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Apr 1, 1998 - MEDICAL LICENSURE AND SPECIALTY CERTIFICATION. IN CANADA .... Assistant Vice President, Examination and Board ...... tics in the pharmacy responsible for dispensing homeopathic and placebo remedies. The end of ...... cian's licensure and standing online, without submitting written requests to ...

CONTENTS QUOTE ..........................................................................................................................................135 INFORMATION

FOR

AUTHORS ...................................................................................................136

PRESIDENT’S MESSAGE ................................................................................................................137 EDITORIAL ....................................................................................................................................138 ALTERNATIVE MEDICINE: I MPLICATIONS COMMITTEE

ON

HEALTH CARE FRAUD ..................................................................................143

MEDICAL LICENSURE IN

CANADA

SPECIAL COMMITTEE

FOR THE

AND

AND THE

DEVELOPMENT

FOR THE

OF A

SPECIALTY CERTIFICATION

UNITED STATES ....................................................................................154

ON

MANAGED CARE.............................................................................166

PERFORMANCE–BASED TEST

OF

CLINICAL SKILLS

UNITED STATES MEDICAL LICENSING EXAMINATION ..........................................177

FEDERATION PROMOTES INTERNATIONAL COLLABORATION ................................................186 FROM OUR INTERNATIONAL EXCHANGES ..............................................................................188 FROM

OUR

MEMBER BOARD EXCHANGES ..............................................................................196

MEDICOLEGAL DECISIONS ..............................................................................................................204

FEDERATION BULLETIN: THE JOURNAL OF MEDICAL LICENSURE AND DISCIPLINE Published Continuously Since 1913 Volume 85 Number 3 1998 All articles published, including editorials, letters, and book reviews, represent the opinions of the authors and do not reflect the official policy of the Federation of State Medical Boards of the United States or the institutions or organizations with which the authors are affiliated unless clearly specified. Editor Patricia Beatty Editorial Assistant Linda F. Vernale Communications Coor dinator David Torres Editorial Committee Runette Flowers, MD 4411 Buckingham Circle Decatur, GA 30035 Robert S. Heidt, Sr, MD 2123 Auburn Avenue, Suite 624 Cincinnati, OH 45219-2906 John E. Mazuzan, Jr, MD 366 South Cove Road Burlington, VT 05401 Emanuel E. Mkrtichian, PA-C 44 Corniche Drive, #D Monarch Beach, CA 92669 Thea Graves Pellman 520 Adams Avenue West Hempstead, NY 11552 Barbara S. Schneidman, MD, MPH American Medical Association Office of Medical Education 515 North State Street Chicago, IL 60610

Treasurer: Bruce H. Hasenkamp, JD* Secretary: James R. Winn, MD Immediate Past President: Susan M. Spaulding*

Printed by The Ovid Bell Press, Inc; Fulton, Missouri. Periodicals postage paid at Fort Worth, Texas, and additional mailing offices.

Federation Board of Dir ectors Ronald C. Agresta, MD Doris C. Brooker, MD Thomas D. Kirksey, MD Bruce A. Levy, MD, JD J. William McCord, DO Rev. Daniel W. Morrissey, OP Stephen I. Schabel, MD George J. Van Komen, MD* *Executive Committee

Change of addr ess: POSTMASTER, send all address changes to Federation Bulletin: The Journal of Medical Licensure and Discipline, Federation Place, 400 Fuller Wiser Road, Suite 300, Euless, TX 76039-3855.

Subscriptions and correspondence about subscriptions should be addressed to the Federation Bulletin: The Journal of Medical Licensure and Discipline, Attention: Subscription Federation Executive Staff Department, Federation Place, 400 Executive Vice President: Fuller Wiser Road, Suite 300, Euless, James R. Winn, MD TX 76039-3855. Subscription price is Deputy Executive Vice President: $40 per year, single copy is $10. Dale L. Austin, BSN, MA Assistant Vice President, Publications, Notification of change of address should be made at least six weeks in Public Relations, and Education: advance. Enclose new and old Carol A. Clothier, BA Assistant Vice President, Examination addresses, including zip code. and Board Action Data Bank Services: For authorization to photocopy: William D. Finical, MBA Material under circumstances not Assistant Vice President, Member within fair use as defined by the Support Services: United States Copyright Law, contact Deborah Modesette, MPA the Federation of State Medical Boards Editors Emeritus of the United States, Inc. Such photoThe Federation Bulletin: The Journal Ray L. Casterline, MD copies may not be used for advertising of Medical Licensure and Discipline Dale G Breaden (ISSN 0114-9306) is published quar- or promotional purposes, for creating new collective works, or for resale. terly by the Federation of State ©Copyright 1998 The Federation Medical Boards of the United States, of State Medical Boards of the United Submissions: Manuscripts, letters to Inc, Federation Place, 400 Fuller States, Inc. the editor, and other materials to be Wiser Road, Suite 300, Euless, TX considered for publication should be 76039-3855. Telephone (817) 868Federation Of ficers addressed to Patricia Beatty, Editor, President: William H. Fleming, III, MD* 4000. Fax (817) 868-4098. Federation Bulletin: The Journal of President Elect: Alan E. Shumacher, MD* Medical Licensure and Discipline, Vice President: George C. Barrett, MD* Federation Place, 400 Fuller Wiser Road, Suite 300, Euless, TX 760393855.

IF WE ARE NOT A GREAT PEOPLE, WE MUST STRIVE IN GOOD FAITH TO PLAY A GREAT

WE CANNOT AVOID MEETING GREAT ISSUES. ALL THAT WE CAN

PART IN THE WORLD.

DETERMINE OURSELVES IS WHETHER WE SHALL MEET THEM WELL OR ILL. –Theodore Roosevelt

INFORMATION

FOR

AUTHORS

The Editorial Committee accepts original manuscripts for consideration of publication in the Federation Bulletin: The Journal of Medical Licensure and Discipline. The Bulletin is a refereed journal, and all manuscripts are reviewed by Editorial Committee members and/or appropriate consultants. (The review process takes six to eight weeks.) Manuscripts should focus on issues of medical licensure and discipline or related topics of education, examination, postgraduate training, ethics, peer review, quality assurance, and public safety. Queries and manuscripts should be sent to the attention of the Bulletin Editor, Federation of State Medical Boards, Federation Place, 400 Fuller Wiser Road, Suite 300, Euless, TX 76039-3855. Manuscripts should be prepared according to the following guidelines: 1. A cover letter should introduce the manuscript, name a corresponding author, and include full address, phone, and fax information. The letter should disclose any financial obligations or conflicts of interest related to the information to be published. 2. The title page should contain only the title of the manuscript. A separate list of all authors should include full names, degrees, titles, and affiliations. 3. The manuscript’s pages should be numbered, and text length should not exceed 5,000 words, with references and tables attached. 4. The number of references should be appropriate to the length of the text. 5. Any table or figure from another source must be referenced. Photos should be marked by label on the reverse side and up direction noted. 6. Commentary, letters to the editor, and reviews are accepted for publication. Such submissions and references should be concise and conform to the format of longer submissions. 7. A hard copy of the submission and a PC-compatible disk copy should be submitted. The word processing program and title of the appropriate file(s) should be indicated. 8. Manuscripts are reviewed in confidence. Editorial changes will be submitted to the corresponding author for approval. The original copy and disk will be returned if the submission is not accepted for publication.

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PRESIDENT’S MESSAGE The Ninth Wave – Are You Ready? It’s almost impossible to move into a new year without reflecting on past accomplishments, and moving beyond to set new goals. As a sound, strategically planned organization, the Federation believes in assessing performance and establishing both short- and long-term goals. Our goals reflect the Federation’s ongoing commitment to assist state medical boards as they assure protection of the public. Since my term began in May, Federation activities and initiatives representing that commitment include the following: The Special Committee on Professional Conduct and Ethics met to begin discussions that will eventually formulate recommendations on two levels: 1) when do behaviors constitute unprofessional conduct and 2) what can you do to alter this behavior. • The Special Committee on Evaluation of Licensure Examinations has begun its work to evaluate and assess the validity of the COMLEX-USA and the USMLE examinations. They will identify the desired scope of an examination and the critical elements used to design, develop, administer, and score a licensure examination. • The Federation was represented at the Third International Conference on Medical Registration in Cape Town, South Africa. Dr. Winn delivered a presentation, A World Federation: Mechanism for International Cooperation, while the focus of my presentation was the benefits of international collaboration among regulatory authorities. Additional information about this meeting is included in this issue. • Plans for next year’s annual meeting, April 22-24, in St. Louis, are well underway. With the “Engineer the Future” theme, members of the Program Committee are busy securing speakers and dignitaries that will certainly engage and benefit those who attend. Topics will include similarities/differences in the complaint and disciplinary models used, the practice of medicine over the Internet, the pros and cons of resident licensure, and malpractice history as a quality of care indicator, to name a few. • Together, the National Board of Medical Examiners and the Federation have begun preparations for the Post-Licensure Assessment System. This system will provide an additional measuring tool for state boards to use when assessing physician competency, and beyond that, to provide prescriptive recommendations where indicated. These are just a few of the many activities the Federation has engaged in to assist medical boards in carrying out their mission of public protection. New innovative ideas in the practice of medicine, never before thought possible, are rapidly changing the face of the profession. As regulators of the profession, we must prepare for the onslaught of change to ensure the provision of quality medical care.

William H. Fleming, III, MD. President, Federation of State Medical Boards of

As each of us prepares to move into a new year, we have the opportunity to create or change our future. There is an ancient superstition of the sea that, inevitably, one wave comes along that is greater than any that has preceded it. It is called the Ninth Wave. It is the powerful culmination of sea and wind, and no greater force on Earth exists. To catch the Ninth Wave at its crest requires special skills and near-perfect timing. I think we are on the brink of a Ninth Wave in medical regulation, the powerful wave that will bring with it significant change. We must prepare now so that when it is our turn to respond, we can catch our Ninth Wave and successfully ride to shore.

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the United States, Inc.

EDITORIAL A REGULATORY PERSPECTIVE ON ALTERNATIVE MEDICINE Editorial adapted from the North Carolina Medical Board’s quarterly publication, the Forum, (No. 3, 1998.)

A recent Los Angeles Times1 article, one of a four-part series, labels alternative medicine “The 18 Billion Dollar Experiment.” The authors, Monmaney and Sloan, write: “Although it is gaining fast in popularity, alternative medicine is still very much an experiment—one that huge numbers of Americans are conducting with themselves as the guinea pigs.” We have in this country what is generally regarded as one of the best health care systems in the world, yet there is a strong market for alternative medicine, and this market is increasing each year. EDGING INTO THE MAINSTREAM According to the Los Angeles Times2 report, the alternative medicine industry is no longer a counter culture; it is edging into the mainstream. There is no doubt that at least part of the demand for alternative medicine results from a certain level of consumer dissatisfaction with so-called “traditional” scientific medicine, and those of use who provide administrative support for medical licensing boards need to take a hard look at this growing consumer demand. Like a business, we need to understand what is happening in the health care marketplace in order to do a better job of recommending improved public protection mechanisms to our licensing boards. The following are some markers indicative of the shift in consumer interest, as published in the above mentioned Los Angeles Times3 article: • herbal supplement sales in the United States: 2.09 billion in 1994; 3.65 billion in 1997 • number of homeopaths: 200 in 1970; 3,000 in 1998 • massage schools: 15 in 1969; 800 in 1998 • drugstore shelf space per store for vitamin, mineral, and herbal supplements at Rite Aide Pharmacies: 8 feet in 1995; 22 feet in 1998

Andrew W. Watry. Executive Director, North Carolina Medical Board. Raleigh, North Carolina.

Use of over-the-counter herbal remedies further demonstrates this trend. In a 1997 mail survey of more than 29,000 US households for the market research firm Hartman & New Hope of Bellevue, Washington, these were the most commonly used herbal supplements (percent of US households): garlic 11%; ginseng 10%; ginkgo biloba 9%; echinacea 7%; St. John’s wort 5%.4 These people are showing up in offices of licensed physicians as well. A cautionary note was sounded by B. Clair Eliason, MD, associate professor of family and community medicine at the Medical College of Wisconsin, in a recent issue of American Medical News: 5 “Doctors need to be open-minded, but it’s important to be skeptical because people are making a lot of money (selling herbal supplements) and patients aren’t always benefiting.”

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Also, some physicians are suggesting that licensed physicians should learn more about alternative approaches to better help and advise patients who are seeking these treatments. A recent anecdote from a North Carolina physician brings this point home. She was treating a patient who had been to another physician for severe menorrhagia. The other physician had been unable to resolve a problem with elevated blood pressure, but when asking the patient about other medications, he didn’t ask about herbs. It turns out the patient was taking ginseng, and studies have linked this herb to elevated blood pressure. So a sensitivity to alternative therapies by another physician helped resolve the problem. Also, the physician who started asking patients about alternative therapies was pleased to observe how patients opened up to her and sought her advice. AN IMPORTANT MESSAGE This burgeoning market presents a regulatory dilemma for medical boards. The challenge is to strike a balance, providing public protection from quackery while not interfering with alternative medical practices that benefit and serve consumers. The North Carolina Medical Board is meeting this challenge through a special Alternative Medicine Committee appointed by its president, Charles E. Trado, MD. The committee is poring over considerable amounts of research material to help the Board make informed decisions on the complaints and concerns that will inevitably accompany the widening use of alternative medicine. The purpose of this editorial is not to speak to what works and what doesn’t work in this rapidly growing field. The jury is still out, and there is a paucity of scientific study concerning many of these therapies, which is why, in most cases, they are labeled “alternative.” The purpose of this editorial is to recognize the emerging role of alternative medicine, to look at factors that might precipitate increased consumer interest, and to suggest, from a regulatory perspective, what many medical consumers may be saying through their choices of health care to those who practice scientific medicine. Their message also is important to those of us involved in medical licensure. THE BURDEN OF PROOF The people of North Carolina, as represented in the General Assembly, have said they want a relatively open marketplace for alternative medicine. Language in the North Carolina General Statutes (NCGS 90-14(a)(6)) provides something of a safe harbor for licensed physicians practicing alternative medicine: “The Board shall not revoke the license of or deny a license to a person solely because of that person’s practice of a therapy that is experimental, nontraditional, or that departs from acceptable and prevailing medical practices unless, by competent evidence, the Board can establish that the treatment has a safety risk greater than the prevailing treatment or that the treatment is generally not effective.” This puts a difficult burden on the Board in addressing complaints where a medical practice may involve a so-called “alternative therapy.” In order for the Board to resolve a complaint about practice that is below minimum standards, it would require the burden of proof to establish a safety risk that is greater than the prevailing treatment or that the therapy is not effective. The problem with alternative therapies is that, unlike more conventional treatments where there are double blind studies about efficacy printed in journals such as the New England Journal of Medicine and the Journal of the American Medical Association, few such scientific data exist about them. The Board is receiving increasing numbers of complaints about alternative therapies as that market expands.

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THE PARADOX It is paradoxical that as medicine becomes more and more sophisticated, there seems to be a tendency to return to earlier health care practices such as homeopathy, naturopathy, reflexology, and other alternative systems. When individuals are asked what drives them away from scientific health care, they almost universally report a frustration with scientific practitioners and the high cost of modern health care. Fee issues are difficult to prosecute unless there is flagrant exploitation or fraud. However, the medical boards are the focal point of consumer complaints about traditional health care rendered by physicians. A look at the complaint and investigation activities of medical licensing boards will yield some important clues on this market shift. After many years in the field of medical licensing and regulation, my observations have led me to several conclusions, which I have summarized below. 1. Improving Communication The largest number of complaints submitted to the Board, and, paradoxically, the complaints we are least capable of resolving, are those involving poor communication between physicians and patients. Many physicians can go through an entire career and not generate so much as one complaint to a medical board. Other physicians, equally competent, generate complaints monthly. This has a lot to do with interpersonal communication skills. Although this observation is anecdotal, it comes from looking at 500 to 600 complaints a year over many years. The specialty of obstetrics is high risk; insurance premiums reflect this. Yet, plenty of obstetricians make it through their entire careers without ever being sued. Their practices are not free of bad outcomes, but they seem to have good rapport with their patients. Risk managers suggest that people skills may have more to do with tort exposure than bad outcomes. Physicians who are short or abrupt with patients are sure to generate a stream of complaints to the Board. This leads to the issue of what drives some people to alternative practitioners. Find a patient who goes to an herbalist and you will probably find that patient has a horror story about a much exaggerated and failed doctor-patient relationship. It is a recurring theme in complaints before the Board, where we hear from people who are not only unhappy with outcomes, but are quite angry with their health care practitioner. These patients are prime candidates for alternative therapists. 2. Educating Consumers Patients who believe in iridology (the study of the iris of the eye to diagnose health and disease) pay good money to have an eye examined for gallbladder disease. You might think the average high school or college anatomy course would give one pause in accepting this approach, but numbers of people seek this kind of health care. To the extent it is practical, I think medical providers at every level should generously supply patients with readable, easily understood health care information such as pamphlets, references to further reading, journal articles, and other material to help them understand modern scientific medicine. 3. Applying Basic Business Principles We need to analyze the medical marketplace and determine what is driving the shift in the preferences of some consumers. What is it about alternative practitioners that patients find appealing? It might include less time spent sitting in the waiting room; more personal contact with the practitioner; a

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caring and compassionate attitude; lower fees for routine services; more community involvement of the practitioner; good business practices, such as routine patient contact and follow-up outside the office; friendly staff; and good accessibility, including availability one or two nights a week after hours to accommodate people on different work schedules. 4. Spreading the Good Word The good and positive aspects in medicine need to be brought to the public’s attention. We need to work particularly on the perception that physicians are part of a closed club, more interested in shielding substandard medical practice than in doing the right thing. Many patients aren’t aware of the quality assurance, peer review, and credentialing activities that take place in hospitals, medical associations, and other health care organizations. Nor are they aware of the work of the medical boards. The Forum, our state medical board’s publication, is but one example of an effort to help consumers appreciate what is going on in medicine to protect them. Although it is uncomfortable for some physicians, publishing the names of disciplined physicians and actions taken against them by the Board helps increase public confidence in medicine. It may also help obviate the need for more radical legislation, such as national licensure, or dissemination of less useful and perhaps harmful information, such as the number of complaints filed against a physician. We have seen situations where angry patients can abuse the system by loading up a practitioner’s file with a number of complaints about the same thing. In my opinion, the disadvantages of making this information public, from a regulatory perspective, outweigh the advantages. By increasing public awareness of all the mechanisms available to minimize substandard medical care or other breaches of trust by physicians, patients may feel more comfortable and will recognize they do have recourse. This, in turn, can inspire a more positive view of scientific medicine. To the physicians reading this editorial: if you involve yourself more actively in peer review, and if you report significant violations to the medical board, you will help counter the impression that physicians tolerate substandard care at the expense of patients. 5. Avoiding Impropriety It goes without saying that physicians need to take special care to avoid any appearance of impropriety. At the federal level, the Stark legislation (regarding self-referral) is one example of a response to a public perception that physicians, more than other professionals, need to be barred from engaging in business activities that appear to be a conflict of interest. Incestuous business practices by physicians are making a regular circuit on network news programs, and all physicians tend to be painted with the same broad stroke as being greedy. Physicians who are abusing Medicaid or Medicare, or some third party insurance carrier, are contributing to this public perception. So even though there may be a tendency to dismiss these kinds of violations as less significant than those that actually cause patient harm, they need to be taken seriously. 6. Becoming a Physician Resource About Alternative Care Many physicians who are experts on alternative medicine suggest physicians learn more about alternative practices so they can be more responsive to their patients who have questions about those practices. Also, talking to patients and responding to questions about alternative therapies could help

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improve patient outcomes. In a recent JAMA6 article, Wetzel, et al, established that 64% of US medical schools offer course work in alternative medicine. IDENTIFYING ABUSES Alternative medicine does not equate with patient abuse. It simply presents more fertile ground for abuses because, in general, there is little or no science supporting many alternative medical practices. The Food and Drug Administration (FDA) doesn’t check to see what is in a bottle of St. John’s wort and no one is checking on labeling of this herb. A recent study, published in the Los Angeles Times,7 identified one St. John’s wort product of the nation’s number one distributor of dietary supplements as having about 20% of labeled potency. You don’t find credible scientific literature to support the practice of iridology or reflexology, and you will find very little science, if any, supporting colonic therapy. Yet the market for these and other alternative medical practices is strong. The Board has taken direction from the General Assembly and is not prosecuting any physicians for engaging in alternative medical practices solely because they are “alternative.” Some of these practices can be dangerous to patients, however. For the Board to successfully prosecute a practitioner for exposing patients to danger by use of an alternative therapy, the Board needs credible expert testimony to establish that the therapy in question “ . . . has a safety risk greater than the prevailing treatment or the treatment is generally not effective.” When asked to do so, qualified physicians should be willing to assist the Board in assessing such matters impartially. CONCLUSION I believe the work of the state medical boards is essential to countering the potential risks involved in the practice of untested and unproven alternative therapies. By taking deliberate action to assure the qualifications, professionalism, and competence of those we license, the boards will contribute measurably to the public’s confidence in modern scientific medicine, which will discourage the growing demand for unproven, unscientific remedies. While this result is not the purpose of vigorous board action, it will be a byproduct of the board's constant effort to improve one of the best health care systems in the world. REFERENCES 1. Monmaney T, Sloan S. Alternative medicine: the $18-billion experiment. Los Angeles Times. Aug 30, 1998;1:1. Metro Desk. 2. Ibid. 3. Ibid. 4. Ibid. Aug 31, 1998;A:11. Metro Desk. 5. Jacob JA. Untended garden. American Medical News Aug 17, 1998;28. 6. Wetzel MS, et al. Courses involving complementary and alternative medicine at U.S. medical schools. JAMA. Sept 2, 1998;280:9;785. 7. Monmany T. Alternative medicine: the $18-billion experiment. Los Angeles Times. Aug 31, 1998;A:1. Metro Desk.

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ALTERNATIVE MEDICINE: IMPLICATIONS THE

COMMITTEE

ON

FOR

HEALTH CARE FRAUD

Introduction: Excerpted from a presentation given at the 1998 Annual Meeting of the Federation of State Medical Boards of the United States, Inc, in Orlando, Florida. Responses to this article are encouraged. I want to begin and end my talk with a challenge: The Federation of State Medical Boards needs to be at the table to carefully design a model of integrated health care for the United States. My task is to convince you that this area—as much of a lightning rod as it is to the medical profession and lay public— needs your involvement. It needs your participation if we are going to create a generation of clinicians who responsibly advise patients about the use or avoidance of alternative medical services. The patient’s perspective is “Is there an alternative caregiver with no ties to the medical establishment, who will be covered by my insurance, and isn’t a quack?” Are all physicians who even consider the integration, co-management, or utilization of alternative therapies quacks by definition? Patients ideally want board certified physicians wearing white coats to give them responsible advice. This is a sociologic problem we must address. The American consciousness views this as a challenge of our daily lives. I am going to touch on some of the complexities of these areas—definitions and terminology, prevalence, educational programs being developed at universities across the country, research challenges and opportunities, and those aspects contained in the Report of the Special Committee on Health Care Fraud that address questionable health care practices. There is no consensus as to a label for this field. The decade of the 1980s could arguably be called the decade of the “un’s” and the “non’s”—non-conventional, unorthodox, unconventional, unproven—and I would add your own selective term, “questionable.” You needn’t be an expert in language to understand the pejorative nature of those descriptors. Sociologists have pointed out that within every medical system, in every culture, there is a dominant and non-dominant medical subculture. In a sense, what we’re dealing with here is the non-dominant medical subculture. We must, I believe, make sense of it and decide how to make it function responsibly. Your challenge is to look at that question from the vantage point of the physician as well as the public’s safety. In the late 1980s and early 1990s, we saw the terms “complementary” and “alternative” emerge in both the lay press and medical literature. The term “complementary medicine” emerged as the preferred term by people who practice certain therapies for their livelihood, eg, chiropractors, acupuncturists, massage therapists, homeopaths, and naturopaths. Complementary therapy also is the term preferred throughout Europe, where these practices are much more common, and are perceived as far less questionable by many members of the medical establishment. The term “alternative medicine” is really a vestige of legislative language from the United States Senate. In 1992, the Subcommittee on Appropriations, chaired by Senator Tom Harkin, revised the National Institute of Health’s (NIH) reauthorization bill so as to include the creation of the Office of Alternative Medicine within the office of the director of the NIH. This was and remains the legislative language used throughout the federal legislative arena in Washington, DC. Alternative medicine is not an ideal term. It leaves many questions and perpetuates misconceptions about the entire field.

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David M. Eisenberg, MD. Director, Center for Alternative Medicine Research and Education. Boston, Massachusetts.

The newest term, popularized by the press, is “integrative medicine,” which definitely sounds more optimistic than “questionable therapies.”

