Medical Malpractice and Medical Error Disclosure: Balancing Facts and Fears

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1 Medical Malpractice and Medical Error Disclosure: Balancing Facts and Fears Mimi Marchev December 2003 Prepared with support from the Robert Wood Johnson Foundation GNL 53

2 Medical Malpractice and Medical Error Disclosure: Balancing Facts and Fears Mimi Marchev December 2003 by National Academy for State Health Policy 50 Monument Square, Suite 502 Portland, ME Telephone: (207) Facsimile: (207) Website: Prepared with support from The Robert Wood Johnson Foundation. GNL53

3 ACKNOWLEDGMENTS The author wishes to thank The Robert Wood Johnson Foundation for its support of this project. This report would not have been possible without the following people who generously contributed their time and expertise to reviewing early drafts. The paper benefitted from their input; however, any errors or omissions are those of the authors alone. Catherine Annas, Project Director, Massachusetts Department of Public Health; Christine Dutton, Senior Counsel, Pennsylvania Department of Health; Fred Heigel, Director, Bureau of Hospital and Primary Care Services, Office of Health Management, New York State Department of Health; Wendy Kronmiller, Assistant Attorney General, Counsel office of Health Care Quality, Office of the Attorney General, Maryland; Richard Lee, Deputy Secretary for Quality Assurance, Pennsylvania Department of Health; and Arthur Levin, Director, Center for Medical Consumers, New York. Special thanks go to Jill Rosenthal of the National Academy for State Health Policy. Her patient and intelligent guidance are always appreciated. This paper draws heavily on and is all the stronger for her impressive work on patient safety and state mandatory reporting systems.

4 TABLE OF CONTENTS Introduction...1 Possible Connections Between Mandatory Reporting and Malpractice Litigation...2 State Strategies to Protect Data and Increase Reporting...4 Including Comprehensive Protection of Data as an Integral Part of the System-Authorizing Statutes...8 Tort Reform...11 Beyond Tort Reform: Alternative Liability Demonstration Projects Proposed by IOM.. 12 Conclusion...13 Appendix A: Selected State Tort Reform Measures Appendix B: Recent State Malpractice Legislative Activity re: Tort Reform ( )

5 INTRODUCTION The Institute of Medicine s 1999 report To Err is Human brought the issues of medical errors and patient safety to state agendas by documenting that medical errors may cause up to 98,000 preventable deaths in U.S. hospitals each year. As part of a comprehensive strategy to improve patient safety, the Institute (IOM) recommended the creation of external reporting systems to identify and learn from errors so as to prevent future occurrences. Two types of reporting systems were discussed. Voluntary systems would collect information about near misses and were envisioned as confidential, having full protection and being for the sole purpose of learning ways to improve patient safety and quality. Mandatory reporting systems would receive reports of serious adverse events and would be linked to systems of accountability and made available to the public. 1 The release of the IOM report in 1999 coincided with another peak in the periodic rises in malpractice insurance premiums. The confluence of these two events and the publicity given both have resulted in both an increase in the number of state mandatory reporting systems and a demand from providers in these states for strong protections of reported data. Faced with two serious problems at the state level and with pressure to do something about both the malpractice insurance crisis and the high incidence of medical errors, states have a unique opportunity to take action and to make significant change in state policy. This policy brief addresses the issues raised by the convergence of medical error reporting and the fear of medical malpractice litigation. It discusses how states protect data with the intention of increasing the compliance level of reporting, examines a sample state protection statute, and explores recent proposals for alternatives that would address the reluctance of many providers to report for fear of possible malpractice litigation. 1 To Err is Human: Building a Safer Health Care System (Washington, D.C.: National Academy Press, 1999). Currently 21 states (CA, CO, CT, GA, FL, KS, ME, MA, MN, NV, NY, NJ, OH, PA, RI, SC, SD, TN, TX, UT, WA) have some form of mandatory reporting systems and several other states have plans or legislation pending to establish systems. 1

