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October 2022  Volume 3Issue 10
Health Law Connections

Compliance Corner—Professional Review Activity, Civil Liability Protection, and NPDB Reporting Requirements

  • October 01, 2022
  • Donald Illich
  • Adam Stanzione
Civil LIability Requirements

The National Practitioner Data Bank (NPDB) requires that hospitals and other health care entities report physicians or dentists who have had a professional review action taken against them for more than 30 days.1 In this article, we explore the rules regarding professional review actions and the impact of the civil liability protections [contained in the regulations that govern NPDB reporting on professional review activity]. This article provides a refresher for health law professionals so they can accurately advise health care entities on NPDB requirements as they relate to professional review activity and civil liability protection.

National Practitioner Data Bank Overview

The NPDB’s mission is to improve health care quality, protect the public, and reduce health care fraud and abuse in the United States. The NPDB is a health workforce tool, created by Congress in 1986, to assist organizations in making well-informed credentialing, privileging, and licensing decisions. It contains information on medical malpractice payments and certain adverse actions related to health care practitioners, entities, providers, and suppliers.

Civil Liability Protection

Health care entities and their staff have protections if they take an action against a practitioner. The immunity provisions in Title IV, Section 1921, and Section 1128E of the Social Security Act protect individuals, entities, and their authorized agents from being held liable in civil actions for reports made to the NPDB unless they have actual knowledge of the falsity of the information contained in the report. These provisions do not protect staff and entities from being sued, but they do protect against monetary damages.

These protections are in place to promote effective peer review and appropriate reporting by entities in an effort to improve patient safety. A hospital or other health care entity that fails substantially to report clinical privileges actions or adverse actions to the NPDB could experience a loss of immunity2 and publication of the hospital’s name in the Federal Register.

Impact of Civil Liability Protection on Professional Review Activity

In addition to the aforementioned provisions, Part A of Title IV provides additional protections to encourage and support professional review activity of physicians and dentists.

Under this section,3 specifically noted in section 11111, Professional Review, there is an outline of the limitation on damages for professional review actions, stating in part:

If a professional review action (as defined in section 11151(9) of this title) of a professional review body meets all the standards specified in section 11112(a) of this title, except as provided in subsection (b) of this section . . . shall not be liable in damages under any law of the United States or of any State (or political subdivision thereof) with respect to the action . . . (Emphasis Added).

(2) Protection for those providing information to professional review bodies

Notwithstanding any other provision of law, no person (whether as a witness or otherwise) providing information to a professional review body regarding the competence or professional conduct of a physician shall be held, by reason of having provided such information, to be liable in damages under any law of the United States or of any State (or political subdivision thereof) unless such information is false and the person providing it knew that such information was false. (Emphasis Added).

These protections, codified in federal law, apply to reporting entities in every state, and offer valuable support when conducting a professional review activity, which is “[a]n activity of a health care entity with respect to an individual health care practitioner . . . [t]o determine whether the health care practitioner may have clinical privileges with respect to . . . the entity . . . [t]o determine the scope or conditions of such privileges . . . or . . . [t]o change or modify such privileges . . . ”4 The conduct of professional review activities through formally adopted written procedures that provide for adequate notice and an opportunity for a hearing is defined as the peer review process. There are laws in place to provide protection for individuals providing information to improve the quality of health care through professional review activity.

Professional Review Action Requirement and Example

A Professional Review Action is “[a]n action or recommendation of a health care entity . . . [t]aken in the course of professional review activity . . . [b]ased on the professional competence or professional conduct of an individual health care practitioner which affects or could affect the health or welfare of a patient . . . [w]hich adversely affects or may adversely affect the clinical privileges . . . of the health care practitioner.”5 An example of proper reporting based upon a professional review action is as follows:

A Hospital initiated an investigation into complaints against a physician. The complaints involved mishandling of patient encounters and notes, as well as various forms of harassment of the staff by the practitioner. The case was reviewed by the Medical Executive Committee (MEC) of the Hospital, who noted that proper patient encounter documentation is essential to patient care and safety. After a case review, 35 patient encounters either had insufficient documentation or no documentation at all. The MEC also noted that while the harassment of Hospital staff may not appear to impact patients directly, it created a poor work environment, hindering the affected staff’s ability to provide their best care to patients. Based on the evidence reviewed by the MEC, it was recommended that per the Hospital’s Bylaws, the physician’s privileges at the Hospital would be terminated in the interest of patient safety and due to concerns about the physician’s professional competence and conduct. Once the physician received notice of the termination, the physician appealed the privileging action asserting that the final determination was the result of an insufficient peer review process. After an appeal hearing by the Hearing Committee, who affirmed the MEC’s decision, the Governing Body (Board) of the Hospital accepted the MEC’s recommendation and affirmed the termination of the physician’s clinical privileges.

In this case, the investigation by the Hospital followed formally adopted written procedures contained in the Bylaws, providing the practitioner with adequate notice and an opportunity for a hearing. The Hospital took a professional review action that adversely affected the physician’s privileges for a period longer than 30 days when the Hospital’s Governing Body took the final action of affirming the termination of the physician’s privileges. The Hospital also asserted that the physician’s conduct could have adversely affected the health or welfare of patients, terminating the physician’s privileges in the interest of patient safety. As such, the Hospital was legally required to report the termination of the physician’s privileges to the NPDB.

Conclusion

Understanding professional review actions and NPDB reporting requirements are important for promoting health care quality and safety. It is also important for entities to realize there are regulations that provide civil liability protections to support professional review activity. Health care entities must report adverse clinical privileges actions on physicians and dentists if the actions meet NPDB reporting requirements. For more information, please see the NPDB Guidebook, which is available at https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp, as well as the NPDB website at www.npdb.hrsa.gov.


Donald Illich and Adam Stanzione, U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Bureau of Health Workforce (BHW), Division of Practitioner Data Bank (DPDB)


 

1 45 C.F.R. § 60.12(a)(1)(i).

3 Pub. L. No. 99-660, title IV, § 411, Nov. 14, 1986, 100 Stat. 3784; Pub. L. No. 100-177, title IV, § 402(c), as added Pub. L. No. 101-239, title VI, § 6103(e)(6)(A), Dec. 19, 1989, 103 Stat. 2208.

4 45 C.F.R. § 60.3.

5 Id.

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