Emerging Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Complementary and Alternative Medical Practices and Dietary Supplement Recommendations:  A Descriptive Study of 19 Integrative Health Care Centers in the United States FREE

Hospitals in the United States increasingly are exploring clinical use of complementary and alternative medical (CAM) therapies such as chiropractic, acupuncture, massage therapy, and nutritional and herbal care.¹ This research documents emerging approaches, across 19 US hospitals, regarding credentialing practices, malpractice liability policies, and pharmacy and therapeutic guidelines governing the integration of CAM therapies and providers into conventional health care delivery systems. Legal rules and regulatory policies in each of these 3 domains leave an uneven map for clinicians and researchers. For example, while every state licenses chiropractors, not all states license practitioners of acupuncture and traditional oriental medicine, massage therapy, and naturopathic medicine.^2- 3 State licensing laws vary in the scope of practice they allow each licensed CAM provider; for example, only some specifically permit acupuncturists to recommend Chinese herbal medicine, while at least 1 state expressly prohibits the practice.³ Similarly, at least 3 states allow unlicensed CAM providers to offer health care services, under certain conditions,³ while in other states, unlicensed providers risk prosecution for unlawful medical practice.² Such variability makes institutional selection of, and credentialing for, CAM providers highly heterogeneous.

In the liability arena, few judicial opinions specifically address clinicians’ use of CAM therapies,^2,4 although increased litigation is likely as physicians are asked to counsel patients regarding use or avoidance of CAM therapies or for referrals to CAM providers.^5- 6 Finally, although questioning patients regarding ingestion of dietary supplements arguably should be part of history taking,⁷ the lack of agreed-on manufacturing standards and insufficiency of information concerning safety and efficacy for dietary supplements (and individual brands of supplements) has led some health care institutions to categorically ban patient use of dietary supplements.^8- 9 Ideally, determining the status of current practices can help clarify whether common approaches are emerging to facilitate reproducible models of integrative health care and generalizable clinical research.

Integrative medicine is defined as health care that “combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness.”¹⁰ Because the universe of US hospitals offering integrative medicine cannot be accurately determined—and is rapidly changing—this pilot survey identified centers from National Institutes of Health–funded research studies concerning CAM therapies, from the Consortium of Academic Health Centers for Integrative Medicine,¹¹ from among attendees at Harvard Medical School Continuing Medical Education courses on delivery of CAM therapies, and from an examination of major, operating integrative care centers.¹² We identified a convenience sample of 21 such academically affiliated and 13 non–academically affiliated hospitals with integrative care centers. We defined the academic medical center as a health care center that includes an allopathic or osteopathic school of medicine, at least one other health professions school or program, and one or more university-owned or -affiliated teaching hospitals.¹³

We sent invitational letters, followed up by a survey and telephone calls, to medical directors of the integrative care centers in these 34 institutions. Twelve (57%) of the 21 academically affiliated centers and 7 (54%) of the 13 non–academically affiliated centers responded with completed surveys from May 1, 2001, through June 1, 2002. Of the 19 total respondents, 11 were tertiary care hospitals, 6 were community hospitals, 1 was a freestanding center associated with a community-based hospital, and 1 was a university-based rehabilitation hospital (see acknowledgments). Institutional review board approval from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass, was obtained.

The professional mix of practitioners participating in integrative care teams reflected no discernible pattern, across institutions, geographic regions, or provider groups within a given institution (Table and Web Appendix 1 [Mind Body Experts and Other Providers]). (All Web appendixes referred to in this article can be found on the Harvard Medical School Osher Institute’s Web site: http://www.osher.hms.harvard.edu/pu_general_pub.html).

Only 40 of the 170 total providers were explicitly required to obtain physician referrals before delivering clinical services to patients (Web Appendix 2 [Practitioner Scope of Practice]). Practitioner autonomy was heterogeneous, with no apparent pattern with regard to academic vs nonacademic affiliation. Slightly more providers were approved (71) than not approved (63) to recommend dietary supplements (ie, herbs, vitamins, and nonherbal supplements). Six of 15 non-MD acupuncturists and 9 of 17 nutritionists were so approved. More than twice as many providers (99 of 170) had authority to treat inpatients than did not have such authority (43 of 170). When asked whether centers had any specific limitations on provider authority other than those indicated in Web Appendix 2, few centers added written comments (Web Appendix 3 [Limitations on Provider Authority and Other Risk Management Strategies]).

