National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners; payment of fees--HRSA. Final rule

This final rule amends the existing regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank) authorizing the reporting and release of information concerning: Payments made for the benefit of physicians, dentists, and other health care practitioners as a result of medical malpractice actions or claims; and certain adverse actions taken regarding the licenses and clinical privileges of physicians and dentists. This final rule removes restrictions on allowed methods of payment for Data Bank fees.     

National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners--PHS. Final regulations

This final rule amends the existing regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank), codified at 45 CFR part 60, authorizing the reporting and release of information concerning: (1) Payments made for the benefit of physicians, dentists, and other health care practitioners as a result of medical malpractice actions or claims; and (2) certain adverse actions taken regarding the licenses and clinical privileges of physicians and dentists. This final rule revises section 60.12 to change the process for collecting user fees from eligible individuals and entities requesting disclosure of information from the Data Bank.     

National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: amendments to data bank regulations to comply with court order and technical correction--HRSA. Final regulations

This final rule amends the existing regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank), codified at 45 CFR part 60, authorizing the reporting and release of information concerning: Payments made for the benefit of physicians, dentists, and other health care practitioners as a result of medical malpractice actions or claims; and certain adverse actions taken regarding the licenses and clinical privileges of physicians and dentists. This final rule revises sections 60.2 and 60.7 to require reporting only by entities which make medical malpractice payments, deleting the reference to reporting by persons (individuals). It also clarifies the reference to "professional society" in section 60.9.     

Participation in the National Practitioner Data Bank--Department of Veterans Affairs. Final rule

This rule sets forth the policy of the Department of Veterans Affairs (VA) for participation in the National Practitioner Data Bank (Data Bank). VA will request information from the Data Bank concerning physicians, dentists and other health care practitioners who provide or seek to provide health care services at VA facilities and will also report information to the Data Bank regarding malpractice payments and adverse clinical privileges actions. The intended effect of this policy is to participate in the Data Bank for the purpose of promoting better health care at VA and non-VA health care facilities.     

Privacy Act; implementation. Office of Inspector General (OIG), HHS. Final rule

This final rule exempts the new system of records, the Healthcare Integrity and Protection Data Bank (HIPDB), from certain provisions of the Privacy Act (5 U.S.C. 552a). The establishment of the HIPDB is required by section 1128E of the Social Security Act (the Act), as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 1128E of the Act directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers or practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners. Regulations implementing the new HIPDB were published in the Federal Register on October 26, 1999 (64 FR 57740). The exemption being set forth in this rule applies to investigative materials compiled for law enforcement purposes.     

Special report on medical staff relationships. Handling "impaired" health care professionals

Applying the doctrine of corporate negligence, courts will, in appropriate circumstances, deem hospitals and other institutional health care providers responsible for the quality of patient care in their institutions and for the consequences of negligent physician performance that could have been discovered and prevented. See, e.g., Darling v. Charleston Community Memorial Hosp., 33 Ill. 2d 326 (1965), cert, denied, 383 U.S. 946 (1966); Johnson v. Misericordia Community Hosp., 99 Wis. 2d 709 (1981); Elam v. College Park Hosp., 132 Cal. App. 3d 332 (1982). In such a climate, and with Data Bank reporting now a reality, neither institutional providers nor health care professionals on their medical staffs can afford to ignore problems of practitioner impairment. Recognizing this reality, some state laws now mandate an organized approach--such as the establishment of an impaired practitioners committee--to problems of professional impairment. However, whether state-mandated or not, providers must have policies and procedures in place to insure not only that impaired professionals are referred to available treatment programs, but that they fully participate in and complete such programs, and achieve rehabilitation, before they return to practice at the institution. The earlier detection and treatment are initiated, preferably before peer review action becomes necessary, the better for patients, institutions, and practitioners themselves.     

Health care fraud and abuse data collection program: technical revisions to Healthcare Integrity and Protection Data Bank data collection activities. Final rule

The rule finalizes technical changes to the Healthcare Integrity and Protection Data Bank (HIPDB) data collection reporting requirements by clarifying the types of personal numeric identifiers that may be reported to the data bank in connection with adverse actions. The rule clarifies that in lieu of a Social Security Number (SSN), an individual taxpayer identification number (ITIN) may be reported to the data bank when, in those limited situations, an individual does not have an SSN.     