6 Possible Connections Between Mandatory Reporting and Malpractice Litigation Medical malpractice is governed by the legal system of torts. Under this system an award of damages to an injured claimant is designed both to compensate those who have been wronged through another s negligence and to deter future wrongs. It is arguable, however, in the case of medical malpractice, whether tort law does either effectively. 2 Most patients injured through medical negligence do not bring malpractice suits, and of those who do, very few receive any compensation. 3 At the same time, any possible deterrent effect of malpractice litigation is mitigated by the findings of studies that show that in many successful suits there was probably no clear showing of negligence on the part of the provider. 4 In this context, a question for states is whether the specter of possible malpractice litigation is hampering the effectiveness of their error reporting systems by creating resistance on the part of providers to freely report medical errors and adverse events. Earlier this year, NASHP completed a survey of 19 of the 21 states with mandatory reporting systems. Almost all of the states participating in the survey reported that facilities often cite concerns about possible medical malpractice litigation as a factor in under reporting of adverse events. 5 While the fear of litigation is undoubtedly real, it remains an open question whether reporting of medical errors with or without legal protection actually leads to a dramatic increase in litigation, especially since most data are disclosed in aggregate form. 6 To date no research on precisely this question has been conducted and no empirical evidence exists to support or refute this concern. In the aforementioned NASHP survey, when asked about any connections between their mandatory reporting systems and medical liability litigation, the majority of states reported that there was no indication that their system had resulted in an increase in the number of malpractice suits. No relationship between mandatory reporting and an increase in malpractice claims was identified through the interviews, regardless of whether the reported data were 2 M. Marchev, The Medical Malpractice Insurance Crisis: Opportunity for State Action (Portland, ME: National Academy for State Health Policy, 2002). See also M. Mello, T.A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform. Texas Law Rev 2002; 80: Marchev, 6 (citing the Harvard Medical Practice Study, Patients, Doctors and Lawyers: Medical Injury, Malpractice Litigation, and Patient Compensation in New York (1990)). 4 T.A. Brennan, C.M. Sox, H.R. Burstin. Relation Between Negligent Adverse Events and the Outcomes of Medical Malpractice Litigation. New England Journal of Medicine 1996; 335(26): M. Marchev, J. Rosenthal, and M. Booth, How States Report Medical Errors to the Public: Issues and Barriers (Portland, ME: National Academy for State Health Policy, 2003), Marchev, Rosenthal, Booth, 13. 2

7 protected or not. This may in part be due to the fact that information is available from other sources, and egregious events are likely already known to the patients and families involved. 3

8 STATE STRATEGIES TO PROTECT DATA AND INCREASE REPORTING The lack of evidence of a causal relationship between mandatory reporting and medical malpractice notwithstanding, in order to allay fears about the use of reported data to spawn malpractice suits and to encourage greater compliance in mandatory reporting systems, most states provide for comprehensive protection of serious adverse event data from compulsory disclosure through the legal process. The level of protection in each state varies (see Table 1) but will include one or more of the following as methods to protect reported data: 7 System design features. The design of mandatory reporting systems can minimize concerns about public disclosure and legal discovery of data. De-identification of data and anonymous reporting are two system design strategies that may make data less useful for discovery, although these features also limit usefulness of the data for accountability and possible consumer information. 8 Public reports of medical error data can be aggregated and de-identified. Exemptions from public disclosure laws. To accommodate public policy considerations that override this basic right of access, as in the case of reporting systems, states may create statutory exemptions to their public disclosure law. Confidentiality protections specific to reporting systems. These protections address provisions of legal process designed to compel disclosure of information and specifically protect data against subpoena, discovery, and admissibility in civil or administrative proceedings. Protections included as an integral part of the reporting system, as opposed to general protections of health information, are more resistant to legal attack because the legislative intent to protect the mandatorily reported data is clear. Peer review privilege. All states with the exception of New Jersey have a peer review privilege under state law. Peer review is used by physicians to hold each other accountable for performance and to analyze errors within their institutions so as to find the causes and avoid repetition. The peer review privilege protects peer review information and participants from the legal process and is intended to encourage participation in the peer review process. 7 For more discussion about tools and strategies that may be used to protect reporting system data from public disclosure, see Lynda Flowers and Trish Riley, State-based Mandatory Reporting of Medical Errors: An Analysis of the Legal and Policy Issues (Portland, ME: National Academy for State Health Policy, 2001), Anonymous reporting undercuts the goals of mandatory reporting and is probably not a desirable design feature because the inability to link an incident to an institution makes it impossible for state officials to investigate incidents, validate data, hold hospitals accountable for making improvements, or publish hospital specific information, should they desire to do so. 4

