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  Vol. 9 No. 1, January 2000 TABLE OF CONTENTS
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Continuity of Care, Informed Consent, and Fiduciary Responsibilities in For-Profit Managed Care Systems

Warren Lee Holleman, PhD; Marsha Cline Holleman, MD, MPH; Julie Graves Moy, MD, MPH

Arch Fam Med. 2000;9:21-25.

ABSTRACT

The replacement of fee-for-service systems by managed care systems offers opportunities for cutting medical costs, integrating health care delivery systems, and improving communication among physicians. Before these benefits can be realized, however, a number of problems must be addressed. First, managed care systems must find ways to foster continuity of care in a market that has thus far proved unstable. Second, managed care systems must find ways to protect the patient's right to fully informed consent even while educating patients about the importance of cost-effectiveness and why certain treatments might not be included in their health plan. Third, managed care systems must find ways to promote physicians' fiduciary responsibilities to patients and to respect physicians' clinical judgments even while creating legitimate incentives to provide cost-effective health care.



INTRODUCTION
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Many primary care physicians now work as providers for managed health care delivery systems, the largest sector of which are the for-profit health maintenance organizations (HMOs). While primary care physicians have benefitted financially from the managed care revolution, many have expressed discomfort in capitulating to these changes. What bothers them most is instability and uncertainty of the managed care marketplace, the extensive paperwork, the loss of professional autonomy, and the interference of third parties in the physician-patient relationship.1-6

Specialist physicians lodge similar complaints about managed care,1-3 and also worry about the loss of income, prestige, and power due to "the increasing role of primary care physicians in controlling the total health care services of their patients."6(p329) Gatekeeping is a powerful metaphor, fraught with images of trolls guarding bridges and armed guards restricting passage to private clubs and communities. In an essay published in numerous newspapers nationwide, 2 leading specialist physicians spoke in near-apocalyptic terms, referring to managed care's "disastrous" impact on "Academic Health Centers of Excellence," the exploitation of patients who "literally become captives of the organization," and the "grave consequences for the quality of health care. . . and for the long-term integrity of the medical profession."7

Some of the concerns expressed by both primary physicians and specialists reflect thinly veiled self-interest, but they also reflect legitimate ethical concerns. In this article, we focus on 3 troublesome areas that primary care physicians are struggling to address in the managed care setting: continuity of care, informed consent, and fiduciary relationships.


ETHICAL CONCERNS
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Continuity of Care

Case 1 involves a female instructor of computer science at a local community college who has hypertension, menometrorrhagia, and unexplained recurrent chest pain. Her employer has changed managed care plans 4 times in the last 5 years. Her long-time physician had managed to enroll himself in 2 of the plans but for the last 2 plans the physician panel was closed to new physicians. This has forced the patient to find 2 new physicians in the last 2 years, chosen from a list of strangers to her, with whom she has had neither the time nor the inclination to develop a strong relationship. Because of the change in physicians, she has undergone multiple procedures, including endometrial biopsy 3 times and cardiac catheterization twice, procedures that her long-time physician believed were unnecessary to repeat. She has lost confidence in her health care and her physicians and worries that if she were to become seriously ill, no one would know her well enough to provide high-quality care.

Do the physician's duties to the patient end when the patient is switched from one health plan to another? How diligently should the physician try to maintain the physician-patient relationship with patients who are involuntarily removed from their plan? What should physicians as a group do to advocate for greater stability, longer continuity of care, and better coordination of care? How essential are continuity of care and coordination of care to the ethical principle of beneficence?

Case 1 is troubling for a number of reasons, not the least of which is that it, like the cases that follow, actually happened. The efforts of physician and patient to cultivate a successful therapeutic relationship—so important in chronic illness—were undermined by a series of business decisions viewing money, not health, as the bottom line. While it is understandable that an occasional change might be justified to achieve significant savings, in this case, change has occurred so frequently as to negate the very purpose of the plan: to provide good health care. As a result of these changes the patient has been inconvenienced, exposed to greater iatrogenic risks of testing and retesting, denied access to a longitudinal relationship with a physician, and has lost confidence and motivation.