Our survey asked respondents to confidentially provide their credentialing policies. The policies we received required evidence of competence, such as some combination of a valid state license (where available by state to the specific provider), specified limits of malpractice liability insurance, evidence of training (eg, documentation of national certification, or of highest certification available; or a specified number of hours of theory and of clinical training), and evidence of experience (eg, letters of reference from patients and/or providers). Additional requirements included interview and skills assessment, evidence of completion of mandatory continuing education units, health clearance, ongoing peer and committee review, and background check.

There was no consistent pattern of liability insurance, either by provider type or between academic and nonacademic centers (Web Appendix 4 [Minimum Required Professional (Malpractice) Liability; Per Claim/Cost per Aggregate]). The most frequent response was a requirement of $1 million per claim/$3 million per aggregate in liability insurance (74 of 170 providers), although there was no response for 66 providers, suggesting that this information may not be readily accessible or may be unknown at many institutions. The remainder of institutional requirements for “other” providers represented in Web Appendix 4 reflected varied responses with regard to malpractice liability insurance: $5 million/unspecified (n = 10); $3 million/unspecified (n = 4); $300 000/$600 000 (n = 4); $1 million/$1 million (n = 4); $4 million/$16.5 million (n = 2); $600 000/$600 000 (n = 2); $2 million/$2 million (n = 1); $1 million/$2 million (n = 1); $1.2 million/$1.2 million (n = 1); “brings own” (n = 1).

While survey respondents differed in whether and how they required providers to obtain patients’ informed consent and to document consent to CAM therapies, most required risk-benefit disclosure in some form. Specifically, of 18 respondents, 8 (5 academic and 3 nonacademic institutions) indicated that their intake forms or medical records contained informed consent language specifically geared to use of CAM therapies; 8 indicated that they did not. Five of the 8 (3 academic and 2 nonacademic institutions) with CAM-specific informed consent forms also required that providers delivering CAM therapies, including dietary supplements, verbally discuss the risks and benefits of these therapies with their patients and document these discussions in the medical record. An additional 6 of 18 indicated that they required discussions only. Four of 18 institutions (2 academic and 2 nonacademic) indicated that they required neither written informed consent nor verbal discussions.

Nine of 19 institutions indicated having no specific comprehensive risk management policies regarding their CAM providers other than the stated minimum requirements for malpractice liability insurance. Some of the institutions indicated that they addressed risk management more informally (Web Appendix 3). When asked what key issues institutions believed needed to be addressed as institutional policy, varied responses included a mix of legal, clinical, and administrative concerns (Web Appendix 5 [Key Issues of Institutional Policy]).

Institutions offered no discernible pattern (or consistently stated rationale for deciding) as to whether providers were hired as employees or independent contractors, across institutions, within institutions by provider type, or within the conventional or CAM domain (Web Appendix 6 [Employee Status]). Overall, 78 providers were hired as employees, 44 were hired as independent contractors, there were 42 nonresponses, and 6 responses were ambiguous (eg, some indicated that the same provider type was hired both ways). There was no appreciable distinction between academic and nonacademic centers.

Responses to questions regarding contractual arrangements, income tax, and billing procedures also were varied and did not clarify the data regarding employee status. Survey results did not disclose whether decisions in this arena reflected liability vs administrative concerns (eg, benefits or costs, such as incentives to participate in clinical team and administrative meetings at the center). We did not collect information on reimbursement by third-party payers.

As summarized in Web Appendix 7 (Policies and Practices Involving Dietary Supplements), only 6 of 19 institutions had formal policies regarding dietary supplements. For the purpose of the survey, dietary supplements were defined for the respondents to include vitamins, minerals, and herbs (such as Ginkgo biloba, saw palmetto, and coenzyme Q10) that were neither approved nor classified by the Food and Drug Administration as drugs. The category did not include liquid caloric supplements.

