Overcoming legal and social barriers to integrative medicine

Medical Law International

Volumn 6, Issue 4, 2004, Pages 339-393

  Cohen, Michael H ^a,b,c,d   Ruggie, Mary ^b,e  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Iowa Writers' Workshop   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e HARVARD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; ACUPUNCTURE; ALTERNATIVE MEDICINE; CHINESE MEDICINE; DIET SUPPLEMENTATION; DOCTOR PATIENT RELATION; EVIDENCE BASED MEDICINE; FINANCIAL MANAGEMENT; GOVERNMENT; HEALTH CARE POLICY; HOMEOPATHY; HOSPITAL CARE; INTEGRATION; LAW SUIT; LEGAL ASPECT; MANIPULATIVE MEDICINE; MASSAGE; MEDICAL DOCUMENTATION; MEDICAL EDUCATION; MEDICAL ERROR; MEDICAL LIABILITY; MEDICAL RESEARCH; MEDICINE; NUTRITION; OUTCOMES RESEARCH; POLITICS; PSYCHOTHERAPY; REVIEW; RISK MANAGEMENT; SOCIAL ASPECT; TRADITIONAL MEDICINE; WELLBEING;

EID: 10944231969     PISSN: 09685332     EISSN: None     Source Type: Journal    
DOI: 10.1177/096853320400600404     Document Type: Review

References (63)

1. The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health NCCAM, for example, presently defines integrative medicine as health care that "combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness." NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE, WHAT IS COMPLEMENTARY AND ALTERNATIVE MEDICINE (available at http://nccam.nih.gov/health/whatiscam/#sup2) [hereinafter referred to as, NCCAM, COMPLEMENTARY MEDICINE].
2. AMERICAN HOSPITAL ASSOCIATION (HEALTH FORUM), 2000-2001 COMPLEMENTARY AND ALTERNATIVE MEDICINE SURVEY (Chicago: American Hospital Association, 2002) (available on-line at www.hospitalconnect.com).
3. See generally MICHAEL H. COHEN, COMPLEMENTARY AND ALTERNATIVE MEDICINE: LEGAL BOUNDARIES AND REGULATORY PERSPECTIVES xi (Baltimore: Johns Hopkins University Press, 1998).
4. See, for example, the analyses of epidemiological surveys in David M. Eisenberg, R.C. Kessler, C. Foster, F.E. Norlock, D.R. Calkin, & T.L. Delbanco, Unconventional Medicine in the United States: Prevalence, Costs, and Patterns of Use, 328 N. ENGL. J. MED. 246, 256 (1993); David M. Eisenberg, R.B. Davis, S.L. Ettner, S. Appel, S. Wilkey, Maria Van Rompay, & R. Kessler, Trends in Alternative Medicine in the United States, 1990-1997: Results of a Follow-up National Survey, 280 JAMA 1569 (1998).
5. See, for example, the analyses of epidemiological surveys in David M. Eisenberg, R.C. Kessler, C. Foster, F.E. Norlock, D.R. Calkin, & T.L. Delbanco, Unconventional Medicine in the United States: Prevalence, Costs, and Patterns of Use, 328 N. ENGL. J. MED. 246, 256 (1993); David M. Eisenberg, R.B. Davis, S.L. Ettner, S. Appel, S. Wilkey, Maria Van Rompay, & R. Kessler, Trends in Alternative Medicine in the United States, 1990-1997: Results of a Follow-up National Survey, 280 JAMA 1569 (1998).
6. Today, physicians are increasingly recognizing that to guide patients concerning CAM therapies, they must be knowledgeable about such therapies. Stephen E. Straus, Complementary and Alternative Medicine: Challenges and Opportunities for American Medicine, ACAD. MED. 572, 573 (2000).
7. NCCAM, supra note 1.
8. See the examples cited in Michael H. Cohen & David M. Eisenberg, Potential Physician Malpractice Liability Associated With Complementary/ Integrative Medical Therapies, 136 ANN. INT. MED. 596 (2002).
9. See David M. Eisenberg, Advising Patients Who Seek Alternative Medical Therapies, 127 ANN. INT. MED. 61 (1997) (arguing that physicians must abandon the policy of "don't ask and don't tell," and should make asking about use of CAM therapies a regular part of the medical interview).
10. Michael H. Cohen & Mary Ruggie, Integrating Complementary and Alternative Medical Therapies in Conventional Medical Settings: Legal Quandaries and Potential Policy Models, 72:2 CINN. L. REV. 671.
11. Id., citing COHEN (1998); see also MICHAEL H. COHEN, BEYOND COMPLEMENTARY MEDICINE: LEGAL AND ETHICAL PERSPECTIVES ON HEALTH CARE AND HUMAN EVOLUTION (Ann Arbor: University of Michigan Press, 2000); Michael H. Cohen, Healing at the Borderland of Medicine and Religion: Regulating Potential Abuse of Authority by Spiritual Healers, 18:2 J. L. & RELIG. 373 (2004).
