Three Important Legal Considerations for Complementary and Alternative Medicine Providers

Complementary and Alternative Medicine (CAM) Providers are an essential part of a vibrant health and wellness system. CAM provider disciplines include chiropractic, acupuncture, functional medicine, integrative medicine, spiritual healing, mindfulness meditation, reiki, ayurvedic medicine, massage, and coaching to name a few. CAM providers typically operate outside traditional health care provider systems, such as hospitals or physician clinics. Often, CAM providers are entrepreneurs who go into business to serve patients or clients because conventional medicine has failed those patients or clients. In my experience as a health lawyer who focuses on serving as the attorney for alternative medicine providers, as well as a patient myself, many clients crave CAM provider services.

Because CAM providers often straddle the worlds of traditional health care and alternative health care, they get caught in legal compliance confusion. There are many questions as to whether traditional health care laws apply to CAM providers. The answer of course is that whether traditional health care laws, such as fraud and abuse laws, Medicare and Medicaid coding laws, Food & Drug Administration laws, HIPAA requirements, state licensure laws, to name a few, depends on the facts and circumstances of each case. That’s why it is imperative that CAM providers hire a lawyer who is familiar with the CAM legal landscape. Based on my experience working as a CAM lawyer, here are the top five legal issues I see impacting CAM providers:

  1. Staying within one’s Scope of Practice.

Scope of practice is a concept relating to state licensure. Many CAM providers do not have state licensure, like health and wellness coaches, aryuvedic and reiki practitioners and some naturopathic doctors, to name a few. Other CAM providers, like chiropractors, acupuncturists or functional medicine providers, may have a license to practice their profession in one state, but not other states. With the growth in virtual practice or telehealth, CAM providers may find themselves wanting to expand their services to states in which they do not have a license, or states that do not recognize their practice as a licensed profession.

A legal risk for CAM providers concerns stepping outside of the scope of their license (if they have one), or offering services that creep into a licensed profession (if they do not have that license). In either case, the CAM provider could be accused of unlicensed practice. Specific to many health and wellness professionals, depending on state law and the circumstances, individuals providing nutritional advice potentially could be subject to state prohibitions against unlicensed practice of various professions, including: medicine, psychology and counseling, and nutrition and dietetics.

State statues define the practice of “medicine” very broadly, typically in terms that involve diagnosis, prevention, treatment, or operation with respect to diseases or human ailments.  The courts often interpret words such as “prevention” and “treatment,” broadly.  This means that non-licensed practitioners of the healing arts can easily run afoul of prohibitions against unlicensed medical practice.

In contrast to the “unlimited” scope of medical licensing, CAM providers like chiropractors have a limited scope of practice, which is defined by statute, regulations, and/or case law. For example, typical statutes provide that chiropractors can manipulate the spine to facilitate the free flow of nerve energy; acupuncturists can perform acupuncture needling, and while they have some diagnostic and therapeutic authority, this is limited to the categories and repertoire of traditional oriental medicine.

Some states carve out exceptions to unlicensed practice if the CAM professional follows certain guidelines. For example, anyone in California can provide nutritional advice or give advice concerning proper nutrition, so long as they do not practice “medicine.”[1]  Under this statute, the terms “providing nutritional advice or giving advice concerning proper nutrition” mean the giving of information as to the use and role of food and food ingredients, including dietary supplements.  The individual must post a designated notice “in an easily visible and prominent place” as follows:[2]

 

NOTICE

State law allows any person to provide nutritional advice or give advice concerning proper nutrition–which is the giving of advice as to the role of food and food ingredients, including dietary supplements. This state law does NOT confer authority to practice medicine or to undertake the diagnosis, prevention, treatment, or cure of any disease, pain, deformity, injury, or physical or mental condition and specifically does not authorize any person other than one who is a licensed health practitioner to state that any product might cure any disease, disorder, or condition.”

 

Another carveout in California, or safe harbor, commonly known as “SB 577,” allows unlicensed CAM providers to practice their trade as long as they disclose to the client in a written statement, using plain language, the following:[3]

  1. That he or she is not a licensed physician.
  2. That the treatment is alternative or complementary to healing arts services licensed by the state.
  3. That the services to be provided are not licensed by the state.
  4. The nature of the services to be provided.
  5. The theory of treatment upon which the services are based.
  6. His or her educational, training, experience, and other qualifications regarding the services to be provided.

However, even with this exception, CAM providers should avoid the unlicensed practice of medicine.  As specifically stated in BPC 2053.6(b)[4]:

Nothing in this section or in Section 2053.5 shall be construed to do the following:

  1. Affect the scope of practice of licensed physicians and surgeons.
  2. Limit the right of any person to seek relief for negligence or any other civil remedy against a person providing services subject to the requirements of this section.”

Such licensing exemptions for alternative practitioners may also exist in other states[5], however, other states, such as Florida, may actively pursue unlicensed practitioners of alternative medicine where the state interprets the activity as violating licensing regulations.

