By Walter G. Mosher, J.D.,
M.H.A., LL.M. candidate
In 1990, the New England Journal of Medicine published a study that astounded physicians and consumers alike by reporting that 33% of the U.S. population used at least one form of alternative medicine. By 1997, in a follow-up study, the researchers concluded that alternative medicine use jumped 42%  and Americans spent more than $27 billion that same year on alternative therapies, despite a lack of clinical studies supporting scientific efficacy for many of these treatments. Nevertheless, the medical literature suggests that Americans are using alternative medicine because they believe it improves their overall health. Aside from the early history of U.S. medicine, the medical profession has successfully fought against these non-traditional therapies by controlling access to them using state medical practice rules and consumer fraud legislation. In response to consumer demand, however, Congress established the National Center for Complementary and Alternative Medicine in 1998 as part of the National Institutes of Health to stimulate, develop, and support research on alternative therapies. Similarly, in November 1998, the Texas State Board of Medical Examiners adopted a significant amendment to their medical practice rules by authorizing physicians to practice "integrative and complementary" in addition to "recognizing that patients have a right to seek integrative and complementary therapies." Since the amendment, limited, if any, published guidance exists as to the understanding these new rules. This article provides an overview of the legal and practice management issues physicians must consider in expanding their practice to integrative and complementary medicine.
What is Complementary and Integrative Medicine?
Many alternative medicine therapies are considered holistic, which generally means that they address the whole person (to include the physical, mental, emotional and spiritual aspects of the patient) in evaluating and providing care. Yet the term "alternative medicine" is unclear, elusive and often confusing because the studies demonstrate that most Americans use these therapies in conjunction with conventional medicine rather than to the exclusion of it. Moreover, with the increase in physicians utilizing these therapies along with their conventional modalities, the term alternative is impractical. Accordingly, other terms commonly used include "complementary" or "integrative" medicine. The National Institutes of Health (NIH) has implemented the phrase Complementary and Alternative Medicine, or simply CAM, and defines it as those healthcare practices that are not currently an integral part of conventional medicine. Likewise, the Texas State Board of Medical Examiners refers to the same practices as "integrative and complementary medicine" and defines it as those "health care methods of diagnosis, treatment or interventions that are not acknowledged to be conventional". The Board then defines conventional medicine as:
It should also be noted that from a policy perspective, the Texas constitution and state legislature provide for a professional recognition of alternative forms of medical practices. Specifically, Article 16, Section 31 of the Constitution of the State of Texas states: "The Legislature may pass laws prescribing the qualifications of practitioners of medicine in this state, and to punish persons for malpractice, but no preference shall ever be given by law to any schools of medicine." Accordingly, the Texas legislature plainly stated in the construction paragraph of the Medical Practice Act, which is the primary regulatory guidance for physicians practicing within the state, that the Act prohibits discriminating against a school or system of medical practice. In short, although modern medicine substantially favors scientifically based modalities, the Texas constitution, legislature, the Texas Board of Medical Examiners and citizens of the state recognize alternative forms of healthcare practices.
Clinical Assessment and CAM Application
According to the Board, the new rules for practicing integrative and complementary medicine are designed to allow physicians a "reasonable and responsible degree of latitude in the kinds of therapies they offer their patients." This expansion in the scope of practice provides considerable protections, as discussed below, for implementing new therapies that are proven or expected to be safe yet provides some therapeutic gain in pain relief, physical or psychosocial functionality. For example, many clinicians recognize that relaxation therapy is a treatment alternative proven to be safe with associated therapeutic gain in improved psychosocial function. In considering whether to utilize a CAM therapy, physicians should conduct the typical clinical assessment, such as establishing a therapeutic relationship with the patient and collecting medical data through history and physical examination, however, the assessment can also include non-conventional methods of diagnosis so long as the patient's chart is appropriately documented. Upon documenting the clinical factors considered, the practice rules enable physicians to discuss and advise patients as to available complementary medicine therapies that may provide improvement in their condition. As discussed in the next section, however, prior to administering the alternative therapy, the new practice rules require documenting counseling sessions as to available treatment options and objectives, obtaining informed consent for the alternative therapy, and monitoring progress of the course of treatment.
Understandably, many physicians maintain concerns about offering patients unconventional therapies with limited proven clinical efficacy, or perhaps more appropriately anecdotal beneficial outcomes, even if the treatment objective are merely an improved quality of life for a limited duration. To answer these concerns, Congress has mandated NIH, through the National Center for Complementary and Alternative Medicine, to be the central advocate for "[e]nsuring high quality, rigorous scientific review", to study the integration of alternative therapies with conventional medical practices, and to provide healthcare professionals and the public reliable information about the safety and effectiveness of CAM practices. In short, NCCAM is designed to be the central research resource for physicians in investigating and integrating of CAM therapies into their clinical practice.
