Potential Grounds for Malpractice Liability in CAM

The table below summarizes some of the major grounds of potential legal claims with which clinicians, institutions, and associations should be concerned.

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Integrative Mental Healthcare: Legal and Ethical Issues

Integrative mental healthcare can be defined as integration in mental healthcare of conventional and complementary and alternative (CAM) therapies for which there is some high-quality scientific evidence of safety and effectiveness. The legally responsible and ethically defensible practice of complementary and alternative medical (CAM) approaches in mental health care is a fundamental concern.

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U.S. v. Australia Complementary Medicine Law: Informed Consent, Licensure, Liability

U.S. physicians, like their Australian counterparts, are deeply interested in legal and ethical issues concerning patient use of complementary and alternative medical (CAM) therapies.Key legal questions of concern to physicians include: (1) malpractice liability for negligent care and for inadequate informed consent; (2) licensure and credentialing; (3) scope of practice (the legally authorized practice boundaries for non-physicians, including CAM providers); (4) regulation of dietary supplements; (5) professional discipline; (6) third-party reimbursement; and (7) health care fraud. In Cohen MH, Legal and ethical issues in complementary medicine: a U.S. perspective, Med J Australia 2004;181:3:168-169, the Medical Journal of Australia features a comparison of key aspects of malpractice liability, informed consent, and licensure in the U.S. with the Australian perspective.

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List of Legal and Ethical Issues in Spiritual Care (Such as Energy Healing)

What legal and ethical issues apply to spirituality in medical care generally as well as mental healthcare? Consider, for example, practices such as energy healing (Reiki, Therapeutic Touch, Polarity).

The same legal and ethical issues apply as they do to CAM generally, only they loom larger. For example, the following questions may arise concerning potential liability.

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APA (American Psychiatric Association) Caucus on CAM

This just in from CAM and Psychiatry authority James Lake, M.D., affiliated with Stanford University School of Medicine: the APA (American Psychiatric Association) Caucus on CAM and integrative approaches in mental health care is up and running. The new Caucus (established May 2004) gathers together prominent psychiatrists exploring spirituality and mental health. Psychiatrists interested in participating in the Caucus should go to the new website at www.apacam.org . Below is the press release with more information. Thanks to James for a labor of love bringing these issues to the forefront. Together with other colleagues such as David Spiegel, M.D. also of Stanford University School of Medicine, James has been pioneering in helping to develop this area.

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Ethics in CAM: An International Perspective

Yet another take on ethical issues in CAM, with an international twist, comes Ernst EE, Cohen MH, Stone J. Ethical problems arising in evidence-based complementary and alternative medicine. J Med Ethics 2004;30: 156-159. In this article, we examine some of the differences between conventional medicine and complementary and alternative medicine, and the implications of those differences for an ethics of CAM.

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Legal and Regulatory Resources in Complementary, Alternative, & Integrative Medicine

In addition to Articles by Michael and Books by Michael, this section offers articles and books by others on complementary, alternative, and integrative medicine law, regulation, ethics and policy.

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CAM Resources - Journals

This part of the blog will be updated regularly with important links to key players in the CAM field.

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Federation of State Medical Board Guidelines

In addition to understanding the fundamentals of professional discipline, it's also a good idea to become familiar with the Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice promulgated by the Federation of State Medical Boards.

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Discipline by State Medical Boards and Others

Disciplinary issues have been among the thorniest facing clinicians, particularly M.D.'s, offering CAM therapies.

While a malpractice lawsuit involves a civil claim by a private party (the patient) against the provider, professional discipline against a CAM provider involves an administrative hearing by a professional regulatory board (for example, the state board of chiropractors but more typically the state medical board).

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Mental Healthcare and CAM

Here's a big secret: mental health care professionals already are practicing CAM under the guise of conventional medicine. Relaxation therapies, such as visualization and guided imagery, clinical hypnotherapy, and other modalities sometimes come under the label "mind-body."

