Ms. M, a patient with a rare skin condition who has failed all relevant conventional therapies, asks her dermatologist, Dr. N, about treatment options involving complementary and alternative medical (CAM) therapies. Dr. N mentions a homeopathic remedy commonly available in pharmacies and health food stores; Ms. M tries the remedy, and the skin condition quickly resolves. She is elated by this success and tells her best friend, a neurologist, who promptly files a complaint with the state medical board, noting that few, if any, physicians of any subspecialty in the state ever recommend homeopathy for any condition. The board holds a hearing at which there is no evidence that Dr. N has ever harmed a patient or acted unskillfully or incompetently in any way. Indeed, several dozen patients testify that Dr. N is a skilled, caring healthcare professional. The board nonetheless decides to revoke Dr. N’s license based on a state statute defining professional misconduct as “any departure from acceptable and prevailing medical standards.” Subsequently, Ms. M sues Dr. N for malpractice, alleging that he failed to adequately discuss the risks and benefits of a different CAM therapy – acupuncture – for her condition, and, in the alternative, that by inducing her to rely on homeopathy he neglected conventional dermatological treatment.
Complementary and alternative medical (CAM) therapies refer to those modalities and whole systems of healing that historically have not been part of the dominant system of medical practice in the West. These CAM therapies include acupuncture and traditional oriental medicine, chiropractic, herbal medicine, massage therapy, and “mind-body” therapies (such as hypnotherapy and guided imagery) (Institute of Medicine of the National Academies, 2005). Integrative healthcare refers to clinical practice that judiciously combines conventional medical therapies and evidence-based CAM therapies, focusing on patient-centered, relationship-driven care (Institute of Medicine of the National Academies, 2005).
This chapter discusses the ethical, legal, and policy aspects of clinical integration of CAM therapies. Legal and ethical rules suggest that inquiry into patient use of CAM therapies, disclosure and discussion of risks and benefits of potentially beneficial CAM therapies, and appropriate warnings as to possible contraindications, adverse reactions, and interference with conventional care, as applicable, should be standard practice. Such conversations will enhance shared decision making, help to balance non-maleficence and patient autonomy interests, and improve the therapeutic alliance, thus reducing the possibility of medical malpractice liability. Guidelines for liability risk management are explored.
Like conventional care, clinical integration of CAM therapies implicates major ethical principles such as beneficence (the obligation to help the patient), non-maleficence (the obligation to “do no harm”), and autonomy (the obligation to honor a patient’s freely made medical choices) (Institute of Medicine of the National Academies, 2005). In general, medical paternalism has tended to trump over patient autonomy interests in CAM therapies, whereas it may now be time to acknowledge the possibility for human transformation afforded by CAM therapies at the boundary of medicine and religion (Cohen, 2004a) alongside historical concerns for preventing healthcare fraud (Cohen, 2003).
To this end, ethical decision-making regarding clinical advice about CAM therapies consider the following factors: severity and acuteness of illness; curability with conventional treatment; invasiveness, toxicities, and side effects of conventional treatment; quality of evidence of safety and efficacy of the CAM treatment; degree of understanding of the risks and benefits of conventional and CAM treatments; knowing and voluntary acceptance of those risks by the patient; and persistence of patient’s intention to utilize CAM treatment (Adams et al., 2002).
Consequently in situations where an illness is not severe or acute, and is not easily curable with conventional treatment, and/or the conventional treatment is invasive and carries toxicities or side effects that are unacceptable to the patient, then, assuming the CAM therapy is not proven unsafe or ineffective, it may be ethically compelling to try the CAM approach for a limited period of time with monitoring conventionally (Adams et al., 2002). The ethical posture is even further improved if the patient understands the risks and benefits, is willing to assume the risk of trying such an approach, and insists on this route. In this case, a monitored “wait-and-see” approach respects the patient’s autonomy interest, while satisfying the clinician’s obligation to do no harm (Adams et al., 2002).