Other terms that have entered the literature include “traditional medicine,” the term preferred by colleagues abroad. This summer we had a World Health Organization (WHO) meeting co-sponsored by the NIH. Leading experts in clinical research, herbs, acupuncture, and physical manipulation from places such as India, China, Tibet, South America, and Africa attended. The term they preferred was “traditional medicine.” The problems we discussed, including those of credentialing, licensure, standardization of product, safety issues, and direct and indirect toxicity, are comparable throughout the global community. We are now, for better or for worse, a global village, and in this area it is extremely important to find consistent language. Internationally, the term “traditional medicine” is preferred since the term “alternative medicine” does not translate well. The newest term, popularized by the press, is “integrative medicine,” which definitely sounds more optimistic than “questionable therapies.” I’m fond of the comment made by one of my colleagues at Harvard Medical School, Tom Inui, MD, a professor of medicine and head of the Department of Prevention in Primary Care, “Ultimately, we’re talking about the delivery of responsible, evidencebased medicine—at which point, the labels become irrelevant.” A brief synopsis, summarized in greater depth in the The New England Journal of Medicine’s 1 survey published in 1993, includes the following functional definition: therapies not commonly taught at US medical schools and not commonly available in US hospitals. In Germany, these are called nichtschulmedizin, or “not-taught-in-school” medicine. In France, they are often referred to as “parallel medicines.” In Chinese, Tibetan, Indian, and Native American cultures, these are simply called “the medicine.” I lived in China for nearly two years at the end of my medical school training. When China opened up in 1979, I was sent as the first medical exchange scholar to Beijing. I was humbled by observations of Chinese medicine’s apparent efficacy. When I returned to the United States, I wanted to create a Center that could distinguish useful from useless treatment. Having done that and having joined the faculty as a primary care physician in the Department of Medicine, at Beth Israel Deaconess Medical Center in Boston, Massachusetts, I was struck by the frequency with which patients, when asked, said they had, in fact, used herbs, acupuncture, massage, or were very interested in trying these therapies. That’s what prompted me to launch a national survey. I simply wanted to document the extent to which Americans use therapies that you and I did not learn much or anything about in medical schools.

When I returned to the United States, I wanted to create a Center that could distinguish

From the aforementioned definition, we came up with 16 representative alternative therapies, some of which, I suspect, would end up on the Federation’s list of “questionable” therapies: acupuncture, biofeedback, chiropractic, commercial diets, energy healing (which includes laying on of hands and energy-emitting devices), folk remedies, religious or spiritual healing by others as opposed to personal prayer, herbal medicines, homeopathic preparations, hypnosis, guided imagery, lifestyle, diet (not low salt or low cholesterol, but macrobiotics or strict vegetarianism), massage therapies, relaxation and meditation techniques, self-help groups, and megadose or high-dose vitamins as distinguished from one-a-day or prescribed vitamins.

useful from useless treatment. The questions of interest included: To what extent did Americans use these 16 therapies to treat their most serious medical problems? What problems did they treat? How often did they tell their physicians? What was the cost? We found that about a third of Americans used at least one of these 16 therapies during the prior 12 months to treat their most serious illness. They spent about $14 billion in 1990, three-quarters of which was out-of-pocket; the remainder going predominately to chiroprac-

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tors. There were more visits—425 million—to providers of alternative therapy than there were to all primary care physicians combined, by about 50 million. Perhaps the most sobering and humbling observation was that 72% of the individuals who said they had used these therapies to treat their most serious illness did not discuss these behaviors with any of their physicians. These were the findings that allowed us to proceed with a research agenda and at the same time, clarifying to the medical community that this is the beginning of a sociological tidal wave approaching the shore. Demographically, the people with the highest rate of use were those in the baby boom generation, then 29-45, now about 35-55 years of age. One out of every two people in this group used alternative therapy either for intervention or health maintenance in 1990. As this group ages and becomes sick more frequently, these individuals will likely use it for therapy as opposed to health maintenance, and this group is increasingly in positions of authority—members of Fortune 500 company boards and the political arena, for example. As such, this will continue to be an important issue for the medical profession because better evidence will be demanded as to when and how these therapies are to be integrated with conventional care and, ultimately, reimbursed. We made three recommendations at the end of that New England Journal1 article. First, we said that medical schools must create educational programs to prepare physicians-in-training and those already in practice to engage in a responsible conversation, given the fact that an estimated one-in-three patients is using one or more alternative therapies to treat the very conditions for which they are seeing physicians. Second, we acknowledged that this was a survey which could not comment about safety, efficacy, or cost offsets, and we urged support from the federal government to create well-designed studies to be performed at our most highly regarded universities. Lastly, we made the suggestion that if every doctor in the country, and by extension, every nurse practitioner and allied health professional, asked their patients if they were using or contemplating the use of chiropractic, acupuncture, herbs, etc, they would observe that one-in-three or possibly one-in-four would say “yes.” Resulting from this intake, we may then be more motivated to learn more about these therapies—the good and the bad— and to have conversations with our patients about these therapies. None of us like to be caught unaware by a patient arriving with a ream of papers off the Internet about topics of which we know nothing. Currently, an estimated 75 out of the 125 medical schools in the United States provide at least one course devoted to the topic of alternative medicine, or have this topic as part of a required course. The problem is that consensus on common core content, educational format, or administrative structure does not exist. What is the minimum amount of information that physicians-in-training should know about chiropractic, acupuncture, homeopathy, herbs, drug-herb interaction, etc? This challenge is now visible, and the regulatory authorities and the boards of medical examiners must look at it head-on. To give you a sense of what has already happened in other countries, Germany’s licensure examinations require a working knowledge of many of the commonly used herbal therapies—what they call “natural medicines.” For example, St. John’s Wort has outsold serotonin re-uptake inhibitors eight-toone in Germany for years. Natural medicines prescribed by German board certified clinicians are commonplace. This is true in many European countries. A course at Harvard Medical School was developed five years ago with support from the John E. Fetzer Institute. We developed our syllabus over the last seven years. It has hundreds of annotated bibliographic citations, historical materials, a selection of the best clinical trials, outcomes research trials, metanalyses, commentaries, letters to the editor—all from respected journals such as the British Medical Journal, Lancet, New England Journal of Medicine, and Journal of the American Medical

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...medical schools must create educational programs to prepare physicians-in-training and those already in practice to engage in a responsible conversation, given the fact that an estimated one-inthree patients is using one or more alternative therapies to treat the very conditions for which they are seeing physicians.

Currently, an estimated 75 out of the 125 medical schools in the United States provide at least one course devoted to the topic of alternative medicine, or have this topic as part of a required course.

Association (JAMA). This syllabus is published as five cases and is available through Harvard Medical School, who maintains the copyright.

The public is under the impression that we have not only proven that the mind can predictably alter physiology in an objective way, but also that the mind can alter the

We also have provided continuing medical education during the last three years. Specifically, we provide a four-day course every March with an intent to provide a safe and neutral place for a discussion of the state-of-the-science and state-of-practice of integrative care. No books or products are sold at this event. The faculty is hand picked and involves people who are researching the most commonly used alternative therapies. The faculty includes two individuals who are MDs as well as being licensed chiropractors, and they both have PhDs in the neurosciences. The individual who describes the state-of-the-science with regard to homeopathy and who has published extensively in Lancet is a board certified internist and a member of the Royal College of Physicians in England. Continuing medical education is important: helping physicians-in-practice identify useful services, ie, where they can go for bibliographic references regarding herbs; how does one co-manage a patient who seeks acupuncture, homeopathy, massage—these are the objectives of the course. We also look at liability and malpractice issues.

natural course of serious or life-threatening illness.

As for issues of safety and efficacy, here are some key questions: “Are they safe, are they effective, and when they work, how do they work? Is it placebo, mind/body expectation, patient provider interaction and charisma of the provider, or do they have specific effects?” This is where the work gets complicated. The public is under the impression that we have not only proven that the mind can predictably alter physiology in an objective way, but also that the mind can alter the natural course of serious or lifethreatening illness. To me, this remains a relatively untested, provocative assertion. But it’s at the core of research involving alternative medicine—figuring out the mechanism whereby the therapy works. In my own opinion, some of these therapies work regardless of belief or expectation. I believe acupuncture can change pain thresholds—not uniformly, but predictably—in humans and animals, regardless of belief. Some herbs have active ingredients that we will ultimately have to identify. Other alternative therapies work in large part because of expectation.

Many people believe in an association between belief in a therapy and its effect size.

Imbedded in this observation, from the research standpoint it is a fascinating question to ponder, namely, whether and how expectation, belief, and lifestyle can impact gene regulation. Maybe there are some people who are more susceptible to the physiologic interaction between belief, expectation, prayer, and their genetic expression. In the middle ground, which is where I find myself, is the question of the extent to which belief or expectation in a therapy amplifies or diminishes the effectiveness of that therapy. Many people believe in an association between belief in a therapy and its effect size. It is worth looking at, but you will probably agree that we have spent precious little time designing studies to explore this association. People who receive a therapy they are excited about may do better with that therapy than people who take the same therapy begrudgingly or at the strong recommendation of a physician or spouse. We have not set up the proper experiments to “biopsy expectation” prior to randomization. David Sackett has pointed out that we recommend therapies based on induction, deduction, or seduction. Most alternative medicine has been developed along empirical, inductive lines of logic. Very few of these therapies have been subjected to randomized double blind control trials. With some humility, we must acknowledge the extent to which conventional care has not always met this standard and how a level playing field needs to be established. All therapies need to be subjected to controlled trials.

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However, seduction is not to be discarded. The realm of anecdote is very powerful. Many of us have a family member, close friend, mentor, or patient with a chronic or life-threatening condition, who, having exhausted conventional medicine, sought the professional services of a chiropractor, herbalist, acupuncturist, or massage therapist and would swear that those services altered the natural course of their illness. Many people know of such cases. A rich science is here to be teased out. Increasing evidence over the last three years suggests that some of these therapies may, in fact, be effective. Evidence with regard to chiropractic for the treatment of acute low back pain has been published in Annals of Internal Medicine 2 and AHCPR Guidelines for Low Back Pain3 (Agency for Health Care Policy and Research). Evidence exists that acupuncture may be effective for the treatment of some kinds of nausea and certain varieties of pain, typically chronic pain (an NIH consensus conference), and that relaxation and meditation techniques may be useful for the treatment of some forms of pain and insomnia—also an NIH consensus statement. The assertion that psychological support can impact the survival time of individuals with advanced malignancy first appeared in an article by Spiegel, et al, in Lancet.4 A large multicenter study is attempting to replicate these findings. Another study suggestive of the same outcome involved people with advanced melanoma. This area remains provocative, but I think we will see more research to look at whether psychological supports impact survival time as well as quality of life.

Increasing evidence over the last three years suggests that some of these therapies may, in fact, be effective.

Two metanalyses in the medical literature argue from the vantage point of having reviewed more than 100 double-blind controlled placebo trials, that in the majority of instances evidence supported that homeopathy was superior to placebo. It is disconcerting to the scientific community, and difficult to me, because I cannot understand any rational mechanism to explain this observation. But I am struck by the comment of David Reilly, a homeopath from Glasgow, Scotland. He has published several meticulously designed studies on homeopathy. These were done at Oxford and elsewhere, with skeptics in the pharmacy responsible for dispensing homeopathic and placebo remedies. The end of one of his papers in Lancet5 rhetorically says, “Either homeopathy works, or the double-blind randomized placebo control trial as we know it does not.” At the very least, some of the areas we are unable to explain prompt us to rethink existing research methodology. From the results of a metanalysis, St. John’s Wort, as an example, is an herb that has come under careful scrutiny, and may, in fact, be effective for moderate depression. The NIH recently funded a $4.5 million grant—the first of its kind—to Duke University to implement a classic double-blind controlled randomized trial. Three arms will be established: St. John’s Wort, serotonin re-uptake inhibitor, or placebo. We have come a long way from saying “this is irrelevant” to now having federal funds to study these treatments carefully. Funding these studies may require millions of dollars and multi-site intervention to make sense of them. We’re going to see more of these studies in the future. “Gingko for Alzheimer’s Disease” has been a headline we all picked up from the front page of our respective newspapers. When these findings are published in JAMA, they are world news. A paper in JAMA6 just a few months ago suggested that one preparation of gingko extract as compared to a placebo in a randomized double-blind trial was effective in moderating, actually diminishing, the cognitive impairment of individuals with modern dementia. To be more explicit, the article was referring to a particular extract of gingko by one company in Germany; not all gingko preparations on the shelf at your health food store.

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Two metanalyses in the medical literature argue from the vantage point of having reviewed more than 100 double-blind controlled placebo trials, that in the majority of instances evidence supported that homeopathy was superior to placebo.

Eleven federally funded Centers

It’s also fair to say that vitamins are now in a gray area between alternative and conventional. Increasingly, we use vitamins to reduce the risk of cardiovascular disease. Again, we have the benefit of hindsight in understanding the mechanism. B6 and folate work to reduce cardiac coronary artery disease, in part through an alteration in homocysteine levels. How many of you would have imagined five or 10 years ago that vitamins would be routinely prescribed not only by cardiologists, but by primary care physicians to reduce risks of cancer or coronary disease? We didn’t know this five years ago. Many of you would have thought this preposterous.

of Excellence have begun to distinguish useful from useless alternative and complementary therapies.

The sociologist’s drill-down question of why people are using alternative treatments will help us reflect on ways in which the pendulum of conventional care has swung too far towards an efficiency model.

Eleven federally funded Centers of Excellence have begun to distinguish useful from useless alternative and complementary therapies. Places like Harvard, Columbia, and the Universities of Texas, California, and Maryland each receive about $400,000 a year in federal funding. We refer to this as a “homeopathic level of funding.” It has allowed us to find faculty at our respective universities who are genuinely interested in questions of efficacy, safety, toxicity, and models of creating responsible integrative care. It is just the beginning, but in my view, the government has taken an important step. I want to highlight one or two projects at our Harvard Center. We have repeated a national survey to look at trends in the use of alternative medicine and will be submitting this data for peer review shortly. In addition to all the trends, I am also interested in tracking the precise brand and type of supplement that patients use. A potential disaster on the horizon looms as a result of insufficient attention to individuals with chronic or life-threatening illnesses who simultaneously take prescription medications and take handfuls of vitamins, herbs, and supplements. The indirect interaction between those herbs, vitamins, supplements, and a prescription drug—particularly among those with renal or liver impairment—is critically important and should be studied by conventional medicine. We need surveillance systems and an understanding of common drug/herb interactions. Additionally, we need to explore the reasons why tens of millions of individuals use both conventional and alternative medicine. We may be missing the obvious. For example, the physical “laying on of hands” to people in pain may result in modest improvement in pain by the time they leave the office. That may be enough for some patients to come back. It also may be a perception that the alternative caregiver is not so squeezed for time, and because of that, they appear more willing to listen. Another frightening factor to consider is the prospect that some of the descriptions or explanatory models, as unacceptable or ludicrous as they may be to us, may be more acceptable and understandable to some individuals with chronic problems. What we learn from the “why” question is the reason for commenting. The sociologist’s drill-down question of why people are using alternative treatments will help us reflect on ways in which the pendulum of conventional care has swung too far towards an efficiency model. This model may be strangling us for time and squeezing out the “therapeutic” encounter. If time is limited to establish a connection with a patient, to check in with them in an agenda-less fashion, then the patient leaves unfulfilled. So what is it that the alternative medicine community is providing which reminds us that we may have gone too far? HMOs and insurance carriers throughout the country have begun to offer alternative medicine programs. They are setting up networks in large metropolitan areas that include licensed chiropractors, acupuncturists, and massage therapists. HMO members go to these offices and get an immediate discount: no paperwork, no covered benefit, no liability issue. Some HMOs and insurers are experiment

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ing with covered benefits or capitation. And in many of these, the physician is told after the fact that they will co-manage patients with the chiropractor, acupuncturist, naturopath, or homeopath. This is the future. Actually, this phenomenon exists already, and may be offered near you within five years. The research questions that we want to address are varied. What services will patients pursue, for what problems, and will this result in an increase or decrease in costs? For instance, people with chronic musculoskeletal pain could see orthopedists, physical therapists, and psychiatrists for reactive depression, thereby using a lot of conventional care. Access to alternative therapies will either result in a cost add-on or may actually diminish the utilization of services overall. These questions have to be tested in randomized trials. We’re doing such a trial at Harvard Pilgrim, the largest HMO in Massachusetts. The pilot study is underway, randomizing people to either usual care or their choice of seeing a chiropractor, acupuncturist, or massage therapist, in addition to usual care—what we call “expanded benefits.” We’ve enlisted 30 people thus far. Everybody who has agreed to participate has selected an alternative provider if they are given that option. To do this, and this is where there’s an overlap in interests, we have created with the chiropractors, acupuncturists, and massage therapists credentialing procedures, and scope of practice guidelines for low back pain. We’ve also piloted data tracking procedures to track every interaction in the office of the alternative care provider. We’ve created tracking forms to look at financial issues of utilization of all health care resources. So we’ve created, if you will, a system to track what happens in both the clinical and financial domains. Within five miles of the target clinic (West Roxbury), we identified 347 licensed chiropractors, acupuncturists, and massage therapists. We are going to increasingly see clinical studies that randomize patients to either usual care or integrative models of care. By integrative models I mean either the utilization of an outpatient network like I’ve just described, or demonstration clinical units that include the best of both—the best of, for example, rheumatology, orthopedics, physical therapy, and occupational therapy as well as chiropractors, acupuncturists, massage therapists, exercise trainers, and meditation experts. One can envision an integrative team that does not yet exist and ask the questions, “What will that team be able to provide to people with chronic low back pain who are out of work for four weeks in terms of clinical outcomes, return to work, rates of surgery; what are the changes in overall utilization of resources as well as satisfaction?” These are clinical experiments that are being planned at our Center.

We are going to increasingly see clinical studies that randomize patients to either usual care or integrative models of care.

Our Center is also spending a lot of time on issues of toxicity,

Our Center is also spending a lot of time on issues of toxicity, trying to generate for you and others a list of which herbs are dangerous individually and which are dangerous when used with prescription drugs. We need to work with the herbal companies and the pharmaceutical companies to get this to you and to all physicians on the Internet and in real time. We’re putting a lot of energy into this and you should know that these are being built not just by universities, but also by for-profit companies. Having reviewed the malpractice claims data for chiropractors, acupuncturists, and massage therapists, and having tried to anticipate what’s going to happen in this brave new world of integrated care—when will the physician or his/her medical group, hospital, or managed care organization be successfully sued for co-management or referral to a licensed alternative provider? I’ve avoided the issue of the patient who rightfully says, “Which therapies do you think work? Which should be avoided?” And the unspoken question, “Will you think less of me for having brought up this

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trying to generate for you and others a list of which herbs are dangerous individually and which are dangerous when used with prescription drugs.

Alternative medicine licensure

conversation?” That’s part of the problem. Many patients think we don’t want to hear about it, not to mention another extreme, the patient who says, “I thought I’d give western medicine one more chance.” Not an easy patient to face, I might add. An article that appeared in The Annals of Internal Medicine7 last July offers my best effort to create a step-by-step strategy for having a conversation with a patient—a strategy that emphasizes shared decision-making in the absence of what you and I would consider exhaustive scientific evidence, pro or con. How do we have this conversation while maintaining our responsibility as evidence-based medical providers?

procedures should parallel the kinds of approaches that have been developed by the Federation.

One of the themes this paper addresses is what you do with a patient who says, “So what do you think about chiropractic for my sciatica?” How many of you have faced a patient like that? Here’s my guess of what’s going on in your mind, but not verbalized to your patient: “Scotty, beam me up.” “Please don’t ask me that.” “You’re not serious, are you?” “I think it’s worthless.” “I don't know.” Or the psychiatric approach, “I don’t know much about it. What are your thoughts?” I would encourage those of you who want to think about this to look at the article. One of the themes is, “Don’t ask and don’t tell must be abandoned,” at least in terms of monitoring unsafe utilization of herbs and unsafe practices. On the topic of licensure, it would be wonderful—as we wrestle with creating licensure standardization across acupuncture, homeopathy, naturopathy, chiropractic—if we could model national standards after the kinds of materials I've heard described today, researching the national licensure of MDs. Alternative medicine licensure procedures should parallel the kinds of approaches that have been developed by the Federation. Similarly, imagine if the Federation took it upon itself to create standards of care—not just for opiates in the treatment of pain, but for the question of when and how it’s appropriate for a physician to co-manage a patient with a licensed alternative caregiver. We will need to create these guidelines if we’re ever going to make sense of integrative care. Guidelines must be defined if physicians are going to feel comfortable in this new world thrust upon them by the market and their managed care payers. I’ll close with two quotes. David Grimes, writing in JAMA,8 said, “Doing everything for everyone is neither tenable nor desirable. What is done should be inspired by compassion and guided by science, and not nearly reflect what the market will bear.” And my own favorite quote from China, zhen jing bu pa huo lien, which literally translated says, “Real gold does not feel the heat of even the hottest fire.” We have the tools to distinguish useful from useless. What gives me optimism about this field is that now, at the turn of the centur y, for the very first time, we have responsible leaders of the alternative practice community sitting at the same table with leaders of academic institutions, federal agencies, and the private sector—insurance carriers, pharmaceutical industries. However, a seat is missing at the table—it’s the seat of regulatory authority from the conventional medical community. I urge you to join with me in making sense of this terribly complicated area.

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The following represents a question-and-answer session that followed Dr Eisenberg’s speech: QUESTIONS:

Q: Regarding your Harvard low back pain study. Do you think you’re going to have enough power with 60 people?

A: That’s the pilot. The larger study will include 500, the grant for $2.5 million is sitting at AHCPR. The pilot is a feasibility study to show that we could collect data, enroll patients into the randomization arms, and implement the study procedures.

Q: The Virginia Board of Medicine licenses acupuncturists and chiropractors, and our Board of Nursing licenses massage therapists, and those were the ones you were more or less concentrating on. But then we have other people out there, and I bring up the therapeutic touch article that was recently in JAMA,9 which said it’s a sham—it’s no good. I realize that’s just one article against therapeutic touch, but in the future we’re going to have to look at therapeutic touch. Chelation therapy—that’s another one that’s been a big problem with our board, as to whether or not this really has efficacy or not for atherosclerotic cardiovascular disease. There are some crazies out there doing some alternative therapy. We just had a big problem with intravenous aloe vera for cancer patients who had metastatic cancer. That’s one of the problems we look at, a problem in alternative medicine A: I agree completely, and let me try to take them one by one. First, a thought I had sitting here listening this morning. If the state boards would be willing in a confidential way to describe, without giving away names, the kinds of cases they are seeing with regard to physicians who are unscrupulous or incompetent, or think of themselves as terribly gifted in alternative medicine but may be unthinking charismatic healers who have lost track of causality—if you gave me examples from your states, I would like to work with you to describe the phenomenology of physicians delivering these kinds of services. What are the general areas in which there’s overlap, whether it’s chelation or intravenous use of herbs or whatever? First, I would take responsibility for synthesizing the information that would have to be screened for identifiers. Second, chelation is a good example. For those of you who are unfamiliar with chelation, it is the use of intravenous EDTA (ethylenediamine tetra-acetic acid), purported to be helpful in the management of individuals with severe claudication or heart disease. Now, we have read the reviews of all the literature in chelation. If any of your boards want them, I can give you these systematic reviews. An exhaustive review of the literature shows four controlled trials, two of them are not well designed. The two better designed studies are not supportive. From my vantage point, given the fact that an estimated 300,000 to 500,000 patients a year receive chelation treatments, usually from MDs who charge $3,000 to $6,000 cash on average, this is a public health problem. It can only be answered by a large, randomized control trial that should be done by NHLBI (National Heart, Lung, Blood Institute). Now, NHLBI has historically not been interested, but this is a great example of where the Federation, standing along with other NIH centers, could walk into the office of the NHLBI and recommend pursuit of a definitive, randomized, double-blind trial. This has to be done, and it doesn’t matter if it costs $2-3 million. Stanford University and my staff have been designing protocols around this for years. When can the research community along with the Federation, those of us who are really trying to distinguish useful from useless, walk to Washington together and voice our interests from a research and public health standpoint? This is a regulatory issue and we need to do this together. Research can be an ally, a partner, part of the navigational instrument.

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Q: While you were in China, I was in osteopathic medical school. We were exposed to and taught a limited amount of acupuncture in medical school together with nutrition. I’m a little surprised that you don’t involve osteopathic medical training as a model for integrative medical care, which it has been since its onset in terms of many things. But that’s more of a comment. My question is, to what degree does your office offer itself as a protector of the public? In terms of chelation, specifically, the Federation has a pretty exhaustive bibliography of its own with regard to the ineffective nature of chelation. The only thing I can see we’re doing is protecting the patient’s placebo effect, that is, if they haven’t blown that $6,000 to the point where they even lose placebo benefit. It seems to me that chelation has been pretty well disproved as a valuable matter for patients, and that perhaps we should expose it at this point. I’m not sure what the larger clinical trial is going to have to offer.

A: Your points are well taken. Osteopathy is one of the best examples of integration. The reason it’s not typically on the map of alternative care is that it’s considered conventional care. You’re here. You’re licensed. You prescribe. You’re a member of the Federation. It is in the terminology I use, for all intents and purposes, more conventional than alternative, with the one exception of manipulation, which you do—which is closer to some of the other manipulative therapies on the board. It is a sociologic fluke, if you will, that is in the gray area, which is very important and that I think needs to be highlighted as an example of responsible integration. Again, as you would probably agree, from surveys, the majority of licensed osteopathic physicians do not do a lot of manipulation as part of their day-to-day practice. Now, getting on to your second point. There have been no randomized trials of chelation for heart disease, which is what we’re interested in. There are none. There are several in peripheral vascular disease, and I would agree with you about its ineffectiveness on that front. But in fairness to people who are doing it, one good definitive study would lay the thing to rest. I agree with you about the scientific evidence, which is not borne out, but one large study in coronary disease would probably do the job.

