Abstracts on legal issues in complementary, alternative, and integrative medicine

For the new year, here is a collection of some abstracts of articles I have authored or co-authored in medical and legal journals on legal issues in complementary, alternative, and integrative medicine.

This is a list I'd put together for the resources section on the law firm website.

"Physicians integrating CAM therapies into clinical practice face many legal challenges, including the fact that legal rules governing CAM providers and practices are new and evolving in many cases. Laws vary by state, and their application depends on the specific clinical scenario in question. As more evidence accumulates regarding safety and efficacy or lack thereof of specific therapies for given conditions, physicians will find clinical knowledge more abundantly mapped and that the parameters of liability are increasingly clear. Meanwhile, good clinical practice and a working knowledge of major legal rules can help provide physicians with a good measure of legal protection in situations involving integration of CAM providers and therapies in conventional medical practice."

Legal issues in complementary and integrative medicine. A guide for the clinician. Med Clin North Am. 2002 Jan;86(1):185-96.

"Physicians are increasingly grappling with medical liability issues as complementary and integrative health care practices are made available in conventional medical settings. This article proposes a framework in which physicians can assess potential malpractice liability issues in counseling patients about complementary and integrative therapies. The framework classifies complementary and integrative therapies according to whether the evidence reported in the medical and scientific literature supports both safety and efficacy; supports safety, but evidence regarding efficacy is inconclusive; supports efficacy, but evidence regarding safety is inconclusive; or indicates either serious risk or inefficacy. Clinical examples in each category help guide the clinician on how to counsel patients regarding use of complementary and alternative medical therapies in a given clinical situation. Specific strategies to reduce the risk for potential malpractice liability include the following: 1) determine the clinical risk level; 2) document the literature supporting the therapeutic choice; 3) provide adequate informed consent; 4) continue to monitor the patient conventionally; and 5) for referrals, inquire about the competence of the complementary and alternative medicine provider. This framework provides a basis for clinical decisions involving complementary and integrative care." Potential Physician Malpractice Liability Associated with Complementary and Integrative Medical Therapies. Annals of Internal Medicine. 16 April 2002 | Volume 136 Issue 8 | Pages 596-603.

"Since the late 19th century, state legislatures and professional medical organizations have developed mechanisms to license physicians and other conventional nonphysician providers, establish standards of practice, and protect health care consumers by establishing standardized credentials as markers of competence. The popularity of complementary and alternative medical (CAM) therapies presents new challenges. This article describes the current status of, and central issues in, efforts to create models for health care credentialing of chiropractors, acupuncturists, naturopaths, massage therapists, and other CAM practitioners. It also suggests a strategy of CAM provider credentialing for use by physicians, health care administrators, insurance companies, and national professional organizations. The credentialing debate reflects fundamental questions about who determines which providers and therapies will be accepted as safe, effective, appropriate, and reimbursable. More nationally uniform credentialing mechanisms are necessary to ensure high standards of care and more generalizable clinical research. However, the result of more uniform licensure and credentialing may be excessive standardization and a decrease in individualization of services. Thus, increased standardization of credentialing for CAM practitioners may alter CAM practice substantially. Furthermore, even credentialed providers can deliver ineffective therapy. The suggested framework balances the desire to protect the public from dangerous practices against the wish to grant patients access to reasonably safe and effective therapies." Credentialing Complementary and Alternative Medical Providers. Annals of Internal Medicine. 17 December 2002 | Volume 137 Issue 12 | Pages 965-973.

"Increasing use of complementary and alternative medical (CAM) therapies by patients, health care providers, and institutions has made it imperative that physicians consider their ethical obligations when recommending, tolerating, or proscribing these therapies. The authors present a risk-benefit framework that can be applied to determine the appropriateness of using CAM therapies in various clinical scenarios. The major relevant issues are the severity and acuteness of illness; the curability of the illness by conventional forms of treatment; the degree of invasiveness, associated toxicities, and side effects of the conventional treatment; the availability and quality of evidence of utility and safety of the desired CAM treatment; the level of understanding of risks and benefits of the CAM treatment combined with the patient's knowing and voluntary acceptance of those risks; and the patient's persistence of intention to use CAM therapies. Even in the absence of scientific evidence for CAM therapies, by considering these relevant issues, providers can formulate a plan that is clinically sound, ethically appropriate, and targeted to the unique circumstances of individual patients. Physicians are encouraged to remain engaged in problem-solving with their patients and to attempt to elucidate and clarify the patient's core values and beliefs when counseling about CAM therapies."

Ethical Considerations of Complementary and Alternative Medical Therapies in Conventional Medical Settings. Annals of Internal Medicine. 15 October 2002 | Volume 137 Issue 8 | Pages 660-664

"Background. Little is known about policies governing the integration of complementary and alternative medical (CAM) therapies and providers.