9 The states whose mandatory reporting systems do not include protections established as an integral part of the system may rely on existing peer review provisions that in most cases pre-date the reporting system. While offering protection to documents resulting from the peer review process, peer review protection is more vulnerable to requests for disclosure through the legal system. Courts have generally enforced the privilege, but there are instances where peer review protection has been held by courts to be trumped by the rights of individuals to information relating to a personal law suit. 9 For these reasons none of the recently established reporting systems rely on existing peer review protections alone. (See Table 2.) As was mentioned previously, the release of the IOM report and the latest spike in malpractice premiums has led to both an increase in the number of state mandatory reporting systems and a demand from providers in these states for strong protections of reported data. Whether or not a connection can be shown between reporting and an increase in litigation, the fear is real and has contributed to the trend of more recently instituted reporting systems having comprehensive statutory protection of data as an integral part of the system-authorizing statutes. 9 Adams v. St. Francis Regional Medical Center, 955 P.2d 1169 (1998). 5

10 Table 1 Legal protections against disclosure of reported data in state confidentiality statutes/regulation State C A C O C T G A F L K S M E M A M N N V N Y N J 2 O H P A R I S C S D T N T X U T W A Data excluded from disclosure under open records provisions T T T T T T T T 3 T T T Data not discoverable T T T T T T T T T T 4 T T T Data not subject to subpoena Data not admissible as evidence in civil proceedings T T T T T 4 T T T T T T T T T T 4 T T T Data not admissible as evidence in administrative proceedings (except disciplinary) T T 1 T T T T T 4 T T T Data confidential T T T T T T T T T T T T T Peer review protections only T T T T T Notes Colorado: CO Revised Statutes, (4)(1999). Connecticut: CT Public Act (g) (19 ). Florida: FL Statutes Chapter (6)(c); (8)(h) (1999). Georgia: O.C.G.A / & #1-Georgia protections include an exception for use of peer review material in licensure actions against hospitals where the effectiveness of the peer review system is at issue (O.C.G.A (b)). Kansas: KS Statutes Annotated (1999). Maine: 22 M.R.S.A. ch (3) (2002). Minnesota: MN Statutes (2003). Nevada: NV Rev. Stat. Ann and 860 (2003). New Jersey: #2-does not have a peer review protection at this time. New York: NY Civil Practice Law and Rules, art. 31 (2000); NY Public Health Law, 2805-m (1999 ). #3-NY can release facility specific aggregate information (annualized data) under a Freedom of Information Act request. Ohio: OH Statutes Pennsylvania: 40 PS 311(a) and 28 PA Code 51.3 (i). Rhode Island: RI Statutes Ch (g); #4- reporting system incorporates peer review protections by reference. South Dakota: SD Statutes CH (----). Tennessee: TN Code Ann Ch 11 (d)(1). Texas: Sub Ch H Utah: R and R ; UC Source: Marchev, Rosenthal, Booth, How States Report Medical Errors to the Public: Issues and Barriers (Portland, ME: National Academy for State Health Policy, 2003). 6

11 Table 2 Trend toward greater protection Comprehensive protections are specific to the reporting system Data received by reporting system are unprotected, or rely on peer review provisions or other general protections not specifically related to the reporting system System established pre-1999 Colorado Florida Kansas New York California Ohio Massachusetts New Jersey Rhode Island South Carolina South Dakota Washington System established post-1999 Connecticut Georgia Maine Minnesota Nevada Pennsylvania* Tennessee Texas Utah** *In Pennsylvania the original reporting system (known as the Chapter 51 system) had reporting protections that were strengthened when their new system was established in **The Utah system was established in 2001, but the data is protected by reference to existing general protections for health data that were established prior to Source: Marchev, Rosenthal, Booth, How States Report Medical Errors to the Public: Issues and Barriers (Portland, ME: National Academy for State Health Policy, 2003). 7

