Complementary & Alternative Medicine: Health Law & Policy

Complementary & Alternative Medicine: Health Law & Policy is scheduled for the Winter Session at Harvard School of Public Health. The Department of Health Policy & Management recently confirmed Michael's appointment as Adjunct Assistant Professor of Health Policy and Management as of July 1, 2008 (and Assistant Professor of Health Policy and Management until then). Here is the link to the Harvard School of Public Health faculty page.

The 2007 course successfully concluded.

Course Objectives:

By the end of the course, students should be able to:

1. Understand of major controversies in health law and policy surrounding the proposed (judicious) integration into mainstream health care of modalities that have historically been outside of biomedicine, and are generally known as "complementary and alternative medical" (CAM) therapies (e.g., therapies as chiropractic, acupuncture, massage therapy, and herbal medicine).

2. Understand attempts by legislatures and courts to solve major legal, regulatory and policy issues confronting clinicians and institutions seeking to conscientiously advise patients concerning use of CAM therapies.

3. Analyze at least one contemporary public health and policy issues concerning integration of CAM therapies in depth, proposing possible solutions.

Course Background:

Issues of legitimization and licensure, definitions of competence, different ideologies around definitions of disease and health, and conflicts between consumer autonomy and medical decision-making have contributed to controversy in the ongoing discussion of selectively integrating CAM therapies into conventional clinical care.

In the late-nineteenth century world of competing medical sects, scientific medicine (or biomedicine) began to dominate health care, including the regulatory environment as well as patient care. The growing power of the biomedical community resulted in increasing use of legal process and ethical rules to restrict other providers. This included expulsion of providers such as homeopaths, naturopaths, and chiropractors from medical societies, prohibition of professional association between them and medical doctors, and the passage of medical licensing laws that broadly defined the "practice of medicine" and encouraged prosecution of nonmedical providers for unlicensed medical practice.

By the 1960s and 1970s, increasing patient interest in therapies such as chiropractic, naturopathy, massage therapy, acupuncture and traditional oriental medicine, nutritional and herbal medicine, folk medicine and spirituality in medicine, and mind-body therapies resulted in greater attention to "holistic health care." This reflected a stated effort to treat illness in terms of its effect on the whole person--on physical, mental, emotional, spiritual, and environmental levels. Holistic health care styled itself as incorporating approaches outside of biomedicine, rather than relying solely on medical diagnosis and treatment.

In 1992, Congress created a tiny office within the National Institutes of Health, known as the Office for Unconventional Medical Practices, to research the above practices. In 1993, an article by David M. Eisenberg, M.D. and others in the New England Journal of Medicine helped define the field for clinicians under the rubric of "alternative medicine." The article used this term to describe therapies not commonly used in U.S. hospitals or taught in U.S. medical schools, including those listed above. In Europe, the term "complementary medicine" was gaining currency to describe these same therapies, which were much more widely accepted outside the U.S. The NIH office later was renamed the Office of Alternative Medicine and then became the National Center for Complementary and Alternative Medicine (NCCAM).

NCCAM presently defines CAM as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available." In offering this definition, NCCAM observes:

A few of the many CAM practices include the use of acupuncture, herbs, homeopathy, therapeutic massage, and traditional oriental medicine to promote well-being or treat health conditions. People use CAM treatments and therapies in a variety of ways. Therapies may be used alone, as an alternative to conventional therapies, or in addition to conventional, mainstream therapies, in what is referred to as a complementary or an integrative approach. Many CAM therapies are called holistic, which generally means they consider the whole person, including physical, mental, emotional, and spiritual aspects.

NCCAM's definition is neither universally accepted nor authoritative, but it does represent a starting point for thinking about what distinguishes (or fails to distinguish) CAM therapies from conventional care.

State (and not federal) law controls much of CAM practice. A significant federal role, however, exists in the regulation of dietary supplements. The federal Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods," however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act ("DSHEA") has allowed manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers have made no claims linking the supplements to a specific disease.

State law regulates use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians, policymakers, and students of public health are: professional licensure and scope of practice, and malpractice. Regarding licensure, each state has enacted a medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients.

Malpractice is defined as unskillful practice, which fails to conform to a standard of care in the profession, and results in injury. The definition is no different in CAM than in general medicine; its application to CAM, however, raises novel questions. Courts rely on medical consensus regarding the appropriateness of a given therapy. A framework for assessing potential liability risk involves assessing the medical evidence concerning safety and efficacy, and then aligning clinical decisions with liability concerns. Yet ultimately, research may or may not establish a specific CAM therapy as an important component part of the standard of care for the condition in question.

Legal rules governing CAM providers and practices are, in many cases, new and evolving. Further, laws vary by state and their application depends on the specific clinical scenario in question. New research is constantly emerging, as are federal and state legislative developments and judicial opinions resulting from litigation.

Three significant developments are:

• approval of final guidelines, by the Federation of State Medical Boards, to govern physician integration of CAM therapies;

• a final report, issued to Congress by the White House Commission on Complementary and Alternative Medicine, making recommendations for federal legislation and policy;

• the 2005 report issued by the Institute of Medicine.

These policy developments are likely to influence future efforts at regulating CAM therapies both at the federal level, where possible, and across states, as well as through the efforts of professional healthcare organizations.

We will update our readings with discussion of current controversies surrounding these documents and other developments in the field. As more evidence accumulates regarding safety and efficacy (or lack thereof) of specific therapies for given conditions, and as legislators and judges clarify the permissible boundaries of health care practices involving CAM therapies, clinical pathways and legal rules will further evolve.
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).
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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.