Formal Policy and Therapeutic Recommendations. Of the 6 of 19 centers responding affirmatively to a question about the existence of formal (stated) policy regarding the use of dietary supplements (Web Appendix 7), only 2 indicated that the policy allows staff to make recommendations involving dietary supplements (and an additional 1 indicated that staff could recommend vitamins only); several institutions indicated that they have draft policies.

Information. Of the 18 centers responding to the question about a source of information within the institution concerning dietary supplements, 15 responded affirmatively and indicated that the information typically was located in the hospital pharmacy, or text (eg, library) and online references in an intranet library. Eleven of the 15 responding indicated that this source of information (eg, the hospital pharmacy) makes recommendations to staff concerning patient use of dietary supplements. Three of the 11 indicated that such recommendations make distinctions between different brands of the same herb.

Outpatient Pharmacy. Six of 19 respondents (3 academic and 3 nonacademic) reported having an outpatient pharmacy that sells dietary supplements (Web Appendix 7). Of these 6, 1 included only herbal products; 5 included herbal products and homeopathic remedies as well as vitamins, minerals, and supplements. An additional respondent indicated that such a pharmacy was in development and would include homeopathic remedies.

Confiscation; Home Supply. Seven of 19 institutions indicated that they confiscate any and all dietary supplements at the time the patient is hospitalized (Web Appendix 7). Additional written responses are included in Web Appendix 8 (Policies Regarding Confiscation of Dietary Supplements), and the criteria used to determine which dietary supplement products patients may continue using during hospitalization are included in Web Appendix 9 (Criteria Regarding Home Supply of Dietary Supplements).

Documentation of Inpatient Use. Eleven of 18 institutions responding to this question required documentation of inpatient use of dietary supplements and 7 indicated that no documentation was required. Six respondents indicated that documentation was required only in the admission note; 2 indicated that documentation was required only in the patient’s hospital chart; and 2 respondents indicated that documentation was required in the admission note, hospital chart, and medication administration record. Eleven respondents specified that the documentation must include the name of the dietary supplement; 9 of the 11 also required the dose, 5 required the indications, and 4 required product identification.

Inpatient Formulary; Influence of Third-Party Reimbursement. Nine of 16 responding institutions reported having an inpatient formulary for dietary supplements. Eight of these 9 included vitamins, minerals, and supplements; the ninth included only vitamins. One also included herbal products. The criteria used to determine which dietary supplement products and brands to include were quite varied (Web Appendix 10 [Criteria Used to Determine Which Dietary Supplement Products to Include in Formulary] and Web Appendix 11 [Criteria Used to Determine Which Dietary Supplement Brands to Include in Formulary]). Two of 13 respondents reported that the availability of third-party reimbursement would influence the decision to include dietary supplements in the formulary (Web Appendix 7). Ten reported that this factor would have no influence, and one indicated “not certain.”

Anesthesia and Surgery Recommendations Regarding Discontinuance of Herbs, Vitamins, and Supplements. Six respondents (all academic centers) indicated that they make formal recommendations regarding the continued use (or discontinuance) of dietary supplements before elective surgery (eg, to discontinue those known or thought to interact with anesthesia or clotting; see Web Appendix 12 [Anesthesia and Surgery Recommendations Regarding Discontinuance of Herbs, Vitamins, and Supplements] and Web Appendix 7). Thirteen other centers did not respond to this question.

Our pilot data suggest that hospitals are using heterogeneous approaches to address licensure, credentialing, and scope of practice of complementary care providers; malpractice liability; and dietary supplement use in efforts to develop models of integrative care. The standardization of provider education, training, and therapeutic approach facilitating consistent research across institutions and states is lacking.

