Clinical guidelines: a defense in medical malpractice suits

Rapidly rising health care costs have been the primary force behind national and state efforts at health care reform. When expenditure increases are adjusted for population growth, per capita costs have increased 1,700 percent since 1960.(1) Among the most frequently cited reasons for the rapidly increasing rate of health care expenditures are the system costs associated with the practice of defensive medicine, which can be defined as "care that does not benefit the patient, and is provided solely to avoid malpractice claims."(2)

Examples of defensive medical practices include excessive diagnostic testing, unnecessary procedures and treatments, and the resulting extra days of inpatient hospitalization. Given the adverse consequences of medical malpractice litigation, including time spent away from the practice of medicine by defendant physicians, it would seem logical that physicians would adopt behaviors in medical practice to avoid litigation exposure.(3)

The insurance compnay-commissioned study authored by Rubin and Mendelson estimates that defensive medical costs, when stated as a percentage of physician and hospital malpractice insurance premiums, range from $5 to $15 billion per year. Clearly, a serious effort to reduce those costs would have an impact on slowing the rate of increase of health care system costs.

Literature Review

The effort to formulate clinical practice guidelines appears to have gained increased momentum in the late 1980s. The Agency for Health Care Policy and Research was created in 1989 through an amendment to the Public Health Service Act, and the agency's Forum for Quality and Effectiveness in Health Care was charged with development and evaluation of practice guidelines. The Institute of Medicine was asked for advice in the effort, and Clinical Practice Guidelines--Directions for a New Program was subsequently published by the Institute.(4)

Hospitals have embraced guidelines as a way of managing the costs of inpatient care in light of reimbursement fixed by prospective payment systems. In a recent national survey, 57 percent of hospital executives indicated that they had formalized the effort of "monitoring and managing clinical processes."(5)

The State of Maine initiated an interesting demonstration project in 1992 on the use of guidelines for selected medical specialties.(6) Vermont, Minnesota, and Florida have adopted similar provisions in state health reform legislation. The Clinton health reform task force also considered having the U.S. Department of Health and Human Services develop a pilot program by which individual states would invest practice guidelines with the force of law for participating providers.(7)

Clinical Guidelines as Defensive Standards of Care

When medical malpractice cases raise a question of whether or not incorrect or inadequate care was rendered to a patient, the plaintiff will ordinarily proceed by attempting to demonstrate that the appropriate standard of care was not met. The most commonly used means of ascertaining the appropriate standard of care is through the introduction of expert testimony by plaintiff and defendant. In addition to the calling of expert witnesses, evidence may also include the introduction of medical treatises; hospital rules and procedures; government regulations; private agency standards, such as those promulgated by the Joint Commission on Accreditation of Healthcare Organizations; and medical staff bylaws.(8)

Finding an expert witness whom a court will recognize can be a difficult task. Potential expert witnesses are frequently reluctant to testify against fellow physicians, and a physician expert witness cannot be forced to testify unless he or she is a party to the suit. As with expert witnesses, other forms of expert testimony admitted at trial can lead to confusion as judges and juries attempt to determine the appropriate weight that should be given to the various sources.

As a means of improving the medical malpractice litigation process for certain types of cases, we propose the statutory adoption by states of clinical guidelines for inpatient hospital care that can be cited as affirmative defenses in physician and hospital medical malpractice suits. Adherence to these clinical pathways would demonstrate that physicians and hospitals ahd met the requisite standard of care. Similar to the current Maine Liability Demonstration Project, adherence to the specified clinical practice guideline could only be raised by the defense in a malpractice case. Established and unrebutted adherence to the clinical practice guidelines would be sufficient to have the court enter a directed verdict for the defendant.

Application of Clinical Guidelines

In using guidelines as a measure of both cost-effective and high-quality medical care, a logical starting point is at the level of inpatient acute care. Diagnosis-specific guidelines serve to direct physician and hospital personnel through a chronological pathway of standard testing, medications, and therapies for a patient with a specific diagnosis. From a liability perspective, physicians adhering to the guidelines would be protected from liability resulting from untoward effects suffered by the patient during inpatient hospitalization. If a physician had felt the need to deviate from the guidelines, he or she would not introduce the guidelines as an affirmative defense.

Development of Guidelines

Clinical guidelines have been developed by many different organizations in recent years. Major reimbursement programs, professional practice societies, and hospitals have looked to clinical pathways as a method of guiding physician and hospital treatment so that the resources expended in the care of a given patient do not exceed anticipated reimbursement. The development methodologies for guidelines published to date have varied. These guidelines include symptom- or condition-specific guidelines, such as Agency for Health Care Policy and Research (AHCPR) guidelines for urinary incontinence or postoperative pain management; diagnosis-specific guidelines; and therapy-specific guidelines, such as for cataract removal.

