Introduction
The wellness industry is booming and fills needs unmet by medical care. Wellness practitioners offer holistic health, coaching, and preventive services in a variety of settings. Many wellness practitioners are not licensed. Most wellness certifications are not recognized by the government or accredited by arbiters of quality. As a result, from a regulatory perspective, wellness is the wild west. The litigation in Braidwood Management, Inc. v. Becerra may eliminate no-cost coverage of preventive services recommended by the U.S. Preventive Services Task Force (USPSTF), which would likely accelerate consumer reliance on the wellness industry for preventive care. Asking consumers to rely on an industry that has no uniform professional standards is risky both from a consumer harm perspective and a regulatory perspective. The wellness industry would be best served by using a “soft law” approach to create standards of care and conduct before the government creates “hard laws” in wellness that would erect barriers to access for both practitioners and consumers. Standards could offer necessary boundaries for wellness practitioners and protect consumers from unethical practitioners. In Part I, this Article explores the current state of the wellness industry, including: (1) who practices it, who uses it, and why; and (2) who trains, hires, insures, and polices wellness practitioners. Part II explains why wellness practitioners should embrace professional standards and how the Braidwood decision may reinforce the appeal of the wellness industry and the need for wellness industry standards. Part III maps out what wellness professional standards may look like, given the types of harm currently experienced by wellness industry consumers. Part III also shows how the wellness industry could develop standards using a soft law approach, such as creating a wellness Standards Development Organization (SDO).
I. The State of the Wellness Industry
A. What Is Wellness?
Wellness is a ubiquitous term and often used in conjunction with “health.” But in the U.S. marketplace and the law, those two terms are distinguishable. In the law, those who work in wellness are uninhibited by robust regulation and free to do things that those who work in health care cannot. For example, federal law provides a free pass on health status discrimination as long as such discrimination occurs inside an employee “wellness” program.Footnote 1 Employers, who are generally prohibited by the Americans with Disabilities Act (ADA) from asking employees about sensitive health information, are able to do so through voluntary wellness programs.Footnote 2 In contrast, federal law prohibits health status discrimination by “health care” insurers through the Health Insurance Portability and Accountability Act (HIPAA) and the Affordable Care Act (ACA).Footnote 3 Furthermore, tax law allows deductions for “health care expenses,”Footnote 4 but not for “wellness benefits.”Footnote 5 The Food and Drug Administration (FDA) demands a rigorous approval process for drugs and medical devices, which by their very definition aim to treat or prevent health conditions.Footnote 6 In contrast, the FDA does not require premarket approval for nutritional supplements, cosmetics, or wellness devices, which constitute many of the products pushed by wellness practitioners.Footnote 7 Another law-related difference between the wellness and health industries, and a key point of this article, is the regulation (or lack thereof) of the industries. Health care is highly regulated through licensure, credentialing, billing, and data privacy requirements. In contrast, there is little to no parallel regulations for wellness.Footnote 8 Indeed, as noted in one health and wellness textbook:
Unlike all other medical and healthcare practitioners, with the notable exception of exercise physiologists, there is no regulation of wellness practitioners. There are no minimal educational requirements, and no state license or registration is needed by anyone providing wellness services. While several organizations offer a certification in the fitness aspect of wellness (e.g., APTA [American Physical Therapy Association] and the American College of Sport Medicine [ACSM]), proof of education or certification in wellness is not required for someone to offer wellness programs.Footnote 9
In the marketplace, wellness is free-ranged and encompasses a wide swath of products, services and practitioners. According to author Colleen Derkatch, wellness culture spans categories that include: (1) monitoring one’s health to prevent a possible disease; (2) self-care by making healthy choices; (3) detoxification through use of natural health products; (4) participation in stress management and relaxation activities; and (5) adopting techniques and engaging in services to become the best version of ourselves in body, mind, spirit and productivity.Footnote 10
These broad views of wellness invite a wide range of products, services, and practitioners to incorporate the concept of “wellness” into their business, resulting in a hard to manage, often confusing — or worse, misleading — wellness marketplace. As one writer noted recently:
“Wellness” is an umbrella term. It can be used to cover forms of traditional Chinese medicine, such as acupressure and acupuncture; aspects of the Indian tradition Ayurveda; and more recent inventions like Reiki, which involves pressure-free caressing and non-touch hand movements. It can also encompass nutritional counseling, herbal supplements, exercise, homeopathy, massage, reflexology, yoga, touch therapy, art therapy, music therapy, aromatherapy, light therapy, and more.Footnote 11
Most of today’s consumers identify wellness as focused on addressing individual lifestyle illnesses and behaviors.Footnote 12 Much of the modern wellness industry operates on the assumption that with appropriate education and lifestyle modifications, people can look and feel more “well.”Footnote 13
This focus on lifestyle and behavior choices feeds the booming wellness market in the United States. A survey by McKinsey & Company (McKinsey) shows that wellness is a major priority for American consumers, who spend more than $450 billion annually on wellness products and services, and that figure will increase more than five percent per year.Footnote 14 Consumers in the United States view wellness in six dimensions:
Health: over-the-counter medicine, vitamins, and personal hygiene
Fitness: fitness clubs, studios, at-home fitness equipment, and fitness wearables
Nutrition: diet programs, subscription food services, nutrition apps, and juice cleanses
Appearance: skin care, dermo-cosmetics, hair care, and salon services
Mindfulness: counseling or therapy, meditation studios, and mindfulness apps
Sleep: sleep supplements, app-enabled sleep trackers, and other sleep-enhancing productsFootnote 15
B. Who Are Wellness Practitioners?
An army of “wellness practitioners” step in to help consumers achieve wellness. This article uses this general term to collectively refer to these practitioners, who go by many names, including health or wellness coaches, life coaches, personal trainers, nutrition counselors or coaches, Reiki practitioners, Ayurveda practitioners, mindfulness/meditation practitioners, holistic health counselors, fitness and exercise specialists, natural healers, aromatherapists, herbalists, sleep specialists, mental wellness coaches, relationship coaches, spiritual coaches and healers, yoga teachers or practitioners, and even hypnotists and psychic mediums.Footnote 16 What these wellness practitioners have in common is that none of them require any credential to start working in their role.Footnote 17 A symptom of this lack of regulation is an ever-evolving nomenclature of who practices “wellness.”
