The Regulation of Complementary and Alternative Medicine (CAM) in South Carolina: What Is Happening and What Needs to Change
By
By
Anna C. Smith[1]*
Say you believe that you have a sinus infection, and rather than immediately taking an antibiotic, you consider an alternative remedy. In seeking an alternative practitioner, such as a naturopath or a homeopath,[2] this individual confirms your belief of a sinus infection and prescribes naturopathic or homeopathic remedies, such as a neti pot, herbal supplements, and an apple cider vinegar concoction. None of the above is particularly alarming and likely all are suggestions you would discover on the internet for “at home” remedies. But what happens if the practitioner was wrong, likely because he was practicing without proper accountability or sufficient education? What if it wasn’t a sinus infection but rather a life-threatening lung infection for which drinking apple cider vinegar would do nothing to help? Or maybe the alternative practitioner was correct, but you ingest a disproportionate amount of the herbal supplements because the “prescription” was vague, resulting in subsequent harm. The alternative practitioner is a small one-man shop with little to no assets. It is unclear what statutory authority he practices under.[3] Furthermore, South Carolina does not require that alternative practitioners have malpractice liability insurance.[4] If you are physically harmed and suffer heavy damages, the alternative practitioner is insolvent, and there is no viable legal remedy for you to pursue. This entire situation is avoidable when proper regulation of complementary and alternative medicine (CAM) occurs. South Carolina should be no exception.
Individuals are pursuing and utilizing CAM at an accelerating rate.[5] States, such as Oregon and Connecticut, have taken notice of this pattern and responded via the legislature.[6] South Carolina, on the other hand, has failed to do so. CAM has the potential to provide additional treatment options[7] and greater access to medical care for South Carolina citizens.[8] Due to the holistic and integrative nature of complementary and alternative practices, these services also have the potential to be available at an affordable cost.[9] Currently, most Americans pay out of pocket for CAM therapies.[10] One report places the national overall out-of-pocket spending on CAM at $34 billion, which constitutes ten percent of the total out-of-pocket health care expenditures in the United States.[11] Unfortunately, insurers are hesitant to cover CAM therapies,[12] which results in Americans spending tens of billions of dollars each year to avail themselves of this medical remedy. If stronger regulation of CAM providers and CAM therapies existed, insurers might be more inclined to respond to customer demands and include coverage for CAM therapies. Then, individuals who desire to utilize both conventional and alternative medicine would not be required to pay out of pocket for CAM therapies in addition to an insurance premium. However, improved quality of healthcare is not solely defined by citizens having greater, diversified access to providers or fewer expenses associated with such access. Quality healthcare is a complex compilation of factors requiring significant regulation in order to protect both the practitioner and the patient.
This Note examines two different varieties of CAM and their relevance in South Carolina, specifically naturopathy and homeopathy. Additionally, this Note argues in favor of regulation of naturopathy in South Carolina and proposes expanding existing regulations in order to provide clarity regarding integrative practices. Furthermore, it considers both national standards of regulation and licensing, as well as specific measures that other states have taken to regulate the use of CAM. Lastly, this Note discusses the potential implications of these standards on South Carolina’s regulatory and licensing schemes.
The term “complementary and alternative medicine” encompasses a wide array of healthcare practices, products, and therapies that are distinct from the practices, products, and therapies used in “conventional” or “allopathic”[13] medicine.[14] Actually defining CAM has been an elusive task.[15] The National Center for Complementary and Alternative Medicine (NCCAM)[16] has developed the most widely accepted definition of CAM to date.[17] This organization defines CAM as a “group of diverse medical and health care systems, practices, and products that are not presently considered to be a part of conventional medicine.”[18] CAM is classified into five different categories, which include alternative medical systems, mind-body interventions, biologically-based treatments, manipulative and body-based methods, and energy therapies.[19]
Homeopathy falls within the scope of CAM.[20] Homeopathy is defined as the practice of treating the symptoms and conditions that constitute disease with remedies that have produced similar symptoms and conditions in someone who is healthy.[21] Homeopathy is often utilized with patients who suffer from chronic illness.[22] While homeopathy can be practiced by an individual who is specifically trained as a homeopath,[23] it is also commonly practiced by various other licensed practitioners, such as “dentists, podiatrists, veterinarians, naturopaths, chiropractors, acupuncturists, physician assistants, nurse practitioners, and nurses.”[24] Homeopathy is considered a complete system of medicine.[25]
Similarly, naturopathy is considered a whole medical system, meaning that it is built upon various theories and practices that have evolved separately from conventional practices of medicine.[26] It views disease as a manifestation of alterations in the processes by which the body heals itself.[27] Naturopathic medicine is not defined by the substances used in treatment but rather by its core principles, which underlie and determine its practice.[28] These principles include: the healing power of nature, finding the cause, doing no harm, treating the whole person, doctor as teacher, preventing disease, and wellness.[29] According to the United States Bureau of Labor Statistics, a naturopath is defined as one who will “diagnose, treat, and help prevent diseases using a system of practice that is based on the natural healing capacity of individuals.”[30] A naturopath “[m]ay use physiological, psychological or mechanical methods.”[31] Specifically, they “[m]ay [also] use natural medicines, prescription or legend drugs, foods, herbs, or other natural remedies.”[32] For the most part, naturopaths come in three different varieties: (1) licensed naturopaths; (2) naturopaths who practice outside of an official status (considered “traditional naturopaths”); and (3) practitioners who are primarily another kind of health professional (i.e., physician’s assistant, nurse practitioner, medical doctor, or doctor of osteopathy) who also happen to practice naturopathy.[33] It is estimated that there are approximately 3,500 licensed naturopathic doctors in the United States.[34]
In 1992, Congress created the Office of Alternative Medicine (OAM), which ultimately became the NCCAM.[35] Research generated from this organization raised awareness in the medical community about the ways in which alternative therapies could potentially be used alongside conventional medicine.[36] The NCCAM provides grants and funding for research related to public health and complementary health approaches.[37]
Since 1988, “prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without [U.S. Food & Drug Administration (FDA)] approval under the enforcement policies in FDA’s Compliance Policy Guide (CPG) 400.400.”[38] In 2015, the FDA held a public hearing to obtain information about the current use of “drug products labeled as homeopathic, as well as the Agency’s regulatory framework for such products.”[39] In response to the information they gathered, the FDA issued a Draft Guidance providing its stance on homeopathic drugs.[40] “Under the Federal Food, Drug, and Cosmetic Act, homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding” as other drugs,[41] and the FDA currently regulates their manufacture and labeling through the Homeopathic Pharmacopoeia of the United States (HPUS).[42] Recently, the FDA has proposed taking a stricter stance on the regulation and enforcement of policies surrounding homeopathic drugs.[43]
