Complementary Therapies for Chronic Kidney Disease

Advances in Chronic Kidney Disease just came out with an entire issue devoted to alternative therapies.

The issue is rich with articles about both potential benefits of CAM therapies in caring for patients with kidney disease, and potential toxicities.

Here's the legal article:

Abstract for Michael H. Cohen, "Legal Issues in Caring for Patients With Kidney Disease by Selectively Integrating Complementary Therapies," 12:3 Adv Chronic Kidney Disease 300.

Clinical integration of complementary and alternative medical (CAM) therapies, such as acupuncture and traditional oriental medicine, chiropractic, herbal medicine, massage therapy, and "mind-body" therapies, into conventional health care raises important legal and risk management issues. Understanding which CAM therapies patients use is legally prudent, as conventional treatment advice may interact with patients' own efforts toward self-care. In addition, nephrologists may limit potential liability for medical malpractice by classifying any given therapy as follows: (1) the medical evidence supports both safety and efficacy--recommend; (2) the medical evidence supports safety, but evidence regarding efficacy is inconclusive--accept but monitor; (3) the medical evidence supports efficacy, but evidence regarding safety is inconclusive--accept but monitor; and (4) the medical evidence indicates either serious risk or inefficacy--avoid and discourage. Applying this framework whether a therapy is labeled "conventional" or "CAM" is consistent with the key recommendation of the recent report by the Institute of Medicine at the National Academy of Sciences on Complementary and Alternative Medicine, namely, to apply the same principles and standards of evidence of treatment effectiveness to all treatments. Liability risk management also includes going beyond legal and ethical informed consent requirements by engaging the patient in shared decision making concerning all material treatment options, including CAM therapies, if supported by evidence. Physicians further should familiarize themselves with documentation standards suggested by the Federation of State Medical Board Guidelines and whether these are applicable in their state or home institution. These steps aim to enable nephrologists to respond to patient interest in CAM therapies in a way that is clinically responsible, ethically appropriate, and legally defensible.

Full text -

Legal Issues in Caring for Patients With Kidney Disease by Selectively Integrating Complementary Therapies

Michael H. Cohen * [MEDLINE LOOKUP]


Sections
Abstract
Health Care Law Relevant to CAM Therapies
Malpractice Considerations
Some Clinical Scenarios and a Liability Framework
Understanding CAM as Part of Comprehensive Care
Dietary Supplements: Especially Problematic
Informed Consent
Fraud and Misrepresentation
Patient Abandonment
Referrals and Vicarious Liability
Liability Risk Management
Federation of State Medical Board Guidelines
Ethical Analysis
Conclusion
References
Publishing and Reprint Information

Abstract TOP

Clinical integration of complementary and alternative medical (CAM) therapies, such as acupuncture and traditional oriental medicine, chiropractic, herbal medicine, massage therapy, and "mind-body" therapies, into conventional health care raises important legal and risk management issues. Understanding which CAM therapies patients use is legally prudent, as conventional treatment advice may interact with patients' own efforts toward self-care. In addition, nephrologists may limit potential liability for medical malpractice by classifying any given therapy as follows: (1) the medical evidence supports both safety and efficacy--recommend; (2) the medical evidence supports safety, but evidence regarding efficacy is inconclusive--accept but monitor; (3) the medical evidence supports efficacy, but evidence regarding safety is inconclusive--accept but monitor; and (4) the medical evidence indicates either serious risk or inefficacy--avoid and discourage. Applying this framework whether a therapy is labeled "conventional" or "CAM" is consistent with the key recommendation of the recent report by the Institute of Medicine at the National Academy of Sciences on Complementary and Alternative Medicine, namely, to apply the same principles and standards of evidence of treatment effectiveness to all treatments. Liability risk management also includes going beyond legal and ethical informed consent requirements by engaging the patient in shared decision making concerning all material treatment options, including CAM therapies, if supported by evidence. Physicians further should familiarize themselves with documentation standards suggested by the Federation of State Medical Board Guidelines and whether these are applicable in their state or home institution. These steps aim to enable nephrologists to respond to patient interest in CAM therapies in a way that is clinically responsible, ethically appropriate, and legally defensible.