Q: In reference to what the last gentleman just said, I was going to suggest that instead of having an MD who was trained chiropractically in your study, you could have had a DO. You would have gotten two for the price of one. In regard to your rules of evidence, you brought up three things. The last one was seduction. Think about the advertisements for herbal preparation and vitamins. Last week the FDA said they were going to more tightly regulate the claims on preparations and vitamins and are going to have a 120-day public comment section. I was wondering what your thoughts are—if what I heard on the news is accurate—about this new FDA process. We have a case pending on chelation and some alternative therapies in Virginia, which people might want to follow. What is your position and thoughts on this? A: With regard to the FDA, regrettably we live in a country that now has an anti-regulatory fervor exemplified in part by the DSHEA Act of the FDA (Dietary Supplement Health and Education Act). The inability of the FDA to regulate herbs and, for that matter, vitamins and most supplements as drugs, is unacceptable and a big mistake. I don’t think there’s ever going to be enough political determination in the next decade to undo a bill that apparently had more letters of support written than were written to Congress for the Vietnam war. So I think we’re stuck with it. I just recently sent in forms to be a member

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of the FDA Advisory Subcommittee on Post-Market Surveillance of Herbs and Supplements, so I will learn more. But I can assure you that I will be a voice that says there are dangers here. It’s a big problem. So I want to assure you that I’m not going to be silent in the wilderness. I abhor the hyperbole and lack of quality control and the difficulty physicians now face with a patient who has a bagful of stuff from Chinatown and says, “What do you think?” That’s the situation now and we’ve got to create a clear way to make sense of it for the patients as well for our own professional status. (For more information, contact the NIH Office of Alternative Medicine’s website—accessed through the NIH—which is linked to all 11 centers. Cases with annotated bibliographies that number in the 100s are not on-line because they’re copyrighted by the president and fellows of Harvard. To receive the cases, contact the Harvard Office of Medical Education.) REFERENCES 1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventionalmedicine in the United States — prevalence, costs and patterns of use: Results of a national survey. N Engl J Med. 1993;328:246-598. 2. Shekelle PG, Adams AH, Chassin MR, Hurwitz EL, Brook RH. Spinal manipulation for low-back pain. Ann Intern Med. 1992;117:590-598. 3. Agency for Health Care Policy and Research. Clinical Practice Guideline Number 14: Acute Low Back Problems in Adults. Rockville: US Department of Health and Human Services; 1994. 4. Spiegel D, Bloom JR, Kraemer HC, Gottheil E. Effect of psychosocial treatment on survival of patients with metastatic breast cancer. Lancet. 1998;2:888-891. 5. Reilly DT, Taylor MA, Mcsharry C, Aitchison T. Is homeopathy a placebo response? Controlled trial of homeopathic potency, with pollen and hayfever as model. Lancet. 1986;2:881-886. 6. Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF. A placebo-controlled, double-blind, randomized trial of an extract of ginkgo biloba for dementia. North American EGb Study Group. JAMA. 1997;278:1327-32. 7. Eisenberg DM.Advising patients who seek alternative medical therapies. Ann Int Med. 1997;127:61-69. 8. Grimes DA. Technology follies. The uncritical acceptance of medical innovation. JAMA.1993;269:3030-3033. 9. Rosa L, Rosa E, Sarner L, Barrett S. A close look at therapeutic touch. JAMA. 1998;279:10051010.

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MEDICAL LICENSURE

AND

SPECIALTY CERTIFICATION CANADA

AND THE

IN

UNITED STATES

PURPOSE The Federation of State Medical Boards occasionally receives requests for information regarding the portability of medical licenses between the United States and Canada. In seeking information about license portability, questions often arise concerning medical education and training performed in Canada. In response, Federation staff have researched the commonalities, differences, and nuances of the licensure process in the two countries. The following information seeks to educate and assist our member boards as they evaluate the training of Canadian licensees. Information regarding certification by the American Board of Medical Specialties (ABMS), as it relies on medical licensure and is linked to approved medical education and training programs also is included. INTRODUCTION Although the United States and Canada share a general commitment to high licensure standards, state medical boards in the United States as well as regulatory agencies in Canadian provinces and territories have specific and often unique requirements to obtain a medical license. Additionally, many differences exist in the requirements for specialty board certification in the two countries. A discussion of the relationship between specialty board certification and licensure is included in this report. The processes required for both licensure and board certification share three common elements: medical education, examinations, and postgraduate training. Following is a detailed review of each of these elements as they relate to medical licensure and board certification.

Deborah M. Modesette, MPA. Assistant Vice President, Member Support Services, Federation of State Medical Boards of the United States, Inc. Euless, Texas.

Medical Licensur e Many Canadian provinces use the term “registration” synonymously with “licensure.” For purposes of this manuscript, the terms will be used interchangeably. Medical Education All US medical regulatory agencies (ie, state medical boards) and all Canadian provincial regulatory agencies (ie, licensing authorities) require the physician-applicant to have graduated from a medical school accredited by the Liaison Committee on Medical Education (LCME) or the Committee on Accreditation of Canadian Medical Schools (CACMS).1 LCME is the national (US) authority for the accreditation of undergraduate medical education programs, sponsored jointly by the Association of American Medical Colleges (AAMC) and the Council on Medical Education of the American Medical Association (AMA). The LCME accredits medical schools in the United States and Canada, while the CACMS accredits only Canadian medical schools. Applicants who have not graduated from an LCMEor CACMS-accredited school are required to pass an additional examination, the Evaluating Examination, prior to entering a postgraduate training program. Successful completion of this examination also makes them eligible for Canadian licensure.

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Examinations All state medical boards and provincial registrars require physician-applicants to have passed an approved licensing examination. State medical boards in the United States accept the following examinations sponsored by the National Board of Medical Examiners (NBME), the Federation, and the American Osteopathic Association (AOA), dependent on the jurisdiction: The Medical Council of Canada

• NBME Parts 1, 2, and 3

(MCC) is the national • FLEX Components 1 and 2 organization responsible for • USMLE Steps 1, 2, and 3 developing Canada’s qualifying • COMLEX Parts 1, 2, and 3

medical examinations and

• NBOME Parts 1, 2, and 3

establishing policies governing

The Medical Council of Canada (MCC) is the national organization responsible for developing Canada’s qualifying medical examinations and establishing policies governing test administration. The MCC includes 24 representatives from the provincial and territorial licensing authorities and one representative from each of Canada’s 16 medical schools. The initial Canadian licensing examination, the Medical Council of Canada Qualifying Examination (MCCQE), is in two parts and is the Canadian counterpart to the United States Medical Licensing Examination (USMLE). The MCCQE differs from the USMLE in that it includes a clinical segment that exposes the examinee to a series of 14 encounters with standardized patients to evaluate actual performance, which pencil-and-paper examinations alone cannot accomplish. Part I of the MCCQE is usually taken upon completion of the final year of medical school, and is considered both an “exit” exam from medical school and an “entrance” exam to postgraduate training. Part II is taken after one year of postgraduate training. Upon satisfactory completion of both parts of the exam, a candidate is eligible to become a Licentiate of the Medical Council of Canada (LMCC), which is required in order to obtain full registration in eight of the 10 provinces and one of the two territories. Part I of the MCCQE is a two-day, four-book examination focusing on the traditional clerkship rotations that include medicine, surgery, obstetrics and gynecology, pediatrics, preventive medicine/community health, and psychiatry. (Note: “Clerkship” refers to the final two years of Canadian medical school education.) This portion of the exam progresses in difficulty from the first through the fourth book; the last of these includes a multiple-choice section (with menus of up to 35 possible responses) and a section of open-ended situational questions. The exam is offered in French or English and is developed by the MCC’s Test Committee. This committee is a representative cross-section of the Canadian population in terms of gender, region, and language. Approximately 2,200 candidates sit for Part I of the MCCQE each year. Part II of the exam consists of 14 clinical situations presented to the examinee. Half of these are 10minute encounters with patients; the other half are five-minute encounters followed by a five-minute segment the examinee must write based on that encounter. Physician-examiners observe candidates and evaluate the encounters and the written work of each examinee. This portion of the MCCQE assesses a candidate’s abilities in the areas of physical examination, obtaining and evaluating a patient’s history, management of acute symptoms, and communication skills with patients seeking

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test administration.

The Medical Council of Canada Qualifying Examination (MCCQE), is in two parts and is the Canadian counterpart to the United States Medical Licensing Examination (USMLE).

advice and counsel. As with Part I, a passing score is set by the Central Examination Committee. Approximately 2,000 candidates take Part II of the MCCQE each year.

Every Canadian provincial regulatory authority except Quebec recognizes Parts I and II of the MCCQE as meeting the core of their examination requirements for licensure.

In addition to the MCCQE Parts I and II, the MCC also administers the Medical Council of Canada Evaluating Examination (MCCEE). This examination is required of all applicants who have not graduated from an LCME- or CACMS-accredited medical school, but who have graduated from an institution listed in the most recent World Directory of Medical Schools issue published by the World Health Organization. Upon successful completion of the MCCEE, an applicant is eligible to sit for Part I of the MCCQE.2 Other required examinations leading to licensure in Canada include the specialty certification examinations the Royal College of Physicians and Surgeons of Canada (RCPSC) and the College of Family Physicians of Canada (CFPC) administer. Before issuing a license, many provincial authorities (see chart) require passage of one of these examinations in addition to successful completion of the MCCQE or USMLE exam sequences. Every Canadian provincial regulatory authority except Quebec recognizes Parts I and II of the MCCQE as meeting the core of their examination requirements for licensure. Some provinces also require other examination sequences in addition to the MCCQE. The chart presents a summary of the acceptable examination sequences throughout Canada. In the chart, “LMCC” represents provinces where the MCCQE Parts I and II are required. When “MCCQE” appears alone, it refers to the pre1992 requirement that consisted of Part I only, as no Part II existed until 1993. Also note that Ontario requires Parts I and II of the exam but does not require LMCC certification. Canadian Province Alberta

ACCEPTED LICENSING EXAMINATIONS LMCC, certificate from RCPSC or certificate from CFPC

British Columbia

LMCC, MCCQE, MCCEE, USMLE, Certificate of Specialization or Fellowship from RCPSC or CFPC

Manitoba

LMCC, FLEX, NBME, USMLE, certificate from RCPSC

New Brunswick

Only LMCC

Newfoundland

LMCC, FLEX, NBME, USMLE

Northwest Territories

MCCEE

Nova Scotia

LMCC, NBME, FLEX, USMLE (US graduates must be licensed in United States.)

Ontario

MCCQE I and II, and RCPSC or CFPC; NBME, FLEX

Prince Edward Island

LMCC

Quebec

LMCC is not recognized; written, oral, and clinical exams in family medicine or a specialty in accordance with requirements of the College des Medecins due Quebec

Saskatchewan

LMCC, FLEX, NBME

Yukon

LMCC

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Quebec is the only province not recognizing or requiring LMCC certification as at least one part of its requirements for licensure. (Note: The licensing authority of the Northwest Territories requires only the MCCEE, but accepts LMCC certification as meeting its requirements.) The Quebec licensing authority accepts only written, oral, and clinical exams in family medicine or in a specialty in accordance with regulations established by the College des Medecins du Quebec (College of Physicians of Quebec). Ontario requires completion of Parts I and II of the MCCQE, as well as completion of the certifying examination that either the RCPSC or CFPC administers.

Most state medical boards recognize postgraduate training

Postgraduate Training Most state medical boards recognize postgraduate training that has been completed in programs accredited by either the Accreditation Council for Graduate Medical Education (ACGME), the RCPSC, or the CFPC. The ACGME accredits residency programs in the United States, while the RCPSC and CFPC are the equivalent accrediting organizations in Canada and accredit only Canadian postgraduate programs. In addition to sponsoring all postgraduate training programs, Canadian medical schools also control jurisdiction and accountability for such programs. Deans of medical schools are accountable to the accreditation teams of the RCPSC and CFPC. Independent hospital programs do not exist as they do in the United States. (Note: Approved postgraduate training is not offered in New Brunswick, Prince Edward Island, or the Yukon Territories since these jurisdictions have no medical schools.) Also, the Federation of Medical Licensing Authorities of Canada (FMLAC) has representatives on the accreditation site teams of both the RCPSC and CFPC. RCPSC and CFPC accreditation standards generally are considered equivalent to the United States counterparts. Most Canadian provinces and territories accept ACGME-approved residency training completed in the United States as satisfying their requirements for licensure. Quebec and Ontario, however, require a physician to complete at least one year of postgraduate training in a Canadian residency program. While approved training programs are similar in each province, the amount of required postgraduate training varies. To maintain oversight of all physicians enrolled in postgraduate training programs, nine of the 10 provincial licensing authorities in Canada issue “educational licenses,” which must be obtained prior to the start of a residency program, remaining in effect until postgraduate training is completed. This mechanism ensures that all residents are subject to the provincial or territorial licensing authority oversight beginning with their first day of postgraduate education. The accompanying chart presents a summary of the postgraduate training requirements Canadian licensing authorities impose.

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that has been completed in programs accredited by either the Accreditation Council for Graduate Medical Education (ACGME), the RCPSC, or the CFPC.

Canadian Alberta

Province

POSTGRADUATE TRAINING REQUIRED two years PGT in RCPSC- or CFPC-approved program

British Columbia

• medical degree + LMCC + RCPCS • medical degree + LMCC + CFPC • medical degree + LMCC + one of two years PGT (one year in Canada) or two years PGT and five years of practice in British Columbia on the temporary register

Manitoba

two years PGTin FMLAC, RCPSC, or CFPC, or ACGME program

New Brunswick

two years PGT in ACGME, RCPSC, or CFPC program

Newfoundland

two years PGT in program approved by CFPC, RCPSC, FMLAC, or ACGME and certification from RCPSC or CFPC

Northwest Territories

RCPSC (or Quebec equivalent) or CFPC (or Quebec equivalent) specialty certification or two years PGT, and 12 months of additional clinical training; and certificate of standing from licensing authorities where applicant is cur rently licensed

Nova Scotia

RCPSC or CFCP certification, or two years PGT (Nova Scotia will be defining the requirements of the third pathway—possibly matching New Brunswick.)

Ontario

one year of Canadian PGT in RCPSC-recognized program or one year active practice in Canada

Prince Edward Island

RSPSC or CFPC or two PGT (Prince Edward Island is presently discussing the specific requirements for third pathway—possibly matching New Brunswick.)

Quebec

two years PGT in family medicine (one year must be completed in Quebec) or full residency program in a specialty (one year must be completed in Quebec); all Canadian training (out side Quebec) must be RCPSC- or CFPCapproved; all United States training must be ACGME-approved

Saskatchewan

two years PGT in ACGME-, RCPSC-, or CFPCapproved program

Yukon

specialty certification from RCPSC

As previously mentioned, the RCPSC and CFPC serve as the Canadian counterpart to the United States’ ACGME in the area of postgraduate training. The Royal College accredits PGT in all specialty areas, and the CFPC accredits PGT in family practice and general medicine. The two earlier charts, however, reveal the primary difference from the US process. In most provinces, an applicant for Canadian licensure must pass the certifying examination these organizations administer prior to receiving a license. Because these organizations confer recognition of

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specialization through their exams, it is also accurate to describe them as the Canadian counterparts to the ABMS. In Canada, however, a physician must choose either RCPSC or CFPC certification, becoming either a “specialist” in the traditional sense (RCPSC) or a family practitioner (CFPC). The basic steps in the licensure and specialty certification process that physicians must complete in each country are outlined in chart format. Board certification is explored further in another section of the manuscript. UNITED STATES PROCESS

CANADIAN PROCESS

LCME-approved medical school USMLE Steps 1 and 2

CACME- or LCME-approved medical school MCCQE Part I

ACGME- or AOA-approved postgraduate training USMLE Step 3

RCPSC- or CFPC-approved postgraduate training MCCQE Part II

Licensure by a state medical board

Certifying exam of RCPSC or CFPC in a specialty or Family Medicine

ABMS board certification

Provincial or Territorial Licensure

BOARD CERTIFICATION Medical Education and Postgraduate Training Canada and the United States approach certification of a medical specialty at different stages in the licensure process. In the United States, all but two ABMS boards (genetics and radiology) require a full and unrestricted license prior to obtaining specialty certification. In Canada, licensure and specialization are intertwined. Every state medical board in the United States requires physicians to have at least one year of postgraduate training prior to issuing a full and unrestricted license. The first year, however, may not include extensive training in a specialty. Further, state medical boards do not require board certification prior to licensure. In fact, the US process is opposite that of Canada: licensure must precede specialty certification for American physicians (except in genetics and radiology). In Canada, physicians must complete postgraduate training prior to licensure, and many provinces require successful completion of the certifying examination the Royal College or the CFPC administers before issuing a license.

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As with board certification in the United States, Canadian physicians must pass a certifying examination the RCPSC gives, which affirms that the physician has met the Royal College’s standards, has satisfactorily completed a defined period of specialty or subspecialty training in a program the Royal College approved, and has successfully completed the certifying examination.

While the certifying boards in both countries (ABMS, RCPSC, and CFPC) generally grant reciprocal recognition with respect to training programs, they do not grant such reciprocal recognition with regard to certifying examinations.

Orthopedic Surgery Otolaryngology Pathology Pediatrics Physical Medicine & Rehabilitation Plastic Surgery Preventive Medicine Psychiatry & Neurology Radiology Surgery Thoracic Surgery Urology

Allergy & Immunology Anesthesiology Colon & Rectal Surgery Dermatology Emergency Medicine Family Practice Internal Medicine Medical Genetics Neurological Surgery Nuclear Medicine Obstetrics & Gynecology Ophthalmology

Examinations Board certification by the ABMS is granted to fully licensed physicians after successful completion of a residency and/or fellowship program, and the specialty board’s certifying examination. Physicians may obtain ABMS board certification in the following specialties: As with board certification in the United States, Canadian physicians must pass a certifying examination the RCPSC gives, which affirms that the physician has met the Royal College’s standards, has satisfactorily completed a defined period of specialty or subspecialty training in a program the Royal College approved, and has successfully completed the certifying examination. The primary difference, however, is that in Canada this process is usually required prior to licensure. A Canadian physician may receive a certificate from the Royal College after successful completion of an examination in the following specialty areas:3 Anesthesia Cardiac Surgery Cardiology Clinical Immunology & Allergy Community Medicine Dermatology Diagnostic Radiology Emergency Medicine Endocrinology & Metabolism Gastroenterology General Pathology General Surgery Geriatric Medicine Hematology

Hematological Pathology Infectious Diseases Internal Medicine Medical Biochemistry Medical Genetics Medical Microbiology Medical Oncology Nephrology Neurology Neuropathology Neurosurgery Nuclear Medicine Obstetrics/Gynecology Occupational Medicine

Ophthalmology Orthopedic Surgery Otolaryngology Pediatric General Surgery Pediatrics Physical Medical/Rehabilitation Plastic Surgery Psychiatry Radiation Oncology Respirology Rheumatology Thoracic Surgery Urology Vascular Surgery

A Canadian physician also may receive certification in Family Medicine from the CFPC upon successful completion of the CFPC certifying examination.4 While the certifying boards in both countries (ABMS, RCPSC, and CFPC) generally grant reciprocal recognition with respect to training programs, they do not grant such reciprocal recognition with regard to certifying examinations. The accompanying chart displays the ABMS requirements for certification for

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each ABMS specialty area. Of particular interest is the information in the column “Training Credit Accepted.” Most ABMS boards will recognize at least some RCPSC training as satisfying their requirements. Also note that in the column, “Other Requirements,” every ABMS board requires a physician seeking specialty certification in the United States to pass its own board examination. The same is true in Canada; while the Royal College will accept ACGME- and ABMS-approved postgraduate training and fellowships, Canadian certification in that specialty is given only after a physician has passed the certifying examination of the Royal College or the CFPC. These factors are important considerations for any physician seeking to relocate his/her practice to Canada.

Because osteopathic physicians trained in the United States are

One final note: Because osteopathic physicians trained in the United States are not graduates of LCME- or CACMS-approved medical schools, they are treated as international medical graduates (IMGs) in Canada. If an osteopathic physician trained in the United States seeks Canadian licensure, he/she must pass the MCCEE prior to satisfying any additional requirements in the province or territory where the physician seeks licensure.

not graduates of LCME- or

CONCLUSION

Canada.

CACMS-approved medical schools, they are treated as international medical graduates (IMGs) in

The Federation has prepared this report as a service to its member medical boards. It is intended to highlight the similarities and differences between the Canadian and American systems of medical licensure and specialty certification. It is not intended to be used as a basis for decision-making by physicians who may be considering moving from one country to another. Physicians who are considering relocating from the United States to Canada are advised to consult the licensing authority in the province or territory where they desire to practice in order to obtain a complete list of all requirements. Another excellent source of information about Canadian licensure requirements is the Canadian Medical Association's publication, MedGuide. Physicians coming to the United States from Canada are urged to contact the medical board in the state where they desire to practice in order to obtain the board’s requirements. General information on United States licensure requirements also is available from the Federation of State Medical Boards’ office. NOTES 1. In Canada, CACMS functions similarly to the LCME. The CACMS, however, accredits only Canadian medical schools. While most provinces accept graduation from schools either organization accredits as meeting their requirements, the LCME remains the most widely recognized accrediting organization. Through significant cross-representation, these two accrediting bodies are intertwined, as several members of each organization sit on the governing board of the other. 2. For complete information about the core examinations required for Canadian licensure, contact the Medical Council of Canada, PO Box 8234, Station T, Ottawa, Ontario K1G 3H7. Tel: (613) 521-6012.

Physicians who are considering relocating from the United States to Canada are advised to consult the licensing authority in the province or territory where they desire to practice in order

3. For complete information about the examinations administered by the RCPSC for specialty certification, contact the Royal College of Physicians and Surgeons of Canada, 774 Echo Drive, Ottawa, Ontario K1S 5N8. Tel: (613) 730-8177. 4. For complete information about the examination administered by the CFPC for certification in family medicine, contact the College of Family Physicians of Canada, 2630 Skymark Avenue, Mississauga, Ontario L4W 5A4. Tel: (905) 629-0900.

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to obtain a complete list of all requirements.

BIBLIOGRAPHY Dauphinee WD. The qualifying examinations of the Medical Council of Canada. Echo. Dec 1996;7:2-3. American Board of Medical Specialties Research and Education Foundation. 1998 Annual Report & Reference Handbook. 1998;122. Canadian Medical Association. MedGuide: An Information and Licensure Handbook for Canadian and Foreign Physicians. Fourth Edition. 1995. The Royal College of Physicians and Surgeons of Canada. College Activities. Available at http://www.rcpsc.medical.org. Accessed March 20, 1998. Medical Council of Canada. Credentials and Registration. Available at http://www.mcc.ca. Accessed March 20, 1998. The College of Family Physicians of Canada. The Certification Examination in Family Medicine. Available at http://www.cfpc.ca/serv04a.htm. Accessed March 20, 1998. College of Physicians and Surgeons of Alberta. Qualifications for registration. Alberta Medical Register. March 1994. Government of the Northwest Territories. Requirements for Licensing of Foreign Medical Graduates. October 1997. Yukon Justice. Licensure Requirements. 1997. College of Physicians and Surgeons of Saskatchewan. Registration Requirements and Procedures. 1997. College des Medecins du Quebec. Requirements for Licensure in the Province of Quebec for Graduates of American Medical Schools or Schools of Osteopathic Medicine in the USA. 1997. The College of Physicians and Surgeons of Prince Edward Island. Registration and Licensing Requirements in Prince Edward Island. April 1997. The College of Physicians and Surgeons of Manitoba. Requirements for Medical Registration. Available at http://www.umanitoba.ca/colleges/cps/_Text/reg1.html. Accessed March 15, 1998. The College of Physicians & Surgeons of British Columbia. Rules Made Under the Medical Practitioners Act Regarding Registration Requirements. October 1995. The College of Physicians and Surgeons of Ontario. Registration and Membership Process. Available at http://www.cpsc.on.ca/regintro.htm#crape. Accessed March 15, 1998. The College of Physicians & Surgeons of Alberta. Net changes to Alberta physician pool. The Messenger. February 1998. 60:6-7. Maryland Board of Physician Quality Assurance. Update on Canadian Licensure Requirements. April 1996.

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CANADIAN LICENSURE AND SPECIALTY CERTIFICATION GLOSSARY OF ACRONYMS ACMC: Association of Canadian Medical Colleges CACMS: Committee on Accreditation of Canadian Medical Schools CFPC: College of Family Physicians of Canada CMQ: College des Medecins du Quebec (College of Physicians of Quebec) FMLAC: Federation of Medical Licensing Authorities of Canada LCME: Liaison Committee on Medical Education LMCC: Licentiate of the Medical Council of Canada MCC: Medical Council of Canada MCCEE: Medical Council of Canada Evaluating Examination MCCQE: Medical Council of Canada Qualifying Examination RCPSC: Royal College of Physicians and Surgeons of Canada

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ATTACHMENT 1: ABMS MEMBER BOARDS: REQUIREMENTS

FOR

GENERAL CERTIFICATION

*ACCREDITATION COUNCIL

FOR

GRADUATE MEDICAL EDUCATION

1. Contact member board for application deadlines 2. Royal College of Physicians and Surgeons of Canada 3. One year of clinical residency or subspecialty pathology training 4. From completion of training 5. More than five years after training require further training

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6. Five years written exam, five years certifying exam 7. College of Family Physicians of Canada 8. College of Physicians of Quebec 9. Base clinical year only 10. Full RCPSC-accredited training only 11. ACGME-equivalent training only 12. Individual basis only

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13. Twelve months maximum 14. If all training completed in Canada (and begun after 7/16/97 if Neurological Surgery) 15. Three general surgery/two plastic surgery 16. Not accepted for practice requirement 17. RCPSC certification required

18. Graduate of Liaison Committee on Medical Education 19. Canadian College of Medical Geneticists 20. AOA-approved training accepted for PGY1 only 21. Only training initiated prior to 7/1/97 may be accepted

TO CONFIRM CURRENT OFFICIAL POLICY OF INDIVIDUAL SPECIALTY BOARDS, CONTACT THE RESPECTIVE BOARD. FROMTHE 1998 AMERICAN BOARDOF MEDICAL SPECIALTIES ANNUAL REPORT AND REFERENCE HANDBOOK . REPRINTEDWITHPERMISSION .