As yoga practice demonstrates, wellness practitioners are typically white, middle-aged women of a high socioeconomic status.Footnote 18 This closely corresponds to data gathered from the career company Zippia, which found that 66 percent of all wellness specialists are women, the same percentage are white, and their average age is forty-seven years old.Footnote 19 Also of note, the vast majority of wellness specialists (71 percent) have a Bachelor’s degree; 16 percent have a master’s degree, about 8 percent have an associate’s degree, 2.3 percent have a high school education, and only 1.4 percent have a certificate.Footnote 20 Notably, many wellness practitioners have left roles in the traditional health care system to work in wellness. A recent article in the Washington Post declares that “nurses are leaving hospitals in droves” and establishing new careers, particularly in the wellness space.Footnote 21 According to a 2022 issue brief from the U.S. Department of Health and Human Services, “22 percent [of frontline nurses] were considering leaving their positions in the next year, and 60 percent of those said they were more likely to do so because of the pandemic.”Footnote 22 Over half of those nurses said “they planned to seek another career, a non-direct care position, or retir[e].”Footnote 23 The unregulated wellness industry can offer flexibility and growth that many burnt-out licensed health care practitioners crave. Finally, it is worth noting that many businesses incorporate the words “wellness” or “self-care” to destigmatize their product or service offering.Footnote 24 Psychedelic drug clinics, such as ketamine clinics, promote themselves as “wellness clinics”;Footnote 25 cannabis has been re-branded as a wellness product;Footnote 26 and even psychic mediums “now work in the general field of wellness, calling themselves ‘intuitives’ or ‘intuitive healers,’ who channel ‘energy’ that helps people discover what they want out of life.”Footnote 27
C. Who Uses Wellness Products and Services, and Why?
Wellness consumer demographics in the United States mimic those of wellness practitioners, which makes sense because many wellness consumers become apostles of wellness after having a positive experience with a wellness product or service.Footnote 28 According to the Centers for Disease Control and Prevention (CDC), non-Hispanic white women are more likely to use yoga, meditation, and chiropractors than men or Hispanic and non-Hispanic Black adults.Footnote 29 Dietary supplement use is also higher among older, white women.Footnote 30 The Pew Research Center found that about twenty percent of Americans have tried alternative treatments — such as herbal dietary supplements, acupuncture, chiropractic, energy therapies, and other therapies that are not part of standard conventional Western-based medical care — in lieu of conventional medicine.Footnote 31 Another twenty-nine percent of Americans have used such alternative treatments in conjunction with conventional medical treatments.Footnote 32 Wellness practitioners provide many of these alternative services. People may use wellness products and services to address a wide range of psychological, emotional, and physical conditions. As Colleen Derkatch postulates, wellness sells because it creates a vision of a good life that is full of purpose and meaning.Footnote 33 That can appear very seductive and captivating for consumers. Indeed, “wellness is a powerful branding technique, one that has an almost horoscopic quality in that it invites consumers to project onto it their desires for self-determination, flourishing, and the good life.”Footnote 34 This likely explains why so many “outlier” products and services, such as cannabis, psychedelic drugs, and psychic mediums, are branded as “wellness” products and services: to elevate their use and attract a new set of consumers.
For many others, wellness offers respite from chronic illness. Individuals with chronic conditions are more likely to use alternative medical treatments than those without such conditions.Footnote 35 For example, research shows individuals turn to yoga for postmenopausal symptoms, low back pain, cancer, and heart disease.Footnote 36 As Derkatch observes, consumer interest in wellness may be:
an expression of broader public concerns about health and healthcare that are not addressed by doctors, public health agencies, or legislators as we collectively work longer hours, get less sleep, live under increasing financial strain, and spend much of our lives sitting (mostly in front of screens), all in the name of productivity.Footnote 37
Indeed, some studies have noted a growing distrust in conventional health care providers.Footnote 38
The failure of conventional health care to support consumers suffering from the demands of modern life is a critical aspect of consumer attraction to wellness, particularly for marginalized groups who are frequently dismissed by the conventional health care system.Footnote 39 One reason so many people, particularly women, turn to wellness practitioners is potential “medical gaslighting” by conventional medicine, or dismissing a patient’s symptoms.Footnote 40 This gaslighting may partially derive from the short time that physicians spend with a patient during a typical medical visit, which ranges between nine and twenty-four minutes.Footnote 41 One study found that “physicians listen to their patients for an average of eleven seconds before interrupting.”Footnote 42 Other surveys show that the vast majority of consumers want the traditional health system to involve wellness activities, such as healthy eating and exercise, but there is a current disconnect between patient desires and experiences.Footnote 43 Nineteen percent of respondents to a survey conducted by The Harris Poll complained about the medical system’s lack of focus on “preventive care and wellness.”Footnote 44 The Harris Poll found that the U.S. health care system most commonly falls short of meeting consumers’ needs with regard to appointment wait times and service costs, in addition to the system’s focus on treating acute problems rather than preventive care and wellness.Footnote 45 Thus, when it comes to focusing on an individual’s overall well-being and offering more holistic services and attention to consumers, the wellness industry stands ready to fill the ever-growing gap left by conventional medicine.Footnote 46 This alarming consumer desire to replace traditional health care with unregulated wellness products and services best emphasizes the urgent and desperate need for wellness practitioner standards.