Licensing requirements vary among jurisdictions and the specific types of CAM.[44] The practice of homeopathy is not officially licensed.[45] There are many training programs and courses in homeopathy in both the United States and abroad;[46] however, no diploma or certificate from any school or program is recognized as a license to practice homeopathy in the United States.[47] Although licensing for homeopathy is generally unavailable in the United States, there are organizations that offer certification in homeopathy.[48] One is the Council for Homeopathic Certification (CHC), which will certify classical homeopaths.[49] Although the CHC doesn’t require a medical degree to be certified, the organization has fairly extensive educational requirements in order to sit for the certification.[50] For example, it requires a minimum of 500 foundational classroom hours in classical homeopathy completed through an ACHENA accredited program[51] or through a program that has been preapproved by ACHENA.[52] The American Board of Homeotherapeutics (ABHt), on the other hand, certifies already-licensed medical doctors and osteopathic physicians in the practice of homeopathy.[53] Absent official licensing and regulation, it is possible to become board certified in homeopathy.[54] Board certification of competency is only available to medical doctors and doctors of osteopathy through the ABHt.[55] There are currently no reputable records detailing how many classical homeopaths are practicing in South Carolina—such a result is both problematic and unacceptable. Furthermore, there is insufficient data to determine the number of existing medical doctors and/or doctors of osteopathy in South Carolina that implement homeopathy into their conventional medical practices (i.e., through integrative medicine).
Naturopathy, on the other hand, is licensed and regulated.[56] In order to become licensed as a primary care naturopath by a state or jurisdiction that both allows and requires licensing, one must graduate from a four-year, professional-level program at a federally accredited naturopathic medical school, study a curriculum that includes current medical science and traditional naturopathic theory, and finally, take and pass a national board exam, the Naturopathic Physicians Licensing Exam (NPLEX).[57] Currently, the NPLEX follows AERA/APA/NCME[58] standards for test development and administration.[59]
There are currently six accredited programs in the United States.[60] In order to qualify as an approved naturopathic program, the program must:
provide two years of graduate level biomedical science coursework as a foundation for clinical training, meet standard requirements for appropriate curriculum and clinical experience, give students a thorough knowledge of diagnostic techniques that can only be acquired through contact with actual patients, require supervised clinical practice on patients seeking naturopathic care, and, finally, the program must have been accredited or pre-accredited by the Council on Naturopathic Medical Education (CNME).[61]
Most states require that the practitioner also adhere to state specific requirements for licensure and partake in continuing education.[62] Currently, only twenty states and the District of Columbia have licensing requirements for naturopathic practitioners.[63] In the past year, eight additional states introduced bills to legalize naturopathic practice.[64] South Carolina was not one of those states.[65] In fact, South Carolina is one of only six states where the practice of naturopathy is considered illegal or where licensure has been abolished.[66]
States have the power and authority to create and implement laws that authorize the practice of medicine.[67] Under its police power, each state has implemented a medical licensing statute or medical practice act.[68] While a state may not prohibit the practice of medicine, it is regularly recognized that “a state, under its police power, may regulate, within reasonable bounds, for the protection of the public health the practice of [medicine or surgery] by defining the qualifications which one must possess before being permitted to practice the same.”[69] South Carolina defines the practice of medicine as “advertising, holding out to the public or representing in any manner that one is authorized to practice medicine in this State”[70] and “offering or undertaking to prevent or to diagnose, correct or treat in any manner, or by any means, methods, or devices, disease, illness, pain, wound, fracture, infirmity, defect, or abnormal physical or mental condition of a person, including the management of pregnancy and parturition.”[71] South Carolina further defines a practitioner as an individual who “has been issued an authorization to practice in [South Carolina],” but provides that “the term does not include persons who have not been issued a license, registration, certification, or other authorization to practice in [South Carolina], except as provided by law for persons licensed in another state or jurisdiction.”[72]
The scope of “practice of medicine” statutes are regularly litigated in many states.[73] Specifically, the primary issue litigated is whether CAM practices and its practitioners fall within the statutory definitions of both “practice of medicine” and “practitioner.”[74] The South Carolina Supreme Court seems to have answered this question in Williams v. Capital Life & Health Ins. Co., holding that anyone engaged in the art of healing—in which stringent educational and licensing provisions have been imposed by statute—is equivalent to a physician within the recognized scope of the particular profession.[75] The court noted: “An osteopath, a homeopath, a chiropractor, a magnetic healer, and a naturopath are alike practitioners in the field of medicine, and it appears to us to be straining at a gnat to enter into a discussion of distinctions between a ‘practitioner of medicine’ and a ‘physician.’”[76]
Nearly one hundred years ago, South Carolina actively regulated naturopathy. In 1920, “South Carolina first recognized ‘osteopaths, homeopaths, chiropractors, naturopaths, magnetic healers and other practitioners of any branch of the healing art’ as ‘Special Practitioners.’”[77] “In 1937, the South Carolina General Assembly passed a comprehensive Naturopathy Act,” wherein the requirements were established for the practice of naturopathy, and in addition, the general assembly created the State Board of Naturopathic Examiners.[78] In 1941, South Carolina greatly increased the educational qualifications required of a practitioner of naturopathy.[79] The 1941 Act required the completion of four years of high school and one year of pre-medical training, as well as the practitioner be a graduate of a recognized school of naturopathy.[80] Obtaining a degree in naturopathy entailed four years of attendance, totaling 4,400 hours and included a variety of medical subjects in its curriculum.[81] In 1949, the pre-medical requirement was raised from one year of training to two years, and the Board of Naturopathic Examiners was authorized to revoke licenses.[82]
Interestingly, however, South Carolina reversed course regarding the regulation of naturopathy, and just a few years later, in 1956, the general assembly enacted the statute that remains the law today.[83] This statute clearly states it is unlawful for anyone, whether licensed or not, to practice naturopathy in the state of South Carolina.[84] The question remains whether this statute successfully eradicated the practice of naturopathy in South Carolina. Can a practitioner avoid violating section 40-31-10 through the common law created by the court in Williams, or did the enactment of the statute override any law previously created?[85] To date, section 40-31-10 has only been challenged once as unconstitutional.[86] The South Carolina Supreme Court in Dantzler v. Callison held that the statute was a valid exercise of the police power of the State and that there would not be unwarranted discrimination in upholding the statute.[87] The court emphasized it is “universally held that it is competent for the legislature to prescribe qualifications for those who are to practice medicine and thus to assure that they shall possess the requisite character and learning and the State may change the qualifications from time to time, making them more rigid.”[88] As it stands, this statute remains the controlling law in South Carolina.