12 INCLUDING COMPREHENSIVE PROTECTION OF DATA AS AN INTEGRAL PART OF THE SYSTEM-AUTHORIZING STATUTES Protections that are in statute and are an integral part of the reporting system will likely provide the most reliable protection Ideally, protection provisions would be sufficient to allay fears of those reporting events that the adverse event information would be used against them, while enabling states to achieve some goals of the reporting system: to spot trends, enhance patient safety through the identification and correction of practices that result in errors or adverse events, provide valuable information to those conducting research on patient safety and evaluation of reporting systems, and inform consumers generally about the safety of their health care system. Thus, while the statutory provisions should be comprehensive and protect data from compulsory disclosure, they should also be explicit about exceptions and allowable uses of the data. Figure 1 is an example of a statute that could be included as part of a mandatory reporting system. It stipulates how reported data will be protected and how they will be disclosed. The sample statutory provision begins with a clear statement of legislative intent to protect reported data by declaring that all information collected pursuant to the reporting system will be confidential and privileged. Given that privileges in the law are generally not favored because they operate to impede access to relevant information, this statement of intent can be key when a party to a malpractice suit attempts to gain access to reported data through the legal process. When balancing competing interests in the context of a lawsuit, a court will give significant weight to the explicit wishes of the legislature. 12 Section I.A. expands upon and adds emphasis to the legislative intent that data not be released in the context of a lawsuit, notwithstanding the interests of parties in accessing all relevant information, by specifying that data may not be disclosed pursuant to the usual methods that parties employ in an attempt to compel disclosure of information, through an open records request, subpoena, discovery, or admission into evidence in a civil, criminal, or administrative hearing. Section I.B. addresses the concern that protections provided in the state reporting system would be waived if the same data were reported to a different entity or for a different purpose. For example, healthcare organizations that are accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) are encouraged, but not required, to report sentinel events to 10 See R.B. Hanscom, M.Mello, R.P. Powers, et al. Legal Liability and Protection of Patient Safety Data. Commissioned paper for the Institute of Medicine Committee on Patient Safety Data Standards, However, in contrast to protections in regulation, statutory protections can be much more more difficult to change once enacted. If states choose to protect reported data through statute, it may be advisable to include a sunset provision to allow for an evaluation of the effectiveness of protections in increasing reporting compliance. 12 See Adams v. St. Francis Regional Medical Center, 264 Kansas 144 (1998). 8

13 JCAHO. Section B ensures that such reporting does not waive protections under this statute. Section I.C. assures providers that the protections offered under this statute would not preempt stronger protections under separate state or federal legislation. Figure 1 Sample Data Protection Statute Section I. Confidentiality. Notifications and reports of adverse events filed pursuant to [the mandatory reporting system] and all information collected or developed as a result of the filing and proceedings pertaining to the filing, regardless of format, are confidential and privileged information. A. Privileged and confidential information under this section is not: 1. Subject to public access under [state open records act], except for data developed from the reports that do not identify or permit identification of the health care facility; 2. Subject to discovery, subpoena, or other means of legal compulsion for its release to any person or entity; or 3. Admissible as evidence in any civil, criminal, judicial, or administrative proceeding. B. The transfer of any information to which this chapter applies by a health care facility to the division or to a national organization that accredits health care facilities may not be treated as a waiver of any privilege or protection established under this chapter or other laws of this state. C. This section may not be construed to limit other privileges that are available under federal law or other laws of this State that provide for greater peer review or confidentiality protections than the peer review and confidentiality protections provided for in Section I. D. For the purposes of Section I, privileged and confidential information does not include: 1. Any final administrative action; 2. Information independently received pursuant to a 3 rd -party complaint investigation conducted pursuant to department rules Section II. Report. The division shall develop an annual report to the Legislature, health care facilities, and the public that includes summary data of the number and types of [adverse events] of the prior calendar year by type of health care facility, rates of change and other analyses and an outline of the areas to be addressed for the upcoming year. The report shall be submitted by [date specified] each year. Section III. Sunset Provision. A. Repeal. This title is repealed on [date specified]. B. Review of Repeal. It is the intention of the Legislature that the appropriate committees of the Legislature should review the annual reports summarizing adverse event data prior to the date of repeal described in subsection A in order to determine whether it is appropriate to extend the authorities provided under this title for a period beyond such date. 9