(Click on a term to search this journal for other articles containing that term.)
Index Words Liability, medical malpractice, informed consent, complementary and alternative medicine, kidney disease

The clinical integration of complementary and alternative medical (CAM) therapies, such as acupuncture and traditional oriental medicine, chiropractic medicine, herbal medicine, massage therapy, and "mind-body" therapies including guided imagery, into conventional health care raises important legal and risk management issues for clinicians and institutions. Integration of CAM therapies in care of patients with kidney disease is no exception. Some may see legal issues as presenting overwhelming obstacles to clinical integration of potentially viable therapies, whereas others are finding ways to surmount institutional roadblocks and manage legal risks effectively.1

Frequently, the process of selectively and judiciously integrative CAM therapies that may be safe and effective involves delicate negotiations between clinicians and patient, bringing out differences in legal, ethical, and clinical perspectives.2 Patients may underreport existing use of CAM therapies. Alternatively, patients may be interested in trying a broad variety of approaches, whereas clinicians may view the existing evidence for safety and efficacy of specific therapies championed by the patient as insufficient to justify recommending these therapies. Yet again, the medical literature may suggest that potential adverse interactions with conventional treatment may result.

To date, few hospitals have created guidelines for their clinicians seeking to advise patients in response to requests for information about the use or avoidance of CAM therapies.3 Professional medical groups often offer little guidance other than cautioning against potential safety and liability risks. This review addresses the salient liability issues and offers risk-management suggestions for clinicians treating patients with kidney disease.


Health Care Law Relevant to CAM Therapies TOP

The law related to CAM therapies is evolving, but the basic principles of health law would seem to apply whether a therapy is labeled "conventional" or "CAM."4 Health care law generally governs the provision of CAM therapies because its principles apply across therapies, whether considered "conventional" or not. Seven critical areas relating to CAM are as follows: (1) licensure, (2) scope of practice, (3) malpractice liability, (4) professional discipline, (5) access to treatments, (6) third-party reimbursement, and (7) fraud. These areas are broadly described with case examples elsewhere.4

In brief, licensure refers to the requirement in most states that health care providers maintain a current state license to practice their professional healing art. Although a few states recently have enacted statutes authorizing nonlicensed, CAM providers to practice,5 in most states, licensure serves as the first hurdle to professional practice. Licensure of CAM providers varies by state; chiropractors, for example, are licensed in every state, whereas massage therapists and acupuncturists are licensed in well over half the states and naturopaths in about a dozen states.6

The scope of practice refers to the legally authorized boundaries of care within the given profession. State licensing statutes usually define a CAM provider's scope of practice, regulations promulgated by the relevant state licensing board (such as the state board of chiropractic) often supplement or interpret the relevant licensing statute, and courts interpret both statutes and administrative regulations.4 For example, chiropractors can give nutritional advice in some states but not others, and, typically, massage therapists are prohibited from mental health counseling.

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. Generally, each CAM profession is judged by its own standard of care (eg, acupuncture, chiropractic therapy, physical therapy, and massage therapy).4 In cases in which the provider's clinical care overlaps with medical care (eg, the chiropractor who takes and reads a patient's x-ray), the medical standard may be applied.4

An in-depth discussion of the intricacies of malpractice insurance is beyond the scope of this review. It should be noted, however, that states vary in their requirements for malpractice coverage,7 and individual insurers vary in their coverage of CAM therapies. The individual practitioner should determine the coverage available and the amount, if any, required by his/her state.

Professional discipline refers to the power of the relevant professional board (in the psychiatrist's case, the state medical board) to sanction a clinician, most gravely 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.4 More recently, the Federation of State Medical Boards has issued Model Guidelines for Physician Use of Complementary and Alternative Therapies, reaffirming this same principle.8

Third-party reimbursement 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.4 In general, insurers have been slow to offer CAM therapies as core benefits, largely because of insufficient evidence of safety, efficacy, and cost-effectiveness, although a number of insurers have offered policyholders discounted access to a network of CAM providers.

Health care fraud refers to the legal concern for preventing intentional deception of patients. Overbroad claims sometimes can lead to charges of fraud and its related legal theory misrepresentation.4 If the clinician or institution submits a reimbursement claim for care that the clinician knew or should have known was medically unnecessary, this also might be grounds for a finding of fraud and abuse under federal law.4


Malpractice Considerations TOP

The area that primarily concerns many clinicians is malpractice liability for clinical inclusion of CAM therapies, particularly because the research for such therapies is less extensive than for many conventional modalities. Indeed, because the research base is smaller, conclusions seem to swing rapidly as new discoveries respectively enhance or diminish validation for such therapies as St. John's Wort to treat moderate depression. Few judicial opinions address malpractice and CAM therapies; the legal landscape is relatively new and subject to rapid change as CAM therapies increasingly penetrate mainstream health care.9 Yet, as suggested, we can extrapolate general principles from malpractice in conventional care because theoretically the same legal concepts and standards should apply, whether the therapy is considered "conventional" or "CAM."10

Medical malpractice (or negligence) generally consists of 2 elements: (1) providing clinical care below generally accepted professional standards and (2) thereby causing the patient injury. The plaintiff (who is suing) usually hires a medical expert to testify that the defendant physician practiced below generally accepted standards of care. There are multiple possible claims of health care malpractice, including misdiagnosis, failure to treat, failure of informed consent, fraud and misrepresentation, abandonment, vicarious liability, and breach of privacy and confidentiality.11 This review will focus on several of these theories of liability, with examples of potentially problematic practices relating to treatment of kidney disease.