D. Who Is Currently Training, Certifying, Hiring, Insuring and Policing Wellness Practitioners?
Just like wellness practitioners themselves, the entities that train, certify, hire and insure wellness practitioners are vast, varied, and fragmented. The rigor and type of wellness practitioner training and certification programs spans from easy to more challenging, but none are required for practice. Wellness practitioners can work in a variety of settings, but again, there is currently no universally accepted way for those who hire wellness practitioners to know whether that practitioner is qualified. The same is true for insurers who offer professional liability insurance to wellness practitioners. Because of the absence of any universally accepted standards, it is difficult to evaluate wellness practitioner credentials and skills.
1. Who Trains and Certifies?
There are countless training and certification programs for wellness practitioners, and the quality of those programs varies widely. Training programs may be marketed as “wellness certificate”Footnote 47 programs, especially for the purposes of worksite wellness programming, or more specific training programs that focus on a particular aspect of wellness like nutrition,Footnote 48 fitness,Footnote 49 coaching,Footnote 50 energy healing,Footnote 51 or mental wellness.Footnote 52 Given the wide range of wellness “specialties,” thousands of programs and organizations exist to educate wellness practitioners. For example, the Yoga Alliance identified 6,000 registered yoga schools alone in 2021.Footnote 53 A simple Google search for a “list of wellness certifications” yields an array of different wellness education organizations, including programs affiliated with universities.Footnote 54 It is worth repeating that certifications are not even necessary to start working in wellness.Footnote 55
Many of the wellness certifications do not require any specific amount of education or experience, even those from the most prestigious universities in the country. For example, a “health enthusiast” with no prerequisites other than an interest in wellness can obtain a certificate from Harvard Medical School in “Health and Wellness: Designing a Sustainable Nutrition Plan.”Footnote 56 Or, in two weeks a “wellness professional” can earn a Wellness Counseling certificate from Cornell College of Human Ecology.Footnote 57 Not only are there low eligibility criteria established by reputable institutions to earn any credential in the wellness industry, but very few of these training programs are accredited by a standards-developing organization. One such accreditation organization is the Institute for Credentialing Excellence (ICE).Footnote 58 ICE does not specialize specifically in establishing and enforcing wellness standards, but rather accredits programs that offer certifications in various industries, including construction, management, food and beverage, finance, manufacturing, and health care.Footnote 59 Of the thousands of wellness certification programs that exist within universities and other private companies, only eighteen organizations offer wellness certification programs that are accredited by ICE, and most of those certifications pertain to fitness.Footnote 60
To obtain accreditation through ICE, wellness certification programs are expected to adhere to “defined standards by a third party”Footnote 61 and a “code of ethics.”Footnote 62 These standards and ethical codes, however, bind on the organizations delivering wellness certification programs, not the individuals receiving certificates and delivering wellness services.Footnote 63 Accredited organizations may have some standards for their students or members who earn certificates, but these are not typically comprehensive and enforcement mechanisms rarely exist to capture any program or participant failure to adhere to the code of ethics.Footnote 64 For example, the Principles of Ethical Behavior for members of the American College of Sports Medicine (ACSM), a membership organization that offers ICE-accredited certification programs in personal training and exercise physiology, are as follows:
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• Treat and/or train people to maintain honesty and integrity.
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• Treat or train people with the utmost care and to the highest level of their professional competence.
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• Maintain confidentiality and protection of personal medical information and other data as required by relevant laws, policies, and ethical standards.
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• Be aware of and adhere to international doping control standards as determined by the List of Prohibited Substances and Methods published by the World Anti-Doping Agency or by the relevant anti-doping authority when treating or training active people.
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• Provide appropriate care and/or train people based on their physical and/or medical conditions.
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• Support research integrity and not support plagiarism, duplicate publication, slandering reputation, etc.
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• Not harass or retaliate against anyone participating in ACSM activities.Footnote 65
This list of ethical principles lacks any guidance concerning marketing, billing practices, previous violations of law or acts of negligence, informed consent, or scope of practice concerns — which, as discussed in Part III, can harm consumers.
