The Honorable Kathleen Sebelius
Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201
Dear Secretary Sebelius:
Public Citizen, a consumer advocacy group representing more than 300,000 members and supporters nationwide, hereby requests that the Department of Health and Human Services (HHS) amend either the HHS regulations at 45 C.F.R. part 60 (National Practitioner Data Bank [NPDB] for Adverse Information on Physicians and Other Health Care Practitioners) or the department’s policy interpretation of these regulations to require the reporting to the NPDB of physicians who voluntarily resign from membership in professional societies while under formal peer-review investigation by such societies for allegations of unethical conduct.
The NPDB was established by Title IV of Public Law 99-660 (Title IV), the Health Care Quality Improvement Act of 1986, as amended. The HHS regulations implementing the NPDB are found at 45 C.F.R. part 60.
The Health Resources and Services Administration (HRSA) operates and maintains the NPDB. According to HRSA, the purposes of the NPDB include the following:
Title IV is intended to improve the quality of health care by encouraging State licensing boards, hospitals, professional societies, and other health care organizations to identify and discipline those who engage in unprofessional behavior; to report medical malpractice payments; and to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment and adverse action history. Adverse actions can involve licensure, clinical privileges, professional society membership, and exclusions from Medicare and Medicaid.
Section 423 [42 U.S.C. § 11133] of Title IV requires any professional society that follows a formal peer-review process for the purpose of furthering quality health care to report to the appropriate state Board of Medical Examiners “a professional review action which adversely affects the membership of a physician in the society.” Section 423 also requires that the Board of Medical Examiners subsequently report such actions by professional societies to the NPDB. (It is our understanding that with the advent of electronic reporting to the NPDB, all health care entities, including professional societies, report adverse actions directly to the NPDB.)
When HHS implemented the NPDB, it failed to require the reporting to the NPDB of physicians who voluntarily resign from membership in professional societies while under formal peer-review investigation by such societies for allegations of unethical conduct, even though section 423 of Title IV could have been reasonably interpreted as imposing such a requirement.
HHS rebuffed attempts by the American Psychiatric Association (APA) to submit to the NPDB reports of physicians who resigned from APA membership
As you will note from the enclosed documents, in 1993 the APA unsuccessfully tried to submit disciplinary reports to the NPDB for psychiatrists who were being investigated for alleged violations of the association’s strict ethical code but who resigned from membership before the society’s investigation was completed.
Because the HHS General Counsel opined at the time that the NPDB legislation did not specifically authorize professional societies to report voluntary resignations from membership in such societies, HHS refused to accept the APA reports, the importance of such reports to patient safety notwithstanding.
In the enclosed letter to HHS dated July 14, 1993, Counsel to the APA made the following points:
- The APA filed such reports in the belief that they may be helpful in protecting the public from unethical conduct by physicians.
- The APA believed that the public and congressional sponsors of the Health Care Quality Improvement Act would be astonished to learn that HHS is denying professional associations the right to voluntarily report unethical conduct.
The HHS refusal to accept the APA’s reports of physicians who voluntarily resigned from APA membership before misconduct investigations were completed is particularly troubling because these investigations often involved allegations of sexual misconduct.
In 1986, the Council on Ethical and Judicial Affairs of the American Medical Association first issued an opinion condemning physician sexual misconduct. In a research study published in 1998, Public Citizen found that the number of physicians disciplined by state medical boards or federal agencies per year for sex-related offenses, including sexual intercourse, rape, sexual molestation, and the trade of sexual favors for drugs, increased significantly between 1989 and 1996. Compared with all physicians included in the study database assembled by Public Citizen, physicians disciplined for sex-related offenses were more likely to practice in the specialties of psychiatry, child psychiatry, obstetrics and gynecology, and family and general practice. Yet, under current HHS policy regarding the NPDB, cases of sexual misconduct have gone, and will continue to go, unreported by professional societies when the guilty practitioners voluntarily resign from membership before misconduct investigations are completed.
The lack of a requirement for such reporting compromises patient safety, particularly when information regarding adverse actions is not otherwise available to state medical boards, hospitals, and other health care entities.
Proposed solution: Amend either the HHS regulations at 45 C.F.R. part 60 or the department’s policy interpretation of these regulations based on current statutory authority
As noted above, section 423 [42 U.S.C. § 11133] of Title IV requires that “a professional review action which adversely affects the membership of a physician in the [professional] society” be reported to the NPDB. Given the definitions of “professional review action” and “adversely affecting” under section 431 [42 U.S.C. § 11151] of Title IV, HHS could reasonably interpret section 423 as requiring the reporting to the NPDB of physicians who voluntarily resign from society memberships while under investigation by professional societies for allegations of unethical conduct.