With a basic clinical assessment of the patients medical and overall health needs, physicians are authorized to tailor a treatment plan for "the individual needs of the patient by which the treatment progress or success can be evaluated" in accord with objectives of improved pain relief, improved physical function or psychosocial function. The practice rules further requires that the "treatment plan shall consider pertinent medical history, previous medical records and physical examination, as well as the need for further testing, consultations, referrals, or the use of other treatment modalities.".
Practice Protections and Procedures
The new practice rules on integrative and complementary medicine shield physicians from disciplinary action by the Board for unprofessional conduct or failure to practice medicine in an acceptable manner solely on the basis of practicing integrative and complementary medicine, so long as the specific practice requirements are met and the CAM therapies utilized do not present "a safety risk for the patient that is unreasonably greater that the conventional treatment for the patient's medical condition." It should be noted, however, that like the Medical Liability and Insurance Improvement Act, the practice rules for integrative and complementary medicine does not protect physicians against liability for knowingly misrepresenting their experience with alternative therapies or promising particular results. Yet physicians are still at liberty to express their opinion, predictions, therapeutic reassurances and expressions of hope. To the end, physicians should utilize the informed consent as a mechanism to educate the patient about their experience, their research and findings, the available conventional and complementary medicine treatment options, and the possible risks and outcomes for each option. These rules, in effect, were designed to provide patient's greater autonomy in choosing their course of treatment by using the informed consent process. Nevertheless, the integrative and complementary practice rules provide considerable protections that effectively encourage physicians to consider and adopt alternative therapies into their practice.
The specific the practice procedures required by the Board are as follows:
1. Assessment. Prior to offering a patient advice as to an alternative therapy, the physician must document the patient's assessment. The assessment must include:
a. The patient's history, diagnosis, and treatment in the chart.
b. Whether conventional treatment options were discussed.
c. Any referral input whether conventional or complementary.
d. The conventional treatments attempted, if any, and their effect.
e. A statement as to any conventional treatments refused by the patient.
f. At lease a verbal informed consent for each complementary treatment plan offered, to include a statement that the risk and benefits of the treatment were discussed with the patient.
g. Whether the complementary therapy could interfere with any other ongoing conventional treatment.
2. Treatment Plan. The physician must document a tailored treatment plan to the patient's individual health needs, as described above, along with the stated objectives of the plan, whether improved pain relief, physical or psychosocial functionality.
3. Periodic Review. The physician must perform a documented periodic review of the patient's care at reasonable intervals as to progress toward the treatment objectives and any new information about the etiology of the patient's complaints and healthcare needs.
4. Maintenance of Medical Records. The physician must maintain complete and accurate medical records of the care provided, particularly the assessment.
Under the Board's rules for practicing integrative and complementary medicine, physicians can now offer nontraditional treatments to their patients without fear of incurring automatic disciplinary action. Moreover, with safe complementary therapies, physicians can also be protected from medical malpractice claims for practicing safe complementary medicine. These rules, however, will require physicians go the extra mile to learn about innovative therapies that are less invasive and toxic but may prove efficacious.
1. D. Eisenberg, et al., Uncoventional Medicine in the United States; Prevalence, Costs and Patterns of Use, 328 NEJM 246 (1993).
2. D. Eisenberg, et al., Trends in Alternative Medicine Use in the United States, 1990-1997, 280 JAMA (1998) 1569, 1574.
3. J. Astin, Why Patients Use Alternative Medicine, 279 JAMA 1548, 1551 (1998).
4. P. Starr, The Social Transformation of Medicine (Basic Books: 1949, Reprinted 1982), 30-59.
5. In Texas, the Medical Practice Act defines the practicing of medicine as "the diagnosis, treatment, or offer to treat a mental or physical disease or disorder or a physical deformity or injury by any system or method, or the attempt to effect cures of those conditions, by a person who . . . directly or indirectly charges money or other compensation for those services." 22 Tex. Admin. Code § 151.002(a)(13).
6. For example, under the Deceptive Trade Practice Act, one of the prohibited commercial practices includes offering "that goods or services have . . . characteristics, ingredients, uses, benefits, or qualities which they do not have." Tex. Bus. & Com. Code Ann. § 17.46(b)(1).
7. 42 U.S.C § 281(b)(1)(F).