In addition, the National Board of Health and Wellness Coaching (NBHWC) has recently become involved in approving wellness certification programs. NBHWC approves health and wellness coaching programs affiliated with universities and other private entities.Footnote 66 NBHWC approval requires wellness coaching programs to meet certain standards, such as minimum numbers of instructional hours and practice coaching sessions, certain skills assessments, and certain faculty requirements (like retaining faculty with coaching backgrounds health and wellness educational degrees).Footnote 67 As of 2024, NBHWC has accredited 126 health and wellness coaching certification programs.Footnote 68
In 2016, NBHWC partnered with the National Board of Medical Examiners to create a “unified code of ethics, education, research, and credentials to standardize training and certification for health coaches.”Footnote 69 The code of ethics applies to any NBHWC credentialed health and wellness coach.Footnote 70 Examples of NBHWC ethical guidelines include:
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• Refraining from unlawful discrimination;
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• Making verbal and written statements that are true and accurate about what health coaching offers;
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• Accurately identifying coaching qualifications, expertise, experience, training and certifications;
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• Avoiding conflicts of interest and disclosing those conflicts when they arise;
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• Maintaining client confidentiality;
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• Having a clear coaching services agreement and honoring the agreement;
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• Avoiding sexual or romantic relationships with clients, employers, students, mentees and supervisees;
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• Respecting the client’s right to terminate the coaching relationship, subject to the provisions of the agreement and remaining alert to indications that there is a shift in the value received from the coaching relationship;
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• Protecting the health, safety and welfare of the client by making appropriate referrals when necessary; and
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• Continuing in the development of the coach’s professional skills.Footnote 71
Although more robust than the ACSM ethical guidelines, the NBHWC Code of Ethics offers little to no guidance about billing and other business practices; just like the ACSM code of ethics, no explicit accountability mechanism exists for coaches who do not adhere to the code.Footnote 72
Despite ICE accreditation and NBHWC approval of a few wellness training programs, there is no enforcement authority or overarching, consensus-based wellness authority at the state or national level that can provide assurance to consumers, employers, and insurers that wellness practitioners are held to enforceable standards of competence and ethics. Moreover, programs accredited or approved by ICE and NBHWC do not capture the universe of wellness practitioners. As noted above, the wellness industry is vast and fragmented. Having standards that apply to all those who identify as “wellness practitioners” would give consumers, employers, and insurers a valuable resource to determine the quality of the wellness services offered.
2. Who Hires?
Wellness practitioners can work independently for corporations as part of a corporate wellness program, insurance brokers,Footnote 73 health care providers,Footnote 74 fitness centers and health clubs,Footnote 75 or startup companies.Footnote 76 Again, unless a company hiring wellness practitioners requires certain credentials to obtain employment, there are no current legal or market-based requirements to which a wellness practitioner must adhere before calling themselves a “wellness practitioner” or working as one. According to a 2022 report on employee wellness industry trends, seventy-six percent of companies are investing in more stress management and resilience resources for their employees.Footnote 77 A Forbes article advises employers interested in investing in such resources to hire a “wellness consultant” or “chief wellness officer,” which could be a “certified health coach” or some other “board-certified practitioner.”Footnote 78 Based on the disorganized and unregulated nature of the wellness industry, employers have little guidance to determine whether someone who calls themselves a “wellness consultant” or “certified health coach” is competent or ethical. And yet, reputable organizations like Forbes encourages employers to seek out such individuals to help employees with stress and resilience.
3. Who Insures?
A number of professional liability insurers offer coverage to a wide variety of wellness practitioners, including CPH & Associates,Footnote 79 Alternative Balance,Footnote 80 Healthcare Providers Services Organization (HPSO),Footnote 81 and CM&F Group.Footnote 82 One insurer confirmed that they have no criteria or standards by which to measure a wellness practitioner’s qualifications and insurability risk.Footnote 83 This insurer expressed significant interest in the creation and adoption of wellness practitioner standards.Footnote 84
Another liability insurer has a client “code of ethics” with which insureds are expected to comply or face nonrenewal of their policy.Footnote 85 But, like the ethical codes for ACSM and NBHWC, this code is not comprehensive and omits guidelines regarding referrals to licensed practitioners, ethical business practices, and misrepresentation of services or credentials.Footnote 86 Importantly, this insurer’s code applies only to those practitioners who self-select into holding a policy with this insurer. Also, consumers harmed by a wellness practitioner covered by this insurer have no recourse because the insurer is not a neutral arbiter of such a dispute. An insurer’s duty and incentive are to defend the insured. Furthermore, no law requires wellness practitioners to obtain professional liability insurance. As a result, those who choose to purchase liability insurance are more likely to be risk averse and steer clear of engaging in harmful conduct. Thus, more comprehensive, national standards are necessary to capture the wider market of “wellness practitioners.”
4. Who Polices?
As already noted, much of the wellness industry is unregulated. Although some wellness certification or membership organizations offer consumers a complaint procedure, such processes appear rare, narrowly applied, and scattered.Footnote 87 There is some policing of wellness activity at the federal level through the Federal Trade Commission (FTC) and the FDA, but that too is limited. For example, the FTC recently issued almost 700 warning letters to wellness companies that were making unsubstantiated claims about their products curing, mitigating, or treating serious diseases like cancer or heart disease.Footnote 88 The FDA Office of Criminal Investigation has brought cases against rogue wellness practitioners and companies, such as medical spas, for illegally obtaining drugs from China.Footnote 89
Enforcement actions by the FDA or FTC do not directly address scope of practice, business practices, or ethical conduct by wellness practitioners, particularly when the wellness practitioner only offers services and does not sell products. Nearly all states prohibit the unlicensed practice of medicine, psychology, and dietetics.Footnote 90 These three licensed disciplines present the most legal risk for wellness practitioners because services permitted within those scopes of practice are often services that wellness practitioners would also like to offer, such as treatment of a client’s physical or mental health condition or advice on diet and nutrition.Footnote 91 Although it is illegal to practice medicine without a license,Footnote 92 a recent survey of thirty-one state medical boards revealed that most do not police the unlicensed practice of medicine. The survey asked the medical boards if they were aware of any cases of the unlicensed practice of medicine by wellness practitioners and, regardless of their response, whether they had any desire to take action against those practitioners; responses are summarized in Table 1.Footnote 93
Table 1. State Medical Board Survey Results Regarding Actions Taken Against Unlicensed Wellness Practitioners
These survey findings suggest that state medical boards lack the interest or capacity to police the unlicensed practice of medicine. As a result, the wellness industry may benefit from having its own mechanism to hold practitioners accountable when engaging in unethical business practices or practicing outside of the scope of any certification. Consumers can police wellness practitioners through legal action; Part II highlights a few such cases. But lawsuits are often cost prohibitive and ineffective at creating lasting change,Footnote 94 particularly because there are no authoritative standards by which to measure wellness practitioners’ duties to their clients. Creating universally accepted standards could help consumers, employers, and insurers evaluate the financial risk of litigation as well as the quality and legitimacy of wellness practitioners.