The ethical principle of beneficence suggests that physicians ought to encourage employers and managed care systems to curb practices that adversely affect patient health and satisfaction.8 One such practice is the way many employers and managed care systems move groups of patients from one provider to another for marginal savings.9-10 As many studies have shown, however, discontinuous care is ineffective care.11 Another problematic area involves the consultation process. A recent study of communication within managed care systems compared with nonmanaged care systems indicated higher rates of referral to unknown specialists and lower rates of communication between generalists and specialists.12 These barriers to communication might be reduced by creating better integrated delivery systems and more effective information systems.5

Some managed care systems have applied their organizational and technological expertise toward improving continuity of care and coordination of care, but problems persist in many organizations. When they persist, the managed care systems fail not only to provide beneficent care but also, because of poor coordination, continuity, and communication, the patient might experience iatrogenic harms. Thus, the system fails to provide nonmaleficent care as well.

Informed Consent

Case 2 involves a 35-year-old unemployed man whose medical care is covered by his wife's managed care plan. He has been treated for schizophrenia by traditional neuroleptic agents with moderate success. Upon consultation with a psychiatrist and a review of the literature, the family physician believes his symptoms will be improved by an expensive new drug that requires frequent laboratory monitoring. The physician inquires and discovers that the new drug is not included in the insurance plan's formulary. The utilization reviewer at the insurance company reminds the physician that if she tells the patient about the new drug the insurance company will stop all payment for any treatment for this patient and might remove the physician from the plan. Angry and incredulous, the physician checks her contract and finds clauses to this effect in the fine print.

Does the patient's right to informed consent entail an obligation on the part of the physician to disclose all legitimate treatments, regardless of whether they are covered by the plan? Does signing a gag order forbidding such disclosure exempt the physician from this responsibility? If the physician believes the plan does not serve the patient's needs, should the physician convey this concern to the patient? If the plan contains financial disincentives to treat and other conflicts of interest that might adversely affect the quality of the patient's care, does the patient's right to informed consent imply a duty of the physician to convey such information?

Traditionally, the right to informed consent has included the right of patients to be told the nature of the illness, the prognosis, the benefits, risks, and side effects of tests and treatments, including legitimate alternative treatments as well as nontreatment.13 Withholding information about a beneficial treatment such as a new neuroleptic agent with reduced side effects violates a fundamental right of the patient. It is the physician's duty to protect this right. Patients who make decisions without adequate information are giving mere consent rather than a truly informed consent.

Contrary to a common misconception, the requirements of informed consent are not met by having the patient sign a paper authorizing a test or treatment. Informed consent refers to the educational and decision-making process that precedes the signing of the document. The signed document is merely a way of recording that the conversation occurred and that the decision was voluntary. Thus, any policy forbidding physicians to talk with patients about alternative treatments violates the patient's right to informed consent.14

In the absence of such gag orders, some physicians will still withhold such information. In fee-for-service systems, physicians had incentives to provide incomplete information to promote services in which the physician had a financial interest. In many managed care systems, physicians have financial incentives to undertreat. In both systems, physicians withhold information because of paternalistic attitudes, the desire to save time, and affiliations with drug companies. Not only do such practices violate a fundamental patient right,15 but they also violate the fundamental nature of medicine: a patient goes to the physician for the physician's expertise, and to limit the information undermines the whole basis for the interaction.

Because gag orders violate the fundamental nature of the clinical encounter, and because they violate the patient's right of informed consent to treatment, many states have outlawed one or more of their forms. As of August 1997, 36 states had passed laws restricting the rights of managed care companies to require physicians to sign gag orders.5

Over the years, managed care companies have instituted 3 types of gag clauses.5 One type forbids physicians from disclosing to patients information about treatments not covered by the plan. A second type prohibits physicians from disclosing any other specific limitations of the plan. A third type forbids physicians from making any negative general comments about the plan. The most common type of gag clause is the first. Prior to the new laws, this type of gag order was present in nearly every physician contract.16 Managed care companies point out that physicians have rarely been censored for violating these clauses, but the severity of the potential punishment serves as a powerful deterrent and interferes with physician-patient communication and quality of patient care.

