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Guidelines from malpractice insurers?

New protocols designed to counter lawsuits from 'errors in diagnosis'

From the November 1998 ACP-ASIM Observer, copyright 1998 by the American College of Physicians-American Society of Internal Medicine.

By Phyllis Maguire

When the 36-year-old daughter of Pensacola, Fla., internist K. Inge Holman, ACP-ASIM Member, discovered a breast mass late last June, she immediately phoned her primary care physician. "She was told her doctor would see her in August," Dr. Holman recalled. "I called a hospital near her to arrange a mammogram and ultrasound, but she still couldn't find a physician."

To prevent further delay, Dr. Holman's daughter traveled from her home in Alabama to Pensacola, where one of her father's colleagues performed a breast biopsy in early July. The mass proved to be benign but, as Dr. Holman pointed out, "It was a frightening example of how complacent some primary care physicians can be in not pursuing diagnoses."

It also illustrates the risk that some physicians are taking when it comes to patient care. Failure-to-diagnose cases now represent one-fifth of all negligence claims and lawsuits, a figure that has been on the rise for the past decade, according to the Physician Insurers Association of America (PIAA), a trade association of physician-owned malpractice carriers. And according to data from the National Practitioner Data Bank Research File, the number of delayed-diagnosis settlements jumped more than 16% between 1993 and 1994, with median payments for those suits rising more than 21% the following year.

Just as significantly, the type of physicians being targeted by delayed-diagnosis claims has changed. While claims for missed and delayed diagnoses were once the province of specialists, primary care physicians—and particularly internists—are increasingly being singled out. According to data PIAA issued last June, "errors in diagnosis" are not only the leading cause of malpractice claims against internists, but they also bring the highest average payout of any claim category, weighing in at more than $178,000 per judgment or settlement. (PIAA classifies "errors in diagnosis" as both the failure to diagnose and delayed diagnoses.)

As a result, malpractice insurers are stepping up their risk management efforts. Most continue to educate physicians through risk management seminars and videos, and many offer financial incentives to encourage physicians to adopt risk management techniques. Yet a few are working directly with physicians to create clinical guidelines to help doctors avoid delayed-diagnosis claims altogether.

One malpractice insurer, the Bedford Hills, N.Y.-based Frontier HealthCare, has collaborated since 1995 with the Florida Society of Internal Medicine to draft protocols to help prevent missed diagnoses. The result is the Early Diagnosis Project, which has issued three clinical guidelines since 1996 that combine clinical protocols with risk management material. In creating the guidelines, Frontier targeted the three conditions that represent well over half of all failure-to-diagnose claims against primary care physicians: breast abnormalities, colorectal conditions, and unstable angina and acute myocardial infarction.

Working with physicians

The idea of malpractice insurers leading an effort to create and distribute clinical guidelines may sound suspect to physicians wary of pressure from health plans, but Frontier officials are quick to point out that physicians were responsible for all of the guidelines' clinical content. Gary Machnowski, Frontier's senior risk management coordinator, said that Frontier, which insures about 12,000 physicians nationwide, shouldered the administrative costs of the Early Diagnosis Project and provided risk management input. The protocols themselves, however, were developed by a volunteer group of physicians, whose steering committee was chaired by Dr. Holman.

Dr. Holman noted that when FSIM physicians were approached by Frontier in 1995 about the possibility of developing guidelines, they were eager to take an active role. "Many of us felt that, as physicians, we'd dropped the ball in letting people do things for us," he said. Particularly in an age of managed care directives, he continued, "doing things for physicians ends up doing things to us."

Like other clinical guidelines, the Early Diagnosis Project protocols were designed to be used during patient examination and evaluation. What is unique about these algorithms, however, is that each is part of a packet that also includes patient handouts that discuss different symptoms and describe various diagnostic procedures; samples for physicians of how to document both the examination and follow-up visit; suggestions on how to create flow sheets to indicate dates for screening procedures and tickler systems to track diagnostic reports and appointments; and an analysis of why physicians get sued.

One section in the breast abnormality booklet, for example, reminds physicians of the high rate of false negatives for clinical breast examinations and advises them to order mammograms, even in cases of unremarkable physical examinations. In addition, language throughout the booklet emphasizes that physicians must stress to patients the importance of follow-up care and screening examinations.

Family physician George D. Harris, MD, chairman of the breast abnormalities guideline task force, uses the Early Diagnosis Project guidelines in his practice. While he said that the clinical guidelines have helped him avoid unnecessary testing, the patient handouts have improved vital communications. "Patients may not recall all that I explain to them in the office, so the handouts reinforce my comments," Dr. Harris said.

Changing roles

The collaboration between an insurance company and a physician group is so novel that several clinical guideline experts contacted for this article didn't feel comfortable talking about the marriage between clinical algorithms and risk management. "Insurers make risk management recommendations, but issuing guidelines is unusual," said Lori Bartholomew, PIAA's director of loss prevention and research. "Insurance companies believe it is the job of hospitals, practices and medical societies to provide that kind of guidance."

