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A Way Out of the Maze: Federal Agency Preemption of State Licensing and Regulation of Complementary and Alternative Medicine Practitioners

Published online by Cambridge University Press:  24 February 2021

Peter J. Van Hemel
Peter J. Van Hemel*
Affiliation:
The College of William & Mary in Virginia; 2001 Boston University
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Extract

In recent years, complementary and alternative medicine (“CAM”) has grown in both popularity and economic import across all segments of society and is now an established presence in the lives of millions of Americans. It has generated its own field of adherents, practitioners, opponents, lobbyists and counter-lobbyists, case law, and regulations. On one side of the CAM equation stand the advocates of CAM: its practitioners and satisfied patients. On the other stand its detractors: its dissatisfied patients, groups within the established or mainstream medical community, and historically, the American Medical Association (“AMA”). In the aggregate, the two sides engage in large scale scientific and philosophical battles over how best to treat or address the health care needs of patients. On a smaller scale, individuals on each side are essentially lobbying to protect their professions and their jobs. The struggle between the two warring camps fills volumes of medical, legal and popular scholarship. However, it is not the point of this Note to address the validity of the debate between CAM and mainstream medicine.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 27 , Issue 2-3: Perspectives on Medical Error: Reactions to the IOM Report , 2001 , pp. 329 - 344
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2020

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References

1 Attaching an exact economic figure to the level of consumption of CAM in the American economy is at best a rough estimate. CAM techniques and practices are a source of constant innovation and expansion. CAM is, furthermore, increasingly being included in insurance payment schemes which should, theoretically, increase its total economic impact. See CAM Inches its Way Toward Mainstream Acceptance, Cal. Health L. Monitor, Oct. 11, 1999, at 4, 4. A widely accepted baseline figure of Americans' spending on Cam treatments estimated $13.7 billion in 1990. See Michael H. Cohen, Complementary and Alternative Medicine, Legal Boundaries and Regulatory Perspectives xi (1998). The latest estimates on the economic impact of CAM place the figure in the range of $27 billion. See 145 Cong. Rec. SI4806 (daily ed. Nov. 18, 1999) (comments of Sen. Daschle (D-SD)). Similarly, some statistics indicate patient visits to CAM providers and practitioners exceed patient visits to primary care providers. See id. See also Cohen, supra at xi.

2 The history of the American Medical Association's opposition to CAM is lengthy. Mainstream, or allopathic, medicine in the late 19th and early 20th centuries faced a significant challenge from homeopathic medicine. See Cohen, supra note 1, at 17-21. As late as the 1950s, the AMA denounced CAM practices as unethical cultist healing in its official Principles of Medical Ethics. See id.

3 See National Center for Complementary and Alternative Medicine, Expanding Horizons of Healthcare, Five-Year Strategic Plan 2001-2005, at 2 (Sept. 25, 2000), available at http://www.nccam.nih.gov/nccam/strategic/nccam-sp.pdf (last visited Mar. 25, 2001) [hereinafter “NCCAM Strategic Plan"]. The National Center for Complementary and Alternative Medicine (“NCCAM”) recognizes the difficulty in assigning one broad and inclusive definition to CAM, which essentially describes it by what it is not. It provides as an alternative definition that CAM may be thought of as “diagnosis, treatment and/or prevention which complements mainstream medicine by contributing to a common whole, by satisfying a demand not met by orthodoxy or by diversifying the conceptual frameworks of medicine.” Id. at 3. Others, chiefly proponents of CAM have offered as a working definition “medical interventions not taught widely at U.S. medical schools or generally available at U.S. hospitals.” See David M. Eisenberg et al., Unconventional Medicine in the United States; Prevalence, Costs, and Patterns of Use, 328 New Eng. J. Med. 246, 246 (1993). This definition, however, has become less helpful as medical schools increasingly include CAM as standard part of the M.D. curriculum. See Boozang, Kathleen M., Is the Alternative Medicine? Managed Care Apparently Thinks So, 32 Conn. L. Rev. 567, 572-73 (2000)Google Scholar. Those who oppose alternative medicine frequently also oppose its definition. See id. at 586 (stating that, “[tjhere is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking. Whether a therapeutic practice is … unconventional or mainstream … is largely irrelevant except for historical purposes and cultural interest.”) (citations omitted).