We found no consistency in approaches to professional provider mix within the integrative care team. Nearly every center included a “mind-body” provider, for example, while only 4 included a naturopath; 16 included a massage therapist, while only 7 included a chiropractor; some included both MD and non-MD acupuncturists, while others included one but not the other. Even within the category of “mind-body” expert, choices ranged from psychiatrist to psychologist to “healing touch therapist” and “spiritual counselor”; and the range of “other” providers included “child life specialist,” “biofeedback technician,” art therapist, movement therapist, and “energy practitioner,” as well as physical therapist, reflexologist, and osteopath. Such diversity may reflect the uneven map of licensure for various CAM providers across states,^2- 3 as well as potential liability concerns^2,14; the lack of clear definitions of integrative clinical care and of “mind-body” care; institutional reluctance to include unlicensed providers (such as naturopathic physicians in some states)²; the present lack of an evidence base concerning the optimal (and most cost-effective) professional provider mix in the integrative team; the effect of personal beliefs and practices (particularly involving herbal medicine) on CAM practices¹⁵; and the influence of decisional norms within institutions on local credentialing decisions.¹⁶

We also found heterogeneity of approaches—again, both across institutions and across providers within institutions—regarding which providers are required to have a physician referral before delivering clinical services (40 yes and 92 no); which may recommend dietary supplements (71 yes and 63 no); and which may treat inpatients (99 yes and 43 no). Generally, conventional providers on the integrative care team and their CAM counterparts had a fair amount of autonomy and authority across institutions; on the whole, there were few explicit (or comparable) scope-of-practice restrictions. Such permissive practices arguably parallel a regulatory landscape in which, in most states, chiropractors, massage therapists, and naturopathic physicians (where licensed) are independent practitioners, not statutorily dependent on physician referral or supervision.^2- 3,17

Although the most common requirement was $1 million per claim/$3 million per aggregate, the requirements were inconsistent across institutions and across providers within institutions. Generally, legal rules governing malpractice liability involving CAM therapies are in flux^2,4- 5 and present uncertainty to clinicians.¹⁸ For some professions (such as acupuncture), the lack of significant published information concerning claims experience makes it difficult to determine definitively what level of insurance should be required.⁶ CAM therapies also account for only approximately 5% of the total medical malpractice insurance market; to date, both the number of claims against CAM providers and the average indemnity paid per claim have been lower than claims against primary care physicians. However, this situation may change as integrative care expands.^4- 6,14

Concerning informed consent, respondents generally seemed aware of the need for disclosure of risks and benefits concerning CAM therapies, although there was no standardized approach, and hospitals differed as to whether such disclosure should be written or verbal and how it should be documented. Inadequate informed consent can be grounds for malpractice liability apart from any negligent care.^2,4 Furthermore, new guidelines by the Federation of State Medical Boards require specified informed consent procedures, at least for physicians counseling patients regarding use of CAM therapies.¹⁹

The respondents had no consistent approach to hiring status. The heterogeneity may reflect financial constraints and/or legal ambiguity concerning institutional liability: health care institutions are vicariously liable for the negligence of their “employees” but not for the negligence of affiliated “independent contractors.”²

Dietary supplement policies also varied. Less than a third of the sample had a formal policy concerning dietary supplements. While 6 of 10 centers indicated selling dietary supplements in their outpatient pharmacy (and 9 of 16 indicated selling in their inpatient pharmacy), there was no consistent rationale regarding which products and brands to include (or explicitly exclude); responses ranged from “no specific criteria” to “cost.” Although approximately a third had a practice of confiscating dietary supplements on the patient’s admission to the hospital, there were no consistent criteria across institutions as to which supplements to allow patients to continue using as home supply; several hospitals allowed ad hoc decisions by attending physicians. Practices also varied concerning requirements for documentation of dietary supplement use, a topic now being addressed by the Joint Commission on the Accreditation of Healthcare Organizations.²⁰

Hospitals differed as to whether the availability of third-party reimbursement would influence their policy concerning dietary supplements; only 6 of 19 respondents made formal recommendations regarding the continued use of supplements before elective surgery.

The generalizability of this pilot study was limited by several factors, including the nonresponse rate (44%). Numerous attempts to reduce the nonresponse rate through follow-up telephone calls and e-mail were unsuccessful. However, it seems unlikely that data from the remaining sites would have significantly reduced the inconsistencies in the responses that were observed from the 19 responding sites.