While South Carolina is not proactively regulating or facilitating access to CAM therapies, it is involved in research regarding alternative medicine. Currently, the University of South Carolina is involved in significant research considering the implementation of CAM therapies to aid chronic illness.[89] Specifically, the University is researching the effects of CAM and inflammation, as inflammation is believed to be the underlying cause of most clinical disorders, including autoimmune diseases, obesity, various cancers, cardiovascular disease, and neurodegenerative diseases.[90] The University is also performing an additional study on the connection between inflammation and colon cancer and the potential benefits of CAM.[91] In support of this research, the University has received over $24 million in funding from the NIH.[92]
Licensing and regulation of CAM is constantly changing and evolving, and in turn, there is a prevalent lack of uniformity across jurisdictions.[93] While legal issues and disputes are inevitable, some of the basic goals of regulation include limiting litigation and aiding the courts by articulating standards. Ambiguity in laws and regulations leaves practitioners with uncertainty as to whether they are properly adhering to these laws and regulations.
A unique example of this issue was addressed in North Carolina.[94] There, a regulatory board sanctioned a medical doctor for unprofessional conduct for administering homeopathic treatments.[95] The issue was whether the doctor’s conduct was within the scope of medicine as defined by North Carolina statute.[96] The court ultimately held that it was not[97] and that the “general risk of endangering the public is inherent in any practices which fail to conform to the standards of ‘acceptable and prevailing’ medical practice.”[98] The court further noted that “certain aspects of regulating the medical profession plainly require expertise beyond that of a layman” and that “while questions as to the efficacy of homeopathy . . . may be open to valid debate among members of the medical profession the courts are not the proper forum for that debate.”[99] This is but one example demonstrating the legal issues that arise when legislation is vague and confusing—and the court responds by saying a debate in their forum is not proper. Such a result leaves practitioners at a crossroads and craving a need for clarity regarding their legal obligations. As discussed previously,[100] the laws and regulations surrounding CAM in South Carolina are somewhat ambiguous. Such uncertainty with these regulatory schemes invites litigation in order to determine which types of practitioners and therapies fall within the scope of medicine as it is statutorily defined.
CAM practitioners also face liability for the unlicensed practice of medicine.[101] This designation can manifest in three different ways: one, providers who actually lack licensure; two, licensed providers who refer to unlicensed ones and are therefore considered to “aid and abet” the unlicensed practice of medicine; and three, licensed providers who expand the scope of their practice beyond what is allowed by the regulatory scheme of their state.[102] Informed consent is not a sufficient defense for the unlicensed practice of medicine.[103] While pervasive in the American legal system, the legal issues surrounding the unlicensed practice of medicine are practically untouched in South Carolina.[104]
There is also an issue that relates to the legal duty of a practitioner of medicine. Currently, there is a growing emphasis towards shared decision making between practitioner and patient, in which the patient is given more autonomy and his preferences are heard and considered by the practitioner.[105] This systematic shift in patient–practitioner communication begs the question of whether a practitioner has a duty to consider CAM modalities in treatment options, and in turn, whether the practitioner is required to disclose these options to the patient.[106] There are conflicting scholarly opinions regarding the duty. On one hand, it is argued that it would be unethical for a medical practitioner to disclose information regarding potentially unsafe and ineffective medical treatments.[107] Conversely, others believe that if a practitioner genuinely believes that some form of alternative treatment is what the patient needs, then the practitioner is ethically and legally required to discuss the risks and benefits of the treatment.[108] The general legal rule, however, is that practitioners will not be liable merely for referring the patient to a CAM practitioner who, in turn, is negligent.[109] But, as the requirements and duties of practitioners shift, so does their likeliness of liability for malpractice.