12. Id., citing COHEN (1998); see also MICHAEL H. COHEN, BEYOND COMPLEMENTARY MEDICINE: LEGAL AND ETHICAL PERSPECTIVES ON HEALTH CARE AND HUMAN EVOLUTION (Ann Arbor: University of Michigan Press, 2000); Michael H. Cohen, Healing at the Borderland of Medicine and Religion: Regulating Potential Abuse of Authority by Spiritual Healers, 18:2 J. L. & RELIG. 373 (2004).
13. Id., citing COHEN (1998); see also MICHAEL H. COHEN, BEYOND COMPLEMENTARY MEDICINE: LEGAL AND ETHICAL PERSPECTIVES ON HEALTH CARE AND HUMAN EVOLUTION (Ann Arbor: University of Michigan Press, 2000); Michael H. Cohen, Healing at the Borderland of Medicine and Religion: Regulating Potential Abuse of Authority by Spiritual Healers, 18:2 J. L. & RELIG. 373 (2004).
14. Cohen & Ruggie, supra note 9.
15. Ibid. Id.
16. Id. The language is taken from our grant.
17. The report is available at http://www.usnews.com/usnews/edu/grad/ rankings/med.
18. Academic Consortium of Health Centers for Integrative Medicine, information available on-line at http://www.pcintegrativemedicine.org/links/ acadcon.asp (accessed 11/19/03.
19. Four of the 27 did not respond to our request for interviews.
20. [Editor: This number may be updated while the article is being reviewed.] Our prior article, Cohen & Ruggie, supra note 9, reported on results of interviews in six of these centers, conducted July through November 2002; the present article reports on interviews with remaining centers through February 2004, and integrates prior data to analyze results from all the centers in the complete sample.
21. See COHEN (2000), supra note 10, at 71-88.
22. Cohen & Ruggie, supra note 9.
23. Ibid. Id.
24. See Michael H. Cohen, Toward A Bioethics of Compassion, 28 IND. L. REV. 667 (1995) (discussing use of narrative in postmodern scholarship to enrich and inform legal perspective).
25. David M. Eisenberg, Michael H. Cohen, Andrea Hrbek, Jonathan Grayzel, Maria I. van Rompay, & Richard A. Cooper, Credentialing Complementary and Alternative Medical Providers, 137 ANN. INTERN. MED. 965 (2002).
26. Ibid. Id.
27. Scope of practice involves the legally authorized boundaries of practice for a non-physician provider. See generally COHEN, supra note 3, at 39-55. For example, massage therapists typically cannot engage in counseling, to the extent this might involve the unauthorized practice of psychology, another licensed profession. Id.
28. Scope of practice involves the legally authorized boundaries of practice for a non-physician provider. See generally COHEN, supra note 3, at 39-55. For example, massage therapists typically cannot engage in counseling, to the extent this might involve the unauthorized practice of psychology, another licensed profession. Id.
29. See Eisenberg et al, supra note 22 (describing distinction between credentialing and privileging).
30. See generally COHEN (2000), supra note 10, at 52-55 for a discussion of shared liability among members of the clinical team; COHEN, supra note 3, at 70 for a discussion of vicarious liability by the institution; see also David M. Studdert, David M. Eisenberg, Francis H. Miller, D.A. Curto, Ted J. Kaptchuk, Troyen A. Brennan, Medical Malpractice Implications of Alternative Medicine, 280 JAMA 1610 (1998) (describing potential malpractice liability of physicians for referrals to CAM providers).
31. COHEN, supra note 3, at 70 for a discussion of vicarious liability by the institution; see also David M. Studdert, David M. Eisenberg, Francis H. Miller, D.A. Curto, Ted J. Kaptchuk, Troyen A. Brennan, Medical Malpractice Implications of Alternative Medicine, 280 JAMA 1610 (1998) (describing potential malpractice liability of physicians for referrals to CAM providers).
32. COHEN, supra note 3, at 70 for a discussion of vicarious liability by the institution; see also David M. Studdert, David M. Eisenberg, Francis H. Miller, D.A. Curto, Ted J. Kaptchuk, Troyen A. Brennan, Medical Malpractice Implications of Alternative Medicine, 280 JAMA 1610 (1998) (describing potential malpractice liability of physicians for referrals to CAM providers).
33. Cohen & Eisenberg, supra note 7.
34. "Health freedom" legislation offers legal protection to physicians who might otherwise be disciplined for integrating CAM therapies. See COHEN, supra note 3, at 92-95 (citing examples). Such legislation differs by state, but essentially provides that physicians shall not be disciplined solely for the fact of incorporating CAM therapies into the therapeutic regimen. Id.