4 See Cohen, supra note 1, at xii-xiii.

5 See id.

6 CAM practices comprise hundreds of techniques. See Nccam, Classification of Alternative Medicine Practices, available at http://www.nccam.nih.gov/nccam/fcp/classify/index-old.html (last visited Oct. 20, 2000). Some CAM practices enjoy a certain degree of popular acceptance, such as acupuncture, while others are slightly more colorful and off the beaten path, such as alternate nostril breathing or the Paleolithic diet. See id. Nccam has adopted a scheme of classification for CAM techniques, placing them into broad categories, based on those adopted at the Office of Alternative Medicine's “Workshop on Alternative Medicine” on September 14-16, 1992 in Chantilly, Virginia. See Nccam Strategic Plan, supra note 3, at ii-iv app. 1. See also Cohen, supra note 1, at 4-5. The categories are: mind-body medicine, alternative medical systems, biologically-based therapies, manipulative and body-based systems, and energy therapies.

7 See Cohen, supra note 1, at 14.

8 See id. at 3-14.

9 See supra note 6. Nccam has its roots in the National Institutes of Health Revitalization Act of 1993, Pub. L. No. 103-43, tit. II, § 209, 107 Stat. 122, 149 (1993) (codified as amended at 42 U.S.C. § 287c-21 (1998)). It was originally known as the Office of Alternative Medicine (OAM). See id. It was subsequently renamed the Office of Complementary and Alternative Medicine (OCAM) and again renamed the National Center for Complementary and Alternative Medicine (NCCAM). See id.; see also Cohen, supra note 1, at xi. Its purpose is “the conduct and support of basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems.” 42 U.S.C. § 287c-21(a) (1998).

10 See Kathleen M. Boozang, Western Medicine Opens the Door to Alternative Medicine, 24 Am. J.L. & Med. 185, 207-08 (1998) (discussing the difficulties in regulating CAM that results from the inapplicability of standard modes of scientific inquiry).

11 See discussion infra Part II.B.3. and accompanying notes.

12 See Mehmet C. Oz, M.D., Michael Cohen 's Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives, 20 J. Legal Med. 141, 149 (1999) (book review) (noting that the “anarchic laissez faire” state regulatory scheme suggested by Cohen would be “detrimental” and encouraging more government intervention).

13 Chiropractors, for example, are comprehensively regulated in Massachusetts. See Mass. Regs. Code tit. 233, § 2.02 (1999).

14 It is difficult to imagine how a state legislature could seriously undertake to supervise, regulate, and police so-called “dance therapy,” for example. Nevertheless, this CAM technique has a significant following with its own 1000-plus member association (the American Dance Therapy Association, or “ADTA”) and its widely distributed research journal, The American Journal of Dance Therapy. Furthermore, the ADTA boasts surprising clinically proven effectiveness. See American Dance Therapy Association, Welcome to the American Dance Therapy Association, at http://www.adta.org (last visited Oct. 20, 2000). According to the ADTA: Dance/movement therapy is the psychotherapeutic use of movement as a process which furthers the emotional, cognitive, social and physical integration of the individual. Dance/Movement therapists work with individuals who have social, emotional, cognitive and/or physical problems. They are employed in psychiatric hospitals, clinics, day care, community mental health centers, developmental centers, correctional facilities, special schools and rehabilitation facilities. See id.

15 Surprisingly, three U.S. jurisdictions have regulated dance therapy. See Cal. Code Regs. tit. 22, § 70055 (1999); D.C. Code Ann. § 2-3309.2 (1999) (requiring practicing dance therapists to register with the Mayor and adhere to guidelines promulgated by the Mayor's office); Wis. Stat. § 440.03(14)(a)(3)(a) (1999) and Wis. Admin. Code § Rl 142.05 (1999) (listing 25 prohibited activities with regard to the practice of dance therapy). South Dakota, on the other hand, does not view dance therapy as worthy of legislative protection and mentions it only in the context of denying any payment for dance therapy (and eight other CAM treatments including “primal scream”) by its Department of Social Services. See S.D. Admin. R. 67:16:41:10(24) (1999).

16 See supra note 6, and infra note 70.

17 For a typical state regulation explaining the licensing criteria for a practicing physician, see Mass. Regs. Code tit. 243, §§ 2.01-2.07 (1999).