The nonresponse rate across various questions may reflect the uncertainty that pervades this field, including concern about sharing data. The length and complexity of the survey, and the lack of a centralized location within each center from which to retrieve the information, may have contributed to missing data. In addition, answers to surveys suggested that some of the follow-up questions simply did not apply to particular institutions, or required information that was unknown to the respondent. Finally, hospitals define and operationalize “integrative care” differently—some create specific centers for “complementary medicine” or “integrative medicine”; others have affiliated clinics devoted to “wellness,” “mind-body,” or similar concepts; and still others have CAM providers in various hospital departments (eg, a non-MD acupuncturist in the pain center) but no “integrative care” unit. Therefore, respondents may not have included all relevant CAM providers in their survey responses, while others may have been overinclusive.

Our pilot study suggests that hospitals across the United States are implementing vastly different practices and policies concerning CAM providers and therapies, as regards credentialing, malpractice liability, and use of dietary supplements. The current environment creates significant impediments to the delivery of consistent clinical care and the implementation of multisite evaluations of the safety, efficacy, and cost-effectiveness (or lack thereof) of CAM therapies (or integrative models) as applied to the management of common medical conditions. Specific obstacles include the following: (1) inconsistency of state laws regarding provider licensure of acupuncturists, massage therapists, chiropractors, naturopaths, and “mind-body” therapists, and corresponding divergence of hospital practices concerning credentialing, limitations on practice authority, and provider mix in the integrative team; (2) divergence of approaches to liability management strategies, including minimum malpractice liability insurance, informed consent practices and documentation, and provider hiring status; and (3) variability of approaches to patient use of, and clinician recommendations involving, dietary supplements, including the presence (or absence) of relevant, formal (stated) policies, the presence (or absence) of various combinations of dietary supplements in the formulary for outpatient and inpatient pharmacies, varying criteria (or lack thereof) regarding which products and brands to include (or explicitly exclude), varying confiscation practices and criteria for allowing home supply, and varying formal recommendations (or lack thereof) regarding the continued use (or discontinuance) of dietary supplements before elective surgery.

Furthermore, institutional inconsistency and ambiguity complicate clinical decision making as well as research, and foster ethical issues.²¹ Such difficulties would likely benefit from national consensus approaches to credentialing, malpractice liability policies, and guidelines for dietary supplement recommendations.

In designing consensus, the regulatory landscape creates several conundrums. Since the US Constitution reserves regulation of health, safety, and welfare (and therefore licensing of health care providers) to the states, diversity of licensing and scope of practice rules across states is unlikely to change.² Nor are hospitals likely to increase standardization of integrative care teams in the absence of data concerning what combinations of providers or therapies are most effective (and safe) for any given condition. Potential liability exposure is difficult to predict, particularly given changing case law and changing levels of evidence for specific therapies,⁵ and local institutional politics are likely to continue playing a significant role in the emergence of models of integrative care.¹⁶ In short, a national, standardized approach to licensure, scope of practice, credentialing, and liability management may not be feasible. In addition to regulatory issues and liability concerns,⁵ ethical issues complicate matters.^14,22- 23

While licensure, credentialing, and scope of practice and liability issues are thorny, dietary supplement policies may lend themselves more easily to research as evidence accumulates regarding safety and efficacy (or lack thereof) and mechanism of supplements, including their potential interactions with conventional medication.⁹ Here greater consensus might be achieved, and hospitals may be able to abandon risky and unsupportable approaches that lack scientific justification.

We offer the following policy recommendations. First, while licensure and scope of practice are matters of state law, either an agency to coordinate federal policy concerning CAM research and practice,²⁴ the Council of Governors, or another appropriate governmental body could encourage CAM professional organizations to develop model legislation and guidelines (where feasible and appropriate) to take the following steps: (1) increase the standardization in minimum required education and clinical training for licensure (and/or adopt a national certifying examination) across states; (2) create standardized, biomedical curricular components for their students; (3) facilitate reduction in scope of practice variations across states; (4) increase the proportion of educational institutions within the profession that are professionally accredited; (5) define or limit potentially misleading uses of the term primary care provider within the CAM profession³; (6) enhance opportunities for licensees to participate in clinical residency in integrative care centers, with the intent of receiving supervision by senior clinicians from both the conventional and CAM communities; and (7) create performance standards and assessment of clinical skills for conventional and complementary care providers who work in integrative care settings.