Part II: Why the Health and Wellness Industries Should Embrace Wellness Professional Standards
There are several reasons why both the health care and wellness industries should embrace wellness practitioner standards. First, in the absence of systematic data collection about wellness outcomes, anecdotal evidence indicates that some wellness practitioners physically, mentally, and financially harm their clients. Wellness standards could more clearly distinguish between health care and wellness and thereby keep patients safe. Second, there is currently no way for consumers, insurers, and employers to confidently judge the qualifications of wellness practitioners — or even the scope of practice of those practitioners. At the moment, many wellness practitioners and companies largely use “wellness” as a marketing gimmick rather than a legitimate method of improving well-being. This harms consumers as well as practitioners concerned with the legitimacy and respectability of their work. Third, creating wellness standards can preempt state government regulation and thus maintain the regulatory flexibility upon which so many in wellness depend.
A. Wellness Harms
Despite limited enforcement by state licensing boards, there is evidence of physical, emotional, and financial harm to individuals by the wellness industry. Indeed, one recent study investigated alternative health care harms, many of which occur within the unregulated wellness industry. The researchers gathered information on alternative health care services, including homeopathy, ayurvedic medicine, reflexology, hydrotherapy, herbal remedies, supplements, diets, aromatherapy, detoxification therapies, meditation, hypnotherapy, and yoga.Footnote 95 The researchers identified numerous direct and indirect harms, included below in Table 2.Footnote 96 Other evidence of harm by wellness practitioners include: false advertising about services offered;Footnote 97 not responding to client requests for help;Footnote 98 administering medical spa treatments (e.g., Botox) without physician oversight;Footnote 99 having sexual relations with clients;Footnote 100 taking financial and emotional advantage of clients and accepting financial gifts from clients;Footnote 101 and promoting sexual conversion therapy to clients struggling with their sexuality and expressing suicidal tendencies.Footnote 102
Table 2. Examples of Wellness Harms and Standards to Address Those Harms
1. Standards Can Reduce Consumer Harm
Table 2 incorporates the non-exhaustive harms identified from the sources above and proposes standards that could be established to mitigate these harms.
It is not only the incidents of harm that should cause an outcry for wellness practitioner standards, but also the wellness industry’s emphasis on personal responsibility as the predominant path to achieving wellness. Many wellness practitioners and programs are oblivious to the role social and structural determinants play in achieving wellness.Footnote 118 This is because it is easier to blame individuals for poor health status and to place responsibility on them to improve their status than it is to zoom out and address the “underlying social determinants of health and structural inequalities that precipitate poor health.”Footnote 119
Standards can foster wellness practitioner awareness of the social, political, legal, and environmental barriers that prevent many people from attaining wellness, such as systemic racism, food deserts or food swamps, unsafe neighborhoods, and poverty. They can also reduce the shame and guilt wellness consumers may feel when interacting with wellness practitioners. The tendency to blame the consumer for making poor choices without accounting for environmental factors beyond the consumer’s control can cause harmful feelings of shame and guilt, undermining a consumer’s wellness rather than improving it.
Moreover, standards for wellness practitioners can help ensure that wellness consumers receive referrals to conventional health care providers when necessary. Wellness services should be complementary to traditional health care, not a substitute for it. Both wellness practitioners and consumers must learn to respect the difference between health care services and wellness services and use each appropriately.Footnote 120 While the U.S. health care system is rife with problems, it still offers evidence-based care that can save lives. For example, as pointed out by author Rina Raphael:
Steve Jobs shunned what might have been timely and lifesaving cancer surgery in lieu of alternative therapies and a strict vegetable diet. (Jobs had a rare form of pancreatic cancer, a neuroendocrine tumor, which is less lethal than the more common forms of pancreatic cancer.) He died at age fifty-six. His biographer, Walter Issacson, reported that he later regretted his rejection of orthodox medical treatment.Footnote 121
The proposed standards in Table 2 are not meant to be exhaustive or authoritative, but rather a starting point. The intent of Table 2 is to evoke alarm that such basic standards, often found in state licensing statutes for licensed health care professionals, do not currently exist in the broader wellness industry, despite the evidence of harm that occurs. The method by which the wellness industry can create more comprehensive and authoritative standards is discussed further in Part III.