Misdiagnosis refers to failure to diagnose a condition accurately or at all; it is malpractice when the failure occurred by virtue of providing care below generally accepted professional standards and the patient was thereby injured. A provider who fails to use conventional diagnostic methods or who substitutes CAM diagnostic methods for conventional ones risks a malpractice verdict. Thus, adding complementary diagnostic systems (such as those of chiropractic and acupuncture) is not itself problematic, as long as the conventional bases are covered.10 For example, it would be perilous to treat headaches as "subluxations" or "displaced chi" if the patient turns out to have a brain tumor. Continuing to monitor conventionally, while maintaining a healthy system of conventional referrals, may be useful in dispelling this type of liability risk.10

Failure to treat by following conventional standards of care also can lead to malpractice liability if the patient is thereby injured. Again, it is not the use of CAM therapies that is problematic in itself but rather overreliance on such therapies, to the exclusion of necessary medical care. Following the earlier example, if a chiropractor continued to treat headaches without referring the patient to a medical doctor to rule out the possibility of a neurologic or cancerous condition, this could constitute failure to treat (or more specifically for the chiropractor, failure to refer to a medical doctor) and thereby malpractice.


Some Clinical Scenarios and a Liability Framework TOP

An interesting variation on the risk of not attending to patient use of CAM therapies is suggested by a recent article on the use of herbal therapies by patients in Italy.12 The authors distributed 720 questionnaires and received 685 completed ones from herbalists asking about dietary supplements the herbalists recommended to patients who required a "natural" treatment to control glycemia. The 10 more frequently suggested herbal remedies were gymnema, psyllium, fenugreek, bilberry, garlic, Chinese ginseng, dandelion, burdock, prickly pear cactus, and bitter melon. The 10 most frequently recommended dietary supplements were biotin, vanadium, chromium, vitamin B6, vitamin C, vitamin E, zinc, selenium, alpha-lipoic acid, and fructooligosaccharides.

The authors concluded that the majority of the products recommended by Italian herbalists "may be efficacious in reducing glycemia," leading to the following conclusions:


If a diabetic patient is already assuming products that even slightly reduce glycemia, we risk to underestimate the level of glucose intolerance, while if the patient stops the complementary treatment after initiating pharmaceutical therapy, in the subsequent visit we may underestimate the effect of our prescription. Therefore, if doctors are to have a role in gate-keeping or advising patients about complementary and alternative medicine, they need to be familiar with this type of medicine. If they choose otherwise, then the provision of complementary and alternative medicine will continue to be patchy and largely outside the conventional care framework, perhaps through a growing network of parallel care providers involving a large number of non-medically qualified practitioners, who patients will continue to access directly.12


Understanding which CAM therapies patients use is legally prudent, if not mandatory as a means of understanding how conventional treatment advice may interact with patients' own efforts toward self-care.

More generally, some CAM therapies, such as mind-body techniques, have been shown safe and/or effective for conditions such as chronic pain and insomnia.13 On the other hand, inclusion of some CAM therapies can raise the specter of direct harm from the therapy or from adverse interactions with conventional care or of indirect harm from diverting the patient from necessary conventional care. For example, herbal products may contain "undisclosed drugs or heavy metals, interaction with the pharmacokinetic profile of concomitantly administered drugs, or association with a misidentified herbal species."14 A recent study reported various renal syndromes after the use of medicinal plants, including tubular necrosis, acute interstitial nephritis, Fanconi's syndrome, hypokalemia or hyperkalemia, hypertension, papillary necrosis, chronic interstitial nephritis, nephrolithiasis, urinary retention, and cancer of the urinary tract.14

In general, the following framework may help the clinician (or institution) classify any given therapy into 1 of 4 regions10: (1) the medical evidence supports both safety and efficacy; (2) the medical evidence supports safety, but evidence regarding efficacy is inconclusive; (3) the medical evidence supports efficacy, but evidence regarding safety is inconclusive; and (4) the medical evidence indicates either serious risk or inefficacy. In A, clinicians clearly should feel comfortable recommending the CAM therapy because a therapy deemed both safe and effective could be recommended regardless of whether it is classified as conventional or CAM. Similarly, in D, clinicians should avoid and discourage patient use of the CAM therapy. Again, the proposition is self-evident: a therapy that is either seriously risky or ineffective should be avoided and discouraged, whether labeled conventional or CAM.