18 The practice of medicine has been licensed in America since colonial days. See Cohen, supra note 1, at 15-16.

19 Under certain circumstances, this authority may be recognized outside the borders of a doctor's licensing state. See Alison M. Sulentic, Crossing Borders: The Licensure of Interstate Telemedicine Practitioners, 25 J. Legis. 1, 3 (1999) (describing the difficulties doctors face in compliance with medical licensure statutes when performing consultations and even diagnostic services across state lines and, in particular, over the Internet).

20 See Walter Gellhorn, The Abuse of Occupational Licensure, 44 U. Chi. L. Rev. 6, 10-19 (1976) (discussing the proliferation of occupational licensure and competition among the learned professions); see also Cohen, supra note 1, at 33 (discussing how licensure elevates the financial and social status of licensees).

21 See Cohen, supra note 1, at 33-34.

22 See Gellhorn, supra note 20, at 9-10. Professor Gellhorn notes that in 1910, Columbia medical school only required a high school diploma for matriculation, and notes that the general educational standards for medical students at the time demanded only the most basic elements of literacy. See id.

23 See id. at 10.

24 See id. at 10-12 (describing how making entry into a regulated occupation expensive in time and/or money, achieves the restrictive consequences of licensure).

25 See infra notes 68-70 and accompanying text.

26 This is the case although the incidence of CAM use by doctors is on the increase. See 145 Cong. Rec. S14806, supra note 1. As discussed infra at Part H.C.3., doctors often use the statutory definition of the “practice of medicine” to ward off competition from CAM as a whole.

27 See Gellhorn, supra note 20, at 11-12. Returning to the example of dance therapy, the American Dance Therapy Association (ADTA) has created its own two-tier structure of accreditation, distinguishing between an ordinary “D.T.R.” (dance therapist registered) and the higher credentialed “A.D.T.R.” (Academy of Dance Therapists registered). See ADTA, Credentials, at http://www.adta.org/credenti.html (last visited Oct. 20, 2000). Interestingly, the entire ADTA Board of Directors has the “A.D.T.R.” credential. See ADTA, Board of Directors, at http://www.adta.org/directors.html (last visited Oct. 21, 2000). It is not the point of this Note to judge the credentials of the ADTA nor to appraise the validity of dance therapy. Rather, dance therapy and the ADTA serve as a useful illustration of a non-mainstream CAM practice which embodies the regulatory problems addressed by this Note.

28 See Gellhorn, supra note 20, at 16.

29 See id. at 16-17.

30 See id. at 17, nn. 39-40.

31 See Cohen, supra note 1, at 34.

32 See Sulentic, supra note 19, at 5-7.

33 See Cohen, supra note 1, at 36.

34 See id.

35 See Sulentic, supra note 19, at 6.

36 For a relatively harsh statutory penalty, see Okla. Stat. tit. 59, § 491 (1999) (making each day of unlicensed practice a distinct and separately punishable offense, subject to fines and prison time).

37 See Cohen, supra note 1, at 36 (stating that uncertified providers may continue to offer services without risking prosecution for unauthorized practices provided they do not use a statutorily defined title). See also Me. Rev. Stat. Ann. tit. 32, § 14307 (West 1999) (using a prototypical “title certification” statute to exclude Reiki practitioners from using the protected title “massage therapist” to describe their practice).

38 See Cohen, supra note 1, at 36.

39 See id.

40 See id.

41 See Ala. Code § 34-43-4 (2000).

42 See Wash. Rev. Code § 18.108.030 (2000).

43 See Tex. Occ. Code Ann. § 455.151 (a) (West 2000).

44 Kansas lacks regulations restricting the practice of massage therapy, noting only in a broad statute that, “[p]ersons who massage for the purpose of relaxation, muscle conditioning, or figure improvement, provided no drugs are used and such persons do not hold themselves out to be physicians or healers,” are not practicing medicine. See Kan. Stat. Ann. § 65-2872(f) (1999).

45 See Cohen, supra note 1, at 117-19 (proposing that the legal system is beginning to reflect a paradigm of integral health care, in which biomedical professionals function cooperatively with complementary and alternative professionals in a partnership of care and healing).