Health care institutions that employ both conventional and alternative professionals face malpractice exposure. As early as 1918, malpractice actions were brought against homeopathic practitioners.[110] The Supreme Court of Iowa in Van Sickle v. Doolittle recognized that a homeopathic physician could be held liable for malpractice and that the “delinquencies, if such there were,” were proper for consideration—in connection with other evidence—in determining whether “he had been negligent.”[111] Similarly, when survivors of a patient who died from cancer brought a medical malpractice action against a naturopathic practitioner, the court held that there was a significant issue in determining whether the naturopathic practitioner actually held himself out to both the public and the patient as a medical doctor.[112] The court noted, however, that non-physicians would be held to the same standard of care as licensed physicians if they “intrude[d] into the practice of medicine.”[113] While there are relatively few malpractice cases against CAM practitioners[114]—at least in comparison to conventional practitioners—this is likely to change as CAM therapies become more popular and continue to be integrated into conventional practices.[115] Courts are also likely to see more claims for malpractice as more practitioners offer CAM therapies and insurers respond by offering coverage for these practices.[116]
In malpractice actions against a CAM practitioner, many courts have recognized the appropriate standard of care as being one in which a practitioner use the same degree of care, diligence, and skill in the treatment of his patient as is possessed and used by prudent, skillful, and careful practitioners of the same school.[117] Therefore, CAM practitioners—such as naturopaths—will be held to the standard of other naturopaths, not to the standard of conventional practitioners. Overall, however, the standard of care tends to be less developed with CAM therapies.[118] In response to this fact, outside of a standard regulation, when determining whether a practitioner has met the standard of care, a court is likely to rely on “medical consensus regarding the safety and efficacy of a given CAM therapy.”[119] Additionally, a court must consider whether the standard of care can be determined first through actual statutes as opposed to the common law. If a regulation outlined the standard of care, then a violation of that standard would essentially establish malpractice per se.[120] Such a result could be undesirable, as there are many factors that determine whether malpractice occurred and allowing a statute to establish malpractice per se fails to sufficiently address these factors.
South Carolina defines medical malpractice as “doing that which the reasonably prudent health care provider or health care institution would not do or not doing that which the reasonably prudent health care provider or health care institution would do in the same or similar circumstances.”[121] However, this statute also explicitly states that a “health care provider” is limited to a “physician, surgeon, osteopath, nurse, oral surgeon, dentist, pharmacist, chiropractor, optometrist, podiatrist, or any similar category of licensed health care provider.”[122] There is currently no case law similar to Van Sickle in South Carolina discussing the implications of a homeopathic physician being found liable for malpractice. As South Carolina does not license naturopathy or homeopathy, a court might be unwilling to allow a malpractice claim to proceed against a party not deemed to be a valid “health care provider.” Such a possibility is problematic in light of the Williams decision allowing an individual to be considered a valid practitioner of medicine, but statutorily, not being able to have a claim asserted against them. It does seem, however, that this statute is sufficiently broad enough to cover any licensed practitioner of medicine who happens to also engage in the practice of CAM.
A final consideration is whether individuals or practitioners have due process rights violated when there are limitations on their ability to pursue or provide a certain type of medical care, CAM included. While some courts have recognized that there is no fundamental right to be able to choose a medical provider,[123] others find that even if a state is not legally required to recognize every practice of medicine, the state “cannot deny to any individual the right to exercise a reasonable choice in the method of treatment of his ills, nor the correlative right of practitioners to engage in the practice of a useful profession.”[124] Such considerations are important to consider when determining the overall implications that arise from the increased regulation of CAM.
The “use of an alternative therapy will result in misdiagnosis or cause a delay in conventional treatment, either through incorrect diagnosis or patient choice of treatment.”[125] While such a statement might be an overreaction—or even a potential misstatement—at its core it addresses the fears and uncertainties underlying the utilization of CAM therapies.
Patients generally lack the necessary knowledge or skills to diagnose or treat themselves. Consequently, there is a strong incentive to entrust this responsibility to licensed medical professionals.[126] While there is a legitimate concern that a lack of regulation might encourage a lack of formal education,[127] some argue that the current regulations of the practice of medicine fail to “best serve the public interest.”[128] For example, it is questionable whether existing licensing schemes’ educational requirements are either effective or necessary. Licensure certainly creates a “perception of legitimacy and accuracy to the claims of CAM providers in the minds of the public,”[129] but is that enough? Arguably, society does not merely desire a “perception of legitimacy and accuracy,” but instead aspires for a legitimate and accurate practice of medicine. However, the prevalence of significantly harmful and ineffective modalities of alternative medicine has decreased over the years, and this can be attributed to the implementation of more regulatory schemes with regard to the practice of medicine.[130]
By the early 1900s, the majority of states had adopted medical practice acts, which provided the educational, training, and professional requirements that physicians must adhere to when entering the profession.[131] Subsequently, a common theme arose in the courtroom—whether these state medical practice acts that regulated the practice of physicians could be applied to individuals practicing alternative medicine as well.[132] Put differently, whether CAM practitioners could be said to be engaged in the practice of medicine.
