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.

Here's a text-based version of the article:

Legal and Ethical Issues in Complementary Medicine: A U.S. Perspective

By Michael H. Cohen, JD

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 [1,2,3] .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 [1]. This article briefly highlights key aspects of the first and second issue, comparing them where possible with the Australian perspective, and then brings an ethical perspective to the discussion.

Duty of Care Regarding Informed Consent
A major issue confronting physicians in everyday clinical practice is the extent to which they have a duty to discuss CAM therapies with their patients. Ian Kerridge's article argues that in Australia, physicians have a "proactive and reactive" duty to do so, as long as the opinion regarding CAM therapies is reasonable. In the U.S., as part of the legal and ethical obligation of informed consent, physicians have a duty to disclose and discuss reasonable and feasible treatment alternatives, together with the risks and benefits of each option [2,3]. While no court has yet held a physician liable for failure to disclose a CAM option, such a rule would be the logical extension of a 1993, federal appeals court case involving a patient's claim that the physician should have disclosed the possibility of trying EDTA chelation therapy rather than coronary bypass surgery to treat a carotid artery. The court stated that disclosure of such a therapeutic alternative would be required if the CAM therapy in question were generally accepted within the medical community [4].

The question of liability connected with referring patients to CAM providers also has been of concern within the U.S. medical community. In the U.S., mere referral to a medical specialist generally does not generate malpractice liability for the specialist's negligence, and similarly, mere referral to a CAM provider should not leave the referring physician liable for subsequent negligence by that provider [5,6]. There are, however, a number of potentially applicable exceptions to this rule. The first involves delay of necessary medical treatment, resulting in patient harm [5,6] The second involves referral to a CAM provider that the referring physician knew or "should have known" might be "incompetent;" this rule suggests an obligation of due diligence in vetting both the provider's credentials and, through reasonable inquiry, the provider's general competence, skill, and practice [5, 6]. A third exception involves "joint treatment" of the patient, a fairly ambiguous term that conceivably could encompass situations in which the physician and CAM provider share information via telephone or email as part of the treatment plan [2, 7].

Licensure and credentialing
A second issue of concern to physicians in everyday clinical practice is understanding the legal authority that CAM providers have to deliver health care services. In the U.S., health care licensure is a matter of state law; thus there is great diversity across states as to who gets licensed, and as to the scope of practice authority allocated to each class of provider by the licensing laws in each state. Across the U.S., the four professional groups who are licensed in most states are, in order: chiropractors (every state); practitioners of acupuncture and traditional oriental medicine (over forty states); massage therapists (over thirty states); and naturopathic physicians (about a dozen states) [8,9]. The numbers vary as professional groups may differently count (or include) mandatory licensure, mere registration, and a myriad of other statutory scheme. In addition, a number of states also allow a wide variety of unlicensed CAM providers to practice under certain circumstances [10].

As compared with the limited scope of practice allocated by licensing laws to both allied health professionals (such as nurses and physical therapists) and CAM providers (such as chiropractors and acupuncturists), physicians in the U.S. have an "unlimited" scope of practice, which means they can generally use all methods that their profession generally accepts as safe and effective to treat a given disease [1]. There are several caveats, however. When physicians practice CAM therapies such as acupuncture, they must be properly trained and appropriately credentialed (although such training and credentialing requirements tend to be far less extensive than for non-MD acupuncturists) [5,9]; and if they provide the patient CAM therapies that are unsafe and ineffective, then physicians are likely to be sued for medical malpractice and/or to receive discipline from the state medical board [1,5].

Ethical Considerations
Whether or not liability results, physicians may find their beliefs and commitment to evidence-based practice in conflict with patient interest in some CAM therapies. One useful approach to help negotiate such conflicts involves balancing the major bioethical principles (e.g., non-maleficence autonomy, beneficence, and justice) on a case-by-case basis [11], bearing in mind that shared decision-making is preferred to the older, more authoritarian model in which the physician simply discloses options without engaging the patient in a negotiated conversation [1,2,3] Thus, there may be a trade-off between granting the physician's desire to avoid all harm to the patient (expressing non-maleficence), and honoring the patient's persistent desire to try a CAM therapy for a time (expressing an autonomy interest) while continuing conventional monitoring [1,5,12].