46 See Gellhorn, supra note 20, at 25-27.

47 See generally Michael H. Cohen, The Risk of Malpractice Liability in Credenlialing Complementary and Alternative Medical Providers, Orange County Law. (Apr. 2000), at 16 (describing the difficulties facing hospitals and health plans in determining the validity and weight of Cam credentials and the impact of diverse state licensing regimes and dubious professional board certification by Cam providers).

48 See Boozang, supra note 3, at 575-78; Nccam Strategic Plan, supra note 3, at 5.

49 See Cohen, supra note 47, at 17-20.

50 See id. In Cohen's article, he includes portions of an interview he conducted with James Dillard, M.D., D.C., C.Ac., who is the Medical Director of Alternative Medicine for the Oxford Health Plan. In the interview, Cohen asks Dillard how Oxford goes about investigating the credentials of various CAM providers to determine whether or not to include them in referral guides under the Oxford plan. When asked how Oxford investigates chiropractors, Dillard states: First again I begin reviewing licensure. However, the second step in medicine—board certification—doesn't work. I have yet to find anything that means anything above licensure in chiropractic. Of course, chiropractors have national boards, just as medical schools have national boards (exams). But board certifications for chiropractic are relatively meaningless—many of these are weekend courses. The question is: to what do you refer to apart from graduating from a Council on Chiropractic Education (CCE) accredited school and getting licensed? My answer is: nothing. Except to... check professional discipline, sanctions, record of malpractice litigation, and ask, do they have adequate malpractice insurance. Id. at 17.

51 See id. at 17-20. On the reliability of various licensing and certification exams by CAM professional associations, Mr. Dillard states: Anyone can start their own board and create an exam: for example, the Quacko medicine board. The question is, is that exam evaluated by any other independent accrediting organization (one which is usually regional)? The board and the exam for quacko medicine will not pass validation by an independent accrediting organization. There is no secondary accreditation for chiropractic and naturopathy that is comparable to that in acupuncture. The Council of Chiropractic Education (CCE) has its own exam, and the national boarding exam is secondarily accredited—but this only allows chiropractors to sit for state board exams in the first place. Similarly, in massage therapy, the national exam is only a substitute for licensure in states in which there is no licensure. The acupuncture exam is above (in addition to) state licensure. Id. at 19-20.

52 See id. at 20. Mr. Dillard's advice on this point reveals a need for uniform national standards: My advice is, don't create your own exam for Joe Blow's health plan—don't become an accrediting organization and create your own internal standards. You want to cite national processes; the more you can cite things that exist and are already vetted outside of your own company, the better off you are in terms of liability. If you have secondary accrediting bodies, this is even better. And it makes your malpractice liability exposure drop. Id.

53 See Cohen, supra note 1, at 24-26.

54 129 U.S. 114(1888).

55 Id. at 122.

56 See text and accompanying notes supra Part II.B. 1.

57 See Gellhorn, supra note 20, at 11-19.

58 See id. at 16-18 n.40 (observing that Milton Friedman places the need for regulatory approval in the medical field in economic terms, claiming that medical professionals end up restricting market entry and raising prices to avoid being driven to “unethical practices”).

59 See Cohen, supra note 1, at 112-13.

60 See Leon Jaroff, What Will Happen to Alternative Medicine?, Time, Nov. 8, 1999, at 77.

61 See generally Cohen, supra note 1 (advocating an organic reform of the existing state regulatory paradigm to include CAM practices).

62 See id. at 35-36 (noting that massage therapists, energy healers, and touch healers generally oppose licensure out of the fear that bureaucracy may impose restrictions on their particular practices, or that it may attempt to reduce an intuitive practice to a set of test questions for a written licensure examination).

63 See Dent, 129 U.S. at 122.

64 See Cohen, supra note 1, at 29-33.

65 See id. at 26.

66 See id.

67 See id.

68 The selection across statutes is quite varied. For very inclusive statutes, see Ark. Code Ann. §17-93-202(2)(b) (Michie 1998); Mich. Comp. Laws Ann. § 333.17001(d) (West 1998). For a less inclusive statute, see Pa. Stat. Ann. tit. 63, § 422.2 (West 1998) (defining medicine and surgery as “the art and science of which the objectives are the cure of diseases and the preservation of the health of man, including the practice of the healing art with or without drugs, except healing by spiritual means or prayer”).