The role of medical boards and licensing with conventional practitioners is now universally accepted.[133] The American Medical Association described its purpose in licensing and regulation this way:
State medical boards are the agencies that license medical doctors, investigate complaints, discipline physicians who violate the medical practice act, and refer physicians for evaluation and rehabilitation when appropriate. The overriding mission of medical boards is to serve the public by protecting it from incompetent, unprofessional, and improperly trained physicians. Medical boards accomplish this by striving to ensure that only qualified physicians are licensed to practice medicine and that those physicians provide their patients with a high standard of care.[134]
While lawmakers tend not to question the necessity or value of licensing and regulation generally with regard to the practice of medicine, they do so when discussing CAM therapies and practitioners. The issue remains, however, that the lack of continuity and consistency in regulating the scope of practice among these state medical practice acts continues to cause confusion in both patients and practitioners and creates unnecessary potential for fraud and abuse.[135]
With that being said, it is true that the regulation and licensing of conventional medicine is not directly synonymous with the regulation of CAM. The regulation of CAM is unique and complicated in the sense that CAM therapies, as previously described, may be provided by medical doctors and similar healthcare providers—or by specialized CAM providers such as a licensed naturopath.[136] Furthermore, there has been a distinct trend toward the integration of CAM therapies with the practice of conventional medicine.[137] Unfortunately, scholarly articles and legal analysis regarding the legal and regulatory implications of including CAM therapies in conventional health care settings are limited.[138] While hospitals are increasingly offering CAM therapies, health maintenance organizations (HMOs) are beginning to cover such therapies, a growing number of physicians are utilizing a variety of CAM therapies in their existing practices, insurance coverage for CAM therapies is increasing, and integrative medicine centers and clinics are being established, there is still little discussion on the legal ramifications of such integration.[139]
This seems to be the case in South Carolina as well, as there is little to no discussion regarding the implications of individuals pursuing CAM therapies even though such patients are continually availing themselves of these services.[140] According to one study, Population-Based Survey of Complementary and Alternative Medicine Usage, Patient Satisfaction, and Physician Involvement, forty-four percent of the individuals surveyed in South Carolina had utilized CAM in the past year.[141] This is in accordance with the national average.[142] Home remedies, herbal therapy, and homeopathy were reported as the most commonly used CAM therapies.[143] The study showed the primary reason South Carolinians utilized CAM therapies was to maintain their health.[144] In South Carolina, white, middle-aged women were more likely to utilize and report the use of CAM than any other demographic.[145] Additionally, a majority of individuals reported that the CAM therapies they used were effective and very few, less than five percent, reported having a negative experience with CAM.[146]
Such positive results and praise from those who have utilized CAM therapies demonstrate that regulation of CAM would be favorable in South Carolina. Licensing and regulation are the general measures taken to protect and promote general welfare and public safety.[147] Such regulation and licensing is particularly important in healthcare, as the more risks that are associated with a practice, the higher the priority to regulate.[148] Licensure also “creates professional standards, elevates a professional image, and eases public concern over quality control.”[149] Furthermore, state medical practice acts tend to express the legislature’s acceptance of selected practices as valid, or at least licensable, health care modalities.
One basic argument in support of regulation is that there are unique threats to the public health that arise from “information asymmetries in a life-threatening emergency when the provider is incompetent to recognize or treat that particular condition.”[150] In response to this problem, states, South Carolina included, can (and should) require training, licensing, and certification in the recognition of these life-threatening emergencies.[151] Underlying this argument is an emphasis on the importance of safety. This requires a presumption, however, that regulation is the best way to promote safe practices—and that absent regulation these specific practices are inherently unsafe.[152]
Arguments against CAM tend to stress that the practices are not safe because they use new technological methods, they are untested, or they lack scientific validation.[153] Interestingly, the medical community as a whole has “a long history of accepting new technologies, and new uses of existing technologies, with little science to connect theoretical foundations to such practical applications.”[154] While CAM therapies arguably should continue to be researched and challenged for their safety prior to implementation, it does not follow that this could—or should—be a viable explanation for the lack of regulation in South Carolina. Furthermore, some scholars suggest that CAM practices are arguably safer than other conventional practices.[155]
One of the reasons CAM is not currently regulated in a sustainable way (in South Carolina and in other states) derives from conventional practitioners and their determinations of efficacy and safety with regard to CAM.[156] These determinations are rooted in assumptions made by conventional practitioners that competent adults cannot make informed decisions about CAM because they are incapable of adequately evaluating the safety and efficacy of CAM therapies.[157] However, there is insufficient evidence to show that conventional practitioners are better equipped to determine standards of safety and efficacy.[158] The competency of conventional practitioners to determine professional standards for conventional medicine is not questioned, but instead, the primary issue is whether they are best suited for establishing standards for CAM therapies.[159]
Many in the medical and legal profession find it reasonable that the same scientific standards for safety and efficacy should apply to both CAM and conventional medicine.[160] This belief is rooted in the idea that there is not “alternative” medicine and “conventional” medicine, but rather that there is only evidence-based medicine.[161] One area it makes sense to have the same scientific standards is where a conventional medical practitioner begins to implement CAM therapies into his practice. This is known as integrative medicine.[162] If this is the case, rather than regulating CAM therapies and practitioners separately, another option is expanding existing state medical acts to ensure that CAM practices are included. While most states enact separate statutes for the various healthcare professions, due to the overlap between the professions, some states have implemented statutes granting the same broad right to “practice medicine” to both physicians and non-physicians alike.[163] Broadness, however, can be easily conflated with vagueness, and vagueness in regulatory schemes is something that should be avoided when possible. As it stands, this Note suggests that the current medical act in South Carolina,[164] while likely broad enough to encompass integrative medicine, is too vague.
If safety and efficacy are the core concerns of whether CAM can be effectively regulated, then these concerns must be considered. There exists a legitimate concern regarding the effectiveness of CAM and whether it will divert individuals from research-based medicine to their physical detriment.[165] Another concern is related to the claim of lower medical costs. If CAM practitioners are not providing medical services that are helpful and improving the health and lives of their patients, then arguably, they are not providing cost-effective solutions, but instead expensive detours. This concern directly relates back to the previous apprehension of individuals being diverted to their own detriment. But should this matter? This Note suggests that these concerns should not be a determination as to whether CAM should be regulated in South Carolina. Safety and efficacy are significant considerations into how CAM is regulated, but these concerns should not determine if regulation should occur. A practice should be regulated if it is in use and if there is potential for harm to consumers due to the lack of proper and efficient regulation. The data is sufficient to show that individuals in South Carolina are pursuing CAM,[166] and it is both the duty of and within the police power of the state to ensure that its citizens are protected and its practices are properly regulated.
The efficacy of any CAM therapy likely depends, at least in part, on the individual patient’s medical history.[167] This makes sense when considering both the definition—and the goal—of alternative medicine as a “whole medical system.” Because so many factors must be considered to determine whether or not treatment is actually effective, data is resultantly varied and inconsistent. A question then arises whether efficacy is actually a subjective standard rather than a scientifically objective one, as well as whether it should be a standard when it comes to CAM.
