; and (3) Which adversely affects or may adversely affect the clinical privileges or membership in a professional society of the health care practitioner.
The Guidebook continues to require eligible health care entities to report: (1) Professional review actions that adversely affect a physician’s or dentist’s clinical privileges for a period of more than 30 days; and (2) Acceptance of a physician’s or dentist’s surrender or restriction of clinical privileges while under investigation for possible professional incompetence or improper professional conduct, or in return for not conducting such an investigation or not taking a professional review action that otherwise would be required to be reported.
Pursuant to the Guidebook, a professional review action that lasts longer than 30 days must be reported, but it also appears that the voluntary acceptance of a restriction must be reported immediately, even if the restriction is to facilitate expedited review and is lifted within 30 days. We are seeking clarification on this issue.
Matters not related to the professional competence or professional conduct of a practitioner should not be reported to the NPDB. Additionally, “administrative” actions that do not involve a professional review action should not be reported to the NPDB. For example, loss of privileges due to termination of a contract or because a physician’s board certification expires causing automatic revocation is not reportable, even if the underlying reasons for the termination relate to quality of care, since the revocation was not the result of a professional review action. Likewise, where suspension of privileges from a first hospital results in the physician’s automatic suspension at a second hospital, the second hospital’s suspension is considered an “administrative” action that does not have to be reported.
The Guidebook adopts an extremely broad interpretation of “investigation.” This is new and extremely important. If a formal, targeted process is used related to a specific practitioner’s professional competence or conduct, this is considered an investigation for the purposes of reporting to the NPDB. However, a routine peer review process under which a health care entity evaluates, against clearly defined measures, the privilege-specific competence of all practitioners (e.g., a quality review of the Department of Surgery) is not considered an investigation for the purposes of reporting to the NPDB. Pursuant to the Guidebook, 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.
A practitioner’s awareness that an investigation is being conducted is not a requirement for reporting to the NPDB. For example, if an investigation related to professional competence issues began prior to the expiration of a physician’s privileges and the physician failed to renew the privileges while the investigation was ongoing, the action must be reported regardless of whether the physician knew he or she was under investigation at the time of the failure to renew privileges. This differs from the reporting requirements under California Business & Professions Code section 805 (Section 805), which means that, in some situations, a report must be made to the NPDB while not necessarily to the Medical Board of California (MBC) under Section 805. But, because a copy of the NPDB report must be sent to the MBC, the MBC is going to learn about the event anyway. Controversies might arise over whether an 805 Report should also have been filed.
Restrictions & Summary Suspensions
A “restriction” is the result of a professional review action based on clinical competence or professional conduct that leads to the inability of a practitioner to “exercise his or her own independent judgment in a professional setting.”
A summary suspension must be reported if it is in effect or imposed for more than 30 days, based on the professional competence or professional conduct of the physician, dentist, or other health care practitioner. In California, this differs from the reporting requirements to the MBC under Section 805, which requires reporting of a summary suspension after 14 days. Notably, the Guidebook provides that summary suspensions may be reported “early” if expected to last more than 30 days, so both the report to the MBC and the report to the NPDB can be made at the same time.
The Guidebook provides that a suspension or restriction of clinical privileges is reportable if it meets reporting criteria, whether the suspension or restriction is called summary, immediate, emergency, precautionary, or any other term. A suspension by any other name is still a suspension under the Guidebook. As a common theme throughout the Guidebook, entities are admonished that the reporting requirements will be construed broadly, giving terms their common or usual meanings. Thus, in practice, entities will not be able to “define” their way around the requirements.
Proctoring may or may not be reportable, depending on the role of the proctor. If the proctor is not required to be present for or approve the procedures (e.g. review of records after procedures occur), the action is not considered a restriction of clinical privileges and should not be reported to the NPDB. However, if the physician or dentist cannot perform certain procedures without proctor approval or without the proctor being present and watching, for a period lasting more than 30 days, the action constitutes a restriction of clinical privileges reportable to the NPDB.
Withdrawal of Initial Applications
The withdrawal of an initial application is not reportable to the NPDB. Under Section 805, however, it is reportable to the MBC if the practitioner withdraws or abandons his or her application for staff privileges or membership or request for renewal of staff privileges or membership after receiving notice that his or her application for membership or staff privileges is denied or will be denied for a medical disciplinary cause or reason.
The Guidebook makes no distinction between temporary clinical privileges and clinical privileges for the purpose of reporting to the NPDB. However, if the temporary privileges expire after reaching their maximum duration, and therefore cannot be renewed while the practitioner is under investigation, a report should not be submitted to the NPDB. This is the same under Section 805 reporting purposes and giving rise to formal hearing rights.
Denial of an application based on a falsification by the applicant can be a reportable event. This is the same under Section 805.
Professional review actions based on disruptive behavior can be reportable based on the patient care implications. For example, if a summary suspension occurred for a physician’s outbursts of anger and throwing charts and instruments in an operating room, it could be reasonably be concluded that the outbursts posed an imminent threat to patient safety and could be reportable.
All medical staffs/peer review bodies know that the NPDB must be queried whenever a practitioner applies for appointment and reappointment. However, the Guidebook makes it clear that a query must be made each time the practitioner applies for clinical privileges. For example, a query must be made whenever a practitioner seeks to expand existing clinical privileges and prior to a grant of temporary privileges even if a query has already been made regarding the initial application.
Centralized Credentialing Systems
Many medical staffs where there are two or more hospitals under common ownership have set up centralized systems to handle the information gathering process related to applications. The Guidebook makes clear that where there is an integrated medical staff across two or more facilities, and one appointment decision covers all facilities/staffs, only one query must be made. However, if there is a centralized information gathering process for two or more independent medical staffs, but a credentialing decision will be made by each staff, then a query must be made on an applicant for each medical staff.
The Guidebook reiterates strict confidentiality rules for the reports obtained through a valid query. A report may be shared within a medical staff/peer review body for that body’s own peer review purposes. However, it is not to be shared outside of the peer review body, including with affiliated but independent medical staffs/peer review bodies. This applies only to the report itself received from the NPDB. The information underlying the report may likely be shared, either through mandatory disclosures such as those required in California by Business & Professions Code section 809.08 or allowed by various court cases.
The Guidebook also touches briefly on confidentiality relating to drug and alcohol treatment. It provides that if a clinical privileges action is taken and the practitioner enters a drug or alcohol treatment or rehabilitation program as a result, the adverse action must be reported. However, the fact that a practitioner entered a drug or alcohol treatment facility should not be reported. See also, e.g., 42 C.F.R. § 2 (Part 2).
Effect of Guidebook
The Guidebook is not law itself but serves as a guide relating to the three significant laws governing the NPDB and codified at 45 CFR Part 60, Title IV of the Health Care Quality Improvement Act of 1986 (HCQIA), Section 5 of the Medicare and Medicaid Patient and Program Protection Act of 1987, and Section 221(a) of the Health Insurance Portability and Accountability Act of 1996.
Hooper, Lundy & Bookman, P.C. has experience in representing Medical Staffs and Health Care Entities for purposes of reporting to the MBC under Section 805 and to the NPDB. For questions relating to these issues, please contact Harry Shulman, Ross Campbell, or Ruby Wood in San Francisco at (415) 875-8500; Jennifer Hansen in San Diego at (619) 744-7300; or Larry Getzoff or Katherine Dru in Los Angeles at (310) 551-8111.