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SPECIAL COMMITTEE

ON

MANAGED CARE PREAMBLE In April 1996, Federation President James E. West, MD, established a Special Committee on Managed Care to evaluate the impact of managed care on the medical regulatory system. President West directed the committee to • evaluate current relationships between managed care organizations (MCOs) and state medical boards to determine the effectiveness of such relationships in providing an appropriate degree of public protection; • determine what data collected by managed care organizations may be used by state medical boards in assessing quality of care rendered by physicians in such organizations and how medical boards may access such data; • review the different forms of contractual relationships between managed care organizations and physicians and determine which types of contracts, if any, might endanger public health and welfare; and • evaluate methods used by managed care organizations in selecting/deselecting physicians for participation and the effect that minor disciplinary actions taken by state medical boards might have on the deselection process. President West also charged the committee with developing recommendations regarding • appropriate mechanisms through which medical boards may establish relationships with managed care organizations; • rules/requirements that state medical boards should develop regarding the practice of medicine in managed care organizations which may enhance public protection; and • alternative forms of discipline to maintain public protection while protecting the physicians against undue exclusion from participation in managed care organizations. The committee met in August 1996, February 1997, May 1997, and September 1997. To ensure a complete and objective report, the committee solicited input from the following organizations: • The American Medical Association provided information about contractual provisions contained in physician contracts with MCOs that could potentially harm patients. • The Kaiser Permanente Foundation, representing the American Association of Health Plans, shared information about its physician credentialing and medical director performance evaluation systems. • The National Committee on Quality Assurance (NCQA) provided information regarding NCQA standards for physician recredentialing, complaint processing, and appeals processes.

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The committee agreed on three fundamental guiding principles in fulfilling its charge. 1. The primary responsibility of a state medical board is to protect the public from the incompetent, unprofessional, improper, and unlawful practice of medicine. 2. The authority for state medical boards to regulate medical practice is determined by each state’s relevant statutes and/or administrative rules. 3. The committee’s conclusions and recommendations would be developed within the framework of the medical profession’s code of ethics, which holds that the doctor must always be an advocate for the patient in matters of the patient’s health and welfare and, therefore, the doctor/patient relationship must be protected from conflicts of interest. SECTION I: OBJECTIVES The committee identified the following objectives: A. Include in its final report for distribution to state medical boards: 1. a glossary of pertinent terms 2. an index of contractual clauses/types that could endanger the public’s health and welfare 3. a listing of data collected by the managed care industry which may be useful to state medical boards in assessing quality of care rendered by physicians in such organizations and how medical boards may access such data 4. an assessment of methods used by managed care organizations in selecting/deselecting physicians for participation 5. recommendations for establishing liaison relationships with managed care organizations to ensure an appropriate degree of public protection 6. recommendations regarding the use of alternative forms of discipline by state medical boards which maintain public protection while protecting the physicians against undue exclusion from participation in MCOs B. Develop recommendations that will improve the sharing of information between state medical boards and managed care organizations and their regulatory bodies. C. Develop strategies that medical boards may use to ensure decisions concerning precertification review or utilization review and appropriateness of care are made by licensed physicians accountable to the state medical board. D. Develop language for inclusion in the Federation policy document, A Guide to the Essentials of a Modern Medical Practice Act, that strengthens medical boards’ regulation of physician activity within managed care networks. E. Develop strategies for use in monitoring state and federal legislative initiatives regarding managedcare that restrict or impact a medical board’s ability to license and discipline physicians.

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F. Develop and implement educational opportunities for medical board members and executive directors, policymakers of managed care organizations and the public regarding the committee’s recommendations. Such educational programs may include regional workshops, sessions at the annual meeting, or articles in the Bulletin.

SECTION II: C OMMITTEE DELIBERATIONS A. Relations Between State Medical Boards and MCOs The Federation conducted a survey confirming that medical boards currently do not have regulatory oversight of MCOs. Rather, MCOs are generally accountable to a state’s department of insurance or department of corporations. There was careful discussion regarding whether or not medical boards should seek out responsibility for regulating MCOs. The committee agreed that while there may be need for further and better state regulation of MCOs, to bring this function under the wing of state medical boards would be extremely difficult, could not be accomplished quickly, and might even be detrimental to the current function of many state medical boards. Therefore, the committee determined early on to confine its deliberations and recommendations to the regulation of physicians. Regulation of MCOs by state medical boards would require major legislative changes and major overhaul of the functions of state medical boards. In determining the types of informal relationships that may exist between state medical boards and MCOs, committee members reviewed models from California, Maryland, and New Jersey that demonstrated interagency relationships between the medical board and the state agency responsible for regulating MCOs. It was apparent that few medical boards have established relationships with managed care organizations or the agencies with responsibility for regulating them. The lack of either formal or informal relationships between medical boards, MCOs and their responsible regulatory agencies may not adequately protect the public, particularly when a quality of care issue involving a physician arises. In order for medical boards to protect the public from physicians who are violating the applicable medical practice act, boards must collaborate with other state agencies to obtain information concerning physicians cited in quality of care complaints. At present, MCOs report only what the law requires. MCOs gather mountains of information concerning physician practice patterns. In its review of data collection practices used by MCOs, the committee determined that, if all data collected were reported to state medical boards, boards would be overwhelmed trying to glean significant data from that which has no bearing on the physician’s ability to practice competently. Specific information regarding MCO physicians who are being investigated or disciplined by the MCO for quality of care issues should be reported to the state medical board. The committee agreed that medical boards should have access to physician performance data for investigative purposes. The committee discussed whether medical boards have jurisdiction over physicians whose positions as MCO medical directors requires them to render decisions that potentially affect patients’ medical care. Critical to this discussion is the question of whether or not the determination of medical necessity is the practice of medicine. Because medical directors and other MCO employees apply medical judgment in determining if a proposed treatment is necessary, the committee agreed that the determination of medical necessity is in fact the practice of medicine. The committee

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determined that MCO employees who evaluate and determine a patient’s need for medical treatment should be licensed physicians accountable to the medical board in the jurisdiction in which the health plan enrollee resides. Such a requirement will give state medical boards jurisdiction to investigate complaints arising from medical precertification decisions made by MCO medical directors. B. Physician Contractual Arrangements The committee recognized the positive influence that managed care could have on the US health care delivery system, and cited the following as having particular potential for improving care: 1.

prevention of unnecessary services to save money

2.

managed formularies to preserve effectiveness of newer antibiotics

3.

outcome studies to help physicians determine efficacy of experimental therapies

4.

regular peer review for quality of care

5.

inspection of physician office practice

6.

reporting of substandard care

7.

more data on patient satisfaction

8.

increased emphasis on preventive medicine

9.

emphasis on quality credentialing processes

10. increased home health services 11. increased patient compliance due to decreased cost The committee reviewed a series of provisions contained in physician contracts routinely used by the managed care community. Many of these provisions could result in patient harm because they either restrict the physician’s ability to communicate with his or her patients, or create a conflict of interest between the patient’s health and the organization’s economic standing. Potential problem areas include 1.

gag rules;

2.

economic advantage to physicians to deny service or referral;

3.

bonuses to physicians based on economic performance;

4.

denials based on cost rather than need;

5.

if refers outside of network, physician has to indemnify plan;

6.

if provides non-covered services, physician cannot recover payment from patient;

7.

physician sanctions for failure to adhere to guidelines;

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8.

deselection, destroying doctor-patient relationship;

9.

unavailability for or untimely approval of emergency care;

10. delays in decisions due to preauthorization requirements; 11. delays in diagnosis due to delayed approval of needed testing; 12. external control over physician decision-making; 13. care by non-physicians; 14. medical decisions by non-physicians; 15. rationing of care due to prioritization; 16. limited referral sources; 17. limited formularies; 18. limited services for chronic care, mental health; 19. early hospital discharge; 20. unilaterally changing plans/contracts; an 21. itinerant surgery by contracted physicians. C. National Organizations Representing the Managed Care Industry A representative of the Kaiser Permanente Foundation, representing the American Association of Health Plans (AAHP), described its mission and role in the managed care industry. This organization serves primarily as a trade association, has no real enforcement powers, and, therefore, may be of little help in solving the problems identified by the committee. The NCQA, on the other hand, accredits MCOs. Many states use NCQA standards as the foundation for developing their MCO licensing standards. Fifty-five percent of MCOs have achieved NCQA accreditation by receiving a passing score on a compliance survey with an extensive list of criteria. Such accreditation is highly sought after, since it makes an MCO much more marketable. Because of the above, the committee determined that NCQA should be encouraged to include standards that would require reporting of quality of care issues to state medical boards. Additionally, other criteria protective of the public might become part of the standards under the urging of FSMB. Even if these efforts were successful, however, it must be remembered that NCQA accreditation (a passing score) could be achieved without complying with many of the criteria important to the Federation. D. Selection For and Deselection From MCO Physician Panels MCOs choose to enter into or terminate physicians’ contracts for a variety of reasons. Some decisions are based on business factors such as a reduced need for specialists, the physician’s inability to appropriately manage costs, or in some cases, because the physician has been sanctioned by a

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statemedical board. Often, however, an MCO’s decision to hire or fire a physician is based on quality of care issues, such as the physician’s inability to abide by or meet the MCO’s quality of care standards. This practice raises concerns. First, MCOs are not likely to notify state medical boards when they deselect physicians for quality of care issues, thereby crippling a medical board’s ability to appropriately protect the public from these practitioners. Second, deselection by multiple MCOs based on minor state medical board actions, even non-disciplinary actions, may effectively put a physician out of business. As a result, medical boards are being pressured to modify their sanctioning procedures by physicians who may be negatively impacted when MCOs base their selection/deselection decisions solely on the fact that a sanction occurred, without consideration for why the sanction was given. In an effort to assist these physicians, some state medical boards have developed and are using sanctions that are structured as confidential arrangements between the physician and the medical board. As such, information about these types of actions is not included as a matter of public record, and, therefore, is not available to MCOs and the public. This practice could potentially undermine public trust in the medical regulatory system as well as subvert the interstate exchange of information which is critical to effective regulation of the medical profession. Prior to deselection, a physician must be granted due process by the MCO. NCQA has promulgated standards to require due process in this situation. The committee believes that these standards must be enforced. Should state medical boards alter their actions based on the above consideration? In states with open meeting laws the question is moot, since MCOs act on the cases presented rather than on a specific board action. In states where the public is informed only of final board actions, however, the specific action taken could have a profound effect on the physician’s future. In spite of this, the committee reaffirmed that the medical board’s primary responsibility is to protect the public, not the physician, and the possibility of deselection, even though an untoward result, should not enter into a board’s disciplinary process. SECTION III: R ECOMMENDATIONS A. State medical boards should establish mechanisms to facilitate regular communication between the board, the MCOs operating within the state, and the government agency through which the MCOs are regulated. Such mechanisms may include 1. a listing of the names and addresses of managed care organizations and their medical directors; 2. letters of agreement to facilitate reporting of disciplinary actions involving a quality of care issue taken by an MCO against a licensed physician; 3. formal reporting mechanisms for state medical boards to obtain information regarding physician quality of care complaints collected by the regulatory agency with jurisdiction over MCOs; and 4. regular liaison meetings involving representatives from the association representing MCOs in a state, the state agency with regulatory responsibility over MCOs, and the state medical board.

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B. State mandatory reporting laws must be clarified and/or amended to require MCOs to report physician quality of care issues, physician impairment, and physician deselection and the reason therefor. C. State medical boards, through legislative or regulatory process, should amend their medical practice acts or appropriate statutes to include the determination of medical necessity or decisions affecting the diagnosis and/or treatment of a patient as the practice of medicine. Further, MCO employees with the ultimate responsibility to make such determinations must hold a current and unrestricted medical license in the state in which the patient of the plan resides. D. State medical boards must, through legislative or regulatory process, require that MCO medical directors hold current and unrestricted medical licenses in the states in which the patients of the plan reside. E. State medical boards should support legislation against contractual provisions that are potentially harmful to the public, including but not limited to the use of gag rules and economic incentives to restrict care. F. State medical boards should modify their medical practice acts or appropriate statutes to include as unprofessional conduct, subject to disciplinary action, the following actions when such actions are taken for the sole purpose of positively influencing the physician’s or plan’s financial well-being: failure to refer, failure to offer appropriate procedures/studies, failure to protest inappropriate managed care denials, failure to provide necessary service, or failure to refer to an appropriate provider. G. State medical boards should encourage the public to report complaints concerning the quality of care received from a physician participating in a managed care network to the state medical board as well as to the managed care organization in which the physician is participating. H. State medical boards should encourage medical schools in their jurisdiction to educate residents and students about ethics of decision making in a managed care environment. I. State medical boards, recognizing their roles as public advocates, should not alter the way in which they sanction or report physicians to protect those physicians from negative economic ramifications resulting from MCOs’ use of physician disciplinary information. Boards should educate their resident MCOs about the significance of various board actions in an effort to prevent inappropriate deselections. J. The Federation of State Medical Boards should encourage the American Medical Association, the American Osteopathic Association, and appropriate public citizens’ groups to advocate on behalf of the medical community to ensure that physicians either not selected by or deselected from managed care panels are provided appropriate due process, particularly when that selection is a result of a minor action taken against a physician by the state medical board. K. The Federation of State Medical Boards should monitor state/federal legislation related to managed care that would impact medical boards’ ability to protect the public through licensing and disciplining physicians. States should report any such legislative activity to the Federation for tracking. L. Federation of State Medical Boards should establish regular communication with appropriate national organizations that interface with the managed care industry, including but not limited to the NCQA, the Joint Commission on Accreditation of Healthcare Organizations, and the AHHP.

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M. The Federation of State Medical Boards should conduct an annual review of standards set by NCQA pertaining to physician performance issues and communicate to NCQA any concerns regarding those standards, including recommending additions or changes to enhance public protection. Ideally, the Federation of State Medical Boards should have a seat on the NCQA. SECTION IV: CONCLUSIONS While the concept of managed care has existed for almost half a century, only since the mid-1980s have MCOs made significant strides in influencing how health care is delivered in the US. MCOs, in general, contribute to containing the cost of health care in the United States, encouraging preventive medicine, and developing useful comparative data measurements regarding physician performance. However, for all the potential positive influences that managed care may have, significant concerns exist regarding cost containment systems used by MCOs that encourage physicians to ration care in exchange for greater monetary rewards. More and more states are choosing to deal with these concerns through legislative means. In fact, at the close of the spring 1997 legislative session, 13 states have passed patient protection acts that include, among other provisions, bans on the use of gag clauses and financial bonuses based on low utilization patterns. MCO medical directors are employees who make decisions for their employers on whether or not procedures are medically necessary. Such decisions are not insurance decisions, but rather medical decisions because they require the physician to apply medical judgment. [Murphy v. Board of Medical Examiners of the State of Arizona, 247 Ariz. Adv. Rep. 35, 949 p. 2d 530 (Ariz. App. 997), Rev. Denied (January 21, 1998).] Requiring medical directors to hold current and unrestricted medical licenses in the state in which the health plan enrollee resides gives the state medical board the authority and jurisdiction to investigate complaints arising from medical precertification decisions made by MCO medical directors. An MCO has the right to terminate a provider’s contract based on quality of care issues, thus protecting its enrollees from an incompetent physician. But unless the state medical board is notified of this action, that physician is free to practice medicine, unrestricted, on patients in other networks and other communities, potentially jeopardizing the health and well-being of the public. State medical boards are charged with protecting the public from the unprofessional, improper, incompetent, unlawful, fraudulent, and deceptive practice of medicine. The Federation, through the work of this committee and through future initiatives, intends to seek common ground with managed care providers and their regulatory bodies, and identify opportunities to collaboratively ensure that managed care enrollees have access to competent, qualified physicians. SECTION V: GLOSSARY The committee identified the following definitions as pertinent to its discussion of managed care. • Capitation (CAP). A contractual arrangement whereby a stipulated dollar amount is established to pay for all health care services delivered to a plan member by a health care provider over a specified period of time. • Employee Retirement Income Security Act (ERISA). A federally mandated plan to provide protection for the pension interests of employees. (ERISA preempts restrictive state health insurance

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laws insofar as they attempt to regulate self-funded employee plans, though courts have held that they can be applied to insurers.) • Financial. Mechanism through which physicians receive payments. • Incentives. To reward behavior impacting utilization of medical services. • Gag Clause. A provision in a managed care contract which prohibits a physician from discussing with a patient a potential diagnosis or therapeutic option if such is not covered by the patient’s benefit plan. • Health Maintenance Organization (HMO). A company (comprehensive health service organization) or set of related entities organized to provide health benefits to an enrolled population, for a predetermined fixed periodic amount paid by the purchaser (government, employer, or individual). Other than emergency services, neither enrollees nor providers receive payment for services obtained or provided outside the network. There are three general types of HMOs: 1. Staff Model. Physicians providing care in this model are salaried by the company which owns the HMO. These physicians usually limit their practices to subscribers of the HMO. Typically, the hospitals also are owned by the HMO, but some services may be contracted to selected hospitals. One example is Kaiser Permanente. 2. Medical Group Model. Physicians providing care under this model are in large multispecialty or primary care medical groups which contract with the HMO. These physicians usually draw the majority of their income from the HMO subscribers. Typically, the HMO contracts with hospitals as needed, but can own hospitals, eg, FHP, Inc, and Mullikin Medical Systems. 3. Independent Practice Association Model. In this model, physicians providing care are organized in IPAs, which contract with the HMO. These physicians generally receive a smaller portion of their income from several different HMOs, as well as indemnity subscribers. Typically, the HMO contracts with hospitals, as needed. Generally, Staff Model HMOs have the lowest cost structures and IPAs have the highest cost structures. • Health Plan Employer Data and Information Set (HEDIS). Standardized performance measures, including both reporting and testing measures, designed to assure that purchasers and consumers have the information they need to reliably compare the performance of managed care organizations. • Independent Practice Association (IP A). A legal entity comprised of practicing physicians who, while maintaining private practices, agree to work together for common managed care business purposes, usually capitated contracts. Typically, the IPA’s Board of Directors is authorized to negotiate with payors or total physician payment and empowered by participating physicians to determine methods and amounts of payment to physicians for professional services. Often formed for purposes of managed care capitated contracts, IPAs are capable of participating in any form of managed care. • Integrated Health Care Delivery System (IDS). A term which describes the aggregation of the complete spectrum of health care providers and organizations necessary to meet the health care needs of a defined patient population, for a predetermined payment under a range of managed care

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payment vehicles with various insurance companies. Included in a single IDS may be primary care physicians, specialists organized in some type of physician organization for managed care, an acute care hospital, rehabilitation services and facilities, long-term care facilities, home health care services, and hospice services. The nature and extent of the relationships can range from contractual agreements among the participants and joint ownership of segments of the IDS, to a single corporate entity. • Managed Care. A system of managing and financing health care delivery that seeks to ensure services provided to managed care plan members are necessary, efficiently provided, and appropriately priced. Through a variety of techniques, such as preadmission certification, concurrent review, financial incentives or penalties, managed care attempts to control access to provider sites where services are received, contain costs, manage utilization of services and resources, and ensure favorable patient outcomes. • Medical Necessity . Those covered services required to preserve and improve the health status of a plan member in accordance with the accepted standards of medical practice by the medical community in the area where services are rendered. • National Committee for Quality Assurance (NCQA). An independent not-for-profit organization nationally recognized as the leader in the effort to measure, assess, accredit, and report on the quality of care provided by the nation’s MCOs. • Patient Advocate. Individual who pleads or argues in favor of a cause, idea, or benefit in relation to a patient. This is considered a fundamental duty inherent in the physician-patient relationship. • Physician Hospital Organization (PHO) . In the managed care context, a business entity formed by a defined group of physicians and a hospital for managed care contracting. Examples of PHO relationships include a partnership model and a parent subsidiary model in which the hospital or the physician organization is the parent. Such organizations also may engage in non-managed care health-related activity such as ownership of facilities, home health services, etc. • Prefer red Provider Arrangement (PPA). An arrangement where a third party payor contracts with a group of medical providers who furnish services at lower than usual fees in return for prompt payment and a certain volume of patients. • Prefer red Provider Organization (PPO). A network of hospitals, doctors, or both who have agreed to a reduced fee in return for varying degrees of limitation on the number of participating providers. Conceptually, the greater the discount the smaller the network, so that participating providers are guaranteed higher volumes of patients. PPO health plans usually require an enrollee to pay a higher copayment for using non-PPO providers. EPILOGUE A draft of this report was circulated to all state medical boards and was presented to a meeting of executive directors of state medical boards. The committee is grateful to those who provided comments. Many of their suggestions have been incorporated into the final report.

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SPECIAL COMMITTEE ON MANAGED CARE Richard D. Zonis, MD, Chair Past Board Member Arizona Board of Medical Examiners Ray Q. Bumgarner, JD State Medical Board of Ohio Runette Flowers, MD Georgia Composite State Board of Medical Examiners Gilbert Hermann, MD Past Board Member Colorado Board of Medical Examiners Robert del Junco, MD Medical Board of California James F. Knapp, MD Past Board Member Minnesota Board of Medical Practice Ann M. Martino, PhD Iowa State Board of Medical Examiners Dinesh Patel, MD Past Board Member Massachusetts Board of Registration in Medicine Carole Shotwell, JD Wyoming Board of Medicine Anita M. Steinbergh, DO State Medical Board of Ohio FEDERATION STAFF Carol A. Clothier, Assistant Vice President Public Relations, Publications and Education

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DEVELOPMENT TEST

OF

OF A

PERFORMANCE-BASED

CLINICAL SKILLS

FOR THE

UNITED

STATES MEDICAL LICENSING EXAMINATION A T RADITION

OF

PERFORMANCE ASSESSMENT

OF

CLINICAL SKILLS

AT THE

NBME

From 1915 until 1964, all candidates for certification by the National Board of Medical Examiners (NBME) were required to demonstrate their patient-centered skills under the scrutiny of a medical examiner. While the fairness of this form of oral examination had been in doubt for some time, the test survived for nearly 50 years because of the profession’s belief in the validity of its message. No one doubted, nor does anyone now doubt, the importance of the clinical behaviors under scrutiny in the oral exam. The positive educational effect of the Part III oral examination was recognized, especially by the students who had to prepare for this anxiety provoking challenge. It was, however, the lack of precision of the measurement itself that resulted in the oral test being dropped from the NBME certification of skills. Indeed, even as the clinical oral was “with sincere regret, discontinued in the Part III examination,” the NBME had already begun efforts to replace the patient-centered oral test with a psychometrically acceptable proxy that might retain its professionally important message.1 D. Klass, MD, FRCP(C) SOME THINGS STAY

THE

SAME

A. De Champlain, PhD

The fundamentals of the challenge facing the NBME have remained unchanged. It remains the obligation of licensure to act in the interest of public health and safety. In this country, it remains an expectation that examination standards for entry to practice will be acceptable to the state medical boards and their Federation [Federation of State Medical Boards (FSMB)], and at the same time, these standards represent important benchmarks for educational programs. The licensure system continues to target for certification the critical elements of physician behavior that are judged to have the greatest impact on health. Licensure puts directly onto center stage, and under public scrutiny, the ability of all candidates to meet the standards of excellence that are the hallmark of the profession. Despite the advances of science and the turmoil affecting health care delivery, the physician’s daily tasks remain surprisingly constant. Medicine is still practiced one patient at a time, and most information about patients is still gathered by skilled history taking and physical examination. The profession still recognizes and adheres to what might be called Peabody’s Law. The significance of the intimate personal relationship between physician and patient cannot be too strongly emphasized, for in an extraordinarily large number of cases, both the diagnosis and treatment are directly dependent on it. One of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.2 Little wonder, then, that the licensure process continues to search for ways to satisfy the central obligation to measure patient-centered clinical skills, at the same time remaining aware of the imperative for fairness and precision in its decision-making process.

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E. Fletcher, MS A. King, MA M. Macmillan, MA National Board of Medical Examiners. Philadelphia, Pennsylvania. Copyright© 1998 by the National Board of Medical Examiners. Reprinted with permission from Proceedings of the Eighth International Ottawa Conference on Medical Education and Assessment. Forthcoming on CD-ROM.

BUT SOME THINGS CHANGE

While there may be many

What has changed is our growing recognition that measurements of many of these critical human behaviors can, in fact, be made with sufficient precision (given appropriate tools and their judicious use), to allow the message of these values to be returned to center stage in the licensure process. While the “rules” of measurement remain constant, the practices of testing have seen major changes in the past decades, especially in the recognition of the values and characteristics of performance assessment.

explanations for the growing

BARROW

adoption of the SP into the

In 1964, Howard Barrows described the first formal use of live simulations in medical education; the programmed or simulated patient (SP).3 This ingenious discovery made possible, for the first time, the construction of a test platform for the teaching and assessment of clinical skills which maintained the essential human element.

culture of US medical schools, none is more powerful than this: medical teaching and testing simply cannot skirt the major acts of the profession.