An argument in favor of regulation of CAM in South Carolina is not an argument in support of less stringent requirements. As the White House Commission on Complementary and Alternative Medicine noted:
[M]ost CAM modalities have not yet been scientifically studied and found to be safe and effective. The fact that many Americans are using CAM modalities should not be confused with the fact that most of these modalities remain unproven by high-quality clinical studies. The Commission believes that conventional and CAM systems of health and healing should be held to the same rigorous standards of good science.[168]
Regulation helps to both raise standards and subsequently enforce them. Additionally, where states believe that there should be higher standards, they have the police power to create them.[169]
In contrast to the above arguments in support of regulation, some scholars argue that regulation of CAM is unnecessary[170] because the reasonable patient has the ability to determine for himself what type of practitioner he wants to see and what type of medicine he wants to be used.[171] This argument is the crutch of informed consent, which some scholars believe is sufficient for satisfying a regulatory scheme.[172] It has been argued that there is no “sound empirical evidence that licensing laws have adequately served consumers.”[173] This argument is supported by propositions that existing licensing schemes have failed to accomplish their intended goals, that regulation is disproportionately costly, and in turn, that there are less expensive alternatives.[174] While there will continue to be an ongoing debate regarding the quality and effectiveness of licensing and regulatory schemes as a whole, this Note argues that when the general assembly balances the costs and benefits of CAM overall, the scales tip in favor of stronger regulation of CAM in South Carolina.
In determining the best manner in which to implement beneficial regulatory schemes in South Carolina, it is advantageous to look to other states to see how they have chosen to best regulate CAM. Specifically, it is helpful to consider the educational requirements each of the below states has enacted in order to qualify for licensure of naturopathy. While the example states have many similarities in the ways they have regulated CAM, there are also unique differences in the regulatory schemes that each has chosen to prioritize and implement accordingly.
In Oregon, naturopathic medicine is defined as the discipline that includes physiotherapy, natural healing processes, and minor surgery, and has as its objective the maintaining of the body in—or of restoring it to—a state of normal health.[175] Additionally, a naturopathic physician is an individual who holds a degree of Doctor of Naturopathic Medicine and is licensed under Oregon statutes.[176] The state felt it was necessary to clarify that this section of the law did not apply to other medical doctors or practitioners, but that it was solely limited to naturopaths.[177] As Oregon requires a license to practice naturopathy, “no person shall practice, attempt to practice, or claim to practice naturopathic medicine” in Oregon without adhering to the statutory provisions.[178]
The minimum educational requirements for licensure to practice naturopathic medicine in Oregon is graduation from an accredited naturopathic school that has been approved by the State Board of Naturopathic Medicine and that teaches adequate courses in all subjects necessary to the practice of naturopathic medicine.[179] The statute also specifies required subjects the individual applying for licensure must be versed in, and subjects the Board may not require—and the Board has the ability to require additional subjects at its discretion.[180]
Oregon is very proactive with regard to CAM. The state is home to one of the six accredited naturopathic schools in the United States.[181] In addition, as utilization and implementation for CAM therapies grows, so does the need for reliable scientific research on these alternative therapies. In response to this need, the Oregon Center for Complementary and Alternative Medicine developed a training program for researchers.[182] This program is designed to include a variety of professional degrees, with the goal of training both “professional track investigators and clinical collaborators.”[183] The program includes individual and group mentoring, a clinical research class, journal club participation, and grant writing development.[184]
While the legislature has been active with CAM, there is no indication that the courts in Oregon have been more involved with litigating issues derived from CAM. This could be a result of the existing licensing and regulatory schemes in place, which provide answers and clarity on issues that would otherwise be litigated.[185]
Similarly, California has determined that naturopathic medicine is a distinct and comprehensive system of primary health care practiced by a naturopathic doctor for the diagnosis, treatment, and prevention of human health conditions, injuries, and disease.[186] California clearly communicates both its public interest goals in furthering this regulatory scheme. “Protection of the public shall be the highest priority for the committee in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.”[187]
The state adheres to standards that align with the national standards for naturopath licensing.[188] The applicant must have received a degree in naturopathic medicine from an approved naturopathic medical school,[189] pass the NPLEX,[190] and have an application reviewed and licensure granted by an advisory committee.[191] The advisory committee, which reviews applications and grants licenses, is composed of various types of practitioners, including naturopathic doctors as well as traditional medical doctors.[192]
Interestingly, while California explicitly regulates the practice of CAM, it is also one of three states that insulates the unlicensed practice of medicine.[193] This legislation protects an individual choosing to engage in certain medical treatments as long as he makes written disclosures to his patients that he or she is not licensed by the state as a “healing arts practitioner.”[194] If such disclosures are made, the practitioner is not in violation of certain provisions of the Medical Practice Act unless the practitioner engages in specified diagnosis, treatment, and other activities forbidden by the statute.[195] The regulatory scheme in California prioritizes continued validation of certain Health Freedom Laws.[196]
“Connecticut is home to about 230 practicing naturopaths (NDs), physicians who specialize in natural treatment of disease and injury.”[197] It also has the oldest laws licensing naturopaths.[198] Connecticut defines the practice of naturopathy as “the science, art and practice of healing by natural methods as recognized by the Council of Naturopathic Medical Education and that comprises diagnosis, prevention and treatment of disease and health optimization by stimulation and support of the body’s natural healing processes.”[199] An individual cannot practice naturopathy in Connecticut without a license, and in order to receive the license, he must pass an examination prescribed by the Department of Public Health with the advice and consent of the board.[200] This exam is similar to the NPLEX and is extensive in its requirements. For example, the exam tests “anatomy, physiology, histology, psychology, chemistry, hygiene, public health, dietetics, jurisprudence, naturopathic pathology, diagnosis and theory and practice of naturopathic therapeutics.”[201] However, if an individual has received national certification and accreditation through the AANMC,[202] the Department of Public Health may grant a license by endorsement.[203]
The regulatory board in Connecticut has been given significant authority, potentially more than that of the courts.[204] The Superior Court of Connecticut determined in Alcorn ex rel. Baum v. Osborn that the state board of naturopathic examiners issued, without examination, a certificate of approval for applicants to practice naturopathy who had been admitted to practice in South Carolina.[205] This grant was made pursuant to an agreement of reciprocity with the South Carolina board[206] of naturopathic examiners.[207] The court held the commissioner was powerless to withhold a certificate of registration to practice, regardless of the fact that South Carolina’s requirements were not remotely equal to Connecticut’s requirements for practicing naturopathy.[208]
One unique aspect of Connecticut’s regulatory scheme is that it requires anyone licensed to practice naturopathy under its statutes to maintain professional liability insurance or other indemnity against liability for professional malpractice.[209] The statute further notes the “amount of insurance which each such person shall carry as insurance or indemnity against claims for injury or death for professional malpractice shall not be less than five hundred thousand dollars for one person, per occurrence, with an aggregate of not less than one million five hundred thousand dollars.”[210]
Additionally, Connecticut is one of three states that licenses individuals with an MD or a DO (Doctor of Osteopathic Medicine) to practice homeopathy.[211] As discussed above,[212] the licensure of homeopathy is generally not accepted. Even in Connecticut, an individual cannot solely become licensed to practice homeopathy.[213] This license is restricted to existing practitioners with other medical degrees.[214] This practice aligns, however, with many states focusing on developing and expanding integrative medicine.[215] States outside of Connecticut, Arizona, and Nevada might begin the process of incorporating statutes that expand the licensure of homeopathy nationally. However, for now, that does not seem to be the trend.