Health care fraud and abuse data collection program: technical revisions to healthcare integrity and protection data bank data collection activities. Interim final rule with comment period

The rule makes technical changes to the Healthcare Integrity and Protection Data Bank (HIPDB) data collection reporting requirements set forth in 45 CFR part 61 by clarifying the types of personal numeric identifiers that may be reported to the data bank in connection with adverse actions. Specifically, the rule clarifies that in lieu of a Social Security Number (SSN), an individual taxpayer identification number (ITIN) may be reported to the data bank when, in those limited situations, an individual does not have an SSN.     

Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document.     

When silence threatens safety: lessons from the first Canberra Hospital neurosurgical inquiry

Despite widespread institutional and professional support, the recommendations of the Bristol Royal Infirmary Inquiry may be insufficient to reduce patient risk from impaired senior medical practitioners. Using the First Inquiry into Neurosurgical Services at the Canberra Hospital as a case study, this article argues that the Bristol-type recommendations--which emphasise reformulation of clinical governance structures, including early reporting of "sentinel events" and compulsory clinical audits--will be ineffective without a reformed institutional ethos that encourages open transparency and respect for those committed to such processes. Such reformulation may need to commence in medical education and involve new strategies including the use of portable digital technology to facilitate self-assessment of performance and immediate reporting of adverse incidents.     

Medicare and Medicaid programs; Medicare-Medicaid coverage data bank requirements: preliminary guidance--HCFA. Notice

This notice informs the public about section 1144 of the Social Security Act, which is self-implementing, and provides preliminary guidance to employers who are required to report information about all individuals covered by group health plans to a newly established Medicare-Medicaid Coverage Data Bank. Information in the data bank will be used to help identify situations where employer group health plans are responsible for making primary payments for services received by Medicare or Medicaid beneficiaries. This notice provides: information on the background and legislative authority for the data bank; definitions of key terms; reporting requirements; the identity of entities that are required to, or may, report; reporting dates; penalties for noncompliance; and methods of reporting.     

Medical Errors: Mandatory Reporting,Voluntary Reporting,or Both?

This work evaluates policy recommendations on medical error reporting systems presented in, To err is human, a report published by the Institute of Medicine. Here mandatory reporting should be applied for adverse events, while voluntary reporting is recommended for near misses. This analysis shows that an error reporting scheme of this type is not an optimal one since both near misses and adverse events may remain unreported. This work makes evident that penalising health care providers for not reporting errors, independent of error category, is crucial for reaching the first-best solution.JEL D82, I18, K42     

Whistleblower protection for nurses and other health care professionals

Because most employees in the United States, including health care professionals, are employed "at will" (which means their employment can be terminated for any reason or no reason, as long as the reason isn't illegal), retaliatory actions by employers toward employees who speak out (i.e., blow the whistle) are not uncommon. Additionally, the law protecting whistleblowing employees varies greatly depending on the state where the employee works or if he or she works for the federal government. This article examines when and under what conditions a nurse or other health care professional may be protected from having an adverse employment action taken against him or her for reporting such issues as patient safety violations or health care fraud. The authors offer issues a nurse or other health care professional should consider before making the decision to blow the whistle. Finally, the authors also discuss the remedies such as reinstatement, back pay, or other compensatory mechanisms that may be available to employees terminated for reporting wrongdoing.     

The state of electroconvulsive therapy in Texas. Part I: reported data on 41,660 ECT treatments in 5971 patients

The Texas Legislature in 1993 mandated a quarterly reporting requirement for hospitals and physicians performing electroconvulsive therapy (ECT) in the state (United States Government hospitals were excluded). The Texas Department of Mental Health and Mental Retardation (TDMHMR) was designated as the agency responsible for collecting and maintaining the data. This paper reviews the ECT data from 16 quarterly reports (09/01/93 through 08/31/97). The reports contained data on 41,660 ECT treatments in approximately 5971 patients. The results of this study support the proposition that ECT is an extremely safe and effective treatment for those individuals suffering from a serious mental illness. In Texas, ethnic groups other than non-Hispanic Anglo-Americans appear to be underserved in regards to ECT. Those patients without appropriate insurance or adequate personal finds are also underserved as a result of the few county and state hospitals performing ECT and the relatively small number of patients treated with ECT at those hospitals. Recommendations are suggested to improve the quality of the database and in informing the public as to the safety and efficacy of this valuable treatment modality. What, at first, was seen as an unwarranted legislative foray into the practice of medicine, has, in the end, become a source of valuable data supporting the use of ECT as an important treatment modality.     