The Institute of Medicine report used this framework and also described two ethical values additional to beneficence, non-maleficence, and autonomy to enrich clinical decision making in integrative care. The two additional considerations are medical pluralism and public accountability. The report defined “medical pluralism” in terms of “acknowledgement of multiple valid modes of healing and a pluralistic foundation for healthcare,” even if some CAM practices are “rooted, at least in part, in forms of evidence and logic other than used in biomedical sciences, often with long traditions and theoretical systems of interpretation divergent from those used in biomedicine” (Institute of Medicine of the National Academies, 2005, p. 169). The report defined “public accountability” in terms including attending to the “needs and desires of multiple constituents within the public sector (e.g., licensed clinicians and other healers, patients, professional organizations, regulatory boards, and other government authorities),” as well as the “heterogeneity of communities and interests within each set of constituents” (Institute of Medicine of the National Academies, 2005, p. 173).
In general, basic principles of health law apply whether a therapy is labeled “conventional” or “CAM” (Cohen, 1998). The critical arenas of legal analysis are (i) licensure, (ii) scope of practice, (iii) malpractice liability, (iv) professional discipline, (v) access to treatments, (vi) third-party reimbursement, and (vii) healthcare fraud. These areas are broadly described with case examples by Cohen (1998), though it is worth briefly summarizing some of the major legal rules that would apply whether discussing integrative pediatrics (Cohen and Kemper, 2005), integrative oncology (Cohen, 2006), integrative cardiology (Schouten and Cohen, 2004), or any other medical specialty or healthcare practice.
This chapter focuses primarily on US law and regulation, although the issues cut across other common law nations, such as the UK (Stone and Matthews, 1996), Canada (Boon, 2002), and Australia (Cohen, 2004b). For example, the Sixth Report, entitled Complementary and Alternative Medicine, issued by the UK House of Lords Committee on Science and Technology (2002) made many regulatory recommendations that paralleled those made the same year in the Final Report by the US White House Commission on Complementary Medicine Policy (2002). Similarly, scholarly counterparts in the UK have argued that the highly individualized, more intuitive, whole-person approach of complementary medicine requires a more dynamic form of ethics-directed self-regulation that facilitates consumer choice while protecting against dangerous and abusive healthcare practices. In a similar vein, the Canadian federal government, like its counterpart in the USA, is deeply concerned with regulation of consumers’ use of natural health products for nutritional purposes (Boon, 2003) (known in the USA as regulation of dietary supplements [Cohen, 2003]).
In the USA, licensure refers to the requirement in most states that healthcare providers maintain a current state license to practice their professional healing art. Historically, medical licensing statutes made the unlicensed practice of “medicine” a crime and defined the practice of “medicine” broadly in terms of “diagnosis” and “treatment” of “any human disease” or “condition” (Cohen, 1998). This put non-licensed practitioners of the healing arts at risk of prosecution for unlawful medical practice.
Over time, chiropractors, massage therapists, naturopathic physicians, practitioners of acupuncture and traditional oriental medicine, and other CAM therapy providers attempted to gain licensure on a state-by-state basis. Providers of CAM therapies may or may not be licensed depending on a particular state’s licensing scheme. Chiropractors, for example, are licensed in every state, whereas massage therapists and acupuncturists are licensed in well over half the states, and naturopathic physicians in at least a dozen states. In most states, practitioners lacking any healthcare license are at risk of prosecution for practicing medicine without a license (Cohen, 1998).
State licensing statutes and regulations by the applicable professional board usually define a CAM provider’s scope of practice, the legally authorized boundaries of care within the given profession (Cohen, 1998). For example, chiropractors can offer nutritional advice, acupuncture, or colonic irrigation in some states but not others (Cohen, 1998). Exceeding one’s scope of practice can lead to charges of practicing other healing arts (such as, for example, medicine) without a license. Some institutions will further limit the practice boundaries of affiliated CAM providers beyond the existing limitations of the practitioner’s legally authorized scope of practice: for example, restricting acupuncturists on hospital staff from offering patients herbal medicine even though the acupuncture licensing statute may consider herbal medicine within acupuncturists’ scope of practice (Cohen and Ruggie, 2004).