The existing regulatory scheme in South Carolina is insufficient. It is filled with informational gaps, legal inconsistencies, and vague regulations, at best. In its current state, the existing scheme allows individuals to label themselves as a homeopath without any regulation or certification of their training or education. This scheme allows individuals who are licensed naturopaths to establish businesses in South Carolina and practice medicine, so long as they do not claim to practice naturopathy. It also allows medical doctors and other similar physicians—as long as they have a valid license in their field—to practice CAM without defining the scopes and bounds of what such a practice entails or regulating their training and education as specific to CAM therapies. The solution is not to eradicate CAM. However, a better, and more feasible, option is to expand the current legislation to clearly define CAM, who is allowed to practice CAM, and what is required for such persons to practice CAM.
In reviewing other states’ regulatory schemes, the educational requirements for licensure to practice naturopathy is consistent. In adopting proper legislation, South Carolina should model these states and adhere to strict educational requirements for initial licensure, as well as continuing education requirements. These requirements include, but are not limited to, abiding by the national standards for licensing naturopathy.[216] The implementation of such requirements would be a drastic change from the existing regulatory scheme in South Carolina; however, this Note posits that to encourage safe and effective practice of medicine in the state, the current ban on naturopathy should be removed. Medicine, including naturopathy, has significantly progressed since this ban was enacted in 1956. The safety and efficacy concerns that existed over half a century ago are not the same as the ones considered now. The statutory ban should be reevaluated in light of aforementioned analysis, and lawmakers should consider that this ban is arguably failing to further any significant public health goals. If naturopathy were legalized and regulated, individuals who fail to meet the mandatory requirements under the new proposed licensing scheme would be liable for the unlicensed practice of medicine. Within this proposed regulatory scheme, this Note postulates that the statute clearly delineate which “healing arts” it covers and which ones it does not—similar to Oregon’s licensing statute.[217] Here, the statute should be limited to covering the licensure of naturopathy.
At this point in time, this Note does not suggest that South Carolina expand current legislation or create new legislation to include licensing homeopathy. Unlike naturopathy, the lack of consistency and federal oversight with regard to the education of homeopaths is disconcerting. Licensing homeopathy in South Carolina would not further the legitimate goals of safety and efficacy in the practice of medicine. The fact that only three states currently license homeopathy—and even then only for physicians with other medical training and licensure—affirms the belief that this form of CAM is not a suitable option for South Carolina citizens. As more research is completed on the practice of homeopathy, the conversation of expanding licensure should be had. Currently, however, there is insufficient evidence to support licensing classical homeopaths or medical professionals, such as medical doctors or doctors of osteopathy, in homeopathy in South Carolina.
In considering the above, this Note proposes that the existing practice of medicine statute[218] be revised to include updated methods of practice, including clarity regarding the use of integrative medicine. Integrative medicine requires entirely different considerations in regard to regulation than what this Note has touched upon. It would likely include, however, the implementation of naturopathic or homeopathic remedies into a licensed physician’s practice. Because of that, I believe it is important to clarify the scopes and bounds of what it means to be a “practitioner of medicine” and what is included in that practice. This is imperative as providers continue to see growth in patient use of CAM, as well as the evolving implementation of CAM into their current practice.[219] Furthermore, if suggested that the existing statute is sufficient to cover the scopes and bounds of integrative medicine, this Note argues that the administrative costs of providing clarity are low—and the benefits of reassuring the practitioners and the patients are high.
Finally, this Note suggests that this proposed licensing scheme require CAM practitioners in South Carolina have liability insurance. This requirement would ensure that if medical malpractice cases arise—and the practitioner is determined to be negligent—the patient has some means of monetary recovery. The requirement that certain professionals maintain liability insurance is standard in this country.
While South Carolina is currently researching CAM,[220] this research is narrow in scope. With additional resources, either from grants and national funding from the NIH—or through programs similar to that offered in Oregon[221]—those practicing CAM in South Carolina can inject their own findings and patient developments into the conversation. The more research that is conducted, the better equipped South Carolina will be to address changes and evolutions to CAM and the healthcare system.