This notion of applying the framework across the board is consistent with the key recommendation of the recent Report by the Institute of Medicine (IOM) at the National Academy of Sciences on Complementary and Alternative Medicine15. The committee recommends that the same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM.

It should be clear that in region A, liability is unlikely because inclusion of the therapy is unlikely to fall below prevailing standards of care (because it is effective) and unlikely to injure the patient (because it is safe). In D, on the other hand, liability is likely because the converse is true: the therapy is likely to fall below prevailing standards of care (because it is ineffective) and likely to injure the patient (because it is seriously risky).

Many CAM therapies will fall within either B or C. Liability is conceivable but probably unlikely, particularly in B, where the product presumably is safe.10 If, however, the patient's condition deteriorates in either case B or C, then the physician should consider implementing a conventional intervention or risk potential liability if the patient becomes injured through reliance on the CAM therapy.10 The best strategy in B and C is to caution the patient and, while accepting the patient's choice to try the CAM therapy, continue to monitor efficacy and safety, respectively.10

Consider, for example, use of chiropractic to treat low-back pain, a therapy widely used within the United States for a condition that afflicts millions of patients and for which conventional care offers few reliable "cures." There is sufficient evidence of safety and efficacy (at this date) that treatment with chiropractic would probably be warranted.10,18 On the other hand, there is poor evidence regarding use of St. John's Wort to treat severe depression; a clinician who relies on herbal formulas in such a case may risk malpractice if the patient continues to slide deeper into the depression and particularly if that results in a physical injury to (or by) the patient.

More relevant to nephrology is the example of acupuncture to help relieve chronic pain in kidney disease (see the articles by Wang and Li; by Garcia, Ma, and Feng; and by Markell in this issue), a therapy that is minimally invasive and potentially beneficial in reducing side effects of analgesics. On the other hand, in patients treated with acupressure, mean pruritus scores were significantly reduced compared with the control group, although no difference in biochemical tests was identified between both groups; thus, the first therapy might be in category A (unambiguously recommend), whereas the second might fall within B (safe but efficacy yet unclear). Notably, the mechanism for such therapies has not unambiguously been adduced.

Likewise, in this issue, Burrowes and Van Houten suggest that, "in the dialysis population, Noni juice should be avoided because of its high potassium content. In addition, bulk-forming laxatives such as flaxseed should be used with caution because of the need for increased fluid intake." Such findings readily lend themselves to categorization of the selected therapies in combination with the conventional treatment in place to fall within regions D (avoid and discourage) and C (caution and monitor for safety) or again possibly D.


Understanding CAM as Part of Comprehensive Care TOP

As suggested, if a condition readily can be cured by conventional care, there is a strong imperative to provide such care. Delay in itself is not negligent, but delay that aggravates the patient's condition or leads to irreversible progression of the disease might be considered negligent. This goes back to the earlier definition of malpractice as providing substandard care and, in so doing, creating patient injury.

On the other hand, engaging the patient in a conversation about options and suggesting or agreeing to a trial run with a CAM therapy that may have some evidence of safety and/or efficacy in the medical literature, while continuing to monitor conventionally, is a strategy that makes sense. Indeed, the IOM Report suggested: "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."15 In short, comprehensive is evidence informed, patient centered, and mindful of the possibility that CAM therapies may in some cases be recommended as useful, in others discouraged as unsafe or ineffective, and in many others be accepted for a time with a readiness to intervene conventionally if the CAM therapy turns out to be either unsafe or ineffective.

What happens if the patient does not abandon conventional therapy but rather has a complication from the interaction of conventional therapy with the CAM therapy and there is little, if any, medical literature to inform the clinician? The liability framework described earlier presents a good guide for the clinician. Unless there is clear evidence of a potential adverse interaction, the clinician can allow the CAM therapy while continuing to monitor conventionally. If the CAM therapy turns out to be either unsafe or ineffective in combination with the conventional therapy, then the clinician accordingly should advise the patient to discontinue use of the CAM therapy. Because research regarding CAM therapies is ongoing and the medical evidence can change rapidly, the clinician should communicate regularly with the patient regarding any new developments and reconsider therapeutic decisions accordingly.


Dietary Supplements: Especially Problematic TOP

Recommendations involving herbal products remain especially problematic. Under the Dietary Supplement Health Education Act of 1994, "dietary supplements" containing vitamins, minerals, amino acids, and herbs generally are regulated as foods, not drugs, and therefore can be sold in interstate commerce without prior proof of safety or efficacy. Further, the Federal Food and Drug Administration rarely interferes with individual clinicians' practices because the Food and Drug Administration is a federal agency and health care practice is regulated under state law.