A new concept in risk management, the use of guidelines "has had its controversies," acknowledged Edward E. Bartlett, PhD, a Rockville, Md.-based risk management consultant and the coordinator of the Early Diagnosis Project. "But the idea that risk management must go beyond documentation procedures is becoming more accepted. We need to look at the clinical issues that lead to lawsuits."

Frontier got involved because its Florida physicians had the highest number of failure-to-diagnose claims among the company's other physician clients at the time. "When we first started insuring family physicians and internists, they were a relatively benign class of doctors as far as failure to diagnose," said Frontier's Mr. Machnowski. "But changes in health care have put internists at the forefront."

As primary care physicians have been thrust into the gatekeeper role, analysts say, they are increasingly finding themselves in the malpractice hot seat. Another factor contributing to the rise in claims is unrealistic patient expectations, according to Dr. Holman. "One consequence of our efforts to encourage women to get mammograms is that the public now believes no one dies of breast cancer if it is diagnosed early enough, which is a huge falsehood," he said. "But that's the perception we're up against, along with the mistaken assumption that breast examinations are something internists don't need to do."

An even bigger misconception among physicians is the belief that failure to diagnose is a specialists' problem. "When a specialist is sued now for failure to diagnose, the primary care physician who referred the patient in the first place is almost always named as co-defendant," said PIAA's Ms. Bartholomew. "Often, a primary care physician first learns about a condition in a patient he or she referred when legal papers against the physician are served."

And misconceptions can lead to mistakes. "We see physician denial too often in failure to diagnose," said Margaret Douglass, RN, director of risk management at Florida Physician Insurance Company (FPIC), a physician-owned insurer that is working with Frontier to disseminate the project's guidelines. "In breast abnormality claims, physicians repeatedly dismiss a woman's concerns by saying she is too young to have breast cancer. Or we find emergency departments just giving patients with terrible mid-chest discomfort a GI cocktail." In some instances, as was the case with Dr. Holman's daughter, physicians simply miss crucial opportunities to examine patients, which can result in malpractice claims.

Guidance

Even though primary care physicians are being held increasingly accountable, few clinical protocols offer guidance. "Most clinical guidelines address disease management issues—how to treat high blood pressure, for example—but very little out there targets diagnosis in the primary care setting," explained Dr. Bartlett. "That's what we looked for."

The booklets in which the guidelines are packaged are strongly slanted toward risk management. "As part of our chest pain protocol, for example, we include guidelines for the front office staff on how to react to patients' phone calls," Dr. Holman said. "That is the type of problem other clinical guidelines elude to but don't adequately address."

But the project is an anomaly. Analysts claim that professional organizations have recently neglected their role in risk management, in part because they are struggling to address physicians' problems with managed care. "Medical organizations are more concerned now with 'survival' issues of managed care and the economic problems affecting their members," said Kenneth Heland, JD, chairman of the Board of Directors of the AMA/Specialty Society Medical Liability Project. "The individual doctor may no longer have access to the experts or research that can provide liability guidance. This could ultimately result in another malpractice crisis."

Because of competition among malpractice insurers, some companies are backing away from mandating physician attendance at risk management meetings, while others are considering reducing the premium credits they give to physicians who participate in risk management activities. Yet two states—Texas and Florida—now mandate risk management programs for insurers selling malpractice policies in those states. And while it is true that there are parts of the country where physicians don't have access to enough risk management programs, other parts of the country such as the Washington, D.C., area "are saturated," said PIAA's Ms. Bartholomew.

"Some of the local risk managers I work with here have programs at hospitals almost constantly," she said. In addition to standard risk management seminars, risk managers are using newsletters, Web sites and video productions to get their message out to their physician clients. Both Frontier and FPIC distribute the Early Diagnosis guidelines to their insured physicians and to managed care companies that send them to their physician networks. The guidelines are also available over the Internet.

Doctor acceptance

One risk management pioneer is Copic Insurance Co. of Englewood, Colo., a physician-owned carrier that insures 80% of Colorado physicians. While the insurer does not create clinical guidelines, it has issued nine different risk management guidelines since 1986 for primary care and specialty physicians. Copic requires physicians to comply with those guidelines in order to receive coverage and has them re-sign compliance agreements when they renew their policies every year.

According to George O. Thomasson, MD, Copic's vice president for medical risk management, many insurance companies are reluctant to issue risk management guidelines, fearing that doctors will be angered by them and take their insurance business elsewhere. "But that hasn't been our experience," he said. "Our doctors appreciate having an agreed-upon standard when it comes time to evaluate questionable situations."

One of Copic's insured physicians is Frederic W. Platt, FACP, a Denver internist who has taught Copic-sponsored communications workshops. Far from dictating to doctors how to practice medicine, Dr. Platt said, Copic's guidelines typically reflect standard medical care. "The guidelines are very sensible, but they do remind me to act sooner rather than later and to err on the side of looking more, instead of less."

