Risk Management

Will Practice Guidelines Provide Malpractice Defense?

By James F. Holzer, JD

Argus, February, 1994

Once again, the White House has fired up its campaign to sell the President’s health care reform package in 1994. A small but important piece of his proposal attempts to deal with the adverse effects of malpractice litigation on physicians. Among other ideas, the plan calls for the Department of Health and Human Services to develop a medical liability pilot project that will make selected clinical practice guidelines a defense tool for physicians accused of malpractice.

The concept is based on a five-year program under way in Maine involving four specialties: anesthesiology, emergency medicine, OB/GYN and radiology. Effective Jan. 1, 1992, 20 practice guidelines created by specialty advisory committees were given the full force and effect of state law. Although the initial goals of the Maine Liability Demonstration Project were to address problems of rising health care costs and limited access to care, the primary focus now appears to be on getting physicians to voluntarily comply with appropriate clinical standards and consequently to reduce the practice of defensive medicine.

To encourage physician participation, the law provides that doctors who opt into the program can use the guidelines as an affirmative defense in a malpractice action to formally demonstrate their compliance with the appropriate standard of care, presumably without the need for expert testimony. Most significant, however, is a provision of the law prohibiting the plaintiff from using the same practice guideline as evidence of physician noncompliance unless it already has been introduced into evidence by the defendant doctor.

Proponents of the new statute argue that this essentially provides doctors with immunity from litigation in selected instances. Opponents, including some malpractice defense attorneys, assert that it is a constitutional challenge waiting to happen. The White House, understandably, likes this idea better than imposing a controversial cap on noneconomic damages which, to no one’s surprise, the plaintiff’s bar is aggressively fighting.

Implications for Ophthalmologists

According to a recent report on the Maine project by the General Accounting Office (GAO), the guidelines adopted by the state advisory committees were essentially chosen from standards and guidelines written and disseminated by national specialty societies. The GAO report also cited the potential medicolegal use of practice guidelines on a broader scale being developed through DHHS’s Agency for Health Care Policy and Research (AHCPR) and by other states such as Florida, which is looking at implementing up to 50 guidelines in areas of “high medical utilization and high cost.”

If not already, ophthalmology soon will be asked to participate in similar efforts to apply specialty-specific practice guidelines to resolve or curtail malpractice litigation. The Academy’s ongoing work in developing Preferred Practice Patterns (PPPs) no doubt will be of growing interest to federal and state lawmakers entertaining pilot programs similar to Maine’s. Despite the thoroughness and high quality of PPPs, it will be more important than ever to remind policymakers that, like many practice guidelines, PPPs are not intended to “… be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the best results.”

As mentioned earlier, the federal government through the AHCPR has been developing and disseminating practice guidelines that, theoretically, could serve as a basis for future standards to be used in medical liability claims. Six guidelines have been developed by AHCPR so far, including one on Cataract in Adults: Management of Functional Impairment (see Ophthalmology, August 1993 Supplement). The agency plans to develop 10 additional guidelines during 1994. Given the proliferation of guidelines (more than 1,300 nationwide) by this and other groups, it is essential to remember that not all guidelines can or should be recognized as having potential use in court or in risk management activities.

The current explosion of guidelines has confused and occasionally derailed risk management efforts to address medical liability problems. Guidelines not developed exclusively for medical liability problems may focus on many broad and diverse aspects of clinical practice well beyond those narrow areas that give rise to medical liability claims. This essentially was confirmed in the Maine project where officials believed that the guidelines, intended in part for liability problems, had to be easy for physicians to use and to demonstrate compliance. Most were only a few pages long and were targeted to define problems or treatments.

Can Practice Guidelines Affect Liability Claims?

The vast majority of Maine physicians from the four specialties elected to participate in the demonstration project despite concern by some insurance officials that liability would increase if plaintiffs eventually were permitted to use the guidelines in court. According to the GAO, most doctors who agreed to participate believed the guidelines were reasonable and merely reflected the way they already were practicing. Others believed the project would reduce claims and ultimately the cost of premiums. Given recent predictions reported in American Medical News that premiums could climb 5% to 15% during the coming year, experimenting with these nontraditional reforms may be well worth a second look by all specialties.

The Physician Insurers Association of America (PIAA), an organization of the country’s major doctor-owned professional liability carriers, including OMIC, recently declared its support of pilot projects that test practice guidelines, provided they are not put into effect on a broader basis until proven to be worthwhile. The organization believes the federal role should be limited to studying projects under way.

As of September 1993, the GAO could find no examples of the Maine guidelines having affected malpractice litigation in the state. Defense attorneys, however, suggest that the guidelines most likely will impact the state’s pretrial screening process. Specifically, if the independent panel required in Maine to initially review all malpractice claims determines that the defendant physician followed a practice guideline, this might discourage the plaintiff attorney from taking the case to trial.

Needless to say, practice guidelines as applied to medical liability claims raise the specter of “cookbook medicine.” Arguments against the development and use of such guidelines include:

1. Plaintiff lawyers might use the writtenstandards to sue more physicians.
2. The guidelines are inflexible and fail to address the unique clinical circumstances of each case.
3. Medicine has done fine so far without formal practice guidelines.

In defense of guidelines for potential use in litigation, the following should be considered:

1. In OMIC’s six-year history involving more than 400 claims, there has not been a successful attempt by a plaintiff to introduce an Academy PPP or similar guideline at trial.
2. Guidelines that are carefully crafted for liability control purposes generally will allow for appropriate deviations and exceptions to preserve the physician’s right to render care in the best interests of the patient.
3. Careful development of consensus-based guidelines for potential use by physicians in defending liability claims may reduce certain types of recurring preventable mishaps and eliminate the proliferation of profiteering medical experts.

For more information on the Maine Liability Demonstration Project, write the U.S. General Accounting Office, P.O. Box 6015, Gaithersburg, MD 20884-6015, and ask for publication GAO/HRD-94-8 Medical Malpractice: Maine’s Practice Guidelines.