Malpractice refers to negligence, which is defined as failure to use due care (or follow the standard of care) in treating a patient, and thereby injuring the patient. While medical standards of care specific to a specialty are applied in medicine, each CAM profession is judged by its own standard of care – for example, claims of chiropractic malpractice will be judged against standards of care applicable to chiropractic treatment (Cohen, 1998). In cases where the provider’s clinical care overlaps with medical care – for example, the chiropractor who takes and reads a patient’s radiograph – then the medical standard may be applied (Cohen, 1998).
Claims for healthcare malpractice resulting from inclusion of CAM therapy can involve allegations of misdiagnosis, failure to treat, failure of informed consent, fraud and misrepresentation, abandonment, vicarious liability, and breach of privacy and confidentiality (Schouten and Cohen, 2004). These are discussed more fully by these authors, but it is worth highlighting some common elements. Firstly, because the definition of malpractice includes both providing substandard care and thereby injuring the patient, adding complementary diagnostic systems (such as those of chiropractic or acupuncture, either by referral or by using modalities within the scope of one’s clinical licensure) is not problematic in itself, so long as the conventional bases are not neglected (Cohen and Eisenberg, 2002). Conversely, a conventional provider who fails to employ conventional diagnostic methods where such methods could have averted unnecessary patient injury, or who substitutes CAM diagnostic methods for conventional ones and thereby causes patient injury, risks a malpractice verdict (Cohen and Eisenberg, 2002). Similarly, it is not malpractice for a CAM provider to use modalities within his or her legally authorized scope of practice, so long as the provider refers to medical care where necessary and appropriate.
Secondly, the legal obligation of informed consent (whether involving conventional medicine or CAM therapies) is to provide the patient with all the information material to a treatment decision – in other words, information that would make a difference in the patient’s choice to undergo or forgo a given therapeutic protocol (Ernst and Cohen, 2001). Failure to provide adequate informed consent can constitute malpractice. The Institute of Medicine’s Report on Complementary and Alternative Medicine (2005, p. x) stated: “The goal should be the provision of comprehensive medical care that is based on the best scientific evidence available regarding benefits and harm, that encourages patients to share in decision making about therapeutic options, and that promotes choices in care that can include CAM therapies, when appropriate.”
Thirdly, while there are few judicial opinions setting precedent regarding referrals to CAM therapists, the general rule of conventional care – that there is no liability merely for referring to a specialist – should apply whether referral is to a practitioner labeled conventional or CAM (Studdert et al., 1998). The major exceptions to this no-liability rule involve a negligent referral (one that delays necessary care and thereby causes harm to the patient, as in referral to a CAM provider that delays necessary conventional care), a referral to practitioner that the referring provider knew or should have known was “incompetent,” and a referral involving “joint treatment,” in which the referring clinician and the practitioner receiving the referral actively collaborate to develop a treatment plan and to monitor and treat the patient (Studdert et al., 1998). “Integrative” care suggests a sufficiently high degree of coordination between the referring provider and the one receiving the referral that a court conceivably could find that a “joint treatment” has occurred and, therefore, liability may be apportioned among conventional and CAM providers sharing diagnostic and therapeutic information (Studdert et al., 1998; Cohen, 2000).
Professional discipline refers to the power of the relevant professional board to sanction a clinician, most seriously by revoking the clinician’s license. The concern over inappropriate discipline, based on medical board antipathy to inclusion of CAM therapies, has led consumer groups in many states to lobby for “health freedom” statutes – laws providing that physicians may not be disciplined solely on the basis of incorporating CAM modalities. More recently, the Federation of State Medical Boards (2002) has issued Model Guidelines for Physician Use of Complementary and Alternative Therapies for: “(1) physicians who use CAM in their practices, and/or (2) those who co-manage patients with licensed or otherwise state-regulated CAM providers.” These guidelines explicitly state that discipline should not be premised on inclusion of CAM therapies alone but should depend on whether the physician has delivered therapies lacking in safety and efficacy. The guidelines are not binding but rather offer a framework for individual state medical boards to regulate physicians integrating CAM therapies.