The medical literature is full of reports about safety concerns associated with various herbal products. In addition to issues of contamination and adulteration and lack of batch-to-batch consistency, clinicians have to consider the possibility of adverse herb-herb as well as herb-drug interactions. The literature on efficacy is sparse compared with comparable pharmaceutical medications, and concerns have been raised about patient use of dietary supplements during care for kidney disease.15 For example, as reported in this issue by Colson and DeBroe, use of CAM therapies "may be an important risk for the development of acute and chronic kidney injury because of several factors: nonconventional preparations rarely meet the required essential standards of consistency in composition and biological activity; many of these products contain undisclosed over-the-counter or prescription drugs or can be adulterated with hormones and glandular extracts; herbal preparations can be contaminated by pesticides and heavy metals; and because of errors in plant identification and confusing terminology, opportunities for mistakes and deliberate substitution can occur."

The authors also note "a lack of reports of adverse events and drug interactions, due to a lack of professional surveillance and specific data on systemic and kidney toxicity are not easily available." They point out that kidney injury/kidney syndromes caused by CAM "consists in acute tubular necrosis/toxicity (eg, Fanconi's syndrome), acute interstitial nephritis, papillary necrosis, hypertension, kidney stones, urinary retention, chronic tubulointerstitial nephritis with fibrosis, urinary tract carcinoma, and acute rejection of the kidney transplant." Colson and De Broe urge nephrologists to extend their knowledge about possible "hazards and toxicity" of dietary therapies, observing that long-term, follow-up studies is lacking in nations where populations heavily rely on traditional herbal preparations. Similarly, Burrowes and Van Houten recommend that "dialysis practitioners should include specific questions about herbs and dietary supplement use in the medical and nutrition histories, and they should increase their knowledge about these products to advise patients appropriately."

In light of these dangers described to date from various dietary supplements, clinician in-office sales of dietary supplements as ancillary to treatment also are especially troublesome. So, too, are any arrangements whereby clinicians receive any percentage or profit from sales of supplements recommended to patients. Such sales can trigger legal antikickback considerations. Sales of dietary supplements also can suggest that the clinician has been not only negligent but potentially reckless, a higher state of culpability, triggering the possibility of punitive as well as compensatory damages.24

But in addition to legal culpability are ethical questions pertaining to conflict of interest. The American Medical Association has opined that physician sale of dietary supplements for profit may present an impermissible conflict of interest between good patient care and profit and thus ethically objectionable. Several states have enacted laws limiting or prohibiting physician sales of dietary supplements.16

Yet another concern is potential discipline by the relevant state regulatory boards, such as the state medical board for physicians. Many of the relevant statues contain generic provisions that allow physician discipline, for example, for such acts as "failure to maintain minimal standards applicable to the selection or administration of drugs, or failure to employ acceptable scientific methods in the selection of drugs or other modalities for treatment of disease."17 Some state medical boards have applied these generic (or catch-all) statutory provisions to physicians offering nutritional treatments.


Informed Consent TOP

The legal obligation of informed consent is to provide the patient with all the information material to a treatment decision, in other words, that would make a difference in the patient's choice to undergo or forgo a given therapeutic protocol. This obligation applies across the board, whether CAM or conventional therapies are involved.18 Materiality refers to information about risks and benefits that is reasonably significant to a patient's decision to undergo or forgo a particular therapy; about half the states judge materiality by the "reasonable patient's" notion of what is significant, whereas the other half judge materiality by the "reasonable physician."18 Presumably, materiality in the latter half means evidence-informed judgments concerning what therapies may be potentially useful.18

The principle of shared decision making takes informed consent a step further, by ensuring that there are not only disclosures by physicians to patients but also full and fair conversations in which patients feel empowered and participatory. The IOM report, as noted earlier, encouraged shared decision as a means of patient empowerment. Updating the patient about changes in medical evidence also is an important part of the informed consent obligation. If the discussion involves an herbal product, the physician should try to deconstruct the notion that "natural" necessarily means "safe."19,20 Some patients are more deferential or compliant to clinical authority, whereas others are resistant. In any event, informing the patient about the changing medical evidence may shift (in 1 direction or another) the patient's willingness to accept the known risks and benefits of the CAM therapy or even to use this therapy.

An interesting question is how the law might treat clinicians who fail to make recommendations for patients regarding nutrition, mind-body, and other readily accepted CAM therapies as adjuncts to conventional care. If medical evidence begins to show safety and efficacy for such therapies and these therapies become more generally accepted within the medical community, there may be liability for clinicians who fail to make helpful, adjunctive recommendations involving CAM therapies.4,21 The case would likely depend on the court's view of whether the medical profession generally accepted the CAM therapy as safe and effective for the patient's condition and, possibly, as a safer and more effective therapeutic option than the conventional drug or treatment route otherwise prescribed.4


Fraud and Misrepresentation TOP

Fraud and misrepresentation involve the knowing inducement of reliance on inaccurate or false information for the benefit of the person committing the fraud and to the detriment of the victim. The practitioner must know the information or representation is false or must recklessly fail to discover its falsity, and the victim must reasonably rely on the representation.