69 Hawaii, for example, has a very inclusive statute which includes hypnotism, and even includes the medicinal use of water and electricity. See Haw. Rev. Stat. § 453-1 (1998). Massachusetts defines acupuncture as the practice of medicine. See Mass. Regs. Code tit. 243, § 2.07(1) (1999).

70 For example, the Nccam classification scheme described in note 6, supra, includes within its seven broad categories, no fewer than 92 recognized CAM techniques, along with 131 herbal, biological product and nutrient therapies. Many of these are used in combination as “overlapping” therapies within and across groups. See Betty F. Lay, Healer-Patient Privilege: Extending The Physician-Patient Privilege to Alternative Health Practitioners In California, 48 Hastings L. J. 633, 633-35 (1997). Furthermore, the NCCAM dedicates several million dollars a year to research and evaluation of new or innovative CAM techniques across the country. For NCCAM's 1999 grant projects, see Nccam, Chart of Nccam-sponsored Research for FY 1999, available at http://www.nccam.nih.gov/nccam/research/grants/rfb/fy99.pdf (last visited Oct. 21, 2000). Individual state legislatures cannot reasonably be expected to stay abreast of the latest developments nor to respond to the latest trends in CAM.

71 The practice of homeopathy, for example, entails the use of highly diluted doses of symptom-inducing substances administered to healthy patients. See Cohen, supra note 1, at 42-43. “Non-contact touch” techniques, such as therapeutic touch, Reiki, and Mari-el, are premised on the concept of energy fields. See id. at 5-6.

72 As usual, the difficulty of crafting meaningful and enforceable regulations in these fields has not prevented States from trying. See id. at 43 (describing the differences across states with regard to the requirements on holistic practitioners). See also M E Rev. Stat. Ann. tit. 32, § 14307 (West 1999) (excluding Reiki practitioners from the title-certification protected practice of massage therapy).

73 See Cohen, supra note 1, at 36-46 (describing, for example, The National Commission for the Certification of Acupuncturists, the Council on Naturopathic Medical Education, the National Certification Board for Therapeutic Massage and Bodywork, and the nationwide licensing scheme for chiropractors).

74 The threat of lobbying captivity—when a supposedly impartial regulating authority becomes beholden to and controlled by the influence of the regulated interest—raises outcries on both sides of the CAM debate. Some commentators observe that when CAM practice groups successfully lobby for mandated insurance coverage, it essentially legitimizes their treatment as medicine, even in the absence of any proof of effectiveness. See Boozang, supra note 10, at 204. Others claim that the AMA's relentless lobbying is regulating CAM out of existence and depriving patients of its potential benefits. See Lori B. Andrews, The Shadow Health Care System: Regulation of Alternative Health Care Providers, 32 Hous. L. Rev. 1273, 1308-09 (1996).

75 See id. at 1298-99, 1308-09.

76 See Chris Rauber, Open to Alternatives: Pressured By Consumer Demand, More Health Plans Are Embracing Nontraditional Treatment Options, Mod. Healthcare, Sept. 7, 1998, at 50, 51. The Washington State Supreme Court recently upheld an insurance regulation requiring all health care plans in the state to pay for alternative care treatments from licensed alternative medical care providers. See Hoffman v. Regence Blue Shield, 991 P.2d 77, 125-26 (Wa. 2000).

77 Christian Science faith healers, for example have historically enjoyed legislative endorsement for Medicare reimbursement of faith healing. The Christian Science church is a notoriously strong and effective lobbyist on health issues. See Marci A. Hamilton, Power, The Establishment Clause, and Vouchers, 31 Conn. L. Rev. 807, 816-18 (1999). See also Rita Swan, On Statutes Depriving A Class of Children of Rights to Medical Care: Can This Discrimination Be Litigated?, 2 Quinnipiac Health L. J. 73, 75-76 (1998) (asserting that the Christian Science church maintains a salaried professional lobbyist in every state on health care issues); David R. Olmos, Herbal Medicine Business Sets Firm Roots in Utah Health: Industry giants such as Nature's Way find the culture and political climate a tonic for rapid growth, L.A. Times, Sept. 1, 1998, at Al (describing the success that a lucrative CAM herbalist industry has had in gaining favorable regulation in Utah).

