The Im Sorry Potential – Error Disclosure Policies and Proposed Legislation Reviewed

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    While medical organizations and ethicists long have advocated full disclosure of complications or errors to patients and their families, the concept of offering apologies and compensation is relatively recent.

    A survey by Gallagher and colleagues published in the Archives of Internal Medicine demonstrated wide variations in doctors’ willingness to disclose errors. Of the more than 2,600 surgeons and medical specialists surveyed, surgeons were more likely than other physicians to believe that an error would result in a lawsuit, yet they also were more likely to report that they definitely would disclose an error. A number of surgical specialties have included in their annual meetings formal debates on the topic, with one side arguing for taking the “high road” while the other argues that disclosure is a “road to self-destruction.” The controversy has been chronicled in the lay press. The legal ramifications of error disclosure are, as yet, uncertain.

    In order to predict how a full disclosure and compensation policy might impact neurosurgical patient care and medical liability, it is necessary to analyze the experience of institutions that have adopted such a policy. Two such institutions are the University of Michigan Health System and the Veterans Affairs Medical Center of Lexington, Ky.

    Rich Boothman, JD, chief safety officer at UMHS, implemented his institution’s policy in 2001. He thinks that knowing the difference between appropriate and inappropriate care is key. If a mistake is made, the institution discloses it promptly and offers compensation. If the institution determines that no mistake was made, they defend. “Do this, and medical malpractice litigation goes away or is reduced to background noise,” he said.

    In June Boothman testified to the U.S. Senate Committee on Health, Education, Labor and Pensions on the success of the UMHS program. The number of claims (pretrial notices through active litigation) was 262 in 2001, dropping to less than 100 since August 2005. The average time for claim processing dropped from 20.3 months to 9.5 months, cutting litigation costs in half. A portion of the savings has been used for patient safety programs.

    A full disclosure policy was implemented in 1987 at the Veterans Affairs Medical Center in Lexington. If it was determined that an error had been made, full details were to be given to the next of kin by the medical leadership of the hospital, along with an expression of “regrets of the institutions and personnel involved.” Families were invited to bring their lawyers to discuss an offer of compensation. As a result of the program, the hospital became among the lowest in claims paid in the VA system according to Steve Kraman, MD, former chief of staff at the VA in Lexington.

    Similar disclosure and compensation programs have been instituted at Minneapolis Children’s Hospitals and Clinics, Dana Farber Cancer Institute in Boston, and Johns Hopkins University in Baltimore.

    Proposed Legislation: MEDIC
    In its May 25 issue, the New England Journal of Medicine published “Making Patient Safety the Centerpiece of Medical Liability Reform,” an article coauthored by U.S. Sens. Hillary Rodham Clinton, D-N.Y., and Barack Obama, D-Ill. The senators acknowledge the escalating insurance premium costs experienced by specialties such as neurosurgery and express concern over the resultant deterioration in patients’ access to care. They also cite the well-known 1999 Institute of Medicine report that attributes from 44,000 to 98,0000 deaths in the United States each year to medical errors. Their conclusion: There is a need to improve patient safety.

    The senators coauthored MEDIC, the National Medical Error Disclosure and Compensation Bill, S. 1784, introduced in September 2005. The main provisions of this bill are to:

    • create an Office of Patient Safety and Health Care within the Department of Health and Human Services;
    • establish the National Patient Safety Data Base, analyzingdata to inform policy and practice recommendations;
    • establish the MEDIC program; and
    • support studies related to MEDIC and the medical liability system.

    The MEDIC legislation would provide federal grant support and technical assistance to physicians and institutions that implement programs of full disclosure and negotiated compensation for medical errors. The proposed bill calls for protected confidentiality for medical personal and protects any apology, preserves the patient’s right to sue, and allows for third party mediation. The anticipated reductions in lowered legal and administrative costs would be earmarked to lower insurance premiums and fund systems changes to improve patient safety.

    Under the provisions of this bill, three key outcome studies would be conducted:

    • Patient safety analysis to determine standards and develop “best practice” tools.
    • Medical liability insurance market analysis to determine sources of increased legal costs and compare efficacy of the various state liability insurance programs.
    • Analysis of cases not resolved successfully under this program.