14 The IOM envisioned mandatory systems that would hold providers accountable and keep the public informed of the safety of the healthcare system. Protecting data from compulsory disclosure for use in a malpractice case does not preclude a state from using the same data to hold providers accountable and/or to analyze sources and causes of errors. In many of the states with mandatory reporting systems, errors or adverse events are reported to the regulatory branch that may take corrective action when necessary. Even in states such as Utah that do not share data with the regulatory branch, the reporting system may also provide a mechanism of accountability. In the case of Utah, the state division that receives error reports also monitors plans of correction and will intervene if a provider has not moved assertively to correct a condition or situation that is causing errors. Section D of the sample statute ensures that states with systems that simultaneously use data for accountability in the licensure and certification process and for data analysis and error prevention are free to disclose the results of their investigations and any action taken pursuant to the investigation. Regarding a principal goal of mandatory reporting as envisioned by the IOM, public access to information, most states that release error data do so in aggregate and de-identified form. While deidentified data limit how useful data will be, for example, to consumers choosing a hospital, aggregate data reports do serve to alert both state legislatures and the public at large to trends and problem areas in the healthcare system. A consumer who is aware of what errors are occurring and under what circumstances will be better prepared to ask their provider appropriate questions. Section II of the sample statute requires that data be released to the legislature and public and elucidates the manner of their release. The sunset clause contained in Section III of the sample statute gives state legislatures the opportunity to study the effectiveness of data protections in increasing reporting compliance and, if shown to be ineffective, the ability to employ other strategies in the efforts to boost compliance and enhance healthcare safety. 13 While most states provide for this dual use, Utah is an exception. The state receives reports of errors into a separate entity and does not share error information with the regulatory branch. 14 In all states, the public can access statements of deficiencies issued as the result of a survey or complaint investigation conducted as part of the state licensing and/or Federal certification process. (The Centers for Medicare and Medicaid Services State Operations Manual, Section 3314 and 42 CFR ) 10

15 TORT REFORM In addition to creating strong protections for reported medical error data, states are attempting to address the issue of the medical malpractice insurance crisis through selected tort reforms. Tort reform in the context of medical malpractice is essentially an attempt to control the frequency and severity of claims, with the goal of reducing the growth of malpractice insurance premiums. 15 There has been a vigorous campaign in recent years by providers and insurance companies urging state legislatures to institute tort reform in general and damage caps in particular. 16 (See Appendix B for recent state tort reform legislative efforts.) The emphasis on caps and other measures designed to restrict the amounts of damage awards, such as abolition of the collateral source rule and joint and several liability, is aimed at increasing the predictability of awards and limiting the liability exposure of the insurance companies, so as to stabilize malpractice insurance premiums. (See Appendix A.) However, this strategy is not designed either to increase reporting compliance or reduce the incidence of medical errors, and no evidence exists to indicate that it would do either one.) The current direction of tort reform which effectively restricts access to the courts coupled with the trend to protect medical error data have raised concerns that consumer access to information is being blocked. In spite of the many problems associated with malpractice litigation, the system is potentially a very rich source of error data which could be used to improve the quality and safety of health care. With all avenues to information being restricted, consumers and injured patients are likely to become increasingly dissatisfied with this trend and may become more assertive in demanding the disclosure of medical error data. 15 For further discussion, see M. Marchev, The Medical Malpractice Insurance Crisis: Opportunity for Sate Action (Portland, ME: National Academy for State Health Policy, 2002). 16 The American Medical Association has designated medical liability reform as its number one priority. See the AMA web site: See also Appendix A for a summary of recent legislative activity initiating tort reform proposals. 11