It is our contention that inattention to gaining a truly informed consent will continue even if all forms of gag orders are outlawed. Gag orders are merely a symptom of a deeper problem, a problem that pervades not only managed care systems but also fee-for-service and many public health care systems. A business climate in which physicians are constantly pressured to cut costs has become a part of the clinical ethos. It has become difficult to justify taking the time to do something as fundamental as discussing an important decision with a patient.

We believe that the practice of medicine should not be reduced to a business transaction governed by the market principles of supply and demand, and caveat emptor: let the buyer beware.17 Free market models work best when producers and consumers have equal knowledge. Physicians are professionals who are sought out for their knowledge. Professionals have fiduciary responsibilities to their clients, and one such responsibility is the duty to educate patients about their choices so that they can give a properly informed consent to treatment.18-19

Such information should be given not simply to protect the patient but to empower him or her to make the best use of the available options. More controversial is the question of how much to tell patients who do not ask or who do not want to know: at a minimum, physicians and managed care companies have a duty to assure that patients have been given a general understanding of how the system of incentives and disincentives works.

Beyond the ethical duty, some states are imposing legal duties on insurance companies to disclose to patients information regarding benefits, provisions, and restrictions of managed care plans to prospective enrollees, as well as criteria for selection of providers in the plan. In some states physicians are also being accorded some protection, as insurance companies are being required to disclose to physicians criteria for selection and termination of providers, criteria for the makeup of the plan's network, and, in the case of physicians terminated from the plan, the reasons for termination and an opportunity for appeal. Patient Protection Acts, whose purpose is to require managed care organizations to disclose to patients the benefits and limitations of their plan, have been passed in several states and legislation is pending in many others.20 A new Texas law allows plaintiffs in medical malpractice suits to name managed care companies along with physicians and other defendants.21

Fiduciary Responsibilities

Case 3 involves a woman who presented to her family physician with newly diagnosed type 2 diabetes mellitus and hyperlipidemia. In the past 2 years she had gained 11 kg as a result of relocating from Europe, where she had walked to work, stores, and church, to the United States, where she drives to these places and to fast food restaurants as well. Recognizing that the standard of care for diabetes treatment includes lifestyle modifications22 but that patients often require structured programs to effect these changes, her physician attempted to enroll her in a diabetes education program. The program meets monthly over the course of 1 year and includes education about the disease as well as instruction and follow-up on exercise and weight loss. Her physician knew that these modalities have outcome-based evidence to support their use in the treatment of diabetes mellitus23-29 and that the patient's managed care plan offered no alternative. The physician submitted a request to the patient's managed care company and after 2 weeks the request was denied. The physician decided to pursue the request, believing that the key to controlling the patient's chronic disease was weight loss and that future health costs could be reduced significantly by enrollment in the program. An additional written request and telephone call by both physician and patient failed, however, to secure coverage by the managed care company for the recommended program.

Does the physician's fiduciary responsibility to her patients require that the physician go this far in advocating the legitimate needs of the patient? Does it require that she go further? If further appeals failed, could this physician continue to practice with integrity in this managed care plan?

There has been considerable discussion, but little consensus, as to the physician's fiduciary responsibility to patients in the managed care setting. In some cases the patient insists on a frivolous test or treatment. In other cases the patient needs a legitimate service, such as mammography, physical therapy, mental health referral, or medications, but the service is not available in the managed care plan. In some cases the patient can pay out of pocket, but often the patient cannot do this without shifting resources away from some other area of need.