2. Standards Can Help Consumers, Insurers, Courts and Employers Know Who (and What) to Trust
The lack of standards in the wellness industry not only permits consumer harm to occur more frequently, but also creates uncertainty and confusion for wellness consumers, practitioners, insurers, courts, and employers about whom and what to trust. Standards have the potential to offer reliable guidance for these stakeholders. For example, standards can offer helpful guideposts on what wellness practitioners can and cannot do.Footnote 122 They set proper expectations for wellness industry consumers and a benchmark by which courts can measure whether the wellness practitioner acted appropriately.Footnote 123 For insurers and employers, standards can help determine whether the practitioner is a safe risk to insure or hire.Footnote 124
The appetite for wellness industry standards is palpable, especially by professional liability insurers. For example, the chief executive officer of one professional liability insurance company that insures about 5,000 wellness practitioners stated that their current professional liability insurance application is uncomfortably limited in the information it gathers about the qualifications and competence of wellness practitioners.Footnote 125 The threshold question on the insurance application is whether the wellness practitioner’s certification or training is currently valid.Footnote 126 If the answer is “no,” then the insurer asks if any training or certification is needed in their state to practice.Footnote 127 As discussed above, because most wellness practices are unregulated, the answer to that question will most always be “no.” This means that the liability insurer has no way of knowing if the applicant is a good insurance risk. The same can be said for employers that hire wellness practitioners or place them inside a workplace wellness program. Because there are no universally accepted standards for wellness practitioners, employers are uncertain whether wellness practitioners are qualified or competent.Footnote 128 Even if a wellness practitioner has a certification, it is challenging for an employer to judge the quality of that certification because no overarching accreditation body has stepped up to oversee the wellness industry.Footnote 129
3. Standards Can Address Preventive Service Concerns After Braidwood v. Becerra
The Northern District of Texas court decision in Braidwood v. Becerra has placed into jeopardy many preventive services that the ACA requires insurers to cover at no cost.Footnote 130 The rationale for this decision is that the ACA requires insurers to cover preventive services that the USPSTF recommends.Footnote 131 The Braidwood Court concluded that the USPSTF members are not properly appointed under the Constitution.Footnote 132 Because they are not properly appointed, health plans should not be required to adopt their recommendations.Footnote 133
Opponents of the Braidwood decision fear that if upheld by the Supreme Court, insurers, including employer-based plans, will no longer offer preventive services or, at a minimum, require cost-sharing. An amicus brief surmises that the “District Court’s decision to vacate all agency actions taken to implement the USPSTF’s recommendations since the enactment of the ACA, and to enjoin enforcement of all future recommendations will allow insurers to either drop preventive care coverage altogether or to reintroduce cost sharing for all preventive services.”Footnote 134 Economists have pointed out that prior to the ACA, comprehensive free preventive coverage was extremely limited because it is not in insurers’ interest to make a long-term economic investment in members’ health.Footnote 135 Eliminating the ACA preventive services provision will lead to a decrease in use of preventive services within the traditional health care system.Footnote 136 As noted previously, consumers are already disappointed and frustrated that traditional health care is not focused enough on prevention.Footnote 137 Upholding the Braidwood Court’s decision to eliminate (or at least undermine) the preventive service requirement under the ACA will likely accelerate use of the wellness industry for preventive care. With this prospect in mind, creating standards for the wellness industry is even more urgent and important.
4. Standards Can Preempt State Action
Because there is evidence of harm by wellness practitioners, and because many people use wellness services to replace conventional health care, eventual government interest in regulating wellness is not only possible, but likely.Footnote 138 State governments are not afraid to add occupations to their licensure statutes. States have created, or have tried to create, licensure requirements for occupations that are not even close to being as potentially harmful as many wellness services. For example, some states engaged in licensing battles for florists, tour guides, bartenders, interior designers, pest exterminators, African-style hair braiders, and house painters.Footnote 139
Moreover, states are not slowing down their rush to license occupations. According to a joint 2020 report by the National Conference of State Legislatures, the National Governors Association, and the Council of State Governments, occupational licensing has grown exponentially over the last sixty years, “comprising nearly 25% of the U.S. workforce, up from 5% nearly 60 years ago.”Footnote 140 Importantly, the report also points out that this increased interest in state occupational licensing has made practicing these licensed occupations in multiple states challenging because of varying licensing requirements.Footnote 141 Increased licensing has also created barriers to work for certain populations, such as those with lower incomes.Footnote 142 Given this growing interest by states in occupational licensing, it is not outlandish to assume that wellness practitioners may be next. Indeed, one researcher has already predicted that complementary and alternative medicine (or “wellness”) activities will be “forced to become more regulated,” warning the legal system to prepare itself for wellness provider malpractice claims and that, in order to do so, it must define the standard of care for those providers.Footnote 143
The call to action in this article is for the wellness industry to collaborate to create universally accepted, national standards to keep state licensure at bay so that wellness practitioners can escape the state-by-state licensing landmines that currently exist in health care. Adopting a national framework will allow wellness practitioners to practice nationally using telehealth rather than subjecting them to the burdensome fifty-state licensing framework, which is outdated given the abundant virtual platform technologies upon which so many people now rely.Footnote 144 Specifically, telehealth use is hampered by state licensure requirements, whose statutes require health practitioners to be licensed in each state where a patient resides.Footnote 145 It is impractical and expensive for most health practitioners to seek licensure in all fifty states. And yet, for many licensed professions, that is necessary to practice their licensed profession using modern telehealth technology.Footnote 146
Creating universally accepted, national standards for wellness can also help the industry avoid price increases for consumers that would inevitably occur under a state licensing model.Footnote 147 Licensing has been shown to increase barriers to entry that adversely affect those with lower incomes and those who already experience barriers to employment, such as young single moms, the formerly incarcerated, and people with disabilities.Footnote 148 This is because licensing leads to higher wages for licensed workers but lower wages to those who are denied access.Footnote 149 The result is higher prices for consumers.Footnote 150 Industry-created national standards could find a better balance between ensuring wellness professional quality and competence through standards while still allowing more people to enter the wellness field than would be possible through licensing. Given the wellness industry’s lack of diversity, access to the field of practice remains an important consideration when crafting controls for the industry.