AND THE

SP M ETHOD

ADOPTION BY MEDICAL SCHOOLS Initially, Barrow’s ideas for the use of simulated (now, standardized) patients were not embraced with any enthusiasm by the world of medical education. Nonetheless, over the years, the logic and utility of the method have been increasingly appreciated to the point that now, almost all US medical schools use SPs in one way or another, and many have built, or are planning to build, organized teaching and assessment programs based on the use of standardized patients.4 RATIONALES

FOR

SP U SE

While there may be many explanations for the growing adoption of the SP into the culture of US medical schools, none is more powerful than this: medical teaching and testing simply cannot skirt the major acts of the profession. As an example, as Erving Goffman has reminded us, one of the central acts of the doctor, a performance required almost every day, and one of increasing importance in our thoroughly medicalized society is, “the special job of informing the infirm who they are going to be.” 5 This task simply cannot be reduced to paper and pencil, or, in the foreseeable future, to computer code, yet it remains an activity for which all trainees must prepare and be held accountable. It is often impractical, uncaring or unethical to use real patients as the educational or assessment platform in an undertaking of this delicacy, and in many others like it. Thus, the necessity for SPs. It is often impractical, uncaring BRIEF HISTORY or unethical to use real patients as the educational or assessment platform in an undertaking of this delicacy, and in many others like it.

OF THE

MULTIPLE-STATION EXAM PROCESS

The possibility of creating human simulations for licensure tests had already surfaced in the 1960s in the Critical Incident Study, prepared by the American Institutes for Research for the NBME.6 But the real impetus for their serious study by the NBME did not develop until a second penny dropped. While the recognition of the “task specific” nature of clinical performance had always been implicit in the very process of medical education, it took formal studies like those of Elstein, Sprafka, and Shulman 7 to convince most medical educators that conclusions drawn on the “competence” of exam candidates based only on performances in a few cases or patients were bound to be flawed. When it comes to clinical performance, there appears to be no single “attribute” to capture, and performance can only be summarized after a careful sampling of many diverse activities has been completed. From the measurement perspective, the variance is more in the tasks than it is in the candidates. From a practical sense, the dropping of this particular penny was noted first by Ronald Harden, who

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developed the idea of the multiple-station clinical examination, termed the OSCE,8 and then, with Ian Hart, and in the best Scottish tradition, exported his work, like fine whiskey and kippered herring, to an appreciative world. This meeting is but one happy testament to the power of their idea. It was then Howard Bar rows, David Newble, and Emil Petrusa who, independently, were among the first to put together the ideas of the OSCE and of SPs to produce a multiple-station examination as a formal measure of clinical performance. The Quebec Licensing Examination (QLex) was the first implementation of this format of examination in a licensure setting,9 followed by the Medical Council of Canada, and now the Educational Commission for Foreign Medical Graduates (ECFMG). The NBME has been pursuing the same goal since the establishment of the Standardized Patient Project in 1989. Under the aegis of the Steering Committee for the Evaluation of Clinical Skills, chaired by Dr George Miller, guiding principles for a test of clinical skills were established, and the methods that might be used for an exam designed to test all candidates for licensure in the United States began to be developed. From 1990 until 1995, a series of field trials and research studies were implemented to test the idea of using the SP method in a high stakes, large scale test. In a major milestone, in 1995, the governors of the [United States Medical Licensing Examination] USMLE (NBME and FSMB) accepted the framework for clinical skills testing that had been developed by the Miller Committee for further development, and the idea of SP testing was incorporated into the current Strategic Plan of USMLE with an initial target date for implementation set for 2001-2002.

The test under construction is designed to certify the patient-centered clinical abilities expected of all beginning PGY1 residents.

Since 1995, the SP Implementation Advisory Committee, chaired by Dean James Hallock, has been active in developing a formal plan for implementation, major elements of which are beginning to emerge. PURPOSE

OF THE

STANDARDIZED PATIENT TEST (SPT)

The test under construction is designed to certify the patient-centered clinical abilities expected of all beginning PGY1 residents. The documentation of these abilities will add a needed dimension to the information currently available from USMLE to state medical boards to help them make more informed licensure decisions about individual candidates. The test targets candidates about to undertake the challenges of the first postgraduate year, since it is at this level that individual trainees, by virtue of their holding the MD degree, are first viewed as “doctors,” both officially and in the eyes of the public. It is also at this level of educational and occupational activity that individual physicians first begin to have substantial contact with patients in relatively unsupervised circumstances. As a result, documentation of the ability of candidates to marshal the fundamental skills crucial for success in direct patient-doctor encounters is mandatory. These abilities, which are integral to the makeup of the competent physicians, include history-taking, physical examination, and communication and interpersonal skills.

designed for administration within the context of already existing USMLE licensure requirements, and will supplement currently

CONTEXT WITHIN USMLE The examination has been designed for administration within the context of already existing USMLE licensure requirements, and will supplement currently available information about individual candidates. The educational framework of the test is similar to that of USMLE Step 2, in that both target entering PGY1 candidates, but the dimensions assessed will sufficiently differ from those of Step 2 to merit a distinct decision arising from the SP component. The test will be made available to all USMLE registrants, but the expectation will be that students in US medical schools will attempt the test soon after having completed their core clinical training. It is the intention of the advisory committee that

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available information about individual candidates.

the test be made broadly available to candidates with as few artificial constraints as possible. The limitations which must be imposed are framed by the interrelated issues of eligibility, timing, and geographic availability. ELIGIBILITY Probably the greatest challenges facing test implementation are the geographic dispersion and numbers of candidates.

Candidates will be students in good standing, or graduates, of LCME-accredited [Liaison Committee on Medical Education] medical schools—or, in the case of candidates from schools not accredited by LCME, equivalently documented by, for example, ECFMG. Because of the nature of the SPT, particularly the fact that real people will be examined as part of the test, candidates will be required to have had preliminary, practical training in clinical skills to be qualified to take the test. Completion of a minimal set of required clinical rotations which feature patient care under supervision, taken as part of a clinical curriculum, will be the benchmark prerequisite. The readiness of candidates, as determined by this criterion, will be documented by their school of origin. TIMING Given the purpose of the test, all candidates should have completed the testing and reporting process of the SPT prior to commencing postgraduate education. This requirement sets the upper limit of timing for the test. Given the eligibility requirements, logistic constraints of implementation, and the range of educational programs in the US medical school community, it is anticipated that students will be most likely to take the exam in their fourth year of training, after most students will have completed core clinical clerkships. Two main windows of testing at sites across the United States are anticipated—the first, and longer, in the first half of the final year (eg, July-December) and the second, and shorter, in the early spring (eg, February-March). A small number of sites might make the test available on a more or less continuous basis. TEST AVAILABILITY Probably the greatest challenges facing test implementation are the geographic dispersion and numbers of candidates. There are 125 US medical schools and about 16,000 potential US candidates for the test each year. We have based our solutions to this challenge on several lines of reasoning, all of which argue for the development of multiple test sites around the country.

In several years of field trial exploration, the NBME has developed contractual relationships with many medical schools with the goal of administering high quality SP tests.

The “customers” for this test are the students themselves. A primary consideration in test planning has been to make the test process as inexpensive and accessible to these candidates as possible. To limit the cost and inconvenience of travel, we plan to administer the test as close to the students’ home medical schools as is practical. The conception and development of SPs for teaching and testing have come from medical schools, and over the years since their first description, many US schools have developed excellent SP programs, many with permanent testing facilities. Rather than building a single purpose test infrastructure from scratch, it seemed reasonable to the advisory committees to assume that testing for licensure could take place using this school-based infrastructure. This dependence of the licensure process upon medical school facilities reflects the traditional relationships between the NBME and US medical schools in clinical assessment, and acknowledges the shared responsibilities of the educational and licensure processes in the successful credentialing of all medical school graduates. In several years of field trial exploration, the NBME has developed contractual relationships with many medical schools with the goal of administering high quality SP tests. The model that we have

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used, in which NBME provides all direct costs for test administration, while the schools provide the test infrastructure in the form of facilities and services that they have developed to serve their own interests, has been satisfactory in preparing for this exam, and should prove equally satisfactory for live testing. A central element of this test administration model is a degree of collaboration that must be present between the NBME and the site institutions at both management and individual staff levels. The ability to sustain the discipline required for the administration of a high stakes licensure test at each of these sites requires bilateral commitment. Based on our growing experience in field trials, we believe that this degree of commitment can be achieved and maintained. The implementation plan proposed 45 test administration sites. Our arrangements with the sites are based on a developing set of criteria for administration at geographically distributed medical schools, so that the test will be made available to most US medical students close to their home medical school. At present, the SP project has ongoing case administration arrangements in place with 29 medical schools. Within two or three years, this number can be increased to the level determined to be optimal for implementation.

A central element of this test administration model is a degree of collaboration that must be present between the NBME and the site institutions at both management and individual staff levels.

TEST SITE CHARACTERISTICS The minimal requirement for each site is the availability of appropriate testing facilities and the presence of an SP training expert designated by the school to work with the NBME for a fixed period of testing time. The fulfillment of this target has been much enhanced by the growth of SP programs and sites at US medical schools. Recent surveys suggest that SPs have become standard features of the teaching and testing landscape in North America.4 At each test site, cases designed and developed by USMLE will be administered under careful USMLE supervision. School personnel will have been trained and accredited by USMLE staff. These school sites will largely accommodate candidates from LCME-accredited schools. Supplementary sites will be available for candidates from non-LCME-accredited schools who cannot be tested in the proposed network of school-based sites. It is anticipated that these nonBLCME-accredited medical graduates will register to take the test under the auspices of the ECFMG, and that ECFMG would be involved in mounting the test at the supplementary site(s) under identical conditions, and using identical cases, to those used at the school sites. The SPT cases are designed to

TEST CONTENT The SPT cases are designed to simulate a mix of patients that is representative of the typical clinical experience of the first postgraduate year. Case development is based on a situationally derived case development matrix, similar in principle to the Step 3 Practice Model.10 This model has, as its principal dimension, typical patient encounters derived by expert analysis of empirically obtained practice information. The second dimension of the model represents physician tasks that are generated from original data obtained by the NBME and the American Institute of Research in the “Critical Incident Study.”5 Data regularly will be added to the model from empirical surveys of appropriate databases and modified by the judgment of clinical experts, to ensure that the cases and physician tasks remain a relevant and valid sample of the target PGY1 experience. Individual cases are defined by a patient encounter blueprint (Table 1), and are developed from the direct experience of expert clinicians. The actual simulations are co-produced by NBME staff working

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simulate a mix of patients that is representative of the typical clinical experience of the first postgraduate year.

with teams of case developers at medical schools. The goals of case development are to ensure that the cases are highly realistic, represent important targeted clinical situations, and, above all, serve as effective measurement instruments.

The goals of case development

TABLE 1. PATIENT ENCOUNTER BLUEPRINT CLASS OF CASES

are to ensure that the cases are highly realistic, represent important targeted clinical situations, and, above all, serve as effective measurement instruments.

DATA GATHERING /

ROUTINE INFORMATION /

COUNSELING / PROFESSIONAL

ASSESSMENT I N DIAGNOSTIC

EDUCATION / COUNSELING

RAPPORT / EMOTIONALLY

CONTEXT

CHARGED CONTEXT

ENCOUNTER FRAMES

Emergent, Acute Limited, Chronic

T ASKS / EVALUATIVE

Hx Px

OBJECTIVES INTERPERSONAL SKILLS POST-ENCOUNTER NOTES ENCOUNTER TYPE (ALL FIRST VISITS)

PPQ

PPQ

List significant Px and/or Hx findings; record comments to patient Information from prior visit available for some cases

Document situation; record approach to patient Information from prior visit available for most cases

Office / Hospital

Office / Hospital / Home

Develop professional relationship for routine counseling regarding health issues; no major emotional situations. Dx not the issue. Contraception, Smoking, Diabetes Maintenance, Hypertension

Professional relationshipbuilding and conduct in emotionally charged situations such as terminal illness, end of the life, or living will. Dx not the issue. Lung Neoplasm, HIV, Alcoholism, Ethical Issues, Depression

ER / Hospital

Assess urgent biomedical problem, Dx in question; can be life threatening Abdominal Pain, Shortness of Breath, Cough, Back Pain

CASE EXAMPLES

Hx Cx

PPQ

SETTING

CHALLENGE

Grave Situation / Behavioral / With strong emotional component Hx Cx

List significant Hx and/or Px findings and differential diagnosis Information from prior visit usually not available

PRIMARY PROFESSIONAL

Well Care, Chronic, Behavioral

Office / Hospital

Assess non-urgent biomedical problem, Dx in question

Hearing Loss, Diarrhea

TEST ADMINISTRATION FORMAT

A sequenced testing format has been proposed as the most convenient and economical method for evaluating large numbers of candidates within a restricted time frame.

The test will be administered in a setting much like a clinic at a teaching hospital or other physician office. Candidates, after appropriate briefing on the format of the test, rotate through a series of stations, each one of which requires the candidate to encounter a standardized patient. Candidates spend 22 minutes at each station, up to 15 minutes directly with the patient, and the remaining time completing a post-encounter note. Each test module will contain about eight cases and, including orientation, a midpoint break, and debriefing, will last about three-and-a-half hours. Two test modules might be administered per day at a given site, and tests will be administered four to five days a week. At average sites, tests might run for approximately six to eight weeks per year. A sequenced testing format has been proposed as the most convenient and economical method for evaluating large numbers of candidates within a restricted time frame. In field trials, we have been evaluating a two-phase format, in which all candidates complete an initial screening test. Based on their performance in these initial cases, a proportion of candidates will be determined to have passed or failed. The remaining candidates would require an additional half-day of testing before a reliable pass or fail decision could be made. SP staff will continue to research the effectiveness and acceptability of a sequential test process.

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SCORING

AND

STANDARD SETTING

Case scores are generated from patient-recorded checklists and rating scales, and from post-encounter notes written by the candidates at the conclusion of each patient encounter. Data from our field trials suggests that each of these instruments contribute important dimensions of performance to the overall score. Considerable progress has been made in developing ways to aggregate these scores based on clinical judgment. In addition, we have made considerable progress in setting exam level standards, and these, too, are based on judgment of committees of physicians.11

At the heart of the implementation process, and of the test, will

STANDARDIZED PATIENTS

be the standardized patients,

At the heart of the implementation process, and of the test, will be the standardized patients, performing their roles, recording physician actions, and rating aspects of physician behavior.

performing their roles, recording

Patients are carefully recruited and trained to portray their cases and to record candidate actions on checklists and rating scales. Detailed criteria for recruiting, training, and monitoring of patients have been developed by training staff at NBME. We have developed all of our patient-related procedures to ensure the accuracy, consistency, and validity of the cases. 12 Other studies of consistency and validity of scoring, including the use of dual patients, standardized examinees, and traveling patients provide evidence that standards of test precision traditional for the NBME will be able to be achieved.13,14

physician actions, and rating aspects of physician behavior.

ADDITIONAL ISSUES Uncertainty still exists in a number of important areas, some of which only live test circumstances will provide convincing answers. SPECIAL ACCOMMODATIONS An important consideration is the extent of special accommodation that may be necessary for the SPT. While no final recommendation has been proposed, it is felt that the performance aspect of the test, and the attendant relationship of the test to real life practice requirements, will be an important consideration in determining test accommodations that would be justified for candidates with a variety of disabilities that might hinder their performance of fundamental clinical tasks. SECURITY In a test that has relatively few “items,” and which is administered over extended periods of time, naturally some concern exists about potential vulnerability to security breaches, and the consequent “invalidity” of test scores. On the other hand, the validity of a performance-based test with the stated objectives of the SPT should be quite robust, even in the face of security leaks, since the crux of the issue is not what candidates “know,” but what they can “do” in a realistic setting. The Advisory Committee has asked for more research to be completed in this area.

An important consideration is the extent of special accommo-

ISSUES

OF

BIAS dation that may be necessary for

Special attention is being paid by the Advisory Committee and project staff to the issue of potential bias in the SPT. Studies underway should provide sufficient data to allow final recommendations to be based on clear knowledge of the susceptibility of test decisions to biased scores or judgments.

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the SPT.

FEASIBILITY

To achieve as much as has been accomplished in this project over the past nine years is much to the credit of a small and dedicated staff here at the NBME.

Based on pilot and research work, the SPT appears feasible for implementation. Final costs, however, cannot yet be accurately predicted because of uncertainty over the number of cases that will need to be administered to candidates, and the extent to which the sequential test process will be able to be applied. A major assumption of the Implementation Advisory Committee and staff is that the overall cost to the candidates must be kept to the minimum, compatible with the high standard of test integrity expected of the USMLE. DECISION PROCESS

AND

TIME FRAME

The time frame of the current USMLE Strategic Plan calls for an implementation plan to be prepared for live testing to commence in the period between 1999 and 2002, and the current working plan targets the years 2001/2002 for live testing to begin. Internal and external reviews are underway of the details of the implementation plan, culminating in a decision on the acceptability and final timing of this implementation plan by the NBME and FSMB. To achieve as much as has been accomplished in this project over the past nine years is much to the credit of a small and dedicated staff here at the NBME. But it should be emphasized that much of the thinking, planning, and creativity in our process has come from our advisory committees and collaborators in medical schools. Far too numerous to name, it is really to these individuals at the schools that we should attribute any measure of our success. They know who they are, and we thank them for their devoted efforts. REFERENCES 1. Hubbard JP, Levit EJ. The National Board of Medical Examiners: the first seventy years. National Board of Medical Examiners; Philadelphia, Pa; 1985:43. 2. Peabody F. As quoted by the editors. Harrison’s Principles of Internal Medicine. Ed 14. McGrawHill; New York; 1997:2. 3. Barrows HS, Abrahamson S. The programmed patient: a technique for appraising student performance in clinical neurology. Journal of Medical Education. 1964;39:802-805. 4. Emerging trends in the use of standardized patients. Contemporary Issues in Medical Education. AAMC. May 1998;1(7). 5. Goffman E. Stigma: Notes on the management of spoiled identity. Touchstone; New York; 1986:35. 6. American Institutes for Research. The definition of clinical competence in medicine: performance dimensions and rationales for clinical skill areas. Prepared for the NBME. Palo Alto, Calif; 1960 (reissued in 1976). 7. Elstein AS, Shulman LS, Sprafka S. Medical Problem Solving. Harvard University Press; Cambridge, Mass; 1978. 8. Harden RM, Stevenson M, Downie WW, Wilson GM. Assessment of clinical competence using an objective structured examination. Br Med J. 1975;1(5955):447-451.

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9. Grand’Maison P, Lescop J, Rainsberry P, Brailovsky CA. Large scale use of an objective structured clinical examination for licensing family physicians. Can Med Assoc J. 1992;146:1735-1740. 10. LaDuca A, Taylor DD, Hill IK. The design of a new physician licensure exam. Evaluation and the Health Professions. 1984;7(2):115-140. 11. Margolis MJ, De Champlain AF, Klass DJ. Setting standards for performance-based assessment of physicians’ clinical skills. Eighth International Ottawa Conference; Philadelphia, Pa; July 1998. 12. King AM, Carr B, Downing B, Klass DJ. A description of National Board of Medical Examiners’ training processes for standardized patient licensing examinations. Eighth International Ottawa Conference; Philadelphia, Pa; July 1998. 13. De Champlain AF, Margolis MJ, King AM, Klass DJ. Standardized patients’ accuracy in recording examinee’s behaviors using checklists. Academic Medicine. 1997;72(10):S85-87. 14. Pangaro LN, Worth-Dickstein H, Macmillan MK, Klass DJ, Shatzer JH. Performance of “standardized examinees” in a standardized patient examination of clinical skills. Academic Medicine. 1997;72(11):S1008-1011.

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FEDERATION PROMOTES INTERNATIONAL COLLABORATION As early as 1977, the Federation of State Medical Boards recognized the importance of fostering relations with medical licensing authorities in countries throughout the world. Over the past 20 years, Federation delegations have visited the Soviet Union, China, Canada, Australia, New Zealand, and Mexico to share information on issues related to medical licensure and regulation. The Federation has encouraged international relations by offering affiliate memberships to licensing authorities of other countries. Currently, all Canadian provincial licensing authorities, as well as the Federation of Medical Licensing Authorities of Canada and the Medical Council of Canada, hold affiliate memberships in the Federation. In 1993, the Federation, under contract with the United States Department of Health and Human Services, planned and conducted the first international conference on medical regulation. Designed to initiate dialogue among the participating nations, the conference focused on the current status of medical regulation in the participating nations, examining current research, and identifying future research needs. Participants met in Washington, DC, in May 1994 and included representatives of Australia, Canada, Ireland, New Zealand, South Africa, the United Kingdom, and the United States. Observers were sent from Egypt, Israel, Mexico, and Taiwan. The conference was successful in stimulating discussion and creating a consensus in favor of continued international dialogue. Conferees concluded that problems faced in the field of medical licensure and discipline are not unique to any one nation and a decision was made to hold a second international conference in Australia in 1996.

Lisa A. Robin. Director, Leadership Support Services. Federation of State Medical Boards of the United States, Inc. Euless, Texas.

The Second International Conference on Medical Registration, held in Melbourne, Australia, in October 1996, experienced increased participation with 20 countries represented. As an active participant in the initial advisory group, several Federation representatives presented papers. Topics included disciplinary procedures and practices, registration of medical students, assessment of international medical graduates, impaired physicians, recertification and maintenance of competence, management of complaints, the international movement of physicians, and issues relative to telemedicine. Following the conference, a decision was made to hold a third conference. On September 21-23, 1998, the South African Medical and Dental Council hosted the Third International Conference on Medical Registration in Cape Town. Again, this conference experienced increased participation with 105 attendees from 21 countries. The Federation played an important role in this conference. The Federation’s executive vice president, James R. Winn, MD, assisted in developing the program and opened the conference’s plenary session on International Cooperation with a presentation titled “A World Federation: Mechanism for International Cooperation.” William H. Fleming, III, MD, Federation president, presented a paper on the benefits of international collaboration among medical regulatory authorities. Information on physician assessment and remediation was

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given by George C. Barrett, MD, vice president of the Federation. Donald E. Melnick, MD, senior vice president and vice president, Division of Evaluation Programs of the National Board of Medical Examiners, explained the US approach to evaluating international medical graduates. These conferences have been very successful in providing a forum for the exchange of ideas and discussion of common problems among the licensing authorities of the world. Through these activities, an understanding of the importance of collaboration is burgeoning and simultaneously generating support for establishing an international federation of licensing authorities. The General Medical Council of the United Kingdom will host the fourth international conference in 2000. Numerous areas exist in which collaboration among the international community will significantly benefit the public. In the last 20 years, we have experienced a rapidly changing world due to the tremendous advances in electronic communication capabilities, increased migration of physicians and other professionals, individuals choosing to receive education and training outside their home countries, and treaties and trade agreements easing traditional borders. These changes are exciting and have provided an opportunity to draw upon the experiences of other medical licensing authorities, thereby enhancing medical regulation in the interest of public protection. The Federation will continue to provide leadership, both nationally and internationally, in the field of medical licensure and discipline and to serve as a resource to the public, to health care organizations, and to state, national, and international medical regulatory authorities. Over the next several months, the Federation will continue to work on the world federation proposal for discussion in conjunction with the annual meeting of the Federation of Medical Licensing Authorities of Canada. This spring, Dr Winn will present the keynote address at an international medical licensing conference in Taipei, Taiwan.

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FROM OUR INTERNATIONAL EXCHANGES Australia From Bulletin, newsletter of the Medical Practitioners Board of Victoria, Autumn 1998 POTENTIAL HIV TRANSMISSI ON IN A SURGICAL SETTING Recent cases in Australia of the transmission of HIV in a surgical setting provided cause for concern. Their occurrence should serve to remind the profession of the need to adhere to strict infection control guidelines and that the reuse of suture material is a serious breach of these guidelines. Following a well-publicized case in New South Wales involving sur gical transmission of HIV, the Victorian Infectious Diseases Reference Laboratory (VIDRL) investigated possible explanations for the transmission of the virus. The case involved four individuals whose only apparent common source of infection was their attendance for minor surgical procedures on the same day at a Sydney clinic. The patients had been treated consecutively, immediately after another patient who was later shown to be infected with HIV. All five patients required the administration of local anesthetic, followed by the suturing of minor wounds. While it is now clear that the four individuals became infected as a result of their attendance at the surgery, the exact route of transmission of the HIV virus remains unknown. Scientists at the VIDRL investigated two possible scenarios that may have caused the transmission. The first explored the possibility of local anesthetic becoming contaminated with blood from the HIV positive patient, thereby providing an environment in which the virus could survive until the same anesthetic was injected into subsequent patients through an injection. These studies showed that a needle or syringe contaminated with HIV positive blood could transfer a small volume of virus if reinserted into a multi-dose anesthetic vial. HIV then survived for at least two hours, or long enough for it to be theoretically possible to infect subsequent recipients of the anesthetic.

The second scenario investigated whether HIV could have been transmitted through suture material that had been reused on other patients after it had been used on the original HIV positive patient. Commercially available suture equipment can be used to insert approximately 20 stitches. However, many minor surgical procedures require the use of only a few stitches, leaving a length of suture thread attached to a needle which could be used to stitch the wounds of subsequent patients. The studies of this scenario involved both in vitro studies with HIV and in vivo studies in cats with feline immunodeficiency virus. They both showed that HIV could be transmitted if suture material was reused. While it is difficult to imagine a doctor deliberately reusing suture material, even accidental reuse would represent a very serious breach of infection control guidelines and would be regarded by the Medical Practitioners Board as unprofessional conduct. The use of multi-dose vials of anesthetics (or other drugs) pose risks which also must be studiously guarded against. Single dose vials or ampoules or prefilled syringes should be used wherever these are available. Where there is no alternative to using a multi-dose vial, great care must be taken to ensure there is no possibility of injecting contaminated material or fluid into the vial and fresh needles and syringes must be used each time the container is used. FEMALE GENITAL MUTIL ATION Female genital mutilation (FGM) is practiced in more than 40 countries around the world, and there are women and girls now living in Australia who underwent the procedure overseas. FGM is most common in communities in Africa, the southern part of the Arab Peninsula, and along the Persian Gulf, as well as in some communities in Southeast Asia. The procedure is most commonly carried out on girls between the ages of four and 10 years.