We believe that physicians working in managed care must maintain a fiduciary relationship with their patients, albeit in a qualified way, as La Puma10 has suggested by his use of the term "proportional advocacy." In the past, under the guise of "patient advocacy," "fiduciary obligation," and the ethical principle of beneficence, some physicians lavished marginally beneficial or unproven benefits on patients. In such situations, the real beneficiaries included the physicians themselves, whose incomes increased in proportion to "benefits" provided patients. Managed care has evolved largely in response to this freewheeling, unstructured system, and it has the potential to steer us back on course.

Unfortunately, some managed care systems have overcompensated by throwing out real benefits along with marginal ones. Consider the case of an adult with somatic symptoms and frequent office visits whose underlying problem involves childhood sexual abuse. Psychotherapy might successfully address her problems but such treatment is not covered by her plan, even though such treatment could reduce overall costs by reducing medical visits, tests, and procedures. Or consider the patient with lumbar disk disease and recurrent pain who requires physical therapy to avoid surgery but has already received his lifetime quota of physical therapy sessions for this diagnosis.

Between overtreatment and undertreatment there is a middle way. The physician's duty to the patient is to provide care that meets the following 2 criteria. First, it must have been shown to help others in a similar condition, or it must fall within the standard of care. Second, provision of this care should not preclude treatment of other patients with a significantly greater likelihood of benefit. When patients demand tests or treatments with no proven clinical benefits, physicians should decline, not because the test or treatment is not covered by the plan, but because it does not meet the criteria of beneficence and justice stated above, and because patient autonomy should never be allowed to override physician integrity.30 On the other hand, when a managed plan fails to provide a test or treatment supported by evidence-based medicine, such as certain mental health needs, physical therapy, or, according to some review panels, mammography of a 45-year-old woman, the physician's fiduciary obligations require advocacy on behalf of the patient, both to meet the patient's need and to change institutional policy. This duty must of course be balanced with the civic duty to conserve scarce medical resources for the sake of patients most likely to benefit from them.31-32

It is the responsibility of the physician to determine whether an intervention is appropriate, but the administrative offices of managed care companies have intruded on this process. In the past, indemnity insurance companies and Medicare and Medicaid policy makers did the same thing, but not as extensively. To shift the decision-making responsibility to bureaucrats, even if they are physicians, takes the authority out of the hand of the one most qualified to decide, the physician with firsthand knowledge of the patient. The concerns become predominantly financial rather than clinical, aggregate without regard to individual variances. The unique nature of each patient's experience of illness is ignored, along with the need to provide care accordingly.

Most managed care companies allow physicians to appeal on behalf of patients for tests and treatments not covered by the plan, and many physicians report that this process works effectively. Many others, however, report frustration at the degree of paperwork, the time spent playing "telephone tag," and the intrusion on the physician-patient relationship. Such a process has become known as rationing by exhaustion. The "hassle factor," not clinical judgment, often becomes the basis for whether a patient receives a particular test or treatment.

Who benefits from rationing by exhaustion? To the extent that rationing by exhaustion encourages cost-effective medicine, prevents resources from being wasted on patients who do not need them, and enables them to be available for those who do, then patients are the beneficiaries. But when the appeals process is so time-consuming that physicians are deterred from making legitimate appeals, or so clinically flawed that such appeals are routinely rejected, the one who stands to lose is the patient, as well as the conscientious physician who wants to do what is best for the patient. Such is the situation in case 3. The patient was not denied "inappropriate" health care so that other patients with more serious problems could receive appropriate care. She was denied appropriate care so that her HMO could stockpile inappropriate amounts of cash, so that executives of her HMO could be paid inappropriately high salaries, and so that the stockholders could become wealthy.33-34 We do not mean to suggest that all HMO profits result from denial of appropriate care. Our concern is that control of costs—and, frankly, greed—sometimes gains preeminence over quality of care.