Third-party reimbursement typically involves a number of insurance policy provisions, and corresponding legal rules, designed to ensure that reimbursement is limited to “medically necessary” treatment; does not, in general, cover “experimental” treatments; and is not subject to fraud and abuse (Cohen, 1998). In general, insurers have been slow to offer CAM therapies as core benefits – largely because of insufficient evidence of safety, efficacy, and cost effectiveness – though a number of insurers have offered policy-holders discounted access to a network of CAM providers.
Finally, healthcare fraud refers to the legal concern for preventing intentional deception of patients. Overbroad claims regarding the potential success of a CAM therapy sometimes can lead to charges of common law fraud, and its related legal theory, misrepresentation (Cohen, 1998). Further, under Medicare and Medicaid fraud and abuse law, if the clinician or institution submits a reimbursement claim for care that the clinician knew or should have known was medically unnecessary, the practitioner could be liable for fraud under applicable federal law (Cohen, 1998) .
The term “policy” often evokes government regulatory policy, though with respect to CAM therapies, policy can also refer to institutional policies and policy by professional medical associations and other actors.
Government policies run the gamut of issues such as which providers should be licensed (Cohen, 1998) to questions of regulating dietary supplements and other natural health products. Within the UK, questions of licensure have been particularly complex, as presently only the professions of osteopathy and chiropractic have statutory licensure, while others (such as acupuncture) rely on professional self-regulation (Stone, 2005).
Hospitals, free-standing clinics, nursing homes, and other healthcare institutions need to attend to institutional policy issues relating to CAM therapies, such as policies for confirming credentials, informed consent procedures, policies relating to limiting potential malpractice liability exposure, and institutional rules regarding continuance of patient use of dietary supplements (Cohen et al., 2005a, b).
The policies of professional medical associations concerning CAM therapies have been shifting over time toward greater acceptance of the fact that many patients do use such therapies on their own and routinely request relevant information about CAM therapies from their physicians. Increasingly, it behooves the medical practitioner to become familiar with the evidence base regarding those CAM therapies commonly in use.
For example, the American Medical Association House of Delegates passed a resolution in May 2006 stating that it would “support the incorporation of complementary and alternative medicine (CAM) in medical education as well as continuing medical education curricula, covering CAM’s benefits, risks, and efficacy.” The British Medical Association (2004), in its Annual Representatives Meeting Policies, enacted a Complementary Medicine Policy, stating that: “complementary therapy should be regulated by statutory authority.” As noted, some healthcare regulatory authorities outside of government have begun to enact more specific policies; a salient example would be the Model Guidelines for Physician Use of Complementary and Alternative Therapies issued by the US Federation of State Medical Boards (2002).
The many empirical studies of CAM therapies have been reviewed by various panels of medical experts, most notably in the USA by the Institute of Medicine (Institute of Medicine of the National Academies, 2005) and in the UK by the Prince of Wales’ Foundation for Integrated Health (2005).
The Institute of Medicine of the National Academies report (2005, Ch. 5 and Table 5-3) culled the best available evidence regarding CAM therapies as did the Cochrane review (Manheimer et al., 2004). With some stated limitations, the former highlighted use of a number of therapies including acupuncture for headache, calcium for prevention of hypertensive disorders and related problems in pregnancy and for bone loss, calcium and vitamin D for corticosteroid-induced osteoporosis, cranberries for preventing urinary tract infection, echinacea for preventing and treating the common cold, electromagnetic fields for osteoarthritis, folic acid and folinic acid for reducing side effects in patients receiving methotrexate, inositol for respiratory distress syndrome in preterm infants, transcutaneous electrical nerve stimulation (TENS) for rheumatoid arthritis in the hand and osteoarthritis in the knee, and TENS and acupuncture for primary dysmenorrhoea.
To supplement the discussion of the Institute of Medicine of the National Academies, primary sources for literature reviews include PubMed (http://nccam.nih.gov/camonpubmed/[maintained by the US National Library of Medicine]), the Clinical Trials site for the National Institutes of Health (www.clinicaltrials.gov), and the Cochrane Collaboration reviews (Manheimer et al. [2004]) and (http://www.compmed.umm.edu/Cochrane/cam_reviews.html). The US National Center for Complementary and Alternative Medicine also provides reviews by treatment or therapy (http://nccam.nih.gov/health/bytreatment.htm).