Standards can also help create a more systematic reporting mechanism regarding consumer harm in the wellness industry and help with data collection. As observed by researchers who tried to study harm in the “alternative health care” industry (which is arguably synonymous with the wellness industry because most of the alternative treatments overlap with wellness services), “no systematic reporting frameworks existed and much of the activity occurred in private practice or was undocumented.”Footnote 151 If the wellness industry wants to maintain as much flexibility as possible and avoid the burdensome fifty-state regulatory landscape that currently exists in health care, then it must preempt government action by creating its own standards.
Part III: Developing Wellness Practitioner Standards Using a Soft Law Model
Although Part II of this Article provides some ideas for what standards might look like to address the harms known to result from some wellness practitioner conduct, the process for developing authoritative, industry-accepted standards should include industry stakeholders if the standards are to be adopted widely. To avoid the patchwork of regulatory landmines within the state licensure system while facilitating national practice through telehealth, this process should rely on a “soft law” model such as SDOs.
A. What Is “Soft Law?”
According to one recent article, when it comes to managing the consequences that can arise from an industry or technology, “society has two alternatives at its disposal.”Footnote 152 The first is traditional government regulation or “hard law.”Footnote 153 Hard law can “force entities to behave in a particular manner through the monopoly power that society has assigned to public authorities.”Footnote 154 For purposes of managing the consequences from the wellness industry, state licensure would be a hard law approach.
The second alternative is “soft law” programming, a governance tool that industry stakeholders can use to define substantive expectations that are not directly enforceable by the government.Footnote 155 According to one scholar, soft law approaches are advantageous over hard law approaches because they avoid legislative gridlock and judicial review, making them more adaptable over time.Footnote 156 Compliance costs are lower because of soft law’s voluntary nature, and there is more legitimacy to the governance mechanism when numerous industry stakeholders voluntarily comply.Footnote 157 Voluntary stakeholder involvement also facilitates innovation and can help diffuse best practices within the industry.Footnote 158 The voluntary nature of soft law governance encourages competition from different standards, producing a “‘race-to-the-top’ effect, leading either to the survival of the most credible system or at least fostering increased rigor across competitors.”Footnote 159 Finally, soft law governance may reinforce hard law by providing hard law standards and benchmarks by which to measure compliance.Footnote 160
Louise Trubek notes that soft law can encourage mutual cooperation among competing stakeholders to exchange knowledge and foster consensus, as well as increase data collection and systemization.Footnote 161 It can also create informal processes to resolve grievances and disputes.Footnote 162 Soft law approaches to resolving grievances and disputes can be superior to malpractice litigation to improve quality.Footnote 163 Trubek observes, “The random selection of cases, the high cost of litigation, and the resistance of health care institutions to use the information gained in lawsuits are all problems with malpractice litigation.”Footnote 164 Given these advantages, and the disadvantages of an impractical state licensure scheme that prevails in traditional health care, this Article advocates for a soft law approach to create and implement standards for wellness practitioners. Although “soft law programs come in a variety of shapes, sizes and roles,”Footnote 165 one type of soft law program is an SDO, the basic principles of which the wellness industry could adopt.
B. Standards Development Organizations (SDOs)
Federal law defines an SDO as a nongovernmental voluntary consensus standards body, as defined in section 2(e) of the Office of Management and Budget Circular A-119, that adheres to the American National Standards Institute (ANSI) Essential Requirements for Due Process for American National Standards.Footnote 166 A voluntary consensus standards body is a type of association, organization, or technical society that plans, develops, establishes, or coordinates voluntary consensus standards development using a process that includes: (1) openness and transparency, with meaningful opportunities for interested parties to participate; (2) meaningful involvement from a broad range of parties with no single interest dominating the decision-making; (3) due process with regard to publicly available policies and procedures, adequate notice of meetings and standards development, sufficient time to review drafts and prepare objections, access to views and objections from participants and a fair and impartial process for resolving conflicting views; (4) an appeals process; and (5) consensus (which does not necessarily mean unanimity).Footnote 167
According to ANSI, SDOs in the United States are generally private-sector, not-for-profit organizations that typically receive funding through membership, publication sales, and certification services, or some combination of the three.Footnote 168 They are not typically subsidized by the federal government and tend to focus on developing standards that fit a particular market need.Footnote 169 To allow competitors in the marketplace to create consensus-based standards, the Standards Development Organization Advancement Act of 2004 (SDOAA) extended antitrust protections to SDOs provided by the National Cooperative Research and Production Act of 1993 (NCRPA).Footnote 170 The NCRPA affords certain antitrust protections to joint ventures engaged in research, development, and production.Footnote 171 The SDOAA expanded the NCRPA to include SDOs.Footnote 172 SDOs and other joint ventures interested in limiting possible antitrust damage exposure must file a notification with the Antitrust Division of the Department of Justice (DOJ) and the FTC.Footnote 173
Some SDOs have taken advantage of the SDOAA protection. For example, the Gap Year Association (GYA) is a national non-profit member association that works to coordinate the growing gap year movement for young adults trying to navigate life after high school.Footnote 174 It is an SDO recognized by the DOJ and FTC.Footnote 175 GYA’s work revolves around four core areas: (1) research; (2) equity and access; (3) resources; and (4) standards and accreditation. Footnote 176 GYA also conducts surveys and systematic data collection, promotes scholarships and inclusivity within the gap year community, and provides professional development opportunities for gap year professionals.Footnote 177 GYA’s standards cover the following areas:
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• Philosophy and Integrity: includes having experiential pedagogical elements, staff training, financial responsibility, admissions, student supervision, insurance, and incident reporting; gap year program materials must reflect actuality of the programs offered; must have cross-cultural awareness.