Unlicensed practice is a crime, and penalties typically can include imprisonment as well as fines.  For example, in California, it is a misdemeanor to use words such as, “dietetic technician, registered,” “dietitian,” “dietician,” “registered dietitian,” “registered dietician,” “registered dietitian nutritionist,” or the letters “RD,” “RDN,” “DTR,” “or any other words, letters, abbreviations, or insignia indicating or implying that the person is a dietitian, dietetic technician, registered, registered dietitian, or registered dietitian nutritionist or to represent, in any way, orally, in writing, in print or by sign, directly or by implication, that he or she is a dietitian, a dietetic technician, registered, a registered dietitian, or a registered dietitian nutritionist.”  (Business & Professions (“B&P)”) Code, Section 2585(c)).

Legal definitions of each profession vary by state, as do enforcement priorities.

Enforcement

To avoid the unlicensed practice of medicine or psychology, unlicensed CAM providers like coaches should refrain from using diagnostic or therapeutic categories with their clients. For example, sometimes undercover investigators will pose as patients and use diagnostic categories in conversation or session, to see whether practitioners will respond in kind.  The investigator might say that they are clinically obese and need help with nutritional advice. An unlicensed practitioner who responds saying they can cure the client’s obesity could be accused of the unlicensed practice of medicine, for example.

At other times, investigators and prosecutors can search online content as evidence of unlicensed practice. For example, if the practitioner’s website contains the term, “eating disorder,” this could be evidence that the practitioner has treated a disease or psychological condition.  Sometimes, the factual circumstances can give rise to a claim of unlicensed practice—for example, the condition itself suggests that the client is seeking disease care.

The bottom line is that even if you have a disclaimer stating you do not practice a licensed profession, what you actually do and say in your practice matters. If you offer specific advice and guidance to clients based on their specific health needs, you may be wandering into the licensed practice of a profession for which you do not hold a license. Offering specific advice and guidance is often outside the scope of many CAM providers, particularly those without a state-issued license. In contrast, offering education and information is something even unlicensed CAM practitioners can do, so long as the information is not misleading or inaccurate. There generally is a First Amendment, “free speech” allowance for providing information and education, as opposed to clinical guidance. We suggest contacting your CAM lawyer to help you stay compliant and within your scope.

  1. Ordering Labs

Similar to the scope of practice issue, many clients of our firm ask whether they can order labs as a CAM provider. When a CAM provider looks at lab test results or other health history forms and then creates a recommendation or treatment plan based on those results, it could be argued that such conduct is equivalent to “treating” a person for a “disorder” or other physical or mental condition.  The more the CAM provider gives personalized recommendations based on lab results or health history forms, the more likely one could interpret such actions as the practice of a licensed profession for which the CAM provider does not hold a license.

From a legal risk perspective, it is best for unlicensed CAM providers to avoid personalized treatment plans as much as possible and instead offer more generalized education and resources while recommending at all times that the client consult their primary care physician for specific conditions.

  1. HIPAA Compliance

The privacy and security rules of the Health Insurance Portability and Accountability Act (HIPAA) generally have not caught up to CAM practices. This is because many CAM providers do not bill insurance, calling into question the applicability of HIPAA privacy and security rules to the typical CAM practice. HIPAA applies only to “covered entities.” There are three types of covered entities:

  1. Health care providers
  2. Health plans
  3. Health care clearinghouses

The most likely covered entity category for CAM providers is “health care provider.” However, for a health care provider to qualify as a HIPAA covered entity, that provider must also conduct HIPAA “standard transactions” electronically. These transactions are typically associated with electronic billing between the provider and health plans, such as electronic claims submission or prior authorization submissions. Many CAM providers do not bill insurance for their services. Thus, it may be that for many CAM providers, HIPAA privacy and security rules do not apply to their practices. However, states may have privacy and security rules with which the CAM provider must comply, so it is important to work with your CAM lawyer to understand your privacy and security obligations. Even if there are no laws specific to CAM provider practice, your patients will likely expect privacy and security standards similar to HIPAA. So, CAM providers may wish to voluntarily adopt HIPAA privacy and security standards to give their clients more comfort about their use and disclosure of health information.

The federal Department of Health and Human Services has issued a guidance document to help you decide whether HIPAA applies to you.

Contact the Center for Health and Wellness Law, LLC to be your CAM attorney so that your coaching, functional medicine, or alternative care practice can thrive.

 

 

[1] B&P Code, Section 2068.

[2] The statute provides: “The notice required by this section shall not be smaller than 8 1/2 inches by 11 inches and shall be legibly printed with lettering no smaller than 1/2 inch in length, except the lettering of the word “NOTICE” shall not be smaller than 1 inch in length.”

[3] Id., §2053.6.

[4] Id., §2053.6.

[5] We have limited our discussion to California and Florida in consideration of your financial limitations, however, per our previous discussions, that the laws for alternative healers vary from state to state.  Here we use SB577 as the model for disclosures and provide general legal guidance for application in other jurisdictions, and have not researched across states, merely introducing CA and FL rules as an examples.