A slightly more sophisticated approach involves balancing seven factors to draw an appropriate ethical conclusion about the best course of action. These factors are: 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; persistence of patient's intention to utilize CAM treatment [5,12]. This framework somewhat parallels the analysis of liability considerations in the U.S. [5, 12].
For example, consider these two cases: (A) The patient has a pre-malignant condition that can be completely cured through surgery, but if left untreated, can progress to invasive cancer. The patient tells her MD that she plans to pursue meditation, colonics and yoga and to work with her Reiki master rather than have surgery [12]. (B)The patient, a woman with recurrent metastatic ovarian adenocarcinoma, asks her oncologist to provide her with conventional treatment but be open to evaluating and guiding her regarding available CAM therapies. [12]. In Case A, the patient's illness can be cured with conventional, although invasive, treatment (surgery); the evidence for CAM is low but the patient understands and accepts risks, and insists on trying CAM therapies. The conclusion would be that it is ethical for the physician to allow the patient to try her regimen of CAM therapies so long as the clinician continues to monitor her condition conventionally [12]. If the risk of cancer increases past a tolerable threshold, the physician should intensify attempts to persuade the patient that it is time to return to conventional methods of treatment [12] In Case B, the clinician should be aware of pertinent evidence and be willing to consider any intervention (CAM or allopathic) that has an acceptable risk-benefit balance [12].

Whatever approach is used, physicians still are learning ways to fruitfully discuss integration of CAM therapies with their patients, as differing value systems and bases of knowledge concerning the therapies in question may leave a gap that only skillful negotiation can bridge [13]. In this respect, the question is less about legal rules alone and more about relationship, conversation, and how the law may help or, hinder these . The way forward for Australian legislators, judges, and policy-makers, as for their U.S. counterparts, includes focusing not only on preventing negligence and fraud, but also on finding ways to facilitate therapeutic exchanges between a variety of healthcare providers and their patients [7]. Framed in this light, the need for international dialogue around common legal and ethical issues pertinent to CAM therapies becomes ever clearer.

[1] Cohen MH. Complementary and alternative medicine: legal boundaries and regulatory perspectives. Baltimore: Johns Hopkins University Press; 1998.

[2] Cohen MH. Beyond complementary medicine: legal and ethical perspectives on health care and human evolution. Ann Arbor: University of Michigan Press; 2000.

[3] Ernst EE, Cohen MH. Informed consent in complementary and alternative medicine. Arch Intern Med 2001;161:19:2288-2292.

[4] Moore v. Baker, 989 F2d 1129, 1132 (11th Cir 1993).

[5] Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med 2002;136:596-603.

[6] Studdert DM, Eisenberg DM, Miller FH, et al . Medical malpractice implications of alternative medicine; 1998; JAMA 280;1610.

[7] Cohen MH, Future medicine: ethical dilemmas, regulatory challenges, and therapeutic pathways to health and human healing in human transformation. Ann Arbor: University of Michigan Press; 2003.

[8] Cohen, MH. Holistic health care: including complementary and alternative medicine in insurance and regulatory schemes. Ariz L Rev 1996;38:83-164.

[9] Eisenberg DM, Cohen MH, Hrbek A, et al . Credentialing complementary and alternative medical providers. Ann Intern Med; 2002;137:965-973.

[10] 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.

[11] Kemper K, Cohen MH. Ethics in complementary medicine: new light on old principles. Contemporary Pediatrics 2004;21:3:61-72.

[12] 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.

[13] Cohen MH, Negotiating integrative medicine: applying negotiation analysis to decision-making involving complementary and alternative medical therapies [Negotiation Journal, in press 2004].