National Practitioner Data Bank for Adverse Information on Physicians and other Health Care Practitioners: charge for self-queries. Health Resources and Services Administration, HHS. Final rule

This final rule amends the existing regulations implementing the Health Care Quality Improvement Act of 1986 (the Act), which established the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank). The final rule amends the existing fee structure so that the Data Bank can fully recover its costs, as required by law. This rule removes the prohibition against charging for self-queries and, therefore, allows the Data Bank to assess costs in an equitable manner. This is consistent with both the Freedom of Information Act and the Privacy Act which allow the Government to charge fees for the reproduction of records. The Data Bank will continue its current practice of sending to the practitioner in whose name it was submitted--automatically, without a request, and free of charge--a copy of every report received by the Data Bank for purposes of verification and dispute resolution.     

Situating forensic traces in time

Situating events and traces in time is an essential problem in investigations. To date, among the typical questions issued in forensic science, time has generally been unexplored. The reason for this can be traced to the complexity of the overall problem, addressed by several scientists in very limited projects usually stimulated by a specific case. Considering that such issues are recurrent and transcending the treatment of each trace separately, the formalisation of a framework to address dating issues in criminal investigation is undeniably needed. Through an iterative process consisting of extracting recurrent aspects discovered from the study of problems encountered by practitioners and reported in the literature, common mechanisms were extracted and provide understanding of underlying factors encountered in forensic practise. Three complementary approaches are thus highlighted and described to formalise a preliminary framework that can be applied for the dating of traces, objects, persons and indirectly events.     

Health care fraud and abuse data collection program: reporting of final adverse actions. Office of Inspector General (OIG), HHS. Final rule

This final rule establishes a new CFR part to implement the statutory requirements of section 1128E of the Social Security Act, as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 221(a) of HIPAA specifically directs the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers and practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners.     

Health care fraud and abuse data collection program: reporting of final adverse actions--Office of Inspector General (OIG), HHS. Notice of proposed rulemaking

This proposed rule would establish a new 45 CFR part 61 to implement the statutory requirements of section 1128E of the Social Security Act, as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 221(a) of HIPAA specifically directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers, or practitioners, and maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners.     

Part I: The NGRI Registry: initial analyses of data collected on Connecticut insanity acquittees

The NGRI Registry is a comprehensive census database collected by the Law and Psychiatry Division of the Department of Psychiatry at the Yale University School of Medicine. This longitudinal database was compiled following a systematic search of all available docket books from the superior courts and mental health records from the state hospitals in Connecticut beginning in January 1970. Detailed life span information is available for 364 insanity acquittees identified during the search. Comparative analyses with four other locales suggested that there were regional differences in diagnoses of and crimes committed by the acquittees. These initial analyses demonstrate the promise of this registry becoming one tool for collaborative research on issues relevant to law and mental health.     

Privacy Act of 1974; report of new system--HCFA. Notice of new system of records

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records, called the "National Provider System (NPS)," HHS/HCFA/OIS No. 09-70-0008. We have provided background information about the proposed system in the "Supplementary Information" section below. Both institutional (e.g., hospitals, skilled nursing facilitaties) and individually identifiable (e.g., physicians and other practitioners) providers are included in the NPS database. The institutional providers' data are covered by section 1106 of the Social Security Act and the Freedom of Information Act, while the individually identifiable providers' data are also covered by the Privacy Act of 1974. Although the Privacy Act requires only that the "routine uses" portion of the system be published for comment, HCFA invites comments on all portions of this notice. See "Effective Dates" for comment period.