Methods. To document emerging approaches in 19 US hospitals regarding credentialing, malpractice liability, and pharmacy policies governing integration of CAM therapies and providers into conventional medical settings, we surveyed 21 academic medical centers and 13 non-academically affiliated hospitals that are nationally visible and are integrating CAM therapies into conventional medical settings. Of the 19 respondents, 11 were tertiary care hospitals, 6 were community hospitals, 1 was a freestanding center associated with a community-based hospital, and 1 was a university-based rehabilitation hospital.

Results. Institutions had no consistent approach to provider mix and authority within the integrative care team, and minimum requirements for professional liability insurance, informed consent disclosure, and hiring status. Less than a third had a formal (stated) policy concerning dietary supplements; those selling supplements in their pharmacy lacked consistent, evidence-based rationales regarding which products and brands to include or exclude. Although many hospitals confiscated patient supplements on admission, institutions had inconsistent criteria regarding allowance of home supply.

Conclusions.Hospitals are using heterogeneous approaches to address licensure, credentialing, scope of practice, malpractice liability, and dietary supplement use in developing models of integrative care. The environment creates significant impediments to the delivery of consistent clinical care and multisite evaluations of the safety, efficacy, and cost-effectiveness (or lack thereof) of CAM therapies (or integrative models) as applied to management of common medical conditions. Consensus policies need to be developed." Emerging Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Complementary and Alternative Medical Practices and Dietary Supplement Recommendations A Descriptive Study of 19 Integrative Health Care Centers in the United States.Arch Intern Med. 2005;165:289-295.

"This research documents policies in 39 randomly selected academic medical centers integrating complementary and alternative medical (CAM) services into conventional care. Twenty-three offered CAM services-most commonly, acupuncture, massage, dietary supplements, mind-body therapies, and music therapy. None had written policies concerning credentialing practices or malpractice liability. Only 10 reported a written policy governing use of dietary supplements, although three sold supplements in inpatient formularies, one in the psychiatry department, and five in outpatient pharmacies. Thus, few academic medical centers have sufficiently integrated CAM services into conventional care by developing consensus-written policies governing credentialing, malpractice liability, and dietary supplement use."

Policies pertaining to complementary and alternative medical therapies in a random sample of 39 academic health centers. Altern Ther Health Med. 2005 Jan-Feb;11(1):36-40.

"Increasing use of complementary and alternative medicine (CAM) therapies such as chiropractic, massage therapy, and herbal medicine, raises questions about the clinically appropriate use of CAM in pediatrics. Nonjudicious use of CAM therapies may cause either direct harm or, by creating an unwarranted financial and emotional burden, indirect harm. When advising patients concerning CAM therapies, pediatricians face 2 major legal risks: medical malpractice and professional discipline. Pediatricians can incorporate these considerations into advising and clinical decision-making about CAM therapies to address the best interest of the pediatric patient while helping to manage potential liability risk. This article provides a suggested framework, including asking the following questions: (1) Do parents elect to abandon effective care when the child's condition is serious or life-threatening? (2) Will use of the CAM therapy otherwise divert the child from imminently necessary conventional treatment? (3) Are the CAM therapies selected known to be unsafe and/or ineffective? (4) Have the proper parties consented to the use of the CAM therapy? (5) Is the risk-benefit ratio of the proposed CAM therapy acceptable to a reasonable, similarly situated clinician, and does the therapy have at least minority acceptance or support in the medical literature? Such an approach ideally can help guide the pediatrician toward clinical conduct that is clinically responsible, ethically appropriate, and legally defensible."

Complementary Therapies in Pediatrics: A Legal Perspective. PEDIATRICS Vol. 115 No. 3 March 2005, pp. 774-780 (doi:10.1542/peds.2004-1093)

"Objective. Many pediatricians and parents are beginning to integrate use of complementary and alternative medical (CAM) therapies with conventional care. This article addresses ethical and policy issues involving parental choices of CAM therapies for their children.

Methods. We conducted a literature search to assess existing law involving parental choice of CAM therapies for their children. We also selected a convenience sample of 18 states of varying sizes and geographic locations. In each state, we inquired within the Department of Health and Human Services whether staff were aware of (1) any internal policies concerning these issues or (2) any cases in the previous 5 years in which either (a) the state initiated proceedings against parents for using CAM therapies for their children or (b) the department received telephone calls or other information reporting abuse and neglect in this domain. We asked the American Academy of Pediatrics and the leading CAM professional organizations concerning any relevant, reported cases.

Results. Of the 18 state Departments of Health and Human Services departments surveyed, 6 reported being aware of cases in the previous 5 years. Of 9 reported cases in these 6 states, 3 involved restrictive dietary practices (eg, limiting children variously to a watermelon or raw foods diet), 1 involved dietary supplements, 3 involved children with terminal cancer, and 2 involved religious practices rather than CAM per se. None of the professional organizations surveyed had initiated proceedings or received telephone calls regarding abuse or neglect concerning parental use of CAM therapies.