It is also imperative that South Carolina citizens are able to pursue CAM therapies affordably. South Carolina’s largest healthcare provider, BlueCross BlueShield, does offer some coverage for CAM therapies.[222] All of the CAM providers with some coverage under Natural Blue, however, are providers that are actively regulated in South Carolina, such as chiropractors[223] and podiatrists.[224] This suggests that insurers require regulation and licensure prior to including coverage for certain providers or therapies. Additionally, this program is not precisely insurance coverage, but rather it is a benefit that provides the policy holder with a member discount for certain CAM providers.[225] The individual insured is then required to pay the provider directly, and it does not process any claims through BlueCross BlueShield.[226] This program, however, is a step in the right direction towards providing more affordable options to South Carolina citizens.
There are still many individuals who do not have health insurance. As of 2014, approximately twenty percent of the population was without health insurance in South Carolina.[227] For these individuals, pursuing medical assistance often is not an option. Since, by its nature (i.e., plant-based and body-based therapies vs. pharmaceuticals) CAM has the ability to be more affordable, utilizing these therapies could be a feasible alternative to not getting medical assistance at all. But absent statues that allow for the practice of CAM in South Carolina, specifically practices such as naturopathy, these individuals cannot legally pursue this medical service as an option.
In pursuing regulation of CAM in South Carolina, it is fairly evident what we do not desire. South Carolinians do not desire a scam science harming its citizens. They cannot afford to have individuals claiming to be practitioners of medicine with little to no education to support such a claim. Additionally, these individuals cannot afford interacting with practitioners evading liability or finding loopholes in the system to escape liability for medical malpractice. This is not to say that doctors—or other well-regulated practitioners—do not engage in such activities. Some do. However, when such actions occur, legal liability attaches to those actions.
Additionally, as of now, there is little data available on who is actually practicing CAM in South Carolina. Regulation of CAM will help create continued accountability for practitioners of medicine. Adequate regulation would require clear records of who is authorized to practice CAM therapies and who is not. Regulation also helps determine and set forth standards of care. And in order to prevent faulty science and uneducated practitioners from running rampant in our community, these standards need to be established. Implementing a clear and concise licensing and regulatory scheme in South Carolina would help do this.
This Note does not argue the use of CAM over or instead of conventional medicine. Encouraging the regulation of a practice of medicine does not necessarily indicate an endorsement of that practice. If there are dangers inherent to CAM, then they are heightened by being pushed aside and disregarded by the general assembly as irrelevant. As medical systems grow and evolve—and individuals become more engaged with their practitioners—there will be a continued interest in CAM, and there should be no confusion as to how practitioners who desire to practice CAM should do so. Practitioners should know whether they will be liable for referring an individual to a CAM practitioner or whether they themselves are allowed to incorporate such therapies into their practice of medicine. Furthermore, as patient autonomy is emphasized, should the reasonable and prudent adult choose to pursue these therapies, there should be options for him to do so legally.
Where the citizens of South Carolina have shown both a need and a desire for access to CAM services—and where many citizens in South Carolina actively pursue and utilize these services—the state should facilitate access to and regulate delivery of these services. The issue of access to CAM therapies has reached a point where it is necessary for the general assembly to reenact a naturopathic physician licensing act and expand the practice of medicine act in order to facilitate access, and regulate the delivery of, CAM services in South Carolina.
Under the FDCA, homeopathic products can enter interstate commerce if they contain ingredients recognized by the Homeopathic Pharmacopeia of the United States (HPUS) and comply with the FDA’s labeling and manufacturing requirements. The HPUS is a compendium of homeopathic monographs produced and updated by the Homeopathic Pharmacopeia Convention of the United States (the Convention). The Convention performs an intensive review of proposed homeopathic monographs before ingredients are accepted into the HPUS. The manufacturer must submit sufficient clinical data to prove efficacy in order for a homeopathic ingredient to be listed in the HPUS. . . . Despite the Convention and FDA’s independent spheres of authority, the two organizations coexist and share responsibility for the safety and efficacy of homeopathic drugs.
Id. ↑
There are no homeopathic drug products marketed in the United States that are FDA-approved. This means that FDA has not evaluated them for safety or effectiveness. Thus, such products may not meet modern standards for safety, effectiveness, and quality. They may also cause harm to consumers who forgo treatment for serious conditions with medical products that have been scientifically proven to be safe and effective. People sometimes assume that homeopathic remedies are unlikely to cause harm because they are marketed as ‘natural.’ However, as with all drug products, the safety of homeopathic drugs depends upon many factors, including the manufacturing quality and the identity and amount of the “active” ingredient. Homeopathic products are often found next to over-the-counter products, and may not be labeled as homeopathic. So consumers may not realize that they have not been evaluated by FDA for safety or effectiveness.
Id. ↑
Laws that require CAM providers to encourage consumers to discuss CAM use with their primary care physician, and that require CAM practitioners to disclose personal qualifications, the nature of the practice, and its inherent risks, will provide consumers with greater access to information than a licensing requirement. Moreover, mandatory disclosure requirements enable the consumer to consider the value and efficacy of the practice on his own terms, instead of viewing the service under the influential rubber stamp of approval that licensure conveys.
Poncetta, supra note 18, at 674. ↑
Upon close examination, then, the justifications for licensure are unpersuasive. Licensure fails to protect consumers who, for the most part, are able to protect themselves. More importantly, current licensure schemes have significant anticompetitive effects. Licensure restricts consumer choice by foreclosing potentially beneficial health care options, and increases health care costs without providing increased quality.
Baron, supra note 170, at 347. ↑
With respect to liability, commentators have noted fewer reported decisions and, generally, fewer lawsuits against alternative medical providers than against medical doctors. It has been suggested that this relative lack of litigation may be attributed to the focus of alternative therapists on care and quality time with patients, to the relatively low risk of injury inherent in alternative therapies, and to their relative safety as compared with conventional medical therapies and the unlikelihood of “clinically significant adverse events.”
Id. (citing Cohen & Ruggie, supra note 135, at 703). ↑