Section 431 of Title IV defines “professional review action” as follows:
The term “professional review action” means an action or recommendation of a professional review body which is taken or made in the conduct of professional review activity, which is based on the competence or professional conduct of an individual physician (which conduct affects or could affect adversely the health or welfare of a patient or patients), and which affects (or may affect) adversely the clinical privileges, or membership in a professional society, of the physician. Such term includes a formal decision of a professional review body not to take an action or make a recommendation described in the previous sentence and also includes professional review activities relating to a professional review action [emphasis added].
Given the above definition, the following definition of “professional review activities,” also from Section 431 of Title IV, is directly relevant to the meaning of “professional review action”:
The term “professional review activity” means an activity of a health care entity with respect to an individual physician-
(A) to determine whether the physician may have clinical privileges with respect to, or membership in, the entity,
(B) to determine the scope or conditions of such privileges or membership, or
(C) to change or modify such privileges or membership.
Therefore, a professional society’s initiation of a formal peer-review investigation into allegations of ethical misconduct by a physician member that could result in the restriction, suspension, or termination of that physician’s membership clearly constitutes a “professional review activity” and therefore a “professional review action” under section 431 of Title IV. Section 431 of Title IV defines “adversely affecting” as follows:
The term “adversely affecting” includes reducing, restricting, suspending, revoking, denying, or failing to renew clinical privileges or membership in a health care entity [emphasis added].
The use of the word “includes” in this definition can be reasonably interpreted as encompassing other outcomes not specifically listed in the definition, such as voluntary resignation from professional society membership in response to a formal investigation, particularly because most of the other definitions in section 431 use the word “means,” rather than “includes.”
In view of the above definitions, there is a reasonable and legally defensible basis for HHS to conclude that the current statutory language under section 423 [42 U.S.C. § 11133] of Title IV provides HHS with the necessary authority to amend either the HHS regulations at 45 C.F.R. part 60 or the department’s policy interpretation of these regulations to stipulate that: (a) a professional society’s initiation of an investigation under a formal peer-review process into allegations of ethical misconduct by a society member is a “professional review action,” and (b) the voluntary resignation from society membership in response to such an investigation is an action that “adversely affects the membership of a physician in the society” (i.e., it ends the membership) and, as such, must be reported to the NPDB.
The Drug Enforcement Agency’s (DEA’s) reporting to the NPDB of voluntary surrenders of DEA Certificates of Registration: An important precedent
The evolution of DEA reporting of adverse actions to the NPDB provides a relevant precedent to support the approach that HHS should take in amending either the regulations at 45 C.F.R. part 60 or the department’s policy interpretation of these regulations.
Section 432 of Title IV required that by 1988, HHS and the DEA enter into a memorandum of understanding related to the DEA’s reporting to the NPDB of “information respecting physicians and other practitioners whose registration to dispense controlled substances has been suspended or revoked under section 824 of title 21.” The statute was silent regarding the reporting of physicians and practitioners who voluntarily surrender their DEA registrations when confronted with a potential adverse action against them by the agency.
In 1997, the Office of Inspector General (OIG) issued a report addressing the reporting of voluntarily surrendered DEA Certificates of Registration to dispense controlled substances. The OIG found that the DEA was not reporting practitioners who voluntarily surrendered their certificates when the practitioners had allegedly violated the Controlled Substances Act and were confronted with possible suspension or revocation of their certificates by the DEA. According to the OIG report, voluntary surrenders of DEA Certificates of Registration represented about three times the number of reports submitted to the NPDB by the DEA. Following the report, joint efforts by the NPDB and DEA staff to implement the OIG recommendation to have the DEA report voluntary surrenders resulted in a significant increase in DEA reports, apparently due at least in part to the increase in reports of voluntary surrenders of Certificates of Registration.
Despite the fact that section 432 of Title IV was silent on the voluntary surrender of DEA Certificates of Registration, and contrary to the long-standing position taken by HHS on professional society reporting of voluntary resignations from membership, HHS pursued efforts to have the DEA report voluntary surrenders to the NPDB. This endeavor should serve as an appropriate precedent for HHS to make parallel changes to the requirements for reporting by professional societies.
For the sake of patient safety, Public Citizen urges HHS to take the necessary action to either amend the HHS regulations at 45 C.F.R. part 60 or the department’s policy interpretation of these regulations to stipulate that: (a) a professional society’s initiation of an investigation under a formal peer-review process into allegations of ethical misconduct by a society member is a “professional review action,” and (b) the voluntary resignation from society membership in response to such an investigation is an action that “adversely affects the membership of a physician in the society” and, as such, must be reported to the NPDB.
As Counsel to the APA noted in their July 14, 1993 letter (copy enclosed), the current HHS position “seems utterly inconsistent with the American people’s demand for, and the Administration’s commitment to, improved quality of care.”
Thank you for your attention to this important matter. Public Citizen looks forward to your response.
Public Citizen’s Health Research Group
Michael A. Carome, M.D.
Public Citizen’s Health Research Group
cc: Mary Wakefield, Ph.D., R.N., Administrator, HRSA