RECOMMENDATIONS
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More research, reflection, and action are needed to define precisely the fiduciary responsibilities of physicians to patients in managed care settings. Such an effort will require tracing the historical development of the fiduciary professional-client relation, comparing the physician-patient relation to other professional relationships, identifying the extent to which the fiduciary relationship was truly fiduciary in the fee-for-service system, and developing guidelines for maintaining the most beneficial aspects of that relation in the managed care setting. Information about outcome-based treatments will be essential to this process. The business ethics literature should also prove useful. Such an effort will require a better understanding of the role of continuity of care, coordination of care, and colleagiality among the network of physicians, nurses, and staff involved in the care of the patient. One practical reform would be to make public the rules of the appeals process in each managed care organization.

More reflection is also needed to redefine the requirements of informed consent in managed care. To what information are patients entitled under current standards of informed consent? How can we maintain the spirit of these standards in managed care settings? To what extent should patients as consumers of medical services be responsible for gathering and interpreting medical and financial information themselves? Answers to these questions will serve as the basis for meeting the legal and ethical requirements of informed consent in the managed care setting.

Most important, perhaps, is the need to develop better ways to assure continuity of care and coordination of care in managed care systems. Such an effort must begin by appraising the extent to which medical care has become fractionalized in the techno-specialist era of medicine35 and the impact of the managed care revolution on continuity of care and coordination of care. Who is responsible—HMO policies, employers, specialist physicians, generalist physicians—for the disruption of continuity when patients move from one managed plan to another? How does this fractionalization affect quality of care? What can be done to encourage greater attention to continuity of care and coordination of care? Certainly family physicians can advocate for state and federal legislation to make it easier for patients to maintain long-term relationships with their physicians.

Managed care systems have the potential to correct many of the deficiencies of the fee-for-service system, most notably: the inability of that system to discipline itself to practice cost-effective medicine; the exclusion of large sectors of the population based on inability to pay; the incentive to overtreat; the failure to inform patients about conflicts of interest and financial incentives to overtreat; and the development of an expensive, disjointed specialist-dominated system. But such improvements by managed care systems will provide only marginal benefits unless they can learn how to be cost-effective without themselves sacrificing fiduciary responsibilities, informed consent, and continuity of care.


AUTHOR INFORMATION
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Accepted for publication January 4, 1999.

William T. Close, MD, offered numerous suggestions for improving the manuscript. Caroline M. Kosnik, MLIS, provided assistance in research.

Corresponding author: Warren L. Holleman, PhD, Baylor Family Practice Center, 5510 Greenbriar, Houston, TX 77005.

From the Department of Family and Community Medicine and the Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Tex (Dr W. Holleman); the Department of Family Practice and Community Medicine, University of Texas–Houston Health Science Center (Dr M. Holleman); and the Department of Family and Community Medicine, Texas A&M University School of Medicine, College Station, Tex (Dr Moy).