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Clinical Research, the FDA and the NIH

Here are some brief throughts about clinical research, the FDA< and the NIH from Cohen, MH. Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation. Derm Ther 2003;16:77-84. The abstract provides a summary of some of the major issues involved in research and clinical practice, and appeared in an issued devoted to review of safety and efficacy of CAM therapies in dermatology.

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Ethics in CAM: A Balancing Test

I'm proud of my colleague and friend Karen Adams, M.D., as lead author of Adams KE, Cohen MH, Jonsen AR, Eisenberg DM. Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med; 2002;137:660-664. We all worked hard to come up with a framework that balanced all the interests at stake--including the patient's--when clinicians have to make ethical decisions about recommending use or avoidance of specific CAM therapies.

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Important Court Cases

Here's a brief summary and analysis of two important cases concerning claims of CAM malpractice: Charell v. Gonzales, and Schneider v. Revici.

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Credentialing CAM Providers

It's important to remember that a variety of personnel may be offering CAM services: physicians; allied health providers (such as nurses); and CAM providers (such as acupuncturists).

Physicians typically get privileges as members of the hospital staff; such privileges will need to be modified to add specified CAM therapies. This may be heavily contested or negotiated with the hospital's medical executive committee.

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How Should Hospitals Handle Dietary Supplements?

How Should Hospitals Handle Dietary Supplements? This is a complex question, in part because it requires consideration of patient demands, administrative concerns, legal issues, ethical questions, and provider predilections. Often physicians find themselves in the middle of this complex equation, able to satisfy neither patients, nor their administrators, nor themselves.

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When Will My IRB Approve My CAM Study?

So far I've submitted to IRBs that seem to understand clinical research involving complementary and alternative medical (CAM) therapies and apply the same rigorous standards (not higher ones) as they do to studies involving conventional care. But this sense of efficiency and fairness apparently has evolved over time--not without stops and starts. I've heard horror stories at other institutions about IRB's taking a year or more to review a protocol simply because it involves chiropractic, acupuncture, or homeopathy.

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Can I Get My Use of CAM Therapies Reimbursed?

Most insurance plans do not offer third-party reimbursement for CAM therapies and those that do tend to offer discounted packages on visits to CAM providers within a network. The number of visits reimbursed is often limited.

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Should Hospitals Offer CAM Therapies? Which Ones?

Patients are asking physicians and hospitals to provide specific CAM therapies as part of their conventional care. How should hospital administrators and staff respond? How can they meet patient interests while maintaining patient safety (and managing liability concerns)?

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How is Complementary and Alternative Medicine (CAM) Regulated?

How is complementary and alternative medicine (CAM) or integrative health care regulated? Who protects the public against dangerous or fraudulent practitioners? What laws govern provision of such therapies as massage therapy, chiropractic, baturopathic medicine (naturopathy), homeopathic medicine (homeopathy), herbal medicine, and acupuncture and traditional oriental medicine?

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What is CAM?

Although many definitions for CAM therapies exist, a helpful working definition is: "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine."

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Are Dietary Supplements Unregulated?

Aren't dietary supplements unregulated? How does that affect the institution's ability to handle their use?

The regulatory category of "dietary supplements" causes institutions (and clinicians) considerable confusion, both clinically and legally. A key to clarifying the legal issues is understanding the Dietary Supplements Health Education Act of 1994, or DSHEA.

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Ethics in Pediatric CAM Care

Michael has published a new study with Kathi J. Kemper, MD, a leading pediatrician in integrative care. The study published in the journal Contemporary Pediatrics offers a number of cases showcasing a framework for legal and ethical analysis by clinicians advising concerning use of CAM therapies in pediatrics.

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Healing at the Borderland of Medicine and Religion

How does the law regulate spiritual and energy healing? Does it regard these practices as "health care" and "medicine" or "religion?" How does the law handle the kinds of potential abuse of power in the relationship between spiritual healer and client? What remedies are available, and what about legal rules governing fraud? How does this compare to the way the law handles misconduct in relationships between provider and patient generally?