Because it involves intentionality or recklessness, as opposed to lack of due care, fraud presents a higher level of culpability than negligence in most malpractice cases. As such, a fraud claim typically opens the defending physician to the possibility of punitive damages. At the same time, fraud is harder to prove because it requires proving a mental state (intention or recklessness) and not simply a negligent act. Nonetheless, fraud can serve as a potent tool to curb overreaching and abusive conduct in provision of CAM therapies.5


Patient Abandonment TOP

Abandoning patients is ethically proscribed and legally yet another ground for suit. Abandonment refers to the unilateral and unjustified termination of the treatment relationship by the physician that results in patient injury. As the term "unjustified" indicates, there are situations in which it is reasonable and appropriate for treating clinicians to unilaterally terminate the treatment relationship. These include threatening or violent patients, patients who repeatedly fail to keep appointments, and patients who are noncompliant to the point in which the clinician can no longer justify seeing them.23 Even when termination of the relationship may seem justified to the clinician, it is advisable (1) to consult with one or more colleagues to see how they assess the situation, (2) make arrangements for emergency coverage until the patient can find another physician, and (3) wherever possible help facilitate the identification of a new physician and transfer of patient care. Ideally, the patient should be transferred to a provider who feels comfortable with the patient's preference yet can offer evidence-based guidance, monitoring, and treatment.22


Referrals and Vicarious Liability TOP

A major concern involves the potential liability exposure for referral to a CAM provider. Although there are few judicial opinions setting precedent regarding referrals to CAM therapists, the general rule in conventional care is that there is no liability merely for referring to a specialist. There is no particular reason why this rule should not be applied to any referral, whether for conventional or CAM care.24

One of the exceptions to this general rule, however, involves "joint treatment," in which various clinicians collaborate to develop a treatment plan and to monitor and treat the patient. Such coordinated care is a premise of integrative care. It suggests that liabilities may be shared within the integrative care team (eg, between the psychiatrist and the acupuncturist).10 Ensuring that referred-to providers have competence and a good track record in their area of expertise will help reduce potential liability risk.


Liability Risk Management TOP

As suggested, a principal strategy to help reduce liability risk involves paying attention to the therapeutic relationship because bad outcomes compounded by bad feelings can lead to litigation. Good communication with patients, which includes tailoring the communication content and style to the needs of the individual patient, has been shown to enhance the perception of the physician's competence and decrease the risk of malpractice.25

Next, good clinical care includes monitoring for potential adverse reactions between conventional and CAM therapies, such as, for example, monitoring for adverse herb-drug interactions, particularly when the patient is ingesting dietary supplements concurrent with medication or surgery. Certainly, the cases have emphasized the importance of conventional diagnosis and monitoring when CAM therapies are recommended or allowed. This is probably the most important means of ensuring that patients do not receive substandard care.10 Continuing to monitor conventionally and intervene conventionally when medically necessary means that the standard of care will have been met and the possibility of patient injury minimized. For example, the physician and patient may wish to try a CAM therapy for a predefined period of time instead of conventional care (eg, a combination of herbal products and lifestyle changes) and return to conventional care (eg, medication) when it becomes necessary.

From a liability perspective, the more acute and severe the condition, the more important it would be to monitor and treat conventionally. Again, the definition of medical malpractice emphasizes failure to follow the standard of care and patient injury. The greater the disease's severity, the more likely patient injury will result from overrelying on a CAM therapy and thus the greater possibility for a lawsuit with concomitant malpractice liability and the more likely the psychiatrist will be held liable for failure to insist on standard, conventional care. Furthermore, the more curable the condition conventionally, the more likely a court would see failure to provide (or even perhaps insist) on such care as negligent.

Another risk-reduction measure is the practice of obtaining consultation. Ongoing supervision and occasional "curbside" consultations regarding a specific case should be documented in the patient's record. These serve to establish the standard of care in the community, can provide valuable input into clinical decision making, and show that the clinician is willing to take extra steps for the benefit of the patient.26

Third, poor medical records can suggest negligence to a jury. In general, it is advisable to keep complete and accurate medical records that include documentation of the patient's medical history concerning use of CAM therapies and of conversations with patients concerning potential inclusion of such therapies. Such thorough documentation can help physicians prove that informed consent requirements were satisfied and also can help protect against undue disciplinary action by state medical boards concerned with use of CAM therapies.10 If the physician recommends or allows use of a CAM therapy based on the medical literature, it is a good idea to keep a backup file of the medical literature supporting the specific medical recommendation. On the other hand, if the physician believes that, based on the medical literature, the patient's continued use of one or more CAM therapies is medically inadvisable and yet the patient insists on using such therapies against medical advice, this event should be documented in the medical record.