16 Beyond Tort Reform: Alternative Liability Demonstration Projects Proposed by IOM In an attempt to address the problems with the current tort system as outlined above, the Institute of Medicine has called for a series of demonstrations to test no-fault, non-judicial systems for medical malpractice. 17 The IOM suggests that four or five states create injury compensation systems outside of the courtroom that are patient-centered and focused on safety. These systems would set reasonable payments for avoidable injuries and provide fair, timely compensation and apologies to a greater number of patients, while stabilizing the malpractice insurance market by limiting health care providers' financial exposure. The projects provide incentives for care providers to develop processes for reporting and analyzing medical mistakes and to involve patients in efforts to reduce errors. Participating states would replace the existing tort system with one of two proposed administrative models:! Provider-based early payment: Under this approach, the federal government would provide reinsurance on a shared-cost basis to self-insured or experience-rated provider groups that agree to identify and promptly compensate patients for avoidable injuries. States would prospectively set limits on non-economic damages, including pain and suffering, for identifiable classes of avoidable injuries.! Statewide administrative resolution: Under this approach, states would grant all health care providers immunity from most tort liability in exchange for mandatory participation in a state-sponsored administrative system to compensate patients for avoidable injuries. The IOM approach involves explicit trade-offs for both providers and consumers. In these demonstration projects, consumers would trade jury trials for faster, fairer and surer compensation. Providers would agree to mandatory reporting and prompt payment in return for reasonable limits on financial exposure. Compensation would be based on avoidability of errors instead of the currently required standard of negligence. Awards would be preset for specific categories of errors, providing the stability needed to contain malpractice premiums more fairly than the arbitrary caps on non-economic damages that are commonly proposed. The IOM approach would replace negative incentives that arguably encourage providers to hide errors and practice defensive medicine with positive incentives to report and reduce errors through evidence-based methods. This could be a very important step toward creating a just culture in which the system could focus on enhancing quality and safety rather than avoiding punishment under the system of tort liability. 17 Institute of Medicine, Fostering Rapid Advances in Health Care: Learning from System Demonstrations (2002). 12

17 CONCLUSION In the ongoing effort of states to guarantee safer health care, the systems designed to investigate and remedy errors (mandatory reporting systems) and to hold providers accountable and act as a deterrence to future errors (the tort system) appear, at times, to work at cross purposes. Mandatory reporting, as envisioned by the IOM, encourages a systems approach and looks to bring mistakes out in the open in order to fix system flaws and thus avoid future lapses. The tort system blames an individual for his wrongdoing and through punishment looks to deter future errors. Both approaches can be said to share the goal of safer health care delivery, but in the current environment of mistrust and fear, the balance may shift temporarily toward more protection of data at the expense of open and public airing of errors. It is not at all certain that stronger protection of data will lead to an increase in reporting. All states with mandatory systems that responded to the NASHP survey cited under reporting as a problem, even those with very comprehensive protections of reported data in place. 18 It may well be that the causes of under reporting are broader than fear of malpractice and are linked to a general provider reluctance to report errors for a wide variety of concerns, including a dislike of regulation, bad publicity, loss of market share, etc. Nevertheless, until the current barriers to reporting are overcome, including the fear of malpractice litigation, states are choosing to protect data from use in malpractice cases. If the trend toward strong comprehensive protection leads to a higher rate of reporting compliance, states will be in a much better position to make needed changes in the health care system to enhance patient safety and to provide useful information to the public based on full reporting. As providers receive valuable feedback from the reporting system and see favorable results, reluctance and fear of reporting may diminish. In contrast, if providers continue to under report even with strong protections in place, the states will be obliged to reevaluate the strategies employed to encourage providers to report errors. As states introduce reporting systems with strong statutory protections, they may want to keep in mind that statutory provisions, especially those with powerful stakeholders supporting them, are difficult to repeal. Thus, states may want to position themselves advantageously for future evaluation and adjustments by 1) providing for research to examine both the reporting/malpractice and the protection/reporting links, and 2) including sunset provisions in the implementing statutes. Either way, it should not be forgotten that consumers have a right to safe health care and have a right to fair compensation if they are injured in the healthcare system. Any reporting system should act ultimately to the public advantage. Protecting data may serve an interim purpose of increasing reporting and creating a safer health care system, but it also impinges on the rights of health care consumers to information. If it is shown in the future that protecting data does not increase reporting, the problems with the malpractice system, in the absence of other valid reasons to 18 Marchev, Rosenthal, and Booth,

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