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In 1996, the Victorian government introduced strict legislation banning the procedure in this State. The practice also constitutes physical abuse under the Crimes & Young Persons Act 1989, and as such, requires mandatory reporting by the medical profession. By law, doctors must notify Protective Services whenever they form a belief on reasonable grounds that a child has suffered or is likely to suffer physical harm associated with actual or planned FGM. The Crimes (Female Genital Mutilation) Act 1996 further states that if a girl or woman normally lives in Victoria, it is illegal to have FGM performed on her in another Australian State or another country. The following procedures constitute prohibited FGM of a child or a woman and are illegal: • removal or cutting out of any part of the female genital area (excise) • stitching up the female genital area (infibulate)

LESSONS FROM INVESTIGATIONS AND HEARINGS Under its charter, the Board investigates every complaint it receives. Initially, a preliminary investigation is conducted either by one of the Board’s investigating officers, a single Board member, or a subcommittee consisting of no more than three Board members. Investigation by a subcommittee is used when a complaint may involve unprofessional conduct, but further information is required. In these cases, the subcommittee interviews the doctor and then makes a recommendation to the Board that the matter be the subject of an informal or formal hearing, or that the matter be closed. Informal hearings are held to examine allegations of unprofessional conduct which are less serious than would require scrutiny at a formal hearing. Informal hearings are closed to the public and accordingly, the names of the doctors involved are not published. The most serious penalty a panel conducting an informal hearing can apply is a reprimand.

• cutting the clitoris or part of the clitoris Some doctors become the subject of informal hearings apparently as a result of their ignorance of their professional responsibilities or their lack of awareness of the risks of certain approaches to medical practice. The Board believes it is relevant to share with the whole of the profession the lessons learned by individual doctors at informal hearings.

• damaging the female genital area in other ways (mutilate) The following procedure further constitutes prohibited FGM of a child and is illegal: • the removal of the clitoral hood of a girl or female baby

To protect the identity of doctors, some details of the following investigations and hearings have been modified for publication. However, the essential messages for the profession should still be clear.

Some surgical procedures are permitted under the Act if they are • necessary for the health of the person and are done by a medical practitioner;

FAILURE • medically necessary during labor or birth and are done by a medical practitioner or midwife; or • necessary as part of a sexual reassignment procedure which is performed by a medical practitioner. Penalties for FGM include fines and/or imprisonment and can be applied to anyone who performs FGM, who helps someone else to perform FGM, or who arranges for someone else to perform FGM. Further information on the law and FGM in Victoria can be obtained by phoning the Office of Women’s Affairs (03) 9651 0530. Education material for health care workers is available from the Royal Australian College of Obstetricians and Gynaecologists (03) 9417-1699.

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TO

ADEQUATELY EXAMINE A PATIENT

A mother alleged that a general practitioner had failed to properly examine her daughter’s injured ankle and had inappropriately conducted the consultation in the waiting area of a medical clinic. At the informal hearing, the mother described taking her daughter to the clinic, paying a consultation fee, and then having her daughter’s ankle x-rayed. She said the doctor had then come into the waiting area of the clinic to inform the family that there was no fracture and that the daughter required “ice, rest, and crutches for perhaps a week.” The next day, the mother took her daughter to their usual family practitioner who conducted a physical examination of the ankle.

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The doctor who was the subject of the complaint claimed that he had removed the shoe of the patient to examine her ankle, but admitted that the consultation had taken place in a busy waiting room. The panel concluded that the doctor had failed to take an adequate history, had not properly examined the patient before or after the x-ray was taken, had failed to provide an adequate plan of management, had inappropriately conducted the consultation in the waiting room, and had failed to give the patient time to ask him questions. The doctor was reprimanded for unprofessional conduct. INAPPROPRIATE PRESCRIBING Case 1: A patient complained that her asthma had worsened after a doctor had prescribed Inderal for her headache and that after taking the prescribed medication, had required inpatient treatment for her asthma. At the informal hearing, the doctor explained that when he saw the patient, her prime complaint was of severe headache. Her records (she had attended that clinic 12 previous times) made no reference to asthma. He agreed with the Hearing Panel that he had prescribed Inderal without discussing its possible side effects with the patient. He also agreed that at the end of the consultation, when the patient asked for a repeat prescription for Bricanyl, he had failed to make the relevant connection. The doctor was aware of his error and its consequences and had apologized for the mistake. The Panel concluded that although the error was serious, it did not represent unprofessional conduct. The Panel reminded the doctor of the importance of seeking information about asthma before prescribing beta blocking drugs. Case 2: A Board subcommittee conducted a preliminary investigation into a complaint alleging that a patient had been inappropriately prescribed naproxen 1,000mg and that the patient’s condition had deteriorated as a result of the medication. The doctor, who had been in general practice for four years, described making a diagnosis of musculoskeletal strain of the right anterior chest to explain the patient’s chest pain. Subsequently, the patient had attended a major hospital where an endoscopy revealed ulcerative oesophagitis, believed to have been aggravated by the anti-inflammatory medication.

The subcommittee recommended to the Board that no action be taken against the doctor, who agreed that in the future he would be very cautious about prescribing anti-inflammatory drugs for undiagnosed chest pain, where the differential diagnosis included oesophagitis or peptic ulcer. FAILURE TO PROVIDE FOR PRIVACY D URING A W ORK COVER EXAMINATION A Board subcommittee conducted a preliminary investigation into a complaint from a female patient, who stated that she felt violated after a physical examination of her back and abdomen by a doctor nominated by the WorkCover Authority. The subcommittee reported to the Board that the complaint had been generated by the doctor ’s failure to clearly communicate to the patient his requirements for the consultation. Specifically, he had not advised the patient that she was not required to remove her underpants and when the patient did so, had failed to provide her with a gown. The subcommittee recommended that the doctor be advised about the need to give clear and specific advice about the removal of clothing and to clearly explain to the patient the reasons for examining different areas of the body. The subcommittee recommended that the complaint be closed. Sexually Intrusive Examinations A young female patient complained that a doctor had violated her doctor/patient trust during a pre-employment medical examination. The complaint centered on the doctor lifting the patient’s bra without warning and the manner in which the doctor had conducted an opthalmoscopic examination. The complaint was assessed by a subcommittee of the Board, which reported to the Board that the doctor’s failure to communicate effectively had caused the patient’s distress and the complaint. As the doctor agreed with this conclusion and accepted advice about the need to take greater care in the future, the subcommittee recommended that the matter be closed. Comment: Doctors need to be aware that some patients may not have had the experience of disrobing for a physical examination. The need for such a step must be explained to patients and their

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prior consent obtained. Where the physical examination could reasonably be considered to be sexually intrusive, care must be taken to adequately communicate with the patient about why disrobing is required and what the examination involves. SEXUAL MISCONDUCT SEMINAR The Board and the office of the Health Services Commissioner jointly hosted a seminar on sexual misconduct by doctors. The seminar explored a range of issues relating to sexual misconduct, including which doctors are at risk of offending, possible mandatory reporting of allegations, and the rehabilitation of offenders. More than 80 people representing interested organizations and a number of different professions took part in the seminar. The most problematic issue debated was the role of the doctor (usually a psychiatrist) who is asked to take over the care of a patient who feels they have been subjected to sexual misconduct by a previous-treating doctor. Some of the doctors at the seminar detailed the competing interests they felt they were required to balance in these circumstances: the patient’s need for confidentiality, therapy, and recovery on the one hand, and on the other the doctor’s own ethical obligation to encourage the patient to report the matter to the Board in an effort to prevent further misconduct and to assist the Board in its role of protecting the community. While there is currently no proposal before the Board for the mandatory reporting of allegations of sexual misconduct, the Board does wish to draw the following issues to the attention of all doctors, and particularly those likely to come into contact with patients traumatized by what they believe is the inappropriate conduct of other doctors. • The Board and its experienced and trained investigative staff are very aware of how stressful it can be for patients to come forward with sexual allegations and for those allegations to be tested in an adversarial environment. The Board will not generally proceed to a formal hearing unless a patient is clearly willing, after adequate counseling, to participate. • Complainants need to have access to independent information and to appropriate support if they are to make a timely decision to report their allegations to the Board. Treating doctors should ensure these patients are aware of the Board’s policies and processes, as described in the Board’s pamphlet titled Trust in the Doctor/Patient Relationship.

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• Treating doctors also need to be aware that a potential complainant may be helped to make a decision by having a discussion with the Board’s experienced investigating officer dedicated to this form of complaint. Such a discussion can be arranged anonymously, without obligation to proceed with the complaint. Access to the independent support counselors contracted to the Board can also be arranged on a similar basis. • It is important that treating doctors who may have information or legitimate concerns about the practice of other doctors do not underestimate the potential value of that information to the Board. During its investigations, the Board receives information from numerous sources. As this information may be crucial to the investigation, it is essential that doctors share rather than withhold material. Finally, it is vital that any doctor who is considering contacting the Board, or who is encouraging a patient to contact the Board, does not see himself/herself as having a role in judging the truth of any allegations. This can only be done by the Board after a thorough investigation and then assessment at a Board hearing.

CANADA From the College, newsletter of the College of Physicians and Surgeons of Manitoba. Volume 34, Number 3, July 1998 DAVID R. MILLER COORDINATOR, COMPUTER-BASED TESTING ADMINISTRATION COMPLEMENTARY MEDICINE The Executive Committee did not approve the previous draft of the Statement on Complementary Medicine document. As a result of considerable discussion which took place at the Semiannual Meeting, the Statement on Complementary Medicine document has had extensive changes. This revised draft will be presented at the Annual Meeting and is available for viewing on the College’s web site at www.umanitoba.ca/colleges/cps.

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Conditions:

Complementary Medicine Preamble All physicians must meet the same standards of practice and any medical act must meet the following criteria: • the context within which it is performed has the informed consent of the patient or appropriate legal authority

Complementary medicine is to be practiced as an adjunct to orthodox medicine, and not as an alternative. The physician also may employ complementary medicine where no evidence-based alternative is available or where these alternatives have been expressly rejected by the patient. • The patient has a right to seek health care from any provider.

• the medical act is carried out in a manner reasonably consistent with the standards recognized by the profession

• A physician must review the scientific literature in order to assess an unproven theory before using it in patient care.

The art of practice and science are historically the two components of orthodox medicine. Today, many physicians are asking for better direction regarding the criteria which must be in those areas of medical practice that are not evidence based. Questions arise such as, “What areas of activities may be considered unacceptable? Are there any specific requirements with respect to patient consent?” This paper is intended to answer such questions, and provide some guidance to physicians who wish to introduce new complementary medicine activities into their practice.

• The nature of the complementary medicine service being provided by a physician must be explained to the patient with regard to the quality of research relative to efficacy, reliability, reproducibility, and risk. • If the complementary medicine may cause harm, the potential for this harm must be fully explained.

Definitions:

• The physician must not provide a service when harm significantly exceeds that of orthodox medicine, or where there is no reasonable expectation of offsetting benefit.

The word “complementary” is used in preference to “alternative” because it implies that the processes are adjuncts, rather than replacements, for orthodox processes.

• Physicians must be aware of the economic well-being of their patients, and advise regarding cost/benefit of any complementary medicine they may propose.

Complementary medicine refers to those processes and interventions used for diagnosis, prevention, therapy, or rehabilitation for which there is no scientific evidence of efficacy, reproducibility, and reliability. Some of these activities have become accepted by the medical community over the years, despite no evidence to support them.

• Where physicians may personally profit from the sale of any device, service, or product associated with the complementary medicine service, they must comply with conflict of interest guidelines.

Orthodox medicine consists of the body of knowledge and art of medicine which are commonly accepted by the medical community. Activities which are shown to be “evidence-based” become part of orthodox medicine. Activities which are discredited by scientific evidence cease to be acceptable and are unorthodox.

The overriding principle of medical practice is Remember first the well-being of the patient. All medical practices must adhere to the same standards.

Diagnosis: Only diagnostic tests acceptable to orthodox medicine will be used to determine a patient’s biochemical, psychological, anatomical, or psychological status.

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BUILDING AN INTERNET-B ASED E XAMINATION FOR THE MCC: ISSUES AND PROGRESS Part 2 From ECHO, newsletter of the Medical Council of Canada, Volume 9, Number 2, June 1998 Part 1 of this article, which appeared in Volume 85, Number 2 of the Federation Bulletin: The Journal of Medical Licensure and Discipline, discussed some of the issues associated with the migration of the Medical Council’s Qualifying Exam (MCCQE) Part I from a paper-and-pencil format to an Internet-based product. We now turn our attention to what has been accomplished so far and what lies ahead.

Montreal Trial The Version 1 product was pilot-tested at the University of Montreal in early December 1997. A rather small group of fourth-year medical school students sat for the exam in the university's computer lab, populated with Macintoshes. Overall, the pilot was a success, and some valuable lessons were learned.

Version 1 Development of the Internet version of the MCCQE Part 1 began in earnest last September. A simple prototype was first developed to demonstrate the feasibility of the concept and to show that both official languages could be supported. (This initial prototype also had a Russian-language option to show that other languages also were possible.) Work then commenced on a more ambitious proto type—Version 1—that would address the main issues identified. The questions used in this version were drawn from the MCC’s Multiple-Choice Question Practice Examination, published in 1994. Each exam comprised 150 questions, divided into five sections of 30 questions each. The questions were read from a text file and presented in a different random order every time. Special care was taken in designing the interface. The main screen where the questions were presented was divided into two frames: a left frame with tools and navigation aids, and a right frame with the section’s questions. The left frame offered a navigation table with the numbers of the 30 questions. A clock on a number brought that question to the top of the right frame. As soon as the candidate chose an answer to a question, its corresponding number in the navigation table turned red, allowing candidates to see at a glance which questions had been answered. Other tools in the left frame include: a clickable link to switch between English and French, a pop-up calculator (written in Java), a pop-up table of normal values for common laboratory tests, and, of course, a button to submit the answers to the 30 questions. A clock was programmed to appear in the status bar at the bottom of the window.

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To prevent candidates from backtracking to previous sections of the exam, the browser windows were customized to remove the normal menu bars and toolbars. In addition, each screen of the exam was presented in a new browser window and the previous window closed, effectively eliminating the possibility of candidates returning to previous screens. For the purposes of the trial, the candidates received feedback on the number of correct answers immediately after submitting a section.

• The exam itself functioned well, although some technical problems arose, one of them serious enough to prevent a session from continuing. The main culprit appeared to be insufficient RAM on the Macintoshes. The response time from the server was good. • Students’ reaction to the exam was very positive. On the questionnaire they were asked to complete at the end of the exam, they gave the exam an overall rating of about four on a scale of one-tofive, with several fives. Students liked the layout of the exam and found it easy to understand and use. They liked being able to move among questions quickly and to be able to change answers easily within a section. They also enjoyed the immediate feedback on their results, although that will not be a feature of the exam in its final form. • Students completed the 150 questions surprisingly quick. Three hours had been allotted for the 150 questions. The first student completed the exam in one hour, 20 minutes and the last of the seven took only about two-and-a-half hours.

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Version 2

University of Ottawa Trial

In response to the results of the Montreal trial, a second version of the exam was developed. On the surface, it looked a little different from the one tested in Montreal, but underneath two major changes had been made.

Version 2 was pilot-tested at the University of Ottawa in April 1998. A total of 74 students sat for the exam over the course of four days, with a maximum of 13 students at any one time. The computers included 12 Pentiums running Windows 95, and one Macintosh.

First, instead of being stored in a flat file, the questions were stored on the server in an Access data base, from which they were directly drawn and manipulated by the software. Additional exam booklets were added to the data base in order to bring the total number of questions available to more than 600.

The results of this trial were helpful. On the positive side, the trial demonstrated that a significant body of candidates could be processed over the course of several days. It also proved the feasibility of generating an exam in real time from a data base using a fairly sophisticated adaptive algorithm. And again, the students’ response was generally favorable. They felt quite comfortable taking the exam on the computer and liked the overall exam format and user interface.

Second, having a true relational data base allowed us to implement a form of adaptive testing, using item-response theory. Our adaptive testing model is being developed by Dr Tom Maguire from Alberta, who has been on assignment with the MCC. Briefly, candidates are presented with a “routing” test as their Section 1. Their scores in each of the six disciplines on that section determine the difficulty of the questions that make up Section 2. Their Section 2 scores by discipline in turn determine the difficulty of Section 3 questions, and so on. By the end of the exam, each candidate has stabilized at the difficulty level in each discipline corresponding to his or her level of competency. This adaptive version of the exam consisted of 168 questions, divided into seven sections of 24 questions each. Candidates received immediate feedback at the end of each section on the number of questions answered correctly and, at the conclusion of the exam, a summary of their ranking by discipline, from one (below average) to four (exceptional). Several other minor innovations were utilized with this version. One was the addition of questions that relied on photographs and charts, which popped up in a separate window in response to a mouse click. Also, a “restore” feature had been programmed, so that if a technical problem caused the exam to crash, logging in again would restore the candidate’s exam to the same state that had existed prior to the crash.

On the negative side, in about 10% of the cases, some kind of technical glitch took place, triggered sometimes by a candidate doing something unpredictable like clicking outside of the exam window or starting to answer questions before the program was fully loaded. The origin of some of the other technical difficulties remained unclear, however. Part of the problem was that we were using the Medical Faculty’s rather congested Internet link (slated for an upgrade soon) and somewhat older equipment. That also may explain the main complaint from candidates: poor response time. Happily, the restart feature of the exam worked well, and all students were able to finish. Looking Ahead The main lesson we learned from these two recent pilots is that field conditions can play havoc with a program that performs fine in development. Clearly, the exam must be made more robust and more reliable in order to meet the needs of the MCCQE. To do so, the client side of the equation will have to be considered more carefully. We will have to exert more control over installation at the university site, ranging from establishing minimum hardware, software, and network standards to perhaps setting up or installing the necessary software ourselves prior to an exam. We also will have to better secure the client computing environment to reduce the risk of candidates accidentally or purposely breaking out of the exam.

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It will be interesting to see how well the results of the Ottawa University trial match our theoretical adaptive testing model. To this end, the students’ scores will be subjected to a variety of statistical analyses. Another major issue that we are now becoming more familiar with is security. To ensure that the exam and its contents remain totally inaccessible to unauthorized users, we are currently evaluating a wide range of security products that can be used to encrypt and authenticate Internet sessions. We hope to run several more pilots this year in different universities, each time improving and extending the exam on the basis of previous testing and additional research. By the end of this year, we should have a fairly definitive product that we can rigorously road-test early in 1999 to iron out any remaining wrinkles. The final version of the computerized MCCQE Part I is scheduled for roll-out in fall 1999. At that time, the MCC will stand as a major player in the field of Internet-based testing.

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FROM OUR MEMBER BOARD EXCHANGES ALABAMA

Record Keeping

From the Alabama Board of Medical Examiners’ NEWSLETTER, Vol 13, Number 2, Summer 1998

Copies of CME credit certificates will not be required to be sent with the relicensure application; however, physicians are required to maintain these personal records for three years following the year in which the CME was earned and make copies available to BME on request.

CME REQUIREMENT FOR ALAB AMA PHYSICIANS Act 89-244 of the Alabama legislature mandated continuing medical education (CME) for all licensed physicians practicing in Alabama. The specific requirements, policies, and procedures are to be set by the Alabama Board of Medical Examiners (BME). Outlined below is a brief summary of the approved BME rules. Basic Requirement Every physician licensed and practicing in Alabama must attain at least 12 hours of Category I CME credit every calendar year (January 1-December 31) to continue to be licensed. Other CME credits also meeting this requirement will be AAFP Prescribed, American College of Obstetricians and Gynecologists (ACOG) Cognates, and Category IA of the American Osteopathic Association. Exemptions From the Requirement 1. Non-resident physicians who are not practicing in Alabama. A physician who resides outside Alabama but maintains a significant practice in Alabama must meet the requirement. (A “significant practice” is practicing medicine in any form for more than 10 calendar days per year.) 2. Retired physicians who do not engage in the practice of medicine in any form. Retirees who want to maintain a current license and be excused from the CME requirement may request a waiver in writing from BME. 3. Initial licensure applicants are exempt from the CME requirement for a particular year, if the licensure action is taken after June 30. 4. Physicians with illness, disabilities, or other circumstances beyond his or her control may apply to BME for a waiver of the requirement. 5. Residents enrolled in residency training programs.

Grace Period Physicians failing to certify on the application as having met this requirement will be notified of this and the possibility of suspension or revocation of license. A grace period (December 31-January 30) may be used to attain needed credits toward meeting the requirement for the preceding year.

ALASKA From BoardNews, newsletter of the Alaska State Medical Board, Vol Two, Number 1, Spring 1998 BOARD ADOPTS POSITI ONS ON TWO IMPORTANT ISSUES In response to requests submitted to the board, the board has adopted positions on two topics: performing independent medical evaluations (IME) by out-of-state physicians without a license, and defining patient abandonment. Over the past years, board staff received numerous calls from patients and Alaska physicians concerned about out-of-state physicians coming to Alaska to conduct IMEs without first obtaining an Alaska license. The board considered this issue and determined that under Alaska Statute 08.64.370(b), an Alaska licensed physician could request an out-of-state physician to assist in the diagnosis and treatment of a case without first obtaining a license. However, in the absence of the requesting Alaska physician, a license would be required of any out-of-state physicians who wished to come to Alaska to conduct independent medical evaluations. The board opined that such examinations fall under the definition of the practice of medicine and therefore requires a license. In September 1996, the board wrote a letter and distributed it to insurance carriers

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and attorneys that advised of the board’s interpretation of AS 08.64.370(b) and the need for a license.

1. a patient history and evaluation sufficient to support a diagnosis;

The second issue, patient abandonment, was addressed by the board at the request of an Alaska physician who wished to have the board’s guidance. The board considered this issue at its April 1997 meeting. The result was the adoption of two sections from the American Medical Association’s Code of Medical Ethics, 4th edition, sections 8.11 “Neglect of Patient” and 8.115 “Termination of the Physician/Patient Relationship.”

2. a diagnosis and treatment plan for the diagnosis;

Section 8.11 Neglect of Patient Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first-aid treatment is essential. Once having undertaken a case, the physician should not neglect the patient. Section 8.115 Termination of the Physician-Patient Relationship Physicians have an obligation to support continuity of care for their patients. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured.

The Alaska State Medical Board felt the need to develop a law that would give physicians guidance in prescribing controlled substances. Regulation 12 AAC 40.975 is now law. It requires physicians and physician assistants to maintain certain minimum records when prescribing controlled substances. It reads:

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The board recognized that it was re-enforcing good medical practice which dictate the creation and maintenance of good medical records documenting careful diagnosis and detailing the treatment of each patient. The law is intended to establish a minimum threshold requirement for those practitioners who do not maintain good records. It did not view this regulation as placing an onerous burden on physicians and physician assistants. The regulation ensures that a clear and comprehensive record is created for patients to document the need for the use of controlled substances.

CALIFORNIA

PHYSICIAN POSTGRADU ATE TRAINING

NEW PRESCRIBING L AW ENACTED

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4. a record of drugs prescribed, administered, or dispensed, including the type of drug, dose, and any authorized refills.

From Action Report, newsletter of the Medical Board of California, Vol 67, October 1998

The board adopted these two references as its position to provide guidance to Alaska physicians. While the board’s position on patient abandonment does not carry the force of law and is not enforceable, it is the board’s hope that physicians will find some direction in this area of practice.

When prescribing a drug that is a controlled substance, as defined in AS 11.71.900, an individual licensed under this chapter shall create and maintain a complete, clear, and legible written record of care that includes, at a minimum,

3. monitoring the patient for the primary condition that necessitates the drug, side effects of the drug, and results of the drug, as appropriate; and

The Medical Board of California has worked with an independent statistician to conduct a major study of the relationship between the number of years of physician postgraduate training and the probability of a disciplinary action being taken against the physician’s state license. The study found that doctors with less than two years of training after completion of medical school were nearly twice as likely to be disciplined as those with two or more years of training. These findings suggest an important, documentable relationship between the length of postgraduate training and practice quality. Based on this study, and on comparisons with the minimum training requirements of medical boards in other states, the Board will introduce legislation in the next session to raise the minimum training requirements for doctors applying for a physician license in California.

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CALIFORNIA’S NEW SPECIAL FACULTY PERMIT PROGRAM The Medical Board of California soon will begin issuing a special type of permit that will authorize eminent academic physicians to practice within California medical schools. The permit will be known as a Special Faculty Permit and is authorized by Section 2168 of the Business and Professions Code. Over the past few years, California’s medical school deans have advised the Division of Licensing that California’s medical schools are losing promising candidates for top academic positions to other states with more flexible licensing laws. Some candidates have cited California’s licensing examination requirements as a factor in their decision to accept offers from medical schools in other states whose laws allow licensure without examination for medical school faculty. The Special Faculty Permit is designed to give California’s medical schools a competitive advantage in recruiting top academic talent from other states and countries to fill positions as deans, department and division chairs, and other leadership positions on the clinical faculty responsible for teaching and clinical research. Section 2168 does not require Special Faculty Permit applicants to pass the routine written and oral examinations that apply to applicants for an unrestricted physician’s license. The criteria for the faculty permit are stringent. To qualify for a permit, candidates will have to be offered a full-time, tenure-track clinical faculty appointment at the full professor rank by one of California’s eight medical schools. Once issued, permits may be renewed biennially as long as the individual continues to hold the qualifying faculty position in the medical school. Since each medical school has a limited number of positions available that will satisfy the statutory criteria, the Division does not expect heavy demand for the special permit. The permit will authorize the faculty member to practice only within the sponsoring medical school. If the permit holder later desires to engage in practice outside the medical school, he or she would need to apply for and meet all of the routine requirements to become eligible for the standard, unrestricted California medical license. The Special Faculty Permit program should benefit our medical schools and all Californians by attracting gifted academic physicians to the state and enhancing California’s position in the national and international medical community.