35. "Health freedom" legislation offers legal protection to physicians who might otherwise be disciplined for integrating CAM therapies. See COHEN, supra note 3, at 92-95 (citing examples). Such legislation differs by state, but essentially provides that physicians shall not be disciplined solely for the fact of incorporating CAM therapies into the therapeutic regimen. Id.
36. These guidelines, available at www.fsmb.org (Model Guidelines for the Use of Complementary and Alternative Therapies by Physicians), provide a series of model rules to guide state medical boards in assessing whether physician use of CAM therapies requires physician discipline. The Federation guidelines establish rules regarding the giving and taking physician licensure across states; the guidelines represent the Federation's response to the health freedom legislation, and one attempt to balance consumer demand for, and clinician interest in, CAM therapies, against the state's interest in safeguarding patients against negligent or unprofessional practice.
37. Wendy A. Weiger, Michael Smith, Heather Boon, Mary Ann Richardson, Ted J. Kaptchuk, David M. Eisenberg, Advising Patients Who Seek Complementary, and Alternative Medical Therapies for Cancer, 137 ANN. INTERN. MED. 889 (2002). The grid is adapted from Cohen & Eisenberg, supra note 7, and adds to that framework suggestions for what kind and level of evidence (e.g., number of randomized controlled trials or other evidence) would be necessary for a given therapy to fit within a given region of the framework.
38. See generally COHEN, supra note 3, at 69 (citing cases, and discussing potential liability of providers of CAM therapies for misrepresentation).
39. Such disclosure arguably respects the patient's autonomy interest and is ethically supportable. See generally Karen E. Adams, Michael H. Cohen, Albert R. Jonsen, David M. Eisenberg, Ethical Considerations of Complementary and Alternative Medical Therapies in Conventional Medical Settings, 137 ANN. INT. MED. 660 (2002) (framing ethical perspectives).
40. This is the liability management approach recommended in Cohen & Eisenberg, supra note 7.
41. Cf. Michael H. Cohen, A Fixed Star in Health Care Reform: The Emerging Paradigm of Holistic Healing, 27 ARIZ. L. J. 79 (1995) (describing competing values of patient autonomy and medical paternalism, and issues of drawing balance concerning use of CAM therapies).
42. As one medical director observed, the integrative care center does not accept insurance (except Medicare and the state equivalent of Medicaid), because its Fellows cannot bill for their time, and the medical doctors cannot bill for time supervising the Fellows. In other words, "mind-body, spirituality, nutrition are not billable-theoretically they're preventative services, but the integrative model is not reimbursed." See generally Alan Dumoff, Coding System for Alternative and Complementary Therapies: It's Not as Easy as ABC, 8:4 Alt./Comp. Therapies 246 (2002).
43. Eisenberg et al., supra note 22. By and large, the centers used only licensed providers, although one center included a naturopath even though naturopaths are not licensed in that state. The medical director explained: "We essentially say, don't order tests or prescribe drugs or otherwise do things that appear to be practicing medicine without a license." Although lacking licensure as a credentialing marker, the hospital in this case developed its own criteria-including completion of degree at a four-year naturopathic college-and limited scope of practice to counseling regarding diet, nutrition, lifestyle and supplements. The medical director added "I've rarely seen a case against an ND."
44. See BARBARA B. MITCHELL, ACUPUNCTURE AND ORIENTAL MEDICINE LAWS (Washington, D.C.: National Acupuncture Foundation, 2002).
45. See generally COHEN, supra note 3, at 73-86 (citing sources); see also Michael Specter, Miracle in a Bottle, THE NEW YORKER 64, 66 (Feb. 2, 2004).
46. See generally COHEN, supra note 3, at 73-86 (citing sources); see also Michael Specter, Miracle in a Bottle, THE NEW YORKER 64, 66 (Feb. 2, 2004).
47. See COHEN, supra note 3, at 79-81 (citing sources); COHEN (2000), supra note 10, at 107-124.
48. See COHEN, supra note 3, at 79-81 (citing sources); COHEN (2000), supra note 10, at 107-124.
49. See FOOD AND DRUG ADMINISTRATION, REGULATIONS ON STATEMENTS MADE FOR DIETARY SUPPLEMENTS CONCERNING THE EFFECT ON THE STRUCTURE OR FUNCTION OF THE BODY, 65 Fed. Reg. 1000 (Jan. 6, 2000).
50. One of the authors explores use of negotiation theory and analysis to create ways around this dilemma, in Michael H. Cohen, Negotiating Integrative Medicine: Applying Negotiation Analysis to Decision-Making Involving Complementary and Alternative Medical Therapies (manuscript currently being submitted to law reviews).
51. See Ralph Snyderman & Andy Weil, Integrative Medicine: Bringing Medicine Back To Its Roots, 162 ARCH. INT. MED. 395, 396 (2002).