REFERENCES
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1. Lewis CE, Prout DM, Chalmers EP, Leake B. How satisfying is the practice of internal medicine? a national survey. Ann Intern Med. 1991;114:1-5.
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4. Emmanuel EJ, Dubler NN. Preserving the physician-patient relationship in the era of managed care. JAMA. 1995;273:323-329. FREE FULL TEXT
5. Miller TE. Managed care regulation: in the laboratory of the states. JAMA. 1997;278:1102-1109. FREE FULL TEXT
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7. DeBakey ME, Anlyan WG. Managed care puts us all at risk. Houston Chronicle. June 18, 1995:1C, 4C.
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9. Emanuel EJ, Brett AS. Managed competition and the patient-physician relationship. N Engl J Med. 1993;329:879-882. FREE FULL TEXT
10. LaPuma J. Anticipated changes in the doctor-patient relationship in the managed care and managed competition of the Health Security Act of 1993. Arch Fam Med. 1994;3:665-671. FREE FULL TEXT
11. Bowman MA, Nicklin DE. New developments in family medicine. JAMA. 1998;279:1437-1438. FREE FULL TEXT
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13. Holleman WL. Medical ethics. In: Mengel MB, Holleman WL, eds. Fundamentals of Clinical Practice: A Textbook on the Patient, Doctor, and Society. New York, NY: Plenum Medical Book Co; 1997:271-295.
14. Moy JG. Informed consent. In: Pfenninger JL, Fowler GC, eds. Procedures for Primary Care Physicians. St Louis, Mo: Mosby; 1994:1071-1075.
15. American Hospital Association. A patient's bill of rights. In: Brody BA, Engelhardt HT Jr, eds. Bioethics: Readings & Cases. Englewood Cliffs, NJ: Prentice-Hall; 1987:388-389.
16. Wynn P. When your plan tells you what not to say. Managed Care. June 1995:33-34.
17. McArthur JH, Moore FH. The two cultures and the health care revolution: commerce and professionalism in medical care. JAMA. 1997;277:985-989. FREE FULL TEXT
18. Clancy CM, Brody H. Managed care: Jekyll or Hyde? JAMA. 1995;273:338-339. FREE FULL TEXT
19. Rodwin MA. Conflicts in managed care. N Engl J Med. 1995;332:604-606. FREE FULL TEXT
20. Division of State Legislation, American Medical Association. Special Report: Update—State PPA Activities. Chicago, Ill: American Medical Association; May 1995.
21. Tex Civil Practice Remedies Code. §1, Title IV, ch 88.
22. Lebovitz HE, Lipsky MS. Management of Type II Diabetes Mellitus. Kansas City, Mo: American Family Physician; 1995. Monograph No. 1.
23. Kerr CP. Improving outcome in diabetes: a review of the outpatient care of NIDDM patients. J Fam Pract. 1995;40:63-75. ISI | PUBMED
24. Kriska AM, LaPorte RE, Patrick SL, Kuller LH, Orchard TJ. The association of physical activity and diabetic complications in individuals with insulin-dependent diabetes mellitus: the epidemiology of diabetes complications study–VII. J Clin Epidemiol. 1991;44:1207-1214. FULL TEXT | ISI | PUBMED
25. Lean MEJ, Powrie JK, Anderson AS, Garthwaite PH. Obesity, weight loss, and prognosis in type 2 diabetes. Diabetic Med. 1990;7:228-233. ISI | PUBMED
26. Beresford SAA, Farmer EMZ, Feingold L, Graves KL. Evaluation of a self-help dietary intervention in a primary care setting. Am J Public Health. 1992;82:79-84. FREE FULL TEXT
27. Schapira DV, Lyman GH, Kumar NB, Baile WF. The effect of duration of intervention and locus of control on dietary change. Am J Prev Med. 1991;7:341-347. PUBMED
28. Wing RR, Koeske R, Epstein LH, Nowalk MP, Gooding W, Becker D. Long-term effects of modest weight loss in type II diabetic patients. Arch Intern Med. 1987;147:1749-1753. FREE FULL TEXT
29. Devlin JT, Hirshman M, Horton ED, Horton ES. Enhanced peripheral and splanchnic insulin sensitivity in NIDDM men after a single bout of exercise. Diabetes. 1987;36:434-439. ABSTRACT
30. Doukas DJ, Fetters M, Ruffin MT, McCullough LB. Ethical considerations in the provision of controversial screening tests. Arch Fam Med. 1997;6:486-490. FREE FULL TEXT
31. Eddy DM. Rationing resources while improving quality: how to get more for less. JAMA. 1994;272:817-824. FREE FULL TEXT
32. Morreim EH. Balancing Act: The New Medical Ethics of Medicine's New Economics. Dordrecht, the Netherlands: Kluwer Academic Publishers; 1991:53.
33. Anders G. HMOs pile up billions in cash, try to decide what to do with it. Wall Street Journal. December 21, 1994:A1, A5.
34. Freudenheim M. Penny-pinching H.M.O.'s showed their generosity in executive paychecks. New York Times. April 11, 1995:C1, C4.
35. Garrison RL. The five generations of American medical revolutions. J Fam Pract. 1995;40:281-287. PUBMED

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Arch Fam Med. 2000;9(1):79-80.
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