Physicians also should familiarize themselves with documentation standards suggested by the Federation of State Medical Board Guidelines and whether these are applicable in their state or home institution. Finally, there is a legal doctrine known as "assumption of risk." The doctrine can, under some circumstances, provide a defense to medical malpractice when the patient has chosen a therapeutic course despite the physician's efforts to dissuade and discourage.24 In some states, if patients continue to use a CAM therapy against the physician's advice and this is documented in the medical record, there may be a defense to a malpractice action.24

Assumption of risk has been allowed as a defense in at least 1 case involving patient election of a CAM therapy instead of conventional care (ie, of a nutritional protocol in lieu of conventional oncology care).24,27 In this case, the court allowed the patient's signing of an appropriate consent form to serve as an "express" assumption of risk and therefore a complete defense to the claim of medical malpractice. In another case, a New York court found that the patient had "impliedly" assumed the risk because she was aware of and voluntarily chose a CAM protocol for cancer care, even without signing the requisite form.28

Based on these cases, some attorneys might advise physicians to have the patient sign a waiver, expressly stating that the patient knowingly, voluntarily, and intelligently chose the CAM therapy or regimen (eg, energy healing and a nutritional protocol) instead of the recommended conventional treatment. Courts, however, tend to disfavor waivers of liability in medical malpractice cases, taking the perspective that medical negligence cannot be waived away and that the physician remains responsible for the patient's treatment.29 Physicians should, nonetheless, engage in clear conversations with patients concerning options involving CAM therapies because such an approach is likely to satisfy informed consent concerns, respect an ideal of shared decision making, and encourage positive relationships that can help mitigate the prospect of litigation.


Federation of State Medical Board Guidelines TOP

As noted, the Federation has passed model guidelines 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."30 These guidelines are not binding but rather offer a framework for individual state medical boards to regulate physicians integrating CAM therapies. They should be read in conjunction with existing medical board guidelines in the state in which the physician practices because the guidelines may provide ways for medical boards to think about integrative practices.

In general, the guidelines "allow a wide degree of latitude in physicians' exercise of their professional judgment and do not preclude the use of any methods that are reasonably likely to benefit patients without undue risk."30 The guidelines also recognize that "patients have a right to seek any kind of care for their health problems" and that "a full and frank discussion of the risks and benefits of all medical practices is in the patient's best interest."30 To this extent, the guidelines implicitly recognize both shared decision making and patients' interest in integrative care.

At the same time, in trying to assess whether an integrative care practice is violative and should trigger physician discipline, the guidelines ask whether the therapy selected is (1) effective and safe? (having adequate scientific evidence of efficacy and/or safety or greater safety than other established treatment models for the same condition); (2) effective, but with some real or potential danger? (having evidence of efficacy, but also of adverse side effects); (3) inadequately studied, but safe? (having insufficient evidence of clinical efficacy, but reasonable evidence to suggest relative safety); and (4) ineffective and dangerous? (proven to be ineffective or unsafe through controlled trials or documented evidence or as measured by a risk/benefit assessment).

Some of these standards may be difficult to meet. For example, the first category is stated in terms of the CAM therapy having greater evidence of safety and/or efficacy than the applicable conventional treatment; there may or may not be available evidence to suggest whether this condition is met. Moreover, the guidelines list these four categories but do not offer suggestions on how to use the categories in clinical decision making.

In addition to these standards, the guidelines provide an extensive checklist of items to which the physician must attend when providing CAM therapies. The psychiatrist practicing integrative care should review these items with legal counsel and determine which are advisable and practical. For example, these items include documentation regarding30 the following: (1) what medical options have been discussed, offered or tried and, if so, to what effect, or a statement as to whether or not certain options have been refused by the patient or guardian; (2) that proper referral has been offered for appropriate treatment and that the risks and benefits of the use of the recommended treatment to the extent known have been appropriately discussed with the patient or guardian; and (3) that the physician has determined the extent to which the treatment could interfere with any other recommended or ongoing treatment. The guidelines also provide that the CAM treatment should have a favorable risk/benefit ratio compared with other treatments for the same condition; be based on a reasonable expectation that it will result in a favorable patient outcome, including preventive practices; and be based on the expectation that a greater benefit will be achieved than that which can be expected with no treatment. Again, the guidelines are suggestive but not binding in any given state, unless adopted by that state's medical board.