    Given the dramatic change in the composition of Congress following the mid-term elections, the legislation could gain momentum rapidly. The bill was referred in September 2005 to the Senate Health, Education, Labor and Pensions Committee, which Sen. Edward Kennedy, D-Mass., is slated to chair in 2007.

    Another bill, the Fair and Reliable Medical Justice Act, S. 1337, introduced by Sens. Mike Enzi, R-Wyo., and Max Baucus, D-Mont., would provide grants to organizations that develop pilot projects to research the feasibility of establishing medical courts.

    Related Developments
    The Colorado Physicians Insurance Company, COPIC, has developed a program called the 3R’s: Recognize, Respond, Resolve. Under this no-fault program, there were 930 qualifying incidents from 2000 to 2004. The average patient reimbursement per incident was $5,326. To date, none of the cases has gone to litigation. Despite good faith efforts, patients occasionally do pursue attorney involvement after an initial 3R’s overture to the patient. In COPIC’s experience, this occurred in less than 2 percent of cases. However, the vast majority of medical malpractice liability insurers have not yet weighed in on the issue.

    The Joint Commission on Accreditation of Healthcare Organizations discussed the policy of requiring apologies in 2001. It shelved the idea due to concerns that apologies could be used against physicians and hospitals under current tort law.

    “Sorry Works,” a grass-roots project developed by the brother of a young patient who suffered a fatal myocardial infarction, has been actively lobbying state legislatures for full disclosure requirements. Two states, Illinois and Vermont, recently have passed legislation that establishes pilot programs to test the efficacy of full disclosure and compensation policies. The Tennessee, Texas and New Jersey legislatures are considering similar legislation.

    Other Western nations also are grappling with this issue as they also begin to experience American-style increases in medical malpractice litigation and its costs. In the United Kingdom, the National Health Service Redress Bill, HL Bill 22, is under consideration by Parliament. It provides limited compensation for those injured by medical mistakes. In Australia, a full disclosure policy has been adapted nationally, but it is voluntary and lacks guidelines or rules for disclosure or compensation.

    The Scope of the Debate
    Some have advocated that the time has come to broaden the scope of the debate. Future efforts may include not only tort reform, but a more comprehensive approach to the malpractice crisis. Within the current tort system, programs to limit frivolous lawsuits, set standards for expert testimony and enforce accountability from experts are being advocated, in addition to caps on noneconomic damages. Medical courts to rule on errors and poor outcomes have been proposed

    The introduction of legislation such as MEDIC may signify a change in the climate of discussions on tort reform. All sides now agree that a problem exists, and all agree that a more trusting physician-patient relationship is desirable.

    Gail L. Rosseau, MD, is director of cranial base surgery at the Chicago Institute of Neurosurgery and Neuroresearch, Chicago, Ill.

    For Further Information

    • Bakalar N: Medical errors? Patients may be the last to know. NY Times, Aug. 29, 2006

    • Clinton HR, Obama B: Making patient safety the centerpiece of medical liability reform. N Engl J Med 354(21): 2205-2208, 2006

    • COPIC’s 3R’s Program. Lessons learned. 2(1), June 2005. www.callcopic.com

    • Gallagher TH, Garbutt JM, Waterman AD, Flum DR, Larson EB, Waterman BM, Dunagan WC, Fraser VJ, Levinson W: Choosing your words carefully: How physicians would disclose harmful medical errors to patients. Arch Intern Med. 166:1585-1593, 2006

    • Institute of Medicine, To err is human: Building a safer health system. Washington, D.C.: National Academy Press; 2000. www.iom.edu

    • Kraman SS, Hamm G: Risk management: Extreme honesty may be the best policy. Ann Intern Med 131(12):963-967, 1999

    • Manser T, Staender S: Aftermath of an adverse event: Supporting health care professionals to meet patient expectations through open disclosure. Acta Anesthesiol Scand 49:728-734, 2005

    • Mavroudis C, Mavroudis CD, Naunheim KS, Sade RM: Should surgical errors always be disclosed to the patient? Ann Thorac Surg 80(2):399-408, 2005

    • The Sorry Works! Coalition, www.sorryworks.net

    • Taft L: Apology and Medical Mistake: Opportunity or Foil? Ann Health Law 14:55-94, 2005

    • Zimmerman R: Doctors’ new tool to fight lawsuits: Saying “I’m sorry.” Wall Street Journal, May 18, 2004

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