Copic backs up its guidelines with an ongoing series of risk management seminars; although attendance isn't mandatory, premium discounts are given for physician as well as office staff participation. And Copic also makes office visits. For the last eight years, its representatives have been visiting each of their insured physician offices, "making sure all those things we holler about in seminars, like record legibility and the documentation of problem statements, are being implemented," Dr. Thomasson said. "Over the years, we've seen significant improvement and identified those practices that are struggling."

Copic's risk management efforts have paid off. The Colorado insurer has seen its increases in claims frequency and severity rank below national rates and its insurance costs have also remained relatively stable over the last five years. It is too soon for Frontier, however, to gauge whether its dissemination of early diagnosis guidelines has had any impact on its frequency of delayed-diagnosis claims.

Unlike Copic, neither Frontier nor FPIC penalize their insured physicians who choose not to use the guidelines, in part because they don't want the guidelines used against physicians in court. "We emphasize that the guidelines are meant to be adapted based on clinical judgment, and that we're not setting up a standard of care," Dr. Bartlett said. "We don't want the protocol to be held up by a plaintiff's attorney as a way to find a doctor guilty of negligence."

For now, however, one measure of the Early Diagnosis Project's success is the fact that the Florida Academy of Family Physicians has endorsed its guidelines. One dozen managed care companies have also sent them out to their physicians. "The HMOs have been quite eager," said Dr. Holman, who takes a pragmatic approach. "As health plans begin to lose their immunity to lawsuits, they need tools to help direct their doctors."

According to Dr. Holman, physician acceptance of the Early Diagnosis Project guidelines follows a "bell-shaped curve. Many see the guidelines and begin to use them; others like them but ignore them while still others, when you say the word 'guideline,' immediately refuse to listen. Guidelines are exactly what we learned in medical school; all we've done is put them down on paper to give physicians a chance to stay out of trouble."

The question is whether physicians can learn to change their ways before that trouble catches up with them. While fairly few physicians actually are found guilty of malpractice—figures from Massachusetts, for example, show that only 5.14% of the state's internists have suffered a malpractice judgment in the last 10 years—many more physicians are dragged through the malpractice process, since, according to Ms. Bartholomew from PIAA, 70% of all malpractice claims close without a payment.

"Sitting down in a deposition to defend a standard of care is very difficult," Ms. Bartholomew said. "It leads physicians to consider how to change their clinical practice to never get into that situation again."


Tips for making the diagnosis—and avoiding a lawsuit

How can you avoid diagnostic errors—and a potential lawsuit? Malpractice experts advise physicians to recognize the clinical conditions and patient personalities that are most likely to produce legal trouble.

"Most doctors operate under the impression that they are at equal risk for every potential diagnosis, but they're not," said George O. Thomasson, MD, vice president for medical risk management at Copic Insurance Co. "That's what risk management is all about."

The Colorado insurer suggests that doctors identify those conditions that account for 80% of the malpractice claims in their specialty. For internists, that short list includes failure to diagnose cancers, failure to diagnose acute myocardial infarction, failure to get informed consent for organ biopsies and medication errors.

Physicians also need to be able to recognize those patients who are likely to sue. According to Dr. Thomasson, people who are generally unhappy and patients who have adverse outcomes are the most predisposed to lawsuits. The worst combination, he warned, is the unhappy person who experiences an adverse outcome.

Here are some other tips:

  • Maintain comprehensive records for those patients for whom a potential diagnostic problem is a concern. "Much of the diagnostic process takes place in doctors' heads," said Dr. Thomasson, "but we write down only our final choice, not a description of the entire process. That's where questions come in. Three years after an adverse outcome, even doctors can't decipher their own hieroglyphics, so they have real problems sounding credible." To be safe, note in the record all the diagnoses you considered, along with your reasons for excluding them.
  • Because lawyers will try to establish that any presumed delay was the physician's fault, be sure to indicate any delays caused by the patient. Those include a patient's reluctance to follow up, for instance, or a pattern of missed appointments. Be sure to indicate also any financial constraints that delayed follow-up care.
  • During the diagnostic process, "pursue your hunches," said Lori Bartholomew, director of loss prevention and research for Physician Insurers Association of America. "Rule out different diagnoses by repeatedly asking the patient additional questions." Insist on repeat tests when faced with bad film resolution or equivocal results.
  • Be aware that procedural errors such as misfiled reports or phone calls not made to patients with unusual findings often cause diagnostic delays. "You must have a good, clean mechanism for follow-through and to make sure patients get the tests that are indicated," Ms. Bartholomew said. "That would save a lot of cancer claims."
  • Consider changing your office manner. "In an effort to reassure patients, doctors sometimes don't express the urgency that's needed," said Gary Machnowski, senior risk management coordinator for Frontier HealthCare. "It's very easy for patients to ignore symptoms if they get the impression their doctor doesn't think it's anything serious. Make sure you don't reassure patients away from following up on their own care."

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