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• Backcountry/Remote Area Risk Management: includes standards around risk management in locations where emergency medical care is more than two hours away, and/or in other remote/under-resourced areas; medical kits, supervisory support and training, and membership in the Overseas Security Advisory Council (OSAC).
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• Service-Learning or Community-Based Learning: must include the community served in planning; must have supervisory training.
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• Independent Student Learning and Internships: must include independent learning, student preparation, internship vetting, and contingency plans.
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• Partnerships: must include clear and documentable understanding of who is responsible for what if the gap year program outsources activities and ensure that GYA’s standards are continued throughout all partnerships.Footnote 178
Gap year programs that meet these standards can receive an accreditation “seal of approval” from the GYA.Footnote 179 Such a seal of approval could give comfort to parents before they entrust their children to gap year organizations and invest thousands of dollars in them.
C. The Case for a Wellness SDO
Similar to how GYA’s standards can offer assurance to nervous parents, wellness practitioner standards can offer assurance to consumers, employers, and insurers. The wellness industry could create its own standard setting organization, a “wellness SDO,” similar to GYA for the gap year industry. Existing credentialing organizations within wellness like ICE, ACSM, and NBHWC are not set up as SDOs particularized for the broader wellness industry; as noted earlier, their standards are not comprehensive and do not address the behaviors or needs of the various types of wellness practitioners.Footnote 180 There is no evidence that these organizations adopt the voluntary consensus standards development process for wellness practitioner stakeholders.
Moreover, ICE does not create professional standards, but rather only accredits some wellness certification programs. ACSM and NBHWC have created some professional standards, but they are not comprehensive, do not use typical SDO processes, and provide no grievance or dispute resolution component should violations of standards occur. As a result, there is room for another standard setting organization that is willing to adopt an SDO, consensus-based approach specifically to wellness practitioner standard creation.Footnote 181 The biggest challenge will be finding or creating such an organization to take on this responsibility.
1. Encouraging Compliance
Several mechanisms would encourage wellness practitioners to comply with the wellness SDO standards. First, adopting the SDO processes involves an inclusive and transparent standard development process, which promotes buy-in from the industry, including wellness practitioners themselves. Second, industry buy-in increases the likelihood that industry stakeholders like employers, insurers, and wellness certification programs will incorporate the standards into their processes. For example, ICE, ACSM, and NBHWC may incorporate the consensus-based standards as part of their membership or accreditation requirements. Employers may require wellness practitioners to adopt the standards as a condition of employment. Liability insurers may require the standards as a condition of insurance, or at least offer a premium discount if the wellness practitioner meets the standards.Footnote 182 Third, the wellness SDO could serve as a resource to consumers who have been harmed by wellness practitioners by offering a grievance process and a publicly available list of practitioners who have been found to violate the standards.Footnote 183 Finally, the wellness SDO could offer wellness practitioner trainings on best practices and help practitioners understand the importance of meeting the standards from a business, legal, and ethical perspective.
2. Wellness SDO Offers Transparency, Structure, and Legitimacy — Not a Veil
A wellness SDO would clarify expectations for wellness practitioners delivering wellness services, while offering consumers some protections and an outlet for grievances. Until a wellness SDO is created, other types of wellness organizations are stepping in to give some structure and guidance to wellness practitioners, but these organizations do not benefit all stakeholders. For example, Pro Advocate Group is a private membership association that gives “legal cover” under the First and Fourteenth Amendments to “alternative healthcare practitioners” who offer therapies and treatments outside of mainstream medicine.Footnote 184 The group promises to eliminate illegal investigations and sanctions by state licensing boards and to allow the practice of alternative medical modalities without fear of discrimination.Footnote 185 The Professional Wellness Alliance is a similar association that offers its members a “defendable legal basis” to practice holistic health by offering a “professional license” by the “#1 health & wellness ministry in the world.”Footnote 186 Both groups claim to have been in existence for decades.Footnote 187 But, rather than setting standards to improve the quality of wellness services provided to consumers, these groups focus on insulating the wellness practitioner from legal action by using constitutional rights of freedom of speech and exercise of religion as a shield against accusations of practicing a health profession without a license.Footnote 188 A wellness SDO can offer all wellness industry stakeholders an opportunity to be transparent about the purpose of wellness services, which in turn can elevate them and give more legitimacy to the industry.
Conclusion
As with many technological advancements, the law is not keeping pace with the growth of the wellness industry. Much of this growth is fueled by a traditional health care system that is not meeting patient needs, and that deficiency is likely to worsen under Braidwood. Given the increasing number of occupational licenses issued by states and the significant hurdles state licensing requirements present to health care practitioners, the wellness industry should heed the warning signs and act swiftly to create a wellness SDO. This SDO can offer all wellness practitioner stakeholders some guidance and protection, and hopefully give more credibility to those practitioners. A wellness SDO could also serve as a wake-up call to traditional health care providers emphasizing that it is past time to adopt more patient-centered practices, and to the legal industry to recognize wellness law as a necessary legal practice area.
Acknowledgements
The author would like to thank Tara Keever, UMKC Law School 2024 graduate, for her valuable research assistance.