78 See Cohen, supra note 1, at 19-21.

79 See National Council Against Health Fraud, Inc., Ncahf Position Paper on Acupuncture, (Sept. 16, 1990), available at http://www.ncahf.org/position/acupuncture.htm (last visited Nov. 21, 1999) (concluding with this admonition to legislators, “Acupuncture licensing should be abolished. Public display of unaccredited degrees by individuals offering any form of health care should be banned. Insurance companies, HMOs and government insurance programs should not be forced to cover acupuncture unless scientific evidence demonstrates that it has value”). See also Boozang, supra note 3, at 604-13.

80 See Boozang, supra note 10, at 186-95.

81 See Gore 2000, Al Gore Unveils Agenda to Improve Health Care for America's Families, at http://www.algore2000.com/agenda/agenda_healthcare.html (last visited Oct. 21, 2000).

82 See Heather Williams, Survey Says More Employers Offer Benefits for Alternative Care, at http://www.insure.com/business/alternativecare200.html (last updated Feb. 18, 2000) (reporting that a survey of 534 members of the International Foundation of Employee Benefit Plans reported that 86% offered some form of CAM coverage, mostly chiropractic care. Approximately 19% of respondents, however, offered CAM treatment coverage other than chiropractic, with 75% of those offering acupuncture. Those employers not offering CAM coverage cited a lack of proof of effectiveness, lack of cost data, and legal/regulatory concerns) (emphasis added). The percentage of HMO coverage of CAM is also on the rise. See Insurance News Network, More HMOs Offering Alternative Medicine Options, at http://www.insure.com/health/landmark399.html (last updated Mar. 11, 1999) (observing that a January, 1999 survey of 114 HMOs nationwide revealed that 67% of HMOs offered at least one type of alternative care, again with chiropractic leading the way. In that survey, 85% of HMO respondents indicated that they believed the relationship between CAM and mainstream medicine would continue to grow closer).

83 See discussion of the Access to Medical Treatment Act, infra Part IV.B.2.

84 See Boozang, supra note 3, at 568-69.

85 See id. at 586-613. Boozang concludes that the current trend of MCOs voluntarily including CAM coverage to insureds despite what she views as a mountain of scientific doubt, or at least uncertainty, is a triumph of consumer preferences over scientific justifications. See id. at n.7.

86 See id. at 577.

87 See id. at 578.

88 See id.

89 See id.

90 See id. atn.61.

91 See id. at 579.

92 See id. at 580-86

93 A similar argument has been made with respect to the growing practice of telemedicine, which faces some of the same licensing and regulatory obstacles that CAM does. See Joy Elizabeth Matak, Note, Telemedicine: Medical Treatment Via Telecommunications Will Save Lives, But Can Congress Answer The Call?: Federal Preemption of State Licensure Requirements Under Congressional Commerce Clause Authority & Spending Power, 22 V"T. L. Rev. 231, 241 (1997) (“State licensure schemes impose a significant burden on telemedicine and may be impeding its widespread use as a viable method for treatments. Until a uniform medical licensing scheme be created, hope of a national network may not be realized.”).

94 See id.; see also U.S. Const, art. VI, cl. 2.

95 See Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 605 (1991).

96 See id. at 604-05.

97 See id. at 605. This is often called field preemption. See id.

98 See id. There is a third category of implicit preemption that is occasionally found by courts when federal goals or objectives reveal an unstated intent to preempt state law. See id.

99 See id.

100 See 15 U.S.C.A. §§ 1331-1341 (1999).

101 15 U.S.C.A. § 1331 (1999).

102 See supra text and notes at Parts II & III.

103 See 15 U.S.C.A. § 1334 (1999).

104 See 15 U.S.C.A. § 1341 (1999).

105 The Nccam, already conveniently located within HHS would be acting in an advisory capacity much as the Interagency Committee on Smoking and Health did under the CLA. See text and notes infra Part V.B.

106 See Lauren A. Greenberg, In God We Trust: Faith Healing Subject to Liability, 14 J. Contemp. Health L. & Pol'Y 451, 455 (1998).