REMINDER TO PHYSICIANS WHO EMPLOY OTHER PROFESSI ONALS Many physicians and their offices, in an attempt to provide a full array of services, sometimes add services of other licensed professionals, usually within the allied health arena, where scope of practice is well defined. The Medical Board recently has become aware that some physicians’ offices employ other licensed professionals, in turn creating responsibilities pursuant to the Practice Act of those professions. Often these professions have their own practice acts with standards that must be met. A frequently cited example is that of a physician specializing in plastic or cosmetic surgery adding electrologists and estheticians to the office. In such cases, the physician may have assumed the responsibility to have the workplace licensed under the Barbering and Cosmetology Act. You should determine if this is the case before employing other licensed personnel. Please remember that physicians have the ultimate responsibility to see that all individuals who work in their offices function within their scope of practice, with valid licenses where a license is required, and that all the requirements of that licensee are fulfilled. In addition to the requirements of the Medical Practice Act, the licensee so employed should be able to advise you of additional requirements, or you may wish to contact your attorney for further guidance.

COLORADO From The Examiner, newsletter of the Colorado Board of Medical Examiners, Department of Regulatory Agencies, State of Colorado, Vol 7, Number 1, April 1998 you should know . . . Child Support Delinquencies Prompt Discipline Delinquencies in child support payments may result in the denial or suspension of professional licenses per legislation signed by Governor Romer in June 1997. This includes any delinquent parent holding a medical license or physician assistant certificate. Other licenses which may be sanctioned are motor vehicle licenses, and recreational hunting and fishing licenses. The law also provides for liens against the real and personal property of delinquent parents. To aid enforcement, the law requires that all licensing agencies maintain records of licensees’ Social Security Numbers. The medical board has begun collecting this data via license renewal forms. Beginning July 1, 1998, the Department of Human Services began notifying Colorado licensing authorities of licensee non-compliance.

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The medical board, in cooperation with the Department of Regulatory Agencies’ Child Support Enforcement Office, will act to suspend licenses as required by law. Please note that suspensions are automatic and the medical board has no discretion with respect to the decision to suspend a license. Reinstatements will not occur until notice of compliance is received from the Department of Human Services. The Board encourages licensees owing past due child support to contact the local county child support office, or the Colorado Department of Human Services, Child Support Enforcement Division.

Chronically Non-compliant Patients Patients who are chronically non-compliant with physicians’ instructions may be found in all specialty areas. In response to complaints filed with the Board, physicians often describe situations where they have tried to work for long periods of time with patients who refuse to comply with treatment directions. It is the opinion of the Board that physicians should evaluate their ability to communicate with these patients, and if necessary should discharge them from their practice. Sufficient notice and time should be given to patients in order to seek medical care elsewhere.

Stadol Now a Scheduled Drug Stadol (butorphanol) in all forms has been placed on the DEA Schedule IV. Prescription orders must now comply with DEA regulations with respect to having the full name and address of both patient and prescriber, as well as the prescriber’s DEA registration number. Orders must be dated and signed on the day issued. Oral orders are permitted; however, prescription orders may not be refilled more than five times or for more than six months. All DEA rules regarding inventory and dispensing apply.

NEW HAMPSHIRE From NEWSLETTER, newsletter of the New Hampshire Board of Medicine, Vol 1, Issue 8, August 1998 WHAT EVERY PHYSICIAN NEEDS TO KNOW ABOUT PUBLIC INFORM ATION

Court Sets Precedent in Arizona BME vs Managed Car e The Federation of State Medical Boards reports that . . . the Arizona Court of Appeals recently affirmed a decision made by a lower court that the Arizona Board of Medical Examiners had the jurisdiction and authority to investigate and take action against the medical director of a managed care provider . . . The Appellate Court determined the medical director is not a provider of insurance, instead he is an employee who makes medical decisions for his employer on whether surgeries or other non-experimental procedures are medically necessary. The Appellate Court has made a distinction that the medical director for a managed health care provider is in fact practicing medicine when determining the medical necessity for a patient. The Court has concluded that the decision a medical director makes could adversely affect the health of a patient and this act can therefore be construed as the practice of medicine. The ruling by the Arizona Appellate Court does not address, nor imply, that the Arizona Board of Medical Examiners has jurisdiction over physicians making medical decisions outside of Arizona.

The Board of Medicine is a state agency, whose mission is to protect the residents of the state from the unlawful, unethical, or impaired practice of medicine. As a state agency, the Board is bound by RSA 91-A, New Hampshire’s “Right to Know” law. That law specifies that governmental agencies must ensure the “greatest possible public access to their actions, discussion, and records . . . ” The Board receives many questions regarding what information about physicians is public. The following is a brief summary of the key aspects of the Board's public information policy. • Unless the Medical Practice Act specifically deems that information as confidential, then it is public. • All applications, hearings, disciplinary actions, and petitions to the board are public. • Any information gathered in the course of a disciplinary investigation is not available to the public, unless and until the investigation results in a notice of public hearing. • Letters of concern are not public information. • The meetings of the Medical Review Subcommittee are confidential. • Letters of complaint are not available to the public. • Lawsuits are, in themselves, public documents, but any board investigation into the suit is confidential unless and until it results in a notice of public hearing.

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LEGISLATIVE UPDATE While education was the top focus of the general court this year, several bills passed which should have a great deal of impact on Board practices in the future. • HB 1262 and SB 501 permit the board to add a part-time physician to its staff and to receive the full-time services of an attorney in the attorney general’s office to act as hearing counsel. The physician will serve as the administrator of the Medical Review Subcommittee (the Board’s investigative committee). Both of these bills will act to bring the Board’s resources more in line with the responsibility it faces in protecting the public. It is hoped that with the addition of these new positions, the Board will become more efficient in handling complaints and more proactive in its investigations. • HB 1457 adds physician assistants to the list of practitioners who can receive and dispense controlled drugs. • SB 385 requires all superior courts in New Hampshire to report to the board when any physician is convicted of a felony. • SB 383 establishes a committee to study the use of telemedicine in New Hampshire. As a result of the passage of this bill, and the public hearing held by the Board on April 1, 1998, the Board has decided to table any consideration of rules changes regarding telemedicine licensure until this study committee completes its work. The Board fully supports additional study into this area.

cian’s licensure and standing online, without submitting written requests to the Board staff. The website address is http://www.llr.sc.edu/me.htm. The Board staff can also receive e-mail at [email protected] ENTIRE RECORD MUST USUALLY BE PROVIDED UPON REQUEST The Board administrator is often asked whether physicians must release records they possess that were provided to them by previous treating physicians. According to the South Carolina Physicians’ Patient Records Act, the answer is “yes.” Doctors may withhold only portions of patient records that they reasonably believe will harm a patient’s physical or emotional well-being. The Physician’s Patient Records Act, S.C. Code of Laws sections 44-115-10 through 44-115-150, governs all patient records transactions in South Carolina. The Act is contained in the Board’s annual directory, and is also posted on the Board’s website. • Section 44-115-20 states that “The physician is the owner of medical records in his possession that were made in treating a patient and of records transferred to him concerning prior treatment of the patient.” • Section 44-115-30 declares that “A patient or his legal representative has a right to receive a copy of his medical record, or have the record transferred to another physician, upon request, when accompanied by a written authorization from the patient or his representative to release the record.” • Section 44-115-60 states in part that “An unreasonable refusal to release the entire medical record constitutes unprofessional conduct and subjects the physician to disciplinary action by the South Carolina State Board of Medical Examiners.”

SOUTH CAROLINA From The Examiner, newsletter of the South Carolina Board of Medical Examiners, Spring 1998 MEDICAL PRACTICE LAWS AND REGUL ATIONS NOW ON BOARD WEBSITE Anyone may now read and download the South Carolina Medical Practice Act and the regulations governing the Board of Medical Examiners on the Board’s Internet website. Also included are related laws such as the Physician’s Patient Records Act, Provider SelfReferral Act, and the Hospital Reporting Act. Also posted are recent policies and procedures adopted by the Board. Future plans for the expanded website include a keyword-searchable physician database that will enable anyone to verify a physi-

Thus, when a physician acquires the records of another physician, he or she becomes the owner of the records, and must release them, with few exceptions, when a patient so requests. VISITING PROFESSORS NORMALLY NEED NOT HOLD SOUTH CAR OLINA LICENSE South Carolina law specifically defines the practice of medicine and describes who may be admitted to practice in the state. South Carolina Code of Laws section 40-47-60 states that “No person shall practice medicine, surgery, or osteopathy within the state unless he is twenty-one years of age and has been authorized to do so pursuant to the provisions of this article.” However, the same

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section grants several basic exceptions to the requirement of a license, such as emergency situations, certain religious practices, and tasks delegated by a physician. State law also exempts certain physicians from licensure, stating in part in section 40-47-240 that the licensing requirements shall not apply to “physicians or surgeons of other states or territories in actual consultation with a licensed physician or surgeon of this State.”

The miscellaneous category can include problems such as practice while not registered; being disciplined in another state; failing FLEX exams; failing to contribute to the Patients Compensation Fund; failing to obtain the required CME credits, yet certifying on the renewal application the credits were obtained; and performing procedures without patient consent, to name a few of the more numerous problems.

In considering the exemptions of section 40-47-240, the Board has interpreted the law to include several specific situations. The Board has stated that “a visiting professor who wants to come to the hospital for usually a one-day period to perform a new surgical technique while instructing others in the procedure” is allowed to do so without having a South Carolina license, because in doing so, the visiting professor is acting “in actual consultation.” The Board has further defined “actual consultation” as “involving teaching or advice to licensed physicians only and does not include prescribing, treating, operating on, or in any other way, managing the health care of a specific patient.” Thus, visiting professors, in most cases, need not be licensed in South Carolina; however, anyone hosting such a person may wish to contact the Board Administrator for clarification.

Not included on this list are the complaints regarding doctor/ patient communication problems. These could be placed under the heading of “rude doctor” demeanor and are not complaints which result in discipline from the medical board. Because the number of complaints is substantial, however, the board cannot help but be concerned that the public’s perception of an uncaring medical profession is becoming more widespread. From the MEB’s standpoint, it appears that good communication with the patient is paramount and probably ranks right up there with good treatment. It is also understood that this is a time of managed care and restrictions being placed on health care providers to hold down costs. So now, more than ever, is a good time for doctors to reflect on their communications with their patients and, in some cases, their families, and how connections can be improved.

WISCONSIN

ROLE OF THE PHYSI CAL THERAPIST ASSISTANT

From Wisconsin Regulatory Digest, newsletter of the Wisconsin Medical Examining Board, Vol 11, No 1, June 1998

Questions have arisen regarding the role of the physical therapist assistant. A physical therapist assistant means an individual who has graduated from a physical therapist assistant associate degree program approved by the American Physical Therapy Association. The State of Wisconsin does not license physical therapy assistants. However, the role of a physical therapist assistant is limited by statute and rule.

STAYING OUT OF TROUBLE Every month the medical examining board (MEB) reviews a number of complaints from consumers regarding their medical care— reports regarding medical malpractice payments and reports from the National Practitioners Data Bank on disciplined doctors from other jurisdictions. These cases are evaluated as to whether or not they should be opened for further investigation. The cases opened for investigation fall into several categories: • Advertising Violation • Fraud/Deceptive Practice • Unlicensed Activity

A physical therapist assistant cannot legally work independently. A physical therapist assistant must practice under licensee supervision. Section 448.52(3), Stats recognizes that a physical therapist assistant may assist a physical therapist in practice under the general supervision of the physical therapist. The affiliated credentialing board has promulgated rules defining “general supervision” in this context.

• Violation of Related Law • Substance Abuse/Impairment • Negligence/Incompetence • Unprofessional Conduct • Prescriptive Practice • Miscellaneous

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A licensed physician may not only refer a patient for physical therapy, he or she could conceivably delegate the performance of therapy directly to a physical therapist assistant.* The doctor should, however, understand that the assistant would then be practicing under the delegated authority of the physician’s own license. A physician should check with his medical malpractice insurer and attorney in considering whether to make such a delegation. *448.03(2) Exceptions. Nothing in this chapter shall be construed either to prohibit, or to require a license or certificate under this chapter for any of the following: . . . (3) Any person providing patient services as directed, supervised, and inspected by a physician or podiatrist who has the power to direct, decide, and oversee the implementation of the patient services rendered.

have signed onto the compact) in which the nurses practices, but does not live, are called “remote states.” These states grant the nurse the privilege to practice in their state as a provision of the interstate compact. However, this is not an additional license. The nurse must hold an unencumbered license in the state of residence to have the privilege to practice in a remote state. The interstate compact addresses the area of jurisdiction only as it relates to practice across state lines. It does not define nursing, nursing practice, or scope of practice—all of which are and will continue to be handled in state practice acts. The nurse practicing in a remote state is expected to practice within the scope and according to the standards of the remote state. This expectation is no different than that which exists under the current regulatory system. Discipline

NEWS FROM OTHER PROFESSIONAL BOARDS From Communique, newsletter of the National Council of State Board of Nursing, Inc, July 1998 HOW DOES THE INTERSTATE COMPACT FOR MUTUAL RECOGNITI ON WORK? The language for an interstate compact in support of a standard approach to a mutual recognition model for nursing regulation was adopted by the National Council Delegate Assembly in December 1997 and enacted recently in Utah. The compact specifically addresses four areas: jurisdiction, discipline, information sharing, and administration of the compact. Jurisdiction To successfully regulate the nursing practice of an individual nurse, each state in which that nurse practices must have jurisdiction over his or her practice. Licensure of the nurse in accordance with the nursing practice act in every state of practice is the mechanism in the current regulatory system that establishes a state’s legal jurisdiction. In a state which has adopted the compact, the mechanism will be that the nurse is licensed only in the state of residence or “home state.” The nurse would need to meet that state’s licensure requirements and abide by the nursing practice act and other applicable state laws, just as currently required. Other states (which

It is essential that both the state of residence and remote state be able to take disciplinary action in order to protect their citizens, regardless of where the nurse or citizen is located. Accordingly, under the terms of the compact, the state of residence and remote state may take action to halt or limit the practice of an incompetent or unethical nurse in their state. The only difference is in the form of that action. The state of residence acts against the nursing license itself (eg, probation, suspension, revocation), while the remote state acts against the practice privilege granted by the compact, such as limiting or halting practice with a cease-and-desist order. It is important to note that both processes include due process for the nurse, and the effects of both forms of action are essentially the same. Under the interstate compact, the authority to practice is being exercised on a larger scale by the nurse. Likewise, the authority to discipline is being exercised on a larger scale by the states. The broadening of authority to practice in several states necessitates the broadening of information sharing to allow states to discipline when appropriate. Within the current regulatory system, most states are authorized to take disciplinary action based on action in another state. This occurs sequentially, with one state taking action and others following. The nurse is afforded due process according to each state’s laws. Under the interstate compact, however, states will be able to

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concurrently cooperate in the discipline process. The compact permits (but does not mandate) states to recoup costs from the nurse when an adverse action is taken. This type of provision is currently in place for several states, and under the compact will be uniformly extended to all participating states. The ability of both the state of residence and the remote state to quickly address discipline is essential to protect the public. The National Council is currently undertaking several activities— including development of a distance technology—to facilitate, demonstrate, and refine the interstate discipline process. Information Sharing An essential component of the interstate compact is the ability for states to have timely licensure and discipline information on each nurse. The compact provides for reporting and maintenance of licensure and discipline information. The National Council, in concert with the membership, has committed to enhancing the current Disciplinary Data Bank (DDB) system and to developing licensure information for endorsement. A more commonly known interstate compact—the one for drivers’ licenses—developed a not-for-profit entity to administer the required information system, with financial support from the federal government. With the adoption of the mutual recognition model for nursing, the National Council, as a not-for-profit agency with an established discipline database and relationship with the state boards of nursing, will add the information system improvements needed to accomplish mutual recognition. It is important to note that the information system is a closed, secure system primarily for use by the boards of nursing, with limited access levels that comply with statutory provisions and limits on providing public information to employers and consumers.

Each state’s nursing practice act specifies what will be regulated, and the state rules and regulations specify how the act will work. In a similar manner, the interstate compact specifies what will be agreed upon between states with regard to jurisdiction, discipline, and information sharing, and its rules and regulations specify how the states will work together. For example, in defining the primary state of residence, the compact specifies that nurses will be licensed in their primary state of residence. There are several currently used definitions for primary state of residence. The compact administrators will decide on the best definition and annotate it in the rules. If a better definition comes forth at a later date, the definition can be altered without legislative action. It is anticipated that the interstate compact rules will go through review in each state in accordance with current provisions in administrative law, with comments returning to the compact administrators. The interstate compact was written in a manner that clearly defines the legal framework, yet allows details to be addressed in the rules. It can be viewed as an overlay to the state nursing practice act that enhances the ability of each board of nursing to protect its citizens. NURSYS © DATABASE SERVICES As of July 1, 1998, the National Council of State Boards of Nursing has awarded contracts with five leading technology companies to develop NURSYS©, a central repository of nurse license information throughout the United States and its territories. Upon completion, NURSYS will provide the ability to collect, track, report, and verify nursing candidate information, licensing information, disciplinary actions, and billing of license verification fees. It is expected that NURSYS will enhance the efficiency, turn-around time, cost, and accuracy involved in the processing of nurse license verifications and endorsements as performed by state boards of nursing.

Administration of the Interstate Compact Finally, the interstate compact for nursing regulation provides for the ability to administer the compact through the formation of a group of designated “compact administrators.” The compact defines a compact administrator as the head of the nurse licensing authority in each state, and gives the administrators joint authority to write rules and regulations to implement the compact.

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MEDICOLEGAL DECISIONS Recent medicolegal decisions involving or of interest to medical boards. Reprinted from THE CITATION.

UNPROFESSIONAL CONDUCT, LICENSURE South Carolina Appellate Court

LICENSURE, REPRIMAND, SURGEO N Missouri Appellate Court

Physician Discipline Care Remanded to Board... In a disciplinary action against a physician, the outcome was of such importance that the clear and convincing standard of proof should have been used.

Surgeon Reprimanded for Pushing Nurse... The reprimand issued to a surgeon who shoved a nurse after a disagreement arose between them was upheld by a Missouri appellate court. The surgeon was scheduled to perform surgery on a patient with a hip fracture. Because x-rays were to be used during the procedure, each member of the surgical team was to have a lead apron to wear. At some point during the presurgical administration of anesthesia, however, the surgeon decided his apron was unsuitable and asked one of the nurses to give him the one she was wearing. When she initially refused, the surgeon proceeded to shove her with such force that she lost her balance. The supervisory nurse quickly intervened to calm tensions and to provide the surgeon with another apron. The procedure was completed without further incident. Afterwards, the nurse, still feeling very disturbed by what had happened, brought a complaint against the surgeon to the state medical board. The board reviewed the testimony of those present in the operating room and determined the surgeon acted in violation of the state statute prohibiting physicians from engaging in unethical and unprofessional conduct. He was suspended from practice for one Sunday and reprimanded. Dissatisfied with the medical board’s decision, the surgeon appealed to the circuit court. In his appeal, he argued that nothing in “physicians and surgeons professional standards requires them to refrain from poking or pushing nurses.” The appellate court declined to concur with this somewhat unusual interpretation of professional standards. The fact of the matter was, in the court’s view, that by striking the nurse the surgeon created the potential for the surgical procedure to be disrupted. In the circumstances, then, where the welfare of a patient potentially has been compromised, a finding the surgeon had engaged in unprofessional conduct was warranted.— Hoffman v. State Board of Registration for the Healing Arts, 936 S.W.2d 182 (Mo. Ct. of App., Dec. 10, 1996)

The South Carolina Board of Medical Examiners stated a physician violated both the provisions of the Medical Practice Act and the Rules and Regulations of the State Board of Medical Examiners when he allegedly engaged in unethical and unprofessional physical contact during prostate examinations of several patients. A three-member panel of the Medical Disciplinary Commission issued a report which found the physician had violated the acts as charged. When the physician appealed, the board conducted a final order hearing, issued a public reprimand of the physician, and placed him on indefinite probation. The physician appealed the decision to the circuit court, which reversed the board’s decision. The circuit court stated the evidence against the physician was not reliable, probative, or substantial. The board appealed to the court of appeals, claiming the final order was supported by substantial evidence, and the circuit court wrongfully substituted its judgment for that of the board with respect to the weight of the evidence on fact questions. Issues before the court of appeals were which standard of proof, preponderance of the evidence, or clear and convincing evidence should be applied by the board of medical examiners in an administrative disciplinary proceeding. The court of appeals also considered whether the decision of the board of medical examiners was clearly erroneous because there was no reliable, probative, or substantial evidence in the record. During the appeal, the physician argued the board had denied him his due process rights when it applied the preponderance of the evidence standard of proof. In addition, the physician contended that clear and convincing evidence should be used in a quasi-criminal proceeding to prove professional misconduct.

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The due process clause of the Fourteenth Amendment put constraints on government decisions when the decisions deprived an individual of their “liberty” or “property.” Due process is a statement about fundamental fairness, which in every case may be different. The Supreme Court of the United States ruled a higher level of certainty was necessary in cases which threaten the individual with a significant deprivation of liberty or stigma. In these instances, the court ruled, a clear and convincing standard of proof was required to preserve fundamental fairness. In a professional disciplinary action, the physician was accused of committing a quasi-criminal act in which a board was seeking to revoke his professional license. There was a profound stigma attached to the outcome, and the physician had a substantial interest to protect his good name and his ability to practice medicine. Using the preponderance of evidence standard of proof carried a much higher degree of risk and was considered inconsistent with due process, according to the court.

LICENSURE, WEIGHT OF E VIDENCE Arizona Appellate Court Nursing License Applicant Cheated... An incident involving cheating on a nursing licensing exam led to a case in which an Arizona appellate court ruled on the degree of evidence needed to support a state administrative decision. The nurse candidate took the licensing exam in July 1993. During the exam, one of the proctors observed her engaged in what appeared to be reading from another candidate’s paper. After several minutes, the proctor went to one of the assistant examiners to seek confirmation of

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Before the second quarter of the examination was administered in the afternoon, the head examiner asked the assistant examiner to sit directly in front of the candidate and to observe her during the entire remaining time. Despite this very close monitoring, the candidate continued to read from her neighbor’s paper. At one point, the assistant examiner instructed her to keep her eyes on her desk, but took no further action to prevent her from cheating. On the following day, the candidate was assigned to sit by herself at a table removed from the other candidates. She was watched that day by proctors and examiners, but no suspicious behavior was observed.

The board contended the physician did not raise the standard of proof issue to the board; therefore, it was not preserved for appeal. The physician responded by stating the final order of the board never identified the standard used. When the physician moved for reconsideration, requesting the board use clear and convincing evidence, the request was denied. In essence, when the board denied the request, it admitted it did not use a clear and convincing standard of proof, but used a lesser standard. Though the physician did not have a duty to request the correct standard be applied, he did have the right to assume the proper standard was applied. The appellate court ruled the physician had preserved the issue by asking for reconsideration. The appellate court reversed the order of the circuit court, and remanded the case to the board for a hearing.—Anonymous v. State Board of Medical Examiners, 473 S.E.2d 870 (S.C. Ct. of App., July 15, 1996; rehearing denied Aug. 22, 1996)

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his belief the candidate was cheating. The assistant examiner watched the candidate from several angles and eventually arrived at the conclusion she was reading from another exam. At this point, he went to the head examiner to report his findings. The observation recommenced, and the same conclusion was drawn. No immediate action was taken.

The day after the exam, the head examiner filed a cheating incident report with the state nursing board, in which she accused the candidate of copying her exam from another candidate. The board then conducted a cheating analysis in order to determine the degree of similarity between the two answer sheets in question. The analysis demonstrated a markedly greater similarity between the first half of the two exams, thus lending support to the accusations of cheating. Further, the degree of similarity between the first quarter of the two exams was so similar as to be almost statistically impossible. With this information in hand, the nursing board disregarded the candidate’s passing score on the exam and denied her licensure as a professional nurse. The candidate requested and was granted a hearing on the matter. She offered the expert testimony of a psychometrician as to the inconclusive nature of the findings that led the nursing board to conclude that she had cheated. The state countered with the testimony of a number of research scientists who found the statistical analysis of the similarity between the two exams was methodologically sound and the conclusions regarding cheating very likely accurate. The hearing officer sided with the nursing board and upheld its denial of a license to the candidate. On appeal, the candidate argued the standard of proof used in the hearing was incorrect; rather than a mere preponderance of the evidence, she maintained, the nursing board was required to show clear and convincing evidence she had cheated. The court disagreed. The language of the state’s Administrative Procedure Act, it

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noted, required that the evidence supporting an administrative decision must be “substantial, reliable, and probative.” The court followed the United States Supreme Court in interpreting such language to mean that a mere preponderance of the evidence is sufficient to support administrative orders.—Culpepper v. State of Arizona, 930 P.2d 508 (Ariz. Ct. of App., Aug. 22, 1996; review denied Jan. 14, 1997) LICENSURE, FRAUD Iowa Supreme Court

actual knowledge of the false statements in his license application in order to make a finding of fraud. It was enough to show that in submitting his application, the physician had acted with reckless disregard for whether or not his statements were true. In the court’s decision, the facts of this case justified such a finding. Accordingly, the court upheld the medical board's denial of the physician's license application.—Rosen v. Board of Medical Examiners of the State of Iowa, 539 N.W.2d 345 (Ia. Sup. Ct., Nov. 17, 1995) ABANDONMENT, NOTICE Oklahoma Supreme Court

Physician Denied License for Fraudulent Application... In its decision on the appeal of a physician who was denied a medical license by the Iowa Board of Medical Examiners, the state Supreme Court addressed the question of what constitutes fraud in procuring a medical license.