Second, stakeholder groups could, individually and collectively, encourage relevant professional organizations and agencies to consider creative ways of using integrative care centers to help further consistent clinical care and research. Such centers could become key educational hubs in which biomedical and CAM clinicians and researchers receive the cross-disciplinary training necessary for safe, evidence-based integrative care and innovative investigation.

Third, regulations should encourage institutional review boards to include CAM providers and other expertise relevant to evaluation of protocols and risks for human subjects in research studies involving study of CAM therapies. Such regulations could reduce potential bias against (or for) CAM protocols, and furnish institutional review boards a broader range of expertise with which to evaluate relevant research.

Fourth, in trying to achieve sufficiently standardized approaches to developing multisite research protocols across states, investigators may find it advantageous to define the modalities specified providers are allowed to offer in clinical trials.³ Finally, the Consortium of Academic Health Centers for Integrative Medicine plans to become a national repository of information concerning preferred institutional practices.¹¹ These steps, without intruding on states’ rights to be “laboratories for experimentation,” and while respecting the diversity of institutional approaches and pluralistic development of models of integrative care, will encourage the development of more consistent policies relating to clinical delivery and research involving integrative care.

Correspondence: Michael H. Cohen, JD, Harvard Medical School Osher Institute, 401 Park Dr, 22-W, Boston, MA 02215 (michael_cohen@hms.harvard.edu).

Accepted for Publication: October 14, 2004.

Funding/Support: This study was supported by unrestricted educational gifts from American Specialty Health, San Diego, Calif, and the Medtronic Foundation Inc, Minneapolis, Minn, and operational support from the Rudolph Steiner Foundation, San Francisco, Calif; a grant from the Greenwall Foundation, New York, NY; grant 1 R01 AT00905 from the National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, Md; and grant IG13LM07475-01 from the National Library of Medicine at the National Institutes of Health. None of the entities sponsoring the project had any influence on the study design, analysis, or writing of the manuscript.

Disclaimer: The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Center for Complementary and Alternative Medicine, the National Library of Medicine, the National Institutes of Health, or any sponsor.

Additional Information: Copies of the survey instrument used for this study can be found on the Harvard Medical School Osher Institute’s Web site, http://www.osher.hms.harvard.edu.

Acknowledgment: We thank Marian Osterweis, PhD (Association of Academic Health Centers, Washington, DC), Roger Wood, LMT, and Shannon Marcotte for their research and administrative assistance with this article, and for their help in providing a list of academically affiliated medical centers. We also thank the participating centers: Alternative Medicine Division, Hennepin County Medical Center (South Minneapolis, Minn); Atlantic Mind Body Center for Complementary Medicine, Morristown Hospital (Morristown, NJ); Center for Complementary Medicine, Lutheran General Hospital (Park Ridge, Ill); Center for Complementary Medicine, University of Pittsburgh Shadyside (Pittsburgh, Pa); Center for Integrative Medicine (Concord, NH); Complementary Medicine Clinics, Stanford University School of Medicine (Palo Alto, Calif); Medical University of South Carolina, Complementary and Alternative Medicine Department (Charleston); Complementary Medicine Program, University of Maryland School of Medicine (Baltimore); Continuum Center for Health and Healing, Beth Israel Medical Center (Albert Einstein Medical College, New York, NY); Georgetown University Medical Center, Departments of Physiology, Biophysics, and Medicine (Washington, DC); Institute for Health and Healing, California Pacific Medical Center (San Francisco); Mercy Hospital, University of New England Osteopathic Medical College (Portland, Me); New York Presbyterian Hospital, Milstein Hospital Building (Columbia University College of Physicians & Surgeons, New York, NY); Osher Center for Integrative Medicine, University of California at San Francisco; Program in Integrative Medicine, University of Arizona School of Medicine (Tucson); Scripps Center for Integrative Medicine (La Jolla, Calif); Siegler Center for Integrative Medicine, St Barnabus Medical Center (Livingston, NJ); Center for Integrative Medicine (San Jose, Calif); and Yale-Griffin Preventive Research Center (Derby, Conn).

Financial Disclosure: Mr Cohen and Dr Eisenberg each receive honoraria from speaking engagements; Mr Cohen represents clients in the area of complementary and alternative medicine through his law office and the Complementary and Alternative Medicine Law Blog.