107 See id. at 465-66; see also 42 C.F.R. § 431.610(b) (1999) (providing that certification for Christian Science sanitoria eligible to receive Medicare/Medicaid payments lies with the First Church of Christ, Scientist in Boston rather than with local State regulatory agencies). Christian Science healers enjoy other special regulatory treatment, such as being explicitly included within the definition of a health care provider in the context of the Family and Medical Leave Act (FMLA). See 5 C.F.R. 630.1202 (2000) (under “health care provider” definition (4)). Interestingly, other CAM groups have apparently made some lobbying headway under the FMLA, which also includes traditional Native American, Eskimo, Aleut and Hawaiian healers, whose credentials are established not by regulations, but rather are established by being recognized by traditional religious leaders as such healers. See id. at definition (5).

108 See 42 U.S.C.A. § 203 (1999) (noting that the surgeon general is authorized to create divisions within the NIH).

109 See 42 U.S.C.A. § 202 (1999).

110 See 42 U.S.C.A. § 203 (1999).

111 For a typical delegation statute, see 15 U.S.C.A. § 1454(a) (1999) (authorizing the Secretary of HHS to promulgate regulations regarding food, drugs, devices and cosmetics).

112 This commonly takes the statutory form of a Congressional authorization to consult with departments or other agencies. See id. at § 1455(c).

113 See supra note 9.

114 As expressed by the Nccam website. See Nccam, Considering CAM, available at http://www.nccam.nih.gov/nccam/fcp/faq/considercam.html (last visited Oct. 21, 2000).

115 Nccam home page, available at http://www.nccam.nih.gov (last visited Oct. 20, 2000). The extended version of Nccam's disclaimer further advises users to consult with their primary health care provider to discuss both the advantages and the risks of CAM treatments. See Nccam, Warning and Disclaimer, available at http://www.nccam.nih.gov/nccam/disclaimer.html (last visited Oct. 20, 2000).

116 Perhaps the best indicator of Nccam's success at remaining independent is that it is criticized both by CAM advocates and by traditional medicine advocates. See Boozang, supra note 10, at 189 (describing both criticism by CAM advocates that Nccam (then OAM) did not include any CAM practitioners in its grant review process, as well as describing an effort by OAM critics to petition Congress to cut funding to the OAM because they perceived it as promoting quackery).

117 See supra text and notes at Part IV.B.l.

118 See Nccam Strategic Plan, supra note 3, at 12.

119 See Gary Dorsey, Alternative Methods, Dose of Tradition; Oversight: As Head of an NIH Office, Dr. Stephen Straus is Determined to Shine the Cold Light of Science on Medical Self-Care, Balt. Sun, Apr. 18, 2000, at Al.

120 See 145 Cong. Rec. S14807-9 (1999).

121 See id. at S14807 (comments of Sen. Daschle (D-SD) who noted that under the Amta, the Nccam's role would be to collect and analyze information on the effectiveness of CAM treatments used by terminal patients because “current information available about the effectiveness of many promising treatments is inadequate”). The Nccam's role under the Amta would also include review and publication of the result of its analysis. See id. at SI4808-9.

122 See id. at S14809 (comments of Sen. Harkin (D-IA).

123 See supra text and notes at Part IV.B.l. (discussing the structure and function of the NCCAM).

124 See supra text and notes at Part IV.A. (discussing federal and regulatory preemption).

125 California has historically been more accepting of CAM practices and techniques and has a large population of CAM practitioners and consumers. See Terence Monmaney & Shari Roan, Hope or Hype? Alternative Medicine is Edging into the Mainstream, with Californians Leading the Way, L.A. Times, Aug. 30, 1998, at A-l, A-12.

126 See Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947) (a commerce case discussing the concerns about federal involvement in an area that traditionally had been occupied by the state).

127 See supra notes 74 & 77.

128 The NCCAM's FY2000 funding is $68.3 million and its budgetary significance has increased during each year since the inception of the OAM, when it had an initial budget of only $2 million. See NCCAM Strategic Plan, supra note 3, at 6.

129 NCCAM projects for FY99 included 58 grants totalling approximately $28.5 million. See Nccam, Chart of NCCAM-Sponsored Research for FY 1999, (last visited Oct. 21, 2000), available http://www.nccam.nih.gov/nccam/research/grants/rfb/fy99.pdf.

130 U.S.C. § 287c-21(a) (Supp. IV 1998).