Initially, for purposes of developing a legal standard, guideline development should begin on a state level. As a means of making the guidelines more acceptable to the provider community, a committee would be formed of representatives from the health care industry who understood the delivery of high-quality patient care in a cost-efficient manner. Ideally, the committee would consist of hospital representatives from clinical, ancillary, and financial areas, as well as practicing physicians.

After diagnosis-specific guidelines developed by professional societies, thirdparty payers, or other providers were reviewed, an initial evaluation tool would be developed by the committee. In order to identify the applicable standard of care, a select number of physicians located in various parts of the state would be surveyed in order to learn their standard of treatment for a particular diagnosis. Because the emphasis of health care reform is on patient care directed by primary care physicians, guideline development should begin with family practitioners and internists.

Following survey completion by the primary care physicians, the committee would evaluate responses in terms of perceived quality of care. Next, subspecialists practicing in the area of guideline development would be invited by the committee to evaluate the clinical guideline for appropriateness of diagnostic testing and therapies. For example, a cardiologist might evaluate the guideline for myocardial infarction; an endocrinologist, diabetic ketoacidosis; general surgeon, hernia repair; etc.

Following final approval by the committee, the guideline would be piloted in selected areas of the state. A strict monitoring process would provide data regarding the appropriateness of the guideline to patient care. Physicians participating in the guideline project would follow the guideline as developed. Any necessary deviation would be documented by the physician and forwarded to the committee for review. Following data analysis, the guidelines would be legislatively adopted as applicable state law and thereby would become the legally recognized standard. The result would provide continual quality outcome data to be utilized for possible future modifications of the guidelines.

Clinical guidelines must be developed through a collaborative effort by those who understand quality and efficiency--i.e., physicians, hospital executives with expertise in finance and operational issues, and legal counsel. The participation of all disciplines will help that ensure guidelines meet the intended objectives.

The adoption of clinical guidelines as statewide standards in medical malpractice will be an incremental process, but it must begin in order to control costs and improve quality. Development and evaluation for cost effectiveness and quality will be ongoing as medical advancements are introduced and outcome data are evaluated. By using guidelines to identify quality standards, health care providers would have an opportunity to help change the malpractice system and improve quality and cost efficiency.

Conclusion

The authors advocate that clinical pathways be legislatively sanctioned at state levels as constituting the appropriate standard of care for the treatment of hospitalized patients. Rather than introducing expert testimony as to what the appropriate standard of care in a particular case should be, the law would specify the standard, and defendants would be granted an affirmative defense for demonstrating adherence to the standard.

Several practical considerations would have to be addressed prior to implementing a series of clinical pathways as standards of care. Many physicians regard clinical pathways as anathema, viewing them as "cookbook medicine" and unreasonable intrusions into the private practice of medicine. Because of the abundant number of pathways currently in circulation, guidelines have been introduced into evidence by plaintiff's counsel in litigation under the current system. However, the authors believe that the availability of pathways as an affirmative defense would weaken physician resistance. If physicians and hospitals had a clear indication of the standards by which their cases would be judged, they would be more willing to accept certain limitations imposed by guidelines.

Rubin and Mendelson believe that immunity from suits based on adherence to guidelines could reduce defensive medicine costs by 25 percent over a five-year period.(2) While they also believe that more comprehensive liability reform and no-fault insurance coverage hold greater possibilities for reducing defensive medicine costs, the authors believe that physician and hospital protection for adherence to standards has a much greater likelihood of adoption in the short term because of the current economic incentive for guideline development and implementation brought about by national and state efforts at health care reform.

References

(1.)George, W., and Tolson, J. Managed Competition: A Health Care System for Pennsylvania. Harrisburg, Pa,: Pennsylvania Economic partnership, 1992.

(2.)Rubin, R., and Mendelson, D. Estimating the Costs of Defensive Medicine. Fairfax, Va.: Lewin-VHI, Inc., 1993.

(3.)Martin, C., and others. "Physicians Psychological Reactions to Malpractice Lititgation." Southern Medical Journal 84(11):1300-4, Nov. 1991.

(4.)Field, M., and Lohr, K., Eds. Clinical Practice Guidelines: Directions for a New Program. Washington, D.C.: National Academy Press, 1990.

(5.)Lumsdon, K., and Hagland, M. "Mapping Care." Hospitals and Health Networks 67(20):34-40, Oct. 20, 1993.

(6.)Smith, G. "A Case Study in Progress: Practice Guidelines and Affirmative Defense in Maine." Journal on Quality Improvement 19(8):355-62, Aug. 1993.

(7.)The White House Domestic Policy Council. The President's Health Security Plan. New York, N.Y.: Time Books, 1993.

(8.)Slee, D. "Negligence." In The Law of Hospital and Health Care Administration. Ann Arbor, Mich.: Health Administration Press, 1988.

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