Adequate Notification Mitigates Charge of Abandonment... A physician was able to terminate a patient/physician relationship during treatment because he had notified the patient, giving her ample time to secure a new physician.

The physician graduated from a college of osteopathic medicine in 1986. In August 1989, he began a three-year preceptorship in dermatology under the supervision of a physician who was practicing in Illinois. The first two years of the preceptorship were approved by the American Osteopathic Association (AOA). During the third year, the supervising physician moved his practice to Iowa, while the younger man stayed on in Illinois. A year later, at the suggestion of the AOA, he completed his preceptorship with a physician in California.

An MRI confirmed a patient had a herniated spinal disk. Though the physician said the best course of treatment would be an operation, he was concerned about safety due to the patient’s other medical conditions. A myelogram and a medical consultation were ordered. The results of the medical consultation confirmed a significant blockage of blood flow to the heart. Because the results had not arrived prior to the time scheduled for surgery, the physician reset the operation for the following week and discharged the patient from the hospital.

During his year in California, the Iowa physician repeatedly asked to become a partner in the practice. When he hesitated to complete the application forms for a medical license, the older physician gave him a blank application form to sign and told him he would complete the rest based on his curriculum vitae. The application form was submitted not long afterwards. Aside from a number of omissions, the application also contained the erroneous statement that the osteopathic physician had completed a three-year preceptorship under the other physician’s supervision. The licensing board discovered the error and denied the application. The osteopathic physician contested the denial, and a hearing followed.

The patient’s son became irate and threatened to call an attorney when he learned of the situation. The physician believed the incident destroyed mutual patient/physician trust and refused to continue treatment. He notified the patient of his decision and gave her names of several other physicians who specialized in her condition. Subsequently, she sued him for negligence and abandonment for delaying the surgery and refusing to continue with her treatment. A trial court granted summary judgment for the physician, and the patient appealed. The court of appeals reversed the decision; however, the Supreme Court affirmed the original decision of the trial court.

At the hearing, the osteopathic physician explained the inaccuracies contained in the application were attributable to the fact it was not he who filled out the form. Despite this explanation, the board found that by signing a blank application form, the physician had committed fraud. It upheld the denial of his application for a medical license. A district court affirmed this decision on judicial review, whereupon the physician brought an appeal. The appellate court issued a ruling in which it pointed out it was not necessary for the medical board to establish the physician had

Courts which had previously tried abandonment cases agreed physicians could terminate a patient/physician relationship when further treatment was required only after they gave proper notification to the patient, and the patient had ample time to secure medical attention from another physician. If a physician did not do so, they were liable for the consequences resulting from abandonment. Though the patient contended she was never given a reason for the abandonment, medical records revealed she was notified about the underlying cause for refusal of treatment. She requested the name of a physician to continue her treatment.

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The Supreme Court ruled the physician gave reasonable notification and gave the patient ample opportunity to secure a new physician. It also was determined at the time of the incident that she was not in a critical or life-threatening state. The court of appeals decision was vacated, and the trial court’s decision was affirmed.—Sparks v. Hicks, 912 P.2d 331 (Okla. Sup. Ct., Feb. 20, 1996) CONFIDENTIALITY, CREDENTIALING Wyoming Supreme Court Discovery of Credentialing Files at Discretion of Court... The question of the scope of discovery of hospital information and documents was addressed in a malpractice case involving a hospital’s alleged negligence in credentialing and reviewing the staff privileges of a surgeon. After filing a malpractice claim, a patient who alleged negligence on the part of the surgeon sought discovery of hospital documents pertaining to the credentialing of the physician as well as materials relating to peer review and quality assurance. The hospital, invoking the confidentiality provisions of the Wyoming Hospital Records and Information Act, refused to produce the documents requested by the patient. The patient thereupon filed motions to compel discovery. The trial court denied the patient’s motions, ruling the documents in question were exempt from discover y. The patient persisted in her attempts. She contended there was a question of fact as to whether the hospital had adhered to the guidelines of the Joint Commission in the appointment, reappointment, credentialing, and privileging of the surgeon. The trial court held a hearing to consider whether the documents were discoverable on the basis of the patient’s contention. After hearing arguments from both sides, the trial judge again refused to compel discovery on grounds of confidentiality. Summary judgment was granted to the hospital, and the patient appealed. The state Supreme Court held in its ruling on the appeal that the trial court was statutorily empowered to weigh the interest of the patient in the pursuit of her case against the hospital’s confidentiality interest. Accordingly, the case was remanded to the trial court with instructions to determine by in-camera inspection of the pertinent documents whether discovery should be allowed.—Harston v. Campbell County Memorial Hospital, 913 P.2d 870 (Wyo. Sup. Ct., April 2, 1996)

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RADIATION ONCOLOGY, HOSPITAL, PRIVILEGES United States District Court Maryland Hospital Denied Summary Judgment on Privileges Issue... In a case involving the relation between a hospital’s peer review process and its business operations, a US District Court ruled that a Maryland hospital was not entitled to summary judgment in a breach of contract suit filed by two physicians formerly on its staff. In 1981, the hospital set up a radiation therapy facility. A radiation oncologist was brought on staff to administer radiation oncology services at the new facility. As part of his employment contract, the oncologist was given the authority to designate which other physicians would receive staff privileges in radiation oncology. In 1987, the oncologist invited a colleague to join the radiation oncology medical group. Sometime thereafter, they formed a professional corporation which effectively controlled the staffing of the radiation oncology facility until June 1992. At that point, the oncologist’s employment contract expired, and he was unable to come to terms with the hospital on renewing it. The radiation facility began thereafter to function with an open staff rather than staff composed exclusively of members or employees of the two physicians’ corporation. Not long after the change in staffing policy, one of the employees of the corporation left in order to set up her own practice. She continued to see patients at the radiation facility. There ensued between her and her former employers a number of disputes concerning patient referrals, scheduling of patients, and peer review. These disputes grew, and eventually the hospital decided it was necessary to reorganize the radiation oncology program into a division of the Department of Radiology, whose members would elect their own leadership. When this change was implemented, the two heads of the corporation were elected division chief and assistant chief, in large part because they still controlled a majority of the voting members of the division. About a month after the division elections, the two heads of the corporation informed the hospital they were in the process of building a radiation oncology facility approximately 25 miles away. This news was alarming to the hospital administration, as a great deal of time and money already had been spent on a plan to expand the hospital-based radiation facility. By way of retaliation, the administration decided to award an exclusive contract to provide radiation oncology services to an outside group. According to terms of this contract, the physicians already manning the facility were to be given priority in hiring. It did not prove possible, however, for the outside group to negotiate an acceptable contract with the two heads of the corporation. A little less than six months after the new service contract had been signed, the

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hospital staff privileges of the heads of the corporation were terminated without a hearing. The two physicians subsequently sued the hospital, claiming the hospital had breached its contract with them when their privileges were terminated. As members of the hospital staff, they contended, they were administratively and legally entitled to a hearing before their privileges could be terminated. The hospital administration responded by arguing the decision to terminate the privileges of the physicians was not one relating to peer review, but instead was based on the operational and financial management of the hospital. On this ground, the hospital moved for summary judgment. The district court found in its review that evidence supported the conclusion that the physicians’ privileges were terminated on a disciplinary basis as a result of their alleged dishonesty, concealment of material facts, and self-dealing. Under the circumstances, there was a genuine issue as to whether the hospital breached its contract with the physicians when it terminated their privileges without a hearing. Summary judgment was denied to the hospital.— Strauss v. Peninsula Regional Medical Center, 916 F.Supp. 528 (D.C., Md., Feb. 29, 1996) ALCOHOLISM, STAFF PRIVILEGES Nebraska Appellate Court Staff Privileges Terminated Because of Alcoholism... The termination of hospital staff privileges of an anesthesiologist with a substance abuse problem was upheld by a Nebraska appellate court. In making its ruling, the court noted it was appropriate in a case such as this one for an appellate court to review a hospital's bylaws to determine whether the actions of its staff and administrators were in full compliance. The anesthesiologist applied for staff privileges at the hospital in July 1993. On her application she admitted that in February 1992 she entered an alcohol rehabilitation center for 30 days of treatment. She further noted that since the treatment, she had been in therapy and was attending Alcoholics Anonymous meetings. The hospital reviewed the application and agreed to grant staff privileges to the anesthesiologist provided she agree to certain conditions. These included continued participation in outpatient treatment programs, verification of such participation, and random drug screenings.

Eleven days after staff privileges had been granted, both a nurse and another physician smelled alcohol on the anesthesiologist’s breath. They reported their finding to hospital administration. The anesthesiologist was notified of the accusations and asked to take appropriate action to resolve the concerns they raised. As a result, she took a leave of absence and entered the hospital’s inpatient alcoholism treatment program. In September 1993, after being informed by hospital administration that any further incidents of a similar nature would result in the termination of her staff privileges, the anesthesiologist returned to work. One month later, the anesthesiologist was arrested for drunk driving with a blood alcohol level of .25. Her daughter was in the car at the time. On the day following her arrest, she failed to appear to provide anesthesia for surgery because she was still in jail. The hospital soon learned of the event and temporarily suspended her staff privileges. The anesthesiologist requested a hearing. At the close of the hearing process, during which she was represented by counsel, the hearing board recommended termination of the anesthesiologist’s staff privileges. The anesthesiologist responded by filing a motion seeking to enjoin the hospital from carrying out the termination. The trial court denied her motion, disagreeing with her that the revocation of her staff privileges was contrary to her contract and to the hospital bylaws. This judgment was upheld on appeal. The appellate court found the anesthesiologist clearly had violated terms of the agreement according her staff privileges. The court also determined hospital staff and administrators had acted in full compliance with the hospital’s bylaws in the process that led to the anesthesiologist’s termination.—Babcock v. Saint Francis Medical Center, 543 N.W.2d 749 (Neb. Ct. of App., Feb. 20, 1996) HOSPITAL, BYLAWS, SUSPENSION OF PRIVILEGES North Dakota Supreme Court Hospital Follows Bylaws in Suspending Physician... The authority of a hospital to issue an indefinite suspension to one of its staff was upheld in a case involving a physician who struck a hospital technician. The physician was a cardiologist who was summoned to the hospital one evening to consult on the case of a patient who was suffering a heart attack. After deciding with the treating physician it was advisable

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to perform an emergency balloon angioplasty, the cardiologist prepared to proceed. When he went to obtain the equipment necessary to perform the procedure, however, he was told by a technician the equipment could not be released to him. The patient’s family had not signed consent forms authorizing emergency surgery, although they had signed the forms for a scheduled, nonemergency operation. The cardiologist responded by going into a rage. He grabbed a telephone receiver from the technician, striking her in the face in the process. He also shouted to the patient that “they are going to kill you” and “they are going to let you die” in reference to the technician and other hospital employees on the scene. The patient responded to the cardiologist’s actions by telling him that he was fired and by asking the treating physician to find him another cardiologist. Afterwards, the hospital suspended the cardiologist for 14 days. During this 14-day period, the hospital decided to continue the suspension until a full investigation of the cardiologist’s conduct could be completed. The cardiologist responded by seeking injunctive relief. He argued before the trial court the injunction was warranted because he was at risk of damage to his professional reputation if the suspension went on for longer than 30 days, in which case the hospital would be required to report it to the National Practitioner Data Bank. The trial court agreed it was unfair to expose the physician to this risk before the investigation had been carried out and granted an injunction in his favor. The hospital maintained in its appeal from the grant of injunctive relief that it was entitled under its bylaws to impose an interim suspension of a physician’s clinical privileges where it was a question of patient safety. After reviewing the bylaws, the appellate court concurred. The physician was not entitled to injunctive relief, it held, as the hospital’s executive committee was permitted to act in line with hospital bylaws to protect the welfare of patients.— Magrinat v. Trinity Hospital, 540 N.W.2d 625 (N.D. Sup. Ct., Dec. 4, 1995) BREAST CANCER, MALPRACTICE, P ATIENT COMPENSATION FUND Louisiana Appellate Court Patient Compensation Fund Liable for Additional Payment... The jury verdict against the family of a cancer patient who sued the state Patients’ Compensation Fund (PCF) for her physician’s failure to timely and properly diagnose her condition was

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reversed by a Louisiana appellate court. The court ruled the PCF was not entitled to challenge at trial the physician’s earlier admission that his malpractice caused the patient’s chance of survival to be reduced. In the summer of 1990, the patient discovered a lump in her left breast. She immediately consulted with a physician who did a breast examination, and then ordered a biopsy. The tumor was diagnosed as malignant. Shortly thereafter, the physician performed a modified mastectomy of the left breast. Since subsequent tests appeared to indicate the cancer had not spread, the doctor told the patient she had a 75% chance of the cancer not recurring. The patient then continued to see the physician for at least four more months, during which time he never performed a mammogram on her right breast, despite her repeated requests to do so. In December 1990, another physician arranged for a mammogram to be performed and detected a tumor which proved to be malignant. The patient had to undergo a modified mastectomy of the right breast. The physician who failed to diagnose cancer in the right breast informed the patient at the time of the second mastectomy that she had less than a 50% chance of survival, and that she would have to receive both chemotherapy and radiation treatment. Over the next four years, the patient suffered a great deal before succumbing to cancer in January 1995. The patient’s family brought a malpractice action against the physician. The physician admitted to malpractice and agreed to settle the case for $100,000. The family then sought additional damages from the PCF. After a trial on the issue of excess damages, a jury determined that more probably than not the physician’s malpractice did not reduce the patient’s chance of survival. Consequently, the patient’s family was not awarded damages. The family moved for a judgment notwithstanding the verdict, but the motion was denied by the trial judge. The family appealed the denial of their motion on a number of grounds. Principal among these was the fact the PCF impermissibly relitigated the issue of causation after the physician had acknowledged in the settlement agreement his causative role in the patient's injury. The court agreed such relitigation was in violation of the statute that established the PCF. On this basis, the court reversed the judgment of the trial court and awarded the patient’s family $400,000. This figure was decided upon because the patient’s chance of survival had been reduced by at least one third and the patient’s $100,000 of the settlement award included.—Greer v. Lamico, 688 So.2d 692 (La. Ct. of App., Jan. 31, 1997; rehearing denied Feb. 20, 1997)

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EMOTIONAL DISTRESS, FRIVO LOUS LAWSUIT, HOSPITAL Texas Appellate Court Patient Claims Emotional Distress for Being Denied Private Room... A hospital was granted summary judgment against the frivolous lawsuit of a former patient who claimed she suffered mental anguish when she was told she would not be assigned to a private room. The patient underwent surgery at the hospital to relieve lower back pain. Four days before the operation occurred, she requested that she be given a private room for postsurgical recovery. The hospital agreed to do so. After surgery, however, the patient was informed by a nurse there were no private rooms available and she would be given a semiprivate room. The patient complained to the nurse and her doctors, pointing out prior arrangements had been made for a private room. As a result of her complaints, she was given a private room. Her recovery proceeded in a timely manner, without complications. Nearly two years later, the patient sued the hospital for the mental anguish she allegedly suffered as a result of the “breach of contract” that took place when she was momentarily denied a private room. This breach of contract, which according to her claim involved refusal to put her in a private room unless she paid a substantial cash deposit, entailed an intentional infliction of emotional distress upon her by hospital staff. The hospital responded by filing a summary judgment motion in which it called the patient’s claim frivolous and in bad faith. It argued to the trial court the patient’s breach of contract claim, which was already untenable because she had been given a private room, was in any case not one from which she could recover damages for mental anguish. The hospital also maintained there was no basis for finding the actions of the hospital staff were outrageous and intended to inflict emotional distress. The trial court agreed with these contentions and granted the hospital’s motion. Further, it imposed $1,000 in sanctions on the patient for bringing a frivolous claim. When the case went to appeal, the appellate court affirmed the grant of summary judgment to the hospital. It found the trial court’s ruling on the breach of contract claim was proper in accordance with the principle that mental anguish damages are not recoverable for breach of contract unless the action or actions that produce the alleged mental anguish are reasonably foreseeable at the time the contract is made. The court also agreed with the trial court the hos-

pital staff had not acted in an outrageous manner when they insisted the patient place a deposit before being given a private room. This insistence was intended to safeguard the hospital’s legal right to secure payment for its services.—Delgado v. Methodist Hospital, 936 S.W.2d 479 (Tex. Ct. of App., Dec. 30, 1996) PODIATRIST, NEGLIGENCE, EXPERT WITNESS Massachusetts Appellate Court Expert Opinion Sufficient to Warrant Trial... The dismissal of a patient’s failure to diagnose claim against a podiatrist was vacated and remanded by a Massachusetts appellate court. In August 1990, the patient went to a clinic in order to be treated for a painful foot. The podiatrist she saw took a medical history in which he learned that several weeks before, another podiatrist scraped a piece of skin underneath one of her toenails while he was cutting them. Additionally, he discovered the patient was diabetic. When he proceeded to examine the toe where the patient had been cut, he noticed it was red and swollen and draining pus. The podiatrist’s diagnosis was cellulitis, for which the patient was to take medication and soak her foot in a Betadine solution followed by application of Bacitracin to the toe. The patient returned for treatment at the clinic several times over the course of the next 70 days. About two months into her treatment, she developed a sore on her right lower leg that was warm to the touch. Her podiatrist treated her for this wound on a regular basis for one week. At the end of this week, he concluded the wound had been reduced substantially and appeared as a superficial ulceration with no cellulitis and no lymphangitis. Less than a month later, the patient was hospitalized with a diabetic septic foot. A toe amputation had to be performed on the third toe of her right foot. The patient brought a malpractice suit against the podiatrist for his alleged negligence in failing to diagnose and treat her septic foot. A medical malpractice tribunal was charged with reviewing the case. At the close of the hearing, the tribunal concluded that based on her expert’s failure to state directly in his affidavit that the podiatrist deviated from the standard of care, the patient did not have a case. Hearing this judgment, the patient’s attorney then requested that her expert be allowed to submit a supplemental affidavit in which he clearly and unequivocally stated the podiatrist had deviated from the standard of care. The tribunal denied this request, reckoning it had come too late. The patient’s claim was dismissed.

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Bringing an appeal from the dismissal of her claim, the patient contended before the appellate court the testimony of her expert was enough to raise a legitimate question of liability appropriate for judicial inquiry. The court found this contention to be compelling. Despite the fact the expert made no direct allegations of deviation from the standard of care on the part of the podiatrist, his affidavit did put into question whether the podiatrist had conformed to good medical practice. As such, the affidavit went far enough to preclude a directed verdict for the podiatrist.—Nickerson v. Lee, 674 N.E.2d 1111 (Mass. Ct. of App., Jan. 27, 1997) NEUROSURGEON, MALPRACTICE, INFORMED CONSENT Nebraska Supreme Court Decision for Neurosurgeon Reversed by Supreme Court... The decision for a neurosurgeon sued by a patient for failing to secure informed consent for spinal surgery was reversed on procedural grounds by a Nebraska appellate court. The state Supreme Court reviewed the case and upheld the decision to remand the case for a new trial. The patient—when in her early teens—underwent two operations for knee injuries. She failed to recover properly after the second of these surgical procedures. Her physician at the time, judging there was a possibility that a spinal injury had occurred, referred her to a neurologist, who in turn referred her to a neurosurgeon. The neurosurgeon discovered a cyst on the patient’s spine, which he removed along with some of the patient’s spine in order to drain the cyst. The cyst recurred a few months later, and the procedure was performed again. After the second operation, the patient developed a progressive kyphosis, a condition involving an abnormally increased convexity in the curvature of the thoracic spine. Later, she underwent operations to correct the problem, but her condition was not eliminated though it was improved. The patient and her mother filed a suit against the surgeon for failing to inform them about the risk of developing kyphosis, a post-operative complication associated with spinal surgery. They also maintained the physician failed to provide appropriate follow-up care. After a trial on the issues, the jury returned a verdict for the surgeon. The patient followed with an appeal. The decision for the neurosurgeon was reversed. Then he petitioned to the state Supreme Court for further review.

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The high court upheld reversal of the decision for the surgeon. It held the trial court’s refusal to accept the patient’s proposed jury instruction on concurrent negligence was erroneous. According to the proposed instruction, the jury would have been advised the physician could be held liable for the patient’s injury even if his allegedly negligent acts were only one part of a series of acts which combined to cause her problem. Though this instruction was not a correct statement of the law, the court found the evidence in this case necessitated some instruction on concurrent negligence be given to the jury. Accordingly, the failure to give such an instruction amounted to reversible error.—McLaughlin v. Hellbusch, 557 N.W.2d 657 (Neb. Sup. Ct., Jan. 3, 1997) INFORMED CONSENT, UROLOGIST, SURGERY New Jersey Superior Court Patient Wins Informed Consent Suit... The decision in favor of a urologist sued for failing to secure the informed consent of a patient before operating to remove a kidney stone was reversed and remanded by a New Jersey appellate court. The patient began to experience severe pain in his lower back early in March 1990. After a week with this pain, his wife took him to an emergency room where he was examined and admitted to the hospital because it appeared he might have a kidney stone. The patient subsequently was seen by a staff urologist. After speaking to the patient and examining x-rays taken in the emergency room, the urologist determined the patient had a kidney stone of less than four millimeters in circumference lodged in his urethra. Surgery was scheduled to remove the stone. The first attempt was not successful. Another operation was performed the next day to implant wires in the patient’s back in preparation for a third surgery, in which the stone hopefully could be located and removed. The second stage resulted in most of the kidney stone being removed with a few fragments remaining in the urethra. During this operation, the urologist placed a stent through the urethra to allow the fragments to be flushed out. He told the patient afterwards he would remove the stent in his office two weeks later. However, the urologist was not able to remove the stent as planned and scheduled another operation.

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The stent had migrated higher in the urethra and the urologist was unable to manage its removal. Over the course of the next three weeks, the patient suffered recurrent pain in his side and back. One more attempt was made to remove the stent, but again without success. Finally, the patient went to see another physician, who was able to remove the stent on his first attempt. The patient decided to sue the urologist for failing to inform him before performing the initial operation to remove the kidney stone that the stone eventually was likely to pass by itself without surgical intervention. At trial, medical experts for both sides disagreed as to whether the patient’s condition warranted surgical intervention. The patient’s expert opined that factors such as the relatively small size of his kidney stone and the absence of any severe accompanying symptoms contraindicated surgery. The urologist’s expert, on the other hand, noted the patient had been suffering back pain for almost a week, and the patient’s x-rays showed the stone was accessible to removal, thus indicating surgery was in order. At the close of trial, the patient moved for a directed verdict on the claim of failure to secure informed consent. The trial court denied the motion, and the jury returned a verdict for the urologist. The patient appealed the denial of the directed verdict motion. The appellate court reviewed the trial record and decided the patient was entitled to further proceedings on the informed consent claim. Where there was a nonsurgical option available, the court held, the urologist was duty bound to apprise the patient of its availability. The failure to do so amounted to a violation of the patient’s right to self-determination. The issue remaining for the jury to decide at trial was whether the urologist’s failure to secure the patient’s informed consent was a proximate cause of his injuries.—Caputa v. Antilles, 686 A.2d 356 (N.J. Sup. Ct., Dec. 24, 1996)

The administrator of the patient’s estate filed a wrongful death suit against the physician based on his alleged negligence in administering the vaccinations and in failing to warn the patient of the dangers of driving after receiving these vaccinations. After conducting a hearing on the administrator’s motion for a preliminary determination on whether the physician owed a duty of care to the patient, the trial court decided in favor of the physician and dismissed the administrator’s action. The administrator appealed this decision. The appellate court upheld the dismissal of the administrator’s action. The fact the administrator did not claim to have had any prior contact with the physician or the patient upon which he could base a claim of reliance was decisive. Additionally, the administrator’s complaint failed to establish the patient’s death as a result of his vaccinations was reasonably foreseeable.—Cram v. Howell, 662 N.E.2d 678 (Ind. Ct. of App., March 22, 1996) GLOSSARY OF LEGAL TERMS Judgment Notwithstanding the Verdict: A determination contrary to a jury verdict based on law and rendered by the judge. Summary Judgment: Assumes the facts do not require a trial and the remaining issues relate to the law only.

The Citation is a medicolegal digest published by Citation Publishing Corporation, Long Grove, Ill. To subscribe, call (800) 626-5210.

VACCINATION, ADVERSE REACTION Indiana Appellate Court Wrongful Death Suit Dismissed... The issue of whether a physician who immunized a patient owed a duty to that patient was considered by an Indiana appellate court in a wrongful death case. In May 1990, a man went to a physician whom he was visiting for the first time for the purpose of receiving various vaccinations and immunizations. After these were administered, the patient twice lost consciousness in the physician’s office. Eventually, after the patient was deemed sufficiently recovered to drive himself home, he left the office. On the way home, he again lost consciousness and was involved in a traffic accident that caused him serious injuries, as a result of which he later died.

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Federation Bulletin

vol 85 Number 3

1998