52. See Michael H. Cohen, Of Rogues and Regulation: A Review of Accommodating Pluralism: The Role of Complementary & Alternative Medicine, 27:3 VT. L. REV. 801 (2003).
53. See Cohen & Eisenberg, supra note 7 (on liability perspectives regarding clinical choices); Adams et al., supra note 30; Edzard E. Ernst & Michael H. Cohen, Informed Consent in Complementary and Alternative Medicine, 161:19 ARCH. INT. MED. 2288 (2001) (discussing informed consent considerations).
54. See Cohen & Eisenberg, supra note 7 (on liability perspectives regarding clinical choices); Adams et al., supra note 30; Edzard E. Ernst & Michael H. Cohen, Informed Consent in Complementary and Alternative Medicine, 161:19 ARCH. INT. MED. 2288 (2001) (discussing informed consent considerations).
55. See Cohen & Eisenberg, supra note 7 (on liability perspectives regarding clinical choices); Adams et al., supra note 30; Edzard E. Ernst & Michael H. Cohen, Informed Consent in Complementary and Alternative Medicine, 161:19 ARCH. INT. MED. 2288 (2001) (discussing informed consent considerations).
56. The authors know of one CAM provider (a chiropractor) who was invited (but declined) to be clinical director of a center; and of another (a naturopathic physician) who for a time served as co-director, with a medical doctor, of a center.
57. For a discussion of separation of privileging from credentialing, see Eisenberg et al., supra note 22.
58. MICHAEL H. COHEN, FUTURE MEDICINE: ETHICAL DILEMMAS, REGULATORY CHALLENGES, AND THERAPEUTIC PATHWAYS TO HEALTH AND HEALING IN HUMAN TRANSFORMATION 93-99 (Ann Arbor: University of Michigan Press, 2003) (citing ABRAHAM MASLOW, TOWARD A PSYCHOLOGY OF BEING 114 (New York: Van Nostrand, 2d ed., 1968)).
59. MICHAEL H. COHEN, FUTURE MEDICINE: ETHICAL DILEMMAS, REGULATORY CHALLENGES, AND THERAPEUTIC PATHWAYS TO HEALTH AND HEALING IN HUMAN TRANSFORMATION 93-99 (Ann Arbor: University of Michigan Press, 2003) (citing ABRAHAM MASLOW, TOWARD A PSYCHOLOGY OF BEING 114 (New York: Van Nostrand, 2d ed., 1968)).
60. Testimony of Donald Novey, M.D. before the Institute of Medicine Committee on Use of Complementary and Alternative Therapies by the American Public, September 2003 (available at www.iom.edu\cam).
61. See generally THE ROLE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE: ACCOMMODATING PLURALISM (Daniel Callahan, ed.) (Washington, D.C.: Georgetown University Press, 2002).
62. As a coda, we might suggest a "next step" for considering integrative care, one that involves contemplating a longer-range future as medical technology-specifically, integration of computerized devices in the human body-affects both medical care and the way that therapies such as acupuncture, chiropractic, and energy healing might affect and be affected by technology. For example, within the next decade, we may see chips communicating wirelessly with other devices inside the body, downloading messages to patients-either visually, or perhaps directly to their brains-concerning their nutritional needs and other health information. See Scott Kirsner, The Right Dose Via Microchip, BOSTON GLOBE D1, D6. As a first pass, innovative forms of research would have to be devised to determine how implantable devices affected, for example, the flow chi in the acupuncture meridians. As humans increasingly become mechanized, bioethics could use theories and philosophies from some of the CAM therapies to help evaluate the balance of beneficence of non-maleficence in terms that acknowledge the integration of all the realms. See generally COHEN, supra note 45, at 251-303 (discussing bioethical perspectives, incorporating CAM theories, on technologies at the borderland of science and spirituality).
63. As a coda, we might suggest a "next step" for considering integrative care, one that involves contemplating a longer-range future as medical technology-specifically, integration of computerized devices in the human body-affects both medical care and the way that therapies such as acupuncture, chiropractic, and energy healing might affect and be affected by technology. For example, within the next decade, we may see chips communicating wirelessly with other devices inside the body, downloading messages to patients-either visually, or perhaps directly to their brains-concerning their nutritional needs and other health information. See Scott Kirsner, The Right Dose Via Microchip, BOSTON GLOBE D1, D6. As a first pass, innovative forms of research would have to be devised to determine how implantable devices affected, for example, the flow chi in the acupuncture meridians. As humans increasingly become mechanized, bioethics could use theories and philosophies from some of the CAM therapies to help evaluate the balance of beneficence of non-maleficence in terms that acknowledge the integration of all the realms. See generally COHEN, supra note 45, at 251-303 (discussing bioethical perspectives, incorporating CAM theories, on technologies at the borderland of science and spirituality).