Ethical Analysis TOP

Adams et al22 offer 7 factors to consider in assessing the ethics of whether or not to offer the patient CAM therapies22: (1) severity and acuteness of illness; (2) curability with conventional treatment; (3) invasiveness, toxicities, and side effects of conventional treatment; (4) quality of evidence of safety and efficacy of the CAM treatment; (5) degree of understanding of the risks and benefits of conventional and CAM treatments; (6) knowing and voluntary acceptance of those risks by the patient; and (7) persistence of patient's intention to use CAM treatment.

These factors dovetail with the liability approach described earlier. Thus, if the illness is not severe or acute, 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 while monitoring conventionally.22 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.22

Consider, for example, the use of hypnotism in an effort to reduce the need for pain killers and anesthesia and to reduce anxiety.31 Such a therapeutic technique, in conjunction with conventional care, if likely safe and potentially effective, would be ethically compelling, assuming the clinician held full and fair conversations with the patient about the potential benefits and risks of such an approach. In similar fashion, conversations about the possibility of acupuncture to relieve chronic pain in kidney disease and acupressure for treatment of pruritus may be warranted.

On the whole, integrative care suggests the need for such conversations.18 Even though the legal obligation of informed consent mandates disclosure of risks and benefits, the premise of integrative care suggests the importance of engaging patients in shared decision making.15 Rather than choosing between the 3 possibilities suggested in the liability analysis described earlier (recommend, tolerate, or reject), clinicians should review all the clinical options with each patients and, in the scenario of "tolerating" (or accepting) the patient's persistent interest in using CAM therapies, be ready to step in with conventional medical care if, as, and when appropriate in shared decision making with the patient.

Notably, the IOM report15 cited this framework with approval. In broader terms, the report highlighted 5 ethical values to be held in balance in public policy conversations about integration of CAM therapies: a social commitment to public welfare, a commitment to protect patients and the public from hazardous health practices, a respect for patient autonomy, recognition of medical pluralism, and public accountability.15 Although autonomy, a commitment to protect patients from harm (nonmaleficence) and a commitment to public welfare (beneficence) are more familiar ethical values, the report defined medical pluralism and public accountability, respectively, as follows: "Serious consideration of the safety, efficacy and potential integration of CAM therapies into conventional medicine means acknowledgement of multiple valid modes of healing, and a pluralistic foundation for health care...Public accountability, like medical pluralism, must include some consideration of the vast array of perspectives that constitute the national (and even international) heritage of healing traditions."15 Without disclaiming the importance of considerations of safety and efficacy, the IOM report also placed a new emphasis on the importance of factoring in multiple perspectives about health and human healing.


Conclusion TOP

The decision as to how to guide the patient deserves serious discussion. Historically, many characterized CAM therapies as a whole as "unproven" and the matter ended there. But the medical evidence regarding safety and efficacy changes rapidly, and both research and legislative developments reflect a shifting environment in which it becomes increasingly important to track information and communicate responsibly with patients. The stated ideal is to respond to patient interest in CAM therapies in a way that is "clinically responsible, ethically appropriate, and legally defensible."32

To do so, those nephrologists who are practicing within in a hospital may have the benefit of guidance from the hospital's legal counsel and those in free-standing integrative care clinics, from their attorneys. Rather than a black-and-white, yes/no response to a therapy labeled as "CAM," the preferred approach is to investigate the literature and advise the patient accordingly. The nephrologist can then decide whether to recommend, approve, or avoid and discourage a given CAM therapy. It is also imperative to ask patients, as part of the medical history, what dietary supplements and other CAM therapies they are currently using, to evaluate the extent to which such concurrent regimens may either accelerate or interfere with conventional care, and to advise the patient accordingly.

In guiding the patient, the nephrologist may wish to bear in mind the ideal of "shared decision making between patient and clinician, in which patient preferences are actively considered and valued," as recently articulated by the IOM report.15 Shared decision making suggests that the conversation goes well beyond the legal and ethical requirement of informed consent toward a respectful exchange in which both parties bear the weight of determining the optimal clinical course. Patients who favor CAM therapies despite medical advice to the contrary should not be abandoned but should be monitored and encouraged to use medically necessary, conventional therapies, and full documentation should be made of relevant conversations and decisions in the medical record. As a last resort, if a nephrologist believes the patient is choosing a therapeutic route that is not clinically supportable, the patient may be referred to another medical specialist who can offer evidence-based care and monitoring in a manner more consistent with the patient's requests.

As medical evidence accumulates either favoring or disfavoring specific therapies, practices and standards of care will change. This, in turn, will better inform clinicians and institutions and shift perceptions of efforts to integrate CAM therapies into conventional medical settings. That shift, in turn, may generate new ways of understanding health care and its regulation in affiliated fields such as law and ethics.


References TOP


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29. Tunkl v Regents of the Univ of Calif (383 Pacific Reporter 2d 441 [Cal 1963])

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