Within the UK the Prince of Wales’ Foundation for Integrated Health has conducted a number of detailed reviews regarding possible integration of CAM therapies in particular areas such as supportive and palliative care (Prince of Wales’ Foundation, 2005). The Foundation has also produced a report entitled Searching the Evidence: Complementary Therapies Research (2006), which reviews evidence relating to women’s health, pain management, and mental health.
In view of the above resources for empirical studies, clinicians can perform their own literature review to determine the relative liability risk pertaining to clinical integration of CAM therapies by assessing whether for a particular CAM therapy (i) the medical evidence supports both safety and efficacy; (ii) the medical evidence supports safety, but evidence regarding efficacy is inconclusive; (iii) the medical evidence supports efficacy, but evidence regarding safety is inconclusive; or (iv) the medical evidence indicates either serious risk or inefficacy (Cohen and Eisenberg, 2002).
In the first instance, clinicians can recommend the CAM therapy without undue fear of liability, as a therapy deemed both safe and effective could be recommended regardless of whether it is classified as conventional or CAM. In the last instance, a therapy that is either seriously risky or ineffective should be avoided and discouraged. Many CAM therapies will fall within the middle two groups, where liability is conceivable but probably unlikely; this would be particularly pertinent in (ii), where the product presumably is safe provided the clinician provides the patient with appropriate risk–benefit disclosure and warnings about possible contraindications and adverse reactions. In both (i) and (ii), clinicians can allow the patient to use the CAM therapy in question, while providing appropriate caution and continuing to monitor conventionally (Cohen and Eisenberg, 2002).
If the patient’s condition deteriorates, then the physician should consider intervening conventionally (Cohen and Eisenberg, 2002). The clinician must remain alert to the medical evidence regarding CAM therapies, and particularly herbal therapies, which may contain previously unclassified hazards; the categorization of therapies over time into any given region of the framework may change according to new medical evidence (Cohen and Eisenberg, 2002). Further, since, as noted, injury to the patient is part of the definition of malpractice, the perception of injury – including a poor physician–patient relationship – can lead to litigation, while improving the therapeutic alliance tends to reduce liability risk (Schouten and Cohen, 2004).
In general, clinicians can attempt to limit liability risk through the following:
The legal doctrine of “assumption of risk” may, in some US states, be available as a defense to medical malpractice involving use of CAM therapies if the patient has knowingly, intelligently, and voluntarily make a choice to try such therapies in addition to or in lieu of conventional care (Schneider v. Revici, 1987). The few US cases on these issues so far have allowed both an express (Boyle v. Revici, 1992) and implied (Charell v. Gonzales, 1997) assumption of risk defense, suggesting that although courts generally tend to disfavor attempts to waive liability for medical malpractice (Tunkl v. Regents of the University of California, 1963) some courts may allow patients to make affirmative choices regarding use of CAM therapies, relieving physicians or some or all of liability.
Dr. N’s conversation with Ms. M concerning treatment options involving CAM therapies such as homeopathy should not, in itself, raise liability concerns. In fact, by describing the risks and benefits of the proposed approach, Dr. N can satisfy the obligation of informed consent and engage Ms. M in shared decision making. By monitoring and standing ready to intervene conventionally when medically necessary, Dr. N could further limit potential malpractice liability risk.
A state whose legislation allows medical board discipline for “any departure from prevailing and acceptable medical standards, irrespective of patient harm,” could conceivably discipline Dr. N merely for discussing homeopathy in this case, though a number of states have “medical freedom” laws that would protect Dr. N from such unwarranted consequences. Furthermore, if Dr. N were to follow the Federation of State Medical Boards (2002) guidelines, disciplinary consequences would similarly be unlikely.
Once again, the above review and analysis are grounded in US law, and although an international, comparative law perspective is beyond the scope of this chapter, the salient issues and areas of controversy cut across nations, with particular resonance among common law countries, which will share basic definitions of practitioner licensure, informed consent, and medical malpractice.