Conclusions. Pediatric use of CAM therapies raises complex issues. Clinicians, hospitals, state agencies, courts, and professional organizations may benefit from a policy framework to help guide decision making."

Pediatric use of complementary therapies: ethical and policy choices. Pediatrics. Electronic Pages.2005; 116: e568 - e575.

"THE INCREASING popularity of complementary and alternative medicine (CAM) poses serious challenges for the physician, not the least being the issue of informed consent. Herein, we review the implications of informed consent. Informed consent should include adequate information about the risks and benefits of all treatment options. The information about potential risks, including frequent, nonserious adverse affects as well as infrequent serious complications, is crucial for patients to know. Failure to disclose the availability, benefits, and risks of CAM treatments could give rise to malpractice claims. We discuss the existing US case law and several hypothetical scenarios. The ethical rules physicians follow in conventional care usually can be applied to treatment with CAM. The focus must be on expressing risks clearly, documenting informed consent adequately, and keeping up-to-date with the emerging evidence on CAM."

Informed Consent in Complementary and Alternative Medicine. Arch Intern Med. 2001;161:2288-2292.

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?

"Although historically, the phenomenon of spiritual healing emerged as a religious practice within the context of specific religious traditions and has traditionally been ascribed only to mystics, saints, and holy persons, in modern times, a variety of spiritual healing practices unconnected with traditional religion have entered mainstream professional health care. These practices are used in a variety of health care professions, from medicine to nursing, dentistry, and other allied health professions.

"For example, some physicians either collaborate with (or refer to) spiritual healers or use "'healing energy' through touch" without naming a particular style, school, or technique, and a spiritual healing modality known as Therapeutic Touch is part of the curriculum in many nursing schools. Use of caring or healing touch is increasingly described as potentially useful in various health care settings, from acute care, to surgery, to obstetrical nursing practice; and Reiki, a Japanese form of energy healing, has even been used in efforts to help survivors recover from torture. Additionally, spiritual healing services are offered by practitioners of "complementary and alternative" medical (CAM) therapies, such as chiropractic, acupuncture, and massage therapy. For example, some practitioners of acupuncture and traditional oriental medicine will practice qigong, a Chinese system of spiritual healing. Similarly, intuitive use of touch is a central component of chiropractic, and is central to many forms of massage therapy. Overall, at least 50,000 health professionals provide about 120 million sessions of spiritual healing to patients annually.

"The prevalence of spiritual healing in the provision of health care services receives extensive attention in the Chantilly Report, a 1992 quasi-governmental report to the National Institutes of Health entitled, "Alternative Medicine: Expanding Medical Horizons." The report describes spiritual healing as a collection of different practices centering around spirituality and notions of healing that are used with increasing frequency as part of professional health care, not only in the provision of CAM services, but also within medicine, nursing, and the allied health professions. The report does not offer definitive guidance on ways to sort out differences, if any, between spiritual healing, faith healing, laying on of hands, prayer, intentionality, and related practices, but it does highlight the increasing use of these practices in a variety of health care settings.

"The practice of spiritual healing in a secular context, within the provision of clinical care, suggests the possibility of regulating spiritual healing as the professional delivery of a health care service. The attached article argues that those who purport to utilize spiritual healing in clinical care within a secular (and frequently medical) context should be--and in fact, are--subject to an array of regulatory controls similar to those imposed on other health care professionals. The article: (1) broadly explores how legal rules regulate spiritual healing as a health care (rather than exclusively religious) practice in the U.S.; (2) conceptualizes the kinds of potential abuse of power in the relationship between spiritual healer and client; and (3) evaluates the extent to which legal rules address--or fail to address--such potential abuse of power in spiritual healing as a professional health care practice."

Cohen MH. Healing at the borderland of medicine and religion: regulating potential abuse of authority by spiritual healers. 18:2 J Law & Relig 2004;373-426.
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The Law Offices of Michael H. Cohen offers corporate legal services, litigation consultation, and expertise in health law with a unique focus on holistic, alternative, complementary, and integrative medical therapies. The law firm represents medical doctors, allied health professionals (from psychologists to nurses and dentists) and other clinicians (from chiropractors to naturopathic physicians, massage therapists, and acupuncturists), entrepreneurs, hospitals, and educational organizations, health care institutions, and individuals and corporations.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).
Sponsorship Sponsorship
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Health care and corporate lawyer Michael H. Cohen has been admitted to the Bar of California, Massachusetts, New York, and Washington D.C. In addition to qualifying as a U.S. attorney, he has been admitted and to the Bar of England and Wales as a Solicitor (non-practicing). For more information regarding the law practice of attorney Michael H. Cohen, see the FAQs for the Law Offices of Michael H. Cohen. Thank you for visiting the Complementary and Alternative Medicine Law Blog.
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