8. 22 Tex. Admin. Code §§ 200.1-200.3
9. K. Boozang, "Is the Alternative Medicine? Managed Care Apparently Thinks So", 32 Conn. L. Rev 567, 572 (2000); see also, supra, Eisenberg, Trends in Alternative Medicine Use.
10. The National Institute of Health further organized complementary and alternative medicine therapies by establishing five major domains: (1) alternative medical systems, (2) mind-body interventions, (3) biologically-based treatments, (4) manipulative and body-based methods, and (5) energy therapies. NIH, National Center for Complementary & Alternative Medicine, Domain Fact Sheet available at www.nccam.nih.gov.
11. 22 Tex. Admin. Code § 200.2(1).
12. 22 Tex. Admin. Code § 200.2(1) specifically defines Integrative and Complementary Medicine as:
14. Naturopathy utilizes the body's inherent ability to heal as improve health. It contains several therapies such as herbal medicine, therapeutic exercise, spinal and soft tissue manipulation and diet and nutritional regimens. Several states have authorized the practice of naturopathy such as Alaska, District of Columbia, Connecticut, Hawaii, Montana, Nevada, New Hampshire, Oregaon, Washington. See Michael Cohen, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (Johns Hopkins Press: 1998), 41-43.
15. Tex. Occ. Code § 151.051(c)(1).
16. Texas also provides licensure for acupuncturist and chiropractors. But see Wilson v. State Board of Naturopathic Examiners, 298 S.W.2d 946 (Tex. 1957) (declaring naturopathy board unconstitutional).
17. 22 Tex. Admin. Code § 200.1.
18. 22 Tex. Admin. Code § 200.3(2).
19. See, e.g., Herbert Benson, M.D., Timeless Healing (Fireside Publishing: 1997) 125-148 (describing the therapeutic benefits of relaxation therapy).
20. Tex. Admin. Code § 200.3(1).
22. 42 U.S.C § 287c-21(f).
23. 42 U.S.C. 287c-21(a), (c).
24. The National Center for Complementary and Alternative Medicine has established two bibliographic databases of CAM information that is accessible through the internet: CAM on PubMed (developed with the National Library of Medicine) and AM Database on CHID (the Alternative Medicine Database on the Combined Health Information Database. Moreover, the NCCAM has established a CAM information clearinghouse with toll-free line (888-644-6226) and email (firstname.lastname@example.org) that provides clinical research and publications upon request, a fax-on-demand system, and referrals to other information resources. See www.nccam.nih.gov.
25. Tex. Admin. Code § 200.3(2).
27. Tex. Admin. Code § 200.3. The Board specifically states, under section 200.3(5), that if procedural requirements are met and "if all the treatment is properly documented, the board will presume such practices are in conformity with the Medical Practice Act, §§ 3.08(4), 3.08(4)(E), and 3.08(18)", which includes the following:
28. The Medical Liability and Insurance Improvement Act provides that the Deceptive Trade Practices Act cannot be used for negligence claims against physicians, however, claims under other theories of liability, such as misrepresentation and breach of warranty, are not precluded. Tex. Rev. Civ. Stat. Ann, Art 4590i, Section 12.01(a); see Sorokolit v. Rhodes, 889 S.W.2d 239, 240 (Tex. 1994) (patient sued plastic surgeon under DTPA for a breast augmentation where the physician guaranteed and warranted that "her breast would look just like those [of a nude model] in the picture she selected" from a magazine).
29. The Texas Deceptive Trade Practices Act outlines a nonexclusive list of acts that are false, misleading, or deceptive under the statute. Tex. Bus. & Com. Code Ann. § 17.46(b)
30. See Jim Perdue, Texas Medical Malpractice Handbook 9 (1989) (stating that while express promises may constitute warranties, therapeutic reassurances and expressions of hope, opinion, and predictions should not).
31. Under 22 Tex. Admin. Code § 200.3(1)(A), "adequate medical records" must exist, which means any records documenting or memorializing the history, diagnosis, and treatment of any patient. 22 Tex. Admin. Code § 165.1 (Medical Records).
32. 22 Tex. Admin. Code § 200.3(B)
34. 22 Tex. Admin. Code § 200.3(C).
36. 22 Tex. Admin. Code § 200.3(D).
37. 22 Tex. Admin. Code § 200.3(E).
38. 22 Tex. Admin. Code § 200.3(2).
39. 22 Tex. Admin. Code § 200.3(3).
40. 22 Tex. Admin. Code § 200.3(4).
41. Although these practice
rules primarily relate to the disciplinary rules of the Texas Board of
Medical Examiners, defense attorneys may avail themselves to protective
jury instructions by judicial notice of the Board's expanded authorized
practice of medicine provisions.