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Technology and Spirituality

Paradoxical as it may seem, is the rapid unfolding of technological "wizardry" a route to spirituality?

Yes and no. Technology is double-edged: it separates and alienates us from our own being while at the same time having the potential to connect us to our deeper potential. Take cell-phones, for example; they connect us to loved ones, important particularly during emergencies and health care crises, yet they also take us out-of-body: witness people on the street, energetically and visually hooked to their gadgetry, or gazing around with vacant eyes because they are literally "not there," not present.

I was reading in Arthur C. Clarke's book 3001: The Final Odyssey about the advent of informational implants in people's palms so that when they great each other (by shaking hands or raising the palm) there will be an exchange of digital (pardon the pun) information.

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Regulation, Religious experience, and Epilepsy

Complementary and alternative medical (CAM) therapies include chiropractic, acupuncture and traditional Oriental medicine, massage therapy, and herbal remedies; mind-body therapies (such as meditative practices and visualization); and folk practices and religious healing. Of these, modalities based on spiritual healing create a number of conundrums for the clinician, including legal, regulatory, and ethical issues. Further, the historic relationship between the study of epilepsy and religious experience suggests particular, potential associations between CAM therapies (and especially spiritual healing) and care for epileptic patients. There are at least two dimensions to this exploration: first, the widespread use of spiritual healing for treatment of epilepsy; and second, the hypothesized connection between epileptic seizures and mystical states. A number of legal rules help address potential abuse of authority by health care professionals, and include: (1) medical licensure; (2) scope of practice; (3) professional discipline; (4) malpractice; and (5) fraud. The longer article offers a preliminary resource for clinicians interested in these topics. Cohen MH, Regulation, religious experience, and epilepsy: a lens on complementary therapies. Epilepsy Behav 2003;4:6:602-606.

Resolving Healthcare Disputes

Litigation produces one winner, one loser, and can entail delays, expenses, and damage to relationships. It is important to weigh the potential costs and benefits before filing a lawsuit,and the option of alternative dispute resolution techniques such as arbitration, mediation, fact-finding, and negotiation to pursue a reasoned, practical, and intuitively satisfying resolution.

Negotiation strategies effectively can be applied to disputes involving CAM therapies, in a way that effectively preserves ongoing relationships between provider and patient, provider and hospital, and/or patient and hospital, that may be critical to current care. Such strategies can help forestall litigation, ideally minimize malpractice risk, and facilitate healing interactions that effectively negotiate health care crises.

Mediation and Healing

Mediation is a healing path: it moves parties to reconcile their differences in an atmosphere that, ideally, improves their connectedness, bridges their separate objectives, and integrates rather than fragmenting through adversarial conduct.

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Negotiating Integrative Medicine

Efforts to integrate complementary and alternative medical (CAM) therapies, such as chiropractic, acupuncture and oriental medicine, massage therapy, and herbal medicine, into conventional medical settings are creating a variety of negotiation challenges between various stakeholders.

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Articles by Michael H. Cohen

Below is a chronological list of articles and book chapters, with links and downloads where publicly available. A list of articles by topic area is available at the Institute for Integrative and Energy Medicine.

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Should I Incorporate or Form a Partnership?

Many individuals starting a business ask: (1) Should I incorporate my business? (2) Am I better off creating a partnership?

There's no easy answer and it all depends on what choices you want to make given what is appropriate to your business, but you may wish to consider several key factors.

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Fahrenheit 9/11

My reviews will be idiosyncratic and focused on books and films tying together issues of complementary and alternative medicine, health care, ethics, law, and spirituality; I will pick up a few elements that correspond to themes in my work or trigger further reflection. Two things stood out for me in Michael Moore's film, Fahrenheit 9/11: curses; rule of the techno-mind's violence. What captures my attention in the film is not politics, but currents of spiritual energy, as I try to connect the dots of what is happening to our world as it pertains to definitions of health and human evolution.

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